On March 21, 2005, FAA issued AD 2005-07-01, Amendment 39-14025 (70 FR 15223, March 25, 2005), which applies to all the Cessna Models 208 and 208B airplanes.

We incorrectly referenced the affected airplane models as C208 and C208B throughout the document. The correct airplane models are 208 and 208B. This action corrects the regulatory text.

This AD requires you to incorporate information into the applicable section of the Airplane Flight Manual (AFM) to assure that the pilot has enough information to prevent loss of control of the airplane while in-flight during icing conditions.

This correction is needed to ensure that the affected airplane models numbers are correct and to eliminate misunderstanding in the field.

The effective date remains March 29, 2005.

The Pipeline Safety Improvement Act of 2002 (“Pipeline Safety Act”), Public Law 107-355, was enacted on December 17, 2002. Section 6 of the Act, codified at 49 U.S.C. 60129, provides protection to employees against retaliation by an employer, defined as a person owning or operating a pipeline facility or a contractor or subcontractor of such a person, because they provided information to the employer or the Federal Government relating to Federal pipeline safety violations or filed, testified, or assisted in a proceeding against the employer relating to any violation or alleged violation of any Federal law relating to pipeline safety, or because they are about to take any of these actions. These rules establish procedures for the handling of whistleblower complaints under the Pipeline Safety Act.

The Pipeline Safety Act whistleblower provisions include procedures that allow a covered employee to file, within 180 days of the alleged discrimination, a complaint with the Secretary of Labor (“the Secretary”). 1 Upon receipt of the complaint, the Secretary must provide written notice both to the person or persons named in the complaint alleged to have violated the Act (“the named person”) and to the Secretary of Transportation of the filing of the complaint, the allegations contained in the complaint, the substance of the evidence supporting the complaint, and the rights afforded the named person throughout the investigation. The Secretary must then, within 60 days of receipt of the complaint, afford the named person an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation. However, the Secretary may conduct an investigation only if the complainant has made a prima facie showing that the alleged discriminatory behavior was a contributing factor in the unfavorable personnel action alleged in the complaint and the named person has not demonstrated, through clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

After investigating a complaint, the Secretary will issue a determination letter. If, as a result of the investigation, the Secretary finds there is reasonable cause to believe that discriminatory behavior has occurred, the Secretary must notify the named person of those findings, along with a preliminary order which requires the named person to: Take affirmative action to abate the violation, reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages to the complainant, as well as costs and attorney's and expert fees reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued. The complainant and the named person then have 60 days after the date of the Secretary's notification in which to file objections to the findings and/or preliminary order and request a hearing on the record. The filing of objections under the Pipeline Safety Act will stay any remedy in the preliminary order except for preliminary reinstatement. If a hearing before an administrative law judge is not requested within 60 days, the preliminary order becomes final and is not subject to judicial review.

If a hearing is held, the Pipeline Safety Act requires the hearing to be conducted “expeditiously.” The Secretary then has 90 days after the “conclusion of a hearing” in which to issue a final order, which may provide appropriate relief or deny the complaint. Until the Secretary's final order is issued, the Secretary, the complainant, and the named person may enter into a settlement agreement which terminates the proceeding. At the complainant's request, the Secretary will assess against the named person a sum equal to the total amount of all costs and expenses, including attorney's and expert witness fees, reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the Secretary issued the order. The Secretary also may award a prevailing employer a reasonable attorney's fee, not exceeding $1,000, if he or she finds that the complaint is frivolous or has been brought in bad faith. Within 60 days of the issuance of the final order, any person adversely affected or aggrieved by the Secretary's final order may file an appeal with the United States Court of Appeals for the circuit in which the violation occurred or the circuit where the complainant resided on the date of the violation. Finally, the Pipeline Safety Act makes persons who violate these newly created whistleblower provisions subject to a civil penalty of up to $1,000. This provision is administered by the Secretary of Transportation.

On April 5, 2004, the Occupational Safety and Health Administration published in the Federal Register an interim final rule promulgating rules that implemented section 6 of the Pipeline Safety Improvement Act of 2002 (“Pipeline Safety Act”), Public Law 107-355, 69 FR 17587-17595. In addition to promulgating the interim final rule, OSHA's notice included a request for public comment on the interim rules by June 4, 2004.

OSHA did not receive any substantive comments during the public comment period. Nor does OSHA believe that modifications to the interim final rule are necessary. Accordingly, the interim final rule published on April 4, 2004, will be repromulgated as the final rule.

This section describes the purpose of the regulations implementing the Pipeline Safety Act and provides an overview of the procedures covered by these regulations.

In addition to general definitions, the regulations contain the Pipeline Safety Act definition of “employer,” and the statutory definitions of “gas pipeline facility,” “hazardous liquid pipeline facility,” “person,” and “pipeline facility” codified in chapter 601 of subtitle VIII of title 49 of the United States Code.

This section describes the several categories of whistleblower activity that are protected under the Act and the type of conduct that is prohibited in response to any protected activity. As under the Energy Reorganization Act (“ERA”) and the environmental whistleblower statutes listed at 29 CFR 24.1(a), refusals to engage in practices made unlawful under applicable Federal law relating to the industry in which the employee is employed are protected activities under the Act if the employee has identified the alleged illegality to the employer. See 49 U.S.C. 60129(a)(1)(B); Timmons v. Franklin Electric Cooperative, Case No. 97-141, 1998 WL 917114 (DOL Adm. Rev. Bd, Dec. 1, 1998); 29 CFR 24.2(c)(2). The employee does not have to prove that the allegedly illegal practice actually violated a Federal pipeline safety law. See Gilbert v. Federal Mine Safety & Health Review Commission, 866 F.2d 1433, 1439 (DC Cir. 1989). The employee must only prove that the refusal to work was properly communicated to the employer and was based on a reasonable and good faith belief that engaging in that work was a practice made unlawful by a Federal law relating to pipeline safety. See Liggett Industries, Inc. v. Federal Mine Safety and Health Review Commission, 923 F.2d 150, 151 (10th Cir. 1991); Eltzroth v. Amersham Medi-Physics, Inc., Case No. 98-002, 1999 WL 232896 *9 (DOL Adm. Rev. Bd, Apr. 15, 1999).

This section explains the requirements for filing a discrimination complaint under the Pipeline Safety Act. To be timely, a complaint must be filed within 180 days of when the alleged violation occurs. Under Delaware State College v. Ricks, 449 U.S. 250, 258 (1980), this is considered to be when the discriminatory decision has been both made and communicated to the complainant. In other words, the limitations period commences once the employee is aware or reasonably should be aware of the employer's decision. Equal Employment Opportunity Commission v. United Parcel Service, 249 F.3d 557, 561-62 (6th Cir. 2001). Complaints filed under the Act must be made in writing, but do not needto be made in any particular form. With the consent of the employee, complaints may be made by any person on the employee's behalf.

The Pipeline Safety Act contains the statutory requirement that a complaint shall be dismissed if the complaint, supplemented as appropriate by interviews with the complainant, fails to make a prima facie showing that protected behavior or conduct was a contributing factor in the unfavorable personnel action alleged in the complaint. Also included in this section is the statutory requirement that an investigation of the complaint will not be conducted if the named person demonstrates by clear and convincing evidence that it would have taken the same unfavorable personnel action in the absence of the complainant's protected behavior or conduct, notwithstanding the prima facie showing of the complainant. Upon receipt of a complaint in the investigating office, the Assistant Secretary notifies the named person of these requirements and the right of each named person to seek attorney's fees from an ALJ or the Administrative Review Board if the named person alleges that the complaint was frivolous or brought in bad faith.

Under this section also, the named person has the opportunity within 20 days of receipt of the complaint to meet with representatives of OSHA and present evidence in support of its position. If, upon investigation, OSHA has reasonable cause to believe that the named person has violated the Act and therefore that an award of preliminary relief for the complainant is warranted, OSHA again contacts the named person with notice of this determination and provides the substance of the relevant evidence upon which that determination is based, consistent with the requirements of confidentiality of informants. The named person is afforded the opportunity, within 10 business days, to provide written evidence in response to the allegation of the violation, meet with the investigators, and present legal and factual arguments as to why preliminary relief is not warranted. This section provides due process procedures in accordance with the United States Supreme Court decision under the Surface Transportation Assistance Act (“STAA”) in Brock v. Roadway Express, Inc., 481 U.S. 252 (1987).

