We published on November 18, 2002 (67 FR 69480), proposed revisions to our regulations entitled “Compliance with Floodplain/Wetlands Environmental Review Requirements” (10 CFR Part 1022), which were promulgated originally on March 7, 1979 (44 FR 12596), to implement the requirements of Executive Order (E.O.) 11988, “Floodplain Management” (42 FR 2951; May 24, 1977), and E.O. 11990, “Protection of Wetlands” (42 FR 26961; May 24, 1977). We also published in our November 18, 2002, Federal Register notice a proposed conforming change to our “National Environmental Policy Act Implementing Procedures” (10 CFR 1021.313).

Publication of the Notice of Proposed Rulemaking began a 60-day public comment period, ending January 17, 2003. Comments were received from three sources: A State, a county, and a member of the public. Copies of these comments are available for public inspection at the DOE Freedom of Information Office Reading Room, Room 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585-0101, (202) 586-3142, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

This document adopts the revisions proposed on November 18, 2002, with certain changes discussed below, and codifies them at 10 CFR parts 1021 and 1022. In accordance with 40 CFR 1507.3, the Council on Environmental Quality (CEQ) reviewed this notice of final rulemaking and concluded that the proposed amendment to the DOE regulations implementing NEPA is in conformance with NEPA and the CEQ regulations. The Secretary of Energy has approved this notice of final rulemaking for publication.

We are revising 10 CFR part 1022 based on our experience implementing the existing requirements for over 20 years. We expect these changes to improve our ability to meet our goals for floodplain and wetland protection in a timely and cost-effective manner. We are revising 10 CFR 1021.313 to conform with 10 CFR 1022.14(c) by allowing floodplain statements of findings to be issued in a final EIS or separately.

The major revisions we are implementing will: (1) Simplify our public notification procedures for proposed floodplain and wetland actions by emphasizing local publication as opposed to publication in the Federal Register, (2) exempt additional actions from the floodplain and wetland assessment provisions of these regulations, (3) provide for immediate action in an emergency with documentation to follow, (4) expand the existing list of credible sources that may be used in determining the location of floodplains and wetlands, and (5) allow floodplain and wetland assessments for actions proposed to be taken under CERCLA to be coordinated with the CERCLA environmental review process rather than the NEPA process. The revisions also will make the rule easier to use by reordering sections to parallel the assessment process, clarifying requirements (such as the differences between floodplain and wetland actions and their respective assessment requirements), and simplifying the rule by deleting provisions that are no longer applicable. The revisions streamline existing procedures and add no new requirements.

We have considered and evaluated the comments received during the public comment period. A number of revisions suggested in these comments have been incorporated into the final rule. The following discussion describes the comments received, provides our response to the comments, and describes any resulting changes to the rule. We also have made editorial and stylistic revisions for clarity and consistency.

In addition to a comment supporting our intent to simplify and restructure the rule, we received one comment objecting to our streamlining effort on the ground that it would make it easier to sabotage environmental protection before the public could know about potential impacts. This comment is speculative. It does not provide any example to show a potentially adverse effect from any of the proposed amendments to the regulations in 10 CFR parts 1021 and 1022. We believe the revised rule will improve our ability to meet our goals for floodplain and wetland protection. We will be able to focus our resources, and those of the public, on the types of proposed actions that our experience demonstrates are most likely to benefit from an examination of alternatives and mitigating measures and increase the efficiency of our environmental reviews (thereby, for example, allowing earlier identification of mitigation actions).

We received a comment pointing to DOE's obligation to comply with the Coastal Zone Management Act, NEPA, and applicable state laws and regulations. We recognize our legal responsibilities and note that it is the intent of the E.O.'s upon which this regulation is based, and the regulation itself, that implementation be coordinated, and when appropriate, integrated with procedures for implementing other requirements, such as those of NEPA. (See §§ 1022.1(b) and 1022.2(b).) We also note that this rulemaking is not a proposal to conduct any activity that would affect any coastal resource. We will comply with 10 CFR part 1022 and all other applicable requirements if we propose any such activity in the future.

Two comments requested clarification of “effects of national concern” as used in determining whether we are required to publish in the Federal Register a notice of proposed action (§ 1022.12(b)) or a floodplain statement of findings (§ 1022.14(e)). In response, we have added a definition to state that effects of national concern are those effects that because of the high quality or function of the affected resource or because of the wide geographic range of effects could create concern beyond the locale or region of the proposed action. The lack of potential effects of national concern does not excuse us from our public notification and participation responsibilities (§§ 1022.3(e), 1022.12, and 1022.14).

One comment recommended that we define terms associated with the exemptions described in § 1022.5(d) to “ensure that the activities contemplated by the proposed rule changes will have only minimal and temporary adverse impacts on the aquatic environment.” We do not believe it is practical or useful to attempt to define all the activities that might fall within the rule's three exemptions. We have, however, added examples for each exemption.

The rule now states that routine maintenance activities (§ 1022.5(d)(1)) are those, such as reroofing, plumbing repair, and door and window replacement, needed to maintain and preserve existing facilities and structures for their designated purpose. We believe that the restrictive conditions stated in § 1022.5(d)(2) and § 1022.5(d)(3) help describe the types of activities that could be exempted, but also have added examples in both sections. For site characterization, environmental monitoring, or environmental research activities (§ 1022.5(d)(2)), the rule now includes the examples of sampling and surveying water and air quality, flora and fauna abundance, and soil properties. For minor modification of an existing facility or structure to improve safety or environmental conditions (§ 1022.5(d)(3)), the rule now includes the examples of upgrading lighting, heating, ventilation, and air conditioning systems; installing or improving alarm and surveillance systems; and adding environmental monitoring or control systems.

We received one comment asking that, when providing public notification, consideration be given to the interest of state government, in addition to local interest, in a proposed action. This has been our practice and is our intent. For clarification, in this final rule, we have added the parenthetical phrase “(e.g., FEMA [Federal Emergency Management Agency, Department of Homeland Security] regional offices, host and affected states, and tribal and local governments)” after “government agencies” in §§ 1022.12(b) and 1022.14(d). Distribution to these parties, and to others as appropriate for a specific proposed action, facilitates public participation.

One comment questioned whether language in § 1022.14(f) would limit distribution of floodplain statements of findings to only those state agencies identified in a particular list of state contacts maintained by the Office of Management and Budget. To clarify our intent to continue to distribute statements of findings to parties interested in or potentially affected by a proposed action, in § 1022.14(f) of the final rule, we have added the word “also.” The rule now states that for actions subject to E.O. 12372, “Intergovernmental Review of Federal Programs,” DOE “also” shall send the floodplain statement of findings to the state in accordance with 10 CFR part 1005 (DOE's regulations for implementing the E.O.).

With regard to a comment that DOE must establish contacts and maintain current information on them, DOE Order 451.1B, “National Environmental Policy Act Compliance Program,” requires each DOE Program and Field Office with NEPA responsibilities to have a Public Participation Plan. With regard specifically to state contacts, we established ongoing relationships with State Clearinghouses in 1990 through contact with the Governors, and we update our State Clearinghouse contacts in the “Directory of Potential Stakeholders for Department of Energy Action under the National Environmental Policy Act,” which is distributed broadly within the Department and made available on the DOE NEPA Web site (http://tis.eh.doe.gov/nepa/guidance.html, under “Public Participation”).

One comment opposed our change to allow discretion in whether to include a floodplain statement of findings within a final EIS. We agree with the commenter that information relevant to potential floodplain and wetland impacts is integral to the evaluation of a proposed action and alternatives within an EIS. A final EIS would consider those impacts and mitigations. For example, both the final EIS and the floodplain assessment would evaluate mitigation measures to minimize harm to or within the floodplain. Nonetheless, a floodplain statement of findings may be issued separately as there may be times when it is not appropriate to incorporate the statement within the final EIS (e.g., when steps to be taken to minimize harm are not determined until after the final EIS is issued, or a phased decision involving sequential records of decision is being made and the findings would not be relevant to the initial record of decision). Moreover, E.O. 11988, upon which the floodplain management portions of this regulation are based, does not specify when in the NEPA process the statement of findings should be published, and E.O. 11990, which addresses wetlands protection, does not require a statement of findings. The E.O.'s allow Federal agencies substantial latitude in implementing the requirements as deemed most appropriate for individual agencies.

One comment sought clarification of the conditions under which we could waive time limits between various steps in the floodplain or wetland environmental review process and requested a definition of emergency actions and emergency situations. The rule allows us to alter the floodplain or wetland assessment process in response to emergencies and in some non-emergency situations.

Section 1022.16(a) allows us to take immediate action in the event of an emergency, forgoing the assessment process required by this rule until after the emergency has been addressed. We will continue to determine what constitutes an emergency (an emergency action or emergency situation) on a case-by-case basis, as is consistent with the manner in which an emergency has been declared in the past in regard to compliance with these and other requirements (e.g., NEPA). We have declared only three emergency exceptions to our NEPA procedures in the past 25 years.

Section 1022.16(b) allows shortening the review process in non-emergency situations in response to “statutory deadlines or overriding considerations of program or project expense or effectiveness.” This section does not allow any exception from completing a required floodplain or wetland assessment nor from following any other provision of this rule or any other applicable requirement before taking action. This provision has been in place since we first promulgated our floodplain and wetland environmental review requirements in 1979, and in practice, we have not experienced difficulty in its implementation.

The comment also asked who determines whether a variance is to be granted. The cognizant DOE official responsible for NEPA or CERCLA implementation, as applicable, normally would consult with the Office of NEPA Policy and Compliance pursuant to § 1022.16(c) before determining whether to grant a variance.

Notable among the editorial and stylistic revisions we made are changes to the definitions of “floodplain and wetland values” and “critical action floodplain” in §1022.4. We reorganized the examples of floodplain and wetland values to improve readability.

We have added to the definition of critical action floodplain a clarification that was included in the preamble to this proposed rule in November 2002. This clarification regards when we will consider a flood with an expected frequency of less than once in a 500-year period, and thus a larger floodplain, in evaluating potential impacts associated with a critical action (i.e., any DOE action for which even a slight chance of flooding would be too great). In this final rule, and as proposed, we define a critical action floodplain as “at a minimum, the 500-year floodplain, that is, a floodplain with a 0.2 percent chance of flooding in any given year.” To this, we have added the clarification that when another requirement applicable to the proposed action requires evaluation of a less frequent flood (i.e., a more severe flood that would inundate a larger floodplain), then we may use the less frequent flood to determine the floodplain for purposes of this rule. For example, where the safety basis documentation under 10 CFR part 830 for a proposed action requires consideration of a 100,000-year flood, then the 100,000-year floodplain could be the critical action floodplain for the proposed action for purposes of this rule.

This rule has been determined not to be a “significant regulatory action” under E.O. 12866, “Regulatory Planning and Review” (58 FR 51735; October 4, 1993), as amended by E.O. 13258 (67 FR 9385; February 28, 2002). Accordingly, today's final regulatory action was not subject to review under that E.O. by the Office of Information and Regulatory Affairs of the Office of Management and Budget.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of E.O. 12988, “Civil Justice Reform” (61 FR 4779; February 7, 1996) imposes on Federal agencies the general duty to adhere to the following requirements: Eliminate drafting errors and needless ambiguity, write regulations to minimize litigation, provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Section 3(b) requires Federal agencies to make every reasonable effort to ensure that a regulation, among other things: Clearly specifies the preemptive effect, if any, adequately defines key terms, and addresses other important issues affecting the clarity and general draftsmanship under guidelines issued by the Attorney General. Section 3(c) of E.O. 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the final rule meets the relevant standards of E.O. 12988.

Today's regulatory action has been determined not to be a “policy that has federalism implications,” that is, it does not have substantial direct effects on the states, on the relationship between the national government and the states, nor on the distribution of power and responsibility among the various levels of government under E.O. 13132, “Federalism” (64 FR 43255; August 10, 1999). Accordingly, no “federalism summary impact statement” was prepared or subjected to review under the E.O. by the Director of the Office of Management and Budget.

Under E.O. 13175 (65 FR 67249; November 9, 2000) on “Consultation and Coordination with Indian Tribal Governments,” DOE may not issue a discretionary rule that has “tribal implications” and imposes substantial direct compliance costs on Indian tribal governments. DOE has determined that this rule would not have such effects and concluded that E.O. 13175 does not apply to this rule.

The revisions to the existing regulations have been reviewed under the Regulatory Flexibility Act of 1980 (5 U.S.C.601 et seq.) and related provisions of E.O. 13272, “Proper Consideration of Small Entities in Agency Rulemaking” (67 FR 53461; August 16, 2002) and DOE's procedures and policies (68 FR 7990; February 19, 2003). The Act requires preparation of an initial regulatory flexibility analysis for any regulation that is likely to have a significant economic impact on a substantial number of small entities. Today's revisions to 10 CFR parts 1021 and 1022 amend DOE policies and streamline existing procedures for environmental review of actions proposed in a floodplain or wetland under two E.O.s. The actions would neither increase the incidence of floodplain and wetland assessments nor increase burdens associated with carrying out such an assessment. Therefore, DOE certifies that this rule will not have a significant economic impact on a substantial number of small entities, and therefore, no regulatory flexibility analysis has been prepared. We received no comments on our decision not to prepare a regulatory flexibility analysis.

No additional information or recordkeeping requirements are imposed by this rulemaking. The changes would actually reduce paperwork requirements by eliminating a requirement that public notices always be published in the Federal Register and by increasing the number of exemptions from requirements for preparing a floodplain or wetland assessment. Accordingly, no clearance by the Office of Management and Budget was required under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

DOE has concluded that promulgation of these revisions to existing regulations falls into a class of actions that would not individually or cumulatively have a significant impact on the human environment, as determined by DOE's regulations implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.). Specifically, the revisions to 10 CFR parts 1021 and 1022 would amend DOE's policies to streamline and simplify existing procedures for environmental review of actions proposed in a floodplain or wetland under two E.O.s. The proposed regulations are covered under the categorical exclusion in paragraph A6, “Rulemakings, Procedural” (rulemakings that are strictly procedural) to Appendix A to subpart D, 10 CFR part 1021. Accordingly, neither an environmental assessment nor an EIS is required.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written assessment of the effects of any Federal mandate in a proposed or final agency regulation that may result in the expenditure by state, tribal, or local governments, on the aggregate, or by the private sector, of $100 million in any one year. The Act also requires a Federal agency to develop an effective process to permit timely input by elected officials of state, tribal, or local governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity to provide timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. DOE has determined that the revisions to 10 CFR parts 1021 and 1022 published today do not contain any Federal mandates affecting small governments, so these requirements do not apply.

E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355; May 22, 2001) requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs in the Office of Management and Budget a Statement of Energy Effects for any significant energy action. Today's rule is not a significant energy action, as that term is defined in the E.O. Accordingly, DOE has not prepared a Statement of Energy Effects.

Section 654 of the Treasury and General Government Appropriations Act of 1999 (Pub. L. 105-277) requires Federal agencies to issue a “Family Policymaking Assessment” for any proposed rule that may affect family well-being. This rule has no impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most dissemination of information to the public under guidelines established by each agency pursuant to general guidelines issued by the Office of Management and Budget. The Office ofManagement and Budget guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed today's notice under the Office of Management and Budget and DOE guidelines, and has concluded that it is consistent with applicable policies in those guidelines.

As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of today's final rule prior to the effective date set forth at the outset of this notice. The report will state that is has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2).

The FAA has determined that notice and opportunity for prior public comment is unnecessary because the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance; however, the FAA invites interested persons to participate in this rulemaking by submitting comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On February 25, 2003, Elliott Aviation Technical Products Development, Inc., PO Box 100, Quad City Airport, Moline, Illinois 61266-0100, applied for a Supplemental Type Certificate (STC) to modify Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes. This model series is currently approved under Type Certificate No. A33EU. The Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes are a small category airplane powered by two Airesearch Manufacturing Company TFE731-2-1C turbofan engines, and have a maximum takeoff weight of 18,300 pounds. This airplane operates with a 2-pilot crew and can hold up to 9 passengers. The modification incorporates the installation of Innovative Solutions & Support (IS&S) Air Data Display Units (ADDU) with an IS&S Air Data Sensor and Analog Interface Unit (AIU). The ADDU replaces the existing analog flight instrumentation and provides additional functional capability and redundancy in the system. The AIU is a digital-to-analog adapter used to adapt signals driving the existing Sperry Flight Guidance Computer. The avionics/electronics and electrical systems installed in this airplane have the potential to be vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR 21.101, Elliott Aviation Technical Products Development, Inc. must show that the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A33EU, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The certification basis for the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes includes 14 CFR part 25 as amended by Amendments 25-1 through 25-20, dated February 1, 1964, except for special conditions and exceptions noted in Type Certificate Data Sheet (TDCS) No. A33EU.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25, as amended) do not contain adequate or appropriate safety standards for the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirement of part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 and become part of the type certification basis in accordance with § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should Elliott Aviation Technical Products Development, Inc. apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A33EU to incorporate the same or similar novel or unusual design feature, these special conditions would also apply to the other model.

