Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act* * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Utah program on January 21, 1981. You can find background information on the Utah program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Utah program in the January 21, 1981, Federal Register (46 FR 5899). You also can find later actions concerning Utah's program and program amendments at 30 CFR 944.15 and 944.30.

By letter dated October 22, 2002, Utah sent us an amendment to its program (UT-042-FOR, Administrative Record number UT-1171) under SMCRA (30 U.S.C. 1201 et seq. ). Utah sent the amendment in response to a June 19, 1997, letter (Administrative Record number UT-1093) that we sent to the State in accordance with 30 CFR 732.17(c).

Utah previously addressed most of the topics included in our June 19, 1997, letter in amendment UT-038-FOR, which we approved in the April 24, 2001 Federal Register (66 FR 20600). However, some of the topics described in our letter changed the small operator assistance program (SOAP) by raising the limit on coal production from 100,000 tons to 300,000 tons and describing changes in the type of assistance available to eligible operators under that program. Our letter noted that those changes might require changes in State statutes. In Utah's case, it must change the SOAP provisions in the Utah Code Annotated (UCA, or Utah's Code or statute) before it can change its implementing rules. The amendment that is the subject of this final rule proposed to make the requisite SOAP changes in Utah's Code. At its own initiative, the State proposed additional changes throughout the same section of its Code that involved other topics pertaining to permit applications to clarify wording and recodify certain parts. The clarifications consisted of rewording and restructuring sentences and phrases and changing punctuation.

Specific changes Utah proposed to make to UCA 40-10-10 in this amendment include: Clarifying 40-10-10-(1), which describes application fees; designating new 40-10-10(2)(a) and clarifying it and (2)(a)(ii), (iii), (iv) and (vi), which generally describe how permit applications and reclamation plans are to be submitted to the State and describe ownership and right of entry information to be included with permit applications and reclamation plans; clarifying 40-10-10(2)(b), (c), and (d) and recodifying subordinate parts of those subsections, which describe the maps and information about legal right of entry, probable hydrologic consequences and other hydrology information, and characteristics of the coal to be mined that must be included in permit applications; removing existing 40-10-10(3) and replacing it with new 40-10-10(3)(a), (a)(i) through (a)(vi), (b), and (c), all of which pertain to assistance available to eligible small operators to gather and pay for certain baseline and survey data and limitations on that assistance; clarifying and recodifying 40-10-10(4)(a) and (b), which address availability of information pertaining to the coal; clarifying 40-10-10(5), which describes how to file a permit application; clarifying and recodifying 40-10-10(6)(a), (b), (b)(i) and (ii), which describe the proof and type of insurance required to accompany a permit application; and clarifying 40-10-10(7), which requires a blasting plan to be part of a permit application.

We announced receipt of the proposed amendment in the January 6, 2003, Federal Register (68 FR 521). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy (Administrative Record number UT-1178). We did not hold a public hearing or meeting because nobody requested one. The public comment period ended on February 5, 2003. We received comments from one Federal agency.

We identified two concerns during our review of the amendment. One involved the proposed change at recodified UCA 40-10-10(2)(d)(ii) that would authorize Utah's Division of Oil, Gas and Mining (DOGM) to waive considerably more application requirements than may be waived under the counterpart Federal provision at Section 507(b)(15) of SMCRA. We discuss this topic further in part III.B.3 of this final rule. The second concern involved Utah's proposed removal of the phrase “for public inspection” from UCA 40-10-10(5), which requires permit applications to be filed at certain public offices in the counties where mining is to occur. Part III.B.5 of this final rule contains our discussion of this topic. We notified Utah of these concerns by letter dated February 21, 2003 (Administrative Record number UT-1180).

Utah responded in a letter dated August 31, 2007, by sending a new formal amendment to us (Administrative Record number UT-1196). The new amendment included proposed revisions to the Utah Code that addressed the two concerns we raised on our February 21, 2003, letter, and that would make additional changes. We decided to process that new formal amendment to the Utah Code as amendment UT-044-FOR. We made the changes Utah proposed in amendment UT-044-FOR available for public comment and published our final decision on those changes to the Utah Code in the August 12, 2008 Federal Register (73 FR 46804). Therefore, no further action is required in this final rule.

Following are the findings we made concerning amendment UT-042-FOR under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment with certain exceptions as described below.

Utah proposed minor editorial changes in wording, punctuation, grammatical, and codification to the following previously-approved statutory provisions. Differences between the following proposed State statutory provisions and the SMCRA provisions (which are listed in parentheses) are minor:

UCA 40-10-10(1), editorial changes to the requirement to include a fee with each application for a surface coal mining and reclamation permit, and the limitation on how much that fee may cost (Section 507(a) of SMCRA);

UCA 40-10-10(4), editorial changes to the requirement to make certain information about coal seams, core and soil samples, and other information available to any person with an interest that may be adversely affected, changes to the description of information that is to be kept confidential, and codifying new subsections (4)(a) and (b) (Section 507(b)(17) of SMCRA);

UCA 40-10-10(6), editorial changes to the requirement for permit applications to include liability insurance certificates, changes to the description of required insurance, and codifying new subsections 40-10-10(6)(a), (6)(b), and (6)(b)(i) and (ii) (Section 507(f) of SMCRA); and

UCA 40-10-10(7), editorial changes to the requirement for permit applications to include a blasting plan (Section 507(g) of SMCRA).

Because these changes are minor and contain wording that is the same as or similar to the corresponding provisions of SMCRA, we find that they are no less stringent than, and are in accordance with, the corresponding provisions of SMCRA.

Utah proposed to make a number of editorial changes at UCA 40-10-10(2) and (2)(a). Most of the editorial changes consist of adding punctuation, word changes, and rephrasing sentences and result in language that is the same as or similar to the corresponding provisions of SMCRA. The State also proposed to codify new subsection (a) to improve the section's paragraph structure.

In addition, Utah's proposed changes at UCA 40-10-10(2)(a)(ii) would replace the term “property” with the term “estate” and rephrase the provision to refer directly to the surface and mineral estates to be mined. Existing UCA 40-10-10(2)(a)(ii) requires permit applications to include information describing “* * * every legal owner of record of the property (surface and mineral) to be mined.” In a telephone conversation of December 26, 2002, DOGM explained that use of the term “estate” is more appropriate (than use of the term “property” is) to address situations in which ownership of surface land and subsurface minerals in areas to be mined is not the same (Administrative Record number UT-1177).

We considered comments suggesting a similar change when we proposed defining the term “property to be mined” at 30 CFR 701.5 (48 FR 44344; September 28, 1983). Commenters asserted “that the term ‘estate to be mined’ would be more correct legally * * *” and would eliminate confusion with the phrase “on and underneath lands” that we proposed as part of the definition at that time. We decided to retain the term “property to be mined” because it is based on the wording of section 507(b)(1) of SMCRA and is a generally understood and recognized term. At the same time, however, we recognized that section 507(b)(1) requires the permit information to list “the legal owners of record of the property to be mined, including the surface and mineral rights” and that the definition at 30 CFR 701.5 “requires inclusion of the estates within the permit area.”

We also recognize, however, that our standard for evaluating Utah's amendment does not require that the State's provisions mirror SMCRA and the Federal regulations. State alternatives to the Federal provisions are acceptable if they are “in accordance with” the requirements of SMCRA and are “consistent with” the Federal regulations, as provided in 30 CFR 732.15(a) (46 FR 53376; October 28, 1981). As defined at 30 CFR 730.5(a), “consistent with” and “in accordance with” mean—

As defined by Black's Law Dictionary, “estate” means “the amount, degree, nature, and quality of a person's interest in land or other property.” Surface land and subsurface minerals of the same parcel constitute real property but might be the property of different owners as separate, or split, “estates.” By distinguishing between the surface and mineral estates, Utah's proposed provision more clearly recognizes that a person's interest in property to be mined might include one or the other estate and not necessarily both. The State's proposed use of the term “estate” in place of “property” is consistent with the practice of split surface land and subsurface mineral ownership often encountered in Utah and elsewhere. In that context, the proposed change makes the provision more specific in terms of requiring information in a permit application that identifies the amount, degree, nature, and quality of a person's interest in the property to be mined.

The Federal counterpart to proposed UCA 40-10-10(2)(a)(ii) is section 507(b)(1)(B) of SMCRA. As noted previously, that provision requires a permit application to contain information identifying—

The counterpart Federal regulations at 30 CFR 778.13 and 13(a) require the permit application to include information identifying each legal or equitable owner(s) of record of the surface and mineral for “the property to be mined.” As defined at 30 CFR 701.5, the term “property to be mined” means—

As defined at Utah Administrative Rule R645-100-200, “property to be mined” means—

The phrase “surface and mineral estate” as proposed at UCA 40-10-10(2)(a)(ii) is the basis for the definitions of “property to be mined” in Utah's Administrative Rule and the Federal regulations. The term “property to be mined” as defined in the Utah Administrative Rules and the Federal regulations has one meaning: “Both the surface and mineral estates within the permit area and the area covered by underground workings * * *.” Conversely, and logically, then, the phrase “both the surface and mineral estates within the permit area and the area covered by underground workings” means “property to be mined.” If “property to be mined” means “both the surface and mineral estates * * *,” then changing the phrase to “surface and mineral estates to be mined” makes the phrase more specific as proposed at UCA 40-10-10(2)(a)(ii) while creating no substantive difference between it and the defined term “property to be mined.” In that context, we consider the proposed term “surface and mineral estate to be mined” to be interchangeable with “property to be mined” in Utah's Code and synonymous with the term “property (surface and mineral), to be mined” in SMCRA.

Utah's proposed change from “property (surface and mineral) to be mined” to “surface and mineral estate to be mined” provides more specificity while still requiring the same information for the same areas covered by the counterpart provisions in the Utah Administrative Rule, SMCRA, and the Federal regulations. Moreover, the phrase is consistent with the definition of “property to be mined” in the Utah Administrative Rule and the Federal regulations. As proposed with the changes described above, we find proposed UCA 40-10-10(2)(a)(ii) is in accordance with and therefore no less stringent than SMCRA and can be approved.

The State proposes several editorial changes to UCA 40-10-10(2)(b) and (c). At UCA 40-10-10(2)(b), it proposes editorial changes to the description of certain information to be included in permit applications, including maps or plans of land to be affected and a statement of right of entry and to mine, editorial changes to a prohibition on adjudicating property title disputes, and codifying new subsections 40-10-10(2)(b)(i), (2)(b)(i)(A) and (B), and 2(b)(ii) (Section 507(b)(9) of SMCRA). One editorial change includes the addition of the phrase “[a] permit application shall include * * *” as subsection (2)(b)(i) to introduce to the discussion of information requirements that follow in recodified subsections (2)(b)(i)(A) through (B)(ii).

At UCA 40-10-10(2)(c), Utah proposes to make editorial changes to the description of certain other information to be included in permit applications concerning probable hydrologic consequences (PHC) of mining and the quantity and quality of surface and groundwater, to requirements for collecting hydrologic data and submitting PHC determinations, and a restriction against permit approval pending inclusion of this information in an application, and codifying new subsections 40-10-10(2)(c)(i), (2)(c)(i)(A), (B), and (C), and (2)(c)(ii) and (iii) (Section 507(b)(11) of SMCRA). An editorial change to this section includes the addition of the phrase “[a] permit application shall also include * * *” to introduce the discussion of information requirements that follow in recodified subsections 2(c)(i)(A) through (C)(iii).

