On January 28, 2008, the President signed into law the National Defense Authorization Act for Fiscal Year 2008 (Pub. L. 110-181), which created the Special Inspector General for Afghanistan Reconstruction (SIGAR). In order to establish procedures to facilitate public interaction with SIGAR, the agency is issuing final regulations under the FOIA and the Privacy Act.

On June 11, 2012 (77 FR 34179) SIGAR published a final rule revising its regulations, 5 CFR Chapter LXXXIII part 9301, establishing procedures for the public to obtain information from the Special Inspector General for Afghanistan Reconstruction under the Freedom of Information Act (FOIA) and the Privacy Act of 1974.

Unfortunately, SIGAR inadvertently omitted several amendments which specifically addressed several public comments the agency received during the interim rule phase.

Accordingly, 5 CFR part 9301 is corrected by making the following correcting amendments:

Background I. Hospice

This final rule revises the regulation for hospice periods of care. The Defense Authorization Act for FY 1992-1993, Public Law 102-190, directed TRICARE to provide hospice care in the manner and under the conditions provided in section 1861(dd) of the Social Security Act (42 U.S.C. 1395x(dd)). Congress' intent was for TRICARE to establish a benefit in the same manner as Medicare. TRICARE originally had the same periods of hospice care used by Medicare; however, over time the Medicare benefit changed, but TRICARE's regulation has not. The TRICARE regulation currently provides for an initial period of 90 days, a subsequent period of 90 days, a second subsequent period of 30 days, and a final period of unlimited duration. Rather than maintaining this level of specificity in the regulation and to ensure that TRICARE and Medicare's benefit periods are equal, we are revising the regulation to state that the distinct periods of care available under the hospice benefit shall be the same as those offered under Medicare's hospice program. Currently under Medicare, patients are entitled to two 90-dayelection periods, followed by an unlimited number of 60-day periods. The level of specific benefits shall be included in the TRICARE Reimbursement Manual, and may be accessed atwww.tricare.mil.

The current regulatory language references specific reimbursement percentages for assistant-at-surgery reimbursement. Rather than including these specific percentage amounts, which would require a regulatory change any time the percentage amounts change, we are making a general statement referring to the current percentages used by Medicare. Our authority for this is 10 U.S.C. 1079(h) which states: Except as provided in paragraphs (2) and (3), payment for a charge for services by an individual health care professional (or other noninstitutional health care provider) for which a claim is submitted under a plan contracted for under subsection (a) shall be equal to an amount determined to be appropriate, to the extent practicable, in accordance with the same reimbursement rules as apply to payments for similar services under title XVIII of the Social Security Act (42 U.S.C. 1395et seq.). The Secretary of Defense shall determine the appropriate payment amount under this paragraph in consultation with the other administering Secretaries. The specific percentages are more appropriately included in the TRICARE Reimbursement Manual, and may be accessed atwww.tricare.mil.

10 U.S.C. 1079(j)(2) provides that the amount to be paid to a provider of services for services provided under a plan covered by this section shall be determined under joint regulations to be prescribed by the administering Secretaries which provide that the amount of such payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under title XVIII of the Social Security Act (42 U.S.C. 1395et seq.).

In accordance with the above statute, the TRICARE/CHAMPUS DRG-based payment system transitioned to adopting the Medicare Severity-DRG based payment system on October 1, 2008. When TRICARE transitioned to the severity-based system, it was necessary to renumber the existing DRGs, and to assign different narrative descriptions to the DRG numbers. As a result, the existing regulatory reference to specific DRG numbers and descriptions became obsolete, so we are removing the numeric references in the regulation and utilizing only the descriptive terminology.

A proposed rule was published on January 13, 2011 (76 FR 2291). Two sets of comments were received on the proposed rule. One commenter supported the proposed rule and urged the DoD to make it final. The other commenter concurred with the reimbursement changes in the proposed rule, but expressed concern that current TRICARE policy does not cover mental and behavioral services when delivered by a physician assistant (PA). They stated that PAs are qualified health care professionals who are authorized by state law to provide a wide range of behavioral health services to patients in all settings.

We appreciate the commenter's interest in TRICARE's behavioral health care services. TRICARE offers a robust behavioral health care program and allows care by qualified mental health providers, as listed in 32 CFR 199.4 as follows: Psychiatrists or other physicians; clinical psychologists, certified psychiatric nurse specialists, clinical social workers, and certified marriage and family therapists; and pastoral and mental health counselors under a physician's supervision. TRICARE views these professionals as qualified behavioral health services providers with the specialized training to ensure quality of care to our beneficiaries. Consequently, we have no plans to expand coverage to allow behavioral health services by PAs.

Section 801 of title 5, United States Code, and Executive Orders (E.O.) 12866 and 13563 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not economically significant. It has been reviewed by the Office of Management and Budget as required under the provisions of E.O. 12866 and 13563.

Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any federal mandate may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year, and thus this final rule is not subject to this requirement.

Public Law 96-354, “Regulatory Flexibility Act” (RFA) (5 U.S.C. 601), requires that each Federal agency prepare a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule is not an economically significant regulatory action, and it has been certified that it will not have a significant impact on a substantial number of small entities. Therefore, this final rule is not subject to the requirements of the RFA.

This final rule does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).

E.O. 13132, “Federalism,” requires that an impact analysis be performed to determine whether the rule has federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. It has been certified that this final rule does not have federalism implications, as set forth in E.O. 13132.

Accordingly, 32 CFR Part 199 is amended as follows:

I. Background

Prior to the enactment of section 706 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111-84), 10 U.S.C. 1086(d) provided that a person who would otherwise receive benefits under section 1086 who is entitled to Medicare Part A hospital insurance is not eligible for TRICARE unless the individual is enrolled in Medicare Part B. When a TRICARE beneficiary becomes eligible for Medicare, Medicare becomes the primary payer and TRICARE is the secondary payer. Retroactive Medicare eligibility determinations therefore caused DoD and Medicare to reprocess claims. Section 706 of the Fiscal Year 2010 National Defense Authorization Act amended 10 U.S.C. 1086(d) to exempt TRICARE beneficiaries under the age of 65 who became Medicare eligible due to a retroactive disability determination from the requirement to enroll in Medicare Part B for the retroactive months of entitlement to Medicare Part A in order to maintain TRICARE coverage. This statutory amendment became effective upon enactment of the Fiscal Year 2010 National Defense Authorization Act on October 28, 2009. Prior to this amendment, beneficiaries who did not purchase Medicare Part B to cover the retroactive period lost their TRICARE eligibility during that period of time. As a result, beneficiaries and providers were then subject to TRICARE recoupment action for care provided during the period of retroactive disability. Pursuant to this amendment, TRICARE remains first payer for any claims filed during the retroactive months and disabled TRICARE beneficiaries are relieved of the financial burden of making retroactive payments to avoid a gap in coverage. This final rule amends the Code of Federal Regulations to conform to current statutory authority regarding TRICARE eligibility.

Additionally, due to an earlier administrative omission, this final rule also amends 32 CFR 199.3 to more clearly address reinstatement of TRICARE eligibility following a gap in coverage due to lack of enrollment in Part B. While most TRICAREbeneficiaries who become eligible for Medicare Part A maintain TRICARE coverage through prompt acceptance of Part B coverage, there are a number of beneficiaries that for one reason or another decline Part B and lose their TRICARE eligibility. For those individuals, they can have that eligibility reinstated at a later date if they re-enroll in Part B. This final rule amends the section on reinstatement of TRICARE eligibility to include beneficiaries who elect to enroll in Medicare Part B following a gap in TRICARE coverage.

We provided a 60-day public comment period following publication of the Proposed Rule in theFederal Register(76 FR 58204-58206) on September 20, 2011. We received no public comments.

Executive Orders 12866 and 13563 require that a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule is not an economically significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA, thus this final rule is not subject to any of these requirements.

This rule will not impose additional information collection requirements on the public. OMB previously cleared the collection requirements under OMB Control Number 0704-0364.

We have examined the impact(s) of the rule under Executive Order 13132, and it does not have policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, therefore, consultation with State and local officials is not required.

This rule does not contain unfunded mandates. It does not contain a Federal mandate that may result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

Accordingly, 32 CFR part 199 is amended as follows:

I. Background

In theFederal Registerof August 31, 2009 (74 FR 44797-44798), the Office of the Secretary of Defense published for public comment a proposed rule that revised the definition of “unlabeled or off-label drug” to “off-label use of a drug or device.” In addition this proposed rule removed the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed under Section 199.4(g)(15).

On January 6, 1997, the Office of the Secretary of Defense published a final rule in theFederal Register(62 FR 627-631) clarifying the TRICARE exclusion of unproven drugs, devices, and medical treatments or procedures and adding the TRICARE definition of unlabeled or off-label drugs. This rule also added the provision for coverage of unlabeled or off-label uses of drugs that are Food and Drug Administration (FDA) approved drugs that are prescribed or administered by a health care practitioner and are used for indications or treatments not included in the approved labeling. We are now modifying the definition of “unlabeled or off-label drug” to “off-label use of a drug or device,” which includes a drug, biologic or device under the regulatory authority of the FDA. However, this proposed rule does not present new agency policy. Rather, it corrects an error and omission from the current rule. Coverage is limited to those indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective and in accordance with nationally accepted standards of practice in the medical community. In addition, the off-label use must be reviewed for medical necessity.

In general, good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices, including combination products, according to their best knowledge and judgment. When providers use a product for an indication not in the approved labeling, they have a responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence. Limiting CHAMPUS cost-sharing to those off-label uses for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe, effective, and in accordance with nationally accepted standards of practice in the medical community will help to ensure there is sufficient scientific evidence supporting the off-label use, without being overly onerous, while still promoting innovations in medical practice that benefit patients.

In reviewing the proposed rule, we discovered that we had inadvertently incorporated the TRICARE reliable evidence standard (as defined in 32 CFR 199.2) as the threshold for reviewing coverage for off-label or unlabeled use. The intent was not to make the standard of review more onerous but rather to expand the application of the existing provision regarding the cost-sharing of off-label use of drugs to also include the off-label use of devices and biologics. As a result, we are withdrawing the changes to the third paragraph of the Note to paragraph (g)(15)(i)(A) in section 199.4 with the exception of replacing the term “unlabeled or off-label uses of drugs” with “off-label uses of drugs and devices,” with an appropriate reference back to the definition of the term in 199.2. “Off-label uses of drugs and devices” includes off-label uses of drugs, biologics, devices, and combination products.

Although most biological products meet the definition of “drugs” under the Federal Food, Drug and Cosmetic Act, and are also regulated under that law, biological products are approved for marketing under the Public Health Services Act by means of a biologics license application. Thus, the definition of “off-label use of a drug or device” has been revised to acknowledge both the Federal Food, Drug and Cosmetic Act and the Public Health Services Act as sources of the FDA's regulatory authority over the marketing of these products.

By law, TRICARE can cost-share only medically necessary supplies and services. Any drug, device, and medical treatment or procedure, the safety and efficacy of which have not beenestablished, as described in Part 199.4(g)(15), is unproven and cannot be cost-shared by TRICARE except as authorized under paragraph 199.4(e)(26). The current regulation and program policy provide a partial list of examples of unproven drugs, devices, and medical treatments or procedures that are excluded from benefits. The intent of this partial list was to provide information on specific examples of emerging drugs, devices, and medical treatments or procedures determined to be unproven by TRICARE based on review of current reliable evidence. Due to the rapid and extensive changes in medical technology it is not feasible to maintain this list in the regulation. Removal of this partial list of examples does not change the exclusion of unproven drugs, devices, and medical treatments or procedures. Removal of the partial list of examples does not change the process TRICARE follows in determining for purposes of benefit coverage when a drug, device, and medical treatment or procedure has moved from the status of unproven to proven medical effectiveness. The intent of this revision is to ensure that benefit determinations are made based on current reliable evidence rather than relying on outdated regulatory and policy provisions. A partial list of unproven drugs, devices, medical treatments, or procedures will continue to be published in the TRICARE Policy Manual atwww.tricare.mil.

We provided a 60-day public comment period following publication of the Proposed Rule in theFederal Register(74 FR 44797-44798) on August 31, 2009. We received no public comments.

Section 801 of title 5, United States Code, and Executive Orders 12866 and 13563 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not an economically significant rule; however, it is a regulatory action which has been reviewed by the Office of Management and Budget as required under the provisions of EOs 12866 and 13563.

Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any federal mandate may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

The “Regulatory Flexibility Act” (RFA) requires each Federal agency to prepare and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule will not significantly impact a substantial number of small entities for purposes of the RFA.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

This rule has been examined for its impact under E.O. 13132 and does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government; therefore, consultation with the State and local officials is not required.

Accordingly, 32 CFR part 199 is amended as follows:

The Coast Guard will enforce the safety zones established for Annual Fireworks Displays within the Captain of the Port, Puget Sound Area of Responsibility in 33 CFR 165.1332 during the dates and times noted below.

The following safety zones will be enforced from 5 p.m. on July 4, 2012 through 1 a.m. on July 5, 2012.

The special requirements listed in 33 CFR 165.1332(b), which can also be found in theFederal Register(75 FR 33700) published on June 15, 2010, apply to the activation and enforcement of these safety zones.

All vessel operators who desire to enter any of the safety zones must obtain permission from the Captain of the Port or his Designated Representative by contacting either the on-scene patrol craft on VHF Ch 13 or Ch 16 or the Coast Guard Sector Puget Sound Joint Harbor Operations Center (JHOC) via telephone at (206) 217-6002.

The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR part 165 and 5 U.S.C. 552(a). In addition to this notice, the Coast Guard will provide the maritime community with extensive advance notification of the safety zones via the Local Notice to Mariners and marine information broadcasts on the days of the events.

Prior to this final rulemaking, 38 CFR 17.170 stated that under certain specified circumstances, “[t]he Director of a [VA] facility is authorized to cause an autopsy to be performed on a veteran who dies outside of a [VA] facility while undergoing post-hospital care under the provisions of 38 U.S.C. 1712 and 38 CFR 17.93.” These cross-references are outdated and incomplete. Post-hospitalcare is now governed by section 1710, not section 1712, and the implementing regulation is now at 38 CFR 17.38. In addition, VA is authorized, under § 17.52, to contract with non-VA facilities to furnish hospital care and medical services to certain veterans in non-VA facilities. This final rule updates the cross-references in § 17.170 to allow VA to order an autopsy of an individual who dies while receiving fee-basis care under § 17.52 and to pay the expense of transporting the body for purposes of performing the autopsy.

This final rule also amends § 17.170 by reorganizing and clarifying the provisions governing whether an autopsy should be performed, including clarifying the applicability of local laws and the determination of the individual authorized to consent to autopsy. This clarifying language allows for ease of interpretation of the methods used to obtain consent for autopsy.

In a document published in theFederal Registeron December 2, 2011 (76 FR 75509), VA proposed the above-described amendments to § 17.170. We provided a 60 day comment period, which ended on January 31, 2012. We received one comment from a member of the general public.

