OSC published notice of proposed revisions to its regulations dealing primarily with the agency's implementation of the Freedom of Information Act (FOIA), with a request for comments and a description of the proposed revisions, in the Federal Register on April 12, 2007 (72 FR 18406). The regulation, as revised, will implement provisions of the FOIA as amended, update information in the current regulation, and contain new and expanded information about the agency's processing of FOIA requests and appeals. Included in the revised regulation are provisions containing updated, revised, or new information about: publicly available records and information; requirements for making FOIA requests, including updated contact information; consultations with and referrals to other agencies; responses to requests, including information about multitrack and expedited processing; requirements for appealing initial decisions on requests, including updated contact information; fees, including new and revised cost information; and business information. Finally, the regulation will address responses to demands by courts or other authorities to an OSC employee for production of official records or testimony in legal proceedings.

OSC received comments in response to the notice from one respondent, a non-governmental organization. After considering those comments, OSC is publishing this final rule, modified as described below, pursuant to 5 U.S.C. 1212(e).

The respondent's comments addressed two aspects of OSC's proposed FOIA regulation. First, the respondent stated that the section 1820.4 (“Timing of responses to requests”) does not set a time limit within which OSC will respond to a FOIA request, and recommended that OSC revise its proposed regulation to include the statutory timeframe for deciding standard FOIA requests. OSC conceived of the proposed regulation primarily as a means by which to implement provisions of the FOIA rather than repeat them. For that reason, section 1820.1 (“General Provisions”) states that the regulation should be read together with the FOIA, and provides the address for the FOIA page on OSC's web site, for additional information about access to agency records, including the statutory timeframe for deciding requests. Nevertheless, OSC is adding the statutory timeframe to the regulation for additional clarity, although in a different section. Section 1820.4 of the regulation describes the order in which OSC processes requests. Section 1820.5 (“Responses to requests”) appears to be the more appropriate section in which to add a description of the statutory timeframe for deciding standard FOIA requests not involving unusual circumstances, and OSC has done so.

Second, the respondent noted that the proposed regulation specified that FOIA requests would be accepted by mail or by fax, but recommended that OSC consider establishing a mechanism to receive FOIA requests electronically. The respondent acknowledged that the FOIA does not require that agencies receive requests by any particular means, but stated that other agencies accept FOIA requests electronically, and cited considerations favoring receipt of FOIA requests by such means. This is not a comment on the proposed regulation, but a recommended change in OSC procedures. In any case, OSC has accepted FOIA requests by fax, a form of electronic receipt, for several years, a practice formally recognized by the proposed regulation. Other mechanisms for electronic receipt may be implemented at some point in the future. If so, notice will be provided to the public on OSC's web site and by further revision of the agency's FOIA regulation.

OSC is submitting a report on this final rule to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

Procedural determinations were published in the notice of proposed rulemaking for the Congressional Review Act, Regulatory Flexibility Act, Unfunded Mandates Reform Act, Paperwork Reduction Act, Executive Order 12866 (Regulatory Planning and Review), Executive Order 13132 (Federalism), and Executive Order 12988 (Civil Justice Reform). There have been no changes in these procedural determinations.

History

On May 7, 2007, the FAA published in the Federal Register a notice of proposed rulemaking to establish a direct route from the Seattle Area to the Phoenix, AZ, area (72 FR 25712). Interested parties were invited to participate in this rulemaking effort by submitting written comments on this proposal to the FAA. No comments were received.

High altitude area navigation routes are published in paragraph 2006 of FAA Order 7400.9P dated September 1, 2006 and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The area navigation routes listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 to establish an RNAV route within the airspace assigned to the Seattle, Los Angeles, Albuquerque, Salt Lake City and Denver Air Route Traffic Control Center (ARTCC). This route provides a direct route from the Seattle, WA area to Phoenix, AZ, and facilitates a more flexible and efficient use of navigable airspace for en route instrument flight rules operations.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures”, paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

1. On March 16, 2007, the Commission issued a Final Rule (Order No. 693)  1 approving, pursuant to section 215 of the Federal Power Act (FPA), 2 83 of 107 proposed Reliability Standards, six of the eight proposed regional differences, and the Glossary of Terms Used in Reliability Standards (glossary) developed by the North American Electric Reliability Corporation (NERC), which the Commission has certified as the Electric Reliability Organization (ERO) responsible for developing and enforcing mandatory Reliability Standards. However, the Commission stated that, although it believed it is in the public interest to make these Reliability Standards mandatory and enforceable, it also found that much work remains to be done. Specifically, it stated that many of these Reliability Standards require significant improvement to address, among other things, the recommendations of the Blackout Report. 3 Therefore, pursuant to section 215(d)(5), we required the ERO to submit significant improvements to 56 of the 83 Reliability Standards that are being approved as mandatory and enforceable. The Commission stated that the remaining 24 Reliability Standards will remain pending at the Commission until further information is provided.

2. Order No. 693 added a new part to the Commission's regulations, which states that this part applies to all users, owners and operators of the Bulk-Power System within the United States (other than Alaska or Hawaii) and requires that each Reliability Standard identify the subset of users, owners and operators to which that particular Reliability Standard applies. The new regulations also require that each Reliability Standard that is approved by the Commission will be maintained on the ERO's Internet Web site for public inspection.

3. In Order No. 693, the Commission stated that there were four possible courses of action that it would take with regard to each proposed Reliability Standard: (1) Approve; (2) approve as mandatory and enforceable; and direct modification pursuant to section 215(d)(5); (3) request additional information; or (4) remand. As mentioned above, the Commission approved 83 Reliability Standards and directed NERC to develop modifications to 56 of the approved Reliability Standards. In approving the Reliability Standards, Order No. 693 stated that, for an initial period, the Commission would rely on the NERC definition of bulk electric system, rather than the statutory Bulk-Power System, and NERC's registration process to provide as much certainty as possible regarding the applicability to and the responsibility of specific entities to comply with the Reliability Standards in the start-up phase of a mandatory Reliability Standard regime. 4 Further, while the Commission did not institute a formal “trial period,” it directed the ERO and Regional Entities to “focus their resources” on the “most serious violations” during an initial period through December 31, 2007. 5

4. The following entities have filed timely requests for rehearing or for clarification of Order No. 693: American Public Power Association (APPA); Avista Corporation, Portland General Electric Company, and Puget Sound Energy, Inc. (collectively, Avista); City of Santa Clara, California (Santa Clara); Cogeneration Association of California and the Energy Producers and Users Coalition (California Cogeneration); ISO-New England, Inc. (ISO-New England); Midwest Independent Transmission System Operator, Inc. (Midwest ISO); National Association of Regulatory Utility Commissioners (NARUC); National Rural Electric Cooperative Association (NRECA); Pacific Northwest Security Coordinator (PNSC); Transmission Agency of Northern California (TANC); and Xcel Energy Services, Inc. (Xcel).

5. PNSC's rehearing request is deficient because it fails to include a Statement of Issues section separate from its arguments, as required by Rule 713 of the Commission's Rules of Practice and Procedure. 6 Rule 713(c)(2) requires that a rehearing request must include a separate section entitled “Statement of Issues” listing each issue presented to the Commission in a separately enumerated paragraph that includes representative Commission and court precedent on which the participant is relying. 7 Under Rule 713, any issue not so listed will be deemed waived. Accordingly, we will dismiss PNSC's rehearing request. 8

6. In any event, PNSC's arguments on rehearing are beyond the scope of this proceeding. PNSC asks the Commission to clarify that PNSC is in compliance with IRO-001 because it has written agreements delineating the responsibilities and authority of the operating personnel who staff its reliability center. Whether any one entity is in compliance with a Reliability Standard is not an issue in the rulemaking.

7. Section 215 of the FPA defines the term “Bulk-Power System” as follows:

8. The NERC glossary, in contrast, states that Reliability Standards apply to the “bulk electric system,” which is defined by its regions in terms of a voltage threshold and configuration, as follows:

9. In Order No. 693, the Commission stated that, for an initial period, it would rely on the NERC definition of bulk electric system and NERC's registration process to provide as much certainty as possible regarding the applicability to and the responsibility of specific entities to comply with the Reliability Standards in the start-up phase of a mandatory Reliability Standard regime. 9 However, the Commission stated that it was concerned about the need to address the potential for gaps in coverage of facilities. The Commission intends to address this matter in future proceedings. As a first step in enabling the Commission to understand the reach of the Reliability Standards, we directed the ERO to provide the Commission with an informational filing that includes a complete set of regional definitions of bulk electric system and any regional documents that identify critical facilities to which the Reliability Standards apply ( i.e. , facilities below a 100 kV threshold that have been identified by the regions as critical to system reliability).

10. However, the Commission disagreed with commenters who suggested that there is no intentional distinction between Bulk-Power System and bulk electric system. This distinction was evidenced by the fact that “Congress did not borrow the term of art—bulk electric system—but instead chose to create a new term, Bulk-Power System, with a definition that is distinct from the term of art used by industry.”  10 Thus, the Commission “confirmed” that the Bulk-Power System reaches farther than those facilities that are included in NERC's definition of the bulk electric system, although choosing to rely on the NERC definition for determining the immediate applicability of the approved Reliability Standards. The Commission indicated that it remained concerned about potential gaps in coverage of facilities and that any change in applicability would be addressed in future Commission proceedings.

11. NRECA asks that the Commission clarify that it has not definitively decided that the term Bulk-Power System as defined in section 215 of the FPA encompasses more than NERC's definition of bulk electric system. Rather, NRECA understands that the Commission deferred on determining whether its jurisdiction expands beyond the bounds of the bulk electric system. NRECA is concerned that Order No. 693 may suggest that the Bulk-Power System is broader than the bulk electric system out of a misapprehension that NERC's definition imposes a rigorous 100 kV “cutoff” when, according to NRECA, it actually provides for more flexibility. Alternatively, if the Commission has definitively interpreted the term Bulk-Power System to encompass more than the bulk electric system, NRECA seeks rehearing.

12. In support of its request for rehearing, NRECA raises three arguments that the Commission erred in determining that the statutory definition of Bulk-Power System is broader than NERC's definition of bulk electric system. First, it contends that such a determination violates a rule of law that the parts of a statute should be construed in accordance with the statute's overall legislative purpose. 11 NRECA explains that section 215 was intended to replace the prior voluntary reliability standards with a mandatory scheme but, to the best of NRECA's knowledge, no participant in the drafting of the legislation expressed the view that Congress intended to expand NERC's scope. 12 NRECA states that, if the issue had been presented, it would have prompted a legislative record. The absence of such record confirms that an intent to expand NERC's scope was never expressed.

13. Second, NRECA contends that an expansive definition of Bulk-Power System is contrary to the text of section 215, which narrows the Commission's reach. Specifically, NRECA contends that the statutory definition of Bulk-Power System makes clear that the term does not encompass all transmission facilities but, rather, only those facilities and control systems “necessary for operating an interconnected electric energy transmission network.” It also points to the statutory definitions of Reliability Standard and Reliable Operation that refer to protecting the system from instability, uncontrolled separation or cascading failures. NRECA infers from this that there is no reason to conclude that Congress included in the definition of Bulk-Power System any facilities other than those that could materially contribute to instability, uncontrolled separation or cascading outages.

14. Third, NRECA posits that, if Congress borrows a term of art that has an established meaning, the established meaning is to apply. 13 NRECA claims that the terms Bulk-Power System and bulk electric system have been used interchangeably for decades and cites examples from both industry documents and Commission orders. According to NRECA, Congress did not adopt NERC's exact definition of bulk electric system because it was insufficiently specific for legislation. NRECA asserts that “Congress used more and different words than NERC in order to provide clarity, but the definition of Bulk-Power System incorporated the exact same facilities as NERC and the regions had always included in their working definition of bulk electric system * * *”  14

15. NARUC seeks clarification that the Commission will “continue relying on NERC's definition of Bulk-Power System” and NERC's registration process beyond the initial period during which mandatory Reliability Standards are in effect. 15 It states that section 215 of the FPA was enacted based on an industry consensus that it would apply to facilities and entities covered by the historical definition of Bulk-Power System. According to NARUC, the term applies to higher-voltage, network facilities that integrate regional transmission networks to ensure the reliability of interconnected system operations. NARUC states that NERC's definition of Bulk-Power System is consistent with section 215 and that a broader interpretation is inconsistent with Congressional intent because such a definition could sweep in facilities such as load centers and local transmission facilities that do not have a material impact on system reliability.

16. NARUC also seeks clarification that, if the Commission determines that NERC's current definition requires revision, NERC should revise the definition using its American National Standards Institute (ANSI)-accredited process. Further, NARUC expresses concern that the Commission has directed the ERO to submit a complete set of regional definitions of bulk electric system and, thus, asks the Commission to clarify that it will continue to defer to the ERO's and Regional Entities' determinations concerning which facilities and entities materially affect the reliability of the interconnected transmission network and should be included in the compliance registry.

17. The Commission will grant NRECA's request for clarification, and thus dismisses its request for rehearing. We agree with NRECA that NERC's definition of bulk electric system does not impose a 100 kV cutoff and provides some flexibility in its application. 16 Although Order No. 693 stated that the Commission believes that the Bulk-Power System reaches farther than those facilities that are included in NERC's definition of the bulk electric system, the Commission has not definitively defined the extent of the facilities covered by the Bulk-Power System. As we stated in Order No. 693, the Commission intends to address concerns regarding the scope of the term Bulk-Power System in future proceedings. NRECA and others will not be legally precluded from presenting arguments in such a proceeding that the terms Bulk-Power System and bulk electric system encompass the same facilities.

18. The Commission notes NRECA's assertion that the Commission's determination that the Bulk-Power System reaches farther than the bulk electric system is contrary to the text of section 215 of the FPA. Because the Commission has not definitively defined the extent of the facilities covered by the Bulk-Power System, the Commission believes that this determination is best made in the context of a Commission proceeding determining the extent of the Bulk-Power System. We make no finding on the matter at this time. The Commission defers judgment on this matter to a later proceeding so that the Commission can develop a record on which to base its final determination.

19. In response to NARUC, the Commission will continue to rely on NERC's definition of bulk electric system, with the appropriate regional differences, and NERC's registration process until the Commission determines in future proceedings the extent of the Bulk-Power System. The requirement that the ERO file a complete set of regional differences was to enable the Commission to understand the current reach of the Reliability Standards. However, we do not agree with NARUC that NERC should be allowed to define Bulk-Power System using its American National Standards Institute (ANSI)-accredited process. The statutory term Bulk-Power System defines the jurisdiction of the Commission. Although the Commission has chosen to defer, for the time being, to the ERO as to which entities must comply with Reliability Standards, the fundamental matter of determining the extent of Commission's jurisdiction cannot and will not be delegated to the ERO.

20. Order No. 693 accepted the ERO's compliance registry process as an appropriate approach to identify the set of entities that are responsible for compliance with a particular Reliability Standard. 17 Further, Order No. 693 explained that NERC has developed a Statement of Compliance Registry Criteria that describes how NERC will identify organizations that may be candidates for registration and assign them to the compliance registry. NERC's compliance registry process identifies and registers entities based on categories of functions within the Bulk-Power System and related Commission-approved Reliability Standards. For example, NERC plans to register individual generator units of 20 MVA or greater that are directly connected to the bulk electric system, generating plants with an aggregate rating of 75 MVA or greater, any blackstart unit material to a restoration plan, or any generator “regardless of size, that is material to the reliability of the Bulk-Power System.” The Commission accepted the Statement of Compliance Registry Criteria, stating that “[w]e believe that NERC has set reasonable criteria for registration* * *”. 18

21. Further, Order No. 693 noted that the Commission's regulations then exempted most qualifying facilities (QFs) from specific provisions of the FPA including section 215. 19 The Commission, however, expressed concerned whether it is appropriate to grant QFs a complete exemption from compliance with Reliability Standards that apply to other generator owners and operators, and noted that the Commission was concurrently issuing a notice of proposed rulemaking proposing to amend the Commission's regulation that exempts most QFs from section 215 of the FPA. The Commission has since issued a final rule eliminating the exemption of QFs from the requirements of section 215 of the FPA. 20

22. California Cogeneration argues that the Commission improperly relied on the ERO's compliance registry process. It contends that the Commission, rather than determining who the “users” of the Bulk-Power System are, has improperly delegated this task to the ERO and Regional Entities. California Cogeneration notes that the NERC registry criteria were submitted for information purposes only. Further, it contends that these criteria are being applied inconsistently among the Regional Entities, noting in particular that Western Electricity Coordinating Council (WECC) has developed supplemental criteria that may result in the registration of entities not captured by the ERO criteria. 21 It also points to discrepancies in ERCOT's registration process.

23. California Cogeneration also argues that Reliability Standards that are not clear in how they are applied or are applied inconsistently are not just and reasonable. It contends that the examples of regional variation in the registration process demonstrate a lack of required clarity and consistency.

24. NRECA asks the Commission to clarify that, in expanding the applicability of certain Reliability Standards, 22 it has not departed from the compliance registry concept or sought to dictate actions by the ERO. Alternatively, the Commission should grant rehearing. According to NRECA, it appears possible, even likely, that the Commission was not specifying that additional entities register, but was merely specifying that the ERO should consider whether entities otherwise required to register (because they meet or exceed specified thresholds, or because they had been to shown to have a material impact on grid reliability) should also be subject to these particular Reliability Standards. 23 If that is the Commission's intended meaning, NRECA requests that the Commission specify the requested clarification and resolve the matter (subject to subsequent consideration by the ERO). However, if the Commission intends to impose a broader obligation, i.e. , to encompass additional entities in the Reliability Standards, then NRECA seeks rehearing.

25. Further, NRECA argues that the Commission should not, as it recognized in Order No. 672-A, prescribe either the text or the substance of a Reliability Standard, including which entities are subject to the Reliability Standards, because that responsibility is reserved to the ERO, subject to the Commission's review. NRECA maintains that the Commission lacks the authority to dictate what a Reliability Standard requires or who it encompasses, as the Commission has recognized previously in Order No. 672-A. NRECA notes that Order No. 693 states that the Commission “agrees that a direction for modification should not be so overly prescriptive as to preclude the consideration of viable alternatives in the ERO's Reliability Standards development process * * *. Thus, in some instances, while we provide specific details regarding the Commission's expectations, we intend by doing so to provide useful guidance to assist in the Reliability Standards development process, not to impede it.”  24

26. Beyond that, NRECA asserts that the Reliability Standards should not apply at all to entities whose scope of activities is too limited to have a material impact on grid reliability. In other words, the specific Reliability Standards should not apply to a distribution provider or a load-serving entity just because it is a distribution provider or a load-serving entity; instead, the Reliability Standards at issue, as well as the Reliability Standards generally, should not apply unless an entity has a material impact on grid reliability. According to NRECA, this concept is central to NERC's compliance registry, and the Commission has not articulated a sound basis for departing from it, notwithstanding the Commission's lack of authority to do so.

27. With respect to COM-001-1 or some replacement standard addressing black start capability, and COM-002-2, for example, NRECA asserts that some entities are functionally irrelevant for black start activities. It argues that having to coordinate black start operations with a large number of small entities, most, if not all, of which are served through interconnections with larger and bigger entities in the hierarchy of the Functional Model, would hinder, rather than facilitate, black start operations. NRECA maintains that the Commission should defer to the ERO's technical expertise.

28. NRECA raises similar concerns with respect to TOP-003-1. According to NRECA, read literally, the Commission appears to recommend delegating the determination of whether entities that fall below the threshold of NERC's definition of bulk electric system should be subject to the standard to “the opinion of the transmission operator, balancing authority, or reliability coordinator.” If so, NRECA asserts that this approach would appear to override both the compliance registry and the ERO, and the Commission would effectively delegate authority that it does not have to entities that could well face incentives to favor their own interests over those of load-serving entities that could be made subject to the Reliability Standards. The Commission cannot delegate authority it does not have in the first place, and the determination should be that of the ERO and the Regional Entity. While NRECA agrees that the ERO and the Regional Entities may and should take the views of the transmission operators, balancing authorities, and reliability coordinators into account, it argues that this is considerably different than simply abdicating the matter to them.

29. NRECA has similar concerns with the treatment of VAR-001-1 with respect to the Commission's “direct[ing] the ERO to address the reactive power requirements of load-serving entities on a comparable basis with purchasing-selling entities.” While NRECA agrees that this may be an appropriate matter for the ERO to consider, it argues that the Commission should not be dictating a particular action, nor should the Commission be overriding the compliance registry approach that it elsewhere endorses in its Final Rule.

30. Accordingly, NRECA requests the Commission to clarify that it has not overridden the compliance registry with respect to COM-001-1, COM-002-2, and TOP-003-0, nor dictated specific changes to those Reliability Standards. Alternatively, NRECA seeks rehearing. Absent the requested clarification, NRECA asserts that the Commission has sought to prescribe the substance of a Reliability Standard in excess of its statutory authority under section 215, contrary to its own recognition of the limitations on its authority in Order No. 672-A, and contrary to Order No. 693 itself. NRECA maintains that the proposed changes could undermine rather than enhance reliability for the reasons stated, and thus involve matters where the Commission should and is required to defer to the ERO's technical expertise.

31. Xcel notes that, pursuant to NERC's registry criteria, NERC will generally register individual generator units of 20 MVA or greater that are directly connected to the bulk electric system. According to Xcel, under NERC's criteria, generators that are connected to distribution facilities are generally exempt from registration as they are not connected to the Bulk-Power System. Xcel seeks rehearing of the Commission's decision to accept this aspect of the ERO's registration process, contending that generating facilities that are connected at a distribution voltage but deliver energy to the transmission system can affect transmission system reliability and, thus, should be subject to mandatory Reliability Standards. Further, Xcel contends that the exclusion of facilities connected at a distribution level creates inappropriate incentives for entities to interconnect generating facilities at the distribution level rather than the transmission level.

32. TANC requests clarification of the Commission's statement that:

33. According to TANC, this statement seems to require all entities subject to the Reliability Standards to register for each requirement applicable to transmission owners, which it states is inconsistent with the Commission's goal of preventing overlap and negates the transmission owner classification in the NERC Functional Model. Therefore, TANC asks the Commission to clarify that only those entities that meet the description of transmission owner provided in NERC's compliance registry and the NERC Functional Model descriptions are required to register as responsible entities for the Requirements applicable to transmission owners.

