This rule corrects the final rule published in the Federal Register on September 13, 2004 (69 FR 55061-55063) that amended the sugar marketing allotment regulations at 7 CFR 1435 with respect to definitions that have had an unintended affect on program administration. In the final rule section 1435.309(c) contained the erroneous word “fall.” This word is corrected to read “full.

The following corrections are made to the DHS interim rule, FR Doc. 04-19906, published in the Federal Register at 69 FR 53318, which becomes effective on September 30, 2004:

This action adds unintentionally omitted text and corrects editorial errors, references, and numerical values as printed in the final rule amending part 71 (January 26, 2004; 69 FR 3698). Because of the numerous corrections in § 71.5(a), the complete text of § 71.5(a) is being reprinted for the convenience of interested members of the public.

The Federal Credit Union Act authorizes an FCU to purchase, hold, and dispose of property necessary or incidental to its operations. 12 U.S.C. 1757(4). Generally, an FCU may only invest in property it intends to use to transact credit union business, that is, to support its internal operations or serve its members. 12 CFR 721.3(d). NCUA's fixed asset rule limits an FCU's investment in fixed assets and imposes requirements on the planning for, use of, and disposal of real property acquired for future expansion. 12 CFR 701.36.

The NCUA Board has a policy of continually reviewing NCUA regulations to “update, clarify and simplify existing regulations and eliminate redundant and unnecessary provisions.” NCUA Interpretive Ruling and Policy Statement (IRPS) 87-2, Developing and Reviewing Government Regulations. As a result of the NCUA's 2003 review, the Board determined that the fixed asset rule should be updated. In April, 2004, the Board published its proposed updates for public comment. 69 FR 21439 (April 21, 2004).

This final rule does not vary significantly from the proposed rule. Like the proposed rule, the only substantive revisions in the final rule from the current rule are to (1) eliminate the requirement that an FCU, when calculating its investment in fixed assets, include its investments in any entity that holds fixed assets used by the FCU, and (2) establish a time frame for submission of requests for waiver of the requirement for partial occupation of premises acquired for future expansion. The final rule also reorganizes the paragraph structure and clarifies the provisions governing an FCU's plans for future expansion into fixed assets. A section-by-section analysis of these revisions follows.

The final rule renumbers § 701.36(c), Investment in Fixed Assets, as § 701.36(a). The final rule retains the requirement that FCUs with $1,000,000 or more in assets cannot invest in fixed assets if the investment would cause the aggregate of all the FCU's fixed assets to exceed five percent of the FCU's shares and retained earnings. The final rule retains the waiver process that allows FCUs to apply for a waiver of the five percent limitation and reorganizes the waiver provisions to simplify them and make them easier to follow.

The final rule renumbers § 701.36(d), Premises, to § 701.36(b). This paragraph contains provisions on real property owned by an FCU that is not currently used to transact credit union business.

The final rule changes the title of this paragraph to “Premises Not Currently Used to Transact Credit Union Business” to better indicate its scope.

The final rule clarifies that requests for waiver of the partial occupation requirement must be in writing and submitted to NCUA within 30 months of acquisition of the premises. The final rule also clarifies that partial use occurs when FCU staff occupy some part of the space on a full-time basis.

The final clarifies that, after real property acquired for future expansion has been held for one year, a board resolution with definitive plans for full utilization must be available for inspection by an NCUA examiner. The final rule also clarifies that full use occurs when the premises are completely occupied by the FCU, or by some combination of the FCU, credit union service corporations (CUSOs), and credit union vendors, on a full-time basis. CUSO and vendor activities must be primarily to support the operations of the FCU or serve its members.

The final rule clarifies and simplifies the provisions on abandoned premises. The final rule revises the provision that an FCU “shall endeavor to dispose of “abandoned premises” at a price sufficient to reimburse the FCU for its investment and costs of acquisition” to state that an FCU must seek fair market value for the property.

The final rule renumbers § 701.36(e), Prohibited Transactions, to § 701.36(c). The rule retains the prohibition on an FCU acquiring or leasing property (without the prior approval of NCUA) from the FCU's insiders, their family members, or corporations and partnerships in which the insider has a significant ownership interest. To ensure that all business forms are covered, the rule adds limited liability companies and “other entities” to this list.

FCUs that qualify for the Regulatory Flexibility (RegFlex) Program are exempt from the five percent limitation on investment in fixed assets. 12 CFR part 742. Accordingly, the final rule adds a new paragraph (d) to § 701.36 with a cross-reference to the RegFlex Program. The rule also reiterates that FCUs that once qualified for the RegFlex Program and its associated exemptions but no longer qualify for RegFlex must comply with all the provisions of the fixed asset rule.

The final rule renumbers § 701.36(b), Definitions, to § 701.36(e). The rule retains the definition of “investment in fixed assets” found in subparagraph (4), but deletes the subparagraph (4)(iv) portion of the definition that includes any investments in, and loans to, a partnership or corporation, including a CUSO, that holds any fixed assets used by the FCU. This portion of the definition is unnecessary and, in some cases, may cause investment in fixed assets to be overstated.

The final rule revises the definition of “retained earnings” in subparagraph (7) to mean “undivided earnings, regular reserve, reserve for contingencies, supplemental reserves, reserve for losses, and other appropriations from undivided earnings as designated by management or the Administration.” The revision recognizes that reserve accounts may be created out of undivided earnings consistent with generally accepted accounting principles. The rule also separates the definitions of “shares” and “retained earnings” and alphabetizes all the definitions to make them easier to locate.

The final rule includes a technical amendment to the RegFlex Program rule reflecting the restructuring of the fixed asset rule.

NCUA received 12 comment letters regarding the proposed rule. Almost all the commenters expressed general agreement with the proposed rule, and, in particular, the clarifications and simplifications. Most of the commenters expressed appreciation for NCUA's policy of reviewing its regulations at least once every three years. Summaries of the comments and the Board's reaction follow.

Almost all the commenters agree with the change in the definition of fixed asset to exclude investments in entities that hold fixed assets used by the FCU.

One commenter believes that lease payments for fixed assets should also be excluded from the calculation of the fixed asset limit. The Board does not want to exclude lease payments. The Board's longstanding position is that an FCU can over-invest in fixed assets through binding lease arrangements just as it can over-invest through outright ownership. See, for example, the preamble to the 1989 final fixed asset rule. 54 FR 18466 (May 1, 1989).

The proposed rule sought to clarify that premises were considered partially occupied when the credit union is using some part of the space on a full-time basis and fully occupied when the credit union, or a combination of the credit union, CUSOs, or vendors, use the entire space on a full-time basis. Almost all the commenters agreed that the clarifications were helpful.

Most commenters believe it is reasonable that credit unions intending to seek a waiver of the requirement for partial occupation of premises within three years should file the request for waiver within 30 months. One commenter asks that, instead of 30 months, the request for waiver be filed within 35 months, one month before the expiration of the three-year period. One commenter objects to the waiver provision and believes it should be eliminated. This commenter is particularly concerned that a credit union that loses its eligibility for the RegFlex Program should not be granted a waiver.

The final rule retains the 30-month notice requirement. Thirty months seems a reasonable amount of time to prepare a waiver request. The Board also believes that the Regional Director should have flexibility to grant waivers in appropriate cases, and the final rule retains this waiver authority.

Several commenters believe NCUA should reduce or eliminate the rule's requirements for both partial and full occupation, but particularly for full occupation. These commenters contend it is difficult for a credit union to obtain a building or lease space that is a perfect fit for the credit union's current and near term plans and the rule's occupation requirements restrict credit union growth and may be anticompetitive. One commenter cites the perceived difficulty rural and low-income credit unions have in finding appropriate office space, and another cites the perceived difficulty a continuing credit union in a merger has in balancing reduced staffing needs with the buildings it inherits in a merger. Another commenter stated that office construction projects take more than three years from first planning to building occupation and that it is “impractical to write a regulation that will inevitably require a waiver.” A few commenters also believe credit unions eligible for the RegFlex program should be exempt from any requirements to fully occupy a building because of the lack of safety and soundness concerns for these credit unions. Two commenters cite with approval the Office of the Comptroller of the Currency's (OCC's) approach to real estate owned by national banks. The OCC requires partial occupation of bank-owned real estate but not always full occupation.

The Board recognizes the difficulties associated with the management of real estate and other fixed assets but believes that the fixed asset rule, as revised by this rulemaking, provides maximum flexibility to FCUs within the bounds of the law and safety and soundness. Federal credit unions are chartered for the purpose of providing financial services to their members and it is not permissible for them to engage in real estate activities that do not support that purpose.

While it may sometimes be difficult for credit unions to find real estate to fit their needs or to downsize real estate holdings following a merger, the Board believes the rule provides enough flexibility to meet various circumstances. The rule allows an FCU to own or lease premises it will not occupy immediately but needs for future expansion and gives FCUs significant leeway on how to achieve both partial and full occupation. For example, there is no set time period within which an FCU must achieve full occupation. While the rule requires an FCU to develop a definitive plan for full occupation, it has an entire year after it acquires property to develop the plan. Further, with regard to partial occupation, the rule permits FCUs to hold real estate for significant periods of time—up to three years—before the FCU has to occupy any of the space. If an FCU needs additional time beyond three years to achieve partial occupation, it may request approval for additional time from its Regional Director. The Board believes that it would be unusual, even when an FCU is constructing its own premises, for the FCU not to achieve partial occupation within three years. Still, if the construction process will take more than three years, a waiver is appropriate and the credit union should obtain it before binding itself contractually to the project.

The Board is aware that the Office of the Comptroller of the Currency has a different view of the powers of national banks under the National Bank Act, but the Board has concluded, for both legal and safety and soundness reasons, that FCUs may not lease real estate to unrelated third parties indefinitely. As noted above, the acquisition of real estate and other fixed assets must support the provision of financial services to credit union members and the Board believes the rule provides significant and sufficient flexibility for FCUs in how they address any excess capacity they may have in fixed assets they acquire.

The current rule limits an FCU's fixed assets to five percent of shares and retained earnings. Credit unions eligible for the RegFlex Program are exempt from this limitation and there is a waiver process that other credit unions may use to avoid the five percent limitation.

A few commenters are concerned with the proposed rule's clarification that credit unions that lose their eligibility for the regulatory flexibility program must again comply with the fixed asset rule's five percent limitation. One commenter suggests that a credit union that loses its status have up to five years to dispose of fixed assets, citing a similar time frame in the rule for disposition of abandoned premises. Another commenter suggests that credit unions with less than 9% net worth should have their RegFlex Program status extended for purposes of compliance with the fixed asset limitation even if they lose their RegFlex status for other purposes. One commenter suggests that NCUA apply the 5% limit on fixed assets to credit unions that have a 7% or less net worth ratio, and that NCUA modify its rule to increase the limit in direct proportion to the amount that the net worth ratio exceeds 7%. Another commenter believes the ratio of fixed assets to a combination of deposits and capital is not a meaningful test of prudent management.

In addressing these comments, the Board first wishes to clarify a statement made in the preamble of the proposed rule. The preamble stated that an FCU eligible for the RegFlex Program with fixed assets exceeding five percent of shares and retained earnings and that subsequently loses its RegFlex eligibility must either reduce its fixed asset holdings below the five percent level or obtain a waiver. The RegFlex Program regulation, however, has a grandfather provision that states:

12 CFR 742.8. Accordingly, an FCU that loses its RegFlex eligibility and finds itself with fixed assets exceeding five percent of shares and retained earnings does not have to divest itself of any fixed assets unless NCUA affirmatively orders it to do so for safety and soundness reasons. If the FCU wants to acquire additional fixed assets, the FCU will need a waiver from the Regional Director before the acquisition if, after acquisition, the FCU would exceed the five percent limit. The Board has amended the final rule text to reflect this more clearly.

