The Commission is making two changes to its emergency preparedness regulations contained in 10 CFR Part 50, Appendix E. The first amendment relates to NRC approval of licensee changes to EALs, paragraph IV.B and the second amendment relates to exercise requirements for co-located licensees, paragraph IV.F.2. A discussion of each of these revisions follows.

EALs are part of a licensee's emergency plan. There is an inconsistency in the emergency planning regulations regarding the threshold for when NRC approval of nuclear power plant licensee changes to EALs is required. Section 50.54(q) states that licensees may make changes to their emergency plans without Commission approval only if the changes “do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of § 50.47(b) and the requirements of appendix E” to 10 CFR part 50. By contrast, Appendix E states that “emergency action levels shall be * * * approved by NRC.” Current industry practice follows the provisions of § 50.54(q). Industry has generally made and implemented revisions to EALs without requesting NRC approval after determining that the changes do not decrease the effectiveness of the emergency plan. When the determination is made that a change constitutes a decrease in effectiveness, licensees submit the changes to the Commission for approval. If a change involves a major change to the EAL scheme, for example, changing from an EAL scheme based on NUREG-0654/FEMA-REP-1, “Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants,” guidance to an EAL scheme based on NUMARC/NESP-007, “Methodology for Development of Emergency Action Levels,” or NEI-99-01, “Methodology for Development of Emergency Actions Levels,” guidance or if the license proposes an alternate method for complying with the regulations, the industry practice has been to seek NRC review and approval before implementing the change.

The Commission believes that prior NRC approval of every EAL change is not necessary to provide reasonable assurance that EALs will continue to provide an acceptable level of safety. This final amendment focuses on EAL changes that are of sufficient significance that a safety evaluation by the NRC is appropriate before the licensee may implement the change. The Commission believes that EAL changes that reduce the effectiveness of the emergency plan are of sufficient regulatory significance that prior NRC review and approval is warranted. This standard is the same standard that the current regulations provide for when determining whether changes to emergency plans (except EALs) require NRC review and approval. As such, this regulatory threshold has a long history of successful application. Therefore, this standard should also be used for EAL changes. On the basis of NRC's inspections of emergency plans, including EAL changes, the Commission believes that licensees have generally made appropriate determinations regarding whether an EAL change reduces the effectiveness of the emergency plan and that licensees have the capability to continue to do so. Limiting the NRC's approval to EAL changes that reduce the effectiveness of emergency plans or to an alternate method for complying with the regulations will ensure adequate NRC oversight of licensee-initiated EAL changes. This both increases regulatory effectiveness (through use of a single consistent standard for evaluating all emergency plan changes) and reduces unnecessary regulatory burden on licensees (who would not be required to submit for approval EAL changes that do not decrease the effectiveness of the emergency plan).

The Commission believes a licensee's proposal to convert from one EAL scheme ( e.g. , NUREG-0654-based) to another EAL scheme ( e.g. , NUMARC/NESP-007 or NEI-99-01 based) or to a proposed alternate method for complying with the regulations is of sufficient significance to require prior NRC review and approval. NRC review and approval for such major changes in EAL methodology is necessary to ensure that there is reasonable assurance that the final EAL change will provide an acceptable level of safety.

Accordingly, the Commission is revising Appendix E to 10 CFR Part 50 to provide that Commission approval of EAL changes is necessary for all EAL changes that decrease the effectiveness of the emergency plan and for changing from one EAL scheme ( e.g. , NUREG-0654-based) to another EAL scheme ( e.g. , NUMARC/NESP-007 or NEI-99-01-based) or for a proposal of an alternate method for complying with the regulations.

The emergency planning regulations were significantly upgraded in 1980 after the accident at Three Mile Island (45 FR 55402; August 19, 1980). The upgraded 1980 regulations required an annual exercise of the onsite and offsite emergency plans. The regulations were amended in 1984 to change the frequency of participation of state and local governmental authorities in nuclear power plant offsite exercises from annual to biennial (49 FR 27733; July 6, 1984). The regulations were amended in 1996 to change the frequency of exercising the licensees' onsite emergency plans from annual to biennial (61 FR 30129; June 14, 1996). Appendix E to part 50, Paragraph IV.F.2, currently provides that the “offsite plans for each site shall be exercised biennially” (emphasis added) with the full or partial participation of each offsite authority having a role under the plans, and that “each licensee at each site” shall conduct an exercise of its onsite emergency plan every 2 years, an exercise that may be included in the full or partial participation biennial exercise. 1 Thus, Paragraph IV.F.2 is ambiguous about the emergency preparedness exercise requirements where multiple nuclear power plants, each licensed to different licensees, are co-located at the same site. Specifically, it is ambiguous regarding whether each licensee must participate in a full or partial participation exercise of the offsite plan every 2 years, or whether the licensees may alternate their participation such that a full or partial participation exercise is held every 2 years and each licensee (at a two-licensee site) participates in a full or partial participation exercise every 4 years.

Upon consideration of the language of the current regulation and the legislative history of the exercise requirements, the Commission believes that the ambiguity in the current regulation shall be interpreted such that each nuclear power plant licensee, co-located on the same site, must participate in a full or partial participation offsite exercise every 2 years (and that each offsite authority is to participate on either a full or partial participation basis in each licensee's biennial offsite exercise). However, upon consideration of the matter, the Commission believes that requiring each licensee on a co-located site to participate in a full or partial participation exercise every 2 years, and for the offsite authorities to participate in each licensee's full or partial participation exercise, is not necessary to provide reasonable assurance that each licensee and the offsite authorities will be able to fulfill their responsibilities under the emergency plan should the plan be required to be implemented. Furthermore, the Commission believes that such an interpretation could impose an undue regulatory burden on offsite authorities. Currently, there is only one nuclear power plant site with power plants licensed to two separate licensees: The James A. FitzPatrick and Nine Mile Point site. Although the ambiguity in Paragraph IV.F.2 has limited impact today, the Commission understands that future nuclear power plant licensing concepts currently being considered by the industry include siting multiple nuclear power plants on either a single site or adjacent, contiguous sites. These plants may be owned and/or operated by different licensees. Therefore, the Commission believes that this final rulemaking is necessary to remove the ambiguity in Paragraph IV.F.2 and clearly specify the emergency preparedness exercise requirements for co-located licensees.

The Commission finds that where two nuclear power plants are licensed to different licensees and meet the definition of being co-located, reasonable assurance of emergency preparedness exists where:

1. The co-located licensees would exercise their onsite plans biennially;

2. The offsite authorities would exercise their plans biennially; and,

3. The interface between offsite plans and the respective onsite plans would be exercised biennially in a full or partial participation exercise alternating between each licensee.

Thus, each co-located licensee would participate in a full or partial participation exercise quadrennially. In addition, when one of the co-located licensees is participating in a full or partial participation exercise, the final rule requires any other co-located licensees to participate in activities and interaction (A&I) with offsite authorities. For the period between exercises, the final rule also requires the licensees to conduct emergency preparedness A&I. The purpose of these A&I would be to test and maintain interface among the affected state and local authorities and the licensees.

The Commission concludes that biennial full or partial participation exercises for each co-located licensee are not warranted and that this final regulation provides a sufficient level of assurance of emergency preparedness for the following reasons. First, the final rule is consistent with the current licensees' practice for the James A. FitzPatrick/Nine Mile Point plants. This practice has been reviewed periodically by the NRC, the Federal Emergency Management Agency (FEMA), and the State of New York. NRC has continued to find that there is reasonable assurance that appropriate measures could be taken to protect the public health and safety in the event of a radiological emergency based on NRC's assessment of the adequacy of the licensees' onsite Emergency Plannings (EP) programs, FEMA's assessment of the adequacy of the offsite EP programs, and the current level of interaction between the onsite and offsite emergency response organizations in the period between full or partial participation exercises.

Second, the central requirement of a “partial participation” exercise under the current regulations is to test the “direction and control functions” between the licensee and the offsite authorities ( i.e. , protective action decision making related to emergency action levels and communications capabilities among affected State and local authorities and the licensee). The final rule contains a requirement that, in each of the 3 years between a licensee's participation in a full or partial participation exercise, each licensee shall participate in A&I with offsite authorities to test and maintain interface. By requiring that the licensee's emergency preparedness organization engage in activities and interactions with offsite authorities to exercise and test effective communication and coordination, the final rule provides the functional equivalent of a biennial exercise which tests the “direction and control functions” between the licensee and the offsite authorities. Id.

Third, the burden of requiring each licensee to participate biennially in a full or partial participation exercise with offsite participation falls most heavily on the offsite authorities ( i.e. , the state and local authorities). The Commission's 1984 and 1996 rulemakings were specifically intended to reduce the schedule for offsite exercises to remove unnecessary burden on offsite authorities. However, the Commission did not explicitly address the unique circumstance of two plants located on a single site, with each plant owned by a different licensee. This final rulemaking addresses the undue burden placed upon offsite authorities in these circumstances.

The final rule defines co-located licensees as two different licensees whose licensed facilities are located either on the same site or on adjacent, contiguous sites, and that share most of the following emergency planning and siting elements:

This paragraph is amended by adding new language governing the type and scope of EAL changes that must receive NRC approval before implementation. The final amendment clarifies that the Commission approval of EAL changes is required for changes that decrease the effectiveness of the emergency plan when a licensee proposes an alternate method for complying with the regulations, when converting from one EAL scheme ( e.g. , NUREG-0654-based) to another EAL scheme ( e.g. , NUMARC/NESP-007 or NEI-99-01-based). The final language also clarifies the existing requirement that applicants for initial reactor operating licenses and initial COLs must obtain Commission approval of initial EALs.

This paragraph is amended to articulate the emergency planning exercise requirements for co-located licensees. Under the final amendment, co-located licensees are required to exercise their onsite plans biennially. The offsite authorities will exercise their plans biennially. The interface between offsite plans and the respective onsite plans will be exercised biennially in a full or partial participation exercise alternating between each licensee. Thus, each co-located licensee will participate in a full or partial participation exercise quadrennially. In addition, when one of the co-located licensees is participating in a full or partial participation exercise, the final rule requires any other co-located licensees to participate in A&I with offsite authorities. For the period between exercises, the final rule also requires the licensees to conduct emergency preparedness A&I. The purpose of A&I is to test and maintain interface among the affected State and local authorities and the licensee. Table 1 provides a graphical description of one possible way of meeting the requirements of the final rule.

A new footnote 6 is also added to provide a definition of co-located licensees. There are two elements to the definition, both of which must be satisfied. First, co-located licensees are two different licensees whose licensed facilities are located either on the same site, or on adjacent, contiguous sites. Secondly, the co-located licensees must share most of the following emergency planning and siting elements.

1. Plume exposure and ingestion emergency planning zones;

2. Offsite governmental authorities;

3. Offsite emergency response organizations;

4. Public notification system; and/or

5. Emergency facilities.

On July 24, 2003 (68 FR 43673), the Commission published a notice of proposed rulemaking and requested public comments by October 7, 2003. A total of seven comment letters were received. One comment letter was from a member of the public, six from utilities. All of the utility letters were in favor of the proposed changes, while the public commenter suggested that the changes were unnecessary. However, the comment letters did provide suggested clarifications to the proposed amendments. A detailed evaluation of each comment received is outlined below.

Comment: In Paragraph IV.B (Assessment Actions), in lieu of adding “or licensee” in the third sentence, one commenter proposed that the following be added after the fourth sentence, “A revision to an EAL must be discussed and agreed on by the licensee and state and local government authorities prior to implementation.”

Response: The Commission disagrees with this comment because the Commission wants the original EAL submittals from applicants and licensees to be discussed and agreed on with the state and local governments and approved by the Commission. Additionally, the Commission continues to want EALs to be reviewed by the state and local governments annually and not only when revisions are made to the EALs.

Comment: “Reference is made throughout the proposed rule to NUMARC/NESP-007 as an alternative EAL scheme. Since the proposed rule was issued for public comment, NRC has endorsed NEI-99-01 as another acceptable EAL scheme. It is proposed that NEI-99-01 be referenced in addition to or in lieu of NUMARC/NESP-007.”

Response: The Commission agrees with this comment and has referenced NEI-99-01 throughout the final amendment accordingly.

Comment: “The sixth and seventh sentences in the proposed Appendix E, Paragraph IV.B appear redundant to § 50.54(q), with regard to emergency plan revisions, and Appendix E Paragraph V, with regard to implementing procedure revisions. Furthermore, these additions might necessitate a complementary change to § 50.4(b)(5) which explicitly references submittals pursuant to § 50.54(q) and appendix E Paragraph V. It is proposed that these two sentences be excluded from the final rule.”

Response: The Commission disagrees with this comment in that sentences six and seven are consistent with § 50.54(q) and 50.4 regarding sending information to the Commission. Therefore, these sentences do not necessitate a complementary change to § 50.4, nor should they be deleted from the final regulation.

Comment: “There is a possible ambiguity in Table 1—Example of Emergency Preparedness Training for Two (2) Co-Located Licensees. The table, as well as the text of the proposed changes, does not indicate that in those years when a licensee participates in a full-participation exercise, that licensee also participates in A&I with offsite response organizations. The result of this ambiguity could be an interpretation that only the non-participating licensee has any responsibility for A&I during an exercise year. The wording of the text and the table should be clarified.”

Response: The Commission agrees and has modified Table 1 accordingly.

Comment: “The list of A&I in the proposed rule contains requirements that may not apply to sites other than the James A. FitzPatrick and Nine Mile Point sites, currently the only site with two power plants licensed to two separate licensees. For instance, the last recommended interaction is “Licensee provides use of weapons firing range to local and state law enforcement (Sheriff, State Police).” While this interaction may have been negotiated as part of a support agreement for offsite response agencies at one site, it may not be appropriate at other sites.”

Response: The Commission agrees and has modified the list of A&I that are now contained in Regulatory Guide 1.101, Rev 5.

Comment: The language in § 50.54(q) could be further improved by establishing clear criteria for what constitutes a decrease in effectiveness of the Emergency Plan. Specifically, the following language should be revised, “may make changes to these plans without Commission approval only if the changes do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of paragraph 50.47(b) and the requirements of Appendix E to this part.”

The commenter suggested to add the words “a change to an emergency plan will not decrease the effectiveness of the plan if the change will not decrease the abilities of the emergency response organization, and/or supporting emergency response facilities and equipment, as required by paragraphs 10 CFR 50.47(b) and appendix E, or equivalent measures approved under 10 CFR 50.47(c), to reasonably assure the adequate protection of public health and safety in the event of a radiological emergency as stated in 10 CFR 50.47(a)(1). The change cannot delete any of the capabilities described in 10 CFR 50.47(b) and (d), or in appendix E to 10 CFR part 50.”

Response: While the Commission recognizes the merits of this comment, revising 10 CFR 50.54(q) to define what is meant by “decreasing the effectiveness” of the emergency plans was not published as part of the proposed rule and is therefore beyond the scope of this rulemaking.

Comment: One commenter believes that clarifying exercise requirements to allow alternating participation in exercises for co-located licensees will remove ambiguity that currently exists. The proposed exercise frequency, coupled with the detailed activities and interactions, will continue to provide a sufficient level of assurance of offsite emergency preparedness. Also, it will provide clear guidance for future licensing actions and avoid undue burden on offsite response organizations. Section B. [69 FR 43675-43676] is very specific in its wording as to what is the responsibility of the licensee. In this regard the rule should not be specific but refer to the commitments defined in the respective emergency response plans. The commenter believes the licensee, state, and local emergency response organizations should have the latitude to determine the appropriate training and implementation responsibilities.

Response: The Commission agrees and has removed the list of A&I from this rulemaking but has placed that list of A&I into Regulatory Guide 1.101, Rev. 5.

