Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This rule has been designated non-significant under section 3(f) of Executive Order 12866.

This final rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612). It has been certified that this action will not have a significant impact on a substantial number of small entities. While Indian Tribal Organizations (ITOs) and State Agencies that administer FDPIR will be affected by this rulemaking, the economic effect will not be significant.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under Section 202 of the UMRA, FNS generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, and Tribal governments or the private sector of $100 million or more in any one year. This rule is, therefore, not subject to the requirements of sections 202 and 205 of the UMRA.

The program addressed in this action is listed in the Catalog of Federal Domestic Assistance under 10.567. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V and related Notice (48 FR 29115, June 24, 1983), the donation of foods in such programs is included in the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132.

The programs affected by the regulatory proposals in this rule are all Tribal or State-administered, Federally-funded programs. The FNS National Office and Regional Offices have formal and informal discussions with State officials on an ongoing basis regarding program issues relating to the distribution of donated foods. FNS meets annually with the National Association of Food Distribution Programs on Indian Reservations (NAFDPIR), a national group of Tribal and State agencies, to discuss issues relating to FDPIR.

This rule is intended to provide consistency between FDPIR and SNAP. The rule was prompted by provisions contained in the Farm Bill, enacted on June 18, 2008. Section 4101 of the Farm Bill permanently excludes combat pay (i.e., additional pay earned because of deployment to or service in a combat zone) from income when determining eligibility for SNAP. Section 4103 removes the maximum limit on the dependent care deduction and Section 4104 excludes from resources any household funds held in qualified tuition program or retirement accounts when determining eligibility for SNAP.

FNS has considered the impact of this rule on ITOs and State agencies that participate in FDPIR. The overall effect is to improve the administration of FDPIR by simplifying and streamlining the eligibility determination process and improve program service to low-income applicants and participants.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is intended to have preemptive effect with respect to any State or local laws, regulations, or policies which conflict with its provisions or which would otherwise impede its full implementation. This final rule will not have retroactive effect. Prior to any judicial challenge to the provisions of this rule or the application of its provisions, all applicable administrative procedures must be exhausted.

FNS has reviewed this rule in accordance with the Department Regulation 4300-4, “Civil Rights Impact Analysis,” to identify and address any major civil rights impacts the rule might have on minorities, women, and persons with disabilities. After a careful review of the rule's intent and provisions, FNS has determined that this rule will not in any way limit or reduce the ability of participants to receive the benefits of donated foods in food distribution programs on the basis of an individual's or group's race, color, national origin, sex, age, or disability. FNS found no factors that will negatively and disproportionately affect any group of individuals.

The Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35;see5 CFR part 1320) requires that OMB approve all collections of information by a Federal agency from the public before they can be implemented. Information collections related to the provisions in this final rule were previously approved under OMB No. 0584-0293.

This rule will affect the reporting and recordkeeping burden for ITOs and State agencies under OMB No. 0584-0293 due to an expected change in number of households participating in FDPIR because of this rule. Documentation supporting the eligibility of all participating households must be maintained by the ITOs and State agencies.

The approved information collection estimates under OMB No. 0584-0293 are as follows:

Estimated total annual burden:1,079,172.41.

Estimated annual recordkeeping burden:746,400.42.

Estimated annual reporting burden:332,771.98.

Changes resulting from this proposed rule will result in the following changes to OMB No. 0584-0293:

Estimated total annual burden:1,079,172.92.

Estimated annual recordkeeping burden:746,400.42.

Estimated annual reporting burden:332,772.49.

These information collection requirements will not become effective until approved by OMB. Once they have been approved, FNS will publish a separate action in theFederal Registerannouncing OMB's approval.

FNS is committed to compliance with the E-Government Act of 2002 to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. In late 2010 and early 2011, USDA engaged in a series of consultative sessions to obtain input by Tribal officials or their designees concerning the affect of this and other rules on tribes or Indian Tribal governments, or whether this rule may preempt Tribal law. In regard to this rule, no adverse comments were offered at those sessions. Further, the policies contained in this rule would not have Tribal implications that preempt Tribal law.

Reports from the consultative sessions will be made part of the USDA annual reporting on Tribal Consultation and Collaboration. USDA will offer future opportunities, such as Webinars and teleconferences, for collaborative conversations with Tribal leaders and their representatives concerning ways to improve rules with regard to their affect on Indian country.

On April 27, 2010, FNS published a proposed rule in theFederal Register(75 FR 22027) to amend the regulations for FDPIR at 7 CFR part 253. The rule contained proposed amendments to 7 CFR 253.6 to align FDPIR with the Supplemental Nutrition Assistance Program (SNAP) relative to the requirements set forth in the Food, Conservation, and Energy Act of 2008 (Farm Bill). The proposed changes were intended to improve program service by: (1) Permanently excluding combat pay from income when determining eligibility for FDPIR (Section 4101 of the Farm Bill); (2) eliminating the maximum limit to the dependent care deduction (Section 4103 of the Farm Bill); (3) excluding household funds held in education savings accounts specified in Section 4104 of the Farm Bill and any other education accounts for which a resource exclusion is provided under the SNAP; (4) clarifying that the current FDPIR resource exclusion for retirement accounts is limited to qualified retirement accounts specified in Section 4104 of the Farm Bill and any other retirement accounts for which a resource exclusion is provided under SNAP; and (5) clarifying that the FDPIR regulations regarding income eligibility are referring to the SNAP net monthly income standard, rather than the SNAP gross monthly income standard. A full discussion of the proposed changes is contained in the April 27, 2010, proposed rulemaking.

Comments were solicited through June 28, 2010, on the provisions of the proposed rulemaking. FNS received 235 comment letters on the proposed regulatory changes, not counting four duplicate comment letters received from the same commenters. All of the comment letters are available for review athttp://www.regulations.gov.Enter“FNS-2009-0017” in the box under “Search Documents” and click on “Go” to view the comments received. One of the comment letters was received after the comment period expired, but we are considering this comment letter nonetheless.

Three of the comment letters were submitted by elected Tribal officials of ITOs that administer FDPIR. Two comment letters were from Tribal/State FDPIR administrators, and one comment letter was from a Tribal health provider. Five comment letters were submitted by national non-profit/advocacy organizations, and five comment letters were from state non-profit/advocacy organizations. One letter was submitted by a private company, and 218 letters were submitted by private citizens.

Four comment letters addressed the provisions of the proposed rule. All four commenters expressed agreement with the provisions of the proposed rule. One commenter stated: “Aligning FDPIR eligibility requirements and income exclusions to be consistent with those allowed by the SNAP (Food Stamps) will allow a greater number of Tribal people to receive benefits through our program, particularly elders and disabled individuals living on fixed incomes * * *.” That commenter also stated: “It is the Tribe's opinion that this regulatory change is equitable and corrects the former disparity in eligibility requirements to receive benefits for our most needy community members * * *.”

The comment letters also addressed issues beyond the scope of the proposed rulemaking. Below is a summary of these other issues and the number of commenters that addressed each issue:

1. Most commenters wrote in regards to the FDPIR resource limit or “asset test.” On January 28, 2010, USDA published a final rulemaking in theFederal Register(75 FR 4469) that aligned the FDPIR resource limit with SNAP's standard policy for the resource limit, i.e., $3,000 for households with at least one elderly/disabled member and $2,000 for all other households. However, SNAP regulations at 7 CFR 273.2(j)(2)(ii) allow SNAP State agencies the option to expand categorical eligibility (commonly referred to as Broad-Based Categorical Eligibility or BBCE) to certain households, which effectively eliminates an asset test for these households because household assets are not considered in the eligibility determination of households that are categorically eligible. Under BBCE, State agencies may consider households categorically eligible for SNAP if all household members receive means-tested non-cash benefits from a program that is funded with over 50 percent of Temporary Assistance for Needy Families Program (TANF) or Maintenance of Effort (MOE) money. SNAP also allows State agencies, with FNS approval, to make households categorically eligible if all members receive a non-cash benefit from a program that receives less than 50 percent funding from TANF or MOE sources, as long as the household's gross income does not exceed 200 percent of the Federal Poverty Guidelines. Non-cash benefits could include such services as employment assistance, childcare, or transportation assistance (i.e.,“hard” BBCE); or receipt of an informational brochure or toll-free 1-800 number about other available programs(i.e.,“soft” BBCE). As of 2009, 15 SNAP State agencies had implemented “hard” BBCE and 26 SNAP State agencies had implemented “soft” BBCE. Eleven SNAP agencies had not implemented BBCE (http://www.fns.usda.gov/snap/rules/Memo/Support/State_Options/8-State_Options.pdf).

Many of the comment letters received in response to the April 27, 2010, proposed rulemaking supported the alignment of FDPIR and SNAP policy in regard to the asset test and BBCE (226 commenters). Many commenters proposed that the FDPIR programs be allowed to follow the SNAP BBCE policy implemented in the state where the FDPIR program is located (225 commenters). Most of these commenters remarked that families living in states that have adopted BBCE under SNAP should not be subject to an asset test under FDPIR (220 commenters). Eight commenters stated that Tribal members should not be subject to stricter asset standards under FDPIR than SNAP, while two commenters wrote in support of eliminating the asset test in FDPIR.

Many commenters requested that USDA adopt their comments on the FDPIR asset test and BBCE in this final rulemaking (225 commenters). We do not feel it is appropriate to include the BBCE option in this final rulemaking. To do so would circumvent the public comment process since that provision was not included in the proposed rulemaking and made available for public comment along with the other provisions contained in this rulemaking. However, these comments are being considered for future rulemaking.

2. Two commenters supported the alignment of SNAP and FDPIR regulations, but the commenters did not specify which provisions should be aligned.

3. One commenter supported the alignment of FDPIR and SNAP in regards to the standard deduction. The commenter stated that SNAP allows a standard deduction that is not allowed under FDPIR. In actuality, SNAP and FDPIR use the same standard deductions, which vary by household size. Under SNAP, the standard deductions are applied as income deductions that are subtracted from the household's gross monthly income as part of the net monthly income test. Under FDPIR, the standard deductions are added to the SNAP net monthly income standards to simplify the income eligibility determination. For example, in fiscal year 2011, the SNAP standard deduction for a four-person household is $153 and the SNAP net monthly income standard is $1,838 for that same sized household. Under FDPIR, the $153 standard deduction is added to the net monthly income standard (i.e., the FDPIR net monthly income standard for a four-person household is $1,991 ($1,838 + $153)).

4. One commenter supported the alignment of FDPIR and SNAP in regards to using gross income to determine eligibility. The commenter remarked that SNAP determines eligibility based on gross income, whereas FDPIR uses net income. In actuality, both SNAP and FDPIR determine eligibility by starting with a household's gross income. Both SNAP and FDPIR determine eligibility by subtracting allowable income deductions from a household's gross monthly income to determine the household's net monthly income, which is then compared to the applicable net monthly income standards, which vary by household size. A household with net monthly income that is higher than the applicable net monthly income standard is ineligible under both SNAP and FDPIR. However, SNAP employs a prescreening test for households without elderly or disabled members prior to calculating the household's net monthly income. SNAP compares the household's gross monthly income to the applicable SNAP gross monthly income standard, which is set at 130 percent of the Federal Poverty Guidelines. If the SNAP household's gross monthly income is higher than the applicable gross income standard, the household is determined ineligible, without conducting the net monthly income calculation. If the SNAP household's gross monthly income is below the gross income test limit, then the certifier conducts the net monthly income test to determine if the household is eligible based on its net monthly income. FDPIR does not use the gross income test to prescreenhouseholds without elderly or disabled members; only the net income test is used under FDPIR.

5. One commenter remarked on the perceived disparity between FDPIR and SNAP in regards to income eligibility guidelines. The commenter stated that SNAP income eligibility guidelines are higher than those used under FDPIR. Both SNAP and FDPIR use 100 percent of the Federal Poverty Guidelines for the net monthly income standard. As discussed above, SNAP uses 130 percent of the Federal Poverty Guidelines for a prescreening test (i.e.,the gross income test) that is applied to all households without elderly or disabled members. However, the SNAP gross income test does not determine eligibility. Households that pass the gross income test are then subject to a net income test, which is the same test used under FDPIR.

6. One commenter recommended that the income standard for all Federal programs be raised to 200 percent of the Federal Poverty Guidelines. FDPIR and SNAP use 100 percent of the Federal Poverty Guidelines as the net monthly income standard.

7. One commenter recommended that all Federal programs adopt a fairer measure of need than the Federal Poverty Guidelines. The commenter suggested the Census Bureau's “Supplemental Poverty Measure” or “Self Sufficiency Standard.”

8. One commenter recommended the appropriation of funding to support Section 4211 of the Farm Bill. Section 4211 authorized USDA to purchase bison meat, as well as traditional Native American foods and locally-grown foods, subject to the availability of appropriated funds. While funds have not been specifically appropriated for this purpose, FNS has made a limited purchase of frozen ground bison meat for program recipients in fiscal year 2011.

9. One commenter suggested that an increase in appropriations for FDPIR food purchases to allow for the purchase of bison and other traditional Native American foods would rectify the inequity that resulted when SNAP benefits were increased by 13.6 percent under the American Recovery and Reinvestment Act of 2009 and FDPIR did not receive a corresponding increase.

10. One commenter suggested an increase in the SNAP asset limit. As discussed above, SNAP's standard policy sets the asset limit at $3,000 for households with at least one elderly/disabled member and $2,000 for all other households.

11. One commenter advocated for the return of lands to the first Americans.

In the following discussion and regulatory text, the term “State agency,” as defined at 7 CFR 253.2, is used to include ITOs authorized to operate FDPIR and the Food Distribution Program for Indian Households in Oklahoma (FDPIHO) in accordance with 7 CFR parts 253 and 254. The term “FDPIR” is used in this final rule to refer collectively to FDPIR and FDPIHO.

The April 27, 2010, rulemaking proposed an amendment to FDPIR regulations at 7 CFR 253.6(e)(3)(xi) to permanently exclude combat pay from income when determining eligibility for FDPIR. The proposed change was intended to align FDPIR regulations with current FDPIR and SNAP policy. Combat pay is defined as additional payment that is received by or from a member of the United States Armed Forces deployed to a combat zone, if the additional pay is the result of deployment to or service in a combat zone, and was not received immediately prior to serving in a combat zone. Based on the comments received on the proposed rulemaking, no changes have been made to the proposed amendatory language.

This provision was implemented by policy memorandum on July 16, 2008, so this amendment will not affect current policy. It will simply ensure that current policy is codified in the regulations.

The April 27, 2010, rule also proposed an amendment to FDPIR regulations 7 CFR 253.6(f)(2) to remove language that imposed a maximum limit on dependent care deductions. This proposed revision was intended to align FDPIR regulations with current FDPIR and SNAP policy. Based on the comments received on the proposed rulemaking, no changes have been made to the proposed amendatory language.

This provision was implemented by policy memorandum on July 16, 2008, so this amendment will not affect current policy. It will simply ensure that current policy is codified in the regulations.

The April 27, 2010, rulemaking proposed an amendment to FDPIR regulations at 7 CFR 253.6(d)(2) to allow a resource exclusion for the value of funds held in a qualified education savings program described in section 529 of Internal Revenue Code of 1986 or in a Coverdell education savings account under section 530 of that Code, and any other education savings program or account for which a resource exclusion is allowed under SNAP. This amendment was intended to ensure consistency in the treatment of these resources in determining FDPIR and SNAP eligibility. Based on the comments received on the proposed rulemaking, no changes have been made to the proposed amendatory language.

FDPIR regulations at 7 CFR 253.6(d)(2) allow the exclusion of pension funds. The April 27, 2010, rulemaking proposed an amendment to FDPIR regulations at 7 CFR 253.6(d)(2) to specify that the FDPIR resource exclusion applies to the value of funds held in retirement accounts described in sections 401(a), 403(a), 403(b), 408, 408A, 457(b), and 501(c)(18) of the Internal Revenue Code of 1986; the value of funds held in a Federal Thrift Savings Plan account as described in 5 U.S.C. 8439; and any other retirement program or account for which a resource exclusion is allowed under SNAP. This amendment does not materially change current FDPIR regulations or policy. It simply revises the regulatory language to mirror section 4104 of the Farm Bill. Based on the comments received on the proposed rulemaking, no changes have been made to the proposed amendatory language.

The April 27, 2010, rulemaking also proposed an amendment to FDPIR regulations at 7 CFR 253.6(e)(1)(i), to clarify that FDPIR applies the SNAP net monthly income standard, not the gross monthly income standard in the FDPIR income eligibility determination. This amendment is for clarification purposes only and does not change current FDPIR policy, nor does it revise current FDPIR income guidelines or eligibility criteria. Based on the comments received on the proposed rulemaking, no changes have been made to the proposed amendatory language.

This AD supersedes EAD 2010-25-51, issued November 24, 2010 (EAD 2010-25-51), which superseded EAD 2010-24-52, issued November 19, 2010 (EAD 2010-24-52). EAD 2010-24-52 superseded EAD 2010-24-51, issued November 12, 2010 (EAD 2010-24-51). EAD 2010-24-51, EAD 2010-24-52, and EAD 2010-25-51 were all issued for the Bell Model 212 helicopters with a certain fitting installed.

EAD 2010-24-51, the initial EAD, was issued for all Bell Model 212 helicopters with a fitting, part number (P/N) 212-010-103-007, S/Ns 9956 through 10005 with a prefix of “A”. That EAD required, before further flight, removing any affected fitting and replacing it with an airworthy fitting. That EAD also prohibited installing any affected fitting on any helicopter. That EAD was prompted by an accident that resulted in several fatalities. During the investigation of the accident, a crack was found on a fitting. Subsequently, four additional fittings from the same manufacturing lot were inspected, and two were found to exhibit the same type of cracking. We issued EAD 2010-24-51 to remove this lot from service to prevent failure of a fitting, loss of a main rotor blade, and subsequent loss of control of the helicopter.

After we issued EAD 2010-24-51, additional fittings from a different manufacturing lot were found to have the same type of crack as that found on the fitting involved in the accident. Therefore, we issued superseding EAD 2010-24-52 to require the same actions as EAD 2010-24-51, and to expand the applicability to include additional fittings. In addition to S/Ns 9956 through 10005 with a prefix of “A”, EAD 2010-24-52 added S/Ns 52, 54, 55, 57 through 65, 67, 69, 70, 71, 73, 103, 112, 113, 137, and 139 with a prefix of “SH” to the applicability. EADs 2010-24-51 and 2010-24-52 were issued as interim actions to address a known unsafe condition, and Bell continued to investigate the cause of the cracking.

Because the root cause of the cracking had not been determined, and due to the severity of a fitting failure, we issued superseding EAD 2010-25-51 to require the same action as EAD 2010-24-52 and to also require performing an MPI on fittings with S/Ns 9911 through 9955, 10006 through 10049, 10075 through 10174, 10455 through 10460, 10581 through 10655, 10742 through 10791, and 10862 through 10946 with a prefix of “A” to detect a crack on those fittings. If you find a crack, you are required to replace the cracked fitting with an airworthy fitting, and within 24 hours, report the information specified in Appendix 1 of the EAD to the Manager, Rotorcraft Certification Office. If you do not find a crack, you are required to reidentify and refinish the fitting in accordance with the specified portion of Alert Service Bulletin (ASB) 212-10-142, dated November 24, 2010 (ASB 212-10-142).

Since we issued EAD 2010-25-51, additional fittings with cracks were found using the MPI process. In response to these findings, Bell issued ASB 212-10-142, Revision A, dated March 21, 2011, that specifies performing an MPI for a crack on all serial-numbered fittings with the same part number in stock or in service. We have determined that certain fittings were not manufactured in accordance with the approved manufacturing processes and controls. Due to the severity of a fitting failure, this superseding AD is being issued to continue to require replacing certain serial-numbered fittings, and to expand the applicability to require performing an MPI for a crack on the remaining serial numbers of the fittings with the same part number. Serial-numbered fittings affected by this superseding AD are listed in Table 1 of the Applicability section of this AD. This superseding AD is being issued to prevent failure of a fitting, loss of a main rotor blade, and subsequent loss of control of the helicopter.

We reviewed Bell Alert Service bulletin (ASB) No. 212-10-141, dated November 11, 2010 (ASB-212-10-141), which specified the immediate removal of the affected fittings, S/Ns A-9956 through A-10005, from service. We also reviewed ASB No. 212-10-141, Revision A, dated November 18, 2010 (ASB 212-10-141 Rev. A), which incorporates additional S/Ns of the affected fittings and specifies removing the affected serial-numbered fittings from service. In ASB 212-10-141, Bell states that they have determined that the fittings may not have been manufactured in accordance with the engineering design requirements and may fracture as a result of the nonconformance.

We have also reviewed Bell ASB 212-10-142, initial release, dated November 24, 2010 (ASB 212-10-142) which specifies performing an MPI on fittings with certain S/Ns to detect a crack on those fittings.

Finally, we have reviewed Bell ASB 212-10-142, Revision A, dated March 21, 2011 (ASB 212-10-142 Rev. A), which includes all serial-numbered fittings except those already inspected and marked with “FM”. ASB 212-10-142 Rev. A specifies 1) within 25 hours time-in-service (TIS) or 15 days, whichever comes first, for all fittings with less than 400 hours TIS; or 2) within 100 hours TIS or 30 days, whichever comes first, for all fittings with 400 or more hours but less than 800 hours TIS; or 3) at the next main rotor teardown inspection or next tension-torsion strap replacement, whichever comes first, for all fittings with more than 800 hours TIS, performing a one-time MPI of the fitting, P/N 212-010-103-007, with all S/Ns in stock or in service. Finally, ASB 212-10-142 Rev. A states that all fittings, S/Ns A-11021 and subsequent, SH-053, SH-066, SH-072, SH-074 through SH-102, SH-104 through SH-111, SH-114 through SH-136, SH-138, and SH-140 and subsequent are not affected by ASB 212-10-142 Rev. A. Bell states that a one-time MPI of the affected fittings is required to ensure continued airworthiness of the fittings.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other helicopters of this same type design.

This AD supersedes EAD 2010-25-51 and requires the following:

• Before further flight, for any helicopter with a fitting, S/N 9956 through 10005, with a prefix of “A”, and S/N 52, 54, 55, 57 through 65, 67, 69, 70, 71, 73, 103, 112, 113, 137, and 139 with a prefix of “SH”, replace the fitting with an airworthy fitting. Any fitting with a S/N identified in this paragraph is no longer eligible for installation on any helicopter.

• Before further flight, for any helicopter with a fitting, S/N 9911 through 9955, 10006 through 10049, 10075 through 10174, 10455 through 10460, 10581 through 10655, 10742 through 10791, and 10862 through 10946, with a prefix of “A”, perform an MPI of each fitting for a crack. If the fitting is cracked, replace it with an airworthy fitting. If the fitting is not cracked, reidentify and refinish the fitting.

• For any fitting with a serial number identified in paragraph (h) in the Compliance section of this AD, perform an MPI of each fitting for a crack:

○ For any fitting with 400 or less hours TIS, perform an MPI within 25hours TIS or 15 days, whichever comes first.

○ For any fitting with more than 400 hours but less than 800 hours TIS, perform an MPI within 100 hours TIS or 30 days, whichever comes first.

○ For fittings with 800 hours or more TIS, perfrom an MPI at the next main rotor hub teardown inspection or tension-torsion strap replacement, whichever comes first.

○ If a fitting is cracked, replace it with an airworthy fitting. If a fitting is not cracked, reidentify and refinish the fitting.

• If a crack is found on any fitting, within 24 hours, report the information requested in Appendix 1 of this AD to the Manager, Rotorcraft Certification Office, FAA, 2601 Meacham Blvd, Fort Worth, Texas 76137, or e-mail7-AVS-ASW-170@faa.gov.

This AD differs from ASB 212-10-142 Rev. A as follows:

• We do not require returning parts to Bell.

• We require performing an MPI before further flight on certain S/N fittings included in the initial release of ASB 212-10-142.

• We require sending information to the Rotorcraft Certification Office and not to Bell.

• Bell uses the term “total time-in-service” to describe compliance times, and we use the term “time-in-service.”

• We specify S/Ns in our AD, and Bell does not specify S/Ns in ASB 212-10-142 Rev. A.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA finds that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because we evaluated all the available information and determined the unsafe condition described is likely to exist or develop in other helicopters of this same type design. Therefore, we find that notice and opportunity for prior public comment are impracticable because of the short compliance times, and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include the Docket Number FAA-2011-0323 and “Directorate Identifier 2011-SW-005-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, tohttp://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD affects 84 helicopters of U.S. registry. We estimate the following costs to comply with this AD:

We estimate a total cost of $456,024 to do the actions required by this AD.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction,

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

The Coast Guard will enforce the safety zone; 33 CFR 165.933-Chicago Harbor, Navy Pier East, Chicago, IL for the following event:

(1)Alexian Brothers Foundation Fireworks;on May 7, 2011 from 9:20 p.m. through 9:40 p.m.

All vessels must obtain permission from the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative to enter, move within or exit the safety zone. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

This notice is issued under authority of 33 CFR 165.933 Safety Zone, Chicago Harbor, Navy Pier East, Chicago IL and 5 U.S.C. 552 (a). In addition to this notice in theFederal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port, Sector Lake Michigan, will issue a Broadcast Notice to Mariners notifying the public when enforcement of the safety zone established by this section is suspended. If the Captain of the Port, Sector Lake Michigan, determines that the safety zone need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the safety zone. The Captain of the Port, Sector Lake Michigan, or his or her on-scene representative may be contacted via VHF Channel 16.

This action follows three key EPA actions regarding Alabama's request for approval of the two visible emissions SIP revisions. The first was an October 15, 2008, final rule (73 FR 60957) approving revisions to the Alabama SIP embodied in two submittals dated September 11, 2003, and August 22, 2008 (Submittals). The second was an April 3, 2009, action granting a February 25, 2009, petition for reconsideration on the October 15, 2008, final action which had approved the SIP revisions. The third was an October 2, 2009, proposed rule (74 FR 50930) identifying two alternative options being considered by EPA as part of the reconsideration process (the alternative proposals were either to affirm the October 15, 2008, rulemaking, thereby approving Alabama's Submittals or to amend the October 15, 2008, rulemaking, thereby disapproving Alabama's Submittals). EPA has now determined that Alabama's Submittals are not approvable pursuant to CAA section 110(l). Detailed background information for this action is available in the proposed rulemaking published on October 2, 2009. 74 FR 50930.

