In 1979, the United States Commission on Civil Rights adopted a set of Employee Responsibilities and Conduct rules as set forth in 45 CFR part 706. See 44 FR 75152, as revised in 2002 at 67 FR 70498. That rule in the pertinent part required employees to obtain approval, in writing, from their supervisors before engaging in outside employment. 45 CFR 706.7.

On August 7, 1992, OGE published new executive branch Standards of Ethical Conduct regulations, which became generally effective on February 3, 1993. The Standards, as corrected and amended, are codified at 5 CFR part 2635. These regulations, together with OGE's executive branchwide financial disclosure and financial interests regulations codified at 5 CFR parts 2634 and 2640, superseded the Commission's old Employee Responsibilities and Conduct regulations at 45 CFR part 706, including the provision requiring employees to obtain prior approval before engaging in outside employment. In a separate rulemaking also being published in the Federal Register today, the Commission is removing its old superseded conduct regulation and replacing it with a residual crossreferences provision.

The Commission, however, has determined, with OGE concurrence, that it is necessary and desirable for the purpose of administering its ethics program to require its employees to again obtain written approval before engaging in outside employment, except for certain volunteer community service activities the DAEO has designated as “generally approved.” Section 7801.102 of new chapter LXVIII of 5 CFR will now require prior approval for outside activities in order to ensure that the activity would not otherwise violate a Federal statute or regulation, including the branchwide Standards. The section includes a definition, at paragraph (d), of outside employment, to mean any form of non-Federal employment, business relationship or activity involving the provision of personal services by the employee, whether or not for compensation. It also provides, at paragraph (c), that upon a significant change in the nature or scope of the outside employment or the employee's official position, the employee is required to submit a revised request for approval. The rule does not include special Government employees in the prior approval provision, since they consist primarily of State Advisory Committee members who serve on the Commission as uncompensated employees. Accordingly, by this rulemaking, the Commission is reinstituting the prior approval requirement, albeit in a modified form in light of the promulgation of the branchwide Standards. Furthermore, in § 7801.101 of 5 CFR, the Commission states the purpose of the supplemental regulation and includes cross-references to other Government ethics regulations applicable to Commission employees in addition to the new part. The cross-referenced regulations are the executive branch Standards, as well as the OGE executive branch financial disclosure and financial interests regulations noted above, and the separate specific executive branchwide employee responsibilities and conduct regulations of the Office of Personnel Management codified at 5 CFR part 735. Moreover, the section identifies the Solicitor as the Designated Agency Ethics Official and requires that employees seeking approval for outside employment obtain the approval of the Designated Agency Ethics Official, except to the extent that volunteer professional activities designated “generally approved” do not require additional prior written approval. In this final rule, the Commission is adding two references in paragraph (a) of 7801.101 to clarify that all of the other regulations referenced are executive branchwide regulations. The Commission is also adding the word “outside” to the word “employment” in definitional paragraph (d) of § 7801.102 to clarify the term being defined. Finally, the Commission is adding a new paragraph (e) to § 7801.102 on volunteer community service activities of its professional and non-professional staff to reflect its new Administrative Instruction, with a cross-reference thereto in paragraph (a). Paragraph (e) addresses the types of clearances needed for both volunteer (pro bono) community service activities that are designated as “generally approved,” or pre-approved by the DAEO, and those that are not so designated. Otherwise, the Commission, with OGE concurrence, is adopting its proposed supplemental standards regulation as final without change.

Because this rule relates to Commission personnel, it is exempt from the provisions of Executive Orders 12866 and 12988.

It has been determined under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this rule does not have a significant economic impact on a substantial number of small entities because it primarily affects Commission employees.

It has been determined that the Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply to this rulemaking document because it does not contain any information collection requirements that require the approval of the Office of Management and Budget.

The Commission has determined that this rulemaking is not a rule as defined in 5 U.S.C. 804, and, thus, does not require review by Congress.

The Equal Credit Opportunity Act (ECOA), 15 U.S.C. 1691-1691f, makes it unlawful for a creditor to discriminate against an applicant in any aspect of a credit transaction on the basis of the applicant's national origin, marital status, religion, sex, color, race, age (provided the applicant has the capacity to contract), receipt of public assistance benefits, or the good faith exercise of a right under the Consumer Credit Protection Act, 15 U.S.C. 1601 et seq. The ECOA is implemented by the Board's Regulation B.

In addition to the general prohibition against discrimination, Regulation B contains specific rules concerning the taking and evaluation of credit applications, including procedures and notices for credit denials and other adverse actions. Under section 202.9 of Regulation B, notification given to an applicant when adverse action is taken must contain the name and address of the federal agency that administers compliance with respect to the creditor. Appendix A of Regulation B contains the names and addresses of the enforcement agencies where questions concerning a particular creditor shall be directed.

The Board recently established a centralized Federal Reserve Consumer Help Center (“Help Center”) for receiving inquiries about creditors for which the Board enforces Regulation B. In September 2007, the Board revised the name and address in Appendix A to reflect the Help Center's address. 72 FR 55020 (Sept. 28, 2007). Although this change was effective October 29, 2007, creditors have until October 1, 2008 to include the new name and address on their adverse action notices. The amendment being made today does not affect that requirement.

The Board has also established centralized telephone numbers that consumers can use to contact the Help Center and inquire about creditors for which the Board enforces Regulation B. In the September 2007 Federal Register notice, the Board included these telephone numbers in Appendix A. As a result, the Board has received questions about whether the telephone numbers must be included in creditors' adverse action notices. Section 202.9 of Regulation B does not require creditors to include telephone, facsimile, or TDD numbers in their adverse action notices. Accordingly, to clarify the matter, the Board is amending Appendix A of Regulation B to eliminate the reference to the telephone numbers. The mandatory compliance date remains October 1, 2008.

Discussion

The FAA proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with an airworthiness directive (AD) to revise AD 2006-16-18, amendment 39-14718 (71 FR 48461, August 21, 2006). The existing AD applies to Sandel Avionics Incorporated (Sandel) Model ST3400 terrain awareness warning system/radio magnetic indicator (TAWS/RMI) units approved under Technical Standard Order(s) C113, C151a, or C151b; as installed on various small and transport category airplanes. The proposed AD was published in the Federal Register on March 13, 2008 (73 FR 13498) to require installing a warning placard on the TAWS/RMI, revising the Limitations section of the airplane flight manual (AFM), and installing upgraded software in the TAWS/RMI.

We provided the public the opportunity to participate in the development of this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

This AD describes the installation of later revisions of software than those specified in AD 2006-16-18; however, this change imposes no new costs on operators. Costs are repeated here for operator convenience only.

This AD affects about 300 airplanes of U.S. registry. The actions take about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $24,000, or $80 per airplane.

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

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

History

The FAA published a direct final rule with request for comments in the Federal Register March 26, 2008 (73 FR 9452), Docket No. FAA-2008-0328, Airspace Docket No. 08-ASW-4, establishing Class E airspace at Hinton, OK. The FAA uses the direct final rule procedure for non-controversial rules where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit an adverse comment, was received within the comment period, the regulation would become effective on June 5, 2008.

No adverse comments were received; thus, this notice confirms that the direct final rule will become effective on this date.

Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9R, signed August 1, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

History

On May 27, 2003, a final rule was published in the Federal Register (68 FR 28707) Revision of J-10. This action realigned J-10 from Farmington, NM to the Flagstaff, AZ Very High Omnidirectional Radio Range Tactical Air Navigation (VORTAC) by removing a route segment via the Drake, AZ. VORTAC. On July 21, 2003, a final rule was published in the Federal Register (68 FR 42962) Airspace Docket No. 02-ANM-10, changing the name of the Farmington VORTAC to the Rattlesnake VORTAC. In that rule, J-10 was written with the route segment that was removed in (68 FR 28707). This action corrects this error by removing “via the Drake, AZ 262° radials;” and inserting “Flagstaff 251° radials; Flagstaff, AZ.”

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

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. It, therefore—(1) is not a “significant regulatory action” under DOT Regulatory Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an Identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. This, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the, Associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

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. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The NASA Grant Handbook at § 1260.75 requires grant officers to complete the NASA Form 1356, Committee on Academic Science and Engineering (C.A.S.E.) Report on College and University Projects. The C.A.S.E. reports had once been the basis for reporting to the National Science Foundation's Federal Science and Engineering Support Survey. The information obtained on the C.A.S.E. reports is available through other available systems and the NF 1356 has been eliminated. Therefore, the requirement for grant officers to complete the form is removed.

The NASA Grant Handbook at § 1260.70 requires that property administration, in most cases, be delegated to the Office of Naval Research (ONR) but it is not clear that the requirement applies to grants that are initially awarded with Government-furnished property. Consequently, many grants without property were unnecessarily being delegated to ONR for administration.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., because the change affects only the internal operating procedure within NASA.

The Paperwork Reduction Act does not apply because this rule does not impose any new recordkeeping or information collection requirements, or collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

On May 21, 2008, the President, marking the Day of Solidarity with the Cuban People, announced that, in support of “Cubans who work to make their nation democratic and prosperous and just,” the relevant U.S. Government agencies would make any regulatory changes necessary “to allow Americans to send mobile phones to family members in Cuba.” The Cuban government announced earlier this year that it will now permit Cubans to acquire and use mobile phones. Recent global events have shown the value that mobile phones and communications devices can provide to those seeking to exercise the fundamental freedoms to which they are entitled under international law.

In support of this Presidential initiative, BIS is taking regulatory action consistent with all relevant laws, including the Cuban Liberty and Democratic Solidarity Act of 1996 (LIBERTAD), to allow exports of mobile phones in specified circumstances. This action is consistent with the ongoing support the United States has provided to individuals who support democracy-building efforts for Cuba by enabling the free exchange of information among persons in Cuba and with persons in other countries.

Consistent with the United States embargo of Cuba, the Export Administration Regulations (EAR) require a license for exports and reexports of all items subject to the EAR to Cuba, with only a limited number of license exceptions. One of those exceptions authorizes exports and reexports of certain items in gift parcels from donors to members of the donor's immediate family in Cuba. This rule amends the terms of License Exception Gift Parcels and Humanitarian Donations (GFT) to permit mobile phones (and related software, batteries, memory cards, chargers, and other accessories for mobile phones) to be included in such gift parcels. This rule also raises the value limit on such gift parcels from $200 to $400. This increase is intended to allow the donor to choose from a variety of currently available mobile phones without having to reduce the quantity of other items, such as medicines or medical supplies in the gift parcel. All other terms of that license exception, including eligible recipients and frequency of shipments are not changed by this rule.

Many gift parcels are shipped from the United States to Cuba through parties who consolidate multiple gift parcels. Under the EAR, a license is required for consolidations of gift parcels. This rule makes no changes to this requirement. Although individual gift parcels may be eligible for export pursuant to License Exception GFT, the consolidated shipments of multiple gift parcels are not eligible for such license exception. BIS has issued a number of licenses to parties authorizing them to export consolidated gift parcels to Cuba. As part of this rule, BIS is issuing a General Order authorizing holders of licenses to use those licenses to export gift parcels containing the mobile phones and related software, batteries, memory cards, chargers and related items that this rule makes eligible for the gift parcel license exception. This modification is necessary because some previously-issued licenses for consolidated shipments list the commodities that may be included in such consolidated gift parcels. This General Order does not, however, increase the total value of exports permitted under, or extend the expiration date of, any license. Issuance of this General Order to modify existing licenses will facilitate implementation of the new policy by allowing consolidators to begin including mobile phones right away rather than having to wait for new licenses to be issued. Consolidators will still need to apply for new licenses authorizing the full array of items to which the gift parcel exception applies as their existing licenses are fully used or expire.

1. This is a significant rule for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor may be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation concerns a collection previously approved by OMB under control number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Miscellaneous and recordkeeping activities account for 12 minutes per submission. BIS believes that this rule will have no effect on the burden imposed by this collection.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States (see 5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable.

Public Participation

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the interim rule. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this interim rule. Comments that will provide the most assistance to CBP in developing these regulations will reference a specific portion of the interim rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. See ADDRESSES above for information on how to submit comments.

On August 5, 2004, the governments of Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, and the United States signed the Dominican Republic—Central America—United States Free Trade Agreement (“CAFTA-DR” or “Agreement”). The stated objectives of the CAFTA-DR include: strengthening the special bonds of friendship and cooperation among the signatory countries and promoting regional economic integration; contributing to the harmonious development and expansion of world trade and providing a catalyst to broader international cooperation; creating an expanded and secure market for goods and services produced in the region; establishing clear and mutually advantageous rules governing trade among the signatory countries; ensuring a predictable commercial framework for business planning and investment; seeking to facilitate regional trade by promoting efficient and transparent customs procedures that reduce costs and ensure predictability for importers and exporters; fostering creativity and innovation, and promoting trade in goods and services that are the subject of intellectual property rights; promoting transparency and eliminating bribery and corruption in international trade and investment; protecting, enhancing, and enforcing basic workers' rights; creating new employment opportunities and improving working conditions and living standards in the region; and implementing the Agreement in a manner consistent with environmental protection and conservation, promoting sustainable development, and strengthening cooperation on environmental matters.

The provisions of the CAFTA-DR were adopted by the United States with the enactment on August 2, 2005, of the Dominican Republic—Central America—United States Free Trade Agreement Implementation Act (the “Act”), Public Law 109-53, 119 Stat. 462 (19 U.S.C. 4001 et seq.). Section 210 of the Act requires that regulations be prescribed as necessary to implement these provisions of the CAFTA-DR.

On February 28, 2006, the President signed Proclamation 7987 to implement the provisions of the CAFTA-DR with respect to El Salvador. The Proclamation, which was published in the Federal Register on March 2, 2006 (71 FR 10827), modified the Harmonized Tariff Schedule of the United States (“HTSUS”) as set forth in Annexes I and II of Publication 3829 of the U.S. International Trade Commission. The modifications to the HTSUS included the addition of new General Note 29, incorporating the relevant CAFTA-DR rules of origin as set forth in the Act, and the insertion throughout the HTSUS of the preferential duty rates applicable to individual products under the CAFTA-DR where the special program indicator “P” appears in parenthesis in the “Special” rate of duty subcolumn. Presidential Proclamation 7996 dated March 31, 2006, which was published in the Federal Register on April 4, 2006 (71 FR 16971), implemented the CAFTA-DR with respect to Honduras and Nicaragua. Presidential Proclamation 8034 dated June 30, 2006, published in the Federal Register on July 6, 2006 (71 FR 38509), implemented the CAFTA-DR with respect to Guatemala. Presidential Proclamation 8111 dated February 28, 2007, published in the Federal Register on March 6, 2007 (72 FR 10025), implemented the CAFTA-DR with respect to the Dominican Republic.

Customs and Border Protection (“CBP”) is responsible for administering the provisions of the CAFTA-DR and the Act that relate to the importation of goods into the United States from a CAFTA-DR Party for which the Agreement has entered into force. Those customs-related CAFTA-DR provisions which require implementation through regulation include certain tariff and non-tariff provisions within Chapter Two (General Definitions), Chapter Three (National Treatment and Market Access for Goods), and Chapter Four (Rules of Origin and Origin Procedures).

Certain general definitions set forth in Chapter Two of the CAFTA-DR have been incorporated into the CAFTA-DR implementing regulations. The tariff-related provisions within CAFTA-DR Chapter Three that are the subject of regulatory action in this interim rule are Article 3.6 (Goods Re-entered after Repair or Alteration) and those relating specifically to textile and apparel goods are Article 3.24 (Customs Cooperation), Article 3.25 (Rules of Origin and Related Matters), Article 3.28 and Annex 3.28 (Preferential Tariff Treatment for Non-Originating Apparel Goods of Nicaragua), and Article 3.29 (Definitions).

Section A of Chapter Four of the CAFTA-DR sets forth the rules for determining whether an imported good qualifies as an originating good of a Party and, as such, is therefore eligible for preferential tariff (duty-free or reduced duty) treatment under the CAFTA-DR as provided for in the HTSUS. The basic rules of origin in Section A of Chapter Four are set forth in General Note 29, HTSUS. Under Article 4.1 of Chapter Four, originating goods may be grouped in three broad categories: (1) Goods that are wholly obtained or produced entirely in the territory of one or more of the Parties; (2) goods that are produced entirely in the territory of one or more of the Parties and that satisfy the specific rules of origin in CAFTA-DR Annex 4.1 (change in tariff classification requirement and/or regional value content requirement) and all other applicable requirements of Chapter Four; and (3) goods that are produced entirely in the territory of one or more of the Parties exclusively from materials that originate in those countries. Article 4.2 sets forth the methods for calculating the regional value content of a good. Articles 4.3 and 4.4 set forth the rules for determining the value of materials for purposes of calculating the regional value content of a good and applying the de minimis rule. Article 4.5 allows production that takes place in the territory of one or more of the Parties to be accumulated such that, provided other requirements are met, the resulting good is considered originating. Article 4.6 provides a de minimis criterion. The remaining Articles within Section A of Chapter Four consist of additional sub-rules, applicable to the originating good concept, involving fungible goods and materials, accessories, spare parts, and tools, packaging materials, packing materials, indirect materials, transit and transshipment, sets, and consultation and modifications. All Articles within Section A are reflected in the CAFTA-DR implementing regulations, except for Article 4.14 (Consultation and Modifications).

Section B of Chapter Four sets forth procedures that apply under the CAFTA-DR in regard to claims for preferential tariff treatment. Specifically, Section B includes provisions concerning obligations related to importations and exportations, claims for preferential tariff treatment, record keeping requirements, verification of preference claims, common guidelines, and definitions of terms used within the context of the rules of origin. All Articles within Section B, except for Article 4.21 (Common Guidelines), are reflected in these implementing regulations.

In order to provide transparency and facilitate their use, the majority of the CAFTA-DR implementing regulations set forth in this document have been included within Subpart J in part 10 of the CBP regulations (19 CFR part 10). However, implementation of the tariff preference and related provisions of CAFTA-DR has also been effected through amendments to a number of other regulatory provisions outside of Subpart J, part 10 within the CBP regulations. The regulatory changes are discussed below in the order in which they appear in this document.

Section 10.31(f) concerns temporary importations under bond. It is amended by adding references to certain goods originating in a CAFTA-DR Party for which, like goods originating in Canada, Mexico, Singapore, Chile, Morocco, and Bahrain, no bond or other security will be required when imported temporarily for prescribed uses. The provisions of CAFTA-DR Article 3.5 (Temporary Admission of Goods) are already reflected in existing temporary importation bond or other provisions contained in Part 10 of the CBP regulations and in Chapter 98 of the HTSUS.

Section 10.581 outlines the scope of Subpart J, Part 10 of the CBP regulations. This section also clarifies that, except where the context otherwise requires, the requirements contained in Subpart J, Part 10 are in addition to general administrative and enforcement provisions set forth elsewhere in the CBP regulations. Thus, for example, the specific merchandise entry requirements contained in Subpart J, Part 10 are in addition to the basic entry requirements contained in Parts 141-143 of the CBP regulations.

Section 10.582 sets forth definitions of common terms used in multiple contexts or places within Subpart J, Part 10. Although the majority of the definitions in this section are based on definitions contained in Article 2.1, Annex 2.1, and Article 3.29 of the CAFTA-DR, and § 3 of the Act, other definitions have also been included to clarify the application of the regulatory texts. Additional definitions that apply in a more limited Subpart J, Part 10 context are set forth elsewhere with the substantive provisions to which they relate.