This section provides that, on the basis of information obtained in the investigation, the Assistant Secretary will issue a finding whether there is reasonable cause to believe that the complaint has merit. If the finding is that the complaint has merit, the Assistant Secretary will order appropriate preliminary relief. The letter accompanying the findings and order advises the parties of their right to file objections to the findings of the Assistant Secretary and to request a hearing, and of the right of the named person to request attorney's fees from the ALJ, regardless of whether the named person has filed objections, if the named person alleges that the complaint was frivolous or brought in bad faith. If no objections are filed within 60 days of receipt of the findings, the findings and any preliminary order of the Assistant Secretary become the final findings and order of the Secretary. If objections are timely filed, any order of preliminary reinstatement will take effect, but the remaining provisions of the order will not take effect until administrative proceedings are completed. Legislative history under the Pipeline Safety Act indicates that Congress intended to assure that the mere filing of an objection would not automatically stay the preliminary order, but that an employer could file a motion for a stay. 148 Cong. Rec. S11068 (Nov. 14, 2002) (section-by-section analysis). Thus, § 1981.106(b)(1) of this rule provides that although the portion of the preliminary order requiring reinstatement will be effective immediately upon the named person's receipt of the findings and preliminary order, regardless of any objections to the order, the named person may file a motion with the Office of Administrative Law Judges for a stay of the Assistant Secretary's preliminary order. OSHA believes, however, that a stay of a preliminary reinstatement order would be appropriate only in the exceptional case. In other words, a stay only would be granted where the named person can establish the necessary criteria for equitable injunctive relief, i.e. , irreparable injury, likelihood of success on the merits, and a balancing of possible harms to the parties and the public.

Where the named party establishes that the complainant would have been discharged even absent the protected activity, there would be no reasonable cause to believe that a violation has occurred. Therefore, a preliminary reinstatement order would not be issued. Furthermore, a preliminary order of reinstatement would not be an appropriate remedy where, for example, the named party establishes that the complainant is, or has become, a security risk based upon information obtained after the complainant's discharge in violation of the Pipeline Safety Act. In McKennon v. Nashville Banner Publishing Co., 513 U.S. 352, 360-62 (1995), the Supreme Court recognized that reinstatement would not be an appropriate remedy for discrimination under the Age Discrimination in Employment Act where, based upon after-acquired evidence, the employer would have terminated the employee upon lawful grounds. Finally, in appropriate circumstances, in lieu of preliminary reinstatement, OSHA may order that the complainant receive the same pay and benefits that he received prior to his termination, but not actually return to work. Such “economic reinstatement” frequently is employed in cases arising under section 105(c) of the Federal Mine Safety and Health Act of 1977. See, e.g. , Secretary of Labor on behalf of York v. BR&D Enters., Inc., 23 FMSHRC 697, 2001 WL 1806020 **1 (June 26, 2001). “Economic reinstatement” also might be appropriate on those occasions in which an employer can establish that sufficient independent grounds exist for staying an immediate order of preliminary reinstatement.

To be effective, objections to the findings of the Assistant Secretary must be in writing and must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, Washington, DC, within 60 days of receipt of the findings. The date of the postmark, facsimile transmittal, or e-mail communication is considered the date of the filing; if the filing of objections is made in person, by hand-delivery or other means, the date of receipt is considered the date of the filing.

The filing of objections is also considered a request for a hearing before an ALJ. This section also provides that a named party seeking attorney's fees for the filing of a frivolous complaint or a complaint brought in bad faith should initially make its request for such fees to the Chief Administrative Law Judge.

This section adopts the rules of practice of the Office of Administrative Law Judges at 29 CFR Part 18, Subpart A. In order to assist in obtaining full development of the facts in whistleblower proceedings, formal rules of evidence do not apply. The section specifically provides for consolidation of hearings if both the complainant and the named person object to the findings and/or order of the Assistant Secretary.

The ERA and STAA regulations provide two different models for agency participation in administrative proceedings. Under STAA, OSHA ordinarily prosecutes cases where a complaint has been found to be meritorious. Under ERA and the other environmental whistleblower statutes, on the other hand, OSHA does not ordinarily appear as a party in the proceeding. The Department has found that in most environmental whistleblower cases, parties have been ably represented and OSHA's participation in the administrative litigation is not a prerequisite for the protection of the public interest served by these proceedings. The Department believes this is likely to be the situation in cases involving allegations of retaliation for providing pipeline safety information. Therefore, this provision utilizes the approach of the ERA regulation at 29 CFR 24.6(f)(1). The Assistant Secretary, at his or her discretion, may participate as a party or amicus curiae at any time in the administrative litigation. For example, the Assistant Secretary may exercise his or her discretion to prosecute the case at any stage of the administrative proceeding; petition for review of a decision of an administrative law judge, including a decision based on a settlement agreement between complainant and the named person, regardless of whether the Assistant Secretary participated before the ALJ; or participate as amicus curiae before the ALJ or in the Administrative Review Board proceeding. We anticipate that ordinarily the Assistant Secretary will not participate in Pipeline Safety Act proceedings, except to approve settlements as described in 29 CFR 1981.111(d). However, the Assistant Secretary may choose to do so in appropriate cases, such as cases involving important or novel legal issues, large numbers of employees, alleged violations which appear egregious, or where the interests of justice might require participation by the Assistant Secretary. The Department of Transportation, at that agency's discretion, also may participate as amicus curiae at any time in the proceedings. OSHA believes it is unlikely that its decision ordinarily not to prosecute meritorious Pipeline Safety Act cases will discourage employees from making complaints about pipeline safety.

This section sets forth the content of the decision and order of the administrative law judge, and includes the statutory standard for finding a violation. The section further provides that the Assistant Secretary's determination as to whether to dismiss the complaint without an investigation or conduct an investigation pursuant to § 1981.104 is not subject to review by the ALJ, who hears the case de novo on the merits.

The decision of the ALJ is the final decision of the Secretary unless a timely petition for review is filed with the Administrative Review Board. Appeals to the Board are not a matter of right, but rather petitions for review are accepted at the discretion of the Board. Upon the issuance of the ALJ's decision, the parties have 10 business days within which to petition the Board for review of that decision. The parties must specifically identify the findings and conclusions to which they take exception, or the exceptions are deemed waived by the parties. The Board has 30 days to decide whether to grant the petition for review. If the Board does not grant the petition, the decision of the ALJ becomes the final decision of the Secretary. If the Board grants the petition, the Act requires the Board to issue a decision not later than 90 days after the date of the conclusion of the hearing before the ALJ. The conclusion of the hearing for this purpose is deemed to be the conclusion of all proceedings before the administrative law judge— i.e. , 10 days after the date of the decision of the administrative law judge unless a motion for reconsideration has been filed in the interim. If a timely petition for review is filed with the Board, any relief ordered by the ALJ, except for a preliminary order of reinstatement, is inoperative while the matter is pending before the Board. This section further provides that, when the Board accepts a petition for review, its review of factual determinations will be conducted under the substantial evidence standard. This standard also is applied to Board review of ALJ decisions under the whistleblower provisions of STAA and the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century. See 29 CFR 1978.109(b)(3) and 1979.110(b).

As with § 1981.106(b)(1), § 1981.110(b) of this rule provides that in the exceptional case, the Board may grant a motion to stay a preliminary order of reinstatement that otherwise will be effective while review is conducted by the Board. As explained above, however, OSHA believes that a stay of a preliminary reinstatement order would only be appropriate where the named person can establish the necessary criteria for equitable injunctive relief, i.e. , irreparable injury, likelihood of success on the merits, and a balancing of possible harms to the parties and the public.

This section provides for the procedures and time periods for withdrawal of complaints, the withdrawal of findings by the Assistant Secretary, and the withdrawal of objections to findings. It also provides for approval of settlements at the investigative and adjudicative stages of the case.

This section describes the statutory provisions for judicial review of decisions of the Secretary and requires, in cases where judicial review is sought, the Administrative Review Board to submit the record of proceedings to the appropriate court pursuant to the rules of such court.

This section describes the Secretary's power under the statute to obtain judicial enforcement of orders and the terms of a settlement agreement. It also provides for enforcement of orders of the Secretary by the person on whose behalf the order was issued.

This section provides that in circumstances not contemplated by these rules or for good cause the Secretary may, upon application and notice to the parties, waive any rule as justice or the administration of the Act requires.

This rule contains a reporting provision (filing a discrimination complaint, § 1981.103) which was previously reviewed and approved for use by the Office of Management and Budget (“OMB”) under 29 CFR 24.3 and assigned OMB control number 1218-0236 under the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

This rule is a rule of agency procedure and practice within the meaning of Section 553 of the Administrative Procedure Act (“APA”), 5 U.S.C. 553(b)(A). Therefore, publication in the Federal Register of a notice of proposed rulemaking and request for comments was not required for these regulations, which provide procedures for the handling of discrimination complaints. Although this rule was not subject to the notice and comment procedures of the APA, the Assistant Secretary provided the public with an opportunity to submit comments on the interim rule. No substantive comments on the rule were received.

Furthermore, because this rule is procedural rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule be effective 30 days after publication in the Federal Register is inapplicable. The Assistant Secretary also finds good cause to provide an immediate effective date for this final rule. It is unnecessary to delay the effective date of the final rule because no changes have been made to the interim final rule, which already has been in effect since April 5, 2004.

The Department has concluded that this rule should be treated as a “significant regulatory action” within the meaning of Section 3(f)(4) of Executive Order 12866 because the Pipeline Safety whistleblower provision is a new program and because of the importance to the Department of Transportation's pipeline safety program that “whistleblowers” be protected from retaliation. Executive Order 12866 requires a full economic impact analysis only for “economically significant” rules, which are defined in Section 3(f)(1) as rules that may “have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.” Because the rule is procedural in nature, it is not expected to have a significant economic impact; therefore no economic impact analysis has been prepared. For the same reason, the rule does not require a Section 202 statement under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq. ). Furthermore, because this is a rule of agency procedure or practice, it is not a “rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 804(3)(C)), and does not require Congressional review. Finally, this rule does not have “federalism implications.” The rule does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government” and therefore is not subject to Executive Order 13132 (Federalism).