34. TANC asks that the Commission specify that, where an existing contract between two parties provides that one is the transmission owner, but the other has agreed to perform the TOP functions, the latter entity be listed in the compliance registry as the responsible entity for the TOP Reliability Standards. Further, TANC maintains that the transmission owner should not be the default entity ultimately responsible for compliance with the TOP Reliability Standards. According to TANC, only the entity accepting responsibility to perform the tasks delegated to it in the agreement should be accountable for the responsibilities assigned to it in the agreement. TANC asserts that, where entities have assigned responsibilities by contract, there is no reason to register those responsibilities to another entity.

35. California Cogeneration claims that Order No. 693 failed to adequately address the unique characteristics of QFs. It states that reliance on the registry process, which is based on the 14 functions identified in the NERC functional model, does not adequately distinguish among different types of generators, including size and location, and their impact on reliability. California Cogeneration states that the Commission, as a remedy to these infirmities, should direct NERC to immediately initiate a stakeholder process to revise the Reliability Standards to identify in greater detail the entities that are responsible for compliance and revise requirements to recognize the operational constraints of different generators. It states that this process should be completed before Reliability Standards become enforceable. Further, California Cogeneration states that the stakeholder process should also develop criteria for determining whether an entity has a “material impact” on reliability.

36. Finally, California Cogeneration states that the Commission was not responsive to issues raised by California Cogeneration in its rulemaking comments regarding individual Reliability Standards that apply to generator owners and operators and needed revisions if they are to be applied to cogenerators. It states that some of these Reliability Standards seem to require information regarding gross generation or load behind the customer's point of interconnection, contrary to an earlier Commission order. 26 While the Commission directed the ERO to consider these concerns during its three-year Work Plan to review each Reliability Standard, California Cogeneration contends this approach does not suffice because cogenerators must comply with the Reliability Standards in the interim.

37. The Commission denies California Cogeneration's request for rehearing concerning the definition of users of the Bulk-Power System. The Commission has not improperly delegated this definition to the ERO and Regional Entities. While NERC proposed the registry criteria, the Commission reviewed the criteria and approved them as appropriate under section 215 of the FPA. Further, the Commission has provided a method by which any entity that disagrees with NERC's determination to place it in the compliance registry may submit a challenge in writing to NERC and, if still not satisfied, may lodge an appeal with the Commission. 27 Therefore, the Commission has the ultimate ability to determine whether an entity should be on the NERC registry.

38. With regard to the fact that certain Regional Entities have created supplemental criteria to determine which entities should be on the registry, we agree with California Cogeneration that this is not appropriate. 28 Order No. 693 accepted NERC's compliance registration process “to provide as much certainty as possible regarding the applicability and responsibility of specific entities under the approved standards.”  29 NERC's Statement of Compliance Registry does not reference supplemental compliance registries created by Regional Entities. While both the Commission and the ERO have made it clear that an entity that falls below the minimum registry criteria may be included on the compliance registry on a facility-by-facility basis, nonetheless NERC's compliance registry places the burden on the Regional Entity to reasonably demonstrate that the organization is a user, owner or operator of the Bulk-Power System. 30 This language contemplates a case-by-case registration of entities outside the NERC criteria, provided that a reasonable demonstration of the need to register the entity  31 is made by the Regional Entity. 32

39. In response to NRECA, in directing the ERO to expand the applicability of certain Reliability Standards, the Commission did not intend to expand the applicability beyond those entities that are on the compliance registry. Rather, we indicated where the Commission believed there was a reliability concern in not applying certain Reliability Standards to a category of registered entities. For example, in COM-001-0, where the Commission directed the ERO to add distribution providers that are essential to the implementation of a black start plan to the Applicability section, this would include only those distribution providers that are on the compliance registry.

40. The Commission agrees with NRECA to the extent that we do not wish that a direction for modification be so overly prescriptive as to preclude the consideration of viable alternatives in the ERO's Reliability Standards development process. However, as stated in Order No. 693, in identifying a specific matter to be addressed in a modification to a Reliability Standard, it is important that the Commission provide sufficient guidance so that the ERO has an understanding of the Commission's concerns and an appropriate, but not necessarily exclusive, outcome to address those concerns. Without such direction and guidance, the ERO might not know how to respond adequately to a Commission proposal to modify a Reliability Standard. 33 Thus, in some instances, while we provided specific details regarding the Commission's expectations, we intended by doing so to provide useful guidance to assist in the Reliability Standards development process, not to impede it.

41. With respect to the specific Reliability Standards cited by NRECA, the Commission first notes that NRECA does not appear to request rehearing on the substance of the directed modifications, but argues that the Commission was too prescriptive procedurally. In many instances, the Commission provided guidance to the ERO and stated that it could develop an alternative to our direction, so long as the alternative is as effective and efficient as the Commission's proposal. However, with respect to the Reliability Standards cited by NRECA, the Commission has identified specific concerns about the gap in applicability in the Reliability Standard. For example, as to COM-001-1 and COM-002-2, the Commission was concerned about having a reliability gap during normal and emergency operations. Section 215(d)(5) of the FPA states:

42. TOP-003-0 contains Requirements that can have a significant impact on both the reliability of the Bulk-Power System and on competition with regard to available transfer capability (ATC). The Commission's approval of TOP-003-0 does not override either the compliance registry or the ERO. The planning authority or transmission planner should inform its Regional Entity if it is not receiving cooperation in getting the information it requires. We note that section 39.2(d) of our regulations requires each user, owner or operator of the Bulk-Power System to provide the Commission, the ERO and the applicable Regional Entity such information as is necessary to implement section 215 of the FPA. If a problem arises in obtaining information necessary to calculate ATC, the Commission may revisit this matter in the future. For example, if entities are unable to obtain the required information under TOP-003-0, the Commission might require the ERO, through the Reliability Standards development process, to develop a provision to ensure that all jurisdictional entities that must provide information pursuant to TOP-003-0 because of a particular reliability need are added to the registry, even if only to meet the requirements of TOP-003-0.

43. The Commission denies Xcel's request for rehearing. As noted by Xcel, NERC's registry criteria state that the ERO and Regional Entities will “generally” register generators greater than 20 MVA and will “generally” exempt generators that are connected to distribution facilities. The use of the term “generally” allows the ERO and Regional Entities flexibility to register a generator meeting those descriptions if the ERO or a Regional Entity determines that the facility is needed for Bulk-Power System reliability. Further, Order No. 693 specifically provided for such an outcome. 34 Therefore, those generating facilities that Xcel is concerned about, which are connected at a distribution voltage but deliver energy to the transmission system, may be required to comply with Reliability Standards depending on a possible case-by-case determination by the ERO or a Regional Entity. Xcel does not provide any support for its claim that this general exclusion of facilities connected at a distribution level creates inappropriate incentives for entities to interconnect generating facilities at the distribution level rather than the transmission level.

44. In response to TANC's concern that Order No. 693 appears to require all entities subject to the Reliability Standards to register for each requirement applicable to transmission owners, we disagree. This statement was made only to ensure that there are no gaps or unnecessary redundancies with regard to the entity or entities responsible for compliance. The Commission did not intend to imply that each user, owner and operator of the Bulk-Power System must comply with those Reliability Standards which apply to transmission owners. Rather, the Commission intended for the ERO to ensure that there is clarity in the registering of entities and that the registration process results in no gaps or unnecessary redundancies.

45. Further, the Commission clarifies that it did not intend to change existing contracts, agreements or other understandings as to who is responsible for a particular function under a Reliability Standard. 35 The Commission believes that allowing an organization to accept compliance responsibility on behalf of its members should cover TAPS' concerns regarding a situation in which two entities have a contract regarding which will perform functions under the Reliability Standards. 36 NERC has filed procedures for allowing such agreements in Docket No. RM06-16-003. The Commission will rule on the particulars of those procedures in that proceeding.

46. The Commission denies California Cogeneration's request for rehearing with respect to exemption of QFs from compliance with mandatory Reliability Standards. As stated in Order No. 696, for reliability purposes, there is no meaningful distinction between QF and non-QF generators that would warrant generic exemption of QFs from mandatory Reliability Standards. 37 Therefore, we disagree with California Cogeneration that Order No. 693 failed to adequately address the unique characteristics of QFs.

47. Whether a generation facility should be subject to Reliability Standards should depend on whether electric energy from the generation facility is needed to maintain the reliability of the Bulk-Power System. The registration criteria adopted by NERC and approved by the Commission, as well as the compliance registry process adopted by NERC and approved by the Commission, are designed to ensure that only those facilities needed to maintain the reliability of the Bulk-Power System are subject to the Reliability Standards. The ultimate decision with respect to individual generation units or plants is, and must be, made on a case-by-case basis. Thus, whether a particular QF or type of QF should be exempt from Reliability Standards is an issue that is more appropriately raised in the context of NERC's establishment of registry criteria for owners and operators of generators, and in the context of NERC's compliance registry process. The reliability of the Bulk-Power System will be better protected by addressing this issue in the NERC compliance registry process, which will ensure that no generator that is needed to maintain the reliability of the Bulk-Power System will be exempt from Reliability Standards, while excusing those generators that are not needed to maintain reliability. Therefore, the Commission rejects California Cogeneration's request that it direct NERC to immediately initiate a stakeholder process to revise the Reliability Standards to identify in greater detail the entities that are responsible for compliance and revise requirements to recognize the operational constraints of QF generators.

48. Order No. 693 explained that NERC has developed a “Functional Model” that defines the set of functions that must be performed to ensure the reliability of the Bulk-Power System. The Functional Model identifies 14 functions and the name of a corresponding entity responsible for fulfilling each function. While the Commission had proposed to require that NERC file future revisions to the Functional Model, Order No. 693 determined that such filing was not necessary. 38 The Commission made this determination based on the characterization offered by numerous commenters that the Functional Model is an evolving guidance document that is not intended to convey firm rights and responsibilities. Further, the Commission agreed with commenters that the applicability section of a particular Reliability Standard should be the ultimate determinant of applicability of each Reliability Standard. While some commenters asked that all revisions to the Functional Model be developed through NERC's ANSI-accredited process, the Commission left to the discretion of the ERO the appropriate means of allowing stakeholder input when revising the Functional Model.

49. TANC requests rehearing of the Commission's determination that future modifications of the Functional Model do not need to be submitted to the Commission for approval. TANC contends that the Functional Model is more than just a guidance document and, rather, is fundamental to determining the applicability of each Reliability Standard. It asserts that the ERO's compliance registry process that is used to identify users, owners and operators of the Bulk-Power System that must comply with Reliability Standards relies on the Functional Model. Thus, according to TANC, a change in the Functional Model affects the applicability and enforcement of each Reliability Standard.

50. Further, TANC contends that the Reliability Standards are not “complete,” a quality objective identified by NERC in the development of Reliability Standards, because the Reliability Standards are dependent on an external document. TANC is concerned that revising the Functional Model could result in additional entities having to comply with Reliability Standards without affording these entities adequate notice of what is expected of them. It notes that terms used in the Functional Model are also defined in the NERC glossary, which was approved by the Commission. Thus, TANC requests that the Commission require the ERO to submit revisions to the Functional Model for Commission approval, either as revisions to the Functional Model or revised terms in the NERC glossary, after development through the ERO's full Reliability Standards development process.

51. Midwest ISO contends that the Commission erred in failing to require NERC to define the distinct roles of the “planning coordinator” and “planning authority.” According to Midwest ISO, while NERC used the term planning authority when it developed the “Version 0” Reliability Standards, it was recognized that there was “[no] common understanding of who or what the Planning Authority was.”  39 Further, Midwest ISO explains that many Reliability Standards describe roles for both the planning authority and transmission planner. Midwest ISO states that, while the latest revision to the Functional Model substitutes the term “planning coordinator” for “planning authority,” this has not resolved the problem because the responsibilities of the planning coordinator “are both more limited and wide-area in nature” and may not be simply substituted for those of planning authority. Midwest ISO notes that certain Regional Entities are registering entities based on the planning authority function as previously defined, and Midwest ISO asks rhetorically whether the ERO can hold a company accountable to a set of Reliability Standards applicable to an entity that it no longer recognizes as valid.

52. Midwest ISO maintains that the Commission did not adequately address Midwest ISO's concerns when it stated in Order No. 693 that the ERO can address such concerns as it updates and revises the Functional Model. According to Midwest ISO, the Reliability Standards state that regions should work closely with the planning coordinators on a common understanding of roles and responsibilities, but such a process will be lengthy and perhaps futile without Commission guidance. Further, Midwest ISO states that, while NERC will address this issue in the long term, the Commission's failure to provide interim clarification or direct NERC to specify the role of the planning coordinator is an error.

53. The Commission denies TANC's request for rehearing. The Commission disagrees with TANC that the Commission-approved Reliability Standards are incomplete. As stated in Order No. 693, the applicability section of a particular Reliability Standard should be the ultimate determinant of applicability of each Reliability Standard. 40 Further, the Commission notes that we required the ERO to update the Glossary of Terms Used in Reliability Standards through the Reliability Standards development process whenever a new or revised Reliability Standard includes a new defined term. 41

54. The Commission disagrees with TANC that the Functional Model is used to identify users, owners and operators of the Bulk-Power System that must comply with Reliability Standards. The compliance registry criteria are used to determine which entities must be listed on the compliance registry, and therefore must comply with Reliability Standards. Changes in the Functional Model cannot require additional entities to comply with Reliability Standards. Consistent with our explanation in Order No. 693, if an entity is registered as a result of a change that emanated from a revision of the Functional Model, the entity would have an opportunity to seek review by the ERO and the Commission. Accordingly, we deny the request for rehearing and will not require NERC to file revisions to the Functional Model.

55. Further, we reject Midwest ISO's contention that the Commission erred in failing to provide guidance in directing NERC to define the distinct roles of the planning authority and planning coordinator. First, as recognized by Midwest ISO, NERC will address this issue as part of its long range plan. This is consistent with the Commission's statement in Order No. 693 that “given that the Functional Model is an evolving guidance document, the ERO can address such concerns as it updates and revises the Functional Model.”  42 Midwest ISO has provided insufficient support for its contention that addressing this matter may be lengthy and futile without Commission intervention. Moreover, consistent with Order No. 693, any ambiguity regarding roles and the responsibility of a particular entity for compliance with a particular Reliability Standard is a matter that should be addressed in the registration of a particular entity.

56. Finally, we disagree with Midwest ISO's suggestion that it is inappropriate to register entities as planning authorities given that the applicability provisions of the Commission-approved Reliability Standards refer to the planning authority and not the planning coordinator. Consistent with our discussion above, revisions to the Functional Model do not convey rights and responsibilities but, rather, the modification to the applicability provision of a Reliability Standard or NERC glossary ultimately determines an entity's obligations.

57. In Order No. 693, the Commission directed the ERO to submit a revised Work Plan to: (1) Reflect modification directives contained in Order No. 693; (2) include the timeline for completion of ATC-related Reliability Standards as ordered in Order No. 890; and (3) account for the views of its stakeholders, including those raised in this proceeding. The Commission required that the ERO set specific delivery dates, explaining that “[a] Work Plan with specific target dates will provide a valuable tool and incentive to timely address the modifications directed in this Final Rule.”  43 Further, Order No. 693 stated that:

58. NRECA asks for clarification, or alternatively rehearing, that Order No. 693 does not allow the imposition and enforcement of deadlines that preclude the ERO from satisfying the due process requirements set forth in section 215 of the FPA or applying its own expertise. NRECA states that a deadline “may be reasonable or unreasonable, and its reasonableness needs to be determined within context” taking into account the complexity of the matter and other considerations. 45 NRECA contends that the imposition and enforcement of an unreasonable deadline conflicts with section 215 as well as Order No. 672. Thus, NRECA seeks clarification that the Commission's assertion of authority to establish deadlines for ERO action represents no more than the authority to “exhort” the ERO to move expeditiously, consistent with its statutory due process obligations. “However, if the Commission is purporting in the Final Rule to reserve the power to specify an unreasonable deadline, that undermines due process and ignores the ERO's technical expertise in contravention of the requirements of section 215, then NRECA seeks rehearing of the Commission's determination.”  46

59. The Commission agrees that it should not impose deadlines that preclude the ERO from satisfying the due process requirements set forth in section 215 of the FPA, and has provided in several previous orders that, in complying with a deadline, NERC must also meet the requirements of the FPA and the Commission's regulations. In our January 2007 Compliance Order , we made it clear that a revision to NERC's expedited Reliability Standards development process must “make it clear that the Commission can order expedited standard development in a specific time frame and that NERC must adhere to that time frame and still allow for due process. ”  47 On rehearing, we further clarified that “any ERO process that provides ‘reasonable notice and opportunity for comment, due process, openness, and balance of interests’ as required by section 215(c)(2)(D) of the FPA, and that also can meet a Commission-imposed deadline pursuant to section 39.5(g) of the Commission's regulations, will comply with this directive.”  48

60. Finally, in Order No. 693, the Commission stated that the ERO should make every effort to meet Commission-ordered delivery dates. However, we acknowledged that “there may be certain cases in which the ERO is not able to meet [the] Commission's deadline. In those instances, the ERO must inform the Commission of its inability to meet the specified delivery date and explain why it will not meet the deadline and when it expects to complete its work.”  49

61. In Order No. 693, while the Commission did not institute a formal “trial period,” it directed the ERO and Regional Entities to “focus their resources” on the “most serious violations” during an initial period through December 31, 2007. 50 Order No. 693 stated that this use of enforcement discretion should apply to all users, owners and operators of the Bulk-Power System. The Commission explained that the goal should be to ensure that, at the outset, the ERO and Regional Entities can assess a monetary penalty in a situation where, for example, an entity's non-compliance places Bulk-Power System reliability at risk. This approach would allow the ERO, Regional Entities and other entities time to ensure that the compliance monitoring and enforcement processes work as intended and that all entities have time to implement new processes.

62. Xcel states that, while it supports the Commission's decision that the ERO and Regional Entities should have the enforcement discretion to calculate but not collect penalties during an initial period, it asks that the Commission provide greater clarity and guidance regarding the circumstances when penalties should be collected and when they should not. It asks that the Commission be as specific as possible in defining the circumstances under which the ERO and Regional Entities should exercise their enforcement discretion. It suggests that the Commission clarify that to assess a penalty a violation must be, at a minimum, (i) an intentional violation of a well-understood Reliability Standard and (ii) a violation that causes substantial harm.

63. The Commission denies Xcel's request for clarification. First, the Commission believes that Xcel's requested clarification would not always capture the most serious violations. Moreover, the Commission in Order No. 693 intentionally declined to develop a threshold that would place limits on the ERO's and Regional Entities' exercise of enforcement discretion; and we decline to do so here as well. Although we clearly allowed for “the ERO or a Regional Entity to take an enforcement action against an entity whose violation causes a significant disturbance,” we also provided that the ERO and Regional Entities can assess a monetary penalty in a situation where, for example, an entity's non-compliance places Bulk-Power System reliability at risk. 51 We did not require that there be actual harm to the Bulk-Power System for the ERO to assess a penalty during the transition period.

64. The Commission believes that it is better to allow the ERO and Regional Entities to use their expertise in determining which violations constitute the most serious. Likewise, the ERO and Regional Entities are in the best position to know how to best use their finite enforcement resources. This will require case-by-case analysis of the circumstances surrounding a situation. Therefore, we will not stipulate a single set of circumstances under which the ERO and Regional Entities should use their enforcement discretion for the initial transition period.

65. In Order No. 693, consistent with Order No. 890, the Commission did not adopt new liability protections. 52 The Commission stated that it did not believe any further action is needed to implement Blackout Report Recommendation No. 8 because the Task Force found that no further action is needed. 53 Further, the Blackout Report indicated that some states already have appropriate protection against liability suits. 54 Finally, the Commission stated that, in Order No. 888, as affirmed by Order No. 890, the Commission declined to adopt a uniform federal liability standard and decided that, while it was appropriate to protect the transmission provider through force majeure and indemnification provisions from damages or liability when service is provided by the transmission provider without negligence, it would leave the determination of liability in other instances to other proceedings. 55

66. Avista seeks rehearing on the Commission's determination not to provide further liability limitations and questions whether it is fair, just and reasonable to deny transmission operators that are not regional transmission organizations (RTOs) or independent system operators (ISOs) the protections afforded to RTOs and ISOs and at the same time impose mandatory Reliability Standards with significant fines and penalties as an enforcement mechanism. 56 Avista argues that the Commission has limited the scope of liability in the pro forma open access transmission tariff (OATT) to instances of gross negligence or intentional misconduct and also limited damages by excluding consequential, indirect or punitive damages for RTOs and ISOs. According to Avista, not providing these same limitations to other transmission operators is, on its face, arbitrary, and may have unintended adverse consequences to the ratepayers of any transmission operator whose operating employee's decisions initiate a large cascading outage, if available insurance is not adequate to cover the risk. Avista argues that enforcement of mandatory Reliability Standards should not depend both on risk of massive liability exposure and upon multi-million dollar civil fines and penalties.

67. The Commission denies rehearing. The Commission has already ruled that the liability standard the Commission has approved for RTOs and ISOs is not appropriate for other transmission providers. 57 Further, we also found without merit assertions that increased liability protections in the pro forma OATT should be viewed as a necessary element of the implementation of the Commission's reliability authority. 58 In the Reliability Policy Statement , 59 the Commission stated that it would consider, on a case-by-case basis, proposals by public utilities to amend their OATTs to include limitations on liability. The Commission further noted that, while this issue has not been resolved on a standardized basis, the Commission has entertained RTO transmission providers' specific proposals to amend their OATTs to include provisions addressing limitations on liability. 60

68. In subsequent orders, the Commission found that the gross negligence and intentional wrongdoing indemnification and liability standard is appropriate for RTOs and ISOs. However, the Commission has declined to extend this protection to all transmission providers. In Southwest Power Pool, Inc. , the Commission explicitly stated “that our acceptance here of the gross negligence and intentional wrongdoing indemnity standard is limited to SPP, in its role as an RTO, and its TOs; we do not intend to extend such protection to all transmission providers.”  61 In Southern Company Services, Inc. , the Commission stated that:

69. Further, we disagree with Avista that there is a risk of massive liability exposure. It offers no new arguments that demonstrate that non-RTO and non-ISO transmission providers are unable to rely on state laws, i.e. , the state laws provide inadequate protection. Avista has not persuaded us to change our policy regarding liability protections applicable to non-RTO and non-ISO transmission providers. Therefore, we deny rehearing.