Comment: One commenter believes the proposed amendment to Appendix E, paragraph IV.B is unnecessary. The commenter states that the conclusion that the current regulations are unclear and can be interpreted to require prior NRC approval for all changes to a licensee's EAL requires a torturous reading of the current language.

Response: The Commission disagrees with this comment. The Commission believes that the regulations are ambiguous enough to be read to require NRC approval for all EAL changes. Consequently, the amendment to appendix E, paragraph IV.B is necessary to clarify that NRC approval of all EAL changes is not necessary to ensure an adequate level of safety.

On October 7, 1992, the Commission published its final Policy Statement on Metrication. According to that policy, after January 7, 1993, all new regulations and major amendments to existing regulations were to be presented in dual units. These final amendments to the regulations contain no units.

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or is otherwise impractical. This final rulemaking addresses two matters:

(1) The circumstances under which a licensee may modify an existing EAL without prior NRC review and approval; and

(2) The nature and scheduling of emergency preparedness exercises for two different licensees of nuclear power plants which are co-located on the same site (co-located licensees). These are not matters which are appropriate for addressing in industry consensus standards, and have not been the subject of these standards. Accordingly, this final rulemaking is not within the purview of the National Technology Transfer and Advancement Act of 1995, Public Law 104-113.

The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR part 51, that the final amendments are not major Federal actions significantly affecting the quality of human environment, and therefore, an environmental impact statement is not required. The basis for this determination reads as follows:

10 CFR 50.54(q) states that licensees may make changes to their emergency plans without Commission approval only if the changes “do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of 10 CFR 50.47(b) and the requirements of Appendix E” to 10 CFR part 50. By contrast, Appendix E states that “emergency action levels shall be * * * approved by NRC.” The industry practice, in general, has been to revise EALs in ways that do not reduce the effectiveness of the emergency plan and to implement the changes in accordance with § 50.54(q) without requesting NRC approval. The Commission believes that the current regulations are unclear and can be interpreted to require prior NRC approval for all licensee EAL changes. The Commission has determined that NRC approval of all EAL changes is not necessary to ensure an adequate level of safety. Thus, the current regulation imposes an unnecessary burden on licensees and the NRC.

10 CFR Part 50, appendix E, requires that the offsite emergency plans for each site shall be exercised biennially with the full or partial participation of each offsite authority having a role under the plans and that each licensee at each site shall conduct an exercise of its onsite emergency plan every 2 years, an exercise that may be included in the full participation biennial exercise. Paragraph IV.F.2 is ambiguous about the emergency preparedness exercise requirements where two nuclear power plants, each licensed to a different licensee, meet the definition of being co-located. Specifically, it is ambiguous regarding whether each licensee must participate in a full-participation exercise of the offsite plan every 2 years, or whether the licensees may alternate their participation, so that a full participation exercise is held every 2 years and each licensee (at a two-licensee site) participates in a full participation exercise every 4 years.

Upon consideration of the language of the current regulation and the legislative history of the exercise requirements, the Commission believes that the ambiguity in the current regulations can be interpreted that each nuclear power plant licensee co-located on either the same site, or two or more adjacent, contiguous sites, must participate in a full participation offsite exercise every 2 years (and that each offsite authority is to participate on either a full or partial participation basis in the licensee's biennial offsite exercise).

However, the Commission believes that requiring each co-located licensee to participate in a full participation exercise every 2 years, and for the offsite authorities to participate in each licensee's full participation exercise, is not necessary to provide reasonable assurance that each licensee and the offsite authorities will be able to fulfill their responsibilities under the emergency plan should the plan be required to be implemented. Furthermore, the Commission believes that this interpretation could impose an undue regulatory burden on offsite authorities. Therefore, the Commission believes that rulemaking is necessary to make clear that each co-located licensee need not participate in a full participation offsite exercise every 2 years.

The Commission finds that where two nuclear power plants are licensed to different licensees and meet the definition of being co-located, reasonable assurance of emergency preparedness exists where:

(1) The co-located licensees would exercise their onsite plans biennially;

(2) The offsite authorities would exercise their plans biennially; and,

(3) The interface between offsite plans and the respective onsite plans would be exercised biennially in a full or partial participation exercise alternating between each licensee.

Thus, each co-located licensee would participate in a full or partial participation exercise quadrennially. In addition, when one of the co-located licensees is participating in a full or partial participation exercise, the final rule requires the other co-located licensee to participate in A&I with offsite authorities. For the period between exercises, the final rule also requires the licensees to conduct emergency preparedness activities and interactions. The purpose of A&I would be to test and maintain interface among the affected state and local authorities and the licensees.

The NRC believes that the environmental impact for the final rule is negligible. The final rule does not require any changes to the design or the structures, systems and components of any nuclear power plant. The final rule would not require any changes to licensee programs and procedures for actual operation of nuclear power plants. Thus, there would be no change in radiation dose to any member of the public which may be attributed to the final rule, nor will there be any changes in occupational exposures to workers. Furthermore, the final rule will not result in any changes that would increase or change the nature of nonradiological effluents from nuclear power plants.

The alternative to the final action is to not revise the regulations ( i.e. , the no action alternative). No environmental impacts are associated with the no action alternative.

Cognizant personnel from the Federal Emergency Management Agency and New York State (for the co-located licensee part of the rule change), were consulted as part of this rulemaking activity.

This final rule increases the burden on co-located licensees to log activities and interactions with offsite agencies during the years that full or partial participation emergency preparedness exercises are not conducted and to prepare a one-time change to procedures to reflect the revised exercise requirements. The public burden for this information is estimated to average 30 hours per co-located licensee per year. Because the burden for this information collection is insignificant, OMB clearance is not required. Existing requirements were approved by the OMB, approval number 3150-0011.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

The NRC has prepared a regulatory analysis on this regulation. This analysis examines the costs and benefits of the alternatives considered by the Commission.

The Commission is making two changes to its emergency preparedness regulations contained in 10 CFR part 50, appendix E. The first amendment relates to the NRC approval of licensee changes to EALs, paragraph IV.B and the second amendment relates to exercise requirements for co-located licensees, paragraph IV.F.2. A discussion of each of these final amendments follows.

EALs are part of a licensee's emergency plan. There is an inconsistency in the emergency planning regulations regarding the threshold for when NRC approval of nuclear power plant licensee changes to emergency action levels is required. Section 50.54(q) states that licensees may make changes to their emergency plans without Commission approval only if the changes “do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of 10 CFR 50.47(b) and the requirements of appendix E” to 10 CFR part 50. By contrast, appendix E states that “emergency action levels shall be * * * approved by NRC.” Current industry practice has been to make revisions to EALs and to implement them without requesting NRC approval, after determining that the changes do not reduce the effectiveness of the emergency plan in accordance with § 50.54(q). When the determination is made that a final change constitutes a decrease in effectiveness, licensees submit the changes to the Commission for approval. If a change involves a major change to the EAL scheme, for example, changing from an EAL scheme based on NUREG-0654 guidance to an EAL scheme based on NUMARC/NESP-007 or NEI-99-01 guidance, or when proposing an alternate method for complying with the regulations, it has been the industry practice to seek NRC review and approval before implementing the change.

The emergency planning regulations were significantly upgraded in 1980 after the accident at Three Mile Island (45 FR 55402; August 19, 1980). The updated 1980 regulations required an annual exercise of the onsite and offsite emergency plans. The regulations were amended in 1984 to change the frequency of participation of state and local governmental authorities in nuclear power plant offsite exercises from annual to biennial (49 FR 27733; July 6, 1984). The regulations were amended in 1996 to change the frequency of exercising the licensees' onsite emergency plans from annual to biennial (61 FR 30129; June 14, 1996). Appendix E, to 10 CFR part 50, paragraph IV.F.2, currently provides that the “offsite plans for each site shall be exercised biennially” with the full or partial participation of each offsite authority having a role under the plans, and that “each licensee at each site” shall conduct an exercise of its onsite emergency plan every 2 years, an exercise that may be included in the full participation biennial exercise. Thus, paragraph IV.F.2 is ambiguous about the emergency preparedness exercise requirements where two nuclear power plants, each licensed to a different licensee, and meet the definition of being co-located. Specifically, it is ambiguous regarding whether each licensee must participate in a full participation exercise of the offsite plan every 2 years, or whether the licensees may alternate their participation so that a full participation exercise is held every 2 years and each licensee (at a two-licensee site) participates in a full participation exercise every 4 years.

Upon consideration of the language of the current regulation and the legislative history of the exercise requirements, the Commission believes that the ambiguity in the current regulations can be interpreted that each co-located nuclear power plant licensee must participate in a full participation offsite exercise every 2 years (and that each offsite authority is to participate on either a full or partial participation basis in each licensee's biennial offsite exercise). However, upon consideration of the matter, the Commission believes that requiring each co-located licensee to participate in a full participation exercise every 2 years, and for the offsite authorities to participate in each licensee's full participation exercise, is not necessary to provide reasonable assurance that each licensee and the offsite authorities will be able to fulfill their responsibilities under the emergency plan should the plan be required to be implemented. Furthermore, the Commission believes that this interpretation could impose an undue regulatory burden on offsite authorities. Currently, there is only one nuclear power plant site with two power plants licensed to two separate licensees: the James A. FitzPatrick and Nine Mile Point site. Although the ambiguity in paragraph IV.F.2 has limited impact today, the Commission understands that future nuclear power plant licensing concepts currently being considered by the industry include siting multiple nuclear power plants on either a single site or adjacent, contiguous sites. These plants may be owned and/or operated by different licensees. Therefore, the Commission believes that this rulemaking is necessary to remove the ambiguity in paragraph IV.F.2 and clearly specify the emergency preparedness exercise obligations of co-located licensees.

The Commission has determined that where two nuclear power plants are licensed to different licensees and meet the definition of being co-located, reasonable assurance of emergency preparedness exists where:

(1) The co-located licensees would exercise their onsite plans biennially;

(2) The offsite authorities would exercise their plans biennially; and

(3) The interface between offsite plans and the respective onsite plans would be exercised biennially in a full or partial participation exercise alternating between each licensee.

Thus, each co-located licensee would participate in a full or partial participation exercise quadrennially. In addition, in the year when one of the co-located licensees is participating in a full or partial participation exercise, the final rule requires the other co-located licensee to participate in A&I with offsite authorities. For the period between exercises, the final rule also requires the licensees to conduct emergency preparedness activities and interactions. The purpose of A&I would be to test and maintain interface among the affected state and local authorities and the licensees.

The final rule defines co-located licensees as two different licensees whose licensed facilities are located either on the same site or on adjacent, contiguous sites, and that share most of the following emergency planning and siting elements.

1. Plume exposure and ingestion emergency planning zones;

2. Offsite governmental authorities;

3. Offsite emergency response organizations,

4. Public notification system; and/or

5. Emergency facilities.

EALs are thresholds of plant parameters (such as containment pressure and radiation levels) used to classify events at nuclear power plants into one of four emergency classes (Notification of Unusual Event, Alert, Site Area Emergency, or General Emergency). EALs are required by appendix E to 10 CFR part 50 and § 50.47(b)(4), and are contained in licensees' emergency plans and emergency plan implementing procedures.

Section 50.54(q) states that licensees can make changes to their emergency plans without Commission approval only if the changes “do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of § 50.47(b) and the requirements of appendix E” to 10 CFR part 50. However, Appendix E to 10 CFR part 50 states that, “These emergency action levels shall be discussed and agreed on by the applicant and state and local governmental authorities and approved by NRC.” Because EALs are required to be included in the emergency plan, the issue is whether changes to EALs incorporated into the emergency plan are subject to the change requirements in 10 CFR 50.54(q), or to the more restrictive requirement in appendix E to 10 CFR part 50.

The NRC's current regulations contained in appendix E to 10 CFR part 50, require that the offsite emergency plans for each site shall be exercised biennially with the full or partial participation of each offsite authority having a role under the plans and that each licensee at each site shall conduct an exercise of its onsite emergency plan every 2 years, an exercise that may be included in the full participation biennial exercise. This exercise requirement, though straightforward, has implementation and compliance problems when two or more licensees' facilities are located either on the same site or on adjacent, contiguous sites, thereby requiring the same state to conduct a full participation exercise with each co-located licensee every year.

There is currently only one site with two licensees, the Nine Mile Point and James A. FitzPatrick site. However, the nuclear industry has expressed the possibility of locating new plants on currently approved sites, possibly with different licensees, thus the need for this final rule change.

Option 1—Revise the regulations to reflect current staff and licensee practices.

Option 2—Not to revise the regulations.

Option 1 for the EAL revisions would amend the existing regulations to eliminate the inconsistency between the requirements of 10 CFR part 50, appendix E and § 50.54(q) relating to approval of changes to EALs and reflect current staff and licensee practice. This would be done by amending appendix E to 10 CFR part 50 to require NRC to approve new EAL schemes, as well as proposals of alternate methods for complying with the regulations, and requiring Commission approval of revisions to EALs that reduce the effectiveness of the emergency plans in accordance with § 50.54(q). The rulemaking would provide a means for licensees to make changes to their EALs while reducing unnecessary regulatory burden.

Once the rule is revised, licensees could make EAL changes that do not decrease the effectiveness of the emergency plan without a submittal for prior approval from the Commission. This approach would reduce the unnecessary regulatory burden on licensees.

Option 2 for EAL changes would retain the inconsistency in the regulations, thereby increasing the unnecessary burden on licensees and the NRC staff in addressing questions on a case-by-case basis.

Option 1 (to amend the regulation) for co-located licensees would maintain safety because emergency planning exercises would continue to be required at the frequency which has provided reasonable assurance that the emergency plans can be implemented. The impact of Option 1 on the resources of licensees and offsite authorities would be minimal. Option 1 would reflect what licensees are currently doing and, therefore, there would not be a change in existing acceptable practices. Clarification of the regulatory requirements would modify wording that has resulted in an ambiguous understanding of the requirements. This option would require NRC resources to conduct the rulemaking. The activities and interactions that would test and maintain the interface for co-located licensees and offsite authorities in the period between exercises will provide a consistent expectation and basis for these activities. The level of A&I adequate to maintain an appropriate level of preparedness would be ensured.

The impact of the no rulemaking option (option 2) for the co-located licensee exercise revision on the resources of staff, licensees and offsite authorities would be minimal. However, without clarification of the regulatory requirements, there would be the continued ambiguity in the requirements for future co-located licensee situations. The impact of these continued ambiguities is that potential confusion over requirements would have to be resolved on a case-by-case basis by the staff. This option would not require NRC resources for conducting a rulemaking.

The final amendments modify current requirements in the NRC's approval of changes to EALs and the participation in emergency preparedness exercises for co-located licensees. The change in the requirement for NRC approval of EALs is being made for consistency, and because it reflects current practice. It reflects the Commission's original intent and does not impose a burden on licensees. However, the second change does modify the information collection requirements and impacts the burden on future co-located licensees. Current co-located licensees have implemented an emergency planning training regime consistent with the final rule.

The final amendment requires that future co-located licensees exercise their onsite plans biennially. The offsite authorities would exercise their plans biennially. The interface between offsite plans and the respective onsite plans would be exercised biennially in a full or partial participation exercise alternating between each licensee. Thus, each co-located licensee will participate in a full or partial participation exercise quadrennially. In addition, in the year when one of the co-located licensees is participating in a full or partial participation exercise, the final rule requires any other co-located licensees to participate in activities and interactions with offsite authorities. For the period between exercises, the final rule requires each licensee to conduct emergency preparedness activities and interactions. Likewise each co-located licensee would log the activities and interactions with offsite authorities that are also conducted in the period between exercises. This final rule does not increase the burden on current co-located licensees because they have an emergency planning training regime consistent with the final rule. Future co-located licensees would keep a log of the A&I with offsite authorities which is estimated to average 30 hours per co-located licensee per year.