As stated above, a few commenters request modification of the five percent limit for FCUs that lose their RegFlex eligibility. The Board does not believe these credit unions need any special variance from the five percent limit. A Regional Director has authority to grant waivers and set conditions on those waivers. For FCUs that lose RegFlex eligibility and have or want fixed assets that would put them over the five percent limit, a Regional Director has authority to establish appropriate fixed asset levels on a case-by-case basis.

The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact a proposed rule may have on a substantial number of small entities (those credit unions under ten million dollars in assets). NCUA believes that, under the current rule, the only burden imposed on small credit unions is the requirement to submit a waiver request if investment in fixed assets exceeds 5% of retained shares and earnings. There are presently about 4,500 small, federally-insured credit unions. Each year, only about ten of these credit unions submit a waiver request, and NCUA estimates each waiver request takes about ten hours to prepare. Accordingly, and as stated in the preamble to the proposed rule, NCUA does not believe the rule imposes a significant economic impact on a substantial number of small entities and no flexibility analysis is required. NCUA received no comments about this conclusion.

The proposed rule requested comment on the information collection requirements contained in the fixed asset rule and advised that NCUA was seeking the reinstatement of Collection of Information, FCU Ownership of Fixed Assets, Control Number 3133-0040. No comments were received. On July 7, 2004, the Office of Management and Budget (OMB) approved the reinstatement of Control Number 3133-0040, with revisions as proposed and an expiration date of July 31, 2007.

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined that this rule does not constitute a policy that has federalism implications for purposes of the executive order.

The NCUA has determined that this rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Pub. L. 105-277, 112 Stat. 2681 (1998).

The Small Business Regulatory Enforcement Act of 1996 (Pub. L. 104-121) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by section 551 of the Administrative Procedure Act. 5 U.S.C. 551. The Office of Management and Budget has determined that this rule is not a major rule for purposes of the Small Business Regulatory Enforcement Fairness Act of 1996.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Bombardier Model DHC-8-101, -102, -103, -106, -201, -202, -301, -311, and -315 airplanes was published in the Federal Register on December 18, 2003 (68 FR 70469). That action proposed to require a detailed inspection of the wing leading edge de-icer boots to determine if they comply with the patch size and/or patch number limits in the critical zone as defined in the aircraft maintenance manual; and corrective action, if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter, an airplane operator, states that the proposed rule requires inspections using limits that were published in the aircraft maintenance manual (AMM) in October 2001. The commenter notes that these limits have all been revised, and now all have revision dates in 2003. In addition, the commenter states that if the new limits are not included in the proposed rule, then operators would be required to find and re-insert the older data into the AMM, which would negate two years of progress in maintaining the leading edge de-icer boots.

We infer that the commenter is requesting that we use the revisions that were published in 2003. We partially agree with the commenter's request. We have not revised paragraph (a) of the final rule to include the new AMM revisions because another suggestion by the same commenter ( see “Request to Insert Limits Directly Into Final Rule”) makes including a reference to these revisions in that paragraph unnecessary. However, we have listed these revisions in new Table 3 of new paragraph (c)(3) of the final rule ( see “Explanation of New Paragraph (c)(3) of the Final Rule”). In addition, because the requirements in the new revisions are less restrictive, those operators who have complied with the limits published in the 2001 revisions are still compliant with the intent of the final rule. Therefore, we have added new Table 4 and new paragraph (e) to the final rule that gives credit to operators who have accomplished the required actions in accordance with the 2001 revisions of the AMM.

The same commenter suggests that, rather than referencing the AMMs for the necessary limits in paragraph (a) of the proposed rule, the FAA insert the necessary limits directly into paragraph (a). The commenter states that the chapters of the AMM referenced in paragraph (a) of the proposed rule contain significantly more information than apply to the patch limits that affect the stall margin. The commenter further states that the limits can be addressed concisely and, therefore, proposes that we specify the actual acceptance criteria in the proposed rule. The commenter states that this would allow operators to revise the AMMs as necessary to provide current information, yet would still mandate the limits that are required. The commenter also suggests that if paragraph (a) is changed as suggested, all references to the AMM in the proposed rule be changed to refer to paragraph (a).

We agree with the commenter's request to change paragraph (a) of the final rule and all references to it in the final rule for the stated reasons. Paragraph (a) has been revised to more clearly define the term, “patch limits” and to specify those specific limits. Additionally, all references to the AMM have been changed to refer to paragraph (a). We also have revised the Summary of the final rule to remove the reference to the limits in the critical zone “as defined in the AMM.”

The same commenter requests that we add a new paragraph to the final rule regarding ferry flights. The proposed paragraph would allow operators of any airplane that has de-icer boots that do not meet the AMM limits to ferry the airplane to a location where repairs can be made, provided the airplane is operated under the limits in Table 2 of the proposed rule. We infer that the operator would like the flexibility to move airplanes to convenient locations for repair without the need to request a special flight permit.

We partially agree with the commenter's request to add a paragraph regarding ferry flights to the final rule. On July 10, 2002, we issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to special flight permits for ferry flights. As stated in 14 CFR 39.23: “[T]he operations specifications giving some operators authority to operate include a provision that allow(s) them to fly their aircraft to a repair facility to do the work required by an airworthiness directive. If you do not have this authority, the local Flight Standards District Office of FAA may issue you a special flight permit unless the airworthiness directive states otherwise. To ensure aviation safety, FAA may add special requirements for operating your aircraft to a place where the repairs or modifications can be accomplished. FAA may also decline to issue a special flight permit in particular cases if we determine you cannot move the aircraft safely.” If an operator does not have the specified authority and requires a special flight permit, we will evaluate any request for a special flight permits on a case by case basis at the time of the request. We do not find it necessary to change the final rule in this regard.

Another commenter is concerned about varying levels of degradation of the de-icer boots in the affected fleet of airplanes. The commenter states that there may be airplanes in operation that do not exceed the limits in the proposed rule, but still have leading edge de-icer boots that are in a state of repair that may degrade the aerodynamic performance of the wing more than other airplanes with less damage.

We infer that the commenter is requesting that we revise the proposed rule to address airplanes that carry varying levels of degradation. We do not agree. The limits in the final rule address the worst-case patch size and patch limits in the wing critical zone. In devising these limits, we assessed the amount of damage that is acceptable for safe flight without the performance penalties cited in Table 2 of this AD. These limits take into account the airplane aerodynamic characteristics and the smoothness of the boots. We have not changed the final rule in this regard.

The same commenter states that it is unclear if the performance penalties cited in Table 2 of the proposed rule are to be included only in the airplane flight manuals (AFM) of airplanes that have boot patches that exceed the patch-number limits, or if the penalties will be applicable to all Model DHC-8 airplanes in a given operator's fleet until all of the proposed inspections and replacements are completed.

From these statements, we infer that the commenter is requesting that we clarify the applicability of the performance penalties listed in Table 2 of the proposed rule. We do not agree that is necessary to change the applicability of the final rule to make this clarification. As stated in paragraph (c) of the final rule, the performance penalties apply only to airplanes that require corrective actions. Airplanes that require corrective actions are those that have boot patches that exceed the limits specified in the AMM. We have not changed the final rule in this regard. However, we have clarified paragraphs (c) and (c)(1) of the final rule based on the addition of a new paragraph (c)(3) to the final rule. These changes are described below in “Explanation of New Paragraph (c)(3) of the Final Rule” and “Explanation of Clarifications Made in Paragraphs (c) and (c)(1) of the Final Rule.”

The same commenter requests that we reduce the 24-month compliance time replacing the wing de-icer boots, which is specified in paragraph (c)(2) of the proposed rule. The commenter states that a 24-month compliance time could allow some airplanes to be exposed to icing conditions for up to three icing seasons.

We do not agree with the request for a shorter compliance time in paragraph (c)(2) of the final rule. In developing the proposed compliance time, we considered the fact that there have been no occurrences of stall problems in the past, and that an airplane that requires corrective action is bound to the performance penalties in Table 2 of the final rule during this 24-month period. We determined that the compliance is appropriate in consideration of the safety implications, the average utilization rate of the affected fleet, the practical aspects of an orderly inspection of the fleet, and the availability of required modification parts. We have not changed the final rule in this regard.

The same commenter requests that there be a clearly delineated ongoing program included in the proposed rule to monitor the number and size of patches on the new boots in order to stay in compliance with AMM limits. The commenter is concerned that the proposed rule is not clear about how operators should monitor the number and size of boot patches on the new boots after replacement, and still stay in compliance with the AMM limits.

We do not agree that it is necessary to delineate a monitoring program. Paragraph (d) of the final rule states that “as of the effective date of this AD, no person may install—on any airplane—a de-icer boot patch in the critical zone of the wing de-icer boots that exceeds the patch limits specified in paragraph (b) of this AD.” Paragraph (d) of this AD is intended to prevent the installation of any patches beyond the specified limits. Therefore, after the boot replacements have been made, it is unnecessary to institute an ongoing monitoring program. We have not changed the final rule in this regard.

After careful review of the available data, including the comments noted above, we have determined that air safety and the public interest require the adoption of the rule with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

Paragraph (c)(3) of the final rule gives operators two methods to choose from for replacing the de-icer boots:

• In accordance with a method approved by either the Manager, Systems and Flight Test Branch, ANE-172, FAA, New York Aircraft Certification Office; or

• In accordance with a method approved by Transport Canada Civil Aviation (or its delegated agent).

The paragraph further states that the applicable chapter of the AMM referenced in Table 3 of paragraph (c)(3) of the final rule is “one approved method.”

We find that allowing operators to accomplish the actions according to one of the cited methods will not impose additional burden for operators to comply with the actions in the AD.

Adding paragraph (c)(3) to this final rule made it necessary to clarify the statements in paragraphs (c) and (c)(1) of the final rule. Paragraph (c) of the final rule now specifically requires operators of airplanes that require corrective actions to do the actions in paragraphs (c)(1) and (c)(2). Paragraph (c)(1) of the final rule now also refers to airplanes that have findings that exceed the patch limits in accordance with paragraph (b)(2) of the final rule.

We estimate that 200 airplanes of U.S. registry will be affected by this AD, that it will take approximately 2 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $26,000, or $130 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

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

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

This amendment to 14 CFR 71 modifies the Class D airspace area, the Class E airspace area designated as a surface area and the Class E airspace area extending upward from 700 feet above the surface at Joplin, MO. An examination of controlled airspace for Joplin, MO revealed that the Class D airspace area and the Class E airspace area designated as a surface area do not comply with airspace requirements for diverse departures from Joplin Regional Airport as set forth in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The examination also revealed that the dimensions and descriptions of extensions to the Class E airspace area extending upward from 700 feet above the surface do not comply with FAA Order 8260.19C, Flight Procedures and Airspace.

This action expands the Joplin, MO Class D and Class E airspace area designated as a surface area from a 4.2-mile to a 4.3-mile radius of Joplin Regional Airport. It also defines the centerline of the northwest extension to the Class E airspace area extending upward from 700 feet above the surface in relation to the 318° bearing from LUNNS LOM, decreases the width of this extension from 2.6 to 1.9 miles each side of centerline and decreases the length from 7.4 to 7 miles from LUNNS LOM. Additionally, the southeast extension to the Class E airspace area extending upward from 700 feet above the surface is no longer required and is deleted from the legal description.