70. In Order No. 693, the Commission required supplemental information for any Reliability Standard that currently requires a regional reliability organization to fill in missing criteria or procedures. 63 The Commission explained that, where important information has not yet been provided, it would not approve or remand such Reliability Standards until the ERO submits further information. Until such information is provided, compliance with the so-called fill-in-the-blank standards should continue on a voluntary basis, and the Commission considers compliance with such Reliability Standards to be a matter of good utility practice. Further, the Commission stated:

71. While APPA believes that Order No. 693 correctly deferred consideration of the “fill-in-the-blank” standards, it requests rehearing of the Commission's approval of other Reliability Standards that incorporate the “fill-in-the-blank” standards. APPA argues that the Commission cannot, lawfully, approve Reliability Standards for immediate enforcement that incorporate those same unreviewed and unapproved regional Reliability Standards.

72. According to APPA, approving a Reliability Standard that references an unapproved fill-in-the-blank standard requires compliance with regional Reliability Standards that the Commission has not reviewed or approved. APPA asserts that the Commission cannot determine if a Reliability Standard that references a pending Reliability Standard is “just, reasonable, not unduly discriminatory or preferential, and in the public interest” for the same reasons that the Commission articulated in determining that it lacked important information needed to evaluate “fill-in-the-blank” standards.

73. APPA also argues that the approved Reliability Standards that reference a fill-in-the-blank standard do not promote uniformity and consistency as required by Order No. 672. APPA asserts that the Commission cannot determine if such Reliability Standards are justified, because the regional standard is more stringent than continent-wide Reliability Standards or is necessitated by a physical difference in the Bulk-Power System, without reviewing the regional standard in question to determine whether one of those two findings is appropriate. APPA also maintains that the Commission cannot conclude that the processes by which the regional practices involved in the referenced fill-in-the-blank standards were developed meet statutory requirements. APPA raises concerns about due process and fundamental fairness, asserting that small entities have often not been included in past regional processes, and may not have received prior notice of the standards with which they must now comply.

74. APPA also argues the Commission is incorrect that “many of these Reliability Standards either refer to the process of collecting data or reference Requirements that entities are generally aware of because they have already been following these Reliability Standards on a voluntary basis.” According to APPA, Reliability Standards may sweep in many small entities that have not been members of regional reliability organizations and have not necessarily complied with standards on a voluntary basis.

75. APPA argues that the Commission's approval of Reliability Standards that make enforceable unreviewed “fill-in-the-blank” standards could trigger registration of a large number of small entities. According to APPA, unless it can be assumed that no change in the scope or content of the fill-in-the-blank standards will result from the ongoing process NERC and the Regional Entities are undertaking to fill in the blanks, mandatory enforcement of the “before” version is likely to sweep in different entities and subject them to different standards than will the “after” version. Further, APPA asserts that, by posing the potential to sweep a large number of small entities onto the compliance registry before the applicable regional standard is approved, the Commission's decision calls into question its adherence in Order No. 693 to the Regulatory Flexibility Act requirements because, absent review of the undisclosed incorporated “fill-in-the-blank” standards, the Commission cannot estimate the number of small systems these Reliability Standards will affect. Further, APPA maintains that the Commission cannot make the requisite determination that a small entity's compliance with an unapproved “fill-in-the-blank” standard has a material impact on reliability, and the Commission cannot find such compliance necessary for Bulk-Power System reliability.

76. Finally, APPA maintains that, even though the Commission stated that the fact that a Reliability Standard references a fill-in-the-blank standard “may be considered in an enforcement action,”  65 the Commission should not have approved such Reliability Standards. According to APPA, the ability of an entity to raise this issue in an enforcement action occurs too late to avoid the harm to many small entities in being required to register and comply with what it calls unapproved regional underfrequency load shedding (UFLS) programs that have not been developed through Commission-approved processes meeting the statutory standard, and which may well differ from the final standard that the Commission approves to fill in the blanks. Nor, according to APPA, does the ability to raise issues relating to fill-in-the-blank standards in an enforcement action avoid the potential for significant distraction of NERC and Regional Entities from more crucial reliability-related duties to instead deal with compliance by numerous small entities that have no material impact on the grid with regional standards that are in a state of flux. APPA also asserts that this statement cannot overcome the fundamental legal deficiency with approving a Reliability Standard that references a fill-in-the-blank standard—that the Commission lacks authority to approve regional reliability standards that require compliance with regional UFLS standards it has neither reviewed nor approved.

77. Xcel contends that the statement that the Commission does not intend to enforce, as an OATT violation, compliance with any Reliability Standard that has not been approved by the Commission under section 215 is confusing. By stating that the Commission does not intend to enforce as an OATT violation compliance with a Reliability Standard that has not been approved by the Commission under section 215, Xcel is concerned that the Commission may intend to enforce as an OATT violation non-compliance with a Reliability Standard that has been approved by the Commission under section 215. Xcel seeks clarification or rehearing on this issue.

78. The Commission denies APPA's request for rehearing and provides further clarification. The Commission continues to believe that the fact that a Reliability Standard simply references a Reliability Standard that was not approved or remanded in Order No. 693 does not alone justify not approving the former Reliability Standard. Rather, such a reference may be considered in an enforcement action, if relevant, but is not a reason to delay approval of the Reliability Standard. Further, we clarify that, in an enforcement proceeding, such a reference can be considered regarding whether a particular Requirement or part of a Requirement in an otherwise approved Reliability Standard is enforceable. 66 The Commission did not err in approving Reliability Standards that reference a pending Reliability Standard because they contain the appropriate level of specificity necessary to provide notice to users, owners and operators of the Bulk-Power System as to what is required. We will discuss the issue raised by APPA in regard to the Protection and Control Systems (PRC) group of Reliability Standards in our discussion of individual Reliability Standards below.

79. In approving a Reliability Standard that references a fill-in-the-blank standard, the Commission is not requiring compliance with the unapproved Reliability Standard. Therefore, it is immaterial how the regional differences discussed in the unapproved Reliability Standard were created. Rather, as addressed more fully in our discussion on the PRC group of Reliability Standards below, the Commission, ERO and Regional Entities will only enforce the data requirements and any requirement that can be independently enforced in those Reliability Standards, and will not enforce compliance with regional criteria created by a regional reliability organization pursuant to an unapproved fill-in-the-blank standard. 67

80. APPA's contention that approving a Reliability Standard that references a fill-in-the-blank standard could trigger additional small entity registration is speculative. At this time, registration is governed by NERC's definition of bulk electric system and its compliance registry criteria. Nothing in a Reliability Standard can cause an entity to be registered if it would otherwise not be required to do so.

81. In response to Xcel, the Commission clarifies that it does not intend to enforce as a violation of good utility practice non-compliance with a Reliability Standard that has been approved by the Commission under section 215. However, where the OATT contains a specific requirement that may be related to a Reliability Standard, for example, an independent obligation under the OATT to calculate transmission capacity, the Commission does not limit its ability to take enforcement action separately against a violation of a Reliability Standard and a violation of a specific OATT provision. Such determinations will be based on the facts of a specific circumstance.

82. Reliability Standard EOP-001-0 requires each transmission operator and balancing authority to develop, maintain and implement a set of plans to mitigate operating emergencies. These plans must be coordinated with other transmission operators and balancing authorities and the reliability coordinator.

83. Order No. 693 approved Reliability Standard EOP-001-0. In addition, the Commission directed the ERO to develop a modification to EOP-001-0 that, among other things, includes the reliability coordinator as an applicable entity. In pertinent part, the Commission found the reliability coordinator to be a necessary entity under EOP-001-0 and directed the ERO to modify the Reliability Standard to include the reliability coordinator as an applicable entity. 68 Recognizing the importance NERC attributes to the reliability coordinator in connection with matters covered by EOP-001-0, the Commission was persuaded that specific responsibilities for the reliability coordinator in the development and coordination of emergency plans must be included as part of this Reliability Standard. The Commission reasoned that, while balancing authorities and transmission operators are capable of developing, maintaining and implementing plans to mitigate operating emergencies for their specific areas of responsibility, unlike reliability coordinators, they do not have a wide-area view.

84. Midwest ISO disagrees with the Commission's mandate to the ERO to make EOP-001-0 applicable to the reliability coordinator. It notes that the Commission correctly did not provide guidance on the reliability coordinators' role in the emergency planning process and appears to have left this issue up to the industry experts. Midwest ISO argues that the industry had already addressed any potential role of the reliability coordinator in emergency planning by declining to make the reliability coordinator an applicable entity in EOP-001-0.

85. The Commission affirms its determination to mandate that the ERO make EOP-001-0 applicable to the reliability coordinator function because it is the highest level of authority responsible for reliable operation of the Bulk-Power System and has a wide-area view. Midwest ISO has not substantively disputed that Requirements for mitigation of emergencies will benefit from including a role for the entity with a wide-area view. The ERO may consider other equivalent alternatives and consider industry concerns in its modification of EOP-001-0.

86. EOP-002-2 applies to balancing authorities and reliability coordinators and is intended to ensure that they are prepared for capacity and energy emergencies. This Reliability Standard requires that balancing authorities have the authority to bring all necessary generation on line, communicate about energy and capacity emergencies with the reliability coordinator and coordinate with other balancing authorities. EOP-002-2 includes an attachment that describes an emergency procedure to be initiated by a reliability coordinator that declares one of four energy emergency alert levels to provide assistance to the load-serving entity.

87. Order No. 693 approved Reliability Standard EOP-002-2. In addition, the Commission directed the ERO to develop a modification to EOP-002-2 that, among other things, would modify the Reliability Standard to ensure that the Transmission Loading Relief (TLR) procedure is not used to mitigate actual Interconnection Reliability Operating Limit (IROL) violations. The Commission found that the TLR procedure may be appropriate and effective for use in managing potential IROL violations, but that the TLR procedure is an inappropriate and ineffective tool for mitigating actual IROL violations or for use in emergency situations as called for in EOP-002-2. Accordingly, the Commission directed the ERO to modify the Reliability Standard to ensure that the TLR procedure is not used to mitigate actual IROL violations. 69

88. Midwest ISO requests that the Commission clarify which of the following conditions constitutes a “potential IROL” violation for purposes of EOP-002-2: (1) The operating limit has been exceeded, but 30 minutes has not elapsed and the operator may yet return the system to normal; or (2) the operating limit has not been exceeded, but appears that it may be if action is not taken quickly. Midwest ISO believes that the second circumstance is the one the Commission identified as being appropriate for TLR mitigation, but reasons that the terminology can be interpreted differently by different operators applying historically different operating practices.

89. The Commission clarifies that a potential IROL violation refers to the second circumstance provided by Midwest ISO, in which “the operating limit has not been exceeded, but appears that it may be if action is not taken quickly.” In such a situation, use of TLR procedures may be appropriate depending on the circumstances. Moreover, actions undertaken under the TLR procedure are not fast and predictable enough for use in situations in which an operating security limit is being violated.

90. EOP-008-0 addresses plans for loss of control center functionality. It requires each reliability coordinator, transmission operator and balancing authority to have a plan to continue reliable operations and to maintain situational awareness in the event its control center is no longer operable.

91. Order No. 693 approved Reliability Standard EOP-008-0. In addition, the Commission directed the ERO to develop a modification to EOP-008-0 that, among other things, includes a Requirement that provides for backup capabilities that, at a minimum, requires transmission operators and balancing authorities that have operational control over significant portions of generation and load to have minimum backup capabilities, but may do so through contracting for these services instead of through dedicated backup control centers. 70

92. Midwest ISO supports the outcome of Order No. 693 with regard to Commission mandates in EOP-008-0. However, it notes that ambiguities and potential misunderstandings could result from imprecise adjectives in the Reliability Standards. Specifically, for purposes of EOP-008-0, Midwest ISO advocates that the Commission should define an amount of load or generation that constitutes a “significant” portion of generation and load that would require entities to have minimum backup capabilities through backup control centers. Alternatively, Midwest ISO proposes that NERC could be directed to create a “safe-harbor” limit below which a system would not be considered significant unless found to be so by the Regional Entity or the ERO.

93. The Commission reiterates its direction in Order No. 693 that the goal of this Reliability Standard is to provide the continuation of Reliable Operation and the maintenance of situational awareness in the event that the primary control center is no longer operational. 71 To that end, every registered reliability coordinator, balancing authority, transmission operator, and centrally dispatched generator operator should have a plan and means of achieving the outcome of the plan upon the loss of their respective control centers. The Commission has identified three requirements as a minimum for the plans—independence from the primary control center, capability to operate for a prolonged period corresponding to the time it would take to replace the primary control center, and the provision of a minimum set of tools and facilities to replicate the critical reliability functions of the primary control center. The Reliability Standard should provide specific Requirements, based on the size or impact to Reliable Operation, to achieve the Commission's requirements.

94. The Commission declines to define a “safe harbor” limit requested by Midwest ISO. We directed the ERO, through the Reliability Standards development process, to identify what Requirements are necessary on which size entities to achieve the Commission's directives and the goal of this Reliability Standard. Since there are many equally efficient ways of achieving the Commission's direction, we will not identify any specific method or safe harbor.

95. FAC-003-1 addresses vegetation management on transmission rights-of-way. As proposed, FAC-003-1 would apply to transmission lines operated at 200 kV or higher voltage (and lower-voltage transmission lines which have been deemed critical to reliability by a regional reliability organization). It would require each transmission owner to have a documented vegetation management program in place, including records of its implementation. Each program must be developed for the geographical area and specific design configurations of the transmission owner's system.

96. Order No. 693 approved Reliability Standard FAC-003-1. In addition, while we did not direct the ERO to submit a modification to the general limitation on applicability to facilities above 200 kV, we required the ERO to address Commission concerns regarding the applicability threshold through the ERO's Reliability Standards development process. 72 The Commission was concerned that the bright-line applicability threshold of 200 kV in this Reliability Standard would exclude a significant number of transmission lines that could impact Bulk-Power System reliability. We stated that, in proposing to require the ERO to modify the Reliability Standard to apply to Bulk-Power System transmission lines that have an impact on reliability as determined by the ERO, we did not intend to make this Reliability Standard applicable to fewer facilities than it is currently, but to extend the applicability to lower-voltage facilities that have an impact on reliability.

97. NRECA asks that the Commission clarify that Order No. 693 did not mandate that FAC-003-1 apply to lines below 200 kV. NRECA believes that a fair reading of Order No. 693 is that the Commission only directed the ERO to give additional consideration to having FAC-003-1 apply to lines below 200 kV and did not purport to require such a modification. 73 However, NRECA claims that other portions of Order No. 693 appear to go further, such as where the Commission states that it is requiring the Reliability Standard “to include a greater number of entities* * *”.  74 In view of the potential ambiguity, NRECA requests that the Commission clarify that it is not dictating a particular outcome to the ERO's deliberations, as such a directive would be contrary to section 215 of the FPA, Order Nos. 672 and 672-A, and other portions of Order No. 693. Alternatively, NRECA requests rehearing.

98. We will grant NRECA's request for clarification. First, in Order No. 693, we specifically stated that “[w]e will not direct NERC to submit a modification to the general limitation on applicability [in FAC-003-1] as proposed in the NOPR.”  75 Further, as a general matter, we stated that a direction for modification should not preclude the consideration of viable alternatives in the ERO's Reliability Standards development process. 76

99. In Order No. 693, the Commission stated that it was concerned that the bright-line applicability threshold of 200 kV would exclude a significant number of transmission lines that could impact Bulk-Power System reliability. We noted that, at that time no regional reliability organization had used its discretion to designate lower voltage lines under the proposed Reliability Standard, even though there are lower voltage lines involving IROL. 77 The Commission was concerned that this approach would not require all transmission lines that could impact Bulk-Power System reliability to be included under this Reliability Standard. While the Commission did not mandate that FAC-003-1 apply to lines below 200 kV, the Commission did require the ERO to address the Commission's concerns through its Reliability Standards development process.

100. IRO-001-1 requires that a reliability coordinator have reliability plans, coordination agreements and the authority to act and direct reliability entities to maintain reliable system operations under normal, contingency and emergency conditions. Requirement R3 provides that a reliability coordinator “shall have clear decision-making authority to act and direct actions to be taken” by applicable entities to “preserve the integrity and reliability of the bulk electric system and these actions shall be taken without delay but no longer than 30 minutes.”

101. Order No. 693 approved Reliability Standard IRO-001-1. In Order No. 693, the Commission declined to adopt a change suggested by Santa Clara that would only require the commencement of corrective control action within a 30-minute limit. We found that the requirement to take action without delay and within the 30-minute limit is important to minimize the amount of time the system operates in an insecure mode and is vulnerable to cascading outages. 78

102. Santa Clara seeks rehearing of the Commission's determination not to order the ERO to modify Reliability Standard IRO-001-1. Santa Clara is concerned that the 30-minute time period during which entities must take remedial action under this Reliability Standard could be too short with respect to physical actions that must be taken where the facilities which are subject to these actions cannot be readily accessed within the 30-minute time period. 79

103. First, Santa Clara maintains that the reliability coordinator could direct that load be dropped within Silicon Valley Power's (SVP) service territory. 80 According to Santa Clara, those directives could only be implemented through a physical activity, such as opening breakers within certain substations, and cannot be accomplished at all times using an electronic signal from SVP's control center. Therefore, Santa Clara claims that, while SVP personnel would respond to the reliability coordinator's directive immediately, the required action might not be able to be accomplished within 30 minutes.

104. As another example, Santa Clara states that SVP has a program through which certain SVP retail customers can commit to reduce base load by 10 percent where an emergency exists in its control area. However, Santa Clara maintains that reducing load by shutting down power to specific buildings can take longer than 30 minutes. Santa Clara states that it is not seeking to have the language in IRO-001-1 modified as it requested in comments to the NOPR. Rather, it seeks to have the Commission grant rehearing to direct NERC to modify IRO-001-1 and allow Santa Clara to work with NERC to develop clarifications and refinements to IRO-001-1 to remedy its concerns.

105. Avista seeks clarification of the intent of Order No. 693 as to whether the authority of a reliability coordinator to issue directives to reliability entities arises out of (i) reliability coordinator contracts or (ii) Commission-approved Reliability Standards without reliance on reliability coordinator contracts. According to Avista, if the authority of a reliability coordinator is non-contractual and arises out of Commission-approved Reliability Standards, the Commission must make sure that such authority is accompanied by equitable treatment of reliability entities. For example, Avista states that the Commission should require equitable compensation for re-dispatch of generation required by the reliability coordinator and emphasizes the need for fair and impartial procedures and methodologies are adopted to ensure that such equitable treatment is provided.

106. Avista states the Commission's statement in Order No. 693 that it “clarifies that it did not intend to change existing contracts, impose new organizational structures or otherwise affect existing agreements that set forth the responsibilities of various entities”  81 applies to existing agreements that affect reliability coordinator functions. According to Avista, provisions of IRO-001-1 seem to imply that, as to the source and scope of authority for a reliability coordinator to issue directives, existing contracts may have been superseded, or rendered moot or unnecessary, by Order No. 693. In particular, Avista contends that Requirement R8 of IRO-001-1 seems to suggest that contracts are unnecessary to authorize reliability coordinators to issue directives. 82

107. Avista asserts that, if transmission operators or balancing authorities or other reliability entities are subject to a non-contractual duty imposed by the Commission under Order No. 693 to comply with the directives of a reliability coordinator, the Commission should clearly indicate such a requirement. It notes that, in another proceeding, Western Electricity Coordinating Council (WECC) seems to suggest that it believes that when the reliability coordination Reliability Standards become mandatory, the existing contracts regarding reliability or security coordination no longer will be relevant and will not be necessary to authorize reliability coordinators to issue mandatory directives to reliability entities. 83

108. On the other hand, Avista maintains that additional provisions of IRO-001-1 suggest that reliability coordinators must have contracts or other written evidence in place that delineate and evidence their authority over reliability entities. For example, Avista cites measure M2 of IRO-001-1, which states that each reliability coordinator shall have and provide upon request evidence that could include, but is not limited to, job descriptions, signed agreements, an authority letter signed by an officer of the company, or other equivalent evidence that will be used to confirm that the reliability coordinator has the authority to act as described in Requirement 3. According to Avista, this provision suggests that the source of authority to issue directives lies in a contractual relationship between the reliability coordinator and each reliability entity covered by the requirements of Requirement R3. 84 In Avista's view, the language in the Purpose section indicates that the purpose of IRO-001-1 is to establish authority of reliability coordinators over reliability entities through contracts, in addition to establishing internal authority through delegations of authority and plans presumably through Requirement R2.

109. Avista asserts that the security coordinator in the Pacific Northwest, PNSC, does not have contractual relationships with reliability entities other than control area operators. Avista contends that, if the authority of a reliability coordinator to issue directives to reliability entities arises out of reliability coordinator contracts, the reliability coordinator will need to enter into contractual relationships with each of the reliability entities within its area—which would expand the scope of and parties to the current PNSC contracts. Further, Avista states that existing contracts may not contain provisions regarding the authority of reliability coordinators to issue directives to reliability entities that fully track the Reliability Standards. 85

110. Therefore, Avista requests rehearing and asks that the Commission require that (1) reliability coordinators develop and file contracts or tariffs that govern their reliability coordination authority and activities, and (2) such contracts or tariffs ensure equitable treatment of reliability entities by reliability coordinators and provide adequate procedures and methodologies to help ensure such equitable treatment. Avista also seeks rehearing for the purpose of expanding the time to transition from the current, voluntary contractual arrangements to the arrangements contemplated by Order No. 693.

111. Specifically, Avista asserts that the Commission should require reliability coordinators to file such contracts or tariffs under section 205 of the FPA. In this regard, Avista states that the Commission should, as a first step, require reliability coordinators to submit for filing their existing contracts, such as the contracts between PNSC and the control area operators. According to Avista, filing of these contracts or tariffs under section 205 should ensure the equitable treatment of reliability entities, provide a mechanism for redress in the event of inequitable treatment, and provide a basis for the Commission's determination that the Reliability Standards approved by Order No. 693 are just and reasonable.

112. In response to Avista, the Commission clarifies that a reliability coordinator's authority to issue directives arises out of the Commission's approval of Reliability Standards that mandate compliance with such directives. Avista is correct that contracts are unnecessary to authorize reliability coordinators to issue directives. Under the voluntary reliability scheme in place prior to section 215 of the FPA, a contractual basis was needed to assure that entities would comply with a reliability coordinator's directive. Pursuant to the current, mandatory reliability scheme established by statute, contracts are no longer needed. We view the concerns raised by Avista as part of the transition from a voluntary to mandatory scheme. Although, as noted by Avisa, IRO-001-1 retains references to contracts, we view these as vestiges of an earlier program that no longer control given the current, mandatory mechanism.