As noted earlier, the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes modified by Elliott Aviation Technical Products Development, Inc. will incorporate systems comprised of dual Air Data Display Units and an analog interface unit that will perform critical functions. These systems may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes modified by Elliott Aviation Technical Products Development, Inc. These special conditions require that new avionics/electronics and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters, and the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical avionics/electronics and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1, OR 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 kHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths identified in the table below for the frequency ranges indicated. Both peak and average field strength components from the table below are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes modified by Elliott Aviation Technical Products Development, Inc. Should Elliott Aviation Technical Products Development, Inc. apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A33EU to incorporate the same or similar novel or unusual design features, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on the Avions Marcel Dassault-Breguet Aviation Model Falcon 10 series airplanes modified by Elliott Aviation Technical Products Development, Inc. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. Therefore, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2000-09-03, amendment 39-11711 (65 FR 25829, May 4, 2000), which is applicable to certain Boeing Model 747-400 series airplanes, was published in the Federal Register on January 30, 2003 (68 FR 4731). The action proposed to continue to require repetitive tests of the cone brake of the central drive unit of the thrust reversers, and corrective actions if necessary. The action proposed to add new requirements for installation of a thrust reverser actuation system (TRAS) lock and various related modifications and installations. The action also proposed to require, following installation of the TRAS lock, repetitive functional tests of the TRAS lock, and corrective action if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received from a single commenter.

The commenter notes that there are later revisions available for certain service bulletins referenced in the proposed AD. The commenter points out the following:

• Lockheed Martin is now Middle River Aircraft Systems (MRAS).

• Lockheed Martin Service Bulletin 78-1007, Revision 1, dated March 18, 1997, has been superseded by MRAS Service Bulletin 78-1007, Revision 2, dated March 10, 1998.

• Lockheed Martin Service Bulletin 78-1020, Revision 2, dated March 20, 1997, has been superseded by MRAS Service Bulletin 78-1020, Revision 3, dated March 16, 1998; and MRAS CF6-80C2B Service Bulletin 78-1020, Revision 4, dated October 10, 2002.

We infer that the commenter is requesting that we revise the final rule to include references to the later revisions of the service bulletins. We concur and have revised paragraphs (d)(2)(i) and (d)(2)(iii) of this AD to reference the service bulletin revisions cited by the commenter as additional acceptable sources of service information.

The same commenter notes that Boeing Service Bulletin 747-31-2242, dated April 18, 1996, which is cited in paragraph (d)(2)(iv) of the proposed AD, specifies installation of integrated display system (IDS) software version 995-0017-012. The commenter similarly notes that Boeing Service Bulletin 747-45-2016 (Revision 1, dated May 2, 1996), which is cited in paragraph (d)(2)(v) of the proposed AD, specifies installation of central maintenance computer (CMC) software version 685-2270-009. The commenter points out that, since the issuance of those service bulletins, the manufacturer has released several additional software versions. The commenter requests that we include the additional software versions as acceptable parts for the purposes of the proposed AD.

We concur and have added references to acceptable versions of the IDS and CMC software into paragraphs (d)(2)(iv) and (d)(2)(v) of this AD, respectively. We note, however, that the manufacturer has delayed release of one of the CMC software versions to which the commenter refers, 685-2270-012. Because we are unable to determine whether that version would be acceptable for compliance with this AD, this final rule does not refer to that version.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

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

Since we issued the proposed AD, we have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 145 airplanes of the affected design in the worldwide fleet. The FAA estimates that 8 airplanes of U.S. registry will be affected by this AD.

The functional test that is currently required by AD 2000-09-03 takes approximately 12 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $6,240, or $780 per airplane, per test cycle.

The installations in Boeing Service Bulletin 747-78-2151, Revision 2, will take approximately 410 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will be provided at no charge. Based on these figures, the cost impact of this requirement on U.S. operators is estimated to be $213,200, or $26,650 per airplane.

The installation specified in Lockheed Martin Service Bulletin 78-1007, Revision 1, or MRAS Service Bulletin 78-1007, Revision 2, will take approximately 60 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will be provided at no charge. Based on these figures, the cost impact of this requirement on U.S. operators is estimated to be $31,200, or $3,900 per airplane.

The installation specified in Boeing Service Bulletin 747-78-2132, Revision 2, will take approximately 223 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will cost between $32,219 and $36,562 per airplane. Based on these figures, the cost impact of this requirement is estimated to be between $46,714 and $51,057 per airplane. The manufacturer may cover the cost of replacement parts associated with this service bulletin, subject to warranty conditions. As a result, the costs attributable to this required action may be less than stated above.

The installation specified in Lockheed Martin Service Bulletin 78-1020, Revision 2, or MRAS Service Bulletin 78-1020, Revision 3 or 4, will take approximately 16 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will be provided at no charge. Based on these figures, the cost impact of this requirement on U.S. operators is estimated to be $8,320, or $1,040 per airplane.

The installation specified in Boeing Service Bulletin 747-31-2242 will take approximately 2 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. The cost of required parts will be negligible. Based on these figures, the cost impact of this requirement is estimated to be $1,040, or $130 per airplane. The manufacturer may cover the cost of replacement parts and labor costs associated with accomplishment of this service bulletin, subject to warranty conditions. As a result, the costs attributable to this required action may be less than stated.

The installation specified in Boeing Service Bulletin 747-45-2016, Revision 1, will take approximately 3 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. The cost of required parts will be negligible. Based on these figures, the cost impact of this requirement is estimated to be $1,560, or $195 per airplane. The manufacturer may cover the labor costs associated with accomplishment of this service bulletin, subject to warranty conditions. As a result, the costs attributable to this required action may be less than stated above.

The functional test that will be required following installation of the TRAS lock would take approximately 12 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this requirement is estimated to be $6,240, or $780 per airplane, per test cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

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

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

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 141-087 for QUEST (moxidectin) 2.0% Equine Oral Gel used for the control of various species of internal parasites in horses and ponies. The supplemental NADA adds a precaution to labeling that the product is for oral use in horses and ponies 6 months of age and older. The supplemental NADA is approved as of May 29, 2003, and the regulations are amended in 21 CFR 520.1452 to reflect the approval and to reflect current format. The basis of approval is discussed in the freedom of information summary.

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

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

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

Fort Dodge Animal Health, Div. of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-216 for QUEST PLUS (moxidectin 2.0%/praziquantel 12.5%) Gel for the treatment and control of various species of internal parasites in horses and ponies. The NADA is approved as of May 14, 2003, and part 520 (21 CFR part 520) is amended by adding new § 520.1453 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning.

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

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

(a) Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(c) Special considerations. See § 500.25 of this chapter.

(d) Conditions of use in horses and ponies—(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.

(2) Indications for use. For treatment and control of large strongyles (Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adults and tissue stages), Triodontophorus brevicauda (adults), T. serratus (adults)); small strongyles (Cyathostomum spp. (adults), Cyathostomum catinatum (adults), Cylicocyclus spp. (adults), Cylicostephanus spp. (adults), Gyalocephalus capitatus (adults), undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae)); ascarids (Parascaris equorum (adults and L4 larval stages)); pinworms (Oxyuris equi (adults and L4 larval stages)); hairworms (Trichostrongylus axei (adults)); large-mouth stomach worms (Habronema muscae (adults)); horse stomach bots (Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars)); and tapeworms (Anoplocephala perfoliata (adults)). One dose also suppresses strongyle egg production for 84 days.

(3) Limitations. For oral use in horses and ponies 6 months of age and older. Not for use in horses and ponies intended for food.

The final regulations that are the subject of these corrections are under sections 457 by the Tax Reform Act of 1986, the Small Business Job Protection Act of 1996, the Taxpayer Relief Act of 1997, the Economic Growth and Tax Relief Reconciliation Act of 2001, the Job Creation and Worker Assistance Act of 2002, and other legislation.

As published, the final regulations (TD 9075) contain errors that may prove to be misleading and are in need of clarification.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Pennsylvania program on July 30, 1982. You can find background information on the Pennsylvania program, including the Secretary's findings, the disposition of comments, and conditions of approval in the July 30, 1982, Federal Register (47 FR 33050). You can also find later actions concerning Pennsylvania's program and program amendments at 30 CFR 938.11, 938.12, 938.15 and 938.16.

By letter dated January 30, 2002 (Administrative Record No. PA 803.23), the Pennsylvania Department of Environmental Protection (PADEP) submitted a comparison of the State regulations at 25 Pennsylvania (Pa.) Code sections 87.151(d), 89.86(e)(2)(ii)(C), and 90.155(d) and the corresponding Federal regulations along with its explanation of why Pennsylvania's regulations are no less effective than their Federal counterparts regarding approval of the configuration and species composition for reclaimed forest land. This letter was submitted in response to the required amendment to the Pennsylvania program codified at 30 CFR 938.16(fff). Following this correspondence, OSM's Harrisburg Field Office, by letter dated February 22, 2002 (Administrative Record No. PA 803.24), submitted a request to the Pennsylvania Department of Conservation and Natural Resource's Bureau of Forestry that it review the regulations at issue. By letter dated March 20, 2002 (Administrative Record No. PA 803.25), the Bureau of Forestry approved the subject regulations. The Bureau of Forestry also noted that it supported the use of native species when practical and discourages the use of invasive species.

We announced our proposal to remove the required amendment in the June 3, 2003, Federal Register (68 FR 33037). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on removing the required amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on July 3, 2003. We received comments from two Federal agencies (the United States Environmental Protection Agency, Region III, and the United States Department of Labor, Mine Safety and Health Administration's New Stanton and Wilkes-Barre Offices). We also received comments from two State agencies (the Pennsylvania Game Commission and the Pennsylvania Historical and Museum Commission, Bureau for Historic Preservation).

Following are the findings we made concerning removing the required amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are removing the required amendment because in the March 20th letter, the Bureau of Forestry stated that it “approve[d] of the Pennsylvania DEP Protection Regulations, particularly the relevant portions of Sections 87.151(d), 89.86(e)(2)(ii)(C), 90.155(d), 90.155(c), 87.155(b)(2), 89.86(e)(2)(ii), and 90.159(b)(2).” The former three regulations approved in the Bureau's letter contain species composition and configuration rules that apply to reclaimed forest land. Because the Bureau has approved the configuration and species composition for reclaimed forest land, as required under 30 CFR 938.16(fff), we have found that Pennsylvania has met the conditions of the required amendment and we are removing it.

We asked for public comments on the amendment (Administrative Record No. PA 803.28), but we did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Pennsylvania program (Administrative Record No. PA 803.28). On July 1, 2003 (Administrative Record No. PA 803.31), the United States Department of Labor, Mine Safety and Health Administration's (MSHA) New Stanton Office wrote to us indicating that the proposed rule did not conflict with any of its rules or regulations. On July 3, 2003 (Administrative Record No. PA 803.30), MSHA's Wilkes-Barre Office wrote to us noting that it had no comments on the proposal.

The Pennsylvania Game Commission (PGC) commented on June 24, 2003 (Administrative Record No. PA 803.29), that it generally approves a species composition that contains a minimum of 75% woody species. However, some endangered and threatened species may require more than 25% of their habitat to be open grassy areas devoid of trees and shrubs. PGC noted that in those cases, it must have the ability to alter the tree to grass ratios. PGC further noted that it supports the recommendations of the Bureau of Forestry and believes that removal of the proposed amendment satisfies the applicable criteria of 30 CFR 732.15.

We believe that the Pennsylvania program currently provides regulations that satisfy PGC's concerns regarding species composition. Pennsylvania's regulations at 25 Pa. Code 87.151(d), 89.86(e)(2)(ii)(C), and 90.155(d) provide that the vegetation configuration and species composition for a postmining land use of fish and wildlife habitat must be established in accordance with guidelines from the Fish and Boat Commission and the PGC. Thus, the program provides for input by the PGC on species composition. In addition, the regulations at 25 Pa. Code 87.138, 89.82, and 90.150 provide protections for threatened and endangered species that require consultation with the PGC. This section also provides additional guidelines for selecting and planting vegetation on areas where the approved postmining land use is fish and wildlife habitat.

The Pennsylvania Historical and Museum Commission, Bureau for Historic Preservation (PHMC) submitted comments on July 3, 2003 (Administrative Record No. PA 803.32). PHMC indicated that removing the referenced amendment will not affect the consideration of cultural resources in the mine reclamation process. PHMC further stated it supported the Pennsylvania Bureau of Forestry recommendation to avoid the use of invasive species which can be harmful to the environment and historic buildings and landscapes.

We agree with PHMC's assessment on removal of the required amendment. With regard to PHMC's comment on invasive species, which reflected the Bureau of Forestry's recommendation, Pennsylvania's regulations are no less effective than the Federal regulations at 30 CFR 816/817.111. The Federal regulations require that the revegetation be comprised of native species or, where necessary to achieve the postmining land use, an approved introduced species; be compatible with plant and animal species of the area, and “meet the requirements of applicable State and Federal seed, poisonous and noxious plant and introduced species laws or regulations.” Similarly, Pennsylvania's regulations at 25 Pa. Code 87.147, 87.149, 89.86, 90.151 and 90.153 also require that the revegetation be of the same seasonal variety native to the area unless an introduced species is necessary to achieve the postmining land use; compatible with animal and plant species; can not be poisonous or noxious species; and must meet the applicable requirements of State and Federal seed and introduced species statutes. Additionally, Pennsylvania informed us in its January 30, 2002 (Administrative Record No. PA 803.23), letter supporting removal of the required amendment that the configuration and species composition for reclaiming forestland is reviewed and approved on a permit-by-permit basis by foresters in its District Mining Offices.

Under 30 CFR 732.17(h)(11)(i) we requested comments on the amendment from EPA (Administrative Record No. PA 803.28). EPA responded on July 17, 2003 (Administrative Record No. PA 803.33), that it has determined that removal of the required amendment at 30 CFR 938.16(fff) would not be inconsistent with the Clean Water Act or other statutes or regulations under its jurisdiction.

Based on the above findings, we are removing the required amendment at 30 CFR 938.16(fff).

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. Pennsylvania does not regulate any Native Tribal lands.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq.).

The Department of the Interior 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.). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the Pennsylvania submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the Pennsylvania submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfounded mandate.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this rule effective less than 30 days after publication in the Federal Register. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

During the start of the Chicago to Saint Joseph sailboat race, the Coast Guard is establishing a safety zone encompassing the starting area. The Coast Guard expects approximately 150 vessels to participate in this event. This safety zone is required to ensure the safety of vessels and spectators from hazards associated with this sailing event. Entry into, transit through or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Chicago or the designated On-Scene Representative. The Captain of the Port Chicago or the designated On-Scene Representative on scene may be contacted on VHF Channel 16.

The safety zone will encompass all waters of Lake Michigan bounded by the arc of a circle with a 1000-foot radius with its center in approximate position 41°52′67″ N; 087°35′24″ W. These coordinates are based upon North American Datum 1983 (NAD 83). All vessels except those officially participating in this event are prohibited from entering the safety zone without the permission of the Captain of the Port Chicago or his on-scene representative.

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

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DOT is unnecessary.

This determination is based on the minimal time that vessels will be restricted from the zone and the zone is in an area where the Coast Guard expects insignificant adverse impact to mariners from the zones' activation.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of commercial vessels intending to transit a portion of an activated safety zone.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The proposed zone is only in effect for 3 hours on the day of the event.

The designated area is being established to allow for maximum use of the waterway for commercial vessels to enjoy the sailboat race in a safe manner. In addition, commercial vessels transiting the area can transit around the area. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Chicago (see ADDRESSES.)

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

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

We have analyzed this proposed rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

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

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

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

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

We have considered the environmental impact of this proposed rule and concluded that, under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1D, this proposed rule is categorically excluded from further environmental documentation. A written categorical exclusion determination is available in the docket for inspection or copying where indicated under ADDRESSES.

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

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

For the duration of the APBA Silver Cup Race, the Coast Guard is establishing a safety zone encompassing the race area to protect participating vessels and spectators from the hazards associated with a power boat race. The Coast Guard expects approximately 30 to 40 vessels to participate in this event. The likely combination of large numbers of recreational vessels and congested waterways could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the race area will help ensure the safety of persons and property of these events and help minimize the associated risks. All persons and vessels shall comply with the directions of the Coast Guard Captain of the Port or the designated On-Scene Representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Chicago or his designated On-Scene Representative and may be reached via VHF radio channel 16.

The safety zone will include all navigable waters of Lake Michigan encompassed by a line connecting the following points beginning at South Pier Head, 43°03.4′ N, 86°15.4′ W; then heading west to 43°03.2′ N, 86°16.2′ W; then south to 43°01.1′ N, 86°15.3′ W; then east to 43°01.4′ N, 86°14.2′ W; then north to 43°03.5′ N, 86°15.0′ W; then back to the point of origin. These coordinates are based upon North American Datum 1983 (NAD 1983).

This temporary rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

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

The Coast Guard certifies under section 605 (b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) that this temporary final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with sec. 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), the Coast Guard offered to assist small entities in understanding this rule so that they can better evaluate its effectiveness and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions, call 1-888-REG-FAIR (1-888-734-3247).

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

The Coast Guard has analyzed this rule under Executive Order 13132, Federalism, and has determined that this rule does not have implications under that Order.

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

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

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

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

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

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

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

A temporary safety zone is necessary to ensure the safety of vessels and spectators from the hazards associated with fireworks display. Based on recent accidents that have occurred in other Captain of the Port zones, and the explosives hazard of fireworks, the Captain of the Port Chicago has determined fireworks launches in close proximity to watercraft pose significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property of these events and help minimize the associated risks. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Chicago or his designated On-Scene representative. The Captain of the Port or his designated On-Scene representative may be contacted via VHF radio Channel 16.