The Department has determined that the regulation will not have a significant economic impact on a substantial number of small entities. The regulation simply implements procedures necessitated by enactment of the Pipeline Safety Act, in order to allow resolution of whistleblower complaints. Furthermore, no certification to this effect is required and no regulatory flexibility analysis is required because no proposed rule has been issued.

Document Preparation: This document was prepared under the direction and control of the Acting Assistant Secretary, Occupational Safety and Health Administration, U.S. Department of Labor.

On July 2, 2003, we published a notice of proposed rulemaking (NPRM) entitled Baltimore Harbor Anchorage Project in the Federal Register (68 FR 39503). We received one phone call commenting on the NPRM. No public hearing was requested, and none was held.

On January 14, 2004 we published a supplemental notice of proposed rulemaking (SNPRM) also entitled Baltimore Harbor Anchorage Project in the Federal Register (69 FR 2095) to solicit for comments on updates made to Anchorage 2. No public hearing was requested, and none was held.

On October 12, 2004 we published a supplemental notice of proposed rulemaking (SNPRM) again entitled Baltimore Harbor Anchorage Project in the Federal Register (69 FR 60592) to better align the anchorages with the Federal navigation project. No comments were received on the SNPRM. No public hearing was requested, none was held.

The U.S. Army Corps of Engineers received Congressional authorization for the Baltimore Harbor Anchorage project in September 2001. Dredging for the Baltimore Harbor Anchorage was completed in May 2003. The objective of this project was to increase the project depths of Anchorage No. 3 and No. 4 to 42ft and 35ft respectively.

The original Federal anchorage project for Baltimore Harbor was designed to accommodate cargo ships with maximum drafts of 33ft and lengths of 550ft. The dimensions of the anchorages changed to accommodate the larger ships that call on the Port that routinely approach 1000ft length overall with drafts of 36 to 38 feet or more. The new coordinates established for Anchorage Nos. 2, 3, and 4, also accommodate the widening of the Dundalk West Channel, a north/south Federal navigation project located between Anchorage No. 3 and Anchorage No. 4 and widening of the Dundalk East Channel bordering Anchorage No. 4. Anchorage No. 3 was divided into two sections: Anchorage 3 Lower (2200′ x 2200′ x 42ft mean lower low water (MLLW)) and Anchorage 3 Upper (1800′ x 1800′ x 42ft MLLW). Anchorage No. 4 was also modified (1850′ x 1800′ x 35ft MLLW).

One comment was received regarding the new coordinates of the anchorages in response to the NPRM (68 FR 39503). Three changes where made based on that comment. The longitude for the fourth coordinate in Anchorage 3 Upper listed as 76° 33′53.6″ W was changed to 76° 32′ 53.6″ W. In Anchorage 2, the sixth position incorrectly listed as 39° 14′43.7″ N, 76° 2′63.6″ W was changed to 39°14′43.7″ N, 76° 32′53.6″ W. Also in Anchorage 2, the second coordinate listed as 39° 14′43.9″ N, 76° 32′27.0″ W was excluded.

Two changes were made to the two northwestern coordinates in Anchorage 2 after the comment period for the NPRM had expired. Therefore, we issued a SNPRM to solicit comments. No comments were received.

Minor changes were made to the geographic points making up Anchorages 1, 2, 5, 6 and 7 to aid in the graphical representations of those anchorages and better align them with the Federal navigation project. One decimal place was added to all coordinates to better define the anchorage boundaries. Therefore, we published a second SNPRM to solicit comments on the changes. No comments were received.

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

The deepening of Anchorage No. 3 and Anchorage No. 4 within the Port of Baltimore accommodates deep draft vessels waiting for an open berth. The Coast Guard does not expect that these new regulations will adversely impact maritime commerce.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which might be small entities: the owners or operators of vessels used for chartering, taxi, ferry services, or any other marine traffic that transit this area of Fort McHenry Channel in Baltimore Harbor. Changes to Anchorage No. 3 and Anchorage No. 4 may change the vessel routing through this area of the harbor. Deepening the anchorages and changing the coordinates for the anchorages will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic can pass safely around the new anchorage areas. The new coordinates for the anchorages are a change in dimension, the size of which will remain proportional to its current size, and their location will not interfere with commercial traffic.

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

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

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2. of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f), of the Instruction, from further environmental documentation. This rule changes the size of Anchorage No. 2, Anchorage No. 3 and Anchorage No. 4 and modifies the regulated uses of these anchorages.

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

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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

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

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

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

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

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

In the Federal Register of March 17, 2004 (69 FR 12676) (FRL-7347-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E6636, 3E6741, and 3E6747) by Interregional Research Project Number (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902 and Nichino America, Inc., Linden Park, Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.511 be amended by establishing a tolerance for residues of the insecticide buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one), in or on the raw agricultural commodities: Fruit, pome, group 11, except apple and apple, pomace at 4.0 parts per million (ppm) (PP 3E6636), apple at 1.2 ppm (PP 3E6636), apple, pomace at 2.5 ppm (PP 3E6636), peach, apricot, and nectarine at 3.0 ppm (PP 3E6741), and avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.30 ppm (PP 3E6747).

In the Federal Register of June 21, 2000 (65 FR 38543) (FRL-6557-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F6087) by Nichino America, Inc., Linden Park, Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19808, (formerly Aventis CropScience, formerly AgrEvo USA Company). The petition requested that 40 CFR 180.511 be amended by establishing a tolerance for residues of the insecticide buprofezin] (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one), in or on the following meat commodities; (Cattle, goats, hogs, horse, and sheep at 0.05 ppm) and kidney commodities for (cattle, goats, hogs, horse, and sheep at 0.05 ppm) respectively.

In the Federal Register of December 22, 2004 (69 FR 76719) (FRL-7689-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F6873) by Nichino America, Inc., Linden Park, Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.511 be amended by establishing increased tolerances for residues of buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one) in or on the following agricultural commodities: Fruit, citrus, Group 10 at 2.5 ppm); citrus, dried pulp at 7.5 ppm; and citrus, oil at 80 ppm.

In the Federal Register of December 23, 2004 (69 FR 76942) (FRL-7694-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F6887) by Nichino America, Inc., Linden Park, Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.511 be amended by establishing tolerances for residues of buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one) in or on the following raw agricultural commodities: Head lettuce at 5 ppm, leaf lettuce at 13 ppm, and Vegetables, cucurbits, group 9 at 0.5 ppm.

Each respective notice included a summary of the petition prepared by the registrant Nichino America, Incorporated, 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808, or the previous, registrant Aventis CropScience.

A private citizen responded to petitions PP 3E6636, 3E6741, 3E6747, 4F6873, and 4F6887. The substantive public comments and corresponding Agency responses are addressed in a separate document available in the docket for this action under Docket identification (ID) number OPP-2004-0362.

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

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

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of buprofezin in or on avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birida, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.30 parts per million (ppm); pome fruit at 4.0 ppm; peach at 9.0 ppm, meat (cattle, goat, hog, horse, and sheep) at 0.05 ppm; kidney (cattle, goat, hog, horse, and sheep) at 0.05 ppm; Lettuce, head at 5.0 ppm, Lettuce, leaf at 13 ppm; Vegetable, cucurbit group 9 at 0.50 ppm; Fruit, citrus, Group 10 at 2.5 parts per million (ppm); Citrus, dried pulp at 7.5 ppm, and citrus, oil at 80 ppm.

EPA's assessment of exposures and risks associated with establishing the tolerance follows:

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by buprofezin as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of June 25, 2003 (68 FR 37765) (FRL-7310-7).

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

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

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

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

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

A summary of the toxicological endpoints for buprofezin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 25, 2003 (68 FR 37765) (FRL-7310-7).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.511) for the residues of buprofezin, in or on a variety of raw agricultural commodities. Tolerances for residues of buprofezin are currently established for ruminant fat, meat byproducts, and liver at 0.05 ppm (40 CFR 180.511). Tolerances are being established for meat (cattle, goat, hog, horse, and sheep) at 0.05 ppm; and kidney (cattle, goat, hog, horse, and sheep) at 0.05 ppm; based on additional animal metabolism studies provided from Nichino America, Inc. Risk assessments were conducted by EPA to assess dietary exposures from buprofezin in food as follows:

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

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ) (ver. 1.30) and Lifeline TM (ver. 2.00) models, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The acute analysis assumed tolerance level residues, 100% crop treated for all uses, and DEEM TM (ver. 7.76) default processing factors for all registered/proposed commodities (Tier 1). The chronic analysis assumed DEEM TM (ver.7.76) default processing factors for all registered/proposed commodities and incorporated percent crop treated estimates and average field trial residues.

ii. Cancer . In accordance with the EPA Guidelines for Carcinogen Risk Assessment, the Carcinogen Assessment Review Commission classified buprofezin as having “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential” based on liver tumors in female mice. The Committee further recommended no quantification of cancer risk.