113. Avista's assertion that, if transmission operators, balancing authorities or other reliability entities are subject to a non-contractual duty imposed by the Commission under Order No. 693 to comply with the directives of a reliability coordinator, the Commission should have clearly indicated such a requirement, is not justified. First, the Commission believes that this duty was clearly laid out in the Reliability Standards themselves. However, the duty to comply with Reliability Standards is imposed by section 215 of the FPA, not by contract. The Reliability Standards approved by the Commission include requirements that certain users, owners and operators of the Bulk-Power System follow directions given by the reliability coordinators. 86 The duty to follow such directions lies in the duty to comply with Reliability Standards as laid out in section 215 of the FPA and the Commission's regulations.

114. The Commission notes that Avista uses the Commission's statement that it “clarifies that it did not intend to change existing contracts, impose new organizational structures or otherwise affect existing agreements that set forth the responsibilities of various entities”  87 for the proposition that the Commission did not intend to change or otherwise affect existing agreements about reliability coordinator functions. We disagree with Avista on this point. The Commission made this statement regarding the responsibility for functions in the Functional Model, especially regarding ISOs, RTOs or any organizations that pool resources. In that statement, we clarified that we were not changing any contract to which an ISO, RTO or pooled resource organization is a party as to who must comply with specific requirements of the Reliability Standards.

115. In response to Avista's arguments regarding Measure M2 of IRO-001-1, the Commission does not believe that this measure imposes a requirement that reliability coordinators must have contracts in place. Measure M-2 of IRO-001-1 requires each reliability coordinator to have and provide upon request evidence that it has the authority to have clear decision-making authority to act and to direct actions to be taken by certain users, owners and operators within its area to preserve the integrity and reliability of the bulk electric system. Neither the Reliability Standard nor the Commission prescribed the form of such evidence.

116. Avista's concerns regarding whether existing contracts, including those regarding the contracts with PNSC, and whether contracts, generally, have been superseded or rendered moot or unnecessary by Order No. 693 are beyond the scope of this proceeding. This proceeding established mandatory Reliability Standards, including those pertaining to directions by reliability coordinators. Reliability coordinator contracts are not before the Commission in this proceeding. Therefore, the Commission cannot rule here on any issue regarding such contracts.

117. The Commission denies Avista's request that the Commission require reliability coordinators to develop and file contracts or tariffs that govern their reliability coordination authority and activities. The Commission understands that reliability must be a primary goal. Each user, owner and operator of the Bulk-Power System must be in compliance with the Reliability Standards so that everyone can have the benefits of using the system. As stated above, the Reliability Standards do not prescribe the form through which each reliability coordinator must provide evidence of its clear decision-making authority to act and to direct actions to be taken by certain entities. To that end, it is unnecessary to require each reliability coordinator to file a contract or tariff.

118. We deny Santa Clara's request for rehearing. In Order No. 693, the Commission noted that various commenters provided specific suggestions to improve or otherwise modify a Reliability Standard that address issues not raised in the NOPR. In such circumstances, the Commission directed the ERO to consider such comments as it modifies the Reliability Standards during the three-year review cycle contemplated by NERC's Work Plan through the ERO Reliability Standards development process. The Commission, however, did not direct any outcome other than that the comments receive consideration. 88

119. However, the Commission denied Santa Clara's specific request to modify Requirement R3 of IRO-001-1, explaining that, when system integrity or reliability is jeopardized, e.g. , when IROLs or SOLs are exceeded, the relevant reliability entities must take corrective control actions to return the system to a secure and reliable state as soon as possible but not longer than 30 minutes. 89 The Commission believes that this reaction time has been vetted through the industry and that the 30-minute time limit for action is important to minimize the amount of time the system operates in an insecure mode and is vulnerable to cascading outages.

120. IRO-005-1 ensures energy balance and transmission reliability for the current day by identifying tasks that reliability coordinators must perform throughout the day. Order No. 693 approved Reliability Standard IRO-005-1.

121. TANC requests clarification as to whether the Commission intended to approve IRO-005-1 or IRO-005-2 in Order No. 693. Although the Commission states that it approves IRO-005-1, 90 TANC notes that NERC submitted a later version, IRO-005-2, in its November filing. Therefore, TANC seeks clarification that the Commission intended to approve IRO-005-1, rather than the more recently filed IRO-005-2.

122. The Commission grants TANC's request for clarification. As stated in Order No. 693, the Commission approved version one of IRO-005. 91

123. MOD-013-1 requires the regional reliability organizations within an Interconnection to develop comprehensive dynamics data requirements and reporting procedures needed to model and analyze the dynamic behavior and response of each Interconnection. More specifically, the regional reliability organization, in coordination with its transmission owners, transmission planners, generator owners and resource planners within an Interconnection, is required to: (1) Participate in development of documentation for their Interconnection data requirements and reporting procedures; (2) participate in the review of those data requirements and reporting procedures at least every five years; and (3) make the data requirements and reporting procedures available to NERC and other specified entities upon request.

124. Because MOD-013-1 is a fill-in-the-blank standard, the Commission stated that it will not approve or remand MOD-013-1 until the ERO submits additional information. However, the Commission directed the ERO to develop a modification to MOD-013-1 to (1) permit entities to estimate dynamics data if they are unable to obtain unit specific data for any reason; (2) require verification of the dynamic models with actual disturbance data and (3) expand the applicability section to include the planning authority, transmission operator and transmission planner.

125. TANC requests that the Commission clarify that it erred in directing the ERO to apply MOD-013-1 to transmission operators and transmission planners. Although the Commission left Reliability Standard MOD-013-1 pending, TANC asserts that the Commission stated that it would adopt the NOPR proposal to expand the applicability section to include planning authorities, but in a later summary paragraph directed the ERO to apply the standard to transmission operators and transmission planners, in addition to planning authorities. 92 TANC states that the inclusion of transmission operators and transmission planners was neither mentioned in the NOPR nor discussed in Order No. 693. In the alternative, TANC requests rehearing.

126. ISO-New England requests rehearing of the Commission's determination to (1) permit entities to estimate dynamics data if they are unable to obtain unit specific data for any reason; (2) require verification of the dynamic models with actual disturbance data; and (3) expand the applicability section to include the planning authority, transmission operator and transmission planner. ISO-New England states that the Commission's direction to the ERO to modify MOD-013-1 appears internally inconsistent with other positions the Commission took in Order No. 693. First, ISO-New England notes that the Commission required the ERO to modify MOD-013-1 because it would allow the use of estimated data but, at the same time, required “verification of the dynamic models with actual disturbance data.”

127. Second, ISO-New England observes that the Commission stated in Order No. 693 that “[f]ailure to provide the data needed for dynamics system modeling and simulation would halt regional reliability assessment processes and impede planners from accurately predicting future system conditions, which would be detrimental to system reliability.”  93 Further, ISO-New England points to the Commission's statement in Order No. 693 that it believes “to achieve the goal of this Reliability Standard of having the ability to accurately model and analyze the dynamic behavior and response of each Interconnection, it is necessary to have accurate data.”  94 In sum, ISO-New England argues that just as the Commission has recognized the importance of accurate data with respect to the administration of other NERC Reliability Standards, the Commission should equally recognize the importance with regard to MOD-013-1.

128. Further, ISO-New England argues that the Blackout Report suggests that actual data should be required. 95 Specifically, ISO-New England points to the Blackout Report's recommendation to improve the quality of system modeling data and data exchange practices. ISO-New England notes that the Blackout Report indicates that “after-the-fact models developed to simulate August 14 conditions and events found that the dynamic modeling assumptions for generator and load power factors in regional planning and operating models were frequently inaccurate.”  96 Further, ISO-New England states that the Task Force commented that, during the investigation process, it too found that data was frequently not available. 97 Consequently, ISO-New England maintains that the Task Force recommended the collection of validated data. 98

129. Finally, ISO-New England states that Order No. 693 leaves too much unclear in terms of its direction that entities should be permitted to estimate dynamics data if unit specific data is unavailable “for any reason.” According to ISO-New England, this exemption appears “overbroad” and could serve as the basis for an asset owner's rejection of any reasonable request for the unit specific data. ISO-New England requests that, if the Commission retains its direction to permit entities to estimate dynamics data, that it narrow the scope of the exemption that asset owners may employ in providing unit specific data.

130. The Commission denies TANC's request for rehearing. TANC correctly identifies that the Commission did not approve or remand MOD-013-1, but provided direction to the ERO concerning the addition of entities not already identified in the Reliability Standard. Although we acknowledge that Order No. 693 did not include a discussion of the addition of transmission operators and transmission planners in the applicability section of this Reliability Standard, in directing the ERO to apply MOD-013-1 to transmission operators and transmission planners, we recognized that transmission operators and transmission planners would be required to perform coordination functions under Requirement R1 of MOD-013-1. Therefore, the Commission directed the ERO to specifically include transmission operators and transmission planners in the applicability section of MOD-013-1 so as to be clear what the Commission considers to be the minimum applicability of this Reliability Standard and to make the Reliability Standard internally consistent.

131. In response to ISO-New England's concerns, the Commission notes that the data referenced in Requirement R1.1 include “items such as inertia constant, damping coefficient, saturation parameters, and direct and quadrature axis reactances and time constants, excitation systems, voltage regulators, turbine-governor systems, power system stabilizers, and other associated generation equipment.” Much of these data will be estimated from similar classes of facilities prior to the facilities going into service. The Commission clarifies that its determination to permit entities to estimate dynamics data if they are unable to obtain unit specific data for any reason is limited to the initial analysis of dynamics data. While we continue to believe that “[a]chieving the most accurate possible picture of the dynamic behavior of the Interconnection requires the use of actual data,”  99 we acknowledge that, in certain circumstances, actual data may not be initially available and only obtained through “verification of the dynamic models with actual disturbance data.” In addition, in Order No. 693, we determined that “the Reliability Standard should include Requirements that such estimates be based on sound engineering principles and be subject to technical review and approval of any estimates at the regional level.”  100 This procedure would allow peer review and approval at a regional level such that an entity could not avoid using sound engineering principles in obtaining the initial data for the model.

132. PRC-007-0 requires transmission owners, transmission operators, load-serving entities and distribution providers to provide, and annually update, their underfrequency data to facilitate the regional reliability organization's maintenance of the UFLS program database. 101 PRC-008-0 requires transmission owners and distribution providers to implement UFLS equipment maintenance and testing programs and provide program results to the regional reliability organization. PRC-009-0 ensures that the performance of a UFLS system is analyzed and documented following an underfrequency event by requiring the transmission owner, transmission operator, load-serving entity and distribution provider to document the deployment of their UFLS systems in accordance with the regional reliability organization's program. Order No. 693 approved Reliability Standards PRC-007-0, PRC-008-0, 102 and PRC-009-0. 103

133. These Reliability Standards reference PRC-006-0, which the Commission did not approve or remand because the regional procedures required by the Reliability Standard had not been submitted and because it applies to regional reliability organizations. 104 The Commission reasoned that since PRC-007-0, PRC-008-0, and PRC-009-0 are existing Reliability Standards that have been followed on a voluntary basis, transmission owners, transmission operators, distribution providers and load-serving entities are generally aware of their requirements. In addition, the Commission stated that a reference in an approved Reliability Standard to an unapproved Reliability Standard may be considered in an enforcement action, but is not a reason to delay approving and enforcing this Reliability Standard.

134. APPA requests rehearing of Commission approval of PRC-007-0, PRC-008-0, and PRC-009-0. As discussed more fully in the section concerning “Fill-in-the-Blank Standards above, 105 APPA believes that each of these three Reliability Standards cannot be approved because it references a fill-in-the-blank standard that was not approved or remanded by the Commission.

135. According to APPA, PRC-006-0 is the Reliability Standard that requires the development of regional UFLS programs and contains detailed and exacting requirements that the regions develop and apply to applicable entities. According to APPA, PRC-006-0 is the source of the design and documentation of regional UFLS programs and is not merely administrative or a simple codification of established industry practice. Rather, APPA asserts that PRC-006-0 sets forth very specific requirements that each regional UFLS program must meet.

136. APPA asserts that PRC-007-0, PRC-008-0 and PRC-009-0 go much further than imposing data requirements. APPA states that PRC-007-0 requires, among other things, that any transmission owner and distribution provider with a UFLS program must ensure that its UFLS program is consistent with its regional reliability organization's UFLS program requirements. PRC-008-0 requires transmission owners and distribution providers to implement UFLS equipment maintenance and testing programs and provide program results to the regional reliability organization. Finally, APPA maintains that PRC-009-0 requires a transmission owner, transmission operator, load-serving entity, and distribution provider that owns or operates a UFLS program to analyze performance under that unapproved program. According to APPA, because the required UFLS program has not been approved or reviewed by the Commission under PRC-006-0, users, owners and operators of the Bulk-Power System cannot be required to have a program consistent with it.

137. APPA maintains that the fact that these three Reliability Standards apply to specific users, owners and operators of the Bulk-Power System, rather than a regional reliability organization, does not justify approval of a reliability standard that requires users, owners and operators of the Bulk-Power System to comply with regional UFLS programs that have not been approved by NERC, and have not been shown to meet the procedural and substantive requirements of section 215 of the FPA and Order No. 672 for Reliability Standards that qualify for approval and enforcement by the ERO and this Commission. Further, APPA contends that, although the Commission appears to have approved these Reliability Standards in part because they have “been followed on a voluntary basis,” many small entities have often not been part of regional reliability organizations and have not necessarily been aware of, much less followed, regional programs on a voluntary basis.

138. We deny APPA's request for rehearing and affirm our approval of Reliability Standards PRC-007-0, PRC-008-0 and PRC-009-0. However, as explained below, we clarify that the limited provisions that relate to the regional UFLS program developed under PRC-006-0 are not enforceable until the Commission approves PRC-006-0. 106 Specifically, any entity that is responsible for compliance with PRC-007-0, PRC-008-0 or PRC-009-0 that currently does not have a UFLS program is not required to develop such a program until PRC-006-0 is approved. Likewise, a responsible entity with an existing UFLS program is not required to comply with a regional UFLS program until the Commission approves PRC-006-0. An explanation for this determination follows.

139. Each of the requirements in PRC-007-0, PRC-008-0 and PRC-009-0, with the exception of Requirement R1 in PRC-007-0, apply only to those entities that have a UFLS program. Therefore, contrary to APPA's assertion, PRC-007-0, PRC-008-0 and PRC-009-0 do not require any entity that does not have a UFLS program to develop one. That requirement would fall under PRC-006-0. To be clear, the Commission will not impose a penalty for the failure to have a UFLS program until such time as PRC-006-0 or a suitable substitute, and the attendant regional UFLS programs, are approved.

140. However, we disagree with APPA that the fact that Requirement R1 references the regional UFLS program precludes us from approving PRC-007-0, PRC-008-0 and PRC-009-0, which provide for updating an entity's UFLS program (PRC-007-0), maintaining the entity's UFLS facilities (PRC-008-0), and reporting on events that involve the entity's UFLS (PRC-009-0). Rather, we uphold our earlier decision to approve these three Reliability Standards with the clarification that Requirement R1 of PRC-007-0 is not enforceable until the Commission approves PRC-006-0. We further clarify, consistent with our discussion above, that, until PRC-006-0 is approved, an entity that does not currently have a UFLS program is not required to develop one or to comply with PRC-007-0, PRC-008-0 and PRC-009-0. However, an applicable entity that currently has a UFLS program must continue to maintain that program as required by these three Reliability Standards. As discussed below, the Requirements of PRC-007-0, PRC-008-0 and PRC-009-0 are necessary for Bulk-Power System reliability and are not dependent on PRC-006-0.

141. PRC-007-0, Requirement R2 states that the applicable entities “shall provide, and annually update, its underfrequency data as necessary for its Regional Reliability Organization to maintain and update a UFLS program database.”  107 It is vital to maintain this safety net that each registered transmission owner, transmission operator, distribution provider and load-serving entity with a UFLS system has a program to annually review the location of their UFLS devices and the magnitude of load that can be collectively activated as necessary. 108 The reason for the annual review is that it is not unusual for loads to be switched among distribution feeders and, with load growth, additional distribution feeders may need to be included to meet the requirements of the entities' UFLS program. In addition, it is necessary to verify that sensitive and critical loads such as hospitals and high impact facilities continue to be excluded from the load shedding program. While it may be necessary to shed load to preserve the Bulk-Power System, it is also good public policy to limit the nature of the facilities that could be interrupted.

142. PRC-008-0, Requirement R1 states that the applicable entities “shall have a UFLS equipment maintenance and testing program in place.” These programs are in place to assure that this last resort system, which has been proven to be necessary to limit the geographic scope of blackouts, operates as expected when required to in accordance with the reliability assessments.

143. PRC-009-0, Requirement R1 identifies what analysis must be completed by the applicable entities after an underfrequency event. It states that “[t]he analysis shall address the performance of UFLS equipment and program effectiveness following system events resulting in system frequency excursions below the initializing set points of the UFLS program.” This requirement assures that actual data on the operation of the UFLS system can be correlated with simulations to provide a check on how well the UFLS system is performing its last resort function.

144. Requirement R1 of PRC-007-0 requires the transmission owner and distribution provider to “ensure that its UFLS program is consistent with its Regional Reliability Organization's UFLS program requirements.” Because the regional UFLS program would be developed pursuant to PRC-006-0, and the Commission has not approved or remanded that Reliability Standard, we agree with APPA that Requirement R1 cannot be enforced as written until the Commission approves PRC-006-0, because Requirement R1 would essentially require compliance with an unapproved Reliability Standard. Because Requirement R1 of PRC-007-0 is not enforceable until the Commission approves PRC-006-0, a transmission owner's or distribution provider's UFLS program cannot be judged for compliance with the unapproved regional UFLS program.

145. While the Commission will not enforce compliance with PRC-006-0, the possible reduction in the amount of load available for underfrequency load shedding can negatively impact the Reliable Operation of the Bulk-Power System. Because of the importance of the UFLS programs and the fact that there currently are no Commission-approved Reliability Standards by which to judge individual UFLS programs, the Commission believes it is important to monitor the current UFLS programs so that we can consider if they provide an adequate safety net for the Bulk-Power System. Therefore, the Commission directs the ERO to collect the frequency and magnitude of load in UFLS systems from applicable entities for this summer, from date of order through September 30, 2007, and perform an analysis as to the ability of the existing system to provide the required last resort function within 90 days of this order. This analysis should consider if the existing UFLS plans together provide an adequate safety net for the Bulk-Power System.

146. In discussing potential ambiguities in the proposed Reliability Standards in Order No. 693, the Commission stated that, even if some clarification of a particular Reliability Standard would be desirable at the outset, making it mandatory allows the ERO and the Regional Entities to provide that clarification on a going-forward basis while still requiring compliance with Reliability Standards that have an important reliability goal. 109 We believe that this principle applies equally to a Reliability Standard where one Requirement may not be enforceable, but the Reliability Standard must be approved to enable enforcement of other Requirements.

147. The reliability goal of PRC-007-0, PRC-008-0 and PRC-009-0 is to provide last resort system preservation measures by implementing an UFLS program. The Commission believes that this is an important reliability goal. The Commission understands that, until PRC-006-0 is approved, the UFLS program implemented will not be the one envisioned in PRC-006-0. We believe that, where a user, owner or operator does have a UFLS program, the data retention and reporting requirements incorporated in these Reliability Standards serve an extremely important goal of providing last resort system preservation measures. NERC can analyze the information to monitor whether the last resort system preservation measures are sufficient in the aggregate for the entire Bulk-Power System. Although the ERO and Regional Entities cannot penalize a user, owner or operator for an insufficient UFLS program until the Commission approves PRC-006-0, collection, analysis and submission of the UFLS information described above will provide NERC and the Commission with invaluable information regarding the reliability of the Bulk-Power System.

148. We further believe that, other than R1 in Reliability Standard PRC-007-0, the Requirements in the PRC Reliability Standards are independently enforceable. For example, R2 of Reliability Standard PRC-007-0 requires a transmission owner or distribution provider with a UFLS program to provide, and annually update, its underfrequency data. Although R2 contains the phrase “(as required by its Regional Reliability Organization),” the Commission believes that it is of vital importance for the transmission owner and distribution provider to update its UFLS data annually and provide it to the ERO. Because we have not approved any regional programs, this parenthetical currently has no meaning in the context of the approved Reliability Standard. Therefore, the Commission believes that these three Reliability Standards only apply to those entities that have a UFLS program, irrespective of whether a region requires it.

149. The Commission also denies rehearing of our approval of PRC-008-0. This Reliability Standard requires each transmission owner and distribution provider with a UFLS program to have a UFLS program in place that includes UFLS equipment identification and the schedule for UFLS equipment testing and maintenance. PRC-008-0 further requires each transmission owner and distribution provider with a UFLS program to implement its UFLS equipment maintenance and testing program and provide UFLS maintenance and testing program results to its regional reliability organization and NERC on request. In this Reliability Standard, any transmission owner or distribution provider that already has a UFLS program must develop its own equipment maintenance and testing program that complies with PRC-008-0. The Commission believes it is of great importance to Bulk-Power System reliability for such entities to perform such maintenance and testing. Because the maintenance and testing programs do not rely on regional reliability organization requirements, but are, rather, developed by the applicable entity itself, the Commission continues to believe that this Reliability Standard is enforceable regardless of whether the Commission has approved PRC-006-0.

150. Finally, the Commission does not believe that the fact that PRC-006-0 has not been approved or remanded necessitates granting rehearing of our approval of PRC-009-0. This Reliability Standard requires a transmission owner, transmission operator, load-serving entity and distribution provider that owns or operates a UFLS program to analyze and document its UFLS program performance in accordance with its regional reliability organization's UFLS program. The Commission acknowledges, as stated above, that currently there is no Commission-approved UFLS program. However, R1 of PRC-009-0 also includes independent criteria by which a user, owner or operator of the Bulk-Power System must analyze its UFLS program. R1 states that:

151. R2 of PRC-009-0 further requires the transmission owner, transmission operator, load-serving entity and distribution provider to provide documentation of the analysis of the UFLS program to its regional reliability organization and NERC on request after a system event. This analysis will better enable NERC to analyze system events and determine what actions need to be taken to ensure the Reliability of the Bulk-Power System.