The safety zone will encompass the waters of the Illinois River within the arc of a circle with a 840-foot radius from the fireworks launch site with its center in the approximate position 41°21.2′ N, 088°23.08′ W. These coordinates are based upon North American Datum 1983 (NAD 1983). The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents.

This temporary rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

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

The Coast Guard certifies under section 605 (b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) that this temporary final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with sec. 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), the Coast Guard offered to assist small entities in understanding this rule so that they can better evaluate its effectiveness and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions, call 1-888-REG-FAIR (1-888-734-3247).

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

The Coast Guard has analyzed this rule under Executive Order 13132, Federalism, and has determined that this rule does not have implications under that Order.

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

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

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

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

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

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

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

VA has amended its Schedule for Rating Disabilities, 38 CFR part 4, by revising that portion of the Musculoskeletal System that addresses disabilities of the spine. The intended effect of this action is to update this portion of the rating schedule to ensure that it uses current medical terminology and unambiguous criteria, and that it reflects medical advances that have occurred since the last review. VA published a notice of proposed rulemaking in the Federal Register on September 4, 2002 (67 FR 56509). Interested persons were invited to submit written comments on or before November 4, 2002. We received comments from two commenters, one from the Disabled American Veterans, and one from a VA employee.

We proposed to evaluate spine disabilities under a General Rating Formula for Diseases and Injuries of the Spine that included the following introductory language: “With symptoms such as pain (whether or not it radiates), stiffness, or aching in the area of the spine affected by residuals of injury or disease”. One commenter felt that including this language does not allow raters to take into account the impairment that may result from asymptomatic residuals or sequelae of diseases or injury of the spine and also that the proposed rating formula would not recognize pain as disabling unless it is present in conjunction with ankylosis or limitation of motion, etc. The commenter went on to say that symptoms such as pain, stiffness, and aching should alone or in combination with each other warrant compensable ratings when severe enough to cause disability.

In response to this comment, we have changed the introductory language quoted above to “With or without symptoms such as pain (whether or not it radiates), stiffness, or aching in the area of the spine affected by residuals of injury or disease”. Doing so removes the requirement that there be pain, stiffness, or aching in order to assign any evaluation under the General Rating Formula for Diseases and Injuries of the Spine. Pain alone cannot be evaluated without being associated with an underlying pathologic abnormality. In the case of spine disabilities, it would be rare for pain not to be present. Pain is often the primary factor limiting motion, for example, and is almost always present when there is muscle spasm. Therefore, the evaluation criteria provided are meant to encompass and take into account the presence of pain, stiffness, or aching, which are generally present when there is a disability of the spine.

The prior schedule directed that a vertebral fracture that did not meet the criteria for a 60-percent or higher evaluation would be evaluated on the basis of limited motion or muscle spasm, with 10 percent added for demonstrable vertebral body deformity. Since the term “demonstrable deformity” was not defined, however, this provision was applied inconsistently. We proposed that a 10-percent evaluation be assigned for a vertebral body fracture with loss of 50 percent or more of the height. One commenter felt that this requirement was too stringent.

As we reported in the preamble to the proposed regulation, a recent medical textbook on disability evaluation states that vertebral fractures with loss of height of the vertebral body of 50-percent or less ordinarily do not require surgery, heal uneventfully, and are compatible with the resumption of normal activities after healing (“Disability Evaluation,” 292-3 (Stephen L. Demeter, M.D., Gunnar B.J. Anderson, M.D., Ph.D., and George M. Smith, M.D., 1996)). Furthermore, should a vertebral body fracture with less than 50 percent loss of height prove to be disabling, it may be evaluated based on any specific disabling residuals that are present, such as pain or limitation of motion. In our judgment, the requirement that there be a loss of 50 percent or more of the height of a fractured vertebral body in order to assign a 10-percent evaluation based on deformity alone has a sound medical basis and will promote consistency, and we have made no change based on this comment.

One commenter felt that it is confusing and illogical to list the evaluation criteria for diagnostic codes 5235 to 5242 after diagnostic code 5243. In response, we have moved the General Rating Formula for Diseases and Injuries of the Spine to the beginning of the Spine subsection. For further clarity, we have added the title “Formula for Rating Intervertebral Disc Syndrome Based on Incapacitating Episodes” to the set of evaluation criteria under diagnostic code 5243 and explained that intervertebral disc syndrome may be evaluated under either rating formula, depending on which is more beneficial to the veteran. All other spine diseases and injuries will be evaluated under the General Rating Formula for Diseases and Injuries of the Spine.

We proposed that the language under diagnostic code 5243 be: “Evaluate intervertebral disc syndrome (preoperatively or postoperatively) either on the total duration of incapacitating episodes over the past 12 months or by combining under § 4.25 evaluations under the General Rating Formula for Diseases and Injuries of the Spine along with evaluations for all other disabilities, whichever method results in the higher evaluation.” A commenter felt that the proposed language was confusing and suggested that we revise it.

We agree that the language could be clearer and have revised it to read: “Evaluate intervertebral disc syndrome (preoperatively or postoperatively) either under the General Rating Formula for Diseases and Injuries of the Spine or under the Formula for Rating Intervertebral Disc Syndrome Based on Incapacitating Episodes, whichever method results in the higher evaluation when all disabilities are combined under § 4.25.”

One commenter felt that painful motion, even if the range of motion is normal, should be one of the criteria for a 10-percent evaluation because usually any limitation of motion is due to pain, and we usually give 10 percent for pain on motion, under §§ 4.45 (The joints) and 4.59 (Painful motion).

As discussed above, we developed evaluation criteria that are meant to take pain and other symptoms into account. Therefore, an evaluation based on pain alone would not be appropriate, unless there is specific nerve root pain, for example, that could be evaluated under the neurologic sections of the rating schedule.

The same commenter said there is no need for criteria for a zero-percent evaluation, since § 4.31 (Zero percent evaluations) states that a zero percent evaluation can be assigned in any case when the requirements for a compensable evaluation are not met. On further consideration, and in view of other changes we have made in the General Rating Formula, we agree and have removed the zero-percent criteria.

The commenter also suggested that we add diagnostic codes for pyriformis syndrome, mechanical back pain due to poor posture, and neck strain to the rating schedule.

Pyriformis syndrome, often called pseudosciatica, is characterized by sciatica-like pain. It is regarded as a pain syndrome or a functional syndrome because there is no demonstrable pathology to account for the symptoms. It is a controversial diagnosis because there is no agreement on how to diagnose it, and there is no way to confirm the diagnosis by testing. We have not added this to the rating schedule because its diagnosis is controversial and uncertain.

Section 4.40 indicates that functional loss of the musculoskeletal system may be due to pain when it is supported by adequate pathology. The diagnosis of mechanical back pain is a broad general diagnosis that does not identify an underlying pathologic process to account for the pain. Most mechanical back pain (70%) is due to lumbar strain or sprain, with 10% due to degenerative changes in discs and facets, 4% due to herniated discs, 4% due to osteoporotic compression fractures, and 3% due to spinal stenosis. (http://www.emedicine.com/pmr/topic73.htm). Examiners should be asked to identify the underlying pathologic process causing back pain, and evaluations can then be made under the appropriate diagnostic codes for spine disabilities that are listed in the rating schedule.

We agree that neck strain is a common disability in veterans and have therefore revised the title of diagnostic code 5237 to “Lumbosacral or cervical strain”. We have also revised the heading of the General Rating Formula for Diseases and Injuries of the Spine accordingly.

One commenter suggested we add a note explaining when to use diagnostic code 5320 (for muscle injury of Group XX muscles (spinal muscles)) rather than 5237 (lumbosacral or cervical strain).

In our judgment, such a note is unnecessary. Diagnostic code 5320 is primarily used for evaluating muscle injuries due to wounds caused by gunshots or other missiles, as § 4.56 (Evaluation of muscle disabilities) indicates. Lumbosacral and cervical strain do not stem from wounds but mainly from work or recreational injuries that involve sudden twisting, overuse, improper lifting, etc., sometimes superimposed on mechanical problems such as obesity, postural defects, or anatomical defects (http://users.rowan.edu, The Merck Manual (17th edition 1999, page 504), http://www.bonetumour.org/book, http://www.emedicine.com/sports/topic69.htm). Muscle strains are, therefore, most appropriately evaluated under diagnostic code 5237 (lumbosacral and cervical strain).

VA appreciates the comments submitted in response to the proposed rule. Based on the rationale stated in the proposed rule and in this document, the proposed rule is adopted with the changes noted.

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

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

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

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

Throughout this document wherever “we,” “us,” or “our” is used we mean EPA.

Under the CAA, EPA may redesignate areas to attainment if sufficient data are available to warrant such changes and the area meets the criteria contained in section 107(d)(3) of the Act. This includes full approval of a maintenance plan for the area. EPA may approve a maintenance plan which meets the requirements of section 175A of the CAA. On May 12, 2003, the State of West Virginia submitted a redesignation request and maintenance plan for the Follansbee PM10 moderate nonattainment area. When approved, the section 175A maintenance plan will become a Federally enforceable part of the West Virginia SIP for this area.

On November 15, 1990, the Clean Air Act (CAA) amendments were enacted. Pursuant to section 107(d)(4)(B), the Follansbee area in Brooke County, West Virginia was designated nonattainment by operation of law. The nonattainment classification and designation of Follansbee as a moderate PM10 area was codified in 40 CFR part 81 on November 6, 1991 (56 FR 56848). Prior to enactment of the CAA amendments this area along with a portion of Jefferson County, Ohio near Steubenville was classified as a single Group I PM10 nonattainment area. Under the 1990 CAA amendments, these two adjacent areas were each designated by operation of law as nonattainment areas. Although the State of West Virginia and the State of Ohio worked together to provide an attainment demonstration for both the Follansbee, West Virginia nonattainment area and the Jefferson County, Ohio nonattainment area, each area is treated separately for purposes of redesignation. Specific information on the Jefferson County, Ohio area's redesignation to attainment can be found in EPA's approval of the State of Ohio's redesignation request and maintenance plan for Jefferson County. (See December 11, 2000, 65 FR 77308).

The Follansbee PM10 nonattainment area in Brooke County, West Virginia is bounded on the north by the Market Street Bridge, on the east by West Virginia Route 2, on the south by the extension of the southern boundary of Steubenville Township in Jefferson County, Ohio, and on the west by the Ohio/West Virginia border.

The adjacent Jefferson County, Ohio area is bounded by Market Street (State Route 43) from the West Virginia /Ohio border west to Sunset Boulevard (U.S. Route 22), Sunset Boulevard west to the Steubenville Township /Cross Creek Township boundary, the Township boundary south to the Steubenville Corporation limit, the corporation boundary east to State Route 7, State Route 7 South to the Steubenville Township /Wells Township boundary, the Township boundary east to the West Virginia Ohio border, and North on the border to Market Street.

Section 107(d)(3)(E) of the CAA specifies five requirements that must be met to redesignate an area from nonattainment to attainment as follows:

The EPA has reviewed the redesignation request submitted by West Virginia for the Follansbee nonattainment area and finds that the request meets the five requirements of section 107(d)(3)(E).

For purposes of assessing air quality, monitoring data in both West Virginia and Ohio was reviewed. The monitor in Brooke County, West Virginia has always been located outside the boundary of the nonattainment area but is included in the review to provide an overall picture of air quality in the area. Three monitors are currently operating in the Jefferson County, Ohio area previously described in section II entitled, Geographic Boundaries. The redesignation request is based upon the three most recent years of quality-assured PM10 air monitoring data (1999-2001) available during preparation of the May 12, 2003 submittal. The PM10 NAAQS includes both a daily and an annual standard. An area is attaining the daily and annual NAAQS if there are no violations, as determined in accordance with 40 CFR 50.6 and appendix K, based upon three complete consecutive calendar years of quality assured monitoring data. The daily standard is met if the expected frequency of values above 150 ug/m3 is 1.0 or less. The data must be collected and quality assured in accordance with 40 CFR part 58, and recorded in the Aerometric Information Retrieval System (AIRS) now known as the Air Quality System (AQS).

West Virginia's formal submittal included data from 1990 through 2002. This data shows that the area has not recorded any exceedances of the daily NAAQS in the past decade. The formal redesignation request is based upon data from 1999 through 2001. This data has been quality assured and recorded in AQS. During the 1999 through 2001 time period, there were no actual exceedances of the daily standard, and the average number of expected exceedances is less than 1.0 for the same time period. During 2002, no exceedances were recorded. Therefore, the area has attained and continues to attain the daily NAAQS. During 1999 through 2002 the maximum annual average recorded at these sites was 35 ug/m3. As the annual standard is based on the average annual mean over three years, the area has attained and continues to attain the annual PM10 standard. Since the area has attained the daily and annual NAAQS based upon the most recent three years of quality-assured data available during preparation of the May 12, 2003 submittal, and continues to attain the NAAQS, the first criterion of section 107(d)(3)(E) has been satisfied. West Virginia has committed to continue monitoring in Brooke County in accordance with 40 CFR parts 53 and 58.

On November 15, 1991, West Virginia submitted an attainment plan to EPA consisting of an attainment demonstration and control measures for the Follansbee area. On July 25, 1994 (59 FR 37696) EPA took a limited approval/limited disapproval action on the submittal. EPA fully approved the control measures portion of the plan, but disapproved the attainment demonstration and took no action on the contingency measures with specific regard to section 172(c)(9) of the CAA. On November 22, 1995, West Virginia submitted a revised attainment demonstration, and EPA approved that attainment demonstration on November 15, 1996 (61 FR 58481) but did not take action on the contingency measures. In this rulemaking, EPA is approving the contingency measures submitted on November 15, 1991 as fulfilling the requirements of section 172(c)(9). Therefore, EPA fully approved all applicable requirements of section 110(a)(2)(I) of the Act, including all applicable requirements of part D (relating to nonattainment), which were due prior to the time of the redesignation request.

Part D of the CAA contains general provisions that apply to all nonattainment plans and certain sections that apply to specific pollutants. Before EPA may redesignate the Follansbee PM10 nonattainment area to attainment, the SIP must have fulfilled the applicable requirements of part D. Under part D, an area's classification indicates the requirements to which it is subject. Subpart 1 of part D sets forth the basic nonattainment requirements applicable to all nonattainment areas. EPA designated the Follansbee area of Brooke County as a moderate PM10 nonattainment area on November 6, 1991 (codified at 40 CFR 81.339). Therefore, to be redesignated to attainment, the area must meet the applicable requirements of subpart 1 of part D, specifically sections 172(c) and 176. Section 189(a) of subpart 4 of the CAA also must be met.

Subpart 1 of part D addresses nonattainment areas in general and subpart 4 addresses PM10 nonattainment areas specifically. Except for contingency measures, all the relevant SIP elements required under sections 172(c) and 189(a) including an emissions inventory, Reasonably Available Control Measures (RACM); and an attainment demonstration were approved by EPA on July 25, 1994 (59 FR 37696) and, November 15, 1996 (61 FR 58481). Although contingency measures were contained in consent orders that were fully approved and incorporated into the West Virginia SIP by EPA on July 25, 1994 (59 FR 37696), our approval did not specifically take action to approve them as contingency measures pursuant to section 172(c)(9) at that time. However, as the consent orders' requirements were made part of the Federally approved SIP, if the area had not reached attainment, the additional reductions from these measures would have been implemented. Within 365 days of receiving notice that attainment had not been achieved, the following sources would have implemented additional PM10 emission reductions: Follansbee Steel would have obtained additional PM10 actual reductions of 0.22 lbs/hr and 0.96 tpy; Wheeling Pittsburgh Steel would have achieved additional actual reductions of 6.5 lbs/hr and 28.5 tpy; International Mill Services would have obtained actual reductions of 0.1 lbs/hr and 0.4 tpy; and Koppers Industries would add additional dust control on access roads. Since the area did attain the standard, these measures were not triggered. Given that the Follansbee area did attain the standard and is being redesignated to attainment, it may be argued that the need for EPA to approve these SIP-approved measures as contingency measures specifically pursuant to section 172(c)(9) is moot. Nonetheless, EPA is now approving these measures as meeting the criteria of section 172(c)(9) for contingency measures in order to be clear that the area has a full approved plan for all applicable Part D requirements. The Federal requirements for new source review (NSR) in nonattainment areas are contained in section 172(c)(5). EPA guidance indicates the requirements of the part D NSR program will be replaced by the prevention of significant deterioration (PSD) program when an area has reached attainment and been redesignated, provided there are assurances that PSD will become fully effective immediately upon redesignation. Regulations for the Prevention of Significant Deterioration of Air Quality were approved into the West Virginia SIP on April 11, 1986 (51 FR 12518). Therefore, the PSD program will become fully effective in the Follansbee area immediately upon redesignation.