As noted, the impact on a co-located licensee to implement the final rule change is 30 hours per year per co-located licensee. This time would be used to maintain a log of the A&I with offsite authorities. At an assumed average hourly rate of $156/hour, the total industry implementation cost is estimated at $9,360. The cost for an individual co-located licensee is $4,680 per year.

With respect to the EAL rule change, licensees would save staff time by having explicit NRC requirements and guidance that will assist the licensees in the proper submittals of EAL changes. The impact of improved regulations on the NRC is a decrease in the amount of staff time needed to review licensee EAL changes. This is estimated to be about a 100 staff-hour reduction or a $8,000 savings to the NRC per year (assuming a $80 hourly rate for NRC staff time). However, it is uncertain as to how many EAL changes might have been received by the NRC.

There would be several additional benefits associated with these amendments. The greatest would be the increased assurance that the Commission's regulations are consistent and not ambiguous. Further, by addressing these issues generically through rulemaking rather than continuing the current case-by-case approach, it is expected that the burden on the NRC staff would be reduced by several hours for each licensee EAL change as well as future co-located licensees' exercise requirements that NRC would need to approve. Another beneficial attribute to this final action is regulatory efficiency resulting from the expeditious handling of future licensing actions by providing regulatory predictability and stability for the EAL changes as well as the exercise requirements for co-located licensees.

As previously discussed, the additional burdens on a licensee and the NRC are expected to be modest. However, a revision of the requirements is desirable to remove ambiguities in the current regulations while maintaining safety and reducing unnecessary regulatory burden.

The final rule takes effect 90 days after publication in the Federal Register .

In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that the final rule will not have a significant economic impact on a substantial number of small entities. The final rule would affect only States and licensees of nuclear power plants. These States and licensees do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act, or the size standards established by the NRC (10 CFR 2.810).

The final rule, which eliminates the need for NRC approval for certain EAL changes, does not constitute a backfit as defined in § 50.109(a)(1). Although 10 CFR 50.54(q) permits licensees to make changes to their emergency plans which do not decrease the effectiveness of the plans, 10 CFR part 50, appendix E currently requires that all EALs shall be approved by NRC. The final rule clarifies the 10 CFR Part 50, Appendix E requirement to permit licensee changes to EALs without NRC approval if the changes do not decrease the effectiveness of the emergency plan. The final rule requires NRC approval for those EAL changes which decrease the effectiveness of the emergency plan, NRC approval when a licensee proposes to change from one EAL scheme to another as well as proposals of an alternate method for complying with the regulations. The final rule clarifies the requirements and represents the current practice of making changes under § 50.54 (q) requirements and is therefore not a backfit.

In addition, the final rule applies prospectively to changes initiated by licensees. The Commission has indicated in various rulemakings that the Backfit Rule does not protect the prospects of a potential applicant nor does the Backfit Rule apply when a licensee seeks a change in the terms and conditions of its license. A licensee-initiated change to an EAL does not fall within the scope of actions protected by the Backfit Rule and, therefore, the Backfit Rule does not apply to this final rulemaking.

The amendment that addresses the regulatory ambiguity regarding exercise participation requirements for co-located licensees applies to the existing co-located licensees for the Nine Mile Point and James A. FitzPatrick site and prospectively to future co-located licensees.

With respect to the Nine Mile Point and James A. FitzPatrick licensees, the final rule would arguably constitute a backfit, inasmuch as there is some correspondence between the licensees and the NRC which may be interpreted as constituting NRC approval of “alternating participation” by each licensee in a full or partial participation exercise every 2 years. The backfit may not fall within the scope of the compliance exception, 10 CFR 50.109(a)(4)(i), in view of the lack of new information showing that the prior NRC approval of “alternating participation” was based upon a factual error or new information not known to the NRC at the time that the NRC approved “alternating participation.” However, these licensees have informally been implementing an emergency planning training regime since year 2000 that is consistent with the final rule. Accordingly, the NRC will not prepare a backfit analysis addressing the Nine Mile Point and James A. FitzPatrick licensees.

With respect to future holders of operating licenses (including combined licenses under Part 52) for nuclear power plants which meet the definition of being co-located, the Commission has indicated in various rulemakings that the Backfit Rule does not protect the prospects of a potential applicant.

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of Office of Management and Budget (OMB).

I. Introduction. II. DOE's Response to Comments. III. Regulatory Review and Procedural Requirements. A. Review Under Executive Order 12866. B. Review Under the Regulatory Flexibility Act. C. Review Under the Paperwork Reduction Act. D. Review Under the National Environmental Policy Act. E. Review Under Executive Order 12988. F. Review Under Executive Order 13132. G. Review Under the Treasury and General Appropriations Act, 1999. H. Review Under the Treasury and General Appropriations Act, 2001. I. Review Under Executive Order 13084. J. Review Under the Unfunded Mandate Reform Act of 1995. K. Review under Executive Order 13211. L. Congressional Notification. I. Introduction

Pursuant to the Atomic Energy Act of 1954 and other laws, DOE carries out a variety of national defense and energy research, development and demonstration activities at facilities around the nation that are owned by the United States Government, under the control and custody of DOE, and operated by management and operating contractors under the supervision of DOE. The use of private industry and educational institutions to operate these kinds of facilities, including the national laboratories and their predecessors, dates back to the Atomic Energy Commission, if not to the Manhattan Project. It has allowed the United States to attract the best minds to do the cutting edge scientific, engineering and technical work critical to DOE's national security mission. By its nature, that work involves highly classified information regarding atomic weapons and other weapons of mass destruction; nuclear naval propulsion; intelligence related to terrorism and other topics of great sensitivity. For more than 50 years, DOE, like its predecessor the Atomic Energy Commission, has had to balance two sets of considerations. On the one hand, DOE must attract the best minds that it can to do cutting edge scientific work at the heart of DOE's national security mission, and DOE must permit its operating and management contractors to function in a manner that permits sufficient dissemination of classified work to be put to the various uses that U.S. national security demands. At the same time, it obviously must take all prudent steps to prevent enemies of this nation from gaining access to work that could be used to the detriment, rather than the enhancement, of vital national security interests.

Over the years periodic contractor lapses in adherence to processes designed to safeguard Restricted Data or other classified information have given rise to concerns about the adequacy of efforts by contractors to protect this kind of information. In order to give DOE an additional tool to assure that these processes are being followed, Congress enacted section 234B of the Atomic Energy Act of 1954. This section grants DOE new authority to impose civil penalties for violations of DOE regulations and orders directed to the safeguarding of this kind of information, as well as confirming DOE's preexisting authority to withhold portions of a contractor's fee by reason of poor performance arising out of such violations. DOE had previously promulgated regulations specifying how it would carry out this latter authority, and today's rule specifies the manner in which it will carry out its civil penalty authority. DOE believes that today's regulation will assist in providing greater emphasis on a culture of security awareness in existing DOE operations, and strong incentives for contractors to identify and correct noncompliance conditions and processes in order to protect classified information of vital significance to this nation. It will also facilitate, encourage and support contractor initiatives for the prompt identification and correction of security problems.

Section 3147 of the National Defense Authorization Act for Fiscal Year 2000 (Public Law 106-65) added a new section 234B to the Atomic Energy Act of 1954 (the Act) (42 U.S.C. 2282b). Section 234B has two subsections. The first subsection, subsection a., provides that any person who: (1) Has entered into a contract or agreement with DOE, or a subcontract or subagreement thereto, and (2) violates (or whose employee violates) any applicable rule, regulation, or order prescribed or otherwise issued by the Secretary of Energy pursuant to the Act relating to the safeguarding or security of Restricted Data or other classified or sensitive information, shall be subject to a civil penalty not to exceed $100,000 for each such violation. The second subsection, subsection b., requires that each DOE contract contain provisions which provide an appropriate reduction in the fees or amounts paid to the contractor under the contract in the event of a violation by the contractor or contractor employee of any rule, regulation or order relating to the safeguarding or security of Restricted Data or other classified or sensitive information.

DOE elected to implement section 234B in two separate rulemakings, one establishing procedural rules to implement subsection a. similar to the procedural rules to achieve compliance with DOE nuclear safety requirements found at 10 CFR part 820, “Procedural Rules for DOE Nuclear Activities,” and the other establishing a procurement clause like the existing clause for conditional payment of fee, profit or incentives, 48 CFR (DEAR) 970.5215-3. On February 1, 2001, DOE published a notice of proposed rulemaking (NOPR) (66 FR 8560) to implement subsection b. of section 234B, concerning reductions in fees or amounts paid to contractors in the event of a security violation. DOE received numerous comments in response to that notice, and responded to them in a notice of interim final rulemaking on December 10, 2003 (68 FR 68771).

On April 1, 2002, DOE published a NOPR at 67 FR 15339 to solicit comments on its proposed framework for an enforcement program for the civil penalty provisions in subsection a. The NOPR requested written comments by July 1, 2002, and invited oral comments at public hearings held in Las Vegas, Nevada on May 22, 2002, and in Washington, DC on May 29, 2002. Written comments were received from eleven sources and oral comments from two. All comments were from representatives of DOE contractors. DOE responds to the major issues raised in comments in part II of this SUPPLEMENTARY INFORMATION .

To a large extent, the regulations in this notice of final rulemaking are self-explanatory. There are, however, several fundamental features which were discussed in the NOPR that bear repeating here. DOE will apply civil penalties only to violations of requirements for the protection of classified information. Classified information is defined as “Restricted Data” or “Formerly Restricted Data” protected against unauthorized disclosure pursuant to the Act and “National Security Information” protected against unauthorized disclosure pursuant to Executive Order 12958, as amended on March 25, 2003, or any predecessor or successor order. Although section 234B refers to “sensitive information,” DOE does not employ this term in today's final regulations because: (1) Neither the statute nor its legislative history defines the term; (2) There is no commonly accepted definition of “sensitive information” within DOE or the Executive Branch; and (3) the legislative history of subsection a. indicates that the Congress was concerned with unauthorized disclosures of classified information. The additional category of unclassified information that might merit inclusion in a regulation imposing civil penalties is Unclassified Controlled Nuclear Information (UCNI), a category of unclassified government information concerning atomic energy defense programs established by section 148 of the Act (42 U.S.C. 2168). However, DOE already has a preexisting regime in place with respect to such information that includes civil penalties. Section 148 provides that any person who violates a regulation or order issued under that section shall be subject to a civil penalty not to exceed $100,000. DOE implemented the provisions of section 148 in regulations contained in 10 CFR part 1017. Since part 1017 already imposes a civil monetary penalty for unauthorized dissemination of UCNI comparable to the penalty specified in section 234B, DOE determined that it is unnecessary to include UCNI in regulations implementing section 234B.

Today's final regulations permit DOE to assess civil penalties for violations of regulations, rules or orders described in § 824.4 of part 824. These are violations of: (1) 10 CFR part 1016 (“Safeguarding of Restricted Data”); (2) 10 CFR part 1045 (“Nuclear Classification and Declassification”); or (3) any other DOE regulation or rule (including any DOE order or manual enforceable under a contractual provision) related to the safeguarding or security of Restricted Data or other classified information that specifically indicates that violation of its provisions may result in a civil penalty pursuant to section 234B, and (4) compliance orders issued pursuant to part 824.

In addition, section 161 of the Act broadly authorizes DOE to prescribe regulations and issue orders deemed necessary to protect the common defense and security (42 U.S.C. 2201). Consistent with the proposed rule, part 824 implements this authority by providing that the Secretary may issue a compliance order requiring a person to take corrective action if a person by act or omission causes, or creates a risk of, the loss, compromise or unauthorized disclosure of classified information even if that person has not violated a rule or regulation specified in § 824.4(a) of part 824. Violation of the compliance order may also result in the assessment of a civil penalty if the order so specifies. While the recipient of a compliance order may request the Secretary to rescind or modify the compliance order, the request does not stay the effectiveness of the order unless the Secretary issues a new order to that effect. The compliance order provisions in 10 CFR 824.4(b) and (c) are modeled after a similar mechanism in 10 CFR part 820, the rule implementing procedures for section 234A of the Act with respect to nuclear safety.

Today's final rule only applies to contractors and others who have entered into agreements or contracts with DOE or subagreements or subcontracts thereto. This is because subsection a. of section 234B provides that what triggers the availability of a civil penalty is the fact that a “person * * * has entered into a contract or agreement with the Department of Energy, or a subcontract or subagreement thereto, and * * * violates (or whose employee violates) any applicable rule, regulation or order.” It is clear from the statutory language, particularly the parenthetical “or whose employee violates” that Congress intended contractors and their subcontractors or suppliers to be responsible for the acts or omissions of their employees who fail to observe these rules, regulations, and orders, rather than contemplating the imposition of civil penalties on employees themselves. Consequently, part 824 provides for the assessment of civil penalties against contractors or subcontractors for their employees' actions but not against the employees themselves. The Atomic Energy Act establishes a separate regime of criminal penalties applicable to individuals for the knowing unauthorized communication of Restricted Data. See sections 224 and 227 of the Atomic Energy Act (42 U.S.C. 2274, 2277).

Subsection d. of section 234B sets limitations on civil penalties assessed against certain nonprofit entities specified at subsection d. of section 234A (hereafter the “named contractors”). For each of the named contractors, the statute provides that no civil penalty may be assessed until the entity enters into a new contract with DOE after October 5, 1999 (the date of enactment) or an extension of a current contract with DOE after October 5, 1999. The statute also limits the total amount of civil penalties assessed against the named contractors in any fiscal year to the total amount of fees paid to that entity in that fiscal year. It should be noted that the limitations applicable to the named contractors also apply to their subcontractors and suppliers regardless of whether they are for-profit or nonprofit.

The fee that represents the cap for civil penalties of nonprofits will be determined pursuant to the provisions of the specific contracts covered by the limitation on nonprofits in section 234B.d.(2).

DOE has decided not to finalize its proposal to cap civil penalties assessed against other DOE contractors that are nonprofit educational institutions under the United States Internal Revenue Code in the same manner as penalties are capped for the named contractors. The statute identifies only the named contractors as those that should receive this treatment. While Congress gave DOE authority to mitigate civil penalties, DOE has concluded that there is not a strong enough case to warrant using that authority in a categorical fashion to cap these penalties without regard to any other consideration for contractor security violations by entities other than those that Congress determined should have their penalties capped in this fashion. Rather, DOE has concluded that its mitigation authority would be better exercised on a case-by-case basis, taking into account all circumstances, both aggravating and extenuating. The final rule and enforcement policy make clear that DOE plans to exercise that authority to mitigate civil penalties based on many considerations, including an entity's financial circumstances. That should be sufficient to ensure that the civil penalty authority is not exercised in a manner that discourages non-profit institutions from seeking DOE contracts. Finally, our decision is consistent with DOE's proposed regulations for 10 CFR part 851 to implement section 234C of the Atomic Energy Act (civil penalties for worker health and safety violations), the most recent legislation providing DOE civil penalty authority.