152. Therefore, the Commission denies rehearing of our approval of PRC-007-0, PRC-008-0 and PRC-009-0. To be clear, we recognize that R1 of PRC-007-0 is not enforceable until the Commission approves PRC-006-0. Because, prior to that approval of PRC-006-0, PRC-007-0, PRC-008-0 and PRC-009-0 only apply to those entities that already have a UFLS program, these Reliability Standards do not require any entity that does not have a UFLS program to develop one, and the Commission will not impose a penalty for an entity's failure to have a UFLS program until the Commission approves PRC-006-0. Further, until PRC-006-0 has been approved, a UFLS program cannot be judged for compliance with an unapproved regional UFLS program. Therefore, the Commission clarifies that, until PRC-006-has been approved, only the data retention and reporting requirements, as well as the requirements for maintenance, testing requirements and analysis of UFLS performance following a triggering event in PRC-007-0, PRC-008-0 and PRC-009-0, are mandatory and enforceable.

153. TOP-008-1 requires a transmission operator to take immediate steps to mitigate System Operating Limit (SOL) and Interconnection Reliability Operating Limit (IROL) violations. Order No. 693 approved Reliability Standard TOP-008-1. 110 Order No. 693 summarized TOP-008-1 as requiring a transmission owner to take immediate steps to mitigate SOL and IROL violations. 111

154. TANC requests clarification that the Commission intended to use the term transmission operator, rather than transmission owner, as the correct applicable entity in Reliability Standard TOP-008-1. 112 TANC states that the text of the ERO-proposed Reliability Standard lists the transmission operator as the only entity to which TOP-008-1 applies. Alternatively, TANC requests rehearing.

155. The Commission will grant TANC's request for clarification. TANC is correct that the Commission's use of the term transmission owner, rather than transmission operator, was in error. The transmission operator is the correct applicable entity in Reliability Standard TOP-008-1.

156. Order No. 693 contains information collection requirements for which the Commission obtained approval from the Office of Management and Budget (OMB). Given that this Order on Rehearing does not revise the regulation text of Order No. 693 and makes only minor clarifications to Order No. 693, OMB approval for this order is not necessary. However, the Commission will send a copy of this order to OMB for informational purposes.

157. In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( http://www.ferc.gov ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.

158. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number, excluding the last three digits of this document, in the docket number field.

159. User assistance is available for eLibrary and the FERC's Web site during normal business hours from our Help line at (202) 502-8222 or the Public Reference Room at (202) 502-8371 Press 0, TTY (202) 502-8659. E-Mail the Public Reference Room at public.referenceroom@ferc.gov.

Background

This document makes technical corrections to § 173.3 of title 19 of the Code of Federal Regulations (19 CFR 173.3) to conform to changes to that section's underlying statutory authority.

Section 173.3 concerns the voluntarily reliquidation of entries and provides that within 90 days from the date notice of the original liquidation is given to the importer, consignee, or agent, the port director may reliquidate on his own initiative a liquidation or reliquidation to correct errors in appraisement, classification, or any other element entering into the liquidation or reliquidation.

Section 501 of the Tariff Act of 1930, as amended (19 U.S.C. 1501), provides the statutory authority for voluntary reliquidations and states that Customs and Border Protection (CBP) may reliquidate an entry within 90 days from the date on which notice of the original liquidation is given or transmitted to the importer, his consignee or agent. Section 1501 was amended by section 2107 of the Miscellaneous Trade and Technical Corrections Act of 2004 (Pub. L. 108-429, 118 Stat. 2598) to include “deemed liquidations” of 19 U.S.C. 1504 as among the types of liquidations CBP is authorized to voluntarily reliquidate. The date of original liquidation of an entry that liquidated by operation of law is the date of deemed liquidation.

This document makes technical corrections to § 173.3 to conform to the broadened scope of 19 U.S.C. 1501, as amended, which authorizes CBP to voluntarily reliquidate entries that have been deemed liquidated by operation of law pursuant to 19 U.S.C. 1504. Examples of types of entries which may be deemed liquidated by operation of law are countervailing duty (CVD), antidumping (AD), or drawback entries.

Because the technical corrections to 19 CFR 173.3 set forth in this document merely conform to the statutory amendments to 19 U.S.C. 1501 effected by section 2107 of the Miscellaneous Trade and Technical Corrections Act of 2004, pursuant to 5 U.S.C. 553(b)(B), CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary. For this same reason, pursuant to 5 U.S.C. 553(d)(3), CBP finds that good cause exists for dispensing with the requirement for a delayed effective date.

Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

These amendments do not meet the criteria for a “significant regulatory action” as specified in E.O. 12866.

This document is being issued in accordance with 19 CFR 0.1(a)(1).

I. Background Status of Dietary Supplements Containing Ephedrine and/or Pseudoephedrine

Dietary supplements containing the List I chemicals ephedrine or pseudoephedrine are regulated as chemical mixtures under the Controlled Substances Act (CSA). DEA originally exempted these products from CSA regulatory control if the total concentration of the ephedrine and/or pseudoephedrine was at or below five percent, in an effort to reduce the regulatory burden on the dietary and nutritional supplement industry (68 FR 23195, May 1, 2003). However, on February 11, 2004, the Food and Drug Administration (FDA) issued a Final Rule (69 FR 6787) declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the FFD&C Act) because these dietary supplements present an unreasonable risk of illness or injury. Effective April 12, 2004, the rule prohibits the sale of dietary supplements containing ephedrine alkaloids such as ephedra (also known as Ma Huang, sida cordifolia and pinellia). The effect of the FDA rule was to ban the lawful marketing of these products.

DEA notes that the FDA ban addresses only the marketing of dietary supplements containing ephedrine alkaloids. The raw materials used to manufacture these dietary supplements are not restricted by the FDA ban. Accordingly, to control those materials, DEA must address the importation, exportation, manufacture, or distribution of chemical mixtures with concentration limits of ephedrine and/or pseudoephedrine at or below five percent. The importation, exportation, manufacture, and distribution of chemical mixtures with concentration limits at or below five percent ephedrine and/or pseudoephedrine are addressed by the CSA and its implementing regulations. As there yet may be legitimate uses for chemical mixtures with concentration limits at or below five percent, the importation, exportation, manufacture, and distribution of these chemical mixtures (for purposes other than use in dietary supplements containing ephedrine alkaloids) are not prohibited by either FDA's ban regarding the marketing of such dietary supplements or by DEA law and regulations. Accordingly, as discussed further below, for DEA to regulate the importation, exportation, manufacture, and distribution of chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent, DEA must remove these chemical mixtures from their exempt status under CSA regulations.

DEA recognizes that ephedra materials containing ephedrine and/or pseudoephedrine are used legitimately by practitioners of Traditional Chinese Medicine. This rulemaking does not restrict the utilization of such material for such legitimate purposes. This rulemaking will simply require importers and suppliers of such material to comply with DEA recordkeeping, registration, quota and import/export requirements.

The ephedrine alkaloids, including, among others, ephedrine, pseudoephedrine, norephedrine, N-methylephedrine, norpseudoephedrine, N-methylpseudoephedrine, are chemical stimulants that occur naturally in some botanicals, but can be synthetically derived. The ingredient sources of the ephedrine alkaloids include raw botanicals ( i.e. , plants) and extracts from botanicals. Ma Huang, ephedra, Chinese Ephedra, and epitonin are several names used for botanical ingredients, primarily from Ephedra sinica Stapf, ephedra equisetina Bunge, Ephedra intermedia var. tibetica Stapf and Ephedra distachya Linne. (the Ephedras), that are sources of ephedrine alkaloids (including ephedrine and pseudoephedrine). Other plant sources that contain such ephedrine alkaloids include Sida cordifolia L. and Pinellia ternata (Thunb.) Makino. Common names that have been used for the various plants that contain ephedrine alkaloids include sea grape, yellow horse, joint fir, popotillo, and country mallow. Although the proportions of the various ephedrine alkaloids in botanical species vary from one species to another, in most species used commercially, ephedrine is typically the predominant alkaloid in the raw material. In addition to chemical mixtures from synthetic sources, this rulemaking includes those plant sources that contain the ephedrine alkaloids, ephedrine and/or pseudoephedrine.

The names desert herb, squaw tea, Brigham tea, and Mormon tea refer to North American species of ephedra that do not contain ephedrine alkaloids but have been misused to identify ephedrine alkaloid containing ingredients. This rulemaking does not pertain to species of ephedra that do not contain ephedrine and/or pseudoephedrine.

On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005. The CMEA mandates that DEA limit the domestic production and importation of materials containing ephedrine and pseudoephedrine (including ephedra) to quantities necessary for medical, scientific and other legitimate purposes (21 U.S.C. 826 and 952(a)(1) as amended). DEA is concerned about the illicit use of ephedra type material in the clandestine production of methamphetamine. While the legitimate market for dietary supplements containing such material has been cut by FDA's recent action, DEA has seen an increasing number of requests for importation of below-five percent ephedrine and/or pseudoephedrine material. DEA notes that there may be legitimate uses for these chemical mixtures. However, in light of FDA's action, DEA is concerned about the intended purpose of such material, especially given that such material has been seized in clandestine drug laboratories.

The Chemical Diversion and Trafficking Act of 1988 (Pub. L. 100-690) (CDTA) was passed by Congress to curtail the diversion of specific chemicals used in the illicit manufacture of controlled substances. The CDTA established recordkeeping and reporting requirements necessary for DEA to identify and track chemical diversion. While the CDTA achieved initial success in curtailing the diversion of chemicals, traffickers soon found and took advantage of certain shortcomings in the law. In the United States (U.S.), traffickers were able to obtain needed supplies by purchasing products that were exempted from regulation under the CDTA. Such products include chemical mixtures.

The CDTA created a definition of “chemical mixture” (21 U.S.C. 802(40)), and exempted chemical mixtures from the definition of “regulated transaction.” (21 U.S.C. 802(39)(A)(vi) as amended by CMEA) Chemical mixtures are defined as “a combination of two or more chemical substances, at least one of which is not a list I chemical or a List II chemical, except that such term does not include any combination of a List I chemical or a List II chemical with another chemical that is present solely as an impurity.” (21 U.S.C. 802(40))

Ephedrine and pseudoephedrine are List I chemicals. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Chemical mixtures containing both these List I chemicals include dietary and nutritional supplements. Prior to FDA's 2004 Final Rule, dietary and nutritional supplements containing both of these chemicals were readily available in the U.S., commonly sold to the public in drug and grocery stores, health and nutrition stores, and through direct marketing campaigns. These dietary and nutritional supplements contained ephedra plant material, or extracts from the ephedra plant. If these dietary and nutritional supplements met certain criteria under the FFD&CA, they were not recognized as drugs under the FFD&CA, but nonetheless were considered to be chemical mixtures governed by DEA law and regulations. In contrast, over-the-counter (OTC) and prescription drug products containing these listed chemicals are not considered chemical mixtures (as long as they are in final FDA approved labeled package form) and instead are specifically addressed in 21 U.S.C. 802(39)(A)(iv) and (v) as amended by CMEA. Also see 21 CFR 1300.02(b)(28)(i).

Prior to the Domestic Chemical Diversion Control Act of 1993 (DCDCA), enacted in April of 1994, transactions involving all chemical mixtures (including dietary supplements) were exempt from recordkeeping, registration and other chemical regulatory control requirements of the CSA. The DCDCA amended the CSA (21 U.S.C. 802(39)(A)(v)) to limit the application of the above stated exemption and provided the Attorney General with the authority to exempt a chemical mixture containing a listed chemical if it is “formulated in such a way that it cannot be easily used in the illicit production of a controlled substance” and “the listed chemical or chemicals contained in the mixture cannot be readily recovered.” As such, only those chemical mixtures meeting these criteria would be exempted from control. Until regulations which delineated criteria and procedures for exempting specific chemical mixtures were finalized, as a practical interpretation of the law, DEA treated all chemical mixtures, including dietary and nutritional supplements, as being exempt from the chemical regulatory requirements of the CSA. (Note that OTC and prescription drug products are not considered chemical mixtures and are addressed separately under 21 U.S.C. 802(39)(A)(iv)). Unless exempted pursuant to law and regulations, the requirements for chemical mixtures included registration for certain handlers of List I chemicals, recordkeeping, reporting and security.

Some chemical mixtures can be and have been used by traffickers in the illicit manufacture of controlled substances. This exemption provided traffickers with an unregulated source for obtaining these chemicals. To address these problems, the DCDCA amended the exemption to provide that only those chemical mixtures specified by regulation would be exempt from the definition of “regulated transaction.”

Regulations regarding the exemption of chemical mixtures were initially proposed by DEA on October 13, 1994 (59 FR 51888). In response to industry concerns, the proposed regulations were withdrawn on December 9, 1994 (59 FR 63738). After consulting with the private sector and carefully considering industry and other concerns, new regulations regarding chemical mixtures were proposed on September 16, 1998 (63 FR 49506). The comment period, which was twice extended, closed on April 16, 1999.

There are thousands of chemical mixtures in legitimate commerce, the majority of which are not useful to the illicit laboratory operator. The NPRM proposed criteria for the determination of whether a chemical mixture would be automatically exempt from CSA regulatory controls. Additionally, the NPRM defined an application process by which manufacturers may apply for an exemption for chemical mixtures that do not qualify for automatic exemption.

The DEA proposed that each chemical be assigned a concentration limit that, if found at or below the limit, will cause the mixture to be treated as exempt from specific provisions of the CSA. This quantitative approach to identifying regulated mixtures was considered necessary due to the complexity of chemical-based commodities and the huge variety of products. These criteria were expected to exempt the vast majority of chemical mixtures containing listed chemicals from regulatory control. The NPRM included the proposed creation of a “Table of Concentration Limits,” in 21 CFR 1310.12. This table lists the concentration limits for each listed chemical.

In recognition that not all mixtures that qualify for exemption can be identified by concentration or category, the DEA also proposed an application process to exempt additional mixtures which are not likely to be diverted for use in the illicit production of controlled substances.

DEA originally proposed a concentration limit of two percent for chemical mixtures containing ephedrine and/or pseudoephedrine. However, based on the comments received from the NPRM (63 FR 49506, Sept. 16, 1998), DEA determined that a five percent concentration limit would be more appropriate. On May 1, 2003, DEA published a Final Rule (68 FR 23195) which established a concentration limit of five percent for chemical mixtures which contain ephedrine and/or pseudoephedrine.

If the concentration of the total ephedrine and/or pseudoephedrine was at or below the five percent limit in a chemical mixture, the mixture was automatically exempted from the registration, reporting, recordkeeping and security requirements of the CSA. That Final Rule primarily addressed those chemicals encountered in dietary and nutritional supplements.

The May 1, 2003, Final Rule also established an exemption for the category of products consisting of unaltered harvested plant material in 21 CFR 1310.12(d)(1). Finally, that rule provided for a process whereby a manufacturer of a product which would otherwise be subject to regulation may request an exemption for that specific product. This process allows chemical mixtures not automatically exempt by the concentration limit to be considered for exempt status under the CSA.

In 2004, FDA issued a Final Rule declaring dietary supplements containing ephedrine alkaloids “adulterated” under the FFD&C Act (69 FR 6787, February 11, 2004). FDA issued this rule after concluding that these products present an unreasonable risk of illness or injury. FDA's Final Rule prohibits the sale of these products and FDA has been seizing dietary supplements containing ephedrine alkaloids since the Final Rule became effective in April 2004. The FDA Final Rule addressed the marketing of dietary supplements containing ephedrine alkaloids; it did not address the importation, exportation, manufacture or distribution of ephedrine and/or pseudoephedrine chemical mixtures with concentration limits at or below five percent, if the chemical mixture is not being marketed as a dietary supplement containing ephedrine alkaloids. DEA notes that there yet may be legitimate uses for such mixtures. As there yet may be legitimate uses for chemical mixtures with concentration limits at or below 5 percent, the importation, exportation, manufacture, and distribution of these chemical mixtures (for purposes other than use in dietary supplements containing ephedrine alkaloids) are not prohibited by either FDA's ban regarding the marketing of such dietary supplements or by DEA law and regulations. In spite of FDA's ban, and corresponding reduction in legitimate need for these chemical mixtures, DEA has seen a significant increase in the number of import requests for ephedra, sparking a concern that these chemical mixtures are being diverted for use in the illicit manufacture of methamphetamine.

On March 9, 2006, the President signed the USA PATRIOT Improvement and Reauthorization Act of 2005 which included the Combat Methamphetamine Epidemic Act of 2005 (CMEA) (Title VII of Pub. L. 109-177). The CMEA placed additional controls on ephedrine and pseudoephedrine and tasked DEA with limiting the domestic production and importation of ephedrine and pseudoephedrine materials to quantities necessary for medical, scientific and other legitimate purposes (21 U.S.C. 826 and 952(a)(1) as amended).

The CMEA imposed new requirements regarding the retail sale of scheduled listed chemical products (products containing ephedrine, pseudoephedrine, or phenylpropanolamine, that may be marketed or distributed lawfully in the United States under the FFD&CA as nonprescription products). In a separate rulemaking, “Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products” [Docket No. DEA-291, RIN 1117-AB05] (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), DEA promulgated regulations implementing these provisions. The CMEA also subjects material containing ephedrine, pseudoephedrine and phenylpropanolamine to manufacturing and import restrictions. Specifically, the CMEA requires that importers of all listed chemicals provide DEA with information regarding the transferee, ( i.e. , the downstream customer) of the chemical, as well as information regarding the quantity of the chemical to be transferred. Importers are further required to provide DEA with a return declaration regarding each import after the transaction is completed (CMEA section 716, 21 U.S.C. 971(d) and (g), as amended). In a separate rulemaking, “Implementation of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers Following Importation or Exportation” [Docket No. DEA-292, RIN 1117-AB06] (72 FR 17401, April 9, 2007; Temporary Stay of Certain Provisions 72 FR 28601, May 22, 2007), DEA promulgated regulations implementing these provisions. Further, the CMEA requires that the notice of importation (DEA Form 486) for ephedrine, pseudoephedrine, and phenylpropanolamine “shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.” (CMEA section 721, 21 U.S.C. 971(h) as amended). In a separate rulemaking, “Information of Foreign Chain of Distribution for Certain List I Chemicals” [Docket No. DEA-295, RIN 1117-AB07], DEA is promulgating regulations to implement this provision. Finally, the CMEA requires DEA to establish import and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine (CMEA sections 713 and 715, 21 U.S.C. 826 and 952 as amended). In a separate rulemaking, “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08] (72 FR 37439, July 10, 2007) DEA promulgated regulations to implement these provisions.

DEA is removing the exemption for five percent ephedrine and/or pseudoephedrine, in part, to fulfill the Congressional mandate of restricting such material to quantities necessary for medical, scientific, and other legitimate purposes (21 U.S.C. 826 and 952(a)(1) as amended). Without removing the exemption for these products, DEA would be unable to effectively limit the importation of ephedrine and pseudoephedrine, as required by the CMEA.

DEA is also authorized to remove an exemption for particular exempt chemical mixtures if it finds evidence of diversion pursuant to 21 CFR 1310.12(e). This regulation provides that should DEA find such evidence, it can “issue, and publish in the Federal Register , notification of the removal of an exemption.” Interested parties are invited to file written comments or objections to the order within 60 days of the date of publication. If any comment or objection raises “significant issues regarding any finding of fact or conclusion of law upon which the order is based, [DEA] shall immediately suspend the effectiveness of the order” and reconsider the application for exemption in light of the comments received.

At most methamphetamine laboratories seized in the U.S., the precursor material was obtained via the diversion of OTC ephedrine or pseudoephedrine products marketed in tablet and capsule form. While the vast majority of products seized at illicit methamphetamine laboratories were OTC drug products, ephedra and ma huang extracts containing ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and pseudoephedrine, and dietary supplement products (containing ephedra and ma huang extracts) have been seized. At this time, the frequency with which these dietary supplement products and extracts are encountered is small. From 1998 through 2005, DEA has documented 20 methamphetamine laboratories where ephedra materials have been seized. The source of precursor chemicals in a seized clandestine laboratory is often not evident, so it is likely that the number of seized laboratories that used such mixtures is actually greater. Ephedra, therefore, can and is being diverted for use as a precursor material for the illicit production of methamphetamine. Were DEA not to regulate chemical mixtures containing ephedrine and/or pseudoephedrine at or below the current five percent concentration limit, DEA is concerned that these products would be more widely diverted for illicit production of methamphetamine, particularly as traffickers look for easily-obtainable product due to the new retail sales, quota and import restrictions imposed by CMEA.

Recently DEA has seen an increasing number of requests for importation of large shipments of ephedra material in concentrations below the five percent ephedrine and pseudoephedrine exemption limit. Traditionally, such ephedra extract material has always been between 6-8 percent ephedrine and/or pseudoephedrine.

As noted above, DEA has seen chemical mixtures with concentration limits of ephedrine and/or pseudoephedrine at or below five percent in clandestine methamphetamine laboratories. Subsequent to implementing regulations which allowed an exemption for below five percent material, DEA has witnessed increased ability of clandestine laboratory operators to extract ephedrine and pseudoephedrine from various bulk materials (including low concentration mixtures). These extraction procedures are shared via the Internet. While these mixtures may contain low concentrations of ephedrine and/or pseudoephedrine, they can be a ready source of supply for methamphetamine traffickers.

Therefore, due to the existing clandestine methamphetamine laboratory problem and the illicit use of extracts and dietary supplements (containing ephedrine and related List I chemicals) as precursor material for the clandestine production of methamphetamine, and the new limitations imposed by the CMEA, DEA is removing the exemption for chemical mixtures having a total concentration of less than (or equal to) five percent ephedrine or pseudoephedrine and is removing the exemption for unaltered ephedra plant material.

This Interim Rule announces the removal of the exemption for chemical mixtures having a total concentration of ephedrine and/or pseudoephedrine of five percent (or less). By removing these exemptions, all chemical mixtures containing ephedrine and/or pseudoephedrine will be regulated chemical mixtures subject to control under the Controlled Substances Act, including registration, recordkeeping, reporting, and security controls. This action will be effective August 24, 2007.

This rulemaking also removes the exemption for the category of products consisting of harvested plant material which is specified in 21 CFR 1310.12(d)(1). Harvested plant material ( i.e. , ephedra) that contains ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine, meeting the definition of chemical mixture, shall no longer be exempt from CSA provisions, even when the plant material is unaltered from its natural state.