The Follansbee area was not required to have a transportation conformity budget for PM10. The most significant causes of nonattainment in this area were emissions from steel and industrial facilities in the area and not mobile source emissions. PM10 emissions from public roads contributed 5% or less to the ambient impacts of PM10 in the Follansbee area. Because the PM10 violations had been caused by stationary sources and motor vehicles were not an important contributor to the nonattainment problem, no additional quantitative analysis for transportation related PM10 impacts are required for conformity purposes. While section 176 provides that a State's conformity revisions must be consistent with Federal Conformity regulations promulgated by EPA, given the nature of the area's former nonattainment problem, it is reasonable to interpret those conformity requirements as not applying for purposes of evaluating the redesignation request.

In order to redesignate an area, EPA must determine that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations and other permanent and enforceable reductions. The State's approved 1991 PM10 SIP for the Follansbee area identified the measures to bring the area into attainment. These measures included emission standards and operating restrictions for various sources of PM10. The facilities that were required to implement additional controls were Follansbee Steel Corporation, International Mill Services, Koppers Industries, Standard Lafarge, Starvaggi Industries Incorporated, and Wheeling Pittsburgh Steel Corporation. All of these facilities received reduced allowable emission rates for PM10. All of these sources except for Follansbee Steel Corporation were required to implement new or improved dust control measures. Both Follansbee Steel and Koppers Industries were required to implement “add-on” control equipment to reduce process PM10 emissions.

In addition to these emission reductions, other reductions have occurred since the attainment demonstration inventory was prepared and the modeled demonstration of attainment was performed. The sinter plant at Wheeling Pittsburgh Steel shutdown in 1999 and operations at International Mill Services have also shutdown. The additional emission reductions resulting from these shutdowns are permanent and enforceable given that any reactivation of these facilities would be subject to applicable new source review requirements.

The May 12, 2003 redesignation request demonstrates that actual enforceable emission reductions are responsible for the air quality improvements in the Follansbee area. EPA finds that emission reductions due to the control measures and emission limitations imposed by the SIP-approved 1991 attainment plan and emission reductions due to permanent and enforceable shutdowns have reduced the ambient PM10 levels such that the Follansbee area attained the NAAQS and continues to attain the NAAQS.

Section 175A of the Act sets forth the necessary elements of a maintenance plan needed for areas seeking redesignation from nonattainment to attainment. The plan must demonstrate continued attainment of the applicable NAAQS for at least 10 years after the EPA approves a redesignation to attainment. Eight years after the redesignation, West Virginia must submit a revised maintenance plan which demonstrates attainment for the 10 years following the initial 10-year period. To address potential future NAAQS violations, the maintenance plan must contain contingency measures, with a schedule for implementation adequate to assure prompt correction of any air quality problems. Under section 175A(d), contingency provisions must include a requirement that the State will implement all control measures that were in the SIP prior to redesignation as an attainment area. EPA is approving the maintenance plan for the Follansbee nonattainment area because EPA finds that the submittal meets the requirements of section 175A. The details of the maintenance plan requirements and how the submittal meets these requirements are detailed in the following paragraphs. A maintenance plan must contain the following elements.

(1) An emissions inventory reflective of PM10 emissions in the monitored attainment years;

(2) A maintenance demonstration which is expected to provide adequate assurance of maintenance over the initial 10-year period;

(3) A commitment to continue monitoring in the area;

(4) A method for verifying continued attainment; and

(5) A contingency plan with specific indicators or triggers for implementation of the plan.

The maintenance plan indicates that the attainment inventory is the emission inventory used to perform the modeling demonstration of attainment and provides updates to that inventory for 2001 for sources in the Follansbee nonattainment area. Emissions have declined somewhat in the area due to the previously described shutdowns. Any future increases in emissions and/or significant changes to the stack configurations/parameters from those modeled in the attainment demonstration due to new or modifying stationary sources would be subject to new source review requirements including a demonstration that the NAAQS is protected.

Steel and industrial facilities were the main cause of nonattainment in the area. The attainment demonstration was based upon allowable emission levels for stationary sources impacting the nonattainment area. PM10 emissions from public on-road sources did not play a significant role in nonattainment and their impacts were less than 5% of the PM10 concentrations. Therefore, no conformity budgets are required for Brooke County. Population in the incorporated area of Follansbee (which is larger than the nonattainment area) has increased slightly since 1990 and may experience a minor increase in population over the next ten years. However, population in Brooke County has been decreasing since 1990 and is expected to continue to decline over the next ten years. Manufacturing employment in the metropolitan area which includes Follansbee has been decreasing since 1994, and this decline in manufacturing is expected to continue for the next 10 years. As a result of these factors, PM10 emissions are expected to remain at or below the emission levels used to demonstrate attainment for the next 10 years. The area, therefore, is expected to maintain the PM10 NAAQS for the next 10 years as it has for the past 10 years. Moreover as noted previously, any future increases in emissions and/or significant changes to the stack configurations/parameters form those modeled in the attainment demonstration due to new or modifying stationary sources would be subject to new source review requirements including a demonstration that the NAAQS is protected.

The maintenance plan includes commitments to continue to operate and maintain the monitor located in Follansbee, Brooke County in accordance with 40 CFR parts 53 and 58. Information regarding the State of Ohio's monitoring commitment can be found in EPA's notice approving the maintenance plan for Jefferson County on December 11, 2000 (65 FR 77308).

In addition to reviewing ambient monitoring data in the Follansbee area on annual basis to verify continued attainment, the State of West Virginia will continue to examine the air quality impact of any major new sources or modifications through its approved PSD program. New minor sources will also be evaluated to assure maintenance of the area. In addition the State will review their PM10 inventory every three years.

The maintenance plan contingency measures consist of control measures on source material handling operations and/or potential fuel switching at fuel burning units. The State will track air quality data in the Follansbee area. Upon a determination that three exceedances of the PM10 standard have occurred within a three-year period, the State will notify subject companies that the potential for a violation exists. The companies must then prepare detailed action plans containing specific measures selected from the contingency measures for implementation in the event of a violation. These plans must be submitted to the West Virginia Department of Environmental Protection (WVDEP) within 6 months of notification that the potential for a violation exists, and the plan shall include an implementation timeline such that the final milestone of the plan calls for implementation of the measures no later than 18 months after the company is notified that a violation has occurred. Within 6 months of a violation, the State will enter into consent orders or a legislative rule to incorporate the specific measures and compliance deadlines in the action plans and these measures will be made federally enforceable.

A new maintenance plan must be submitted to EPA within eight years of the redesignation of the nonattainment area, as required by section 175(A)(b). This subsequent maintenance plan must constitute a SIP revision and provide for the maintenance of the PM10 NAAQS for a period of 10 years after the expiration of the initial 10 year maintenance period. The State commits to submit a SIP revision as required by section 175(A)(b).

General SIP elements are delineated in section 110(a)(2) of Title I, part A. These requirements include but are not limited to the following: submittal of a SIP that has been adopted by the state after reasonable notice and public hearing, provisions for establishment and operation of appropriate apparatus, methods, systems and procedures necessary to monitor ambient air quality, implementation of a permit program, provisions for part C, Prevention of Significant Deterioration (PSD), and part D, New Source Review (NSR) permit programs, criteria for stationary source emission control measures, monitoring and reporting, and provisions for public and local agency participation. For the purposes of redesignation, the West Virginia SIP was reviewed to ensure that all requirements under the amended CAA were satisfied through approved SIP provisions for the Follansbee nonattainment area. EPA has concluded that the Commonwealth's SIP for the Follansbee nonattainment area satisfies all of the section 110 SIP requirements of the CAA and that all applicable requirements of part D have been satisfied.

EPA is approving West Virginia's request to redesignate the Follansbee PM10 nonattainment area to attainment because the State has complied with the requirements of section 107(d)(3)(E) of the CAA. In addition, EPA is approving the West Virginia's maintenance plan for the Follansbee area as a SIP revision because it meets the requirements of section 175A. Lastly, we are approving the contingency measures submitted in the November 15, 1991 submittal as meeting the criteria of section 172(c)(9). EPA has prepared a Technical Support Document (TSD) in support of this rulemaking. Copies are available upon request, from the person identified in the FOR FUTHER INFORMATION CONTACT section. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. 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 October 27, 2003 without further notice unless EPA receives adverse comment by September 26, 2003. 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.

You may submit comments either electronically or by mail. To ensure proper receipt by EPA, identify the appropriate rulemaking identification number WV061-6031a in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

A. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

1. E-mail. Comments may be sent by electronic mail (e-mail) to morris.makeba@epa.gov, attention WV-061-6031a. EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly without going through Regulations.gov, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

2. Regulations.gov. Your use of Regulations.gov is an alternative method of submitting electronic comments to EPA. Go directly to http://www.regulations.gov, then select “Environmental Protection Agency” at the top of the page and use the “go” button. The list of current EPA actions available for comment will be listed. Please follow the online instructions for submitting comments. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

3. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in the ADDRESSES section of this document. These electronic submissions will be accepted in WordPerfect, Word or ASCII file format. Avoid the use of special characters and any form of encryption.

B. By Mail. Written comments should be addressed to the EPA Regional office listed in the ADDRESSES section of this document. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at the EPA Regional Office, as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in the official public rulemaking file. The entire printed comment, including the copyrighted material, will be available at the Regional Office for public inspection.

Do not submit information that you consider to be CBI electronically to EPA. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the official public regional rulemaking file. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public file and available for public inspection without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

You may find the following suggestions helpful for preparing your comments:

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. 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 October 27, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action, redesignating the Follansbee, Brooke County, West Virginia PM10 area to attainment and approval of the area's maintenance plan and contingency measures, 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 a Federal or State government agency involved in administration of environmental quality programs. Potentially affected entities may include, but are not limited to:

• Federal or State Government Entity, (NAICS 9241), i.e., Departments of Agriculture, Environment, etc.-

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

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0253. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.-

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.-

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

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on sweet potato, roots at 0.02 parts per million (ppm). This tolerance will expire and is revoked on June 30, 2006. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.-

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.-

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

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.-

Ineffectiveness of registered alternatives in controlling sedges, pigweeds, and other broadleaf weeds has allowed these weeds to flourish and become more problematic each year. Louisiana has declared a crisis exemption under FIFRA section 18 for the use of flumioxazin on sweet potato, roots for control of certain broadleaf weeds. -

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of flumioxazin in or on sweet potato, roots. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on June 30, 2006, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on sweet potato, roots after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.-

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether flumioxazin meets EPA's registration requirements for use on sweet potato, roots or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of flumioxazin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Louisiana to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for flumioxazin, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of flumioxazin and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for residues of flumioxazin in or on sweet potato, roots at 0.02 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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 endpoint. 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. -

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x10-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flumioxazin used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.568) for the residues of flumioxazin, in or on peanuts and soybean seed. Risk assessments were conducted by EPA to assess dietary exposures from flumioxazin in food as follows: -

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For this acute analysis the assumption was made that 100% of the crops with flumioxazin tolerances are treated with flumioxazin. In addition, the assumption was made that all commodities contain tolerance level residues when consumed, with the exception of those with default processing factors. Default processing factors were used for peanuts-butter (1.89x) and for soybeans-sprouted seeds (0.33x). As the exposure and risk estimates were low, no further refinements were made to this analysis.-

ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM® analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For this chronic analysis the assumption was made that 100% of the crops with flumioxazin tolerances are treated with flumioxazin. In addition, the assumption was made that all commodities contain tolerance level residues when consumed, with the exception of those with default processing factors. Default processing factors were used for peanuts-butter (1.89x) and for soybeans-sprouted seeds (0.33x). As the exposure and risk estimates were low, no further refinements were made to this analysis.-

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flumioxazin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of flumioxazin. -

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

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

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

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

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

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flumioxazin is not registered for use on any sites that would result in residential exposure.-

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

EPA does not have, at this time, available data to determine whether flumioxazin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, flumioxazin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that flumioxazin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

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

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

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

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer. -

When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to flumioxazin in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of flumioxazin on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to flumioxazin will occupy 6% of the aPAD for females 13 years and older. In addition, despite the potential for acute dietary exposure to flumioxazin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of flumioxazin in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flumioxazin from food will utilize 4% of the cPAD for the U.S. population, 12% of the cPAD for children 3-5 years old, the subpopulation at greatest exposure and 11% of the cPAD for children 1-2 years old. There are no residential uses for flumioxazin that result in chronic residential exposure to flumioxazin. In addition, despite the potential for chronic dietary exposure to flumioxazin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of flumioxazin in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flumioxazin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed. -

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

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:furlow.calvin@epa.gov.

There are no Codex, Canadian or Mexican maximum residue limits established on soybeans or peanuts.

Therefore, the tolerance is established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on sweet potato, roots at 0.02 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0253 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 October 27, 2003.-

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.-

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.-

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.” -

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. -

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. -

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by the docket ID number OPP-2003-0253, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).--

This final rule establishes a time-limited tolerance under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be potentially affected by this action if you are a Federal or State Government Agency involved in administration of environmental quality programs (i.e., United States Departments of Agriculture, Environment, etc). Potentially affected entities may include, but are not limited to:

• Federal or State Government Entity (NAICS 9241).

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

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2003-0254. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtm_00/Title_40/40cfr180_00.html, a beta site currently under development.

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

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346(a), is establishing tolerances for the combined residues of thiamethoxam and CGA-322704 on hops at 0.10 ppm; bean, succulent at 0.02 ppm; and bean, dried at 0.02 ppm. These tolerances will expire and are revoked on December 31, 2006. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18-related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of FIFRA authorizes EPA to exempt any Federal or State Agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA) of 1996. EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The States of Washington and Idaho requested the use of thiamethoxam on succuelent and dry bean seed to control leaf hoppers. EPA has authorized under FIFRA section 18 the use of thiamethoxam on succulent and dry bean seed for control of leaf hoppers in Washington and Idaho. After having reviewed the submissions, EPA concurs that emergency conditions exist for these States. The State of Oregon requested the use of thiamethoxam on hops to control garden symphylans. EPA has authorized under FIFRA section 18 the use of thiamethoxam on hops for control of garden symphylans in Oregon. After having reviewed the submission, EPA concurs that an emergency condition exists for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of thiamethoxam in or on hops, succulent bean seed and dry bean seed. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances will expire and are revoked on December 31, 2006, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on hops, succulent beans and dry beans after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether thiamethoxam meets EPA's registration requirements for use on hops, succulent bean seed and dry bean seed or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of thiamethoxam by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Washington and Idaho (succulent and dry bean seed) and Oregon (hops) to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for thiamethoxam, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of thiamethoxam and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for the combined residues of thiamethoxam and CGA-322704 on hops at 0.10 ppm; bean, succulent at 0.02 ppm; and bean, dried at 0.02 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

The dose at which no observed adverse effect levels are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. 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.

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

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established for the combined residues of thiamethoxam, in or on a variety of raw agricultural commodities (RAC). The following RAC's have established tolerances: Barley, canola, cotton, sorghum, wheat, tuberous and corm vegetables crop subgroup, fruiting vegetables, crop group, tomato paste, cucurbit vegetables crop group, pome fruits crop group, milk and the meat and meat by products of cattle, goats, horses, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from thiamethoxam in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerence level residues and 100% crop treated.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEMTM analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 nationwide CSFII and accumulated exposure to the chemical for each commodity. The chronic exposure estimates are based on Tier 3 analyses that incorporate anticipated residues and percent crop treated (PCT) for most commodities.

iii. Cancer. Cancer dietary exposure has been estimated using the DEEM-FCID version 1.3. The cancer exposure estimates are based on Tier 3 analyses that incorporate anticipated residues and PCT for most commodities.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will issue a Data Call-In for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

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

The Agency used PCT information as follows: Potatos, 19%; fruiting vegetables, 15%; cucumbers, 5%; melons, 13%; casabas, 44%; crenshaws, 44%; squash, 44%; pumpkins, 44%; apples, 5%; crabapples, 53%; pears, 9%; quinces, 53%; loquat, 53%; barley, 0.1%; sorghum, 9%; wheat, 2%; canola, 55%; cotton, 20%.

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

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

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

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

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

Based on the PRZM/EXAMS and SCI-GROW models, the EECs of thiamethoxam for acute exposures are estimated to be 7.1 parts per billion (ppb) for surface water and 1.94 ppb for ground water. The EECs for chronic exposures are estimated to be 0.43 (non-cancer) and 0.13 ppb (cancer) for surface water and 1.94 ppb for ground water (cancer and non-cancer).

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

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

EPA does not have, at this time, available data to determine whether thiamethoxam has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, thiamethoxam 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 thiamethoxam has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

2. Prenatal and postnatal sensitivity. The developmental toxicity studies indicated no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetus to in utero exposure based on the fact that the developmental NOAELs are either higher than or equal to the maternal NOAELs. However, the reproductive studies indicate effects in male rats in the form of increased incidence and severity of testicular tubular atrophy. These data are considered to be evidence of increased quantitative susceptibility for male pups when compared to the parents.