The editorial changes to UCA 40-10-10(2)(b) and (c) are intended to make Utah's Code easier to read and understand. Most of those changes are minor and contain wording that is the same as or similar to the corresponding provisions of SMCRA. As a result, we find that they are no less stringent than, and are in accordance with, the corresponding provisions of SMCRA.

Though intended to make the Code easier to read and understand, the proposed introductory phrases at recodified UCA 40-10-10(2)(b)(i) and 2(c)(i) described above may appear to limit the information requirements to permit applications. Existing UCA 40-10-10(2), which includes existing (2)(b) and (c), describes information that must be included “in the permit application and the reclamation plan submitted as part of a permit application * * *.” The proposed recodified version of UCA 40-10-10(2)(a) retains the reference to the reclamation plan. However, the proposed introductory phrases at UCA 40-10-10(2)(b)(i) and (2)(c)(i) refer to information that must be included in a permit application and do not reference a reclamation plan.

Despite the omission of references to a reclamation plan in the proposed introductory phrases at proposed UCA 40-10-10(2)(b)(i) and (2)(c)(i), we believe the revised wording is not limiting. “Permit” is defined at UCA 40-10-3(11) as—

UCA 40-10-3(18) defines “reclamation plan” as—

UCA 40-10-10 applies to—

Further, existing UCA 40-10-10(2) (and proposed recodified UCA 40-10-10(2)(a)) describe information submitted with the “permit application and the reclamation plan submitted as part of a permit application* * *.”

UCA 40-10-11 sets forth requirements the State must follow in approving permit applications. UCA 40-10-11(2)(b) prohibits Utah from approving a permit application unless the—

Sections 507(b)(9) and (b)(11) of SMCRA are the Federal counterparts to proposed UCA 40-10-10(b)(i) through (ii) and (c)(i) through (iii). Section 507(b) of SMCRA, which includes subsections (b)(9) and (b)(11), describes information that must be submitted in the “permit application” and does not refer to a reclamation plan. The provisions that follow in Section 508 of SMCRA, however, describe information to be included in reclamation plans that must be—

Our review of Utah's Code, as summarized above, shows that the proposed introductory phrases will not limit information required in permit applications. A reclamation plan remains a required part of the application for a permit to conduct surface coal mining and reclamation operations in Utah. An applicant for a permit to conduct surface coal mining and reclamation operations still must submit to the State an application demonstrating that the applicant can accomplish the reclamation requirements of Chapter 10 of Title 40 of the Utah Code Annotated. Though UCA 40-10-10 combines in one section the State's counterparts to Sections 507 and 508 of SMCRA and is worded somewhat differently, we interpret proposed UCA 40-10-10(2)(b) and (c) and their subordinate parts to require the same type of information in a permit application as is required in counterpart sections 507 and 508 of SMCRA. We therefore find that the proposed changes at UCA 40-10-10(2)(b) and (c) are not inconsistent with and are no less stringent than the provisions of SMCRA and can be approved.

Utah proposes to make a number of editorial changes at UCA 40-10-10(2)(d). Existing UCA 40-10-10(2)(d) describes information required in permit applications that describes results of test borings, core samplings, physical and chemical characteristics of the coal seam, overburden, and of the strata under the coal. It also authorizes DOGM to waive the requirement for this information if a written finding concludes it is unnecessary. Utah proposes to codify these provisions as new subsections (2)(d)(i) and (2)(d)(i)(A) through (F) and to codify the waiver provision as new subsection (2)(d)(ii). Most of the editorial changes are minor. However, a change Utah proposed in this amendment to the waiver provision would make it less stringent than SMCRA.

Existing (2)(d) allows DOGM to waive the requirements “* * * of this Subsection * * *” if it finds, in writing, that they are unnecessary. We interpret the existing waiver's reference to “this Subsection” to mean existing subsection (d), which is limited to the information described above and is consistent with the scope of the waiver in the counterpart Federal provision at Section 507(b)(15) of SMCRA.

As proposed at UCA 40-10-10(2)(d)(ii) in amendment UT-042-FOR, however, Utah would revise its provision by allowing DOGM to waive the application requirements of “* * * this Subsection (2) * * *” upon finding, in writing, that they are unnecessary. By specifically referring to “Subsection (2)” of UCA 40-10-10, the Division may waive much more information than is described under existing subsection (2)(d) or proposed subsections (2)(d)(i) and (2)(d)(i)(A) through (F). Entire subsection (2) describes required application information about ownership, maps and plans, hydrology and probable hydrologic consequences, as well as the test borings, core samplings, and the physical and chemical characteristics of the coal, the overburden, and the stratum underlying the coal. That includes considerably more information than may be waived under Section 507(b)(15) of SMCRA, which says the provisions of “this paragraph (15) may be waived” if the regulatory authority determines, in writing, that they are unnecessary. Referenced “paragraph (15)” of Section 507(b) of SMCRA is limited to descriptions of test borings and core samplings and the physical and chemical characteristics of the coal, the overburden, and the stratum underlying the coal.

For the reason described above, we found proposed subsection 40-10-10(2)(d)(ii) is less stringent than the counterpart Federal provision at Section 507(b)(15) of SMCRA. We notified Utah of our finding in a letter dated February 21, 2003 (Administrative Record number UT-1180). Utah responded in a letter dated August 31, 2007, by sending a new formal amendment to us (Administrative Record number UT-1196). The new amendment included proposed revisions to the Utah Code that addressed the concern we raised on our February 21, 2003, letter and other proposed changes. We decided to process that new formal amendment to the Utah Code as amendment UT-044-FOR and published it in the August 12, 2008 Federal Register (73 FR 46804). As a result, no further action is required, on the changes Utah proposed at UCA 40-10-10(2)(d) through (2)(d)(ii) in amendment UT-042-FOR.

Utah proposed to remove the existing provisions for small operator assistance at UCA 40-10-10(3), replace them with new provisions, and reorganize and codify the entire subsection as UCA 40-10-10(3)(a), (3)(a)(i) through (vi), (3)(b), and (3)(c). These are the statutory changes Utah must make before it may change its rules in response to items X.A.2, 3, and 4 of the June 19, 1997, letter we sent to the State under 30 CFR 732.17.

Proposed UCA 40-10-10(3)(a) is similar to counterpart Section 507(c)(1) and (c)(1)(A) through (F) of SMCRA in all ways but one. It establishes an upper limit on total annual coal production of 300,000 tons from all sources as the basic criterion for operators to meet to be eligible for small operator assistance. It also provides that the Division will pay for the cost of assistance upon an eligible operator's written request. Unlike SMCRA, however, it proposes to make DOGM's payment for assistance contingent on the availability of funds under SMCRA.

In the regulatory program Utah submitted to us in 1980 for review and Secretarial approval, the State conditioned its payment of costs for assistance to small operators “ * * * upon receipt of funding from the Office of Surface Mining” (Administrative Record numbers UT-1 and UT-2). We concluded that the contingency made Utah's Code inconsistent with, and less stringent than, SMCRA because it “lessens the requirement that all small operators be provided this service * * *” (45 FR 70481, 70484; October 24, 1980). As a result, we disapproved the proposed contingency in Utah's original program submittal and required the State to amend its Code to remove it as one condition of the Secretary's approval (46 FR 5899, 5900; January 21, 1981). Once Utah removed the proposed contingency, we removed that condition of program approval effective June 22, 1982 (47 FR 26827; 26828).

We implemented the “Procedures and Criteria for Approval or Disapproval of State Programs and Small Operator Assistance” in the January 18, 1983, final rule Federal Register (48 FR 2266). In the preamble to that final rule, we explained that “* * * States will have the option of requesting grant assistance for funds appropriated for the SOAP * * *” while noting that “* * * there are a variety of mechanisms through which the State may provide the required section 507(c) [of SMCRA] analyses and statements * * *” without being required to “* * * participate in the SOAP grants program.” We also said “[c]osts for providing SOAP services using alternative mechanisms would be eligible for funding under the State's * * * grant as outlined in 30 CFR Part 735 * * *.” Further, we noted that, “[u]nder § 795.11, as proposed, a State intending to administer a small operators assistance program under a grant from OSM could submit a grant application for funding of the program under the procedures of 30 CFR Part 735 * * *” (48 FR 2266; 2266 and 2267).

At the same time, we characterized 30 CFR Part 795 as an elective means of complying with the requirements of Section 507(c) of SMCRA ( Id. at 2267, 2268). In the discussion of 30 CFR 795.2, we explained that it—

Finally, in the preamble discussion of 30 CFR 795.9, we said—

The regulation at 30 CFR 795.9(a) referenced above provides for paying the costs of services described at sections 795.9(b)(1) through (6), which are the regulatory counterparts to Sections 507(c)(1)(A) through (F) of SMCRA. These SMCRA provisions, in turn, are the Federal counterparts to sections 40-10-10(3)(a)(i) through (vi) of Utah's Code as proposed in this amendment.

Proposed UCA 40-10-10(3)(a), (b), and (c) will provide Utah with an updated mechanism to provide assistance to eligible small operators. Under those proposed provisions, payment for services is contingent on the availability of funds under SMCRA consistent with our continuing position that we will not require DOGM “* * * to provide funds for the purpose of § 795.9(a) beyond those funds authorized by Section 401(b)(1) of the Act and appropriated by Congress * * *.”

Our review found that cross-references in proposed UCA 40-10-10(3)(a)(i), (ii), and (iii) are consistent with the counterpart cross-references in SMCRA.

Proposed UCA 40-10-10(3)(b) would require those activities described at (3)(a)(i) through (iv) to be performed by a qualified laboratory or other entity. It is worded consistent with the counterpart provision at Section 507(c)(1) of SMCRA.

Finally, proposed UCA 40-10-10(3)(c) requires an operator who received assistance under SOAP to reimburse DOGM if the Division finds that the operator's production exceeded 300,000 tons in the 12-month period immediately following issuance of that operator's mining permit. It is worded consistent with the counterpart provision at Section 507(h) of SMCRA.

For the reasons described above, we find that proposed UCA 40-10-10(3)(a), (3)(a)(i) through (iv), (3)(b), and (3)(c) are in accordance with and no less stringent than the counterpart provisions of SMCRA.

Existing UCA 40-10-10(5) requires mine permit applications to be filed with the county clerk for public inspection, or at some other public office approved by DOGM, in the county where mining is to occur. The requirement excludes information about the coal seam. Utah proposes to change this section to make minor editorial changes in wording and punctuation. It also proposes to remove the phrase “for public inspection” from the filing requirement.

Removing the phrase “for public inspection” appears to remove the provision's purpose. Absent the requirement to make an application available for public inspection, there is no other reason stated in this provision for requiring it to be filed with the county clerk or in another public office. The existing approved provision directs the applicant to file a copy of the application specifically so the public can inspect it at a public office in the county where mining is to occur.