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

The Agency used PCT information as follows:

• 5% crop treated (PCT) for cantaloupes;

• 2.5% crop treated for cotton, grapefruit, grapes, lemons, limes, oranges, squash, tangelos, tangerines, tomatoes, and watermelon;

• Market share % crop treated was projected not to exceed 5% for apples, and 13% for peaches;

• All other crops currently registered and/or proposed commodities were assumed to be 100% crop treated.

The Agency believes that the three conditions listed in Unit C. 1. iii. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. For previously registered crops, EPA used an average of the values from these surveys over the last 5 years for estimating PCT for chronic dietary exposure assessments. For most newly registered crops, the Agency assumed 100% PCT. In estimating PCT for the apples and peaches as newly-registered crops, EPA assumed that the PCT for buprofezin would at least equal or exceed the PCT for the leading comparable insect growth regulatory pesticide alternative on that crop. For peaches, PCT for buprofezin was projected to potentially exceed the leading alternative's PCT by a factor of five because buprofezin has a slight cost advantage over the alternative on that crop. With regards to apples, buprofezin was projected to slightly exceed sales of the leading alternative's PCT because buprofezin is an excellent technical fit as an insect pest management (IPM) insecticide for apples. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation.

As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which buprofezin may be applied in a particular area.

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

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

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

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

Based on the GENEEC, PRZM/EXAMS and SCI-GROW models, the EECs of buprofezin for acute exposures are estimated to be 19.2 parts per billion (ppb) for surface water and 0.1 ppb for ground water. The EECs for chronic exposures are estimated to be 4.5 ppb for surface water and 0.1 ppb for ground water.

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

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

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

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

2. Prenatal and postnatal sensitivity . The Agency concluded that the available studies provided no indication of increased susceptibility of rats or rabbits following in utero exposure or of rats following prenatal/postnatal exposure to buprofezin.

3. Conclusion . There is a complete toxicity data base for buprofezin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X.

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

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to buprofezin will occupy 5.0% of the aPAD for females 13 to 19 years old. In addition, there is potential for acute dietary exposure to buprofezin] in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 1 of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, the chronic aggregate risk assessment takes into account average exposure estimates from dietary consumption of buprofezin (food and drinking water). However, there are no residential uses for buprofezin that result in chronic residential exposure to buprofezin. Therefore, the chronic aggregate risk assessment will consider exposure from food and drinking water only. There is potential for chronic dietary exposure to buprofezin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:

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

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Buprofezin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported. Increased relative liver weights were reported in female dogs. Buprofezin was not carcinogenic to male and female rats. In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported. Buprofezin was negative in in vitro and in vivo genotoxicity assays. The findings from the published literature indicate that buprofezin causes cell transformation and induces micronuclei in vitro . In the absence of a positive response in an in vivo micronucleus assay, the Agency concluded that buprofezin may have aneugenic potential, which is not expressed in vivo . In sum, buprofezin was negative in the rat, negative for mutagenicity and negative for male mice; however, in female mice, a slight or marginal increase in combined adenomas and carcinomas was observed. Given these findings in the cancer and mutagenicity studies, EPA regards the carcinogenic potential of buprofezin as very low and concludes that it poses no greater than a negligible cancer risk to humans.

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

Plants . Adequate enforcement methodology gas chromatography using nitrogen phosphorus detection is available to enforce the tolerance expression.

Livestock . The Agency has successfully validated method BF/11/97 for enforcement of the livestock tolerances and the method was forwarded to FDA's Technical Editing Group for publication in a future revision of the Pesticide Analytical Manual I (PAM I).

The methods 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 Canadian, Mexican, or Codex maximum residue limits (MRLs) established for buprofezin in/on any of the commodities associated with the current petition. Therefore, harmonization is not relevant.

Therefore, the tolerance is established for residues of buprofezin, in or on avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birida, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola] at 0.30 ppm; Fruit, Pome, Crop Group 11 at 4.0 ppm; Peach at 9.0 ppm; Meat (cattle, goat, hog, horse, and sheep) at 0.05 ppm; and Kidney (cattle, goat, hog, horse, and sheep) at 0.05 ppm; Lettuce, head at 5.0 ppm; Lettuce, leaf at 13 ppm; and Vegetable, cucurbit group 9 at 0.50 ppm; Fruit, citrus, Group 10 at 2.5 ppm; citrus, dried pulp at 7.5 ppm; and citrus, oil at 80 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0412 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 June 7, 2005.

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

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

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0412, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing time-limited tolerances for combined residues of the fungicide triflumizole and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in or on parsley, leaves at 9.0 parts per million (ppm); dandelion, leaves at 7.0 (ppm); swiss chard at 7.0 (ppm); collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa at 9.0 ppm; broccoli at 1.0 ppm; and coriander, leaves (cilantro) at 9.0 ppm. These tolerances will expire and are revoked on June 30, 2008. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

Texas has declared a crisis exemption under FIFRA section 18 for the use of triflumizole on parsley; dandelion; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese, napa; broccoli; and coriander, leaves (cilantro) for control of powdery mildew. Texas states the effective control of powdery mildew over the 70 to 90-day growing season requires two additional applications of a systemic pesticide beyond those permitted on the currently registered alternative labels.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of triflumizole in or on parsley; dandelion; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese napa; broccoli; and coriander, leaves (cilantro). In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary time-limited tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these time-limited tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances will expire and are revoked on June 30, 2008, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on parsley, leaves; dandelion, leaves; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese napa; broccoli; and coriander, leaves (cilantro) after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether triflumizole meets EPA's registration requirements for use on parsley; dandelion; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese napa; broccoli; and coriander, leaves (cilantro) or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of triflumizole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Texas to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for triflumizole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of triflumizole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of triflumizole in or on parsley, leaves at 9.0 parts per million (ppm); dandelion, leaves at 7.0 (ppm); swiss chard at 7.0 (ppm); collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa; at 9.0 ppm; broccoli at 1.0 ppm; and coriander, leaves at 9.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

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

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). The Food Quality Protection Act of 1996 (FQPA) added to FFDCA section 408(b)(2)(C) an additional safety factor to protect children's health. Where this additional FQPA safety factor is retained, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.476) for the combined residues of triflumizole, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from triflumizole in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance level residues and 100% crop treated for all registered and proposed uses.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A refined, chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using anticipated residues (ARs) from average field trial residues for apple, grape, pear, cherry, cucurbit, strawberry, and milk commodities; registered and proposed tolerances for all other commodities; percent crop treated (CT) information for apple, grape and pear commodities; and 100% CT information for all other uses.

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

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

The Agency used PCT information for the registered uses on grape, apple, and pear. EPA based these assumptions on use data for the period 1996 to 1997 and 1998. For all other registered uses as well as these uses, EPA assumed that 100% of the U.S. crop would be treated with triflumizole.

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

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

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentrations in Groundwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water, EPA will generally use FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

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

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

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of triflumizole for acute exposures are estimated to be 191 parts per billion (ppb) for surface water and 0.12 ppb for ground water. The EECs for chronic exposures are estimated to be 40 ppb for surface water and 0.12 ppb for ground water.

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

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

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

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

1. In general . Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . There is qualitative evidence of increased susceptibility demonstrated in the oral prenatal developmental toxicity studies in rats. Developmental toxicity resulted in fetal death as compared to maternal toxicity which included decreases in body weight gain and food consumption and increases in placental, spleen and liver weights at the same dosages. No quantitative or qualitative evidence of increased susceptibility was demonstrated in the prenatal developmental toxicity studies in rabbits or the multi-generation reproduction studies in rats. In the rabbit developmental studies, 24-hour fetal survival was decreased at the highest dose tested. This endpoint is not a recommended guideline parameter and is generally believed to have limited value in the assessment of development toxicity; rather, it is more an indicator of fetal endurance in the absence of critical maternal care, following removal from the uterus. The Hazard Identification Assessment Review Committee did not consider this effect to be a measurement of treatment-related effects on fetal viability and, thus, did not consider it to be relevant to the assessment of fetal susceptibility. There was no evidence of quantitative or qualitative susceptibility in the 2-generation reproduction study in rats. In that study, increased gestation length was observed at the study LOAEL. In rats, this alteration in normal reproductive function can result in equally adverse consequences (i.e., mortality) in both dams and offspring.

3. Conclusion . In the Agency's previous triflumizole human health risk assessment, the following toxicity studies were determined to be data gaps: A 28-day rat inhalation study Guideline Number (GLN) 870.3465)), acute rat neurotoxicity study (GLN 870.6200), and subchronic rat neurotoxicity study (GLN 870.6200). The acute and sub-chronic neurotoxicity studies have been submitted, reviewed by the Agency and determined to be acceptable. As a result, the following has changed: (1) Selection of an acute endpoint for the general U.S. population (including infants and children); and (2) the removal of the 3x database uncertainty factor (UFDB). All other aspects of the most recent risk assessment remain unchanged.

As acceptable acute and sub-chronic neurotoxicity studies have been submitted, the Agency has determined that the 3x UFDB should be removed from the acute and chronic RfDs. In addition, the FQPA SFC recommended a special FQPA SF be reduced to 1x. The Agency has re-evaluated the quality of the exposure and hazard data; and, based on these data, concluded that the special FQPA SF remain at 1x. The conclusion is based on the following:

• The toxicity database is complete for FQPA assessment.