Effective August 24, 2007, any chemical mixture that contains ephedrine or pseudoephedrine will be treated as a List I chemical. Transactions that meet or exceed the cumulative monthly threshold for the listed chemical, set forth at 21 CFR 1310.04, shall be regulated transactions. Persons interested in handling a regulated mixture must comply with the following:

Registration. Any person who manufactures, distributes, imports or exports a regulated mixture, or proposes to engage in such activities, with respect to a regulated mixture containing a List I chemical, shall obtain a registration pursuant to the CSA (21 U.S.C. 822). Regulations describing registration for List I chemical handlers are set forth in 21 CFR part 1309.

Separate registration is required for manufacture, distribution, importing, and exporting. A separate registration is required for each principal place of business at one general physical location where List I chemicals are manufactured, distributed, imported, or exported by a person (21 CFR 1309.23). Effective August 24, 2007, any person manufacturing, distributing, importing, or exporting any amount of a regulated mixture will become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons who are subject to the registration requirement to immediately complete and submit an application for registration and for DEA to immediately issue registrations for those activities. Therefore, in order to allow continued legitimate commerce in regulated mixtures, DEA is establishing in 21 CFR 1310.09 a temporary exemption from the registration requirement for persons desiring to engage in activities with regulated mixtures, provided that DEA receives a properly completed application for registration on or before August 24, 2007. The temporary exemption for such persons will remain in effect until DEA takes final action on their application for registration.

The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, are effective on August 24, 2007. Therefore, all transactions of chemical mixtures containing ephedrine or pseudoephedrine will be regulated, if at or above threshold, while an application for registration or exemption is pending. This is necessary because not regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.

Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to the regulated mixture, nor does it supersede state or local laws or regulations. All handlers of a regulated mixture must comply with applicable state and local requirements in addition to the CSA regulatory controls.

Records and Reports. The CSA (21 U.S.C. 830) requires certain records to be kept and reports to be made involving listed chemicals. Regulations describing recordkeeping and reporting requirements are set forth in 21 CFR Part 1310. A record must be made and maintained for two years after the date of a regulated transaction involving a List I chemical. Only a distribution, receipt, sale, importation, exportation, brokerage or trade of a regulated mixture above the established threshold is a regulated transaction (21 CFR 1300.02(b)(28)).

Each regulated bulk manufacturer of a regulated mixture shall submit manufacturing, inventory, and use data on an annual basis (21 CFR 1310.05(d)). Bulk manufacturers producing the mixture solely for internal consumption, e.g. formulating a nonregulated mixture, are not required to submit this information. Existing standard industry reports containing the required information are acceptable, provided the information is readily retrievable from the report.

21 CFR 1310.05 requires that each regulated person shall report to DEA any regulated transaction involving an extraordinary quantity, an uncommon method of payment or delivery, or any other circumstance that causes the regulated person to believe that the listed chemical will be used in violation of the CSA. Section 1310.03(c) requires that regulated persons who engage in a transaction with a nonregulated person or who engage in an export transaction that involves ephedrine or pseudoephedrine, including drug products containing these chemicals, and uses or attempts to use the Postal Service or any private or commercial carrier must file monthly reports of each such transaction.

Imports/Exports. All imports/exports and brokered transactions of regulated mixtures containing ephedrine and/or pseudoephedrine shall comply with the CSA (21 U.S.C. 952, 957 and 971). Regulations for importation and exportation of List I chemicals are described in 21 CFR part 1313. Separate registration is necessary for each activity (21 CFR 1309.22).

Security. Regulated persons must provide effective controls and procedures to guard against theft and diversion of regulated mixtures. Regulated persons must store the regulated mixtures in containers sealed so that tampering will be evident; if the mixture cannot be stored in a sealed container, access to the chemicals must be controlled (21 CFR 1309.71).

Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where regulated persons may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of a regulated mixture or where records relating to those activities are maintained, are controlled premises as defined in 21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for administrative inspections of these controlled premises as provided in 21 CFR Part 1316 Subpart A.

The Administrative Procedure Act (APA) generally requires that agencies, prior to issuing a new rule, publish a notice of proposed rulemaking in the Federal Register . The APA also provides, however, that agencies may be excepted from this requirement when “the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B).

With publication of this interim rule, DEA is invoking this “good cause” exception to the APA's notice requirement based on the combination of several extraordinary factors. Section 713 of the CMEA (21 U.S.C. 826 as amended) requires the establishment of production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DEA implemented these requirements in a separate rulemaking, “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08] (72 FR 37439, July 10, 2007). DEA cannot establish such quotas if certain products containing these List I chemicals are not regulated. To not regulate these products while at the same time establishing production quotas would create a loophole which traffickers could exploit domestically. CMEA also mandates that imports of ephedrine, pseudoephedrine, and phenylpropanolamine are prohibited except for such quantities as the Attorney General (DEA by delegation) finds necessary to provide for medical, scientific, or other legitimate purposes (CMEA section 715, 21 U.S.C. 952 as amended). DEA is further required to establish import quotas for these three List I chemicals. In order for DEA to establish quotas and meet its obligation to prohibit imports except those necessary to provide for a medical, scientific, or other legitimate purpose, as required by the CMEA, DEA must exercise regulatory control over chemical mixtures containing pseudoephedrine and ephedrine. To exercise this control, DEA must eliminate the exemption for chemical mixtures containing these List I chemicals.

DEA is concerned about the increasing number of requests for importation of below-five percent ephedrine or pseudoephedrine material. After the recent FDA action which bans dietary supplements containing such material, DEA has not been able to determine the legitimate need for importation of such material. Therefore, in an effort to eliminate the undocumented importation and domestic distribution of such material, and to comply with all of the new requirements imposed by the CMEA discussed above, DEA is removing these exemptions.

As has been discussed previously in this rulemaking, DEA has seized chemical mixtures containing ephedrine and/or pseudoephedrine with concentrations of less than five percent at 20 domestic clandestine laboratories over the past several years. The source of precursor chemicals in a seized clandestine laboratory is often not evident, so it is likely that the number of seized laboratories that used such mixtures is actually greater. Further, the CMEA specifically prohibits all importation of ephedrine, pseudoephedrine, and phenylpropanolamine except those quantities which the Attorney General finds to be necessary for medical, scientific, and other legitimate purposes. These seizures, coupled with the new requirements limiting importation of ephedrine, pseudoephedrine, and phenylpropanolamine, as well as the establishment of production and import quotas for these three List I chemicals, necessitate that DEA remove the concentration limit for these previously exempt chemical mixtures. Engaging in traditional notice and comment rulemaking would prevent DEA from complying with the mandates of CMEA to limit the importation and domestic production of these materials.

Were DEA not to regulate chemical mixtures containing ephedrine and/or pseudoephedrine at or below the current five percent concentration limit, DEA is concerned that these products would be more widely diverted for illicit production of methamphetamine, particularly with the new quota and import restrictions imposed by CMEA. Accordingly, DEA finds that it is impracticable to conduct notice and comment rulemaking regarding the removal of the exemption for chemical mixtures with concentration limits at or below the current five percent limit. If DEA did not act in this manner, traffickers would have ready access to chemical mixtures which DEA has demonstrated are being used currently to illicitly manufacture methamphetamine. Allowing such illicit manufacture to continue during the pendancy of rulemaking would be contrary to the public interest and the intent of the Combat Methamphetamine Epidemic Act of 2005. The broad scope of the new law, as well as the expedited effective dates, is a clear reflection of Congress' concern about the nation's growing methamphetamine epidemic and its desire to act quickly to prevent further illicit use of these chemicals.

In light of these factors, DEA finds that “good cause” exists to issue this interim rule without engaging in traditional notice and comment rulemaking. In so doing, DEA recognizes that exceptions to the APA's notice and comment procedures are to be “narrowly construed and only reluctantly countenanced.” Am. Fed'n of Gov't Employees v. Block, 655 F2d 1153, 1156 (D.C. Cir. 1981) (quoting New Jersey Dep't of Envt. Prot. v. EPA, 626 F.2d 1038, 1045 (D.C. Cir. 1980)). Based on the totality of the circumstances associated with the CMEA, DEA finds that invocation of the “good cause” exception is justified.

Further, the APA also provides that, while agencies are generally required to publish final rules at least 30 days before they become effective, they may be exempt from this requirement as well “for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). As discussed previously, DEA has recently seen a significant increase in the number of requests for importation of large quantities of these chemical mixtures. After the recent FDA action which bans dietary supplements containing such material, DEA has not been able to determine the legitimate need for importation of such material. DEA is concerned about the potential illicit use of such material for clandestine methamphetamine manufacture, particularly as traffickers look for easily-obtainable product due to the retail sales limits recently imposed by the CMEA. Delaying the effective date of this rule could provide a significant loophole for domestic illicit methamphetamine manufacturers to take advantage of for their illegal activities. Therefore, DEA finds good cause not to delay the effective date of this rule.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 605(b)). The (RFA) applies to rules that are subject to notice and comment. As explained above, DEA has determined that public notice and comment are not necessary. Consequently, the RFA does not apply. DEA notes, however, that as explained in the discussion under Executive Order 12866, the costs of this rule are low, requiring only registration, maintenance of records, reports on unusual transactions, thefts or losses, and mail order transactions, and security. Other than the registration fee and the reports, these requirements can generally be met by standard business practices.

DEA has determined that dietary supplements containing ephedrine alkaloids, including bulk material used to formulate these supplements, are the principal chemical mixtures that contain ephedrine and/or pseudoephedrine. Dietary supplements containing such ephedrine alkaloids have been banned by FDA. Due to (1) The CMEA mandate that DEA limit the domestic production and importation of materials containing ephedrine and pseudoephedrine to quantities necessary for medical, scientific and other legitimate purposes; (2) the elimination of the previous lawful status of such products as dietary supplements; and (3) the potential illicit use of such products as precursor material for illicit production of methamphetamine, DEA is removing the exemption for low concentration material, including harvested plant material. This industry is comprised mainly of small businesses, as defined by U.S. Small Business Administration (SBA) regulations (13 CFR part 121). However, the lawful marketing of dietary supplements containing ephedrine alkaloids has been banned by FDA. As such, this regulatory action is not expected to impact any manufacturers whose product can still lawfully be marketed under the FFD&CA. Persons who import or distribute chemical mixtures containing ephedrine and/or pseudoephedrine at or below the previously-exempt five percent concentration limit will be affected by this rule. This rule will not have a significant economic impact on those persons. However, DEA is seeking comment specifically regarding the potential impacts of this regulation.

DEA is not prohibiting the importation, exportation, manufacture, or distribution of chemical mixtures containing ephedrine or pseudoephedrine in concentrations less than or equal to five percent. Rather, DEA is regulating the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. Chemical mixtures containing the List I chemicals ephedrine and pseudoephedrine will still be available for use.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. DEA has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget (OMB).

The rule will impose relatively low costs on regulated persons. Other than the annual registration fee of $1,247, there are few costs associated with the rule. The records required on regulated transactions can be met with standard business records. Reports on unusual sales, thefts, and losses will be filed infrequently by any one person. Those who sell covered mixtures and deliver them to the end user through the mail or other delivery services will have to file a monthly report. The monthly report requires only the registrant's name and registration number, the purchaser's name and address, the shipping address (if different), the name and quantity of the chemical, and the date of shipment; all of this information is available from standard business and shipping records. These reports may be filed electronically. The security requirements do not exceed standard business practices for the protection of both the security and quality of these products. DEA has not determined the number of firms potentially affected by the rule, but does not expect it to be high.

This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988.

This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The Drug Enforcement Administration is eliminating the current exemption for chemical mixtures with concentration limits of the List I chemicals ephedrine and/or pseudoephedrine of less than or equal to five percent. This means that all chemical mixtures containing the List I chemicals ephedrine and/or pseudoephedrine are regulated chemical mixtures, regardless of concentration limits.

Due to this change in the regulations, all persons who import, export, manufacture, or distribute chemical mixtures containing these two List I chemicals will be required to register with DEA. They will also be required to file reports regarding certain transactions, should certain criteria be met.

DEA does, however, provide a mechanism whereby a person may seek an exemption from these regulatory requirements for a specific chemical mixture, if DEA determines that such a chemical mixture cannot be used by traffickers to manufacture controlled substances illicitly.

DEA notes that the lawful marketing of dietary supplements containing this material has been banned by FDA. As such, this regulatory action is expected to impact no manufacturers, whose product can still lawfully be marketed under the FFD&CA.

Therefore, as the impact of this regulation is minimal, DEA is making minor adjustments to the OMB information collections entitled “Application for Registration Under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration under Domestic Chemical Diversion Control Act of 1993” (OMB control number 1117-0031, DEA Form 510), “Report of Mail Order Transactions” (OMB control number 1117-0033), and “Import/Export Declaration for List I and List II Chemicals” (OMB control number 1117-0023). DEA is specifically seeking comment regarding the number of persons who may be affected by this regulation.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Copyright Office published an interim regulation in the Federal Register on July 6, 2007, which, for the purpose of implementing an online registration system, amended its regulations governing the procedures by which the public submits, and the Office processes, copyright registrations and recordations. This document makes non-substantial corrections to errors contained in the interim regulations.

Claims, Copyright, Registration requirements.

I. Background

On May 30, 2007 (72 FR 29914), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed approval of Pennsylvania's redesignation request, a SIP revision that establishes a maintenance plan for the Franklin County Area that provides for continued attainment of the 8-hour ozone NAAQS for at least 10 years after redesignation, and a 2002 base-year emissions inventory. The formal SIP revisions were submitted by PADEP on December 14, 2006. Other specific requirements of Pennsylvania's redesignation request and SIP revision for the maintenance plan, and the rationale for EPA's proposed actions are explained in the NPR and will not be restated here. No public comments were received on the NPR.

On December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006). On June 8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No. 04-1201, in response to several petitions for rehearing, the DC Circuit clarified that the Phase 1 Rule was vacated only with regard to those parts of the rule that had been successfully challenged. Therefore, the Phase 1 Rule provisions related to classifications for areas currently classified under subpart 2 of Title I, part D of the Act as 8-hour nonattainment areas, the 8-hour attainment dates, and the timing for emissions reductions needed for attainment of the 8-hour ozone NAAQS remain effective. The June 8 decision left intact the Court's rejection of EPA's reasons for implementing the 8-hour standard in certain nonattainment areas under subpart 1 in lieu of subpart 2. By limiting the vacatur, the Court let stand EPA's revocation of the 1-hour standard and those anti-backsliding provisions of the Phase 1 Rule that had not been successfully challenged. The June 8 decision reaffirmed the December 22, 2006 decision that EPA had improperly failed to retain four measures required for 1-hour nonattainment areas under the anti-backsliding provisions of the regulations: (1) Nonattainment area nonattainment New Source Review (NSR) requirements based on an area's 1-hour nonattainment classification; (2) Section 185 penalty fees for 1-hour severe or extreme nonattainment areas; and (3) measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the Act, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour NAAQS, or for failure to attain that NAAQS. In addition the June 8 decision clarified that the Court's reference to conformity requirements for anti-backsliding purposes was limited to requiring the continued use of 1-hour motor vehicle emissions budgets until 8-hour budgets were available for 8-hour conformity determinations, which is already required under EPA's conformity regulations. The Court thus clarified that 1-hour conformity determinations are not required for anti-backsliding purposes.

For the reasons set forth in the May 30, 2007 (72 FR 29914) proposed rulemaking, EPA does not believe that the Court's rulings alter any requirements relevant to this redesignation action so as to preclude redesignation, and do not prevent EPA from finalizing this redesignation. EPA believes that the Court's December 22, 2006 and June 8, 2007 decisions impose no impediment to moving forward with the redesignation of the Franklin County Area to attainment, because even in light of the Court's decisions, redesignation is appropriate under the relevant redesignation provisions of the Act and longstanding policies regarding redesignation requests.

In the May 30, 2007 (72 FR 29914) proposed rulemaking, EPA proposed to find that the Franklin County Area had satisfied the requirements under the 1-hour standard whether the 1-hour standard was deemed to be reinstated or whether the Court's decision on the petition for rehearing was modified to require something less than compliance with all applicable 1-hour requirements. Because EPA proposed to find that the Franklin County Area satisfied the requirements under either scenario, EPA is proceeding to finalize the redesignation and to conclude that the Franklin County Area met the requirements under the 1-hour standard applicable for purposes of redesignation under the 8-hour standard. These include the provisions of EPA's anti-backsliding rules, as well as the additional anti-backsliding provisions identified by the court in its rulings. In its June 8, 2007 decision the Court limited its vacatur so as to uphold those provisions of the anti-backsliding requirements that were not successfully challenged. Therefore, EPA finds that the Franklin County Area has met the anti-backsliding requirements, see 40 CFR 51.900 et seq.; 70 FR 30592, 30604 (May 26, 2005), which apply by virtue of the Franklin County Area's classification for the 1-hour ozone NAAQS, as well as the four additional anti-backsliding provisions identified by the Court, or alternatively, that such requirements are not applicable for purposes of redesignation. In addition, with respect to the requirement for transportation conformity under the 1-hour standard, the Court in its June 8 decision clarified that for those areas with 1-hour motor vehicle emissions budgets, anti-backsliding requires only that those 1-hour budgets must be used for 8-hour conformity determinations until replaced by 8-hour budgets. To meet this requirement, conformity determinations in such areas must continue to comply with the applicable requirements of EPA's conformity regulations at 40 CFR Part 93. The court clarified that 1-hour conformity determinations are not required for anti-backsliding purposes.

EPA is approving the Commonwealth of Pennsylvania's redesignation request, maintenance plan, and the 2002 base-year emissions inventory because the requirements for approval have been satisfied. EPA has evaluated Pennsylvania's redesignation request that was submitted on December 14, 2006, and determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes that the redesignation request and monitoring data demonstrate that the Franklin County Area has attained the 8-hour ozone standard. The final approval of this redesignation request will change the designation of the Franklin County Area from nonattainment to attainment for the 8-hour ozone standard. EPA is approving the maintenance plan for the Franklin County Area submitted on December 14, 2006 as a revision to the Pennsylvania SIP. EPA is also approving the MVEBs submitted by PADEP in conjunction with its redesignation request. In addition, EPA is approving the 2002 base-year emissions inventory submitted by PADEP on December 14, 2006 as a revision to the Pennsylvania SIP. In this final rulemaking, EPA is notifying the public that we have found that the MVEBs for nitrogen oxides (NO X ) and volatile organic compounds (VOCs) in the Franklin County Area for the 8-hour ozone maintenance plan are adequate and approved for conformity purposes. As a result of our finding, the Franklin County Area must use the MVEBs from the submitted 8-hour ozone maintenance plan for future conformity determinations. The adequate and approved MVEBs are provided in the following table:

With respect to the 1-hour ozone NAAQS, EPA has determined pursuant to section 181(b)(2) of the CAA that the Franklin County Area has attained the 1-hour NAAQS for ozone. On the basis of this determination, EPA is also determining that the following nonattainment area requirements of part D to Title 1 of the CAA are not applicable to the Franklin County Area for so long as it continues to attain the 1-hour NAAQS for ozone: The requirements of section 172(c)(1) concerning the submission of the ozone attainment demonstration and reasonably available control measure requirements, the requirements of section 172(c)(2) concerning reasonable further progress (RFP), and the requirements of section 172(c)(9) concerning contingency measures for RFP or attainment. If a violation of the 1-hour ozone NAAQS is monitored in the Franklin County 1-hour ozone nonattainment area, these determinations shall no longer apply.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Redesignation of an area to attainment under section 107(d)(3)(e) of the Clean Air Act does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Because this action affects the status of a geographical area, does not impose any new requirements on sources, or allows the state to avoid adopting or implementing other requirements, this action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 24, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action, approving the redesignation of the Franklin County Area to attainment for the 8-hour ozone NAAQS, the associated maintenance plan, the 2002 base-year emissions inventory, and the MVEBs identified in the maintenance plan, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On June 1, 2007 (72 FR 30521), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed approval of Pennsylvania's redesignation request, a SIP revision that establishes a maintenance plan for the Harrisburg Area that provides for continued attainment of the 8-hour ozone NAAQS for at least 10 years after redesignation, and a 2002 base-year emissions inventory. The formal SIP revision was submitted by PADEP on March 27, 2007. Other specific requirements of Pennsylvania's redesignation request, the SIP revision for the maintenance plan, and the rationale for EPA's proposed actions are explained in the NPR and will not be restated here. No public comments were received on the NPR.

On December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (D.C. Cir. 2006). On June 8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No. 04-1201, in response to several petitions for rehearing, the D.C. Circuit clarified that the Phase 1 Rule was vacated only with regard to those parts of the rule that had been successfully challenged. Therefore, the Phase 1 Rule provisions related to classifications for areas currently classified under subpart 2 of Title I, part D of the Act as 8-hour nonattainment areas, the 8-hour attainment dates, and the timing for emissions reductions needed for attainment of the 8-hour ozone NAAQS remain effective. The June 8 decision left intact the Court's rejection of EPA's reasons for implementing the 8-hour standard in certain nonattainment areas under subpart 1 in lieu of subpart 2. By limiting the vacatur, the Court let stand EPA's revocation of the 1-hour standard and those anti-backsliding provisions of the Phase 1 Rule that had not been successfully challenged. The June 8 decision reaffirmed the December 22, 2006 decision that EPA had improperly failed to retain four measures required for 1-hour nonattainment areas under the anti-backsliding provisions of the regulations: (1) Nonattainment area New Source Review (NSR) requirements based on an area's 1-hour nonattainment classification; (2) Section 185 penalty fees for 1-hour severe or extreme nonattainment areas; and (3) measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the Act, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour NAAQS, or for failure to attain that NAAQS. In addition the June 8 decision clarified that the Court's reference to conformity requirements for anti-backsliding purposes was limited to requiring the continued use of 1-hour motor vehicle emissions budgets until 8-hour budgets were available for 8-hour conformity determinations, which is already required under EPA's conformity regulations. The Court thus clarified that 1-hour conformity determinations are not required for anti-backsliding purposes.

For the reasons set forth in the proposal, EPA does not believe that the Court's rulings alter any requirements relevant to this redesignation action so as to preclude redesignation, and do not prevent EPA from finalizing this redesignation. EPA believes that the Court's December 22, 2006 and June 8, 2007 decisions impose no impediment to moving forward with the redesignation of this Area to attainment, because even in light of the Court's decisions, redesignation is appropriate under the relevant redesignation provisions of the Act and longstanding policies regarding redesignation requests.