Section 10.583 sets forth the procedure for claiming CAFTA-DR preferential tariff treatment at the time of entry and, as provided in CAFTA-DR Article 4.16.1, states that an importer may make a claim for CAFTA-DR preferential tariff treatment based on a certification by the importer, exporter, or producer or the importer's knowledge that the good qualifies as an originating good. Section 10.583 also provides, consistent with CAFTA-DR Article 4.15.4(d), that when an importer has reason to believe that a claim is based on inaccurate information, the importer must correct the claim and pay any duties that may be due.

Section 10.584, which is based on CAFTA-DR Articles 4.15.4 and 4.16, requires a U.S. importer, upon request, to submit a copy of the certification of the importer, exporter, or producer if the certification forms the basis for the claim. Section 10.584 specifies the information that must be included on the certification, sets forth the circumstances under which the certification may be prepared by the exporter or producer of the good, and provides that the certification may be used either for a single importation or for multiple importations of identical goods.

Section 10.585 sets forth certain importer obligations regarding the truthfulness of information and documents submitted in support of a claim for preferential tariff treatment. Section 10.586, which is based on CAFTA-DR Article 4.17, provides that the certification is not required for certain non-commercial or low-value importations.

Section 10.587 implements CAFTA-DR Article 4.19 concerning the maintenance of relevant records regarding the imported good.

Section 10.588, which reflects CAFTA-DR Article 4.15.2, authorizes the denial of CAFTA-DR tariff benefits if the importer fails to comply with any of the requirements under Subpart J, Part 10, CBP regulations.

Section 10.589, which implements CAFTA-DR Articles 4.18 and 4.19.1, sets forth certain obligations of a person who completes and issues a certification for a good exported from the United States to a Party. Paragraphs (a) and (b) of § 10.589, reflecting CAFTA-DR Article 4.18.1, require a person who completes such a certification to provide a copy of the certification to CBP upon request and to give prompt notification of any errors in the certification to every person to whom the certification was given. Paragraph (c) of § 10.589 reflects Article 4.19.1, concerning the recordkeeping requirements that apply to a person who completes and issues a certification for a good exported from the United States to a Party.

Sections 10.590 through 10.592 implement CAFTA-DR Article 4.15.5, which allows an importer who did not claim CAFTA-DR tariff benefits on a qualifying good at the time of importation to apply for a refund of any excess duties at any time within one year after the date of importation. Such a claim may be made even if liquidation of the entry would otherwise be considered final under other provisions of law.

Sections 10.593 through 10.605 provide the implementing regulations regarding the rules of origin provisions of General Note 29, HTSUS, Chapter Four and Article 3.25 of the CAFTA-DR, and section 203 of the Act.

Section 10.593 sets forth terms that are defined for purposes of the rules of origin.

Section 10.594 sets forth the basic rules of origin established in Article 4.1 of the CAFTA-DR, section 203(b) of the Act, and General Note 29(b), HTSUS. The provisions of § 10.594 apply both to the determination of the status of an imported good as an originating good for purposes of preferential tariff treatment and to the determination of the status of a material as an originating material used in a good which is subject to a determination under General Note 29, HTSUS. Section 10.594(a) specifies those goods that are originating goods because they are wholly obtained or produced entirely in the territory of one or more of the Parties.

Section 10.594(b) provides that goods that have been produced entirely in the territory of one or more of the Parties so that each non-originating material undergoes an applicable change in tariff classification and satisfies any applicable regional value content or other requirement set forth in General Note 29, HTSUS, are originating goods. Essential to the rules in § 10.594(b) are the specific rules of General Note 29(n), HTSUS, which are incorporated by reference.

Section 10.594(c) provides that goods that have been produced entirely in the territory of one or more of the Parties exclusively from originating materials are originating goods.

Section 10.595 reflects CAFTA-DR Article 4.2 concerning the basic rules that apply for purposes of determining whether an imported good satisfies a minimum regional value content (“RVC”) requirement. Section 10.596, reflecting CAFTA-DR Articles 4.3 and 4.4, sets forth the rules for determining the value of a material for purposes of calculating the regional value content of a good as well as for purposes of applying the de minimis rules.

Section 10.597, which is derived from CAFTA-DR Article 4.5, sets forth the rule by which originating materials from the territory of one or more of the Parties that are used in the production of a good in the territory of another Party will be considered to originate in the territory of that other country. In addition, this section also establishes that a good that is produced by one or more producers in the territory of one or more of the Parties is an originating good if the good satisfies all of the applicable requirements of the rules of origin of the CAFTA-DR.

Section 10.598, as provided for in CAFTA-DR Article 4.6, sets forth de minimis rules for goods that may be considered to qualify as originating goods even though they fail to qualify as originating goods under the rules specified in § 10.594. There are a number of exceptions to the de minimis rule as well as a separate rule for textile and apparel goods.

Section 10.599, as provided for in CAFTA-DR Article 4.7, sets forth the rules by which “fungible” goods or materials may be claimed as originating.

Section 10.600, as set forth in CAFTA-DR Article 4.8, specifies the conditions under which a good's standard accessories, spare parts, or tools are: (1) Treated as originating goods; and (2) disregarded in determining whether all non-originating materials undergo an applicable change in tariff classification under General Note 29(n), HTSUS.

Sections 10.601 and 10.602, which are derived from CAFTA-DR Articles 4.9 and 4.10, respectively, provide that retail packaging materials and packing materials for shipment are to be disregarded with respect to their actual origin in determining whether non-originating materials undergo an applicable change in tariff classification under General Note 29(n), HTSUS. These sections also set forth the treatment of packaging and packing materials for purposes of the regional value content requirement of the note.

Section 10.603, as set forth in CAFTA-DR Article 4.11, provides that indirect materials, as defined in § 10.582(m), are considered to be originating materials without regard to where they are produced.

Section 10.604, which is derived from CAFTA-DR Article 4.12, sets forth the rule that an originating good loses its originating status and is treated as a non-originating good if, subsequent to production in the territory of one or more of the Parties that qualifies the good as originating, the good: (1) Undergoes production outside the territories of the Parties, other than certain specified minor operations; or (2) does not remain under the control of customs authorities in the territory of a non-Party.

Section 10.605, which is based on CAFTA-DR Articles 3.25.9 (Rules of Origin and Related Matters) and 4.13 (Sets of Goods), provides that, notwithstanding the specific rules of General Note 29(n), HTSUS, goods classifiable as goods put up in sets for retail sale as provided for in General Rule of Interpretation 3, HTSUS, will not qualify as originating goods unless: (1) Each of the goods in the set is an originating good; or (2) the total value of the non-originating goods in the set does not exceed 10 percent of the adjusted value of the set in the case of textile or apparel goods, or 15 percent of the adjusted value of the set in the case of goods other than textile or apparel goods.

Section 10.606 sets forth procedures for claiming CAFTA-DR tariff benefits for certain non-originating cotton or man-made fiber apparel goods of Nicaragua that are entitled to preference under an applicable tariff preference level (“TPL”).

Section 10.607, which is based on CAFTA-DR Article 3.28 and Annex 3.28, describes the non-originating cotton or man-made fiber apparel goods of Nicaragua that are eligible for TPL claims under the CAFTA-DR.

Section 10.608, as authorized by § 1634(c)(1) of the Pension Protection Act of 2006 (Pub. L. 109-280, 120 Stat. 1163), requires an importer claiming preferential tariff treatment on a non-originating cotton or man-made fiber apparel good of Nicaragua specified in § 10.607 to submit a certificate of eligibility issued by the Government of Nicaragua.

Consistent with § 10.604, § 10.609 provides that a good of Nicaragua that is otherwise eligible for preferential tariff treatment under an applicable TPL will not be considered eligible for preference if it: (1) Undergoes production outside the territories of the Parties, other than certain specified minor operations; or (2) does not remain under the control of customs authorities in the territory of a non-Party.

Section 10.610 provides for the denial of a TPL claim if the importer fails to comply with any applicable requirement under Subpart J, Part 10, CBP regulations, including the failure to provide documentation, when requested by CBP, establishing that the good met the conditions relating to transshipment set forth in § 10.609(a).

Section 10.616 implements CAFTA-DR Article 4.20 which concerns the conduct of verifications to determine whether imported goods are originating goods entitled to CAFTA-DR preferential tariff treatment. This section also governs the conduct of verifications directed to producers of materials that are used in the production of a good for which CAFTA-DR preferential duty treatment is claimed.

Section 10.617, which reflects CAFTA-DR Article 3.24, sets forth the verification and enforcement procedures specifically relating to trade in textile and apparel goods.

Section 10.618 provides the procedures that apply when preferential tariff treatment is denied on the basis of an origin verification conducted under this subpart.

Section 10.619 implements CAFTA-DR Article 4.20.5 and § 206(b) of the Act, concerning the denial of preferential tariff treatment in situations in which there is a pattern of conduct by an importer, exporter, or producer of false or unsupported CAFTA-DR preference claims.

Section 10.620 concerns the general application of penalties to CAFTA-DR transactions and is based on CAFTA-DR Article 5.9.

Section 10.621 reflects CAFTA-DR Article 4.15.3 and § 206(a)(1) of the Act with regard to an exception to the application of penalties in the case of an importer who promptly and voluntarily makes a corrected claim and pays any duties owing.

Section 10.622 implements CAFTA-DR Article 4.18.2 and § 206(a)(2) of the Act, concerning an exception to the application of penalties in the case of a U.S. exporter or producer who promptly and voluntarily provides notification of the making of an incorrect certification with respect to a good exported to a Party.

Section 10.623 sets forth the circumstances under which the making of a corrected claim or certification by an importer or the providing of notification of an incorrect certification by a U.S. exporter or producer will be considered to have been done “promptly and voluntarily”. Corrected claims or certifications that fail to meet these requirements are not excepted from penalties, although the U.S. importer, exporter, or producer making the corrected claim or certification may, depending on the circumstances, qualify for a reduced penalty as a prior disclosure under 19 U.S.C. 1592(c)(4). Section 10.623 also specifies the content of the statement that must accompany each corrected claim or certification.

Section 10.624 implements CAFTA-DR Article 3.6 regarding duty-free treatment for goods re-entered after repair or alteration in a CAFTA-DR Party.

Current § 10.699 of the CBP regulations, which sets forth the conditions and requirements that apply for purposes of submitting requests for refunds of any excess customs duties paid with respect to entries of textile or apparel goods entitled to retroactive tariff treatment under the CAFTA-DR (see CAFTA-DR Article 3.20 and § 205 of the Act), is redesignated as § 10.625 so as to conform numerically to the new provisions added to Subpart J, Part 10, by this interim rule. In addition, paragraph (a) of redesignated § 10.625, relating to the applicability of this section, is revised by deleting certain redundant language set forth in new § 10.581 (Scope) of Subpart J, Part 10.

An amendment is made to § 24.23(c), which concerns the merchandise processing fee, to implement § 204 of the Act, providing that the merchandise processing fee is not applicable to goods that qualify as originating goods under the CAFTA-DR.

Part 162 contains regulations regarding the inspection and examination of, among other things, imported merchandise. A cross-reference is added to § 162.0, which is the scope section of the part, to refer readers to the additional CAFTA-DR records maintenance and examination provisions contained in Subpart J, Part 10, CBP regulations.

A conforming amendment is made to § 163.1 to include the maintenance of any documentation that the importer may have in support of a claim for preference under the CAFTA-DR as an activity for which records must be maintained. Also, the list of records and information required for the entry of merchandise appearing in the Appendix to Part 163 (commonly known as the (a)(1)(A) list) is also amended to add the documentation in the importer's possession supporting an CAFTA-DR claim for preferential tariff treatment.

Part 178 sets forth the control numbers assigned to information collections of CBP by the Office of Management and Budget, pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13. The list contained in § 178.2 is amended to add the information collections used by CBP to determine eligibility for preferential tariff treatment under the CAFTA-DR and the Act.

Under the Administrative Procedure Act (“APA”) (5 U.S.C. 553), agencies generally are required to publish a notice of proposed rulemaking in the Federal Register that solicits public comment on the proposed regulatory amendments, consider public comments in deciding on the content of the final amendments, and publish the final amendments at least 30 days prior to their effective date. However, section 553(a)(1) of the APA provides that the standard prior notice and comment procedures do not apply to an agency rulemaking to the extent that it involves a foreign affairs function of the United States. CBP has determined that these interim regulations involve a foreign affairs function of the United States because they implement preferential tariff treatment and related provisions of the CAFTA-DR. Therefore, the rulemaking requirements under the APA do not apply and this interim rule will be effective upon publication. However, CBP is soliciting comments in this interim rule and will consider all comments received before issuing a final rule.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 of September 30, 1993 (58 FR 51735, October 1993), because it pertains to a foreign affairs function of the United States and implements an international agreement, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866. Because a notice of proposed rulemaking is not required under section 553(b) of the APA for the reasons described above, the provisions of the Regulatory Flexibility Act, as amended (5 U.S.C. 601 et seq.), do not apply to this rulemaking. Accordingly, this interim rule is not subject to the regulatory analysis requirements or other requirements of 5 U.S.C. 603 and 604.

These regulations are being issued without prior notice and public procedure pursuant to the APA, as described above. For this reason, the collections of information contained in these regulations have been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) under control number 1651-0125.

The collections of information in these regulations are in §§ 10.583 and 10.584. This information is required in connection with claims for preferential tariff treatment under the CAFTA-DR and the Act and will be used by CBP to determine eligibility for tariff preference under the CAFTA-DR and the Act. The likely respondents are business organizations including importers, exporters and manufacturers.

Estimated total annual reporting burden: 4,000 hours.

Estimated average annual burden per respondent: .2 hours.

Estimated number of respondents: 20,000.

Estimated annual frequency of responses: 1.

Comments concerning the collections of information and the accuracy of the estimated annual burden, and suggestions for reducing that burden, should be directed to the Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to the Trade and Commercial Regulations Branch, Regulations and Rulings, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW. (Mint Annex), Washington, DC 20229.

This document is being issued in accordance with § 0.1(a)(1) of the CBP regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain customs revenue functions.

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to NADA 141-203 that provides for the addition of a 50-milligram size of DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and inflammation in dogs. The supplemental NADA is approved as of May 16, 2008, and 21 CFR 520.538 is amended to reflect the approval.

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

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

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

Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141-286 that provides for the veterinary prescription use of PANACUR Plus (ivermectin, fenbendazole, and praziquantel) Soft Chews for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs. The NADA is approved as of May 9, 2008, and the regulations are amended in 21 CFR part 520 by adding § 520.1200 to reflect the approval.

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

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

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

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

In the Federal Register of December 11, 1995 (60 FR 63578), FDA published a final rule revising part 803 (21 CFR part 803) and requiring medical device manufacturers to submit certain reports relating to adverse events, including a requirement under § 803.55 to submit baseline reports on FDA Form 3417 or an electronic equivalent. Section 803.55 requires manufacturers to submit baseline reports when the manufacturer submits the first adverse event report under § 803.50 for a device model. In addition, § 803.55 requires annual updates of each baseline report.

The baseline report includes address information for the reporting and manufacturing site for the device, device identifiers, the basis for marketing for the device (e.g., the 510(k) number or PMA number), the FDA product code, the shelf life of the device (if applicable) and the expected life of the device, the number of devices distributed each year, and the method used to calculate that number. In the Federal Register of July 31, 1996 (61 FR 39868), FDA stayed the requirement for manufacturers to submit information on the number of devices distributed each year and the method used to calculate that number, because of questions raised about the feasibility of obtaining such information and the usefulness of such information once submitted to FDA.

With the requirement for these two data elements stayed, the data submitted in baseline reports largely overlapped with the data submitted in individual adverse event reports. That is, FDA had access to much of the information included in baseline reports through the individual adverse event reports submitted on the MedWatch mandatory reporting form (FDA Form 3500A). Two notable exceptions were the basis for marketing and the FDA product code, data elements that were included in the baseline reports but were not included in the FDA Form 3500A and its instructions.

The basis for marketing and the FDA product code were, however, subsequently incorporated into the FDA Form 3500A and its instructions. In the Federal Register of December 27, 2004 (69 FR 77256), FDA announced proposed modifications to FDA Form 3500A, which included adding an entry for the basis for marketing (PMA or 510(k) number). In the Federal Register of December 7, 2005 (70 FR 72843), FDA announced that the Office of Management and Budget approved these modifications under the Paperwork Reduction Act of 1995. FDA also modified the instructions for FDA Form 3500A to state that manufacturers use the FDA product code when completing the entry for “Common Device Name” on FDA Form 3500A.

With the addition of these two data elements (basis for marketing and FDA product code) to FDA Form 3500A and its instructions, the information submitted in FDA Form 3500A largely replicates the information submitted in baseline reports. As a result, the agency deems the baseline reporting requirement in § 803.55 no longer necessary. The agency believes that removing § 803.55 will reduce the reporting burden for manufacturers without impairing the agency's receipt of device adverse event information.

In this direct final rule, FDA is removing § 803.55, which requires manufacturers to submit a baseline report when they submit the first report under § 803.50 involving a device model and provide annual updates thereafter. In addition, this direct final rule makes conforming amendments to §§ 803.1(a), 803.10(c), and 803.58(b) to remove references to baseline reports and to § 803.55. Finally, this direct final rule removes the terms “device family” and “shelf life” from the definitions in § 803.3 because these terms are used only in the context of baseline reports.

In the Federal Register of November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures” that described when and how FDA will employ direct final rulemaking. We believe that this rule is appropriate for direct final rulemaking because it is intended to make noncontroversial changes to existing regulations. We anticipate no significant adverse comment.

Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the Federal Register a companion proposed rule that is identical to the direct final rule. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. Any comments received in response to the companion proposed rule will also be considered as comments regarding this direct final rule.

We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register. If we receive any significant adverse comment, we intend to withdraw this final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. For example, a comment recommending an additional change to the rule will not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.

If we withdraw the direct final rule, all comments received will be considered under the companion proposed rule in developing a final rule under the usual notice-and-comment procedures under the APA (5 U.S.C. 552a et seq.). If we receive no significant adverse comment during the specified comment period, we intend to publish a confirmation document in the Federal Register within 30 days after the comment period ends.

FDA is issuing this direct final rule under the device and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).

The agency has determined under 21 CFR 25.30(h) and (i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this direct final rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The direct final rule amends the existing medical device reporting regulation to remove § 803.55, which requires that manufacturers submit baseline reports, and makes conforming amendments to §§ 803.1(a), 803.3, 803.10(c), and 803.58(b) to remove references to baseline reports and to § 803.55 and to remove the terms “device family” and “shelf life.” This final rule does not impose any new requirements but instead removes a reporting requirement for manufacturers that FDA deems no longer necessary. The agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current (2006) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

This direct final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

This amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during July 2008, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during July 2008, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during July 2008.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 5.95 percent for the first 20 years following the valuation date and 5.02 percent thereafter. These interest assumptions represent an increase (from those in effect for June 2008) of 0.27 percent for the first 20 years following the valuation date and 0.27 percent for all years thereafter.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 3.50 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent an increase from those in effect for June 2008 of 0.25 percent in the immediate annuity rate and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during July 2008, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

EPA is making a correction to the document published on May 1, 2008 (73 FR 23957), approving revisions to Alabama's SIP incorporating rule changes to Alabama's PSD program. As part of the background information provided in the May 1, 2008, document, EPA made an inadvertent misstatement on page 23958, column 1, first full paragraph. This paragraph begins with the phrase, “The ‘reasonable possibility’ standard identifies, for sources and reviewing authorities * * *” and ends with the phrase, “the reasonable possibility standard did not result in any actual changes to the corresponding federal rule.” 73 FR 23958. This last quoted statement does not correctly describe EPA's recent revisions to its NSR rules regarding the meaning of the term “reasonable possibility” in those rules. EPA's final action regarding “reasonable possibility” did result in changes to federal rules found at 40 CFR parts 51 and 52. See, 72 FR 72607, December 21, 2007.

