On July 30, 1999 (64 FR 41338), the Commission published a proposed rule for public comment that would amend its regulations governing the domestic licensing of SNM for certain licensees authorized to possess a critical mass of SNM. The Commission's action was in response to a Petition for Rulemaking, (PRM)-70-7, submitted by the Nuclear Energy Institute (NEI), which was published on November 26, 1996 (61 FR 60057). The proposed rule was intended to grant the NEI PRM in part and would modify the petitioner's proposal. The majority of the proposed modifications to Part 70 were included in a proposed new Subpart H, “Additional Requirements for Certain Licensees Authorized to Possess a Critical Mass of Special Nuclear Material.” These modifications were proposed in order to increase confidence in the margin of safety at the facilities affected by the rule.

In developing the proposed rule, the Commission sought to achieve its objectives through a risk-informed and performance-based regulatory approach that included: (1) The identification of performance requirements for prevention of accidents or mitigation of their consequences; (2) the performance of an ISA to identify potential accidents at the facility and the items relied on for safety; (3) the implementation of measures to ensure that the items relied on for safety are available and reliable to perform their function when needed; (4) the maintenance of the safety bases, including the reporting of changes to the NRC; and (5) the allowance for licensees to make certain changes to their safety program and facilities without prior NRC approval.

The 75-day public comment period on the proposed rule ended on October 13, 1999. During and after the public comment period, the NRC staff posted on the NRC web site revised versions of the draft Standard Review Plan (SRP) that would implement the proposed requirements ( i.e., on August 4, 1999, a complete draft SRP was posted, and revised chapters, taking into account comments received, were posted during the period March 16-April 3, 2000). In addition, three stakeholder meetings were held to discuss the SRP (September 14-15, 1999, February 9, 2000, and April 18-19, 2000).

In preparing the final rule, the NRC staff carefully reviewed and considered more than 90 comments on the rule, included in 9 individual letters filed during the public comment period. In addition, 13 submittals containing more than 200 specific comments were received on the SRP. To simplify the analysis, the NRC staff grouped all written comments on the rule into the following major topic areas: Performance Requirements and Design Criteria; Content of Applications and ISA Summary; Safety Program; Change Process, License Renewal and Backfit; Definitions; and Miscellaneous. A more detailed analysis is also documented as an attachment to SECY-00-0111. A review of the comments and NRC staff's responses follow:

Comment A.1: One commenter stated that the proposed rule should specify dose limits for anticipated occurrences similar to those in §§ 72.104 and 72.106. This part of the rule would then cover the range of likelihood (anticipated, likely, unlikely, and highly unlikely) of potential accidents that could occur at nuclear fuel cycle facilities. This could result in an increase in the number of structures, systems, and components (SSCs) relied on for safety and would impact the design, operation, and licensing of the mixed-oxide (MOX) facility.

Response: No change in the rule language has been made. The dose limits for normal operation are contained in 10 CFR Part 20 [viz., 0.05 Sv (5 rem) Total Effective Dose Equivalent (TEDE)/yr for a trained worker]. The NRC staff views “anticipated occurrences” to be conditions of normal operations, and believes that the measures currently used by Part 70 licensees to comply with Part 20 have been and will continue to be successful in protecting workers and the public during normal operations. Thus, there is insufficient justification to require identification of “items” to demonstrate compliance with Part 20 during normal operations.

Comment A.2: One commenter proposed that the NRC maintain consistency with past precedent ( i.e. , the Commission's rationale in Part 60) and eliminate the specific worker dose limits in Part 70.

Response: No change in rule language has been made. The regulatory experience and industry events that initiated the effort to add a systematic accident analysis to Part 70 primarily involved health impacts to workers as opposed to the public. The NRC staff believes that the rule's focus on both the potential impacts on workers and the public is appropriate. Based on the discussions and correspondence with the industry and public during development of the proposed rule, and all other comments on the proposed rule, there appears to be general consensus on this approach.

Comment A.3: One commenter stated, in response to the Federal Register notice request for comments on the clarity and effectiveness of the language used (per June 1, 1998, Presidential Memorandum), that the language in § 70.61(b) and (c) could be substantially clearer; the commenter provided an alternative plain language version of this section.

Response: The language in the proposed rule was written in response to public comments to focus on risk ( i.e., likelihood times consequence) of accidents. The language has been changed, in response to the comment, to provide additional clarity. The proposed revisions provided by the commenter, however, are not merely editorial but represent substantive changes. They appear to have eliminated the concept of limiting risk, and instead, focused on the likelihood of accidents. The revised language in the rule attempts to retain the emphasis on controlling accident risks within appropriate performance requirements.

Comment A.4: Three commenters expressed concerns about how the worker dose limits in § 70.61(f) would be applied to “co-located workers.” One commenter suggested that the performance requirements in § 70.61 consider the individuals working in the nearby facilities as public when performing an accident analysis to determine the consequences of the accidents that may occur at the facility. The commenter concluded that this would result in a more stringent application of safety requirements for the protection of workers ( e.g., additional items relied on for safety) at the MOX Fuel Fabrication Facility, Pit Disassembly, Conversion Facility, Immobilization Facility, and any other nearby DOE facilities, and would also have a substantial impact on the cost of the MOX facility. A second commenter agreed with this assessment, noting that a worker (as defined in § 70.4) who leaves the controlled area to perform a work-related function would have to be treated as a member of the public when performing an ISA and would be subject to the more stringent public radiation exposure limits. Outside of the controlled area the TEDE limit of 1 mSv (0.1 rem) for members of the public would apply [cf. 10 CFR 20.1301(a)(1)] rather than the annual TEDE occupational dose limit of 50 mSv (5 rems) (10 CFR 20.1201). According to this commenter, this problem has already arisen at the Hanford Tank Waste Remediation System where co-located workers are governed by the appreciably lower public dose limits. A third commenter agreed with the above positions and also stated that the NRC intends to consider individuals outside of the controlled boundary as workers if they are subject to Part 20 requirements. The commenter noted, as did the first commenter, that DOE requirements in 10 CFR Part 835 provide an equivalent level of protection, such that co-located workers—who are subject to the requirements of either Part 20 or 10 CFR Part 835—should be considered “workers,” provided the licensee can demonstrate the ability to provide management measures ( e.g., notification, evacuation, etc.) in the event of an emergency.

Response: NRC regulations do not specifically address personnel designated as “co-located” workers. In response to the comments, the first sentence in § 70.61(f) was changed to read as follows: “Each licensee must establish a controlled area, as defined in § 20.1003. In addition, the licensee must retain the authority to exclude or remove personnel and property from the area.” The licensee can set the controlled area at any location around its facility as long as it maintains control of that area as specified in Part 20 and retains the authority to exclude or remove personnel and property from the area. If the controlled area included the nearby Department of Energy (DOE) facilities, then NRC would consider the personnel working at those facilities to be “workers” for the purposes of the performance requirements of § 70.61, provided the conditions of § 70.61(f)(2) are met. The DOE and its contractors could satisfy these conditions by documenting their compliance with the requirements of 10 CFR 19.12(a)(1)-(5). To emphasize that the § 70.61(f)(2) requirements, regarding 10 CFR Part 19 training, can be satisfied in combination with existing training, rather than separate training solely devoted to 10 CFR Part 19, 10 CFR 70(f)(2) has been changed to read: “Provides training that satisfies 10 CFR 19.12(a)(1)-(5)”. To emphasize that the training provided to satisfy § 70.61(f)(2) requirements includes making individuals aware of the risks associated with accidents involving the licensed activities as determined by the ISA, the word “to” was changed to “and,” so that it now reads “to these individuals and ensures that they are aware of the risks associated with accidents”.

Regarding the concern about the worker who leaves the controlled area, the risk levels of § 70.61 for the public pertain to any individual, including workers, outside the controlled area. On the other hand, with respect to the applicability of the Part 20 occupational dose limit of 0.05 Sv (5 rem)/yr TEDE, a worker can receive an occupational dose and be subject to the Part 20 occupational limit, regardless of his location—including activities outside the controlled area. The “assigned duties performed in the course of employment” is the distinguishing factor for radiation workers consistent with the definition of “occupational exposure” in 10 CFR 20. The changes to Part 70, including the “worker” definition, do not affect this. In this comment, the relationship between Part 20 annual limits for radiation exposure and the § 70.61 standards for a forward-looking severe accident assessment have been misinterpreted. Part 70 revisions do not limit doses outside a controlled area to 1 mSv (0.1) rem/yr.

Comment A.5: One commenter recommended that baseline criterion (8) be rewritten as follows: “the design of items relied on for safety must provide for adequate inspection, testing, and maintenance, or adequate training, testing and qualification for personnel whose activities are relied on for safety, to ensure their availability and reliability to perform their function when needed.”

Response: No change in rule language has been made. The baseline design criteria are applied from the outset of new design work and are primarily focused on physical design and facility features. The intent is to achieve a conservatively designed facility tolerant of both upsets and human errors. Adequate training, testing, and qualification, as noted in the comment, will be required as management measures under § 70.62, but the NRC does not see a need for the facility physical design to incorporate such training, testing, and qualification of personnel.

Comment A.6: One commenter stated that the baseline criterion on environmental and dynamic effects [§ 70.64a(4)] is unclear. For example, the commenter questioned the need for a formal Equipment Environmental Qualification Program, similar to that required under 10 CFR 50.49 and Regulatory Guide 1.89. According to the commenter, the NRC should clarify this requirement and should not impose requirements that may not be appropriate or necessary because of the nature of the processes at non-reactor nuclear facilities.

Response: No change in rule language has been made. The baseline design criterion on environmental and dynamic effects does not require a formal Equipment Environmental Qualification Program, similar to that required under 10 CFR 50.49 and Regulatory Guide 1.89. This criterion applies only to new facilities and new processes and is intended to ensure that potential ambient conditions are considered during the design of the facility.

Comment A.7: Two commenters had concerns regarding the defense-in-depth definition in § 70.64. One commenter stated that the definition does not reflect the defense-in-depth design philosophy as defined in WASH-1250, “The Safety of Power Reactor and Related facilities,” which outlined three levels of safety concepts in the design of a nuclear facility. According to the commenter, the definition presented in §§ 70.64(b)(1) and (2) oversimplifies and does not adequately represent the implementation of the defense-in-depth philosophy in the design. In particular, the commenter noted that the preference for engineered controls over administrative controls and features that reduce challenges to items relied on for safety are only partially implemented in the concept [of defense-in-depth]. Another commenter agreed, stating that § 70.64(b)(1) appeared unnecessarily prescriptive by discouraging a licensee from using anything but an engineered safety control. According to this commenter, as long as the licensee can satisfactorily demonstrate that an administrative safety control or a system of administrative and engineered controls will enable the performance criteria to be satisfied, the choice of items relied on for safety and the nature of “defense-in-depth” practices that is applied should be flexible. The commenter's view is that this flexibility, in the grading of defense-in-depth safety concepts, would be consistent with the ability granted a licensee to grade all aspects of its safety program [cf. § 70.62(a)].

Response: With respect to the footnote to § 70.64(b) that describes defense-in-depth, which applies to new facilities and new processes at existing facilities, the NRC staff believes that it does reflect the defense-in-depth design philosophy as defined in WASH-1250. Further, it reflects the Commission's current guidance on the relationship between defense-in-depth and risk-informed regulation that is discussed in the Commission policy white paper, “Risk-Informed and Performance-Based Regulation.” With respect to §§ 70.64(b)(1) and (2), the NRC staff did not mean to imply that these provisions encompassed the defense-in-depth philosophy.

Comment A.8: One commenter recommended that the emergency capability baseline design criterion in § 70.64(a)(6)(ii) address on-site personnel (rather than all personnel). The commenter suggested that the rule language be rewritten as “Evacuation of on-site personnel; and * * *.”

Response: The NRC agrees with the comment. The proposed change has been made and is consistent with the intent of the original rule language.

Comment A.9: One commenter stated that the criticality performance objective in § 70.61(d) is not related to §§ 70.61(b) or 70.61(c); yet, the three conditions are all linked together. The commenter suggested that subpart (d) should be segregated from (b) and (c) if (d) is preserved as an independent entry (as would seem preferable). Otherwise (d) should be subsumed under (b) and/or (c), and the regulatory basis for criticality prevention should be predicated on the risks and/or consequences of the accidents, rather than the presence of initiator precursor, per se.

Response: No change in the rule language has been made. The NRC believes that a separate performance requirement for nuclear criticality prevention is appropriate. The NRC staff recognizes that many (but not all) nuclear criticality accidents would reasonably be expected to result in worker doses that exceed the high- and intermediate-consequence standards in § 70.61(b) or (c). However, regardless of the dose directly resulting from the accident, an inadvertent nuclear criticality should be avoided. This is consistent with the Commission's goal to prevent inadvertent criticalities, as reflected in the NRC Strategic Plan (NUREG-1614).

Comment B.1: One commenter stated that the rule should not prescribe an acceptable level of detail required in the application, but should defer this issue to the SRP. The commenter noted that, although progress has been made in certain areas ( e.g., use of language such as “* * * types of accident sequences * * *.”), in § 70.65(b)(6), which requires the applicant to list all items relied on for safety for high- and intermediate-consequence accidents, the required level of descriptive detail for items relied on for safety (”sufficient detail”) remains vague. The commenter recommends that information at the “systems level” should be required, rather than at the “component” or “sub-component” level.

Response: The NRC disagrees with the comment. The current language permits the description of information at a systems level provided that there is enough detail to understand the function of the system in relation to the performance requirements. The degree of detail provided in the ISA Summary, with the other information available to NRC staff, must be sufficient for the NRC staff to make the determination specified in § 70.66 ( i.e., that the performance requirements of the regulation are satisfied).

Comment B.2: One commenter stated that the list of items relied on for safety should not include procedures that the personnel must follow. According to the commenter, since procedures are constantly being adjusted, revised, and improved, their inclusion in the list of items relied on for safety would necessitate frequent revisions, to the ISA Summary, that may have little if any safety significance.

Response: § 70.65(b)(6) requires a list, in the ISA Summary, briefly describing each item relied on for safety. It does not require procedures to be listed in the ISA Summary. Therefore, the rule language permits the approach described in the comment. Typically, the actual personnel action would be regarded as an item relied on for safety and this would be expected to be addressed in the ISA Summary.

Comment B.3: Two commenters had concerns about the relationship among the ISA, the ISA Summary, and the safety program. One commenter recommended that the NRC clarify the relationship of the ISA Summary to the license and the safety basis to ensure consistency throughout the rule with the intent expressed in § 70.65(b). The commenter was concerned that the wording of § 70.65(a) is inconsistent with the idea, presented in § 70.65(b), that the ISA Summary will not be incorporated in the license. The commenter suggested removing the language in § 70.65(a) that references the inclusion of the ISA Summary in the license application, since that requirement is adequately covered in § 70.65(b). The commenter also recommended that a discussion of management measures be included as part of the ISA Summary. The second commenter stated that the rule implies that the ISA Summary, as part of the safety program, is part of the license. Further, the same commenter stated that the “Statement of Considerations” erroneously states that the results of the ISA must be submitted for NRC approval.