We notified Utah of our concern in a letter dated February 21, 2003 (Administrative Record number UT-1180). Utah responded in a letter dated August 31, 2007, by sending a new formal amendment to us (Administrative Record number UT-1196). That amendment included proposed revisions to the Utah Code that addressed the concern we raised on our February 21, 2003, letter. We decided to process that new formal amendment to the Utah Code as amendment UT-044-FOR and published it in the August 12, 2008 Federal Register (73 FR 46804). As a result, no further action is required on the changes Utah proposed at UCA 40-10-10(5) in amendment UT-042-FOR.

We asked for public comments on the amendment (Administrative Record numbers UT-1173 and UT-1178) but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and Section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Utah program (Administrative Record number UT-1173).

The Salt Lake City, Utah, office of the U.S. Department of Agriculture, Natural Resources Conservation Service (NRCS), responded to our request in an e-mail message dated November 29, 2002 (Administrative Record number UT-1175). NRCS said it reviewed the formal amendment and had no comments on it.

Under 30 CFR 732.17(h)(11)(i) and (ii), we are required to get concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ).

None of the revisions that Utah proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. However, we requested comments from the EPA under 30 CFR 732.17(h)(11)(i) (Administrative Record number UT-1173). EPA responded in a telephone conversation on December 2, 2002, that it had no comments on the amendment (Administrative Record number UT-1176).

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On October 31, 2002, we requested comments on Utah's amendment (Administrative Record number UT-1173), but neither responded to our request.

Based on the above findings, we approve, with the following exceptions, Utah's October 22, 2002 amendment:

We defer a decision until we complete our review of amendment UT-044-FOR, as discussed in finding number III.B.3, on proposed changes to UCA 40-10-10(2)(d) through (2)(d)(ii), concerning information requirements for permit applications, including information about test borings, core samplings, and chemical and physical characteristics of the coal seam, overburden, and strata underlying the coal, and a provision for waiving the requirement for that information; and

We also defer a decision until we complete our review of amendment UT-044-FOR, as discussed in finding number III.B.5, on proposed changes to UCA 40-10-10(5), concerning the requirement to file a copy of a permit application for public inspection with the county clerk or an appropriate public office.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 944, which codify decisions concerning the Utah program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrates that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

Section 503 of SMCRA provides that a State may not exercise jurisdiction under SMCRA unless the Secretary approves the State's program. Similarly, 30 CFR 732.17(a) requires that any change of an approved State program be submitted to OSM for review as a program amendment. The Federal regulation at 30 CFR 732.17(g) prohibits any changes to approved State programs that are not approved by OSM. In our oversight of the Utah program, we will recognize only the statutes, regulations and other materials we have approved, together with any consistent implementing policies, directives and other materials. We will require Utah to enforce only approved provisions.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under Sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and Section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. The changes that are the subject of this rule are limited to aspects of the small operator assistance program and mine permit applications applicable to coal mining and reclamation on non-Indian lands within the jurisdiction of the State of Utah. The rule does not involve or affect Indian tribes in any way.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of Section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based on counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect on a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied on the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million;

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This determination is based on the fact that the State submittal, which is the subject of this rule, is based on counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or Indian tribal governments or the private sector of $100 million or more in any given year. This determination is based on the fact that the State submittal, which is the subject of this rule, is based on counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is needed to minimize potential danger to the public during the event. The necessary information regarding the change of date for this annual recurring marine event was not provided with sufficient time to publish an NPRM. The potential dangers posed by a high speed power boat race conducted on the waterway with other vessel traffic makes special local regulations necessary to provide for the safety of participants, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions. On scene Coast Guard and local law enforcement vessels will also provide actual notice to mariners.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support vessels, spectator craft and other vessels transiting the event area. However advance notifications will be made to users of Choptank River via marine information broadcasts, local notice to mariners, commercial radio stations and area newspapers.

Annually, the Chesapeake Bay Powerboat Association sponsors the “Cambridge Offshore Challenge”, on the waters of the Choptank River at Cambridge, Maryland. The event consists of approximately 100 offshore powerboats conducting high-speed competitive races between the Route 50 Bridge and Oystershell Point, MD. A fleet of spectator vessels is anticipated. The regulation at 33 CFR 100.501 is effective annually for the Cambridge Offshore Challenge marine event. The table to § 100.501, event No. 27 establishes the enforcement date for this marine event. This regulation proposes to temporarily change the enforcement date from “September—4th or last Saturday and Sunday” to the third Saturday and Sunday in September, holding the marine event on September 20 and 21, 2008. The Chesapeake Bay Powerboat Association who is the sponsor for this event intends to hold this event annually; however, they have changed the date of the event for 2008 so that it is outside the scope of the existing enforcement period. Due to the need for vessel control during the power boat races, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.

The Coast Guard will temporarily suspend the regulations at 33 CFR 100.501 by changing the date of enforcement in the table to § 100.501 to reflect the event will be conducted in 2008 on the third Saturday and Sunday in September, September 20 and 21, 2008. This change is needed to accommodate the sponsor's schedule. The special local regulations will be enforced from 11:30 a.m. to 5:30 p.m. on September 20 and 21, 2008, and will restrict general navigation in the regulated area during the marine event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the effective period. The regulated area is needed to control vessel traffic during the event to enhance the safety of participants and transiting vessels.

In addition to notice in the Federal Register , the maritime community will be provided extensive advance notification via the Local Notice to Mariners, and marine information broadcasts so mariners can adjust their plans accordingly.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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.

Although this rule prevents traffic from transiting a portion of the Choptank River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety deemed necessary. Vessel traffic will be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Choptank River during the event.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only a 6-hour period. Vessel traffic will be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 5100.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded under the Instruction that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. We have made a determination under the Instruction that this action is not likely to have a significant effect on the human environment.

Under figure 2-1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

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

• Crop production (NAICS code 111).

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

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

Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-1069 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 27, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-1069, by one of the following methods:

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

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

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

In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-7), 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 7E7235) by Interregional, Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.532 be amended by establishing tolerances for residues of the fungicide cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on the food commodities tomato at 0.40 parts per million (ppm); tomatillo at 0.40 ppm; tomato, paste at 1.0 ppm; avocado at 1.2 ppm; sapote, black at 1.2 ppm; canistel at 1.2 ppm; sapote, mamey at 1.2 ppm; mango at 1.2 ppm; papaya at 1.2 ppm; sapodilla at 1.2 ppm; star apple at 1.2 ppm; herbs subgroup19A, fresh at 25 ppm; herbs subgroup 19A, dried at 170 ppm; vegetable, root and tuber, group, leaves at 9.0 ppm; vegetable, root, except sugarbeet subgroup at 0.60 ppm; lemon at 0.6 ppm; lime at 0.6 ppm; kiwifruit at 1.8 ppm; onion, dry bulb at 0.50 ppm; onion, green at 1.2 ppm; strawberry at 7.0 ppm; and cucurbits at 0.40 ppm. That notice referenced a summary of the petition prepared by IR-4, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is revising some of the items as proposed in this Unit. The reason for these changes is explained in Unit IV.D.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for residues of cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine on tomato; tomatillo; tomato, paste; avocado; sapote, black; canistel; sapote, mamey; mango; papaya; sapodilla; star apple; parsley, leaves; parsley, dried leaves; vegetable, leaves of root and tuber, group 2; vegetable, root, except sugarbeet, subgroup 1B; lemon; lime; citrus, dried pulp; citrus, oil; kiwifruit; onion, bulb; onion, green; strawberries; vegetable, cucurbit, group 9; and meat byproducts of cattle, goats, horses and sheep. EPA's assessment of exposures and risks associated with establishing 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.

Cyprodinil has low acute toxicity via the oral, dermal, and inhalation routes. Cyprodinil is mildly irritating to the eyes and negligibly irritating to the skin. It is a dermal sensitizer. The major target organs of cyprodinil are the liver in both rats and mice and the kidney in rats. Liver effects were consistent among male and female rats and mice in both subchronic and chronic studies and typically included increased liver weights along with increases in serum clinical chemistry parameters associated with adverse effects on liver function (i.e., increased cholesterol and phospholipid levels). Microscopic lesions in rats and mice included hepatocyte hypertrophy and hepatocellular necrosis. In the kidneys, adverse effects were manifested as chronic tubular lesions and chronic kidney inflamation following subchronic exposure of male rats. Chronically, cyprodinil caused increased kidney weights and progressive nephropathy in male rats. Chronic effects in dogs were limited to decreased body-weight gain, decreased food consumption and decreased food efficiency. Liver toxicity was not seen in the dog. The hematopoietic system also appeared to be a target of cyprodinil, causing mild anemia in rats exposed subchronically. There was no evidence of carcinogenic potential in either the rat chronic toxicity/carcinogenicity or mouse carcinogenicity studies and no concern for mutagenicity. There was no evidence of increased susceptibility in the developmental rat or rabbit study following in utero exposure or in the 2-generation reproduction study following prenatal or postnatal exposure. No clinical signs of toxicity suggestive of neurobehavioral alterations nor evidence of neuropathological effects were observed in the available oral-toxicity studies. There was also no evidence of a neurodevelopmental effect in the rat or rabbit developmental toxicity studies or in the rat 2-generation reproductive-toxicity study.

Specific information on the studies received and the nature of the adverse effects caused by cyprodinil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Cyprodinil Human Health Risk Assessment for the uses in/on tomato, avocado, herbs, root vegetables, leaves of root and tuber vegetables, lemon, lime, cucurbits, kiwifruit, green and dry bulb onions, and strawberries , page 16 in docket ID number EPA-HQ-OPP-2007-1069.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which the LOAEL of concern are identified or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for cyprodinil used for human risk assessment can be found at http://www.regulations.gov in document Cyprodinil Human Health Risk Assessment for the uses in/on tomato, avocado, herbs, root vegetables, leaves of root and tuber vegetables, lemon, lime, cucurbits, kiwifruit, green and dry bulb onions, and strawberries , page 22 in docket ID number EPA-HQ-OPP-2007-1069.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to cyprodinil, EPA considered exposure under the petitioned-for tolerances as well as all existing cyprodinil tolerances in (40 CFR 180.532). EPA assessed dietary exposures from cyprodinil in food as follows:

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

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance-level residues, DEEM default processing factors and assumed 100 percent crop treated (PCT) for all existing and proposed commodities.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance level residues, DEEM default processing factors, and assumed 100 PCT for all existing and proposed commodities.

iii. Cancer An aggregate exposure assessment for the purpose of assessing cancer risk was not performed because cyprodinil has been classified as “not likely to be carcinogenic to humans.”

iv. Anticipated residue and PCT information . EPA did not use anticipated residue and/or PCT information in the dietary assessment for cyprodinil. Tolerance level residues and 100 PCT were assumed for all existing and proposed food commodities.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyprodinil in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyprodinil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

For surface water the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) Tier 2 aquatic models were used, and for ground water, the Tier 1 aquatic model Screening Concentration in Ground Water (SCI-GROW) was utilized. For the assessment, maximum application rates and minimum intervals between applications were used. The Agency has concluded that the transformation product CGA-249287 of cyprodinil is of potential concern for drinking water sources. Therefore, estimated drinking water concentrations (EDWCs) of CGA-249287 were also simulated using the PRZM/EXAMS and SCI-GROW models. For surface water, this degradate was modeled individually, as opposed to the use of the total residue approach due to the fact that only one degradate was modeled and sufficient information was available for the modeling.