• There was no quantitative or qualitative evidence of increased susceptibility in the rabbit fetuses following in utero exposure or the rat following prenatal and postnatal exposure in the rat reproduction study.

• There was evidence of qualitative susceptibility in the developmental rat study; however, there are no residual uncertainties, and the use of the developmental NOAEL and the endpoint for the acute RfD for females 13 to 50 would be protective of the prenatal toxicity following an acute dietary exposure.

• There is no evidence of increased quantitative or qualitative susceptibility in the rat developmental neurotoxicity study.

• The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100% CT information for all commodities. By using these screening-level assessments, actual exposures/risks will not be underestimated.

• The chronic dietary food exposure assessment utilizes ARs and % CT data verified for several existing uses. For all proposed use, tolerance-level residue and 100% CT is assumed. The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/risk.

• The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health-protective, high-end estimates of water concentrations which will not likely be exceeded.

• There are no registered or proposed uses of triflumizole that would result in residential exposure.

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

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to triflumizole will occupy 6% of the aPAD for the U.S. population, 9% of the aPAD for females 13 to 49 years old, and 21% of the aPAD for children 1 to 2 years old, the population at greatest exposure. In addition, despite the potential for acute dietary exposure to triflumizole in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of triflumizole in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to triflumizole from food will utilize 5% of the cPAD for the U.S. population, 4% of the cPAD for all infants ( < 1 year old) and 13% of the cPAD for children 1 to 2 years old, the subpopulation at greatest exposure. There are no residential uses for triflumizole that result in chronic residential exposure to triflumizole. In addition, despite the potential for chronic dietary exposure to triflumizole in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of triflumizole in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term and intermediate-term risk . Short-term and intermediate-term aggregate exposure assessments take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). For triflumizole, the Agency did not perform short-term or intermediate-term assessments because there are currently no registered or proposed uses for homeowner application and residential post- application exposures are expected to be negligible.

4. Aggregate cancer risk for U.S. population . Since triflumizole has been determined not to be carcinogenic, it is not expected to pose a cancer risk.

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

Adequate enforcement methodology (gas chromatography/mass spectrometry detector (GC/MSD) method (Morse Method METH-115, Revision #3)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no Codex, Canadian or Mexican maximum residue limits established for triflumizole residues in/on crop commodities. Therefore, no compatibility issues exist with regard to the proposed U.S. tolerances discussed in this risk assessment.

The petitioner should submit adequate limited field rotational crop data on wheat at plant-back intervals longer than 120 days. Alternatively, the petitioner has the option of submitting a full set of residue field trials on all intended rotational crops other than leafy and root vegetables.

Therefore, tolerances are established for combined residues of triflumizole and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in or on parsley, leaves at 9.0 ppm; dandelion, leaves at 7.0 ppm; swiss chard at 7.0 ppm; collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa at 9.0 ppm; broccoli at 1.0 ppm; and coriander, leaves at 9.0 ppm.

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides that the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0054 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 June 7, 2005.

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

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

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by the docket ID number OPP-2005-0054, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes time-limited tolerances under section 408 of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

1. Legislative: Under section 10(j) of the Act, the Secretary of the Department of the Interior can designate reintroduced populations established outside the species' current range, but within its historical range, as “experimental.” Based on the best scientific and commercial data available, we must determine whether experimental populations are “essential,” or “nonessential,” to the continued existence of the species. Regulatory restrictions are considerably reduced under a Nonessential Experimental Population (NEP) designation.

Without the “nonessential experimental population” designation, the Act provides that species listed as endangered or threatened are afforded protection primarily through the prohibitions of section 9 and the requirements of section 7. Section 9 of the Act prohibits the take of an endangered species. “Take” is defined by the Act as harass, harm, pursue, hunt, shoot, wound, trap, capture, or collect, or attempt to engage in any such conduct. Service regulations (50 CFR 17.31) generally extend the prohibitions of take to threatened wildlife. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve federally listed species and protect designated critical habitat. It mandates that all Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also states that Federal agencies will, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.

With the experimental population designation, a population designated is treated for purposes of section 9 of the Act as threatened regardless of the species' designation elsewhere in its range. Threatened designation allows us greater discretion in devising management programs and special regulations for such a population. Section 4(d) of the Act allows us to adopt whatever regulations are necessary to provide for the conservation of a threatened species. In these situations, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the special 4(d) rule contains the prohibitions and exemptions necessary and appropriate to conserve that species. Regulations issued under section 4(d) for NEPs are usually more compatible with routine human activities in the reintroduction area.

For the purposes of section 7 of the Act, we treat an NEP as a threatened species when the NEP is located within a National Wildlife Refuge or National Park, and section 7(a)(1) and the consultation requirements of section 7(a)(2) of the Act apply. Section 7(a)(1) requires all Federal agencies to use their authorities to conserve listed species. Section 7(a)(2) requires that Federal agencies, in consultation with the Service, insure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of a listed species or adversely modify its critical habitat. When NEPs are located outside a National Wildlife Refuge or National Park, we treat the population as proposed for listing and only two provisions of section 7 would apply—section 7(a)(1) and section 7(a)(4). In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities.

Individuals that are used to establish an experimental population may come from a donor population, provided their removal will not create adverse impacts upon the parent population, and provided appropriate permits are issued in accordance with our regulations (50 CFR 17.22) prior to their removal. In the case of the boulder darter and spotfin chub, the donor population is a captive-bred population, which was propagated with the intention of re-establishing wild populations to achieve recovery goals. In addition, it is possible that wild adult stock could also be released into the NEP area.

2. Biological information: The endangered boulder darter is an olive- to gray-colored fish that lacks the red spots common to most darters. It is a small fish, approximately 76 millimeters (mm) (3 inches (in)) in length. Although boulder darters were historically recorded only in the Elk River system and Shoal Creek (a tributary to the Tennessee River), scientists believe, based on the historical availability of suitable habitat, that this darter once inhabited fast-water rocky habitat in the Tennessee River and its larger tributaries in Tennessee and Alabama, from the Paint Rock River in Madison County, Alabama, downstream to at least Shoal Creek in Lauderdale County, Alabama (U.S. Fish and Wildlife Service 1989). Currently, it is extirpated from Shoal Creek (a tributary to the Tennessee River) and exists only in the Elk River, Giles and Lincoln Counties, Tennessee, and Limestone County, Alabama, and the lower reaches of Richland Creek, an Elk River tributary, Giles County, Tennessee (U.S. Fish and Wildlife Service 1989).

The spotfin chub is also olive colored, but with sides that are largely silvery and with white lower parts. Large nuptial males have brilliant turquoise-royal blue coloring on the back, side of the head, and along the mid-lateral part of the body. It is also a small fish, approximately 92 millimeters (mm) (4 inches (in)) in length. The spotfin chub was once a widespread species and was historically known from 24 upper and middle Tennessee River system streams, including Shoal Creek. It is now extant in only four rivers/river systems—the Buffalo River at the mouth of Grinders Creek, Lewis County, Tennessee; the Little Tennessee River, Swain and Macon Counties, North Carolina; Emory River system (Obed River, Clear Creek, and Daddys Creek), Cumberland and Morgan Counties, Tennessee; the Holston River and its tributary, North Fork Holston River, Hawkins and Sullivan Counties, Tennessee, and Scott and Washington Counties, Virginia (U.S. Fish and Wildlife Service 1983; P. Shute, TVA, pers. comm. 1998).

Since the mid-1980s, Conservation Fisheries, Inc. (CFI), a nonprofit organization, with support from us, the Tennessee Wildlife Resources Agency (TWRA), U.S. Forest Service, National Park Service, Tennessee Valley Authority (TVA), and Tennessee Aquarium, has successfully translocated, propagated, and reintroduced the spotfin chub and three other federally listed fishes (smoky madtoms, yellowfin madtoms, and duskytail darters) into Abrams Creek, Great Smoky Mountains National Park, Blount County, Tennessee. These fish historically occupied Abrams Creek prior to an ichthyocide treatment in the 1950s. An NEP designation for Abrams Creek was not needed since the entire watershed occurs on National Park Service land, section 7 of the Act applies regardless of the NEP designation, and existing human activities and public use of the Creek are consistent with protection and take restrictions needed for the reintroduced populations. Natural reproduction by all four species in Abrams Creek has been documented, but the spotfin chub appears to be the least successful in this capacity (Rakes et al. 2001; Rakes and Shute 2002). We have also worked with CFI to translocate, propagate, and reintroduce these same four fish into an NEP established for a section of the Tellico River, Monroe County, Tennessee (67 FR 52420, August 12, 2002). Propagated fish of these four species were released into the Tellico River starting in 2003 and continuing in 2004. It is still too early to determine the success of these releases, but it is believed that the habitat and water quality is sufficient to ensure future success similar to the Abrams Creek reintroductions. CFI has also successfully propagated boulder darters and augmented the only known population of the species in the Elk River system in Tennessee.