3. Conclusions. Based on:

i. Effects on endocrine organs observed across species.

ii. The significant decrease in alanine amino transferase levels in the companion animal studies and in the dog studies.

iii. The mode of action of this chemical in insects (interferes with the nicotinic acetyl choline receptors of the insect's nervous system) thus a developmental neurotoxicity study is required.

iv. The transient clinical signs of neurotoxicity in several studies across species.

v. The suggestive evidence of increased quantitative susceptibility in the rat reproduction study, the Agency is retaining the FQPA factor which is l0X.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + chronic non-dietary, non-occupational 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 EPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to thiamethoxam in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of thiamethoxam on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to thiamethoxam will occupy 3% of the aPAD for the U.S. population; 2% of the aPAD for females 13 years and older; 7% of the aPAD for all infants <1 year old; and 9% of the aPAD for children 1-2 years old. In addition, despite the potential for acute dietary exposure to thiamethoxam in drinking water, after calculating DWLOCs and comparing them to conservative EECs of thiamethoxam in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to thiamethoxam from food will utilize 4% of the cPAD for the U.S. population, 8% of the cPAD for all infants <1 year old and 12% of the cPAD for children 1-2 years old. There are no residential uses for thiamethoxam that result in chronic residential exposure to thiamethoxam. In addition, despite the potential for chronic dietary exposure to thiamethoxam in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of thiamethoxam in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Thiamethoxam 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 were previously addressed.

5. Aggregate cancer risk for U.S. population. At the present time, there are no uses of thiamethoxam that will result in non-dietary, non-occupational (i.e., residential) exposures. Therefore, aggregate cancer risk estimates for thiamethoxam address only the food and drinking water pathways of exposure. EECs for thiamethoxam for comparison to the DWLOCs are 1.94 μg/L for cancer scenarios. The Agency does not have aggregate risk concerns when the estimated residues in water are less than the DWLOCs.

For cancer risk, which is estimated for the total U.S. population only, the DWLOC is 2.15 μg/L and assumes a negligible risk level of 3 x 10-6 rather than 1 x 10-6. For risk management purposes, EPA considers a cancer risk to be greater than negligible when it exceeds the range of 1 in 1 million, however the Agency has generally treated cancer risks up to 3 in 1 million as within the range of 1 in 1 million. The DWLOC value indicates that aggregate exposure to thiamethoxam is not likely to exceed the Agency's level of concern as shown in the following Table 4:

EPA recognizes that the active ingredient clothianidin is identical to the thiamethoxam metabolite-of-concern CGA-322704; however, clothianidin has not been classified as a carcinogen and therefore, it has been removed from the cancer assessment.

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 thiamethoxam residues.

Adequate enforcement methodology High Performance Liquid Chromatography using Ultra Violet or Mass Spectrometry (HPLC/UV or MS) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no CODEX, Canadian, or Mexican maximum residue limits that impact this action.

The thiamethoxam label currently contains the following rotational crop restriction: Immediate rotation to any crop on the label or to cucurbit vegetables, fruiting vegetables, cotton, sorghum, corn, wheat, barley, canola, tuberous and corm vegetables, and tobacco. For all other crops, a 120-day plant back interval must be observed. That restriction is adequate to cover the requested section 18 use as a seed treatment for succulent and dried beans. Hops is not rotated and, therefore, does not raise any potential rotational crop issues.

Therefore, the tolerances are established for the combined residues of thiamethoxam and CGA-322704 on hops at 0.10 ppm; bean, succulent at 0.02 ppm; and bean, dried at 0.02 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0254 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 October 27, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3.Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by the docket ID number OPP-2003-0254, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes time-limited tolerances under section 408 of the FFDCA. The Office of Management and Budget 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the [tolerances] in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

• Crop producers (NAICS 111)

• Animal producers (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket. EPA has established an official public docket for this action under docket identification ID number OPP-2003-0279. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_ 00/Title_40/4 0cfr180_00.html, a beta site currently under development.

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

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the insecticide diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its metabolites 4-chlorophenlyurea and 4-chloroaniline (CPU) and (PCA)], in or on wheat and barley grain at 0.05 parts per million (ppm), wheat and barley straw at 0.50 ppm, wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated grain fractions at 30 ppm. These tolerances will expire and are revoked on December 31, 2005. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of (FQPA) 1996. EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The requesting States (Idaho, Montana, and Washington) are experiencing severe outbreaks of grasshoppers in their wheat and barley fields this year. In most areas, densities of grasshoppers have reached 40 or more per square yard, and without the use of diflubenzuron, the Applicants estimate that yield could drop by 50%, resulting in severe crop devastation and significant economic impact to wheat and barley producers in these States. It is believed that the mild winters over the last several years have allowed grasshopper nymphs to survive the winter and multiply more rapidly in the spring, leading to population explosions of grasshoppers to levels of up to 60 grasshoppers per square foot in some cases. The Applicants state that materials registered for grasshopper control either are not effective with populations at the current levels, are toxic to beneficial insects, or provide insufficient residual control, given the outbreak levels of grasshopper infestation. Under the crisis provisions (40 CFR 166.40) of section 18 of FIFRA the Applicants used diflubenzuron on wheat and barley for control of grasshoppers.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of diflubenzuron in or on barley and wheat commodities. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2005, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on barley and wheat commodities after that date will not be unlawful, provided it is demonstrated pursuant to section 408(l)(5) that the residues are the result of the application or the use of a pesticide at a time and in a manner that was lawful under FIFRA, and the residues do not exceed levels that were authorized by these tolerances at the time of that application or use. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues they allow are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether diflubenzuron meets EPA's registration requirements for use on barley and wheat or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of diflubenzuron by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any States other than Montana, Washington, and Idaho to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for diflubenzuron, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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

Consistent with section 408(b)(2)(D) of the FFDCA , EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of diflubenzuron and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of diflubenzuron in or on wheat and barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated grain fractions at 30 ppm.

EPA has received objections to a separate tolerance-setting involving the use of diflubenzuron on pears. These objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although that proceeding remains ongoing, EPA has considered whether it is appropriate to establish the emergency exemption tolerances for diflubenzuron on wheat and barley commodities while the objections are still pending.

Factors taken into account by EPA included how close the Agency is to concluding the proceedings on the objections, the nature of the current action, whether NRDC's objections raised non-frivolous issues, and the extent to which the issues raised by NRDC had already been considered by EPA. Although NRDC's objections are not frivolous, the other factors all support establishing these tolerances at this time. First, the objections proceeding is unlikely to conclude prior to when action is necessary on this petition. [NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA initiated a 60 day public comment period on them in the Federal Register on June 19, 2002 (67 FR 41628) (FRL-7167-7). That comment period was extended until October 16, 2002 in the Federal Register of September 17, 2002 (67 FR 58536) (FRL-7275-3),] and EPA is now examining the extensive comments received. Moreover, NRDC itself submitted further information to the Agency in June 2003, and the Agency is in the process of evaluating that information as well. Second, the nature of the current actions are extremely time-sensitive as they address emergency situations. Third, the issues raised by NRDC are not new matters but questions that already have been the subject of considerable evaluation by EPA and comment by stakeholders. Accordingly, EPA is proceeding with establishing these tolerances for diflubenzuron. EPA has determined at this time that these tolerances rest on a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residues involved. As suggested above, if during the life of these tolerances EPA determines that any experience with, scientific data on, or other relevant information on this pesticide indicates that the residues these tolerances allow are not safe, EPA will take action to revoke the tolerances prior to their otherwise applicable expiration date. The action EPA is taking at this time should not be construed to constitute action on NRDC's aforesaid objections. The Agency continues to consider those objections and information concerning them, including the new information which NRDC submitted in June 2003.

The most recent estimated aggregate risks resulting from the use of diflubenzuron, are discussed in the Federal Register of September 19, 2002 (67 FR 59017) (FRL-7200-4), final rule establishing tolerances for residues of diflubenzuron in/on grass forage, fodder, and hay; peppers; stone fruits; and tree nuts. In that prior action, risk was estimated using anticipated residue (AR) information based on field trial data and percent crop treated (PCT) information for some commodities. Available residue data indicate that the use pattern for these emergency exemptions will not result in residues of diflubenzuron in excess of the following levels: Wheat and barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated grain fractions at 30 ppm.

Therefore, tolerances are being established for these commodities at these levels. The risk assessment related to incremental addition of these items at this level to dietary exposure is discussed below. Refer also to the September 19, 2002 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies in part upon that risk assessment and the findings made in that Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment.

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. A summary of the toxicological dose and endpoints for diflubenzuron for use in human risk assessment is discussed in the final rule mentioned above, published in the Federal Register of September 19, 2002 (67 FR 59017) (FRL-7200-4).

EPA assessed risk scenarios for diflubenzuron under chronic exposures only. Chronic risk estimates were calculated for the residues of toxicological concern, the parent compound of the insecticide diflubenzuron (N-[[4-chlorophenyl)amino]-carbonyl]-2,6-difluorobenzamide) and its metabolites, CPU and PCA. For the chronic analysis, ARs and PCT information for some commodities were also used. An acute dietary exposure analysis was not performed, because there were no acute toxicological endpoints identified (no effects of concern occurring as a result of a 1 day or single exposure). Short-term aggregate exposure, which takes into account residential exposure plus chronic exposure, was not assessed since diflubenzuron is not registered for use on any sites that would result in substantial residential exposure. Intermediate-term aggregate exposure, which takes into account residential exposure plus chronic exposure to food and water was not assessed, because intermediate-term exposure to diflubenzuron would not be expected from the registered and proposed use patterns. Aggregate cancer risk for the U.S. population was assessed, since the metabolite, CPU, is of concern for aggregate cancer risk and could be found in drinking water.

A refined, chronic dietary exposure assessment was conducted for the general U.S. population and various population subgroups using the Dietary Exposure Evaluation Model (DEEMTM) Version 1.3. software with the Food Commodity Intake Database (FCID). The chronic analysis was performed using ARs and PCT information for several registered plant and livestock commodities, and recommended tolerance-level residues and 100% CT information for all proposed commodities. The chronic dietary exposure estimates are below levels of concern (<100% of the chronic population adjusted dose (cPAD)) for that general U.S. population and all population subgroups. The most highly exposed population subgroups are all infants <1 year old and children 1-2 years old (both at 3% of the cPAD).

A cancer dietary exposure assessment from consumption of PCA and CPU was conducted in the previous risk assessment. Based on the submitted metabolism studies, there are two possible sources for dietary exposure to PCA and CPU: Residues in fungi (mushrooms), and residues in animal commodities (milk and liver). As the wheat and barley uses will not result in additional dietary exposure to PCA and CPU, an updated cancer dietary exposure assessment was not needed to support the current section 18 request. The results of the previous cancer analysis indicated that the estimated cancer dietary risk associated with the use of diflubenzuron is below the Agency's level of concern

Dietary exposure from drinking water. For the current use on wheat and barley, a chronic aggregate exposure (food + drinking water) assessment was performed. Acute, short-term and intermediate-term aggregate risk assessments were not performed because an acute dietary endpoint was not selected and there are no registered or proposed non-food uses resulting in significant residential exposure, respectively. A cancer aggregate exposure (food + drinking water) assessment was not conducted because, as mentioned above, the current uses will not result in additional dietary exposure to CPU.

Since EPA does not have ground water and surface water monitoring data to calculate a quantitative aggregate exposure, Drinking Water Levels of Concern (DWLOCs) were calculated. A DWLOC is a theoretical upper limit on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, drinking water, and through residential uses. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, body weights, and pesticide uses. Different populations will have different DWLOCs. EPA uses DWLOCs in the risk assessment process to assess potential concern for exposure associated with pesticides in drinking water. DWLOC values are not regulatory standards for drinking water. To calculate DWLOCs, the dietary food estimates (from DEEMTM-FCID) were subtracted from the population adjusted dose (PAD) value to obtain the maximum water exposure level. DWLOCs were then calculated using the standard body weights and drinking water consumption figures: 70kg/2L (U.S. population and adult male), 60 kg/2L (adult female and youth), and 10kg/1L (infants and children). For chronic dietary exposure, EPA's level of concern is exceeded when estimated dietary risk exceeds 100% of the cPAD.

The chronic drinking water assessment resulted in chronic DWLOCs for the overall U.S. population of 690 parts per billion (ppb), and for all infants (<1 year old) and children (1-2 years) of 190 ppb (the population subgroups with the lowest DWLOC). All chronic DWLOCs were well above the chronic estimated environmental concentration (EEC) for ground water of 0.067 ppb. The chronic DWLOCs were also above the chronic EEC for surface water of 0.32 ppb.

Thus, results of the chronic analysis indicate that the estimated chronic dietary risk associated with the proposed use of diflubenzuron is below levels of concern, and chronic aggregate risk estimates are also below the level of concern.

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 diflubenzuron residues.

Adequate methods are available for the analysis of diflubenzuron, PCA, and CPU in crops. Three enforcement methods for diflubenzuron are published in the Pesticide Analytical Method Volume II (PAM II) as Methods I, II, and III.

There are no Codex proposals, Canadian, or Mexican limits for residues of diflubenzuron on wheat and barley commodities. Therefore there are no compatibility issues associated with the proposed tolerances.

One application per growing season may be made of the pesticide, diflubenzuron, to wheat and barley, at a rate of 2.0 fl. oz. product (0.44 fl. oz. of active ingredient) per acre. Applications may be made by ground or aerial equipment. A preharvest interval of 45 days must be observed, and all label directions on the federally registered label, as well as the section 18 use directions must be followed.

Therefore, the tolerance is established for combined residues of diflubenzuron, and its metabolites CPU and PCA, in or on wheat and barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated grain fractions at 30 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0279 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 October 27, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by the docket ID number OPP-2003-0279, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes time-limited tolerances under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

A. What Is Codification?

Codification is the process of placing a State's statutes and regulations that comprise the State's authorized hazardous waste management program into the Code of Federal Regulations (CFR). Section 3006(b) of RCRA, as amended, allows the Environmental Protection Agency (EPA) to authorize State hazardous waste management programs to operate in lieu of the Federal hazardous waste management regulatory program. EPA codifies its authorization of State programs in 40 CFR part 272 and incorporates by reference State statutes and regulations that EPA will enforce under sections 3007 and 3008 of RCRA and any other applicable statutory provisions.

The incorporation by reference of State authorized programs in the CFR should substantially enhance the public's ability to discern the current status of the authorized State program and State requirements that can be Federally enforced. This effort provides clear notice to the public of the scope of the authorized program in each State.

New Mexico initially received Final authorization effective January 25, 1985, (50 FR 1515) to implement its Base Hazardous Waste Management program. Subsequently, the EPA approved additional program revision applications effective April 10, 1990 (55 FR 4604); July 25, 1990 (55 FR 28397); December 4, 1992 (57 FR 45717); August 23, 1994 (59 FR 29734); December 21, 1994 (59 FR 51122); July 10, 1995 (60 FR 20238); January 2, 1996 (60 FR 53708) as affirmed by EPA in the Federal Register notice published on January 26, 1996 (61 FR 2450)); and March 10, 1997 (61 FR 67474). The EPA incorporated by reference New Mexico's then authorized hazardous waste program effective December 13, 1993 (58 FR 52677); August 21, 1995 (60 FR 32113); November 18, 1996 (61 FR 49265); and July 13, 1998 (63 FR 23224). Effective October 9, 2001 (66 FR 42140), EPA granted authorization to New Mexico for additional program revisions. In this document, EPA is approving a conforming change to the New Mexico regulations at Title 20, Chapter 4, Part 1, New Mexico Administrative code, section 20.4.1.1103, and incorporating by reference the authorized State hazardous waste program in New Mexico. The State's provision at section 20.4.1103 clarifies that references to any provisions of 40 CFR Part 280 within the text of any other provision of 40 CFR as adopted in Part 1 would mean the New Mexico Underground Storage Tank Regulations, 20 NMAC 5.1 through 5.16.

The purpose of today's Federal Register document is to codify New Mexico's base hazardous waste management program and its revisions to that program. EPA provided notices and opportunity for comments on the Agency's decisions to authorize the New Mexico program, and EPA is not now reopening the decisions, nor requesting comments, on the New Mexico authorizations as published in the Federal Register notices specified in Section B of this document.

This document incorporates by reference New Mexico's hazardous waste statutes and regulations and clarifies which of these provisions are included in the authorized and Federally enforceable program. By codifying New Mexico's authorized program and by amending the Code of Federal Regulations, the public will be more easily able to discern the status of Federally approved requirements of the New Mexico hazardous waste management program.

The EPA is incorporating by reference the New Mexico authorized hazardous waste program in subpart GG of 40 CFR part 272. Section 272.1601 incorporates by reference New Mexico's authorized hazardous waste statutes and regulations. Section 272.1601 also references the statutory provisions (including procedural and enforcement provisions) which provide the legal basis for the State's implementation of the hazardous waste management program, the Memorandum of Agreement, the Attorney General's Statements and the Program Description, which are approved as part of the hazardous waste management program under Subtitle C of RCRA.

The EPA retains its authority under statutory provisions, including but not limited to, RCRA sections 3007, 3008, 3013 and 7003, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions and to issue orders in authorized States. With respect to these actions, the EPA will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than any authorized State analogues to these provisions. Therefore, the EPA is not incorporating by reference such particular, approved New Mexico procedural and enforcement authorities. Section 272.1601(b)(2) of 40 CFR lists the statutory provisions which provide the legal basis for the State's implementation of the hazardous waste management program, as well as those procedural and enforcement authorities that are part of the State's approved program, but these are not incorporated by reference.

The public needs to be aware that some provisions of New Mexico's hazardous waste management program are not part of the Federally authorized State program. These non-authorized provisions include:

(1) provisions that are not part of the RCRA subtitle C program because they are “broader in scope” than RCRA subtitle C (see 40 CFR 271.1(i));

(2) Federal rules for which New Mexico is not authorized, but which have been incorporated into the State regulations because of the way the State adopted Federal regulations by reference.