In its proposal, EPA proposed to find that the Area had satisfied the requirements under the 1-hour standard whether the 1-hour standard was deemed to be reinstated or whether the Court's decision on the petition for rehearing was modified to require something less than compliance with all applicable 1-hour requirements. Because EPA proposed to find that the Area satisfied the requirements under either scenario, EPA is proceeding to finalize the redesignation and to conclude that the Area has met the requirements under the 1-hour standard applicable for purposes of redesignation under the 8-hour standard. These include the provisions of EPA's anti-backsliding rules, as well as the additional anti-backsliding provisions identified by the Court in its rulings. In its June 8, 2007 decision, the Court limited its vacatur so as to uphold those provisions of the anti-backsliding requirements that were not successfully challenged. Therefore, EPA finds that the Area has met the anti-backsliding requirements, see 40 CFR 51.900 et seq; 70 FR 30592, 30604 (May 26, 2005) which apply by virtue of the Area's classification for the 1-hour ozone NAAQS, as well as the four additional anti-backsliding provisions identified by the Court, or that such requirements are not applicable for purposes of redesignation. In addition, with respect to the requirement for transportation conformity under the 1-hour standard, the Court in its June 8 decision clarified that for those areas with 1-hour motor vehicle emissions budgets, anti-backsliding requires only that those 1-hour budgets must be used for 8-hour conformity determinations until replaced by 8-hour budgets. To meet this requirement, conformity determinations in such areas must comply with the applicable requirements of EPA's conformity regulations at 40 CFR part 93. The Court clarified that 1-hour conformity determinations are not required for anti-backsliding purposes.

EPA is approving the Commonwealth of Pennsylvania's redesignation request, maintenance plan, and the 2002 base-year emissions inventory because the requirements for approval have been satisfied. EPA has evaluated Pennsylvania's redesignation request that was submitted on March 27, 2007 and determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes that the redesignation request and monitoring data demonstrate that the Harrisburg Area has attained the 8-hour ozone standard. The final approval of this redesignation request will change the designation of the Harrisburg Area from nonattainment to attainment for the 8-hour ozone standard. EPA is approving the maintenance plan for the Harrisburg Area submitted on March 27, 2007 as a revision to the Pennsylvania SIP. EPA is also approving the MVEBs submitted by PADEP in conjunction with its redesignation request. In addition, EPA is approving the 2002 base-year emissions inventory as a revision to the Pennsylvania SIP submitted by PADEP on March 27, 2007. In this final rulemaking, EPA is notifying the public that we have found that the MVEBs for NO X and VOCs in the Harrisburg Area for the 8-hour ozone maintenance plan are adequate and approved for conformity purposes. As a result of our finding, the Harrisburg Area must use the MVEBs from the submitted 8-hour ozone maintenance plan for future conformity determinations. The adequate and approved MVEBs are provided in the following table:

The Harrisburg Area is subject to the CAA's requirement for the basic nonattainment areas until and unless it is redesignated to attainment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Redesignation of an area to attainment under section 107(d)(3)(e) of the Clean Air Act does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this final rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This final rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Because this action affects the status of a geographical area, does not impose any new requirements on sources, or allows the state to avoid adopting or implementing other requirements, this action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 24, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action, approving the redesignation of the Harrisburg Area to attainment for the 8-hour ozone NAAQS, the associated maintenance plan, the 2002 base-year emissions inventory, and the MVEBs identified in the maintenance plan, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT .

In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr .

In a direct final rule published on April 25, 2007, (72 FR 20431)(FRL-7742-2) EPA took action to move existing active and inert ingredient plant-incorporated protectant tolerance exemptions from 40 CFR part 180, Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food to 40 CFR part 174, Procedures and Requirements for Plant-Incorporated Protectants , subpart W. EPA also made some conforming changes to the text of the individual exemptions that were transferred from part 180 so that they would be consistent with part 174, as well as some minor technical corrections to the wording of certain individual exemptions. Since this action was issued as a direct final rule the changes had a delayed effective date and did not become effective until July 24, 2007. Included in the redesignation and revision of part 174, subpart W was §174.452 which was redesignated as §174.501.

In the May 9, 2007 issue of the Federal Register (72 FR 26300), EPA issued a final rule which extended the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP) by revising §174.452. The extension of the temporary exemptions was requested in a petition submitted by Syngenta Seeds, Inc. to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The May 9, 2007 final rule eliminated the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008.

Section 174.452 as printed in the May 9, 2007 issued of the Federal Register codified the current and correct version of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton in §174.452. The May 9, 2007 version of §174.452 became effective on May 9, 2007. However, §174.452 was redesignated as §174.501 in the April 25, 2007 issue of the Federal Register . The redesignation and revision becomes effective no earlier than July 24, 2007, if no adverse comment is received. Once the direct final rule becomes effective the revision of §174.452 as published in the May 9, 2007 issue of the Federal Register will be wiped out because §174.452 will no longer exist. With this technical amendment EPA is revising §174.501 to read the same as §174.452 which, as was stated above, will be eliminated once the direct final rule becomes effective.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because the original issuance of the revised §174.452 was properly executed and the impact of the delayed effective date for the April 25, 2007 final rule removing the content of that section was inadvertent. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

No. This final rule does not impose any new requirements. It only implements a technical correction to the Code of Federal Regulations (CFR). As such, this action does not require review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not impose any 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) (Public Law 104-4). Nor does it require prior consultation with State, local, and tribal government officials as specified by Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993) and Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998), or special consideration of environmental justice related issues under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 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 since this action is not subject to notice-and-comment requirements under the Administrative Procedure Act (APA) or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ).

EPA's compliance with these statutes and Executive Orders for the May 9, 2007 final rule, which established an extension of the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP), is discussed in the preamble for the final rule (72 FR 26300).

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ- OPP-2007-0446 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 September 24, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0446, by one of the following methods:

•  Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

•  Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•  Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for of the insecticide, diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in or on lemon at 0.8 parts per million (ppm). This tolerance expires and is revoked on December 31, 2010. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations (CFR).

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

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

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

EPA is also revising the tolerance expression in § 180.377(b) to be consistent with the preferable wording as expressed in § 180.377(a)(2).

In the fall of 2005 and spring of 2006, active infestations of Diaprepes root weevil were detected including one lemon orchard (28 acres) in commercial sites in Long Beach, Newport Beach, Carlsbad, Encintas, and La Jolla, California. The California Department of Food and Agriculture (CDFA) has quarantined these sites and has already initiated eradication treatments using products that impact various life stages of this insect. The emergency use of diflubenzuron is needed to treat the egg stage of the weevil when they are detected in lemon. The overall program involves treatment for larval and adult stages as well. EPA has authorized under FIFRA section 18 the use of diflubenzuron on lemon for control of Diaprepes root weevil in California. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of diflubenzuron in or on lemon. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance expires and is revoked on December 31, 2007, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on lemon after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of diflubenzuron and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of diflubenzuron in or on lemon at 0.8 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm . A summary of the toxicological endpoints for diflubenzuron used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 19, 2002 (67 FR 59006) (FRL-7200-4).

1. Dietary exposure from food and feed uses . Tolerances for residues of diflubenzuron are established under 40 CFR 180.377. Tolerances listed in 40 CFR 180.377(a)(1) are expressed in terms of diflubenzuron per se . Under this section, tolerances of 0.05-6.0 ppm are established for residues in/on eggs; milk; fat and meat of cattle, goat, hog, horse, poultry, and sheep; poultry meat byproducts; cottonseed; mushroom; grapefruit, orange (sweet); tangerine; soybean hulls; and globe artichoke. Tolerances listed in 40 CFR 180.377(a)(2) are expressed in terms of the combined residues of diflubenzuron and its metabolites 4-chlorophenylurea (CPU) and 4-chloroaniline (PCA). Under this section, tolerances of 0.02-55.0 pm are established for residues in/on rice grain and straw; barley grain, straw, and hay; oat, forage, grain, hay, and straw; wheat forage, grain, hay, and straw; grain aspirated fractions; brassica, leafy greens, subgroup 5B; grass, forage, fodder, and hay, group 17; tree nuts (group 14); peanut, peanut hay and refined oil; pistachios; fruit, stone (group 12) except cherry; meat byproducts of cattle, goat, hog, horse, and sheep; pear; pepper; pummelo; turnip greens; and almond hulls. Time-limited tolerances listed in 40 CFR 180.377(b) are expressed in terms of the combined residues of diflubenzuron and its metabolites CPU and PCA, expressed as the parent diflubenzuron, in connection with use of the pesticide under Section 18 Emergency Exemptions granted by EPA. Risk assessments were conducted by EPA to assess dietary exposures from diflubenzuron in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The diflubenzuron toxicology studies indicated no possibility of such an effect for either the general U.S. population (including infants and children) or the females 13-50 years old population subgroup for diflubenzuron; therefore, an acute dietary exposure analysis was not performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM-FCID TM ) analysis evaluated the individual food consumption as reported by respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary-exposure assessment was conducted using the established/recommended tolerances for all food commodities, 100% CT information for all proposed and existing uses, and DEEM( TM ) Version 7.81 default processing factors for some processed commodities.

iii. Cancer . The Agency has classified diflubenzuron as “Group E,” evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. Therefore, EPA classified PCA as a “Group B2” probable human carcinogen. The Agency determined for those commodities that contained PCA and CPU, the Q1* of PCA should be used to calculate the cancer risk from the sum of these two metabolites.

Based on the submitted metabolism studies, there are two possible sources for dietary exposure to PCA and CPU: Residues in mushrooms and residues in milk and liver. Because human exposure to PCA and CPU will not be affected by the proposed new uses, and EPA has previously concluded that exposure to these compounds is safe, therefore, the cancer dietary risk from PCA and CPU will not be addressed in this document. For a detailed discussion on the exposure and risks to PCA and CPU, please refer to the September, 2002 Federal Register document titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67 59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm .

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to assess dietary exposure to diflubenzuron in drinking water based on measured drinking water concentrations. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of diflubenzuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppfed1/models/water/index.htm . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of diflubenzuron and the major degradate CPU for chronic exposures are estimated to be 2.76 parts per billion (ppb) for surface water and 0.208 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM , Version 2.03). For chronic dietary risk assessment, the annual average concentration of 2.76 ppb was used to represent the drinking water contribution to chronic dietary exposure for diflubenzuron.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Although there are no registered homeowner uses, there are registered uses for professional applications to outdoor residential and recreational areas to control mosquitoes, moths, and other insects. In addition, certain residential use sites will be treated in association with this emergency exemption for the control of the Diaprepes root weevil. However, EPA considers the potential for post-application residential exposure to be low. Further, diflubenzuron has a low dermal absorption rate (0.5%) and will be only applied to the tree canopy.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to diflubenzuron and any other substances and diflubenzuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that diflubenzuron has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

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

2. Prenatal and postnatal sensitivity . Based on the developmental and reproductive toxicity studies, there is no indication of increased susceptibility of rats or rabbits to in utero or postnatal exposure.

3. Conclusion . There is a complete toxicity database for diflubenzuron and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the additional FQPA 10X safety factor to protect infants and children was not needed. This decision was based on the following:

i. There is a complete toxicity database for diflubenzuron;

ii. There is no indication of increased susceptibility of rats or rabbits to in utero or postnatal exposure;

iii. A developmental neurotoxicity study (DNT) with diflubenzuron is not required;

iv. Food and drinking water exposure assessments will not underestimate the potential exposure for infants and children; and

v. The potential for post-application residential exposures are expected to be limited. Due to the low dermal absorption rate (0.5%) of diflubenzuron, and since it is only applied to the tree canopy to control gypsy moths and mosquitoes, minimal bystander contact is expected.

1. Acute risk . Because there were no toxic effects attributable to a single dose of diflubenzuron, it is not expected to pose an acute risk.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to diflubenzuron from food will utilize 12% of the cPAD for the U.S. population, 12% of the cPAD for all infants less than 1 year old and 38% of the cPAD for children 1-2 years old. There are no residential uses for diflubenzuron that result in chronic residential exposure to diflubenzuron. EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

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

The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.

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

The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.

5. Aggregate cancer risk for U.S. population . Based on the available evidence, which included adequate carcinogenicity studies in rats and mice, and battery of negative mutagenicity studies, diflubenzuron has been classified as “Group E,” evidence of non-carcinogenicity for humans, by the Agency. As noted in Unit III.C.1.iii. of this document, the Agency has concluded that human exposure to PCA and CPU (metabolites of diflubenzuron) will not be affected by the proposed new uses. EPA has previously found aggregate exposure to these compounds to be safe. (September 19, 2002, 67 FR 59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm .

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

There are adequate enforcement methods, published in the Pesticide Analytical Manual (PAM, Vol. II), for determining diflubenzuron residues of concern. In addition, a new analytical methodology for plant commodities was successfully validated by an independent laboratory as well as by Agency chemists at the Analytical Chemistry Branch (ACB)/Biological and Economics Analysis Division (BEAD) in conjunction with an approved rice petition (PP 8F4925). The new methods were forwarded to the Food and Drug Administration (FDA) for publication in PAM Vol. II as Roman Numeral Methods. These methods can separately determine residues of diflubenzuron by gas chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass spectrometry (MS).

The Codex Alimentarius has established maximum residue limits (MRL), expressed in terms of diflubenzuron per se , for many commodities including: Apple (5 ppm), citrus fruits (0.5 ppm), edible offal (mammalian) (0.1 ppm), eggs (0.05 ppm), meat (from mammals other than marine mammals) (0.1 ppm), milks (0.02 ppm), mushrooms (0.3 ppm), pear (5 ppm), pome fruits (5 ppm), poultry meat (0.05 ppm), rice (0.01 ppm), and rice straw and fodder (dry) (0.7 ppm). As the U.S. residue definition includes CPU and PCA, compatibility is not possible with the proposed tolerance.

Therefore, the tolerance is established for of the insecticide diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6- difluorobenzamide and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on lemon at 0.8 ppm.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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).

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).

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

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

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

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

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

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

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0076 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 as required by 40 CFR part 178 on or before September 24, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0076, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of April 14, 2006 (72 FR Page 19507) (FRL-8063-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F7012) by Dow AgroSciences LLC, Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.605 be amended by establishing an exemption from tolerance for residues of the herbicide penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, in or on fish and shellfish resulting from its use as an aquatic herbicide. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV. below.

The Registrant modified their submission and requested tolerances be established. The reason for these changes is explained in Unit IV.C.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with section 408(b)(2)(D), of the FFDCA and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 24, 2004 (EPA-HQ-OPP-2004-0286), (FRL-7678-6).

For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded.

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

A summary of the toxicological endpoints for penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) used for human risk assessment can be found at www.regulations.gov in document “Penoxsulam. Human Health Risk Assessment for Proposed Uses on Fish and Shellfish. PC Code: 119031, Petition No: 5F7012, DP Num: 325461.” at page 42 in Docket ID EPA-HQ-OPP-2006-0076.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, EPA considered exposure under the petitioned-for tolerances as well as all existing penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) tolerances in (40 CFR 180.605). EPA assessed dietary exposures from penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) in food as follows:

i. Acute exposure . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998; Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues.

iii. Cancer . Penoxsulam was classified as “Suggestive Evidence of Carcinogenic Potential.” There is some cancer concern, but the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment (see Unit III.E.5).

iv. Anticipated residue and percent crop treated (PCT) information . EPA assumed tolerance level residues and 100% of the crop is treated.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide). Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the FQPA Index Reservoir Screening Tool and Screening Concentrations in Groundwater models, the estimated environmental concentrations (EECs) of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for acute exposures are estimated to be 150 parts per billion (ppb) for surface water and 150 ppb for ground water. The EECs for chronic exposures are estimated to be 150 ppb for surface water and 150 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) is currently registered for the following residential non-dietary sites: Turf/lawn. EPA assessed residential exposure using the following assumptions:

• 1,000 ft 2 per day by low pressure hand wand or back pack sprayer for spot treatment of lawns

• 0.5 acres per day by push-type granular spreader for broadcast treatment of lawns

• 0.06 lb active ingredient (ai) per acre for broadcast treatment

• 0.0014 to 0.0016 lbs per 1,000 ft 2 for spot treatment

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) and any other substances and penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . Based on the results of the submitted toxicology studies, EPA concluded that no FQPA safety factor is needed (i.e. 1X) since there are no residual uncertainties for prenatal and/or postnatal toxicity.

3. Conclusion . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:

i. There was no toxicologically significant evidence observed of neurotoxicity in either the acute or chronic neurotoxicity study.

ii. No definitive quantitative or qualitative susceptibility was observed in either of the developmental rat or rabbit studies.

iii. Significant dose-related effects in the 2-generation reproduction study were limited to the delay in preputial separation. No other endpoints of reproductive toxicity or offspring growth and survival were affected by treatment.

iv. The chronic dietary food exposure assessment utilizes proposed tolerance level residues and 100% crop treated for all commodities. By using these conservative assessments, actual and chronic exposures/risks will not be underestimated.

v. The dietary drinking water assessment (Tier 1 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations.

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded.

1. Acute risk . There were no treatment-related effects observed in any of the available toxicity studies on penoxsulam that could be considered to have resulted from a single dose of penoxsulam. Therefore no acute exposure is expected.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for the most highly exposed population subgroup from food and water, which utilizes 7% of the cPAD is all infants (<1 year old).

3. Short-term risk and intermediate term risk . For this aquatic use pattern, short- and intermediate-term aggregate exposure takes into account residential exposure, exposure while swimming, plus chronic exposure to food and water (considered being a background exposure level). There is a potential for post application exposure from oral and dermal routes of exposure while swimming in aquatic sites and/or from turf (lawns, golf courses, sports fields, and sod farms) sites treated with penoxsulam.

EPA used the SWIMODEL from the Residential Standard Operating Procedures (SOPs) to assess dermal and oral exposure to recreational swimmers. Parameters used in calculating exposure and risk are based on information for competitive swimmers both adult and children (6 years old) in swimming pools which includes an exposure duration of 5 hours. It is anticipated that recreational swimmers in weed infested areas would be less likely to swim with their heads immersed than recreational swimmers in weed-free swimming pools. Since there were no short-term dermal, systemic, neuro or developmental toxicity concerns, the short-term post application assessment addresses only the oral exposure, which results in the same estimated dose for intermediate-term exposure. Thus a short-term aggregate exposure was not required, and the intermediate-term post application exposure assessment combined both oral and dermal exposures, and is also protective for short-term exposure. Short- and intermediate-term postapplication exposures resulted in MOEs> 100 and are therefore not a concern to the Agency. The Agency considers the swimmer dermal and oral MOEs to be over estimates of the actual risk, and therefore swimming exposure assessment was not used in assessing the short- and intermediate-term aggregate risk, and only the exposure resulting from the turf use was assessed.

The short-term aggregate risk assessment estimates include both oral and inhalation exposures appropriate to the population of concern. Short-term dermal exposure was not aggregated because no toxicological endpoint was selected. For adults, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because oral exposure from the residential use as a handler is not expected in adults and no short-term dermal endpoint was selected, only the short-term residential exposure by inhalation is expected in adults. The worst-case MOE residential exposure estimate was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for U.S. population. As the aggregate MOE is greater than 100, the short-term aggregate risk to adults does exceed EPA's level of concern.

For children/toddlers, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because post-application inhalation exposure is negligible and no short-term dermal endpoint was selected, only short-term residential exposure from oral exposure was included with food and drinking water in the short-term aggregate risk assessment for children/toddlers. The worst-case MOE residential exposure estimate for children was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for all infants (<1 year old), the child population subgroup with the highest estimated chronic dietary food exposure. As the aggregate MOE is greater than 100, the short-term aggregate risks to children do not exceed EPA's level of concern.

Because the amount of residues on turf after 30 days will be negligible, both inhalation and dermal exposure is negligible, and therefore no intermediate-term aggregate exposure assessment from this turf use is required.

4. Aggregate cancer risk for U.S. population . The cancer potential for penoxsulam is classified as “Suggestive Evidence of Carcinogenic Potential.” The classification is based on an increase in large granular lymphocyte leukemia (also called mononuclear cell leukemia (MNCL)) in male Fischer 344 rats. There were increased tumors at all dose levels which exceeded the laboratory historical control data. There is considerable controversy as to the significance and relevance of the tumors for humans, but they cannot be discounted in the overall weight of the evidence. While there is some cancer concern, the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) residues.

Adequate enforcement methodology, using high performance liquid chromatograph with tandem mass spectroscopy-mass spectroscopy detector (LC/MS/MS), and is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no CODEX maximum residue limits (MRLs) for fish; fish, shellfish, mollusc; and fish, shellfish, crustacean.

Comments were received from a private citizen objecting to this product being used in the world, and that the product is too dangerous to be allowed use. A print-out of what appears to be EPA's summary of the toxicological effects and tolerances for rice were included. No other information was provided. EPA has found that there is a reasonable certainty of no harm to humans after considering all pertinent toxicology studies and the exposure levels of humans to penoxsulam.

Therefore, the tolerance is established for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, in or on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 ppm. The registrant initially requested exemptions from tolerances for fish and shellfish. Based upon review of the data supporting the petition by EPA and subsequent to completion of this risk assessment, the registrant revised their submission and requested tolerances for finfish at 0.01 ppm; shellfish, crustacean at 0.01 ppm; and shellfish, mollusc at 0.02 ppm. For consistency the commodity terms are revised to fish at 0.01 ppm; fish, shellfish, crustacean at 0.01 ppm; and fish, shellfish, mollusc at 0.02 ppm.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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).

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).

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

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

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

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

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

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

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0313 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 as required by 40 CFR part 178 on or before September 24, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0313, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Facility Docket telephone number is (703) 305-5805.