Based on the Tier 2 PRZM/EXAMS and the Tier 1 SCI-GROW models, the EDWCs of cyprodinil and its transformation product CGA-249287 for acute exposures are estimated to be 34.56 parts per billion (ppb) for surface water and 0.108 ppb for ground water. For chronic exposures for non-cancer assessments the concentrations are estimated to be 20.05 ppb for surface water and 0.108 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 34.56 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 20.05 ppb was used to assess the contribution to drinking water.

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

Cyprodinil is not registered for any specific use patterns that would result in residential exposure.

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

EPA has not found cyprodinil to share a common mechanism of toxicity with any other substances, and cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyprodinil does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety (MOS) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different MOS will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity . There are no concerns or residual uncertainties for prenatal and/or postnatal exposure.

3. Conclusion . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for cyprodinil is complete.

ii. There is no indication that cyprodinil is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that cyprodinil results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to cyprodinil in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyprodinil.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyprodinil will occupy 4% of the aPAD for females 13-49 years old, the only population group of concern.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyprodinil from food and water will utilize 67% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for cyprodinil.

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

Cyprodinil is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to cyprodinil through food and water and will not be greater than the chronic aggregate risk.

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

Cyprodinil is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to cyprodinil through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5. Aggregate cancer risk for U.S. population . Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to assess the carcinogenic potential, cyprodinil was classified as “not likely to be carcinogenic to humans.” Therefore, cyprodinil is not expected to pose a cancer risk to humans.

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

Adequate enforcement methodology (high performance liquid chromatography with ultraviolet detector (HPLC/UV)) is available to enforce the tolerance expression on plant commodities. In addition, a high performance liquid chromatography with mass spectrometry (HPLC/MS) method (Method No. GRM010.01A) is available for determining residues of cyprodinil and its metabolite CGA-304075 (free+conjugated) in livestock commodities. These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no established or proposed Canadian or Mexican MRLs for cyprodinil on any of the plant commodities of interest in these petitions. There are Codex MRLs for tomato, bulb onion, cucurbit, and summer squash. Tomato has a proposed tolerance of 0.45 ppm and a Codex MRL of 0.5 ppm, therefore no change in the tolerance is necessary for harmonization purposes. The Codex MRLs for bulb onion at 0.3 ppm (vs 4.0 ppm for green onion and 0.60 ppm for dry bulb onion), cucurbit at 0.2 ppm (vs 0.70 ppm for cucurbit vegetables), and summer squash at 0.2 ppm (vs 1.0 ppm for head and stem Brassica, 5A) were established based on application levels from 0.21 to 0.26x the domestic rate. Harmonization of U.S. tolerances on these commodities is not possible at this time.

Codex MRLs have been established for livestock commodities, and these MRLs are set at the method LOQ. For both the Canadian and Codex MRLs, the regulated residues include cyprodinil per se. As the U.S. definition for cyprodinil residues in livestock commodities is different than those established for Canada and Codex, harmonization of U.S. tolerances on livestock commodities is not possible at this time.

EPA received one comment to the Notice of Filing that had a general objection to “this product being allowed on food.” The comment contained no scientific data or other substantive evidence to rebut this conclusion or the Agency's finding that there is a reasonable certainty that no harm will result from aggregate exposure to cyprodinil from the establishment of these tolerances. The Agency has received these same or similar comments from this commenter on numerous previous occasions. Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), and 69 FR 63096 (October 29, 2004) for the Agency's previous responses to these objections.

Based upon review of the data supporting the petitions, EPA determined that separate tolerances are needed for fresh parsley at 35 ppm; dried parsley at 170 ppm; citrus, dry pulp at 8.0 ppm; citrus, oil at 340 ppm; and meat byproducts of cattle, goats, horses and sheep at 0.02 ppm. EPA is establishing those tolerances in this action. In addition, EPA revised the tolerances for tomato from 0.40 ppm to 0.45 ppm; tomatillo from 0.40 ppm to 0.45 ppm; herb subgroup 19A fresh from 25 ppm to 3 ppm and re-naming herb subgroup 19A fresh, except parsley; herb subgroup 19A dried from 170 ppm to 15 ppm and re-naming herb subgroup 19A, dried, except parsley; leaves of root and tuber vegetables from 9.0 ppm to 10 ppm; root vegetables, except sugar beet subgroup from 0.60 ppm to 0.75 ppm; cucurbits from 0.40 to 0.70 ppm. EPA revised these tolerance levels based on analyses of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data.

Therefore, tolerances are established for residues of cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on the food commodities tomato at 0.45 ppm; tomatillo at 0.45 ppm; tomato, paste at 1.0 ppm; avocado at 1.2 ppm; sapote, black at 1.2 ppm; canistel at 1.2 ppm; sapote, mamey at 1.2 ppm; mango at 1.2 ppm; papaya at 1.2 ppm; sapodilla at 1.2 ppm; star apple at 1.2 ppm; parsley, leaves at 35 ppm; parsley, dried leaves at 170 ppm; vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, root, except sugarbeet, subgroup 1B at 0.75 ppm; lemon at 0.60 ppm; lime at 0.60 ppm; citrus, dried pulp at 8.0 ppm; citrus, oil at 340 ppm; kiwifruit at 1.8 ppm; onion, bulb at 0.60 ppm; onion, green at 4.0 ppm; strawberry at 5.0 ppm; vegetable, cucurbit, group 9 at 0.70 ppm; and meat byproducts of cattle, goats, horses and sheep at 0.02 ppm.

Also, the following entries in the table in paragraph (a)(1) are changed to read as follows: “herb subgroup 19A, fresh” is amended to “herb subgroup 19A, fresh, except parsley”; “herb subgroup 19A, dried” is amended to “herb subgroup 19 A, dried, except parsley”..

Further, the following entry is removed from the table in paragraph (a)(1): “Carrot” because of the establishment of the vegetable, root tolerance by this action.

And lastly, the following entries are removed from the table in paragraph (a)(2): “Onion, bulb” “onion, green”, and “strawberry” because permanent tolerances are being established by this action.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-1020 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 October 27, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-1020, by one of the following methods.

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

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

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

In the Federal Register of November 2, 2007 (72 FR 62237) (FRL-8153-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F7236) by Growth Products Ltd., P.O. Box 1259, White Plains, NY 10602. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus subtilis GB03. This notice included a summary of the petition prepared by the petitioner Growth Products Ltd. One comment was received in response to this notice expressing opposition to expanding the number of toxic poisons and expressing dissatisfaction with the level of safety EPA provides Americans. Pursuant to its authority under the FFDCA, EPA conducted a comprehensive assessment of Bacillus subtilis GB03, including a review of an acute oral toxicity/pathogenicity study in the rat, an acute dermal toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an acute intravenous toxicity/pathogenicity study in the rat and a primary eye irritation study in the rabbit. EPA review of these studies indicated that the active ingredient was not toxic to test animals when administered via the oral, dermal, intravenous or pulmonary routes of exposure. The active ingredient was not infective or pathogenic to test animals when administered via the oral, pulmonary and intravenous routes. No reports of hypersensitivity have been recorded from personnel working with this organism. Based on these data, the Agency has concluded that there is a reasonable certainty that no harm will result from dietary exposure to residues of Bacillus subtilis GB03 in or on food and feed. Thus, under the standard in FFDCA section 408(c)2, an exemption from the requirement for a tolerance is appropriate.

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

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

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

Toxicological data on the active ingredient has been previously accepted to support the current exemption from the requirement of a tolerance for residues (for seed treatment of agricultural commodities) and various registrations by the manufacturer Bayer CropScience (formerly Gustafson LLC). Studies on the active ingredient include the following:

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

Dietary exposure to the microbial pesticide is likely to occur. However the lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the microbe support the establishment of an exemption from the requirement of a tolerance for Bacillus subtilis GB03.

1. Food . Dietary exposure to the microbe is expected to be minimal. The risk posed to adults, infants and children is minimal because of the low acute oral toxicity/pathogenicity potential of the microbial pesticide. In addition, standard practices of washing, peeling, cooking or processing fruits and vegetables reduces residues of Bacillus subtilis GB03 and further minimizes dietary exposure.

2. Drinking water exposure . Exposure to humans from residues of Bacillus subtilis GB03 in consumed drinking water would be unlikely. The proposed and existing use sites of Bacillus subtilis do not include direct application to aquatic environments. Potential exposure to surface water would be negligible. The intended use of Bacillus subtilis GB03 is treatment of growing plants and crops for the purposes of disease control. The risk of the microorganism passing through the soil to ground water is minimal to unlikely. Additionally, the bacteria would not tolerate the conditions water is subjected to in a drinking water treatment facility (including: chlorination, pH adjustments, and/or filtration). If oral exposure should occur through drinking water, the Agency concludes that such exposure would present insignificant risk due to the lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the microbe.

The use sites for these products include residential garden sites, as well as agricultural sites. Bacillus subtilis is ubiquitous in the environment. Based on evaluations of the Tier I acute toxicity tests, the Agency believes that the potential aggregate non-occupational risk derived from dermal and inhalation exposure through the application of Bacillus subtilis GB03 is well below the currently tested microbial safety levels.

No mechanism of toxicity in mammals has been identified for Bacillus subtilis GB03. Therefore, no cumulative effect with other related organisms is anticipated. Because the available data demonstrate a low toxicity/pathogenicity potential of the active ingredient, adverse dietary effects are unlikely.

FFDCA section 408(b)(2)(C) as amended by the Food Quality Protection Act (FQPA) of 1996, provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children.

Based on the acute toxicity information discussed in Unit III, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to the United States population, including infants and children, to residues of Bacillus subtilis GB03. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because the data available on Bacillus subtilis GB03 demonstrate a low toxicity/pathogenicity potential. Bacillus subtilis is not a human pathogen and has not been implicated in human disease, but has been isolated as a rare contaminant from human infections. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the considerations of consumption patterns, special susceptibility, and cumulative effects do not apply to pesticides without a demonstrated significant adverse effect.

The Agency has no information to suggest that Bacillus subtilis GB03 has an effect on the endocrine system. No specific tests have been conducted with Bacillus subtilis GB03 to determine such effects. However, the submitted toxicity/pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. Bacillus subtilis GB03 is a ubiquitous organism in the environment and there have been no reports of the organism affecting endocrine systems. Therefore, it is unlikely that this organism would have estrogenic or endocrine effects and it is practically non-toxic to mammals.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation; therefore, the Agency has concluded that an analytical method is not required for enforcement purposes for Bacillus subtilis GB03.

No Codex maximum residue level exists for Bacillus subtilis GB03.