These modifications provide controlled airspace of appropriate dimensions to protect aircraft departing from the executing SIAPs to Joplin Regional Airport and bring the legal descriptions of the Joplin, MO Class D and Class E airspace areas into compliance with FAA Orders 7400.2E and 8260.19C. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9M, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. Class E airspace areas designated as surface areas and Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraphs 6002 and 6005 respectively of the same FAA Order. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulations will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the data on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submiting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited to the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18824/Airspace Docket No. 04-ACE-50.” The postcard will be date/time stamped and returned to commenter.

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

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

On April 4, 2003, the Deputy Administrator of the DEA published a final rule in the Federal Register (68 FR 16427) amending § 1308.11(g) of Title 21 of the Code of Federal Regulations to temporarily place AMT and 5-MeO-DIPT into Schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). This final rule, which became effective on the date of publication, was based on findings by the Deputy Administrator that the temporary scheduling of AMT and 5-MeO-DIPT was necessary to avoid an imminent hazard to the public safety. Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) requires that the temporary scheduling of a substance expires at the end of one year from the effective date of the order. However, if proceedings to schedule a substance pursuant to 21 U.S.C. 811(a)(1) have been initiated and are pending, the temporary scheduling of a substance may be extended for up to six months. On March 31, 2004, the Acting Deputy Administrator published a notice of proposed rulemaking in the Federal Register (69 FR 16838) to place AMT and 5-MeO-DIPT into Schedule I of the CSA on a permanent basis. The temporary scheduling of AMT and 5-MeO-DIPT, which would have expired April 3, 2004, was extended to October 3, 2004 (69 FR 17034, April 1, 2004). One comment was received regarding the proposed placement of these substances into Schedule I of the CSA.

The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for AMT and 5-MeO-DIPT. The Acting Deputy Administrator submitted these data to the Acting Assistant Secretary for Health, Department of Health and Human Services (DHHS). In accordance with 21 U.S.C. 811(b), the Acting Deputy Administrator also requested a scientific and medical evaluation and a scheduling recommendation for AMT and 5-MeO-DIPT from the Acting Assistant Secretary of DHHS. On September 17, 2004, the Acting Assistant Secretary for Health recommended that AMT and 5-MeO-DIPT be permanently controlled in Schedule I of the CSA.

Alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) are tryptamine (indoleethylamine) derivatives and share several similarities with the Schedule I tryptamine hallucinogens such as alpha-ethyltryptamine (AET) and N,N-dimethyltryptamine (DMT). Several other tryptamines also produce hallucinogenic/stimulant effects and are controlled as Schedule I substances under the CSA (bufotenine, diethyltryptamine, psilocybin and psilocyn). Although tryptamine itself appears to lack consistent hallucinogenic/stimulant effects, substitutions on the indole ring and the ethylamine side-chain of this molecule result in pharmacologically active substances (McKenna and Towers, J. Psychoactive Drugs, 16: 347-358, 1984). The chemical structures of AMT and 5-MeO-DIPT possess the critical features necessary for hallucinogenic/stimulant activity. In drug discrimination studies, both AMT and 5-MeO-DIPT substitute for 1-(2,5-dimethoxy-4-methylphenyl)-aminopropane (DOM), a phenethylamine-based hallucinogen in Schedule I of the CSA. The potencies of DOM-like discriminative stimulus effects of these and several other similar tryptamine derivatives correlate well with their hallucinogenic potencies in humans (Glennon et al. , Eur. J. Pharmacol. 86: 453-459, 1983).

AMT, besides its full generalization to DOM, also partially mimics amphetamine and 3,4-methylenedioxymethamphetamine (MDMA) in drug discrimination tests in experimental animals. AMT increases systolic and diastolic arterial blood pressures, dilates pupils and produces strong motor stimulant effects. The behavioral effects of orally administered AMT (20 mg) in humans are slow in onset, occurring after 3 to 4 hours, and gradually subsiding after 12 to 24 hours, but may last up to 2 days in some subjects. The majority of the subjects report euphoria, stimulation, muscle tension, muscle ache, nervous tension, irritability, restlessness, dizziness, impaired motor coordination, unsettled feeling in stomach, inability to relax and sleep, and visual effects such as blurry vision, apparent movement of objects, sharper outlines, brighter colors, longer after images, and visual hallucinations. The majority of the subjects equate the effects of a 20 mg dose of AMT to those of 50 micrograms of lysergic acid diethylamide (LSD). AMT also produces dextroamphetamine-like mood elevating effects in humans (Hollister et al. , J. Nervous Ment. Dis., 131: 428-434, 1960; Murphree et al. , Clin. Pharmacol. Ther. 2: 722-726, 1961).

Similar to other classical hallucinogens, AMT binds to serotonin receptors. It also inhibits 5-HT uptake, induces catecholamine release and inhibits monoamine oxidase activity. The available experimental evidence suggests that both serotonergic and dopaminergic systems mediate behavioral effects of AMT.

5-MeO-DIPT produces pharmacological effects similar to those of several Schedule I hallucinogens. The synthesis and preliminary human psychopharmacology study on 5-MeO-DIPT was first published in 1981 (Shulgin and Carter, Comm. Psychopharmacol. 4: 363-369, 1981). According to this report, subjective effects of 5-MeO-DIPT are substantially similar to those of MDMA, 3,4-methylenedioxyamphetamine (MDA) and 4-Bromo-2,5-dimethoxyphenethylamine (2C-B). 5-MeO-DIPT is an orally active hallucinogen. Following oral administration of 6-10 mg, 5-MeO-DIPT produces subjective effects with an onset of about 20-30 minutes, a peak at about 1-1.5 hours and duration of about 3-6 hours. Subjects who have been administered 5-MeO-DIPT are talkative and disinhibited. 5-MeO-DIPT dilates pupils. High doses of 5-MeO-DIPT produce nausea, jaw clenching, muscle tension and overt hallucinations with both auditory and visual distortions. As mentioned above, 5-MeO-DIPT fully mimics the discriminative stimulus effects of DOM, a Schedule I hallucinogen. According to the discriminative stimulus studies conducted by the Drug Evaluation Committee of the College on Problems of Drug Dependence, 5-MeO-DIPT dose-dependently (0.1-3 mg/kg, IP) generalizes to LSD with a maximal response of about 70% at doses (3 mg/kg) that severely disrupted responding.

The abuse of stimulant/hallucinogenic substances in popular all night dance parties (“raves”) and in other venues has been a major problem in Europe since the 1990s. In the past several years, this activity has spread to the United States. The Schedule I controlled substance MDMA and its analogues, collectively known as Ecstasy, are the most popular drugs abused at these raves. Their abuse has been associated with both acute and long-term public health and safety problems. These raves have also become venues for the trafficking and abuse of other substances in place of or in addition to “Ecstasy.” AMT and 5-MeO-DIPT belong to such a group of substances.

The abuse of AMT and 5-MeO-DIPT began to spread in 1999. Since that time, these tryptamines have been encountered by law enforcement agencies in several states. These substances have been commonly encountered in tablet, capsule or powder forms. The tablet form often bears imprints commonly seen on MDMA tablets such as spider, alien head and “?” logos. These tablets also vary in colors such as pink, purple, red, and orange. The powder in capsule was also found to vary in colors such as white, off-white, gray, and burnt orange. Data from law enforcement officials indicate that 5-MeO-DIPT is often sold as “Foxy” or “Foxy Methoxy”, while AMT has been sold as “Spirals” at least in one case. Data gathered from published studies indicate that these are administered orally at doses ranging from 15-40 mg for AMT and 6-20 mg for 5-MeO-DIPT.

According to the Florida Department of Law Enforcement (FDLE) report issued in 2002, the abuse by teens and young adults of AMT and 5-MeO-DIPT is an emerging problem. There have been reports of abuse of AMT and 5-MeO-DIPT at clubs and raves in Arizona, California, Florida and New York. Many tryptamine-based substances are illicitly available from United States and foreign chemical companies and from individuals through the Internet. There is also evidence of attempted clandestine production of AMT and 5-MeO-DIPT in Nevada, Virginia and Washington, DC.

According to data from the System to Retrieve Information on Drug Evidence (STRIDE), since 1999 Federal law enforcement authorities seized 34 drug exhibits and filed 14 cases pertaining to the trafficking, distribution and abuse of AMT during 1999 to 2003. The corresponding STRIDE data for 5-MeO-DIPT included 63 drug exhibits pertaining to 32 cases. AMT drug seizures included 21 capsules and 1,011.8 grams of powder, while 5-MeO-DIPT drug seizures included 12,070 tablets, 560 capsules, and 6,532.3 grams of powder. Since 2001, the National Forensic Laboratory Information System (NFLIS) registered 10 and 12 cases of AMT and 5-MeO-DIPT, respectively. AMT drug exhibits included 17 dosage units and 7.53 grams of powder, while 5-MeO-DIPT drug exhibits included 24 capsules, 3 tablets and 14.42 grams of powder.

AMT and 5-MeO-DIPT share substantial chemical and pharmacological similarities with other Schedule I tryptamine-based hallucinogens in Schedule I of the CSA. AMT shares pharmacological effects of amphetamine, a stimulant, and DOM and LSD, the Schedule I hallucinogens. AMT acts as a stimulant, produces euphoria and increases heart rate and blood pressure. The evidence suggests that 5-MeO-DIPT mimics pharmacological effects of MDMA, MDA, and 2C-B, the Schedule I hallucinogens. It also partially mimics amphetamine effects. The risks to the public health associated with the above mentioned controlled substances are well known and documented. AMT and 5-MeO-DIPT, similar to other tryptamine-or phenethylamine-based hallucinogens, through the alteration of sensory perception and judgment can pose serious health risks to the user and the general public. Tryptamine, the parent molecule of AMT and 5-MeO-DIPT, is known to produce convulsions and death in animals (Tedeschi et al. , J. Pharmacol. Exp. Ther. 126: 223-232, 1959). Following extensive studies on AMT as a possible antidepressant drug in 1960s, The Upjohn Company concluded that AMT is a highly toxic substance and discontinued the clinical studies on this substance. In fact, there were two recent published case reports describing the instances of emergency department admissions resulting from abuse of AMT and 5-MeO-DIPT in 2003 (Long et al. , Vet. Human Toxicol., 45: 149, 2003; Meatherall and Sharma, J. Anal. Toxicol., 27: 313-317, 2003). There has been at least one confirmed death caused by the abuse of AMT in Florida in 2003. The above data show that the continued, uncontrolled tablet or capsule production, distribution and abuse of AMT and 5-MeO-DIPT pose hazards to the public health and safety. There are no recognized therapeutic uses of these substances in the United States.

The DEA received one comment from an organization in response to the proposed placement of AMT and 5-MeO-DIPT into Schedule I of the CSA. This organization did not support the proposed placement of these drugs into Schedule I on the following basis: (1) They believed insufficient data exists to support placement into Schedule I as the mere use of these substances was not abuse and (2) Prohibiting the possession of these substances is a substantial infringement of the fundamental right of adults to freedom of thought. Both the DEA and the DHHS have found that sufficient scientific, trafficking and abuse data, as summarized herein, does exist to place AMT and 5-MeO-DIPT in Schedule I of the CSA on a permanent basis. As these substances have no legitimate medical use in the United States, the trafficking in, and use by individuals for the psychoactive effects they produce, is considered abuse. In addition, the control of these substances in Schedule I of the CSA does not violate any legally protected right.