The commenter agreed with all of the proposals. Therefore, VA will make no changes based on this comment. The commenter stated that “[w]hen an autopsy is required for this purpose it is necessary to complete it in a timely fashion. Simplifying the language will help to achieve this goal by clarifying which laws to consult, addressing the requirements needed to achieve consent, and stating clearly the limitations on time.” We thank the commenter for taking the time to review this rulemaking.

Based on the rationale set forth in the preamble to the proposed rule and in this final rule, VA is adopting the proposed rule as a final rule without any substantive changes. We made a couple of nonsubstantive edits to proposed § 17.170(a)(1).

Title 38 of the Code of Federal Regulations, as revised by this rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action, and it has been determined not to be a significant regulatory action under Executive Order 12866.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will not cause a significant economic impact on health care providers, suppliers, or entities since only a small portion of the business of such entities concerns VA beneficiaries. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program numbers and titles for this final rule are as follows: 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on June 21, 2012, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as follows:

In a final rule published in theFederal Registeron February 8, 2010, (73 FR 6098), VA established new 38 CFR part 74 setting forth a mechanism for verifying ownership and control of VOSBs, including SDVOSBs. At that time, with respect to 38 CFR 74.15, VA anticipated that annual examinations were necessary to ensure the integrity of the Verification Program. This was deemed consistent with the annual Federal size and status recertification requirement in the Central Contractor Registry.

In administering this program since February 2010, VA has concluded that an annual examination is not necessary to adequately maintain the integrity of the program and proposes a 2-year eligibility period. This change is appropriate because VA conducts a robust examination of personal and company documentation to verify ownership and control by Veterans of applicant businesses. In addition to verifying individual owners' service-disabled veteran status or veteran status, in accordance with 38 CFR 74.20(b), VA reviews an applicant's financial statements; Federal personal and business tax returns; personal historystatements; articles of incorporation/organization; corporate by-laws or operating agreements; organizational, annual and board/member meeting records; stock ledgers and certificates; State-issued certificates of good standing; contract, lease and loan agreements; payroll records; bank account signature cards; and licenses. Given the depth of this review, annual re-verification examinations have become an unnecessary administrative burden on both applicants/participants and VA.

Given this extensive initial examination, VA is confident that the integrity of the verification program will not be compromised by establishing a 2-year eligibility period. Other integrity aspects of the program remain adequate to oversee a 2-year eligibility period. Once verified, 38 CFR 74.15(a) mandates that the participant must maintain its eligibility during its tenure and, if ownership or control changes occur, must inform VA's Center for Veterans Enterprise (CVE) of any changes that would adversely affect its eligibility. Moreover, in accordance with 38 CFR part 74.20(a), VA has the right to conduct random, unannounced site examinations of participants or to conduct a further examination upon receipt of specific and credible information that a participant is no longer eligible. Lastly, in the course of specific SDVOSB/VOSB set-aside acquisitions, VA contracting officers and also competing SDVOSB/VOSBs have the right to raise a SDVOSB/VOSB status protest to VA's Office of Small and Disadvantaged Business Utilization (OSDBU) if either has a reasonable basis upon which to challenge the SDVOSB/VOSB status of a verified firm.

Establishment of a longer, 2-year eligibility period is consistent with other Federal set-aside programs. With respect to the Historically Underutilized Business Zone (HUBZone) small business certification program, U.S. Small Business Administration (SBA) regulations at 13 CFR 126.500 require that any qualified HUBZone small business concern seeking to remain on the HUBZone approved list must recertify every 3 years with SBA. With regard to SBA's Section 8(a) Business Development program, SBA authorizes a program term of up to 9 years in 13 CFR 124.2. For VA's SDVOSB/VOSB verification program, VA has now determined that a program term of 2 years is reasonable given the mandatory nature of VA's SDVOSB/VOSB set-aside authority in contrast to the discretionary nature of the HUBZone and Section 8(a) set-aside programs. In accordance with 38 U.S.C. 8127 and VA Acquisition Regulation, 48 CFR Part 819, VA is required to set aside any open market procurement for SDVOSBs and then VOSBs, first and second respectively, if two or more such concerns are reasonably anticipated to submit offers at fair and reasonable pricing. Given the large volume of appropriated funds subject to these set-aside requirements, a 2-year eligibility period prior to re-examination is deemed reasonable to adequately balance the burden on SDVOSB/VOSBs and to protect the integrity of the program.

The Secretary of Veterans Affairs finds good cause to issue this interim final rule prior to notice and comment procedures. The interim rule makes only a minor modification to extend the eligibility period for SDVOSB/VOSBs after VA's initial robust verification examination and approval from 1 year to 2 years. The rule will reduce the administrative burden on SDVOSB/VOSB participants by eliminating annual re-verification submissions. The integrity of the program remains protected by the initial robust and detailed verification examination, the regulatory requirement of participants to report changes to ownership and control during their eligibility period, VA's authority to conduct random site examinations and to re-examine eligibility upon receipt of any reasonably credible information affecting SDVOSB/VOSB verified status, and, for individual acquisitions, the status protest process, where VA contracting officers or competing vendors can challenge the SDVOSB/VOSB status of offerors if a reasonable basis can be asserted to be decided by VA OSDBU on SDVOSB/VOSB set-aside acquisitions. For these reasons, the Secretary of Veterans Affairs is issuing this as an interim final rule. In view of the detrimental effects of continuing an unnecessary administrative burden on program participants and verifying officials, and to avoid delays in verification caused by repetitive annual reviews, the Secretary finds it is impracticable, unnecessary, and contrary to public interest to delay the effective date of this regulation for the purpose of soliciting advance public comment. The Secretary of Veterans Affairs will consider and address comments that are received within 60 days of the date this interim final rule is published in theFederal Register.

For these same reasons, and because this interim final rule relieves a restriction, the Secretary finds that this rule will be effective on the date of publication.

The Regulatory Flexibility Act, 5 U.S.C. 601-612, applies to this final rule. This interim final rule is generally neutral in its effect on small businesses because it relates only to small businesses applying for verified status in VA's SDVOSB/VOSB verified database. The overall impact of the rule will benefit small businesses owned by veterans or service-disabled veterans because it will reduce their administrative burden associated with maintaining verified status by extending the need for re-verification by VA from 1 year to 2 years. VA has estimated the cost to an individual business to be less than $100.00 for 70-75 percent of the businesses seeking verification, and the average cost to the entire population of veterans seeking to become verified is less than $325.00 on average. Increasing the verification period will decrease the frequency of any such costs. On this basis, the Secretary certifies that the adoption of this interim final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, under 5 U.S.C. 605(b), this regulation is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned byanother agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866.

VA has already established the SDVOSB/VOSB verification program in regulation at 38 CFR part 74, and the minor change in this interim final rule will solely modify the term of eligibility after initial verification from 1 year to 2 years in 38 CFR 74.15(a) before re-verification would be required.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This interim final rule would have no such effect on State, local, and tribal governments, or on the private sector.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

This interim final rule affects the verification guidelines of veteran-owned small businesses, for which there is no Catalog of Federal Domestic Assistance program number.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on June 22, 2012, for publication.

For the reasons set out in the preamble, VA amends 38 CFR part 74 as follows:

Based on EPA's review of the quality-assured and certified monitoring data for 2007-2009, and in accordance with section 179(c)(1) of the CAA, EPA is determining that the St. Louis area attained the 1997 annual PM2.5NAAQSby the applicable attainment date of April 5, 2010. The St. Louis area is comprised of Jefferson County, Franklin County, St. Louis County, St. Louis City, and St. Charles in Missouri, and Madison, Monroe and St. Clair Counties, and Baldwin Township in Randolph County in Illinois. On May 23, 2011, EPA published a final rulemaking making a determination that the St. Louis area attained the 1997 annual PM2.5NAAQS based on quality-assured, quality controlled and certified ambient air monitoring data for the 2007-2009 monitoring period and thereby suspended the requirements for the St. Louis area to submit an attainment demonstration and associated reasonably available control measures (RACM), a reasonable further progress (RFP) plan, contingency measures, and other planning State Implementation Plan (SIP) revisions related to attainment of the 1997 annual PM2.5NAAQS so long as the area continues to attain the 1997 Annual PM2.5NAAQS. See 76 FR 29652. Further information regarding that action is available in the notice proposing that action, published on March 7, 2011, at 76 FR 12302.

Today's final action merely makes a determination that the St. Louis area attained the 1997 annual PM2.5NAAQS by its applicable attainment date. This action does not revisit the prior attainment determination or reconsider the suspension of the requirements for the St. Louis area to submit an attainment demonstration and associated RACM, an RFP plan, contingency measures, and other planning SIP revisions related to attainment of the standard. More information regarding the 1997 annual PM2.5NAAQS and the area's attainment of that NAAQS is available at 76 FR 29652 (May 23, 2011). A detailed discussion of EPA's review of the monitoring data showing attainment of the standard can be found in the March 7, 2011 proposed action and the May 23, 2011 final action.

Other specific requirements of the determination and the rationale for EPA's action today are explained in the Notice of Proposed Rulemaking (NPR) published on December 20, 2011 (76 FR 78869). The comment period closed on January 19, 2012. No comments were received in response to the NPR.

Today's action is a determination that the St. Louis area attained the 1997 annual PM2.5NAAQS by its applicable attainment date of April 5, 2010, consistent with CAA section 179(c)(1). Finalizing this action does not constitute a redesignation of the St. Louis area to attainment of the 1997 annual PM2.5NAAQS under section 107(d)(3) of the CAA. Further, finalizing this action does not involve approving maintenance plans for the St. Louis area as required under section 175A of the CAA, nor would it find that the St. Louis area has met all other requirements for redesignation. The designation status of the St. Louis area remains nonattainment for the 1997 annual PM2.5NAAQS until such time as EPA determines that the area meets the CAA requirements for redesignation to attainment and takes action to redesignate the area.

This action is a final determination, based on quality-assured and certified monitoring data for the 2007-2009 monitoring period, that the St. Louis area attained the annual PM2.5NAAQS by its applicable attainment date of April 5, 2010. This action is being taken pursuant to section 179(c)(1) of the CAA and is consistent with the CAA and its implementing regulations.

This final action merely makes a determination of the St. Louis area's attainment of the 1997 PM2.5NAAQS based upon complete, quality-assured, and certified ambient air quality data, pursuant to statutory mandate, and does not impose additional requirements beyond those imposed by state law. This final action makes a non-discretionary determination of the St. Louis area's attainment of the 1997 PM2.5NAAQS based solely upon complete, quality-assured, and certified ambient air quality data, as mandated by CAA section 179(c)(1). For that reason, this final action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this final rule determines that the St. Louis area attained the 1997 annual average PM2.5NAAQS by its applicable attainment date does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIPs are not approved to apply in Indian country located in the states, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

Therefore, 40 CFR part 52 is amended as follows:

Table of Contents I. What is the background for this final action? II. What is EPA's response to comments received on this action? III. What is the effect of this final action? IV. Final Action V. Statutory and Executive Order Reviews I. What is the background for this final action?

Regional haze is visibility impairment that is produced by a multitude of sources and activities which are located across a broad geographic area and emit fine particles (e.g., sulfates, nitrates, organic carbon, elemental carbon, and soil dust), and their precursors (e.g., sulfur dioxide (SO2), nitrogen oxides (NOX), and in some cases, ammonia and volatile organic compounds). Fine particle precursors react in the atmosphere to form fine particulate matter (PM2.5) which impairs visibility by scattering and absorbing light. Visibility impairment reduces the clarity, color, and visible distance that one can see. PM2.5can also cause serious health effects and mortality in humans and contributes to environmental effects such as acid deposition and eutrophication.

In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I areas which impairment results from manmade air pollution.” On December 2, 1980, EPA promulgated regulations to address visibility impairment in Class I areas that is “reasonably attributable” to a single source or small group of sources, i.e., “reasonably attributable visibility impairment.”See45 FR 80084. These regulations represented the first phase in addressing visibility impairment. EPA deferred action on regional haze that emanates from a variety of sources until monitoring, modeling, and scientific knowledgeabout the relationships between pollutants and visibility impairment were improved.

Congress added section 169B to the CAA in 1990 to address regional haze issues. EPA promulgated a rule to address regional haze on July 1, 1999 (64 FR 35713), the Regional Haze Rule (RHR). The RHR revised the existing visibility regulations to integrate into the regulation provisions addressing regional haze impairment and established a comprehensive visibility protection program for Class I areas. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309. The requirement to submit a regional haze SIP applies to all 50 states, the District of Columbia, and the Virgin Islands. 40 CFR 51.308(b) requires states to submit the first implementation plan addressing regional haze visibility impairment no later than December 17, 2007.

On December 17, 2007, NC DENR submitted a revision to North Carolina's SIP to address regional haze in the State's and other states' Class I areas. On February 28, 2012, EPA published an action proposing a limited approval of North Carolina's December 17, 2007, SIP revision to address the first implementation period for regional haze.1 See77 FR 11858. EPA proposed a limited approval of North Carolina's December 17, 2007, SIP revision to implement the regional haze requirements for North Carolina on the basis that this revision, as a whole, strengthens the North Carolina SIP. See section II of this rulemaking for a summary of the comments received on the proposed actions and EPA's responses to these comments. Detailed background information and EPA's rationale for the proposed action is provided in EPA's February 28, 2012, proposed rulemaking.

Following the remand of CAIR, EPA issued a new rule in 2011 to address the interstate transport of NOXand SO2in the eastern United States.See76 FR 48208 (August 8, 2011) (“the Transport Rule,” also known as the Cross-State Air Pollution Rule (CSAPR)). On December 30, 2011, EPA proposed to find that the trading programs in the Transport Rule would achieve greater reasonable progress towards the national goal of achieving natural visibility conditions than would best available retrofit technology (BART) in the states in which the Transport Rule applies (including North Carolina).See76 FR 82219. Based on this proposed finding, EPA also proposed to revise the RHR to allow states to substitute participation in the trading programs under the Transport Rule for source-specific BART. EPA finalized this finding and RHR revision on June 7, 2012 (77 FR 33642).

Also on December 30, 2011, the DC Circuit stayed the Transport Rule (including the provisions that would have sunset CAIR and the CAIR FIPs) and instructed the EPA to continue to administer CAIR pending the outcome of the court's decision on the petitions for review challenging the Transport Rule.EME Homer Cityv.EPA,No. 11-1302.

EPA received two sets of comments on the February 28, 2012, rulemaking proposing a limited approval of North Carolina's December 17, 2007, regional haze SIP revision. Specifically, the comments were received from the Southern Environmental Law Center (on behalf of the National Parks Conservation Association and the Sierra Club) and the U.S. National Park Service. Full sets of the comments provided by all of the aforementioned entities (hereinafter referred to as “the Commenter”) are provided in the docket for today's final action. A summary of the comments and EPA's responses are provided below.