DOE also has determined on a somewhat different approach from the one in the proposed rule for allocating responsibility among various DOE officials for the performance of certain administrative responsibilities relating to the imposition of civil penalties, including issuance of the preliminary notice of violation, issuance of final notice of violation, and settlement of enforcement actions. DOE's NOPR called for all of these responsibilities to be carried out by the Deputy Secretary on the recommendation of the Director of the Office of Security. DOE has concluded that there is no compelling reason for making the Deputy Secretary responsible for these functions in the first instance. Moreover, DOE believes it is desirable to make the procedures for part 824 consistent with the procedural framework in 10 CFR part 820 (civil penalties for nuclear safety violations) and the proposed part 851 regulations (civil penalties for worker health and safety violations). In both those frameworks, a DOE official subordinate to the Secretary and the Deputy Secretary is the official charged with initiating enforcement and related responsibilities in the case of non-NNSA contractors; in the case of NNSA contractors, the subordinate DOE official makes a recommendation to the NNSA Administrator, who then determines whether or not to accept that recommendation. In the case of a dispute between the responsible DOE official and the NNSA Administrator, the matter may be referred to the Deputy Secretary.

The part 824 rule adopted today adopts a similar framework, under which the Secretary designated a subordinate DOE official to carry out the administrative responsibilities in the case of non-NNSA contractors, but in the case of NNSA contractors this official makes a recommendation to the NNSA Administrator who decides whether or not to accept that recommendation. If the NNSA Administrator disagrees with the cognizant DOE official's recommendation, and the disagreement cannot be resolved by the two officials, the DOE official may refer the matter to the Deputy Secretary for resolution.

The Secretary of Energy has approved this notice of final rulemaking for publication.

The following discussion describes the major issues raised in comments, provides DOE's response to these comments, and sets forth or describes any resulting changes to the rule. DOE has also made a few editorial, stylistic and format changes for clarity and consistency, but DOE does not describe them in detail because they do not substantially change the terms of the proposed regulations.

A number of commenters argued that DOE's proposed enforcement program under section 234B was deficient in that it lacked an important feature of 10 CFR part 820, a general enforcement policy statement. Without a statement of general enforcement policy, these commenters viewed the proposed regulations as vague and thus susceptible to uneven, or unduly harsh application. Commenters feared that this could mean that a single inadvertent mis-classification of a document might result in a civil penalty.

Based on consideration of these comments, DOE has included in today's final regulations “Appendix A to Part 824—General Statement of Enforcement Policy,” which is closely modeled after “Appendix A to Part 820.” Appendix A to part 824 includes the following important features of the part 820 model:

Violations of DOE classified information security requirements have varying degrees of security significance. Therefore, the security significance of each violation is to be identified as the first step in the enforcement process. Violations of DOE classified information security requirements are categorized in three levels of severity. These levels are discussed in section V. of appendix A to this part. Table 1.—Severity Level Base Civil Penalties in appendix A provides the base civil penalty amount for each level of violation.

Many comments were received regarding the overall fairness of the proposed regulations and the need to ensure a consistent and equitable enforcement process.

Appendix A specifically states that DOE's goal in the compliance arena is to enhance and protect the common defense and security at DOE facilities by fostering a culture among both DOE line organizations and contractors that actively seeks not only to attain compliance with DOE classified information security requirements but also to sustain it. The DOE enforcement program and policy has been developed with the express purpose of achieving a culture committed to the best possible security at DOE's facilities. Appendix A sets out substantial incentives to the contractors for the early self-identification, reporting and prompt correction of problems which constitute, or could lead to, violations. Thus, the application of adjustment factors may result in no civil penalty being assessed for violations that are identified, reported and promptly and effectively corrected by the contractor. On the other hand, ineffective programs for problem identification and correction are unacceptable. For example, if a contractor fails to disclose and promptly correct violations of which it should be aware or should have been aware, substantial civil penalties are warranted and may be sought, including the assessment of civil penalties for continuing violations on a per day basis.

DOE received several comments that expressed the view that these regulations are premature principally because DOE is imposing new security standards by this rulemaking and contractors deserve additional funding and time to meet these new standards. DOE disagrees with these comments. No new DOE classified information security requirements are being imposed on contractors by these regulations themselves, which only set up the policies and procedures for an enforcement program that may impose civil penalties for requirements established elsewhere.

Several comments objected to civil penalties applying to violations that occurred prior to the effective date of these regulations, 30 days after the date of this publication. Paragraph (b) of section 3147 of the National Defense Authorization Act for Fiscal Year 2000 specifically states that “[s]ubsection a. of section 234B of the Atomic Energy Act * * * applies to any violation after the date of enactment of this Act.” Congress specified a different effective date for the application of civil penalties against nonprofit contractors listed in section 234A.d. (after entry into a new contract or extension of a current contract), but did not provide a similar limitation with respect to other DOE contractors.

Two issues were raised with respect to the limitation of liability for nonprofits in proposed § 824.2(b). This section would implement subsection d. of section 234B that sets limitations on civil penalties assessed against certain entities specified at subsection d. of section 234A. Some commenters argued that the cap on civil penalties, specifying that the total amount of civil penalties imposed may not exceed the fee for that fiscal year, should apply to all contractors. For reasons similar to those noted above for not finalizing its proposed approach of extending this limitation to all non-profits, DOE has not accepted this position. Rather it has concluded that it should not broaden the category of contractors to whom this limitation applies beyond the specific list identified by Congress. As DOE explained, in all other instances, it will evaluate mitigation on a case-by-case basis taking into account all relevant aggravating and mitigating circumstances.

The second issue relates to the limitation of liability for subcontractors of nonprofit contractors. Consistent with sections 234A. and 234B., today's final regulations provide at § 824.2(b)(1) that the limitations on liability apply to all subcontractors and suppliers, whether for-profit or nonprofit, of the seven named entities working at the named sites specified in subsection d. of section 234A. Commenters have indicated that this list in section 234A.d. is not current in that some of the named sites are no longer operated by the named contractors. Therefore, these commenters argue that the limitations on liability should extend to all subcontractors and suppliers of any contractor at the named sites. DOE rejects this view on the ground that Congress expressly cross-referenced, in section 234B.d., the section 234A.d. list of exceptions and that any change in that list should be accomplished, if at all, by legislative amendment.

A number of comments expressed the view that DOE needed to clarify the relationship between these regulations and the regulations of DOE's Office of Procurement and Assistance Management that implement paragraph b. of section 234B. That paragraph requires that each DOE contract contain provisions which provide an appropriate reduction in the fees or amounts paid to the contractor under the contract in the event of a violation by the contractor or contractor employee of any rule, regulation or order relating to the security of classified information. Commenters raising this issue were concerned that contractors might be subjected to both a civil penalty and a reduction in fee for one violation. Congress contemplated this possibility when it enacted both subsections a. and b. of section 234B without a requirement to choose between the two. By contrast, in the later enacted section 234C Congress specifically did require DOE to elect between civil and contractual penalties ( see section 234C.d.). Consistent with the omission of any such provision in section 234B, today's regulations neither require nor preclude such a choice.

Certain contractors commented in favor of implementing section 234B by using the process and procedures in the Contract Disputes Act, 41 U.S.C. 601-613, rather than the procedures in the proposed rule. In DOE's view, the administration of a system for imposition of civil penalties, as required by a statute, does not fall under the purposes of the Contract Disputes Act. Jurisdiction for agency boards of contract appeals, defined at 41 U.S.C. 607(d), consists only of appeals of contracting officer decisions. Section 234B provides that the powers and limitations applicable to the assessment of civil penalties under section 234A shall apply to the assessment of civil penalties under section 234B. Section 234A gives the Secretary the authority to determine, compromise or modify civil penalties to be imposed under section 234A. after opportunity for an agency hearing pursuant to 5 U.S.C. 554, before an administrative law judge appointed pursuant to 5 U.S.C. 3105. Appeals from these determinations may be made to a U.S. court of appeals.

The applicability of the Major Fraud Act, 41 U.S.C. 256(k), to civil penalty proceedings for security violations was raised by commenters who stated that DOE needs to clarify how that Act relates to investigations into suspected or alleged violations of DOE classified information security requirements. They recommended that DOE issue an interpretation stating that as long as a contractor is exempt by statute from the payment of civil penalties, the Major Fraud Act shall not be considered applicable by reason of the “monetary penalty” provision of that act. The Major Fraud Act does not make distinctions in its reimbursement prohibitions for different categories of contractors. Even those contractors that are exempt from civil penalties under other statutory or regulatory authority are subject to the reimbursement prohibitions of the Major Fraud Act. In other words, once a government-initiated proceeding has commenced which relates to a violation of, or failure to comply with, a law or regulation, the Act's restrictions apply to investigation proceeding costs, even if the outcome of the proceeding cannot be the actual payment of a monetary penalty. The cost principle at 48 CFR (FAR) 31.205-47, which implements the Act, provides that proceeding costs not made unallowable may be reimbursed, but only to the extent that the amounts of such costs do not exceed 80% of the reasonable and allocable proceeding costs incurred by a contractor.

Some commenters argued that without a “statute of limitations” a Management and Operating (M&O) contractor might be held liable for the acts or omissions of a former M&O contractor at a DOE site thus nullifying DEAR 970.5231-4 “Preexisting Conditions” which currently provides some protection to contractors new to a facility. DOE's experience with Part 820 regarding nuclear safety violations has not indicated that the absence of a “statute of limitations” provision is a problem. DOE will adopt a common sense approach in applying Part 824 and not penalize an M&O contractor for the acts or omissions of a predecessor unless the new contractor knows or should reasonably know that a violation exists. Also, one of the provisions in the “Preexisting Conditions” clause places a duty on the new contractor to inspect the facility and timely identify to the contracting officer conditions which could give rise to a liability.

DOE has revised proposed §§ 824.2 (“Applicability”) and 824.3 (“Definitions”) to address comments requesting clarification of the applicability of the regulations. These comments expressed the view that the regulations were vague and overly broad. DOE agrees that more precise language in two places in these two subsections is warranted. One comment pointed out that proposed § 824.2(a) was too broad in that it made the regulations applicable to “any entity that is subject to DOE security requirements for the protection of classified information.” This exceeds the authority conferred by the statute, which is limited to contractors and subcontractors of the Department. Section 824.2(a), as published today, tracks the language of section 234B which states that the regulations apply to any person that has entered into a contract or agreement with DOE, or a subcontract or subagreement thereto.

Also, in response to comments raising questions about the applicability of the proposed regulations to the National Nuclear Security Administration (NNSA), § 824.3 now contains a definition of the “Department of Energy.” This definition clarifies that these regulations are applicable to contractors of all components of DOE, including the NNSA.

In addition to adding a definition of the term “Department of Energy” discussed in section D of this supplementary information, DOE has made other changes in the definitions in § 824.3, in response to the comments or for purposes of clarification. DOE has revised the definition of the term “classified information” in response to a comment to track more clearly the language in the definition of that term in Executive Order 12958, as amended on March 25, 2003. We have deleted the definition of the term “contractor” because the term is not actually used in the operational sections of the regulation. Finally, we also have revised the definition of the term “Director” and, as revised, the term means “the DOE Official, or his or her designee, to whom the Secretary has assigned responsibility for enforcement under this part.”

DOE did not accept the comment that the definition of the term “person” is too broad in that it includes parents and affiliates of a contractor. Those making this comment argued that extending liability to parents and affiliates goes beyond what is permitted by section 234B and that this extension of liability is unfair. DOE disagrees. The last sentence of the definition of the term “person” in § 820.2, the DOE nuclear safety regulations implementing section 234A, states that, for purposes of civil penalty assessment, the term also includes affiliated entities, such as a parent corporation. Section 234B.c. states that the powers and limitations applicable to the assessment of civil penalties under section 234A, with certain exceptions pertaining to the nonprofit entities identified at subsection d. of that section, shall apply to the assessment of civil penalties under section 234B. Therefore, DOE believes that a broad definition of the term “person” is appropriate.

It was clear to DOE from a number of comments received about the proposed scope of the regulations that DOE should revise § 824.4 (Civil penalties”) to identify more clearly the DOE security requirements covered by these regulations. In response to one comment, DOE has incorporated language that specifies that § 824.4 applies only to acts or omissions related to “classified information protection” requirements, rather than security requirements more generally.

DOE agrees with the comment that the reference to 10 CFR part 1046 “Physical Protection of Security Interests” should not be included in § 824.4. Section 234B makes civil penalties applicable to classified information protection requirements, not requirements for the DOE protective force, such as medical and physical fitness standards. The two remaining DOE regulations, 10 CFR part 1016 (“Safeguarding of Restricted Data”) and 10 CFR part 1045 (“Nuclear Classification and Declassification”) are the only current DOE regulations containing classified information protection requirements whose violation is a predicate for civil penalties under today's rule.

DOE received one comment that DOE should impose civil penalties only for violations of regulations promulgated in accordance with the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq. , and of those DOE orders and other documents in the DOE Directive System specifically identified in the contractor's contract with DOE. Other commenters argued that no civil penalties should arise out of the violation of any classified information protection requirement except a requirement set forth in a DOE regulation. In some cases, the commenters did not indicate why DOE should exclude violations of DOE orders as the grounds for assessing a civil penalty. Commenters who did say why they opposed including DOE orders argued that inclusion: (1) Would make the proposed regulations overly broad; (2) would not provide contractors with adequate notice of what requirements DOE intended to enforce with civil penalties; and (3) would differ from DOE's enforcement policy in 10 CFR part 820 which implements section 234A of the Act with respect to nuclear safety violations.

In the rule adopted today, DOE has revised the language of the proposed rule to clarify the extent to which civil penalties will be imposed for violations of requirements in DOE orders or manuals as well as for violations of compliance orders. Specifically, § 824.4(a) and (b) have been rewritten to read as follows:

(a) Any person who violates a classified information protection requirement of any of the following is subject to a civil penalty under this part:

(1) 10 CFR part 1016—Safeguarding of Restricted Data;

(2) 10 CFR part 1045—Nuclear Classification and Declassification; or

(3) Any other DOE regulation or rule (including any DOE order or manual enforceable against the contractor or subcontractor under a contractual provision in that contractor's or subcontractor's contract) related to the safeguarding or security of classified information if the regulation or rule provides that violation of its provisions may result in a civil penalty pursuant to subsection a. of section 234 B. of the Act.

(b) If, without violating any regulation or rule under paragraph (a) of this section, a person by any act or omission jeopardizes the security of classified information, the Secretary may issue a compliance order to that person requiring that person to take corrective action and notifying the person that violation of the compliance order is subject to a notice of violation and assessment of a civil penalty. If a person wishes to contest that compliance order, the person must file a notice of appeal with the Secretary within 15 days of receipt of the compliance order.”

DOE believes that this approach appropriately carries out the Congressional policy set out in section 234B. Section 234B stressed two considerations in determining whether a civil penalty should be imposed: the status of the entity on whom the penalty might be imposed as a contractor or subcontractor, and the violation by that entity of an “applicable rule, regulation or order prescribed or otherwise issued by the Secretary pursuant to this Act relating to the safeguarding or security of Restricted Data or other classified information.” DOE's security orders and manuals are rules within the meaning of the APA (5 U.S.C. 551(4)). In light of these two considerations, DOE believes the statute is best carried out, with respect to orders and directives, by applying it to violations of those that are applicable to the contractor by virtue of its contract and that provide for the imposition of civil penalties, as well as to violations of any applicable regulations.

DOE believes that the revised language should resolve contractor concerns about vagueness and uncertainty as to what are the sources for classified information control requirements that may give rise to violations subject to civil penalties. Certain commenters feared that they might be penalized for violations of verbal, e-mail or other guidance in documents that supplemented DOE orders or manuals. Today's rule makes clear that the contractor will have fair notice since DOE only intends to enforce by civil penalties the provisions of a DOE order or manual enforceable against the contractor under its contract that provides that violations of its classified information protection provisions may result in a civil penalty. DOE considers it the responsibility of its contractors to “flow down” to their subcontractors and suppliers the requirements of those orders and directives to which civil penalties apply.