There is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of the Bacillus subtilis GB03 in or on all food and feed commodities. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as discussed above, no toxicity or pathogenicity to mammals has been observed in test animals.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

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

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

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

Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0987 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 27, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0987 by one of the following methods:

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

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

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

In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-7), 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 7E7256) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.480 be amended by establishing tolerances for combined residues of the fungicide fenbuconazole, alpha-[2-(4-chlorophenyl)- ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)- 1-propanenitrile, and its metabolites RH-9129, cis-5-(4-chlorophenyl)- dihydro-3-phenyl-3-(1H-1,2,4- triazole-1-ylmethyl)-2-3 H-furanone, and RH-9130, trans-5-(4- chlorophenyl)dihydro-3-phenyl-3- (1H-1,2,4-triazole-1-ylmethyl)-2-3 H- furanone, expressed as fenbuconazole in or on pepper at 0.40 parts per million (ppm). That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

In addition, §180.480(a)(1), is revised to remove reference to “time-limited tolerance” as this section is dedicated to, and only contains, permanent tolerances. Also, §180.480(a)(2) is deleted in its entirety as it relates solely to time-limited tolerances in paragraph (a)(1) and there are no such tolerances in paragraph (a)(1). In addition, the time-limited tolerance under §180.480(b) Section 18 emergency exemptions, for blueberry at 1.0 ppm that expired on 12/31/07 is deleted.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for combined residues of fenbuconazole on pepper at 0.40 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

EPA has evaluated the available toxicity data and considered their 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.

Fenbuconazole has low acute toxicity and is neither skin or eye irritants nor a dermal sensitizer. In subchronic and chronic feeding studies the liver was the main target of toxicity. At the LOAEL in the subchronic studies, there were changes in liver histopathology, predominantly hepatocellular hypertrophy. At doses higher than the LOAEL in the rat, the thyroid was a secondary target organ with increased follicular cell size. In the chronic studies, liver effects were seen (including hepatocellular hypertrophy and vacuolization, changes in liver enzymes, and increased liver weights), as well as decreased body weight gains. Again, in the chronic rat study, the thyroid was a secondary target with increased thyroid and parathyroid weights and thyroid follicular cell hypertrophy. In addition, increased mean T4 and decreased TSH were found in the high-dose rats near the end of the study. In the chronic dog study, kidney and adrenal weights were also increased. Males and females throughout the studies appeared to be equally sensitive to fenbuconazole toxicity, except in the chronic mouse study, where male mice appeared to be more sensitive than the females.

In the rat and rabbit developmental toxicity studies and the two generation study in rats, all effects in the pups occurred in the presence of maternal toxicity, including changes in body weight and body weight gains in rats and decreased food consumption and clinical signs in rabbits. Developmental effects included increased post-implantation loss and decreased fetuses per dam in the rat developmental study; increased early resorptions in the rabbit developmental study; and decreased mean pup body weight, increased number of stillborn pups, decreased number of total offspring delivered, and decreased viability index of pups in the two generation study in rats. No increased qualitative or quantitative susceptibility was observed in any of the studies. There was no evidence of neurotoxicity in any of the studies available in the toxicology database.

Fenbuconazole is not mutagenic. Fenbuconazole is classified as a Group C, possible human carcinogen, and febuconazole’s human cancer risk is assessed quantitatively by a low dose extrapolation model applied to the experimental animal tumor data.

Specific information on the studies received and the nature of the adverse effects caused by fenbuconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fenbuconazole (7E7256) - Human Health Risk Assessment for the Proposed Use on Peppers at page 14 in docket ID number EPA-HQ-OPP-2007-0987-0003.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for fenbuconazole used for human risk assessment can be found at http://www.regulations.gov in document Fenbuconazole (7E7256) - Human Health Risk Assessment for the Proposed Use on Peppers at page 25 in docket ID number EPA-HQ-OPP-2007-0987-0003.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to fenbuconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing fenbuconazole tolerances in (40 CFR 180.480). EPA assessed dietary exposures from fenbuconazole in food as follows:

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

In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, the acute dietary exposure analysis is based on tolerance-level residues and 100% crop treated assumptions. The only population subgroup that is relevant for this acute assessment is females of child-bearing age (i.e., females 13-49 years old).

ii. Chronic(non-cancer) exposure . In conducting the chronic dietary (food + water) exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, the chronic (non-cancer) dietary exposure analyses uses average residues from field trials. For many of the crops, separate studies were submitted and reviewed. For those crops, multiple averages were calculated and the highest average value was used in the analysis. The non-cancer dietary analysis assumes 100% crop treated.

iii. Cancer . The cancer exposure analysis uses average residues from field trials. In addition, estimates of average percent crop treated were used for certain commodities.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Anticipated residue data were used in the chronic (non-cancer) and cancer dietary risk analyses but not in the acute dietary risk analysis. For many crops, the anticipated residues used were the highest per-study-volume average residue value from the field trial studies for each crop that were submitted by the registrant.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In the cancer dietary exposure analysis, the Agency used the following estimated PCT information:

Apples 1%, apricots 10%, blueberries 40%, cherries 20%, grapefruit 40%, nectarines 10%, oranges 1%, peaches 15%, pecans 15%, prunes 1%, and tangerines 1%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in the preceding paragraphs have been met. With respect to Condition a, PCT estimates are derived from sources as discussed in the preceding paragraphs including Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fenbuconazole may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models to determine the drinking water concentrations that were used in the dietary exposure analysis and risk assessment for fenbuconazole. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenbuconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

The assessments included conservative estimated drinking water concentrations (EDWC) based on either the pepper or the cherry use. Modeled surface water EDWCs are based on the maximum label application rate to peppers (acute value) or cherries (chronic and cancer values) while the groundwater EDWC is based on the maximum label application rate to cherries. The acute assessment is highly conservative with respect to evaluating potential impacts of dietary exposure to fenbuconazole on human health. The chronic (non-cancer) and cancer assessments are moderately conservative with respect to evaluating potential impacts of dietary exposure to fenbuconazole on human health.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fenbuconazole for acute exposures are estimated to be 24.1 parts per billion (ppb) for surface water and 0.031 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are estimated to be 16.5 ppb for surface water and 0.031 ppb for ground water. The EDWCs for chronic exposures for cancer assessments are estimated to be 11.7 ppb for surface water and 0.031 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). Fenbuconazole is not registered for any specific use patterns that would result in residential exposure.

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

Fenbuconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism of toxicity, refer to EPA’s website at http://www.epa.gov/ pesticides/cumulative .

Fenbuconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including fenbuconazole, U.S. EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov , docket ID number EPA-HQ-OPP-2005-0497. Additional information regarding the use proposed for fenbuconazole in this action can also be found at http://www.regulations.gov in document: “Dietary Exposure Assessments for the Common Triazole Metabolites 1,2,4-Triazole, Triazolylalanine, Triazolylacetic Acid, and Triazolylypyruvic Acid; Updated to Include New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole; and a Change in Plant-back Restriction for Tetraconazole” in docket ID number EPA-HQ-OPP-2007-0987-0006.

1. In general . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity . Available data provided no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to fenbuconazole. In the prenatal developmental study in rats and rabbits and the 2-generation study in rats, effects in the offspring were observed only at or above those treatment levels which resulted in maternal toxicity.

The degree of concern for infants and children exposed to fenbuconazole in utero and/or postnatally is low; there are no residual uncertainties. The toxicology database for fenbuconazole is complete and adequate for risk assessment purposes. Acceptable developmental studies in rats and rabbits and the 2-generation reproduction study in rats did not show evidence of increased susceptibility in offspring exposed to fenbuconazole in utero and/or postnatally. A NOAEL for acute effects has been selected for the subpopulation females (13-49 years old) based on developmental effects (increased resorptions and decreased live fetuses per dam) seen at the LOAEL in the developmental rat study. By regulating on the effects of concern for this subpopulation, the risk assessment is protective of potential effects to infants and children.

3. Conclusion . There is a complete toxicity data base for fenbuconazole and exposure data are complete or are estimated based on data that reasonably account for potential exposures. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for fenbuconazole is complete.

ii. There is no indication that fenbuconazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that fenbuconazole results in increased susceptibility in utero to rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study

iv. There are no residual uncertainties identified in the exposure databases. Although somewhat refined, the dietary food exposure assessments were based on reliable data that will not underestimate exposure to fenbuconazole residues in food. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenbuconazole in drinking water. These assessments will not underestimate the exposure and risks posed by fenbuconazole.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenbuconazole will occupy 3.1 % of the aPAD for females 13-49 years old, the only subgroup of concern because of the toxicological properties of fenbuconazole.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenbuconazole from food and water will utilize 6.8% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure, and 2.3% of the cPAD for the general U.S. population. There are no residential uses for fenbuconazole that result in chronic exposure. EPA does not expect aggregate exposure to exceed 100% of the cPAD for any population subgroup.

3. Short- and intermediate-term risks . Short- and intermediate-term aggregate exposures take into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fenbuconazole is not registered for any use patterns that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from exposure to fenbuconazole through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population . Dietary exposure (food + water) is the only source of exposure to fenbuconazole that is expected to be chronic (cancer exposure is considered to be life-time exposure). The chronic (cancer) aggregate exposure and risk estimates are based on those for the general U.S. population group. In this case the risk is based on a cancer potency (Q 1 *) value of 3.59 × 10 − 3 and a dietary exposure to fenbuconazole of 0.000473 mg/kg/day. The estimated cancer risk that resulted from this assessment is 1.7 × 10 − 6 . Typically, EPA is concerned when the cancer risk estimate associated with food and drinking water exceeds the range of 1 in 1 million (1 × 10 − 6 ) . This risk range includes computed risks as high as 3 × 10 − 6 . As a result, cancer risk to the general U.S. population is below the Agency’s level of concern.

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

Adequate enforcement methodology (gas chromatography with nitrogen-phosphorus detection) 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 .

Maximum Residue Levels (MRLs) for residues of fenbuconazole have been established by Codex, Canada, and Mexico. The residue definition for both Codex and Mexico is fenbuconazole, per se . The Canadian residue definition, however, is the combined residues of fenbuconazole and its metabolites, RH-9129 and RH-9130, each expressed as parent (i.e., the same as the U.S. tolerance definition). There are no established or proposed Canadian, Mexican, or Codex MRLs for fenbuconazole on pepper.

By this action, §180.480(a)(1), is revised to remove reference to “time-limited tolerance” as this section is dedicated to, and only contains, permanent tolerances. Also, §180.480(a)(2) is deleted in its entirety as it relates solely to time-limited tolerances in paragraph (a)(1) and there are no such tolerances in paragraph (a)(1). In addition, the time-limited tolerance under §180.480(b), section 18 emergency exemptions, for blueberry at 1.0 ppm that expired on 12/31/07 is deleted.

Therefore, tolerances are established for combined residues of the fungicide fenbuconazole, alpha-[2-(4-chlorophenyl)- ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)- 1-propanenitrile, and its metabolites RH-9129, cis-5-(4-chlorophenyl)- dihydro-3-phenyl-3-(1H-1,2,4- triazole-1-ylmethyl)-2-3 H-furanone, and RH-9130, trans-5-(4- chlorophenyl)dihydro-3-phenyl-3- (1H-1,2,4-triazole-1-ylmethyl)-2-3 H- furanone, expressed as fenbuconazole in or on pepper at 0.40 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

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

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

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

Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0604 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 27, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0604, by one of the following methods:

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

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

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

In the Federal Register of August 22, 2007 (72 FR 47010) (FRL-8142-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7230) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 180.231 be amended by establishing tolerances for combined residues of the herbicide dichlobenil, 2,6-dichlorobenzonitrile, and its metabolite, 2,6- dichlorobenzamide, in or on rhubarb at 0.15 parts per million (ppm); caneberry, subgroup 13a and wild raspberry at 0.1 ppm; and bushberry, subgroup 13b; aronia berry; bluberry, lowbush; buffalo currant; chilian guava; european barberry; highbush cranberry; honeysuckle; jostaberry; juneberry; lingonberry; native currant; salal; and sea buckthorn at 0.15 ppm. That notice referenced a summary of the petition prepared by Chemtura USA Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and recent changes in EPA’s crop grouping regulations, EPA has revised the tolerance level for rhubarb and the commodity terms for the berry tolerances. The reasons for these changes are explained in Unit IV.C.