Based on CFI's success and intimate knowledge of these two fishes and their habitat needs, we contracted with CFI to survey Shoal Creek in order to determine if suitable habitat exists in this creek for reintroductions, and if we could expand our ongoing fish recovery efforts to these waters (Rakes and Shute 1999). Rakes and Shute (1999) concluded that about 20 miles (32 km) of Shoal Creek above the backwaters of the Wilson Reservoir appeared to contain suitable reintroduction habitat for both fishes. The boulder darter and spotfin chub were last collected from Shoal Creek in the 1880s, and since then both were apparently extirpated from this reach. We believe the boulder darter was extirpated by the combined effects of water pollution and the impoundment of lower Shoal Creek with the construction of Wilson Dam (U.S. Fish and Wildlife Service 1989). We believe that similar factors led to the extirpation of the spotfin chub. However, as a result of implementation of the Clean Water Act by the U.S. Environmental Protection Agency (EPA) and State water and natural resources agencies, and the pollution control measures undertaken by municipalities, industries, and individuals, the creek's water quality has greatly improved and its resident fish fauna have responded positively (Charles Saylor, TVA, pers. comm. 2002; based on his bioassays).

3. Recovery Goals/Objectives: The boulder darter ( Etheostoma wapiti ) (Etnier and Williams 1989) was listed as an endangered species on September 1, 1988 (53 FR 33996). We completed a recovery plan for this species in July 1989 (U.S. Fish and Wildlife Service 1989). The downlisting (reclassification from endangered to threatened) objectives in the recovery plan are: (1) To protect and enhance the existing population in the Elk River and its tributaries, and to successfully establish a reintroduced population in Shoal Creek or other historical habitat or discover an additional population so that at least two viable populations exist; and (2) to complete studies of the species' biological and ecological requirements and implement management strategies developed from these studies that have been or are likely to be successful. The delisting objectives are: (1) To protect and enhance the existing population in the Elk River and its tributaries, and to successfully establish reintroduced populations or discover additional populations so that at least three viable populations exist (the Elk River population including the tributaries must be secure from river mile (RM) 90 downstream to RM 30); (2) to complete studies of the species' biological and ecological requirements and implement successful management strategies; and (3) to ensure that no foreseeable threats exist that would likely impact the survival of any populations.

The spotfin chub (=turquoise shiner) ( Cyprinella (= Hybopsis ) monacha ) (Cope 1868) was listed as a threatened species on September 9, 1977, with critical habitat and a special rule (42 FR 45526). The critical habitat map was corrected on September 22, 1977 (42 FR 47840). We completed a recovery plan for this species in November 1983 (U.S. Fish and Wildlife Service 1983). We also established an NEP for the spotfin chub and three other federally listed fishes for a section of the Tellico River in Monroe County, Tennessee, on August 12, 2002 (67 FR 52420). The delisting objectives in the recovery plan are: (1) To protect and enhance existing populations so that viable populations exist in the Buffalo River system, upper Little Tennessee River, Emory River system, and lower North Fork Holston River; (2) to ensure, through reintroduction and/or the discovery of two new populations, that viable populations exist in two other rivers; and (3) to ensure that no present or foreseeable threats exist that would likely impact the survival of any populations.

The recovery criteria for both fishes generally agree that, to reach recovery, we must: (1) Restore existing populations to viable levels, (2) reestablish multiple, viable populations in historical habitats, and (3) eliminate foreseeable threats that would likely threaten the continued existence of any viable populations. The number of secure, viable populations (existing and restored) needed to achieve recovery varies by species and depends on the extent of the species' probable historical range ( i.e. , species that were once widespread require a greater number of populations for recovery than species that were historically more restricted in distribution). However, the reestablishment of historical populations is a critical component to the recovery of both the boulder darter and spotfin chub.

4. Reintroduction site: In May 1999 letters to us, the Commissioner of the Alabama Department of Conservation and Natural Resources (ADCNR) and the Executive Director of the TWRA requested that we consider designating NEPs for the spotfin chub and boulder darter and reintroducing both species into Shoal Creek, where they historically occurred.

We previously established NEPs for the spotfin chub and three other federally listed fishes in the Tellico River, Tennessee, on August 12, 2002 (67 FR 52420). Reintroductions of the spotfin chub were initiated in the Tellico River in 2002 and were continued in 2003 and 2004 along with the first reintroductions of the remaining three fish species. These reintroduced fish are being monitored. We believe the Tellico River is suitable for the establishment of viable populations of each of these four fish and anticipate success as this recovery project proceeds. Establishment of viable populations of the spotfin chub in both the Tellico River under the existing regulation and in Shoal Creek under this regulation will help achieve an objective in the recovery of this fish. However, it will take several years of monitoring to fully evaluate if populations of this fish (and the other fishes) have become established and remain viable in these historic river reaches.

Based on the presence of suitable habitat, the positive response of native fish species to habitat improvements in Shoal Creek, the presence of similar fish species that have similar habitat requirements to both of these fishes, the recommendations mentioned above, and the evaluation of biologists familiar with Shoal Creek, we believe that Shoal Creek, from the mouth of Long Branch to the backwaters of the Wilson Reservoir, is suitable for the reintroduction of the boulder darter and spotfin chub as NEPs.

According to P. Rakes (CFI, pers. comm. 2005), the best sites to reintroduce these fishes into Shoal Creek are between CM 33 (53 km) and CM 14 (22 km). Therefore, we plan to reintroduce the boulder darter and spotfin chub into historical habitat of the free-flowing reach of Shoal Creek between CM 33 and CM 14. This reach contains the most suitable habitat for the reintroductions. Neither species currently exists in Shoal Creek or its tributaries.

5. Reintroduction procedures: The dates for these reintroductions, the specific release sites, and the actual number of individuals to be released cannot be determined at this time. Individual fish that would be used for the reintroductions primarily will be artificially propagated juveniles. However, it is possible that wild adult stock could also be released into the NEP area. Spotfin chub and boulder darter propagation and juvenile rearing technology are available. The parental stock of the juvenile fishes for reintroduction will come from existing wild populations. In some cases, the parental stock for juvenile fish will be returned back to the same wild population. Generally, the parents are permanently held in captivity.

The permanent removal of adults from the wild for their use in reintroduction efforts may occur when one or more of the following conditions exist: (1) Sufficient adult fish are available within a donor population to sustain the loss without jeopardizing the species; (2) the species must be removed from an area because of an imminent threat that is likely to eliminate the population or specific individuals present in an area; or (3) when the population is not reproducing. It is most likely that adults will be permanently removed because of the first condition: sufficient adult fish are available within a donor population to sustain the loss without jeopardizing the species. An enhancement of propagation or survival permit under section 10(a)(1)(A) of the Act is required. The permit will be issued before any take occurs, and we will coordinate these actions with the appropriate State natural resources agencies.

6. Status of reintroduced population: Previous translocations, propagations, and reintroductions of spotfin chubs and boulder darters have not affected the wild populations of either species. The use of artificially propagated juveniles will reduce the potential effects on wild populations. The status of the extant populations of the boulder darter and spotfin chub is such that individuals can be removed to provide a donor source for reintroduction without creating adverse impacts upon the parent population. If any of the reintroduced populations become established and are subsequently lost, the likelihood of the species' survival in the wild would not be appreciably reduced. Therefore, we have determined that these reintroduced fish populations in Shoal Creek are not essential to the continued existence of the species. We will ensure, through our section 10 permitting authority and the section 7 consultation process, that the use of animals from any donor population for these reintroductions is not likely to jeopardize the continued existence of the species.

Reintroductions are necessary to further the recovery of these species. The NEP designation for the reintroduction alleviates landowner concerns about possible land and water use restrictions by providing a flexible management framework for protecting and recovering the boulder darter and spotfin chub, while ensuring that the daily activities of landowners are unaffected. In addition, the anticipated success of these reintroductions will enhance the conservation and recovery potential of these species by extending their present ranges into currently unoccupied historical habitat. These species are not known to exist in Shoal Creek or its tributaries at the present time.

7. Location of reintroduced population: The NEP area, which encompasses all the sites for the reintroductions, will be located in the free-flowing reach of Shoal Creek (a tributary to the Tennessee River), Lauderdale County, Alabama, and Lawrence County, Tennessee, from the mouth of Long Branch downstream to the backwaters of the Wilson Reservoir. Section 10(j) of the Act requires that an experimental population be geographically separate from other wild populations of the same species. This NEP area is totally isolated from existing populations of these species by large reservoirs, and neither fish species is known to occur in or move through large reservoirs. Therefore, the reservoirs will act as barriers to the species' downstream movement into the Tennessee River and its tributaries and ensure that this NEP remains geographically isolated and easily distinguishable from existing wild populations. Based on the fishes' habitat requirements, we do not expect them to become established outside the NEP. However, if any of the reintroduced boulder darters and spotfin chubs move outside the designated NEP area, then the fish would be considered to have come from the NEP area. In that case, we may propose to amend the rule and enlarge the boundaries of the NEP area to include the entire range of the expanded populations.

The designated NEP area for the spotfin chub in the Tellico River (67 FR 52420) does not overlap or interfere with this NEP area for Shoal Creek in Tennessee and Alabama because they are geographically separated river reaches.

Critical habitat has been designated for the spotfin chub (42 FR 47840, September 22, 1977); however, the designation does not include this NEP area. Critical habitat has not been designated for the boulder darter. Section 10(j)(2)(C)(ii) of the Act states that critical habitat shall not be designated for any experimental population that is determined to be nonessential. Accordingly, we cannot designate critical habitat in areas where we have already established, by regulation, a nonessential experimental population.