In today's rule, DOE is departing from the practice under 10 CFR part 820 regarding the imposition of civil penalties for of nuclear safety violations. Part 820 limits the scope of penalty-bearing nuclear safety requirements to those published in the CFR or set forth in compliance orders. DOE has not taken the step of departing from the approach taken in part 820 lightly. However, DOE does not believe that it can fully implement the kind of comprehensive security enforcement program that both Congress and DOE believe is required for the protection of sensitive national security interests without inclusion of relevant DOE orders and manuals. In the security area, DOE and its predecessor agencies have historically imposed requirements on contractors by internal directives rather than codified regulations. While more may be done by regulation in the future, the current reality is that many significant DOE security requirements are not promulgated by regulation. To fully carry out the program Congress contemplated in light of the serious security issues that face us today, DOE believes it should include provisions in orders and manuals enforceable against the contractor under its contract that provide that their violation carries with it the risk of a civil penalty, thereby allowing it to impose civil penalties for such violations in appropriate circumstances.

Several commenters asserted that the language of proposed § 824.4(b) was too vague and overly broad in that it stated that the Secretary may issue a compliance order if a person by act or omission “jeopardizes” the security of classified information. DOE agrees with this comment and has modified that provision to track the language of a comparable provision in part 820. The sentence now states that the Secretary may issue a compliance order if a person by act or omission causes, or creates a risk of, the loss, compromise or unauthorized disclosure of classified information.

DOE did not accept the comment made by a number of contractors that civil penalties should be assessed only if there is actual loss or compromise of classified information, not just the threat of the loss or compromise. DOE believes this takes an overly narrow view of its contractors' and its own obligations to protect classified information. If a contractor by its acts or omissions places classified information at risk, that contractor has already failed to live up to those obligations. To the extent actual compromise is relevant, it is relevant in the context of the exercise of enforcement discretion. As stated in the enforcement policy at appendix A, DOE may exercise that discretion not to assess a civil penalty or to mitigate the civil penalty under appropriate circumstances, when, for example, the contractor self reports and takes corrective actions.

DOE received several comments asserting that section 234B does not specify that a violation that is a continuing violation must constitute a separate violation for purposes of computing the civil penalty. DOE disagrees. Section 234B.c. cross-references section 234A which provides in subsection a. that if any violation is a continuing one, each day of such violation shall constitute a separate violation for the purpose of computing the applicable civil penalty. Consistent with subsection b. of section 234A, which is also picked up by section 234B's cross-reference, DOE does have authority to address inequities that may arise from this through its authority to compromise, modify or remit a penalty. It anticipates that it will exercise that authority based on mitigating factors in § 824.13 and the general enforcement policy in appendix A if the contractor exercises due diligence in identifying and correcting security problems. But as an initial matter, under the statutory provision as Congress enacted it, DOE believes that the cross-reference has the effect of defining each day of violation as a separate violation.

DOE also received comments seeking clarification of when a civil penalty will begin, i.e. , the date the violation is noticed or first occurred, and when will it end. The civil penalty begins on the date the act or omission that gives rise to the violation first occurred, but in no case before October 5, 1999. It ends when corrective action has been completed.

DOE has revised proposed § 824.5, “Notice of violation.” DOE revised the rule to accommodate comments objecting to the use of criminal law enforcement terminology in the preliminary notice of a civil violation. Specifically, commenters objected to the words “accused” and “charged.” Therefore, the preliminary notice of violation will notify the person of the date, facts, and nature of each act or omission, “constituting the alleged violation,” not “with which the person is charged.” Section 824.6(d) now refers to a person “notified of an alleged violation,” rather than “accused of a violation.”

In response to numerous comments, DOE has also decided that §§ 824.6 and 824.7 in this final rule should more closely follow the procedures in part 820 with which DOE contractors are familiar. Therefore, DOE has replaced procedures regarding a “notice of violation” in proposed § 824.5 with more extensive and detailed procedures regarding a “preliminary notice of violation” and a “final notice of violation” in §§ 824.6 and 824.7. These sections set forth more precisely the responsibilities of both the agency and the recipient of either type of notice and the effect of various actions by the agency or the recipient.

The one comment DOE received regarding discovery argued that a contractor should have equal rights with the agency. More specifically, the comment suggested that the authority of the Deputy Secretary to issue subpoenas in § 824.5 should be deleted and that language should be added to § 824.10(d) to provide that the Hearing Officer may issue subpoenas on behalf of the contractor. DOE has accepted this comment with respect to the Hearing Officer's authority, but DOE believes that the officials responsible for the administration of the civil penalty rule also should possess the authority to issue subpoenas since, for example, there may be a need to issue subpoenas in the investigatory stage of a case prior to a hearing. As discussed above in section I, while the NOPR called for the Deputy Secretary to carry out the administrative responsibilities under part 824 in the case of both non-NNSA contractors and NNSA contractors, the final rule makes a subordinate DOE official designated by the Secretary responsible for exercising the rule's procedural functions when non-NNSA contractors are involved, and the Administrator of NNSA, on the recommendation of the Director, responsible for exercising the rule's principal procedural functions when NNSA contractors are involved.

One comment suggested that DOE revise proposed § 824.7 to make clear that the purpose of the hearing is not for the contractor “to answer under oath or affirmation” the allegations. DOE agrees and the proposed section, renumbered § 824.8 now states that any person who receives a final notice of violation under § 824.7 may request a hearing concerning the allegations contained in that notice. Another comment stated that proposed § 824.11(e) should provide that DOE not only has the burden of proving, by a preponderance of the evidence, that a violation has occurred, but also the appropriateness of the amount of the proposed civil penalty. DOE has accepted this comment and revised what is now § 824.12(e) to track the language of 10 CFR part 820.29(d) with which contractors are familiar. Section 824.12(e) now reads as follows:

“DOE has the burden of going forward with and of proving by a preponderance of the evidence that the violation occurred as set forth in the final notice of violation and that the proposed civil penalty is appropriate. The person to whom the final notice of violation has been addressed has the burden of presenting and of going forward with any defense to the allegations set forth in the final notice of violation. Each matter of controversy shall be determined by the Hearing Officer upon a preponderance of the evidence.”

One comment objected on due process grounds to language that could be interpreted to mean that the Hearing Officer could exclude pertinent testimony from the hearing if the testimony is classified. This was not DOE's intent, and DOE has revised proposed § 824.11(d) to clarify how the Hearing Officer is to treat classified information and other information protected from public disclosure by law or regulation. Section 824.12(d) now provides as follows:

“The Hearing Officer must use procedures appropriate to safeguard and prevent unauthorized disclosure of classified information or any other information protected from public disclosure by law or regulation, with minimum impairment of rights and obligations under this part. The classified or otherwise protected status of any information shall not, however, preclude its being introduced into evidence. The Hearing Officer may issue such orders as may be necessary to consider such evidence in camera , including the preparation of a supplemental initial decision to address issues of law or fact that arise out of that portion of the evidence that is classified or otherwise protected.”

Section 824.13 sets out the mitigating factors that the Hearing Officer will consider in determining the amount of the civil penalty. The mitigating factors listed are identical to those in section 234A of the Act, since section 234B provides that, “the powers and limitations applicable to the assessment of civil penalties under section 234A shall apply.” DOE has added the general enforcement policy at appendix A to explain further how DOE intends to determine the amount of a civil penalty and what actions a contractor may take to influence that penalty. DOE believes that § 824.13, combined with appendix A, adequately addresses all appropriate mitigation factors. Accordingly, DOE has rejected comments urging that such factors as lack of funding or intentional misconduct of an employee be added to the list in § 824.13.

DOE received one comment suggesting that the proposed regulations should be amended to specify clearly when the agency's final action has occurred in order for the contractor to calculate the deadline for seeking judicial review of the agency's action. DOE has revised the regulations to expand and clarify the stages in the enforcement process, including what constitutes a final order enforceable against a person (see §§ 824.7 and 824.13). Additionally, although the proposed regulations provided that judicial review of a Hearing Officer's initial decision would be available only after a party appealed that decision to the Secretary, the final regulations do not provide for a losing party to appeal the Hearing Officer's initial decision to the Secretary. Instead, the regulations permit the Secretary, at his discretion, within thirty days after the Hearing Officer files the initial decision, to review the initial decision and file a final order. If the Secretary does not choose to review the initial decision within 30 days of its filing, then it becomes a final agency action.

One comment sought clarification as to whether DOE Headquarters and a DOE local office could each assess a penalty for the same offense. Only DOE Headquarters has authority to assess civil penalties.

DOE received one comment asking whether security violations revealed during audits and inspections may give rise to civil penalties. Audits and inspections may form the basis for an allegation or finding of violation under part 824, just as is the case with respect to nuclear safety violations under part 820.

Today's regulatory action has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” (58 FR 51735, October 4, 1993). Accordingly, today's action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget.

The rule was reviewed under the Regulatory Flexibility Act of 1980, Public Law 96-354, which requires preparation of an initial regulatory flexibility analysis for any rule that is likely to have significant economic impact on a substantial number of small entities. This rulemaking applies principally to large entities who are M&O contractors and establishes procedures but does not itself impose costs on the contractors or subcontractors. Therefore, DOE certifies that this regulation will not have a significant economic impact on a substantial number of small entities and, therefore, no regulatory flexibility analysis has been prepared.

No new information or record keeping requirements are imposed by this rulemaking. Accordingly, no Office of Management and Budget clearance is required under the Paperwork Reduction Act. (44 U.S.C. 3501 et seq. )

DOE has concluded that promulgation of this rule 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, this rule deals only with agency procedures, and, therefore is covered under the Categorical Exclusion in paragraph A6 to subpart D, 10 CFR part 1021. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

With respect to the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996) imposes on Executive agencies the general duty to: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and to promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that a regulation: (1) Clearly specifies its preemptive effect, if any; (2) clearly specifies any effect on existing federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies its retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of the applicable standards in section 3(a) and 3(b) to determine whether they are met or if it is unreasonable to meet one or more of them. DOE has completed the required reviews and has determined that, to the extent allowed by law, the rule meets the relevant standards of Executive Order 12988.

Executive Order 13132 (64 FR 43255, August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined today's rule and has determined that it does not preempt State law and does 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. No further action is required by Executive Order 13132.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Public Law 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family well-being. Today's rulemaking would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has not prepared 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 OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct 7, 2002). DOE has reviewed today's notice under the OMB and DOE guidelines, and has concluded that is consistent with applicable policies in those guidelines.

Under Executive Order 13084 (Consultation and Coordination with Indian Tribal Governments), DOE may not issue a discretionary rule that significantly or uniquely affects Indian tribal governments and imposes substantial direct compliance costs. This rulemaking would not have such effects. Accordingly, Executive Order 13084 does not apply to this rulemaking.

Title II of the Unfunded Mandates Reform Act of 1995 requires each agency to prepare a written assessment of the effects of any Federal mandate in a proposed or final rule that may result in the expenditure by State, local, and tribal governments and the private sector, of $100 million in any single year. DOE has determined that today's regulatory action does not impose a Federal mandate on State, local, or tribal governments or on the private sector.

Executive Order 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 (OIRA), Office of Management and Budget, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on the energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. Today's regulatory action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

As required by 5 U.S.C. 801, DOE will report to Congress promulgation of the rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804.

A final rule; request for comments AD, FR Doc. 05-40, that applies to certain RRD Tay 611-8, Tay 620-15, Tay 620-15/20, Tay 650-15, Tay 650-15/10, and Tay 651-54 turbofan engines with ice-impact panels installed in the low pressure (LP) compressor case, was published in the Federal Register on January 6, 2005 (70 FR 1172). The following corrections are needed:

History

On Tuesday, November 30, 2004, the FAA proposed to amend 14 CFR part 71 to establish a Class E surface area and to modify other Class E airspace at Independence, KS (69 FR 69554). The proposal was to establish a Class E surface area at Independence, KS. It was also to modify the Class E5 airspace and its legal description by enlarging the area to protect for diverse departures from the Independence Municipal Airport and by revising the Independence Municipal Airport ARP used in the Class E airspace legal description. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E airspace designated as a surface area for an airport at Independence, KS. Controlled airspace extending upward from the surface of the earth is needed to contain aircraft executing instrument approach procedures to Independence Municipal Airport. Weather observations will be provided by an Automatic Weather Observing/Reporting System (AWOS) and communications will be direct with Kansas City Air Route Traffic Control Center.

This rule also revises the Class E airspace area extending upward from 700 feet above the surface at Independence, KS. An examination of this Class E airspace area revealed it does not comply with airspace requirements for diverse departures from Independence Municipal Airport as set forth in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The examination also revealed discrepancies in the Independence Municipal Airport ARP used in the airspace legal description. This action corrects these anomalies. The areas will be depicted on appropriate aeronautical charts.

Class E airspace areas designated as surface areas are published in Paragraph 6002 of FAA Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of the same Order. The Class E airspace designations listed in this document will be published subsequently in the Order.

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

This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Independence Municipal Airport.

On Tuesday, November 30, 2004, the FAA proposed to amend 14 CFR part 71 to establish a Class E surface area at Lawrence, KS (69 FR 69556). Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E airspace designated as a surface area for an airport at Lawrence, KS. Controlled airspace extending upward from the surface of the earth is needed to contain aircraft executing instrument approach procedures to Lawrence Municipal Airport. Weather observations will be provided by an Automated Surface Observing System (ASOS) and communications will be direct with Kansas City Air Route Traffic Control Center. The area will be depicted on appropriate aeronautical charts.

Class E airspace areas designated as surface areas are published in Paragraph 6002 of FAA Order 7400.9M, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

This rules is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient user of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Lawrence Municipal Airport.

Federal Register document 04-24259, published on Friday, October 29, 2004 (69 FR 63056), modified the Class E airspace area extending upward from 700 feet above the surface at Sedalia, MO. The modification expanded the airspace area for diverse departures and modified or deleted extensions to the airspace area to provide controlled airspace of appropriate dimensions for aircraft executing instrument approach procedures to Sedalia Memorial Airport. The Sedalia Memorial Airport airport reference point (ARP) is used in the airspace legal description. However, publication of a revised Sedalia Memorial Airport ARP in the National Flight Data Digest on January 6, 2005, requires a further revision to the Sedalia, MO Class E airspace area.

Accordingly, pursuant to the authority delegated to me, the legal description of the Class E airspace area extending upward from 700 feet above the surface at Sedalia, MO, as published in the Federal Register on Friday, October 29, 2004, (69 FR 63056) (FR Doc. 04-24259) is corrected as follows:

The Internal Revenue Code authorizes the Secretary of the Treasury to offset Federal tax refund payments to satisfy debts owed to the United States and to collect past-due support for States. Under the Internal Revenue Service Restructuring and Reform Act of 1998, Pub. L. 105-206, 112 Stat. 685, 779 (1998), the authority to offset tax refund payments was amended to allow for the offset of Federal tax refund payments to collect past-due, legally enforceable State income tax obligations reported to the Secretary of the Treasury by States. The amendments authorizing such offsets were effective January 1, 2000.

Offsets to collect delinquent State income tax debts from Federal tax refunds are processed through the Treasury Offset Program (TOP), which is operated by FMS, the disbursing office for the Treasury Department. TOP is a centralized offset program through which FMS offsets tax refund payments, as well as other nontax Federal payments, to collect delinquent debts owed to Federal agencies and States. This rule governs only the offset of one type of payment ( i.e. , tax refunds) to pay one type of delinquent debt ( i.e. , past-due, legally enforceable State income tax obligations).

On December 20, 1999, FMS published a notice of proposed rulemaking, 64 FR 71233 (NPRM), concerning the offset of tax refunds to collect delinquent income tax obligations owed to States. On the same day, FMS published an interim rule with request for comments, 64 FR 71228, which contained the text for the NPRM. The closing date for comments regarding the proposed and interim rules was January 19, 2000.