Response: The NRC generally agrees with the comment. The rule language in § 70.65(a) has been changed to remove the reference to the ISA Summary and management measures. This removes the implication that the ISA Summary is part of the license. With respect to the relationship of the ISA Summary to the management measures, although under the proposed rule, the elements of the ISA Summary did not explicitly include management measures, one of the elements [70.65(b)(4)] of the ISA Summary required information that demonstrates compliance with the performance requirements. Such a demonstration requires information about management measures. As suggested in the comment, the language in § 70.65(b)(4) has been clarified to explicitly include a description of the management measures. With regard to the comment that the “Statement of Considerations” erroneously “states that the results of the ISA must be submitted for approval”, the assertion that the “Statement of Considerations” is erroneous is incorrect—the “Statement of Considerations” is accurate. In response to this comment, and to clarify the role of the ISA Summary in licensing determinations, changes have been made to § 70.62(c)(3)(ii) and § 70.66. In particular, § 70.62(c)(3)(ii) has been modified to specifically state that the ISA Summary is submitted for approval consistent with the “Statement of Considerations” for the proposed rule. Section 70.66 states that this submission will be approved if the Commission determines that “the applicant has complied with the requirements of § 70.21, § 70.22, § 70.23, and § 70.60 through § 70.65.” The degree of detail provided in the ISA Summary [contents of the ISA Summary are described in § 70.65(b)] and the other information available, must be sufficient for the NRC staff to make the determination specified in § 70.66. To supplement staff understanding of information submitted, NRC may visit the facility during the licensing review to ensure a sufficient safety basis for operation.

Comment B.4: Two commenters were concerned with the broad nature of the requirement in § 70.65(b)(3) that seeks information on each process analyzed in the ISA, regardless of the risk associated with the process. According to one commenter, the ISA Summary should only address those processes for which accident sequences have been identified that would produce consequences that exceed the performance criteria of § 70.61.

Response: The NRC staff needs some information on each process analyzed in the ISA to assess completeness and quality of the licensee's ISA process and to understand and assess the completeness and functions of the items relied on for safety. The degree of detail provided in the ISA Summary, together with the other information available, must be sufficient for the NRC staff to make the determination specified in § 70.66. In addition the information is useful in confirming the adequacy of emergency planning.

Comment B.5: According to one commenter, § 70.65(b) implies that the ISA Summary is a single document. In practice, the commenter noted that it will be a sequence of documents that cover the facility, and if multiple documents are submitted, they should all be in the same format.

Response: The NRC agrees that multiple ISA Summaries are allowed for each facility resulting in the possibility that the ISA Summary will be a sequence of documents rather than consisting of a single document. The definition of ISA Summary in § 70.4 has been changed to reflect this process. NRC staff approval of individual documents ( e.g., on a process basis) will be conditioned to allow for subsequent identification of system interaction effects that may be identified through the review of other ISA summary documents submitted.

Comment B.6: One commenter stated that the requirement, in § 70.65(b)(7), to provide information on the locations of onsite chemicals, is unnecessary.

Response: No change in the rule language has been made. Section 70.65(b)(7) does not require information on the locations of onsite chemicals to be submitted to the NRC. The regulation requires a description of the proposed quantitative standards used to assess the consequences to an individual from acute chemical exposure to licensed material or chemicals produced from licensed material. This information is necessary to ensure safety and is consistent with NRC's Memorandum of Understanding (MOU) with the Occupational Safety and Health Administration (OSHA).

Comment B.7: One commenter objected to the requirement to provide process descriptions, noting that American Institute of Chemical Engineers (AIChE) guidelines may result in the process being broken into “nodes” or “segments.” The commenter suggested that the rule should specify the descriptions of segments or nodes that could only be combined into a process if the boundaries established for the hazard analysis match.

Response: The NRC agrees with the comment, but does not believe a change in the rule language is needed. The intent of the § 70.65(b)(3) requirement is to provide process information so that the NRC staff can understand: What activities are performed at the site that involve hazardous materials associated with or produced from licensed radiological material, including any use, storage, manufacturing, or handling of those materials; what was analyzed in the ISA; and the hazards identified in the ISA. The AIChE guidelines use the term “process nodes” with respect to Hazard and Operability Analysis (HAZOP) and define it as “sections of equipment with definite boundaries * * * within which process parameters are investigated for deviations * * *.” In HAZOP analyses, the term “node” designates a pipeline or vessel that has a common design intent. In meeting the § 70.65(b)(3) requirement, several nodes may be combined.

Comment C.1: Three commenters questioned the narrow definition of the safety program that is presented in § 70.62(a) and recommended deleting it from the rule language. According to the commenters, the safety program is broader than the three elements identified in § 70.62(a)(1) as process safety information, ISA, and management measures. The commenters noted that fuel cycle facility safety programs encompass the three elements identified plus all the other topics addressed in the license application. This includes, for example, radiation safety, criticality safety, chemical safety, and fire protection, in addition to the three elements directly associated with the ISA.

Response: The NRC staff agrees in principle with the comment. The term “safety program,” as used in § 70.62 (a), is related to the elements needed to demonstrate compliance with the performance requirements in § 70.61. This safety program consists of process safety information, ISA, and management measures. There is no intent to indicate that these elements represent the total safety program at the facility. Therefore, the rule language was clarified by changing “The three elements of the safety program; namely process safety information, integrated safety analysis, and management measures, are described in paragraph (b) through (d) of this section * * *” to “Three elements of this safety program; namely process safety information, integrated safety analysis, and management measures, are described in paragraph (b) through (d) of this section.”

Comment C.2: One commenter stated that the current proposed rule offers sufficient flexibility in selecting ISA methodology so that a broad spectrum of facilities can be addressed and such that licensees have flexibility to interface with their site processes, procedures and resources.

Response: The Commission agrees with the comment; therefore, no change was made to the rule language with respect to ISA methodologies. The final rule offers sufficient flexibility in selecting an ISA methodology that can be used to analyze a facility's site, processes and procedures.

Comment C.3: Two commenters were concerned about the implementation of the final rule, and, in particular, the time frame for compliance with those aspects of the rule not related to the completion of the ISA and the submittal of the ISA Summary. One commenter, citing the experience when Part 20 was revised, recommended an effective date sufficiently far into the future so programmatic changes could be implemented at the operating facilities and any necessary conforming license amendments could be completed. Regarding the latter issue, both commenters cited 10 CFR 20.1008 as an example of how potential contradictions between license applications and regulations could be addressed. One commenter recommended including an additional provision of this type, especially in light of license conditions that have been added to licenses recently renewed by the NRC.

Response: The NRC agrees with the comment. In § 70.76(a), it states that “this provision shall apply for subpart H requirements as soon as the NRC approves that licensee's ISA Summary pursuant to § 70.66. For requirements other than Subpart H, this provision applies regardless of the status of the approval of a licensee's ISA Summary.” In addition, Appendix A was revised to include the following: “Licensees must comply with reporting requirements in this appendix, except for (a)(1), (a)(2), and (b)(4), after they have submitted an ISA Summary in accordance with § 70.62(c)(3)(ii). Licensees must comply with (a)(1), (a)(2), and (b)(4) after October 18, 2000.” In addition, § 70.62(c)(3)(ii) was revised to further clarify implementation schedules for existing licensees.

Comment C.4: Two commenters stated that a graded approach should be used in determining the management measures that need to be applied to items relied on for safety. One commenter recommended that the language in § 70.62(d) should be changed as follows: “The measures applied to a particular engineered or administrative control or control system may be graded commensurate with the reduction of the risk attributable to that control or control system.” The other commenter recommended that other factors besides risk including consequences, life cycle, and magnitude of hazard involved, should be used to determine appropriate management measures.

Response: The NRC agrees with the comment and has made the suggested change to the rule language in § 70.62(d). Regarding the question of considering other factors besides “risk,” the NRC notes that the grading of measures to consequences, life cycle, and magnitude of hazard, is part of grading the measures to risk. The phrase used in the rule—“commensurate with the reduction of risk attributable to that item”—does not imply requiring a quantitative determination of the risk significance of any particular item relied on for safety. The rule is non-prescriptive regarding the grading approach and criteria to be used, allowing applicants to propose such details.

Comment C.5: One commenter stated that the 4-year period for conducting the ISA and for modifying the facility to address any identified unacceptable performance deficiencies may be too short and recommended a 5-year period instead. According to the commenter, a 5-year time-frame would be consistent with the time allowed for existing licensees that have committed, by license condition, to perform ISAs. The commenter also recommended that the period should start on the date when the NRC approves the plan required in § 70.62(3)(i), noting that if the clock starts on the effective date of the rule and the NRC takes one year to approve the ISA plan, the licensee will be unduly hampered. In addition, the commenter stated that there should be some incentive for the NRC to complete its approval process in a timely manner and recommended imposition of a 90-day limit for NRC to issue a decision on the acceptability of a licensee's ISA approach. The commenter also recommended that appropriate and sufficient time be allowed for the licensee to present a plan to the NRC and to implement the plan to correct any identified unacceptable performance deficiencies.

Response: Regarding the proposal for a 5-year period for conducting the ISA and correcting all unacceptable deficiencies, the NRC believes that the 4-year period proposed in the proposed rule is reasonable. However, NRC recognizes that there may be some instances where modifications resulting from the ISA cannot be completed within the 4 years specified and has modified § 70.62(c)(3)(ii) to accommodate these instances by clarifying that NRC may approve extensions for reasons that are beyond the control of the licensee. Regarding the licensee being unduly hampered because of the time required for the NRC staff to approve the plan required by § 70.62(c)(3)(i), the NRC staff expects to complete the licensing review within 90 days, assuming that the information submitted is complete. However, the time it takes the NRC to approve the plan will depend on the quality of the plan submitted by the licensee. In addition, current industry development of an ISA Summary guidance document should facilitate the licensing review process.

Comment C.6: One commenter stated that the plan required in § 70.62(c) which should be submitted within 6 months of the effective date of the rule, should pertain only if a licensee has not already completed the actions outlined in § 70.62(c)(3)(ii).

Response: The implementation plan and the ISA must satisfy the requirements in the final rule. If the actions outlined in § 70.62(c)(3)(ii) have been completed, then all that would be required to satisfy § 70.62(c)(3)(i) is submission of a description of any additional work that must be performed to meet the requirements in Subpart H of the rule, or a confirmation that the work submitted meets the requirements in Subpart H of the rule.

Comment C.7: Four commenters disagreed with the requirement in § 70.62(a)(3) to establish and maintain a log of failures of items relied on for safety. One commenter stated that the requirement should be rewritten to be performance-based rather than prescriptive. The commenter noted that most licensees have an incident reporting and corrective action system, which is used for all activities at the facility. As long as these systems meet the performance objective, it seems unnecessary for the rule language to be prescriptive in how it is met. Another commenter agreed, stating that it is inappropriate to impose this extra record-keeping burden on the licensee, because the licensee already has to generate records of this nature to manage its business and another different log is unnecessary work. Another commenter noted that because of the reporting requirements of § 70.62(a)(2) and § 70.74(a)(1), the NRC will already possess all of the information sought in the “log” of § 70.62(a)(3).

Response: The NRC generally agrees with the comment that maintenance of the failure log would be unnecessarily prescriptive. Regarding the concern about prescriptiveness, the rule has been revised to eliminate the requirement for licensees to establish and maintain a specific log of information developed and maintained elsewhere. However, the final rule requires that data be readily retrievable and available. This information is necessary to evaluate the reliability and availability of items relied on for safety, the likelihood of failure of the items, and the effectiveness of management measures implemented by the licensee. The NRC also anticipates this information will be reviewed during periodic inspections by NRC as part of the revised oversight process that is being developed. Regarding the redundancy of reporting, the rule currently requires the licensee to report only any loss or degradation of items relied on for safety that results in failure to meet the performance requirements of § 70.61. The requirements of § 70.62(a)(3) include a much broader set of items, including all items relied on for safety or management measures that have failed to perform their function.

Comment D.1: Five commenters were concerned about the requirement in § 70.72(d)(1) to submit changes to the ISA Summary every 90 days. Two commenters stated that an annual update [similar to the annual Final Safety Analysis Report updates for reactors per 10 CFR 50.71(e)] should suffice, considering that the potential consequences of reactor accidents are significantly greater than those at fuel cycle facilities. One commenter stated that an annual update to the ISA Summary would be consistent with the reporting requirements (for changes to records) of § 70.72(d)(3). Another commenter stated that the 90-day reporting of changes is entirely too frequent, which would mean that the facility and the NRC would always have change reporting in progress. According to the commenter, there is no need for NRC to have this “real-time” knowledge; rather, it is only important that the licensee have “real-time” knowledge. The commenter noted that the NRC only needs reasonably current knowledge, because the current ISA is available and accessible at the site. The commenter believes that a 12-month to 24-month update for reporting, as used in other places, is satisfactory and more efficient, noting that this seems clearly justified based on the fact that all the information is available at the site and accessible to the NRC at any time.

Response: The NRC agrees with the comment that submitting updates to the ISA Summary to the NRC can be less frequent than required in the proposed rule. The final rule requires only annual reporting within 30 days after the end of the calender year during which the changes occurred.

Comment D.2: One commenter noted that, under § 70.72, the NRC should define “periodically” in the context of reporting of changes made to SSCs etc.

Response: The NRC determined that no change to the reporting requirements is necessary in response to the comment. The comment referenced language in the “Statement of Considerations” not the rule. The specific reporting requirements were defined in the proposed rule and are included, as revised, in the final rule.

Comment D.3: Two commenters were concerned about the footnote in § 70.72(c) that attempts to explain new types of accident sequences. Both commenters stated that the language in the footnote would require nearly all process changes to be approved by NRC through a license amendment, which would be in conflict with the overall objectives for the proposed rule. Both commenters recommended that the footnote be deleted.

Response: The NRC agrees that the footnote did not successfully clarify the definition of “new types of accident sequences.” Thus, the footnote has been deleted from the final rule. The NRC staff will develop a guidance document, with input from stakeholders, to describe an acceptable change process that meets the requirements of the final rule in more detail. The degree of detail provided in the ISA Summary, together with the other information available, must be sufficient for the NRC staff to make the determination specified in § 70.66. In addition, the NRC staff had added a discussion to Chapter 3 of the SRP to describe an acceptable level of detail in the identification of the types of accident sequences.