State provisions that are “broader in scope” than the Federal program are not part of the RCRA authorized program and EPA will not enforce them. Therefore, they are not incorporated by reference in 40 CFR part 272. For reference and clarity, 40 CFR 272.1601(b)(3) lists the New Mexico regulatory provisions which are “broader in scope” than the Federal program and which are not part of the authorized program being incorporated by reference. “Broader in scope” provisions cannot be enforced by EPA; the State, however, may enforce such provisions under State law.

With respect to any requirement pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) for which the State has not yet been authorized, EPA will continue to enforce the Federal HSWA standards until the State is authorized for these provisions.

The EPA is not amending 40 CFR part 272 to include HSWA requirements and prohibitions that are implemented by EPA. Section 3006(g) of RCRA provides that any HSWA requirement or prohibition (including implementing regulations) takes effect in authorized and not authorized States at the same time. A HSWA requirement or prohibition supersedes any less stringent or inconsistent State provision which may have been previously authorized by EPA (50 FR 28702, July 15, 1985). EPA has the authority to implement HSWA requirements in all States, including authorized States, until the States become authorized for such requirement or prohibition. Authorized States are required to revise their programs to adopt the HSWA requirements and prohibitions, and then to seek authorization for those revisions pursuant to 40 CFR part 271.

Instead of amending the 40 CFR part 272 every time a new HSWA provision takes effect under the authority of RCRA section 3006(g), EPA will wait until the State receives authorization for its analog to the new HSWA provision before amending the State's 40 CFR part 272 incorporation by reference. Until then, persons wanting to know whether a HSWA requirement or prohibition is in effect should refer to 40 CFR 271.1(j), as amended, which lists each such provision.

Some existing State requirements may be similar to the HSWA requirement implemented by EPA. However, until EPA authorizes those State requirements, EPA can only enforce the HSWA requirements and not the State analogs. EPA will not codify those State requirements until the State receives authorization for those requirements.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This rule incorporates by reference New Mexico's authorized hazardous waste management regulations and does not impose new burdens on small entities. Accordingly, I certify that this action 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 merely incorporates by reference certain existing State hazardous waste management program requirements which EPA already approved under 40 CFR part 271, and with which regulated entities must already comply, 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). For the same reason, this action also does not have tribal implications within the meaning of Executive Order 13175 (65 FR 67249, November 6, 2000). It does not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. This action will not have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely incorporates by reference existing authorized State hazardous waste management program requirements without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

The requirements being codified are the result of New Mexico's voluntary participation in EPA's State program authorization process under RCRA Subtitle C. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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 document 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 in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective October 27, 2003.

There were typographical and effective date errors in the tables of authorities published as part of the following authorization notices for Oklahoma. The affected entries are as follows:

1. December 9, 1998 (63 FR 67800) authorization notice:

(a) All references to “Sec. 2-7-104” are corrected to “Sec. 2-2-104”;

(b) Specific to Checklist 151 (Item 4), the second reference to “2-7-106” is corrected to “2-7-107A(10)” the corresponding effective date of “July 1, 1994” is corrected to “July 1, 1993”.

2. March 29, 2000 (65 FR 16258) authorization notice:

(a) Specific to Checklist 154 (item 2) and Checklist 159 (item 7), the references to “2-2104” are corrected to “Sec. 2-2-104”;

3. January 2, 2001 (66 FR 28) authorization notice:

(a) Specific to Checklist 166 (Item 1), the reference to “2-2-106” is corrected to “2-7-106” .

Codification is the process of placing a State's statutes and regulations that comprise the State's authorized hazardous waste management program into the Code of Federal Regulations (CFR). Section 3006(b) of RCRA, as amended, allows the Environmental Protection Agency (EPA) to authorize state hazardous waste management programs to operate in lieu of the federal hazardous waste management regulatory program. EPA codifies its authorization of the state programs in 40 CFR part 272 and incorporates by reference state statutes and regulations that EPA will enforce under sections 3007 and 3008 of RCRA and any other applicable statutory provisions.

The incorporation by reference of state authorized programs in the Code of Federal Regulations should substantially enhance the public's ability to discern the current status of the authorized state program and state requirements that can be federally enforced. This effort provides clear notice to the public of the scope of the authorized program in each state.

Oklahoma received final authorization to implement its Base Hazardous Waste Management program, effective January 10, 1985, (49 FR 50362) . Subsequently, the EPA approved additional program revision applications effective on June 18, 1990 (55 FR 14280), November 27, 1990 (55 FR 39274), June 3, 1991 (56 FR 13411), November 19, 1991 (56 FR 47675), November 29, 1993 (58 FR 50854), December 21, 1994 (59 FR 51116), April 27, 1995 (60 FR 2699), March 14, 1997 (62 FR 12100), July 14, 1998 (63 FR 23673) and November 23, 1998 (63 FR 50528). The EPA incorporated by reference Oklahoma's then authorized hazardous waste program effective December 13, 1993 (58 FR 52679), July 14, 1998 (63 FR 23673) and October 25, 1999 (64 FR 46567). Effective February 8, 1999 (63 FR 67800), May 30, 2000 (65 FR 16528), July 10, 2000 (65 FR 29981), and March 5, 2001 (66 FR 28), EPA granted authorization to Oklahoma for additional program revisions. In this document, EPA is approving a change to the Oklahoma regulations at OKLA. ADMIN. CODE section 252:205-7-4, which makes it clear that transporters are prohibited from mixing or combining incompatible hazardous waste within a common container.

The purpose of today's Federal Register document is to codify Oklahoma's base hazardous waste management program and its revisions to that program. EPA provided notices and opportunity for comments on the agency's decisions to authorize the Oklahoma program. EPA is not now reopening the decisions, nor requesting comments, on the Oklahoma authorizations as published in the Federal Register notices specified in Section B of this document.

This document incorporates by reference Oklahoma's hazardous waste statutes and regulations and clarifies which of these provisions are included in the authorized and federally enforceable program. By codifying Oklahoma's authorized program and by amending the Code of Federal Regulations, the public will be more easily able to discern the status of federally approved requirements of the Oklahoma hazardous waste management program.

The EPA is incorporating by reference the Oklahoma authorized hazardous waste program in subpart LL of 40 CFR part 272. 40 CFR 272.1851 incorporates by reference Oklahoma's authorized hazardous waste statutes and regulations. Section 272.1851 also references the statutory provisions (including procedural and enforcement provisions) which provide the legal basis for the state's implementation of the hazardous waste management program, the Memorandum of Agreement, the Attorney General's Statements and the Program Description, which are approved as part of the hazardous waste management program under Subtitle C of RCRA.

The EPA retains its authority under statutory provisions, including but not limited to, RCRA sections 3007, 3008, 3013 and 7003, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions and to issue orders in all authorized states. On occasion when EPA might need to undertake these actions, it will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than any authorized state analogues to these provisions. Therefore, the EPA is not incorporating by reference any such approved Oklahoma procedural and enforcement authorities. 40 CFR 272.1851(b)(2) lists the statutory provisions which provide the legal basis for the state's implementation of the hazardous waste management program, as well as those procedural and enforcement authorities that are part of the state's approved program, but these are not incorporated by reference.

The public needs to be aware that some provisions of Oklahoma's hazardous waste management program are not part of the federally authorized state program. These non-authorized provisions include:

(1) Provisions that are not part of the RCRA subtitle C program because they are “broader in scope” than RCRA subtitle C (see 40 CFR 271.1(i));

(2) Federal rules for which Oklahoma is not authorized, but which have been incorporated into the state regulations because of the way the state adopted Federal regulations by reference.

State provisions that are “broader in scope” than the Federal program are not part of the RCRA authorized program and EPA will not enforce them. Therefore, they are not incorporated by reference in 40 CFR part 272. For reference and clarity, 40 CFR 272.1851(b)(3) lists the Oklahoma regulatory provisions which are “broader in scope” than the Federal program and which are not part of the authorized program being incorporated by reference. “Broader in scope” provisions cannot be enforced by EPA; the state, however, may enforce such provisions under state law.

Oklahoma has adopted but is not authorized for the Federal rule regarding exclusion of a waste from the list of hazardous waste, 40 CFR 260.20 et seq., (“delisting”) published on July 15, 1985 (50 FR 28702) and amended on June 27, 1989 (54 FR 27114); and the Federal rules published in the Federal Register on October 5, 1990 (55 FR 40834); February 1, 1991 (56 FR 3978); February 13, 1991 (56 FR 5910); April 2, 1991 (56 FR 13406); May 1, 1991 (56 FR 19951); December 23, 1991 (56 FR 66365); June 29, 1995 (60 FR 33912) and May 26, 1998 (63 FR 28556). Therefore, these Federal amendments included in Oklahoma's adoption by reference at OKLA. ADMIN. CODE sections 252:205-7-4, 252:205-3-2(b) through 252:205-3-2(k), are not part of the state's authorized program and are not part of the incorporation by reference addressed by today's Federal Register document.

With respect to any requirement pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) for which the State has not yet been authorized, EPA will continue to enforce the Federal HSWA standards until the State is authorized for these provisions.

The EPA is not amending 40 CFR part 272 to include HSWA requirements and prohibitions that are implemented by EPA. Section 3006(g) of RCRA provides that any HSWA requirement or prohibition (including implementing regulations) takes effect in authorized and not authorized states at the same time. A HSWA requirement or prohibition supersedes any less stringent or inconsistent state provision which may have been previously authorized by EPA (50 FR 28702, July 15, 1985). EPA has the authority to implement HSWA requirements in all states, including authorized states, until the states become authorized for such requirement or prohibition. Authorized states are required to revise their programs to adopt the HSWA requirements and prohibitions, and then to seek authorization for those revisions pursuant to 40 CFR part 271.

Instead of amending the 40 CFR part 272 every time a new HSWA provision takes effect under the authority of RCRA section 3006(g), EPA will wait until the state receives authorization for its analog to the new HSWA provision before amending the state's 40 CFR part 272 incorporation by reference. Until then, persons wanting to know whether a HSWA requirement or prohibition is in effect should refer to 40 CFR 271.1(j), as amended, which lists each such provision.

Some existing state requirements may be similar to the HSWA requirement implemented by EPA. However, until EPA authorizes those state requirements, EPA can only enforce the HSWA requirements and not the state analogs. EPA will not codify those state requirements until the state receives authorization for those requirements.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This rule incorporates by reference Oklahoma's authorized hazardous waste management regulations and does not impose new burdens on small entities. Accordingly, I certify that this action 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 merely incorporates by reference certain existing State hazardous waste management program requirements which EPA already approved under 40 CFR part 271, and with which regulated entities must already comply, 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). For the same reason, this action also does not have tribal implications within the meaning of Executive Order 13175 (65 FR 67249, November 6, 2000). It does not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. This action will not have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely incorporates by reference existing authorized state hazardous waste management program requirements without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

The requirements being codified are the result of Oklahoma's voluntary participation in EPA's State program authorization process under RCRA Subtitle C. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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 document 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 in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective October 27, 2003.

Prior to its eradication, smallpox (variola) was a serious illness that manifested either as outbreaks of variola major with death rates of greater than 20 percent or variola minor with death rates approaching 1 percent. Those who survived were frequently left with significant disabilities, such as blindness. Smallpox (vaccinia) vaccine (referred to in this rule as the “smallpox vaccine”) was an essential tool for the successful global eradication of smallpox (variola), announced by the World Health Organization in 1980. Despite such eradication, concern exists that terrorists may have access to the smallpox (variola) virus (referred to in this rule as the “smallpox virus”).

On December 13, 2002, the President announced a plan to protect the population of the United States against the threat of a possible smallpox attack. This plan was based on heightened concerns, in the wake of the attacks of September and October 2001, that terrorists may have access to the smallpox virus and may attempt to use it against the population of the United States and government facilities abroad. Under this plan, which the Secretary is actively working to implement, State and local governments have formed volunteer smallpox response teams that will be prepared to provide critical services to the population of the United States in the event of a smallpox virus attack.

In furtherance of the President's plan, the Secretary issued a Declaration Regarding Administration of Smallpox Countermeasures on January 24, 2003 (68 FR 4212). In this Declaration, the Secretary declared that “a potential bioterrorist incident makes it advisable to administer, on a voluntary basis, covered countermeasures specified * * * for prevention or treatment of smallpox [(virus infection)] or control or treatment of adverse events related to smallpox vaccination, to [specified] categories of individuals. * * *” The specific “covered countermeasures” described in the Declaration are smallpox vaccines, cidofovir and derivatives thereof, and Vaccinia Immune Globulin. The categories of persons to whom the Secretary recommended the administration of such covered countermeasures, on a voluntary basis, included certain health care workers, members of smallpox response teams identified by State or local government entities or the Department of Health and Human Services, certain public safety personnel, and certain personnel associated with certain Federal facilities abroad. The Secretary recommended that such persons volunteer to receive the smallpox vaccine in order to ensure that critical personnel would be able to mobilize immediately and provide critical services to the population of the United States in the event of a smallpox virus attack. The Secretary's Declaration became effective on January 24, 2003, and will remain effective until January 23, 2004, unless the Secretary extends or shortens the effective period of the Declaration by amendment.

The smallpox vaccine contains a live vaccinia virus that induces immunity to smallpox infection, but does not lead to variola infection or disease. Vaccinia virus is an orthopox type virus that is different from, but related to, the smallpox virus. Different strains of vaccinia have been used in the development of smallpox vaccines throughout the world, with some strains causing more injuries than other strains. The New York City Board of Health strain, “the NYCBH strain,” is the only strain currently used in vaccines administered in the United States. The NYCBH strain was selected for use in such vaccines because it has shown itself to be both relatively safe and effective when compared to other vaccinia strains. Nevertheless, the routine use of smallpox vaccination in the United States and several other countries, irrespective of the strain used, was discontinued prior to the certification of global eradication of smallpox. This was due to the relatively high complication rate observed with the smallpox vaccine, in addition to the lower risk of importation of smallpox with the increasing success of the global eradication program.

Because the vaccinia virus in the smallpox vaccine is live, it can be transmitted to other parts of the body of the vaccine recipient, e.g., by touching a vaccination site before it has healed and then touching another part of the recipient's body (self-inoculation), or to another person, e.g., by touching a vaccination site in a recipient before it has healed and then touching another person (accidental person-to-person inoculation). For purposes of this rule, the term “vaccination” refers to the administration and receipt of the smallpox vaccine and not through contact. Likewise, for purposes of this rule, the term “inoculation” is meant to refer to transmission of and subsequent infection with the vaccinia virus through a means other than smallpox vaccination, as described above.

Even though several studies documented the rate of serious complications after receipt of the smallpox vaccine during the 1960s and 1970s, these rates may be higher today as more individuals are immunocompromised, which has the same meaning for purposes of this regulation as immunosuppressed or immunodeficient. Furthermore, persons receiving primary smallpox vaccination under a smallpox emergency response plan will be doing so as adults. The earlier studies also primarily sought information only on what was known already to be caused by the smallpox vaccine. Unrecognized adverse reactions that may become more clearly evident with improved surveillance may not have been studied in the past.

The SEPPA authorized the Secretary to establish and implement the Smallpox Vaccine Injury Compensation Program. Under the Program, certain persons may receive benefits and/or compensation for covered injuries, described below, sustained as a result of such vaccination or accidental vaccinia inoculation. Specifically, SEPPA authorizes the Secretary to make available such benefits and/or compensation to two categories of persons who sustain covered injuries, provided they meet other legal requirements, e.g., filing deadlines. The first category, described as “recipients,” includes certain persons who volunteer for and are selected to be a member of a smallpox emergency response plan and are vaccinated with smallpox vaccine. In the event that recipients sustain covered injuries as the result of the administration of the smallpox vaccine or other covered countermeasures listed in the Secretary's Declaration, they may be entitled to benefits and/or compensation under the Program. The second category, described as “contacts,” includes certain persons who sustained covered injuries as the result of vaccinia contracted through accidental vaccinia inoculation through contact with categories of recipients described in the SEPPA or the contacts of such recipients. In addition, survivors of deceased recipients or contacts may be eligible for benefits and/or compensation under the Program in certain circumstances. Persons who do not meet the criteria for one of these categories (e.g., individuals who receive the smallpox vaccine, but not as part of an approved smallpox emergency response plan) will not be entitled to benefits.

In order to obtain benefits and/or compensation under the Program, eligible individuals in these categories must file a request with the Program and demonstrate to the Secretary in their requests that applicable eligibility, benefits, and compensation criteria are satisfied. Persons filing such requests with the Program are described as requesters. The benefits and compensation available under the Program include compensation for medical care, lost employment income, and a death benefit for certain survivors of persons who died as the result of a covered injury. A requester's entitlement to such benefits and compensation will vary depending upon the nature of the requester's condition, the requester's particular personal circumstances, e.g., whether the requester has insurance coverage, and the completeness of the request and accompanying documentation.