In relevant but brief part, on September 11, 2003, ADEM submitted a voluntary1 request for EPA approval of a SIP revision (2003 Submittal) containing proposed revisions to the existing EPA-approved visible emissions portion of the Alabama SIP, found at Alabama Administrative Code (AAC) 335-3-4-.01, “Visible Emissions,” and pertaining to sources of particulate matter (PM) emissions.2 Inan action published on April 12, 2007 (72 FR 18428), EPA proposed to approve the 2003 Submittal contingent upon the State of Alabama submitting a revised SIP submittal addressing EPA's concerns regarding impacts of the rule changes on attainment of the National Ambient Air Quality Standards (NAAQS), as set forth in 72 FR 18428-18434. EPA's proposal notice explained that the State would have to provide EPA with a revised SIP submittal consistent with certain changes described by EPA in the April 12, 2007, notice of proposed rulemaking before EPA could approve the revisions. The proposal notice also described EPA's rationale for requesting the additional submittal. Specifically, EPA noted that the 2003 Submittal was not approvable because the revision “would allow a source to emit at a higher allowable average opacity percent level (as measured by a COMS—Continuous Opacity Monitoring System—in six-minute increments) on a quarterly basis as well as allowing higher short term excursions than the current approved SIP allows.” 72 FR at 18430/3. EPA further explained that “in the absence of a supporting demonstration of compliance with the CAA requirements from the State, we believe that the 2003 SIP submittal is not approvable as submitted.”Id.

On August 22, 2008, Alabama, through ADEM, provided EPA with an amended submittal (2008 Submittal). After further evaluation, EPA determined that it could approve the Submittals (i.e., the 2003 Submittal as amended by the 2008 Submittal). On October 15, 2008, EPA took final action to incorporate into the Alabama SIP, the revisions to Alabama's visible emissions rule included in the Submittals. 73 FR 60957. EPA's rationale for its approval is discussed in that final action. In order to approve the Submittals in 2008, EPA relied on two main findings: “(1) The revision would not increase the allowable average opacity levels; and (2) the relationship between changes in opacity and increases or decreases in ambient PM2.5levels cannot be quantified readily for the sources subject to this SIP revision, and is particularly uncertain for short-term analyses.” 73 FR 60959/2. The October 15, 2008, final action was effective on November 14, 2008 (by its terms, the Alabama rule change became effective, and thus applicable to sources, on May 14, 2009).

Following the October 2008 final action, EPA received two petitions for reconsideration submitted on behalf of the Alabama Environmental Council (AEC) and other parties (Petitioners), one on December 12, 2008, and one on February 25, 2009. EPA considered these petitions under section 553(e) of the Administrative Procedures Act (APA) and the CAA. The first petition for reconsideration raised procedural and substantive concerns with EPA's October 15, 2008, final action.3 EPA denied the December 12, 2008, petition via letter on January 15, 2009. The second petition incorporated by reference the issues raised in the first petition and also identified additional substantive and procedural concerns not included in the first petition.4 EPA granted the Petitioners' second request for reconsideration of the October 15, 2008, final action via letter on April 3, 2009. In that letter, EPA explained that it anticipated initiating a new rulemaking process to provide additional opportunities for public comment.

On December 12, 2008, Petitioners filed a lawsuit in the Eleventh Circuit Court of Appeals challenging EPA's October 15, 2008, final action. EPA and the appellants subsequently jointly stayed the litigation pending the conclusion of EPA's reconsideration process. EPA's October 2, 2009, proposed rule was EPA's initiation of a new rulemaking process to reconsider its prior action on the Submittals. In that proposal, EPA articulated two alternative options and sought public comment on both. One option was to affirm the October 15, 2008, final action (thus approving the Submittals) and the other was to amend the October 15, 2008, final action (thus disapproving the Submittals). The bases for each alternative were described in detail in the October 2, 2009, proposed rulemaking. 74 FR at 50932-50934. The responses to the comments EPA received on the October 2, 2009, proposed action are summarized in section III of this rulemaking.

EPA is now taking final action to amend its October 15, 2008, final action and to disapprove Alabama's 2003 and 2008 SIP Submittals regarding its visible emissions rule. As EPA explained in its October 2, 2009, proposed rulemaking, the primary issue for resolution is whether approval of the Submittals is consistent with the requirements of the CAA, specifically, the requirements of section 110(l). If the approval were appropriate under section 110(l), EPA would need to consider whether it would also meet the requirements of section 193, given that the visible emissions rules in question were in effect prior to November 15, 1990, and apply to some sources that are located in areas designated nonattainment for one or more NAAQS. In light of the fact that this SIP revision would apply statewide, including nonattainment areas, EPA has concluded that it cannot approve the SIP revision under section 110(l) if it would worsen air quality by allowing increased emissions of criteria pollutants or precursors to such criteria pollutants. In particular, if the revision would result in increases in emissions of pollutants for which an area is designated nonattainment, specifically PM2.5, EPA considers that allowing increased emissions of such pollutants would interfere with the area's ability to attain the NAAQS.5 See, e.g.,70 FR 53(January 3, 2005); 70 FR 28429 (May 18, 2005) (previous rulemaking actions addressing section 110(l)).

In this particular circumstance, the analysis of whether the Submittals satisfy the CAA is made more difficult by the uncertainty in the precise relationship between the opacity of a stack emission stream and the mass of PM in the same emission stream at the affected sources. After consideration of all the issues raised by the Petitioners in their February 2009 petition for reconsideration, as well as comments received on the October 2, 2009, proposed rulemaking from many industry groups, individual companies, state agencies, and other non-governmental organizations, EPA has concluded that disapproving the 2003 and 2008 Submittals results in the interpretation of the CAA that is most consistent with the plain text and legislative history of the CAA, as well as the air quality goals set forth in the CAA. What follows is EPA's explanation of its analysis, which involves a discussion of the following: (1) The role of visible emissions in NAAQS attainment and maintenance; (2) the history of Alabama's visible emissions rule; (3) consideration of CAA section 110(l); (4) comparison of the original rule to the revised SIP-approved rule; (5) the role of uncertainty in EPA's analysis; and (6) the types of information that would be particularly useful in developing a visible emissions SIP revision.

Opacity may be defined as the degree to which emissions reduce the transmission of light and obscure the view of an object in the background. 40 CFR 60.2. Opacity is important because it provides information regarding pollutants visible to the eye leaving an emissions source. In general, the more that opaque particles pass through an emissions point, the more light will be blocked, thus increasing the opacity percentage. However, variables such as the size, number, and composition of the particles in the emissions can result in variations in the percentage of opacity.

Historically, visible emissions have been an important tool for implementation of PM NAAQS and, in particular, for the implementation and enforcement of PM limits on sources to help attain the NAAQS. Visible emissions have been a useful tool to indicate overall operation and maintenance (O & M) of a facility and its emissions control devices even before modern instruments that measure PM on a direct, continuous basis existed. The observation of greater than normal visible emissions, particularly on a recurring basis, has served as an indication that incomplete combustion or other changes to the process and/or the control device had or were occurring; such changes frequently led to increased PM emissions. Although opacity is not a criteria pollutant, opacity standards continue to be used as an indicator of the effectiveness of emission controls for PM emissions, or to assist with implementation and enforcement of PM emission standards for purposes of attaining PM NAAQS. Opacity measurements can serve as an indicator of a well-maintained, well-operated source and that such sources should be able to achieve visible emissions that comply with opacity limits. For example, data submitted by one commenter show routine source operation with opacity of about five percent.6 Conversely, visible emissions at much higher percentages (such as those allowed by Alabama's revised rules), particularly on a recurring basis, may indicate that a source is in violation of applicable SIP or permit mass limits as well.

Many commenters agreed that the precise relationship between opacity and PM emissions was uncertain. Despite this uncertainty, there is a general relationship between opacity and particulate matter mass emissions. As a result, increases in opacity can be indicative of changes in emissions control device performance or source operation, which in turn can lead to increases in mass emissions.

Furthermore, based on the information contained in the record for this action and a general lack of opacity and corresponding PM emissions data received to date, it is apparent that the mass of emissions based on short-term increases in opacity cannot be quantified readily for each of the 19 sources affected by the SIP revisions in the Alabama Submittals.7 There are several contributors to the uncertainties associated with relating mass emissions to increases in opacity, including: (1) Differences between combustion technology characteristics and fuel components; (2) differences in control technology types, temperatures at which they operate, and load characteristics; (3) the recognition that both opacity and mass emissions are subject to significant variability over short periods of time and fluctuations such that one may act independently of the other; and (4) differences between the mass of particles that exists at the point of opacity measurement by the COMS (e.g., in the stack) and the direct PM2.5that forms immediately upon exiting the stack (that are related to fuel components more than to control technology).

EPA first approved Alabama's visible emissions rules into the Alabama SIP in 1972. 37 FR 10842, 10847 (May 31, 1972). The State submitted the visible emissions rules as part of its SIP for attainment and maintenance of the total suspended particulates (TSP) NAAQS (the predecessor to the PM NAAQS). The State has revised these rules three times in support of those goals.

Historically, Alabama has had areas with attainment problems for the various PM NAAQS. Originally, EPA designated some areas in Alabama as nonattainment for the TSP NAAQS. In 1987, EPA replaced the TSP NAAQS with the PM10NAAQS, and all areas of Alabama were designated as attainment for those NAAQS. 56 FR 11101 and 58 FR 67734. All areas of Alabama remain designated attainment for the PM10NAAQS. In 1997, EPA promulgated new annual and 24-hour particulate matter NAAQS, using PM2.5as the indicator. Effective April 5, 2005, EPA designated portions of Alabama, in the Birmingham and Chattanooga areas, as nonattainment for the 1997 PM2.5NAAQS. 70 FR 944. In 2006, EPA promulgated new PM2.5NAAQS, significantly tightening the 24-hour standards. Effective December 14, 2009, the Birmingham area was designated nonattainment for the 24-hour PM2.5 NAAQS, as revised in 2006. The Birmingham area remains designated as nonattainment for both the 2006 24-hour and 1997 annual PM2.5NAAQS. Chattanooga remains designated as nonattainment for the 1997 annual PM2.5NAAQS. Alabama's visible emissions rules continue to be a part of the Alabama SIP for attainment and maintenance of the PM NAAQS.

The SIP revision at issue affects the applicable visible emissions limits at approximately 19 stationary source facilities.8 These 19 facilities include older coal-fired utilities, cement manufacturing facilities, and pulp and paper facilities, among others. Five of these facilities are located in or near nonattainment areas for the current PM2.5NAAQS. Specifically, Cheney Lime and Cement Company (Allgood), Ernest C. Gaston Electric Generating Plant (Alabama Power Company (APC)), and William Crawford Gorgas Electric Generating Plant (APC) are located within the Birmingham nonattainment area for the 1997 annual and 2006 24-hour PM2.5NAAQS; Bowater Incorporated (Westover) is located near that area. In addition, Widows Creek Fossil Plant (Tennessee Valley Authority (TVA)) is located in the Chattanooga nonattainment area for the 1997 annual PM2.5NAAQS. Other facilities affected by these visible emissions rules may also impact these or other nonattainment areas.

The geographic location of affected sources covered by the visible emission rules in the EPA-approved SIP is relevant. This is because (as is discussed more fully below) EPA interprets section 110(l) to prohibit approval of SIP revisions that would increase emissions of pollutants for which an area is designated nonattainment, in the absence of offsetting emission reductions or an attainment demonstration addressing the rule changes at issue.

Opacity remains an important tool that states and EPA rely upon in establishing and enforcing PM-related standards for SIPs and other standards promulgated under the CAA (such as New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants). For example, opacity measurements can serve as an indicator of compliance with PM emissions between PM stack tests. The Submittals would provide sources with the flexibility to allow for visible emissions of up to 100 percent opacity (previous maximum opacity was 40 percent) for up to 2.4 consecutive hours per day9 (previous consecutive maximum time for “exempt” periods per day was 6 minutes). This change, like all SIP revisions, must be consistent with section 110(l).

In considering whether to approve the SIP revision at issue in this action, EPA must evaluate the changes embodied in the Submittals from the State in light of the requirements of section 110(l). Section 110(l) of the CAA provides, in relevant part, that:

Congress added section 110(l) during the 1990 amendments to the CAA as support for the cornerstone of the SIP program in the CAA—the attainment and maintenance of the NAAQS. 101 Stat. 2404 (101 Pub. L. 549) (November 15, 1990). The provision was added as part of general revisions to section 110 to address EPA actions on SIP revisions, in part responding to court cases such as a Ninth Circuit Court of Appeals case,Abramowitzv.EPA,832 F.2d 1071 (9th Cir. 1987), which discussedTrainv.NRDC,421 US 60 (1975) (both cases addressed EPA consideration of SIP revisions in light of some evaluation of whether the revision at issue would affect the NAAQS,i.e.,the impacts upon attainment or maintenance of the NAAQS). S. Rep. No. 101-228 (Report of the Committee on Environment and Public Works, United States Senate) (1990 CAA Legis. Hist. 8338, 8360-8363).

By its plain language, section 110(l) applies to every SIP revision submitted by a state. In evaluating whether a given SIP revision would interfere with attainment or maintenance, as required by section 110(l), EPA generally considers whether the SIP revision will allow for an increase in actual emissions into the air over what is allowed under the existing EPA-approved SIP. EPA has not required that a state produce a new complete attainment demonstration in order to make every revision to its SIP, provided that the status quo air quality is preserved. For the Submittals at issue in this action, EPA's view has been that if the SIP revision does not interfere with attainment or maintenance of the NAAQS, then it is unlikely to interfere with other applicable requirements. For example, if EPA concludes that emissions of PM allowed under the SIP are not increasing as a result of the SIP revision, then no additional control requirements would be required under section 193.

EPA has historically interpreted section 110(l) as requiring the Administrator to have some basis on which to conclude that a SIP revision would not interfere with attainment and maintenance of the NAAQS, or any other applicable requirement, before EPA could approve the SIP revision. EPA has regularly requested such information from the state to support a revision, particularly where there was some uncertainty regarding the impacts of the SIP revision. For example, in 2005, the State of North Carolina submitted a SIP revision that raised issues similar to the Alabama proposal. After considerable discussion between EPA and North Carolina about what revisions would be consistent with the requirements of section 110(l), the State submitted a SIP revision that addressed key issues. The rules in the revision retained the same number of total minutes and maximum levels of opacity allowed during excursion periods as under the prior EPA-approved SIP (i.e.,the four hourly six minute exceedance periods allowed under the existing North Carolina SIP could occur at any time, including consecutively, during a 24-hour period, but the allowable maximum opacity levels during these periods was not increased). In particular, EPA did not adopt an “average daily opacity” approach for North Carolina, which would have allowed extended periods of high opacity (in excess of 40 percent).See70 FR 61556 (October 25, 2005). Similarly, EPA has proposed to disapprove a visible emissions SIP revision for Ohio in which that state sought to relax limitations on the number of occasions of excess opacity per hour, potentially allowing entire days with elevated opacity. The revision was submitted without a section 110(l) showing that the relaxation in opacity requirements would not reflect increased emissionsthat would interfere with attainment and maintenance of the NAAQS or other requirements of the CAA. 70 FR 36901 (June 27, 2005).

EPA recognizes that 110(l) analyses are case-specific and that the scope and nature of the analysis will vary, depending on the factual details of the SIP revision at issue.See, e.g., Hallv.EPA,273 F.3d 1146 (9th Cir. 2001) andKentucky Resources Council, Inc.,v.EPA,467 F.3d 986 (6th Cir. 2006);see also,61 FR 16,050, 16,051 (April 11, 1996) (actions on which theKentucky Resources Councilcase were based).11 However, in the absence of a full attainment or maintenance demonstration, EPA has consistently required a sufficient basis in the record for concluding that the SIP revision would not interfere with attainment and maintenance of the NAAQS, or any other applicable CAA requirement.12

The substantive starting point for evaluating any SIP revision is to consider the differences between the current EPA-approved SIP rule and the revised rules being proposed by the state in the revision. Many of these differences were highlighted by the Petitioners and other parties during the public comment process on both the April 2007 proposal and the October 2, 2009, reconsideration proposal.

In this case, we began our analysis by comparing the rule in effect in the Alabama SIP at the time of EPA's April 2007 proposed action (hereafter “the previous rule”) with the 2003 and 2008 Submittals (hereafter “the current rule”). Under both rules, the maximum number of exempt six-minute periods13 allowed per day is the same—24; the maximum “allowable average quarterly opacity”14 is approximately the same—22 percent under the previous rule, and 21.6 percent under the current rule; and the maximum “allowable average daily opacity” is the same under both rules—22 percent.15 However, there are two significant differences16 between the previous rule and the current rule. The first is that the current rule allows for maximum visible emissions of 100 percent opacity during the exempt periods, while the previous rule allowed for maximum visible emissions of only 40 percent opacity during such periods. AAC 335-3-4-.01(4) (current rule). The second is that the current rule allows exceedances of the 20 percent SIP standard for intervals of up to 2.4 consecutive hours (i.e.,up to 24 consecutive six-minute periods per calendar day), while the previous rule allowed exceedances of the 20 percent SIP standard for intervals of only 0.1 consecutive hours (i.e.,one six-minute period per hour).17 Thus, the two key differences are that the current rule allows for opacity to increase up to 100 percent and allows up to 2.4 consecutive hours of opacity at that level (i.e.,the “bundling” of high opacity periods) per day. A critical question, therefore, is whether the significant increase of the maximum allowable opacity from 40 percent to 100 percent for such extended periods could result in more PM emissions were sources to take advantage of the changed limits.

In EPA's original approval notice, we adopted a limited analytical framework for addressing this question. We did not conclude that the proposed change in the SIP would not result in increased PM emissions. Rather, we established a new metric of “average daily opacity” (and “average quarterly opacity”) and concluded that section 110(l) did not prohibit approval of a SIP revision that allowed significantly increased opacity levels for longer consecutive periods of time because the revision would not increase the allowable average opacity levels (on either a quarterly or daily basis). This analysis was focused on opacity and operational conditions regarding opacity as opposed to a focus on the relationship between opacity and PM mass emissions, in part because EPA did not have any useful source-specific data regarding the relationship between opacity and PM mass emissions at the affected facilities.

EPA also concluded that the relationship between changes in opacity and increases or decreases in ambient PM2.5levels could not be quantified readily for the sources subject to the SIP revision, and was particularly uncertain for short-term analyses and that the level of uncertainty about whether increased opacity levels allowed under the revision would allow increased mass emissions was sufficiently high that, in the absence of additional information to confirm a change in emissions one way or the other, section 110(l) did not prohibit approval of the SIP revision.

After reconsideration, however, EPA's position is that both of the findings that provided the foundation for its initial approval of the SIP revision were not strong enough to support approval under the CAA. EPA concludes that, as it was described in the Submittals, the concept of “average daily opacity” is not a useful tool for evaluating whether the Submittals are likely to maintain current air quality, particularly given the lack of other limitations on opacity exceedances in the Submittals. One of the primary purposes of opacity limits is to ensure that PM control devices are operating within normal parameters. Thus, larger and longer exceedances of an opacity limit (e.g.,100 percent opacity or other high opacity levels over a longer period of time such as 2.4 consecutive hours), which may indicate problems with a control device or other significant changes in emissions, are more significant than shorter and smaller exceedances. Under the approach of the revised rule, a control device could temporarily shutdown or malfunction, potentially resulting in 100 percent opacity, for an hour or two and the source could still be in compliance with the 22 percent average daily limit. By contrast, an opacity limit that requires consistent compliance at 20 percent, and allows only one excursion of six minutes per hour to 40 percent opacity will limit larger and longer excursions.

In addition, an opacity limit that requires consistent compliance at 20 percent and allows only one excursion of six minutes per hour to 40 percent opacity helps ensure that sources and their control devices are properly maintained, operated, and controlled. In EPA's experience, a source that is properly maintained, operated andcontrolled should be capable of meeting the opacity requirements of the Alabama SIP without this revision. EPA is concerned that the allowance of higher levels and longer consecutive durations of opacity exceedances, even with an “average daily opacity” cap, would undermine an important purpose of the opacity limit, to ensure proper O & M of sources and their control devices.

After reviewing the issues raised in the petition for reconsideration and additional information received during the reconsideration public comment period, EPA concludes that the approach utilized to evaluate the Submittals in the October 15, 2008, rulemaking resulted in a fundamentally incomplete analysis. Requiring a source to maintain an average daily opacity of 22 percent does not provide assurance that the source will generally achieve the same level of PM control (and emissions) as a source which meets a limit of 20 percent opacity, except for one six-minute period per hour at 40 percent. Accordingly, the approach of the prior notice, which focused solely on maintaining an overall average daily (and quarterly) opacity does not provide an adequate framework for assessing the impact of the Submittals on emissions and air quality, which is the touchstone of the analysis required under section 110(l).

EPA did receive modeling from a variety of sources (which is discussed in the Response to Comments portion of today's action, beginning with Comment 19) which attempt to show the impact on air quality from the changes to the opacity requirements in the Submittals. In addition to EPA's discussion in the Response to Comments section, EPA's Technical Support Document addressing the modeling identifies the information gaps that prevented EPA from conducting the type of source-specific analysis that would be necessary for completion of an adequate 110(l) evaluation. For example, elements that are missing from the submitted modeling include: data from all the sources and source categories affected by the Alabama Submittals; a demonstration of the relationship between PM emissions and opacity at a particular facility and source-category; consideration of emissions from other sources in the modeled area; condensable PM data; explanation for background PM levels used in the evaluation; and an explanation of the use of PM10as a surrogate for PM2.5; among other concerns. As EPA noted in its evaluation of modeling submitted during the first comment period:

As was noted earlier, a key issue in evaluating the Submittals is the element of uncertainty in the relationship between opacity and PM mass emissions. Many SIP submittals involve some level of uncertainty. EPA has never, and does not now, take the position that a small possibility that an attainment SIP might turn out not to result in attainment of the NAAQS, or to prevent a violation of the NAAQS, or that a SIP revision might worsen air quality, necessitates denial of a SIP revision. EPA recognizes that attainment planning generally requires a high degree of technical judgment, and often involves some degree of uncertainty. In EPA's prior approval, we concluded that the level of uncertainty concerning the impact of the SIP revisions on emissions of PM from sources was so great that EPA could not make a technical judgment as to whether or not approval of the Submittals would likely interfere with attainment and maintenance of the NAAQS or any other applicable requirements. In the face of such uncertainty, EPA concluded that section 110(l) did not prohibit the approval of the revisions at issue. After reconsideration, EPA has concluded that its traditional, and more precautionary, approach to interpreting section 110(l) is appropriate.

There is a general relationship between opacity and PM emissions such that an increase in opacity means the concentration of smaller particles, larger particles, or both, increases.See, e.g.,Malm, William C., “Introduction to Visibility,” Cooperative Institute for Research in the Atmosphere, May 1999 at Chap. 2, p. 8. However, because increases in the quantity of smaller particles may be accompanied by decreases in the quantity of larger particles, and vice versa, changes in opacity do not necessarily reflect corresponding changes in the mass of PM emissions. While source-specific relationships between opacity and PM emissions may be obtained through testing, they can be influenced by a variety of circumstances such as fuel compositions and types of equipment malfunction that may occur. Therefore, while changes in opacity generally indicate changes in PM emissions, there is uncertainty about quantifying the specific level of PM emissions associated with varying levels of opacity.

EPA has previously explained the elements of that uncertainty in its proposed reconsideration action. 74 FR at 50933. One key element is the recognition that both opacity and mass emissions are subject to significant variability of short periods of time and fluctuations such that one may act independently of the other.Id.Thus, EPA concludes (and many commenters also acknowledged) that there is a relationship between opacity and PM such that periods of high opacity can result in increased PM emissions, which in turn can cause or contribute to a PM NAAQS violation. We can say with certainty that periods of high opacity would cause interference with the PM NAAQS in some circumstances. What EPA does not know is precisely when such changes in opacity would cause the interference, particularly for a variety of source types. This is the unknown element discussed in detail in EPA's proposal and this final action.

Section 110(l) was intended to allow SIP revisions in the absence of full attainment demonstrations, but EPA's view is that Congress would not have wanted EPA to approve SIP revisions where EPA lacked not only an attainment demonstration but also any basis for concluding that the SIP revision would not interfere with attainment or maintenance of the NAAQS, and other applicable requirements. Accordingly, consistent with our past practice in considering SIP revisions, EPA concludes that there must be either a contemporaneous attainment demonstration or some other basis for concluding that a SIP revision will not interfere with attainment, and that uncertainty alone is not a sufficientbasis for approving a SIP revision. Moreover, EPA has also concluded, following reconsideration, that there is a sufficient likelihood that the SIP revision at issue in this action could allow increased mass emissions over what would have been allowed under the previously approved SIP rule and that, in the absence of additional information or limitations, the revision is not approvable under section 110(l). As noted by commenters during the reconsideration process, although a precise correlation between mass emissions and opacity for an individual source can be difficult to ascertain, the changes contemplated in the Submittals are such that changes in emissions, including increases, are possible under the opacity levels allowed by the SIP revision. Given the location of affected sources within nonattainment areas, EPA has concluded that additional emissions from such sources would interfere with attainment and maintenance of the NAAQS in these areas.

EPA recognizes that there are circumstances in which a source will record opacity levels in excess of a 20 percent standard without necessarily increasing its mass emissions, but there are also many circumstances where increased opacity levels are associated with increased mass levels. The Submittals would provide sources with the flexibility to allow for visible emissions of up to 100 percent opacity for up to 2.4 consecutive hours per day. The degree of operational flexibility associated with the Submittals is such that EPA concludes that the opacity limits in the Submittals are likely overall to allow increased PM emissions. Even though every instance of operation at greater than 20 percent opacity may not result in increased emissions, and though EPA cannot precisely quantify the effect of approving the Submittals on the information in the record, it is reasonably foreseeable that approving the Alabama Submittals would allow increased mass emissions, for at least some sources and under at least some conditions, over the PM emission levels that would have been allowed under the previously approved SIP rule. Given this situation, section 110(l) requires disapproval of the Submittals absent additional limitations which would significantly diminish the likelihood that mass emissions increases will occur. The result of the disapproval is simply that Alabama's previous EPA-approved visible emissions rule will become the federally-enforceable rule in the SIP (although EPA urges that Alabama take any regulatory action necessary to avoid having a State-effective rule that is different from the SIP-approved rule).

In EPA's October 2, 2009, reconsideration proposal following reconsideration, EPA included a section entitled, “III. What Additional Information Would EPA Like To Receive?” 74 FR 50934. EPA specifically requested information on the nature of the relationship between opacity and PM mass emissions over both the short and long term and when the opacity and PM mass emissions may have a predictable relationship to one another. Id. EPA also requested source-specific data from Alabama facilities affected by the Submittals. EPA also included a bulleted list of more specific types of information that could assist in conducting an analysis on the impacts of a SIP revision on the air quality of the affected area (i.e., a 110(l) analysis). Id. Providing guidance on development of a general visible emissions SIP revision is difficult because opacity and visible emissions are most easily evaluated in a source-specific context. However, states may consider the following information useful.