Based on all the available information gathered and reviewed by the DEA and in consideration of the scientific and medical evaluation and scheduling recommendation by the Assistant Secretary of the DHHS, the Deputy Administrator has determined that sufficient data exist to support the placement of AMT and 5-MeO-DIPT into Schedule I of the CSA pursuant to 21 U.S.C. 811(a). The Deputy Administrator finds:

(1) AMT and 5-MeO-DIPT have a high potential for abuse.

(2) AMT and 5-MeO-DIPT have no currently accepted medical use in treatment in the United States.

(3) AMT and 5-MeO-DIPT lack accepted medical safety for use under medical supervision.

In accordance with 21 U.S.C. 811(h)(5), the Deputy Administrator hereby vacates the order temporarily placing AMT and 5-MeO-DIPT into Schedule I of the CSA published in the Federal Register on April 4, 2003.

With the issuance of this final order, AMT and 5-MeO-DIPT continue to be subject to regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a Schedule I controlled substance, including the following:

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports AMT and 5-MeO-DIPT or who engages in research or conducts instructional activities with respect to AMT and 5-MeO-DIPT or who proposes to engage in such activities must submit an application for Schedule I registration in accordance with part 1301 of Title 21 of the Code of Federal Regulations.

2. Security. AMT and 5-MeO-DIPT are subject to Schedule I security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75 (a) and (c) and 1301.76 of Title 21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels and labeling for commercial containers of AMT and 5-MeO-DIPT which are distributed on or after October 29, 2004 shall comply with requirements of §§ 1302.03 -1302.07 of Title 21 of the Code of Federal Regulations.

4. Quotas. Quotas for AMT and 5-MeO-DIPT are established pursuant to Part 1303 of Title 21 of the Code of Federal Regulations.

5. Inventory. Every registrant required to keep records and who possesses any quantity of AMT and 5-MeO-DIPT is required to keep an inventory of all stocks of the substances on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every registrant who desires registration in Schedule I for AMT and 5-MeO-DIPT shall conduct an inventory of all stocks of AMT and 5-MeO-DIPT.

6. Records. All registrants are required to keep records pursuant to §§ 1304.03, 1304.04 and §§ 1304.21-1304.23 of Title 21 of the Code of Federal Regulations.

7. Reports. All registrants required to submit reports in accordance with § 1304.33 of Title 21 of the Code of Federal Regulations shall do so regarding AMT and 5-MeO-DIPT.

8. Order Forms. All registrants involved in the distribution of AMT and 5-MeO-DIPT must comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations.

9. Importation and Exportation. All importation and exportation of AMT and 5-MeO-DIPT must be in compliance with part 1312 of Title 21 of the Code of Federal Regulations.

10. Criminal Liability. Any activity with AMT and 5-MeO-DIPT not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after September 29, 2004 will continue to be unlawful.

The Deputy Administrator of the DEA hereby certifies that the placement of AMT and 5-MeO-DIPT into Schedule I of the CSA will not have a significant economic impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action involves the control of two substances with no currently accepted medical use in the United States.

This final rule is not a significant regulatory action for the purposes of Executive Order 12866. Drug Scheduling matters are not subject to review by the Office of Management and Budget pursuant to provisions of Executive Order 12866, section 3(d)(1).

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

This final 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. Therefore, in accordance with Executive Order 13132, it is determined that this rule will not have sufficient federalism implications to warrant the preparation of a federalism assessment.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $114,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The hydroplane race poses several dangers to the public including excessive noise, objects falling from any accidents, and hydroplanes racing at high speeds in proximity to other vessels. Accordingly, prompt regulatory action is needed in order to provide for the safety of spectators and participants during the event. If normal notice and comment procedures were followed, this rule would not become effective until after the date of the event. The Coast Guard finds that good cause exists for not publishing an NPRM, because doing so would be contrary to the interests of public safety because immediate action is necessary to protect the public.

Under 5 U.S.C.(d)(3), for the same reasons cited above, the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register .

This rule will create two regulated areas, a race area and a viewing area. These regulated areas restrict the movement of spectator, non-participant, vessels during hydroplane races. These regulated areas assist in minimizing the inherent dangers associated with hydroplane races. These dangers include, but are not limited to, excessive noise, race craft traveling at high speed in close proximity to one another and to spectator craft, and the risk of airborne objects from any accidents associated with hydroplanes. In the event that hydroplanes require emergency assistance, rescuers must have immediate and unencumbered access to the craft. The Coast Guard, through this action, intends to promote the safety of personnel, vessels, and facilities in the area. Due to these concerns, public safety requires these regulations to provide for the safety of life on the navigable waters.

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

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated area established by this rule encompasses an area near Port Angeles Harbor, not frequented by commercial navigation. The regulation is established for the benefit and safety of the recreational boating public, and any negative recreational boating impact is offset by the benefits of allowing the hydroplanes to race. This rule is effective from 9 a.m. on October 1, 2004 through 5 p.m. on October 3, 2004 Pacific Daylight Time. For the above reasons, the Coast Guard does not anticipate any significant economic impact.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit this portion of Port Angeles Harbor during the time this regulation is in effect. The zone will not have a significant economic impact due to its short duration and small area. The only vessels likely to be impacted will be recreational boaters and small passenger vessel operators. The event is held for the benefit and entertainment of those above categories. Because the impacts of this proposal are expected to be so minimal, the Coast Guard certifies under 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this rule will not have a significant economic impact on a substantial number of small entities.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the ( FOR FURTHER INFORMATION CONTACT ) section. 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 would call 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 Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule would not impose an unfunded mandate.

This rule would 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 concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian tribal governments, because it 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.

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) (42U.S.C. 4321-4370f), and have concluded that there are not 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)(h), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(h), of the Instruction, and “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

The U.S. Department of Agriculture is clarifying the effect of the transition provisions of the National Forest System land and resource management planning regulation at 36 CFR part 219 (65 FR 67514) adopted on November 9, 2000 (2000 planning rule). The transition provisions govern National Forest System planning during the transition period originally set forth in the 2000 planning rule and amended by interim final rules promulgated on May 17, 2001 (66 FR 27552), and May 20, 2002 (67 FR 35431).

Section 219.35(a) of the transition provisions requires the responsible official, during the transition period, to consider the best available science in implementing and, if appropriate, in amending existing plans. Section 219.35(b) currently allows the responsible official, during this period, to elect to prepare plan amendments and revisions using the provisions of the 1982 planning rule. Section 219.35(d) currently exempts projects implementing land and resource management plans from compliance with the substantive provisions of the 2000 planning regulation during the transition period.

The transition period began on November 9, 2000. The May 17, 2001 and May 20, 2002 interim final rules amended the 2000 planning rule to extend the transition period until final adoption of the proposed revision to the 2000 planning rule published on December 6, 2002 (67 FR 72770). During this period, while the substantive provisions of the 2000 rule are not binding, the transition provisions remain in effect.

Considerable uncertainty has arisen regarding the impact of the 2000 planning rule and the transition provisions. Some courts have properly determined the 1982 planning rule is no longer in effect. Others, however, have enforced its provisions. See, e.g., Forest Watch v. United States Forest Service , 322 F.Supp. 2d 522 (D. Vt. 2004) (“Applicable regulations require the Forest Service to “consider the best available science” when implementing the forest plan,” citing 36 CFR 219.35(a)); Clinch Coalition v. Damon , 316 F.Supp. 2d 364, 381 (W.D.Va. 2004) (suggesting that the 1982 planning rule could not be applied to a 2001 decision, yet considering the decision under both 1982 planning rule and 2000 planning rule); Chattooga Conservancy v. USFS and Georgia Transmission Corporation , 2:03-CV-0101 (March 3, 2004) (1982 planning rule provision “eliminated when the National Forest System Land and Resource Management Planning rule was amended in November of 2000.”); Shawnee Trail Conservancy v. Nicholas , Case No. 02-cv-4065-JPG (S.D. Ill.) (June 30, 2004) (“On November 9, 2000, the Department of Agriculture made wholesale changes to the relevant regulations, making prior citations obsolete.”). This uncertainty has affected the ability of the Forest Service to utilize fully the provisions of § 219.35 paragraph (a) to consider the best science available in plan amendments and project decision making. For example, while population data have been held to be required for management indicator species under the 1982 rules, other tools often can be useful and more appropriate in predicting the effects of projects that implement a land management plan, such as examining the effect of proposed activities on the habitat of specific species; using information identified, obtained, or developed through a variety of methods, such as assessments, analysis, and monitoring results; or using information obtained from other sources such as State fish and wildlife agencies and organizations such as The Nature Conservancy. The purpose of this interpretative rule is to clarify that, both for projects implementing plans and plan amendments, paragraph (a)'s mandate to use the best available science applies.

The transition provisions as originally enacted, and now twice amended, explicitly refer to the 1982 planning rule as the rule “in effect prior to November 9, 2000.” At the same time, given the extension of the effective date of paragraph (d), within which site-specific decisions must comply with the 2000 planning rule (68 FR 53294), it is clear that site-specific decisions entered into during the transition period are not to comply with the substantive provisions of the 2000 planning rule. This interpretative rule clarifies that until a new final rule is promulgated, the transition provisions of the 2000 planning rule, as amended by the May 2002 interim final rule remain in effect, including the requirement of § 219.35 paragraph (a) of the transition provisions that responsible officials consider the best available science in implementing national forest land management plans and, as appropriate, plan amendments. Pursuant to paragraph (b), the provisions of the 1982 planning rule may continue to be used only for plan amendments and revisions upon election of the responsible official. Appropriate plan amendments and projects proposed during the transition period should be developed considering the best available science in accordance with § 219.35 paragraph (a).

Misunderstandings have arisen concerning the law to be applied to site-specific projects and plan amendments decided during the transition period. To clarify the intent of § 219.35, the Department is adopting this interpretative rule.

This rulemaking consists of an interpretative rule and is issued by the Department to advise the public of the Department's preexisting construction of one of the rules it administers—that is, 36 CFR 219.35, in the context of National Forest System land and resource management planning. See, e.g., Shalala, Secretary of Health and Human Services v. Guernsey Memorial Hosp. , 514 U.S. 87, 99 (1995). Therefore, under 5 U.S.C. 553(b)(A), this rulemaking is exempt from the notice and comment requirements of the Administrative Procedure Act, and, pursuant to 5 U.S.C. 553(d)(2), this rule is effective immediately upon publication in the Federal Register .

It has been determined that this is not an economically significant rule. This interpretative rule will not have an annual effect of $100 million or more on the economy nor adversely affect productivity, competition, jobs, the environment, public health or safety, nor State or local governments. This rulemaking will not interfere with an action taken or planned by another agency. Finally, this action will not alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients of such programs. Accordingly, this rulemaking is not subject to Office of Management and Budget (OMB) review under Executive Order 12866.

Moreover, this rulemaking has been considered in light of Executive Order 13272 regarding proper consideration of small entities and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which amended the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). It is therefore certified that this rule will not have a significant economic impact on a substantial number of small entities as defined by the Act. This rule will not impose record keeping requirements; will not affect small entities' competitive position in relation to large entities; and will not affect small entities' cash flow, liquidity, or ability to remain in the market.

This rulemaking has no direct, indirect, or cumulative effect on the environment, but merely clarifies the intent of the Department concerning the consideration of the best available science to inform decision making that implements land management plans. Section 31.1b of Forest Service Handbook 1909.15 (57 FR 43168; September 18, 1992) excludes from documentation in an environmental assessment or impact statement “rules, regulations, or policies to establish Service-wide administrative procedures, program processes, or instruction.” Based on the nature and scope of this rulemaking, the Department has determined that the interpretative rule falls within this category of actions and that no extraordinary circumstances exist which would require preparation of an environmental assessment or an environmental impact statement.