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....”

2,6-Dichlorobenzamide (BAM) is a common metabolite and soil degradate of dichlobenil and the fungicide fluopicolide. BAM is the major residue detected in plants following dichlobenil use and is, therefore, a residue of concern. For this reason, aggregate exposure and risk associated with BAM were assessed separately from dichlobenil. In assessing aggregate exposure and risk for BAM, EPA considered exposures associated with both dichlobenil and fluopicolide uses.

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for combined residues of dichlobenil and its metabolite, 2,6-dichlorobenzamide (BAM) on bushberry subgroup 13-07B, caneberry subgroup 13-07A and rhubarb at 0.15 ppm, 0.10 ppm and 0.06 ppm, respectively. EPA's assessment of exposures and risks associated with establishing 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.

In acute toxicity tests, dichlobenil demonstrated moderate acute toxicity via the oral, dermal and inhalation routes. It is neither a dermal irritant, eye irritant, nor a dermal sensitizer. In the subchronic and chronic oral toxicity studies in hamsters, rats and dogs, the liver was the primary target organ. For example, in a 90-day oral toxicity study in rats, inflammation and necrosis were observed in the liver of males, and increased liver weight and liver histopathology (swelling and vacuolation of hepatocytes) were observed in females. In a 90-day oral toxicity study in hamsters, increased liver weight, enlarged liver (with rough surface) and swollen hepatocytes were observed in females. In addition, decreased weight of the prostate and mineralization of the prostate were reported in males. Increased liver weights and hepatic enzymes, as well as liver histopathology, were observed at lower doses in two chronic dog toxicity studies, as well as in the combined chronic toxicity/carcinogenicity study in the rat.

In addition to the liver, the nose is considered a target organ for dichlobenil. Olfactory toxicity was observed following dermal and inhalation exposures in toxicity studies that were either published in the open literature (dermal) or submitted to the Agency (inhalation). In each study, degeneration of the olfactory epithelium, which is composed of olfactory sensory neurons, was observed. Olfactory toxicity was not observed in the chronic oral (capsule) toxicity study in the dog. No other evidence of neurotoxicity was seen in the toxicity studies for dichlobenil.

EPA classified dichlobenil as a Group C (possible human) carcinogen based on the results of carcinogenicity studies in hamsters and rats and its structural similarity to bromoxynil and thiobenzamide, which are associated with hepatocellular tumors in rodents. In a high-dose hamster study, there was a treatment-related increase in liver adenomas and combined adenomas/carcinomas in males at the highest dose tested; however, this dose was considered excessive, based on decreased body weight gains and severe hepatotoxicity. In a second hamster study, performed at lower, but adequate doses, there was no treatment-related increase in the incidence of any tumor type. In the rat study, there was a treatment-related increase in the incidence of hepatocellular tumors in females only. Based on the weight of the evidence, EPA classified dichlobenil as a possible human carcinogen but determined that the chronic dietary risk assessment based on the cPAD would be protective of any potential cancer effects for the following reasons: The liver tumors seen in male hamsters occurred only at an excessively high dose. The increases in liver tumors in the rat were statistically significant in only one sex (females), while tumors were predominantly benign adenomas and supporting evidence was weak at best. Although the tumor type (hepatocellular) is considered unusual for the strain of rat tested, tumors did not occur to an unusal degree or with an early onset. Further, dichlobenil was determined to be non-mutagenic in bacteria and mammalian cells, as well as non-clastogenic in several mammalian assays ( in vitro and in vivo ).

In the rat prenatal developmental toxicity study, maternal effects (decreased body weight gain, food consumption and food efficiency) were seen at the mid- and high doses, whereas no prenatal developmental effects occurred at any dose. In the rabbit developmental toxicity study, prenatal effects (an increase in total resorptions/dam, post-implantation loss, as well as external, visceral, and skeletal anomalies) occurred in the presence of maternal toxicity (severe decreases in body weight gain (120%) and food consumption (30%)). In the rat reproduction study, effects in the pups (decreased body weight during weaning in both F1 (16-23%) and F2 (19-22%) generation pups) occurred at a lower dose than that which resulted in parental toxicity (decreases in premating and gestation body weight gain and premating food consumption in both parental and F1 generation adults), indicating increased quantitative susceptibility of the pups.

Delayed maturity of the uterus was observed in all high-dose females tested in the chronic oral (capsule) toxicity study in the dog. A marked decrease in mean uterine weight at the high dose confirmed this finding. Ovarian weights were also decreased in high-dose females, but no alterations were observed microscopically. These results are suggestive of modulation of the female endocrine system in this study; however, the dose utilized in the dichlobenil risk assessment for the chronic RfD is almost forty times lower than that at which the effects were observed and is considered protective of any potential endocrine modulation.

BAM demonstrated moderate acute toxicity via the oral route of exposure. In subchronic and chronic toxicity studies, the primary oral effects seen in the rat and dog were body weight changes. Adverse liver effects were also observed but at doses of BAM that were higher than those of dichlobenil. There is no evidence that BAM is either mutagenic or clastogenic; nor is there evidence of endocrine mediated toxicity. BAM is considered to be neurotoxic, based on clinical signs of neurotoxicity following oral exposure in several short-term assays, in addition to toxicity to the olfactory sensory neurons observed following single intraperitoneal exposures of mice to BAM. In the absence of carcinogenicity study data for a second species (a rat study is available), the EPA has assumed that BAM’s carcinogenic potential is similar to that of dichlobenil, the parent compound having the greatest carcinogenicity potential. Dichlobenil is classified as a ‘‘group C, possible human carcinogen.’’ Quantification of cancer risk is based on the cPAD approach which requires comparison of the chronic exposure to the cPAD. Using this methodology will adequately account for all chronic toxic effects, including carcinogenicity, likely to result from exposure to dichlobenil and, therefore, to BAM.

Specific information on the studies received and the nature of the adverse effects caused by dichlobenil and BAM, as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies, can be found at http://www.regulations.gov in the documents Dichlobenil; Human Health Risk Assessment for Proposed Uses on Rhubarb; Caneberry, Subgroup 13-07A; and Bushberry, Subgroup 13-07B , page 37 and 2,6-Dichlorobenzamide (BAM ); 2,6-Dichlorobenzamide (BAM ) as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries (Subgroup 13-07A), and Bushberries (Subgroup 13-07B , page 17 in docket ID number EPA-HQ-OPP-2007-0604.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for dichlobenil and BAM used for human risk assessment can be found at http://www.regulations.gov in the documents Dichlobenil; Human Health Risk Assessment for Proposed Uses on Rhubarb; Caneberry, Subgroup 13-07A; and Bushberry, Subgroup 13-07B , page 19 and 2,6-Dichlorobenzamide (BAM ); 2,6-Dichlorobenzamide (BAM ) as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries (Subgroup 13-07A), and Bushberries (Subgroup 13-07B , page 5 in docket ID number EPA-HQ-OPP-2007-0604.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to dichlobenil, EPA considered exposure under the petitioned-for tolerances as well as all existing dichlobenil tolerances in 40 CFR 180.231. In evaluating dietary exposure to BAM, EPA considered exposure resulting from all proposed and registered uses of dichlobenil and fluopicolide. EPA assessed dietary exposures from dichlobenil and BAM in food as follows:

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

a. Dichlobenil . An effect of concern attributable to a single exposure was not identified for the general population, including infants and children; however, such effects (an increase in total resorptions/dam, post-implantation loss, as well as external, visceral, and skeletal anomalies) were identified for the population subgroup females, 13 to 49 years old. In estimating acute dietary exposure of females, 13 to 49 years old, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that 100 percent of all crops with established or pending tolerances are treated with dichlobenil and contain tolerance-level residues.

b. BAM . EPA identified an effect of concern attributable to a single exposure for the general population (lethargy after a single dose in a dose range finding assay for an in vivo mouse erythrocyte micronucleus assay) and for females 13 to 49 years old (increased incidences of late abortion and skeletal and visceral anomalies in a rabbit developmental toxicity study). In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used maximum residues of BAM from fluopicolide and dichlobenil field trials on food commodities with established/pending tolerances. The assessments assumed 100 percent crop treated (PCT) for all commodities except apples, blueberries, cherries, peaches, pears and raspberries.

ii. Chronic exposure . a. Dichlobenil . In conducting the chronic dietary exposure assessment, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that 100 percent of all crops with established or pending tolerances are treated with dichlobenil and contain tolerance-level residues.

b. BAM . In conducting the chronic dietary exposure assessment, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used maximum residues of BAM from fluopicolide and dichlobenil field trials on food commodities with established/pending tolerances. The assessments assumed 100 PCT for all commodities except apples, blueberries, cherries, cranberries, peaches, pears and raspberries.

iii. Cancer . EPA classified dichlobenil as a Group C, possible human, carcinogen but determined that the chronic dietary risk assessment based on the cPAD would be protective of any potential cancer effects. The weight of the evidence supporting this determination is discussed in unit III.A. (Toxicological Profile). EPA has assumed that BAM’s carcinogenic potential is similar to that of dichlobenil, the parent compound having the greatest carcinogenicity potential. As with dichlobenil, the chronic dietary risk assessment based on the cPAD is expected to protect for any potential cancer effects. Separate cancer exposure assessments are not needed for dichlobenil or BAM.

iv. Anticipated residue and PCT information . EPA did not use anticipated residues in the dietary risk assessments for dichlobenil but did use anticipated residues (maximum field trial residues) for BAM. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

The Agency used PCT information as follows:

The Agency did not use PCT information in the dichlobenil dietary risk assessments. For the BAM acute assessment, maximum PCT estimates were used for the following commodities: Apples, blueberries, cherries, peaches and pears, each at 2.5%; and raspberries at 5%. For the BAM chronic assessment, average PCT estimates were used for the following commodities: Apples, blueberries, cherries, peaches and pears, each at 1%; raspberries at 5%; and cranberries at 45%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which dichlobenil may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessments for dichlobenil and BAM in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of dichlobenil and BAM. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of dichlobenil for acute exposures are estimated to be 298 parts per billion (ppb) for surface water and 0.93 ppb for ground water. The estimated drinking water concentrations (EDWCs) of dichlobenil for chronic exposures for non-cancer assessments are estimated to be 4.6 ppb for surface water and 0.93 ppb for ground water.