As a general matter, states may find it instructive to look at visible emissions SIP revisions that EPA has approved. An example is the North Carolina approval previously referenced in this rulemaking. 70 FR 61556. As was noted earlier in this rulemaking, there are two key differences between the North Carolina action and the Alabama Submittals now being disapproved. First, the North Carolina action did not allow additional minutes of opacity exceptions. Second, the North Carolina action did not change the percentage of opacity allowed during the exception periods.

More generally, EPA expects that providing assurance that a source will comply with a rule that allows no more than one 6-minute exceedance per hour and opacity readings no greater than 40 percent clearly requires more effective control equipment and/or operating procedures than it takes to assure a source will comply with a rule that allows longer consecutive periods of exempt opacity excursions and at higher opacity levels. Opacity and PM emissions are related closely enough that control equipment effective enough to meet the more stringent opacity standard (in terms of the number of consecutive excursions allowed and the level of opacity excursions allowed) will also provide a greater level of PM emissions control. Due to the importance of first understanding the relationship between opacity and PM emissions at the affected sources, source-specific SIP revisions have historically been used by most states in developing different visible emissions standards for a source, particularly when those standards are less stringent than existing standards. Source-specific SIP revisions allow for the ability to analyze the PM/opacity relationship and establish an appropriate opacity limit that will not impact the NAAQS. The technical analysis for such rule changes would likely involve collection of parallel mass and opacity data for the source in question. If that information indicates that there will be increases in PM mass emissions or opacity, then further analysis would be required to ensure that the increased emissions associated with the increased opacity (or rule change at issue) will not interfere with attainment, reasonable further progress, or any other applicable requirement of the CAA (the 110(l) factors), for that particular source and locale. Further, a more definitive modeling assessment of the effect of any proposed rule would include the representative range of emission rates and/or conditions producing 100 percent opacity for each type of source affected by the rule.

When source-specific information is available, the uncertainty about the relationship between opacity and mass, and the implication of the changes in opacity on PM emissions, is reduced and there may be a basis upon which to make an informed judgment about the impacts of the change with respect to section 110(l). Further, source-specific actions are much more discrete since they typically apply at a particular unit of a particular facility, thus eliminating the need to evaluate the statewide impact of the change. EPA has undertaken source-specific opacity revisions.See, e.g.,66 FR 33027 (June 20, 2001) (approving a source-specific revision affecting 14 units in Alaska). Similarly, a focus on a particular source category may also allow for more specific understanding regarding the relationship between opacity and PM emissions at the affected facilities and the rule's overall impact to air quality. 73 FR 36485 (June 27, 2008) (proposing disapproval of source-category specific revision; notice explains how a source-category revision may be developed).

EPA is not suggesting that every revision to an opacity standard requires source-specific analyses. If a submission provides a sufficient basis for EPA to conclude that changes to a visible emissions requirement will not result inincreased PM emissions in a nonattainment area over what would have been allowed under the previously approved SIP rule (or otherwise interfere with any applicable requirement of the CAA), then EPA anticipates that it would be approvable under section 110(l). Ultimately, the key issue that must be addressed in any 110(l) analysis of an opacity SIP revision is an evaluation regarding the impact of that revision on PM emissions and the NAAQS. As was noted earlier, because Alabama's Submittals were voluntary revisions to the SIP and not mandated, Alabama has no obligation to develop another visible emissions revision.

The following are EPA's responses to the significant adverse comments on EPA's October 2, 2009, proposal. EPA is obligated to respond to adverse comments received and thus, has reviewed the comments that were adverse to a disapproval of the State's SIP revisions. EPA is now responding to those comments. Many of the comments overlapped or were redundant, so in order to assist with readability of the responses, we have organized the comments and responses into subject-matter groupings identified below.

Comment 1.Commenters argued that because EPA's October 2, 2009, reconsideration proposal notice did not select an option, or at least disclose to the public which option EPA preferred, EPA's interpretation of the relevant CAA provisions and their application to the situation here will be entitled to no deference upon judicial review. Also, the commenters asserted that their ability to comment on the proposal is hamstrung by EPA's failure to articulate which option EPA would choose.

Response 1.EPA does not agree with commenters' characterization of the October 2, 2009, proposed rulemaking. That proposal described two alternative actions in detail—including the technical, legal, and policy bases for each of the respective actions. EPA provided sufficient information for each alternative for commenters to participate meaningfully and for either alternative proposal to be finalized, depending upon what additional information was developed as a result of the reconsideration. EPA has previously used the alternative proposal option when dealing with a particularly complex rulemaking (see, e.g.,proposal regarding California-Imperial Valley Planning Area, 66 FR 42187 (August 10, 2001)). In this case, EPA's interest in ensuring public comment on the two primary options was best achieved through the alternative proposals. There is no indication of any commenter being unable to provide meaningful comments. Numerous commenters provided substantive comments on both of the two proposals. The substance of the commenters' own comments reflect that they were on notice of the factual and legal issues relevant to the reconsideration.

Comment 2.Commenters asserted that there is no new record evidence provided by EPA, Petitioners, or other interested parties in order to support the second petition for reconsideration of EPA's approval of the SIP revision in the October 2008 final action.

Response 2.EPA's authority to reconsider a SIP rulemaking derives from both the Administrative Procedures Act (APA) section 553(e) as well as authority in the CAA. The APA provides the opportunity for any person to “petition for the issuance, amendment, or repeal of a rule.” 5 U.S.C. 553(e). The APA does not explicitly limit this right based on new evidence or any other limitations alleged by commenter. Even if there were such a limitation, EPA disagrees that the second petition for reconsideration did not raise issues that warranted reexamination of the factual and legal basis for the October 2008 action.

Comment 3.Commenters argued that the CAA does not authorize EPA to continue to entertain petitions for reconsideration “indefinitely” after a specific CAA process has been followed and reconsideration has been denied. According to the commenters, the CAA allows EPA to “call” an approved State SIP for legal deficiencies, but does not allow EPA to continue to reconsider its actions on a state-submitted SIP revision after the revision is approved. Commenters also argued that EPA lacks authority to reverse its approval of the SIP revisions because EPA may only change its standard for review of SIP revisions under section 110(l) prospectively—i.e.,EPA may only apply an allegedly new reading of section 110(l) to new state requests for SIP revision. The commenters further argued that any request for reconsideration of a final SIP approval must follow the procedures identified in CAA section 110(k)(5) for seeking a change to a previously approved SIP revision (noting that section 307 does not apply and section 553(e) of the APA cannot be used to bypass 110(k)).

Response 3.EPA disagrees with the commenters' views of EPA's authority to reconsider rulemakings under these circumstances. An administrative agency has the authority to reconsider its decisions, unless Congress specifically limits the agency's discretion to do so.See, e.g., Gun South, Inc.v.Brady, 877 F.2d 858, 862 (11th Cir. 1989) (holding that agencies have implied authority to reconsider and rectify errors even though the applicable statute and rules do not provide expressly for such reconsideration). The DC Circuit Court recently affirmed this authority inNew Jerseyv.EPA, 517 F.3d 574 (D.C. Cir. 2008), where it explained that an agency normally can change its position and reverse a prior decision but that in the case before it, Congress limited EPA's ability to remove sources from the list of hazardous air pollutant source categories, once listed, by requiring EPA to follow the specific delisting process at CAA section 112(c)(9).See also, e.g., Trujillo v.General Electric Co., 621 F.2d 1084, 1086 (10th Cir. 1980) (“Administrative agencies have an inherent authority to reconsider their own decisions, since the power to decide in the first instance carries with it the power to reconsider”). EPA recently applied this approach in connection with California conformitySIPs. EPA had approved the SIPs based on a mobile source model that was current at the time of EPA's approval. EPA proceeded to update the mobile source model, but under the previous SIP approvals, conformity decisions would continue to be made on the basis of those previous SIP approvals, and would not take into account the updates to the mobile source model. To remedy this problem, EPA conducted a rulemaking that revised the previous SIP approvals so that they were limited to the period before States submitted, and EPA found adequate, the mobile source budgets in new SIPs based upon the update of the mobile source model.See74 FR 55292, 55342 (October 27, 2009) (discussing EPA's inherent authority to reconsider SIP actions).See also73 FR 21528 (August 22, 2008) (EPA final action on reconsideration of previous Georgia SIP action).

The commenters questioned EPA's authority to reconsider a SIP action and appear to suggest that EPA's authority is limited to only a SIP “call” under section 110(k)(5) of the CAA. The SIP call process, however, is a distinct and separate authority that Congress has given to EPA for use when EPA determines that a current SIP is substantially inadequate to attain or maintain compliance with the CAA requirements.See, e.g., Sierra Clubv.Georgia Power Company,443 F.3d 1346, 1348 (11th Cir. 2006) (describing the separate revision provisions under the CAA and the SIP call process generally). The SIP call process was not intended to be the sole means of revising the SIP and does not displace EPA's authority to reconsider its approval.18 While the two processes may be complementary, the authority to reconsider an action and the authority to issue a SIP call are not mutually exclusive, and one or the other may be appropriate in different circumstances.

As the commenters correctly noted, EPA's approval of a SIP revision is not subject to the rulemaking requirements of the CAA section 307(d) because it does not fall within the enumerated categories in section 307(d)(1) of the CAA. Section 307(b)(1), to which a SIP revision rulemaking is subject, contemplates the “filing of a petition for reconsideration by the Administrator of any otherwise final rule or action.” 42 U.S.C. 7607(b)(1). Courts have also found that EPA must follow the rulemaking requirements of the APA when evaluating a SIP submission (see, e.g., Hall, 273 F.3d at 1161), including section 553(e). Finally, the very nature of a SIP is that it is not a static document; it is regularly revised to account for new EPA standards and new emissions reduction technologies. 42 U.S.C. 7410(a)(2)(H).

Furthermore, EPA notes that the SIP revision at issue did not take effect by its own terms until after the date on which EPA granted the second petition for reconsideration. No sources affected by the revisions to the Alabama SIP should have been required to alter their facilities or their operations in reliance on the prior EPA approval. EPA's view is that a source that is properly maintained, operated and controlled should have no difficulty complying with either the pre-existing or the revised version of visible emissions rules in the SIP, or even complying simultaneously with both versions of the SIP, which suggests that the reconsideration process should not have been disruptive for any source. In the present case, EPA concluded that reconsideration of its approval of the Submittals was necessary to ensure that the final decision was consistent with the plain text and legislative history, and air quality goals of the CAA, given the facts at issue in this situation. While the result of EPA's action today is that Alabama's Submittals are disapproved, the effective date for such disapprovals will be the effective date of this final action. Thus, there is nothing retroactive about today's final action.

Comment 4.Commenters argued that if EPA reverses its approval of the Submittals now, that would be arbitrary, contrary to EPA's statutory authority and its responsibility to implement the CAA, and in violation of EPA's “delegation commitment” to Alabama under the CAA.

Response 4.As a point of clarification, Alabama is authorized to implement certain portions of the CAA through its SIP. Commenters do not explain the “delegation commitment” reference. Such terminology is inapposite as the majority of CAA programs are “authorized,” not “delegated,” particularly with regard to those embodied in a SIP. Some CAA programs, such as section 112, are routinely “delegated” by EPA to states; however, section 112 programs are not SIP programs. EPA's responsibility to implement the CAA extends to ensuring that its decisions are based in the CAA and its implementing regulations. In the instant action, EPA is reversing a previous approval decision because after reconsideration, EPA has concluded that a disapproval is required based on known technical information (as opposed to uncertainty) and an interpretation of section 110(l) that is most consistent with the plain text and legislative history of the CAA, as well as the air quality goals set forth in the CAA. As was explained above, EPA's reconsideration process is well grounded in statutory authority.

Comment 5.Commenters asserted that EPA's reconsideration proposal notice does not provide any information about the legal authority that the Agency believes justifies its action. The commenters further argued that it is incumbent upon the Agency to disclose the legal basis upon which it proposes to act and to provide the public with the opportunity to comment on that asserted basis, and that without such an explanation from EPA, the October 2, 2009, proposal notice is deficient and does not provide an adequate basis upon which the Agency can lawfully take action.

Response 5.EPA does not agree with commenters' assessment. The October 2, 2009, reconsideration proposal includes two alternative options for final action—both based upon application of section 110(l) of the CAA. Section 110(l) applies to all SIP revisions and limits EPA's legal authority to approve revisions to existing EPA-approved SIP provisions. The reconsideration proposal notice explained the alternative proposed actions as well as the interpretation of section 110(l) that would support each of the alternatives. The substance of the comments reflects that the commenters were in fact on notice of the factual and legal issues that EPA raised for reconsideration.

Comment 6.Commenters asserted that certain documents received in response to a Freedom of Information Act (FOIA) request do not support the reopening of the public comment period.

Response 6.As was explained earlier, there is no prohibition on EPA's authority to review a final action and allow for a new public comment period on that action. EPA has provided the basis of the reconsideration of the October 15, 2008, final rule—the CAA and the APA. Whether documents obtained through a FOIA support EPA's reconsideration, in the opinion of the commenter, is not relevant.

Comment 7.Commenters asserted that EPA appears to be considering a “policy change” in how it interprets and applies section 110(l) in the reconsideration process. Commenters argued that if EPA wants the State to amend its approved SIP to reflect revised EPA policy on section 110(l), EPA must act under section 110(k)(5) of the CAA and not through a “unilateral” notice andcomment process. Commenters asserted that they are aware of no other situation where EPA has proposed to act in this manner to “withdraw” a final approval of a SIP revision.19

Response 7.EPA's interpretation of 110(l) that is outlined in this final action is consistent with EPA's historic interpretation of 110(l), the plain text of the CAA, and the legislative history of the CAA (as well as court opinions that have considered 110(l)). EPA's decision is based on its re-evaluation of the likelihood that approval of the Submittals will result in increases of allowable PM emissions. In amending its previous action, EPA is placing greater weight on the technical aspects of the SIP Submittals that are known to have the potential for adverse impacts on the NAAQS as a result of allowing greater levels and durations of opacity exceedances. This change does not represent a policy shift, but rather, an analytical reconsideration of what decision is most supported by the CAA, given the facts at issue in this rulemaking. Moreover, EPA's reconsideration process in this action was far from “unilateral.” By reopening the rulemaking for additional public comment, and setting forth the legal, technical, and policy bases for that alternative outcomes in the reconsideration process, EPA sought to ensure that the public had an opportunity to comment and review the possible options.

Ironically, if anything, the SIP call process apparently preferred by commenters is more “unilateral” in that such a process is initiated after EPA has concerns that an existing SIP is substantially inadequate and often requires a state to take action to revise its SIP following EPA's final action on the SIP call. Here, EPA's disapproval will result in a rule coming back into effect that was in effect for years. Alabama will not be required to submit a revised SIP revision. Further, as explained above, EPA has used the alternative proposal approach in the past. While the approach is not appropriate in all regulatory actions, it serves an important purpose of seeking public comment in the unusual circumstance in which two potentially supportable decisions exist and additional information or input from the public may be helpful to EPA in making a final decision.

Comment 8.Commenters stated that EPA's prior analysis of the SIP revision remains sound and that there is no basis for reversing the conclusions of that analysis. According to the commenters, the rigors of the prior SIP revision process insured that the concerns raised by the Petitioners have already been heard and considered by both ADEM and EPA multiple times. The commenters argued that the petition for reconsideration raised no issues that were not or could not have been raised during the prior rulemaking process. Therefore, the commenters argued that reversing the prior approval of Alabama's Submittals at this point and in this manner would not only be an abuse of EPA's authority under the CAA, it would be the height of arbitrary and capricious Agency action.

Response 8.EPA does not agree with the commenters' assessment. For the reasons described in this final notice, EPA has determined that reconsidering its prior approval and seeking additional notice and comment on the factual and legal issues raised by the Petitioners was an appropriate action. In reversing its prior approval, EPA has concluded that disapproval is necessary pursuant to the plain text of the CAA, its legislative history, and the air quality goals described therein. EPA appreciates that there has been substantial discussion about the merits of the Submittals, including various opportunities for public comment. Ultimately, however, when weighing alternatives, EPA's final decision must be the one that is most consistent with the CAA, even if that decision is reached through a reconsideration process. EPA has already addressed its authority to review the October 15, 2008, final action in response to comments above.

Comment 9.Commenters asserted that in granting the second petition for reconsideration and re-opening the rulemaking for further public comment, EPA ignores the lack of a legal basis for reconsideration, its earlier rejection of AEC's arguments for reconsideration on the merits, and its thorough review and technical analysis of the effect of these SIP revisions during the earlier rulemaking itself. According to the commenters, reconsidering a SIP approval sets a poor precedent and undermines regulatory certainty and the integrity of EPA's rulemaking processes.

Response 9.EPA does not agree with commenters' assessment. To the contrary, the reconsideration process has ensured that EPA has left no issue unconsidered in its analysis of the Submittals. EPA's final action on the Submittals, while amended from its previous action, is strongly grounded in the CAA, the APA, and sound science. This action furthers the purposes of the CAA, is based on the substantive requirements of the CAA, and follows the rulemaking requirements of the CAA and the APA. Thus, the action supports regulatory certainty and the integrity of SIP process.See, e.g.73 FR 21528 (August 22, 2008) (EPA reconsideration of Georgia SIP action). Indeed, the fact that the CAA and the APA provide bases for reconsidering regulatory decisions demonstrates that Congress expected EPA to take necessary action to revise its actions when a party raises factual or legal issues that the Agency finds justify reconsidering such actions.

Comment 10.Commenters questioned why EPA granted the petition for reconsideration of the approval of Alabama's Submittal because the Petitioners have provided no new information.

Response 10.As was discussed above, the APA does not restrict EPA's authority to reconsider a rule to a specific record or timeframe. EPA was petitioned for reconsideration of a rule and EPA granted that reconsideration because it concluded that the petition raised factual and legal issues that justified further evaluation. The second petition for reconsideration raised numerous reasons why EPA's October 15, 2008, final action should be reconsidered, including several reasons not identified in the first petition for reconsideration. Thus, commenters' characterization of the second petition for reconsideration as providing no new information is also not correct.

Comment 11.Commenters asserted that data submitted to EPA show that there is no reliable or direct correlation between opacity and PM emissions. In addition to several sources of uncertainty in the relationship between changes in opacity and increases or decreases in PM2.5levels cited by EPA in the April 12, 2007, proposal notice, the commenters argued that other variables affecting the relationship of opacity and PM mass emissions include stack diameter, stack gas temperature, particle density (a function of coal type), and flue gas water vapor content. The commenters argued that many, if not most, of these variables are beyond the control of source operators. Therefore, the commenters stated that while opacity can serve as an indicator of whether the boiler and related pollution control equipment at a specific source are well-controlled and well-operated, changes to opacity of emissions,including changes to the SIP limits applicable to opacity in a SIP, cannot be presumed to have any direct effect on ambient concentrations of PM.

Response 11.EPA generally agrees with commenters that there is inherent uncertainty in the precise relationship between opacity and ambient concentrations of PM, although we note that some variables are less likely to vary during a single source's operation (as opposed to among different sources). EPA also agrees (as a general matter) with commenters' statements that opacity is useful as an indicator of a source's operations and control technology. Moreover, opacity can be a reliable indicator of PM emissions when appropriate source-specific testing is carried out and correlations are established for the particular source, operating characteristics, and fuel supply.

EPA disagrees, therefore, that increases in opacity of emissions per se could not reflect any increases in mass emissions under any circumstances, in particular in the case of the significant increases in the percentage opacity and the duration of excursion time at issue in these SIP revisions. This comment highlights the importance of ensuring that the final decision made by EPA to approve a SIP revision is based on a reasoned application of that knowledge within the confines of the CAA.

Comment 12.Commenters argued that available data continue to demonstrate there is no reliable, generally applicable relationship between opacity and the PM NAAQS. The commenters asserted that previous technical studies submitted by APC in the rulemaking confirm this lack of correlation. The commenters referred to prior comments for the assertion that: “Because opacity is dependent on so many factors, there is no general relationship between opacity and particulate loading.”

Response 12.EPA agrees that opacity data from different individual sources are very specific to the source and to the manner in which it is being operated for the period over which data is collected. In other words, source operation affects data produced by the source. Thus, EPA and others must consider not only the data on opacity and PM, but also the details regarding the facility and its operating characteristics as part of developing an opacity/PM correlation. As a result, such data from one facility may be of limited value in extrapolating reliable conclusions about emissions from another facility. However, EPA expects that sufficiently high increases in opacity up to 100 percent for extended periods can represent some impact on PM emissions from the sources affected by the rules at issue in the Alabama SIP revisions. As noted by comments received through the reconsideration process, although the precise correlation between the mass and opacity of emissions may vary, significant increases in opacity to its highest measurable level at the same source are likely to result in additional PM emissions from that source. Given that several sources are located in and near nonattainment areas, such additional emissions are inconsistent with the prohibition of section 110(l) on SIP revisions that will interfere with attainment and maintenance of the NAAQS.

Comment 13.One commenter asserted that EPA's prior conclusion that greater opacity does not necessarily mean greater PM emissions is entirely reasonable.

Response 13.EPA appreciates commenters' position on this issue—the uncertainty inherent in the relationship between opacity and PM is discussed at length in this final action. While EPA agrees that greater opacity does not necessarily (in all circumstances) mean greater PM emissions, EPA does expect that some periods of greater opacity (particularly of high opacity for longer periods of time) are likely in at least some circumstances to be accompanied by greater PM emissions.

Comment 14.A commenter agreed that it is difficult to accurately characterize differences in direct PM2.5emissions attributable to short-term increases in opacity and further commented that: (1) The type of event causing the short-term increase in opacity will most probably have an effect on any direct PM2.5emissions differences associated with the event, and (2) based on the cumulative size distribution table in AP-42 (Compilation of Air Pollutant Emission Factors), any increase in PM emissions associated with short-term increases in opacity would most likely occur in particle sizes larger than direct PM2.5.

Response 14.Commenter appears to refer to Table 1-1.6, “Cumulative Particle Size Distribution and Size-Specific Emission Factors for Dry Bottom Boilers Burning Pulverized Bituminous and Subbituminous,” which is found in Chapter 1 of EPA's AP-42,Compilation of Air Pollutant Emission Factors(http://www.epa.gov/ttn/chief/ap42/). This table suggests that for units having pollutant emissions controlled by electrostatic precipitators (ESPs), PM2.5accounts for only 29 percent of total PM emissions. EPA agrees the type of event causing an increase in opacity of emissions may have an effect on the size distribution of PM emissions. However, EPA disagrees that increases in PM emissions associated with increases in opacity would most likely occur in particle sizes larger than 2.5 micrometers in aerodynamic equivalent diameter, since the circumstance that causes an opacity increase could occur while a PM control device is operating properly, as described by the value contained in the AP-42 table, or while a PM control device is not operating properly, a condition not described in the AP-42 table. The uncertainty regarding the impact of opacity increases on PM emissions is further complicated because particles approximately 1.0 micrometer in diameter have greater potential for increasing opacity than larger particles.See, e.g.,Malm, William C., “Introduction to Visibility,” Cooperative Institute for Research in the Atmosphere, May 1999 at Chap. 2, p. 8. Thus, for the increases in opacity contemplated in the SIP revisions at issue in this rulemaking, EPA is concerned that this increased opacity would probably include additional particles of the very types that would be problematic for purposes of attaining and maintaining the PM2.5NAAQS.

Comment 15.Commenters argued that with regard to EPA's request for additional information addressing the relationship between opacity and PM emissions generally, only the relationship between opacity and direct PM2.5would be relevant to the situation at hand, and that this information would be virtually impossible to obtain due to the inclusion of larger particles which are an inevitable part of any effluent gas stream.

Response 15.EPA agrees that information concerning the relationship between opacity and PM2.5emissions from a facility would be most relevant for purposes of evaluating impacts on the PM2.5NAAQS, but EPA notes that no commenter provided such data, despite EPA's specific request for such specific data. 74 FR 50934 (October 2, 2009). EPA disagrees that this information would be virtually impossible to obtain. By way of example, some sources are obtaining and reporting these data as part of the current electrical utility maximum achievable control technology (MACT) rule information collection request. Also, under section 110(l) of the CAA, EPA may not approve revisions to SIP if the revisions would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the CAA. Because there are also NAAQS for PM10,states and EPA must also consider potentialimpacts of increases of larger particles if increased opacity were to include the emissions of larger particles from a source as the commenter asserted. For 110(l) purposes, analysis of a SIP revision must include all of the current NAAQS, to the extent that the changes in the SIP revision could affect such NAAQS. With respect to this action, EPA has only focused on the potential impacts of the SIP revision on the PM2.5NAAQS because those are the standards that EPA anticipates are most implicated by the increases in opacity at issue.

Comment 16.Commenters argued that although an increase in opacity can be a good indication that PM emissions at the stack also are increasing, the magnitude of mass emissions relative to any one opacity value and the increase in mass emissions relative to increase in opacity generally are not quantifiable. Accordingly commenters asserted that an increase in opacity would provide no information regarding emission levels of PM2.5,as opposed to PM10or total PM, and argued that any correlation between opacity and PM would have to be source specific, and even then, uncertainties remain. The commenters also criticized EPA's information on opacity and PM, noting that the charts included in the docket do not contain sufficient information to evaluate the relationship between opacity and PM.

Response 16.EPA agrees that an increase in opacity can be a good indication that PM emissions at the stack also are increasing. It is for this reason that we are disapproving the SIP revision embodied in the Submittals, even though the magnitude of mass emissions relative to any one opacity value and the increase in mass emissions relative to increase in opacity generally are not quantifiable. EPA also agrees with the commenters that a correlation between mass and opacity can be derived at a specific source, and EPA has in the past approved SIP revisions that relied on such correlations with sufficient technical analysis.

EPA disagrees, however, that information about opacity increases provides no information regarding PM2.5emissions specifically. Rather, information about opacity increases without concurrent PM2.5emissions data or an established correlation between opacity and PM2.5emissions cannot be expected to yield definitive information concerning increases in PM2.5emissions. The memorandum in the docket, EPA-R04-OAR-2005-AL-0002-0064, provides the information known to EPA about the charts referenced by the commenter, EPA-R04-OAR-2005-AL-0002-0045 and EPA-R04-OAR-2005-AL-0002-0047. Further, the charts provided in the docket demonstrate the inherent uncertainty in the relationship between opacity and filterable PM mass emissions by showing a range of mass emission rates associated with a single opacity value and a range of opacity values associated with a single mass emissions rate. However, uncertainty about the precise correlation between mass and opacity as a general matter, does not mean that opacity increases never represent concurrent increases in the mass of PM emissions from a source. To the contrary, given the large increases in maximum allowable opacity and for the periods of time at issue in the SIP revision contemplated in the Submittals, EPA expects that it is likely that there could be increases in mass emissions.