FMS did not receive any comments on the NPRM by the close of the comment period. Likewise, FMS did not receive any comments on the interim rule, which served as the text for the NPRM. Therefore, the interim rule is adopted, without change, as a final rule.

This final rule is not a significant regulatory action as defined in Executive Order 12866. Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. The basis for this certification is that this rule only assists States in the collection of past-due legally enforceable State income tax debt. Therefore, a regulatory flexibility analysis is not required.

FMS has determined that good cause exists to make this final rule effective upon publication without providing the 30-day period between publication and the effective date contemplated by 5 U.S.C. 553(d). The purpose of a delayed effective date is to afford persons affected by a rule a reasonable time to prepare for compliance. However, in this case, FMS has been collecting past-due income tax obligations owed to States by tax refund offset since January 2000. Procedures affecting States submitting delinquent income tax obligations for collection and persons owing delinquent income tax obligations to States remain substantially unchanged. This final rule provides important guidance that is expected to facilitate States' participation in the tax refund offset program. Therefore, FMS believes that good cause exists to make the rule effective upon publication.

On December 10, 2004, we published a notice of proposed rulemaking (NPRM) entitled Regulated Navigation Areas, Security Zones, and Temporary Anchorage Areas; St. Johns River, Jacksonville, FL in the Federal Register (Volume 69, Number 237). We received one letter commenting on the proposed rule. No public meeting was requested, and none was held.

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 . Delaying the effective date would be contrary to the public interest because the events will take place less than 30 days after publication and immediate action is needed to minimize potential danger to the public, port and waterways. There is significant national security interest during the Super Bowl in protecting the waterways surrounding downtown Jacksonville, cruise ships, nearby vessels, and the public from destruction, loss, or injury from sabotage or other subversive acts, accidents or other causes of a similar nature.

In light of terrorist attacks on New York City and the Pentagon in Arlington, VA, on September 11, 2001, and the continuing concern for future terrorist and or subversive acts against the United States, especially at high visibility events where a large number of persons are likely to congregate, the Coast Guard is establishing temporary regulated navigation areas and security zones in certain waters of the St. Johns River.

The Super Bowl is a sporting event, hosted each year in a different city in the United States, sponsored by the National Football League (NFL). Super Bowl XXXIX will be held in Jacksonville, FL, on Sunday, February 6, 2005, at ALLTEL Stadium. Security measures for Super Bowl XXXIX and the events preceding it, including temporary regulated navigation areas, security zones and anchorages designated herein, are necessary from February 2, 2005, to February 7, 2005, and are needed to safeguard the maritime transportation infrastructure, the public, and designated participants from potential acts of violence or terrorism during Super Bowl XXXIX activities.

The planning for these regulated navigation areas and security zones has been conducted in conjunction with federal, state and local law enforcement agencies. There is significant national security interest during the Super Bowl in protecting the waterways surrounding downtown Jacksonville, cruise ships, nearby vessels, and the public from destruction, loss, or injury from sabotage or other subversive acts, accidents or other causes of a similar nature.

These regulations amend existing security zones established at 33 CFR § 165.759 to increase the fixed security zones around cruise ships docked at the Talleyrand Marine Terminal and the Jacksonville Cruise Ship Passenger Terminal from 100 yards to 400 yards.

These regulations also amend existing anchorage regulations established at 33 CFR 110.183 by removing Anchorage A, modifying Anchorage B, and establishing various temporary anchorages marked by buoys. Some of the temporary anchorages will be exclusively for use by small recreational vessels and others will be for larger recreational vessels and commercial vessels.

Coast Guard Marine Safety Office Jacksonville received one letter comment in response to the notice of proposed rulemaking. The letter requested clarification on the procedures by which permission to remain within a security zone by a vessel already in the zone when it becomes effective is requested from the Captain of the Port. The inquiry was addressed by telephone and the procedures described in paragraph (c)(2) of proposed § 165.T07-090 were explained. Additionally, a minor modification to the text of the temporary final rule was made.

This temporary final rule will incorporate the following changes to the proposed rule:

(1) Security Zones : The proposed rule explained how vessels or persons desiring to enter or transit the security zones could seek permission from the Captain of the Port or his designated representatives on VHF Channel Marine 12, but did not give a corresponding instruction for vessels or persons desiring to remain when located within a zone at the time it becomes effective. This temporary final rule contains a clarifying sentence to include the instruction that vessels or persons within a security zone when it becomes effective may contact the Coast Guard Captain of the Port or his designated representatives on VHF Channel Marine 12 to seek permission to remain in the security zone.

(2) Anchorage Regulations : The proposed rule added new paragraph (c) to existing anchorage regulations in 33 CFR 110.183 to modify the coordinates for Anchorage B. The temporary final rule changes the latitude of the point of beginning for Anchorage B from 30°21′00″ N to 30°20′50″ N, for greater accuracy.

(3) Anchorage Regulations : The proposed rule added new paragraph (e) to existing anchorage regulations at 33 CFR § 110.183 to limit anchoring between the Fuller Warren Bridge and the Matthews Bridge to recreational vessels 40 feet or less in length within areas to be marked by temporary buoys. This temporary final rule broadens the proposed restriction to allow anchoring between the Fuller Warren Bridge and the Matthews Bridge by recreational vessels 60 feet or less in length within areas to be marked by temporary buoys.

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

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Although the regulated navigation areas apply to a large section of the St. Johns River, traffic will be allowed to pass through the zones with the permission of the Captain of the Port Jacksonville or his designated representatives. Additionally, the Coast Guard has consulted with industry representatives to obtain concurrence with the rule and has attended public meetings with recreational boaters to discuss impact of the rule. Before the effective period, the Coast Guard will issue maritime advisories widely available to users of the river.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in portions of the St. Johns River at various times between February 2, 2005 and February 7, 2005.

These regulations will not have a significant economic impact on a substantial number of small entities for the following reasons. Each area, zone or anchorage restriction in this rule will only be in effect for a limited duration. With the exception of vessels carrying certain dangerous cargo as defined in 33 CFR 160.204, vessels will still be allowed to transit after obtaining authorization from the Captain of the Port or his designated representatives. All vessels carrying certain dangerous cargo as defined in 33 CFR 160.204 will be prohibited from transiting the security zones. Based upon consultation with local industry representatives it has been determined there is no regular traffic of such vessels on the St Johns River through the area of the anticipated security zones and no such traffic is expected.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. On December 10, 2004, we published a notice of proposed rulemaking (NPRM) for this rule in the Federal Register (Volume 69, Number 237) on December 10, 2004. One comment was received in response to the NPRM.

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

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f) and (g), of the Instruction, from further environmental documentation. As anchorage regulations, regulated navigation areas and security zones, the temporary final rules satisfy the requirements of paragraphs 34(f) and (g).

Under figure 2-1, paragraph (34)(f) and (g) of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Publishing a NPRM and delaying its effective date would be contrary to public interest, since immediate action is needed to protect mariners against potential hazards associated with oil spill recovery operations and to ensure the safety of the environment on the Delaware River and its tributaries. Due to the amount of time needed to clean up the oil spill, this safety zone is needed to facilitate safe oil spill recovery operations.

On November 27, 2004 at 9:30 p.m. the T/V ATHOS I reported a major discharge of oil on the waters of the Delaware River. Oil spill response operations are being conducted in the safety zone. A number of oil spill response vessels and clean up personnel will be in the safety zone during the duration of the response operations. This rule establishes a safety zone, on the Delaware River covering all the waters of the area bound from the Tacony-Palmyra Bridge to the Bellevue/Marcus Hook ship ranges, at Buoy 2M. Mariners will only be allowed to transit the safety zone with the permission of the COTP or his designated representative. The safety zone will protect mariners and oil spill responders from the hazards associated with spill recovery and clean up operations. The Captain of the Port will notify the maritime community, via marine broadcasts, of the ability of vessels to transit through the safety zone. Mariners allowed to travel through the safety zone with the permission of the COTP must maintain a minimum safe speed, in accordance with the Navigation Rules as seen in 33 CFR Chapter I, Subchapters D and E.

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).

We expect the economic impact of this proposed rule to be 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), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

This rule will have virtually no impact on any small entities. This rule does not require a general notice of proposed rulemaking and, therefore, it is exempt from the requirement of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impact on small entities.

Therefore, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C 605(b)) that this rule will not have a significant impact on a substantial number of small entities.

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

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency?s responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-743-3247).

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it 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. We invite your comments on how this rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the Order.

We have analyzed this rule under Executive Order 12211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We encourage you to submit comments and related materials. Comments and related materials must reach the Docket Management Facility on or before March 13, 2005.

If you submit a comment, please include your name and address, identify the docket number for this rulemaking [CGD09-05-001], indicate the specific section of this document to which each comment applies, and give the reason for each comment. You may submit your comments and material by mail or delivery to the docket management facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this rule in view of them.

We do not now plan to hold a public meeting. But you may submit a request for one to the docket management facility at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

We did not publish a notice of proposed rulemaking (NPRM) for this rulemaking. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This potential hazard to vessels and people only recently became apparent, and therefore we were unable to publish an NPRM followed by a final rule. At this point, it would be impracticable and contrary to the public interest to provide for notice and comment, due to the need to prevent the risk of electrocution to vessels and their crew/passengers. During the initial enforcement of this regulated navigation area, comments will be accepted and reviewed and may result in a modification to the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists to make this rule effective less than 30 days after publication in the Federal Register . Delaying this rule would be impracticable and contrary to the public interest of ensuring the safety of persons and vessels, and immediate action is necessary to prevent possible loss of life or property.

On January 7, 2005, the U.S. Army Corp of Engineers, in close coordination with the U.S. Coast Guard, conducted preliminary safety tests on the Chicago Sanitary and Ship Canal at Mile Marker 296.5 in the vicinity of the demonstration electrical dispersal barrier located on the canal near Romeoville, IL. This barrier was constructed to prevent Asian Carp from entering Lake Michigan through the Illinois River system by generating a low-voltage electric field across the canal. The Coast Guard and Army Corps of Engineers conducted field tests to ensure the continued safe navigation of commercial and recreational traffic across the barrier; however, results indicated a significant arcing risk and hazardous electrical discharges as vessels transited the barrier posing a significant risk to navigation through the barrier. To mitigate this risk, navigational and operational restrictions will be placed on all vessels transiting through the vicinity.

Until this potential hazard to navigation can be rectified, the Coast Guard will require vessels transiting the regulated navigation area to adhere to specified operational and navigational requirements. These requirements include: All vessels are prohibited from loitering in the vicinity of the electrical dispersal barrier. “Vicinity” of the electrical dispersal barrier is defined as the Chicago Sanitary and Ship Canal from the north side of the Romeo Highway Bridge at Mile Marker 296.1 to the aerial pipeline arch located at Mile Marker 296.7. Vessels may enter this section of the waterway with the sole purpose of transiting to the other side, and must maintain headway throughout the transit. All personnel on open decks must wear a Coast Guard approved Type I personal flotation device while in the “vicinity” until subsequent field testing determines the waters in this area do not pose significant risk to human life. Vessels may not moor or lay up on the right or left descending banks. Towboats may not make or break tows. Vessels may not pass (meet or overtake) in the “vicinity” and must make a SECURITE call when approaching the barrier to announce intentions and work out passing arrangements on either side. Commercial tows transiting the barrier must be made up with wire rope to ensure electrical connectivity between all segments of the tow.

These restrictions are necessary for safe navigation of the barrier and to ensure the safety of vessels and their personnel as well as the public's safety due to the electrical discharges noted during recent safety tests conducted by the Army Corps of Engineers. Deviation from this rule is prohibited unless specifically authorized by the Commander, Ninth Coast Guard District or his designated representative.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget 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 rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This determination is based on the fact that traffic will still be able to transit through the RNA.

This rule does not require a general notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impact on small entities.

We suspect that there may be small entities affected by this rule but are unable to provide more definitive information. The risk, outlined above, is severe and requires that immediate action be taken. The Coast Guard will evaluate as more information becomes available.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment to the Docket Management Facility at the address under ADDRESSES. In your comment, explain why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the point of contact listed in ADDRESSES. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore this rule is categorically excluded, under figure 2-1, paragraph 34(g) from further environmental documentation. This temporary rule establishes a regulated navigation area and as such is covered by this paragraph.

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

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 a NPRM. Publishing a NPRM, which would incorporate a comment period before a final rule could be issued, and delaying the rule's effective date is contrary to public safety because immediate action is necessary to protect the public and waters of the United States.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The Coast Guard will issue a broadcast notice to mariners and may place Coast Guard vessels in the vicinity of this zone to advise mariners of the restriction.

This rule is needed to protect spectator craft in the vicinity of the fireworks presentation from the hazards associated with transport, storage, and launching of fireworks. Anchoring, mooring, or transiting within these zones is prohibited, unless authorized by the Captain of the Port, Jacksonville, Florida. The temporary safety zone encompasses all waters 500 yards east and west of the Main Street Bridge, 500 yards east of the Acosta Bridge, and 500 yards west of the Hart Bridge.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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

The Coast Guard certifies under section 5 U.S.C. 605(b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for one hour and the impact on routine navigation are expected to be minimal because traffic may transit safely around the zone and traffic may enter upon permission of the Captain of the Port or his representative.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or 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 substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have 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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

This action sets forth the dispute resolution procedures based on the Class Deviation that are to be used in lieu of the dispute procedures contained in 40 CFR 30.63 and 40 CFR part 31, subpart F, 40 CFR 31.70 for the resolution of EPA assistance agreement competition-related disputes and disagreements. These procedures will ensure that applicants are provided with a meaningful and effective dispute resolution process for assistance agreement competition-related disputes and disagreements. The procedures provide that unsuccessful applicants will receive timely notification that EPA determined that their application or proposal was either ineligible for an award or was not selected for an award. Applicants may then, upon request, obtain a timely debriefing on the basis for the Agency's decision. Debriefings may be oral or written but are mandatory if the applicant intends to file a dispute in order to minimize misunderstandings between the Agency and the applicant and provide an opportunity to expeditiously resolve differences without the need to file a formal dispute. The applicant may file a formal dispute within 15 calendar days after the debriefing.

In addition to establishing a nationally consistent assistance agreement competition disputes process, the procedures in this document clarify roles and responsibilities and specify the circumstances in which applicants may dispute EPA decisions. Agency Officials must appoint a Grants Competition Disputes Decision Official (GCDDO) to resolve the dispute; the GCDDO cannot be involved in the decision that is the subject of the dispute. The GCDDO determines whether the issues raised in the dispute warrant delaying the competitive process until the dispute is resolved. These procedures also generally limit disputes to eligibility-type determinations made by EPA and generally do not allow an applicant to challenge a scoring or ranking determination, unless there is a compelling reason or an issue of national significance which would warrant EPA review of the dispute. The procedures also establish that the GCDDO's decision will constitute final agency action for the purposes of judicial review with no right to any further EPA review.

In addition, EPA headquarters and regional program offices may, with the approval of the EPA Grants Competition Advocate, adopt dispute resolution procedures that are “substantially the same” as the procedures contained in this document. Each EPA announcement for a competitive assistance agreement will either include or reference the applicable disputes procedure for that particular competition (if referenced, the announcement will indicate how applicants can obtain a copy of the dispute procedures).

Regulated Entities: The assistance agreement competition-related disputes procedures covered by this action apply to all entities which compete for competitive assistance agreement awards that are subject to the applicable EPA assistance agreement procedures found at 40 CFR parts 30, 31, and 35 unless the part 35 regulations contain specific dispute procedures that apply to such awards.