This rulemaking has been analyzed in accordance with the principles and criteria contained in Executive Order 12360, and it has been determined that the rule will not pose the risk of a taking of private property, as the interpretative rule is limited clarification of the intent of the transition procedures in the November 9, 2000, planning rule.

This rule has been analyzed under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that this rule does not constitute a significant energy action as defined in the Executive order.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. The rule (1) does not preempt State and local laws and regulations that conflict with or impede its full implementation; (2) has no retroactive effect; and (3) will not require the use of administrative proceedings before parties could file suit in court challenging its provisions.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), which the President signed into law on March 22, 1995, the Department has assessed the effects of this rule on State, local, and Tribal governments and the private sector. This rule will not compel the expenditure of $100 million or more by any State, local, or Tribal government, or anyone in the private sector. Therefore, a statement under section 202 of the Act is not required.

The Department has considered this rule under the requirements of Executive Order 13132, Federalism. The Department has determined that the rule conforms with the federalism principles set out in this Executive order; will not impose any significant compliance costs on the States; and will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications as defined by Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. Therefore, advance consultation with Tribes is not required.

This rule does not contain any recordkeeping or reporting requirements or other information collection requirement as defined in 5 CFR part 1320. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ) and implementing regulations at 5 CFR part 1320, Controlling Paperwork Burden on the Public, do not apply.

The Department is committed to compliance with the Government Paperwork Elimination Act (44 U.S.C. 3504), which requires Government agencies to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

This document publishes amendments to parts 3, 4, and 6 of 39 CFR, amending the Bylaws of the Board of Governors of the United States Postal Service. The Board amended parts 3 and 4 to reserve the election of the Board's Vice Chairman to a vote of the Governors, rather than a vote of the entire Board. In part 6, the Board changed the procedure for establishing an annual schedule of meetings to conform to current practice. The Board also amended part 6 to change from 5 to 4 the number of Governors required for a quorum to vote on a recommended decision of the Postal Rate Commission.

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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of January 28, 2004 (69 FR 4138-4143) (FRL-7337-3), 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 1F6300) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. This amended the petition previously announced in the Federal Register of January 4, 2002 (67 FR 592-597) (FRL-6812-2) by including raw agricultural commodity subgroup 01C. The petition requested that 40 CFR 180.579 be amended by establishing tolerances for combined residues of the fungicide fenamidone, and its metabolites in or on the raw agricultural commodities: Potato, 0.05 parts per million (ppm), tomato, 1.0 ppm; tomato paste, 3.5 ppm, tomato puree, 3.5 ppm, bulb vegetable crop group, 1.5 ppm; cucurbit crop group, 0.1 ppm; head lettuce, 15.0 ppm; leaf lettuce, 20.0 ppm; wheat grain, 0.05 ppm, wheat straw, 0.5 ppm; wheat forage, 0.5 ppm, and wheat hay, 0.5 ppm. Tolerances were also proposed for fenamidone and its metabolite RPA 410193 on imported wine grapes at 0.5 ppm. Agency review of the residue data indicates that the following tolerance levels are appropriate: Fenamidone, 4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino), (S)-, in or on garlic, bulb at 0.20 ppm; garlic, great headed at 0.20 ppm; grape (imported) at 1.0 ppm, leek at 1.5 ppm, onion, dry bulb at 0.20 ppm; onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 ppm; shallot, fresh leaves at 1.5 ppm; tomato at 1.0 ppm; tomato, paste at 2.2 ppm; tomato, puree at 2.0 ppm; vegetable, cucurbit, group 09 at 0.15 ppm and vegetable, tuberous and corm, subgroup 01C at 0.02 ppm and also for the combined residues of fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)) and its metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl) in or on fat (beef, goat, and sheep) at 0.10 ppm; meat (beef, goat, and sheep) at 0,10 ppm, meat byproducts (beef, goat, and sheep) at 0.10 ppm; milk at 0.02 ppm; wheat forage at 0.15 ppm; wheat, grain at 0.10 ppm; wheat, hay at 0.50 ppm; wheat, straw at 0.35 ppm. The Agency is establishing tolerances for animal tolerances based on review of the residue data and evaluation of food animal diets, which could include wheat forage and hay. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing.

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 fenamidone, in or on garlic, bulb at 0.20 ppm; garlic, great headed at 0.20 ppm; grape (imported) at 1.0 ppm, leek at 1.5 ppm, onion, dry bulb at 0.20 ppm; onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 ppm; shallot, fresh leaves at 1.5 ppm; tomato at 1.0 ppm; tomato, paste at 2.2 ppm; tomato, puree at 2.0 ppm; vegetable, cucurbit, group 09 at 0.15 ppm and vegetable, tuberous and corm, subgroup 01C at 0.02 ppm and also for the combined residues of fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino), (S)-) and its metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl) in or on fat (beef, goat, and sheep) at 0.10 ppm; meat (beef, goat, and sheep) at 0,10 ppm, meat byproducts (beef, goat, and sheep) at 0.10 ppm; milk at 0.02 ppm; wheat forage at 0.15 ppm; wheat, grain at 0.10 ppm; wheat, hay at 0.50 ppm; wheat, straw at 0.35 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 fenamidone are discussed in the Federal Register of September 27, 2002 (67 FR 7196-7198). There have been no changes in the toxicological profile since that Federal Register notice and therefore, the Agency will not repeat the entire table in this final rule but refers to the original document.

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. A 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 fenamidone used for human risk assessment is shown in Table 1 of this unit:

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 at (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 January 5, 2001 (66 FR 1129) (FRL-6761-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP (8E4966 and 8E4967) by Morflex Inc., 2110 High Point Road, Greensboro, NC 27403. That notice included a summary of the petition prepared by the petitioner.

The petition requested that 40 CFR 180.1001 (c), and (e) be amended by establishing an exemption from the requirement of a tolerance for residues of acetyl tributyl citrate (ATBC) also known as citric acid, 2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and triethyl citrate (TEC) also known as citric acid, triethyl ester (CAS Reg. No. 77-93-0). There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the 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. . . .”

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

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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 and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by ATBC also known as citric acid, 2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and TEC also known as citric acid, triethyl ester (CAS Reg. No. 77-93-0) are discussed in this unit. Both chemicals are derivatives of citric acid. ATBC is prepared by esterification of butyl alcohol with citric acid, followed by acetylation. TEC is prepared by esterification of ethyl alcohol with citric acid.

The Agency evaluated the toxicity data base submitted by the petitioner, Morflex which included a 2-generation reproductive study, and several articles from open literature. Other reliable sources of information used by the Agency in performing this assessment are information from the internet on (1) World Health Organization (WHO) evaluations, (2) British Industrial Biological Research Association (BIBRA) abstracts, and (3) the Opinion of the European Commission, Health and Consumer Protection Directorate-General (CSTEE), and (4) structure-activity-relationship (SAR) assessments performed on surrogate chemicals as prepared by the Agency's Office of Pollution Prevention and Toxics. The toxicological databases for these chemicals are a mixture of guideline studies performed in the last 15 years and older studies from the 1970s and 1950s. These older studies are more difficult to evaluate given the different standards of reporting that existed some years ago.

Both ATBC and TEC have low acute oral toxicity (Toxicity Category IV). Ocular irritation is moderate. Both are Toxicity Category IV for dermal irritation. Neither are human sensitizers. Both chemicals have been reviewed by other entities. None of these organizations indicated any specific concerns for ATBC or TEC. Based on the submitted studies, neither ATBC or TEC is mutagenic.

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 31, 2004 (69 FR 16921) (FRL-7348-4), 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 petitions (PP 2F6468 and 3E6746) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103 and IR-4, Technology Center, of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petition prepared by FMC Corporation, the registrant. Comments on the petition were filed by B. Sachau, 15 Elm St., Florham Park, NJ 07932. A response to these comments is provided in Unit V.

In the Federal Register of July 28, 2004 (69 FR 45042) (FRL-7365-2), 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 petitions (PP 2F6468, 3E6746, 4E6814, and 3F6584) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103 and IR-4, Technology Center, of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petition prepared by FMC Corporation, the registrant. Comments on the petition were filed by B. Sachau, 15 Elm St., Florham Park, NJ 07932, and Bonita Poulin, R. R. #3, Brockville, Ont. A response to these comments is provided in Section V.

The petitions requested that 40 CFR 180.515(a) be amended by establishing proposed tolerances for combined residues of the herbicide carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid), in or on: Acerola at 0.1 parts per million (ppm); almond hulls at 0.20 ppm and grass, forage, fodder and hay, group 17 at 12 ppm; hops at 0.05 ppm; avocado at 0.1 ppm; atemoya at 0.1 ppm; banana at 0.1 ppm; berry group 13 at 0.1 ppm; birida at 0.1 ppm; borage, seed at 0.1 ppm; cacao at 0.1 ppm; cactus at 0.1 ppm; canistel at 0.1 ppm; cherimoya at 0.1 ppm; citrus, crop group 10 at 0.1 ppm; citrus cultivars and/or hybrids of grapefruit and pummelo, including uniq fruit at 0.1 ppm; coconut at 0.1 ppm; coffee at 0.1 ppm; crambe, seed at 0.1 ppm; custard apple at 0.1 ppm; date at 0.1 ppm; feijoa at 0.1 ppm; fig at 0.1 ppm; fish at 0.2 ppm; flax, seed at 0.1 ppm; grape at 0.1 ppm; grapefruit at 0.1 ppm; guava at 0.1 ppm; guayule at 0.1 ppm; herbs and spice group 19 at 0.1 ppm; horseradish at 0.1 ppm; ilama at 0.1 ppm; Indian mulberry at 0.1 ppm; jabotica at 0.1 ppm; Juneberry at 0.1 ppm; kava at 0.1 ppm; kiwi fruit at 0.1 ppm; lingonberry at 0.1 ppm; lychee at 0.1 ppm; longan at 0.1 ppm; mango at 0.1 ppm; mustard seed, Indian at 0.1 ppm; mustard seed, field at 0.1 ppm; mustard seed, black at 0.1 ppm; okra at 0.1 ppm; olive at 0.1 ppm; palm heart, leaves at 0.1 ppm; passionfruit at 0.1 ppm; papaya at 0.1 ppm; pawpaw at 0.1 ppm; peanut at 0.1 ppm; persimmon at 0.1 ppm; pistachio at 0.1 ppm; pome fruit, crop group 11 at 0.1 ppm; pomegranate at 0.1 ppm; pulasan at 0.1 ppm; pummelo at 0.1 ppm; rambutan at 0.1 ppm; rapeseed, Indian at 0.1 ppm; rapeseed, seed at 0.1 ppm; safflower, seed at 0.1 ppm; salal at 0.1 ppm; sapodilla at 0.1 ppm; sapote, black at 0.1 ppm; sapote, mamey at 0.1 ppm; shellfish at 0.2 ppm; sorghum, sweet, stalks at 0.1 ppm; sorghum, sweet, syrup at 0.1 ppm; soursop at 0.1 ppm; Spanish lime at 0.1 ppm; star apple at 0.1 ppm; starfruit at 0.1 ppm; stone fruit, crop group 12 at 0.1 ppm; strawberry at 0.1 ppm; strawberrypear at 0.1 ppm; stevia at 0.1 ppm; sugar apple at 0.1 ppm; sugarcane at 0.1 ppm; sunflower, seed at 0.1 ppm; ti, leaves at 0.1 ppm; tea at 0.1 ppm; tree nut, crop group 14 at 0.1 ppm; tuberous and corm vegetables, crop subgroup 1C at 0.1 ppm; vanilla at 0.1 ppm; vegetable, brassica, leafy, group 5 at 0.1 ppm; vegetable, bulb, group 3 at 0.1 ppm; vegetable, cucurbit group 9 at 0.1 ppm; vegetable, foliage of legume, group 7 at 0.1 ppm; vegetables, fruiting, group, crop group 8 at 0.1 ppm; vegetable, leaves of root and tuber, group 2 at 0.1 ppm; vegetable, leafy, except brassica, group 4 at 0.1 ppm; vegetable, legume, group 6 at 0.1 ppm; vegetable, root and tuber, group 1 at 0.1 ppm; wasabi, roots at 0.1 ppm; and wax jambu at 0.1 ppm.