Comment 17.Commenter disputed the relationship between opacity and PM mass emissions based upon EPA statements in an unrelated rulemaking. The commenter asserted that despite providing the option for use of PM continuous emissions monitoring system (CEMS) as a compliance method for PM mass limits in revised NSPS Subparts D and Da, EPA also recently suggested it had concerns regarding the accuracy of PM CEMS measurements above 0.030 pounds per million British Thermal unit (lb/mmBtu). As a result, the commenter argued that EPA declined to exempt units operating above that level from the NSPS opacity standard even when such sources install PM CEMS. 74 FR 5070 (January 28, 2009). Commenter requested, to the extent EPA relies on data from PM CEMS above 0.030 lb/mmBtu in this proceeding, that the Agency explain how it resolved those concerns.

Response 17.EPA disagrees with the commenter's conclusions regarding PM CEMS measurement accuracy above 0.030 lbs/mmBtu. As mentioned in the citedFederal Registernotice, the contribution of filterable PM to opacity at these emission levels (less than 0.030 lb/mmBtu) is generally negligible, and sources with mass limits at this level or less will operate with little or no visible emissions (i.e.,less than 5 percent opacity). As a result, EPA expects that an opacity standard is no longer necessary for such sources because the PM mass emission rate standard is substantially tighter, and the use of PM CEMS with continuous monitoring of PM emissions is more effective than opacity monitoring in these circumstances.

This comment is also not germane to today's action because the SIP revisions at issue did not include the requirement that the affected sources install PM CEMS as a precondition to the revision of the applicable opacity standard. As noted above, opacity standards serve an important role in assuring compliance with PM limits, for example by alerting regulators to problems with source operation or control measures that would not otherwise be noted except during a stack test for PM emissions, which occur only periodically. In some circumstances, opacity is the emission standard that is the subject of an enforcement case.

Comment 18.A commenter articulated the position that its facilities are operating in compliance with PM limits in the title V permits and as a result, the opacity rule is not likely to impact PM compliance. The commenter further opined that ADEM should address any PM nonattainment issues separately from this rulemaking.

Response 18.EPA disagrees with the assessment that opacity is unlikely to have any effect on PM emissions for all the reasons explained in this final action regarding that relationship. Further, Alabama's visible emissions rule is a part of Alabama's plan to attain and maintain the PM NAAQS. Even though it has been in the SIP for some time, the rule was originally included for that purpose. Thus there is nothing separate about this action and Alabama's PM nonattainment issues—the rule at issue here is part of Alabama's overall plan to address the PM NAAQS. Further, if a source is in compliance with the opacity and PM limits, then this disapproval action should have little effect on that source.

Comment 19.Commenters argued that modeling is not required to demonstrate that changes to Alabama's opacity rule will not implicate the NAAQS. Nonetheless, commenters argued that ADEM performed a modeling analysis demonstrating that even earlier versions of the SIP revision (predating the Submittals that EPA approved in October 2008) would not adversely affect air quality attainment or RFP under very conservative assumptions about the relationship between opacity and PM emissions. In addition, commenters argued that updated modeling from a consultant, ENSR (now known as AECOM), updated ADEM's 2003 modeling in 2007 using AERMOD (an atmospheric dispersion modeling system and EPA's preferred model since 2005) and confirmed ADEM's earlier modeling results. Commenters argued that APC and TVA have performed subsequent modeling that alsosupported the conclusion that the increased opacity permitted by the SIP revisions in the Submittals would not interfere with attainment and maintenance of the NAAQS or other requirement of the CAA. Commenters asserted that these modeling results show no problem with the NAAQS even under unrealistic, worst-case conditions. APC also discussed modeling done at APC Plants Barry and Greene and TVA Plant Colbert which APC believes supports affirming EPA's 2008 final action approving the Alabama SIP revisions. Commenters further noted that ADEM performed a modeling analysis demonstrating that the SIP revisions would not affect air quality attainment under very conservative assumptions about a relationship between opacity and PM emissions. According to the commenters, modeling performed by TVA confirms that particulate emissions from the Colbert facility would not interfere with maintenance of the PM10or PM2.5NAAQS, even for the unrealistic scenario in which the ESPs are shut down for 10 percent of the time every day of the year.

Response 19.EPA disagrees with the commenter's assertions. As discussed in 73 FR 60961 (October 15, 2008), all modeling results are predicated on a known or assumed correlation between opacity and PM mass emissions. Because this correlation can differ for each source and operating condition, modeling that does not use source-specific correlations does not and cannot demonstrate with certainty the impact of changes in opacity on PM NAAQS. With respect to the modeling described by the commenters, the models do not demonstrate that the Submittals would not interfere with attainment or maintenance of the NAAQS because the models do not appear to have included condensable PM or background analyses, to have assessed the impact of nearby PM emissions sources, or to have assessed the impact of secondary PM formation. Generally, however, the utility of modeling would still be limited because the precise relationship between opacity levels and PM mass emissions is not known. The docket for this action includes a technical support document (TSD) summarizing the modeling that EPA received and some of the key assumptions and other issues that impacted the utility of the modeling.

Comment 20.Commenters argued that EPA has routinely approved SIP demonstrations based on the use of air models, rightly concluding in such matters that the use of the air models leads to a reasonable demonstration of compliance with the NAAQS.

Response 20.As a general matter, EPA agrees that modeling can be a useful tool in appropriate circumstances. In this case, the modeling provided did not reduce uncertainty regarding the relationship between opacity and PM emissions sufficiently to support approval of the Submittals. Further, the modeling did not conclusively demonstrate that there would be no impact on the NAAQS. Thus, EPA could not conclude that the modeling submitted supported approval of the Submittals under section 110(l). EPA's modeling TSD provides more information on the modeling submitted to EPA as part of this action.

Comment 21.Commenters stated that monitoring data show a decline in ambient PM2.5and PM10levels at monitors that could potentially be impacted by TVA's Colbert and Widows Creek Plants.

Response 21.EPA acknowledges that ambient PM levels have been improving in many parts of the country as a result of rigorous state and EPA efforts to control emissions from many sources of various types. EPA wants to maintain these improvements and to support further improvements for protection of public health as many areas are still designated nonattainment for the NAAQS. Indeed, this is among the reasons why reviewing SIP revisions pursuant to section 110(l) is such an important exercise.

Comment 22.Commenters argued that Petitioners' claims regarding “bundling” or other potential ways of “using” Alabama's visible emissions revisions to somehow reduce control efforts while still meeting permit requirements are misplaced. According to the commenters, it is extremely difficult to achieve continuous or near-continuous compliance with the opacity rules, so there is absolutely no incentive to try to “game” the system by trying to achieve less than maximum opacity control at any one time. Further, commenters argued that facility procedures aimed at minimizing opacity levels at all times in order to avoid non-exempted exceedances insofar as practicable remain intact after the rule revisions went into effect January 1, 2009.

Response 22.The commenters' argument appears to be that even though “bundling” could occur, it will not, because sources are diligently striving to minimize their opacity levels. While EPA certainly expects that sources are seeking to minimize their opacity levels, EPA's analysis of the revision considered what the two versions of the Alabama rules allowed—and not necessarily how sources were operating under each rule scenario. As with the modeling submitted by many commenters, the primary problem associated with their conclusions about the amount of PM emissions during longer periods of elevated opacity is the reliance on an assumed relationship between opacity and PM emissions that has not been established for the specific source. As mentioned previously, this relationship is unknown for each source and operating condition, absent sufficient evaluation. EPA disagrees that the “bundling” of periods of high opacity could never reflect higher PM mass emissions.

EPA understands the difficulties associated with operating older facilities, but disagrees that continuous compliance with opacity rules can be achieved only through extreme difficulty. The Alabama SIP opacity limits in effect following this disapproval should generally be capable of being met by a source that is properly maintained, operated and controlled. There are control technologies and operational paradigms that allow older facilities to comply with Alabama's pre-October 15, 2008, opacity rules (this was recognized by the court in the TVA Colbert case,Sierra Clubv.TVA,592 F. Supp. 2d 1357 (N.D. Ala. 2009)).

Comment 23.Commenter explained that to attempt to bundle six-minute opacity exceedances would necessitate a purposeful “turn-down” of the unit's ESP and, thus, result in non-compliance with two provisions of the commenter's Lowman Plant's major source operating permit (title V permit): (1) That “all air pollution control devices * * * be * * * operated at all times in a manner so as to minimize the emissions of air contaminants,” and (2) once the emissions exceed a six-minute average opacity of 20 percent, corrective actions must be taken within two hours.

Response 23.EPA's analysis of the SIP revisions at issue is governed by, among other provisions, section 110(l) of the CAA. In that context, as was explained previously, EPA must compare the existing SIP and the proposed SIP revision. While affected sources may have permit limits that are more stringent than the applicable SIP regulations, EPA's analysis must focus on what the SIP itself would allow. Permits may be revised from time to time, depending on applicable requirements. As a result, the type of analysis completed by the commenter based on the applicable permits mightbe changed over time. Further, while EPA would, of course, be concerned by a purposeful “turn-down” of any control device, EPA expects that there are other circumstances under which extended periods of consecutive exemptions would allow high opacity levels (and mass emissions) that would not occur in a well-operated, well-controlled, and well-maintained plant. EPA appreciates PowerSouth Energy Cooperative's (PSEC's) analysis, which demonstrates that this disapproval action should have little effect on the vast majority of sources.

Comment 24.Commenters provided data in three attachments provided by PSEC showing emissions during the period of January 1, 2009, thru September 30, 2009, clearly indicate that no “bundling” occurred. For example, Attachment 1 shows that of the total of 90 six-minute periods of excess opacity (i.e.,six-minute averages of opacity greater than 20 percent), including startup/shutdown and load change periods, there were 40 occurrences of isolated six-minute periods of excess opacity; 14 occurrences of two consecutive six-minute periods of excess opacity; four occurrences of three consecutive six-minute periods of excess opacity; one occurrence of four consecutive six-minute periods of excess opacity; and one occurrence of six consecutive six-minute periods of excess opacity.

Response 24.EPA appreciates the submission of operating data. One of the difficulties with the technical analysis regarding opacity is that details regarding facility operation can impact both opacity and PM in different ways. Further, EPA must consider the effect of the Submittals on how a facility may be allowed to operate, not just how the facility actually has been operating. With these considerations in mind, the operating data were informative, but not determinative, because even if a facility currently operates as the commenters describe, the facility would be allowed to operate otherwise under Alabama's proposed SIP revisions.

Comment 25.Commenters suggested that this 22 percent limit ensures that the average daily opacity under the revised SIP is no greater than under the previous SIP. The commenters asserted that this fully responds to AEC's hypothesis of the “bundling of high opacity periods” and concerns about the elimination of the “40 percent cap” under the revised SIP. Further the commenters explained the use of a daily opacity limit to establish short-term equivalency is appropriate because a calendar day is the shortest period over which compliance with the PM NAAQS is measured. The commenters stated that AEC provides no supporting data on the bundling and operating data provided, which commenters believe demonstrates that bundling has not occurred.

Response 25.The Commenters' statements are incomplete. While the 22 percent limit does serve the purpose of ensuring subject sources are constrained by the same maximum allowable average daily opacity as under the previously approved SIP (as explained in EPA's 2008 final notice), these SIP revisions would allow opacity levels of up to 100 percent during exempt periods and for multiple consecutive exempt periods, neither of which was previously authorized under the SIP. The prior version of the visible emissions rule capped maximum opacity at 40 percent and limited the time at such level to only six minutes per hour. Further, whether “bundling” in fact has occurred in the past is not the focus of EPA's analysis for purposes of section 110(l).20 As part of this reconsideration, EPA has had to re-evaluate the concept of the “22 percent daily cap” supported by the commenter. EPA has concluded that even with an “average daily opacity” cap, these SIP revisions undermine the purpose and effectiveness of the opacity standard by allowing extended periods of high opacity. Such high opacity can be indicative of problems with control device operation or other circumstances potentially leading to increased mass emissions. Given that some sources affected by the opacity limits at issue in the SIP revisions are located within designated nonattainment areas, EPA concludes that this likelihood of increased emissions renders the Submittals unapprovable under section 110(l).

Comment 26.Commenters argued that the equivalency between the previous and revised SIPs, with respect to the short-term and long-term emission rates, will ensure that there will be no interference with NAAQS notwithstanding the bundling of high opacity periods. Further, the commenters mentioned that in approving the North Carolina SIP revision for visible emissions, EPA concluded that such bundling through the “elimination of the current restriction of no more than one six minute exception period per hour” does not “pose a problem for purposes of Section 110(l).” Commenters cite to 70 FR at 61558 for support.

Response 26.As EPA explained earlier in this final action, the North Carolina opacity revisions are not analogous to Alabama's opacity revisions for the main reason that Alabama's revisions allow for periods of opacity up to 100 percent, whereas the North Carolina revision retained the same maximum opacity of 40 percent. The allowance for this high opacity level, along with the lengthy time allowed for elevated opacity (up to 2.4 consecutive hours), was not present in the North Carolina case.

Comment 27.Commenters argued that plant operating data confirm that the bundling of high opacity periods does not occur in practice. Further, the 22 percent cap resolves any concerns regarding the bundling were it to occur.

Response 27.EPA appreciates commenters' information on actual operations; however, as explained previously EPA's analysis under section 110(l) focuses on what the revised SIP rules would allow. Further, as discussed above, the 22 percent cap does not resolve EPA's concerns about extended periods of very high opacity.

Comment 28.Commenters argued that the rule really has nothing to do with air quality, and that if it did, EPA would have to justify and explain why it is proposing to condemn an opacity rule that is numerically more stringent and that has fewer exemptions than many other states' opacity rules.

Response 28.EPA does not agree with commenters' statements. Alabama's visible emissions rule is part of Alabama's EPA-approved SIP, and part of its plan to attain and maintain the PM NAAQS. As a result, any revision of the EPA-approved opacity rules is subject to evaluation under section 110(l) of the CAA. Furthermore, the extended consecutive periods of opacity exemptions allowed renders this standard uniquely less stringent than any other EPA-approved opacity rule.

Comment 29.Commenters argued that the daily opacity limit is neither necessary for approval nor unlawful. According to the commenters, because EPA's proposed approval was not based on a finding that the rule would not allow any more PM during a 24-hour period than the old rule, it is not necessary for the daily limit to meet such a criterion.

Response 29.EPA disagrees that the potential for more PM emissions as a result of elevated opacity is not germane to this action. EPA's prior approval of the SIP revisions was based on uncertainty about whether the revisionsto the opacity standard would allow more PM emissions during a 24-hour period. EPA would not have previously proposed approval if the record clearly demonstrated that the rule would have resulted in increased PM in nonattainment areas. After reviewing public comment and the State's revised submissions, EPA based its prior approval in part on the average daily opacity limit included in the revision. At that time, EPA accepted certain assumptions, including that the 22 percent daily opacity limit would serve to lessen the potential for elevated emissions of PM associated with the increases in opacity. Following EPA's reconsideration and review of information submitted to EPA, EPA no longer accepts that the average daily opacity limit is an appropriate or effective tool for evaluating the impact of the Submittals on PM emissions. Given EPA's position that there is a sufficient likelihood of increased PM emissions associated with the elevated opacity allowed under the SIP revisions, the Submittals are not approvable under 110(l).

Comment 30.Commenter argued that while the Clean Air Fine Particle Implementation Rule requires that direct PM2.5emissions be addressed in PM2.5attainment demonstration SIPs, the primary thrust of the regulation is the control of precursor compounds and not direct PM2.5emissions. According to the commenters, if the Alabama attainment plans are similar to those of Tennessee in that sulfates are identified as the main contributor to fine particulate matter and reliance is being placed on reductions of sulfur dioxide (SO2) to demonstrate compliance, with no measure specified for stationary direct PM2.5, then the Petitioners' assertion that approval of the Alabama SIP revisions would adversely affect PM2.5attainment or RFP has no merit and should be rejected. The commenters explained that if this is the case then the Petitioner's assertion that approval of the Alabama SIP revisions would not be consistent with sections 110(l) and 193 of the CAA should also be rejected as having no merit unless it can be demonstrated that a fixed source of direct PM2.5is a significant contributor to a nonattainment area. Additionally, according to the commenters, this should be an adequate affirmative demonstration that the requirements of sections 110(l) and 193 of the Act are not an issue. Further, the commenters asserted that even for areas achieving conformance with the PM2.5ambient standard, for which no SIP would be required, the effect of the reductions of PM2.5precursors would be so dominant as to negate any changes to direct PM2.5emissions.

Response 30.As was explained earlier, given that ADEM did not submit a full attainment demonstration specifically addressing this rule and did not propose any offsetting reductions to compensate for emission increases in nonattainment areas, EPA's analysis is necessarily focused on the comparison between the previous EPA-approved version of the visible emissions rules and the revisions that the State seeks, in order to ensure that the revision would not allow an increase in emissions of pollutants that would interfere with attainment or maintenance of the NAAQS, or with other requirements of the CAA. A primary consideration, therefore, is whether the revisions could result in increases in emissions of a type for which the area where the source is located is designated nonattainment. In this context, EPA must evaluate the relative stringencies of the two versions of the opacity rules, as was explained earlier.

EPA notes that the commenter's arguments here are premised upon what might or might not be appropriate in the context of a nonattainment SIP for certain pollutants in an area. EPA does not agree that the implementation regulations for the 1997 PM2.5NAAQS are designed or intended to ignore direct PM2.5emissions from sources, and evaluation of controls for such emissions is a required element of such a SIP. While it may be correct that a nonattainment SIP in a particular area might be designed to focus upon emissions of SO2and nitrogen oxides, or other PM2.5precursors, as an attainment strategy, it does not follow that emissions of PM2.5from the sources subject to Alabama opacity rule do not impact attainment and maintenance of these NAAQS. Considerations mentioned by the commenters might be relevant in the evaluation of the attainment demonstration accompanying a nonattainment SIP for the 1997 PM2.5NAAQS, but they are not relevant in the context of a section 110(l) analysis.

Comment 31.Commenters argued that Alabama's revised SIP for visible emissions is a small piece in the overall PM attainment puzzle. According to the commenter, any incremental primary PM2.5emissions increase as a result of revising the SIP, assuming for purposes of argument that such an increase occurs, would be an inconsequential contributor to the PM2.5attainment status against the background of the significantly greater secondary PM2.5(sulfate and nitrate) contributions. The commenter asserted that viewed in this broader context, EPA could reasonably conclude, based on the equivalency demonstration, that the revised SIP is consistent with the earlier SIP.

Response 31.The comment fails to appreciate EPA's limitations in reviewing SIP revisions, as described in section 110(l). In addition, EPA did not receive an “equivalency demonstration” from ADEM that addressed all the elements in section 110(l). Further, an increase of PM emissions by any increment would make it more difficult for areas in Alabama to attain and maintain the NAAQS. EPA has considered the SIP as a whole, and concludes that the potential increase renders the revisions not approvable.

Comment 32.Commenters explained that following new data collected under the current SIP confirms that EPA's prior analysis was sound:

A. New data collected under the current SIP shows there is no “bundling;”

B. New data collected under the current SIP shows that daily opacity has improved; and

C. New data collected under the current SIP shows why the rule makes sense.

Response 32.EPA appreciates the submission of these data. EPA disagrees, however, with the conclusions that the commenters draw from the data. The commenters' focus on what is actually happening with respect to “bundling” and opacity levels fails to consider what could happen under the SIP revision. EPA's analysis pursuant to section 110(l) must focus on the differences between the two versions of the visible emissions rules in terms of what they would allow and not on the choices individual facilities may have made to date in terms of opacity and PM emissions. Thus, EPA does not agree that the data presented by commenters support approval of the Submittals. The commenters did not, unfortunately, submit data to establish what the PM mass emissions were during periods of elevated opacity at these sources.

Comment 33.Commenter saw no basis for the supposition that Alabama's opacity rule revisions will affect PM NAAQS compliance. The commenters asserted that as indicated in the attachments, PSEC's Lowman Unit 1's opacity compliance continues to be very good. Additionally, the commenters explained that annual particulate emission testing in 2008 and 2009 indicate PM emissions well below thestandard and show no difference before and after the opacity rule revisions.

Response 33.EPA acknowledges that some facilities affected by the SIP revisions may be operating at opacity levels below those required by the Alabama SIP. Indeed, a source that is well-controlled, well-maintained, and well-operated could achieve opacity levels well below 20 percent. However, EPA's obligation under section 110(l) is to consider how a facility could operate under the new rule—not how it typically operates or has historically operated. Moreover, EPA notes that annual PM testing offers valuable but limited information about mass emissions because the testing occurs only once per year for a limited period of time. The question not addressed by the comments is what the PM mass emissions would be, were a source to be operating at the 100 percent opacity for 2.4 hours contemplated by the SIP revision at issue.

Comment 34.Commenters asserted that there are no new data that would support EPA's withdrawal of its approval of the rule.

Response 34.As was discussed previously, EPA's authority to reconsider a SIP revision is not limited only to circumstances where there are new data. EPA has already explained in today's action why its prior approval was not consistent with the purposes of section 110(l), and that reconsideration and disapproval is appropriate. Notably, the reconsideration was initiated before the revised rule went into effect and that sources should be capable of complying with either rule or both rules simultaneously.

In addition, EPA disagrees that no new information supports this disapproval. A number of commenters have submitted data and information that, while not directly addressing the questions that EPA posed, nevertheless help to illustrate the problems with the SIP revisions. For example, information submitted by AEC suggests that at least some sources, under some conditions, could have increased PM emissions during the longer periods of higher opacity that would be permissible under the revised visible emissions rules in the Submittals.SeeComment Letter from George E. Hays and attachments (on behalf of Alabama Environmental Council, among others), Docket No. EPA-R04-OAR-2005-AL-0002-0089.1. Moreover, many of the commenters during the reconsideration process submitted comments in which their analysis suggested that there is a relationship between PM mass emissions and opacity, even if the precise correlation cannot be established without much more rigorous testing and evaluations on a source specific basis.SeeModeling TSD. As was noted earlier, even some of the commenters opposing EPA's disapproval action identified the uncertainty in the relationship between opacity and PM mass emissions, and the possibility of the SIP revisions resulting in emission increases.See, e.g.,Comment Letter from Lauren E. Freeman (on behalf of the Utility Air Regulatory Group) at 4, Docket No. EPA-R04-OAR-2005-AL-0002-0086.1.

Comment 35.Commenter noted that with regard to EPA's request for information on condensable PM, COMS do not measure condensable PM, which is in a gaseous form at stack conditions.

Response 35.EPA acknowledges the response, which underscores one component of the uncertainty inherent in the relationship between opacity and PM emissions.

Comment 36.Commenters asserted that while EPA has consistently (and correctly) noted the uncertain relationship between opacity and PM for short-term analysis, any question regarding how this uncertainty might impact PM, in this case, has now been eliminated entirely with the addition of the 22 percent daily average requirement. Commenters further stated that ADEM's August 2008 submittal remedied any “uncertainty” question with respect to 24-hour PM by including an additional restriction on daily average opacity, so that the average daily opacity allowed under the revision is now no greater than under the previous SIP.

Response 36.EPA has shown through calculations, that the maximum allowable average daily opacity under both the previous rule and the revised rule is 22 percent. However, as discussed above, the revised visible emissions rule at issue in the SIP revisions would allow sources to operate in a manner they could not under the previous rule—including increases in opacity concentrations up to 100 percent for an extended period of time. As a result, under the revised rule, sources may now be permitted to cause much more opacity to levels that would have been a violation under the previous EPA-approved SIP rules. Such emissions include very high concentrations of excess opacity for extended periods. EPA has thus concluded that the “average daily opacity” cap provides no assurance against increased mass emissions. Indeed, as discussed above, EPA has concluded that there is a sufficient likelihood of increased mass emissions under the revisions so as to make it unapprovable under section 110(l).

Comment 37.Commenters stated that there is always some uncertainty when attainment or interference with a NAAQS is considered in a SIP process because it involves an element of prediction and reliance on modeling. Further, commenters explain their positions that section 110(l) does not require absolute certainty and EPA should not substitute “could” for “would” in the 110(l) context.

Response 37.EPA agrees the Act does not require attainment demonstrations or other technical analysis of impacts on attainment or maintenance of the NAAQS to an “absolute certainty.” However, to make a determination that the NAAQS will not be adversely impacted, EPA must at least be able to reach the conclusion that this is most likely the case. In this action, EPA is relying on what is known about the relationship between opacity and PM emissions to conclude that the State's revised visible emissions rules in the Submittals is less stringent than the previous EPA-approved rule, and that the likely increases in emissions of PM at affected sources would be inconsistent with section 110(l). Under the revised rule, a source could exceed its 20 percent opacity limit for well over an hour (up to 100 percent opacity). In contrast, the previous SIP-approved rule allowed only one occurrence per hour of a 6-minute average opacity above 20 percent (and only up to 40 percent). Control equipment that is effective enough to avoid a second occurrence of 6-minute average opacity above 20 percent will make even the first occurrence an infrequent event. Likewise, control equipment and operating procedures that are effective enough to enable a unit to meet the requirements of the previous SIP will also allow a lesser quantity of PM emissions than control equipment and operating procedures that are sufficient to comply with the current SIP revision but do not necessarily enable a unit to comply with the previous SIP rule.

In addition, contrary to the commenters' belief, this is not dependent upon replacing the word “would” with the word “could.” EPA's conclusion is that available evidence indicates that some of the affected sources would have increases in PM emissions, and that these emissions would occur in locations where such increased emissions would interfere with attainment and maintenance of the NAAQS. Commenters evidently misconstrue “uncertainty” about theprecise amount of such likely emissions increases as evidence that no such increases could occur.

Comment 38.Commenters raised concerns regarding PM CEMS technology, and the representativeness of PM emissions data obtained during Performance Specification (PS) 11 testing.See40 CFR part 60, Appx. B. Briefly, the commenters asserted that PS 11 correlation testing, which requires disabling of PM control devices under artificial conditions in order to obtain sufficient variability in PM emissions to satisfy the PS 11 statistical criteria, rarely provide data representative of actual operations or control device malfunctions. Commenters also noted that it would not make sense to require sources to spend money to install PM CEMS or to perform periodic performance tests in order to develop a source-specific correlation between opacity and PM.