Background: The regulatory disputes resolution coverage currently found at 40 CFR 31.70 was initially codified in the CFR on September 30, 1983 at 40 CFR 30.303(b) and 40 CFR part 30, subpart L (1983). 48 FR 4506 (September 30, 1983). At that time, EPA changed the assistance agreement disputes process from an adversarial, trial type process before the EPA Board of Assistance Appeals, to a more informal system administered by Agency program managers. The preamble to the final rule described the 1983 changes to the disputes process as follows:

The new process will:

1. Encourage cooperation between the Agency's officials and those applying for and receiving assistance.

2. Develop a good administrative record to support the Agency's final decisions.

3. Provide applicants and recipients high-level review of Agency decisions and a forum for resolving disputes informally, expeditiously, and inexpensively.

4. Provide applicants and recipients a written decision explaining the basis for the position.

Fair and consistent dispute resolution remains a central principle of administering EPA's assistance programs. The procedures in subpart L continue to give recipients and applicants the right to request a high level review of decisions concerning issues arising under the EPA assistance programs. 48 FR at 45060.

These same disputes provisions and processes were included in EPA regulations found at 40 CFR parts 30 and 31 implementing the “common rules” for OMB Circular A-102 in 1988 and OMB Circular A-110 in 1996. 53 FR 8034, 8076 (March 11, 1988); 61 FR 6066, 6081 (February 15, 1996). The dispute provisions were moved from 40 CFR part 30, subpart L to 40 CFR part 31, subpart F, 40 CFR 31.70, when EPA implemented OMB Circular A-102 through 40 CFR part 31. The Agency's rule implementing OMB Circular A-110 incorporates the 40 CFR 31.70 disputes procedures at 40 CFR 30.63. However, neither OMB Circular A-102 nor A-110 contains government-wide assistance agreement dispute provisions.

Based on the language in the preamble discussed above referencing the applicability of the disputes process to applicants, EPA concluded that the assistance agreement disputes process would apply if an applicant for a competitively awarded agreement chose to dispute a decision that it was either ineligible to compete for the agreement or that its application was not selected for funding based on the merits of the proposal. Consequently, EPA's September 2002 Policy for Competition in Assistance Agreements provided that the Agency would follow the 40 CFR 31.70 process for disputes and disagreements related to EPA assistance agreement competitions.

Notwithstanding the statements in the 1983 preamble regarding assistance agreement applicants, the 40 CFR 31.70 disputes provisions are geared to effectively resolve cost allowability or assistance agreement administration disputes rather than competition-related disputes and disagreements that may arise in connection with the award of assistance agreements. This disputes process does not specify any time frame for an applicant to dispute a decision or for EPA to issue a final decision. It does not provide Agency selection and award officials with nationally consistent policies and procedures for the resolution of assistance agreement competition-related disputes or for determining whether the application/proposal evaluation and award process needs to be delayed when an applicant files a dispute. The process is time consuming, particularly since it includes two administrative appeal levels, and resource intensive for both EPA and aggrieved applicants and is not suitable for the resolution of competition-related disputes and disagreements.

In order to address these issues for assistance agreement competition-related disputes and disagreements, this action sets forth dispute resolution procedures that will provide applicants with a meaningful dispute resolution process that is better suited for competition-related disputes and disagreements than the 40 CFR part 30 and 40 CFR part 31, subpart F dispute procedures. Accordingly, pursuant to 40 CFR 31.6(d), the Director of the EPA Grants Administration Division has issued a Class Deviation approving the use of these procedures.

Statutory and Executive Order Reviews: Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to OMB review. Because this grant action is not subject to notice and comment requirements under the Administrative Procedures Act or any other statute, it is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) or sections 202 and 205 of the Unfunded Mandates Reform Act of 1999 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments. This action does not have tribal implications, as specified in Executive Order 13175 (63 FR 67249, November 9, 2000). This action will not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action 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. This action does not involve technical standards; 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 action 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., generally provides that before certain actions may take affect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. Since this final grant action contains legally binding requirements, it is subject to the Congressional Review Act, and EPA will submit this action in its report to Congress under the Act.

EPA establishes assistance agreement competition-related dispute resolution procedures as follows:

1. The authority citation for the assistance agreement competition-related disputes resolution procedures in this document is the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301(3).

2. The disputes resolution procedures that will apply to EPA assistance agreement competition-related disputes and disagreements will be referenced or included in competitive announcements and are as follows:

a. Whenever practicable, disputes and disagreements relating to assistance agreement competition-related decisions and actions must be resolved at the lowest level possible.

b. The procedures and time frames specified below are designed to provide for an efficient, effective, and meaningful dispute resolution process. EPA Program Offices may use “substantially the same” dispute procedures as those specified herein if they are approved by the EPA Grants Competition Advocate (GCA) and provide applicants with a meaningful dispute resolution process. A meaningful dispute resolution process is one that affords unsuccessful applicants the opportunity for an effective remedy if they succeed on their dispute.

c. Notification: (1) The Program Office conducting the competition must provide applicants with timely written or e-mail notification that they were (i) determined to be ineligible for award consideration as a result of the threshold eligibility review of their application/proposal ( e.g., the application/proposal failed to meet the threshold eligibility criteria in the announcement), or (ii) not selected for award based on their ranking/scoring after an evaluation of their application/ proposal against the ranking and selection factors in section V of the announcement.

(2) Notification of ineligibility must be provided by the Program Office to the applicant within fifteen calendar days of the decision finding that the applicant was not eligible for award consideration because of a failure to meet the threshold eligibility criteria in the announcement; notification to applicants that they were not selected for award based on the ranking/scoring of their proposal/application must be provided by the Program Office to the applicant within fifteen calendar days of the final selections for award.

(3) The notification letter or e-mail must indicate, as appropriate, that the applicant and/or its application/proposal was not eligible for award consideration based on the threshold eligibility review, or not selected for award based on the ranking/scoring of its application/proposal, and generally explain the reasons why. It must also advise the applicant that it may request a fuller debriefing (and notify the applicant that it must make its debriefing request within fifteen calendar days of receiving the notification letter or e-mail) of the basis for the ineligibility determination or selection decision. Debriefings, however, are not required when an applicant's proposal/application is rejected solely because it failed to meet a submission deadline date specified in section IV of the announcement ( e.g., it was received, postmarked, etc., after the deadline established in the announcement making it a late proposal/application).

d. Debriefings: (1) Debriefings may be done orally ( e.g., face to face, telephonically) or in writing at the discretion of the Program Office, although oral debriefings are strongly preferred because they provide a better opportunity to resolve questions and issues in an expedited manner. For oral debriefings, the Program Office will conduct the debriefing of the unsuccessful applicant at a mutually agreeable time and place as soon as practicable after receiving the debriefing request; for written debriefings, the Program Office will provide the unsuccessful applicant with a written debriefing as soon as practicable after receiving the debriefing request. All debriefings, but particularly those for applicants that were deemed ineligible for award consideration for failure to meet the threshold eligibility factors in the announcement, must be conducted in a timely manner so that the applicant has the opportunity to obtain a meaningful remedy if they successfully challenge the ineligibility determination.

(2) Upon receiving a debriefing request from an unsuccessful applicant, the Program Office must promptly notify the Director, Office of Grants and Debarment, or regional award official, as appropriate, so that a Grants Competition Dispute Decision Official (GCDDO) can be designated.

(3) The oral or written debriefing will be limited to explaining why the applicant was found ineligible for award consideration or why it was not selected for award and must not disclose any information protected from disclosure by applicable law or regulation ( e.g., the Freedom of Information Act, Privacy Act), including trade secrets, privileged or confidential commercial, financial or other information exempt from disclosure under the Freedom of Information Act, or the identity of review panel members or other reviewers. The Program Office should consult with Office of General Counsel/Office of Regional Counsel (OGC/ORC) attorneys before any oral debriefing and allow them to review any written debriefing response before it is sent. Further, any questions relating to what type of information may be disclosed at a debriefing must be directed to OGC/ORC attorneys or the Grants Competition Advocate.

(4) The debriefing explanation will, as appropriate:

(A) Identify the threshold eligibility criteria that the applicant failed to meet and specify the basis for the Agency's determination that the proposal/application or applicant was not eligible for award consideration because of failure to meet the threshold eligibility criteria.

(B) Provide the applicant with the numerical ( e.g., points) or other basis for scoring/ranking its proposal/application under the evaluation criteria used in the competition.

(C) Provide the applicant with information on the strengths and weaknesses of its proposal/application in terms of the specific evaluation criteria used in the competition.

(D) Provide responses to relevant questions regarding whether the evaluation and selection procedures contained in the announcement were followed and why the applicant was not selected for award. However, the debriefing must not include point by point comparisons of the applicant's proposal/application to other proposals/applications.

(E) Identify the GCDDO.

e. Filing of a Dispute: (1) After receiving a debriefing, an unsuccessful applicant or their representative may file a written dispute with the appropriate GCDDO. When there was an oral debriefing, the written dispute must be received by the GCDDO within fifteen calendar days of the debriefing date; when there was a written debriefing, the written dispute must be received by the GCDDO within fifteen calendar days of when the applicant received the written debriefing letter. The written dispute must include a detailed statement of the legal and/or factual basis for the dispute, the remedy that the applicant is seeking, information on how to communicate with the applicant or its representative ( e.g., phone and fax numbers, e-mail address), and any documentation relevant to the dispute. Disputes may only be filed with the GCDDO after a debriefing; disputes filed before, or in the absence of, a debriefing will be dismissed. Furthermore, the GCDDO is only required to consider disputes on the following grounds:

(A) Where an applicant challenges the EPA determination that it and/or its proposed project is ineligible for funding based on the applicable statute, regulation, or announcement requirements; or

(B) Where the applicant challenges the decision that it is not eligible for award consideration because EPA determined that its proposal/application did not meet the threshold eligibility requirements contained in the announcement.

(2) Unsuccessful applicants whose proposal/application was rejected solely because it was received late, or who were not selected for award based on the ranking/scoring of its proposal/application after a full evaluation by EPA based on the ranking and selection criteria in section V of the announcement ( e.g., challenges to the Agency's technical evaluation or ranking/scoring of the applicant based on the ranking and selection factors in section V of the announcement), are not entitled to file disputes with the GCDDO. Such disputes will be dismissed by the GCDDO except as may be provided for in paragraph (3) below. In addition, the GCDDO may dismiss any dispute that is clearly untimely filed, raises issues that the GCDDO will not consider, or that fails to set forth a detailed statement of the legal and/or factual basis for the dispute.

(3) The GCDDO, for good cause shown and where there are compelling reasons, or where he/she determines that a dispute raises significant issues of widespread interest to the assistance agreement community, may consider an untimely filed dispute or any other dispute filed by an unsuccessful applicant. The GCDDO will invoke this discretion sparingly.

f. If a dispute is filed, the GCDDO must consult with the Program Office, OGC/ORC, and the GCA, and then determine whether it is in the Agency's best interest to delay the award process pending resolution of the dispute, particularly for disputes involving threshold eligibility issues.

g. Unsuccessful applicants must be provided with reasonable access to Agency records relevant to the dispute in a manner consistent with the standards contained in the Freedom of Information Act. EPA will not disclose materials exempt from disclosure under the Freedom of Information Act.

h. Upon receiving a dispute, the GCDDO will establish a process and schedule for resolving the dispute and communicate this to the applicant and affected Program Office. At his or her discretion, the GCDDO may (i) request additional information from the applicant or Program Office and/or (ii) meet by phone or in person with the unsuccessful applicant and/or Program Office.

i. After reviewing all of the information relevant to the dispute, the GCDDO, after consultation with the GCA, and with the concurrence of the OGC/ORC, will timely issue a final written decision regarding the dispute. The GCDDO's decision will constitute final agency action and is not subject to further review within the Agency.

On November 14, 2003, the South Carolina Department of Health and Environmental Control submitted revisions to the South Carolina SIP. These revisions were published in the South Carolina State Register on August 28, 1998 and June 25, 1999, revising Regulation 61-62.1 Definitions and General Requirements. The revisions include modifications to existing definitions and additions of new definitions and text to clarify Permitting Requirements.

a. In Regulation 61-62.1, Section I—Definitions, the State noted a discrepancy in the definition of Volatile Organic Compounds (VOC) and submitted a revised definition to restore uniformity to the SIP.

a. In Regulation 61-62.1, Section I—Definitions, the following definitions are being modified using language more consistent with State and Federal regulations:

The following terms are being added to Section I:

The following terms are being deleted from Section I:

All subsequent definitions have been renumbered and formatted for consistency.

b. In Regulation 61-62.1, Section II—Permit Requirements, the existing text in A.2. and G.8.a. is being revised to include an exemption for the review and signature of construction permit applications. The exemption states that professional engineers employed by the government may also review and sign these documents if they are preparing applications for the Federal government.

c. In Regulation 61-62.1, Section II, A.3., the existing language is revised to clearly define construction permit exempt facilities. Part of the existing text in Section II. A.3. will be renumbered to Section II. A.4.

d. The SIP amendments to Regulation 61-62.1 were done concurrently with amendments to the State-only Regulation 61-62.5, Standard No. 3, Emissions from Incinerators. EPA will not be acting on the amendments to Regulation 61-62.5, Standard No. 3 because it is not a part of the federally approved SIP.

EPA is approving the aforementioned changes to the State of South Carolina SIP because they are consistent with the Clean Air Act and EPA policy. The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective March 28, 2005 without further notice unless the Agency receives adverse comments by February 25, 2005.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on March 28, 2005 and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 . 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).

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 March 28, 2005. 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 may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

You may be potentially affected by this action if you are a federal or state government agency involved in administration of environmental quality programs (i.e., Departments of Agriculture, Environment, etc). 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 .

In addition to using EDOCKET (http://www.epa.gov/edocket/) , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

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 imidacloprid, [[(1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on bananas at 1.0 parts per million (ppm) and sunflower at 0.05 ppm. These tolerances will expire and are revoked on December 31, 2007. 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 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Imidacloprid was requested by the State of Hawaii for use on bananas because of the ineffectiveness of currently registered insecticides in controlling the banana leaf aphid, and the insect's ability to vector Bananas Bunchy Top Virus (BBTV). EPA has authorized under FIFRA section 18 the use of imidacloprid on bananas for control of banana aphids in Hawaii. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

The States of Minnesota, Nebraska, and North Dakota declared crises for use of imidacloprid on sunflower seed to control wireworms due to the loss of the use of lindane and the lack of a viable alternative to control this pest on this crop.

As part of its assessment of these emergency exemptions, EPA assessed the potential risks presented by residues of imidacloprid in or on bananas and sunflowers. 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, 2007, 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 bananas and/or sunflowers 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 imidacloprid meets EPA's registration requirements for use on bananas and/or sunflower 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 imidacloprid 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 Hawaii to use this pesticide on bananas and the States of Minnesota, Nebraska, and North Dakota to use this pesticide on sunflower seed 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 imidacloprid, 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 imidacloprid and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of imidacloprid in or on bananas at 1.0 ppm and sunflower at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances 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 (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the 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 (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for imidacloprid used for human risk assessment is shown in Table 1:

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET (http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

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 combined residues of the herbicide fluroxypyr 1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on onion at 0.02 parts per million (ppm). This tolerance will expire and is revoked on June 30, 2007. 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.