EPA is now correcting the entirety of that first full paragraph at 73 FR 23958 by replacing it with the following paragraph:

“The `reasonable possibility' standard identifies, for sources and reviewing authorities, the circumstances under which a major stationary source undergoing a modification that does not trigger major NSR must keep records. EPA's December 2007 action clarified the meaning of the term `reasonable possibility' through changes to the federal rule language in 40 CFR parts 51 and 52. In the present case, although Alabama's rules include the term `reasonable possibility,' Alabama's rules require recordkeeping for facilities for which there is a reasonable possibility as well as those for which there is not. Therefore, Alabama's SIP revisions are approvable.”

I. General Information A. Does This Action Apply to Me? B. How Can I Get Copies of This Document and Other Related Information? C. Under What Legal Authority Is This Final Rule Issued? D. What is the Comment Response Document? II. Background and Definition of Water Transfers III. Rationale for the Final Rule A. Legal Framework B. Statutory Language and Structure C. Legislative History IV. Public Comment V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. General Information A. Does This Action Apply to Me?

This action applies to those involved in the transfer of waters of the United States. The following table provides a list of standard industrial codes for operations potentially covered under this rule.

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility is affected by this action, you should carefully examine the applicability criteria in 40 CFR 122.3. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

1. Docket. EPA has established an official public docket for this action under Docket ID No. EPA-HQ-OW-2006-0041. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although listed in the index, some information, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Water Docket in the EPA Docket Center, EPA West, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Web site under the Federal Register listings at http://www.regulations.gov.

This final rule is issued under the authority of sections 402 and 501 of the Clean Water Act., 33 U.S.C. 1342 and 1361.

EPA received a large number of comments on the proposed rule, including thousands of form letters. EPA evaluated all of the comments submitted and prepared a Comment Response Document containing both the comments received and the Agency's responses to those comments. The Comment Response Document complements and supplements this preamble by providing more detailed explanations of EPA's final action. The Comment Response Document is available at the Water Docket.

Water transfers occur routinely and in many different contexts across the United States. Typically, water transfers route water through tunnels, channels, and/or natural stream water features, and either pump or passively direct it for uses such as providing public water supply, irrigation, power generation, flood control, and environmental restoration. Water transfers can be relatively simple, moving a small quantity of water a short distance, or very complex, transporting substantial quantities of water over long distances, across both State and basin boundaries. Water transfers may be of varying complexities and sizes; there may be multiple reservoirs, canals, or pumps over the course of the transfer, or the route may be a more direct connection between the donor and the receiving waterbody. There are thousands of water transfers currently in place in the United States, including sixteen major diversion projects in the western States alone. Examples include the Colorado-Big Thompson Project in Colorado and the Central Valley Project in California.

Water transfers are administered by various federal, State, and local agencies and other entities. The Bureau of Reclamation administers significant transfers in western States to provide approximately 140,000 farmers with irrigation water. With the use of water transfers, the Army Corps of Engineers keeps thousands of acres of agricultural and urban land in southern Florida from flooding in former areas of Everglades wetlands. Many large cities in the west and the east would not have adequate sources of water for their citizens were it not for the continuous redirection of water from outside basins. For example, both the cities of New York and Los Angeles depend on water transfers from distant watersheds to meet their municipal demand. In short, numerous States, localities, and residents are dependent upon water transfers, and these transfers are an integral component of U.S. infrastructure.

The question of whether or not an NPDES permit is required for water transfers arises because activities that result in the movement of waters of the U.S., such as trans-basin transfers of water to serve municipal, agricultural, and commercial needs, typically move pollutants from one waterbody (donor water) to another (receiving water). Although there have been a few isolated instances where entities responsible for water transfers have been issued NPDES permits, Pennsylvania is the only NPDES permitting authority that regularly issues NPDES permits for water transfers. Pennsylvania began issuing permits for water transfers in 1986, in response to a State court decision mandating the issuance of such permits. See DELAWARE Unlimited v. DER, 508 A.2d 348 (Pa. Cmwlth, 1986). In addition, some Courts of Appeals have required NPDES permits for specific water transfers associated with the expansion of a ski resort and the supply of drinking water. See, e.g., Dubois v. U.S. Dep't of Agriculture, 102 F.3d 1273 (1st Cir. 1996); Catskill Mountains Chapter of Trout Unlimited, Inc. v. City of New York, 273 F.3d 481 (2nd Cir 2001), aff'd, Catskill Mountains Chapter of Trout Unlimited, Inc. v. City of New York, 451 F.3d 77 (2nd Cir 2006). Otherwise, however, water transfers have not been regulated under section 402 of the Clean Water Act (CWA or the Act).

The Supreme Court recently addressed the issue of whether an NPDES permit is necessary for the mere transfer of water in South Fla. Water Mgmt. Dist. v. Miccosukee Tribe of Indians, 541 U.S. 95 (2004). The Supreme Court in Miccosukee vacated a decision by the 11th Circuit, which had held that a Clean Water Act permit was required for transferring water from one navigable water into another, a Water Conservation Area in the Florida Everglades. The Court remanded the case for further fact-finding as to whether the two waters in question were “meaningfully distinct.” 1 If they were not, an NPDES permit would not be required. The Court declined to resolve the question of whether water transfers require NPDES permits when the waterbodies at issue are meaningfully distinct. The Court noted that some legal arguments made by the parties regarding this question had not been raised in the lower court proceedings and noted that these arguments would be open to the parties on remand. Id. at 109.

On August 5, 2005, EPA issued a legal memorandum entitled “Agency Interpretation on Applicability of section 402 of the Clean Water Act to Water Transfers” (“interpretive memorandum”). The principal legal question addressed in the interpretive memorandum was whether the movement of pollutants from one water of the U.S. to another by a water transfer is the “addition” of a pollutant potentially subjecting the activity to the permitting requirement under section 402 of the Act. Based on the statute as a whole and consistent with the Agency's longstanding practice, the interpretive memorandum concluded that Congress generally expected water transfers would be subject to oversight by water resource management agencies and State non-NPDES authorities, rather than the permitting program under section 402 of the CWA.

On June 7, 2006, EPA proposed regulations based on the analysis contained in the interpretive memorandum to expressly state that water transfers are not subject to regulation under section 402 of the CWA. The Agency proposed to define water transfers as “an activity that conveys waters of the United States to another water of the United States without subjecting the water to intervening industrial, municipal, or commercial use.” The Act reserves the ability of States to regulate water transfers under State law and this proposed rulemaking was not intended to interfere with this State prerogative. See CWA section 510.

EPA is issuing a final regulation that is nearly identical to the proposed rule. (Minor changes have been made for clarity.) Through today's rule, the Agency concludes that water transfers, as defined by the rule, do not require NPDES permits because they do not result in the “addition” of a pollutant. Consistent with the proposed rule, EPA defines water transfers in the following manner: “Water transfer means an activity that conveys or connects waters of the United States without subjecting the transferred water to intervening industrial, municipal, or commercial use.” In order to constitute a “water transfer” under this rule, and, therefore, be exempt from the requirement to obtain an NPDES permit, the water being conveyed must be a water of the U.S.2 prior to being discharged to the receiving waterbody. If the water that is being conveyed is not a water of the U.S. prior to being discharged to the receiving body, then that activity does not constitute a water transfer under today's rule. Additionally, the water must be conveyed from one water of the U.S. to another water of the U.S. Conveyances that remain within the same water of the U.S., therefore, do not constitute water transfers under this rule, although movements of water within a single water body are also not subject to NPDES permitting requirements. As the rule makes clear, in order to be a water transfer under the rule, the water must be conveyed without being subjected to an intervening industrial, municipal, or commercial use.

Consider water that is being moved from Reservoir A to Reservoir B in a different watershed. In order to get from Reservoir A to Reservoir B, the water must first be released through a dam. The water then travels down River A, which is considered a water of the U.S. Next, the water is conveyed from River A to River B through a tunnel. Finally, the water travels down River B, also a water of the U.S., and flows into Reservoir B. There are several points in this example where water is conveyed from one body to another, but not all of those points would themselves constitute a “water transfer” because they are not the conveyance of “waters of the United States to another water of the United States.” The first example is the release from Reservoir A to River A. This does not constitute a water transfer under EPA's definition because the water on both sides of the dam is part of the same water of the U.S.3 The next movement is the release from River A into River B, through a tunnel. This release constitutes a water transfer under the scope of this rule because it conveys water from one water of the U.S. to another water of the U.S. without subjecting the water to an intervening industrial, municipal or commercial use. Therefore, unless this conveyance itself introduces pollutants into the water being conveyed, the release will not require an NPDES permit under today's rule. River B's subsequent flow into Reservoir B, which is formed by a dam on Reservoir B, does not constitute a water transfer because it is merely movement within the same water of the U.S., and, as discussed above, would not require an NPDES permit for such movement.

The remainder of the preamble to this final rule is organized as follows. Section III discusses the rationale for the final rule based on the language, structure, and legislative history of the Clean Water Act. Section IV summarizes and responds to the major comments received in response to the scope of the proposed rule. Section V reviews statutory provisions and various executive orders.

On June 7, 2006, EPA published a proposed rule that would exclude from NPDES permit requirements discharges from water transfers that do not subject the water to an intervening industrial, municipal, or commercial use, so long as pollutants are not introduced by the water transfer activity itself. This proposal, like EPA's August 5, 2005, interpretive memorandum, explained that no one provision of the Act expressly addresses whether water transfers are subject to the NPDES program but described the indicia of Congressional intent that water transfers not be so regulated. Therefore, today's rule appropriately defers to congressional concerns that the statute not unnecessarily burden water quantity management activities and excludes water transfers from the NPDES program. This section will review the legal framework for evaluating EPA's interpretation of the CWA, explain the Agency's interpretation of the CWA, including a brief survey of prior litigation over the relevant statutory terms, and outline the relevant legislative history.

Under what is traditionally viewed as Chevron analysis, a court examining the legality of an agency's interpretation of a statute is to first ask whether the statute speaks clearly to the precise question at issue and must give effect to the unambiguously expressed intent of Congress if such unambiguous intent can be discerned. Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 842-843 (Chevron); National Ass. of Homebuilders, et al. v. Defenders of Wildlife, et al., 127 S.Ct. 2518, 2534 (2007) (NAHB). To the extent that a statute does not speak clearly to the specific issue, the Agency interpretation must be upheld if it is based on a permissible construction of the statute. Chevron, 467 U.S. at 843; NAHB, 127 S.Ct. at 2534. Courts are required to accept an agency's reasonable interpretation of a statute, even if this interpretation differs from what the court believes is the “best” statutory interpretation. National Cable and Telecommunications Ass'n, et. al. v. Brand X, et al., 545 U.S. 967, 980 (2005) (Brand X).

Deference to an agency interpretation of a statute under Chevron is appropriate where Congress has authorized an agency to make rules carrying the force of law, and such authorization is apparent where the agency is empowered to make rules or adjudicate issues or there are other indications of comparable congressional intent. United States v. Mead Corp., 533 U.S. 218 (2001). Congress has expressly authorized EPA to prescribe regulations as are necessary to administer the CWA, and today's rule has been promulgated to address the question whether water transfers require NPDES permits. CWA section 501(a); 33 U.S.C. 1361(a); 71 FR 32887 (June 7, 2006).

As discussed below, EPA has reviewed the language, structure and legislative history of the CWA and concludes that today's rule, which clarifies that NPDES permits are not required for transfers of waters of the United States from one water body to another, is a permissible construction of the statute. Taken as a whole, the statutory language and scheme support the conclusion that permits are not required for water transfers.

The Clean Water Act prohibits the discharge of a pollutant by any person except in compliance with specified statutory sections, including section 402. CWA section 301(a). The term “discharge of a pollutant” is defined as “any addition of any pollutant to navigable waters from any point source.” CWA section 502(12). The legal question addressed by today's rule is whether a water transfer as defined in the new regulation constitutes an “addition” within the meaning of section 502(12).

The term “addition” has been interpreted by courts in a variety of contexts that are relevant here. Several courts of appeals have determined that water flowing through dams and hydroelectric facilities does not constitute an addition of a pollutant under the CWA. Specifically, the Court of Appeals for the D.C. Circuit agreed with EPA that the term “addition” may reasonably be limited to situations in which “the point source itself physically introduces a pollutant into a water from the outside world.” National Wildlife Fed'n v. Gorsuch, 693 F.2d 156, 175 (D.C. Cir. 1982) (Gorsuch) (accepting EPA's view that the requirement for an NPDES permit “is established when the pollutant first enters the navigable water, and does not change when the polluted water later passes through the dam from one body of navigable water (the reservoir) to another (the downstream river).”) The Court of Appeals for the Sixth Circuit reached the same conclusion with regard to a hydropower facilities operating on Lake Michigan. National Wildlife Fed'n v. Consumers Power Co. 862 F.2d 580, 584 (6th Cir. 1988) (Consumers Power) (agreeing with the Gorsuch Court's conclusion that EPA's construction of “addition” is a permissible one). Both the Gorsuch and Consumers Power courts accorded deference to EPA's interpretation of the CWA, and specifically to its interpretation of the term “addition.” Gorsuch, 693 F.2d at 166-167; Consumers Power, 862 F.2d at 584.

Three other Courts of Appeals, however, have concluded that where a water transfer involves distinct waters of the United States, the transfer constitutes an “addition” of pollutants. Dubois v. U.S. Dept. of Agriculture, et al., 102 F.3d 1273, 1298-1300 (1st Cir. 1996); Catskill Mountains Chapter of Trout Unlimited, Inc. v. City of New York, 273 F.3d 481, 491-93 (2nd Cir. 2001) (Catskill I); Miccosukee Tribe of Indians v. South Florida Water Management District, 280 F.3d 1364 (11th Cir. 2002), vacated by Miccosukee, 541 U.S. at 112.4 These three Courts of Appeals construed the term “addition” so as to include transfers of water from one body to another distinct body (Catskill I, 273 F.3d at 491 (“EPA's position * * * is that for there to be an `addition,' a `point source must introduce the pollutant into navigable water from the outside world.' We agree with this view provided that `outside world' is construed as any place outside the particular water body to which pollutants are introduced.”) (internal citations omitted, emphasis added); Catskill II, 451 F.3d at 82-85) or transfers that cause water to move in a direction it would not ordinarily flow (DuBois, 102 F.3d at 1297; Catskill I, 273 at 493-94 (explaining DuBois); Miccosukee, 280 F.3d at 1368-69).

In pending litigation, on the other hand, the United States has taken the position that the Clean Water Act generally does not subject water transfers to the NPDES program:

Brief for the United States in Friends of the Everglades v. South Florida Water Management Dist., No. 07-13829-H (11th Cir.).

The Agency has concluded that, taken as a whole, the statutory language and structure of the Clean Water Act indicate that Congress generally did not intend to subject water transfers to the NPDES program. Interpreting the term “addition” in that context, EPA concludes that water transfers, as defined by today's rule, do not constitute an “addition” to navigable waters to be regulated under the NPDES program. Instead, Congress intended to leave primary oversight of water transfers to state authorities in cooperation with Federal authorities.

In interpreting the term “addition” in section 502(12) of the statute, EPA is guided by several principles. “Addition” is a general term, undefined by the statute. Partly for this reason, the courts have accorded substantial discretion to EPA in interpreting the term in the context of the “dams” cases. Gorsuch, 693 F.2d at 175 (finding the statute capable of supporting multiple interpretations, the legislative history unhelpful, and concluding that Congress would have given EPA discretion to define “addition” had it expected the meaning of the term to be disputed); Consumers Power, 862 F.2d at 584-85 (agreeing with the analysis in Gorsuch). Moreover, several alternative ways of interpreting the term “addition” have been proposed in the context of water transfers. As noted above, EPA's longstanding position is that an NPDES pollutant is “added” when it is introduced into a water from the “outside world” by a point source. Gorsuch, 693 F.2d at 174-175. Under one interpretation, advanced by the 2nd Circuit in Catskill Mountain, “the outside world” means anywhere outside the particular waterbody receiving the pollutant, and so a permit in that case was required for movement of pollutants between distinct waterbodies. Catskill I, 273 F.3d at 491. EPA does not agree with this understanding of the term “outside world” as evinced by its long-standing practice of generally not requiring NPDES permits for transfers between water bodies, which it has defended against court challenges asserting that such transfers do require such permits. Rather, EPA believes that an addition of a pollutant under the Act occurs when pollutants are introduced from outside the waters being transferred.

As noted above, various courts have reached different conclusions in determining when movement of waters of the United States containing pollutants constitutes an “addition” of a pollutant. To resolve the confusion created by these conflicting approaches, the Agency has looked to the statute as a whole for textual and structural indices of Congressional intent on the question whether water transfers that do not themselves introduce new pollutants require an NPDES permit.

Statutory construction principles instruct that the Clean Water Act should be interpreted by analyzing the statute as a whole. United States v. Boisdore's Heirs, 49 U.S. 113, 122 (1850). The Supreme Court has long explained “in expounding a statute, we must not be guided by a single sentence or member of a sentence, but look to the provisions of the whole law, and its object and policy.” Id. See also, Gustafond v. Alloyd Co., Inc., 513 U.S. 561, 570 (1995), Smith v. United States, 508 U.S. 223, 233 (1993), United States Nat'l Bank of Or. v. Independent Ins. Agents of Am., Inc., 508 U.S. 439, 455 (1993). In general, the “whole statute” interpretation analysis means that “a statute is passed as a whole and not in parts or sections and is animated by one general purpose and intent. Consequently, each part or section should be construed in connection with every other part or section so as to produce a harmonious whole.” Norman J. Singer, Statutes and Statutory Construction vol. 2A § 46:05, 154 (6th ed., West Group 2000). As the Second Circuit has explained with regard to the CWA:

A holistic approach to the text of the CWA is needed here in particular because the heart of this matter is the balance Congress created between federal and State oversight of activities affecting the nation's waters. The purpose of the CWA is to protect water quality. Congress nonetheless recognized that programs already existed at the State and local levels for managing water quantity, and it recognized the delicate relationship between the CWA and State and local programs. Looking at the statute as a whole is necessary to ensure that the analysis herein is consonant with Congress's overall policies and objectives in the management and regulation of the nation's water resources.

While the statute does not define “addition,” sections 101(g), 102(b), 304(f), and 510(2) provide a strong indication that the term “addition” should be interpreted in accordance with the text of the more specific sections of the statute. In light of Congress' clearly expressed policy not to unnecessarily interfere with water resource allocation and its discussion of changes in the movement, flow or circulation of any navigable waters as sources of pollutants that would not be subject to regulation under section 402, it is reasonable to interpret “addition” as not including the mere transfer of navigable waters.

The specific statutory provisions addressing the management of water resources—coupled with the overall statutory structure—provide textual support for the conclusion that Congress generally did not intend for water transfers to be regulated under section 402. The Act establishes a variety of programs and regulatory initiatives in addition to the NPDES permitting program. It also recognizes that the States have primary responsibilities with respect to the “development and use (including restoration, preservation, and enhancement) of land and water resources.” CWA section 101(b).