Response 38.EPA disagrees with the commenter's views regarding PM CEMS technology and PS 11 testing, especially in the context of evaluating the SIP revisions at issue here. The procedures of PS 11 are conducted to develop a source-specific PM emissions correlation for an individual source operating over a range of PM emissions conditions through comparison of results from PM emissions testing and PM CEMS. Note that PS-11 does not require PM control devices to be disabled. Those PM measurement and testing correlation procedures differ from an opacity and PM emissions correlation, which is the fundamental issue requiring resolution for addressing the visible emissions rules revision in Alabama's Submittals. EPA also disagrees that use of PM CEMS or periodic performance testing could be “nonsensical” in determining a source-specific correlation between opacity and PM emissions. Indeed, as EPA has previously explained, source-specific approaches such as concurrent opacity and PM emissions measurements may be one way to determine “* * * any useful and definitive relationships between stack particulate mass emissions values and their corresponding opacity levels * * *” 73 FR 60962 (October 15, 2008).

EPA agrees that data obtained over a range of operating and control device conditions would be necessary to develop a site-specific correlation between opacity and PM emissions and that a single, site-specific correlation should not be extrapolated to other sources. Retaining Alabama's original visible emissions rule (the pre-October 15, 2008, final rule) relieves ADEM (and affected sources) from performing an assessment of increased source opacity on PM emissions.

Comment 39.Commenters suggested that the source-specific nature of the opacity/PM relationship does not mean that the uncertain impact of a particular change in an opacity rule can be resolved by requiring source-specific testing.

Response 39.EPA agrees that a well-designed data collection program should be able to reduce to acceptable levels, if not eliminate, most of the uncertainty associated with the relationship between PM emissions and opacity resulting from changing opacity limits. However, as the commenters themselves argue, the variability in the relationship between PM emissions and opacity limits is such that, absent the use of PM CEMS, source specific evaluation would be one way to determine the impacts of the change at a given source. EPA through this disapproval is not determining that the only means to revise an opacity standard is through source by source evaluation, nor is EPA requiring that with today's action.

Comment 40.Commenters argued that to the extent that EPA seeks information on PM compliance methods in order to assess the costs of requiring Alabama to impose more source-specific PM testing in order to evaluate the impact of its revised opacity rule, commenters disagree that such an evaluation is required under CAA 110(l).

Response 40.EPA agrees that an assessment of the cost of a potential requirement for source-specific testing is not necessary pursuant to section 110(l). In order to fully provide the public with an opportunity to comment on the proposed action, EPA sought specific information, including costs, to assist the public in identifying what information might be useful to EPA. EPA has already explained how it considered the SIP revisions and the basis for its final action.

Comment 41.Commenters stated that because EPA correctly found the revisions would not interfere with the attainment or maintenance of the NAAQS or any other requirement of the CAA, section 110(l) concerns are not implicated. The commenters stated that as long as a SIP revision does not “interfere with” air quality (i.e.,make it worse), EPA must approve it. According to the commenter, Alabama's rule is consistent with the development of an overall plan for attainment, in that all of the sources subject to the Rule are also subject to various other programs and requirements that EPA has approved to ensure the NAAQS are protected.

Response 41.Commenters' focus on “air quality” is a good point—and was EPA's primary concern as well. EPA's action in this case focuses on the known differences between the previous EPA-approved SIP rules and the SIP revisions in the Submittals, and what is known regarding the technical aspects of the relationship between opacity and PM mass emissions. Specifically, that the revised rule allows extended periods of much higher opacity that were not previously authorized. EPA has concluded that available evidence indicates that the revised rule could result in more emissions, and thus interfere with attainment and maintenance of the NAAQS, to use the commenters' term, “make it worse.” Further, for older facilities (such as the ones subject to the visible emissions rule at issue), particularly those that are less controlled, opacity can be an important indicator of operation and control device performance, which, in turn, can affect air quality. In this context, and lacking reliable scientific correlations between opacity emissions and PM NAAQS violations, EPA has concluded that the rule changes described in the Submittals are not approvable under section 110(l).

With respect to the commenters' argument that other regulatory programs exist to help insure attainment and maintenance of the NAAQS, EPA agrees. However, for the sources affected by the visible emissions rules at issue, the opacity standards provide an important tool to assure compliance with these other measures. The mere existence of a regulatory framework to provide for the attainment of the NAAQS does not negate the need for effective tools to assure that the framework succeeds.

Comment 42.Commenters stated that unless ADEM relied upon the opacity standard to comply with the PM NAAQS, section 110(l) considerations do not come into play. The commenters further stated that in this case, Alabama did not rely on the opacity standard to demonstrate attainment of the PM NAAQS.

Response 42.Alabama's visible emissions rule is part of Alabama's plan to attain and maintain the NAAQS, and it is in the EPA-approved SIP (and has been for a long time). Any revision to the SIP is subject, by the plain text of the CAA, to the requirements of section 110(l).

Comment 43.Commenters stated that EPA's October 2008 approval applied and satisfied the correct CAA section 110(l) standard. According to thecommenters, EPA is not required to re-examine the adequacy of the level of reductions provided in a plan that has already achieved attainment, or speculate how a requested SIP revision might fit into the mix of controls that may be chosen by the state to support a future attainment demonstration with respect to a new standard. The commenters argued that EPA's review under CAA section 110(l) only needs to address whether the revision would affect the status quo. EPA could have (and in commenters' view, should have) limited its review to whether the revision interfered with the requirement to assess good O & M of PM control equipment between PM stack tests. Further the commenters asserted that because Alabama did not rely on a short-term opacity/PM relationship to support its previously approved PM attainment demonstration, EPA was not required to analyze changes in the opacity standard for equivalency under section 110(l).

Response 43.EPA does not agree with commenters' characterization of EPA's obligation under section 110(l). As a point of clarification, Alabama has several nonattainment areas, including PM2.5nonattainment areas. The State's visible emissions rule applies to a group of stationary sources Statewide—it does not apply only in designated attainment areas. Thus, EPA does not agree with commenters' argument that because Alabama is currently attaining some NAAQS, EPA's consideration under section 110(l) should be different. Further, as was noted earlier, in the absence of an attainment demonstration regarding the rules at issue, EPA can approve a SIP revision for a nonattainment area only if EPA finds that it will not worsen air quality by increasing emissions of a nonattainment pollutant, and it is otherwise consistent with attainment and maintenance of the NAAQS. Even accepting the commenters' argument that the opacity standard is intended to be a gauge of good O & M of a source, the SIP revisions contemplated in the Submittals raise concerns because the revisions allow facilities to emit up to 100 percent opacity for extended periods of time—which is hard to square with the need to assure good source operation. Indeed, other commenters have asserted that opacity at such levels is the equivalent to turning off any relevant control device for an extended period of time. Even under what EPA understands commenters' argument to be, the SIP revisions present serious concerns about good O & M and would not be approvable.

Comment 44.Commenters explained their view that 110(l) does not impose on states a requirement to “demonstrate” that each proposed revision will not interfere with attainment or require EPA to reject each revision that presents “some remote possibility for interference.” Commenters cited toKentucky Resources Council (KRC), Inc.v.EPA,467 F.3d 986, 994-95 (6th Cir. 2006) for support.

Response 44.Section 110(l) prohibits any SIP revision that would have the effect of interfering with attainment or maintenance of the NAAQS, RFP, or any other requirements of the CAA. Typically, states elect to provide the requisite information necessary to establish that their intended SIP revisions would not have any of these effects. EPA often works with states to evaluate the effects of a given SIP revision. In the final analysis, however, EPA is not authorized to approve any SIP revision that has such effects.

When, as here, available information indicates that the SIP revision at issue could result in the increase in PM emissions at some sources located in or near designated PM nonattainment areas, EPA has concluded that the SIP revision is not approvable and that residual uncertainty about the precise amount of additional PM emissions that would be associated with the dramatic increases in opacity does not render the revision approvable.

Commenters' citation toKRC,467 F.3d 986, is misplaced because the case supports EPA's disapproval action. In that case, the Sixth Circuit considered an EPA action approving revisions to the Kentucky SIP regarding Kentucky's inspection and maintenance (I/M) program that removed the requirement from the active portion of Kentucky's SIP. The Court explained that Congress did not intend for EPA to “reject each and every SIP revision that presents some remote possibility for interference. Thus, where the EPA does not find that a SIP revision would interfere with attainment, approval of the revision does not do violence to the statute.”KRCat 994. The Court upheld EPA's view that:

Comment 45.Commenters make a distinction between attainment and nonattainment areas for purposes of a 110(l) analysis. Commenters appear to suggest that because Alabama had no outstanding nonattainment plans due in the time frame of the October 15, 2008, final rule, that the 110(l) analysis should address whether the revision would affect the status quo.

Response 45.EPA agrees that the 110(l) analysis for a nonattainment area should, in the absence of an attainment demonstration, assure at least that the status quo is maintained. Thus, EPA will generally not approve a SIP revision that allows additional emissions of pollutants for which an area is designated nonattainment in the absence of offsetting reductions. Because EPA now concludes that Alabama's SIP revisions are likely to result in an increase in PM emissions, for which parts of Alabama are designated nonattainment, it cannot be approved consistent with section 110(l).21 While EPA has previously required a more robust 110(l) analysis for nonattainment areas, there is still an analysis required for attainment areas. Section 110(l) applies to all SIP revisions, regardless of whether the revision is impacting attainment areas or nonattainment areas. Alabama's visible emissions rule at issue is part of Alabama's plan to attain and maintain the NAAQS. The analysis under 110(l) does not depend on what SIP revisions are currently due, although 110(l)requires EPA to consider other applicable requirements in the SIP.

Comment 46.Commenters explained that because they believe that there is no relationship between opacity and PM, the inquiry as to 110(l) could end there. Commenters also argued against substituting the words “could interfere” for “would interfere” in 110(l).

Response 46.EPA does not agree that there is no relationship between opacity and PM emissions. Rather, EPA concludes that there is a general relationship between opacity and PM emissions, but for a specific source and its operating characteristics, there is uncertainty about whether increases in opacity are accompanied by increases in PM emissions without examination of each source at issue. In addition, EPA does not substitute the words “could interfere” for “would interfere” in interpreting and applying 110(l). For any given source at any given time, it is accurate to say that increased opacity could be accompanied by increased PM emissions. However, in evaluating what would be allowed under the Submittals across all sources and circumstances, EPA concludes it is likely that the increased opacity allowed by the Submittals would result in increased PM emissions. EPA judges the significant increase in the flexibility in the opacity exemptions allowed to sources under the revised rule is great enough that, absent a convincing demonstration otherwise, the Agency may only conclude the revised rule hinders (i.e.,“would interfere” with) efforts to attain and maintain compliance with the PM NAAQS.

Comment 47.Commenters explained that changes to Alabama's Visible Emission Rule do not affect compliance with PM limits. According to the commenter, Alabama has not relied on opacity limits to demonstrate attainment with the PM NAAQS. Thus, the commenter argued that section 110(l) does not apply here at all.

Response 47.Section 110(l) applies, by its plain text, to all SIP revisions including Alabama's 2003 and 2008 Submittals. Contrary to the commenter's belief, the State has historically included the visible emissions rules in its SIP for purposes of attainment and maintenance of the PM NAAQS. The fact that the State may not have sought specific SIP credit attributable to the opacity limits (not to be confused with SIP credit for the PM limits that such opacity limits are designed to assure compliance with) does not mean that the opacity limits are not part of the SIP.

Comment 48.Commenters explained that 110(l) does not require absolute certainty regarding interference with attainment and maintenance of the NAAQS. According to the commenters, EPA has never taken that position and it would be a departure from Agency practice to take such a position. Commenters cited toKRCv.EPA,467 F.3d 986 (6th Cir. 2006) andGalveston-Houston Ass'n for Smog Prevention (GHASP)v.EPA,289 Fed. Appx. 745 (5th Cir. 2008). Commenters concluded that EPA cannot rely on mere uncertainty as a basis for disapproving a SIP revision.

Response 48.EPA agrees that section 110(l) does not require absolute certainty. EPA's decision today relies on certainties concerning the impacts of the revisions to Alabama's visible emissions rules in the Submittals. These certainties include that the Alabama rule would allow for increase of maximum opacity from 40 percent to 100 percent and would allow such increases for up to 2.4 hours at a time, instead of for only six minutes per hour. EPA is disapproving the revision because while there are uncertainties—such as precisely when PM mass emissions would increase or by what precise amount—EPA expects that it is likely in at least some circumstances to result in increases in PM mass emissions. EPA generally, absent an attainment demonstration or offsetting emission reductions, will not approve a SIP revision that results in increases in emissions of a pollutant for which an area is designated nonattainment pursuant to the requirements of section 110(l). EPA has already discussed theKRCcase in a previous response. TheGHASPcase supports EPA's position in this action because that was another case where the court upheld EPA's interpretation that section 110(l) requires that a SIP revision must at least maintain status quo air quality to be approvable.

Comment 49.Commenters argued that it is not clear what EPA means when it says that “Alabama has not provided EPA with an affirmative demonstration that the [Rule] will not interfere with the attainment and maintenance of the NAAQS” (74 Fed. Reg. at 50933), since, in the commenters' view, that is exactly what the 2008 revision adding the 22 percent daily average cap ensures. Commenters further stated that to require Alabama to provide more than the modeling of its 2003 submittal would be contrary to what the CAA requires and would be essentially asking for the impossible given the acknowledged uncertainty between opacity and PM, particularly for short-term analysis.

Response 49.EPA does not agree with the commenters' interpretation of 110(l) or characterization of what was provided to EPA. As was explained above, EPA has concluded that the interpretation of 110(l) that is most consistent with the plain text, legislative history, and air quality goals of the CAA is that in order to approve the SIP revision, there must be some reasonable basis for concluding that the SIP revision will not interfere with attainment or maintenance of the NAAQS, consistent with the requirements of 110(l). As commenters acknowledged, the evaluation for this particular SIP revision is challenging due to the inherent uncertainty in the relationship between opacity and PM mass emissions at a given source. For this reason, it is even more important that the demonstration be sufficient to ensure that EPA is complying with section 110(l).

A fundamental purpose of 110(l) is to allow SIP revisions in the absence of a full attainment demonstration provided that such revisions are consistent with continued attainment and maintenance of the NAAQS. To the extent that emission increases of a particular SIP revision cannot be modeled with some level of certainty regarding impact on the NAAQS, section 110(l) may bar that SIP revision, absent equivalent offsetting emissions reductions and in the absence of an attainment or maintenance demonstration. In EPA's judgment, the analysis submitted in connection with the SIP revisions at issue here fails to provide a reasonable basis on which to conclude that the changes would not interfere with attainment and maintenance of the NAAQS. EPA concludes that the CAA prohibits this SIP revision because air emissions could be allowed to increase and thus, worsen air quality in nonattainment areas.

Comment 50.Commenters argued that there is no basis for reversing EPA's prior analysis because the current SIP ensures opacity will be equal to or lower than that allowed under the previous SIP. Commenters further stated that EPA demonstrated mathematically that both the suggested changes in its 2007 proposal to approve the Rule and in Alabama's 2008 revisions as submitted are at least as stringent as Alabama's existing SIP and even more stringent than the 2003 revisions.

Response 50.As discussed above, EPA has concluded after reconsideration that it is not appropriate to measure the stringency of the SIP revisions in the Submittals using an“average daily limit.” Alabama's revised rule allows for extended periods of operation at high levels of opacity that were not previously authorized. Absent a showing that a source's PM emissions would not be elevated if it was permitted to have opacity at up to 100 percent for up to 2.4 hours a day, EPA has concluded that the SIP revisions would be inconsistent with section 110(l).

Comment 51.Commenters argued that Alabama has made an affirmative demonstration that the visible emissions standards in the previous SIP and the revised SIP are equivalent. Alabama's previous visible emissions rule allowed opacity of up to 40 percent for one six-minute period per hour. The revised rule allows the same maximum time of higher opacity in a single day (up to 144 minutes per day), but eliminates the 40 percent cap. To assure equivalency with the previous rule, the revised SIP limits the daily average opacity to less than 22 percent. The basis for derivation of the 22 percent limit was clearly set out in EPA's final rule. 73 FR at 60958-59 (October 15, 2008).

Response 51.As explained above, as a result of this reconsideration EPA disagrees that the two versions of the visible emissions rules could be equivalent, as explained in detail in the Rule Comparison TSD included in the docket. Ultimately, if the impacts of the two versions were actually equivalent, there would be no reason for Alabama to seek the SIP revisions. The practical reality is that the revised rule allows for opacity increases not previously authorized (both in concentration and quantity of time). Furthermore, the rule at issue specifically affects facilities which for one reason or another are not subject to any other opacity limit—and thus this opacity limit is particularly important both for air quality and as an indicator of facility O & M. While EPA understands the commenters' concerns, EPA does not agree that the two versions of the visible emissions rules are equivalent.

Comment 52.One commenter stated that EPA's approval was entirely consistent with section 110(l). According to the commenter, EPA made an “appropriate inquiry” under section 110(l) to protect the NAAQS because it made an equivalency determination and did not rely solely on uncertainty as a basis for the approval. This commenter believes that any uncertainty is erased by the 22 percent cap.

Response 52.EPA's October 15, 2008, final action relied heavily on the uncertainty inherent in the relationship between opacity and PM mass emissions. The October 15, 2008, action was different from other 110(l) analyses previously completed by EPA for that reason. EPA agrees that this rule presents particularly complex technical issues but has ultimately decided that heavy reliance on uncertainty as a basis for approval is not the decision most consistent with the CAA. Section 110(l) is intended to preclude SIP revisions that could have adverse consequences for public health, and accordingly EPA thinks that it should continue to interpret the provision using a precautionary principle to ensure such public health protection in the face of uncertainty about the impacts of a SIP revision.

Comment 53.Commenters drew comparisons between Ohio's recent opacity proposal and North Carolina's previous opacity proposal and concluded that Alabama's opacity limits are far below those of other states (specifically, North Carolina and Georgia).

Response 53.EPA does not agree with commenters' assessment of opacity requirements in other states. Alabama's revised rule was unique in that it allows opacity of up to 100 percent (not allowed under the recent North Carolina revisions)—and it allows such opacity for up to 2.4 consecutive hours. Opacity revisions, by nature, require detailed case-by-case analyses. Due to the specific circumstances of a state (i.e.,attainment status, affected facilities, topography, etc…), it is difficult to directly compare opacity rules from state to state (or SIP to SIP). While previous opacity decisions are informative, no other state presents a circumstance totally analogous to Alabama's circumstances. In addition, EPA has proposed to disapprove comparable revisions to the visible emissions rules in the Ohio SIP for reasons comparable to those described in this final action.

Comment 54.One commenter argued that without a regulatory mechanism to address excess emissions reported from COMS, such as that used by Alabama, sources are vulnerable to enforcement actions for short term opacity excursions that have negligible environmental effects.

Response 54.The environmental effect of individual “short-term” opacity excursions depends upon the duration and level of such exceedances, as well as the relationship between opacity and PM emissions at the source where they occur. This is one reason why EPA has concluded that use of an “average daily opacity” cap, in which longer excursions at higher levels are allowed to be “averaged out” with periods of normal operation at lower opacity levels, does little to help reduce PM emissions. Therefore, an “average daily opacity cap” is not a sufficient basis to approve the proposed SIP revisions. Frequent recurrence of such events may reflect the need to improve source operation or emission controls in order to comply with the opacity limit, but that would be masked by the averaging effect of an average daily opacity standard.

In the case of the visible emissions rule changes at issue in these SIP revisions, some sources may have to take action to improve their opacity performance in order to comply with the previous SIP rule. Finally, today's action does not impede the State's ability to exercise its own enforcement discretion in the event that it decides a given opacity violation does not warrant such action.

Comment 55.Commenters explained that when utilizing COMS that yield opacity data for nearly 100 percent of source operating time, given the extremely short data averages utilized for opacity data (six-minute data averages), time periods of excess occur from even the best operated sources.

Response 55.EPA acknowledges that some sources may have difficulty in complying with 20 percent opacity limits 100 percent of the time, especially when events out of the source's control occur, but EPA expects that all sources can comply with the pre-existing version of the visible emissions rule that will be in place as a result of today's disapproval action. EPA expects that any unusual difficulties for specific sources would ease as sources subject to Alabama's visible emissions rule take steps to improve their opacity performance.

Comment 56.One commenter explained that 40 CFR 60.284(e) is the recognition by EPA that some type of exemption time period is necessary when opacity regulations are enforced by a continuous in-stack monitoring system and that this regulation is probably the basis of the Alabama SIP revisions. The commenter further explained its view that the “the preamble to both the NSPS (40 CFR 60.7(c)) and the MACT [maximum achievable control technology] (40 CFR 63.10(e)(3))” both state that sources required to submit reports of excess emissions from continuous in-stack monitoring systems are only required to submit summary reports of the excess emissions data and not detailed reports, provided that the total duration of excess is less than one percent of thetotal operating time of the monitored source for the operating time period and that the monitor downtime is less than five percent of the total operating time of the monitored source for the reporting time period. The commenter considered these two regulations as a “de facto” recognition by EPA of [the need for] exemption time periods similar to that proposed in the Alabama SIP revisions.

Response 56.EPA disagrees with the premise of the comment, as it misses the mark concerning what is relevant in the context of a SIP revision for purposes of section 110(l). The NSPS and SIPs serve different purposes under the CAA. The NSPS are industry-specific nationally uniform air emission standards that limit the amount of emissions allowed from new sources or from modified existing sources. They are technology-based standards, meaning that they contain industry-specific limitations based on the best available technology. Under section 111 of the CAA, a standard of performance must reflect the degree of emission limitation and the percentage reduction achievable through application of the best technological system of continuous emission reduction that the Administrator determines has been adequately demonstrated. Such determinations take into consideration the cost of achieving such emission reduction and any non-air quality health and environmental impact and energy requirements. The fact that such standards contain various reporting requirements about excess emissions does not address the issues relevant to an analysis to support a SIP revision.

SIPs are EPA-approved state plans for the establishment, regulation, and enforcement of air pollution standards—the NAAQS. Under section 110 of the Act, each state must adopt a plan to provide for implementation, maintenance, and enforcement of the primary and secondary NAAQS within the state. Because SIPs serve a different purpose than the NSPS, EPA evaluates them differently. For example, the NSPS provide exemptions from compliance during brief periods such as startup, shutdown, and malfunctions (SSM). Such automatic exemptions are not appropriate for SIP rules because SIPs are ambient-based standards and any emissions above the allowable may cause or contribute to violations of the NAAQS. Generally, because SIPs must provide for attainment and maintenance of the NAAQS and the achievement of prevention of significant deterioration increments, EPA's policy is that all periods of excess emissions must be considered violations. SIPs can contain regulations with affirmative defenses for violations that occur due to events not reasonably within the control of the source, but they should not contain automatic exemptions. EPA's policy with respect to appropriate SIP provisions is contained in the 1999 memorandum entitled “State Implementation Plans (SIPs): Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown.”

Comment 57.Commenters explained that despite its best efforts, continuous compliance with the 20 percent opacity limit is an unachievable goal, and imposing penalties for failing to achieve an unattainable goal does not promote continuous, long term environmental improvement.

Response 57.EPA's final action does not impose penalties or implicate any specific enforcement actions. Rather, it simply finds that Alabama's revisions to its visible emissions rule are not approvable under section 110(l) of the CAA. EPA encourages the commenter to discuss specific compliance concerns with ADEM. Sources should generally be capable of complying with the Alabama opacity rule, but we remain open to considering further SIP revisions that provide greater assurance that PM emissions will not increase as a result.

Comment 58.Commenters argued that the visible emissions rule in the revised SIP is appropriate under 40 CFR 51.212(b). Some commenters also discussed that the “indirect” use of COMS for compliance determinations adopted by Alabama and many other states is based on the approach adopted by EPA under the NSPS, which also specify Method 9 as the compliance method but require reporting of COMS data as an indicator of good control device O & M. The commenters asserted that because ADEM's rule continues to use COMS data as an indicator of good O & M, but now simply provides an option for its use “directly * * * for compliance determinations,” respecting the independently enforceable opacity limit as allowed under Appendix P, the rule continues to meet EPA's criteria. Other commenters highlighted the position that 51.212 provides states with discretion and the Alabama rule enhances enforcement through use of COMS.

Response 58.In the present action, EPA is not evaluating the approvability of the SIP revision to Alabama's visible emission rule revisions in light of the requirements of 40 CFR 51.212. While EPA agrees that this provision requires states to have SIPs with appropriate methods to assure compliance with emissions limits, EPA is not here addressing whether the revisions at issue would or would not meet those requirements. EPA's analysis for the present action focused on the section 110(l) limitations on EPA's authority to approve a SIP revision. Even if Alabama's revised visible emissions rule were consistent with section 51.212, this would not alleviate the concerns that EPA has with respect to section 110(l).

Comment 59.Commenters stated that ADEM's two percent criterion is consistent with policies developed by EPA in the 1980s to support the use of continuous monitors. Commenters noted that there is no national standard on visible emissions and ADEM's use of a flexible approach is consistent with part 51.

Response 59.In the present rulemaking, EPA is not articulating a position on ADEM's enforcement discretion or policies regarding enforcement discretion, although EPA is aware of the fairly recent Eleventh Circuit Court's opinion addressing ADEM's enforcement discretion in a visible emissions context. As was explained earlier, EPA acknowledges the various comments that support ADEM's Submittals by citing to other federal requirements. However, EPA's analysis was focused on its authority under section 110, and the review of ADEM's Submittals that is most supported by the CAA.

Comment 60.Commenters explained that although Alabama's visible emissions rule may have some role in evaluating long-term PM control device operation, it is no longer the primary means by which major sources assure compliance with SIP limits on PM. Commenters believe that this role is now filled by EPA's CAM rule at 40 CFR part 64.

Response 60.EPA's present action is not dependent upon whether the State's visible emissions rule is the “primary” means for evaluating compliance with PM limits, although that has been and continues to be a legitimate reason for such opacity limits in SIPs. EPA's present action is based primarily on its obligation under section 110(l) not to approve SIP revisions that would interfere with attainment or maintenance of the NAAQS or other applicable requirements of the CAA. EPA agrees that the CAM rule provides additional support for evaluation ofcontrol device operation; however, CAM applicability and methodologies vary from facility-to-facility. The CAM rule is designed to provide reasonable assurance of ongoing compliance with applicable emissions limits, such as the PM emission limits of the SIP. But CAM requirements are in addition to the requirements of Alabama's visible emissions rule; as a result, the commenters' statements do not resolve whether the revisions to the visible emissions rule satisfy section 110(l).