Comment 1:The Commenter incorporates by reference comments that it submitted to EPA on February 28, 2012, regarding the Agency's December 30, 2011, proposed rulemaking to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for North Carolina and other states subject to the Transport Rule.See76 FR 82219. The Commenter also restates several of these comments, including the following: the Transport Rule does not comply with EPA's criteria for an alternative to BART; the State cannot rely on the proposed “Better than BART” rulemaking given the DC Circuit's action staying implementation of the Transport Rule; EPA has not accounted for the differences in averaging time under BART, the Transport Rule, and in measuring visibility impacts; EPA's modeling assumed nitrate levels that are often lower than real-world conditions; in some instances, EPA relied on a single monitor to assess visibility conditions in multiple Class I areas; EPA uses a simple arithmetic mean to conclude that visibility improvements will be greater under the Transport Rule than BART; and EPA's proposed “Better than BART” determination relies on a 2014 base case that does not account for permanent emissions reductions at non-BART eligible sources.

Response 1:These comments are beyond the scope of this rulemaking. In today's action, EPA is finalizing a limited approval of North Carolina's regional haze SIP. EPA did not propose to find that participation in the Transport Rule is an alternative to BART in this action nor did EPA reopen discussions on the CAIR provisions as they relate to BART.2 As noted above, EPA proposed to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for North Carolina in a separate action on December 30, 2011, and the Commenter is merely reiterating and incorporating its comments on that separate action. EPA addressed these comments concerning the Transport Rule as a BART alternative in a final action that was published on June 7, 2012, and has determined that they do not affect the Agency's ability to finalize a limited approval of North Carolina's regional haze SIP. EPA's responses to these comments can be found in Docket ID No. EPA-HQ-OAR-2011-0729 atwww.regulations.gov.

Comment 2:The Commenter asserts that the proposed limited approval of North Carolina's regional haze SIP violates the CAA and RHR because a regional haze plan's BART requirements and long-term strategy to achieve reasonable progress cannot be evaluated in isolation from one another. The Commenter supports its position by repeating statements made in its February 28, 2012, comments on the Agency's proposed December 30, 2011, rulemaking to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for North Carolina and other states subject to the Transport Rule. For example, the Commenter states that “[b]ecause BART is a critical component to achieving reasonable progress, neither the states nor EPA are authorized to exempt sources from the RHR's BART requirements without considering how doing so will affect the overarching reasonable progressmandate. * * * Concluding that CSAPR achieves greater reasonable progress toward achieving natural visibility conditions than BART, without regard to defined reasonable progress goals, is arbitrary and contrary to law under the Clean Air Act and the RHR.”

Response 2:As discussed in the response to Comment 1, today's action does not address reliance on CAIR or CSAPR to satisfy BART requirements. Comments related to the approvability of CAIR or CSAPR for the North Carolina regional haze SIP are therefore beyond the scope of this rulemaking and were addressed by EPA in a separate action published on June 7, 2012 (77 FR 33642). EPA addressed the Commenter's repeated statements regarding the interrelatedness of BART, the LTS, and RPGs in that final rulemaking action and those responses support this limited approval action.3

Comment 3:The Commenter asserts that EPA does not have the authority under the CAA to issue a limited approval of North Carolina's regional haze SIP. The Commenter contends that section 110(k) of the Act only allows EPA to fully approve, partially approve and partially disapprove, conditionally approve, or fully disapprove a SIP.

Response 3:As discussed in the September 7, 1992, EPA memorandum cited in the notice of proposed rulemaking,4 although section 110(k) of the CAA may not expressly provide authority for limited approvals, the plain language of section 301(a) does provide “gap-filling” authority authorizing the Agency to “prescribe such regulations as are necessary to carry out” EPA's CAA functions. EPA may rely on section 301(a) in conjunction with the Agency's SIP approval authority in section 110(k)(3) to issue limited approvals where it has determined that a submittal strengthens a given state's implementation plan and that the provisions meeting the applicable requirements of the Act are not separable from the provisions that do not meet the Act's requirements. EPA has adopted the limited approval approach numerous times in SIP actions across the nation over the last twenty years. A limited approval action is appropriate here because EPA has determined that North Carolina's SIP revision addressing regional haze, as a whole, strengthen the State's implementation plan and because the provisions in the SIP revision are not separable.

The Commenter states that EPA's action “conflicts with the plain language of the [CAA]” and cites several federal appellate court decisions to support its contention that section 110(k) of the Act limits EPA to a full approval, “a conditional approval, a partial approval and disapproval, or a full disapproval.” However, adopting the Commenter's position would ignore section 301 and violate the “ `fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme' * * *. A court must therefore interpret the statute `as a symmetrical and coherent regulatory scheme,' * * * and `fit, if possible, all parts into an harmonious whole.' ”FDAv.Brown & Williamson Tobacco Corp.,529 U.S. 120, 133 (2000) (quotingDavisv.Michigan Dept. of Treasury,489 U.S. 803, 809 (1989),Gustafsonv.Alloyd Co.,513 U.S. 561, 569 (1995), andFTCv.Mandel Brothers, Inc.,359 U.S. 385, 389 (1959)). Furthermore, the cases cited by the Commenter did not involve challenges to a limited approval approach, and one of the cases,Abramowitzv.EPA,832 F.2d 1071 (9th Cir. 1988), predates the 1990 CAA amendments enacting section 110(k).

Comment 4:The Commenter contends that it was inappropriate for the State to “rel[y] on CAIR (and now CSAPR)” in determining RPGs and that due, in part, to this reliance, the State “failed to evaluate numerous sources that contribute significantly to visibility impairment at the State's Class I areas” and that it “cast doubts on the validity of DAQ's modeling.” The Commenter therefore believes that EPA should not approve the SIP unless the State considers additional reasonable progress from the 16 electric generating units (EGUs) excluded from the reasonable progress analyses and the State conducts further analyses in setting its RPGs (or EPA “ensure[s] that DAQ follows through on its commitment to re-evaluate its ability to meet its RPGs in the five-year progress review, pursuant to 40 CFR 52.308(g)”). The Commenter also states that “even when the uniform rate of progress [URP] is predicted to be met, the state still has an obligation `to go beyond the URP analysis in establishing RPGs * * * to determine whether additional progress would be reasonable based on the statutory factors.' ”

Response 4:The State took into account emissions reductions expected from CAIR to determine the 2018 RPGs for its Class I areas, and this approach was fully consistent with EPA guidance at the time of SIP development. In the regional haze program, uncertainties associated with modeled emissions projections into the future are addressed through the requirement under the RHR to submit periodic progress reports in the form of a SIP revision. Specifically, 40 CFR 51.308(g) requires each state to submit a report every five years evaluating progress toward the RPGs for each mandatory Class I area located in the state and for each Class I area outside the state that may be affected by emissions from the state. Since this five-year progress re-evaluation is a mandatory requirement, it is unnecessary for EPA to take additional measures to “ensure” that the State meets its reporting obligation.

Regarding the need to go beyond the URP analysis when establishing RPGs, EPA affirmed in the RHR that the URP is not a “presumptive target;” rather, it is an analytical requirement for setting RPGs.See64 FR 35731. In determining RPGs for the North Carolina Class I areas, the State identified sources through its area of influence methodology for reasonable progress control evaluation and described those evaluations in its SIP. For its EGUs subject to CAIR, DAQ reviewed the statutory factors (i.e., the costs of compliance, the time necessary for compliance, the energy and non-air quality environmental impacts of compliance, and the remaining useful life of any potentially affected sources) as evaluated by EPA for CAIR.

Comment 5:The Commenter states that in exempting EGUs from a BART analysis for particulate matter “on the basis that their contribution to visibility impairment modeled less than 0.5 deciview, it does not appear that DAQ considered the cumulative impact of those sources that did not individually exceed the 0.5 dv threshold, but collectively may cause or contribute to impairment.” The Commenter cites to EPA guidelines in 70 FR 39161 to support its belief that this exemption threshold “applies when all visibility impairing pollutants are modeled together, not one pollutant at a time, as used by DAQ.” According to theCommenter, when considering the modeling impacts from coarse particulate matter (PM10) alone for the exempted sources, their combined “contribution to visibility impairment greatly exceeds the 0.5 dv contribution threshold,” calling into question the “validity of DAQ's exemptions of multiple sources from BART.”

Response 5:As discussed in the proposal, (seesection IV.C.6.B.2, February 28, 2012, 77 FR 11873), North Carolina adequately justified its contribution threshold of 0.5 deciview. While states have the discretion to set an appropriate contribution threshold considering the number of emissions sources affecting the Class I area at issue and the magnitude of the individual sources' impacts, the states' analysis must be consistent with the CAA, the RHR, and EPA'sGuidelines for BART Determinations Under the Regional Haze Ruleat Appendix Y to 40 CFR Part 51 (BART Guidelines). Consistent with the regulations and EPA's guidance, “the contribution threshold should be used to determine whether an individual source is reasonably anticipated to contribute to visibility impairment. You should not aggregate the visibility effects of multiple sources and compare their collective effects against your contribution threshold because this would inappropriately create a `contribution to contribution' test.”See also70 FR 39121. North Carolina's analysis in the regional haze SIP revision was consistent with EPA's regulations and guidance on the issue of cumulative analyses.

Regarding modeling in North Carolina's submittal that uses PM only for its BART-eligible EGUs, EPA previously determined that this approach is appropriate for EGUs where the State proposed to rely on CAIR to satisfy the BART requirements for SO2and NOX.5

Comment 6:The Commenter believes that “it is simply absurd for North Carolina to exempt” Blue Ridge Paper Products from the obligation to install BART and that the State “should work with the company to develop a facility-wide emissions reduction plan by 2013 and to implement the plan by 2018.”

Response 6:In accordance with the BART Guidelines, to determine the level of control that represents BART for each source, the State first reviewed existing controls on the five BART-eligible units at the Blue Ridge facility to assess whether these constituted the best controls currently available, then identified what other technically feasible controls are available, and finally, evaluated the technically feasible controls using the five BART statutory factors. The units subject to the BART requirements at Blue Ridge Paper include the two recovery furnaces, their associated smelt dissolving tanks, and the black liquor oxidation system. DAQ concluded that BART for all of these emissions sources is the existing emissions control systems currently in place. As discussed in the proposal (seesection IV.C.6.C, February 28, 2012, 77 FR 11874), DAQ evaluated the available controls for BART and determined that these additional controls were either technically or economically infeasible. EPA has reviewed North Carolina's analyses and concluded that they were conducted in a manner that is consistent with EPA's BART Guidelines and EPA'sAir Pollution Control Cost Manual(http://www.epa.gov/ttncatc1/products.html#cccinfo).Therefore, the conclusions reflect a reasonable application of EPA's guidance to these sources.

Comment 7:The Commenter contends that EPA must require North Carolina to include “a retirement discussion that provides a realistic picture of future emissions from BART-subject sources” in its SIP pursuant to 40 CFR 51.308(d)(3)(v) as there is “no discussion of planned or potential EGU (or other source) retirements due to changes in energy markets, new regulations, and other factors.”

Response 7:Source retirement and replacement schedules are explicitly part of the emissions inventory that the State used to project future conditions. The projected inventories for 2009 and 2018 account for post-2002 emissions reductions from promulgated and proposed federal, state, local, and site-specific control programs. For EGUs, the Integrated Planning Model (IPM) was run to estimate emissions of the proposed and existing units in 2009 and 2018. These results were adjusted based on state and local air agencies' knowledge of planned emissions controls at specific EGUs. In the case of North Carolina, DAQ replaced all IPM 2009 results with emissions projections from Duke Power's and Progress Energy's North Carolina Clean Smokestacks Act Compliance Plan for 2006. For non-EGUs, Visibility Improvement State and Tribal Association of the Southeast (VISTAS) used recently updated growth and control data consistent with the data used in EPA's CAIR analyses and supplemented by state and local air agencies' data and updated forecasts from the U.S. Department of Energy. These updates are documented in the MACTEC emissions inventory report “Documentation of the 2002 Base Year and 2009 and 2018 Projection Year Emission Inventories for VISTAS” dated February 2007 (Appendix D of the North Carolina regional haze SIP submittal). The technical information provided in the record demonstrates that the emissions inventory in the SIP adequately reflects projection 2018 conditions and that the LTS meets the requirements of the RHR and is approvable. EPA finds that these inventories provide a reasonable assessment of future emissions from North Carolina sources.

Comment 8:According to the Commenter, it was “inappropriate and arbitrary for DAQ to use the [State's Clean Smokestack's Act] cost per ton of SO2removed as the cost threshold for evaluating reasonable progress controls. The only rationale DAQ offered in support of this decision was that DAQ `believes it is not equitable to require non-EGUs to bear a greater economic burden than EGUs for a given control strategy'. * * * EPA acknowledges that `the use of a specific threshold for assessing costs means that a state may not fully consider available emissions reduction measures above its threshold that would result in meaningful visibility improvement,' but proposes to approve North Carolina's reasonable progress analysis anyway. EPA should re-evaluate this decision in its final action on this proposal, especially in light of the fact that DAQ determined that no additional reasonable controls were required at any of the sources affecting visibility in North Carolina's Class I areas.”

Response 8:As noted in EPA's Reasonable Progress Guidance,6 the states have wide latitude to determine appropriate additional control requirements for ensuring reasonable progress, and there are many ways for a state to approach identification of additional reasonable measures. States must consider, at a minimum, the four statutory factors in determining reasonable progress, but states have flexibility in how to take these factors into consideration.

After reviewing DAQ's methodology and analyses and the record prepared byDAQ, EPA finds North Carolina's conclusion that no further controls are necessary at this time acceptable. As discussed in EPA's February 28, 2012, proposal, the State adequately evaluated the control technologies available at the time of its analysis and applicable to this type of facility and consistently applied its criteria for reasonable compliance costs.See77 FR 11872. The State also included appropriate documentation in its SIP of the technical analysis it used to assess the need for and implementation of reasonable progress controls. Although the use of a specific threshold for assessing costs means that a state may not fully consider available emissions reduction measures above its threshold that would result in meaningful visibility improvement, EPA believes that the North Carolina SIP ensures reasonable progress.

In approving North Carolina's reasonable progress analysis, EPA is placing great weight on the fact that there is no indication in the SIP revision that North Carolina, as a result of using a specific cost effectiveness threshold, rejected potential reasonable progress measures that would have had a meaningful impact on visibility in its Class I areas.

Comment 9:The Commenter believes that EPA should require the State to verify that units 3 and 4 at PCS Phosphate have been shut down.

Response 9:The construction permit for the new unit 7 required the shutdown of these two units as a condition of commencing operation. The new unit is operating, and units 3 and 4 have been shut down.

Comment 10:The Commenter states that “[a]ssurances of the State's `intent' to `have discussions' and to `encourage' pollution reduction measures” at Blue Ridge Paper, provided in response to the Federal Land Managers' (FLMs') request that the State describe a plan to consult with Blue Ridge Paper on potential control actions prior to 2018 that may warrant a higher cost of control for reasonable progress, “does not satisfy the requirement to demonstrate reasonable progress toward the State's visibility goals.”

Response 10:North Carolina did not rely on additional controls at this facility to demonstrate that the State would meet its RPGs for this first implementation period, and DAQ stated in its SIP revision that additional controls are not required at the facility during the first implementation period. The State did not rely on the “discussions” and “encouragement” to contribute any emissions reductions to meeting the RPG goals for this first implementation period. It also made clear that conclusions reached regarding appropriate levels of control to meet reasonable progress for this first implementation period did not extend to the next implementation period. In subsequent implementation periods, North Carolina will once again determine the pollutants and sources with the greatest impact on visibility and implement appropriate emissions reduction measures as part of North Carolina's LTS for future implementation periods.