Among the criteria that must be satisfied in order for a person to be entitled to such benefits and/or compensation is the requirement that a person sustained a “covered injury” as the result of the administration of a covered countermeasure or as the result of an accidental vaccinia inoculation. A requester can demonstrate that such a covered injury, an injury either proven or presumed to be caused by the vaccinia virus contained in the smallpox vaccine or transmitted through accidental vaccinia inoculation and meeting all applicable requirements, occurred through two alternative mechanisms. First, in accordance with the SEPPA, a recipient or contact shall be presumed to have sustained a covered injury as the result of the administration of or exposure to the smallpox vaccine if the requester submits sufficient documentation demonstrating that the event is included on an injury table (i.e., the Table) created by the Secretary with the onset of the first symptom or manifestation within the time interval specified on the Table. For this reason, if an otherwise eligible person sustained an injury listed on the Table in the time interval listed on the Table, the Secretary will presume, solely for purposes of the Program, that this event was caused by the smallpox vaccine. Such a requester need not actually demonstrate that the vaccine or the vaccinia contracted from accidental vaccinia inoculation caused the underlying injury, only that an injury listed on the Table was sustained with the first manifestation within the time interval listed on the Table.

This presumption is not conclusive, however. The Secretary may determine, based on his review of the relevant evidence, that an injury meeting the Table requirements was most likely caused by other factors and was not caused by the smallpox vaccine or exposure to vaccinia in contact cases. In these circumstances, the Table presumption could be rebutted, and the requester may not be entitled to benefits and/or compensation under the Program.

The alternative mechanism to demonstrate that a covered injury was sustained is available when a requester cannot demonstrate that a Table injury occurred within the time interval listed on the Table. In such circumstances, the requester must submit sufficient documentation showing that the smallpox vaccine or other covered countermeasures, or the vaccinia contracted from accidental vaccinia inoculation, actually caused the injury that is the basis for the request. In evaluating such claims, the Secretary will employ a preponderance of the evidence standard, taking into consideration all relevant medical and scientific evidence, including all relevant medical records.

As authorized and mandated under the SEPPA, the Secretary is herein establishing, at 42 CFR 102.21, a Table that identifies injuries, i.e., illnesses, disabilities, injuries, or conditions, referred to as “Table injuries,” that shall be presumed to result from the administration of or exposure to the smallpox vaccine, as well as the time interval in which the first symptom or manifestation of each such injury must manifest in order for this presumption to apply. The Secretary is further including Table Definitions and Requirements, set forth in 42 CFR 102.21(b), which define the terms and conditions included in the Table and set forth the requirements necessary to establish Table injuries. As such, the Table Definitions and Requirements are considered a part of the Table.

At this time, the Secretary is seeking public comment on the Table established through this interim final rule. The Secretary will solicit comments on other matters pertaining to the implementation of the Program in the future, when the Secretary publishes a companion rule detailing the policies and procedures for the implementation of the Smallpox Vaccine Injury Compensation Program.

This interim final rule establishes the Table, which includes the covered injuries for the smallpox vaccine and the relevant time intervals for “recipient requests” (requests concerning injuries in relation to the administration of the smallpox vaccine) and “contact requests” (requests concerning injuries in relation to vaccinia contracted through accidental vaccinia inoculation from another person). In order to obtain the presumption of causation afforded by the Table, a requester filing a recipient request must demonstrate that the onset of the recipient's first symptom or manifestation of an injury listed on the Table occurred within the timeframe listed on the Table in relation to the administration of the smallpox vaccine. Likewise, in order to obtain the Table presumption of causation, a requester filing a contact request must demonstrate that the onset of the contact's first symptom or manifestation of the injury listed on the Table occurred within the time interval listed on the Table in relation to any date in the exposure period.

A contact may be exposed to vaccinia on any date in the exposure period, which is the span of time during which transmission of vaccinia virus from a vaccine recipient or another contact shedding vaccinia can occur. The risk of exposure from viral shedding from a recipient or contact is generally considered no longer to exist when the scab from each vaccinial lesion spontaneously falls off, which usually occurs approximately three weeks after vaccination or inoculation in a healthy person and may be considerably longer in the immunocompromised or those experiencing injuries such as eczema vaccinatum.

The time intervals listed on the Table for recipients reflect the quantity of time between vaccination and the onset of the first symptom or manifestation of the Table injury. For contacts, because the exact time the vaccinia virus is transmitted cannot generally be pinpointed, the time intervals listed on the Table reflect a comparable quantity of time between exposure to vaccinia (i.e. any point in the exposure period) and the onset of the first symptom or manifestation of the Table injury.

The injuries included on the Table, as well as the time intervals set forth for both recipients and contacts, represent the Secretary's best effort to include a comprehensive listing of injuries believed to be causally related to the smallpox vaccine. The Table is meant to represent the known NYCBH strain injuries where credible medical evidence suggests that the smallpox vaccine has a causal role in the injury and the time intervals in which such known events first manifest in relation to the administration of the smallpox vaccine, or the exposure to vaccinia in contact cases. However, the Table covers all smallpox vaccines administered under the Secretary's Declaration. With future generations of smallpox vaccines, the Secretary may need to amend the Table to fit the injury profile of the new vaccine.

Although the occurrence of many of the injuries included on the Table appears to be exceedingly rare, the Secretary is including such injuries on the Table in order to ensure that people who are otherwise eligible for benefits and/or compensation under the Program will receive the Table's presumption of causation in those instances in which the credible medical literature persuasively suggests a causal relationship between the smallpox vaccine and the injury. The Table presumption can be rebutted if the Secretary determines, based on a review of the relevant evidence, that an injury meeting the Table requirements was not caused by the smallpox vaccine or exposure to vaccinia in contact cases.

The Secretary is aware of anecdotal reports of ischemic heart disease, such as angina pectoris or myocardial infarction (heart attacks) occurring in a few individuals following receipt of the smallpox vaccine. The Secretary has included vaccinia-related myocarditis, pericarditis, and myopericarditis as Table injuries but, at this time, there is no clear scientific evidence to support including ischemic heart disease as a separate Table injury.

Nevertheless, where a requester can demonstrate that an ischemic heart disease following a covered Table injury was likely caused by, or was a health complication (i.e., sequela) of, the Table injury, we expect that the requester will be eligible for benefits associated with the ischemic heart disease.

Should sufficient scientific evidence be forthcoming that ischemic heart disease (absent these Table conditions) is caused by the vaccine, the Secretary would amend the Table (see discussion below), with retroactive effect, to include this condition too. Furthermore, even absent a Table injury for ischemic heart disease, requesters may provide sufficient evidence of causation in fact for this injury, which might also lead to Program benefits.

The Secretary will provide further information in the forthcoming companion regulation as to how he will determine whether an event was caused by, or was a health complication of, a covered injury.

In addition to specific injuries, the Table includes a category for any death resulting from an injury included on the Table in which the injury arose within the time interval set forth on the Table. No time interval is specified for the category of death. Therefore, so long as the Secretary determines that the death resulted from an injury meeting the Table requirements, the death can occur at any time subsequent to the injury and not necessarily in the time interval set forth on the Table.

The Table's Definitions and Requirements, set forth in 42 CFR 102.53(b), define and describe the scope of the terms included on the Table. As such, the listings included on the Table are to be read in conjunction with the Definitions and Requirements. For each Table injury, the Table Definitions and Requirements must be satisfied.

By law, requesters will be required to provide documentation showing that they meet other eligibility criteria, separate from the Table, in order to demonstrate eligibility to receive benefits and/or compensation under the Program. For example, each requester filing a contact request is required by law to demonstrate to the Secretary that the contact contracted vaccinia through accidental vaccinia inoculation during the effective dates of the Secretary's Declaration, or up to 30 days thereafter. This requirement applies to all contact requests filed, regardless of whether the injury in question is included on the Table. For this reason, the requirement that a requester with a contact request demonstrate that the contact contracted vaccinia within the time interval specified by law is not incorporated into the Table. The companion regulations that the Secretary will issue in the future will provide detailed information concerning this requirement and other requirements that requesters must satisfy beyond those that pertain exclusively to injuries included on the Table.

A requester may be eligible to receive benefits and/or compensation available through the Program even if the underlying injury is not included on the Table, as defined through the Definitions and Requirements, or did not occur within the time-frame included on the Table. Because such requesters will not be afforded the presumption of causation given to requesters who establish Table injuries, requesters filing requests based on non-Table injuries must submit documentation that demonstrates to the Secretary that the injury underlying the request was actually caused by the administration of the covered countermeasure, or by vaccinia through accidental vaccinia inoculation in contact requests. The Secretary will give full and fair review of all such requests.

Medical evidence available concerning a possible causal link between the vaccinia virus and particular conditions may not be sufficient for the Secretary to add such conditions to the Table. However, such evidence together with medical documentation introduced by particular requesters may be sufficient for requesters with such conditions to persuade the Secretary that the vaccinia virus from vaccination or inoculation was a significant factor in causing the condition. For example, medical literature suggests that the vaccinia virus has caused acute vaccinial arthritis (VA) or vaccinial osteomyelitis (VO) in isolated instances. As a result, requesters with such conditions may be entitled to compensation even when such conditions are not included on the Table. In order to demonstrate that a particular person's condition was caused by the vaccinia virus through vaccination or inoculation, requesters must provide evidence demonstrating such a link, e.g., evidence that the vaccinia virus was present in an infected joint in a case of alleged VA or in an osteomyelitis in a case of alleged VO. Such evidence may persuade the Secretary to determine that the person sustained a covered, albeit a non-Table, injury. Likewise, persons in whom a malignant melanoma (MM), basal cell carcinoma (BCC), or squamous cell carcinoma (SCC) originated with the first manifestation in a vaccination or inoculation scar may be able to demonstrate to the Secretary that the vaccinia virus caused the MM, BCC, or SCC. This is consistent with the rare cases in the medical literature in which a causal link has been suggested between the vaccinia virus and such skin tumors, e.g., persons who developed new tumors, i.e., MM, BCC, or SCC (as the first manifestation of each tumor) in separate vaccinial scars from separate vaccinations given years apart.

To decide whether benefits and/or compensation under the Program are available in relation to a request that does not concern a Table injury, the Secretary will review the materials provided in each case. In reviewing these requests, the Secretary will employ a preponderance of the evidence standard, taking into consideration relevant medical and scientific evidence. The Secretary will provide further information concerning such requests when he publishes the companion final rule setting forth the administrative implementation of the Program.

The Secretary was statutorily directed to establish a Table identifying injuries presumed to result from the administration of or exposure to the smallpox vaccine. The SEPPA did not direct the Secretary to establish such a Table in relation to injuries presumed to result from the administration of other covered countermeasures. Nonetheless, certain requesters may still be entitled to benefits and/or compensation in relation to injuries that resulted from covered countermeasures other than the smallpox vaccine, i.e., Vaccinia Immune Globulin, cidofovir and derivatives thereof. Requesters filing requests in relation to such injuries are not afforded the presumption of causation given to requesters who have sustained Table injuries. For this reason, a requester filing a request in relation to such non-vaccine covered countermeasures, as with any non-Table request, must demonstrate to the Secretary that the administration of the covered countermeasure actually caused an injury for which benefits and/or compensation may be available under the Program.

In accordance with Section 263(a)(2) of the Public Health Service Act (PHS Act), as established by SEPPA, the Secretary is authorized to amend by regulation the Table established in this interim final rule. The Secretary intends to monitor injuries in relation to covered countermeasures, including the smallpox vaccine. Based upon the best scientific evidence available, the Secretary will amend the Table to add new injuries, to modify the governing time intervals, or to modify Table definitions, when the evidence supports doing so. Such amendments will apply to pending requests and to requests filed after the amendments take effect. Requesters who become eligible with respect to an injury on the Table as the result of such an amendment may file a request based on the amendment within the time period prescribed by law.

Through the enactment by the SEPPA of Section 263(a)(1) of the PHS Act, the Secretary was directed to establish by interim final rule a table identifying injuries that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each such injury must manifest in order for such presumption to apply. In accordance with that statutory directive, the Secretary is herein establishing such a Table, including Definitions and Requirements. As noted earlier, the establishment of this Table by interim final rule was authorized by statute.

The Secretary has further determined, under 5 U.S.C. 553(b), that it is contrary to the public interest to follow the notice of proposed rulemaking procedures before issuance of these regulations, because such a process might delay the continuing implementation of the President's plan to protect the population of the United States against the threat of a smallpox (variola) attack. A significant element of this plan, which is also an important priority of the Secretary, is the increased voluntary participation of persons in smallpox emergency response plans throughout the Nation, which includes voluntary immunization with the smallpox vaccine. The companion regulation, which will serve to implement the Program, will be issued after this regulation is in effect. The sooner that this regulation becomes effective, the sooner potential requesters will be able to assess their eligibility to recover benefits and/or compensation from the Program and to recover such benefits and/or compensation, if eligible. For the same reasons, the Secretary has determined that there is good cause to waive a delay in the rule's effective date.

As noted above, comments will be accepted at the above listed address for a period of 60 days following the publication of this rule.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety distributive and equity effects). In addition, under the Regulatory Flexibility Act (RFA), if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

Congress has found it necessary to appropriate $42,000,000 for the administration of, and payment of the Program. Because any resources required to implement the regulatory requirements imposed by the SEPPA are not required by virtue of the establishment of a Table, and because the Secretary will conduct an independent analysis concerning any burdens associated with the implementation of the Program when the Secretary publishes the companion regulations setting forth the Program's administrative implementation, the Secretary has determined that no resources are required to implement the provisions included in this regulation. Therefore, in accordance with the RFA of 1980, and the Small Business Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

The Secretary has also determined that this proposed interim final rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. The Secretary has determined that the proposed interim final rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

The Secretary has also reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

On the basis of family well-being, the provisions of this interim final rule will not affect the following family elements: family safety, family stability, marital commitment; parental rights in the education, nurture and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

In this interim final rule, the Secretary establishes a Smallpox (Vaccinia) Vaccine Injury Table identifying injuries that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the onset of the first symptom or manifestation of each such injury must manifest in order for such presumption to apply. The Secretary also is providing Table Definitions and Requirements. This interim final rule is based upon legal authority. This interim final rule will have the effect of affording certain persons a presumption that particular injuries were sustained as the result of the administration of or exposure to the smallpox vaccine. Because the Table establishes a presumption of causation, it relieves requesters of the burden of demonstrating causation for covered events.

This interim final rule has no information collection requirements.

On June 23, 2003, we published a direct final rule [68 FR 37091] that notified the public of the Coast Guard's intent to amend its appellate procedures to provide explicit authority for appeal of decisions or actions taken by the Director, Great Lakes Pilotage. We have not received an adverse comment, or notice of intent to submit an adverse comment, on this rule. Therefore, the rule will go into effect as scheduled.

This summary of the Commission's First Report and Order, IB Docket Nos. 02-34 & 02-54, FCC 03-102, adopted April 23, 2003, and released on May 19, 2003. The complete text of this First Report and Order is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554, and also may be purchased from the Commission's copy contractor, Qualex International, Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC 20554, telephone (202) 863-2893, facsimile (202) 863-2898 or via e-mail qualexint@lol.com. It is also available on the Commission's Web site at

Paperwork Reduction Act Analysis: The actions taken in the First Report and Order have been analyzed with respect to the Paperwork Reduction Act of 1995 (PRA), Pub. L. 104-13, and §§ 25.137(d)(4), 25.164(c) through (e), and 25.165 have been found to impose new or modified reporting requirements or burdens on the public. Implementation of these new or modified reporting and recordkeeping requirements has been approved by the Office of Management and Budget (OMB). OMB granted approval for this information collection by means of a Notice of Action for collection number 3060-1007 dated August 13, 2003.

Regulatory Flexibility Analysis: As required by the Regulatory Flexibility Act (RFA),1 an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rule Making (NPRM) in IB Docket No. 02-34.2 The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.3

Need for, and Objectives of, the Proposed Rules. The objective of the proposed rules is to discourage parties from filing “speculative” satellite applications, i.e., applying for a satellite license without intending to construct the satellite facilities. These rule revisions are needed because speculative satellite applications can delay or preclude other parties from obtaining a satellite license and providing service to the public.

Summary of Significant Issues Raised by Public Comments In Response to the IRFA. No comments were submitted in response to the IRFA.

Description and Estimate of the Number of Small Entities To Which Rules Will Apply. 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 proposed rules, if adopted.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.”5 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.6 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 A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.”8 Nationwide, as of 1992, there were approximately 275,801 small organizations.9 “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.”10 As of 1992, there were approximately 85,006 such jurisdictions in the United States.11 This number includes 38,978 counties, cities, and towns; of these, 37,566, or 96 percent, have populations of fewer than 50,000. The Census Bureau estimates that this ratio is approximately accurate for all governmental entities. Thus, of the 85,006 governmental entities, we estimate that 81,600 (91 percent) are small entities. Below, we further describe and estimate the number of small entity licensees that may be affected by the proposed rules, if adopted.

The rules adopted in this First Report and Order affect satellite operators. The Commission has not developed a definition of small entities applicable to satellite operators. Therefore, the applicable definition of small entity is generally the definition under the SBA rules applicable to Satellite Telecommunications.12 This definition provides that a small entity is expressed as one with $11.0 million or less in annual receipts.13 1997 Census Bureau data indicate that, for 1997, 273 satellite communication firms had annual receipts of under $10 million. In addition, 24 firms had receipts for that year of $10 million to $24,999,990.14

In addition, Commission records reveal that there are approximately 240 space station operators licensed by this Commission. We do not request or collect annual revenue information, and thus are unable to estimate of the number of licensees that would constitute a small business under the SBA definition. Small businesses may not have the financial ability to become space station licensees because of the high implementation costs associated with satellite systems and services.

Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements. In this First Report and Order, the Commission adopts a mandatory electronic filing requirement for space station license applicants. The Commission believes that filing satellite license applications electronically is no more burdensome than submitting paper applications, because a majority of satellite applicants currently file their applications electronically on a voluntary basis.

None of the other rules adopted in this First Report and Order are expected to increase the reporting, record keeping and other compliance requirements of any licensee.

Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant alternatives that it has considered in developing its 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 and reporting requirements under the rule for such 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 such small entities.”15

In this proceeding, we adopt rule revisions designed to allow the Commission to issue satellite licenses faster than is now possible, which will enable satellite operators to provide service faster, and to attract investors faster. This will have a positive economic impact on all satellite licensees, including small entities.

In the NPRM, the Commission proposed applying a first-come, first-served procedure to all satellite applications, including non-geostationary satellite applications. In the First Report and Order, the Commission concluded that applying a first-come, first-served procedure to non-geostationary satellite applications could enable one applicant to unreasonably exclude others, including small entities, from the market. Accordingly, the Commission rejected this proposal.

Report to Congress: The Commission will send a copy of the First Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of the First Report and Order, including FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the First Report and Order and FRFA (or summaries thereof) will also be published in the Federal Register. See 5 U.S.C. 604(b).

Summary of Report and Order: In this document, the Commission adopts new satellite licensing procedures, intended to enable the Commission to issue satellite licenses more quickly. First, the Commission establishes a queue for satellite applications, based on the date and time they are filed. If an application is filed before a needed international frequency allocation is adopted, the application will be returned as premature. If an application is filed before a needed domestic frequency allocation is adopted, the application will be considered only pursuant to a waiver of the Table of Frequency Allocations, 47 CFR 2.106. If an application is filed after international and domestic frequency allocations are adopted, but before the Commission adopts service-band specific service rules, the application will be considered only subject to default service rules adopted in the First Report and Order. Included in those default service rules is a requirement for the applicant to disclose its orbital debris mitigation proposals, if any. This requirement is based on the record in IB Docket No. 02-54. In addition, as explained further below, the Commission adopts different procedures for non-geostationary satellite orbit (NGSO) satellite system applications and geostationary satellite orbit (GSO) applications. If an applicant files an application before there are GSO/NGSO sharing criteria for that band, then we will consider only GSO applications or NGSO applications, depending on which is filed first, until the Commission adopts sharing criteria. If a GSO application and an NGSO application are filed at the same time, the band will be split proportionally between GSOs and NGSOs.

Second, the Commission adopts different procedures for different types of satellite applications. When a non-geostationary satellite orbit (NGSO) application or a geostationary satellite orbit (GSO) Mobile Satellite Service (MSS) application (together, “NGSO-like”) reaches the front of the queue, the Commission starts a modified processing round, and divides the available spectrum equally among all the qualified applicants. If a licensee loses or surrenders its license, the spectrum assigned to that licensee will be reassigned to the remaining licensees, unless the number of remaining licensees is sufficient to make reasonably efficient use of the frequency band. The Commission presumes that this number is three. In this case, the Commission will announce another processing round for the newly available spectrum. Similarly, the Commission will start another processing round if there are fewer than three qualified applicants in the initial processing round.

When a non-geostationary satellite (GSO) application other than a GSO MSS application reaches the front of the queue, the Commission considers it on a first-come, first-served basis. The Commission will grant each of those applications if the applicant is qualified, and the proposed satellite would not conflict with any other previously licensed satellite. If two or more qualified GSO-like applications are filed at the same thousandth of a second, the Commission will divide the spectrum equally among the qualified applicants at that orbit location. If a GSO-like licensee loses its license, that orbit location will become available for another GSO-like applicant on a first-come, first-served basis.

For both the modified processing round and first-come, first-served procedures, the Commission revises its rules for amendments to satellite applications and modifications to satellite licenses.

In addition, the Commission eliminates the anti-trafficking rule for satellites, together with new safeguards to protect against speculation. By eliminating the anti-trafficking rule, the Commission will no longer review transfer of control applications to determine whether the transaction is the sale of a bare license for profit. The Commission will still review such applications to determine whether the transaction will further the public interest, convenience, and necessity.

Together with the elimination of the anti-trafficking rule, the Commission adopts safeguards to protect against speculation. First, the Commission replaces the financial qualification rules with a bond requirement. Formerly, the Commission required satellite license applicants to show that they have financing available to construct and launch the satellite and operate it for one year. Here, the Commission replaces that requirement with a requirement that licensees post a bond within 30 days of grant of the license, payable upon missing a milestone. The bond amount is $7.5 million for NGSO-like applications, and $5 million for GSO-like applications. The amount of the bond may be reduced when the licensee meets each of its milestones.

The Commission also adopts new milestones. The NGSO-like milestones are now: (1) Contract execution; (2) critical design review; (3) commencement of construction; (4) launch; and (5) bring entire system into operation. The GSO-like milestones are (1) contract execution; (2) critical design review; (3) commencement of construction; and (4) launch. In addition, the Commission adopts information requirements for licensees to demonstrate that they have met each of the new milestones.

To protect further against speculative applications, the Commission adopts a limit on the number of pending applications and unbuilt satellites any applicant may have in any frequency band. Those limits are five GSO orbit locations and one NGSO satellite system. So that applicants do not undercut the policy goals of these limits, the Commission also adopts an attribution rule prohibiting a party from filing a satellite application if it holds more than 33 percent of the total asset value of applicants with applications for five GSO orbital locations, and one NGSO satellite system, in any frequency band, pending before the Commission. Stricter limits apply to applicants who establish a pattern of missing milestones. Applicants who have established such a pattern, and have two or more applications pending, or two licensed-but-unbuilt satellite systems of any kind, will not be permitted to file another GSO-like application or NGSO-like application in any frequency band.

In addition to these safeguards, the Commission prohibits applicants from selling their place in the queue, and require applications to be substantially complete.

The Commission adopts a number of other provisions in this First Report and Order. First, the Commission adopts mandatory electronic filing of space station applications. Second, the Commission creates a streamlined procedure for replacement satellite applications. Third, the Commission revises its full frequency reuse requirements. The Commission also extends the license terms of certain satellite licenses from 10 to 15 years. Finally, the Commission established a freeze on new satellite applications. This freeze is terminated as of August 27, 2003.

In addition, the Commission revises the procedures for non-U.S.-licensed satellite operators seeking access to the U.S. market, to be consistent with the new procedures for U.S. license applications. The Commission also adopted provisions for Permitted List satellite modifications, replacements of Permitted List satellites, and changes of ownership of satellites on the Permitted List.

Accordingly, it is ordered, pursuant to sections 1, 2, 4(i), 4(j), 7(a), 11, 301, 303(c), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(j), 157(a), 161, 301, 303(c), 303(f), 303(g), 303(r), that this First Report and Order in IB Docket Nos. 02-34 and 02-54 is hereby adopted.

It is further ordered that parts 1 and 25 of the Commission's rules are amended.

It is further ordered that the provisions of this First Report and Order in IB Docket Nos. 02-34 and 02-54, other than §§ 25.137(d)(4), 25.164(c) through (e), and 25.165, will be effective August 27, 2003.

It is further ordered that §§ 25.137(d)(4), 25.164(c) through (e), and 25.165, as adopted in this First Report and Order, will be effective September 11, 2003.

It is further ordered that, effective upon the adoption date of this First Report and Order in IB Docket Nos. 02-34 and 02-54, no applications for space station licenses for any satellite service addressed in this First Report and Order will be accepted for filing. This freeze will continue until August 27, 2003.

It is further ordered that the license term of each space station license issued on or before April 17, 2002, and in effect on the release date of this Order, is hereby extended to 15 years, starting on the date the licensee certified to the Commission that the space station was successfully placed in orbit and its operations fully conform to the terms and conditions of its authorization.

It is further ordered that the Consumer Information Bureau, Reference Information Center, shall send a copy of this First Report and Order in IB Docket Nos. 02-34 and 02-54, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

All sea turtles that occur in U.S. waters are listed as either endangered or threatened under the Endangered Species Act of 1973 (ESA). The Kemp's ridley (Lepidochelys kempii), leatherback (Dermochelys coriacea), and hawksbill (Eretmochelys imbricata) turtles are listed as endangered. The loggerhead (Caretta caretta) and green (Chelonia mydas) turtles are listed as threatened, except for breeding populations of green turtles in Florida and on the Pacific coast of Mexico, which are listed as endangered.

Sea turtles are incidentally taken and killed as a result of numerous activities, including fishery trawling activities in the Gulf of Mexico and along the Atlantic seaboard. Under the ESA and its implementing regulations, taking sea turtles is prohibited, with exceptions identified in 50 CFR 223.206, or if in accordance with the terms and conditions of a biological opinion issued under section 7 of the ESA or an incidental take permit issued under section 10 of the Act. The incidental taking of turtles during shrimp or summer flounder trawling is exempted from the taking prohibition of section 9 of the ESA if the conservation measures specified in the sea turtle conservation regulations (50 CFR 223) are followed. The regulations require most shrimp trawlers and summer flounder trawlers operating in the southeastern United States (Atlantic Area, Gulf Area, and summer flounder sea turtle protection area, see 50 CFR 223.206) to have a NMFS-approved TED installed in each net that is rigged for fishing to provide for the escape of sea turtles. TEDs currently approved by NMFS include single-grid hard TEDs and hooped hard TEDs conforming to a generic description, the flounder TED, and one type of soft TED the Parker soft TED (see 50 CFR 223.207).

TEDs incorporate an escape opening, usually covered by a webbing flap, that allows sea turtles to escape from trawl nets. To be approved by NMFS, a TED design must be shown to be 97 percent effective in excluding sea turtles during testing based upon specific testing protocols (50 CFR 223.207(e)(1)). Most approved hard TEDs are described in the regulations (50 CFR 223.207 (a)) according to generic criteria based upon certain parameters of TED design, configuration, and installation, including height and width dimensions of the TED opening through which the turtles escape.

On February 21, 2003, NMFS issued a final rule (68 FR 8456), amending the sea turtle conservation regulations to protect large loggerhead, green, and leatherback sea turtles. The final rule became effective April 15, 2003, with the exception of the Gulf Area where it will become effective on August 21, 2003. The February final rule requires that all shrimp trawlers fishing in the offshore waters of the southeastern United States (Atlantic Area and Gulf Area) and the inshore waters of Georgia and South Carolina use either a double cover flap TED, a single-grid hard TED with a 71-inch (180-cm) opening, or a Parker soft TED with a 96-inch (244-cm) opening in each net rigged for fishing. In inshore waters, except those of Georgia and South Carolina, the rule allows the use of a single-grid hard TED with a 44-inch (112-cm) opening, a Parker soft TED with a 56-inch (142-cm) opening, and a hooped hard TED with a 35-inch (89-cm) by 27-inch (69-cm) escape opening.

Since publication of the final rule (68 FR 8456, February 21, 2003), NMFS has tested a new hooped hard TED design developed in Louisiana (the Coulon TED) that contains a larger escape opening than the hooped hard TED design used in inshore waters. Louisiana fishermen prefer the Coulon TED due to its higher shrimp retention, and its efficiency and quickness in releasing both turtles and fish bycatch. Because of the desire of fishermen to continue to use this style of TED in offshore waters and their assertion that it could indeed be made large enough to release leatherback turtles, the Southeast Fisheries Science Center's Harvesting Systems and Engineering Branch worked with the inventor of the Coulon TED and fishermen who use it to develop and test a large Coulon style TED to evaluate its ability to release large loggerhead, green, and leatherback turtles.

NMFS tested the large Coulon style TED using testing protocols designed to evaluate a TED's ability to release large turtles. The protocols were developed during the testing and approval of the double cover TED (66 FR 24287, May 14, 2001). NMFS used the average carapace measurements of 15 nesting female leatherback turtles to construct a pipe-framed model of a leatherback turtle. This model measured 40 inches wide by 21 inches (102 cm by 53 cm) deep. The test was performed by a diver swimming repeatedly through the trawl with the model and pushing it through the TED opening. During these tests, the diver was able to push the model through the opening with ease. When the model was inverted (simulating the dorsal surface of the turtle oriented against the TED frame), the diver was still able to push the model through the opening with ease.

A large Coulon style TED with a hinged door covering the escape opening to within 12 inches (30 cm) from the back edge of the opening was also tested to determine its ability to release small turtles. The small turtle protocol calls for the release of 25 turtles, released one at a time, into a trawl towed at 2.5 knots (55 FR 41092, October 9, 1990). Each turtle is given 5 minutes to escape; if the turtle does not escape within 5 minutes, it is retrieved by divers and is considered to have been captured. The capture rate is then compared to that of a control TED (in this case a top-opening double cover flap TED).

During the week of June 22, 2003, 25 small turtles were exposed to the large Coulon style TED with a hinged door and all 25 turtles escaped quickly and easily. The Southeast Fisheries Science Center's Harvesting Systems and Engineering Branch believes that this particular configuration of the large Coulon style TED would be the most difficult for small turtles to escape from because of the weight and size of the door. However, when compared to the control TED, the average escape times did not differ significantly; the average escape time for the control TED was 62 seconds compared to 68 seconds for the Coulon style TED with the hinged door. Based upon the tests described above, NMFS determined that the large Coulon style TED meets the regulatory turtle release rate requirement.

Therefore, on July 30, 2003, NMFS published a proposed rule (68 FR 44722) requesting comments on allowing the use of a large hooped hard TED in the offshore waters of the Atlantic and Gulf of Mexico. NMFS received two comments on the proposed rule.

Comment 1: The University of Georgia Marine Extension Service is concerned that the codified text specifying construction materials for TEDs in the proposed rule requires that if steel rod is used to construct a single grid hard TED or an inshore hooped hard TED the steel rod used must have an outside diameter of 1/2 inch (1.27 cm). This is a significant change from the required 1/4 inch (.64 cm) currently required.

Response: NMFS thanks the commenter for bringing this to our attention. This is a typographical error in the proposed rule and has been corrected in this final rule.

Comment 2: An environmental organization stated that although they do not oppose NMFS allowing the use of the Coulon TED, they asserted that any certified TED must continue to be reviewed, monitored and enforced to ensure that it is effectively releasing sea turtles. The commenter stated that NMFS must increase the monitoring and enforcement of the TED regulations to ensure that these devices are performing as specified.

Response: NMFS agrees that any TED certified for use in the shrimp fishery should be monitored to ensure proper performance. NMFS Southeast Fisheries Science Center's Harvesting Systems and Engineering Branch works closely with the industry, net manufacturers, observer program, and enforcement to ensure that any problems encountered with the performance of TEDs during fishing conditions is addressed through further gear development and testing. NMFS enforcement will continue to enforce and monitor the TED requirements, including the Coulon TED. However given the anticipated limited use of the Coulon TED, NMFS does not intend to commit extra resources towards monitoring this device.

NMFS is issuing a rule allowing the use of an offshore hooped hard TED that has to meet certain minimum construction standards, in addition to the construction standards specified for hard TEDs generally. The frame for this TED must be made of aluminum rod with a minimum outside diameter of 5/8 inch (1.59 cm) or aluminum tubing with a minimum outside diameter of 1 inch (2.54 cm) and a minimum wall thickness of 1/8 inch (0.32 cm). The escape opening must have a horizontal measurement of no less than 40 inches (102 cm) wide and a forward measurement of no less than 35 inches (89 cm). The front hoop on an offshore hooped hard TED must have an inside horizontal measurement of at least 40 inches (102 cm) and an inside vertical measurement of at least 30 inches (76 cm). The minimum clearance between the deflector bars and the forward edge of the escape opening must be at least 23 1/4 inches (59 cm). The measurement between support bars must be no less than 40 inches (102 cm) (see Figure 1 for illustrations of the offshore hooped hard TED and its dimensions)

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands (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 CFR part 679. The allocation of the Pacific ocean perch TAC in the Eastern Aleutian District of the BSAI was established as 3,238 metric tons (mt) by the final 2003 harvest specifications for groundfish in the BSAI and the reserve apportionment (68 FR 9907, March 3, 2003). The allocation of Pacific ocean perch TAC in the Eastern Aleutian District of the BSAI to Community Development Quota (CDQ) participants was established as 263 mt by the final 2003 harvest specifications for groundfish in the BSAI.

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS, has determined that the allocation of the Pacific ocean perch TAC in the Eastern Aleutian District of the BSAI has been reached. Therefore, NMFS is requiring that further catches of Pacific ocean perch TAC in the Eastern Aleutian District of the BSAI be treated as prohibited species in accordance with § 679.21(b).

As of August 19, 2003, 125 mt of the Pacific ocean perch CDQ reserve in the Eastern Aleutian District of the BSAI remains unharvested. Therefore, CDQ participants are not yet required to treat catch of Pacific ocean perch in the Eastern Aleutian District of the BSAI as a prohibited species.

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 contrary to the public interest. This requirement is contrary to the public interest as it would delay the prohibition of retention, lead to exceeding the TAC of Pacific ocean perch in the Eastern Aleutian District of the BSAI, 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 § 679.20 and is exempt from review under Executive Order 12866.