Comment D.4: Three commenters were concerned about the requirements, in § 70.72, regarding configuration management and the overly broad process for making changes at licensed facilities. One commenter stated that the requirements, as written, apply to all site, structures, processes, systems, equipment, components, computer programs, and activities of personnel, regardless of safety significance. The commenter noted that compliance with these requirements would appear to require configuration management and change control applied to everything on the site of the licensed facility; that could include the wastewater treatment facility, a laser facility, the administration building, maintenance of the shrubbery, etc. Every change would require an evaluation and a summary submitted to the NRC, even though inclusion in the change control process would make no contribution to the safety of licensed operations and would impose an undue burden on the licensee. To remedy this, the commenter recommended that the configuration and change process be limited to any “changes to the site, processes or items relied on for safety as described in the ISA Summary.” Another commenter agreed, stating that the requirement is too broad and all-encompassing and would require configuration management evaluation of changes having no or absolutely minimal effect on health and safety ( e.g. , office remodeling, planting of shrubbery, changing paint colors). The commenter suggested that rather than control every change by means of configuration management, the licensee should first rely on internal procedures to screen any proposed changes initially for their potential safety significance.

Response: No change in the rule language has been made. The emphasis of this requirement is clearly on licensed operations and the associated safety controls. If a licensee has established a configuration management system in accordance with § 70.72(a), it is important the licensee use the system to evaluate every change made at a facility that could affect safety ( i.e. , generally not shrubbery, paint color) to ensure that any impacts from those changes on the safety of operations is identified, considered, documented, before implementing the change. In some cases, the analysis would be trivial because no known hazards would be involved in the change ( e.g. , certain changes in the administration building, or changes to shrubbery). Often it is clear that there are no safety implications associated with the proposed change. However, there may be special cases in which apparently minor changes could adversely affect safety, such as installation of a drinking water fountain in a radiological control area. In addition, every change which is assessed in the configuration management system does not need to be submitted to the NRC. Section 70.72(d)(2) states that only those changes to records required by § 70.62(a)(2) need to be submitted. These would include changes to the process safety information, ISA, and management measures. In addition, with respect to the use of an “initial screening” mechanism, the NRC staff considers an initial screening to assess the safety impact of a change to be part of an evaluation, as called for in § 70.72(a). In some cases, this screening will be sufficient.

Comment D.5: One commenter stated that §§ 70.72(c)(1)(i), (c)(2), and (c)(3) are wrong to use the ISA Summary as the decision-making document. The commenter noted that the ISA, the detailed licensee-generated information and evaluations that the licensee uses to manage its program, comprises the information base for decisions. Summaries only provide a general level of information about the more important elements of the safety system for operations as determined under the licensed program.

Response: No change in the rule language has been made. The ISA Summary is prepared based on the ISA, and contains key information that is directly related to facility safety, such as a list of items relied on for safety, a description of hazards identified in the ISA, and a general description of the types of accident sequences. The contents of the ISA Summary are described in § 70.65(b). The NRC staff could review the adequacy of changes using the ISA instead of the ISA Summary, but this approach would require submission of a greater amount of information to NRC and would pose an unnecessary burden on the licensee. (Also, see response to Comment B.3.)

Comment D.6: Two commenters are concerned about the annual requirement in § 70.72(d)(3) to submit a brief summary of all changes to the records required by § 70.62(a)(2). According to one commenter, the submittal would cover process safety information [§ 70.62(b)] including procedures, drawings, and detailed equipment lists. The commenter does not believe the NRC requires a summary of changes to this type information. A second commenter agreed, stating that the wording of this section will inadvertently and significantly expand the information that would have to be reported. In particular, the view was expressed that § 70.72(d) would require the licensees to submit voluminous information that could include the update to process safety information, including drawings, flow process diagrams, and piping and instrumentation diagrams. The commenter suggested that this section should be reworded to read: “a brief summary of all changes to the integrated safety analysis and ISA summary, that are made without prior Commission approval, must be submitted to the NRC every 12 months * * *.”

Response: No change in the rule language has been made. The regulation currently requires submission of “* * * a brief summary of all the changes to the records required by § 70.62(a)(2) * * *” This does not require the submittal of actual charts and drawings but a written summary of the changes made. For the reasons cited in the response to comment D.1, it is important that the NRC be knowledgeable of changes made to this information.

Comment D.7: One commenter noted that, unlike § 50.59, the requirements of § 70.72 do not call for the submittal of a brief description and summary safety evaluation for each change. The commenter believes that the NRC would benefit from a description of changes made to the ISA Summary. Accordingly, § 70.72 should require brief descriptions and summary safety evaluations of each change made pursuant to § 70.72 and require that an updated ISA Summary be provided on a biennial basis.

Response: No change in the rule language has been made. The brief summaries of changes submitted under the requirements of § 70.72(d)(2) would be expected to include an explanation of each change, the reasons why the change was made, and why it did not require pre-approval. This information will be included in a guidance document to be developed. The NRC staff views this as sufficient and does not anticipate the need for licensees to submit a summary safety evaluation for each change, as long as each change has been made in accordance with the final rule and the approved process.

Comment D.8: Two commenters questioned the current timeframe (10 years) or the need for renewal of licenses, suggesting that the new rule, in effect, resulted in a “living license.” One commenter stated that if a “living license” is truly the outcome as described in the Supplementary Information , renewal periods as long as 20 years would be appropriate. The other commenter noted that with updates required every 12 months there is no real need for the NRC to renew the license—it only becomes a maintenance chore to confirm periodically that the licensing basis remains intact. The commenter believes that the living license concept provides advantages for the NRC and the licensee.

Response: Although the NRC generally agrees with those comments, no change in the rule language has been made. A specific time period for renewals is not specified in Part 70 and to establish one in the rule would require consideration of many factors, such as compliance with the National Environmental Policy Act and the impact of the loss of commitments linked to license renewal, that were not addressed in the current rulemaking ( e.g., financial assurance for decommissioning). Establishment of a new term for licenses ( e.g., 20 years) in 10 CFR 70 would require an analysis of these factors and an opportunity for public comment. The NRC staff will evaluate whether a longer term for fuel cycle licenses is appropriate in light of the new requirements in Subpart H. In any case, even if NRC ultimately declines to extend the term of the fuel cycle licenses (nominally 10 years), the burden of license renewal should be significantly reduced because the licensee will be required to maintain current the ISA Summary, items relied on for safety, and management measures.

Comment D.9: Five commenters recommended that a backfit provision similar to that in 10 CFR 50.109 or 10 CFR 76.76 should be included in the final rule. One commenter stated that the backfit provision should apply to current proposed changes at existing facilities. Another commenter stated that the backfit provision should be immediately effective for those processes or parts of an existing facility for which an ISA has been completed. A third commenter favored an immediately effective backfit provision. However, as an alternative, the commenter would make the provision effective for facilities or systems for which the ISA has been completed and the ISA Summary submitted to the NRC. A fourth commenter stated that deferring consideration of a backfit provision would be evading an extremely important issue, expressing the view that it is vital that a formal, systematic, and disciplined review of new, changed, or differing positions that could backfit existing facilities be applied to increase regulatory certainty. According to the commenter, no change to the backfit language in 10 CFR 50.109, which has been used successfully to control backfits at power reactors in the past, is needed to allow for qualitative analysis. 10 CFR 50.109, which the commenter endorses, is viewed as neither a quantitative nor a qualitative backfit provision. In contrast to the statement made in the Statement of Considerations of the proposed rule, the commenter does not believe that a comprehensive risk baseline is necessary before reasoned judgments can be made on the benefits and risks of a proposed backfit.

Response: The Commission agrees that regulatory stability and certainty can be improved by establishing a backfit provision for fuel cycle facilities covered by Subpart H of the final rule. Consequently, NRC has included a backfit provision in the rule in § 70.76. The wording of § 70.76 is similar to the current language in § 76.76. For requirements other than Subpart H, this provision will apply immediately after NRC publication of backfit guidance. For Subpart H requirements, this provision shall apply for a licensee as soon as the NRC approves that licensee's ISA Summary pursuant to § 70.66. The NRC will publish guidance that will address the qualitative versus quantitative analysis issue and consideration of chemical risks. The NRC staff anticipates completing this guidance within six months of the publication of the final rule. Under the § 70.76 backfit provision, a backfit analysis is not required for modifications necessary to bring the facility into compliance with the rule, including the performance requirements in Subpart H. The subject of backfit is discussed in more detail in an attachment to SECY-00-0111.

Comment E.1: One commenter recommended a change (from 4 percent to 5 percent enrichment) in the definition of a critical mass of SNM to reflect the higher enrichments that are currently in use.

Response: The definition of critical mass of SNM in Part 70 is used solely to determine when Subpart H applies. To emphasize this point, the definition was changed to include the phrase, “for purposes of subpart H.” The definition, including the 4 percent figure, is identical to that used in § 70.24, which requires criticality accident alarms and other related measures.

Comment E.2: Regarding the issue of “reasonable assurance,” two commenters stated that, in the definition of available and reliable to perform their function when needed, the use of the term “ensure” implies a level of certainty that is unrealistically high. Both commenters recommended replacing the term “ensure” with the term “provide reasonable assurance.” One commenter also recommended removing the word “continuous” from the definition, which would now read “* * * means that * * * items relied on for safety will perform their intended safety function when needed and management measures will be implemented to provide reasonable assurance of compliance with the performance requirements of § 70.61.”

Response: The definition was revised to remove the word “continuous,” but no change was made regarding “ensure.” With respect to “ensure,” the proposed rule language does not indicate a level of certainty that is unrealistic. The term “ensure” is used extensively throughout NRC's regulations in the context of a licensee's obligations to connote “make sure” or “make certain.” Specifically, elsewhere in Part 70 alone, the term is used in this context eight times: §§ 70.24(a)(3), 70.32(j), 70.38(g)(4)(iii), 70.51(a)(10), 70.52(c), 70.57(b)(3), 70.57(b)(4), and 70.57(b)(6). Whereas, the term “reasonable assurance” is used just once in Part 70, in § 70.23(b), to describe the level of assurance that the Commission must find in order to approve construction. The use of “ensure” in the definition of “available and reliable to perform their function when needed”' in § 70.4 is appropriate. In short, licensees “ensure” and the Commission determines “with reasonable assurance.” Regarding the issue of “continuous compliance,” the definition of “available and reliable” in § 70.4 has been modified to delete the word “continuous.” This change recognizes the concept that a failure of an item relied on for safety does not automatically infer a failure to meet the performance requirements of § 70.61. In addition, the NRC recognizes that items relied on for safety may temporarily not be available ( i.e., not continuous) when taken out of service for maintenance or functional testing; however, the performance requirements must still be met. A discussion has been added to Chapter 3 in the SRP to address the relationship of failures of items relied on for safety to meeting the performance requirements.

Comment E.3: One commenter stated that there is a “disconnect” regarding the definition of the term items relied on for safety and recommends that the term be replaced by the term Measures relied on for safety.

Response: The reason for the comment is not clear, but perhaps the commenter objects to the use of the term “item” to refer to a personnel action. Part 70 does, in fact, allow human actions to be items relied on for safety and permits flexibility in determining how the items and measures are defined. Consequently, the Commission has retained the original text in the final rule. (See related Comments B.2. and E.4.)

Comment E.4: One commenter was concerned that the term items relied on for safety includes “activities of personnel,” and proposed changing the definition in 70.4 to limit items relied on for safety to “structures, systems, equipment, and components.” According to the commenter, it is reasonably straightforward to classify physical items as being relied upon for safety, and to apply graded quality assurance controls, including management measures, to design, construction, operation, and maintenance, etc., of those physical items, based on their respective safety functions. The commenter stated that it can be confusing to try and classify and grade items when they include “personnel activities,” since an activity has little importance absent the context of its influence on a physical item's safety function. Removing “personnel activities” from the definition of items relied on for safety would not limit their importance but rather, would put activities in context with the structures, systems, equipment, or components to which they are related, without necessitating a change in the balance of the proposed rule. The commenter stated that removing personnel activities from the definition of items relied on for safety will also help address the concern raised (in comment B.2) regarding the treatment of procedures as items relied on for safety.

Response: No change was made to the rule language. Human actions that are relied on to prevent an accident ( i.e., administrative controls) are as important as the “physical items” needed to prevent an accident. Just as there are measures ( e.g., maintenance, configuration management) needed to ensure the availability and reliability of physical controls, there are analogous measures ( e.g., training, procedures) needed to ensure the availability and reliability of human actions. Graded approaches that can be applied to the maintenance of a physical control depending on the risk significance of the control could also be applied to the training of workers who perform safety functions, depending on the risk significance of the human's actions. Although the reliability of engineered controls may be higher than administrative controls, the final rule allows licensees the flexibility to employ both engineered as well as administrative controls.

Comment E.5: One commenter stated that the NRC should define the terms likely, unlikely, highly unlikely, and credible in the rule so that there will be one set of definitions applied to all nuclear fuel facilities. The commenter stated that this will minimize the interpretation and application of these terms in the ISA.

Response: No change in the rule language has been made. Part 70 applies to different types of fuel cycle facilities, some of which are more complex and have more accident sequences than others. Accordingly, since the application of the terms in the rule will be necessarily specific to the individual context in which they are applied, the development of a definition for these terms in the rule language is impracticable. The Commission, however, will provide general guidance on the application of the terms unlikely and highly unlikely in the SRP to aid licensees in implementing the provisions of the rule.

Comment E.6: One commenter recommended a change in the definition of worker. In particular, the language “* * * exposure to radiation and /or radioactive material from licensed and unlicensed sources of radiation” would be replaced with “* * * exposure to radiation and /or radioactive material from licensed sources of radiation, and radiation from man-made non-regulated sources ( e.g., an individual).” As originally defined, persons who are subject to occupational doses from natural sources of radiation, ( e.g., airline pilots and astronauts subject to high cosmic background might be included, whereas workers involved with the possession or use of unlicensed radioactive materials might not be). The commenter stated that the proposed change removes this source of confusion.

Response: The NRC staff agrees in principle with the comment. However, the commenter's proposed change does not eliminate the confusion ( e.g., some man-made unlicensed sources of radiation are part of background or otherwise not included in occupational doses as defined in NRC's radiation protection standards in 10 CFR 20). Instead, in response to the comment, the definition in § 70.4 was changed to: Worker, as used in Subpart H, means an individual who receives an occupational dose as defined in 10 CFR 20.1003.

Comment F.1: One commenter recommended that the criticality requirements of § 70.24 be revised to permit alternate criticality control provisions to be accepted for DOE facilities without requiring an exemption.

Response: Comments on § 70.24 are outside the scope of the rulemaking.

Comment F.2: Two commenters recommended changes in the decommissioning requirements of §§ 70.22(a)(9) and 70.38. In particular, one commenter recommended that the timeliness and schedule provisions in the decommissioning requirements of § 70.38 be revised to include separate requirements for DOE facilities.

Response: Comments on §§ 70.22(a)(9) and 70.38 are outside the scope of the rulemaking.