Comment 11:The Commenter claims that there is no information in the docket supporting the cost estimates for Blue Ridge Paper Products used by the State to determine that “there are no cost-effective controls available for these units at this time within the cost threshold established for this reasonable progress assessment. . . . Without supporting data in the docket, neither we nor EPA can determine that the proper costing methodology was followed.”

Response 11:Blue Ridge Paper Products submitted supporting materials to the State for the BART determination that adequately document the cost methodology for the control equipment (included in Appendix L.10 of North Carolina's regional haze SIP submittal). North Carolina also summarized its evaluation methodology for lower sulfur coal options for two additional units evaluated for reasonable progress (Appendix H of the North Carolina's regional haze SIP submittal). Since this analysis involved the use of alternative coals, it is based on the cost premium for these coals and no costs for additional control equipment are projected. EPA has reviewed the supporting materials provided by DAQ and finds no reason to question the estimates or the conclusions reached by the State.

Comment 12:The Commenter recommends that EPA defer action on the Reasonable Progress analysis for Blue Ridge Paper Products until the State conducts a “valid four-factor analysis” and provides that analysis for public review. Specifically, the Commenter “could find no information in the docket to support any of the `cost of compliance' estimates presented by EPA” and without such documentation, the Commenter is “unable to provide informed comments on their validity or on the conclusions upon which they were based.”

Response 12:See the response to Comment 11. In addition, EPA notes that the Commenter was provided a draft of the North Carolina's regional haze SIP for review prior to the State's release of the SIP revision for public comment, and that the SIP revision went through public notice and comment rulemaking before the State submitted it to EPA. The Commenter raised no concerns with the adequacy of the documentation prior to EPA's proposed limited approval action.

Under CAA sections 301(a) and 110(k)(6), and EPA's long-standing guidance, a limited approval results in approval of the entire SIP revision, even of those parts that are deficient and prevent EPA from granting a full approval of the SIP revision.7 Today, EPA is finalizing a limited approval of North Carolina's December 17, 2007, regional haze SIP revision. This limited approval results in approval of North Carolina's entire regional haze submission and all its elements. EPA is taking this approach because North Carolina's SIP will be stronger and more protective of the environment with the implementation of those measures by the State and having federal approval and enforceability than it would without those measures being included in its SIP.

EPA is finalizing a limited approval of a revision to the North Carolina SIP submitted by the State of North Carolina on December 17, 2007, as meeting some of the applicable regional haze requirements as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-308.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Under the Paperwork Reduction Act, 44 U.S.C. 3501et seq.,OMB must approve all “collections of information” by EPA. The Act defines “collection of information” as a requirement for answers to “* * * identical reporting or recordkeeping requirements imposed on ten or more persons * * *”. 44 U.S.C. 3502(3)(A). The Paperwork Reduction Act does not apply to this action.

The RFA generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the CAA do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the federal-state relationship under the CAA, preparation of flexibility analysis would constitute federal inquiry into the economic reasonableness of state action. The CAA forbids EPA to base its actions concerning SIPs on such grounds.Union Electric Co.,v.EPA,427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under sections 202 of the UMRA of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a federal mandate that may result in estimated costs to state, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that today's action does not include a federal mandate that may result in estimated costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector. This federal action approves pre-existing requirements under state or local law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

Federalism(64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the federal government provides the funds necessary to pay the direct compliance costs incurred by state and local governments, or EPA consults with state and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has Federalism implications and that preempts state law unless the Agency consults with state and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule.

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

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Section 12 of the NTTAA of 1995 requires federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 27, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.Seesection 307(b)(2).

40 CFR part 52 is amended as follows:

Regional haze is visibility impairment that is produced by a multitude of sources and activities which are located across a broad geographic area and emit fine particles (e.g., sulfates, nitrates, organic carbon, elemental carbon, and soil dust), and their precursors (e.g., sulfur dioxide (SO2), nitrogen oxides (NOX), and in some cases, ammonia and volatile organic compounds. Fine particle precursors react in the atmosphere to form fine particulate matter (PM2.5) which impairs visibility by scattering and absorbing light. Visibility impairment reduces the clarity, color, and visible distance that one can see. PM2.5can also cause serious health effects and mortality in humans and contributes to environmental effects such as acid deposition and eutrophication.

In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I areas which impairment results from manmade air pollution.” On December 2, 1980, EPA promulgated regulations to address visibility impairment in Class I areas that is “reasonably attributable” to a single source or small group of sources, i.e., “reasonably attributable visibility impairment.”See45 FR 80084. These regulations represented the first phase in addressing visibility impairment. EPA deferred action on regional haze that emanates from a variety of sources until monitoring, modeling, and scientific knowledge about the relationships between pollutants and visibility impairment were improved.

Congress added section 169B to the CAA in 1990 to address regional haze issues. EPA promulgated a rule to address regional haze on July 1, 1999 (64 FR 35713), the Regional Haze Rule (RHR). The RHR revised the existing visibility regulations to integrate into the regulation provisions addressing regional haze impairment and established a comprehensive visibility protection program for Class I areas. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309. The requirement to submit a regional haze SIP applies to all 50 states, the District of Columbia, and the Virgin Islands. 40 CFR 51.308(b) requires states to submit the first implementation plan addressing regional haze visibility impairment no later than December 17, 2007.

On September 22, 2008, and May 9, 2011, MDEQ submitted revisions to Mississippi's SIP to address regional haze in the State's and other states' Class I areas. On February 28, 2012, EPA published an action proposing a limited approval of Mississippi's SIP revisions to address the first implementation period for regional haze.1 See77 FR 11879. EPA proposed a limited approval of Mississippi's SIP revisions to implement the regional haze requirements for Mississippi on the basis that this revision, as a whole, strengthens the Mississippi SIP. See section II of this rulemaking for a summary of the comments received on the proposed actions and EPA's responses to these comments. Detailed background information and EPA's rationale for the proposed action is provided in EPA's February 28, 2012, proposed rulemaking.See77 FR 11879.

Following the remand of CAIR, EPA issued a new rule in 2011 to address the interstate transport of NOXand SO2in the eastern United States.See76 FR 48208 (August 8, 2011) (“the Transport Rule,” also known as the Cross-State Air Pollution Rule (CSAPR)). On December 30, 2011, EPA proposed to find that the trading programs in the Transport Rule would achieve greater reasonable progress towards the national goal of achieving natural visibility conditions than would Best Available Retrofit Technology (BART) in the states in which the Transport Rule applies.See76 FR 82219. Based on this proposed finding, EPA also proposed to revise the RHR to allow states to substitute participation in the trading programs under the Transport Rule for source-specific BART. EPA finalized this finding and RHR revision on June 7, 2012 (77 FR 33642).

Also on December 30, 2011, the D.C. Circuit stayed the Transport Rule (including the provisions that would have sunset CAIR and the CAIR FIPs) and instructed the EPA to continue to administer CAIR pending the outcome of the court's decision on the petitions for review challenging the Transport Rule.EME Homer Cityv.EPA,No. 11-1302.

EPA received three sets of comments on the February 28, 2012, rulemaking proposing a limited approval of Mississippi's regional haze SIP revisions. Specifically, the comments were received from the National Park Service, Sierra Club, and the Chevron Products Company. Full sets of the comments provided by all of the aforementioned entities (hereinafter referred to as “the Commenter”) are provided in the docket for today's final action. A summary of the comments and EPA's responses are provided below.

Comment 1:The Commenter believes that Mississippi's regional haze SIP is inadequate because it does not properly identify sources that should be subject to a reasonable progress analysis and disagrees with MDEQ's decision to not subject Mississippi Power Company—Plant Watson (Plant Watson) and the DuPont Delisle facility to a reasonable progress control evaluation on the basis that Louisiana did not identify these plants as potentially impacting the Breton Wilderness Area (Breton). The Commenter recognizes that it should be the responsibility of the state in which a federal Class I area is located to determine which sources should be evaluated for reasonable progress but also states its belief that, when a state fails to adequately address the federal Class I areas within its borders, the responsibility for protecting visibility at that federal Class I area shifts to those states who have identified sources within their boundaries that impact that federal Class I area. Therefore, the Commenter contends that MDEQ should consider applying some level of control to the two aforementioned facilities even though the Louisiana regional haze SIP submittal did not specifically identify them in its control strategy for Breton. The Commenter also states that there is no evidence that Mississippi consulted or corresponded with Louisiana regarding the potential visibility impacts from these two facilities.

Response 1:EPA disagrees with the Commenter's conclusion that the responsibility for developing an adequate long-term strategy (LTS) shifts from states with federal Class I areas within their boundaries to neighboring states. EPA's regulations are clear that “[w]here the State has emissions that are reasonably anticipated to contribute to visibility impairment in any mandatory Class I Federal area located in another State or States, the State must consult with the other State(s) in order to develop coordinated emission management strategies.” 40 CFR 52.308(d)(3)(i).

MDEQ has met its obligation to consult with Louisiana. In December 2006 and in May 2007, the State Air Directors from the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) states held formal interstate consultation meetings to discuss the methodology proposed by VISTAS for identifying sources to evaluate for reasonable progress. The states invited Federal Land Managers (FLMs) and EPA representatives to participate and to provide additional feedback, and the State Air Directors discussed the results of analyses showing contributions to visibility impairment from states to each of the federal Class I areas in the VISTAS region. Mississippi received letters from Louisiana and Alabama transmitting prehearing drafts of their regional haze SIPs and provided documentation of this correspondence and summaries of formal consultation meetings in Appendix J of the September 2008 Mississippi SIP submittal. MDEQ concurred on the reasonable progress goals (RPGs) for Breton and the Sipsey Wilderness Area and committed to continue collaboration with these states in the preparation of future VISTAS studies and analyses and in addressing regional haze issues in future implementation periods.

In addition, 40 CFR 51.308(d)(3)(ii) requires each state that causes or contributes to impairment in a mandatory federal Class I area to demonstrate that it has included in its implementation plan all measures necessary to obtain its share of the emissions reductions needed to meet the progress goals for the area. MDEQ has met its obligations with regard to obtaining emissions reductions since no additional control measures specific to Mississippi were identified by the Louisiana reasonable progress analysis. As noted in the proposal, after the time of Mississippi's original 2008 SIP submittal, Louisiana completed and submitted a regional haze SIP to address visibility at Breton. Neither Plant Watson nor the DuPont DeLisle facility were identified by Louisiana, either through consultations with Mississippi or in the Louisiana regional haze SIP, as sources potentially impacting Breton for which a reasonable progress control evaluation would be needed. Thus, EPA believes it is appropriate for Mississippi to determine that no further control analysis was necessary at these facilities at this time. Since Breton is in Louisiana, EPA believes that Mississippi appropriately relied on Louisiana's determination of which sources to prioritize for reasonable progress control evaluation during this implementation period. Mississippi has committed to continue to consult with Louisiana to assess the potential impact of facilities in Mississippi to help meet the visibility goals for Breton for future implementation periods.

Comment 2:The Commenter states that MDEQ improperly estimated emissions reductions for 2018 and that Mississippi's projection of future visibility conditions for 2018 is based on “uncertain federal and state pollution control projects, including, in large part, on the emissions reductions anticipated from CAIR.” The Commenter also believes that anticipated emissions reductions resulting from the other control programs considered by Mississippi (e.g., Industrial Boiler Maximum Achievable Control Technology, the Atlanta/Birmingham/Northern Kentucky 1997 8-hour ozone nonattainment area SIP) are just as uncertain as those resulting under CAIR and the Transport Rule, and that Mississippi “need[s] to base its LTS on concrete, definite emissions reductions.” The Commenter requests that, at a minimum, EPA should ensure that MDEQ follows through on its commitment to re-evaluate its ability to meet its RPGs in the five-year progress review.

Response 2:The technical information provided in the record demonstrates that the emissions inventory in the SIP adequately reflects projected 2018 conditions and that the LTS meets the requirements of the RHR and is approvable. Mississippi's 2018 projections are based on the State's technical analysis of the anticipated emissions rates and level of activity for electric generating units (EGUs), other point sources, nonpoint sources, on-road sources, and off-road sources based on their emissions in the 2002 base year, considering growth and additional emissions controls to be in place and federally enforceable by 2018. The emissions inventory used in the regionalhaze technical analyses that was developed by VISTAS with assistance from Mississippi projected 2002 emissions (the latest region-wide inventory available at the time the submittal was being developed) and applied reductions expected from federal and state regulations affecting the emissions of volatile organic compounds and the visibility impairing pollutants NOX, PM, and SO2.

To minimize the differences between the 2018 projected emissions used in the Mississippi regional haze submittal and what actually occurs in 2018, the RHR requires that the five-year review address any expected significant differences due to changed circumstances from the initial 2018 projected emissions, provide updated expectations regarding emissions for the implementation period, and evaluate the impact of these differences on RPGs. It is expected that individual projections within a statewide inventory will vary from actual emissions over a 16-year period. For example, some facilities may shut down whereas others may expand operations. Furthermore, economic projections and population changes used to estimate growth often differ from actual events; new rules are modified, changing their expected effectiveness; and methodologies to estimate emissions improve, modifying emissions estimates. The five-year review is a mechanism to assure that these expected differences from projected emissions are considered and their impact on the 2018 RPGs is evaluated. In the regional haze program, uncertainties associated with modeled emissions projections into the future are addressed through the requirement under the RHR to submit periodic progress reports in the form of a SIP revision. Specifically, 40 CFR 51.308(g) requires each state to submit a report every five years evaluating progress toward the RPGs for each mandatory federal Class I area located in the state and for each federal Class I area outside the state that may be affected by emissions from the state. Since this five-year progress re-evaluation is a mandatory requirement, it is unnecessary for EPA to take additional measures to “ensure” that the State meets its reporting obligation. In the specific instances of uncertainty of future reductions cited by the Commenter, the State's analysis of projected emissions and its reliance on these projections to address its share of the emissions reductions needed to meet the RPGs for Breton in accordance with 40 CFR 51.308(d)(3)(ii) satisfy EPA guidance and the requirements of the regional haze regulations.

Comment 3:The Commenter does not believe that MDEQ can rely on CAIR or the Transport Rule to exempt the seven power plants with BART-eligible EGUs from an SO2and NOXBART analysis. The Commenter enclosed letters that it submitted to EPA on February 28, 2012, with its comments on the Agency's proposed December 30, 2011, rulemaking to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for Mississippi and other states subject to the Transport Rule.See76 FR 82219. The Commenter incorporates the comments in these letters by reference and repeats a subset of those comments, including the following: The Transport Rule cannot serve as the BART-alternative for the regional haze SIP process in Mississippi; EPA has not demonstrated that the Transport Rule assures greater reasonable progress than source-specific BART; EPA failed to account for the geographical and temporal uncertainties in emissions reductions inherent in a cap-and-trade program such as the Transport Rule; EPA underestimated the visibility improvements from BART using “presumptive BART rather than actual BART;” EPA did not consider subsequent revisions to the Transport Rule budget that increase emission allocations for EGUs in Mississippi; and EPA has not accounted for the differences in averaging time under BART, the Transport Rule, and in measuring visibility impacts.