Congress also made clear that the Clean Water Act is to be construed in a manner that does not unduly interfere with the ability of States to allocate water within their boundaries, stating:

Water transfers are an essential component of the nation's infrastructure for delivering water that users are entitled to receive under State law. Because subjecting water transfers to a federal permitting scheme could unnecessarily interfere with State decisions on allocations of water rights, this section provides additional support for the Agency's interpretation that, absent a clear Congressional intent to the contrary, it is reasonable to read the statute as not requiring NPDES permits for water transfers. See United States v. Bass, 404 U.S. 336, 349 (1971) (“unless Congress conveys its purpose clearly, it will not be deemed to have significantly changed the federal-state balance.”)

An additional statutory provision, section 510(2), similarly provides:

Finally, one section of the Act—304(f)—expressly addresses water management activities. Mere mention of an activity in section 304(f) does not mean it is exclusively nonpoint source in nature. See Miccosukee 541 U.S. at 106 (noting that section 304(f)(2)(F) does not explicitly exempt nonpoint sources if they also fall within the definition of point source). Nonetheless, section 304(f) is focused primarily on addressing pollution sources outside the scope of the NPDES program. See H.R. Rep. No. 92-911, at 109 (1972), reprinted in Legislative History of the Water Pollution Control Act Amendments of 1972, Vol. 1 at 796 (Comm. Print 1973) (“[t]his section * * * on * * * nonpoint sources is among the most important in the 1972 Amendments”) (emphasis added)). This section directed EPA to issue guidelines for identifying and evaluating the nature and extent of nonpoint sources of pollution,6 as well as processes, procedures and methods to control pollution from, among other things, “changes in the movement, flow or circulation of any navigable waters or ground waters, including changes caused by the construction of dams, levees, channels, causeways, or flow diversion facilities.” CWA 304(f)(2)(F) (emphasis added).

While section 304(f) does not exclusively address nonpoint sources of pollution, it nonetheless “concerns nonpoint sources” (Miccosukee, 541 U.S. at 106) and reflects an understanding by Congress that water movement could result in pollution, and that such pollution would be managed by States under their nonpoint source program authorities, rather than the NPDES program. Today's rule accords with the direction to EPA and other federal agencies in section 101(g) to work with State and local agencies to develop “comprehensive solutions” to water pollution problems “in concert with programs for managing water resources.”

The text of these sections of the Act together demonstrate that Congress was aware that there might be pollution associated with water management activities, but chose to defer to comprehensive solutions developed by State and local agencies for controlling such pollution. Because the NPDES program focuses on discharges from point sources of pollutants, it is not the kind of comprehensive program that Congress believed was best suited to addressing pollution, which is the term used for the nonpoint source program. It is this type of non-point source pollution that may be associated with water transfers.

In several important ways, water transfers are unlike the types of discharges that were the primary focus of Congressional attention in 1972. Discharges of pollutants covered by section 402 are subject to “effluent” limitations. Water transfers, however, are not like effluent from an industrial, commercial or municipal operation. Rather than discharge effluent, water transfers convey one water of the U.S. into another. Additionally, the operators of water control facilities are generally not responsible for the presence of pollutants in the waters they transport. Rather, those pollutants often enter “the waters of the United States” through point and nonpoint sources unassociated with those facilities and beyond control of the project operators. Congress generally intended that pollutants be controlled at the source whenever possible. See S. Rep. No. 92-414, p. 77 (1972) (justifying the broad definition of navigable waters because it is “essential that discharge of pollutants be controlled at the source”).7 The pollution from transferred waters is more sensibly addressed through water resource planning and land use regulations, which attack the problem at its source. See, e.g., CWA section 102(b) (reservoir planning); CWA section 208(b)(2)(F) (land use planning to reduce agricultural nonpoint sources of pollution); CWA section 319 (nonpoint source management programs); and CWA section 401 (state certification of federally licensed projects). Congress acknowledged this when it directed Federal agencies to co-operate with State and local agencies to develop comprehensive solutions to prevent, reduce, and eliminate pollution in concert with programs for managing water sources.

The Agency, therefore, concludes that, taken as a whole, the statutory language and structure of the Clean Water Act indicate that Congress generally did not intend to subject water transfers to the NPDES program. Interpreting the term “addition” in that context, EPA concludes that water transfers, as defined by today's rule, do not constitute an “addition” to navigable waters to be regulated under the NPDES program. Rather, Congress intended to leave primary oversight of water transfers to state authorities in cooperation with Federal authorities.

The legislative history of the Clean Water Act also supports the conclusion that Congress generally did not intend to subject water transfers to the NPDES program. First, the legislative history of section 101(g) reveals that “[i]t is the purpose of this [provision] to insure that State [water] allocation systems are not subverted.” 3 Congressional Research Serv., U.S. Library of Congress, Serial No. 95-14, A Legislative History of the Clean Water Act of 1977, at 532 (1978); see PUD No. 1 of Jefferson County v. Washington Dep't of Ecology, 511 U.S. 700, 721 (1994).

Notably, the legislative history of the Act discusses water flow management activities in the context of the nonpoint source program only. In discussing section 304(f), the House Committee Report specifically mentioned water flow management as an area where EPA would provide technical guidance to States for their nonpoint source programs, rather than an area to be regulated under section 402.

In the legislative history of section 208 of the Act, the House Committee report noted that in some States, water resource management agencies allocating stream flows are required to consider water quality impacts. The Report stated:

Thus, Congress recognized that the new section 402 permitting program was not the only viable approach for addressing water quality issues associated with State water resource management. The legislative history makes clear that Congress generally did not intend a wholesale transfer of responsibility for water quality away from water resource agencies to the NPDES authority. Rather, Congress encouraged States to obtain approval of authority to administer the NPDES program under section 402(b) so that the NPDES program could work in concert with water resource agencies' oversight of water management activities to ensure a “balanced management control system.” Id.

In sum, the language, structure, and legislative history of the statute all support the conclusion that Congress generally did not intend to subject water transfers to the NPDES program. Water transfers are an integral part of water resource management; they embody how States and resource agencies manage the nation's water resources and balance competing needs for water. Water transfers also physically implement State regimes for allocating water rights, many of which existed long before enactment of the Clean Water Act. Congress was aware of those regimes, and did not want to impair the ability of these agencies to carry them out. EPA's conclusion that the NPDES program does not apply to water transfers respects Congressional intent, comports with the structure of the Clean Water Act, and gives meaning to sections 101(g) and 304(f) of the Act.

Based on these reasons, today's rule is within EPA's authority and consistent with the CWA.

EPA received many comments from the public and a number of states stating that the Agency does not have authority to exclude from the requirement to obtain NPDES permits, a specific class of dischargers (in this case, water transfers). These commenters were concerned that the proposed rule could jeopardize the NPDES and water quality standards (WQS) programs. In particular, they feared that point source regulation of discharges from impoundments used to settle mining wastes might fall outside the scope of section 402 if the proposed rule were finalized. In response to these comments, the Agency believes that impoundments used to settle mining process water or waste water would generally constitute “waste treatment systems” designed to meet the requirements of the CWA and would be excluded from the definition of “waters of the United States.” See 40 CFR 122.2 (definition of “Waters of the United States”). The addition of pollutants from a waste treatment system to a water of the United States triggers the permitting requirement, and today's rule therefore does not affect the permitting of such facilities.

Some commenters argued that the proposed rule is inconsistent with section 404 of the CWA (permits for dredged or fill material). They stated that dredged material is listed as a pollutant under section 502 of the CWA and that the proposed rule implies that dredged material never requires a permit unless the dredged material originates from a waterbody that is not a water of the U.S. EPA believes that today's final rule will not have an effect on the 404 program. The statutory definition of “pollutant” includes “dredged spoil,” which by its very nature comes from a waterbody. 33 U.S.C. 1362(6); 40 CFR 232.2; United States v. Hubenka, 438 F.3d 1026, 1035 (10th Cir. 2006); United States v. Deaton, 209 F.3d 331, 335-336 (4th Cir. 2000); Borden Ranch Partnership v. United States, 261 F.3d 810, 814 (9th Cir. 2001). Because Congress explicitly forbade discharges of dredged material except as in compliance with the provisions cited in CWA section 301, today's rule has no effect on the 404 permit program, under which discharges of dredged or fill material may be authorized by a permit. 33 U.S.C. 1344.

As explained above, EPA disagrees that Congress generally intended water transfers to obtain NPDES permits. EPA believes that this action will add clarity to an area in which judicial decisions have created uncertainty, and for reasons previously described in section III of this preamble, concludes that Congress generally intended to leave the oversight of water transfers to authorities other than the NPDES program. Congress made clear that the CWA is to be construed in a manner that does not unduly interfere with the ability of States to allocate water within their boundaries. Specific statutory provisions in the CWA addressing the management of water resources denote that Congress generally did not intend for water transfers to be regulated under section 402 of the CWA. Rather, sections 101(b), 208, and 304(f), in particular, establish a variety of programs and regulatory initiatives that more appropriately address water transfers. EPA's conclusion that the NPDES program does not apply to water transfers respects Congressional intent and comports with the structure of the CWA.

In the proposed rule, EPA specifically requested comment on whether the proposed definition of a water transfer properly achieves the Agency's objective. Many commenters supported the Agency's proposed definition, either generally or explicitly. On the other hand, some commenters found the proposed definition too narrow and suggested that the Agency defer to state law. Others found the definition overly broad and suggested that it may encompass too many activities. These concerns, among others, are addressed in the following discussions.

In response to the comment suggesting that the proposed definition of a water transfer is too narrow and should also include transfers between waterbodies defined as waters of the State, even where they do not constitute waters of the United States under the CWA, EPA believes that making such a change would not be appropriate because the NPDES program only applies to waters of the U.S. The same commenter also suggested that EPA defer to state law in defining a water transfer. In response, the Agency finds that a definition applicable nationwide is important to provide consistency in the application of this rule. However, nothing in this rule precludes a State, under State law, from regulating water transfers that are not subject to section 402 of the Clean Water Act. States may not exclude from NPDES permit requirements sources that are point sources under Federal law, including those that do not meet the definition of a water transfer in today's rule. For example, a point source that subjects waters of the United States to an intervening industrial, municipal or commercial use could not be exempted from NPDES permitting requirements under State law.

This rule expressly states that “discharges from a water transfer” are not subject to NPDES permitting. The Agency defines a water transfer as “an activity that conveys or connects waters of the United States without subjecting the transferred water to intervening industrial, municipal, or commercial use.” A water transfer is an engineered activity that diverts a water of the U.S. to a second water of the U.S. Thus, commenters who read the natural convergence of two rivers as being a water transfer are incorrect, though such natural convergences also do not require NPDES permits.

Some commenters sought clarification of certain elements of the term “water transfer” while others suggested changes they believed would either clarify or improve the scope of the term. Commenters suggested that EPA change the use of the term “activity” to either “occasion,” “instance,” or “occurrence,” such that the definition would read: “water transfer means an instance in which waters of the U.S. are conveyed * * *.” The commenters' concern is that the term “activities” narrows the rule to only human directed or controlled events rather than any instance in which water supplies are moved. The Agency disagrees that the change is necessary. By “activity,” the Agency means any system of pumping stations, canals, aqueducts, tunnels, pipes, or other such conveyances constructed to transport water from one water of the U.S. to another water of the U.S. Such a system may consist of a single tunnel or pumping station or it may require the use of multiple facilities along the course of the transfer to reach the second water of the U.S.

A discharge of a pollutant associated with a water transfer resulting from an intervening commercial, municipal, or industrial use, or otherwise introduced to the water by a water transfer facility itself would require an NPDES permit as any discharge of a pollutant from a point source into a water of the U.S. would. The most frequent comment on the proposed definition was that the phrase “intervening industrial, municipal, or commercial use” was unclear or overbroad.8 EPA disagrees that this phrase is unclear or overbroad, and provides clarification and examples of intervening uses below.

For example, if the water is withdrawn to be used as cooling water, drinking water, irrigation, or any other use such that it is no longer a water of the U.S. before being returned to a water of the U.S., the water has been subjected to an intervening use.9 In contrast, a water pumping station, pipe, canal, or other structure used solely to facilitate the transfer of the water is not an intervening use.

The reintroduction of the intake water and associated pollutants from an intervening use through a point source is an “addition” and has long been subject to NPDES permitting requirements. See, e.g., 40 CFR 122.2 (definition of process wastewater); 40 CFR 125.80 through 125.89 (regulation of cooling towers); 40 CFR 122.45(g) (regulations governing intake pollutants for technology-based permitting); 40 CFR Part 132, Appendix F, Procedure 5-D (containing regulations governing water quality-based permitting for intake pollutants in the Great Lakes). Moreover, a discharge from a waste treatment system, for example, to a water of the United States, would not constitute a water transfer and would require an NPDES permit. See 40 CFR 122.2. In these situations, the reintroduction of water and that water's associated pollutants physically introduces pollutants from the outside world and, therefore, is an “addition” subject to NPDES permitting requirements. The fact that some of the pollutants in the discharge from an intervening use may have been present in the source water does not remove the need for a permit, although, under some circumstances, permittees may receive “credit” in their effluent limitations for such pollutants. See 40 CFR 122.45(g) (regulations governing intake pollutants for technology-based permitting); 40 CFR Part 132, Appendix F, Procedure 5-D (containing regulations governing water quality-based permitting for intake pollutants in the Great Lakes).

Similarly, an NPDES permit is normally required if a facility withdraws water from a water of the U.S., removes preexisting pollutants to purify the water, and then discharges the removed pollutants (perhaps in concentrated form) back into the water of the U.S. while retaining the purified water for use in the facility. An example of this situation is a drinking water treatment facility which withdraws water from streams, rivers, and lakes. The withdrawn water typically contains suspended solids, which are removed to make the water potable. The removed solids are a waste material from the treatment process and, if discharged into waters of the U.S., are subject to NPDES permitting requirements, even though that waste material originated in the withdrawn water. See, e.g., In re City of Phoenix, Arizona Squaw Peak & Deer Valley Water Treatment Plants, 9 E.A.D. 515, 2000 WL 1664964 (EPA Envtl. App. Bd. Nov. 1, 2000) (rejecting, on procedural grounds, challenges to NPDES permits for two drinking water treatment plants that draw raw water from the Arizona Canal, remove suspended solids to purify the water, and discharge the solids back into the Canal); Final NPDES General Permits for Water Treatment Facility Discharges in the State of Massachusetts and New Hampshire, 65 FR 69,000 (2000) (NPDES permits for discharges of process wastewaters from drinking water treatment plants).

The Clean Water Act also clearly imposes permitting requirements on publicly owned treatment works, and large and medium municipal separate storm sewer systems. See CWA sections 402(a), 402(p)(1)-(4). Congress amended the Clean Water Act in 1987 specifically to add new section 402(p) to better regulate stormwater discharges from point sources. Water Quality Act of 1987, Public Law 100-4, 101 Stat. 7 (1987). Again, this interpretation regarding water transfers does not affect EPA's longstanding regulation of such discharges. These examples are mentioned to illustrate what is meant by “intervening industrial, municipal, or commercial use,” and are situations not associated with water transfers.

Some commenters, including State agencies with hydroelectric resources, utilities, and water districts expressed concern that if hydroelectric operations incidental to a water transfer were considered an intervening use, the water transfer would be disqualified from the exemption. Utilities often take advantage of the change in elevation over the course of a water transfer by installing hydroelectric facilities. The California State Water Resources Control Board highlighted in their comment that the Central Valley Project includes eleven power plants and that the State Water Project, the Los Angeles Aqueduct, and the All American Canal also contain hydroelectric power plants.

Today's rule does not affect the longstanding position of EPA and the Courts that hydroelectric dams do not generally require NPDES permits. See Gorsuch, 693 F.2d 156; Consumers Power 862 F.2d 580. EPA agrees that the transfers described in California are excluded from NPDES permitting requirements unless, as discussed below, the hydroelectric facility itself introduces a pollutant such as grease into the water passing though the dam.

Comments were also submitted regarding pollutants that were added by the water transfer. Commenters expressed concern that water transfers may have significant impacts on the environment, including (1) the introduction of invasive species, toxic blue-green algae, chemical pollutants, and excess nutrients; (2) increased turbidity; and (3) alteration of habitat (e.g., warm water into cold water or salt water into fresh water). In response to these comments, EPA notes that today's rule does not interfere with any of the states' rights or authorities to regulate the movement of waters within their borders. Rather, this rule merely clarifies that NPDES permits are not required for water transfers. States currently have the ability to address potential in-stream and/or downstream effects of water transfers through their WQS and TMDL programs. Nothing in today's rule affects the ability for states to establish WQS appropriate to individual waterbodies or waterbody segments.

The final rule, consistent with the proposed rule, would require NPDES permits for “pollutants introduced by the water transfer activity itself to the water being transferred.” Water transfers should be able to be operated and maintained in a manner that ensures they do not themselves add pollutants to the water being transferred. However, where water transfers introduce pollutants to water passing through the structure into the receiving water, NPDES permits are required. Consumers Power, 862 F.2d at 588; Gorsuch, 693 F.2d at 165, n. 22.

In those instances where a water transfer facility does itself introduce pollutants into the water being transferred, the scope of the required NPDES permit would only be for those added pollutants. Such a permit would not require the water transfer facility to address pollutants that may have been in the donor waterbody and are being transferred.10 Furthermore, EPA expects these additions will probably be rare. EPA considers the likelihood of such additions to be similar to the frequency of additions of leaks of oil from the turbines at hydroelectric dams. In a review of the NPDES permits issued to dams, EPA was able to identify only a minimal number of permits issued to address this concern.

Many utilities and water districts commented that it was unclear whether naturally occurring changes to the water would require a permit. For example, as water moves through dams or sits in reservoirs along the transfer, chemical and physical factors such as water temperature, pH, BOD, and dissolved oxygen may change. The Agency views these changes the same way it views changes to water quality caused by water moving through dams (National Wildlife Fed'n v. Gorsuch, 693 F.2d 156 (D.C. Cir. 1982)); they do not constitute an “addition” of pollutant subject to the permitting requirements of section 402 of the Act.

EPA would also like to make clear that this rule does not change the Agency's position regarding the application of pesticides directly to waters of the United States. See 71 FR 68483; 40 CFR 122.3(h). Ditches and canals are commonly treated with pesticides to control pest species such as algae to facilitate flow, and today's rule has no effect on the exclusion provided to such activities from NPDES permit requirements set forth in 40 CFR.122.3(h).

In the preamble to the proposed water transfers rule, EPA solicited public comment on an option that would provide an additional provision allowing the NPDES authority to designate particular water transfers as subject to NPDES permit requirements on a case-by-case basis. EPA received nearly sixty comments from states, municipalities, environmental groups, water districts, industry and others regarding EPA's consideration of this “designation authority” approach. Comments addressing EPA's discussion of such designation authority were mixed regarding their opposition to, or agreement with, this approach. The following paragraphs provide additional details regarding comments the Agency received on this option.

Commenters who opposed the designation option generally believed that this provision would be legally unsupportable and practically unworkable. The most frequently cited reason for opposing this approach was a belief that the Clean Water Act provides no authority to regulate water transfers on a case-by-case basis. Other commenters were concerned that designating some water transfers, but not others, as subject to NPDES permit requirements would result in states treating water transfers in an inconsistent manner. Several commenters stated that the existence of an impairment is not an appropriate or relevant test for determining whether or not an activity should be subject to the NPDES program. Some commenters also stated that EPA already has regulations in place with regard to use impairments, at 40 CFR 131.10, which afford flexibility in responding to unique factual circumstances where uses may be impacted by pollutants not subject to NPDES permitting under section 402.