8. Management: The aquatic resources in the reintroduction area are managed by the ADCNR and TWRA. Multiple-use management of these waters will not change as a result of the experimental designation. Private landowners within the NEP area will still be allowed to continue all legal agricultural and recreational activities. Because of the substantial regulatory relief provided by NEP designations, we do not believe the reintroduction of boulder darter and spotfin chub will conflict with existing human activities or hinder public use of the area. The ADCNR and the TWRA have previously endorsed the boulder darter and spotfin chub reintroductions under NEP designations and are supportive of this effort. The NEP designation will not require the ADCNR and the TWRA to specifically manage for reintroduced boulder darter and spotfin chub.

The Service, State employees, and CFI, Inc., staff will manage the reintroduction. They will closely coordinate on reintroductions, monitoring, coordination with landowners and land managers, and public awareness, among other tasks necessary to ensure successful reintroductions of species.

(a) Mortality: The Act defines “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity such as recreation ( e.g. , fishing, boating, wading, trapping or swimming), forestry, agriculture, and other activities that are in accordance with Federal, Tribal, State, and local laws and regulations. A person may take a boulder darter or spotfin chub within the experimental population area provided that the take is unintentional and was not due to negligent conduct. Such conduct will not constitute “knowing take,” and we will not pursue legal action. However, when we have evidence of knowing ( i.e. , intentional) take of a boulder darter or spotfin chub, we will refer matters to the appropriate authorities for prosecution. We expect levels of incidental take to be low since the reintroduction is compatible with existing human use activities and practices for the area.

(b) Special Handling: Service employees and authorized agents acting on their behalf may handle boulder darter and spotfin chub for scientific purposes; to relocate boulder darter and spotfin chub to avoid conflict with human activities; for recovery purposes; to relocate boulder darter and spotfin chub to other reintroduction sites; to aid sick or injured boulder darter and spotfin chub; and to salvage dead boulder darter and spotfin chub.

(c) Coordination with landowners and land managers: The Service and cooperators identified issues and concerns associated with the boulder darter and spotfin chub reintroduction before preparing this rule. The reintroduction also has been discussed with potentially affected State agencies, businesses, and landowners within the release area. The land along the NEP site is privately owned. International Paper owns a large tract within the NEP area and has expressed a strong interest in working with us to establish these fish in their stretch of the creek. Most, if not all, of the identified businesses are small businesses engaged in activities along the affected reaches of this creek. Affected State agencies, businesses, landowners, and land managers have indicated support for the reintroduction, if boulder darter and spotfin chub released in the experimental population area are established as an NEP and if aquatic resource activities in the experimental population area are not constrained.

(d) Potential for conflict with human activities: We do not believe these reintroductions will conflict with existing or proposed human activities or hinder public use of the NEP area within Shoal Creek. Experimental population special rules contain all the prohibitions and exceptions regarding the taking of individual animals. These special rules are compatible with routine human activities in the reintroduction area.

(e) Monitoring: After the first initial stocking of these two fish, we will monitor annually their presence or absence and document any spawning behavior or young-of-the-year fish that might be present. This monitoring will be conducted primarily by snorkeling or seining and will be accomplished by contracting with the appropriate species experts. Annual reports will be produced detailing the stocking rates and monitoring activities that took place during the previous year. We will also fully evaluate these reintroduction efforts after 5 and 10 years to determine whether to continue or terminate the reintroduction efforts.

(f) Public awareness and cooperation: On August 26, 1999, we mailed letters to 80 potentially affected congressional offices, Federal and State agencies, local governments, and interested parties to notify them that we were considering proposing NEP status in Shoal Creek for two fish species. We received a total of four responses to the 1999 notification, all of which supported our proposed designation and reintroductions.

The EPA supported the proposal, commended the ADCNR, TWRA, and us for the proposal and its projected beneficial results, and stated that the reintroductions would assist them in meeting one of the goals of the Clean Water Act—restoring the biological integrity of the Nation's water.

The TVA strongly supported the concept of reintroducing extirpated species, but also cautioned that past industrial discharges into Shoal Creek could potentially limit or prevent the survival of sensitive fishes in the creek.

The Tennessee Department of Environment and Conservation applauded our (TWRA, CFI, and us) efforts to restore Shoal Creek fishes. They also supported the proposed reintroductions under NEP status, because the designation will ensure that current human uses of Shoal Creek are given due consideration in recovery efforts for the species.

Dr. David Etnier, Department of Ecology and Evolutionary Biology, University of Tennessee, Knoxville, Tennessee, supported the reintroductions and concluded that he saw no compelling reason to delay them.

We have informed the general public of the importance of this reintroduction project in the overall recovery of the boulder darter and spotfin chub. The designation of the NEP for Shoal Creek and adjacent areas would provide greater flexibility in the management of the reintroduced boulder darter and spotfin chub. The NEP designation is necessary to secure needed cooperation of the States, landowners, agencies, and other interests in the affected area.

Based on the above information, and using the best scientific and commercial data available (in accordance with 50 CFR 17.81), the Service finds that releasing the boulder darter and spotfin chub into the Shoal Creek Experimental Population Area under a Nonessential Experimental Population designation will further the conservation of the species.

In addition, we are making two minor technical corrections to the existing regulations regarding these species:

(1) The spotfin chub was listed with critical habitat and a special rule on September 9, 1977, under the scientific name of Hybopsis monacha . The current list of endangered and threatened species at 50 CFR 17.11(h), the existing experimental population on the Tellico River in Tennessee at 50 CFR 17.84(m), and the critical habitat designation at 50 CFR 17.95(e) all use the scientific name Cyprinella (= Hybopsis ) monacha for the spotfin chub. However, the special rule at 50 CFR 17.44(c) uses the scientific name Hybopsis monacha for the spotfin chub. In the proposed rule (69 FR 61774, October 21, 2004), we proposed correcting the text for the special rule at 50 CFR 17.44(c) by changing the scientific name for the spotfin chub from Hybopsis monacha to Cyprinella (= Hybopsis ) monacha to make this section consistent with the text of the existing regulations for the spotfin chub. During the comment period, it was brought to our attention that the scientific name for the spotfin chub has recently been changed to Erimonax monachus (Nelson et al. 2004). This name change has occurred in a peer-reviewed journal and has acceptance in the scientific community. Therefore we are correcting the text for the current list of endangered and threatened species at 50 CFR 17.11(h), the existing experimental population on the Tellico River in Tennessee at 50 CFR 17.84(m), the critical habitat designation at 50 CFR 17.95(e), and the special rule at 50 CFR 17.44(c) by changing the scientific name for the spotfin chub from Cyprinella (= Hybopsis ) monacha to Erimonax monachus (see Regulation Promulgation section below).

(2) Unlike many of the existing experimental population regulations at 50 CFR 17.84, the entries for the experimental populations for the Tellico River in Tennessee at 50 CFR 17.84(e) and (m) do not include a map. We are adding a map for these entries in order to provide clarity for the public and make this section consistent with the text of the existing regulations for other experimental populations.

In the October 21, 2004, proposed rule (69 FR 61774), we requested that all interested parties submit comments or information concerning the proposed NEP. We contacted appropriate Federal, State, and local agencies, county governments, elected officials, scientific organizations, and other interested parties and invited them to comment on the proposed NEP. We also provided notification of this document through e-mail, telephone calls, letters, and news releases faxed and/or mailed to affected elected officials, media outlets, local jurisdictions, and interest groups. We provided the document on the Service's Tennessee Field Office Internet site following its release.

During the public comment period, we received comments from four parties: One State agency, two universities, and one nonprofit organization. Of the four parties responding, three supported the proposed NEP and one was neutral. The Alabama Department of Conservation and Natural Resources submitted comments as peer reviewers. The State agency's comments are reflected in Peer Review Comment 1 and 2 below.

In conformance with our policy on peer review, published on July 1, 1994 (59 FR 34270), we solicited independent opinions from four knowledgeable individuals who have expertise with these species within the geographic region where the species occurs, and/or familiarity with the principles of conservation biology. We received comments from two of the four peer reviewers. These are included in the summary below and incorporated into this final rule.

We reviewed all comments received from the peer reviewers and the public for substantive issues and new information regarding the proposed NEP. Substantive comments received during the comment period have either been addressed below or incorporated directly into this final rule. The comments are grouped below as either peer review or public comments.

(1) Comment: The proposed reintroduction is for Shoal Creek in Lauderdale County, Alabama; however, there is another Shoal Creek in Limestone County, Alabama, that is a tributary to the Elk River. Limestone County is adjacent to Lauderdale County and a recent survey by the Geological Survey of Alabama collected two boulder darters in this Shoal Creek, which was a new tributary record for this species. Because there are two creeks named “Shoal” in adjacent counties, it might help to differentiate between the two creeks to lessen any potential confusion.

Response: We have clarified the description of the Shoal Creek in Lauderdale County, Alabama, that occurs within the NEP by stating that this Shoal Creek is a tributary to the Tennessee River. The Shoal Creek in Limestone County, Alabama, is a tributary to the Elk River. This, along with the county it occurs in, should adequately differentiate between the two creeks.