Based on the Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of BAM for acute exposures are estimated to be 21 parts ppb for surface water and 56.2 ppb for ground water. The estimated drinking water concentrations (EDWCs) of BAM for chronic exposures for non-cancer assessments are estimated to be 8.6 ppb for surface water and 56.2 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment for dichlobenil, the water concentration value of 298 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment for dichlobenil, the water concentration value of 4.6 ppb was used to assess the contribution to drinking water. For acute and chronic dietary risk assessment for BAM, the water concentration value of 56.2 ppb was used to assess the contribution to drinking water.

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

There are several dichlobenil products that may be used around roses and other woody ornamentals in established residential plantings. Since they are approved for professional applicator use only, residential handler exposures are not expected. Post-application exposure of adults and children to dichlobenil and BAM from the use of dichlobenil products on ornamental plantings is expected to be negligible and, therefore, was not assessed.

Fluopicolide is currently registered for the following uses that could result in residential exposure to the metabolite/degradate BAM: Residential turfgrass and recreational sites. EPA assessed residential exposure to BAM using the following assumptions: Residential handler exposure was not evaluated for turf uses, because the metabolite BAM is believed to form slowly in plants and soil after the product containing parent fluopicolide has been applied. Residential post-application exposure via the dermal route is likely for adults and children entering treated lawns; however, post-application exposure via the inhalation route is expected to be negligible. Toddlers may also be exposed via incidental ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during post-application activities on treated turf. Post-application exposures are expected to be of short and intermediate duration.

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 dichlobenil (parent) or its metabolite BAM and any other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that dichlobenil (parent) or its metabolite BAM has a common mechanism of toxicity with other substances. EPA has aggregated BAM exposure from both use of dichlobenil and fluopicolide. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity . The pre- and postnatal toxicology database for dichlobenil includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was no evidence of increased qualitative or quantitative susceptibility of in utero rats or rabbits in the developmental toxicity studies for dichlobenil. In the rat reproduction study, effects in the pups (decreased body weight during weaning) occurred at a lower dose than that which resulted in parental toxicity (decreases in premating and gestation body weight gain and premating food consumption), indicating increased quantitative susceptibility of the pups. However, the degree of concern for the body weight changes in pups is low. There are clear NOAELs for effects in both the pups and parental animals; and EPA is using the pup NOAEL, which is 6-fold lower than the dose at which decreased pup body weight was observed, to assess incidental oral exposure of children.

There was no evidence of increased prenatal susceptibility in the rabbit developmental toxicity study for BAM. In this study, an increase in the incidences of late abortion, as well as visceral and skeletal anomalies, was observed at the high dose. However, severe maternal toxicity (severely decreased body weight gain and food consumption and late abortion) was also observed at the same dose.

3. Conclusion - i. Dichlobenil . EPA has determined that the 10X FQPA SF must be retained for all prechronic (i.e., acute and subchronic) oral exposure scenarios. EPA has also determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for all other (i.e., chronic, dermal or inhalation) exposure scenarios. These decisions are based on the following findings:

a. The dichlobenil database is incomplete to the extent that the existing data have not assayed the potential for dichlobenil to induce olfactory toxicity following short-term (prechronic) oral exposure. Olfactory toxicity has been assayed and demonstrated after dermal, inhalation and intraperitoneal exposure of rodents to dichlobenil. No oral studies, to date, have reported olfactory toxicity for dichlobenil; however, olfactory toxicity was assayed in only one study - a chronic dog study - submitted to the Agency. In the chronic dietary dog study, no effects on the nasal epithelium from long term exposure were observed. Due to the uncertainty regarding the potential for dichlobenil to induce olfactory toxicity following oral exposure of prechronic duration, EPA has retained the 10X FQPA SF. For chronic exposures and prechronic dermal and inhalation exposure scenarios, the 10X SF is not needed to account for database uncertainty. Olfactory toxicity was not observed in the chronic oral dog study, and the doses selected for dermal and inhalation exposure risk assessments are based on a very sensitive and conservative endpoint (olfactory histopathology - epithelial damage). This is a conservative endpoint because it is unknown whether this olfactory histopathology would have an adverse effect on the function of the sense of smell.

b. Apart from the degenerative effects of dichlobenil on olfactory sensory neurons, there are no other indications of neurotoxicity in any of the studies available for dichlobenil. The 10X FQPA SF being retained for prechronic oral exposure scenarios is adequate to account for olfactory neurotoxicity. For dermal and inhalation exposure scenarios, EPA is using a very sensitive endpoint that should be protective of all populations, including infants and children.

c. There is no evidence that dichlobenil results in increased susceptibility in in utero rats or rabbits in the prenatal developmental toxicity studies. Although there is evidence of quantitative susceptibility in the 2-generation reproduction study in rats, the degree of concern is low, and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of dichlobenil.

d. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed assuming 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to dichlobenil in drinking water. Residential exposure of infants and children to dichlobenil is expected to be negligible. These assessments will not underestimate the exposure and risks posed by dichlobenil.

ii. BAM: EPA has retained the 10X FQPA SF for BAM for those exposure scenarios that do not rely on dichlobenil toxicity data. These scenarios are acute dietary for the general population (including infants and children) and females 13-49 years of age; chronic dietary; and incidental oral non-dietary. Although EPA has developmental, reproduction, and subchronic and chronic toxicity studies for the metabolite BAM, and a structure activity analysis indicates EPA has identified its principal toxicological effects and level of toxicity, EPA is retaining the FQPA 10X SF due to remaining questions regarding the systemic neurotoxic potential of BAM, including olfactory toxicity via the oral route of exposure and the use of a LOAEL in assessing acute dietary risk for the general population. For the dermal and inhalation routes of exposures, for which the Agency is relying on dichlobenil toxicity data, EPA has reduced the FQPA SF for BAM toxicity to 1X, based on a comparison of toxicity via the intraperitoneal route of exposure showing that higher doses of BAM are needed to induce levels of olfactory toxicity that are similar to those caused by dichlobenil. Olfactory toxicity, the most sensitive endpoint, was the endpoint chosen for these exposure scenarios. Other factors EPA considered in the FQPA SF decisions for BAM include the following:

a. To compensate for deficiencies in the toxicology database for BAM, EPA performed a comparative analysis of the toxicity of BAM and the parent compounds, dichlobenil and fluopicolide, using the available animal data and DEREK analysis. DEREK is a toxicology application that uses structure-activity relationships to predict a broad range of toxicological properties based on a comprehensive analysis of a compound’s molecular structure. Based on the available animal data and Derek analyses, BAM does not appear to cause different organ specific toxicities compared to fluopicolide and dichlobenil. The kidney and liver toxicities are common to all three compounds. With respect to relative toxicity, conclusions from the evaluation of the animal studies appear to confirm that both fluopicolide and dichlobenil appear to be more or equally toxic compared to BAM. A full discussion of EPA’s comparative toxicity analysis of BAM, dichlobenil and fluopicolide can be found at http://www.regulations.gov in the document Comparative Toxicity using Derek analysis for Dichlobenil, Fluopicolide and BAM in docket ID number EPA-HQ-OPP-2007-0604. Based on the results of the available animal data and the DEREK analysis, EPA concludes that the safety factors discussed in the previous paragraph are adequate.

b. There is no evidence that BAM results in increased susceptibility of in utero rabbits in the prenatal developmental toxicity study.

c. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were refined using reliable PCT information and anticipated residue values calculated from residue field trial results. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to BAM in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by BAM.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk . An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to dichlobenil will occupy 33% of the aPAD for females, 13 to 49 years old, the only subpopulation at risk from acute exposure to dichlobenil.

EPA performed two different acute risk assessments for BAM - one focusing on females 13 to 49 years old and designed to protect against prenatal effects and the other focusing on acute effects relevant to all other population groups. The more sensitive acute endpoint was seen as to prenatal effects rather than other acute effects. For females 13 to 49 years old, the acute dietary exposure from food and water will occupy 28% of the aPAD addressing prenatal effects. As to acute effects other than prenatal effects, the acute dietary exposure from food and water to BAM will occupy 28% of the aPAD for infants less than 1 year old, the population subgroup with the highest estimated acute dietary exposure to BAM.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to dichlobenil from food and water will utilize 30% of the cPAD for children, 1 to 2 years old, the population group receiving the greatest dichlobenil exposure. Chronic exposure to BAM from food and water will utilize 93% of the cPAD for infants, less than 1 year old, the population group receiving the greatest BAM exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of dichlobenil or BAM is not expected.

3. Short-/intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account short- or intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Although dichlobenil is registered for use on ornamentals in residential areas, residential handler exposures are not expected and post-application exposures of adults and children are expected to be negligible. Therefore, the short-term aggregate risk is the sum of the risk from exposure to dichlobenil through food and water and will not be greater than the chronic aggregate risk.

Fluopicolide is currently registered for uses that could result in short- and intermediate-term residential exposure to its metabolite, BAM, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term oral residential exposures to BAM. It is not appropriate to aggregate dietary (i.e., oral) exposures and dermal exposures because the toxic effects identified for the oral and dermal exposure pathways differ. Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of 3,200 for infants and 5,400 for children, 1 to 2 years old. The aggregate MOEs for infants and children include food and drinking water exposures to BAM from all existing and new uses of dichlobenil and fluopicolide, as well as post-application incidental oral exposures from activities on lawns treated with fluopicolide. MOEs for dermal exposures on treated lawns are 10,000 for adults and 6,000 for infants/children. As noted above, it is not appropriate to aggregate chronic exposure from food and water with oral exposures. Post-application inhalation exposure of adults and children is expected to be negligible.

4. Aggregate cancer risk for U.S. population . The Agency has determined that quantification of human cancer risk is not necessary for dichlobenil or BAM and that the chronic risk assessments based on the established cPADs are protective of potential cancer effects. Based on the results of the chronic risk assessments discussed in Unit III.E.2, EPA concludes that dichlobenil and BAM are not expected to pose a cancer risk.

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

Adequate enforcement methodology (Pesticide Analytical Manual (PAM) Vol. II, Method A, a gas-liquid chromatography/electroconductivity detector (GLC/ECD) method) is available to enforce the tolerance expression. In addition, dichlobenil is completely recovered using the multiresidue methods in PAM Vol. I Sections 302 and 304. BAM is completely recovered using Section 302.

No CODEX, Canadian or Mexican maximum residue limits (MRLs) have been established for dichlobenil.

Based upon review of the data supporting the petition and recent changes in EPA’s crop grouping regulations, EPA has revised the tolerance level for rhubarb and the commodity terms for the berry tolerances. The tolerance for rhubarb was reduced from 0.15 ppm to 0.06 ppm, the lower limit of method validation (LLMV), based on the absence of detectable residues in the field trials.

IR-4 petitioned for individual tolerances on caneberry, subgroup 13a and wild raspberry; bushberry, subgroup 13b; aronia berry; bluberry, lowbush; buffalo currant; chilian guava; european barberry; highbush cranberry; honeysuckle; jostaberry; juneberry; lingonberry; native currant; salal; and sea buckthorn. In the Federal Register of December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a final rule that revised the crop grouping regulations. As part of this action, EPA expanded and revised berries group 13. Changes to crop group 13 (berries) included adding new commodities, revising existing subgroups and creating new subgroups (including Caneberry subgroup 13-07A and Bushberry subgroup 13-07B, which include the berry commodities requested in IR-4’s petition and cultivars, varieties, and/or hybrids of these).