Comment F.3: One commenter expressed concern with the language in § 70.23(b), which states that the Commission will approve construction of a plutonium processing and fuel fabrication facility only after determining that the design bases of SSCs, and the attendant quality assurance program are adequate to protect against natural phenomena and the consequences of potential accidents. In particular, the commenter stated that this provision, as written, seems contrary to other changes being proposed under the draft rule, because it addresses consequences of potential accidents, as opposed to the risk associated with credible accidents.

Response: Section 70.23(b) has not been modified in this rulemaking. The reference to “consequences” in the rule language does not preclude a risk-informed approach in satisfying this requirement. The NRC will need to consider the risk, and thus the likelihood of consequences of potential accidents occurring, in order to determine whether there is reasonable assurance of protection against such consequences. This consideration of risk will be important in determining the need for (and the ability of) the applicant to reduce the likelihood of accidents and to mitigate their consequences.

Comment F.4: One commenter recommended that § 70.11 be revised to reflect the applicability of NRC authority over a MOX fuel fabrication facility owned by the DOE, pursuant to changes in law last year.

Response: The NRC agrees with the comment, but believes a separate rulemaking is required. Since October 17, 1998, when the amendment to Section 202 of the Energy Reorganization Act of 1974 was enacted, § 70.11, as well as several other subsections of the regulations, need to be updated to reflect this legislative change. However, to address this subsection and all the other instances, and to avoid the necessity for potential future revisions of this type, the NRC intends to institute an administrative-type rule amendment to conform all of the references to Section 202 in the regulations, including § 70.11, to merely cite Section 202, rather than repeat the text of that section. Because this rule change affects various parts of the regulations, it will be conducted independently of the current Part 70 amendments.

Comment F.5: One commenter stated that as additional DOE facilities are licensed by the NRC under Part 70, the NRC should ensure that the requirements address the full range of fissionable and fissile materials at these facilities.

Response: This issue is beyond the scope of the rulemaking. It will be addressed, if necessary, in the future.

Comment F.6: One commenter agreed that the proposed rule is entirely consistent with the U.S. Environmental Protection Agency's Risk Management Program regulations and the general duty clause of the Clean Air Act, and contains appropriate complementary safety measures for facilities possessing a critical mass of SNM.

Response: No response necessary.

Comment F.7: One commenter strongly recommended that the NRC adopt, by reference, the 1998 edition of National Fire Protection Association (NFPA) 801, “Facilities Handling Radioactive Materials.” NFPA 801 would apply to § 70.62, “Safety program and integrated safety analysis,” that addresses protection from all relevant hazards, including radiological, criticality, fire, and chemical. The NFPA standard would also apply to § 70.64, “Requirements for new facilities or new processes at existing facilities,” that addresses fire protection. The reference to NFPA 801 is in keeping with the requirements of Public Law 104-113, “National Technology Transfer and Advancement Act,” that requires Federal agencies to use private sector-developed national consensus technical standards in carrying out public policy, wherever appropriate.

Response: The suggested change would be an unnecessarily prescriptive rule requirement. Instead, the NRC identifies the standards in NFPA 801 and 600 as an acceptable approach for demonstrating compliance with 10 CFR Part 70 in the SRP.

Comment F.8: One commenter noted that the proposed rule incorporates the current terms of the MOU between the NRC and OSHA. This should avoid misunderstanding and result in more effective implementation for all concerned parties.

Response: Although the rule is consistent with the NRC-OSHA MOU, the rule itself does not incorporate the terms of the MOU. Nevertheless, the NRC agrees with the spirit of the comment.

Comment F.9: Two commenters expressed concern over those portions of §§ 70.22 and 70.23 of the existing rule that address the regulation of plutonium processing and fuel fabrication facilities. One commenter asked if § 70.22 (f) should be coordinated with § 70.65. The commenter noted that it is not clear if the requirements are collateral, complementary, or redundant. The same commenter stated that § 70.23(b) should be examined to clarify the need for this requirement in light of similar information being submitted pursuant to § 70.65. The second commenter agreed, stating that § 70.22(f) requires plutonium-related applicants to provide information on the facility site and design basis of principal SSCs, etc., as part of the license application. The commenter believed that this information is also required in other sections of the revised rule, and thus is redundant.

Response: No change in the rule language has been made. The requirements are not viewed as redundant, considering: the timeframe for submittal of information required by the two sections could be different; and § 70.23(b) contains a requirement for NRC construction approval before the start of construction.

Comment F.10: Two commenters were concerned about the construction authorization provisions in §§ 70.23(b) and 70.23(a)(7). According to one commenter, irrespective of § 70.65, the construction authorization provision in § 70.23(b) appears to be an unnecessary step and should be considered for deletion by the NRC. If the NRC chooses to retain § 70.23(b), the NRC should clarify how the authorization process would be conducted, given that the procedural step has never been exercised. Furthermore, the NRC should identify how the “design basis” authorization is defined, why it is necessary, and how it relates to the ISA. The second commenter noted that § 70.23(a)(7), which applies to other Part 70 licensees, allows construction to commence based on a conclusion by the Director, NRC Office of Nuclear Material Safety and Safeguards, that environmental impacts have been appropriately addressed. The commenter stated that this discretion afforded the NRC under § 70.23(a)(7)— i.e., NRC's authority over construction associated with “any * * * activity which the Commission determines will significantly affect the quality of the environment” is adequate to ensure the sufficiency of information provided to the NRC to authorize or disallow construction. The commenter proposes that § 70.23(a)(7) be clarified for applicability to plutonium facilities, and that §§ 70.22(f), 70.23(a)(7),and 70.23(b) be eliminated. Doing so would avoid the preconception that, irrespective of design features and material composition, plutonium is “more special” than other SNM.

Response: No change in the rule language has been made. The Atomic Energy Commission specifically established these requirements (see 36 FR 9786; May 28, 1971 and 36 FR 17573; September 2, 1971) for plutonium facilities in recognition of the potential exposures and ground-contamination levels that may result if only a small fraction of the dispersible plutonium in process were released (see SECY-R 188, March 17, 1971). The current revisions to Part 70 do not impact this section and therefore, the suggested change is outside the scope of the rulemaking. Regarding the authorization process, the NRC staff has clarified this process in a letter to Duke, Cogema, Stone & Webster, dated September 10, 1999. The design basis was also identified in this letter. NRC provided additional guidance on this process in the draft Standard Review Plan for a Mixed Oxide Fuel Fabrication Facility. In addition, the NRC staff is currently assessing the opportunities for hearings associated with the review of a license application for a plutonium processing facility and may offer additional guidance on this topic later in 2000.

Comment F.11: One commenter noted that, under § 70.23(a)(8), the NRC will approve a plutonium facility's license application only after construction of principal SSCs has been completed in accordance with the application. Certainly this is not a requirement unique to plutonium facilities. The NRC already has the authority to grant licenses conditional on successful completion of certain actions (such as successful start-up testing, training, etc. ). Completion of construction in accordance with the license application seems such an obvious condition that this specific provision seems redundant and therefore unnecessary.

Response: The NRC established § 70.23(a)(8) specifically for plutonium processing facilities. Because the current revisions to Part 70 do not impact this section, comments regarding this section are outside the scope of the rulemaking. See response to Comment F.10.

Comment F.12: One commenter noted that the terminology in Appendix A (b)(1) clearly ties the failure to the performance requirements. The phrase, “and which results in failure to meet the performance requirements of § 70.61” is very clear. This phrase should be consistently included in Appendix A (b)(2)-(5) using the exact same wording.

Response: No change in the rule language has been made. The linkage to the failure to meet the performance requirements is already included in Appendix A (b)(2) and (b)(3). For the events described in Appendix A (b)(4) and (5), the NRC staff desires to be informed when such events occur, regardless of the licensee's determination with respect to the performance requirements. In these cases, the NRC staff will independently confirm the licensee's assessment of whether the performance requirements were met, on the basis of the information reported.

Comment F.13: One commenter stated that the reporting requirements of § 70.50 continue to misrepresent the principles of the 1988 NRC-OSHA MOU. Section 70.50(c)(1)(iii)(A) requires the reporting of chemical hazards and § 70.50(c)(1)(iii)(B) requires the reporting of personnel exposures to chemicals. According to the commenter, although the MOU principles have been correctly incorporated into other proposed revisions to Part 70 ( e.g. , §§ 70.4, 70.61(b), 70.62(c), 70.64(a), 70.74, and Appendix A), they were incorrectly referenced in § 70.50. MOU principle (2) limits NRC jurisdiction to regulation of chemical hazards of licensed material and hazardous chemicals produced from licensed material. The two aforementioned sections of § 70.50 should be corrected to properly incorporate the MOU principles.

Response: The rule was revised in response to the comment to reflect more precisely the language in the NRC-OSHA MOU.

Comment F.14: One commenter noted that applicants for licenses to operate new facilities or new processes at existing facilities would be expected (“Statements of Consideration,” 64 FR 41346) to update their ISAs, based on as-built conditions, and submit the results to the NRC before operation. The process for uranium enrichment facilities that must comply with § 70.23a would differ from this description. Uranium enrichment facilities would submit a complete license application, including an ISA Summary, for construction and operation. This application would be the basis for NRC review, and culminate in issuance of a license for construction and operation. After issuance of the license, the licensee would institute change control under § 70.72. The licensee would then be required to submit summaries of changes and ISA Summary updates as required by § 70.72. An inspection would verify that the facility has been constructed in accordance with the license, before operation, as required by § 70.32(k). No pre-operational submittal and review of an updated ISA Summary are anticipated for uranium enrichment facilities because their configuration would be controlled after issuance of the construction and operation license.

Response: As recognized by the commenter, no changes to the rule are necessary. The differences in the licensing process for enrichment facilities other than the gaseous diffusion plants (regulated under 10 CFR Part 76) reflect the process mandated in Section 193 of the Atomic Energy Act of 1954, et. seq.

This section has been changed to reflect the redesignations of §§ 70.61 and 70.62 as §§ 70.81 and 70.82, respectively.

The definition of “available and reliable to perform their function when needed” has been modified to eliminate the need to maintain “continuous” compliance with the performance requirements of § 70.61. The definition of “configuration management” has been modified to clarify its role as a “management measure.” The definition of “critical mass of special nuclear material” has been modified to emphasize that the definition is only for the purposes of Subpart H. The definition of “double contingency” has been changed to provide minor clarification. The definition for “worker” has been clarified and has been revised to emphasize that the definition is only for purposes of Subpart H. The definitions of “ISA” and “ISA Summary” have been changed to indicate that the ISA can be performed on a process by process basis and the ISA Summary can be submitted in multiple documents that cover all the portions of the facility.

The reporting requirements for hazardous chemicals have been revised to be consistent with the language of the 1988 NRC-OSHA MOU (53 FR 43950; November 22, 1988).

The applicability of the Subpart H requirements has been revised to clarify when the requirements will take effect.

The performance requirements in §§ 70.61(b) and (c) have been revised to provide clarification. The requirement to establish a controlled area in § 70.61(f) has been revised to clarify the conditions for establishing the controlled area, and to clarify the applicability of the performance requirements to individuals within the controlled area. The requirement in § 70.61(f)(2) to provide training “in accordance with” 10 CFR 19.12(a)(1)-(5) has been revised to clarify that equivalent training is acceptable. The new language specifies that this training must “satisfy” 10 CFR 19.12(a)(1)-(5).

The requirement to establish and maintain a safety program in § 70.62(a)(1) has been revised to clarify that the safety program referred to in this section is focused on the safety program for satisfying the new Subpart H requirements, and that the application of management measures may be graded according to risk. Section 70.62(a)(3) has been modified to make it performance-based by eliminating the prescriptive requirement to maintain a log of failures for items relied on for safety. Section 70.62(c)(3) has been revised to clarify the schedule for planning and performing an ISA, correcting all performance deficiencies, and submitting the ISA Summary to the NRC for approval. The ISA Summary can be submitted as a single document, or as a sequence of documents ( e.g. , on a process basis). The approval process for the ISA Summary will require the issuance of a license amendment; however, a license condition will be established that allows the licensee to make changes in accordance with § 70.72, including certain changes that do not require prior NRC approval. In addition, a provision has been added to the schedule for complying with the requirements in subpart H for factors beyond control of the licensee. This would allow additional time for correcting a performance deficiency if the NRC approves. Also § 70.62(d) has been modified to reflect that management measures may be graded commensurate with the reduction in risk.

Section 70.64(a) has been revised to provide the correct reference, § 70.62(c), to the performance of an ISA. Section 70.64(a)(6)(ii) has been modified to specify that the required emergency capability is concerned with the evacuation of only on-site personnel.

Section 70.65(a) has been revised to clarify that the ISA Summary is not part of the safety program description required for inclusion in the license application. Rather, the ISA Summary, that contains a description of management measures, is submitted with the license application.

Section 70.66(b) has been added to clarify, for existing licensees, the basis for Commission approval of the ISA plan, submitted under § 70.62(c)(3)(i), and the ISA Summary, submitted under § 70.62(c)(3)(ii).

Section 70.72(c)(1) has been revised to eliminate the footnote, which did not adequately clarify the meaning of “new types of accident sequences.” The revised section 70.72(d)(3) replaces proposed rule section 70.72(d)(1) to reflect a modified schedule for submission of revised ISA Summary pages.

Section 70.76 was added to include requirements for performing a backfit analysis. The wording in § 70.76 is similar to the current language in § 76.76 for gaseous diffusion plants with one exception, 70.76(a)(4)(i). The exception in § 70.76(a)(4)(i) relates to the backfit requirements being inapplicable to changes associated with bringing the facility in compliance with the requirements of the new subpart H. The backfit section includes a provision stating that it shall apply for subpart H requirements as soon as NRC approves that licensee's ISA Summary (contents of ISA Summary described in § 70.65(b)) pursuant to § 70.66 and, for requirements other than Subpart H, it shall apply immediately after NRC publication of backfit guidance.

This section has been changed to reflect the redesignations of §§ 70.13a, 70.14, 70.61, 70.62, 70.71, and 70.72 as §§ 70.14, 70.17, 70.81, 70.82, 70.91, and 70.92, respectively, and the addition of §§ 70.66, 70.73, and 70.76.

This section has been changed to reflect the redesignations of §§ 70.61 and 70.62 as §§ 70.81 and 70.82, respectively.

Definitions of the following 12 terms have been added to this section to clarify the meaning of certain terms and phrases used in the new Subpart H: “Acute,” “Available and reliable to perform their function when needed,” “Configuration management,” “Critical mass of SNM,” “Double contingency principle,” “Hazardous chemicals produced from licensed materials,” “Integrated safety analysis,” “Integrated safety analysis summary,” “Items relied on for safety,” “Management measures,” “Unacceptable performance deficiencies,” and “Worker.”

This section reflects an administrative change to redesignate this section, formerly § 70.13a.

This section reflects an administrative change to redesignate this section, formerly § 70.14.