According to the State of Colorado, due to a long string of mild winters, volunteer potatoes have become a more important problem. They are especially difficult to control in onions, and due to the noncompetitive nature of onions versus the large vigorous growth of volunteer potatoes, they result in very large yield reductions if not controlled. None of the currently registered herbicides for onions provide acceptable control of volunteer potatoes. EPA has authorized under FIFRA section 18 the use of fluroxypyr 1-methylheptyl ester on onion for control of volunteer potatoes in Colorado. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of fluroxypyr 1-methylheptyl ester in or on onion. 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, 2007, 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 onion 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 fluroxypyr 1-methylheptyl ester meets EPA's registration requirements for use on onion 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 fluroxypyr 1-methylheptyl ester 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 Colorado 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 fluroxypyr 1-methylheptyl ester, 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 fluroxypyr 1-methylheptyl ester and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of fluroxypyr 1-methylheptyl ester in or on onion 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 (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for fluroxypyr 1-methylheptyl ester 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 180.535) for the combined residues of fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, in or on a variety of raw agricultural commodities including barley, corn, grass, oats, sorghum, wheat, milk, and meat, kidney, meat byproducts and fat of cattle, goat, hog, horse, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from fluroxypyr 1-methylheptyl ester in food as follows:

i. Acute exposure . Quantitative Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. There were no toxic effects attributable to a single dose. Therefore, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to fluroxypyr and hence no quantitative acute dietary risk assessment was performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM , version 1.3) which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made: an unrefined, Tier 1 chronic-dietary exposure assessment using tolerance-level residues and assuming 100% crop treated (CT) for all commodities, and default processing factors for all commodities.

iii. Cancer . Fluroxypyr has been classified as not likely to be carcinogenic to humans. Therefore, a quantitative exposure assessment was not conducted to assess cancer risk.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fluroxypyr 1-methylheptyl ester 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 fluroxypyr 1-methylheptyl ester.

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 %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 fluroxypyr 1-methylheptyl ester they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of fluroxypyr 1-methylheptyl ester for chronic exposures are estimated to be 1.6 ppb for surface water and 0.017 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). Fluroxypyr is currently registered for use on the following residential non-dietary sites: Residential turfgrass and recreational sites such as golf courses and sports fields. The risk assessment was conducted using the following residential exposure assumptions: Adults and children may be exposed to fluroxypyr residues from dermal contact with turf during postapplication activities. Toddlers may receive short- and intermediate-term oral exposure from incidental ingestion during postapplication activities. Residential handlers may receive short-term dermal and inhalation exposure to fluroxypyr when mixing, loading and applying the formulations.

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 fluroxypyr 1-methylheptyl ester 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, fluroxypyr 1-methylheptyl ester 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 fluroxypyr 1-methylheptyl ester 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. Developmental toxicity studies . In a prenatal developmental study in rats the Maternal NOAEL is 300 mg/kg/day and the LOAEL is 600 mg/kg/day based on increased maternal deaths and decreased body weight gains and food consumption. The Developmental NOAEL is 600 mg/kg/day and a LOAEL was not established.

In a prenatal developmental study in rabbits the Maternal NOAEL is 500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based on increased abortions. The Developmental NOAEL is 500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based on increased abortions.

3. Reproductive toxicity study . In a reproduction and fertility study the Parental/Systemic NOAEL is 100 mg/kg/day effects (Males) and 500 mg/kg/day (Females) with a LOAEL of 500 mg/kg/day (Males) / 1,000 mg/kg/ day (Females), based on kidney effects in males and females and increased deaths in females. The Reproductive NOAEL is 750 mg/kg/day for males and 1,000 mg/kg/day for females. A LOAEL was not established. Offspring NOAEL is 500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based on decreased pup weight and body weight gain and slightly lower survival.

4. Prenatal and postnatal sensitivity . There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with fluroxypyr. There is no evidence of increased susceptibility of rats in the reproduction study with fluroxypyr. EPA concluded there are no residual uncertainties for prenatal and/or postnatal exposure.

5. Conclusion . There is a complete toxicity data base for fluroxypyr and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be removed and instead, a different additional safety factor of 1X should be used. The FQPA factor is removed because: There is no evidence (quantitative/ qualitative) of increased susceptibility following in utero exposure to the acid and the ester of fluroxypyr in rats and rabbits, or following pre and/or postnatal exposure to the acid of fluroxypyr in rats; there are no concerns or residual uncertainties for pre- and/or post-natal toxicity; there is no evidence of neurotoxicity or neuropathology in the available studies; the toxicological database is complete for FQPA assessment; the chronic dietary food exposure assessment utilizes tolerance level residue estimates and assumes 100% CT for all commodities, thus not likely to underestimate exposure/risk; the dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded; and the residential exposure assessment was conducted using standard assumptions which are based on carefully reviewed data.

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 fluroxypyr 1-methylheptyl ester 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 fluroxypyr 1-methylheptyl ester on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . An endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to fluroxypyr.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fluroxypyr from food will utilize < 1% of the cPAD for the U.S. population, < 1% of the cPAD for all infants, and < 2% of the cPAD for children (1-2 years old), the subpopulation at greatest exposure. Based upon the use pattern, chronic (non-dietary) residential exposure to residues of fluroxypyr is not expected.In addition, there is potential for chronic dietary exposure to fluroxypyr in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit.

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluroxypyr is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fluroxypyr. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 31,000 for the U.S. population and 4,500 for children (1-2 years old). These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of fluroxypyr in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's LOC, as shown in Table 3.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluroxypyr is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for fluroxypyr. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 31,000 for the U.S. population and 4,500 for children (1-2 years old). These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of fluroxypyr in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's LOC, as shown in Table 4. of this unit:

5. Aggregate cancer risk for U.S. population . Fluroxypyr has been classified as not likely to be carcinogenic to humans. Therefore, fluroxypyr is expected to pose at most a negligible cancer risk.

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fluroxypyr 1-methylheptyl ester residues.

The gas chromatography/mass selective detector (GC/MSD) enforcement method, submitted by Dow AgroSciences LLC, has been validated for the determination of residues of fluroxypyr and fluroxypyr 1-MHE as the acid equivalent in plant commodities. The method for livestock commodities has been validated for the determination of residues of fluroxypyr and fluroxypyr 1-MHE in cow milk and liver. The proposed plant and animal method is adequate for enforcement of tolerances in/on field corn, sweet corn, sorghum, range and pasture grass, and animal commodities as a result of this use. Fluroxypyr has been tested through the FDAs Multiresidue Methodology, Protocols C, D, and E. The results have been published in the FDA Pesticide Analytical Manual, Volume I .

There is neither a Codex proposal, nor Canadian or Mexican limits, for residues of fluroxypyr in/on onion. Harmonization is not an issue for this time-limited tolerance.

Therefore, the tolerance is established for combined residues of fluroxypyr 1-methylheptyl ester, fluroxypyr 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on onion 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-2005-0008 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 March 28, 2005.

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

Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit 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 ADDRESSES . Mail your copies, identified by the docket ID number OPP-2005-0008, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a 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 an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

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

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

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

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

In the Federal Register of July16, 2003 (68 FR 42022) (FRL-7312-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F6560) by BASF Corporation, 26 Davis Drive, Research Triangle Park, North Carolina 27709. The petition requested that 40 CFR 180.513 be amended by establishing a tolerance for residues of the insecticide 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, chlorfenapyr, in or on all foods at 0.01 parts per million (ppm). That notice included a summary of the petition prepared by BASF Corporation, the registrant. Three public comments (OPP-2003-0205-0001 (Green Party, MI), OPP-2003-0205-0002 (Fluoride Action Network), and OPP-2003-0205-0003 (BASF Corporation)) were received in response to the registrant's petition. The substantive public comments and corresponding Agency responses are addressed in a separate document available in the docket for this action under Docket identification (ID) number OPP-2004-0362.

The Green Party, MI took exception with the use of a tolerance to provide a “ safe” level of pesticide residues in food. The Agency acknowledges this comment but notes that the Agency is authorized by section 408(b)(A)(i) of the Federal Food, Drug, and Cosmetic Act to establish tolerances. The Fluoride Action Network (FAN) provided a number of comments on the Agency's safety determination for chlorfenapyr including raising concerns about: (1) its role in “Mad Cow Disease” (transmissible spongiform encephalopathies), (2) aggregate exposure to chlorfenapyr and other fluorine and bromine containing pesticides and inerts, (3) aggregate exposure to chlorfenapyr and other neurotoxicants, (4) its role in neurodegenerative diseases and disease processes, (5) the status of a conditionally required developmental neurotoxicity study, and (6) public access to risk assessments and other supporting documentation. BASF, the chlorfenapyr registrant, provided a detailed response to the issues raised by FAN.

The substantive public comments and corresponding Agency responses are addressed in a separate document available in the docket for this action under Docket identification (ID) number OPP-2004-0362. The Agency considered all of the substantive comments and saw no basis to support the claims that were made in the public comments. Again, the Agency's complete reasoning is discussed in the comment response document. As to FAN's comments regarding access to Agency documents on chlorfenapyr, EPA would note that there are extensive documents on chlorfenapyr on EPA's website. However, the Agency agrees with the comment that generally more access to information supporting this and other decisions is desirable, and in fact, the Registration Division, Office of Pesticide Programs is currently reviewing its procedures for docketing to address this concern.

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

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

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of chlorfenapyr on all foods except fruiting vegetables at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by chlorfenapyr as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of September 26, 2003 (Vol. 68 No. 187 FR 55519-55527) (FRL-7320-8).

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

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

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 - 5 ), one in a million (1 X 10 - 6 ), or one in ten million (1 X 10 - 7 ). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this nonlinear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

A summary of the toxicological endpoints for chlorfenapyr used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 26, 2003 (Vol. 68 No. 187 FR 55519-55527) (FRL-7320-8).

1. Dietary exposure from food and feed uses. The tolerance established in 40 CFR 180.513 is further amended to set tolerances for residues of chlorfenapyr in or on all foods except fruiting vegetables at 0.01 ppm. Risk assessments were conducted by EPA to assess dietary exposures from chlorfenapyr in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure.

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM Version 2.03), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each food item. The 1994-96, and 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or baked; or wheat flour - cooked; fresh or baked) using publicly available recipe translation files developed jointly by USDA/Argricultural Research Service (ARS) and EPA. Consumption data are retained as individual consumption events for acute exposure assessment. The following assumptions were made for the acute exposure assessments: Unrefined tier 1 acute dietary exposure assessments using tolerance-level residues and assuming 100% crop treated (CT) for all registered and proposed commodities, and default DEEM TM Version 7.76 processing factors for all commodities were conducted. The acute dietary exposure estimates are below EPA's level of concern ( < 100% aPAD) at the 95 th exposure percentile for females 13-49 years old ( < 15% aPAD), and the general U.S. population ( < 6% of the aPAD), and all other population subgroups. The most highly exposed population subgroup (other than females 13-49 years old) is children 1-2 years old, at < 9% of the aPAD.

ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each food item. The 1994-96 and 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or baked; or wheat flour - cooked; fresh or baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment. The following assumptions were made for the chronic exposure assessments: unrefined, Tier 1 chronic dietary exposure using tolerance-level residues, assuming 100% CT for all registered and proposed commodities. The Agency concluded that the chronic dietary exposure estimates are below HED's level of concern ( < 100% cPAD for the general U.S. population ( < 23% of the cPAD) and all population subgroups. The most highly exposed population subgroup is children 1-2 years old, at < 45% of the cPAD.

2. Dietary exposure from drinking water. There is no concern for exposure to residues of chlorfenapyr in drinking water based on the approved, pending and proposed directions for use and chlorfenapyr's physical and chemical properties. Approved uses in the United States include applications to ornamental plants inside greenhouses, to a narrow band of soil adjacent to buildings and as a crack-and-crevice and spot treatments inside non-food/feed structures. In food handling areas chlorfenapyr is also applied as a crack-and-crevice and spot treatment inside structures. Chlorfenapyr has extremely low water solubility (120 parts per billion at 25° C) and is also immobile in soil and does not leach because it is strongly adsorbed to all common soil types.

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). Non-dietary exposure to chlorfenapyr is expected to be negligible based on assessments made by EPA for all currently approved uses: ornamentals grown in greenhouses, as a termiticide, and for indoor applications for general pest control. These assessments were based on the physicochemical characteristics of the compound, the intended use patterns, and available information concerning its environmental fate. The vapor pressure of chlorfenapyr is less than 1 x 10 -7 mm of mercury (Hg). Therefore, the potential for non-occupational exposure by inhalation is insignificant. These assessments also apply to the use in food/feed handling areas as a crack-crevice and spot treatment.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to chlorfenapyr and any other substances and chlorfenapyr does not appear to produce a toxic metabolite produced by other substances. EPA has also evaluated comments submitted that suggested there might be a common mechanism between chlorfenapyr and other named pesticides that cause brain effects. EPA concluded that the evidence did not support a finding of common mechanism for chlorfenapyr and the named pesticides. For the purposes of this tolerance action, therefore, EPA has not assumed that chlorfenapyr has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

The Agency previously identified that a developmental neurotoxicity (DNT) study was required for chlorfenapyr, based on the presence of neuropathology (CNS lesions), and neurotoxic signs seen in adult rats (males) and mice (both sexes). Considering the effects seen and the doses at which those effects occurred, the Agency concluded that a 10X safety factor is required until the data are received and evaluated.

2. Prenatal and postnatal sensitivity. There is no evidence (qualitative or quantitative) for increased susceptibility following in utero exposure in the developmental toxicity studies in rats and rabbits or prenatal/postnatal exposure in the 2-generation reproduction study in rats. In both the rat and rabbit developmental toxicity studies maternal toxicity included decreased body weight gain. No developmental toxicity was noted in rats up to the highest dose tested of 225 mg/kg/day. Developmental toxicity in rabbits (increased post implantation loss) occurred at a higher dose than maternal toxicity. In the 2-generation reproduction study in rats, parental and offspring toxicity included body weight decrements at similar doses. No reproductive effects were noted up to the highest dose tested.

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

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

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

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

There are no existing or proposed uses of chlorfenapyr which would result in contamination of drinking water or residential exposures. Therefore, an aggregate-exposure risk assessment was not performed.

Samples of composited meals from the subject study were analyzed for residues of chlorfenapyr using American Cyanamid GC/ECD (Gas Chromatograph/Electron Capture Detector) Method M 2398. This method has undergone a successful petition method validation (PMV). The reported limit of quantitation (LOQ) is 0.01 ppm. The submitted concurrent recovery data indicate that GC/ECD Method M 2398 is adequate for determining residues of chlorfenapyr per se in/on composited meal samples. The data requirement for multiresidue methods has been satisfied pending FDA review and acceptance of the multiresidue methods.

An adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no established Codex, Canadian, or Mexican maximum residue levels (MRLs) for chlorfenapyr on all foods except fruiting vegetables at 0.01 ppm; therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.

A tolerance has been previously established for Vegetables, fruiting. group 8, at 1.0 ppm. The establishment of additional residue level tolerances for chlorfenapyr on all food (as requested by the petitioner) must therefore, exclude Vegetables, fruiting, group 8. The registrant (BASF) was required to submit a revised Section F, excluding Vegetables, fruiting, group 8 commodity from the petition. The registrant (BASF) has met this condition. In addition, data are required as a condition of registration. These were previously discussed in Unit IV. C. of the final rule published in the Federal Register of September 26, 2003 (Vol. 68 No. 187 FR 55519-55527) (FRL-7320-8).

Therefore, the tolerance is established for residues of 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, chlorfenapyr, in or on all foods except Vegetables, fruiting group 8 at 0.01 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0362 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 March 28, 2005.

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

Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14 th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. 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: Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0362, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

This is a synopsis of the Commission's Report and Order, MB Docket No. 04-367, adopted January 5, 2005, and released January 10, 2005. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the General Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 04-249, adopted January 5, 2004, and released January 10, 2004. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street, SW., Washington, DC. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the General Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).