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 combined residues of carfentrazone-ethyl and its metabolite, carfentrazone-ethyl chloropropionic acid, on Vegetable, root and tuber, group 01 at 0.10 ppm; vegetable, leaves of root and tuber, group 2 at 0.10 ppm; vegetable, bulb, group 3 at 0.10 ppm; vegetable, leafy, except brassica, group 4 at 0.10 ppm; vegetable, brassica, leafy, group 5 at 0.10 ppm; vegetable, legume, group 6 at 0.10 ppm; vegetable, foliage of legume (except soybean), group 7 at 0.10 ppm; vegetable, fruiting, group 8 at 0.10 ppm; vegetable, cucurbit, group 9 at 0.10 ppm; fruit, citrus, group 10 at 0.10 ppm; fruit, pome, group 14 at 0.10 ppm; fruit, stone, group 12 at 0.10 ppm; berry, group 13 at 0.10 ppm; nut, tree, group 14 at 0.10 ppm; herbs and spices, group 19 at 2.0 ppm; almond, hull at 0.20 ppm; grape at 0.10 ppm; grass, forage at 5.0 ppm; grass, hay at 8.0 ppm; canola at 0.10 ppm; hop, dried cones at 0.10 ppm; peanut at 0.10 ppm; peanut, hay at 0.10 ppm; strawberry at 0.10 ppm; sugarcane at 0.10 ppm; sunflower, seed at 0.10 ppm; okra at 0.10 ppm; stevia at 0.10 ppm; pistachio at 0.10 ppm; coconut at 0.10 ppm; strawberrypear at 0.10 ppm; date at 0.10 ppm; fig at 0.10 ppm; papaya at 0.10 ppm; avocado at 0.10 ppm; sapote, black at 0.10 ppm; canistel at 0.10 ppm; sapote, mamey at 0.10 ppm; mango at 0.10 ppm; sapodilla at 0.10 ppm; star apple at 0.10 ppm; pummelo at 0.10 ppm; guava at 0.10 ppm; feijoa at 0.10 ppm; jaboticaba at 0.10 ppm; wax jambu at 0.10 ppm; starfruit at 0.10 ppm; passionfruit at 0.10 ppm; acerola at 0.10 ppm; lychee at 0.10 ppm; longan at 0.10 ppm; Spanish lime at 0.10 ppm; rambutan at 0.10 ppm; pulasan at 0.10 ppm; sugar apple at 0.10 ppm; atemoya at 0.10 ppm; custard apple at 0.10 ppm; cherimoya at 0.10 ppm; ilama at 0.10 ppm; soursop at 0.10 ppm; biriba at 0.10 ppm; lingonberry at 0.10 ppm; Juneberry at 0.10 ppm, salal at 0.10 ppm; kiwifruit at 0.10 ppm; pomegranate at 0.10 at ppm; persimmon at 0.10 ppm; pawpaw at 0.10 ppm; palm heart at 0.10 ppm; palm heart, leaves at 0.10 ppm; kava, kava at 0.10 ppm; ti, leaves at 0.10 ppm; ti, roots at 0.10 ppm; wasabit, roots at 0.10 ppm; cactus at 0.10 ppm; sorghum, sweet at 0.10 ppm; rapeseed, seed at 0.10 ppm; rapeseed, forage at 0.10 ppm; mustard, seed at 0.10 ppm; flax, seed at 0.10 ppm; safflower, seed at 0.10 ppm; crambe, seed at 0.10 ppm; borage at 0.10 ppm; olive at 0.10 ppm; banana at 0.10 ppm; cacao at 0.10 ppm; tea at 0.10 ppm; mulberry, Indian at 0.10 ppm; vanilla at 0.10 ppm; coffee at 0.10 ppm; horseradish at 0.10 ppm; fish at 0.30 ppm; shellfish at 0.30 ppm; meat, byproducts (cattle, goat, horse, and sheep) at 0.10 ppm; meat (cattle, goat, horse, and sheep) at 0.10 ppm; fat (cattle, goat, horse, and sheep) at 0.10 ppm and milk at 0.05 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 carfentrazone-ethyl are discussed in the Unit III.A. of the final rule on carfentrazone-ethyl published in the Federal Register of August 9, 2000 (65 FR 48620) (FRL-6597-7).

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 carfentrazone-ethyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of August 9, 2000 (65 FR 48620).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.515(a) for the combined residues of carfentrazone-ethyl and its metabolite, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from carfentrazone-ethyl 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.

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For the acute analyses, conservative estimates of expected residues were assumed for all food commodities with current or proposed carfentrazone-ethyl tolerances, and it was assumed that all of the crops included in the analysis were treated. Percent Crop Treated (PCT) and/or anticipated residues were not used in the acute risk assessment.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For the chronic analyses, conservative estimates of expected residues were assumed for all food commodities with current or proposed carfentrazone-ethyl tolerances, and it was assumed that all of the crops included in the analysis were treated. PCT and/or anticipated residues were not used in the chronic risk assessment.

iii. Cancer . Carfentrazone-ethyl is classified as “not likely” a human carcinogen.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/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 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. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 driinking 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 carfentrazone-ethyl they are further discussed in the aggregate risk sections in Unit III.E.

Based on the FIRST and SCI-GROW models, the EECs of carfentrazone-ethyl for acute exposures are estimated to be 34.3 parts per billion (ppb) for surface water and 13.4 ppb for ground water. The EECs for chronic exposures are estimated to be 19.0 ppb for surface water and 13.4 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).

Carfentrazone-ethyl is currently registered for use on the following residential non-dietary sites: Ornamental lawns and turf (application by commercial operators only. There is a proposed aquatic use under review. The risk assessment was conducted using the following residential exposure assumptions: Exposures to toddlers in the residential lawn setting would be higher than that encountered by toddlers in an institutional setting, such as in schools and parks. It was anticipated that herbicide application to homeowner lawns is a seasonal event, thus, only short-term post-application residential exposures were conducted. A swimmer exposure assessment was conducted based on the proposed aquatic application. The swimmer assessment estimates exposures from oral (ingestion) and inhalation routes. No systemic toxicity was seen at the limit-dose (1,000 milligrams/kilogram/day (mg/kg/day)) in a 21-day dermal toxicity study in rats, therefore, these risk assessments are not required. Based on the use pattern, long-term exposure is not anticipated.

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 carfentrazone-ethyl and any other substances and carfentrazone-ethyl 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 carfentrazone-ethyl 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 . There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with carfentrazone-ethyl. There is no evidence of increased susceptibility of rats in the reproduction study with carfentrazone-ethyl. EPA concluded there are no residual uncertainties for prenatal and/or postnatal exposure.

3. Conclusion . EPA concluded that, based on the absence of residual uncertainties for prenatal and/or postnatal exposure and complete toxicology, environmental fate, residue chemistry data bases, and the conservative assumptions used when generating the dietary and residential exposure estimates, there are reliable data showing that it is safe for infants and children to remove the additional 10X safety factor.

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 youth 13-19, 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 carfentrazone-ethyl will occupy less than 1% of the aPAD for the U.S. population and all population subgroups.

In addition, there is potential for acute dietary exposure to carfentrazone-ethyl in drinking water. After calculating DWLOCs and comparing them to the EECs for surface 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, EPA has concluded that exposure to carfentrazone-ethyl from food will utilize ≤75% of the of the cPAD with children 1-2 years old the population subgroup with the highest exposures. Based the use pattern, chronic residential exposure to residues of carfentrazone-ethyl is not expected. In addition, there is potential for chronic dietary exposure to carfentrazone-ethyl in drinking water. After calculating DWLOCs and comparing them to the EECs for surface 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).

Carfentrazone-ethyl is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for carfentrazone-ethyl.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures (including potential aquatic exposure) aggregated result in aggregate MOEs of 72,875 for the general population and 22,339 for children 1-2 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of carfentrazone-ethyl in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 3 of this unit:

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 carfentrazone-ethyl residues.

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

There is neither a Codex proposal, nor Canadian or Mexican maximum residue limits, for residues of carfentrazone-ethyl and F8426-Cl-PAC in/on the proposed crops, livestock, fish, or shellfish. Therefore, harmonization is not an issue.

Residue chemistry: Successful Agency Validation of Proposed Livestock/Fish/Shellfish Enforcement Method.

Three comments were received in response to the notices of filing. Two comments from B. Sachau objected to the proposed tolerances because of the amounts of pesticides already consumed and carried by the American population. She further indicated that testing conducted on animals have absolutely no validity and are cruel to the test animals. Bonita Poulin commented that she doesn't approve of more chemical contamination of our food when we should be decreasing the residual poisons building up within us, which are already causing health problems. She also indicated that there are safe alternatives available.

Ms. Sachau's and Ms. Poulin's comments contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to carfentrazone ethyl, including all anticipated dietary exposures and all other exposures for which there is reliable information.