Paragraph (c) has been reworded to include information to be transmitted when making verbal or written reports to the NRC. The new information derives from the specifics of the new Subpart H, such as sequence of events and whether the event was evaluated in the ISA. To the extent the new information is also applicable to licensees not subject to Subpart H, the information was added with no differentiation noted. The new information that would only apply to Subpart H licensees is noted.

This section lists the types of NRC licensees or applicants that are subject to the new Part 70, Subpart H, and describes when the new requirements will be effective.

This section identifies the performance requirements that licensees subject to Part 70, Subpart H must satisfy. These performance requirements explicitly address the risks to workers or members of the public and the environmental releases caused by accidents. Because accidents are unanticipated events that usually occur over a relatively short period of time, the Part 70 changes seek to ensure adequate protection of workers, members of the public, and the environment by limiting the risk (product of likelihood and consequence) of such accidents. If, without the implementation of controls, a high consequence event under § 70.61(b) is highly unlikely, then it is not necessary for the licensee to apply the engineered or administrative controls mentioned in the rule. Similarly, if, without the implementation of controls an intermediate consequence event under § 70.61(c) is unlikely, then it is not necessary for the licensee to apply the engineered or administrative controls mentioned in the rule.

This section describes requirements for establishing and maintaining a safety program that demonstrates compliance with the performance requirements of § 70.61. The elements of this safety program include the compilation of process safety information, the performance of an ISA, and the application of management measures to ensure the availability and reliability of items relied on for safety.

This section describes baseline design criteria for new facilities or new processes at existing facilities. The application of these criteria, which are similar to the general design criteria in Part 50, Appendix A; Part 72, Subpart F; and 10 CFR 60.131, are consistent with good engineering practice, which dictates that certain minimum requirements be applied as design and safety considerations for any new nuclear process or facility. The baseline design criteria do not provide relief from compliance with the performance requirements of § 70.61.

In addition to the information that currently must be submitted to the NRC under § 70.22, for a license application, this section requires additional information to be submitted to demonstrate compliance with the new subpart H requirements. In particular, this additional information includes a description of the applicant's safety program established under § 70.62. This information will be incorporated in the license, as appropriate. The ISA Summary must be submitted with the license application or in accordance with 70.62(c)(3)(ii), but will not be incorporated in the license.

This section contains the provision that the applicant must comply with the requirements of §§ 70.60 through 70.65 (in addition to §§ 70.21 through 70.23, in the existing regulation) before a license will be granted. It also contains the requirements for approving the ISA plan and the ISA Summary for existing licensees. If the ISA Summary is submitted as a sequence of documents ( e.g. , on a process basis), NRC staff approval of an individual document will be conditioned for system interaction effects that may be identified through the review of other ISA Summary documents submitted.

This section contains requirements that govern changes to site, structures, systems, equipment, components, and activities of personnel after a license application has been approved. It requires the licensee to establish and use a configuration management system to evaluate changes and the potential impacts of those changes before implementing them. The regulation permits the licensee to make certain changes without NRC pre-approval, but requires the licensee to submit a brief summary of the changes plus updated ISA Summary pages annually within 30 days after the end of the calender year during which the changes occurred.

This section contains the requirements for renewing licenses. It references the existing renewal requirements and the additional contents of application in § 70.65.

This section contains new requirements, in addition to those in existing Parts 20 and 70, for reporting events to the NRC. The new approach, based on consideration of the performance requirements established in 10 CFR 70.61(b), is intended to eventually replace and modify the approach licensees have currently been using for reporting criticality events under NRC Bulletin 91-01. The new approach would cover all types of events, not just criticality events, and establish a timeframe for reporting that is scaled according to risk.

This section contains requirements for performing a backfit analysis that are based on those in 10 CFR 76.76. It will become effective after NRC publication of backfit guidance. NRC staff will work with stakeholders to develop backfit guidance which will include making clear that an adequate demonstration can be based on quantitative or qualitative evaluations of the nature of the increase in the overall health and safety protection of the public. The NRC will publish a separate Federal Register notice upon publication of the guidance to indicate the effectiveness of § 70.76. After that notice is published, this provision will not be applied to Subpart H requirements until the NRC approves the licensee's ISA Summary pursuant to § 70.66. If the approved ISA Summary is one of a sequence of approvals ( e.g. , on a process basis), the backfit provision will apply to the portion of the facility covered by that ISA Summary document. However, the backfit provision does not apply to changes to those portions of the facility that are required by the NRC staff to address system interaction effects identified through the review of other ISA Summary submissions for that facility.

This section has been changed to reflect the redesignations of §§ 70.13a, 70.14, 70.61, 70.62, 70.71, and 70.72 as §§ 70.14, 70.17, 70.81, 70.82, 70.91, and 70.92, respectively, and the addition of §§ 70.66, 70.73, and 70.76.

This appendix contains a list of events that licensees must report to the NRC. These events are categorized according to their consequences (or potential consequences) and fall into two classes: a 1-hour or 24-hour reporting timeframe. The emphasis on consequences, rather than risk, is appropriate in this case because the event has already occurred. Appendix A also requires concurrent reporting of events when a news release is made or if other Government agencies are notified, as is done under 10 CFR 50.72, to enhance coordination and support NRC's ability to respond to questions concerning the safety of NRC-licensed facilities.

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 this rule is not a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not required.

The amendments to 10 CFR Part 70 are intended to provide increased confidence in the margin of safety at certain facilities that possess a critical mass of SNM. To accomplish this objective, the amendments: (1) Identify appropriate performance requirements and the level of protection needed to prevent or mitigate accidents that exceed such requirements; (2) require affected licensees to perform an ISA to identify potential accidents at the facility and the items relied on for safety; (3) require the implementation of measures to ensure that the items relied on for safety are available and reliable to perform their functions when needed; (4) require the safety bases to be maintained, and changes reported to the NRC; (5) allow for licensees to make certain changes to their safety program and facilities without prior NRC approval; (6) require reporting of certain events; and (7) require a backfit analysis under specified conditions.

The rule language that defines the performance requirements is relevant to the question of environmental impact. Licensees are required to protect against the occurrence of or to mitigate the consequences of accidents that could adversely affect workers, the public, or the environment. For example, licensees are required to provide an adequate level of protection against a “release of radioactive material to the environment outside the restricted area in concentrations that, if averaged over 24 hours, exceed 5000 times the values specified in Table 2 of Appendix B to 10 CFR Part 20.” Implementation of the new amendments, including the requirement to protect against events that could damage the environment, is expected to result in a significant improvement in licensees', NRC's, other governmental agencies', and the public's understanding of the risks at these facilities and licensees' ability to ensure that those risks are appropriately controlled. For existing licensees, any deficiencies identified in the ISA (which must be completed within 4 years) will need to be promptly addressed. For new licensees, operations will not begin unless licensees demonstrate an adequate level of protection against potential accidents identified in the ISA. As a result, the safety and environmental impact of the new amendments is positive. There will be less potential adverse impact on the environment from licensed operations carried out under the final rule than if those operations were carried out under the existing Part 70 regulation. Thus, the Commission has determined, based on the Environmental Assessment that supports the rule, that there will be no significant impact on the human environment from this action.

The NRC requested public comments on any environmental justice considerations that may be related to this rule. No comments were received in response to this request.

The NRC also requested the States' views on the environmental assessment for this rule. No comments were received in response to this request.

The Environmental Assessment is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the Environmental Assessment are available from Barry Mendelsohn, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001, telephone (301) 415-7262; e-mail: btm1@nrc.gov.

This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). These requirements were approved by the Office of Management and Budget, approval number 3150-0009.

The public reporting burden for this information collection is estimated to average 92 hours per response and the recordkeeping burden is estimated to average 548 hours, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of this information collection, including suggestions for reducing the burden, to the Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@NRC.GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0009), Office of Management and Budget, Washington, DC 20503.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

The Commission has prepared a regulatory analysis on this final regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment are available from Barry Mendelsohn, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001, telephone (301) 415-7262; e-mail: btm1@nrc.gov.

As required by the Regulatory Flexibility Act, as amended, 5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant economic impact on a substantial number of small entities. The regulation affects facilities that are authorized to possess a critical mass of SNM and that are engaged in one of the following activities: enriched uranium processing; fabrication of uranium fuel or fuel assemblies; uranium enrichment; enriched uranium hexafluoride conversion; plutonium processing; fabrication of mixed-oxide fuel or fuel assemblies; scrap recovery of SNM or any other activity involving a critical mass of SNM that the Commission determines could significantly affect public health and safety or the environment. These licensees do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act, nor the size standards published by the NRC (10 CFR 2.810).

The National Technology Transfer Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this regulation, the NRC will use the following voluntary consensus standard—ANSI/ANS Standard 8.1-1983, “Nuclear Criticality Safety in Operations with Fissionable Material Outside Reactors” developed by the American Nuclear Society. Portions of the standard were used in the definition of double contingency and in § 70.61(d). A consensus standard with the complete scope of the requirements established in this rulemaking does not exist. The Commission will reference ANS 8.1 and other consensus standards, as appropriate, as acceptable approaches to demonstrate compliance with specific portions of the final rule. This will be addressed in the Standard Review Plan that is being established with the rule.

The NRC has determined that the backfit rule does not apply to this final rule; therefore, a backfit analysis is not required for this final rule because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR Chapter I. However, future changes to the requirements in subpart H or NRC requirements that apply to facilities covered by subpart H will be subject to the backfit requirements in § 70.76 established in this rule.

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 OMB.

The Departmento de Aviacao Civil (DAC), which is the airworthiness authority for Brazil, notified the FAA that an unsafe condition may exist on certain EMBRAER Model EMB-135 and EMB-145 series airplanes. The DAC advises that it received reports of Gamah coupling failures on certain EMB-145 airplanes, which resulted in significant fuel leakage. One of the incidents occurred during landing and resulted in over 1,000 pounds of fuel being spilled on to the airport runway. The other incident occurred while the airplane was being refueled and the amount of fuel leaked is unknown. This condition, if not corrected, could result in fuel leakage and consequent fire in or around the wing.

The Gamah couplings installed on Model EMB-145 series airplanes are the same as those installed on Model EMB-135 series airplanes. Therefore, the latter model also is affected by the identified unsafe condition and is included in the applicability of this AD.

The manufacturer has issued Embraer Alert Service Bulletin S.B. 145-28-A014, dated August 25, 2000, which describes procedures for a one-time visual inspection of the hinge and locking fastener of the Gamah couplings of the fuel system tubing located in the wing dry bay to detect discrepancies, and follow-on corrective actions. (The follow-on actions consist of replacing of the affected Gamah couplings and securing those couplings with locking wire if discrepancies are detected, or securing the Gamah couplings with locking wire if no discrepancies are detected.) Accomplishment of the action specified in the service bulletin is intended to adequately address the identified unsafe condition. The DAC classified this service bulletin as mandatory and issued Brazilian emergency airworthiness directive 2000-09-01, dated September 1, 2000, in order to assure the continued airworthiness of these airplanes in Brazil.

This airplane model is manufactured in Brazil and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent failure of the rivets of the Gamah coupling and consequent separation of a Gamah coupling, which could result in fuel leakage and consequent fire in or around the wing. This AD requires a one-time inspection of the hinge and locking fastener of the Gamah coupling of the fuel system tubing located in the wing dry bay to detect discrepancies, and follow-on corrective actions. The actions are required to be accomplished in accordance with the service bulletin described previously.

Operators should note that the alert service bulletin specifies installation of an additional retention device to secure the Gamah couplings with tie-down straps or locking wire; however, this AD allows use of the locking wire only.

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

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

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-301-AD.” The postcard will be date stamped and returned to the commenter.

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

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

The Departmento de Aviacao Civil (DAC), which is the airworthiness authority for Brazil, notified the FAA that an unsafe condition may exist on all EMBRAER Model EMB-135 and EMB-145 series airplanes. The DAC advises that it received a report of damage to the pins and elastomeric inserts in the hermetically sealed wire connectors of the electrical fuel pumps located in the main wing fuel tanks. Such damage can lead to the failure of certain electrical connectors due to heat generation caused by erosion of the connectors and subsequent arcing across the connector pins of the fuel pump. This condition, if not corrected, could result in fuel fire or explosion.

The manufacturer has issued Embraer Alert Service Bulletin S.B. 145-28-A013, dated August 16, 2000, which describes procedures for repetitive visual inspections of the electrical connectors of the fuel pumps to detect discrepancies (including blackened connector pins, damage to elastomeric insert, cracks, erosion or charring), and follow-on corrective actions. The follow-on actions consist of replacement of the fuel pump if discrepancies are detected, inspection of mating airplane connectors for damage, and replacement of the airplane connectors with new connectors, if damaged. Additionally, if there are no discrepancies, the service bulletin specifies replacement of the socket contacts of the connectors with new contacts. The service bulletin references the Embraer Wiring Manual which describes procedures for replacement of the connectors and socket contacts; and the Embraer Airplane Maintenance Manual which describes procedures for replacement of the fuel pump.

The DAC classified this alert service bulletin as mandatory and issued Brazilian airworthiness directive 2000-08-01, dated August 25, 2000, in order to assure the continued airworthiness of these airplanes in Brazil.

These airplane models are manufactured in Brazil and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent failure of the electrical connectors of the fuel pumps, which could result in leakage of fuel from the electrical connector or electrical arcing across the connector pins of the pump, and consequent fuel fire or explosion. This AD requires repetitive inspections of the electrical connectors of the fuel pumps to detect discrepancies, and follow-on corrective actions. The actions are required to be accomplished in accordance with the alert service bulletin described previously, except as discussed below.

This is considered to be interim action. The manufacturer has advised that it currently is developing a modification that will positively address the unsafe condition addressed by this AD. Once this modification is developed, approved, and available, the FAA may consider additional rulemaking.

Operators should note that although the alert service bulletin specifies replacement of the electric fuel pump only where greater than 30% of the wire connector pin surface is blackened, discolored, or charred, this AD mandates replacement of the fuel pump if any discrepancies (including blackened connector pins, damage to elastomeric insert, cracks, erosion or charring), are detected. The FAA has determined that, because of the safety implications and consequences associated with any blackening, discoloration, or charring (which are indicative of electrical arcing and a possible ignition source in close proximity to the fuel tank), any discrepant fuel pump and its mating airplane connector must be replaced before further flight.

The alert service bulletin specifies accomplishment of the repetitive inspections every 400 flight hours or at the next 'A' check. The FAA finds that such a compliance time will not ensure that the repetitive inspections are accomplished in a timely manner. In developing an appropriate compliance time for the inspections, the FAA considered not only the manufacturer's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, as well as the compliance time for the actions required. The FAA finds accomplishment of the repetitive inspections at intervals not to exceed 400 flight hours after accomplishment of the initial inspection, as specified in the Brazilian airworthiness directive, to be warranted, in that those intervals represent an appropriate amount of time allowable for affected airplanes to continue to operate without compromising safety.