Other commenters supported inclusion of the designation authority provision in the final rule. Some of these commenters thought this approach would be helpful in instances where the transfer involves interstate waters because NPDES permits would provide a tool to protect receiving water quality—especially in situations in which water quality standards differed in the two relevant states. In addition, several states indicated that being allowed the option of designating water transfers as requiring an NPDES permit on a case-by-case basis was important to them and cited the following three reasons for supporting this approach: (1) The designation option is consistent with Congress's general direction against unnecessary federal interference with state allocation of water rights and states' flexibility on handling water transfers; (2) states would be unable to require NPDES permits for water transfers on a case-by-case basis in the absence of the designation option; and (3) some water transfers should be considered discharges of pollutants, so it is important to retain NPDES authority in these cases.

Some commenters suggested additional programs and authorities that states can use as an alternative to NPDES permitting such as the 401 water quality certification program or a memorandum of understanding or agreement.

After considering these comments, EPA has decided not to include a mechanism in 123.3 for the permitting authority to designate water transfers on a case-by-case basis as needing an NPDES permit. This conclusion is consistent with EPA's interpretation of the CWA as not subjecting water transfers to the permitting requirements of section 402. Moreover, as discussed elsewhere in this preamble, states currently have the ability to address potential in-stream and/or downstream effects of water transfers through their WQS and TMDL programs and pursuant to state authorities preserved by section 510, and today's final rule does not have an effect on these state programs and authorities.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action.” Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.

This action does not impose any new information collection burden because this final rule generally excludes water transfers from requiring an NPDES permit. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations 40 CFR 122.21 and 123.25 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-0086, EPA ICR number 0226.18.

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

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

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

For purposes of assessing the impacts of today's final rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant adverse economic impact on a substantial number of small entities. Because EPA is simply codifying the Agency's longtime position that Congress did not generally intend for the NPDES program to regulate the transfer of one water of the United States into another water of the United States, this action will not impose any requirement on small entities.

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

EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. EPA is simply codifying the Agency's longtime position that Congress did not generally intend for the NPDES program to regulate the transfer of a water of the United States into another water of the United States. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. For the same reason, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, today's rule is not subject to the requirements of section 203 of UMRA.

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

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

This final rule does not have Federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Today's rule does not change the relationship between the government and the States or change their roles and responsibilities. Rather, this rule confirms EPA's longstanding practice consistent with the Agency's understanding that Congress generally intended for water transfers to be subject to oversight by water resource management agencies and State non-NPDES authorities, rather than the permitting program under section 402 of the CWA. In addition, EPA does not expect this rule to have any impact on local governments.

Further, the revised regulations would not alter the basic State-Federal scheme established in the Clean Water Act under which EPA authorizes States to carry out the NPDES permitting program. EPA expects the revised regulations to have little effect on the relationship between, or the distribution of power and responsibilities among, the Federal and State governments. Thus, Executive Order 13132 does not apply to this rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed rule from State and local officials. EPA received comments from States that favored and opposed the rule. States that favored the rule were primarily drier, Western states. These States argued that their State laws provide adequate and appropriate authority to address the impacts from water transfers and that permitting would negatively impact State water rights allocations. This latter point was also raised by water districts, which are quasi-governmental entities, and by local governments. States that were opposed to the rule argued that they had an interest in using their NPDES authority to prevent potential water quality impairments caused by water transfers and disagreed with EPA's analysis of the Clean Water Act.

Executive Order 13175, entitled, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.”

This final rule does not have tribal implications, as specified in Executive Order 13175. It will neither impose substantial direct compliance costs on tribal governments, nor preempt Tribal law. Today's rule clarifies that Congress did not generally intend for the NPDES program to regulate the transfer of waters of the United States into another water of the United States. Nothing in this rule prevents an Indian Tribe from exercising its own authority to deal with such matters. Thus, Executive Order 13175 does not apply to this rule.

In the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and tribal governments, EPA specifically solicited additional comments on the proposed rule from tribal officials. Comments from tribal governments were considered in the development of this final rule. Since the issues identified by tribal governments were not unique to their concerns, EPA has addressed these issues generally in its response to comments.

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

This regulation is not subject to Executive Order 13045 because it is not economically significant as defined under E.O. 12866, and because the Agency does not have reason to believe that it addresses environmental health and safety risks that present a disproportionate risk to children. Today's rule would simply clarify Congress' intent that water transfers generally be subject to oversight by water resource management agencies and State non-NPDES authorities, rather than the permitting program under section 402 of the CWA.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, EPA has concluded that this rule is not likely to have any adverse energy effects.

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

Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. Today's rule would simply clarify Congress' intent that water transfers generally be subject to oversight by water resource management agencies and State non-NPDES authorities, rather than the permitting program under section 402 of the CWA.

The Congressional Review Act, 5 U.S.C. section 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective August 12, 2008.

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 FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2007-0596 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 August 12, 2008.

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-2007-0596, 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 August 1, 2007 (72 FR 42070) (FRL-8141-5), 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 tolerance petition (PP 6F7141) by Aberdeen Road Company d/b/a Hercon Environmental, P.O. Box 453, Emigsville, PA 17318-0435. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of (Z)-7,8-epoxy-2-methyloctadecane. This notice included a summary of the petition prepared by the petitioner Aberdeen Road Company d/b/a Hercon Environmental.

There was only one comment received in response to the notice of filing. The commenter suggested that there should not be an exemption for (Z)-7,8-epoxy-2-methyloctadane because the commenter felt that “plants should not have to grow with toxic chemicals on them;” that the Agency “is not protecting the public health of the American public which is dying from all kinds of cancers;” and further of not properly evaluating pesticides in general.

Agency Response: (Z)-7,8-epoxy-2-methyloctadecane is a naturally occurring substance produced by the female gypsy moth (Lymantria dispar) as a pheromone to attract the male gypsy moth. The activity of this pesticide is specific to the Gypsy moth, and when applied to forests, it confuses the male gypsy moth searching for a mate; this reduces the moth population's ability to successfully reproduce itself without killing individuals in the population. The Agency's assessment of the naturally occurring pheromone's specific, non-toxic mode of action, its low acute toxicity and exposure profiles (see Unit III.), and its intended non-food uses indicate negligible dietary risks associated with the unintended application of (Z)-7,8-epoxy-2-methyloctadecane to areas adjacent to agricultural areas (Refs. 2 and 3).

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require 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.... ” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues ” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The AI, (Z)-7,8-epoxy-2-methyloctadecane (also known as Disparlure), is an aliphatic hydrocarbon compound containing 19 carbons and a single epoxide bond. It is a naturally occurring lepidopteran pheromone produced by female gypsy moths (Lymantria dispar) to attract males. When used as a pesticide, the pheromone is intended to disrupt mating by disorienting males during their in-flight search for females. (Z)-7,8-epoxy-2-methyloctadecane was registered by the Agency in 1986 as a non-food use pesticide to lower the incidences of gypsy moth mating in residential, municipal, and shade tree areas; recreational areas such as campgrounds, golf courses, parks and parkways; ornamental and shade tree forest planting; shelter belts, rights of way and other easements. While (Z)-7,8-epoxy-3-methyloctadecane is not intended to be sprayed directly on food or feed crops, the Agency has expressed concern that there may be a potential for regular and significant exposure from residues of the pesticide on food and feed crops as a result of unintentional spray or drift. Therefore, at the recommendation of the Agency, a request to establish an exemption for the requirement of a tolerance has been made by the applicant.

This tolerance exemption is supported by toxicity data on a structurally related substance, epoxylated soybean oil (ESO), in anticipation of frequent and significant exposure to food and feed crops near treated areas. All the data normally required to support a tolerance exemption are not available for (Z)-7,8-epoxy-2-methyloctadecane; therefore, the data on ESO was submitted to address concerns about inadvertent residues on food or feed crops. The Agency has agreed to consider the toxicity data on epoxylated soybean oil, since it is chemically similar to (Z)-7,8-epoxy-2-methyloctadecane (Disparlure), and the data requirements normally required for a food use can support an assessment of potential dietary risks associated with possible residues of the pesticide from spray drift (Refs. 1, 2 and 3).

Historically the AI, (Z)-7,8-epoxy-2-methyloctadecane, has been used as a non food use pesticide and, therefore, no data that address the data requirements required by the Agency in support of food use pesticides have been generated using this AI. Therefore, in order to satisfy these data requirements and address the issue of whether or not food and feed crops that are inadvertently affected by residues of (Z)-7,8-epoxy-2-methyloctadecane are safe, the Agency has bridged from toxicity data generated on a structurally related substance, epoxylated soybean oil, to both satisfy the food use toxicity data requirements for (Z)-7,8-epoxy-2-methyloctadecane and to conduct a risk assessment. As stated in this Unit, data normally required for a food use can support an assessment of potential dietary risks associated with possible residues of the pesticide from spray drift (Refs. 1 and 3).

ESO is a compound that is structurally related to (Z)-7,8-epoxy-2-methyloctadecane and has already been fully assessed by the Agency as an inert ingredient. ESO and (Z)-7,8-epoxy-2-methyloctadecane are similar, from a structural perspective, in that both compounds contain one or more epoxide bonds, thus the basis for the Agency's decision to allow the bridging of toxicity data from ESO to (Z)-7,8-epoxy-2-methyloctadecane. Epoxide bonds are three-membered rings, made up of 2 carbons and 1 oxygen, bonded together in a triangular shape. The epoxide bond is very unstable in the environment and this instability makes the bond very reactive such that it reacts to whatever is in the environment (i.e. proteins, nucleophiles) (Refs. 3 and 4). This information is key in determining the potential risks to the (Z)-7,8-epoxy-2-methyloctadecane compound since it is the reactive epoxide groups in both compounds that mostly contribute to the toxicological activity itself (Refs. 3 and 4). Epoxides in general are formed outside of the body (environmental epoxides) or they are synthesized in the body. Environmental epoxides are generally less toxic than epoxides that are synthesized in the body (Refs. 3 and 4). Both epoxides behave in the environment in the same way. The epoxide content of (Z)-7,8-epoxy-2-methyloctadecane is double that of ESO. While this information does suggest that (Z)-7,8-epoxy-2-methyloctadecane could be more reactive than ESO, this potential toxicity is essentially attributed to the fact that (Z)-7,8-epoxy-2-methyloctadecane has more epoxide groups (16%) than ESO (8%). Even though there are more reactive epoxide groups that belong to (Z)-7,8-epoxy-2-methyloctadecane, these reactive epoxides are environmental epoxides (i.e. found outside the body), and based on the literature, and as stated in Unit IV., the second paragraph, environmental epoxides are less toxic than those synthesized in the body (Refs. 3 and 4).

As stated in this Unit, environmental epoxides, such as (Z)-7,8-epoxy-2-methyloctadecane react in the environment. When the AI is released into the environment the epoxide groups of the AI will most likely interact with nucleophilic sites in the environment, such as proteins in food, and will not be absorbed in their active form (Refs. 3 and 4). Based on the behavior of environmental epoxides, such as this AI, the Agency has extrapolated the potential risks (if any) to humans and animals from consuming food and/or feed commodities the contain residues of (Z)-7,8-epoxy-2-methyloctadecane as a result of indirect or unintended spray or drift. The Agency has determined that even if residues of the AI were to occur on food/feed commodities, the reaction of epoxides in (Z)-7,8-epoxy-2-methyloctadecane (Disparlure) would in all probability react with proteins (such as those already found in foods) during digestion and would not be absorbed in their active form to cause any toxicological effects (Refs. 3 and 4). Additionally, there are also a number of ways the body can detoxify epoxides like Disparlure if they are absorbed in an active form (Ref. 4). These are:

1. Spontaneous decomposition,

2. Nonenzymatic reaction with glutathione,

3. Reaction with glutathione catalyzed by glutathione transferase,

4. Hydration by epoxide hydrolase, and

5. Minor mechanisms such as cytochrome P450 hydrolysis (Refs. 3 and 4).

Further, acute oral toxicity studies on both substances indicated that their toxicity is low (Toxicity Category IV) which is consistent with these general characteristics of environmental epoxides. Therefore, use of toxicity data on ESO to define endpoints for the assessment of dietary exposure estimates associated with inadvertent treatment of food or feed crops with (Z)-7,8-epoxy-2-methyloctadecane (Disparlure) is reasonable. ESO data - including application of maximum uncertainty factors - define endpoints used in risk characterization for (Z)-7,8-epoxy-2-methyloctadecane, and data requirements to support the petition for exemption from the requirement of tolerances for the AI have been waived by the Agency based on the negligible risks described in this Unit.

Acute oral toxicity (rat) (OPPTS GLN 870.1100): Based on acute oral toxicity studies in rats, (Z)-7,8-epoxy-2-methyloctadecane has very low toxicity and is classified into Toxicity Category IV. No adverse effects or deaths were seen in rats that received an oral dose of undiluted (Z)-7,8-epoxy-2-methyloctadecane at 5,000 milligram per kilogram of bodyweight (mg/kg/bw) (Master Record Identification (MRID) Number 45529801). ESO also has very low acute oral toxicity lethal dose (LD)50 > 5,000 mg/kg (Toxicity Category IV; Refs. 2 and 3).

Information from The Scientific Panel on Food Additives (European Commission on Food Safety) was considered which included a two-year chronic oral toxicity study in rats given diets containing up to 5% ESO. The no observed adverse effect level (NOAEL) was approximately 140 mg/kg/day and the lowest observed adverse effect level (LOAEL) was approximately 1,400 mg/kg/day. Observed effects were slight changes in liver, kidney and uterus weights. The published summary also concluded that ESO was not carcinogenic when fed to rats. Based on the data, a tolerable daily intake of 1 mg/kg/day was determined for ESO (Refs. 1, 2, and 3).

The European Food Safety Authority (EFSA) report (2004) also described a developmental toxicity study in which ESO was given to pregnant rats during gestation at daily oral doses of 0, 100, 300 or 1,000 mg/kg/day (Ref. 1). No maternal or developmental effects were noted at any dose level according to the summary submitted (Ref. 3).

The EFSA review indicated that ESO was administered daily by oral gavage to rats at the 100, 300 and 1,000 mg/kg bw/day dose levels for 71 and 15 days before mating in males and females, respectively, until day 21 post-partum of F1 litters; no toxic effects were noted in parental animals or their offspring (Ref. 1). Under the experimental conditions, the highest tested dose of 1,000 mg/kg bw/day was found to be the NOAEL, and no LOAEL was reported (Ref. 3).

A bacterial reverse mutation assay using Salmonella typhimurium and Escherichia coli was conducted on (Z)-7,8-epoxy-2-methyloctadecane with and without activation. The study concluded that (Z)-7,8-epoxy-2-methyloctadecane was not mutagenic in bacteria under the conditions of the study.

In assessing the hazard associated with (Z)-7,8-epoxy-2-methyloctadecane, its has been characterized in terms of epoxylated soybean oil. All toxicological effects were observed at or above limit doses (≥5,000 mg/kg/bw for acute oral toxicity and ≥1,000 mg/kg/bw/day for reproductive, developmental and chronic toxicity studies) (Ref. 3). Based upon the Agency's standard hazard assessment protocol, if there is an incomplete data set for assessment of developmental toxicity (studies in two species) and a one-generation reproduction toxicity study (rather than a multi-generation reproduction study), an uncertainty factor of 3X is retained for consideration of the sensitivity of infants and children (Ref. 3). Moreover, there is uncertainty regarding the structure-activity relationship between Disparlure and ESO (16% versus 7-8% epoxide by weight, respectively) and the lack of repeated-dose studies on both substances to adequately support bridging from ESO data to Disparlure (at least one repeated-dose study on both substances) for purposes of assessing the dietary risks associated with use of the mating disruptor (Ref. 3). To account for this, an additional 10X uncertainty factor is applied (Ref 3). Therefore, the 1,000 mg/kg/day endpoint was divided by 1,000 for general population risk characterizations (uncertainty factors of 10X for interspecies extrapolation, 10X for intraspecies variation, and 10X for uncertainties regarding bridging from data on a surrogate substance) to determine a reference dose (RfD) of 1 mg/kg/day; a population adjusted dose (PAD) of 0.33 mg/kg/day for infants and children is determined when the FQPA safety factor (3X) is retained (Ref. 3).

Comparing this with the maximum estimated exposure for pesticidal use of Disparlure, the result does not exceed the Agency's level of concern (LOC) because the estimated exposure is less than 1% of the RfD (Ref. 3). Based on the behavior of epoxides in the environment and during ingestion, we conclude that toxicologically significant residues will not result (refer to Unit III.; Refs. 3 and 4). Even when the maximum potential for inadvertent residues from the non-food uses of this pesticide are compared with the most conservative estimate of hazard, there is reasonable certainty that no harm will result to the U.S. population from exposure to this pesticide when used according to label instructions (Ref. 3). In the event that a food-use is requested, the Agency would require repeated-dose studies such as a 90-day subchronic feeding study (OPPTS 870.3100) and a prenatal developmental toxicity study (OPPTS 870.3700) on Disparlure.

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

In general, the epoxide (oxirane ring formed by an oxygen and two carbon atoms) is the reactive group in (Z)-7,8-epoxy-2-methyloctadecane and other epoxides, and is expected to contribute the most to biological or toxicological activity of (Z)-7,8-epoxy-2-methyloctadecane (Ref. 4; see Ref. 3). The unstable oxirane ring can open and react with DNA, protein, or other nucleophilic substances. This means that if (Z)-7,8-epoxy-2-methyloctadecane were to be ingested then most likely the epoxide would react with the proteins in food during digestion (i.e. it would be digested). As stated in the literature (deBethizy and Hayes (Ref. 4), epoxides formed in animals are apparently more toxic than those present in the environment because they react with proteins and DNA in the animal's tissue (Refs. 3 and 4). If the AI were to result on food/feed commodities, the epoxide or reactive group of that AI is more likely to break down and react with nucleophiles and proteins that are found in food and would not be absorbed in their active form (Refs. 3 and 4). However, even if they are absorbed in their active form, epoxides can be detoxified in the human body via:

1. Spontaneous decomposition,

2. Nonenzymatic reaction with glutathione,

3. Reaction with glutathione catalyzed by glutathione transferase,

4. Hydration by epoxide hydrolase, and

5. Minor mechanisms such as cytochrome P450 hydrolysis (Ref.s 3 and 4).

In general, these considerations are expected to reduce the potential risk.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and on all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Given the use pattern of this AI, residues of the AI on food/feed crops as a result of unintentional spray or drift, as stated throughout this document, is not expected. However, the Agency has determined that even if residues of the AI were to occur on food/feed commodities, the reactive groups of the active would not be absorbed in their active form to cause any toxicological effects. While it is reasonable to assume that no toxicological effects would occur given the unliklihood of absorption and the low toxicity of the AI, the EPA has further examined the potential for dietary exposure from unintentional spray or drift and absorption and has estimated the potential risks (if any) to humans, including infants and children, from the consumption of food commodities that have been inadvertently treated with the AI. Assuming that dietary exposure has occurred the Agency considered potential exposure estimates for two representative scenarios including pasture grass and apple orchards.