Response 3:These comments are beyond the scope of this rulemaking. In today's action, EPA is finalizing a limited approval of Mississippi's regional haze SIP. EPA did not propose to find that participation in the Transport Rule is an alternative to BART in this action nor did EPA reopen discussions on the CAIR provisions as they relate to BART.2 As noted above, EPA proposed to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for certain states in a separate action on December 30, 2011, and the Commenter is merely reiterating and incorporating comments submitted on that separate action. EPA addressed the Commenter's February 28, 2012, comments concerning the Transport Rule as a BART alternative in a final action that was published on June 7, 2012, and has determined that they do not affect the Agency's ability to finalize a limited approval of Mississippi's regional haze SIP. EPA's response to these comments can be found in Docket ID No. EPA-HQ-OAR-2011-0729 atwww.regulations.gov.

Comment 4:The Commenter asserts that because “the BART component of Mississippi's RH SIP is an essential element to the state's LTS for achieving its RPGs, Mississippi's treatment of CAIR (and now EPA's proposed substitution of CSAPR for CAIR) as an acceptable BART-alternative must be addressed in this present comment process. Separating the BART analysis from the remaining portion of the RH SIP would result in an inadequate SIP.” The Commenter supports its position by repeating statements made in its February 28, 2012, comments on the Agency's proposed December 30, 2011, rulemaking to find that the Transport Rule is “Better than BART” and to use the Transport Rule as an alternative to BART for Mississippi and other states subject to the Transport Rule. For example, the Commenter states that “EPA cannot exempt sources from the RHR's BART requirements without full consideration of how that exemption would affect the overarching reasonable progress mandate.”

Response 4:As discussed in the response to Comment 3, today's action does not address reliance on CAIR or CSAPR to satisfy BART requirements. Comments related to the approvability of CAIR or CSAPR for the Mississippi regional haze SIP are therefore beyond the scope of this rulemaking and were addressed by EPA in a separate action published on June 7, 2012 (77 FR 33642). EPA addressed the Commenter's repeated statements regarding the interrelatedness of BART, the LTS, and RPGs in that final rulemaking action and those responses support this limited approval action.3

EPA believes the Commenter overstates the overarching nature of the changes due to CAIR or CSAPR. The reliance on CAIR in the Mississippi submittal was consistent with EPA policy at the time the submittal wasprepared. CSAPR is a replacement for CAIR, addressing the same regional EGU emissions, with many similar regulatory attributes. The need to address changes to the LTS resulting from the replacement of CAIR with CSAPR was acknowledged in the proposal, and as stated in the proposal, EPA believes that the five-year progress report is the appropriate time to address any changes to the RPG demonstration and, if necessary, the LTS. EPA expects that this demonstration will address the impacts on the RPG due to the replacement of CAIR with CSAPR as well as other adjustments to the projected 2018 emissions due to updated information on the emissions for other sources and source categories. If this assessment determines an adjustment to the regional haze plan is necessary, EPA regulations require a SIP revision within a year of the five-year progress report.

Comment 5:The Commenter believes that EPA's December 30, 2011, proposed substitution of CSAPR for source-specific BART is uniquely problematic in Mississippi since CSAPR only covers ozone season NOXemissions in the State. According to the Commenter, EPA should require year-round NOXcontrols since any controls that might be installed to meet CSAPR will not protect Breton, the Sipsey Wilderness Area, or other nearby federal Class I areas during the seven months outside of the ozone season. The Commenter reiterates that Mississippi must address BART for SO2and PM since the State is no longer included in a trading program for SO2. One of the Commenters also expressed concern with EPA's statement that the disapproval of the BART provisions for SO2will trigger a 24-month clock for EPA to either implement a FIP to address those requirements or approve a revised SIP from the State that addresses SO2BART. The Commenter believes that this approach allows the State to further delay conducting SO2BART analyses for its BART-eligible EGUs and that these analyses must be conducted immediately.

Response 5:As discussed in the response to Comment 3, today's rule takes final action on the limited approval of Mississippi's regional haze SIP revisions. EPA did not propose to find that participation in the Transport Rule is an alternative to BART in this rulemaking. As noted above, EPA made this proposed finding in a separate action on December 30, 2011. These comments are therefore beyond the scope of this rulemaking and were addressed, as appropriate, by EPA in its final action (published on June 7, 2012) on the December 30, 2011, proposed rule. EPA has determined that the comments do not affect the Agency's ability to finalize a limited approval of Mississippi's regional haze SIP. Regarding the timing of a FIP, the EPA statement identified by the Commenter is a summary of the statutory requirements in section 110(c) of the CAA.

Comment 6:According to the Commenter, Mississippi should have considered the cumulative impacts of the PM emissions from the Moselle and D Morrow facilities when performing BART determinations and should not have modeled these sources in isolation of one another or without regard to PM emissions from sources in other states impacting any federal Class I area. The Commenter also believes that MDEQ should have considered both filterable and condensable PM when conducting its modeling.

Response 6:As discussed in the proposal, (see section IV.C.6.B.2, February 28, 2012, 77 FR 11889), Mississippi adequately justified its contribution threshold of 0.5 deciview. While states have the discretion to set an appropriate contribution threshold considering the number of emissions sources affecting the federal Class I area at issue and the magnitude of the individual sources' impacts, the states' analysis must be consistent with the CAA, the Regional Haze regulations and EPA'sGuidelines for BART Determinations Under the Regional Haze Ruleat Appendix Y to 40 CFR Part 51 (BART Guidelines). Consistent with the regulations and EPA's guidance, “the contribution threshold should be used to determine whether an individual source is reasonably anticipated to contribute to visibility impairment. You should not aggregate the visibility effects of multiple sources and compare their collective effects against your contribution threshold because this would inappropriately create a `contribution to contribution' test.”See also70 FR 39121. Mississippi's analyses in its regional haze SIP revisions were consistent with EPA's regulations and guidance on the issue of cumulative analyses.

It is unclear what condensable PM emissions the Commenter believes that the State should have included in its visibility modeling. Each of the units evaluated for BART in Mississippi's regional haze SIP submittal followed the VISTAS modeling protocol and considered the contribution of total PM10and PM2.5(as a subset of the total PM10) as well as condensable PM (primarily sulfuric acid mist) (see Appendix L of Mississippi's regional haze SIP submittal). Regarding modeling in Mississippi's submittal that uses PM only for its BART-eligible EGUs, EPA previously determined that this approach is appropriate for EGUs where the State proposed to rely on CAIR to satisfy the BART requirements for SO2and NOX.4

Comment 7:The Commenter states that Mississippi's BART analyses for Chevron Products' Pascagoula refinery (Chevron) and Mississippi Phosphates Corporation (MPC) are insufficient, and therefore, EPA cannot approve the State's regional haze SIP. Regarding Chevron, the Commenter disagrees with MDEQ's determination that significant visibility improvement could not be gained at reasonable cost over the improvements already attained through the facility's air permits and a June 7, 2005, consent decree. The Commenter contends that a more robust cost analysis is necessary to assure that the costs outweigh the visibility benefits from the evaluated pollution controls and that Mississippi should have considered additional pollution control technologies in its analysis such as selective catalytic reduction and selective non-catalytic reduction for NOX. Regarding MPC, the Commenter believes that the best available control technology (BACT) emissions limits for SO2(determined to be BART) are not sufficiently stringent because it believes that emissions limits determined to be BACT for sulfuric acid plants at other facilities have been set at lower levels. The Commenter does not believe that Mississippi provided an adequate explanation as to why it did not set its BACT level as low as those set for similar facilities. The Commenter is also concerned that Mississippi's regional haze SIP does not discuss enforceable limits for NOX, particulates, or sulfuric acid mist at the facility and states that MDEQ should have analyzed emissions limits at other facilities when evaluating BART.

Response 7:As stated in Appendix Y of 40 CFR part 51, available retrofit control options are those air pollution control technologies with a practical potential for application to the emissions unit and the regulated pollutant under evaluation. In identifying “all” options, a state must identify the most stringent option and a reasonable set of options for analysis that reflects a comprehensive list of available technologies. It is notnecessary to list all permutations of available control levels that exist for a given technology; the list is complete if it includes the maximum level of control that each technology is capable of achieving.5

For Chevron, MDEQ concluded that all the planned controls in the aforementioned consent decree for the Chevron facility were BART. The State then evaluated additional control options for BART for the most significant units that remain uncontrolled after the planned emissions controls were installed. The costs and visibility impacts were assessed in accordance with EPA guidance. Emissions reductions from the evaluated control options are projected to provide limited visibility improvements ranging from 0.043 deciview to 0.16 deciview, which are beyond those expected from the already planned emissions reductions. For each option, the total cost effectiveness and incremental cost effectiveness exceed $29 million per deciview; therefore, Mississippi determined that these options are not BART. A detailed analysis is provided in Appendix L10 of Mississippi's regional haze SIP submittal.

Regarding MPC, BACT and BART are both case-specific determinations. MDEQ determined BACT to be the replacement of vanadium catalyst with cesium catalyst in the third and fourth converter passes, yielding emissions of 3.0 pounds of SO2per ton of sulfuric acid produced. MDEQ believes that this BACT determination is sufficient because sulfuric acid plants with more stringent limits had a 3/1 converter design as compared to MPC's current 2/2 converter design. Even though the technology being applied is identical to that applied to other facilities, the 3/1 design achieves a higher conversion rate resulting in approximately a 50 percent reduction of SO2in the exhaust compared to the exhaust from a 2/2 converter design. MPC identified mist eliminators as the most effective sulfuric acid mist control technology, and MDEQ determined BART to be vertical tube mist eliminators in the interpass absorption tower. The final absorption tower already has these mist eliminators installed. MPC also proposed to replace the economizer prior to the final absorption tower with a larger one which will have the effect of lowering the exhaust gas temperature and thus reducing sulfuric acid mist emissions. Since the vertical tube mist eliminators are the most efficient add-on control technology, no additional control technologies were considered. MPC has determined a sulfuric acid mist limit of 0.10 pound sulfuric acid mist per ton of sulfuric acid produced, and MDEQ considers this limit consistent with recent BACT determinations since it is among the most stringent achieved in practice. Concerning NOXand particulates, sulfuric acid plants are not a primary source of NOXor PM emissions. See Mississippi's May 9, 2011, regional haze SIP submittal for a detailed discussion of the determination and the permit to construct.

EPA has reviewed MDEQ's analyses and concluded they were conducted in a manner that is consistent with EPA's BART Guidelines and reflect a reasonable application of EPA's guidance to these sources.

Comment 8:The Commenter contends that Mississippi's regional haze SIP must be revised to address Reasonably Attributable Visibility Impairment (RAVI) within three years of a FLM certifying visibility impairment and that the State's commitment to address RAVI, should a FLM certify visibility impairment, is not enough.

Response 8:The State's regional haze SIP revisions do not address RAVI requirements since RAVI is addressed by a different regulation than the RHR. EPA's visibility regulations direct states to coordinate their RAVI LTS provisions with those for regional haze and require the RAVI portion of a SIP to address any integral vistas identified by the FLMs. However, as stated in the March 28, 2012, proposed rulemaking, there are no federal Class I areas in Mississippi. There are no integral vistas in Mississippi or nearby federal Class I areas, no federal Class I areas near Mississippi are experiencing RAVI, nor are any Mississippi sources affected by the RAVI provisions. Thus, the Mississippi regional haze SIP revisions did not explicitly address the coordination of the regional haze with the RAVI LTS, although Mississippi did commit to ongoing consultation with the FLMs throughout the implementation process. EPA finds that Mississippi's regional haze SIP appropriately addresses the RAVI visibility provisions in its LTS. The commitments in Mississippi's SIP are consistent with the regulatory requirements for this provision.

Comment 9a:The Commenter claims that EPA must disapprove Mississippi's regional haze SIP because the SIP does not explain how monitoring data and other information will be used to determine the contribution of emissions from within the State to regional haze visibility impairment at Class I areas (see combined response below for comments 9a and 9b).

Comment 9b:The Commenter states that the SIP must clearly identify the method by which the State intends to report visibility monitoring to the EPA. If Mississippi plans to rely on the referenced Visibility Information Exchange Web System (VIEWS) Web site for reporting, the Commenter believes that the SIP must clearly state that Mississippi intends to use the Web site as its way of reporting visibility monitoring data and that “it is not sufficient for Mississippi to `encourage' VISTAS to maintain the web site.” The Commenter also believes that Mississippi's SIP needs to have an enforceable mechanism to transmit the Interagency Monitoring of Protected Visual Environments (IMPROVE) data to EPA as well as an enforceable mechanism to ensure that the IMPROVE data is continually gathered by Mississippi “unless it is gathered by other entities such as VISTAS and the National Park Service” or EPA “must disapprove the SIP submittal in this regard.”

Responses 9a, b:As noted by the Commenter, the primary monitoring network for federal Class I areas potentially affected by sources in Mississippi is the IMPROVE network. The responsibility for assuring that there is adequate monitoring and reporting of this data is with the state where the federal Class I area is located, and there are no IMPROVE sites in Mississippi since it has no federal Class I areas. In the SIP submittal, Mississippi states its intention to continue to consult with the FLMs annually on monitoring data from the IMPROVE network for federal Class I areas in adjacent states that might be affected by Mississippi sources. Monitoring data is different from emissions data or analyses conducted to attribute contribution, and these analyses are therefore part of the ten-year implementation period updates conducted by the states.

In its SIP revisions, Mississippi states its intention to rely on the IMPROVE network for complying with the regional haze monitoring requirement in EPA's RHR for the current and future regional haze implementation periods. Data produced by the IMPROVE monitoring network will be used nearly continuously for preparing the five-year progress reports and the 10-year SIP revisions, each of which relies on analysis of the preceding five years of data. The VIEWS Web site has been maintained by VISTAS and the other regional planning organizations (RPOs) to provide ready access to the IMPROVEdata and data analysis tools. Mississippi is encouraging VISTAS and the other RPOs to maintain the VIEWS or a similar data management system to facilitate analysis of the IMPROVE data. Mississippi cannot legally bind federal and state legislatures to continue to fund the monitoring program for regional haze. Mississippi's SIP adequately addresses this provision and explains how monitoring data and other information has been and will be used to determine the contribution of emissions from within the State to regional haze visibility impairment at federal Class I areas.

Under CAA sections 301(a) and 110(k)(6) and EPA's long-standing guidance, a limited approval results in approval of the entire SIP revision, even of those parts that are deficient and prevent EPA from granting a full approval of the SIP revision.6 Today, EPA is finalizing a limited approval of Mississippi's regional haze SIP revisions. This limited approval results in approval of Mississippi's entire regional haze SIP and all its elements. EPA is taking this approach because Mississippi's SIP will be stronger and more protective of the environment with the implementation of those measures by the State and having federal approval and enforceability than it would without those measures being included in its SIP.