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

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

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification (e.g., reasons or data) for each request.

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-300-AD.” The postcard will be date stamped and returned to the commenter.

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

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

A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

What caused this AD? Several operators of Raytheon Beech Models 1900C and 1900D airplanes have reported chafing of the wing fuel quantity wiring harness against the wing fuel quantity wiring harness supports (located at the wing wiring harness lighting hole mounts). The Model 1900C (C-12J) airplanes are also susceptible to this condition.

The lightning hole mounts at each wing rib support the wing fuel quantity wiring harness. The following could occur and cause the above-referenced condition:

• Vibration and fuel movement cause the insulation on the wiring harness to chafe on the tie straps used to secure the harness to the lightning hole mounts; and

• Exposed conductors of the wiring harness could then contact each other and result in an incorrect fuel quantity indication or the indicator reading zero.

In addition to the above condition on the Raytheon Beech Models 1900C, 1900C (C-12J), and 1900D airplanes, the O-rings in Wiggins couplings that join the electrical conduit internal to the wing fuel tanks could leak and allow fuel to enter the conduit. This could result in a fire or explosion.

What is the potential impact if FAA took no action? If not corrected in a timely manner, the above-referenced conditions could result in the following:

• Chafing between the wing fuel quantity wiring harness and the internal wing harness supports at each wing rib location could cause the fuel quantity indication to become unreliable. This could leave the flight crew without an indication of the amount of fuel in the airplane during flight; and

• Fuel leaking through the wiring carry-through conduit and into the wing tip or wheel well area could lead to a fire or explosion.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Raytheon Beech Models 1900C, 1900C (C-12J), and 1900D airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on March 22, 2000 (65 FR 15278). The NPRM proposed to require you to install a spiral wrap around the wing fuel quantity wiring harness and apply an adhesive sealant to the Wiggins couplings on the internal fuel tank wiring carry-through conduit. Accomplishment of the proposed action as specified in the NPRM would be in accordance with Raytheon Mandatory Service Bulletin No. SB 28-3299, Issued: December, 1999.

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. The following presents the comments received on the proposal and FAA's response to each comment:

What is the commenter's concern? One commenter states that the NPRM does not clarify how much chafing damage is allowed before the fuel quantity harness must be replaced. The commenter requests that FAA include allowable limits, sketches, or definitions that dictate how much chafing is allowed on the fuel quantity harness.

What is FAA's response to the concern? The intent of this AD action is to provide protection for the fuel quantity harness so that chafed or shorted wing fuel quantity harness wires do not occur on the affected airplanes. We believe that incorporating the actions of the proposed AD will provide the protection necessary on the fuel quantity harness. This NPRM does not propose replacement or repair of the fuel quantity harness. As with any aircraft part, the fuel quantity harness should be replaced if it has deteriorated to a point where it is not effective.

We are not changing the AD as a result of this comment.

What is the commenters' concern? Two commenters do not believe that FAA's estimate of the number of workhours necessary to accomplish the actions proposed in the NPRM is correct. One commenter states that, based on discussions with other operators, the workhours should be increased from 10 to 12. Another commenter believes 20 workhours is appropriate and lists all the steps necessary to accomplish the proposed actions.

What is FAA's response to the concern? The procedures necessary to accomplish the actions proposed in the NPRM are included in Raytheon Mandatory Service Bulletin No. SB 28-3299, Issued: December, 1999. We obtained the 10-workhour figure directly from this service bulletin. Raytheon has informed us that several owners/operators of the affected airplanes have already had the proposed actions accomplished and that on average the 10-hour estimate is correct. Some airplanes may require more time and some may require less. The exact time is dependent upon the experience of the mechanic, the availability of proper equipment, and the condition of the wire harness as stated in the “Manpower” section of the service bulletin.

We are not changing the AD as a result of these comments.

What is the commenter's concern? One commenter states that FAA failed to include the cost of replacing damaged fuel quantity harnesses and the revenues lost by taking the airplanes out of operation to accomplish the AD action.

What is FAA's response to the concern? As we stated earlier, the intent of this AD action is to provide protection for the fuel quantity harness so that chafed or shorted wing fuel quantity harness wires do not occur on the affected airplanes. The cost impact of this AD addresses the cost of the actions to meet this intent. The FAA has no way of determining the number of fuel quantity harnesses that may need to be replaced. We also cannot estimate the revenue certain operators may lose while accomplishing the AD action. We did however structure the compliance time of the proposed AD to coincide with regularly scheduled maintenance activities.

We are not changing the AD as a result of this comment.

What is the commenter's concern? One commenter states that the compliance time of 3 months or 600 hours time-in-service (TIS), whichever occurs first, will require some operators to accomplish the AD action within 9 to 10 weeks. We infer that the commenter wants the compliance time extended.

What is FAA's response to the concern? The FAA established the compliance time so that the accomplishment of the AD could coincide with regularly scheduled maintenance activities. Raytheon has informed us that many aircraft are already in compliance with the AD. For these reasons, we believe that the compliance time gives all airplane owners/operators ample time to complete the AD action. As with any AD action, we will consider compliance time extensions provided they provide an acceptable level of safety and are submitted through the alternative method of compliance procedures specified in the AD.

We are not changing the AD as a result of this comment.

What is the commenter's concern? One commenter states that its maintenance database does not contain information to support the actions proposed in the NPRM. This commenter also believes that placing sealer over the Wiggins fitting does not guarantee that the fitting will not leak. We infer that the commenter wants FAA to withdraw the NPRM.

What is FAA's response to the concern? Raytheon provided FAA with several reports of chafed and shorted fuel quantity harness wires that were found during maintenance and refurbishment. Although the addition of sealer to the fitting cannot provide a guarantee that it will never leak (nothing will provide this guarantee), we have determined that the likelihood of leakage is greatly reduced.

We are not changing the AD as a result of this comment.

What is FAA's final determination on this issue? We carefully reviewed all available information related to the subject presented above and determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We determined that these minor corrections:

• Will not change the meaning of the AD; and

• Will not add any additional burden upon the public than was already proposed.

What is the compliance time of this AD? The compliance time of this AD is whichever of the following that occurs first:

• Within the next 3 months after the effective date of this AD; or

• Within the next 600 hours TIS after the effective date of this AD.

Why is the compliance time in both calendar time and hours TIS? Chafing damage is a direct result of airplane usage; however, the fuel leakage problem could result regardless of whether the airplane is utilized. Therefore, to assure that both problems are addressed in a timely manner without inadvertently grounding any of the affected airplanes, we are utilizing a compliance based upon both hours TIS and calendar time.

How many airplanes does this AD impact? The FAA estimates that 303 airplanes in the U.S. registry will be affected by this AD.

What is the cost impact for the affected airplanes on the U.S. Register? We estimate that it will take approximately 10 workhours per airplane to accomplish the actions required by this AD, and that the average labor rate is approximately $60 an hour. There is no cost for parts to accomplish this AD. Based on these figures, we estimate the total cost impact of this AD on U.S. operators at $181,800, or $600 per airplane.

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

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

The FAA published this direct final rule with a request for comments in the Federal Register on July 12, 2000 (65 FR 42856). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on November 30, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on July 12, 2000 (65 FR 42858). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on November 30, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on July 12, 2000, (65 FR 42859). The FAA uses the direct final rulemaking procedure for a noncontroversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on October 5, 2000. No adverse comments were received, and, thus, this action confirms that this direct final rule will be effective on that date.

On July 3, 2000, the FAA published in the Federal Register a direct final rule; request for comments which revises the Class E airspace at Oelwein, IA (FR document 00-16662, 65 FR 40990, Airspace Docket No. 00-ACE-12). An error was subsequently discovered that the Hampton NDB should be the Oelwein NDB. This action corrects that error. After careful review of all available information related to the subject presented above, the FAA has determined that air safety and the public interest require adoption of the rule. The FAA has determined that this correction will not change the meaning of the action nor add any additional burden on the public beyond that already published. This action corrects the error in the airspace designation and confirms the effective date to the direct final rule.

The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on November 30, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA has developed RNAV Z RWY 16, RNAV Z RWY 34, RNAV Y RWY 16 and RNAV Y RWY 34 SIAPs to serve the Pella Municipal Airport, Pella, IA. The amendment to Class E airspace at Pella, IA, will provide additional controlled airspace at and above 700 feet AGL in order to contain the SIAPs within controlled airspace, and thereby facilitate separation of aircraft operating under Instrument Flight Rules (IFR). The amendment at Pella Municipal Airport, IA, will provide additional controlled airspace for aircraft operating under IFR and revise the ARP. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-26.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “sifnificant regulatory action” under Executive Order 12866; (2) is not a “sigfnificant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The Postal Service is revising Global Direct—Mexico to better reflect the domestic postal products offered by Mexico Postal Administration and to offer U.S. customers a wider range of direct entry products into Mexico. Global Direct—Mexico will offer three main products: Letter Mail, Direct Mail (A and B), and Publications. There are presort requirements for these services.

Global Direct—Mexico Letter Mail is for personalized communications; correspondence; and transactions such as statements of account, invoices, and financial statements. Items may be in envelopes or other sealed wrappers or may be prepared as self-mailers or double cards. The maximum weight is 1,000 grams (35.3 ounces). The minimum size is 90 millimeters in width and 105 millimeters in length. The maximum size is 140 millimeters in width and 148 millimeters in length. Rates are based on weight and whether the items are post coded.

The rates for Global Direct—Letter Mail are:

Global Direct—Direct Mail is for advertising mail, catalogs, directories, nonregistered publications, printed matter, and merchandise samples. Contents must not be of a personal or confidential nature, but personalized advertising letters are acceptable. Statements of account, invoices, and financial statements must be sent as Letter Mail. Catalogs, publications, brochures, and similar items may be mailed unenclosed. Items mailed in envelopes or wrappers may not be sealed but must be closed with tabs or by similar means. Self-mailers and double cards containing promotional messages must be closed with tabs or by similar means. There are two categories of Mexico Direct Mail, A and B, which are based on weight or size.

Direct Mail A items may weigh up to 1000 grams. The minimum size is 90 millimeters in width and 105 millimeters in length. The maximum size is 140 millimeters in width and 148 millimeters in length. Rates are based on weight. The rates for Global Direct—Mexico Direct Mail A are:

Direct Mail B items must have a minimum weight of 1,000 grams but may not exceed 5,000 grams. The minimum size is 81 millimeters in width and 114 millimeters in length. The maximum size is 324 millimeters in width and 458 millimeters in length. Rates are based on weight. The rates for Global Direct—Mexico Direct Mail B are:

Global Direct—Mexico Publications service is for magazines and other periodical publications which are registered with the government of Mexico and are enclosed in sealed envelopes or wrappers. Publications cannot weigh more than 1,000 grams. The minimum size is 90 millimeters in width and 140 millimeters in length. The maximum length is 609.6 millimeters and the maximum length, width, and thickness combined is 914.4 millimeters. The rates for Global Direct—Mexico Publications are:

Although the Postal Service is exempted by 39 U.S.C. 410(a) from the advance notice requirements of the Administrative Procedure Act regarding proposed rulemaking (5 U.S.C. 553), the Postal Service invites public comment on the interim rule at the above address.

The Postal Service adopts the following amendments to the International Mail Manual, which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 20.1.

The official record for the NO X SIP call rulemaking, as well as the public version of the record, has been established under docket number A-96-56 (including comments and data submitted electronically as described below). The EPA has added new sections to that docket for purposes of today's rulemaking. The public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as confidential business information, is available for inspection from 8:00 a.m. to 5:30 p.m., Monday through Friday, excluding legal holidays. The rulemaking record is located at the address in ADDRESSES at the beginning of this document. In addition, the Federal Register rulemakings and associated documents are located at http://www.epa.gov/ttn/rto/.

On September 24, 1998 (63 FR 57356, October 27, 1998), EPA took final action requiring 22 States and the District of Columbia (23 States) to regulate emissions of nitrogen oxides (NO X ), one of the main precursors of ground-level ozone, on the basis that these emissions contribute to the transport of ozone across State boundaries in the eastern half of the United States. The EPA found that sources and emitting activities in the 23 States emit NO X in amounts that significantly contribute to nonattainment of the 1-hour ozone NAAQS. Separately, EPA also determined that sources and emitting activities in the 23 States emit NO X in amounts that significantly contribute to nonattainment of the 8-hour ozone NAAQS. The EPA also concluded that the level of NO X reductions necessary to address the significant contribution for the 8-hour NAAQS was the same as for the 1-hour NAAQS. The EPA set forth requirements for each of the affected upwind States to submit SIP revisions prohibiting those amounts of NO X emissions which significantly contribute to downwind nonattainment. To accomplish this goal, each State is required to submit a SIP, providing for NO X reductions in amounts such that any remaining emissions would not exceed the level specified in EPA's SIP call regulations for that State in 2007. 1,2

The EPA promulgated the revised 8-hour ozone NAAQS in July 1997, and the NAAQS were challenged by a number of parties. On May 14, 1999, the D.C. Circuit issued an opinion questioning the constitutionality of the CAA authority to review and revise the NAAQS, as applied in EPA's revision to the ozone and particulate matter NAAQS. See American Trucking Ass'ns v. EPA, 175 F.3d 1027 (D.C. Cir. 1999). 3 The court also addressed other issues, including EPA's authority to implement a revised ozone standard. Based on the statutory provisions regarding classifications and attainment dates under sections 172(a) and 181(a), the court determined that, although the statute allowed EPA to promulgate a more stringent ozone NAAQS, the statute provided no authority for EPA to require States to comply with a more stringent ozone NAAQS.

The EPA and the Department of Justice sought rehearing on whether the CAA, as applied by EPA, violated the constitution and on whether the issue of EPA's implementation authority was appropriately before the court and, if so, whether the CAA prohibited EPA from implementing a more stringent ozone NAAQS. 4 On October 29, 1999, the three-judge panel that issued the initial decision granted in part and denied in part EPA's rehearing request with respect to whether EPA had authority to implement a more stringent ozone NAAQS. American Trucking Association v. EPA, 195 F.3d 4 (D.C. Cir. 1999). The three-judge panel, in a two-to-one decision, denied EPA's rehearing request on the constitutional issue; and the full court also denied EPA's request for rehearing on that issue. 5

With respect to EPA's implementation authority, the panel modified its decision to find that EPA may implement a more stringent ozone NAAQS only in conformity with the planning provisions specific to ozone, located in subpart 2 of part D of title I of the CAA. Judge Tatel did not join in the majority opinion, but filed a separate concurring decision on the basis that he read the majority decision to allow EPA to implement the more stringent 8-hour NAAQS once an area had attained the 1-hour ozone NAAQS. 195 F.3d at 11.