In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7196) by Interregional Research Project No. 4, 500 College Road East, Suite 201W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 180.473 be amended by establishing a tolerance for combined residues of the herbicide glufosinate-ammonium and its metabolites expressed as butanoic acid, 2-amino-4-(hydroxymethyl phosphinyl)-, monoammonium salt, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as glufosinate free acid equivalents, in or on pistachio at 0.1 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience LP, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe”. Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” an that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information”. This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of glufosinate-ammonium and its metabolites on pistachio at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

On May 3, 2006 the Agency published a final rule (71 FR 25942, FRL-8060-3) establishing tolerances for combined residues of glufosinate ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, and its metabolite, 3-methylphosphinicopropionic acid in or on barley hay, barley straw, buckwheat fodder, buckwheat forage, oat forage, oat hay, oat straw, rye forage, rye straw, teosinte, triticale, wheat forage, wheat hay and wheat straw at 0.40 ppm. On September 29, 2003, the Agency published a final rule (68 FR 55833, FRL-7327-9) establishing tolerances for combined residues of glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-,monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on bushberry subgroup, lingonberry, juneberry and salal at 0.15 ppm, cattle, fat at 0.40 ppm, cattle, meat at 0.15 ppm, cattle, meat byproducts at 6.0 ppm, cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, egg at 0.15 ppm, goat, fat at 0.40 ppm, goat, meat at 0.15 ppm, goat, meat byproducts at 6.0 ppm, hog, fat at 0.40 ppm, hog, meat at 0.15 ppm, hog, meat byproducts at 6.0 ppm, horse, fat at 0.40 ppm, horse, meat at 0.15 ppm, horse, meat byproducts at 6.0 ppm, milk at 0.15 ppm, poultry, fat at 0.15 ppm, poultry, meat at 0.15 ppm, poultry, meat byproducts at 0.60 ppm, sheep, fat at 0.40 ppm, sheep, meat at 0.15 ppm, and sheep, meat byproducts at 6.0 ppm, rice, grain at 1.0 ppm, rice, straw at 2.0 ppm, and rice, hull at 2.0 ppm.

When the Agency conducted the risk assessments in support of the 2003 and 2006 tolerance actions, it assumed that glufosinate-ammonium residues would be present on pistachio at 0.10 ppm, equivalent to the previously established tolerance for the tree nut crop group. Under current regulations, pistachio is not included in the tree nut crop group; however, the residue field trial data required to establish a tolerance on the tree nut crop group may be relied upon to establish a tolerance at the same level on pistachio. Since EPA assumed glufosinate-ammonium residues would be present on pistachio at 0.10 ppm in its most recent risk assessments, establishing the pistachio tolerance will not change the estimated aggregate risks resulting from use of glufosinate ammonium, as discussed in the May 3, 2006 (71 FR 25942, FRL-8060-3) and September 29, 2003 (68 FR 55833, FRL-7327-9) Federal Registers . Refer to these Federal Register documents, available at http://www.regulations.gov , for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register documents in support of this action.

Based on the risk assessments discussed in the final rules published in the Federal Registers of May 3, 2006 (71 FR 25942, FRL-8060-3) and September 29, 2003, (68 FR 55833, FRL-7327-9), EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to glufosinate-ammonium residues.

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

There is an established CODEX maximum residue limit (MRL) of 0.1 ppm for residues of glufosinate-ammonium on tree nuts, including pistachios, which is consistent with the U.S. tolerance being established for pistachio. There are no Canadian or Mexican MRLs established for tree nuts or pistachio.

Therefore, the tolerance is established for combined residues of glufosinate-ammonium, (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on pistachio at 0.10 ppm.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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. , nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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).

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).

The Congressional Review Act, 5 U.S.C. 801 et seq. , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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).

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 et seq. ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

This is a synopsis of the Commission's Memorandum Opinion and Order, MB Docket No. 04-427 adopted June 20, 2007, and released June 22, 2007. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will not send a copy of this Memorandum Opinion and Order in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the petition for reconsideration was dismissed.

This is a summary of the Commission's Memorandum Opinion and Order , ET Docket No. 04-151, FCC 07-99, adopted May 22, 2007 and released June 17, 2007. The full text of this document is available on the Commission's Internet site at http://www.fcc.gov. It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone (202) 488-5300; fax (202) 488-5563; e-mail FCC@BCPIWEB.COM.

1. The Memorandum Opinion and Order (MO&O) addresses petitions for reconsideration filed in response to the Commission's Report and Order , 70 FR 24712, May 11, 2005, in prior proceedings relating to the 3650-3700 MHz band (3650 MHz band). The parties petitioning for reconsideration were: BRN Phoenix (BRN); the Enterprise Wireless Alliance (EWA); Intel Corporation, Redline Communications and Alvarion (jointly); Motorola; Redline Communications; the Satellite Industry Association (SIA); the Wireless Communications Association (WCA); and the Wi-Max Forum.

2. The MO&O affirms the Commission's previous decisions to create a spectrum environment that will encourage multiple entrants and stimulate the expansion of broadband service to rural and under served areas. To facilitate rapid deployment in the band, the Commission maintains the previously adopted, non-exclusive licensing scheme. Additionally, the Commission declines to reconsider the requirement that equipment operating in the 3650 MHz band incorporate a contention-based protocol, a technology that permits multiple licensees to share spectrum by ensuring that all licensees receive reasonable opportunities to operate in the band. The Commission clarifies the meaning of contention-based protocol and modifies the rules to limit the operation of equipment using “restricted” contention-based protocols (those that are not capable of avoiding co-frequency interference with all other types of contention-based protocols) to the lower 25 megahertz portion of the 3650 MHz band. The Commission's actions should facilitate operation of the widest variety of broadband technologies with minimal risk of interference in both the near and long terms. The order should further reduce the potential for co-channel interference, provide additional protections to the multiple users in the band under the current licensing regime, and create incentives for the rapid development of broadly compatible contention technologies.

3. Additionally, the Commission denies requests for reconsideration of the previously adopted power limits for fixed and mobile transmissions in the band, concluding that the limits adopted serve to protect against interference both among the band's licensees and with satellite earth stations. Finally, it denies requests to modify the out-of-band emission limits in the rules and declines to revise the rules regarding coordination with satellite licensees operating in the grandfathered exclusion zones around satellite earth stations.

4. The Commission adopted a nationwide non-exclusive licensing scheme for the 3650 MHz band in order to create a spectrum environment conducive to the prompt entry by multiple broadband providers in under-served markets—and at low entry costs and with minimal regulatory delay. The Commission concluded that the non-exclusive licensing model, in conjunction with operational and technical safeguards (such as the contention-based protocol and a registration requirement), would obligate licensees to cooperate to avoid harmful interference. The Commission concluded that the licensing rules it adopted would “ensure open access to this spectrum for nominal application fees and allow effective and efficient use of this spectrum in response to market forces.” This, the Commission reasoned, would encourage “rapid deployment of broadband technologies” and advance the “goal of bringing broadband services to all Americans, including consumers living in less densely populated rural and suburban areas.

5. All of the arguments for making modifications to the licensing rules rest on the assumption that non-exclusive licensing will frustrate potential users of the band and its efficient use. The Commission disagrees with these projections. While it acknowledges that the use of a non-exclusive licensing approach must be accompanied with the means to ensure that multiple users can operate successfully in the band, the Commission concludes that it adopted appropriate and practical mechanisms to ensure such an outcome.

6. The Commission declines to alter the band's cooperation requirement to approximate the rights available in an exclusive licensing model. It is not persuaded that the various steps that parties suggest in this regard would more effectively further the public interest and the Commission's goals in this proceeding than the current non-exclusive licensing scheme or that the benefits of these proposed changes overweigh the costs. For example, creating the type of first-in-time rights that parties suggest would give initial market entrants the ability to structure their operations in a manner that could impede subsequent providers' ability to offer viable services and diminish any incentive that such initial market entrants might have in negotiating interference avoidance measures to accommodate new entrants. Requiring the use of third-party frequency coordinators would also add an unnecessary extra layer of process that operators would have to satisfy before deploying their equipment and initiating service. Given the use of contention protocols in the band, the Commission declines to require a separate entity to serve as a gate-keeper for the spectrum. Similarly, performance standards and the attendant reporting obligation would duplicate the discipline that the market will already provide. If an operator is not providing adequate service, other operators will be free to deploy their facilities in the market and begin their own operations.

7. The Commission disagrees that non-exclusive licensing will make the band unusable. The licensing procedures adopted for the band provide no first-in-time right to exclude others from entering a market, as would be necessary to make squatting behavior profitable. To the contrary, the cooperation and contention-based protocol rules both require that licensees take various steps to accommodate (or at least avoid interfering with) the operations of other licensees in their area. Similarly, these requirements should eliminate licensee behavior that could overcrowd the band to the detriment of all users. They will prevent licensees from consuming the full band and crowding out the transmissions of other operators. Licensees that must coordinate their operations with other licensees and deploy equipment that avoids harmful interference will not be able to overwhelm their neighbors.

8. In contrast to an exclusive licensing model in which a licensee may exclude others from a particular license area, the non-exclusive licensing model adopted in the 3650 MHz Order requires a potential entrant to consider that the presence of other licensees will require cooperative use and may, at times, restrict the amount of spectrum and/or time that spectrum is available to any particular licensee. That trade-off, however, does not automatically render the spectrum unusable.

9. In the 3650 MHz Order, the Commission explained that contention-based protocols, which it required for fixed, base and mobile equipment operating in the band, would “allow multiple users to share the same spectrum by defining the events that must occur when two or more devices attempt to simultaneously access the same channel and establishing rules by which each device is provided a reasonable opportunity to operate.” The Commission's goal in adopting the contention requirement was to speed deployment in the 3650 MHz band by allowing multiple entrants to provide service. It saw the protocol as a means to “ensure efficient and cooperative shared use of the spectrum.” The Commission chose not to require a specific contention-based protocol, leaving it to industry and standards bodies to determine appropriate protocols. The Commission cautioned, though, that equipment would not be certified for use in the band if it appeared “to be designed to preclude others from using this spectrum.” The Commission stated that it would monitor use of the spectrum, and would modify the rules if there appeared to be significant problems in this regard.

10. The Commission concludes that the public interest is best served by retaining the requirement that fixed, base and mobile equipment operating in the band incorporate a contention-based protocol. Given the decision to retain non-exclusive licensing in the 3650 MHz band, the Commission continues to believe that equipment incorporating a contention-based protocol will provide a cost-effective means to enable multiple users to operate on the same frequencies in the band without interfering with one another. With contention-based protocol requirement, operators and their customers will not have to rely on frequency coordination prior to the initiation of service; this will reduce costs and delay.

11. The Commission is not persuaded that the shortcomings that petitioners ascribe to contention protocols will necessarily limit use of the band to short range applications. Competing evidence indicates that contention technology is suitable for many different applications that the 3650 MHz Order envisioned, including long range operations. Long range transmissions typically would be point-to-point using narrow beams. Point-to-point transmissions at the power limits adopted for the band will have a lower potential for interference and allow providers to use this band for backhaul operations, especially in less congested rural areas. The Commission's goal of providing for multiple entrants in the band can best be accomplished if users have the flexibility to choose the technology most appropriate to meet their needs. Accordingly, the Commission denies those petitions for reconsideration that seek elimination of the contention protocol requirement.

12. The Commission clarifies that the 3650 MHz rules provide for certification of a variety of devices that may use different types of protocols or interference avoidance mechanisms that satisfy the contention definition that applies to the 3650 MHz band. The definition of what constitutes a valid contention protocol for the 3650 MHz band is broad enough to encompass different types of contention protocols and interference avoidance mechanisms, thereby promoting innovation and product development. As stated in the 3650 MHz Order , equipment for use in the 3650 MHz band must incorporate a mechanism that allows “multiple users to share the same spectrum * * * and establish[es] rules by which each device is provided a reasonable opportunity to operate.”

13. The record reveals two broad categories of contention-based protocols, both of which appear to the requirements for operation in the 3650 MHz band. Nonetheless, they may not be compatible with each other, and the use of both types could result in co-frequency interference and thus frustrate the Commission's goal of allowing for multiple entrants in the band. Under the Commission's rules, contention-based protocols can be categorized as either “unrestricted” or “restricted.” Unrestricted protocols are broadly compatible and function to prevent interference even with other, dissimilar contention technologies on the market. A listen-before-talk technology like that in Wi-Fi devices is a prime example of an unrestricted contention-based protocol. On the other hand, restricted contention protocols can prevent interference only with other devices incorporating the same protocol.

14. Allowing the use of different protocols in the band will serve the goal of speeding deployment of service, since operators will be able to deploy many different technologies, including those already being developed for use in the 3650 MHz band world-wide. Nonetheless, the potential exists for conflict between certain types of protocols, which could result in interference and/or a denial of access to the band for certain users. To resolve this conflict, the Commission will certify equipment using a restricted contention protocol but will limit the operation of such equipment to the lower 25 megahertz of the 3650 MHz band. On the other hand, equipment using an unrestricted contention protocol will be allowed to operate throughout the 50 megahertz in the 3650 MHz band, since it will be able to detect other transmissions throughout the band and thus avoid co-frequency interference anywhere in the band. The Commission concludes that this approach will ensure efficient use of the spectrum and permit the prompt deployment in this country of equipment that is already being used in this spectrum in other countries around the globe. Permitting a number of different contention based technologies to operate in the band will also provide additional flexibility to licensees to choose the best suitable technology for the type of services they plan to provide.

15. The Commission will implement this approach through the equipment certification process, under which it will examine for compliance with the rules all equipment proposed for use in the 3650 MHz band. It will condition the certification for equipment using a restricted protocol to limit its operation and tuning range to the bottom 25 megahertz of the band. The registration database will include the FCC identification number, reflecting the equipment certification condition restricting the licensee's operating frequency range if the licensee employs equipment using a restricted contention-based protocol.

16. The Commission recognizes that manufacturers, through software upgrades or other means may alter the emission characteristics of previously deployed devices so that they move from the restricted to the unrestricted category. To the extent that this occurs, the manufacturer will be responsible for complying with the Commission's rules regarding the need for new equipment certification before the device will be permitted to tune over the full 50 megahertz of the 3650 MHz band. Further, affected licensees must update their base and fixed station registrations to reflect this change.

17. By contrast, the Commission will not condition the certification for equipment incorporating an unrestricted contention-based protocol, thus allowing such equipment to operate throughout the full 50 MHz of the band. This should create an added incentive for industry groups and manufacturers to speed their development and deployment of such technology. In the long term, this, should improve the quality of service in the 3650 MHz band, furthering the public interest. At the same time, however, permitting restricted contention technologies to operate in the lower 25 MHz of the band will ensure that a wider range of currently available equipment may be immediately deployed in the band.

18. The Commission denies the petitions for reconsideration to the extent that they seek elimination of the requirement that equipment in the 3650 MHz band incorporate a contention-based protocol.

19. The Commission notes the request by BRN Phoenix that the Commission certify its Advanced Antenna System as the (apparently sole) contention-based protocol for use in the 3650 MHz band. The Commission expects that a variety of different contention technologies will qualify for deployment in the band. BRN, like other parties may seek certification for its Advanced Antenna System from the Laboratory Division of the Commission's Office of Engineering and Technology.

20. In setting the power limits for transmissions in the 3650 MHz band, the Commission balanced numerous competing factors to “serve the public interest and foster the expeditious introduction of new terrestrial services in the 3650 MHz band.” These factors included (1) the importance of interference protection for grandfathered satellite earth stations and federal government radiolocation stations and (2) the need to ensure efficient use of the band by avoiding mutual interference among licensed operators. To this end, the Commission adopted a peak power density of 25 Watts per 25 MHz of bandwidth and no greater than 1 watt per 1 MHz of bandwidth for fixed operations and imposed a limit of 1 Watt per 25 MHz of bandwidth for mobile operations.

21. The Commission declines to increase the power limits for either fixed or mobile operations in the 3650 MHz band. In adopting power limits for this band, the Commission balanced the potential for inter-service and intra-service interference with the need to provide for satisfactory service by 3650 MHz devices. At the same time, the Commission was concerned that the combination of power limits and the size of the earth station exclusion zones that it adopted would adequately protect from harmful interference the grandfathered satellite operations and Federal Government radiolocation stations.

22. The Commission concludes that the 3650 MHz Order set the 3650 MHz power limits at an appropriate level. The levels adopted are adequate to support commercially viable services and will allow licensees to operate effectively in the band without unacceptably interfering with each other's operations (provided they deploy equipment incorporating an appropriate contention technology). At the same time, the power limits, combined with the size of the protection zones for grandfathered satellite earth stations, will prevent terrestrial operations in the band from interfering with in-band satellite operations.

23. The Commission declines BRN's request to reconsider the limit on power output in the 3650 MHz band. In the 3650 MHz Order, the Commission balanced the public interest factors that BRN raises in its petition. Specifically, it considered the issues surrounding “deployment of advanced antenna systems, including sectorized and adaptive array systems.” It balanced the need for “flexibility for licensees to employ a wide variety of advanced antennas to meet their needs” with the goal of protecting satellite earth stations. In so doing, it concluded that, “to allow flexibility in deployment” of these systems, it would allow such antennas to operate with a slightly higher power output. BRN Phoenix identifies no deficiency in the Commission's decision that would warrant reconsideration. Accordingly, the Commission denies its petition in this regard.

24. The Commission took several steps to minimize the extent to which terrestrial operations in the 3650 MHz band would affect the operations of satellite operators in both the conventional C-band (3700-4200 MHz) and the extended C-band (3625-3700 MHz). First, the Commission established protection zones with a radius of 150 km around the earth stations of grandfathered Fixed Satellite Service (FSS) operators in the 3650 MHz band. The Commission ruled that licensees in the 3650 MHz band could establish Fixed Service operations within the protection zones only with the consent of the affected FSS operator. For 3650 MHz licensees, the Commission established fixed station operating power limits of 25 Watts and mobile station operating power limits of 1 Watt. Additionally, the Commission sought to avoid out-of-band interference by requiring operators to limit emissions into adjacent bands by a minimum attenuation of 43 + 10 log(P) below the transmit power.

25. The Satellite Industry Association (SIA) sought reconsideration of the 3650 MHz Order, arguing that the newly authorized terrestrial operations in the 3650 MHz band will create interference in the adjacent 3700-4200 band that, contrary to the public interest, could disrupt C-band satellite operations. The Commission concludes that SIA's analysis contains overly conservative assumptions about path loss attenuation, the necessary C/I protection ratio and the arrival angle of a 3650 MHz signal at a satellite earth station. Each of these assumptions contributes to the overly pessimistic picture that SIA paints in its analysis. When these assumptions are adjusted to reflect more realistic operational scenarios the attenuation requirement in the 3650 MHz Order adequately protects operations in adjacent bands.

26. The Commission may, however, require greater suppression of the out-of-band emissions of a 3650 MHz operator in those rare instances when a 3650 MHz transmitter falls near the main beam and in a line of sight of a satellite earth station.

27. SIA argued that the potential exists for emissions from the 3650 MHz transmitters to saturate the low noise block converters (LNBs) on FSS earth stations operating in the adjacent C-band at 3700-4200 MHz. SIA requests that the Commission reconsider the permissible power level for fixed and base stations, at least in the upper half of the 3650 MHz band (that closest to the C-band) and set it at a level below the 25-watt figure that the prior order adopted.

28. The Commission declines to reconsider the permissible power limits in the 3650 MHz band as SIA requests. A review of the analysis that SIA provides for its argument on LNB saturation reveals that it is based on two very conservative assumptions. The predicted saturation is most pronounced when the arrival angle of the satellite antenna is 5 degrees. At greater arrival angles—as will exist for the great majority of earth stations—the interference projected by SIA's analysis is reduced. The Commission also notes that SIA has again assumed free space assumptions for its propagation analysis. Employing a path loss exponent greater than 2, as was done for the OOB emissions estimate, significantly reduces the potential interference.

29. Given the smaller separation distances necessary to alleviate LNB saturation predicted by a more realistic propagation model, a modest coordination effort should allow satellite earth stations to operate effectively, despite the presence of nearby operations in the 3650 MHz band. The Commission expects 3650 MHz licensees and satellite operators to undertake such coordination where necessary. The registration requirement for fixed and base station operations in the band will facilitate this coordination. In the registration process, licensees in the 3650 MHz band will be required to provide identification and location information for their fixed and base stations, as well as the technical information necessary for interference analysis.

30. The Commission rejects the argument that the authorization of operations in the 3650 MHz band improperly places the burden of avoiding interference on incumbents. It is not Commission policy to protect incumbent licensees against all emissions from adjacent bands; this is particularly true when the emissions are a foreseeable result of prior allocation orders. Installation of appropriate filters on satellite earth stations can adequately address the LNB saturation issue that SIA now raises.

31. Petitioners urge the Commission to impose the guidelines of the Commission's part 101 rules as a framework for the coordination of 3650 MHz operations within the exclusion zones established around grandfathered FSS earth stations. They contend that this would expedite fixed station entry without creating interference risk to the grandfathered FSS earth stations.

32. The Commission declines to adopt the part 101 rules as the sole means of coordination for those 3650 MHz licensees seeking to operate fixed services within the exclusion zones that the Commission established around grandfathered FSS earth stations. The part 101 rules, inter alia, “prescribe the manner in which portions of the radio spectrum may be made available for private * * * microwave operations that require transmitting facilities on land.” In doing so, however, they set out specific coordination procedures and interference protection criteria for covered fixed microwave transmitters. Rather than impose these specific procedures and criteria, the Commission prefers to allow the parties involved to choose for themselves the rules governing their particular negotiations.

33. Pursuant to the authority contained in sections 4(i), 302, 303(e), 303(f), and 307 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(c), 303(f), and 307, this Order on Reconsideration is hereby adopted.

34. Pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g), and 405, that the petitions for reconsideration, filed by Motorola and Redline and seeking clarification regarding the contention-based protocol requirement are granted to the extent discussed in the Memorandum Opinion and Order.

35. Part 90 of the Commission's rules is amended as specified in rule changes, and such rule amendments shall be effective August 24, 2007.

36. Pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g), and 405, that the remainder of the petitions for reconsideration filed by Motorola and Redline, as well as the reconsideration petitions of BRN Phoenix, the Enterprise Wireless Alliance, the Satellite Industry Association, the Wireless Communications Association, the Wi-Max Forum, and the joint petition of Intel, Redline and Alvarion are denied.

37. The Commission will send a copy of the Memorandum Opinion and Order, in a report to be sent to Congress pursuant to the Congressional Review Act. 1 In addition, the Commission will send a copy of the Memorandum Opinion and Order, to Congress and the Government Accountability Office.

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

The 2007 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA is 4,244 metric tons (mt) as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2007 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,194 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 19, 2007.

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

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

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

The 2007 TAC of northern rockfish in the Western Regulatory Area of the GOA is 1,439 metric tons (mt) as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2007 TAC of northern rockfish in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,389 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for northern rockfish in the Western Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of northern rockfish in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 19, 2007.

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

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

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

The 2007 TAC of pelagic shelf rockfish in the Western Regulatory Area of the GOA is 1,466 metric tons (mt) as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2007 TAC of pelagic shelf rockfish in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,416 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pelagic shelf rockfish in the Western Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of pelagic shelf rockfish in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 19, 2007.

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

This action is required by § 679.20 and is exempt from review under Executive Order 12866.