1. Food — i. Apples. The Agency used apples as one representative in conducting its food assessment since apples are a significant commodity by a sensitive subpopulation (infants and children). For the apple exposure analysis, the Agency obtained a kg apples/A value from U.S. Department of Agriculture (USDA) statistics and used the worst-case application rate of 60 grams (g) (Z)-7,8-epoxy-2-methyloctadecane/Acre (A) (two applications of 30 g/A per season) for an apple orchard (unintentional application). The maximum potential concentration of (Z)-7,8-epoxy-2-methyloctadecane was estimated to be 6 mg/AI/kg of apples (i.e., 6 parts per million (ppm); Ref 3). This 6 ppm value is an overestimate because its determination assumes: All the (Z)-7,8-epoxy-2-methyloctadecane is directly applied to an apple orchard (a misuse) and all of the AI applied will be on or in the apples (not sticking to foliage or other inedible plant parts). (Z)-7,8-epoxy-2-methyloctadecane residues are also likely to be reduced by their reactivity, the AI's physical/chemical properties, and washing or processing treated apples before their consumption (Ref. 3).

Based on the amount of the AI/kg of crop it was determined that the amount of (Z)-7,8-epoxy-2-methyloctadecane consumed from treated apples for the general population, children, and adults would be 0.005, 0.03 and 0.002 mg/A.I./kg/bw per day, respectively (Ref. 3). As noted in the introduction to this Unit IV. Aggregate Exposures, by the time Disparlure-treated apples are consumed, the epoxides in the AI are likely to have broken down or reacted with nucleophiles such as proteins in the apples and would not be absorbed in their active form (Refs. 3 and 4).

ii. Pasture. A pasture grass exposure analysis was presented in the applicant's petition, which was based on maximum recommended single application rates (30 g/AI/A) and a model for estimating potential exposure for grazing cattle (described at http://www.epa.gov/oppefed1/ecorisk_ders/toera_analysis_exp.htm). The largest estimate was determined to be 0.14 mg Disparlure/kg cattle body weight per day (Ref. 3). This estimate of the potential exposure was based on the assumption that all the Disparlure applied to an acre of short grass would be consumed as if the AI was intentionally applied to the pasture rather than drifting from a nearby treated area (Ref. 3). A more realistic assumption in the exposure analysis was that 10% or less of the pasture grass would be impacted by spray drift, thereby reducing the exposure estimate to 0.014 mg Disparlure/kg cattle bw/day (Ref. 3). Also, applications in any given area would not be done more than one or two days each year which further reduces the potential exposure to cattle. As noted in the second paragraph of Unit IV., the metabolic pathways that break down epoxides in animals are expected to further reduce the potential for dietary exposure preventing detection or bioaccumulation of Disparlure residues in cattle feeding on inadvertently treated pasture grass. Therefore, a dietary assessment for meat, milk and meat by-products was not conducted by the Agency (Ref 3).

2. Drinking water exposure. Exposure to residues of (Z)-7,8-epoxy-2-methyloctadecane in consumed drinking water is unlikely because of the reactivity of such epoxides in the environment (see discussion under Unit IV. Aggregate Exposure; Refs. 3 and 4), and the AI is not directly applied to water. Therefore, drinking water exposure is not expected to pose any quantifiable risks due to a lack of residues of toxicological concern.

There are no residential, school, or day care uses proposed for (Z)-7,8-epoxy-2-methyloctadecane (Disparlure). Since the proposed use is for agricultural non-food crops the potential for non-occupational, non-dietary exposures to (Z)-7,8-epoxy-2-methyloctadecane by the general population, including infants and prolonged inhalation exposure to non-sticking flakes in unlikely (Ref. 2).

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish an exemption from 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.” These considerations include the possible cumulative effects of such residues on infants and children. EPA has considered the potential for cumulative effects of (Z)-7,8-epoxy-2-methyloctadecane and other substances in relation to common mechanism of toxicity. Common mechanisms of toxicity are not relevant to a consideration of cumulative exposure to (Z)-7,8-epoxy-2-methyloctadecane because it is not toxic to mammalian systems. Because, since Disparlure is an environmental epoxides (formed outside the body) which are generally considered less toxic than epoxides synthesized inside the body (Ref. 4). The reactive epoxide in Disparlure's structure would most likely react with proteins in food during digestion and would not be absorbed in their active form to induce toxicological effects (Ref. 4). There are also a number of ways the body can detoxify epoxides like Disparlure if they are absorbed in an active form (Ref. 4). Also the acute oral toxicity study on Disparlure indicated that the toxicity is low (Toxicity Category IV). Thus, the Agency does not expect any cumulative or incremental effects from exposure to residues of (Z)-7,8-epoxy-2-methyloctadecane when applied/used as directed on the label and in accordance with good agricultural practices. Additionally, when comparing the most conservative estimate of hazard to the maximum potential for inadvertent residues from the non-food uses of Disparlure, the result does not exceed the Agency's LOC (i.e.: Estimated exposure is less than 1% of the RfD; Ref. 3). Margins of Exposure (MOE) based on estimated exposure and hazard (the 140 mg/kg/day NOAEL from a chronic toxicity study in rats) range from 4,600 to 65,000 (Ref. 3). When the resulting MOE is greater than 100, the Agency's LOC is not exceeded and there is reasonable certainty of no harm to human health (Ref. 3).

1. U.S. population. The Agency has determined that there is reasonable certainty that no harm will result to the U.S. Population from aggregated exposure to residues of (Z)-7,8-epoxy-2-methyloctadecane. This includes all dietary exposures and other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the chemicals low acute toxicity, it is a naturally occurring lepidopteran pheromone produced by female gypsy moths (Lymantria dispar), is similar in chemical structure to compounds of low chronic toxicity (ESO), and has a very low potential for human exposure. (Ref. 2).

2. Infants and children. FFDCA section 408 provides that EPA shall apply an additional tenfold MOE for infants and children in the case of threshold effects. Margins of exposure are often referred to as uncertainty or safety factors, and are used to account for potential prenatal and postnatal toxicity and any lack of completeness of the database. Based on available data and other information, EPA may determine that a different MOE will define a level of concern for infants and children or that a MOE approach is not appropriate. Based on all the available information the Agency reviewed on (Z)-7,8-epoxy-2-methyloctadecane, including a lack of threshold effects, the Agency concluded that (Z)-7,8-epoxy-2-methyloctadecane is practically non-toxic to mammals, including infants and children. Since there are no effects of concern, the provision requiring an additional margin of safety does not apply.

There is no evidence to suggest that (Z)-7,8-epoxy-2-methyloctadecane functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

Because this is an exemption from the requirement of a tolerance without numerical limitations, no analytical method is required.

There are no CODEX maximum residue levels for residues for (Z)-7,8-epoxy-2-methyloctadecane for unintentional spray or drift from application when treating trees and shrubs along or within pastures, as well as unintentional spray and drift to non-target vegetation including native and ornamental species, and food and feed crops.

Based on the low toxicity in animal testing, and the expected low exposure to humans, no risk to human health is expected from use of the chemical on food crops.

1. EFSA. (2004) Opinion of the Scientific Panel on Food Additives, Flavorings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to the use of Epoxidized soybean oil in food contact materials. EFSA Journal 64: 1-17.

2. Gonzales, A. (June 27, 2007) USEPA Memorandum - Tolerance Exemption Petition Review for (Z)-7,8-epoxy-2-methyloctadecane.

3. Gardner, R. & A. Gonzales (January 8, 2008) USEPA Memorandum - Dietary Risk Considerations Supporting a Petition for Exemption from the Requirement of a Tolerance for (Z)-7,8-epoxy-2-methyloctadecane.

4. de Bethizy, J.D., and J.R. Hayes. 2001. “Metabolism: Determinant of Toxicity” Ch. 3 in Principles and Methods of Toxicology, 4th Edition. A.W. Hayes, ed. Taylor & Francis. Philadelphia, PA. pp. 123-124.

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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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:

• 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 Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (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-2007-1107 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 August 12, 2008.

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-2007-1107, 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 FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for combined residues of the herbicide fenoxaprop-ethyl, [(±)-ethyl 2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoate], and its metabolites (2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-dihydrobenzoxazol-2-one) in or on grass forage and hay at 0.05 parts per million (ppm). These time-limited tolerances expire and are revoked on December 31, 2010. EPA will publish a document in the Federal Register to remove the revoked tolerances from the CFR.

Section 408(l)(6) of 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 time-limited tolerances to set binding precedents for the application of section 408 of FFDCA to other tolerances and exemptions. Section 408(e) of 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 FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Oregon Department of Agriculture (ODA) states that an emergency situation has arisen from weed problems that were once controlled with an older product, under Special Local Needs (SLN) registrations that were in effect from 1987 to 2002. Since 2002, the growers have been lacking a method to effectively control the problem weeds and the problem has continued to worsen since the SLNs were cancelled. The ODA states that none of the herbicides currently registered for use on grasses grown for seed are effective for controlling the weed species addressed by their request, or do not provide adequate control, due to timing of application, or spectrum of control. Cultural controls are not viable alternatives due to the soil type, steep terrain, density of grass stand; or adaptability of the weed species to various grass seed production systems, such as varying planting date, row spacing, or grass variety planted. In grass seed production, the presence of noxious weed seeds like wild oat, results in significant discounts to the sale prices, and certain states and countries completely prohibit sale of grass seed containing noxious weed species; thus, growers suffer losses of significant sales. Certain weed species can also cause yield losses of up to 50% under moderate to high infestation levels. Therefore, ODA states that an urgent and non-routine situation has arisen, with significant economic losses expected. After having reviewed the submission, EPA determined that emergency conditions exist for this State, and that the criteria for an emergency exemption are met. EPA has authorized under FIFRA section 18 the use of fenoxaprop-ethyl on grasses grown for seed for control of grassy weeds in Oregon.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of fenoxaprop-ethyl in or on grass forage and hay. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of 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 FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2010, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on grass forage and hay after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fenoxaprop-ethyl meets FIFRA's registration requirements for use on grasses grown for seed or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of fenoxaprop-ethyl by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for persons in any State other than Oregon to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for fenoxaprop-ethyl, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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

Consistent with the factors specified in FFDCA 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 expected as a result of this emergency exemption request and the time-limited tolerances for combined residues of fenoxaprop-ethyl on grass forage and hay at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fenoxaprop-ethyl used for human risk assessment is discussed in Unit II. of the final rule published in the Federal Register of April 22, 1998 (63 FR 19829) (FRL-5782-1).

EPA believes that no changes need to be made as a result of this section 18 emergency exemption use on grasses grown for seed, to the conclusions of the risk assessment discussed in the final rule published on April 22, 1998 in the Federal Register (63 FR 19829) (FRL-5782-1) which established tolerances in barley commodities. EPA has used barley data to estimate residues which could occur on the hay and forage from grasses grown for seed, and this section 18 use is not expected to change the aggregate exposure estimates from the 1998 barley assessment. This conclusion is based upon the position that this section 18 use will not contribute to human dietary exposure for the following reasons:

1. This section 18 use does not involve use on human foods; and

2. This section 18 use is unlikely to alter the dietary burden for livestock (and corresponding residues in livestock tissues) because the resulting feed commodities do not comprise a significant part of livestock diet.

Therefore, because EPA has reasonable certainty of no harm from dietary exposure from the existing uses, and, that this use on grasses grown for seed pursuant to the emergency exemption would not increase dietary exposure, EPA is establishing these time-limited tolerances for grass hay and forage.

Since the time of the 1998 risk assessment, there has been a shift to (+) fenoxaprop-ethyl (the r-isomer enriched (95%) formulation of fenoxaprop-ethyl) as the primary active ingredient (also referred to as fenoxaprop-P-ethyl to denote the direction in which it rotates polarized light), rather than a 50:50 mix of (±)fenoxaprop-ethyl (the racemic mixture of the r- and s- isomers) both referred to in this document as the parent, fenoxaprop-ethyl. The current tolerance action is for fenoxaprop-ethyl, which covers both the “+” and “-” isomers. The analytical method used to determine residues of fenoxaprop-ethyl and its metabolites, expressed as the parent, is unable to distinguish between stereochemical isomers. Further, adequate data was provided (for barley) to indicate that comparable residue results are obtained from application of either the 50:50 mixture, or the so-called “enriched” mixture. At the time of the change in formulation, EPA determined that the established tolerances would protect human health and that the existing toxicology data supported the continued registration with the enriched formulation. EPA determined that there was a reasonable certainty of no harm from the continued registrations of the enriched formulation. EPA has determined that, for the purposes of this section 18 use only, the residue data for barley may be relied on for grass hay and forage, since the use patterns are nearly identical. For these reasons, as well as those given in Unit IV.B.1. and 2., the agency believes that the existing data are adequate to support these tolerances.

EPA concludes that establishing the tolerances for grass hay and forage, as set forth in this document, will not change the estimated aggregate risks, as discussed in the April 22, 1998 Federal Register. Refer to the April 22, 1998 Federal Register document 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 document in support of this action.

Based on the risk assessments discussed in the final rule published in the Federal Register of April 22, 1998, 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 fenoxaprop-ethyl residues.

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

There are no established Codex tolerances for fenoxaprop-ethyl and its metabolites in or on grass forage or hay.

Therefore, time-limited tolerances are established for combined residues of fenoxaprop-ethyl [(±)-ethyl 2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid], and its metabolites (2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-dihydrobenzoxazol-2-one), in or on grass hay and grass forage, both at 0.05 ppm. These tolerances expire and are revoked on December 31, 2010.

This final rule establishes tolerances under sections 408(e) and 408(l)(6) 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 final rule has been exempted from review under Executive Order 12866, this final 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

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 9, 2000) do not apply to this final rule. In addition, this final 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).

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction

The EPA Region 6 office is publishing this direct final notice of deletion of the Double Eagle Refinery Co. Site, Oklahoma City, Oklahoma County, Oklahoma from the NPL. The NPL constitutes Appendix B of 40 CFR part 300, which is the Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as a list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in. 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at the deleted sites warrant such actions.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective August 12, 2008 unless EPA receives adverse comments by July 14, 2008. Along with the direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the “Proposed Rules” section of the Federal Register. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this notice explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Double Eagle Refinery Co. Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA actions to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate to protect public health and the environment. In making a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the state, whether any of the following criteria have been met:

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

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

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) EPA consulted with the state of Oklahoma prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete copublished today in the “Proposed Rules” section of the Federal Register.

(2) EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through the Oklahoma Department of Environmental Quality, has concurred on the deletion of the Site from the NPL.

(3) Concurrent with the publication of this direct final Notice of Deletion, a notice of availability is being published in The Oklahoman and is being distributed to appropriate federal, state and local government officials and other interested parties. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final notice of deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management of Superfund sites. As mentioned in section II of this document, Sec. 300.425 (e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions should future conditions warrant such actions.

The following information provides EPA's rationale for deleting this Site from the NPL.

The Site occupies the Southeast Quarter (SE 1/4) of section 35, Township 12 North, Range 3 West, Indian Meridian, Oklahoma County, Oklahoma City, Oklahoma. Located at 301 N Rhode Island (generally South of NE 4th Street and West of Martin Luther King Boulevard), the Site extends over approximately 12 acres. The Double Eagle Refinery collected, stored, and re-refined used oils and distributed the recycled product. The refinery was active as early as 1929.

In 1986 through 1988, EPA conducted investigations of the Site. The sampling results revealed elevated levels of volatile organic compounds, semi-volatile organic compounds, and metals found in surface water, soil, sediment, and ground water. The Site also was found to contain acidic sludges in on-site lagoons or pits.

The data from these sampling efforts resulted in the Site being proposed for the Superfund NPL on June 24, 1988, 53 FR 23978, and the Site was included on the NPL on March 31, 1989, 54 FR 10512.

The May 1992 Remedial Investigation (RI) reported potential additional lifetime cancer risks to on-site workers that may have access to the Site of 1.2 x 10E-04, which is two orders of magnitude higher than the criterion of acceptability. Due to the unsecured nature of the site, other unacceptable risks were possible to trespassers and the resident of one nearby house. The shallow ground water was not considered a potential source of drinking water and was reported of limited potential beneficial use due to the high value of Total Dissolved Solids (TDD), however concerns of potential contamination to the deeper Garber-Wellington aquifer, triggered further investigations into the ground water to ensure protection of this source. Regionally, Oklahoma City receives its public water supply from reservoirs surrounding the city.

The Site was divided into two operable units, a source control operable unit and a ground water operable unit. EPA issued a Record of Decision on September 28, 1992 for the source control operable unit. The remedial action activities for the source control operable unit, initiated in August 1997, consisted of asbestos abatement and demolition of existing structures, on-site neutralization and stabilization of wastes, and off-site disposal at a permitted landfill. The remedial action was completed in March 2000.

EPA issued a ground water Record of Decision on April 19, 1994. The remedial action activities for the ground water operable unit, initiated in December 1996, consisted of quarterly ground water monitoring for three years followed by semi-annual monitoring for three years. EPA issued an Explanation of Significant Difference in January 2006, and documented a final decision to discontinue further semi-annual monitoring.

EPA issued a Final Close Out Report on March 7, 2006, which affirmed that the remedial action activities for the source control operable unit and ground water operable unit had been completed and were consistent with CERCLA, as amended, and to the extent practicable, the NCP.

EPA issued a second Explanation of Significant in May 2008 to clarify the final decision for clean up levels and document the need for Institutional Controls and Five-Year Reviews.

An element of the selected remedy is to place notices to the property deed warning of the site hazards. These notices were filed pursuant to Oklahoma Statutes, Title 27A (2000 Supp.), Section 2-7-123(B), by the Oklahoma Department of Environmental Quality in 2001. These notices declare the sites considered appropriate for activities associated with industrial/commercial uses, the anticipated future land use according to the ROD. Furthermore, the Oklahoma City Zoning maps indicate the land use for the sites as classified for industrial.

A component of the ground water ROD is to ensure future potential users of the lower Garber-Wellington aquifer are not exposed to contaminants from the site. As part of Operation and Maintenance activities, the State maintains the institutional controls and reviews records of wells drilled in the area to ensure shallow ground water is not used, and additional wells are not installed in the area.

The remedial action cleanup activities at the Double Eagle Refinery Site are consistent with the objectives of the NCP and will provide protection to human health and the environment. The source control operable unit cleanup goals were to provide for commercial/industrial reuse of the Site. During the remedial action confirmation samples were collected to ensure that all materials left at the Site were below the cleanup goals. The remedial action objectives for the ground water operable unit, to ensure that future potential users of the lower Garber-Wellington aquifer are not exposed to contaminants from the Site and to ensure that the North Canadian River is not impacted by contaminants from the Site, have also been met by the remedial actions at the Site.

The Remedial Investigation identified the shallow aquifer as a Class III aquifer (the water is not suitable for human consumption). As indicated through the ground water monitoring events, and the additional investigations conducted, it was confirmed that the shallow ground water in the alluvium is not usable as a drinking water source. During a 1996 investigation, additional wells were drilled below 200 feet in depth to document the presence of a shale aquitard, which is approximately 160+ feet deep. This shale within the Garber Sandstone acts as an “aquitard” to separate the upper and lower ground water aquifers, and provides protection to the lower aquifer from the migration of contaminants in the shallow ground water. The deeper ground water of the Garber-Wellington aquifer below the shale aquitard is below cleanup goals.

The remedial action objective “to ensure future potential users of the deeper Garber-Wellington aquifer are not exposed to contaminants from the site” is achieved through the State monitoring of the installation of any additional wells in the area.

The ODEQ has committed to performing Operation and Maintenance (O&M) activities at the Site. In March 2006, the ODEQ submitted the Site O&M Plan to EPA, which defines the long-term O&M activities for the Site. O&M activities consist of maintaining the institutional controls on the Site and semi-annual search of well drilling records to ensure that no drinking water wells are installed on or near the Site.