EPA is finalizing a limited approval of revisions to the Mississippi SIP submitted by the State of Mississippi on September 22, 2008, and May 9, 2011, as meeting some of the applicable regional haze requirements as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-308.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Under the Paperwork Reduction Act, 44 U.S.C. 3501et seq.,OMB must approve all “collections of information” by EPA. The Act defines “collection of information” as a requirement for answers to “* * * identical reporting or recordkeeping requirements imposed on ten or more persons * * *”. 44 U.S.C. 3502(3)(A). The Paperwork Reduction Act does not apply to this action.

The RFA generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the CAA do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the federal-state relationship under the CAA, preparation of flexibility analysis would constitute federal inquiry into the economic reasonableness of state action. The CAA forbids EPA to base its actions concerning SIPs on such grounds.Union Electric Co.,v.EPA,427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under sections 202 of the UMRA of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a federal mandate that may result in estimated costs to state, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that today's action does not include a federal mandate that may result in estimated costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector. This federal action approves pre-existing requirements under state or local law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

Federalism(64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the federal government provides the funds necessary to pay the direct compliance costs incurred by state and local governments, or EPA consults with state and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has Federalism implications and that preempts state law unless the Agency consults with state and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule.

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

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Section 12 of the NTTAA of 1995 requires federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 27, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.Seesection 307(b)(2).

40 CFR part 52 is amended as follows:

I. General Information A. Does this action apply to me?

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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2011-0397 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 27, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0397, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket,along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof July 20, 2011 (76 FR 43231) (FRL-8880-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7855) by IR-4,500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.434 be amended by establishing tolerances for residues of the fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-dichlorobenzoic acid (DCBA) and expressed as parent compound, in or on bean, snap at 0.8 ppm; bean, succulent shelled at 0.15 ppm; bean, dry seed at 0.3 ppm; legume, foliage at 25 ppm; tomato at 2.5 ppm; fruit, citrus, group 10-10 at 8.0 ppm; fruit, stone, group 12, except plum at 7.0 ppm; and plum at 1.0 ppm. The petition also requested that the existing tolerance for stone fruit group 12 at 1.0 ppm be removed upon establishment of the requested tolerances. That notice referenced a summary of the petition prepared by Syngenta, the registrant, which is available 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, EPA has modified the levels at which tolerances are being set for various commodities as well as some commodity definitions. The reason for these changes is 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.* * *”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for propiconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with propiconazole 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.

Propiconazole has low to moderate toxicity in experimental animals by the oral, dermal and inhalation routes. It is moderately irritating to the eyes, and minimally irritating to the skin. It is a dermal sensitizer. Propiconazole is readily absorbed by the rat skin with 40% absorption within 10 hours of dermal application.

The primary target organ for propiconazole toxicity in animals is the liver. Increased liver weights were seen in mice after subchronic or chronic oral exposures to propiconazole at doses greater than 50 milligrams/kilograms/day (mg/kg/day). Liver lesions such as vacuolation of hepatocytes, ballooned liver cells, foci of enlarged hepatocytes, hypertrophy and necrosis are characteristic of propiconazole toxicity in rats and mice. Mice appear to be more susceptible to its toxicity than rats. Decreased body weight gain in experimental animals was seen in subchronic, chronic, developmental and reproductive studies. Dogs appeared to be more sensitive to the localized toxicity of propiconazole as manifested by stomach irritation at 6 mg/kg/day and above.

In rabbits, developmental toxicity occurred at a higher dose than the maternally toxic dose, while in rats, developmental toxicity occurred at lower doses than the maternally toxic doses. Increased incidences of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft palate malformations were noted in two studies in rats. In one published study in rats, developmental effects (incomplete ossification of the skull, caudal vertebrae and digits, extra 14th rib and missing sternebrae, malformations of the lung and kidneys) were reported at doses that were not maternally toxic.

In the 2-generation reproduction study in rats, offspring toxicity occurred at a higher dose than the parentally toxic dose, suggesting lower susceptibility of the offspring to the toxic doses of propiconazole in this study.

Propiconazole was negative for mutagenicity in the in vitro BALB/C 3T3 cell transformation assay, bacterial reverse mutation assay, Chinese hamster bone marrow chromosomal aberration assay, unscheduled DNA synthesis studies in human fibroblasts and primary rat hepatocytes, mitotic gene conversion assay and the dominant lethal assay in mice. Hepatocellular proliferation studies in mice suggest that propiconazole induces cell proliferation followed by treatment-related hypertrophy in a manner similar to the known hypertrophic agent phenobarbital.

Propiconazole was carcinogenic to male mice. Propiconazole was not carcinogenic to rats or to female mice. The Agency classified propiconazole as a possible human carcinogen and recommended that, for the purpose of risk characterization, the reference dose (RfD) approach be used for quantification of human risk. Propiconazole is not genotoxic and this fact, together with special mechanistic studies, indicates that propiconazole is a threshold carcinogen. Propiconazole produced liver tumors in male mice only at a high dose that was toxic to the liver. At doses below the RfD, liver toxicity is not expected; therefore, tumors are also not expected.

Specific information on the studies received and the nature of the adverse effects caused by propiconazole 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 athttp://www.regulations.govin docket ID number EPA-HQ-OPP-2011-0397 on pages 43-49 of the document titled “Propiconazole Human Health Risk Assessment for a Section 3 Registration on Snap beans, Succulent shelled beans, Dry Beans, and Post-harvest use on Tomato, Citrus Fruit, and Stone fruit.”

Once a pesticide's toxicological profile is determined, EPA identifiestoxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). 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 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for propiconazole used for human risk assessment is discussed in Unit B of the final rule published in theFederal Registerof Wednesday, May 11, 2011 (76 FR 27261) (FRL-8873-2).

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to propiconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing propiconazole tolerances in 40 CFR 180.434. EPA assessed dietary exposures from propiconazole 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.

Such effects were identified for propiconazole. 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 levels and 100 percent crop treated (PCT) for all existing and proposed uses.

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 levels and 100 PCT for all existing and proposed uses.

iii.Cancer.EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to propiconazole. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.,chronic exposure.

iv.Anticipated residue and percent crop treated (PCT) information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for propiconazole. Tolerance level residues and/or 100 PCT were assumed for all 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 propiconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of propiconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://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 propiconazole for acute exposures are estimated to be 55.78 parts per billion (ppb) for surface water and 0.64 ppb for ground water, for chronic exposures for non-cancer assessments are estimated to be 21.61 ppb for surface water and 0.64 ppb for ground water and for chronic exposures for cancer assessments are estimated to be 13.24 ppb for surface water and 0.64 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 55.8 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 21.6 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). Propiconazole is currently registered for the following uses that could result in residential exposures: turf, ornamentals, and in paint. EPA assessed residential exposure using the following assumptions: Short-term risk to toddlers was assessed for incidental oral and dermal exposure. The highest incidental oral and dermal exposure scenarios are expected from residential use on turf. Short-term risk to adults was assessed for dermal and inhalation residential handler exposure as well as from post-application dermal exposure. Adult handlers have some inhalation exposure; however, based on the low vapor pressure of propiconazole, negligible post application inhalation exposure is anticipated to occur. The highest post application exposure from residential use on turf was used to assess risk to short-term aggregate exposures.

The only residential use scenario that will result in potential intermediate-term exposure to propiconazole is dermal and incidental oral post application exposure to children from wood treatment (antimicrobial use).

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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.”

Propiconazole is a member of the conazole 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 oftoxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). 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, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

Propiconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including propiconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic 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 Food Quality Protection Act (FQPA) safety factor (SF) 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 athttp://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-0497, and an update to assess the addition of the commodities included in this action may be found in docket ID number EPA-HQ-OPP-2011-0397, in the document titled “Common Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk Assessment to Address The Amended Propiconazole Section 3 Registration to Add Uses on Snap beans, succulent shelled beans, dry beans, tomato (post-harvest, citrus (post-harvest), and stone fruit (post-harvest), Difenoconazole, and Flutriafol.”

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.In the developmental toxicity study in rats, fetal effects observed in this study at a dose lower than that evoking maternal toxicity are considered to be quantitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole. In the developmental toxicity study in rabbits, neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole was observed in this study. In the 2-generation reproduction study in rats, neither quantitative nor qualitative evidence of increased susceptibility of neonates (as compared to adults) to prenatal and/or postnatal exposure to propiconazole was observed. There is no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with propiconazole. In the rat acute neurotoxicity study, there was evidence of mild neurobehavioral effects at 300 mg/kg/day, but no evidence of neuropathology from propiconazole administration. Although there was quantitative evidence of increased susceptibility of the young following exposure to propiconazole in the developmental rat study, the Agency determined there is a low degree of concern for this finding and no residual uncertainties because the increased susceptibility was based on minimal toxicity at high doses of administration, clear NOAELs and LOAELs have been identified for all effects of concern, and a clear dose-response has been well defined.

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 propiconazole is complete except for the lack of immunotoxicity and subchronic neutotoxicity studies. In the absence of specific immunotoxicity studies, EPA has evaluated the available propiconazole toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. There was no evidence of adverse effects on the organs of the immune system in any propiconazole study. In addition, propiconazole does not belong to a class of chemicals (e.g.,the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be immunotoxic. Based on the considerations in this Unit, EPA does not believe that conducting a special Harmonized Guideline 870.7800 immunotoxicity study will result in a POD less than the NOAEL of 10.0 mg/kg/day used in calculating the cPAD for propiconazole, and therefore, an additional database uncertainty factor is not needed to account for potential immunotoxicity.

In the absence of the subchronic neurotoxicity study, EPA has evaluated the available propiconazole toxicity data to determine whether an additional database uncertainty factor is needed to account for potential neurotoxicity after repeated exposures. With the exception of the developmental studies in the rat, there were no indications in any of the repeated dose studies that propiconazole is neurotoxic. In the developmental studies in the rat, there were some clinical signs of neurotoxicity at 300 mg/kg/day but not at lower doses. Further, there is no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with propiconazole. In the rat acute neurotoxicity study, there was evidence of mild neurobehavioral effects at 300 mg/kg, but no evidence of neuropathology from propiconazole administration. Based on the considerations in this Unit, EPA does not believe that conducting a Harmonized Guideline 870.6200b subchronic neurotoxicity study will result in a POD less than the NOAEL of 10 mg/kg/day used in calculating thecPAD for propiconazole, and therefore, an additional database uncertainty factor is not needed to account for potential neurotoxicity from repeated exposures.

iii. Although an apparent increased quantitative susceptibility was observed in fetuses and offspring, for the reasons noted in this Unit residual uncertainties or concerns for prenatal and/or postnatal toxicity are minimal.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to propiconazole 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 propiconazole.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to propiconazole will occupy 77% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to propiconazole from food and water will utilize 63% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of propiconazole is not expected.

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).

Propiconazole is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to propiconazole.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 130 for toddlers (children 1 to 2 years old), between 110 and 1700 for adults from handler activities and 290 for adults from post-application activities. Because EPA's level of concern for propiconazole is a MOE of 100 or below, these MOEs are not of concern.

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).

Propiconazole is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to propiconazole.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 74 for toddlers (children 1 to 2 years old). The aggregate MOE is 74, which is less than the target MOE of 100. However, this aggregate MOE is based on 100 PCT and tolerance-level residues concerning food exposure, conservative (protective) assumptions in the ground and surface water modeling, and similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. Additional refinements incorporating average field trial and/or percent crop treated information would result in MOEs well above the target MOE of 100. Therefore, this scenario is not of concern.

5.Aggregate cancer risk for U.S. population.The Agency considers the chronic aggregate risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk.

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

Adequate enforcement methodology, a high performance liquid chromatography with ultraviolet detection method (HPLC/UV Method AG-671A) 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; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established an MRL for propiconazole for any of the subject commodities in this document.

Based on the Agency's evaluation of the residue data submitted with the petition, for all proposed commodities, with the exception of the level for the citrus fruit group 10-10 (8.0 ppm), the Agency has modified the levels for which tolerances are being established. The proposed tolerances for snap bean, succulent shelled beans, stone fruit group 12 except plum, and plum are being reduced to 0.70 ppm, 0.10 ppm, 4.0 ppm, and 0.60 ppm, respectively. The proposed tolerances for foliage of legume foliage, dry bean seed, and tomato are being increased to 30 ppm, 0.40 ppm, and 3.0 ppm, respectively, and the commodity definition for legume foliage is being changed to “vegetable, foliage of legume, group 7.” Lastly, a tolerance for citrus oil is being established at 1000 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial datausing the Agency's Tolerance Spreadsheet in accordance with the Agency'sGuidance for Setting Pesticide Tolerances Based on Field Trial Data.

Therefore, tolerances are established for residues of propiconazole, (1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole) and its metabolites determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on bean, snap at 0.70 ppm; bean, succulent shelled at 0.10 ppm; vegetable, foliage of legume, group 7 at 30 ppm; bean, dry seed at 0.40 ppm; tomato at 3.0 ppm; fruit, citrus, group 10-10 at 8.0 ppm; fruit, stone, group 12, except plum at 4.0 ppm; plum at 0.60 ppm; and citrus, oil at 1000 ppm. Additionally, the established tolerance is removed for fruit, stone, group 12 at 1.0 ppm.

This final rule establishes tolerances under FFDCA section 408(d) 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, entitled “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. 3501et 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 FFDCA section 408(d), 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. 601et 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 FFDCA section 408(n)(4). 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2009-0029 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 27, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 Confidential Business Information (CBI) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0029, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7488) by Nippon Soda Co., Ltd., c/o Nisso America, Inc., 45 Broadway, Suite 2120, New York, NY 10006. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide cyflufenamid, in or on cucurbit vegetables (crop group 9) at 0.05 parts per million (ppm); pome fruit (crop group 11), 0.05 ppm; apple, wet pomace, at 0.10 ppm; small fruit vine climbing, except fuzzy kiwifruit (subgroup 13-07F) at 0.15 ppm; grape, raisin, at 0.30 ppm, and low growing berry (subgroup 13-07G), except cranberry, at 0.20 ppm. That notice referenced a summary of the petition prepared by Nippon Soda Co., Ltd., c/o Nisso America, Inc, the registrant, which is available in the docket, athttp://www.regulations.gov. There were no comments received in response to the notice of filing

Based upon review of the data supporting the petition, EPA has slightly increased the tolerances for pome fruit (Crop Group 11), 0.05 ppm to 0.06 ppm, and cucurbits (Crop Group 9), 0.05 to 0.07 ppm. 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. * * *”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyflufenamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyflufenamid 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. Cyflufenamid has low acute toxicity via the oral, dermal and inhalation routes of exposure. Though slightly irritating to the eye, cyflufenamid is not a skin irritant or sensitizer. In the mammalian toxicology database, the liver was the primary target organ for cyflufenamid toxicity. Across species, duration and gender, changes in weight, clinical chemistry and pathology indicated treatment-related perturbations in and adverse effects on liver function.

Thyroid effects due to treatment with cyflufenamid, seen only in the rat, included increased follicular cell hypertrophy (as well as increased organ weight) and neoplastic thyroid follicular adenomas. Kidney effects related to treatment included increased kidney weight accompanied by tubular vacuolation and slight decreases in sodium and chloride concentrations.