(2) Comment: Section 5 of the proposed rule states that artificially propagated juveniles will most likely be reintroduced, but wild adult stock could also be used. The literature states that adult and juvenile spotfin chubs require slightly different habitats, thus reintroduction with juveniles should be done to account for those differences.

Response: It is our intent to release primarily juvenile spotfin chubs that have been raised by CFI. We have worked closely with CFI to determine the appropriate habitats for releasing these juvenile fish. If we do release any wild adult stock, we will work with CFI and the State Wildlife Agencies to ensure that the appropriate habitat is identified for their release.

(3) Comment: The newest names list for fish has been released and the scientific name of the spotfin chub has been changed to Erimonax monachus .

Response: We have reviewed the reference provided and concur that the scientific name of the spotfin chub has changed from Cyprinella (= Hybopsis ) monacha to Erimonax monachus . We have made the appropriate changes in the section titled “Other Changes to the Regulations” (see above).

(4) Comment: The Etnier and Williams 1989 description of the boulder darter was cited, but does not appear in the Literature Cited section.

Response: This citation has been added to the Literature Cited section.

(5) Comment: Boulder darters may be able to use reservoirs for dispersal purposes, and success of this introduction might make it easier for them to reach the mouth of the Flint River or perhaps some other fairly large Tennessee River tributaries in Alabama.

Response: We believe that the reservoirs will act as barriers to the species' downstream movement into the Tennessee River and its tributaries and will ensure that this NEP remains geographically isolated and easily distinguishable from existing known wild populations in the Elk River watershed. However, we also state that if any of the reintroduced boulder darters or spotfin chubs move outside the designated NEP area, then the fish would be considered to have come from the NEP area. In that case, we may propose to amend the rule and enlarge the boundaries of the NEP area to include the entire range of the expanded populations.

(6) Comment: Environmental Defense fully supports the proposal to establish new experimental populations of the boulder darter and the spotfin chub.

Response: We appreciate Environmental Defense's support of this important recovery effort to restore these fish back into this portion of their historical range.

(7) Comment: No source population for brood stock or wild adult stock is identified in the proposed rule for the spotfin chub.

Response: The Service has not identified the source population for the spotfin chub because no decision has been made at this time on which source population should be used. A final decision will be made in concert with our State partners once we have reviewed the best available scientific information.

(8) Comment: No protocol is outlined to determine if progeny from brood stock reflects the genetic diversity present in the source population.

Response: CFI states that it takes as many adults from the source population as the Federal and State agencies believe is appropriate to remove without harming the source population and within limits of practicality. CFI also states that it ensures that as many adults as possible are involved in reproduction. This sometimes involves cycling different males in and out of production. CFI emphasizes the importance of these reintroductions being long-term projects where new parental stock is brought into production every year or two from the original source population. We believe that this method maximizes our potential to have offspring that have similar genetic diversity to the source population and increases the recovery chances for these species within the limited amount of funding that Federal and State agencies have available to them.

We are making this rule effective upon publication. In accordance with the Administrative Procedure Act, we find good cause as required by 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in the Federal Register . We currently have two year classes of propagated boulder darters available for release. The juvenile class of boulder darters will be ready to spawn this spring for the first time. In order for this group of boulder darters to have the maximum amount of time to accomplish their first spawn, these fish need to be placed into Shoal Creek in April. The earlier in April these fish can be released, the more likely they are to spawn this spring. The older class of boulder darters are at the end of their spawning lives and must be placed into Shoal Creek by early May in order to ensure that they will have a chance to successfully spawn one last time in the wild. The 30-day delay would be contrary to the public interest because it would result in a loss of spawning for the first-time juvenile class and the last-time older class, and this would result in natural spawning not occurring in Shoal Creek until the spring of 2006.

In accordance with the criteria in Executive Order 12866, this rule to designate NEP status for the boulder darter and spotfin chub in Shoal Creek, Lauderdale County, Alabama and Lawrence County, Tennessee, is not a significant regulatory action subject to Office of Management and Budget review. This rule will not have an annual economic effect of $100 million or more on the economy and will not have an adverse effect on any economic sector, productivity, competition, jobs, the environment, or other units of government. The area affected by this rule consists of a very limited and discrete geographic segment of lower Shoal Creek (about 28 CM (44 km)) in southwestern Tennessee and northern Alabama. Therefore, a cost-benefit and economic analysis will not be required.

We do not expect this rule to have significant impacts to existing human activities ( e.g. , agricultural activities, forestry, fishing, boating, wading, swimming, trapping) in the watershed. The reintroduction of these federally listed species, which will be accomplished under NEP status with its associated regulatory relief, is not expected to impact Federal agency actions. Because of the substantial regulatory relief, we do not believe the proposed reintroduction of these species will conflict with existing or proposed human activities or hinder public use of Shoal Creek or its tributaries.

This rule will not create inconsistencies with other agencies' actions or otherwise interfere with an action taken or planned by another agency. Federal agencies most interested in this rulemaking are primarily the EPA and TVA. Both Federal agencies support the reintroductions. Because of the substantial regulatory relief provided by the NEP designation, we believe the reintroduction of the boulder darter and spotfin chub in the areas described will not conflict with existing human activities or hinder public utilization of the area.

This rule will not materially affect entitlements, grants, user fees, or loan programs, or the rights and obligations of their recipients. Because there are no expected impacts or restrictions to existing human uses of Shoal Creek as a result of this rule, no entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients are expected to occur.

This rule does not raise novel legal or policy issues. Since 1984, we have promulgated section 10(j) rules for many other species in various localities. Such rules are designed to reduce the regulatory burden that would otherwise exist when reintroducing listed species to the wild.

The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Although most of the identified entities are small businesses engaged in activities along the affected reaches of this creek, this rulemaking is not expected to have any significant impact on private activities in the affected area. The designation of an NEP in this rule will significantly reduce the regulatory requirements regarding the reintroduction of these species, will not create inconsistencies with other agencies' actions, and will not conflict with existing or proposed human activity, or Federal, State, or public use of the land or aquatic resources.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule will not have an annual effect on the economy of $100 million or more. It will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions. This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises. The intent of this special rule is to facilitate and continue the existing commercial activity while providing for the conservation of the species through reintroduction into suitable habitat.

The NEP designation will not place any additional requirements on any city, county, or other local municipality. The ADCNR and TWRA, which manage Shoal Creek's aquatic resources, requested that we consider these reintroductions under an NEP designation. However, they will not be required to manage for any reintroduced species. Accordingly, this rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required since this rulemaking does not require any action to be taken by local or State governments or private entities. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1501 et. seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities ( i.e. , it is not a “significant regulatory action” under the Unfunded Mandates Reform Act.).

In accordance with Executive Order 12630, the rule does not have significant takings implications. When reintroduced populations of federally listed species are designated as NEPs, the Act's regulatory requirements regarding the reintroduced listed species within the NEP are significantly reduced. Section 10(j) of the Act can provide regulatory relief with regard to the taking of reintroduced species within an NEP area. For example, this rule allows for the taking of these reintroduced fishes when such take is incidental to an otherwise legal activity, such as recreation ( e.g. , fishing, boating, wading, trapping, swimming), forestry, agriculture, and other activities that are in accordance with Federal, State, and local laws and regulations. Because of the substantial regulatory relief provided by NEP designations, we do not believe the reintroduction of these fishes will conflict with existing or proposed human activities or hinder public use of the Shoal Creek system.

A takings implication assessment is not required because this rule (1) will not effectively compel a property owner to suffer a physical invasion of property and (2) will not deny all economically beneficial or productive use of the land or aquatic resources. This rule will substantially advance a legitimate government interest (conservation and recovery of two listed fish species) and will not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects to warrant the preparation of a Federalism Assessment. This rule will not have substantial direct effects on the States, in the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. The State wildlife agencies in Alabama (ADCNR) and Tennessee (TWRA) requested that we undertake this rulemaking in order to assist the States in restoring and recovering their native aquatic fauna. Achieving the recovery goals for these species will contribute to their eventual delisting and their return to State management. No intrusion on State policy or administration is expected; roles or responsibilities of Federal or State governments will not change; and fiscal capacity will not be substantially directly affected. The special rule operates to maintain the existing relationship between the States and the Federal Government and is being undertaken at the request of State agencies (ADCNR and TWRA). We have cooperated with the ADCNR and TWRA in the preparation of this rule. Therefore, this rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism Assessment pursuant to the provisions of Executive Order 13132.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and that it meets the requirements of sections (3)(a) and (3)(b)(2) of the Order.

Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) require that Federal agencies obtain approval from OMB before collecting information from the public. 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 control number. This rule does not include any new collections of information that require approval by OMB under the Paperwork Reduction Act.

We have determined that the issuance of this rule is categorically excluded under our National Environmental Policy Act procedures (516 DM 6, Appendix 1.4 B (6)).

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 229511), Executive Order 13175, and the Department of the Interior Manual Chapter 512 DM 2, we have evaluated possible effects on federally recognized Indian tribes and have determined that there are no effects.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.

The principal author of this rule is Timothy Merritt (see ADDRESSES section).