Hazardous substances remain at the Site above levels that allow for unlimited use and unrestricted exposure. Therefore, the EPA must conduct a statutory five-year review of the remedy no less than every five years after the initiation of the remedial action pursuant to CERCLA section 121(c), and as provided in the current guidance on Five-Year Reviews (OSWER Directive 9355.7-03B-P, Comprehensive Five-Year Review Guidance, June 2001). Based on the five-year reviews, EPA will determine whether human health and the environment continue to be adequately protected by the implemented remedy. Five-year reviews for this Site were completed in July 29, 2002 and May 15, 2007. The reviews found that the remedy remains protective of human health and the environment, and that the Site appears to have been properly maintained during the period between reports. The next five-year review will occur no later than May 15, 2012.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

A Public Comment period was established when the site was proposed to the National Priorities List, and Public Meetings were conducted on July 1992 and August 1993 to discuss the proposed remedies for the soil and the groundwater operable units. With this Notice of Deletion, a 30-day public comment period is established before making this deletion final.

The EPA, with concurrence of the State of Oklahoma, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective August 12, 2008 unless EPA receives adverse comments by July 14, 2008. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect and, EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction

The EPA Region 6 office is publishing this direct final notice of deletion of the Fourth Street Abandoned Refinery Site, Oklahoma City, Oklahoma County, Oklahoma from the NPL. The NPL constitutes Appendix B of 40 CFR Part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as a list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in Sec. 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions in the unlikely event that conditions at the site warrant such action.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective August 12, 2008 unless EPA receives adverse comments by July 14, 2008. Along with the direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the “Proposed Rules” section of the Federal Register. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this notice explains the criteria for deleting sites from the NPL. Section III discusses the procedures that EPA is using for this action. Section IV discusses the Site and explains how the Site meets the deletion criteria. Section V discusses EPA actions to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate to protect public health and the environment. In making a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the state, whether any of the following criteria have been met:

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

ii. all appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) EPA consulted with the state of Oklahoma prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the “Proposed Rules” section of the Federal Register.

(2) EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through the Oklahoma Department of Environmental Quality, has concurred on the deletion of the Site from the NPL.

(3) Concurrent with the publication of this direct final Notice of Deletion, a notice of availability is being published in The Oklahoman and is being distributed to appropriate federal, state and local government officials and other interested parties. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final notice of deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management of Superfund sites. As mentioned in section II of this document, Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions should future conditions warrant such actions.

The following information provides EPA's rationale for deleting this Site from the NPL.

The Site occupies the Southwest Quarter (SW 1/4) of Section 36, Township 12 North, Range 3 West, Indian Meridian, Oklahoma County, Oklahoma City, Oklahoma. Located at 2200 Block NE 4th Street (South of NE 4th Street and East of Martin Luther King Boulevard), the Site extends over approximately 27 acres. The Fourth Street Abandoned Refinery collected, stored, and re-refined used oils and distributed the recycled product. The refinery was active from the 1940s to the late 1960s or early 1970s.

In 1985 through 1988, EPA conducted investigations of the Site. The sampling results revealed elevated levels of volatile organic compounds, semi-volatile organic compounds, and metals found in surface water, soil, sediment, and ground water. The Site also was found to contain acidic sludges in on-site lagoons or pits.

The data from these sampling efforts resulted in the Site being proposed for the Superfund NPL on June 24, 1988, 53 FR 23978, and the Site was included on the NPL on March 31, 1989, 54 FR 10512.

The May 1992 Remedial Investigation report identified the Site as containing remnants of the dismantled refinery, including waste impoundments and an exposed tar mat. The potential additional lifetime cancer risks to the on-site workers were estimated at 3.0 × 10E-03, which are three orders of magnitude higher than the criterion of acceptability. The shallow ground water was not considered a potential source of drinking water and was reported of limited potential beneficial use due to the high value of Total Dissolved Solids (TDD), however concerns of potential contamination to the deeper Garber-Wellington aquifer, triggered further investigations into the ground water to ensure protection of this source. Regionally, Oklahoma City receives its public water supply from reservoirs surrounding the City.

The Site was divided into two operable units, a source control operable unit and a ground water operable unit. EPA issued a Record of Decision on September 28, 1992 for the source control operable unit. The remedial action activities for the source control operable unit, initiated in March 1995, consisted of on-site neutralization and stabilization of wastes, and off-site disposal at a permitted landfill. The remedial action was completed in April 1996.

EPA issued a ground water Record of Decision on September 30, 1993. The remedial action activities for the ground water operable unit, initiated in December 1996, consisted of quarterly ground water monitoring for three years followed by semi-annual monitoring for three years. EPA issued an Explanation of Significant Difference in January 2006, and documented a final decision to discontinue further semi-annual monitoring.

EPA issued a Final Close Out Report on March 7, 2006, which affirmed that the remedial action activities for the source control operable unit and ground water operable unit had been completed and were consistent with CERCLA, as amended, and to the extent practicable, the NCP.

EPA issued a second Explanation of Significant Difference in May 2008 to clarify the final decision for clean up levels and document the need for Institutional Controls and Five-Year Reviews.

An element of the selected remedy is to place notices to the property deed warning of the site hazards. These notices were filed pursuant to Oklahoma Statutes, Title 27A (2000 Supp.), Section 2-7-123(B), by the Oklahoma Department of Environmental Quality in 2001. These notices declare the sites considered appropriate for activities associated with industrial/commercial uses, the anticipated future land use according to the ROD. Furthermore, the Oklahoma City Zoning maps indicate the land use for the sites as classified for industrial.

A component of the ground water ROD is to ensure future potential users of the lower Garber-Wellington aquifer are not exposed to contaminants from the site. As part of Operation and Maintenance activities, the State maintains the institutional controls and reviews records of wells drilled in the area to ensure shallow ground water is not used, and additional wells are not installed in the area.

The remedial action cleanup activities at the Fourth Street Abandoned Refinery Site are consistent with the objectives of the NCP and will provide protection to human health and the environment. The source control operable unit cleanup goals were to provide for commercial/industrial reuse of the Site. During the remedial action, confirmation samples were collected to ensure that all materials left at the Site were below the cleanup goals. The remedial action objectives for the ground water operable unit, to ensure that future potential users of the lower Garber-Wellington aquifer are not exposed to contaminants from the Site and to ensure that the North Canadian River is not impacted by contaminants from the Site, have also been met by the remedial actions at the Site.

The Remedial Investigation identified the shallow aquifer as a Class III aquifer (the water is not suitable for human consumption). As indicated through the ground water monitoring events, and the additional investigations conducted, it was confirmed that the shallow ground water in the alluvium is not usable as a drinking water source. During a 1996 investigation, additional wells were drilled below 200 feet in depth to document the presence of a shale aquitard, which is approximately 160+ feet deep. This shale within the Garber Sandstone acts as an “aquitard” to separate the upper and lower ground water aquifers, and provides protection to the lower aquifer from the migration of contaminants in the shallow ground water. The deeper ground water of the Garber-Wellington aquifer below the shale aquitard is below cleanup goals.

The remedial action objective “to ensure future potential users of the deeper Garber-Wellington aquifer are not exposed to contaminants from the site” is achieved through the State monitoring of the installation of any additional wells in the area.

The ODEQ has committed to performing Operation and Maintenance (O&M) activities at the Site. In March 2006, the ODEQ submitted the Site O&M Plan to EPA, which defines the long-term O&M activities for the Site. O&M activities consist of maintaining the institutional controls on the Site and semi-annual search of well drilling records to ensure that no drinking water wells are installed on or near the Site.

Hazardous substances remain at the Site above levels that allow for unlimited use and unrestricted exposure. Therefore, the EPA must conduct a statutory five-year review of the remedy no less than every five years after the initiation of the remedial action pursuant to CERCLA Section 121(c), and as provided in the current guidance on Five-Year Reviews (OSWER Directive 9355.7-03B-P, Comprehensive Five-Year Review Guidance, June 2001). Based on the five-year reviews, EPA will determine whether human health and the environment continue to be adequately protected by the implemented remedy. Three five-year reviews for this Site have been conducted to date, the first one on October 18, 2000, the second one on July 29, 2002 and the third one on May 15, 2007. All the reviews found that the remedy remains protective of human health and the environment, and that the Site appears to have been properly maintained during the period between reports. The next five-year review will occur no later than May 15, 2012.

Public participation activities required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and CERCLA Section 117, 42 U.S.C. 9617, have been satisfied, and documents which EPA generated and/or relied on are available to the public in the information repositories.

A Public Comment period was established when the site was proposed to the National Priorities List, and Public Meetings were conducted on July 1992 and August 1993 to discuss the proposed remedies for the soil and the groundwater operable units. With this Notice of Deletion, a 30 day public comment period is established before making this deletion final.

The EPA, with concurrence of the State of Oklahoma, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective August 12, 2008 unless EPA receives adverse comments by July 14, 2008. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect. The EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

The EPA Region 6 office is publishing this direct final Notice of Deletion of the Old Inger Oil Refinery Site, near Darrow, Ascension Parish, Louisiana from the NPL. The NPL constitutes Appendix B of 40 CFR part 300, which is the Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as a list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 300.425(e) (3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at the deleted sites warrant such actions.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effectiveAugust 12, 2008 unless EPA receives adverse comments by July 14, 2008. Along with the direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the “Proposed Rules” section of the Federal Register. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion, and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.

Section II of this notice explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Old Inger Refinery Site and explains how the Site meets the deletion criteria. Section V discusses EPA's actions to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate to protect public health and the environment. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the state, whether the following criteria have been met:

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

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

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

Pursuant to CERCLA section 121 (c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) EPA consulted with the state of Oklahoma prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the “Proposed Rules” section of the Federal Register.

(2) EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through the Oklahoma Department of Environmental Quality, has concurred on the deletion of the Site from the NPL.

(3) Concurrent with the publication of this direct final Notice of Deletion, a notice of availability is being published in the Ascension Citizen and is being distributed to appropriate federal, state and local government officials and other interested parties. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final notice of deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management of Superfund sites. As mentioned in section II of this document, section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL:

The Site is located approximately 4.5 miles north of Darrow, Ascension Parish, Louisiana on the east bank of the Mississippi River on Highway 75. The Site extends over approximately 16 acres and is bounded to the north by the Louisiana Highway 75, the levees of the Mississippi River to the south and to the east and west by vacant lots.

The Site is a former waste oil reclamation facility that began operation in 1967. During operations lagoons were used for disposal of waste sludges and oils. Periodically, the materials in the lagoons were pumped into the adjacent swamps to maintain storage capacity. Some of the Site problems included a large spill during unloading of used oil from a barge, tanks overfilling, and drums and construction debris being buried in lagoons. After the major spill in 1978, the property changed ownership. The new owners had intended to clean up the Site, but abandoned it in 1980.

From April 1983 through August 1988, five emergency removal actions were conducted to stabilize the Site including: Site security, migration control, excavation and containment of consolidated soils, sampling and analysis. These immediate actions reduced the potential for contact with Site contamination and the farther spread of contaminated materials to make the Site safer while long-term cleanup activities proceeded.

Investigations by both the EPA and LDEQ revealed the presence of contaminated waste oils, sludges, sediments, and water. From the investigations, it was determined that the types and concentrations of contaminants at the Site posed a potential hazard to human health and the environment. The Site was subsequently placed on the National Priorities List for remediation under CERCLA as the State's highest priority site.

The EPA, with concurrence from the State of Louisiana, signed the ROD on September 25, 1984. The major components of the selected remedy included:

• Closing and sealing of an ungrouted on-site well.

• Pumping and treatment of the shallow ground water aquifer via carbon adsorption.

• Carbon adsorption treatment and discharge of contaminated fluids.

• In situ containment and capping of slightly contaminated soils.

• On-site land treatment of heavily contaminated soils and sludges.

• Disposal of contaminated wood.

• Land Use Restrictions.

The initial phase started in 1990 and was completed in 1992. During this phase, contaminated liquids and sludges were removed from the surface impoundment, and the wastewater treatment plant and the on-site land treatment unit were constructed.

A second phase was started in 1998 and completed in 2002. During this phase, contaminated soils were excavated, treated in the land treatment unit returned back to the excavation. Approximately 15,712,300 gallons of water were treated in the treatment plant; approximately 63,398 tons of soils were excavated and treated; the Site was graded and approximately 40,000 cubic yards of clay and 24,800 cubic yards of topsoil were applied to build a cap.

The final phase of remedial work involved the evaluation of the shallow groundwater. A network of monitoring wells was installed and a quarterly sampling and evaluation program was instituted to run for a period of two years.

In summary, the Site was remediated by removing the impoundments, tanks, associated refinery equipment and debris. Contaminated soils were treated by on-site bioremediation of the affected media in a land treatment unit, capped with a clay cap and revegetated with a topsoil layer and native grasses. Finally, the shallow ground water was investigated and no unacceptable risks were identified.

The Institutional Controls (ICs) at the Site include a lien on the property for the amount of the remedial costs, which shows that the property has contaminants, and has been subject to a remedial action; and a notice in the mortgage and conveyance records stating that residual contaminant concentrations remain at the Site but are below established remedial standards.

The EPA, with concurrence from the State of Louisiana, signed an Explanation of Significant Difference on September 12, 2006. This document explains why closing an onsite well, and further pumping and treatment of ground water, were not implemented after other remedial activities were implemented.

A Final Close Out Report was signed on September 12, 2006.

The 1984 ROD identified that the most significant risk levels to public health and the environment were generated by the heavily contaminated soils and sludges and present a risk of migration of contaminated ground water and contaminating offsite drainageways.

EPA Region 6 and the State of Louisiana agree that carbon adsorption and discharge off site of contaminated fluids and land treatment for heavily contaminated soils and sludges were alternatives which effectively mitigated and minimized the most immediate risks to public health and the environment and limited future risk of the migration of contaminated ground water.

Residual waste left in place does not allow for “unlimited use and unrestricted exposure (uu/ue).” Residual contaminant concentrations remain at the Site but are below established remedial standards. As indicated above, ground water monitoring was conducted quarterly for two years to confirm that shallow ground water does not represent an unacceptable risk and meets the requirements of the State under the Louisiana Risk Evaluation and Corrective Action Program (RECAP).

Long term O&M activities will be to maintain the cap and to ensure the fencing remains intact and secure. Activities conducted by the State include periodic mowing and tracking the maintenance of the Site cap, and the continuation of Five-Year reviews to be conducted by the EPA every five years.

The threshold for Five-Years Reviews is unlimited use/unrestricted exposure. Future Five-Year Reviews will continue to monitor the maintenance of the ICs, and the limited use of the Site at the toe of the Mississippi River levee, to ensure protection of human health and the environment. The most recent Five-Year Review was completed on July 23, 2007.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

The EPA, with concurrence of the State of Louisiana, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective August 12, 2008 unless EPA receives adverse comments by July 14, 2008. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect, and EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

In 1992, OGE issued a final rule setting forth uniform executive branch Standards of Ethical Conduct (generally effective on February 3, 1993) and an interim final rule on financial disclosure, and in 1996 issued a final rule on financial interests for executive branch departments and agencies of the Federal Government and their employees. Those three executive branchwide regulations, as corrected and amended, are codified at 5 CFR parts 2634, 2635 and 2640. Together those regulations have superseded the old Commission regulations, based on prior OPM standards, on employee responsibilities and conduct at 45 CFR part 706 which the Commission adopted in 1979. See 44 FR 75152, as revised in 2002 at 67 FR 70498. Accordingly, the Commission is removing its superseded regulations, and adds in place thereof, a new section containing residual crossreferences to the provisions at 5 CFR parts 2634, 2635 and 2640, as well as to the new Commission regulation supplementing the executive branchwide standards that is being separately published today elsewhere in this issue of the Federal Register for codification in a new chapter LXVIII of 5 CFR, to consist of part 7801 In addition, the Commission is including in its residual section a reference to the separate, specific executive branchwide provisions regarding gambling, safeguarding the examination process and conduct prejudicial to the Government which are set forth in 5 CFR part 735, as amended and reissued by OPM in 1992 and 2006. Those specific branchwide restrictions are not covered by OGE's Standards of Ethical Conduct regulation; furthermore, they are self-executing and do not require any department or agency republication. In this final rule, the Commission is also correcting the prior proposed residual cross-references section citation to read 706.1”. Otherwise, the Commission is adopting its proposed residual regulation as final without change.

Because this rule relates to Commission personnel, it is exempt from the provisions of Executive Orders 12866 and 12988.

It has been determined under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this rule does not have a significant economic impact on a substantial number of small entities because it primarily affects Commission employees.

It has been determined that the Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply to this rulemaking document because it does not contain any information collection requirements that require the approval of the Office of Management and Budget.

The Commission has determined that this rulemaking is not a rule as defined in 5 U.S.C. 804, and, thus, does not require review by Congress.

This is a summary of the Commission's Second Report and Order, DA 08-1094, released on May 9, 2008. The complete text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. This document 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 (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via e-mail at http://www.bcpiweb.com. It is also available on the Commission's Web site at http://www.fcc.gov.

1. In a July 2004 Report and Order, the Commission reconfigured the 800 MHz band to eliminate interference to public safety and other land mobile communication systems operating in the band, 69 FR 67823, November 22, 2004. However, the Commission deferred consideration of band reconfiguration plans for the border areas, noting that “implementing the band plan in areas of the United States bordering Mexico and Canada will require modifications to international agreements for use of the 800 MHz band in the border areas.” The Commission stated that “the details of the border plans will be determined in our ongoing discussions with the Mexican and Canadian governments.”

2. In a Second Memorandum Opinion and Order, adopted in May 2007, the Commission delegated authority to PSHSB to propose and adopt border area band plans once agreements are reached with Canada and Mexico, 72 FR 39756, July 20, 2007.

3. In July 2007, the U.S. and Canada reached an agreement on a process that will enable the U.S. to proceed with band reconfiguration in the border region. Consequently, on November 1, 2007, PSHSB issued a Further Notice of Proposed Rulemaking seeking comment on specific proposals for reconfiguring the eight U.S.-Canada border regions. The Commission received ten comments and eight reply comments in response to the FNPRM

4. On May 9, 2008, PSHSB issued a Second Report and Order establishing reconfigured band plans in the U.S.-Canada border regions. The band plans adopted in the Second Report and Order are designed to separate-to the greatest extent possible-public safety and other non-cellular licensees from licensees that employ cellular technology in the band.

5. The Final Regulatory Flexibility Analysis required by section 604 of the Regulatory Flexibility Act, 5 U.S.C. 604, is included in Appendix A of the Second Report and Order.

6. The Second Report and Order does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore it does not contain any new or modified “information burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198.

7. As required by the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Further Notice of Proposed Rulemaking (FNPRM), 72 63869, November 13, 2007, in WT Docket 02-55. PSHSB sought written public comment on the proposals in the FNPRM, including comment on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

8. This Second Report and Order continues the Commission's efforts to reconfigure the 800 MHz band to eliminate an ongoing and growing problem of interference to public safety and other land mobile communications systems in the 800 MHz band. Specifically, in this order, PSHSB adopts post-rebanding band plans for the regions of the U.S. immediately adjacent to the U.S.-Canada border. These post-rebanding band plans include region specific variations. The reconfiguration of the 800 MHz band in the U.S.-Canada border regions is in the public interest because it will allow the Commission to eliminate interference in these regions to public safety and other land mobile communication systems. Interference is eliminated by separating—to the greatest extent possible—public safety and other non-cellular licensees from licensees that employ cellular technology in the 800 MHz band.