The EPA filed a petition requesting the Supreme Court to review the D.C. Circuit's decision regarding the constitutional and implementation issues. The Supreme Court granted EPA's request on May 22, 2000. 6

The litigation continues to create uncertainty with respect to when EPA may be able to move forward to fully implement the revised 8-hour NAAQS; thus, EPA continues to believe that it is imprudent to rely on the 8-hour NAAQS as an independent, alternative basis for the NO X SIP call at this time. Instead, EPA believes the most prudent course—and one respectful of the Court's conclusions in American Trucking —is to stay the findings in the SIP call that emissions in certain States contribute significantly to nonattainment of the 8-hour ozone NAAQS in certain downwind States. 7 The effect of such a stay is described in section II, below.

Nine States and a variety of industry and industry and labor organizations challenged the NO X SIP call rule. The State petitioners requested the court to stay the obligation under the SIP call that States submit SIPs that regulated the necessary level of NO X emissions by September 30, 1999. On May 25, 1999, the court granted the States' request, staying the SIP submission deadline pending further order of the court. 8 Michigan v. EPA, No. 98-1497 (D.C. Cir., May 25, 1999) (order granting stay in part).

In November 1999, EPA requested the court to stay its consideration of the petitioners' issues regarding the 8-hour basis for the NO X SIP call based on the D.C. Circuit's decision regarding the 8-hour NAAQS, including the decision on rehearing, and the prospect of continued litigation regarding that NAAQS. The EPA provided that it planned to stay its finding in the NO X SIP call related to the 8-hour ozone NAAQS. The court granted EPA's motion. State of Michigan v. EPA, 213 F.3d 663, 670-671 (D.C. Cir. 2000).

On March 3, 2000, the court issued a decision, largely upholding the NO X SIP call rule with respect to the 1-hour ozone NAAQS. However, the court remanded a few issues to the Agency and vacated the rule as it applied to three States. The court did not address its pending stay of the SIP submission requirement.

More specifically, the court determined that EPA had not provided a sufficient opportunity for comment on two issues: (1) the definition of electric generating units as it relates to cogeneration units; and (2) the control level the Agency assumed for stationary internal combustion engines. State of Michigan v. EPA 213 F.3d at 691-93. On April 11 and 13, 2000, EPA informed the 19 States and the District of Columbia by letter of the Agency's calculation of the effect of this aspect of the decision on the emissions “budget” for each State.

With respect to Wisconsin, the court determined that EPA inappropriately included Wisconsin based on its contribution to 1-hour ozone nonattainment levels that were occurring over Lake Michigan. The Court held that the readings over the Lake could not be considered to “contribute significantly to nonattainment in * * * any other State.” State of Michigan v. EPA, 213 F.3d at 681. The court also vacated the rule as it applies to Georgia and Missouri under the 1-hour standard on the basis that EPA had not explained why it was appropriate to base the SIP call on emissions throughout each entire State when there was evidence indicating that emissions in certain parts of those States did not contribute significantly to downwind nonattainment for the 1-hour NAAQS. State of Michigan v. EPA, 213 F.3d 681-85.

The EPA is currently taking steps to issue proposed rules addressing the issues remanded or remanded and vacated by the court.

Subsequently, EPA requested the court to lift its stay of the requirement for States to submit SIPs. Many of the petitioners in the case filed motions for rehearing by the three-judge panel that issued the decision, as well as the full court. On June 22, 2000, the court granted, in part, EPA's motion to lift the stay of the SIP submission obligation. In its order, the court noted that at the time the stay was issued, States had 128 days remaining to submit their plans (the time between May 25, 1999 and September 30, 1999). The court provided that EPA should allow 128 days from the date of the court's order for States to submit their plans. Thus, under the court's order, SIPs are due October 30, 2000. In addition, both the panel and the full court denied the requests for rehearing.

The EPA is amending the final NO X SIP call rule to stay its findings related to the 8-hour NAAQS. The EPA believes it should not continue implementation efforts under section 110 with respect to the 8-hour standard that could be construed as inconsistent with the court's ruling while these issues are being considered by the Supreme Court. Given this position, EPA believes that the Agency should not continue to move forward with findings under section 110 based on the 8-hour standard. Thus, EPA is staying indefinitely the findings of significant contribution based on the 8-hour standard, pending further developments in the NAAQS litigation. The requirements of the SIP call, including the findings of significant contribution by 19 States and the District of Columbia, and the necessary emissions reductions and related statewide budgets, as tempered by the court's remand of the internal combustion engine and EGU issues, are fully and independently supported by EPA's findings under the 1-hour NAAQS. Since the rule was based independently on the 1-hour NAAQS, a stay of the findings based on the 8-hour standards would have no effect on the required remedy for the 19 States and the District of Columbia. For these States, the effect of the stay would be that States would have no obligation during the pendency of the stay to regulate NO X emissions under the SIP call rule for purposes of addressing downwind nonattainment of the 8-hour NAAQS. These 20 States would remain obligated to move forward to regulate emissions of NO X for the purpose of addressing their contribution to downwind nonattainment of the 1-hour standard.

However, the court vacated the SIP call rule, based on EPA's findings for the 1-hour standard, for three States—Wisconsin, Georgia, and Missouri. The effect of EPA's stay of the findings under section 110 based on the 8-hour standard is to stay the requirement for these three States to submit any SIP in response to the SIP call. 9 Thus, these three States would have no obligation under the SIP call until such time as EPA either lifts the stay of the findings under section 110 based on the 8-hour standard or completes rulemaking in response to the court's vacatur and remand of the 1-hour basis of the SIP call rule and makes new findings under section 110 based on the 1-hour standard.

Four commenters submitted comments on the March 2, 2000 proposal. The comments are summarized below along with EPA's responses.

Comment: Three commenters suggest that EPA deny and eliminate all findings and provisions based on the 8-hour standard in light of the court's decision in ATA, remanding that standard to EPA. One commenter also claims that EPA must adjust any emission reduction requirements to reflect only those needed to achieve the 1-hour standard. One of these commenters believes that EPA's proposal to stay the 8-hour basis of the SIP call rule is a “second best” approach.

Response: The court in ATA remanded, but did not vacate, the 8-hour standard. Because the 8-hour standard remains in effect, EPA does not believe that it is necessary for the Agency to vacate the 8-hour basis of the NO X SIP call rule. Moreover, the Supreme Court has granted EPA's petition for certiorari and thus will be reviewing the D.C. Circuit's decision. Due to the uncertainty created by the pending litigation, regarding whether the 8-hour standard may be fully implemented, EPA believes it is appropriate to stay the 8-hour basis for the SIP call rule, such that States and sources are not required to move forward with implementing control measures designed solely to attain the 8-hour NAAQS at this time. However, it is premature to presume that implementation of the 8-hour standard will not move forward in the future. Thus, EPA believes the best approach at this time is to stay, but not withdraw, the 8-hour basis of the SIP call rule.

With respect to the claim that EPA needs to adjust the emission budgets to reflect only those emissions reductions needed to achieve the 1-hour NAAQS, EPA notes that no adjustments due to staying the findings for the 8-hour NAAQS are necessary. The EPA assessed each State's contribution for the 1-hour NAAQS independent of its assessment of the State's contribution for the 8-hour NAAQS. See 62 FR 60,326 (Nov. 7, 1997); 63 FR 57,377, and 57,395 (Oct. 27, 1998). However, EPA ultimately determined that the “significant contribution” of emissions that each State needed to address was the same regardless of whether the reductions were needed for the 1-hour standard or the 8-hour standard. Therefore, EPA promulgated only one emissions budget relevant for each State.

In addition, EPA notes that the budgets were not for the purpose of ensuring attainment of either NAAQS in downwind States. Rather, the budgets were for the purpose of addressing each upwind State's significant contribution to nonattainment in downwind areas. As EPA noted in the final SIP call rule, all of the downwind, 1-hour nonattainment areas (and many of the downwind areas violating the 8-hour standard) generally were expected to need additional local emissions reductions beyond those required by the SIP call to reach attainment of the respective NAAQS. Because EPA's analysis focused on addressing the emissions that significantly contribute to a downwind area's nonattainment problem (as provided under section 110(a)(2)(D)), rather than addressing the level of emissions reductions that would bring a downwind area into attainment for a particular standard, it is not unexpected that the budget levels would be the same for the 1-hour and 8-hour standards.

Comment: One commenter recommends that EPA stay the NO X SIP call rule in all respects until such time as there is a final, non-appealable resolution of the litigation on the SIP call rule, and that EPA go through notice-and-comment rulemaking to lift the stay after the litigation is complete. Another commenter suggests that EPA stay the NO X SIP call rule until both the SIP call litigation and the ATA litigation are finally resolved. The commenter expresses concern over EPA's efforts to implement the NO X SIP call rule and EPA's rule under section 126 of the CAA (directly regulating sources of NO X ) while litigation is still pending on those cases and on the technical amendments regarding budget corrections. The commenter suggests that the pending litigation makes it virtually impossible for sources to plan for compliance.

Response: This rulemaking concerns a limited issue—whether EPA should stay the 8-hour basis of the NO X SIP call rule in light of the court's decision in ATA remanding that standard. That decision, in no way, calls into question the 1-hour NAAQS and the need for States to develop SIPs to address that standard. Thus, the pending ATA litigation does not justify a stay of the findings under section 110 based on the 1-hour standard. Moreover, on June 22, 2000, the D. C. Circuit lifted its stay of the requirement for States to submit SIPs in accordance with the SIP call rule and has denied the requests for rehearing of its decision in the SIP call litigation. While parties may seek further review of that decision in the Supreme Court and the challenges to the technical corrections are pending, EPA notes that the mere fact that litigation is pending regarding an Agency action does not warrant a stay of the challenged regulation. As a general matter, regulations remain in effect pending litigation.

Comment: One commenter expressed support for EPA's proposal to stay the 8-hour basis for the NO X SIP call rule. The commenter also stated that reliance on the 8-hour NAAQS prior to designation of areas for that standard was premature.

Response: The EPA is taking final action as proposed and as supported by the commenter. In the final SIP call rule, EPA disagreed with the commenter's position that EPA may not require States to address interstate transport for a NAAQS prior to the time EPA designates areas for that standard. That issue was raised in the SIP call litigation and the court has stayed its consideration of the issue based on EPA's decision to stay the 8-hour basis of the SIP call rule. That issue has not influenced EPA's decision to stay the 8-hour basis for the SIP call rule and could be considered by the court if and when EPA lifts its stay.

Comment: One commenter claims that EPA “obfuscates the interdependence of the 1-hour and 8-hour bases for the NO X SIP call and Section 126 rules” by claiming that the findings for each standard were “separate.” The commenter believes that EPA's basis for both the SIP call rule and the section 126 rule is the 8-hour NAAQS. The commenter notes that the EPA-calculated emissions reductions from baselines in the NO X SIP call rule assume achievement of the 8-hour NAAQS. Two commenters are concerned that the stay has no effect since sources will need to implement all remaining portions of the rule.

Response: In the final SIP call rule, EPA clearly stated that it independently assessed significant contribution for the 1-hour and 8-hour ozone NAAQS. See 62 FR 60,326; 63 FR 57,377, and 57,395. In requesting the court to stay the limited issues raised exclusively regarding the 8-hour basis for the SIP call, EPA also clearly articulated that the 8-hour and 1-hour bases were wholly independent of each other and that “the emission reductions that must be achieved, and the requirement for States to submit SIPs meeting NO X budgets are fully and independently supported by EPA's findings under the 1-hour NAAQS alone.” Motion for Stay of Judicial Consideration of Certain Issues Raised In Petitioners' Briefs at 3, Michigan v. EPA, (No. 98-1497, D.C. Cir.) Nov. 19, 1999. The court granted EPA's request to stay consideration of the 8-hour basis for the SIP call and upheld in most significant respects the 1-hour basis for the SIP call. No party has sought rehearing on the grounds that the 1-hour standard alone cannot support the SIP call rule.

The EPA agrees with the commenters that the stay of the 8-hour basis of the rule will have no effect on the emissions budget for those 19 States and D.C. that are still covered by the NO X SIP call based on the 1-hour standard. As provided above, EPA determined that the level of reductions needed to address significant contribution for the 1-hour NAAQS is the same as the level needed to address the 8-hour NAAQS and thus the budgets are the same. 10 Thus, the stay has no practical effect on the SIP that these 19 States and D.C. will need to submit to address the SIP call.

Comment: One commenter claims that EPA should provide in the final rule, as it did in its similar stay of the 8-hour basis of the section 126 rule, that EPA would lift the stay of the 8-hour basis of the SIP call rule only through notice-and-comment rulemaking.

Response: The EPA agrees that it would need to lift the stay through rulemaking. In that rulemaking, EPA also would consider whether to modify the findings based on the 8-hour standard in light of the court's decision with respect to the findings for the 1-hour standard.

Under Executive Order 12866, (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget (OMB) because this action is simply staying its finding in the NO X SIP call related to the 8-hour ozone standards. The final NO X SIP call was submitted to OMB for review. The EPA prepared a regulatory impact analysis (RIA) for the final NO X SIP call titled “Regulatory Impact Analysis for the NO X SIP Call, FIP, and Section 126 Petitions.” The RIA and any written comments from OMB to EPA and any written EPA responses to those comments are included in the docket. The docket is available for public inspection at the EPA's Air Docket Section, which is listed in the ADDRESSES section of this preamble. This action does not create any additional impacts beyond what was promulgated in the final NO X SIP call, therefore, no additional RIA is needed.

This action also does not impose any additional enforceable duty, contain any unfunded mandate, or impose any significant or unique impact on small governments as described in the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). The EPA prepared a statement for the final NO X SIP call rule that would be required by UMRA if its statutory provisions applied and consulted with governmental entities as would be required by UMRA. Because today's action does not create any additional mandates, no further UMRA analysis is needed.

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

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

This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action stays EPA's findings in the NO X SIP call rule related to the 8-hour ozone NAAQS and imposes no additional burdens beyond those imposed by the final NO X SIP call rule. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's action does not significantly or uniquely affect the communities of Indian tribal governments. The EPA stated in the final NO X SIP call rule that Executive Order 13084 did not apply because the final rule does not significantly or uniquely affect the communities of Indian tribal governments or call on States to regulate NO X sources located on tribal lands. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

In addition, this action does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). For the final NO X SIP call, the Agency conducted a general analysis of the potential changes in ozone and particulate matter levels that may be experienced by minority and low-income populations as a result of the requirements of the rule. These findings are presented in the RIA.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) a small business as defined in the Small Business Administration's (SBA) regulations at 13 CFR 12.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

This action will not impose any requirements on small entities. This action stays EPA's findings in the NO X SIP call rule related to the 8-hour ozone NAAQS and does not itself establish requirements applicable to small entities.

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

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045, because this action is not “economically significant” as defined under Executive Order 12866 and the Agency does not have reason to believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children.