Treatment-related cardiotoxicity was noted in the rat and mouse feeding studies. Observed myocardial vacuolation and lipidosis may be attributed to decreased lipid metabolism; cyflufenamid caused an approximately 50% inhibition of carnitine palmitoyltransferase in both rat and mouse heart microsomal fractions in a non-guideline mechanistic study. Carnitine palmitoyltransferase is involved in the transport of long chain fatty acids into the mitochondrial matrix for oxidation. Fatty acid oxidation is an important source of energy for ATP production in the mitochondria.

Cyflufenamid-induced brain vacuolation was specific to the dog and not associated with any apparent clinical sign of neurotoxicity. Supplementary studies investigating this phenomenon determined that vacuolation was due to myelin edema affecting the white matter of the cerebrum and thalamus. Furthermore, this brain lesion was partially reversed after a 13-week recovery period (following 90-day exposure) and fully reversed after a 26-week recovery period. This effect was not observed in any other species. A subchronic neurotoxicity study in rats showed no evidence of neurotoxicity.

Effects on reproductive organs and/or parameters were noted in several subchronic studies at doses greater than the respective Lowest Observed Adverse Effect Level (LOAELs). Decreased uterus and cervix weights, adrenal cortical hypertrophy and reduced quality and quantity of spermatozoa were observed in dogs. Leydig cell hypertrophy was observed in rats and mice. It is unclear what toxicological significance should be ascribed to these findings since they may be secondary to systemic toxicity or hepatic enzyme induction. Mating performance and fertility in the P/F0generation were both unaffected by treatment with cyflufenamid in the 2-generation reproductive toxicity study in rats. Sex ratio, sexual maturation, estrous cyclicity, sperm quantity and quality, mating performance and fertility, gestation and viability indices in the F1generation were all unaffected by treatment.

Cyflufenamid is classified as “likely to be carcinogenic to humans.” This was based on the presence of two tumor types in two species: Thyroid follicular cell tumors in male rats and liver tumors in male mice. There is no concern for mutagenicity or clastogenicity. The unit risk, Q1*, of cyflufenamid based upon male mouse liver combined adenoma and carcinoma tumor rates is 6.61 × 10−3(mg/kg/day)−1in human equivalents.

Specific information on the studies received and the nature of the adverse effects caused by cyflufenamid 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 athttp://www.regulations.govin document “Human Health Risk Assessment,” docket ID number EPA-HQ-OPP-2009-0029.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). 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 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for cyflufenamid used for human risk assessment is shown in Table 1 below. No hazards were identified for acute dietary across all populations. For dermal short and intermediate term exposures no adverse effects were observed in the dermal toxicity study and there are no concerns for developmental or neurological toxicities, therefore no hazards are expected for these exposure scenarios.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to cyflufenamid, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from cyflufenamid in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for cyflufenamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, this dietary assessment was based on average field trial residues for all proposed crops and 100% crop treated (CT). Empirical processing factors were used for apple juice and grape juice. A separate tolerance was set for grape, raisin; therefore, the processing factor for this commodity was set at 1. For all other processed commodities, Dietary Exposure Evaluation Model (DEEM) version 7.81 default processing factors were assumed.

iii.Cancer.Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.,chronic exposure.

iv.Anticipated residue and percent crop treated (PCT) information.EPA did not use PCT information in the dietary assessment for cyflufenamid. One-hundred PCT were assumed for all food commodities.

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.

2.Dietary exposure from drinking water.The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyflufenamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyflufenamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://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 cyflufenamid for acute exposures are estimated to be 1.14 parts per billion (ppb) for surface water and 4.68 ppb for ground water. Chronic exposures for non-cancer assessments are estimated to be 0.03 ppb for surface water and 4.68 ppb for ground water. Chronic exposures for cancer assessments are estimated to be 0.01 ppb for surface water and 4.68 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

For acute dietary risk assessment, no toxic effects attributable to a single exposure to cyflufenamid have been identified; therefore, an acute reference dose (aRfD) has not been established and an acute dietary exposure assessment was not conducted.

For chronic and cancer dietary risk assessments, the ground water concentration value of 4.68 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).

Cyflufenamid is proposed to be registered for the following uses that could result in residential exposures: Mixing, loading, and applying a soluble concentrate formulation of cyflufenamid for treatment of ornamental plantings and trees. EPA assessed residential exposure using the following assumptions: Based on the use patterns, residential handlers could be exposed to cyflufenamid on a short-term basis. A short-term dermal endpoint was not identified; therefore, only short-term non-cancer inhalation risks and cancer risks for residential handlers were assessed.

When determining the potential for residential post-application exposure, the Agency considers foliar residues, leaf to skin/hand residue transfer, children's hand-to-mouth residue transfer, and exposure time. In the case of cyflufenamid, potential exposure to adults and children would be negligible for the following reasons:

• Activities such as pruning/thinning ornamentals or playing in and around ornamentals when residues may be present on the day of the application are unlikely to co-occur;

• If present, leaf to skin residue transfer would be negligible because of the minimal frequency and duration of contact;

• Children young enough to exhibit hand-to-mouth behavior would not typically play in ornamental beds or trees.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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 cyflufenamid to share a common mechanism of toxicity with any other substances, and cyflufenamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyflufenamid 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 Web site athttp://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.There is no evidence of susceptibility followingin uteroand/or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. There are no residual uncertainties concerning pre- and postnatal toxicity and no neurotoxicity concerns.

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 cyflufenamid is complete, with the exception of an acute neurotoxicity study (ACN, OPPTS 870.6200a). The absence of this study does not raise any uncertainties with regard to the safety of infants and children for the following reasons. First, no acute affects have been attributed to cyflufenamid. In an acute oral toxicity study, adverse effects were noted on the day of administration (limit dose) but not thereafter; clinical signs of piloerection, hunched posture, unsteady gait, pallid extremities, increased salivation, ungroomed appearance and abnormal respiration were observed in the majority of animals receiving 5,000 mg/kg and generally resolved by Day 2 of the study. Second, an acceptable, guideline subchronic neurotoxicity study is available and in it repeat exposure to doses up to approximately 500 mg/kg/day did not elicit any neurotoxic effects as assessed in the functional observational battery, motor activity, neurohistopathology or brain morphometrics. Third, cyflufenamid is not an apparently neurotoxic chemical based on clinical toxicity assessments incorporated within the developmental and chronic rat studies. In several short-term studies in rats (subacute and subchronic feeding, plaque-forming cell assay, one-generation pilot, developmental toxicity), no neurobehavioral signs were observed at the highest doses tested. While the relevant and reversible effect of brain vacuolation was observed in the subchronic dog study at approximately 70 mg/kg/day, it is observed in the absence of overt neurotoxicity and nowhere else in the toxicology database. Finally, based on this information, an acute neurotoxicity screening test is very unlikely to yield a point of departure less than the chronic NOAEL of 4.4 mg/kg/day if any adverse effects are observed at all. Even if the chronic point of departure was used in assessing acute risk, there would be no risk concern based on acute dietary exposure.

ii. There is no indication that cyflufenamid 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 cyflufenamid results in increased susceptibility inin uterorats 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. The chronic dietary assessment assumed 100% crop treated for all commodities and utilized average field trial residues for all proposed crops, default and empirical processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyflufenamid 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 cyflufenamid.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancerrisks, EPA calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, cyflufenamid is not expected to pose an acute risk.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyflufenamid from food and water will utilize 1% of the cPAD for all infants (<1 year old) the population group receiving the greatest exposure.

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). Because no short-term adverse effect was identified, cyflufenamid is not expected to pose a short-term 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). Because no intermediate-term adverse effect was identified, cyflufenamid is not expected to pose a intermediate-term risk.

5.Aggregate cancer risk for U.S. population.Aggregate cancer exposure takes into account residential handler exposure, plus chronic exposure to food and water (considered to be a background exposure level). The aggregate cancer risk (food, water, and residential) is 9.7 × 10−7.

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 cyflufenamid residues.

Adequate multiresidue methods test data for cyflufenamid were submitted. Acceptable recoveries of cyflufenamid from a non-fatty matrix (grape) were achieved under Protocol E. Acceptable recoveries from a fatty matrix (milk) were also achieved under Protocol F. EPA recommends that Food and Drug Administration (FDA) multiresidue methods be used as the primary enforcement method. The submitted data will be forwarded to the FDA for further evaluation.

Adequate enforcement methodologies are available to enforce the tolerance expression. The LC/MS/MS method (Method 070276) was submitted for the determination of cyflufenamid residues in/on pome fruit, cucurbit vegetables, grapes, and strawberries. The proposed enforcement method (Method 070276) which monitors only one transition ion, in combination with the FDA multiresidue method meets the OPPTS Residue Chemistry Test Guidelines for acceptable tolerance enforcement methods (SOP Number ACB-019). An enforcement method for livestock commodities is not needed because tolerances for cyflufenamid residues of concern in meat, milk, poultry, and eggs are not required to support the proposed uses based on the results of the goat metabolism study and the calculated dietary burden.

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; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for cyflufenamid. Cyflufenamid is not registered in Canada.

The EPA increased the proposed tolerance for pome fruit crop group 11 from 0.05 ppm to 0.06 ppm and for cucurbit crop group 9 from 0.05 ppm to 0.07 ppm. These changes were made by EPA based on North American Free Trade Agreement (NAFTA) tolerance calculation procedures according to the Standard Operating Procedure (SOP)Guidance for Setting Pesticide Tolerances Based on Field Trial Data.

Therefore, tolerances are established for residues of cyflufenamid, in or on Apple, wet pomace, 0.10 ppm; Berry, low growing, subgroup 13-07G, except cranberry, 0.20 ppm; Fruit, pome, group 11, 0.06 ppm; Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F, 0.15 ppm; Grape, raisin, 0.30 ppm; Vegetable, cucurbit, group 9, 0.07 ppm.

This final rule establishes tolerances under FFDCA section 408(d) 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, entitled “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. 3501et 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 FFDCA section 408(d), 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. 601et 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 FFDCA section 408(n)(4). 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

This document announces that on May 16, 2012 OMB approved, for a period of three years, the information collection requirements contained in the Commission'sReport and Order,FCC 12-55. The OMB Control Number is 3060-1170. The Commission publishes this notice as an announcement of such approval. Because the information collection was pre-approved prior to the adoption or publication of the final rule, the effective date of this information collection is 30 days after the final rule under FCC 12-55 is published in theFederal Register. 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, 3060-1170, in your correspondence. The Commission will also accept your comments via email atPRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email tofcc504@fcc.govor call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that on May 16, 2012 it received OMB pre-approval for the information collection requirements contained in the modifications to the Commission's rules found in 47 CFR 90.209(b)(7).

Under 5 CFR part 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 current, valid OMB Control Number. The OMB Control Number is 3060-1170.

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 total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number:3060-1170.

OMB Approval Date:May 16, 2012.

OMB Expiration Date:May 31, 2015.

Title:Section 90.209(b)(7)—Bandwidth limitations.

Form Number:N/A.

Type of Review:New collection.

Respondents:Business or other for-profit entities.

Number of Respondents and Responses:27 respondents; 25 responses.

Estimated Time per Response:0.5 up to 8.4 hours.

Frequency of Response:On occasion, third party disclosure requirement.

Obligation to Respond:Required to obtain or retain benefits.

Total Annual Burden:22 hours.

Total Annual Cost:$52,500.

Privacy Impact Assessment:N/A.

Nature and Extent of Confidentiality:None.

Needs and Uses:This information will be used to help ensure that 800 MHz public safety licensees are not impacted by EA-based 800 MHz SMR licensees exceeding the channel spacing and bandwidth requirement in part 90 of the Commission's rules as modified under FCC 12-55. Pursuant to this notice, 800 MHz public safety licensees within the notice area will be able to monitor their networks for any increase in harmful interference in and around the time that an EA-based 800 MHz SMR licensee begins operations that exceed the existing channel spacing and bandwidth limitation in part 90.

If you would like to participate in this rulemaking, you may submit comments and related materials. All comments received will be posted, without change, tohttp://www.regulations.govand will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (FMCSA-2012-0020), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, or by fax, mail or hand delivery, but please use only one of these means. We recommend that you include your name and a mailing address, an email address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. As a reminder, FMCSA will only consider adverse comments as defined in 49 CFR 389.39(b) and explained below.

To submit your comment online, go tohttp://www.regulations.gov,click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Rule” and insert “FMCSA-2012-0020” in the “Keyword” box. Click “Search,” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

To view comments, go tohttp://www.regulations.gov,click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “FMCSA-2012-0020” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. If you do not have access to the Internet, you may also view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. e.t., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted onbehalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008 issue of theFederal Register(73 FR 3316).

FMCSA publishes this direct final rule under 49 CFR 389.11 and 389.39, because the Agency has determined that the rule makes non-controversial, minor amendments to 49 CFR part 369 that will reduce reporting requirements for certain for-hire motor carriers. FMCSA does not expect any adverse comments. If no adverse comments or notices of intent to submit an adverse comment are received by July 27, 2012, this rule will become effective as stated in theDATESsection. In that case, approximately 30 days before the effective date, we will publish a document in theFederal Registerstating that no adverse comments were received and confirming that this rule will become effective as scheduled. However, if we receive any adverse comments or notices of intent to submit an adverse comment, we will publish a document in theFederal Registerannouncing the withdrawal of all or part of this direct final rule. If we decide to proceed with a rulemaking following receipt of any adverse comments, we will publish a separate notice of proposed rulemaking (NPRM) and provide a new opportunity for comment.

A comment is considered “adverse” if the comment explains why this rule or a part of this rule would be inappropriate, including a challenge to its underlying premise or approach, or would be ineffective or unacceptable without a change.

Section 14123 of title 49, United States Code, requires the filing of annual financial reports by certain for-hire motor carriers of property and household goods (Form M).

The annual reporting program was implemented on Dec. 24, 1938 (3 FR 3158) (the first annual report for 1938 was due by Mar. 31, 1939) and subsequently was transferred from the Interstate Commerce Commission (ICC) to the U.S. Department of Transportation's (DOT) Bureau of Transportation Statistics (BTS) on January 1, 1996. The Secretary of DOT delegated to BTS the responsibility for the program on December 17, 1996 (61 FR 68162-02). Responsibility for collection of Form M (for-hire property carriers, including household goods carriers) and Form MP-1 (for-hire passenger carriers), including quarterly reporting requirements for such forms (Form QFR), was transferred from the BTS to the FMCSA on August 17, 2004 (69 FR 51009), and the regulations were redesignated as 49 CFR part 369 on August 10, 2006 (71 FR 45740). FMCSA has continued to collect carriers' annual reports and to furnish copies of the reports requested under the Freedom of Information Act.

Subsection 14123(a)(2) of title 49, United States Code, allows the Agency to require quarterly financial reports from for-hire property and passenger carriers, but it does not mandate that the Agency require these reports to be submitted. These requirements are included in 49 CFR Part 369 and apply to Class I (average annual gross transportation operating revenues of $10 million or more) and Class II (average annual gross transportation operating revenues of $3 million dollars or more, but less than $10 million) for-hire motor carriers of property. The requirements also apply to Class I (average annual gross transportation operating revenues of $5 million or more) for-hire motor carriers of passengers.