Therefore, the tolerance is established for combined residues of carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid), all expressed as carfentrazone-ethyl, in or on vegetable, root and tuber, group 01 at 0.10 ppm; vegetable, leaves of root and tuber, group 2 at 0.10 ppm; vegetable, bulb, group 3 at 0.10 ppm; vegetable, leafy, except brassica, group 4 at 0.10 ppm; vegetable, brassica, leafy, group 5 at 0.10 ppm; vegetable, legume, group 6 at 0.10 ppm; vegetable, foliage of legume (except soybean), group 7 at 0.10 ppm; vegetable, fruiting, group 8 at 0.10 ppm; vegetable, cucurbit, group 9 at 0.10 ppm; fruit, citrus, group 10 at 0.10 ppm, fruit; pome, group 14 at 0.10 ppm; fruit, stone, group 12 at 0.10 ppm; berry, group 13 at 0.10 ppm; nut, tree, group 14 at 0.10 ppm; herbs and spices, group 19 at 2.0 ppm; almond, hull at 0.20 ppm; grape at 0.10 ppm; grass, forage at 5.0 ppm; grass, hay at 8.0 ppm; canola at 0.10 ppm, hop, dried cones at 0.10 ppm; peanut at 0.10 ppm; peanut, hay at 0.10 ppm; strawberry at 0.10 ppm; sugarcane at 0.10 ppm; sunflower, seed at 0.10 ppm; okra at 0.10 ppm; stevia at 0.10 ppm; pistachio at 0.10 ppm; coconut at 0.10 ppm; strawberrypear at 0.10 ppm; date at 0.10 ppm; fig at 0.10 ppm; papaya at 0.10 ppm; avocado at 0.10 ppm; sapote, black at 0.10 ppm; canistel at 0.10 ppm; sapote, mamey at 0.10 ppm; mango at 0.10 ppm; sapodilla at 0.10 ppm; star apple at 0.10 ppm; pummelo at 0.10 ppm; guava at 0.10 ppm; feijoa at 0.10 ppm; jaboticaba at 0.10 ppm; wax jambu at 0.10 ppm; starfruit at 0.10 ppm; passionfruit at 0.10 ppm; acerola at 0.10 ppm; lychee at 0.10 ppm; longan at 0.10 ppm; Spanish lime at 0.10 ppm; rambutan at 0.10 ppm; pulasan at 0.10 ppm; sugar apple at 0.10 ppm; atemoya at 0.10 ppm; custard apple at 0.10 ppm; cherimoya at 0.10 ppm; ilama at 0.10 ppm; soursop at 0.10 ppm; biriba at 0.10 ppm; lingonberry at 0.10 ppm; Juneberry at 0.10 ppm, salal at 0.10 ppm; kiwifruit at 0.10 ppm; pomegranate at 0.10 at ppm; persimmon at 0.10 ppm; pawpaw at 0.10 ppm; palm heart at 0.10 ppm; palm heart, leaves at 0.10 ppm; kava, kava at 0.10 ppm; ti, leaves at 0.10 ppm; ti, roots at 0.10 ppm; wasabit, roots at 0.10 ppm; cactus at 0.10 ppm; sorghum, sweet at 0.10 ppm; rapeseed, seed at 0.10 ppm; rapeseed, forage at 0.10 ppm; mustard, seed at 0.10 ppm; flax, seed at 0.10 ppm; safflower, seed at 0.10 ppm; crambe, seed at 0.10 ppm; borage at 0.10 ppm; olive at 0.10 ppm; banana at 0.10 ppm; cacao at 0.10 ppm; tea at 0.10 ppm; mulberry, Indian at 0.10 ppm; vanilla at 0.10 ppm; coffee at 0.10 ppm; horseradish at 0.10 ppm; fish at 0.30 ppm; shellfish at 0.30 ppm; meat, byproducts (cattle, goat, horse, and sheep) at 0.10 ppm; meat (cattle, goat, horse, and sheep) at 0.10 ppm; fat (cattle, goat, horse, and sheep) at 0.10 ppm and milk at 0.05 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0256 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 29, 2004.

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 d(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.

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 the 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 the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

•  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 July 7, 2004 (69 FR 40831) (FRL-7362-2), EPA issued a proposed rule to revoke certain tolerances and tolerance exemptions for residues of the insecticides allethrin and bendiocarb, plant growth regulator fenridazon potassium, herbicide molinate, and biological pesticide Burkholderia cepacia . Also, the July 7, 2004 proposal provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under the Federal Food, Drug, and Cosmetic Act (FFDCA) standards.

In this final rule, EPA is revoking certain tolerances and tolerance exemptions for residues of the insecticides allethrin and bendiocarb, plant growth regulator fenridazon potassium, herbicide molinate, and the biological pesticide Burkholderia cepacia because these specific tolerances and exemptions correspond to uses no longer current or registered under FIFRA in the United States. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to revoke those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or domestic commodities legally treated.

EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:

1. Prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.

2. EPA independently verifies that the tolerance is no longer needed.

3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.

Today's final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the Federal Register of July 7, 2004 (69 FR 40831), EPA received one comment during the 60-day comment period, as follows:

Comment . EPA received a comment from the California Rice Commission (CRC), who expressed support for EPA's decision to revoke the tolerances for residues of molinate in or on rice grain and rice straw, each with an expiration date of September 1, 2009. Also, the CRC expressed support for the molinate 5-year phase out and stated that the phase out allows rice growers a phase in period for newer pesticides while the registrants work with EPA in bringing replacement products to market. The CRC described itself as a statutory organization representing 2,500 rice growers who farm approximately 500,000 acres of California farmland.

Agency response . EPA appreciates the support of the CRC on the phase out of molinate, which has been a tool for California rice growers in controlling pests. The phase out and tolerance revocations for molinate are discussed in detail elsewhere in this document.

1. Allethrin . Many food use registrations for allethrin were canceled in 1989 and 1991 due to non-payment of maintenance fees. After reviewing labels for allethrin stereoisomer active ingredients (bioallethrin, 004003; s-bioallethrin, 004004; and d-cis-trans-allethrin, 004005), EPA has determined that their current active registered uses are not associated with any of the existing tolerances in 40 CFR 180.113 or tolerance exemptions in 40 CFR 180.1002 for allethrin (004001). The allethrin stereoisomers are primarily used as flying insect killers and repellents.

EPA defines the tolerances and exemptions in 40 CFR 180.113 and 180.1002 as pertaining solely to allethrin (004001) as the active ingredient. This is the earliest form of the allethrin stereoisomers, and may be referred to as a racemic mixture. Because there are no active registrations for use of allethrin (004001) on commodities associated with these tolerances or tolerance exemptions, these tolerances and tolerance exemptions are no longer needed. Therefore, EPA is revoking the 30 tolerances in 40 CFR 180.113 for residues of allethrin in or on apple, postharvest; barley, grain, postharvest; blackberry, postharvest; blueberry, postharvest; boysenberry, postharvest; cherry, postharvest; corn, grain, postharvest; crabapple, postharvest; currant, postharvest; dewberry, postharvest; fig, postharvest; gooseberry, postharvest; grape, postharvest; guava, postharvest; huckleberry, postharvest; loganberry, postharvest; mango, postharvest; muskmelon, postharvest; oat, grain, postharvest; orange, postharvest; peach, postharvest; pear, postharvest; pineapple, postharvest; plum, postharvest; plum, prune, fresh, postharvest; raspberry, postharvest; rye, grain, postharvest; sorghum, grain, grain, postharvest; tomato, postharvest; and wheat, grain, postharvest. Note, huckleberry was listed separately from blueberry and plum was listed separately from plum, prune, fresh in a final rule published in the Federal Register of July 1, 2003 (68 FR 39435) (FRL-7316-9), which revised tolerance nomenclatures.

Also, EPA is revoking 43 tolerance exemptions in 40 CFR 180.1002 for residues of allethrin in or on apples, artichokes (Jerusalem), beans, beets, beets, sugar; broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, chickory, chinese cabbage, citrus, collards, corn, endive, escarole, garlic, horseradish, kale, kohlrabi, leeks, lettuce, mushrooms, mustard greens, onions, parsley, parsnips, peaches, pears, peppers, potatoes, radishes, rutabagas, salsify, shallots, sorghum (milo), sorghum, grain; spinach, sweet potatoes, tomatoes, and turnips.

For FQPA tolerance reassessment purposes, EPA will count the 73 revocations as a total of 69 tolerance reassessments because in the baseline of tolerances to be counted toward reassessment, the tolerance for huckleberry is counted with blueberry, the tolerance for plum is counted with plum, prune, fresh; the tolerance exemption for escarole is counted with endive; and the tolerance exemption for sorghum milo is counted with the sorghum grain exemption.

2. Bendiocarb . On April 26, 2002 (67 FR 20767) (FRL-6833-8), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant for cancellation of the last active bendiocarb registrations for food use. EPA approved the registrants' requests for voluntary cancellation and issued cancellation orders with an effective date of October 24, 2002, and allowed the registrant to sell and distribute existing stocks for a period of 12 months after the cancellation request was received; i.e., until approximately April 26, 2003. There are no active registrations and the tolerances are no longer needed. Therefore, EPA is revoking the non-numerical tolerances in 40 CFR 180.530 for residues of the insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate, known as bendiocarb, in or on processed food and animal feed with an expiration/revocation date of April 26, 2005, in order to allow end-users sufficient time to exhaust existing stocks.

3. Burkholderia cepacia type Wisconsin . On August 28, 2002 (67 FR 55236) (FRL-7189-4), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant for cancellation of the last active Burkholderia cepacia type Wisconsin registrations for food use. EPA approved the registrant's requests for voluntary cancellation and issued cancellation orders with an effective date of February 27, 2003, and allowed the registrant to sell and distribute existing stocks for a period of 12 months after the cancellation request was received; i.e., until May 13, 2003. The Agency believes that sufficient time has passed for stocks to have been exhausted and for treated commodities to have cleared the channels of trade. Because there are no active registrations and the tolerance exemption is no longer needed, EPA is revoking the tolerance exemption in 40 CFR 180.1115 for residues of Burkholderia cepacia type Wisconsin in or on all raw agricultural commodities when applied to plant roots and seedling roots, or as a seed treatment for growing agricultural crops.

4. Fenridazon potassium . On July 25, 2003 (68 FR 44081) (FRL-7315-6), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of a request from the registrant for cancellation of the last active fenridazon potassium product registration. EPA approved the registrants' requests for voluntary cancellation and issued cancellation orders on November 5, 2003 (68 FR 62582) (FRL-7328-7), with an effective date of November 5, 2003. The registrant has not manufactured the canceled product since 1989. No existing stocks are expected to be in the channels of trade. No active registrations exist and therefore the tolerances are no longer needed. Consequently, EPA is revoking the tolerances in 40 CFR 180.423 for residues of the hybridizing agent potassium salt of fenridazon in or on cattle, fat; cattle, kidney; cattle, liver; cattle, meat; cattle, meat byproducts; egg; goat, fat; goat, kidney; goat, liver; goat, meat; goat, meat byproducts; hog, fat; hog, kidney; hog, liver; hog, meat; hog, meat byproducts; horse, fat; horse, kidney; horse, liver; horse, meat; horse, meat byproducts; milk; poultry, fat; poultry, meat; poultry, meat byproducts; sheep, fat; sheep, kidney; sheep, liver; sheep, meat; sheep, meat byproducts; wheat, grain; and wheat, straw.

5. Molinate . On September 17, 2003 (68 FR 54451) (FRL-7324-7), EPA published a notice in the Federal Register under section 6(f)(1) of FIFRA announcing its receipt of requests from the registrants to voluntarily cancel registrations of all their molinate products, and to modify the terms and conditions of their molinate registrations. After considering comments received, EPA decided to accept the registrants' requests for voluntary cancellation. On April 7, 2004 (69 FR 18368) (FRL-7350-9), the Agency issued a cancellation order with an effective date of June 30, 2008, and a modification of the terms and conditions of the molinate registrations. The 2002 sales level of the molinate active ingredient will be the maximum amount that the registrants will sell or distribute in 2004, 2005, and 2006. The registrants may not sell or distribute any more than 75% of the 2002 sales levels in the year 2007, and sell or distribute more than 50% of the 2002 sales levels in the year 2008.

As stated in the cancellation order of April 7, 2004 (69 FR 18368), registrants will provide annual production/sales reports to EPA beginning in the year 2004 through 2009, and inventory reports for the years 2007, 2008, and 2009. These reports will be submitted by September 30 of each year to the Agency's Chemical Review Manager for molinate. Failure by either registrant to comply with the sale or distribution limits contained in the molinate registration constitutes grounds for immediate cancellation of the registration without opportunity for a hearing.

After June 30, 2008, the registrants may not sell or distribute any molinate products except to distribute the molinate active ingredient in 2009 for the purposes of facilitating usage by August 31, 2009. No use of products containing molinate will be permitted after the 2009 growing season (August 31, 2009). Currently, this is a state registration under FIFRA section 24, active only in California, Tennessee, and Texas. Because the tolerances on rice are no longer needed beyond the 2009 growing season, EPA is revoking the tolerances in 40 CFR 180.228 for residues of the herbicide S-ethyl hexahydro-1H-azepine-1-carbothioate, known as molinate, in or on rice, grain and rice, straw with an expiration/revocation date of September 1, 2009.