In addition, the National Technology Transfer and Advancement Act of 1997 does not apply because today's action does not require the public to perform activities conducive to the use of voluntary consensus standards under that Act. The EPA's compliance with these statutes and Executive Orders for the underlying rule, the final NO X SIP call, is discussed in more detail in 63 FR 57477-57481 (October 27, 1998).

The EPA stated in the final NO X SIP call that an information collection request was pending. Today's action imposes no additional burdens beyond those imposed by the final NO X SIP call. Any issues relevant to satisfaction of the requirements of the Paperwork Reduction Act will be resolved during review and approval of the pending information collection request for the NO X SIP call.

Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final actions by EPA. This section provides, in part, that petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit if (i) the agency action consists of “nationally applicable regulations promulgated, or final action taken, by the Administrator,” or (ii) such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

Any final action related to the NO X SIP call is “nationally applicable” within the meaning of section 307(b)(1). As an initial matter, through this rule, EPA interprets section 110 of the CAA in a way that could affect future actions regulating the transport of pollutants. In addition, the NO X SIP call requires 22 States and the District of Columbia to decrease emissions of NO X . The NO X SIP call also is based on a common core of factual findings and analyses concerning the transport of ozone and its precursors between the different States subject to the NO X SIP call. Finally, EPA has established uniform approvability criteria that would be applied to all States subject to the NO X SIP call. For these reasons, the Administrator has also determined that any final action regarding the NO X SIP call is of nationwide scope and effect for purposes of section 307(b)(1). Thus, any petitions for review of final actions regarding the NO X SIP call must be filed in the Court of Appeals for the District of Columbia Circuit within 60 days from the date final action is published in the Federal Register .

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. The 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). This rule will be effective October 18, 2000.

Throughout this document, “we,” “us” and “our” refer to EPA.

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

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically .You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301046. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA issued two final rules, one published in the Federal Register of October 13, 1998 (63 FR 54594) (FRL-6030-3), and the other published in the Federal Register of November 26, 1997 (62 FR 62986) (FRL-5750-9), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limited tolerances for the combined residues of hexythiazox and its metabolites at 3.0 ppm on strawberry; at 0.1 ppm on dates; and at 0.1 ppm on cotton, undelinted seed; and at 2.0 ppm on cotton gin byproducts, with expiration dates of September 15, 2000 (strawberry and dates) and October 1, 1999 (cotton). EPA established the tolerances because 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 the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be established without providing notice or period for public comment.

EPA received requests to extend the use of hexythiazox on strawberry, dates, and on cotton for this year's growing season due to the continued lack of effective registered products to control mite species in the cultivation of these crops. After having reviewed each submission, EPA concurs that emergency conditions continue to exist. EPA has authorized under FIFRA section 18 the use of hexythiazox on strawberry, dates, and on cotton for control of various mite species in California (all three commodities) and Florida (strawberry only).

EPA assessed the potential risks presented by residues of hexythiazox in or on strawberry, dates, and cotton. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule of October 13, 1998 (63 FR 54594). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerance will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended (in the case of strawberry and dates) and re-established (in the case of cotton) for an additional 2-year period. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations (CFR). Although these tolerances will expire and be revoked on October 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on strawberry, dates, and cotton after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerance. 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.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301046 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 17, 2000.

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 (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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) 260-4865.

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.

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301046 to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. 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 file format 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 FFDCA section 408. 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). 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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).

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273 and 279.

We conclude that Florida's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Florida Final authorization to operate its hazardous waste program with the changes described in the authorization application. Florida has responsibility for permitting Treatment, Storage, Disposal Facilities (TSDFs) within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in Florida, including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in Florida subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Florida has enforcement responsibilities under its state hazardous waste program for violations of such program, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

• Do inspections, and require monitoring, tests, analyses or reports

• Enforce RCRA requirements and suspend or revoke permits

• Take enforcement actions regardless of whether the State has taken its own actions

This action does not impose additional requirements on the regulated community because the regulations for which Florida is being authorized by today's action are already effective, and are not changed by today's action.

EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today's Federal Register we are publishing a separate document that proposes to authorize the state program changes.

If EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the state program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw that part of this rule but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Florida initially received Final authorization on January 29, 1985, effective February 12, 1985 (50 FR 3908), to implement the RCRA hazardous waste management program. We granted authorization for changes to their program on December 1, 1987, effective March 3, 1988 (52 FR 45634), December 16, 1988, effective January 3, 1989 (53 FR 50529), December 14, 1990, effective February 12, 1991 (55 FR 51416), February 5, 1992, effective April 6, 1992 (57 FR 4371), February 7, 1992, effective April 7, 1992 (57 FR 4738), May 20, 1992, effective July 20, 1992 (57 FR 21351), November 9, 1993, effective January 10, 1994, (58 FR 59367), July 11, 1994, effective September 9, 1994 (59 FR 35266), August 16, 1994, effective October 17, 1994 (59 41979), October 26, 1994, effective December 27, 1994 (59 FR 53753), April 1, 1997, effective June 2, 1997 (62 FR 15407). The authorized Florida program was incorporated by reference into the CFR on January 20, 1998, effective March 23, 1998 (63 FR 2896).

On July 17, 2000, Florida submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. Florida's revisions consist of provisions contained in HSWA Clusters I and II (Corrective Action), RCRA Cluster III (Corrective Action Management Units), and RCRA Cluster VII (Organic Air Emission Standards). We now make an immediate final decision, subject to receipt of written comments that oppose this action, that Florida's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant Florida Final authorization for the following program changes:

There are no State requirements in this program revision considered to be more stringent or broader in scope than the Federal requirements.

Florida will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization until the permits expire or are terminated. We will not issue any more new permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Florida is not yet authorized.

Florida is not authorized to carry out its hazardous waste program in Indian country within the State, which includes:

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart K for this authorization of Florida's program changes until a later date.

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes state requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by state law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this action authorizes 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). For the same reason, this action also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes state requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks.

Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq., as 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 document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective November 17, 2000.

The Environmental Protection Agency (EPA) Region 5 announces the deletion of the Cliff/Dow Dump Site, Marquette, Marquette County, Michigan, from the National Priorities List (NPL), appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300. EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and maintains the NPL as the list of these sites. EPA and the State of Michigan have determined that the remedial action for the Site has been successfully executed. EPA will accept comments on this action for thirty days after publication of this action in the Federal Register .

Section II of this action explains the criteria for deleting sites from the NPL. Section III discusses the procedures that EPA is using for this action. Section IV discusses the history of the Cliff/Dow Site and explains how the Site meets the deletion criteria. Section V states EPA's action to delete the Site from the NPL unless dissenting comments are received during the comment period.

Section 300.425(e) of the NCP provides that Sites may be deleted from, or recategorized on the NPL where no further response is appropriate. In making a determination to delete a Site from the NPL, EPA shall consider, in consultation with the state, whether any of the following criteria has been met:

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

(ii) All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if the Site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the site above levels that allow for unlimited use and unrestricted exposure, EPA's policy is that a subsequent review of the Site will be conducted at least every five years after the initiation of the remedial action at the Site to ensure that the Site remains protective of public health and the environment. In the case of this Site, EPA will not conduct any five year reviews since no wastes were left on Site. EPA determined that conditions at the Site remain protective of public health and the environment. As explained below, the Site meets the NCP's deletion criteria listed above. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the site shall be restored to the NPL without the application of the Hazard Ranking System (HRS).

The following procedures were used for the intended deletion of the Site:

(1) All appropriate responses under CERCLA have been implemented and no further action by EPA is appropriate; (2) The MDEQ concurred with the proposed deletion decision; (3) A notice has been published in the local newspaper and has been distributed to appropriate federal, state, and local officials and other interested parties announcing the commencement of a 30-day dissenting public comment period on EPA's Direct Final Action to Delete; and, (4) All relevant documents have been made available for public review in the local Site information repositories. EPA is requesting only dissenting comments on the Direct Final Action to Delete.

For deletion of the Site, EPA's Regional Office will accept and evaluate public comments on EPA's Final Notice before making a final decision to delete. If necessary, the Agency will prepare a Responsiveness Summary, responding to each significant comment submitted during the public comment period. Deletion of the Site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. The NPL is designed primarily for informational purposes and to assist Agency management. As mentioned in Section II of this document, § 300.425(e)(3) of the NCP states that the deletion of a Site from the NPL does not preclude eligibility for future response actions.

The following site summary provides the Agency's rationale for the proposal to delete this Site from the NPL.

The Cliff/Dow Disposal Site is located in the north half of section 10 T48N, R25W of Marquette County, in a wooded area off County Road 550, about one half mile west of Dead River in the City of Marquette, Michigan. The two-acre Site is currently owned by the City of Marquette, and is zoned “deferred use”. Recreational activity in the area is concentrated along the river and associated with sport fishing. The area around the Site is largely undeveloped. A small area to the east of the Site, and property to the north of the Site is zoned industrial. A tourist park, operated by the City of Marquette, is located southeast of the Site across the river.

The Ciff/Dow Chemical Company was the operator of the Site from 1954 until the mid 1960's. The Dow Chemical Company and The Cleveland Cliffs Company owned the stock of the Cliff/Dow Chemical Company. In 1968 the Georgia-Pacific corporation and the E.L. Bruce Company acquired the stock of the Cliff/Dow Chemical Company from the Dow Chemical Company and the Cleveland-Cliffs Iron Company, and continued to do business under the name of Royal Oak Charcoal Company. During this time period, hazardous substances were disposed in a small bog depression at the County Road 550 Site.

In 1981 hikers reported to Marquette city officials of having their clothing contaminated by surface tar at the fill area. Subsequent sampling and analysis of fill material by the EPA in 1982 indicated the presence of high concentrations of organic Hazardous Substance List (HSL) compounds, primarily polyaromatic hydrocarbons (PAHs) and phenols. EPA placed the Cliff/Dow Site on the Federal National Priorities List (NPL) of hazardous waste sites in September 1983. The Dow Chemical Company, the Cleveland Cliffs Iron Company, the Georgia-Pacific Corporation, and the City of Marquette were sent Special Notice Letters pursuant to section 122 of CERCLA. These letters stated that they were considered Potentially Responsible Parties (PRP's) at the Cliff-Dow Superfund Site, and requested their participation in the remediation of the fill area. On September 25, 1984, in response to a release or a substantial threat of a release of hazardous substances at or from the Site, the PRP's signed a 106 Administrative Consent Order for conducting a Remedial Investigation/Feasibility Study (RI/FS) and pre-design for the Site. A snow fence was placed around the fill in November 1984 to deter unauthorized entry. In November 1984, RI/FS field work began. The RI report was completed in August 1987, and the FS was completed in April 7, 1989. In September 1989, a Record of Decision (ROD) was issued by the EPA for the Site. The Proposed Plan had selected off-site disposal of the fill material for the proposed remedy. During the Public comment period the PRP's requested that the EPA allow them to demonstrate that on-site biological treatment would meet all nine remedy selection criteria and be more cost effective than off-site disposal. All factors considered, EPA determined that enhanced biological treatment of the residually contaminated fill material would be a viable innovative treatment technology. It would be the selected remedy if it could be demonstrated during the remedial design pilot studies, that the ROD requirements could be achieved by on-site biological treatment in a reasonable time frame. The major components of the selected remedial action in the ROD included:

• Excavation and treatment, via incineration, of approximately 200 cubic yards of exposed tar;

• Excavation, segregation and treatment, via incineration, of approximately 200 cubic yards of buried tar;

• Excavation and treatment, via enhanced biological treatment, of approximately 9,200 cubic yards of residual contaminated fill material;

• Import of clean backfill and topsoil cover/revegetation of excavation area;

• Site deed restrictions that prevent installation of drinking water wells within the vicinity of the contaminated groundwater boundaries and the disturbance of fill material until health based remedial action goals had been achieved; and

• Groundwater/air monitoring program to confirm the adequacy of enhanced biological treatment of residual contaminated fill material and in-situ biotreatment of residual groundwater contamination.

On June 27, 1990, the remedial action for the excavation and incineration of exposed and readily accessible tar was completed. The tar was excavated and incinerated at an off-site incinerator. On January 4, 1992, the Marquette County Health Department issued an Order prohibiting installation of any water wells on the Site until future factual evidence shows that the groundwater is suitable for use as drinking water at this location. On November 25, 1992, the City of Marquette placed Restrictive Covenants on the fill area restricting activities at the Site that may result in human health exposure greater than the cleanup standards in the ROD. These activities satisfy the institutional control and deed restriction requirements of the ROD. In August 1993, the PRPs issued the results of a bench scale Forced Air Biological Treatment (FABT) study. The FABT did not demonstrate that the ROD clean-up values could be obtained at a reasonable cost, in a reasonable time frame. Further requests by the Agency for more comprehensive site characterization indicated that the tar fraction was more extensive than the RI had indicated. Field studies by the PRP's to demonstrate that the tar could be segregated from the fill material were also unsuccessful. On July 5, 1995, consistent with the Proposed Plan, and as provided for in the ROD, the PRPs accepted a Unilateral Order for removal and disposal of all tar and fill from the Site with contamination above ROD clean up levels, and quarterly monitoring of select Site wells for a one year period.

In the summer of 1995, the PRPs excavated 28,000 tons of contaminated Site material, sent it to an off-site licensed landfill for disposal, and replaced it with clean borrow material and seeded. Four quarterly groundwater monitoring events occurred at the Site after the remedy was complete. One well showed trace amounts of benzene, these results being consistent with early RI findings. Results of all other wells were either non-detect or well below risk and hazard index criteria. Confirmatory Sampling at Dead River also supported the findings that there was no groundwater problem.

The groundwater monitoring program implemented during the quarterly Operation and Maintenance (O & M) phase was performed in accordance with the approved Quality Assurance Project Plan for O & M. The laboratory used for the analysis of the groundwater samples was determined to be acceptable for use by the U.S. EPA Region 5 Environmental Sciences Division based on previous laboratory audits. Split samples were also analyzed by the MDNR, and were in agreement with the PRPs results. The post RA groundwater analytical results were below health based concerns. Therefore, EPA and the MDEQ have decided to remove this Site from the NPL.

The remedy selected for this Site has been implemented in accordance with the ROD. The remedy has resulted in the significant reduction of the long-term potential for release of contaminants, therefore, threats to human health and the environment have been minimized. EPA and the State of Michigan find that the remedy implemented continues to provide adequate protection of human health in the environment.

The MDEQ concurs with the EPA that the criteria for deletion of the Site have been met. Therefore, EPA is deleting the Site from the NPL.

This action will be effective November 17, 2000. However, if EPA receives dissenting comments by October 18, 2000, EPA will publish a document that withdraws this action.

The Federal Communications Commission published a document amending part 1 of the Commission's rules in the Federal Register on December 9, 1999 (64 FR 68946). This document corrects the Federal Register as it appeared in rule FR Doc. 99-31620, published on December 9, 1999 (64 FR 68946).