EPA indicated in the December 7, 2007 final rule as well as the earlier May 23, 2007 proposed rule (72 FR 28920 (FRL-8126-1) that, for existing petitions for which a Notice of Filing had been published, the Agency would attempt to conform these petitions to the rule. Therefore, consistent with this rule, EPA is establishing tolerances on Caneberry subgroup 13-07A and Bushberry subgroup 13-07B. All of the berry commodities for which IR-4 requested tolerances are included in these revised subgroups.

EPA concludes it is reasonable to revise the petitioned-for tolerances so that they agree with the recent crop grouping revisions because:

1. Although the new crop groups/subgroups include several new commodities, the added commodities are closely related minor crops which contribute little to overall dietary or aggregate exposure and risk; and dichlobenil/BAM exposure from these added commodities was considered when EPA conducted the dietary and aggregate risk assessments supporting this action; and

2. The representative commodities for the revised crop group/subgroups have not changed.

Therefore, tolerances are established for combined residues of dichlobenil, 2,6-dichlorobenzonitrile, and its metabolite, 2,6-dichlorobenzamide, in or on bushberry subgroup 13-07B at 0.15 ppm; caneberry subgroup 13-07A at 0.10 ppm; and rhubarb at 0.06 ppm. The existing tolerances on individual members of bushberry subgroup 13-07B (blueberry) and caneberry subgroup 13-07A (blackberry and raspberry) that are superseded by the new crop subgroup tolerances at the same tolerance levels are being removed.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

This is a correction to a summary of the Commission's Report and Order in WT Docket No. 02-353, FCC 03-251, adopted on October 16, 2003 and released on November 25, 2003. The Report and Order adopted licensing, technical, and competitive bidding rules to govern the use of the spectrum at 1710-1755 MHz and 2110-2155 MHz, which had previously been allocated for advanced wireless services, in a manner that would enable service providers to put this spectrum to use for any purpose consistent with its allocation.

As published, the final rules contain an error in § 27.1134 in Table 1. The Commission inadvertently omitted the abbreviation for the word kilometers (km) after the category heading `Radius of Operation' in Table 1: Protected Department of Defense Facilities. This correction restores the information that was inadvertently omitted.

This document announces that, on August 21, 2008, OMB approved, for a period of three years, the information collection requirements contained in the Commission's Second Report and Order concerning Carriage of Digital Television Broadcast Signals , FCC 08-86, published at 73 FR 24502, May 5, 2008. The OMB Control Number that is assigned to these information collection requirements is 3060-0980. The Commission publishes this notice as announcement of the effective date of the rules and announcement of OMB approval for information collections. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0980, in your correspondence. The Commission will also accept your comments via the Internet if you send them to PRA@fcc.gov .

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on August 21, 2008, for the information collection requirements contained in the Commission's rules at 47 CFR 76.66(b)(1), 47 CFR 76.66(d)(2)(vi) and non-rule requirements contained in paragraph 16 (see 73 FR 24502). The OMB Control Number assigned is 3060-0980 for all of the information collection requirements contained in 47 CFR 76.66(b)(1), 47 CFR 76.66(d)(2)(vi), and non-rule requirements contained in paragraph 16 (see 73 FR 24502). The total annual reporting burden for respondents for the collection is estimated to be: 10,280 respondents; 11,938 responses; and a total annual burden hours of 12,146 hours, and $16,000 total annual cost burden.

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The bottomfish fishery in Federal waters around Hawaii is managed under the Fishery Management Plan for Bottomfish and Seamount Groundfish Fisheries of the Western Pacific Region (Bottomfish FMP), developed by the Western Pacific Fishery Management Council (Council) and implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing bottomfish fishing by U.S. vessels in accordance with the Bottomfish FMP appear at 50 CFR part 665 and at subpart H of 50 CFR part 600.

On April 4, 2008, NMFS published a final rule (73 FR 18457) that implemented Amendment 14 to the Bottomfish FMP to end the overfishing of bottomfish in the Hawaiian Archipelago. The regulations established by Amendment 14 at § 665.72 authorize NMFS to set an annual TAC limit for Deep 7 bottomfish, as recommended by the Council and based on the best available scientific, commercial, and other information, and taking into account the associated risk of overfishing. The Deep 7 bottomfish are onaga ( Etelis coruscans ), ehu ( E. carbunculus ), gindai ( Pristipomoides zonatus ), kalekale ( P. sieboldii ), opakapaka ( P. filamentosus ), lehi ( Aphareus rutilans ), and hapu'upu'u ( Epinephelus quernus ). The fishery is monitored using information reported by holders of State commercial marine licenses (State CML) through monthly catch reports submitted to the State. Beginning with the 2008-09 MHI bottomfish fishing year, fish catch and effort information from non-commercial fishermen who fish for bottomfish in Federal waters around Hawaii are obtained through a Federal logbook program administered by NMFS. This information is used in combination with the State catch reports to monitor the annual TAC.

When the TAC for the year is projected to be reached, NMFS is required to publish notification that the fishery will be closed beginning on a specified date until the end of the fishing year in which the TAC is reached. During the closure, no person may fish for, possess, or sell any Deep 7 bottomfish in the MHI, except as otherwise authorized by law. Specifically, fishing for, and the resultant possession or sale of, Deep 7 bottomfish by vessels legally registered to Mau Zone, Ho omalu Zone, or Pacific Remote Island Areas bottomfish fishing permits, and conducted in compliance with all other laws and regulations, are not affected by the closure. There is no prohibition on fishing for or selling other non-Deep 7 bottomfish species throughout the year.

For the 2007-08 fishing year, the TAC was established by the Council at 178,000 lb (80,739 kg) (73 FR 18718, April 7, 2008). Monitoring of the fishery indicated that the MHI bottomfish fishery harvested the TAC in April 2008. In accordance with regulation § 665.72, and as a result of reaching the TAC, NMFS published a temporary rule closing the fishery on April 16, 2008 (April 7, 2008; 73 FR 18717), and a related correction notice (73 FR 20001; April 14, 2008). The fishery is scheduled to reopen on September 1, 2008, the date the temporary rule expires.

The Council held its 142nd meeting in Honolulu in June 2008. At that meeting, the Council learned that additional data had been obtained for the fishery and that the new data were integral to the analysis by NMFS to update the bottomfish stock assessment. An updated stock assessment provides the best scientific basis upon which the Council can make its recommendation on a TAC. Inasmuch as an updated bottomfish stock assessment was not available at the June meeting, the Council was not able to recommend a TAC in accordance with the best scientific information available, as required by regulation § 665.72(a) and Magnuson-Stevens Act National Standard 2. The new stock assessment is to be available before the Council's next meeting in October 2008. Accordingly, the Council, by majority vote, recommended that NMFS delay the opening of the fishery until November 15, 2008.

NMFS has been informed that the State will be taking action to extend the temporary closure to bottomfish fishing in State waters around the MHI from August 31 until November 14, 2008, and is expecting NMFS to do the same for Federal waters.

This delay in opening the fishery is necessary to prevent overfishing of Hawaiian bottomfish. From 1990-2004, annual commercial landings of Deep 7 bottomfish caught in Federal waters of the MHI ranged from approximately 29,000 to 81,000 lb (13,154 to 36,741 kg). The catch during September and October of each year during the same period ranged from 27,000 to 62,000 lb (12,247 to 28,123 kg), representing 13 to 24 percent of the Deep 7 species landed annually by commercial fishermen from Federal waters.

The potential contribution of the catch from Federal waters to overfishing of Hawaiian bottomfish is clear when one considers the relative portion of landings from Federal waters to the total Deep 7 bottomfish landings from both State and Federal waters. Annually, the landings from Federal waters during 1990-2004 comprised 12 to 25 percent of the total MHI landings. September landings from Federal waters made up 6 to 24 percent of the MHI total, and October landings comprised 10 to 28 percent of the total. Non-commercial landings of Deep 7 bottomfish are currently unknown, but they certainly add to the mortality of Deep 7 bottomfish, and are believed to be substantial.

Thus, in the absence of a TAC, any fishing for Deep 7 bottomfish during September and October could potentially worsen overfishing in the MHI. The delay in opening the fishery is necessary to prevent overfishing in, and preserve sustainable management of, the bottomfish fishery, based on the best scientific information available. Without the emergency rule to delay the opening, a TAC cannot be published that would be consistent with Magnuson-Stevens Act National Standard 1 (preventing overfishing) and National Standard 2 (being based on the best available scientific information). To allow the fishery to open without a TAC would, moreover, be contrary to existing management regulations intended to end bottomfish overfishing, create extreme confusion among the public, and affect the joint effort of the Council, NMFS, and the State in addressing the overfishing condition of bottomfish complex in the MHI. In addition, the inconsistency between State and Federal regulations would seriously compromise the State's enforcement abilities to extend the closure of the Deep 7 bottomfish fishery in State waters until mid-November 2008.

NMFS is developing an environmental assessment (EA) for a proposed and final rule on TAC alternatives for the 2008-09 fishing year. The EA will be made available to the public for comment before the Council's meeting in October 2008, with sufficient time for the public comments to be considered by the Council, prior to the Council recommending a TAC for the 2008-09 fishing year, and in conjunction with the updated stock assessment.

Pursuant to authority set forth at U.S.C. 553(b)(B), the Assistant Administrator Fisheries, NOAA, (AA) finds it is contrary to the public interest to provide for prior notice and an opportunity for public comment. Fishing for Deep 7 bottomfish without an established TAC could worsen overfishing in the MHI. A TAC cannot be published that would be consistent with Magnuson-Stevens Act National Standards 1 and 2, so the emergency rule is necessary to delay the opening of the fishery from September 1, 2008, to November 15, 2008. Fishery statistics indicate that the amount of bottomfish harvested in Federal waters, alone, during September and October could reach 50 percent of the previous TAC. Based on preliminary information, the TAC for the 2008-09 fishing year may be reduced, and if fishing continues at historical levels during September and October on a much-reduced TAC, overfishing is likely to result, absent a delay of the opening.

Similarly, the need to implement these measures in a timely manner to delay of the opening of the Deep 7 bottomfish fishery to prevent overfishing, reduce confusion among the public, and minimize inconsistency between State and Federal regulations, constitutes good cause under authority contained in 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. The impact to fishermen of this temporary closure is minimal because closing the fishery upon reaching the TAC is intended to benefit the fishery by ending overfishing and providing sustainable bottomfish resources. Bottomfish fishermen typically fish for non-Deep 7 bottomfish (in addition to the Deep 7 bottomfish that is temporarily closed) and also participate in troll fishing for pelagic species. These other fisheries are not affected by the closure, so fishermen are provided alternative fishery opportunities during the closure for Deep 7 bottomfish.

Accordingly, this emergency temporary rule will be effective upon filing for publication at the Office of the Federal Register. Public comments on the emergency closure will be accepted for 15 days after publication of this emergency rule in the Federal Register .

Pursuant to the authority set contained in 5 U.S.C. 603, this emergency rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is issued without opportunity for prior notice and opportunity for public comment. Accordingly, no regulatory flexibility analysis is required, and none was prepared.

This emergency rule has been determined to be not significant for purposes of Executive Order 12866.