Also, in 40 CFR 180.228, EPA is removing the “(N)” designation from all entries to conform to current Agency administrative practice (“(N)” designation means negligible residues).

It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.

With the exception of certain tolerances for bendiocarb and molinate, for which EPA is revoking certain tolerances/exemptions with specific expiration/revocation dates, the Agency is revoking specific tolerances/exemptions for allethrin, Burkholderia cepacia , and fenridazon potassium, and revising commodity terminologies effective on September 29, 2004. With the exception of bendiocarb and molinate, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have cleared the channels of trade. EPA is revoking certain bendiocarb and molinate tolerances with expiration/revocation dates of April 26, 2005, and September 1, 2009, respectively.

Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residue of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration (FDA) that: (1) The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and (2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

By law, EPA is required by August 2006, to reassess the tolerances in existence on August 2, 1996. As of September 15, 2004, EPA has reassessed over 6,840 tolerances. In this final rule, EPA is revoking a total of 110 tolerances and tolerance exemptions. For FQPA tolerance reassessment counting purposes, EPA counts the 73 revocations for allethrin as 69 reassessments because the tolerances for huckleberry and plum are counted with blueberry and plum, prune, fresh; respectively, and the tolerance exemptions for escarole and sorghum milo are counted with endive and sorghum grain, respectively. Therefore, 106 tolerances/exemptions are counted as reassessed toward the August 2006 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/ . On the Home Page select “Laws and Regulations,” then select “Regulations and Proposed Rules” and then look up the entry for this document under “ Federal Register --Environmental Documents.” You can also go directly to the “Federal Register” listings at http://www.epa.gov/fedrgstr/ .

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0260 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 29, 2004.

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

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

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV.A.1., 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-2004-0260, 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 revokes specific tolerances established under section 408 of FFDCA. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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 as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. 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 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 12680) (FRL-7347-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 3E6551, 3E6639, 3E6701, 3E6742, and 3E6803) by IR-4, 681 US Highway #1 South, New Brunswick, NJ 08902-3390. These petitions requested that 40 CFR 180.516 be amended by establishing tolerances for residues of the fungicide fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on bean, dry and bean, succulent at 0.4 parts per million (ppm) (PP 3E6701); citrus, crop group 10 at 10 ppm; citrus, dried pulp at 20 ppm, citrus, oil at 500 ppm, and pomegranate at 2.0 ppm (PP 3E6803); fruit, pome, group 11 at 5.0 ppm, yam at 8.0 ppm, and melon subgroup 9A at 0.03 ppm (PP 3E6742); kiwifruit at 20 ppm (PP 3E6551); and leafy greens subgroup 4A, except spinach at 30 ppm (PP 3E6639). That notice included a summary of the petitions prepared by Syngenta Crop Protection, Incorporated, the registrant. Subsequently, PP 3E6803 has been amended to delete citrus, dried pulp at 20 ppm, and pomegranate at 2.0 ppm. In addition, “citrus, oil” at 500 ppm, and “yam” at 8.0 ppm has been translated to “grapefruit, oil” at 500 ppm, and “yam, true” at 8.0, respectively. There were no comments received in response to the notice of filing.

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 tolerances for residues of fludioxonil on bean, dry; bean, succulent at 0.4 ppm; citrus, crop group 10 at 10 ppm; fruit, pome, group 11 at 5.0 ppm; grapefruit, oil at 500 ppm; kiwifruit at 20 ppm; leafy greens subgroup 4A, except spinach at 30 ppm; melon subgroup 9A at 0.03; and yam, true at 8.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances 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 fludioxonil 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 December 29, 2000 (65 FR 82927) (FRL-6760-9).

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 fludioxonil used for human risk assessment is shown in Table 1. of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.516) for the residues of fludioxonil, in or on a variety of raw agricultural commodities which includes the following: Brassica, head and stem, Brassica, leafy greens, bushberry, caneberry, carrot, cereal grain, forage, fodder, and straw, cotton gin byproducts, cotton, undelinted seed, flax, seed, grape, grass, forage, fodder and hay, herb and spice group, juneberry, leafy vegetables except Brassica, lingonberry, longan, lychee, non-grass animal feed, dry bulb and green onion, peanut hay, peanut, pistachio, pulasan, rambutan, rapeseed and rapeseed forage, safflower seed, salal, Spanish lime, stone fruit, strawberry, sunflower seed, turnip greens, bulb vegetables, cucurbit vegetables, fruiting legume vegetables, root and tuber vegetables, foliage of legume vegetables, and watercress. Risk assessments were conducted by EPA to assess dietary exposures from fludioxonil in food as follows:

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

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An unrefined, Tier 1 acute dietary exposure assessment used tolerance-level residue values and 100% crop treated (CT) as assumptions for all of the registered and proposed uses.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially refined, Tier 2 chronic dietary exposure assessment was conducted for the general U.S. population and related population subgroups. Tolerance-level values and a default of 100% CT were used for all the current and proposed fludioxonil tolerances except for apple, grapefruit, lemon, lime, orange, and pear. Average application rate (AR) values replaced tolerances for apple, grapefruit, lemon, lime, orange, and pear. In addition, processing factors from processing studies were used for apple juice and citrus juices.

iii. Cancer . EPA's Cancer Peer Review Committee (CPRC) classified fludioxonil as a Group D chemical that is considered not classifiable as to human carcinogenicity. Therefore, a cancer risk assessment was not performed.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fludioxonil 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 fludioxonil.

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will 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. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 fludioxonil they are further discussed in the aggregate risk sections in Unit III.E.1.-4.

Based on the FIRST and SCI-GROW models, the EECs of fludioxonil for acute exposures are estimated to be 132 parts per billion (ppb) for surface water and 0.11 ppb for ground water. The EECs for chronic exposures are estimated to be 49 ppb for surface water and 0.11 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).

Fludioxonil is currently registered for use on the following residential non-dietary sites: Turfgrass and ornamentals in residential landscapes (registered product: Medallion®, EPA Reg. No. 100-769). Medallion® is a wettable powder in water-soluble packets, and the current label indicates that this product is “for professional use only.” As such, no residential handler (i.e. applicator) exposures are anticipated. However, short- and intermediate-term dermal (adults and toddlers), and incidental ingestion (toddlers) post-application residential exposures are anticipated based on the use pattern for turfgrass applications detailed on the Medallion label (specifies that the product be applied at 14-day application intervals, with an annual maximum rate of 2 lbs ai/A/yr, which equates to about 3 applications at the maximum per application rate. Also, fludioxonil has half-lives ranging from 95 to 440 days in thatch sod). A residential post-application dermal assessment was not performed since the risks from short- and intermediate-term dermal exposure are negligible. Short- and intermediate-term dermal endpoints were not selected due to the NOAEL of 1,000 mg/kg/day (highest dose tested) in the 28-day dermal toxicity study in rats and also since there were no developmental concerns. EPA has concluded that there are no significant post-application exposures anticipated from treated landscape ornamentals. Therefore, the risk assessment was conducted using the following residential exposure assumption: Post-residential lawn applications for toddler incidental ingestion.

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 fludioxonil and any other substances and fludioxonil 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 fludioxonil 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 developmental and reproductive toxicity data did not indicate increased quantitative or qualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure.

3. Conclusion . There is a complete toxicity data base for fludioxonil 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 because:

• The toxicology data base is complete.

• The developmental and reproductive toxicity data did not indicate increased quantitative or qualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure.

• A developmental neurotoxicity study is not required because there was no evidence of neurotoxicity in the current toxicity data base.

• The exposure assessment approach will not underestimate the potential dietary (food and water) and non-dietary exposures for infants and children resulting from the use of fludioxonil.

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 fludioxonil will occupy 0.13% of the aPAD for females 13 years and older. In addition, there is potential for acute dietary exposure to fludioxonil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 2. of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fludioxonil from food will utilize 39.4% of the cPAD for the U.S. population, 43.7% of the cPAD for all infants < 1 year old, 65.2% of the cPAD for children 1-2 years old, and 39.4% of the cPAD for females 13-49 years old. Based on the use pattern, chronic residential exposure to residues of fludioxonil is not expected. In addition, there is potential for chronic dietary exposure to fludioxonil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3. 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). Fludioxonil is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fludioxonil.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 390 for all infants < 1 year old, 300 for children 1-2 years old, and 320 for children 3-5 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of fludioxonil in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 4. of this unit:

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). Fludioxonil is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for fludioxonil.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 160 for all infants < 1 year old, 120 for children 1-2 years old, and 130 for children 3-5 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of fludioxonil in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 5. of this unit:

5. Aggregate cancer risk for U.S. population . EPA has classified fludioxonil in “Group D” - not classifiable as to human carcinogenicity. Based on available data, the Agency concludes that the proposed use of fludioxonil does not present discernable aggregate cancer risk.

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

Adequate enforcement methodology is available to enforce the tolerance expression. Apple, pear, kiwifruit, cantaloupe, yam, citrus, and pomegranate were analyzed for fludioxonil using Syngenta tolerance enforcement method AG-597B, Analytical Method for the Determination of CGA-219417 in Crops by High Performance Liquid Chromatography Including Validation Data, with Modifications. Head and leaf lettuce, lima bean, dry bean, and snap bean were analyzed for fludioxonil using Novartis working method AG-631B, Determination of Residues of CGA-219417 in Crops by High Performance Liquid Chromatography with Column Switching.

Adequate enforcement methodology (liquid chromotography) 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 tolerances/maximum residue levels (MRLs) for fludioxonil residues on kiwifruit, yam, bean, dry and bean, succulent, citrus, leafy greens except spinach, melons, or pome fruit. Thus, harmonization is not an issue at this time.

Therefore, the tolerances are established for residues of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on bean, dry; bean, succulent at 0.4; citrus, crop group 10 at 10 ppm; fruit, pome, group 11 at 5.0 ppm; grapefruit, oil at 500 ppm; kiwifruit at 20 ppm; leafy greens subgroup 4A, except spinach at 30 ppm; melon subgroup 9A at 0.03; and yam, true at 8.0 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0321 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 29, 2004.

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-2004-0321, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

This is a summary of the Commission's Order, DA 04-2923, adopted on September 8, 2004, and released on September 13, 2004. The complete text of this Order is available for inspection and copying during normal business hours in the FCC Reference Information Center, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. In addition, the complete text may be retrieved from the FCC's Web site at http://www.fcc.gov . The text may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone (202) 488-5300, or (800) 378-3160.

The Order amends § 0.121(b) of the rules to update the geographical coordinate locations of the Commission's protected field installations where radio spectrum monitoring operations are conducted. Specifically, the Order deletes the geographical coordinates of the Commission's Anchorage, Alaska monitoring facility from the list of protected field installations set forth in § 0.121(b) of the rules. These locations are protected from harmful radio frequency interference to the Commission's monitoring activities that could be produced by the proximity of any nearby radio transmitting facilities.

Pursuant to the authority contained in sections 4(i) and (5) of the Communications Act of 1934, as amended, and § 0.231(b) of the rules, part 0 of the rules is amended as set forth in the rule changes.

As the rule amendment adopted in the Order pertains to agency organization, procedure and practice, the notice and comment provision of the Administrative Procedure Act contained in 5 U.S.C. 553(b) is inapplicable.

The Commission will not send a copy of this Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rule are rules of agency organization, procedure, or practice that do not “substantially affect the rights or obligations of non-agency parties.”

The rule amendment set forth in the rule changes will become effective September 29, 2004.