9. No parties have raised significant issues in response to the IRFA.

10. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

11. Nationwide, there are a total of approximately 22.4 million small businesses, according to SBA data. A “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 2002, there were approximately 1.6 million small organizations. The term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2002 indicate that there were 87,525 local governmental jurisdictions in the United States. We estimate that, of this total, 84,377 entities were “small governmental jurisdictions.” Thus, we estimate that most governmental jurisdictions are small. Below, we further describe and estimate the number of small entities—applicants and licensees—-that may be affected by our action.

12. Wireless Telecommunications Carriers (except Satellite). Since 2007, the Census Bureau has placed wireless firms within this new, broad, economic census category. Prior to that time, such firms were within the now-superseded categories of “Paging” and “Cellular and Other Wireless Telecommunications.” Under the present and prior categories, the SBA has deemed a wireless business to be small if it has 1,500 or fewer employees. Because Census Bureau data are not yet available for the new category, we will estimate small business prevalence using the prior categories and associated data. For the category of Paging, data for 2002 show that there were 807 firms that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. For the category of Cellular and Other Wireless Telecommunications, data for 2002 show that there were 1,397 firms that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, we estimate that the majority of wireless firms are small.

13. Public Safety Radio Licensees. Public safety licensees who operate 800 MHz systems in the U.S.-Canada border region will be required to relocate their station facilities according to the post-rebanding plans listed in this Second Report and Order. As indicated above, all governmental entities with populations of less than 50,000 fall within the definition of a small entity.

14. Business, I/LT, and SMR licensees. Business and Industrial Land Transportation (B/ILT) and Special Mobile Radio (SMR) licensees who operate 800 MHz systems in the U.S.-Canada border region will be required to relocate their station facilities according to the band plans proposed in this Second Report and Order. Neither the Commission nor the SBA has developed a definition of small businesses directed specifically toward these licensees. Therefore we will use the SBA size standard for wireless firms, supra, and incorporate that analysis by reference here.

15. Also, Sprint Nextel Corporation (Sprint) will be affected by the post-rebanding band plans in this Second Report and Order but it is not a small carrier.

16. We adopt no new reporting, recordkeeping or other compliance requirements in this Second Report and Order. As noted in Section B of the Second Report and Order, public safety, B/ILT, SMR licensees and wireless service providers who operate 800 MHz systems in the U.S.—Canada border region will be required to relocate their station facilities according to the post-rebanding band plans specified in this Second Report and Order. Also, Sprint Corporation will pay the cost of relocating incumbent licensees.

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

18. Non-NPSPAC Public Safety Systems in the 806-809/851-854 MHz Band. In the FNPRM, we proposed that in the border areas, the 806-809/851-854 MHz block would be shared by non-NPSPAC public safety licensees that were originally licensed in the block and NPSPAC licensees relocating from the former NPSPAC block at 821-824/866-869 MHz. Because non-NPSPAC public safety systems operate on channels with 25 kHz spacing, while NPSPAC systems operate on 12.5 kHz-spaced channels, we sought comment on alternatives for accommodating both NPSPAC and non-NPSPAC public safety systems in the same spectrum block. Our proposed channel plan for this portion of the band provided for a combination of 25 kHz and 12.5 kHz spaced channels. The overwhelming majority of commenters in the record oppose non-uniform channelization of the 806-809/851-854 MHz band, and instead urge us to adopt a uniform band plan of 12.5 kHz-spaced channels for this block with the tighter emission masks applicable to NPSPAC channels. These commenters argue that a uniform band plan would improve spectrum efficiency, avoid the complexities caused by intermingling public safety licensees operating on differing channel plans with differing emission masks, and would be more compatible with the NPSPAC channelization plan in adjacent non-border regions. Commenters suggest that non-NPSPAC licensees operating with 25 kHz channel spacing should either be relocated above the 806-809/851-854 MHz bloc or should be converted to 12.5 kHz spacing.

19. Based on the comments received in response to our proposal, we have decided to create a uniform 12.5 kHz-spaced channel plan for the 806-809/851-854 MHz block in the border regions. Thus, public safety licensees will benefit from the increased spectrum efficiency created by a uniform channel plan for this portion of the band. Furthermore, Sprint will bear the cost of any changes needed to accommodate public safety licensees with equipment capable of operating according to the channel plan for the 806-809/851-854 MHz portion of the band.

20. NPSPAC Facilities on Canada Primary Channels. In the FNPRM, we sought comment on how to accommodate U.S. NPSPAC licensees that currently operate on a secondary basis to licensees in Canada in the Canadian primary portion of the NPSPAC band. We suggested placing these licensees on the lowest available Canada primary channels in the band. Many NPSPAC commenters, however, advocate relocating these facilities to U.S. primary spectrum, i.e. , relocating them 15 megahertz downward to the 806-809/851-854 MHz band, which is U.S. primary spectrum. These commenters note that many NPSPAC licensees in the border regions use both U.S. primary and Canada primary NPSPAC channels in their systems and operate seamlessly across the entire NPSPAC block despite the fact that some of their channels are on Canada primary spectrum. Consequently, we have instructed the Transition Administer (TA) to accommodate these systems on U.S. primary spectrum in the 806-809/851-854 MHz portion of the band whenever possible. Relocating these systems to U.S. primary spectrum in the 806-809/851-854 MHz portion of the band will provide border area public safety NPSPAC licensees with the capability to interoperate with public safety NPSPAC licensees outside the border area. In addition, Sprint will bear the cost of relocating these systems.

21. Separation of Non-ESMR (High-Site B/ILT and SMR) and ESMR Systems. In the FNPRM, we sought to separate non ESMR (high-site B/ILT and SMR) from ESMR systems to the extent feasible, but noted that some continued interleaving of non-ESMR and ESMR systems might be necessary in the border regions (Regions 1-6) due to the limited amount of available U.S. primary spectrum. We sought comment on the degree to which the new band plan should accommodate such interleaving, and whether other technical rules would be required to mitigate potential interference. Commenters overwhelmingly oppose continued interleaving of B/ILT and high site SMR systems with ESMR systems. Consequently, we have instructed the Transition Administrator to assign replacement channels to B/ILT and high-site SMR licensees in Canada Border Regions 1 through 6 in a manner which separates these licensees from ESMR systems. B/ILT and high-site SMR licensees will benefit from our decision because these licensees will be subject to less interference then if they remained interleaved with ESMR systems. In making this decision, we have reminded Sprint of its obligation to provide all relocating licensees with comparable facilities including B/ILT and high site SMR licensees in the Canada border even if this means replacing some combiners in order to compensate for the decreased frequency separation between channels for these licensees.

22. B/ILT, High-Site SMR and ESMR Operations on Canada Primary Channels. U.S. licensees may continue to be licensed on Canada primary channels, provided the maximum power flux density (PFD) per 25 kHz from their systems does not exceed −107 dB(W/m2) at or beyond the border. Accordingly, B/ILT and high-site SMR licensees that currently use Canada primary channels in Regions 1 through 6 may remain on these channels subject to the above PFD limits. B/ILT and high-site SMR licensees will benefit from our decision here because these licensees will continue to have access to Canada primary spectrum along the border.

23. In the FNPRM, we also sought comment on whether Sprint should be permitted to remain on Canada primary spectrum below 817/862 MHz. Sprint states that it extensively relies on these channels to provide wireless services to its subscribers and to provide access to spectrum for its roaming partner in Canada TELUS. Other commenting parties state that they would not object to Sprint's continued operation in the Canadian primary portion below 817/862 MHz as long as full interference protection is provided to adjacent non-ESMR operations. We will permit Sprint to remain grandfathered on these channels in the non-ESMR portion of the band as long as they provide full interference protection to all non-ESMR licensees. Public safety, B/ILT and high-site SMR licensees will benefit from our decision because they will be eligible for interference protection from these grandfathered facilities.

24. Mutual Aid Channels. As proposed in the FNPRM, we establish new mutual aid channels with 25 kHz spacing in the new border area NPSPAC band plan to match the mutual aid channels in the non-border NPSPAC band plan. Public safety licensees in the Canada border will benefit from this decision because they will be able to interoperate with public safety licensees outside the Canada border region.

25. TELUS Operations on U.S. Primary Channels. In the FNPRM, we noted that Commission had reached an agreement with Industry Canada on a process that enables the U.S. to proceed with rebanding in the border region. As part of this agreement, we noted that the U.S. and Canada will discuss whether certain Canadian facilities authorized on U.S. primary spectrum under SCP can be grandfathered. Several commenting parties expressed concern about the impact to U.S. licensees from grandfathering stations in Canada on U.S. primary spectrum. Therefore, in this Second Report and Order, we clarify that once the TA has assigned replacement channels to all U.S. licensees, we will examine whether certain TELUS facilities operating today on U.S. primary spectrum under SCP can be grandfathered without negatively impacting U.S. licensees. Only those TELUS stations which would create no conflicts with reconfigured U.S. licensees will be considered for grandfathering. Consequently, the grandfathering of TELUS stations on U.S. primary spectrum will have no negative impact on public safety, B/ILT or high-site SMR licensees.

26. Region-Specific Band Plans. In the FNPRM, we sought comment on region specific band plans for reconfiguring the 800 MHz band in the Canada Border in order to eliminate an ongoing and growing problem of interference to public safety and other land mobile communications systems in this band. Commenting parties generally supported our band plan proposals. Consequently, in this Second Report and Order, we adopt reconfigured band plans for licensees in the 800 MHz band along the U.S.—Canada border. Under these band plans, public safety systems will relocate to U.S. primary spectrum in the lower portion of the band. Commenting parties supported relocating public safety systems to the lowest portion of the band to maximize the spectral separation between public safety and ESMR systems. In addition, B/ILT, high-site SMR and ESMR systems will relocate higher in the band on U.S. primary spectrum above 815/860 MHz. These band plans contain certain region-specific variations. Because the reconfiguration of the 800 MHz band in the U.S.—Canada border regions seeks to eliminate interference to public safety, B/ILT and high-site SMR licensees, these band plans will minimize the cost that these licensees would otherwise incur to resolve interference. Further, Sprint will pay the cost of relocating incumbent licensees.

27. Planning, Negotiation, and Mediation. In the FNPRM, we proposed establishing expedited timelines for planning, negotiations, and mediation similar to those established in the Commission's September 2007 Public Notice for non-border licensees. While some commenters supported a 12 month planning period, we are not persuaded that rebanding in the Border areas requires such a lengthy period that could unduly delay rebanding implementation. We establish planning limits of 90, 100, and 110 days which correspond to the number of units in a licensee's system. We also establish a process under which licensees may request additional planning time. With regard to negotiation and mediation, we establish a 30 day period for licensees to negotiate Frequency Reconfiguration Agreements with Sprint and if necessary a 20 day period within which licensees and Sprint may mediate unresolved issues. If licensees are unable to resolve issues with Sprint after the 20 day mediation period, then the 800 MHz Transition Administrator shall transmit such matters to the Public Safety and Homeland Security Bureau for review within 10 days after the end of the mediation period. Sprint, however, bears the costs of band reconfiguration.

28. Rebanding Implementation. In the FNPRM, we sought comment on the sequence and timing of rebanding activity in the Canadian border region once a final band plan is adopted and the 800 MHz Transition Administrator issues replacement channel assignments to border area licensees. In this Second Report and Order, we envision the sequence of band reconfiguration in all Regions will occur in two-stage process that will take into account regional variations. All of the relocations will occur through spectrum swaps with Sprint and Sprint will bear the costs of reconfiguration.

29. The Commission will send a copy of the Second Report and Order, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the SBREFA. In addition, the Commission will send a copy of the Second Report and Order, including the FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the Second Report and Order and the FRFA (or summaries thereof) will also be published in the Federal Register.

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

31. Accordingly, it is ordered, pursuant to sections 4(i) and 332 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 332, this Second Report and Order is adopted.

32. It is further ordered that the amendments of the Commission's rules set forth in Appendix D are adopted, effective August 12, 2008.

33. It is further ordered that the Final Regulatory Flexibility required by section 604 of the Regulatory Flexibility Act, 5 U.S.C. 604, and as set forth in Appendix A herein is adopted.

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

Confidentiality of an employee's test results is a cornerstone of the balance between public safety and employee privacy that is crucial to the Department of Transportation's testing program. Early in the Department of Transportation's drug testing program, we recognized the need for confidentiality of employee testing information and reflected this in our December 1, 1989 Federal Register notice (54 FR 49854). This rule required the Medical Review Officer (MRO) to disclose positive drug test result information only to employers. The rule also required laboratories to maintain employee test records in confidence, but permitted laboratories to disclose a positive drug test result to the employee, employer, or the decision maker in a lawsuit, grievance or other proceeding initiated by or on behalf of the employee as a result of the employee's positive drug test.

Congress passed the Omnibus Transportation Employee Testing Act of 1991, which directed the Department to implement significant changes to its substance abuse testing program, and specifically referenced providing for the confidentiality of employee test results. The Department amended its drug and alcohol testing regulations to implement these statutory requirements. (59 FR 7340; February 15, 1994). As provided in the original 1989 DOT rules and the 1994 amendments, Part 40 includes strict and specific provisions for maintaining the confidentiality of employee testing records. Specifically, employers are permitted to release employee drug and alcohol testing records to other employers only upon written consent from the employee, and only when the consent authorized the release to a specifically identified individual.

In 2000, the Department revised its drug and alcohol testing regulations (65 FR 79462). In this revision, the Department prohibited MROs from disclosing employee drug testing information to other employers and prohibited service agents and employers from using blanket releases. We intended in 2000 for State safety agencies with regulatory authority over employers to be provided with certain testing information about an individual employee with no signed releases necessary. In recent years, several States have passed legislation requiring the release of certain test result and refusal information for all CDL holders without the employees' consent. Specifically, the States have required employers and/or their service agents to report to their respective State CDL issuing and licensing authorities the drug and alcohol violations of employees who are CMV drivers with CDLs. We do not want our regulations to have the effect of prohibiting employers and TPAs of owner-operators from providing the drug and alcohol test results of CMV drivers with CDLs. Consequently, the Department must take rapid action to avoid any such conflict.

The Department believes that State action to suspend or revoke the CDLs of CMV drivers who violate DOT rules until they demonstrate that they have successfully completed the SAP process can have important safety benefits. We support State legislation that can reliably provide State CDL licensing authorities with the information they need to take such action. In particular, the Department is concerned that, in the absence of such action, CMV drivers with CDLs who do not seek required Substance Abuse Professional (SAP) evaluations, yet continue to perform safety-sensitive duties after they violate the Department's drug and alcohol regulations (so-called “job hoppers”), pose an unacceptable safety risk to the public. We believe measures taken by States to suspend or revoke the CDL licenses of CMV drivers who violate DOT drug and alcohol rules will enhance the Department's efforts to ensure that such drivers are evaluated by SAPs and receive treatment or education before they resume safety-sensitive duties.

To be consistent with our policy in enforcing the existing regulations and because we want to ensure that 49 CFR Part 40 is supportive of such State legislation, we are acting at this time to amend section 40.331. This amendment specifies that employers are authorized to respond—without conflict with Part 40 confidentiality requirements—to State law requirements by providing drug and alcohol violation information to State CDL licensing authorities on all CMV drivers with CDLs who are covered by DOT testing rules. This same authorization applies to TPAs for owner-operators, since they are the party in the best position to provide this data if owner-operators choose not to report their own violations. We note that this amendment does not authorize the release of individually identifiable testing information outside the scope of the State laws requiring its provision to a State agency for safety purposes. For example, if a State statute requires employers to provide information on positive tests and refusals to the DMV for purposes of taking action against the driver's CDL, it would be improper for the DMV to release the test information to other third parties without the written consent of the driver.

An employer, or a TPA for an owner-operator, is in the best position to provide this information reliably to State authorities because it is the only entity with knowledge and information about all drug and alcohol violations for an employee. For example, an MRO will not necessarily know that an employee refused to go to the collection site. Since MROs are not involved in the alcohol testing process, MROs will not have any information concerning an alcohol test. Likewise, a breath alcohol technician will not have any information about an employee's drug test result. A SAP will have no records on an employee who has not sought evaluation and treatment after a rule violation. Many service agents are located out of State and may not know of a State law requirement, and in any case they may not be readily subject to State law jurisdiction. Most have no way of knowing whether the employee is a CMV driver with a CDL or which DOT agency regulates the employee. Employers, on the other hand, have all this information, and are in-State employers subject to the State's jurisdiction.

This amendment is not a mandate to employers or TPAs for owner-operators to send information to State authorities. It simply authorizes them to comply with the specifics of State information collection requirements. For example, if State A requires only positive drug tests to be transmitted to its Department of Motor Vehicles, an employer or TPA could provide only records of the employee's positive drug test without written employee consent. The employer or TPA could not provide “blanket” information about refusals or alcohol tests to State A without written employee consent, since this was not required by State law. We note that enforcement of State laws that apply to a given employer or TPA would remain a State responsibility.

The statutory authority for this rule derives from the Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et seq.) and the Department of Transportation Act (49 U.S.C. 322).

The Department has determined that this rule may be issued without a prior opportunity for notice and comment because providing prior notice and comment would be unnecessary, impracticable, or contrary to the public interest. Because several States already have laws requiring the reporting of test result information and other States may be contemplating enacting such laws, it is important to clarify the status of employers and TPAs for owner-operators seeking to comply with these laws. As States work with drug testing program participants to implement their laws, it is essential that the Department work, without delay, to avoid any potential conflicts with Federal regulations that could impede such employers and TPAs from providing needed information to State agencies. It is important to resolve, as soon as possible, questions that States and other participants have already raised about the relationship of State law and DOT regulations in this area. Issuing the interim final rule should help to avoid confusion that could, to some extent, diminish the safety benefits that the combination of Federal and State requirements concerning persons who violate drug testing rules would otherwise have.

This rule clarifies that, in the interest of safety, employers and TPAs for owner-operators may comply with State reporting requirements to disclose to their State CDL authorities the DOT drug and alcohol violations of CMV drivers with CDLs. It would be inadvisable for the Department to delay issuing this rule and consequently to delay the safety benefits from continued compliance by employers with State laws. For the same reasons, the Department finds that there is good cause to make the rule effective immediately.

The Department has determined that this action is not considered a significant regulatory action for purposes of Executive Order 12866 or the Department's regulatory policies and procedures. The interim final rule makes minor modifications to our rules to clarify that employers and TPAs for owner-operators are authorized to release employee-specific drug and alcohol testing information where required by State law.

This rule is being adopted solely to clarify that DOT rules do not conflict with State laws requiring employers to submit drug and alcohol test results to State safety agencies. As such, it imposes no compliance costs on any business or governmental entity. Any costs resulting from compliance of employers with State laws are attributable to those State laws, not to this rule. Given the absence of compliance costs to anyone, I certify that the interim final rule does not have a significant economic impact on a substantial number of small entities.

The benefits of this rule, which are not quantifiable, involve potential improvements to safety as the result of State procedures that could prevent violators of DOT rules from driving commercial vehicles for a time and in helping to prevent “job hopping” by drivers who test positive for one company and then seek a job at another company. It is important for the Department and States to begin realizing these benefits at this time.

The Department has analyzed this proposed action in accordance with the principles and criteria contained in Executive Order 13132, and has determined that, by explicitly facilitating the operation of State laws, the amendments is consistent with the Executive Order and that no consultation is necessary. It avoids the preemption of State laws with respect to the reporting of testing information by employers and third-party administrators providing services to owner-operators.