Comment 61.Commenters explained that the D.C. Circuit Court's vacatur of 40 CFR part 63 provisions pertaining to SSM and its impact on the opacity SIP revision are irrelevant. Further, commenters noted that SSM provisions are not at issue in the instant SIP revision.

Response 61.EPA does not agree with the blanket statement that SSM provisions are not at issue in the instant SIP revision. As part of EPA's 110(l) evaluation, EPA may consider the SIP as a whole—including other provisions, such as SSM provisions, that may further affect the consequences of a given SIP revision. In this case, EPA's analysis focused primarily on the provisions of the visible emissions rule that the State actually sought to change in the Submittals. However, EPA may consider the entirety of a rule, and the SIP, in completing a 110(l) analysis.

Comment 62.Commenters explained that the Submittals on opacity are not required to comply with RACT and that there is no requirement for EPA to review “unrelated SIP revisions requests” for future RACT compliance. Moreover, commenters stated that when Alabama does submit a SIP revision to address RACT, EPA is not compelled to require that revision to establish any particular opacity standard. Another commenter stated that Alabama's revised SIP imposes the proper opacity RACT standard. Several commenters noted that the Petitioners will have separate opportunity to challenge RACT determinations is RACT-specific rulemaking.

Response 62.RACT refers to equipment and practices that reduce pollutant emissions that are reasonably available and both technologically and economically feasible. RACT usually applies to existing sources in nonattainment areas. Since EPA has concluded that this revision is not approvable under section 110(l) for the reasons already stated, it is not necessary to determine whether Alabama has relied on opacity limits to meet its RACT obligations.

Notably, section 172 of the Act,Nonattainment plan provisions in general,requires nonattainment plans “shall provide for the implementation of all reasonably available control measures as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology) and shall provide for attainment of the national primary ambient air quality standards.” Section 172 requirements, including RACT, are applicable requirements of the CAA which section 110(l) evaluations may consider.

Section 110(l) requires that EPA consider whether the revision at issue would interfere with the NAAQS, and any other applicable requirement concerning attainment and RFP. Thus, EPA is authorized to consider whether the revision would interfere with an area's ability to comply with RACT or other requirements in the SIP. In this case, however, EPA's review was primarily focused on interference with the NAAQS. While some applicable requirements may be subject to separate SIP revisions, as was noted by several commenters, that does not mean that EPA is prohibited from considering whether revision of a rule at issue may implicate another applicable requirement. RACT issues are likely to also be addressed separately in other SIP revisions.

Comment 63.Commenters noted that EPA's final action was not inconsistent with EPA policies on excess emissions and director's discretion.

Response 63.As was previously noted by EPA in the 2007 proposal and the October 2008, action, the director's discretion provisions under Alabama rule 335-3-4-.01(1)(c) and (d) are unchanged by the SIP revisions. As a result, periods of excess emissions allowed in a permit pursuant to those provisions remain unchanged under Alabama's rules. EPA did, however, consider Alabama's provisions for excess emissions in evaluating the rule as a whole and comparing it with the previous EPA-approved SIP rule. These types of details become relevant, particularly when parties compare Alabama's visible emissions rules with those in other states. In this action, EPA is not taking any action on Alabama's existing SIP-approved rules that implicate director's discretion and excess emissions.

EPA is taking final action to amend an October 15, 2008, final rulemaking on two SIP revisions regarding the State of Alabama's rules for visible emissions from certain stationary sources. EPA has now determined upon reconsideration that Alabama's SIP revisions, dated September 11, 2003, and August 22, 2008, are not approvable pursuant to CAA section 110(l). Accordingly, EPA is now disapproving the revisions submitted by the State of Alabama on September 11, 2003, and August 22, 2008. As a result of this action, Alabama's visible emissions rule that was in the SIP prior to the October 15, 2008, final action will be the “current” SIP-approved rule. Alabama is urged to undertake rulemaking in order to conform its SIP-approved rule with its State-effective rule.

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

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501et seq.,because these SIP disapprovals under section 110 will not in-and-of itself create any new information collection burdens but simply disapproves certain State requirements for inclusion into the SIP. Burden is defined at 5 CFR 1320.3(b).

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-profitenterprises, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. This rule will not have a significant impact on a substantial number of small entities because EPA understands that only one small entity will be affected by this rule. Furthermore, even if additional small entities were affected by this rule, this rule would not have a significant economic impact on any small entity because it simply restores a long-standing requirement of the Alabama SIP concerning visible emissions.

Therefore, after considering the economic impacts of today's rulemaking on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538 “for State, local, or tribal governments or the private sector.” EPA has determined that the disapproval 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 determines that pre-existing requirements under State or local law should not be approved as part of the Federally approved SIP. It imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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

This action does not have Federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely disapproves certain State requirements for inclusion into the SIP and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, Executive Order 13132 does not apply to this action.

This action does not have tribal implications, as specified in Executive Order 13175 (59 FR 22951, November 9, 2000), because the SIP EPA is disapproving would not apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. This action does not involve or impose any requirements that affect Indian Tribes. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This SIP disapproval under section 110 will not in-and-of itself create any new rules but simply disapproves certain State requirements for inclusion into the SIP.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. We have concluded this rule is not likely to have a significant adverse effect on the supply, distribution or use of energy because this rule applies only to 19 facilities in Alabama and simply restores a long-standing rule concerning visible emissions.

Section 12(d) of the NTTAA of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (e.g.,materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. NTTAA directs EPA to provide Congress, through the OMB, explanations when the Agency decides not to use available and applicable VCS.

EPA believes that this action is not subject to requirements of Section 12(d) of NTTAA because application of those requirements would be inconsistent with the CAA. Today's action does not require the public to perform activities conducive to the use of VCS.

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

EPA lacks the discretionary authority to address environmental justice in this action. In reviewing SIP submissions, EPA's role is to approve or disapprove State choices, based on the criteria of the CAA. Accordingly, this action merely disapproves certain State requirements for inclusion into the SIPunder section 110. Accordingly, it 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.

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). This rule will be effective May 6, 2011.

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 June 6, 2011. 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.SeeCAA section 307(b)(2).

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged 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 eCFR site athttp://www.gpoaccess.gov/ecfr.To access the harmonized test guidelines referenced in this document electronically, please gohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

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-2009-0325 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 June 6, 2011. 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-2009-0325, by one of the following methods:

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

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

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

In theFederal Registerof August 19, 2009 (74 FR 41898) (FRL-8426-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9F7549) by Gowan Company, 370 South Main Street, Yuma, AZ, 85364. The petition requested that 40 CFR 180.448 be amended by establishing tolerances for residues of the insecticide hexythiazox, trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as parts per million of the parent compound), in or on corn, sweet, kernel plus cob with husk removed at 0.1 parts per million (ppm); corn, sweet, forage at 3 ppm; bean, dried at 0.4 ppm; and bean, succulent at 0.4 ppm. That notice referenced a summary of the petition prepared by Gowan Company, 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 revised the proposed tolerance levels for corn, sweet, forage; and bean, succulent to 4 ppm and 0.3 ppm, respectively. Thereasons 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for hexythiazox including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with hexythiazox 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.

Hexythiazox has low acute toxicity by the oral, dermal and inhalation routes of exposure. It produces mild eye irritation, is not a dermal irritant, and is negative for dermal sensitization. Hexythiazox is not a developmental or reproductive toxicant. The toxicology database for hexythiazox provides no indication of increased susceptibility in rats or rabbits fromin uteroand postnatal exposure to hexythiazox. The database does not show any evidence of treatment-related effects on the nervous system or the immune system. Hexythiazox is classified as “likely to be carcinogenic to humans”. EPA has determined that a non-quantitative risk assessment approach (i.e., nonlinear, reference dose (RfD) approach) was appropriate and protective of all chronic effects including potential carcinogenicity of hexythiazox.

Specific information on the studies received and the nature of the adverse effects caused by hexythiazox 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 “Hexythiazox. Human Health Risk Assessment to Support New Uses on Sweet Corn, Dry Beans and Succulent Beans,” page 24 in docket ID number EPA-HQ-OPP-2009-0325.

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 hexythiazox used for human risk assessment can be found in the final rule published in theFederal Registerof March 17, 2010 (Vol. 75 FR 12691) (FRL-8813-7), and athttp://www.regulations.govin document “Hexythiazox. Human Health Risk Assessment to Support New Uses on Sweet Corn, Dry Beans and Succulent Beans,” page 11 in docket ID number EPA-HQ-OPP-2009-0325.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to hexythiazox, EPA considered exposure under the petitioned-for tolerances as well as all existing hexythiazox tolerances in 40 CFR 180.448. EPA assessed dietary exposures from hexythiazox 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 hexythiazox; 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 USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance level residues, assumed 100 percent crop treated (PCT), and incorporated DEEM default processing factors.

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 in theFederal Registerof March 17, 2010 (Vol. 75 FR 12691) (FRL-8813-7), EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to hexythiazox. 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 hexythiazox. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water.The Agency used screening levelwater exposure models in the dietary exposure analysis and risk assessment for hexythiazox in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of hexythiazox. 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), the estimated drinking water concentration (EDWC) of hexythiazox for chronic exposures for non-cancer and cancer assessments is estimated to be 4.5 ppb for surface water. Since surface water residue values greatly exceed groundwater EDWCs, surface water residues were used in the dietary risk assessment.

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

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).

Hexythiazox is not currently registered for any specific use patterns that would result in residential exposure. However, the following uses that could result in residential exposures are pending registration in the near future and are included in this risk assessment: Turf, ornamental landscape plantings, ornamental plants, trees and vines in nurseries, residential fruit trees, nut trees, caneberries, and orchids.

Both adults and children may be exposed to hexythiazox residues from contact with treated lawns or treated plants. The exposure and risk assessment included risks to adult handlers from inhalation exposures. The exposure assessment for children included risks from incidental oral exposure resulting from transfer of residues from the hands or objects to the mouth, and from incidental ingestion of soil. Details of the residential exposure and risk assessment are contained in the final rule published in theFederal Registerof July 14, 2010 (75 FR 40741), and athttp://www.regulations.govin document “Hexythiazox. Human Health Risk Assessment to Support New Uses on Sweet Corn, Dry Beans, and Succulent Beans,” page 16 in docket ID number EPA-HQ-OPP-2009-0325.

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 hexythiazox to share a common mechanism of toxicity with any other substances, and hexythiazox does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that hexythiazox 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.The prenatal and postnatal toxicology data base indicates no increased susceptibility of rats or rabbits toin uteroand/or postnatal exposure to hexythiazox.

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 hexythiazox is incomplete under the new 40 CFR part 158 data requirements for conventional pesticides, which requires certain generic testing, including acute and subchronic neurotoxicity studies and an immunotoxicity study. However, the toxicology database does not show any evidence of treatment-related effects on the nervous system or the immune system. The overall weight of evidence suggests that this chemical does not directly target either system. Although acute and subchronic neurotoxicity studies and an immunotoxicity study are required as a part of new data requirements in the 40 CFR part 158 for conventional pesticide registrations, the Agency does not believe that conducting these studies will result in a lower POD than any currently used for risk assessment, and therefore, a database uncertainty factor (UFDB) is not needed to account for the lack of these studies.

ii. There is no indication that hexythiazox 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 hexythiazox 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 dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. The dietary risk assessment is highly conservative and not expected to underestimate risk. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to hexythiazox 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 hexythiazox.

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.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting froma single oral exposure was identified and no acute dietary endpoint was selected. Therefore, hexythiazox 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 hexythiazox from food and water will utilize 51% of the cPAD for children 1-2 years of age, 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 hexythiazox 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).

There are potential short-term exposures from the pending residential uses for hexythiazox. The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to hexythiazox.

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 15,000 for adults and 1,900 for children. Because EPA's level of concern for hexythiazox 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).

There are potential intermediate-term exposures from the pending residential uses for hexythiazox. The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to hexythiazox.

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 aggregate MOEs of 15,000 for adults and 2,200 for children. Because EPA's level of concern for Hexythiazox is a MOE of 100 or below, these MOEs are not of concern.

5.Aggregate cancer risk for U.S. population.As discussed in Unit III.C.1.iii, EPA concluded that regulation based on the chronic reference dose will be protective for both chronic and carcinogenic risks. As noted in this unit there are no chronic risks of concern.

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 hexythiazox residues.

Adequate enforcement methodology (high performance liquid chromatography method with UV detection (HPLC/UV)) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov.

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 U.N. 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.

A Codex MRL for common beans (pods and/or immature seeds) is currently established at 0.5 ppm. It is not possible to harmonize the U.S. tolerance with the Codex MRL since the Codex MRL is for parent compound only and the U.S. expression includes metabolites of concern. There are no Canadian or Mexican MRLs for beans and there is no Codex, Canadian or Mexican MRL for sweet corn commodities.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance levels for corn, sweet, forage; and bean, succulent to 4 ppm and 0.3 ppm, respectively. The tolerance spreadsheet in the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data was used to determine appropriate tolerance levels for sweet corn forage, dried beans and succulent beans. The tolerance spreadsheet was not used for sweet corn kernel plus cob with husk removed (K+CWHR) because >65% of the residues were<LOQ. The data indicate that the proposed tolerance for sweet corn forage is too low, the recommended tolerance is 4.0. Additionally, the tolerance spreadsheet indicates that the proposed level of 0.4 ppm is too high for succulent beans. The tolerance should be set at 0.3 ppm.

Therefore, tolerances are established for residues of hexythiazox,trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety(expressed as parts per million of the parent compound), in or on corn, sweet, kernel plus cob with husk removed at 0.1 ppm; corn, sweet, forage at 4 ppm; bean, dried, seed at 0.4 ppm; and bean, succulent at 0.3 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the RegulatoryFlexibility 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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://www.gpoaccess.gov/ecfr.

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-2009-0636 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 June 6, 2011.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-2009-0636, by one of the following methods:

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

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

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

In theFederal Registerof January 6, 2010 (75 FR 864) (FRL-8801-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP 9F7589 and PP 9E7588) by Bayer CropScience LP, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by adding a section for the herbicide indaziflam and establishing tolerances therein for residues of indaziflam,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, in or on fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; pistachio; grape; and olive; each at 0.01 parts per million (ppm) and almond, hulls at 0.20 ppm (PP 9F7589). Additionally, Bayer CropScience LP requested an import tolerance for sugarcane, sugar, refined at 0.01 ppm (PP 9E7588). That notice referenced a summary of the petitions prepared by Bayer CropScience LP, 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 petitions, EPA has modified the petitioner's request by lowering the proposed tolerance level for almond, hulls from 0.20 ppm to 0.15 ppm. EPA is also revising the proposed commodity term, “Sugarcane, sugar, refined” to read “Sugarcane, refined sugar.” Additionally, EPA is revising the citrus and pome fruit crop group names and the requested tolerance expression. 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for indaziflam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indaziflam follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The toxicology database for indaziflam is complete and adequate for selecting toxicity endpoints for risk assessment. The scientific quality of the data is relatively high, and the toxicity is well-characterized for all types of effects, including potential developmental, reproductive, immunologic and neurologic toxicity.

Indaziflam has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not irritating to the eye or skin and is not a dermal sensitizer.

The nervous system is a target for indaziflam in rats and dogs. In the dog degenerative neuropathology of the brain, spinal cord and sciatic nerve was reported in the dog following both subchronic and chronic oral exposure. Neuropathology in the dog was the most sensitive effect and was selected as the risk assessment endpoint for allrepeated exposure scenarios. In the rat, histopathology of the brain and pituitarypars nervosawas observed following chronic exposure. Clinical signs of neurotoxicity were observed in both species in several studies, including rat adult and developmental neurotoxicity studies. Decreased motor activity observed in the rat acute neurotoxicity study was selected as the appropriate endpoint for assessing acute oral exposures.

In addition to the neurological system, chronic exposure was associated with degenerative renal effects in the rat and mouse, hypertrophy (considered adaptive), increased macrovacuolation and multinucleated hepatocytes in the rat liver, increased follicular cell hypertrophy and colloid alteration in the rat thyroid, degeneration in rat reproductive tissues including atrophied seminal vesicles (males), and in female mice, blood-filled ovarian cysts/follicles (females) and gastric lesions. Thyroid and gastric effects were also observed following subchronic exposure of the rat. Decreased body weight gains were generally observed in the available subchronic and chronic studies. No systemic toxicity was observed in a 28-day dermal toxicity study in the rat.

Developmental effects in offspring were absent or limited to doses that also caused systemic toxicity in the adult. In the rat developmental toxicity study, decreased fetal weight was observed in the presence of maternal effects that included decreased body weight and clinical signs of toxicity. No developmental effects were observed in rabbits up to maternally toxic dose levels. Decreased pup weight and delays in sexual maturation (preputial separation in males and vaginal patency in females) were observed in the rat 2-generation reproductive toxicity study, along with clinical signs of toxicity, at a dose causing parental toxicity that included clinical signs and decreased weight gain. In the developmental neurotoxicity study, transiently decreased motor activity (PND 21 only) in male offspring was observed and was considered a potential neurotoxic effect. It was observed at a dose that also caused clinical signs of neurotoxicity along with decreased body weight in maternal animals.

There was no evidence of carcinogenicity observed in the 2-year dietary rat or mouse carcinogenicity bioassays and no evidence of genotoxicity in mutagenicity studies (reverse gene mutation in bacteria, forward gene mutation in mammalian cells) orin vitroandin vivochromosomal aberration assays. Based on the lack of evidence of carcinogenicity or genotoxicity, the Agency classified indaziflam as “not likely to be carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by indaziflam, 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 “Indaziflam: Human health risk assessment for use in citrus, stone, and pome fruits; grapes; tree nuts; pistachios; olives; and sugar cane (imported refined sugar),” p. 41 in docket ID number EPA-HQ-OPP-2009-0636.

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 NOAEL are observed and the LOAEL which adverse effects of concern are identified. 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 indaziflam used for human risk assessment is shown in the table below of this unit.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to indaziflam, EPA considered exposure under the petitioned-for tolerances. There are no tolerances currently established for indaziflam. EPA assessed dietary exposures from indaziflam 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 indaziflam. 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 assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with indaziflam. DEEM-FCID, Version 2.03 default concentration factors were used to estimate residues of indaziflam in processed commodities with the exception of the empirically derived raisin processing factor of 2.8x.

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 assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with indaziflam. DEEM-FCID, Version 2.03 default concentration factors were used to estimate residues of indaziflam in processed commodities with the exception of the empirically derived raisin processing factor of 2.8x.

iii.Cancer.Based on the results of carcinogenicity studies in rats and mice, EPA classified indaziflam as “Not Likely to be Carcinogenic to Humans” therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv.Anticipated residue and percent crop treated (PCT) information.EPA did not use anticipated residue or PCT information in the dietary assessment for indaziflam. Tolerance level residues and 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water.The residues of concern in drinking water include indaziflam and its degradates: Triazine indanone, indaziflam-carboxylic acid, indaziflam-olefin, indaziflam-hydroxyethyl, fluoroethyl-diaminotriazine (FDAT), and dihydroaminotriazine (a degradate of FDAT). The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for indaziflam and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of indaziflam and its degradates. 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 indaziflam and its degradatesfor acute exposures are estimated to be 84 parts per billion (ppb) for surface water and 3.7 ppb for ground water. The chronic exposures for non-cancer assessments are estimated to be 26 ppb for surface water and 3.7 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 84 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 26 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).Indaziflamis currently registered for the following uses that could result in residential exposures: Residential turfgrass and recreational areas. EPA assessed residential exposure using the following assumptions: There is a potential for short-term exposure of homeowners applying products containing indaziflam on home lawns. There is also a potential for short- and intermediate-term post-application exposure of adults and children entering lawn and recreation areas, including golf courses, which have been treated with indaziflam. Indaziflam post-application inhalation exposures are expected to be negligible due to its low vapor pressure, low application rates, and the types of application equipment used (i.e., hand-held equipment that is not likely to generate a vapor). Therefore, a quantitative post-application inhalation exposure assessment was not considered necessary. EPA assessed the following residential exposure scenarios:

i. Short-term dermal and inhalation exposures of residential handlers using various types of application equipment and formulation types on the proposed residential use sites;

ii. Short-term post-application dermal exposures of adults and children entering treated turf areas; and

iii. Short-term postapplication incidental oral exposures of children from contact with treated turfgrass.

Since the doses and endpoints selected to assess short- and intermediate-term exposures are the same, a separate quantitative intermediate-term assessment was not completed; the short-term risk assessments are protective of intermediate-term risks.

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 indaziflam to share a common mechanism of toxicity with any other substances. Indaziflam and its metabolite fluoroethyldiaminotriazine (FDAT) contain a triazine moiety within their chemical structures. Several triazine herbicides were determined by EPA to have a common mechanism of toxicity based on their ability to disrupt the hypothalamic-pituitary-gonadal axis (U.S. EPA, 2002). The triazine common mechanism group (TCMG) includes atrazine, simazine, propazine, and the metabolites desethyl-s-atrazine (DEA), deisopropyl-s-atrazine (DIA), and diaminochlorotriazine (DACT). Indaziflam and its metabolite FDAT were considered for incorporation into the TCMG by EPA based on structure; indaziflam, FDAT, and the TCMG members contain a common triazine moiety. However, EPA determined that it would not be appropriate to include indaziflam and FDAT in the TCMG for the following reasons:

i. The structure of indaziflam and FDAT are unique in that they contain a fluoroethyl group at the 2-position of the triazine ring, whereas the TCMG members contain a chlorine substituent at the 2-position of the triazine ring and;

ii. Indaziflam and FDAT do not elicit the same toxicological responses shared by the TCMG members. The TCMG members cause an increase in mammary gland tumors in rats and multiple developmental effects such as attenuation of the luteinizing hormone surge, altered pregnancy outcome, and delayed preputial separation. Although delayed sexual maturation was observed in the rat reproductive toxicity study, the effects occurred only at the highest dose. None of the other effects associated with the TCMG members were observed in the carcinogenicity, developmental, or reproductive guideline studies for indaziflam. In a non-guideline study, FDAT delayed vaginal patency in a dose-dependent manner. However, none of the other characteristic developmental effects of the TCMG members were observed, and this effect only occurred at higher doses compared to DACT. Therefore, unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA found that neither indaziflam nor its metabolite FDAT have a common mechanism of toxicity with any other substances, and indaziflam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that indaziflam 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,seeEPA'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.The pre- and post-natal toxicity database for indaziflam includes guideline rat and rabbit developmental toxicity studies, a 2-generation reproduction toxicity study in rats and a developmental neurotoxicity study in rats. As discussed in Unit III.A., there was no evidence of increased pre- or post-natal susceptibility of fetuses or offspring in any of these studies.

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 indaziflam is considered complete and includes acceptable developmental toxicity studies in rats and rabbits, a 2-generation reproductive toxicity study in rats, a developmental neurotoxicity in rats, acute and subchronic neurotoxicity screening studies in rats, and an immunotoxicity study.

ii. There is no evidence that indaziflam results in increased pre- or post-natal susceptibility of rats or rabbits in the prenatal developmental studies of rats in the 2-generation reproduction study, or of rats in the developmental neurotoxicity study.

iii. There are no significant residual uncertainties in the exposure databases. The final report on the stability of indaziflam in frozen storage and processing data for citrus oil were only recently submitted by the petitioner and are currently undergoing full review at the Agency; however, based on a preliminary screening of the data, EPA does not expect these studies to have a measurable impact on exposure estimates for indaziflam.

a.Storage stability.Preliminary information from the study indicates that indaziflam is stable in frozenstorage over a 25-26 month period, well beyond the 17-month period that samples from the residue field trials were stored frozen prior to analysis.

b.Citrus oil processing data.Although all citrus commodities from submitted field trials and a processing study have total residues below the method limit of quantitation (LOQ) at a 5× exaggerated application rate, data were required for the processed commodity citrus oil due to the extremely high theoretical concentration factor (1000x). Citrus oil was not analyzed during the originally submitted processing study. Data from the recently submitted study indicate that indaziflam residues concentrate in citrus oil at approximately 11.7x compared to those in citrus raw agricultural commodities (RACs). Based on this preliminary concentration factor, the total residues in citrus oil are still estimated to be less than the LOQ. Therefore, EPA believes that the tolerance of 0.01 ppm (the LOQ) for citrus fruit is adequate to cover residues in citrus oil, as no finite residues would be expected in citrus oil even at exaggerated rates.

The dietary food exposure assessments were performed assuming tolerance-level residues and 100 PCT for all commodities. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to indaziflam in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children including incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by indaziflam.

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.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to indaziflam will occupy 3% of the aPAD for infants, less than 1 year 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 indaziflam from food and water will utilize 10% of the cPAD for infants, less than 1 year 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 indaziflam 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). Indaziflam 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 indaziflam.

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 2,400 for adults and 1,300 for children. For adults, EPA aggregated short-term residential handler inhalation and dermal exposure with chronic dietary exposure from food and water. For children, EPA aggregated short-term dermal and incidental oral residential exposures plus chronic dietary exposure from food and water. Because EPA's level of concern for indaziflam is for MOEs below 100, 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). Since the doses and endpoints selected to assess short- and intermediate-term exposures to indaziflam are the same, a separate quantitative intermediate-term assessment was not completed; the short-term risk assessments are protective of both short- and intermediate-term risks.

5.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, indaziflam is not expected to pose a cancer risk to humans.

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

Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) Method DH-003-P07-02) is available to enforce the tolerance expression. The method is able to determine, separately, residues of indaziflam and FDAT. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;telephone number:(410) 305-2905;e-mail address: residuemethods@epa.gov.

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 U.N. 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 indaziflam.

EPA is lowering the almond, hulls tolerance proposed at 0.20 ppm to 0.15 ppm based on analysis of the field trial data using the Agency's NAFTA-harmonized tolerance/MRL calculator in accordance with theGuidance for Setting Pesticide Tolerances Based on Field Trial Data.EPA is also revising the proposed commodity term, “Sugarcane, sugar, refined” to read “Sugarcane, refined sugar” to agree with the Agency's Food and Feed Vocabulary. Additionally, EPA is revising the requested tolerance expression to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that thetolerances cover residues of the herbicide indaziflam, including its metabolites and degradates, but that compliance with the tolerance levels is to be determined by measuring only indaziflam,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, in or on the commodities.