On January 18, 2011, the President issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011), which required agencies, among other things, to prepare plans for reviewing existing rules. On February 16, 2011, DOT published a notice requesting comments on its regulatory review plan (76 FR 8940). A public meeting on this issue was held on March 14, 2011. DOT placed all of the comments it received in docket DOT-OST-2011-0025, along with a transcript of the March 14 meeting. DOT received 102 comments, many offering multiple suggestions. One person argued that the financial reporting requirements transferred from the ICC to FMCSA provide no discernible benefits to the government or industry.

FMCSA rescinds the quarterly financial reporting requirements for certain for-hire motor carriers of property (Form QFR) and for-hire motor carriers of passengers (Form MP-1). This burden can be removed without an adverse impact on safety or the Agency´s ability to maintain effective commercial regulations over the for-hire trucking and passenger-carrying industries. FMCSA does not currently use the quarterly reports because the reports cover a small subset of the motor carriers of property and motor carriers of passengers that are subject to the Agency's safety oversight and the financial reporting data is not necessary to monitor carriers' safety performance. The information collected does not currently support any Agency regulatory function, nor does it have practical utility for the Agency or for those carriers who must comply with the reporting requirement.

This direct final rulemaking is non-controversial because it “Make[s] minor changes to rules regarding statistics and reporting requirements, such as a change in reporting period (for example, from quarterly to annually) or eliminat[es] a type of data collection no longer necessary” 49 CFR 389.39(a)(5). Elimination of the outdated and unnecessary quarterly reporting requirement falls squarely within the intended purpose of a direct final rule. FMCSA, therefore, finds there is good cause to dispense with the normal notice and comment procedures since reducing the reporting requirement is not likely to be controversial. Consequently, receipt of public comments prior to finalizing this action is unnecessary. 49 CFR 389.11.

For the reasons discussed in the Background section, above, FMCSA amends 49 CFR part 369 by eliminating the quarterly reporting requirement under 49 CFR 369.1 and 369.4. In addition, FMCSA makes other conforming technical amendments to 49 CFR 369.8, 369.9, and 369.11.

In the course of redesignating 49 CFR part 1420 as 49 CFR part 369 in 2006 (August 10, 2006, 71 FR 45740), the authority citation for part 369 was inadvertently corrupted by adding references to (1) 5 U.S.C. 553 and 559 of the Administrative Procedure Act relating to rulemaking and administrative law judges, and (2) 16 U.S.C. 1456, a provision of the Coastal Zone Management Act (CZMA) of 1972. These statutes provide no authority for part 369 and the references have therefore been removed.

When developing this direct final rule, FMCSA considered numerous statutes and executive orders related to rulemaking. The Agency's analyses are summarized below.

Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993) as supplemented by E.O. 13563 (76 FR3821, January 18, 2011), FMCSA must determine whether a regulatory action is “significant” and, therefore, subject to Office of Management and Budget (OMB) review and the requirements of the E.O. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.

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 (OMB) has not reviewed it under that Order. This rule will not have a significant economic impact. In fact, elimination of the reporting requirement will, if anything, have a beneficial economic impact on industry.

Under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, Title II, 110 Stat. 857), FMCSA is not required to prepare a final regulatory flexibility analysis under 5 U.S.C. 604(a) for this final rule because the agency has not issued an NPRM prior to this action.

This rule eliminates two quarterly reporting requirements that are currently reported to OMB under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Form QFR Quarterly for property carriers, authorized by OMB under information collection 2126-0033, is two pages long and takes approximately 27 minutes for each of the approximately 111 carriers to complete. This report is filed 4 times per year, so the total burden hour impact per filer per year is 4 × 27/60 = 1.8 hours. Multiplying this figure by the 111 carriers that file quarterly reports yields a total burden estimate of 200 hours.

FMCSA assumes that completion and submission of Form QFR is performed by an accountant designated by the business entity. The median salary of an accountant in the truck transportation industry is $25.90 per hour (BLS, May 2010).1 Two adjustments are made to this hourly compensation estimate. First, employee benefits are estimated at 50.0 percent of the employee wage.2 Second, employee wage and benefits are increased by 27 percent to include relevant firm overhead.3 Applying the estimated 50.0 percent factor for employee benefits and 27 percent for overhead results in $49.34 in hourly compensation for the accountant ($25.90 × (1 + 0.50) × (1 + 0.27) = $49.34). The total annual salary cost burden associated with the filings is $9,868 ($49.34 × 200 hours = $9,868.00).

The Class I passenger carrier financial quarterly survey (MP-1 Quarterly), which is two pages long and takes about 18 minutes to complete for the estimated 2 participating carriers is authorized by OMB under information collection 2126-0031. Since this report is also filed 4 times per year, the total burden hours associated with the requirement are 4 × 18/60 × 2 = 2.4 hours.

FMCSA believes the completion and submission of Form MP-1 is typically performed by a business and financial operations expert designated by the business entity because of the level of detail in the financial reports. The median salary of a business and financial operations expert in the interurban and rural bus transportation industry is $26.41 per hour (BLS, May 2010).4 Two adjustments are made to this hourly estimate. First, employee benefits are estimated at 50.0 percent of the employee wage.5 Second, employee wage and benefits are increased by 27 percent to include relevant firm overhead.6 Applying the estimated 50.0 percent factor for employee benefits and 27 percent for overhead results in $50.31 in hourly compensation for the business and financial operations expert ($26.41 × (1 + 0.50) × (1 + 0.27) = $50.31). The total annual salary cost burden associated with the filings is $121 ($50.31 × 2.4 hours = $120.74, rounded to the nearest dollar).

Collectively, eliminating these reporting requirements reduces the burden to industry by 202.4 hours and $9,989.

The PRA requires that each agency “shall certify * * * that each collection of information * * * is necessary for the proper performance of the functions of the agency, including that the information has practical utility.” 44 U.S.C. 3506(c)(3)(A); 5 CFR 1320.5(d)(1)(iii). FMCSA can no longer certify that the quarterly requirements are “necessary for the proper performance of the functions of the agency.” Therefore, FMCSA is discontinuing the quarterly reporting requirements.

A rule has federalism implications 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 the States. FMCSA has analyzed this rule under that Order and have determined that it does not have federalism implications.

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 aState, local, or tribal government, in the aggregate, or by the private sector of $143.1 million (which is the value of $100,000,000 in 2010 after adjusting for inflation) or more in any 1 year. This rule would not result in such an expenditure.

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.

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

FMCSA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has 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 will not 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 Agency analyzed this direct final rule for the purpose of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321et seq.) and determined under our environmental procedures Order 5610.1, published March 1, 2004 (69 FR 9680), that this action is categorically excluded under two categorical exclusions (CEs) in the Order from further environmental documentation. These are found in Appendix 2, paragraph 4, which covers data and information gathering, and Appendix 2, paragraph 6(y)(2) concerning reports provided by motor carriers. This direct final rulemaking makes minor changes to rules regarding “a change in reporting period (for example, from quarterly to annually) or eliminating a type of data collection no longer necessary,” as authorized by 49 CFR 389.39(a)(5). The action involves no extraordinary circumstances that would have any effect on the quality of the environment. Thus, the action does not require an environmental assessment or an environmental impact statement.

FMCSA also analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c), (42 U.S.C. 7401et seq.) and implementing regulations promulgated by the Environmental Protection Agency. Approval of this action is exempt from the CAA's general conformity requirement since it does not result in any potential increase in emissions that are above the general conformity rule'sde minimisemission threshold levels (40 CFR 93.153(c)(2)). This action merely eliminates a reporting requirement.

The Categorical Exclusion Determination is available for inspection or copying in the regulations.gov Web site listed underADDRESSES.

In consideration of the foregoing, FMCSA amends 49 CFR part 369 in title 49, Code of Federal Regulations, chapter III, subchapter B, as follows:

The HMSP requirement became effective for motor carriers as of January 1, 2005. Additionally, 49 CFR part 385, subpart E identifies which motor carriers must hold a HMSP, and establishes the application process for a HMSP. It also specifies the need for a carrier's crash rate and driver, vehicle, and HM OOS rates to be below the 70th percentile and describes other conditions that must be satisfied to qualify for this permit. As specified in § 385.407(a)(2), FMCSA will not issue a HMSP to a motor carrier having a crash rate in the top 30 percent of the national average, or a driver, vehicle, HM, or total OOS rate in the top 30 percent of the national average, as indicated in MCMIS. The methodologies for calculating these rates are posted on the FMCSA Web sitewww.fmcsa.dot.gov. More conditions are set forth in § 385.407 that require a carrier to have a Satisfactory safety rating, certify that it has a satisfactory security program, and be properly registered with the Pipeline and Hazardous Materials Safety Administration (PHMSA). The carrier also is required to submit proof of minimum levels of financial responsibility as stated in § 387.9.

Pursuant to 49 CFR 390.19, a motor carrier is required to file its MCS-150 form with FMCSA every two years. The application for the HMSP was incorporated into the MCS-150 as an expanded version of the form entitled “MCS-150B or Combined Motor Carrier Identification Report and HM Permit Application.” Thus, the HMSP must be renewed every two years. Revision to the calculations of the crash and OOS rates will not change this requirement.

On November 7, 2007, FMCSA published a Notice of Enforcement Policy (72 FR 62795) explaining the methodology used by the Agency to calculate those averages. The rates had been calculated using roadside inspection data in MCMIS for both HM and non-HM inspections for driver and vehicle OOS rates. For the HM OOS rate, only inspections that indicated that HM was present were used. The applicant motor carriers needed to have a least three roadside inspections indicated in MCMIS for each of the 2-year rate calculation timeframes. For instance, when calculating the 2005-2006 registration cycle rates, in order to be included in the calculation, a motor carrier would had to have at least three roadside inspections during the 2003-2004 time period.

During the course of the program, the calculated 70th percentile OOS thresholds have fluctuated causing uncertainty in the industry. It has become increasingly more difficult for a motor carrier to attain or retain a HMSP because it must maintain OOS rates below 7.14% for drivers, 33.33% for vehicles, and 3.45% for HM. These rates compare with the national averages for all motor carriers at 5.51%, 20.72%, and 4.50% respectively.

A historical picture of the OOS and crash rates, data from the entire eight-year period since the inception of the program, was used in the calculations (2003-2010) for the fixed rates. This provides a balanced perspective of motor carrier performance over a longer period of time and virtually eliminates the short term fluctuations that some motor carriers experience. It is also reflective of all of the time periods used to calculate rates for the present and three former registration periods. The threshold rate calculation included only carriers that had at least 12 inspections over the 8 years previously described, making this analysis comparable to the 3-inspections-per-cycle method used in previous calculations. The main difference in the fixed-rate calculations when compared to previous 2-year calculations is that, due to the number of inspections required during the extended timeframe (12), the number of inspections with an HM OOS rate of 0.00% decreased. This resulted in raising the overall HM OOS average for the population of motor carriers used in the calculation, and while higher, it is a more appropriate indicator of placarded motor carriers' roadside inspection HM OOS performance.

In order to calculate the fixed crash rate, a MCMIS snapshot was taken on February 24, 2012. The 8-year period was divided into four 2-year periods reflecting fiscal years (FY) 2003-2004, FY 2005-2006, FY 2007-2008, and FY 2009-2010. Qualifying motor carriers had at least 2 crashes in at least one 2-year period. Then the number of power units for each qualifying 2-year period was captured based on snapshots taken immediately after the end of each FY. The crash rate for each 2-year period motor carrier was then determined in each time period by taking the number of crashes indicated and dividing by the number of power units times two. Finally, all carrier/time period combinations were ranked based on crash rate, with a resulting crash rate threshold at the 70th percentile of 0.13636.

Since this evaluation criterion is a departure from the methods used in the previous years of the HMSP program, the OOS rates and 70th percentile thresholds have shifted, and in some instances increased when compared to previous years. The driver and HM OOS rates are higher because the calculations included carriers that have 12 inspections over 8 years as opposed to only 3 inspections over 2 years. There are more companies with non-zero OOS rates, and thus the 70th percentile is higher than what was previously seen with using only 3 inspections over a 2-year timeframe. FMCSA sees this as a necessary adjustment to the methodology based on experience over the life of the program, that more accurately reflects motor carrier inspection activity and performance with no diminution of safety.

Utilizing the methodologies described above, the top (worst-performing) 30th percentile of the National averages were determined by establishing a cut-off at the numerical threshold value located at the 70th percentile in each category using eight years of data. All carriers with a driver, vehicle, or HM OOS rate less than the cut-off are considered to be below the National Average for each category, and, therefore, eligible for participation in the program. Carriers with a driver, vehicle, or HM OOS rate that is equal to or greater than the cut-off in each category are in the 30th percentile, or the worst-performing category, and will be denied an HMSP.

FMCSA Web sites,www.fmcsa.dot.govandwww.safersys.org/HazMatRates.aspxwill continue to provide notice to the regulated community on how FMCSA calculates the National averages and threshold figures for the top-performing motor carrier population. The new threshold rates will remain effective for all future registration periods until such time as FMCSA can incorporate eligibility standards into the Safety Measurement System. These rates will provide the standard for granting or denying HMSPs beginning immediately, and will remain in effect until further notice.

Table 1 below shows the calculated National average cut-off threshold rates established for past Registration Cycles and the Fixed Rates:

When a motor carrier submits an HMSP application through the MCS-150B process, FMCSA examines the current one year (12 months) of the carrier's crash and OOS data. This policy is consistent with the Agency's practice of reviewing one year of motor carrier's records during the conduct of a compliance review. The period examined is the 12 months immediately preceding the date that the application is processed in MCMIS. A motor carrier should therefore, calculate its vehicle, driver, and HM OOS rates in each of the three categories by examining the number of inspections and OOS violations during the preceding 12-month period before applying. To determine its OOS rate, the carrier would divide the number of OOS inspections by the total number of inspections for each category. The resulting figure is the motor carrier's OOS rate for that category. For driver and vehicle OOS calculations, the carrier should use all inspections, both HM and non-HM. For the HM OOS calculation, the carrier should use only HM inspections. The FMCSA does not consider a single OOS violation in any one category to be statistically valid. Thus, OOS rates will be calculated only for carriers with more than one OOS violation in the previous 12-month period.

FMCSA likewise examines one year of crash data to determine a carrier's crash rate. A motor carrier should divide the number of crashes for the previous 12-month period by the total number of power units that it operated during that period, prior to applying. For example, if a motor carrier had 2 crashes and 10 power units, the crash rate would be 0.20 based upon a calculation of (2/10 = 0.20), and would thus be ineligible for obtaining an HMSP because the carrier's crash rate is above the established 70th percentile of 0.136. FMCSA does not consider a single crash to be statistically valid. Thus, crash rates will be calculated only for carriers with more than one crash in the previous 12-month period.

While the rates will remain fixed, motor carriers will still be required to update their MCS-150B every two years. The OOS rates in this document are effective for the remainder of the current registration cycle (January 1, 2011 through December 31, 2012) and all 2-year registration cycles starting with the cycle that begins on January 1, 2013. This method for determining crash and driver, vehicle, and HM OOS rates will remain in effect until such time as FMCSA can incorporate eligibility standards into the Safety Measurement System or otherwise updated through the publication of a notice.