EPA was petitioned for tolerances on citrus fruit group 10 and pome fruit group 11. In theFederal Registerof December 8, 2010 (75 FR 76284) (FRL-8853-8), EPA issued a final rule that revised the crop grouping regulations. As part of this action, EPA expanded and revised the existing citrus fruit group 10 and pome fruit group 11. Changes to crop group 10 included adding the specialty commodities Australian desert lime, Australian finger lime, Australian round lime, Brown River finger lime, Japanese summer grapefruit, Mediterranean mandarin, Mount White lime, New Guinea wild lime, Russell River lime, sweet lime, Tachibana orange, Tahiti lime, tangelo, tangor, trifoliate orange, and uniq fruit; creating subgroups; revising the representative commodities; and naming the new crop group citrus fruit group 10-10. Changes to crop group 11 included adding the specialty commodities azarole, medlar, Asian pear, Chinese quince, Japanese quince, and tejocote; creating subgroups; revising the representative commodities; and naming the new crop group pome fruit group 11-10. EPA indicated in the December 8, 2010 final rule as well as the earlier January 6, 2010 proposed rule (75 FR 807) (FRL-8801-2) that, for existing petitions for which a Notice of Filing had been published, the Agency would attempt to conform these petitions to the rule. Therefore, consistent with this rule, EPA has assessed exposure to the herbicide, indaziflam, assuming use under the revised crop groups. Because revising the requested crop groups to the updated crop groups did not result in a risk of concern, EPA is proposing to establish tolerances for indaziflam residues on citrus fruit group 10-10 and pome fruit group 11-10.

Therefore, tolerances are established for residues of the herbicide indaziflam, including its metabolites and degradates, in or on fruit, citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 at 0.01 ppm; fruit, stone, group 12 at 0.01 ppm; nut, tree, group 14 at 0.01 ppm; pistachio at 0.01 ppm; almond, hulls at 0.15 ppm; grape at 0.01 ppm; olive at 0.01 ppm; and sugarcane, refined sugar at 0.01 ppm. Compliance with the tolerance levels is to be determined by measuring only indaziflam,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, in or on the commodities.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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 UnitedStates 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:

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://www.gpoaccess.gov/ecfr.

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-2005-0307 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 June 6, 2011. 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-2005-0307, by one of the following methods:

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

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

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

In theFederal Registerof November 30, 2005 (70 FR 71836) (FRL-7747-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 3E6536 for mandarin oranges/mandarins; PP 4F4324 for almond nuts and almond hulls; PP 4F4333 for broccoli, cabbage, lettuce, and peppers) by Dow AgroSceinces LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petitions requested that 40 CFR 180.176 be amended by establishing tolerances for residues of the fungicide mancozeb, zinc manganese ethylenebis dithiocarbamate, in or on mandarinoranges/mandarins at 5.0 parts per million (ppm) (PP 3E6536), almond nuts at 0.1 ppm and almond hulls at 10.0 ppm (PP 4F4324); and broccoli at 13.0 ppm, cabbage at 10.0 ppm, lettuce at 10.0 ppm, and peppers at 7.0 ppm (PP 4F4333). That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available in the docket,http://www.regulations.gov.One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is setting the tolerances at levels different than originally requested in the petitions, with the exception of almond. The reason for these changes is explained in Unit IV.D. The request for mandarin oranges has been withdrawn.

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

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

Mancozeb is a member of the ethylene bisdithiocarbamate (EBDC) group of fungicides that also includes the related active ingredients maneb and metiram. Mancozeb, maneb and metiram, are all metabolized to ethylenethiourea (ETU) in the body and all degrade to ETU in the environment. Therefore, EPA has considered the aggregate or combined risks from food, water and non-occupational exposure resulting from mancozeb alone and ETU from all sources (i.e.,the other EBDC fungicides) for this action.

In response to the petitions submitted to establish tolerances for residues of mancozeb on almond, cabbage, leaf lettuce, peppers, and broccoli, EPA completed two risk assessments in 2007:

• A mancozeb risk assessment which considered all existing and proposed uses for mancozeb, and

• An ETU risk assessment that considered exposure to ETU from all sources (mancozeb, metiram, and maneb) for all existing and proposed uses.

Although the 2007 mancozeb review showed risks that were acceptable, the 2007 ETU review demonstrated unacceptable cancer risks, therefore preventing the Agency from acting on the petitions for almond, cabbage, leaf lettuce, peppers, and broccoli. The Agency worked to refine the cancer risk assessment for ETU. A refined cancer risk assessment for ETU from all sources has been completed and the Agency is now prepared to act on the proposed tolerances for almond, cabbage, leaf lettuce, peppers, and broccoli. Because the 2010 ETU review dealt strictly with refining the cancer risk, the Agency will be relying on three risk assessments to support this tolerance document. These assessments are as follows:

• A 2007 risk assessment for mancozeb for acute, short-term, intermediate-term, chronic, and cancer risk (refer to risk assessment in the Docket EPA-HQ-OPP-2005-0307 titled “Mancozeb: Human Health Risk Assessment to Support Proposed New Uses on Broccoli, Cabbage, Lettuce, Peppers and Almonds”),

• A 2007 risk assessment for ETU for acute, short-term, intermediate-term and chronic risk (refer to risk assessment in the Docket EPA-HQ-OPP-2005-0307 titled “Ethylenethiourea (ETU) from EBDCs: Health Effects Division (HED) Human Health Risk Assessment of the Common Metabolite/Degradate ETU”),

• A 2010 addendum to the 2007 ETU assessment for cancer risk (refer to risk assessment in the Docket EPA-HQ-OPP-2005-0307 titled “Addendum to the Aggregate Human Health Risk Assessment of the Common Metabolite/Degradate Ethylene Thiourea (ETU) to Support New Tolerances on Imported Grapes and Bananas for Metiram and for New Tolerances for Mancozeb on Almonds, Broccoli, Cabbage, Lettuce, and Peppers.”).

In theFederal Registerof April 16, 2010, (75 FR 19967) (FRL-8822-2) the voluntary cancellation of the last product containing maneb registered for use in the United States was announced by the Agency. Therefore, it is important to note that since all products for maneb have been cancelled and there are limited existing stocks for maneb still in the channels of trade, the risk assessments for ETU likely overestimates the exposures to this common metabolite. EPA's assessment of exposures and risks associated with mancozeb and ETU follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In addition to evaluating mancozeb, EPA also evaluated the risks of ETU, a contaminant, metabolite and degradation product of mancozeb and the other EBDC group of fungicides, which includes the related active ingredients metiram and maneb.

1.Mancozeb.Mancozeb is not acutely toxic via the oral, dermal or inhalation routes of exposure. Further, mancozeb is not a skin irritant nor is it a skin sensitizer, although it does cause mild eye irritation. The findings in multiple studies demonstrate that the thyroid is a target organ for mancozeb. Thyroid toxicity was manifested as alternations in thyroid hormones, increased thyroid weight, and microscopic thyroid lesions (mainly thyroid follicular cell hyperplasia). These effects are due to the ETU metabolite. In a subchronic study in the rat, neuropathology was seen (injury to peripheral nerves) microscopically with associated clinical signs (abnormal gait and limited use of rear legs) and loss of muscle mass. An acute neurotoxicity study with mancozeb has been completed and reviewed since the 2007 risk assessment; neuropathology was not observed, and minimal effects upon motor activity were observed at high doses. The Agency conducted a preliminary dietary assessment using a point-of-departure from this study and found no risk concerns. Other toxicity included increases in bilateral retinopathy in the chronic rat study. Elevated cholesterol and a mild, regenerative, anemia occurred in subchronic and chronic dog studies.

Mancozeb is rapidly absorbed and eliminated in the urine. In oral rat metabolism studies with radiolabelledmancozeb and other EBDCs, an average 7.5%in vivometabolic conversion of EBDC to ETU occurred, on a weight-to-weight basis. Metabolism data indicate mancozeb does not bio-accumulate. Mancozeb has been tested in a series ofin vitroandin vivogenotoxicity assays, which have shown that it exhibits weak genotoxic potential.

Thyroid follicular cell adenomas and carcinomas were increased in high-dose males and females in the combined rat toxicity/carcinogenicity study with mancozeb. Doses in a mouse study were too low to assess carcinogenicity, and there were no treatment-related changes in tumor rates. Historically, mancozeb's potential for carcinogenicity has been based on its metabolite ETU, which is classified as a probable human carcinogen. However, since ETU is known to be the chemical causing the thyroid tumors observed, the cancer assessment has been done only for ETU rather than the parent compound.

Developmental defects in the rat developmental toxicity study included hydrocephaly, skeletal system defects, and other gross defects which occurred at a dose causing maternal mortality and did not indicate increased susceptibility of offspring. Abortions occurred in the rabbit developmental toxicity study at the high dose which also caused maternal mortality, and there was no indication of enhanced susceptibility of offspring in the rabbit. There was no evidence of reproductive toxicity in the 2-generation reproduction study in rats.

2.ETU.The thyroid is a target organ for ETU; thyroid toxicity in subchronic and chronic rat, mouse, and dog studies included decreased levels of T4, increases or decreases in T3, compensatory increases in levels of TSH, increased thyroid weight, and microscopic thyroid changes, chiefly hyperplasia. Overt liver toxicity was observed in one chronic dog study. ETU is classified as a probable human carcinogen based on liver tumors in female mice.

Developmental defects in the rat developmental study were similar to those seen with mancozeb, and included hydrocephaly and related lesions, skeletal system defects, and other gross defects. These defects showed increased susceptibility to fetuses because they occurred at a dose which only caused decreased maternal food consumption and body weight gain.

Specific information on the studies received and the nature of the adverse effects caused by mancozeb 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 the document titled “Mancozeb: Human Health Risk Assessment to Support Proposed New Uses on Broccoli, Cabbage, Lettuce, Peppers and Almonds” on pages 13-15 in docket ID number EPA-HQ-OPP-2005-0307.

Additionally, specific information on the studies received and the nature of the toxic effects caused by ETU as well as the NOAEL and the LOAEL from the toxicity studies can be found athttp://www.regulations.govin document titled “Ethylenethiourea (ETU) from EBDCs: Health Effects Division (HED) Human Health Risk Assessment of the Common Metabolite/Degradate ETU” on pages 16-17 in docket ID number EPA-HQ-OPP-2005-0307.

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,see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for mancozeb and ETU used for human risk assessment is discussed in Unit IV.B. of the final rule published in theFederal Registerof August 18, 2010 (75 FR 50902) (FRL-8841-1).

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to mancozeb, EPA considered exposure under the petitioned-for tolerances as well as all existing mancozeb tolerances in 40 CFR 180.176. In evaluating dietary exposure to ETU, EPA considered exposure under the petitioned-for tolerances discussed in this document as well as all existing uses of the EBDC group of fungicides (maneb, metiram, mancozeb) including the uses for which there are maneb tolerances even though all maneb registrations have been canceled. EPA assessed dietary exposures from mancozeb and ETU 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 mancozeb and ETU. 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).

a.Mancozeb.The following assumptions were made for the acute exposure assessments: The Agency conducted a highly refined, probabilistic acute dietary assessment incorporating maximum percent crop treated information for new and existing uses, field trial or monitoring data, and processing and cooking factors.

b.ETU.The following assumptions were made for the acute exposure assessments: The Agency conducted a highly refined, probabilistic acute dietary assessment incorporating maximum percent crop treated information for new and existing EBDC uses, field trial or monitoring data for existing EBDC uses, and processing and cooking factors. It was assumed that commodities would not be treated with more than one EBDC in a season, as there are label restrictions regarding treatment with multiple EBDCs. Percent crop treated was estimated by summing the percent crop treated for the individual EBDCs. For residue values, EPA used either market basket survey data or field trial data. For a few commodities, mancozeb-derived ETU from mancozeb field trial data were used for both mancozeb and maneb because maneb field trial data were not available and application rates were sufficiently similar to estimate maneb-derived ETU values.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII.

a.Mancozeb.The chronic dietary exposure and risk assessment for mancozeb (non-cancer and cancer) incorporated average values based either on field trial data or monitoring data and average percent crop treated data for new and existing uses, as well as processing and cooking factors.

b.ETU.Chronic anticipated residues were calculated from field trial data on EBDCs or monitoring data for ETU. Averages of the field trial and market basket survey residues were used. EPA also used PCT data.

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. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear 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. Mancozeb degrades and/or metabolizes to ETU which causes thyroid tumors; therefore, EPA has historically attributed mancozeb's carcinogenicity to the formation of ETU, which is classified as a probable human carcinogen. The Agency has used the cancer potency factor (Q1 *) of 0.0601 (mg/kg/day)-1for ETU (based on liver tumors in female mice) for risk assessment. Therefore, cancer risk from exposure to mancozeb has been calculated by estimating exposure to mancozeb-derived ETU and using Q1* for ETU. The same approach has been taken for the other EBDCs. EPA's estimated exposure to mancozeb-derived ETU and ETU from other EBDCs included ETU residues found in food as well as ETU formed by metabolic conversion on parent mancozeb in the body (conversion rate of 0.075). EPA relied on the same estimates used for the chronic exposure assessment in assessing cancer risk.

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

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

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

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

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

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

In the 2007 acute risk assessment for mancozeb, the Agency estimated the PCT for existing uses as follows:

Apple, 41%; asparagus, 34%; barley, 0.9%, beet, sugar, 2.9%; cantaloupe, 10%; carrot, 13%; casaba, 10%; corn, field, 1%; corn, sweet, 22%; cottonseed, oil, 0.8%; cucumber, 32%; grape, 14%; honeydew melon, 13%; oat, 1%; onion, dry bulb, 77%; peanut, 2.3%; pear, 51%; potato, 50%; pumpkin, 10%; rice, 1%; rye grain, 1%; squash, summer, 86%; squash, winter, 10%; tomato, 80%; watermelon, 30%; wheat, grain, 2.3%.

In the 2007 chronic risk assessment for mancozeb, the Agency estimated the PCT for existing uses as follows:

Apple, 26%; asparagus, 16%; barley, 0.2%, beet, sugar, 1.3%; carrot, 9%; casaba, 8%; corn, field, 1%; corn, sweet, 12%; cottonseed, oil, 0.2%; cucumber, 18%; grape, 9%; honeydew melon, 8%; oat, 1%; onion, dry bulb, 38%; peanut, 0.9%; pear, 32%; potato, 36%; pumpkin, 8%; rice, 1%; rye grain, 1%; squash, summer, 41%; squash, winter, 8%; tomato, 49%; watermelon, 28%; wheat, grain, 0.9%.

In the 2007 acute risk assessment for ETU the Agency estimated the PCT for existing uses as follows:

Apple, 65%; asparagus, 30%; barley, 2%; bean, dried, 2.5%; beets, sugar, 15%; Brussels sprouts, 32%; cantaloupe, 12.5%; carrot, 2.5%; casaba, 12.5%; cauliflower, 15%; celery, 12%; chickpea, 2.5%; Chinese waxgourd, 15%; chive, 20%; collards, 10%; corn, field, 2.5%; corn, sweet, 17.5%; cottonseed, oil, 3.5%; cranberry, 31%; cucumber, 40%; eggplant, 65%; fennel, Florence, 12%; fig, 1%; garlic, 25%; grape, 81.5%; grape, wine, 81.5%; guar, seed, 1%; honeydew melon, 12.5%; kale, 5%; leek, 25%; mustard greens, 5%; oat, 2%; onion, dry bulb, 85%; peanut, 3.5%; pear, 55%; potato, 85%; pumpkin, 15%; rice, 2.5%; rye grain, 2%; squash, summer, 35%; squash, winter, 0%; tomato, fresh, 80%; tomato, processed, 25%; turnip tops, 86%; walnut, 37.5%; watermelon, 55%; wheat, grain, 3.5%.

In the 2007 chronic risk assessment for ETU the Agency estimated the PCT for existing uses as follows:

Apple, 42%; asparagus, 21%; barley, 2%; bean, dried, 1%; beets, sugar, 6%; Brussels sprouts, 21%; cantaloupe, 6%; carrot, 8%; casaba, 6%; cauliflower, 5%; celery, 12%; chickpea, 1%; Chinese waxgourd, 5%; chive, 10%; collards, 10%; corn, field, 1%; corn, sweet, 11%; cottonseed, oil, 2%; cranberry, 31%; cucumber, 20%; eggplant, 45%; fennel, Florence, 12%; fig, 1%; garlic, 25%; grape, 60%; grape, wine, 60%; guar, seed, 1%; honeydew melon, 6%; kale, 6%; kohlrabi, 1%; leek, 10%; mustard greens, 5%; oat, 2%; onion, dry bulb, 60%; peanut, 2%; pear, 40%; potato, 63%; pumpkin, 6%; rice, 1%; rye grain, 2%; squash, summer, 25%; squash, winter, 25%; tomato, fresh, 54%; tomato, processed, 54%; walnut, 31%; watermelon, 10%; wheat, grain, 2%.

For the 2010 ETU cancer risk assessment the Agency estimated the PCT for existing uses as follows:

Apple, 51%; asparagus, 15%; barley, 1%; bean, dried, 1%; beets, sugar, 3.5%; Brussels sprouts, 15%; cantaloupe, 7.5%, carrot, 5%; cauliflower, 10%; chickpea, 1%; collards, 31%; corn, field, 1%; corn, sweet, 6%; cottonseed, oil, 11%; cranberry, 45%; cucumber, 30%; eggplant, 30%; fig, 5%; flaxseed, 11%; garlic, 25%; grape, 6%; grape, wine, 26%; guar, seed, 1%; kale, 73%; leek, 15%; mustard greens, 22%; oat, 11%; onion, dry bulb, 75%; peanut, 2%; pear, 35%; potato, 67.5%; pumpkin, 20.5%; rice, 1%; rye grain, 11%; safflower, oil, 11%; squash, summer, 57%; squash, winter, 26%; tomato, fresh, 30%; tomato, processed, 30%; turnip tops, 36%; walnut, 36%; watermelon, 45%; wheat, grain, 11%.

In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the mostrecent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

In the 2007 acute risk assessment for mancozeb, the Agency estimated the PCT for new uses as follows:

Almond, 35%; broccoli, 9%; cabbage, 47%; cabbage, Chinese, 47%; head lettuce 66%; leaf lettuce 61%; pepper, bell, 48%; pepper, non-bell, 48%.

In the 2007 chronic risk assessment for mancozeb, the Agency estimated the PCT for new uses as follows:

Almond, 35%; broccoli, 7%; cabbage, 42%; cabbage, Chinese, 42%; head lettuce 58%; leaf lettuce 59%; pepper, bell, 43%; pepper, non-bell, 43%.

For the 2007 ETU acute assessment, the Agency estimated the PCT for new uses as follows:

Almond, 50%; broccoli, 22%; cabbage, 82%; cabbage, Chinese, 82%; pepper, bell, 88%; pepper, non-bell, 88%.

For the 2007 ETU chronic assessment, the Agency estimated the PCT for new uses as follows:

Almond, 45%; broccoli, 17%; cabbage, 57%; cabbage, Chinese, 57%; pepper, bell, 73%; pepper, non-bell, 73%.

For the 2010 ETU cancer assessment, the Agency estimated the PCT for new uses as follows:

Almond, 28%; broccoli, 15%; cabbage, 62%; cabbage, Chinese, 62%; pepper, bell, 74%; pepper, non-bell, 74%.

EPA estimates the percent crop treated for new uses (PCTn) of a pesticide represent the upper bound of use expected during the pesticide's initial 5 years of registration. The PCTn recommended for use in the chronic dietary assessment is calculated as the average PCT of the pesticide or pesticides that are the market leader or leaders, (i.e.,the pesticides with the greatest PCT) on that site over the three most recent years of available survey data. The PCTn recommended for use in the acute dietary assessment is the maximum observed PCT over the same period. Comparisons are only made among pesticides of the same pesticide types (e.g., the market leader for fungicides on the use site is selected for comparison with a new fungicide). The market leader included in the estimation may not be the same for each year since different pesticides may dominate at different times.

Typically, EPA uses USDA/NASS as the source data because it is publicly available and directly reports values for PCT. When a specific use site is not reported by USDA/NASS, EPA uses proprietary data and calculates the PCT given reported data on acres treated and acres grown. If no data are available, EPA may extrapolate PCTn from other crops, if the production area and pest spectrum are substantially similar.

EPA refines PCTn estimates based on approaches other than the market leader approach if the previous PCTn estimates based on the market leader indicate that the chemical exposure potentially poses a risk of concern. EPA considers the pest or pest spectrum targeted by the chemical for the new uses and identifies other pesticides already registered on that crop that target the same pest or pest spectrum. The PCTn is calculated based on the data from the three most recently available pesticide usage surveys. If multiple chemicals are identified that target the same pest spectrum, then the one with the highest PCT is selected from each year/crop combination. Consideration is also given to the potential for the development of resistance for each chemical using data available from the Resistance Action Committees.

EPA has considered all available relevant information and concludes that it is unlikely that the PCTn values will be exceeded during the next 5 years.

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

2.Dietary exposure from drinking water—i.Mancozeb.The Agency has determined that mancozeb is very short-lived in soil and water, and would not reach water used for human consumption whether from surface water or ground water.

ii.ETU.ETU is highly water soluble, and may reach both surface and ground water under some conditions. The ETU surface water Estimated Drinking Water Concentrations (EDWCs) were generated using a combined monitoring/modeling approach. Results of a surface water monitoring study conducted by the ETU Task Force were used to refine the outputs of the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM-EXAMS) models; the site/scenario modeled was application of an EBDC fungicide on peppers in Florida, and was chosen to produce the highest EDWC acute values. The ground water EDWC was detected in a Florida community water system intake in a targeted ground water monitoring study conducted by the EBDC task force from 1999 to 2003. Both these surface and ground water values represent upper-bound conservative estimates of the total ETU residual concentrations that might be found in surface water and ground water due to the use of the EBDC fungicides.

Based on the PRZM/EXAMS and monitoring studies, the EDWCs of ETU acute and chronic exposures are estimated to be 25.2 parts per billion (ppb), and 0.1 ppb, respectively for surface water. The EDWC for chronic exposure is estimated to be ppb for ground water 0.21.

Estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 25.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment of ETU, the water concentration of value 0.21 ppb was used to assess the contribution to drinking water. For cancer dietary risk assessment of ETU, the water concentration of value 0.21 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).

i.Mancozeb.Mancozeb is currently registered for use on the following residential sites: Home gardens, golf courses, and sod farms (potential exposure to mancozeb is from residues remaining on transplanted turf). The Agency has determined that it is appropriate to aggregate chronic exposure through food with short- and intermediate-term residential exposures to mancozeb. Since residues of mancozeb are not expected in drinking water, only mancozeb food residues are considered.

The two scenarios that were evaluated for mancozeb are the “short/intermediate-term home garden aggregate (adult)” which considers residential handler exposures (inhalation) to adult applicators combined with average food exposures and the “short/intermediate-term treated turf aggregate (toddler)” which considers residential incidental oral exposures to toddlers combined with average food exposures. The only postapplication scenario for adults in contact with treated turf (golf courses) is via the dermal route of exposure. Since no dermal endpoints were selected for mancozeb, a quantitative risk assessment for this scenario is not required.

ii.ETU.ETU non-dietary exposure is expected as a result of the registered uses of mancozeb and the other EBDCs on home gardens, golf courses and sod farms. For ETU, aggregate exposure sources include food, drinking water, home gardening activities and golfing. The Agency has determined that it is appropriate to aggregate chronic exposure through food with short- and intermediate-term residential exposures to mancozeb.

The three scenarios that were evaluated for ETU are as follows: The first is the “short/intermediate-term home garden aggregate” which combines handler exposures (inhalation and dermal) and postapplication garden exposures (dermal) plus average daily food and drinking water exposure for adults and postapplication garden exposures (dermal) plus average daily food and drinking water exposure for youth. The second is the “short-term treated turf aggregate (toddlers)” which combines treated turf post application exposures (incidental oral and dermal) plus average daily food and drinking water exposure for toddlers. And the last is the “short/intermediate-term treated turf aggregate” which considers short-term residential exposures (dermal) plus average daily food and drinking water exposure for adults such as golfing on treated turf. This assessment is protective of adult and youth golfers. Although exposure to children golfing could be almost twice that of the adult golfer because of increased surface area/body weight (SA/BW) ratios, younger golfers are not expected to use the golf course for the same length of time as adolescents and adults. The shorter duration on the golf course for younger golfers offsets the higher SA/BW; therefore, risks from short-term post-application exposures to young golfers are likely to be similar to risks for adult golfers.

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.”

As previously mentioned, the risk estimates summarized in this document are those that result only from the use of mancozeb, and ETU derived from mancozeb and the other EBDC chemicals, which are all dithiocarbamates. For the purposes of this action, EPA has concluded that mancozeb does not share a common mechanism of toxicity with other substances. The Agency reached this conclusion after a thorough internal review and external peer review of the data on a potential common mechanism of toxicity.

EPA concluded that the available evidence does not support grouping the dithiocarbamates based on a common toxic effect (neuropathology) occurring by a common mechanism of toxicity (related to metabolism to carbon disulfide). After a thorough internal and external peer review of the existing data bearing on a common mechanism of toxicity, EPA concluded that the available evidence shows that neuropathology can not be linked with carbon disulfide formation. For more information, please see the December 19, 2001 memo, “The Determination of Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity” on the internet athttp://www.epa.gov/oppsrrd1/cumulative/dithiocarb.pdf.

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—i.Mancozeb.In the rat developmental study, developmental effects were observed in the presence of severe maternal effects, including maternal mortality and clinical signs. In the rabbit developmental study, developmental effects (spontaneous abortions) were observed at the same dose (80 mg/kg/day) at which maternal effects included mortality and clinical signs. In the rat reproduction study, no effects were observed in offspring, while thyroid effects and body weight gain decrements occurred in adults.

ii.ETU.There was evidence of increased susceptibility of fetuses to ETU in the rat developmental studies because hydrocephaly occurred at doses below that causing maternal toxicity. Acceptable reproductive and rabbit developmental toxicity studies were not available for ETU. As a result, the Agency evaluated the level of concern for the effects observed when considered in the context of all available toxicity data. In addition, the Agency evaluated the database to determine if there were residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the ETU risk assessment.

3.Conclusion—i.Mancozeb.In the 2007 assessment, EPA retained the presumptive 10X FQPA safety factor for the protection of children due to the absence of a required developmental neurotoxicity study. That study has recently been received. Neurotoxicity was not observed in the study, and the young animals did not show susceptibility, as compared to the adults, for the slight toxicity that was observed (reduced body weight gain). Additionally, since the completion of the 2007 assessment, EPA has imposed a new data requirement for immunotoxicity data and such data hasnot been submitted for mancozeb. The absence of an immunotoxicity study does not raise significant uncertainty. In the absence of that study, the available toxicity data for mancozeb have been thoroughly examined for any information which suggests a potential for immunotoxicity. The analysis did not reveal such information and the Agency does not believe that conducting the immunotoxicity study will result in a point of departure (POD) less than the currently selected PODs for risk assessment.

Because EPA is relying on the 2007 assessment in evaluating acute and chronic risks, EPA is retaining the children's safety factor determination in that assessment (retain the additional 10X factor). EPA expects that once that determination is revisited, the children's safety factor will be lowered or removed entirely due to the submission of the DNT study and the fact that immunotoxicity is not a concern with mancozeb. These changed circumstances certainly do not support an additional safety factor higher than 10X. Further, as discussed below, EPA believes that the 2007 risk assessment does not underestimate exposure to mancozeb. Accordingly, EPA concludes that the 2007 determination on the children's safety factor protects the safety of infants and children.

ii.ETU.The toxicity database for ETU is not complete. EPA lacks the following studies: A DNT study; a developmental study in rabbits; a 2-generation reproduction study; and a comparative thyroid study in adults and offspring. Given these multiple data gaps for studies that directly assess the risk to the young, EPA does not have reliable data to remove or modify the presumptive 10X FQPA safety factor.

No further safety factor to protect is needed for the following reasons. First, the Agency determined that the degree of concern for the susceptibility seen in ETU developmental studies was low. The reasons for this conclusion are:

• The teratogenic effects of ETU have been well-characterized in numerous studies in the published literature, as well as in a guideline study submitted by the registrant. In addition, since metabolism studies have shown that approximately 7.5% of mancozeb converts to ETU in mammalian systems, the extensive toxicity database with mancozeb on developmental effects provide extensive information about pre- and post-natal toxicity of ETU;

• There is a clear NOAEL for these effects and the dose-response relationship, although steep, is well characterized in the numerous developmental studies in rats.

• The developmental endpoint with the lowest NOAEL was selected for deriving the acute RfD.

• The target organ (thyroid) was selected for deriving the chronic RfD as well as endpoints for non-dietary exposures (incidental oral, dermal, and inhalation). Since the ETU doses selected for overall risk assessments will address the concern for developmental and thyroid toxicity, there are no residual uncertainties with regard to prenatal and/or postnatal toxicity.

Second, the information on ETU gleaned from the extensive mancozeb database on effects other than development effects also reduces, to a degree, the uncertainty arising from the significant datagaps for ETU.

Third, EPA has concluded that the exposure assessment, although refined, is unlikely to under-estimate potential exposures especially considering exposure to maneb was included even though all maneb products have been canceled. In making this judgment, EPA has taken into account that it is relying on three separate reviews in this Notice:

• A 2007 risk assessment for mancozeb for acute, short-term, intermediate-term, chronic, and cancer risk,

• A 2007 risk assessment for ETU for acute, short-term, intermediate-term and chronic risk, and

• A 2010 addendum to the 2007 ETU assessment for cancer risk—and that the percent crop treated estimates differ slightly between reviews.

In comparing the percent crop treated information from 2007 and 2010, there are some increases in usage for some crops, and there are decreases in usage for other crops. These differences appear to largely offset each other. Further, most of the increases are attributable to estimated increases in maneb usage but, as noted, maneb was canceled in 2010 and it is unlikely that existing stocks are sufficient to sustain prior usage levels much less any increased usage. An EPA sensitivity analysis of the main contributors to ETU exposure showed no significant increase in exposure from the changed percent crop treated estimated. The percent crop treated values used in these risk assessments are detailed in the memo titled “Mancozeb. Discussion on Percent Crop Treated Values Used in Aggregate and Chronic Assessments” in docket number EPA-HQ-OPP-2005-0307.

In any event, there are two other aspects of the exposure assessment that are likely to significantly overstate exposure to mancozeb and ETU. First, exposure estimates for some crops, including bananas, a high-consumption food, include the assumption that everything consumed in the United States has been treated. Second, the residue data used in the assessment for the proposed commodities and many other crops are based on crop field trials. Monitoring studies conducted for several crops have shown that residues on foods close to the point of consumption are much lower than the residues found in crop field trials.

For all of these reasons, EPA concludes that it has not underestimated exposure to mancozeb and ETU.

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 (Mancozeb).The mancozeb acute aggregate assessment considers acute exposure to mancozeb only and not ETU. Further, this assessment is based on residues of mancozeb in food only since residues of mancozeb are not expected in drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to mancozeb will occupy 6.9% of the aPAD for females 13-49 years of age, the only population group of concern.

2.Acute risk (ETU).Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to ETU will occupy 87% of the aPAD for females 13-49 years of age, the only population group of concern.

3.Chronic risk (Mancozeb).There are no long-term residential exposure scenarios for mancozeb and there is not likely to be residues of mancozeb in drinking water. Therefore, the long-term or chronic (non-cancer) aggregate risk for mancozeb includes contribution from food alone. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to mancozeb from food will utilize 3.3% of the cPAD for children 1-2 years of age, the population group receiving the greatest exposure.

4.Chronic Risk (ETU).The aggregate chronic risks were calculated using foodand water exposure only because golfing and toddler transplanted turf exposure scenarios were considered to occur only on a short term basis. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ETU from food and water will utilize 58% of the cPAD for children (1 to 2 years old), the population group receiving the greatest exposure.

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

Mancozeb is currently registered for uses that could result in short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food with short- and intermediate-term residential exposures to mancozeb. The two scenarios that were evaluated for mancozeb are the following:

i.Short/intermediate-term home garden aggregate (adult).The aggregate short/intermediate-term home garden MOEs for adults are 110,000. Because for mancozeb EPA is concerned only with MOEs that are below 1,000, this MOE does not raise a risk concern.

ii. Short-term treated turf aggregate (toddler) .The mancozeb short-term aggregate risk (MOE) for toddlers exposed to treated turf is 1,100. Because for mancozeb EPA is concerned only with MOEs that are below 1,000, this MOE does not raise a risk concern.

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

Mancozeb is currently registered for uses that could result in short- and intermediate-term residential exposure to ETU. The 2007 assessment also included products containing maneb which were expected to result in short- and intermediate-term exposure. As previously discussed, these products have since been cancelled. The Agency determined that it was appropriate to aggregate chronic exposure through food with short- and intermediate-term residential exposures to ETU. The three scenarios that were evaluated for ETU are the following.

i.ETU short/intermediate-term home garden aggregate.The ETU short/intermediate-term home garden aggregate MOEs for adults is 13,000 and 17,000 for youth, respectively. Because for ETU EPA is concerned only with MOEs that are below 1,000, this MOE does not raise a risk concern.

ii.ETU short-term treated turf aggregate (toddlers).The ETU short-term treated turf aggregate MOE for toddlers is 1,100. Because for ETU EPA is concerned only with MOEs that are below 1,000, this MOE does not raise a risk concern.

iii.ETU short/intermediate-term treated turf aggregate.The ETU short-term treated turf aggregate MOE for golfers is 6,100. Because for ETU EPA is concerned only with MOEs that are below 1,000, this MOE does not raise a risk concern.

7.Aggregate cancer risk for U.S. population (mancozeb and ETU).As noted earlier in this document, mancozeb degrades and/or metabolizes to ETU which causes the same types of thyroid tumors as those seen when animals are dosed with mancozeb; therefore, EPA has historically attributed mancozeb's carcinogenicity to the formation of ETU, which is classified as a probable human carcinogen (B2).

The cancer risks were aggregated using the food and drinking water doses for the general population and the food, water and recreational doses for golfers, home gardeners and athletes. The average daily dose was used for food and water exposures and the lifetime average daily dose was used for the recreational exposures. The aggregate doses were multiplied times the potency factor for ETU, 0.0601 (mg/kg/day)−1to determine the cancer risks. The risk is estimated to be 3 × 10−6.

EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or 1 × 10−6) or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the logarithmic scale; for example, risks falling between 3 × 10−7and 3 × 10−6are expressed as risks in the range of 10−6. Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10−6until the calculated risk exceeds approximately 3 × 10−6. This is particularly the case where some conservatism is maintained in the exposure assessment. Although the ETU exposure risk assessment is refined, it retains significant conservatism in that, for leafy greens, field trial data and not market basket data on similar crops is used in estimating exposure. The leafy greens have tended to be among the top contributors to the aggregate risk (along with water and leaf lettuce). For other commodities, market basket data has shown reductions in residues one to two orders of magnitude lower than field trial data. Moreover, the only remaining EBDC registration for leafy greens (maneb) was canceled in 2010 but the exposure assessment does not take this into account. Additional conservatism is included in the exposure assessment by the assumption of 100 percent crop treated for many commodities. Accordingly, EPA has concluded the aggregate cancer risk for all existing mancozeb and other EBDC uses and the uses associated with the tolerances established in this action fall within the range of 1 × 10−6and are thus negligible.

8.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 mancozeb residues.

Adequate methods are available for the enforcement of tolerances for the plant commodities which are the subject of this request. The Pesticide Analytical Method (PAM) Vol. II lists Methods I, II, III, IV, and A for the determination of dithiocarbamate residues in/on plant commodities. The Keppel colorimetric method (Method III) is the preferred method for tolerance enforcement. The Keppel method determines EBDCs as a group by degradation to CS2. The analytical methodology for ETU is based on the original method published by Olney and Yip (JAOAC 54:165-169).

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;telephone number:(410) 305-2905;e-mail address: residuemethods@epa.gov.

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 U.N. Food and Agriculture Organization/World Health Organization foodstandards 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.

There are no established or proposed Codex MRLs for residues of mancozeb; however, Codex limits for mancozeb and similar fungicides are grouped under dithiocarbamates measured as carbon disulfide. There are Codex MRLs for almonds; almond hulls; cabbages, head; lettuce, head; cos lettuce; peppers, sweet. Tolerances for the EBDC pesticides are expressed in terms of carbon disulfide (CS2), which is the same as the Codex tolerance expression. The level of 0.1 ppm for almonds is also the same as the Codex MRL for almonds. However, for the reasons indicated below, the tolerance levels being established for the other subject crops cannot be harmonized with the associated Codex MRLs.

• Based on the calculations in the Agency's tolerance spreadsheet, in accordance with the Agency's “Guidance for Setting Pesticide Tolerances Based on Field Trial Data,” the appropriate tolerance level for cabbage is 9.0 ppm. The tolerance level cannot be harmonized with Codex; the highest residue level in the crop field trials (6.0 ppm in CS2equivalents) is greater than the Codex MRL for cabbage (5 ppm).

• The available data indicate that the appropriate tolerance level for head lettuce is 3.5 ppm. The tolerance level cannot be harmonized with Codex; the highest residue level in the crop field trials (2.2 ppm in CS2equivalents) is considerably less than the Codex MRL of 10 ppm for head lettuce.

• The available data indicate that the appropriate tolerance level for leaf lettuce is 18 ppm. The tolerance level cannot be harmonized with Codex; the highest residue level in the crop field trials (14 ppm in CS2equivalents) is greater than the Codex MRL for Cos lettuce (10 ppm).

• The appropriate tolerance level for pepper is 12 ppm. The tolerance level cannot be harmonized with Codex as the Codex MRL has been established for sweet pepper only.

• The appropriate tolerance level for almond hulls is 4 ppm. This value cannot be harmonized with Codex as it is significantly below the Codex MRL of 20 ppm.

The company Cerexagri, Inc. submitted a comment on the initial notice of filing in 2006. Cerexagri proposed that EPA reject the petitions for reasons primarily dealing with information included in the risk assessment provided by Dow AgroSciences in the petitions. The Agency conducts its own risk assessments and does not rely on those provided by registrants. For example, Cerexagri did not agree with Dow AgroSciences proposal to assume that “mancozeb uses will simply replace a share of the existing maneb market”. Nor did Cerexagri agree with Dow AgroSciences use of market basket data to extrapolate expected residues on the proposed commodities. The EPA did not base PCT estimates for new commodities based on the assumption that one EBDC will replace another but instead used its standard market leader approach to determine appropriate PCT numbers. Further, the EPA relied on the results of the crop field trial data to estimate exposure to the proposed commodities and many other crops. Results of the Market Basket Survey were only used for commodities/chemicals associated with the survey. Therefore, the objections voiced by Cerexagri are not relevant to the conclusions reached by the Agency regarding these petitions.

Finally, Cerexagri requested that the EPA first engage in a public process that would seek the participation of the grower community, research community and other interested parties before determining which new uses of EBDC fungicides should be approved because approval of the uses requested in this petition may preclude the approval of other uses. EPA, however, has followed all procedural requirements in the FFDCA section. Moreover, in the time since this petition was submitted, no further uses of EBDCs have been requested.

All of the tolerance levels being established in this document, with the exception of almond, are different than the levels requested in the original tolerance petitions. EPA revised the tolerance levels based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's “Guidance for Setting Pesticide Tolerances Based on Field Trial Data.”

Therefore, tolerances are established for residues of mancozeb, zinc manganese ethylenebis dithiocarbamate in or on almond at 0.1 ppm; almond, hulls at 4 ppm; broccoli at 7 ppm; cabbage at 9 ppm; lettuce, head at 3.5 ppm; lettuce, leaf at 18 ppm; and pepper at 12 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determinedthat Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on thoseobjections. 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-2009-0493 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 June 6, 2011.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-2009-0493, by one of the following methods:

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

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

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

In theFederal Registerof August 19, 2009 (74 FR 41898) (FRL-8426-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7550) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709-2014. The petition requested that 40 CFR part 180 be amended by establishing permanent tolerances for residues of the insecticide ethiprole [5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(ethyl)-sulfinyl]-1H-pyrazole-3-carbonitrile], expressed as parent equivalent, in or on cattle, fat at 0.1 parts per million (ppm); cattle, liver at 0.1 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except liver at 0.02 ppm; eggs at 0.05 ppm; goat, fat at 0.1 ppm; goat, liver at 0.1 ppm; goat, meat at 0.01 ppm; goat, meat byproducts, except liver at 0.02 ppm; hog, fat at 0.1 ppm; hog, liver at 0.1 ppm; hog, meat at 0.01 ppm; hog, meat byproducts, except liver at 0.02 ppm; horse, fat at 0.1 ppm; horse, liver at 0.1 ppm; horse, meat at 0.01 ppm; horse, meat byproducts, except liver at 0.02 ppm; milk at 0.01 ppm; poultry, fat at 0.1 ppm; poultry, meat at 0.01 ppm; poultry, meat byproducts at 0.05 ppm; rice, grain at 3.0 ppm; sheep, fat at 0.1 ppm; sheep, liver at 0.1 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts, except liver at 0.02 ppm; and tea, dried at 50 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience LP, 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 a number of the petitioned-for tolerances for ethiprole. 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethiprole, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with ethiprole 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.

Ethiprole has a low acute toxicity via the acute oral, dermal, and inhalation routes of exposure, and is not a skin sensitizer nor a skin or eye irritant. In the mammalian toxicology database, the critical effects of ethiprole are hepatoxicity and thyroid toxicity. The rat was the most sensitive species overall after administration of ethiprole. Evidence of hepatoxicity is seen in the 28-day mouse and rat; 90-day rat and dog; chronic/carcinogenicity rat and mouse; 2-generation rat; developmental rat; and subchronic neurotoxicity rat studies, and was manifested as increased liver weight and hepatocellular hypertrophy. Other indicators of hepatotoxicity include:

1. Increased prothrombin time as observed in the 28- and 90-day rat studies; and

2. Changes in clinical chemistry such as increased alanine transaminase activity, increased alkaline phosphates activity, increased cholesterol, increased triglycerides, and increased total protein concentration.

Liver toxicity was also observed within the mice chronic/carcinogenicity study. A statistically significant increased incidence (12%) of hepatocellular adenoma (HCA) was observed in females at the highest dose tested (HDT), when compared to controls (6/50 vs. 0/50). These benign tumors were only observed in high dose females where a reduced survival rate was also observed. Since no treatment-related HCA were reported at the lower dose levels, the dose-dependent effect could not be established. In addition, no hepatocellular carcinoma was noted in either sex. Given the lack of genotoxicity potential, the absence of carcinoma following a prolonged exposure to ethiprole, and the absence of any dose relationship, this increased incidence of HCA in high dose female mice was, therefore, considered to be due to a threshold mechanism with a probable phenobarbital-like action hepatocellular hypertrophy associatedwith transient liver cell proliferation followed by a steady state.

Thyroid toxicity was also observed in numerous studies throughout the ethiprole database. These studies include the 28- and 90-day rat; chronic/carcinogenicity rat; 2-generation rat; and subchronic neurotoxicity rat studies. The results/observations of the 3 mechanistic studies conducted in rats suggest that ethiprole exerts effect by inducing hepatic microsomal enzymes (e.g.,T4-glucuronyl transferase). This mechanism can lower the circulating levels of thyroid hormones (T4 and T3), resulting in a release from negative feedback inhibition and a compensatory increased secretion of thyroid stimulating hormone (TSH) by the pituitary gland. This negative feedback loop results in increased TSH levels to compensate for the reduced T4 blood levels, since glucuronyl transferase in the liver is conjugating and removing T4 via the bile. The chronic hypersecretion of TSH predisposes the sensitive rodent thyroid gland to develop an increased incidence of focal hyperplasic and neoplasic (adenomas) lesions by a secondary (epigenetic) mechanism. The thyroid toxicity observed in adult rodents was manifested as increased thyroid weight, thyroid follicular hyperthrophy along with higher TSH plasma levels, and reduced T4 (thyroxine) plasma levels. A study that evaluates homeostasis and the developing nervous system in the young is not available.

Based on a battery of mutagenicity studies, ethiprole is not considered to be genotoxic. In accordance with theEPA's Final Guidelines for Carcinogen Risk Assessment(March 2005), ethiprole is classified as “Suggestive Evidence of Carcinogenic Potential.” This classification is based on benign liver tumors in female mice, and benign thyroid tumors in male rats. While the evidence from animal data is suggestive of carcinogenicity, a cancer risk to humans from dietary exposure to ethiprole is of low concern and the cRfD is deemed protective of any potential cancer risk based on the following weight-of-evidence considerations:

1. The liver tumors in mice were benign with no progression to malignancy;

2. The thyroid tumors in rats were also benign (with no progression to malignancy), and the increase in the tumor incidences at the high dose did not reach statistical significance when compared to controls;

3. In both species (mice and rats), tumors were observed only at the HDT (i.e.,there was a lack of evidence of a dose-response relationship);

4. There is no concern for mutagenicity/genotoxicity;

5. The no-observed-adverse-effect-level (NOAEL) of 0.85 milligrams/kilograms/day (mg/kg/day) used for deriving the cRfD is approximately 86-fold lower than the dose (73 mg/kg/day) that induced benign tumors in mice; and

6. The retention of the 10x FQPA SF yields a chronic Population Adjusted Dose (cPAD) that provides even more protection for non-cancer dietary risk (i.e.,the cPAD of 0.003 mg/kg/day is approximately 2,400-fold lower than the dose at which tumors were seen).

Thus, for all these reasons, the Agency has determined that the cPAD will adequately account for all chronic effects, including carcinogenicity, likely to result from exposure to ethiprole.

More detailed information on the studies received and the nature of the adverse effects caused by ethiprole as well as the NOAEL and the LOAEL from the toxicological studies can be found in the document entitled, “Ethiprole: Human Health Risk Assessment for Proposed Uses on Imported Rice and Tea,” dated December 1, 2010, by going tohttp://www.regulations.gov.The referenced document is available in the docket established by this action, which is described underADDRESSES. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2009-0493. Double-click on the document to view the referenced information on pages 13-20 of 60.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) 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 the NOAEL and the lowest-observed-adverse-effect-level (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,see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

The acute and chronic dietary endpoints were not harmonized with Canada's Pesticide Management Regulatory Agency (PMRA) due to policy differences. For both endpoints, PMRA chose the prenatal developmental toxicity study in rabbits as their POD. PMRA considered this endpoint to be protective of all populations, including pregnant women and their fetuses. EPA did not choose the prenatal developmental toxicity study in rabbits for the acute dietary endpoint as the observed increased incidence of abortions in the dams occurred from days 21 to 28 days of gestation, and was not considered to be a single dose (acute) effect since it did not occur within 1 to 2 days of dosing. In addition, EPA did not rely on the prenatal developmental toxicity in rabbits for the chronic dietary assessment since it is not a long-term study. Instead, EPA relied on the combined chronic/carcinogenicity oral (dietary) toxicity rat study in which thyroid and liver toxicity were observed at 3.21 mg/kg/day with a NOAEL of 0.85 mg/kg/day. This chronic rat study is protective of the effects observed in the rabbit developmental study selected by Canada's PMRA. A summary of the toxicological endpoints for ethiprole used for human health risk assessment is shown in the table of this unit.

More detailed information on the toxicological endpoints for ethiprole can be found in the document entitled, “Ethiprole: Human Health Risk Assessment for Proposed Uses on Imported Rice and Tea,” dated December 1, 2010, by going tohttp://www.regulations.gov.The referenced document is available in the docket established by this action, which is described underADDRESSES. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2009-0493. Double-click on the document to view the referenced information on page 21 of 60.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to ethiprole, EPA considered exposure under the petitioned-for tolerances. Acute and chronic dietary (food only) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCIDTM), Version 2.03. The dietary assessments assumed that 100% of crops with the requested uses of ethiprole were treated and that all treated crops contained residues at tolerance-level residues for acute and chronic dietary exposure. In addition, empirical processing factors were assumed for the requested crop uses. EPA assessed dietary exposures from ethiprole 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. An unrefined, acute dietary exposure assessment using tolerance-level residues, empirical processing factors and assuming 100 percent crop treated (PCT) for the proposed commodities was conducted for the general U.S. population and various population subgroups.

ii.Chronic exposure.An unrefined chronic dietary risk analysis was conducted with the DEEM-FCIDTMmodel, assuming tolerance-level residues, empirical processing factors, and 100 PCT.

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. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier non-cancer key event. If carcinogenic mode of action data is 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 determined that the cPAD will adequately account for all chronic effects, including carcinogenicity, likely to result from exposure to ethiprole. No separate exposure assessment pertaining to cancer risk was performed for ethiprole; rather, EPA relied on the chronic exposure assessment described in this Unit for assessing the risk of all chronic effects, including cancer.

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

More detailed information on the acute and chronic dietary (food only)exposure and risk assessment for ethiprole can be found in the document entitled, “Ethiprole: Acute and Chronic Dietary (Food Only) Exposure and Risk Assessment for Proposed Imported Tolerances on Rice and Tea,” dated December 1, 2010, by going tohttp://www.regulations.gov.The referenced document is available in the docket established by this action, which is described underADDRESSES. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2009-0493. Double-click on the document to view the referenced information on pages 6-8 of 12.

2.Dietary exposure from drinking water.Ethiprole and its degradates were not considered for drinking water assessment because ethiprole is not registered for use in the U.S.; therefore, exposure to drinking water is precluded.

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

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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ethiprole and any other substances, and ethiprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has not assumed that ethiprole has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity, and to evaluate the cumulative effects of such chemicals,seethe policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's 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 ten-fold (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 safer for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data are available to EPA to support the choice of a different factor.

2.Prenatal and postnatal sensitivity.Although no teratogenic effects were observed in the existing toxicology database, there is uncertainty regarding the potential impact of ethiprole on thyroid hormone homeostasis in the developing organism. Given the observations that thyroid hormones were affected in several studies throughout the ethiprole database and the critical role thyroid hormones play in the development of the nervous system, the Agency is requiring a developmental thyroid toxicity study to assess for more subtle effects that may not be identified in the available core guideline studies.

3.Conclusion.Based on the hazard and exposure data, the Agency is retaining the 10x FQPA SF due to the lack of a developmental thyroid toxicity study in rats. As described previously, hormonal changes (decreased T4 plasma levels, increased TSH plasma levels and alteration in thyroid weights) were observed in several studies following oral administration of ethiprole. Therefore, there is concern that perturbation of thyroid homeostasis may lead to hypothyroidism, and possibly result in adverse effects on the developing nervous system. Since the developmental and reproductive studies do not assess the thyroid in the developing animals, EPA has required that a developmental thyroid assay be conducted to evaluate the impact of ethiprole on thyroid hormones, structure and/or thyroid hormone homeostasis during development. EPA's determination on the FQPA SF is based on the following:

i. The toxicological database for ethiprole is complete with the exception of a developmental thyroid toxicity study in juvenile rats, which is needed to address potential prenatal and perinatal thyroid toxicity. Thyroid toxicity was noted throughout the toxicological database; however, the thyroid toxicity was assessed in adult animals only.

ii. In mammals, no neurotoxic effects were observed during the subchronic neurotoxicity study in which adverse effects of increased thyroid and liver weights were observed at 7.2/33 mg/kg/day (LOAEL) in males and females, respectively. The acute neurotoxicity study yielded a LOAEL of 250 mg/kg/day for decreased locomotor activity (both sexes, day 1) and FOB findings in both sexes on the day of treatment (4 hours after dosing). The FOB findings include increased tremors (females), decreased grooming (both sexes), decreased arousal alert (females), increased number of animals for which no assessment of gait was possible (females), increased eye closure (females), increased standing/sitting hunched (females), decreased activity and rearing counts (females), increased hindlimb and forelimb grip strength (males), decreased forelimb grip strength (day 8) (females), decreased splay (females, day 1), and increased splay (males, day 8). The similarity in the NOAELs from the acute neurotoxicity and subchronic neurotoxicity studies are consistent with the metabolism data that suggests that ethiprole is not accumulated in the system.

A developmental neurotoxicity (DNT) study is not required for ethiprole. In view of the fact that thyroid toxicity appears to be the most sensitive endpoint, and thyroid hormones play a critical role in the development of the nervous system, the Agency is requiring the developmental thyroid toxicity study in lieu of the DNT.

iii. There is no evidence that ethiprole 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 in the exposure database for ethiprole. Since the dietary exposure estimates were based on several conservative assumptions, the Agency does not believe that the exposure estimates are underestimated.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. For linear cancer risks, EPA calculates thelifetime 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. For this action, there is potential exposure to ethiprole from food only.

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for dietary and non-dietary acute exposures, EPA has concluded that acute exposure to ethiprole from food only will utilize 4% of the aPAD for the general U.S. population and 14% of the aPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for ethiprole. Based on the explanation in Unit III.C.3., regarding residential use patterns, acute residential exposure to residues of ethiprole is not expected.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ethiprole from food only will utilize 22% of the cPAD for the general U.S. population and 42% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for ethiprole. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of ethiprole is not expected.

3.Aggregate cancer risk for U.S. population.Based on the data summarized and referenced in Unit III.A., EPA has concluded that the cRfD/cPAD for ethiprole is protective of the cancer effects. As noted in this Unit, the chronic exposure for the general U.S. population utilizes 22% of the cPAD.

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

The submitted data are adequate to satisfy residue analytical methods data requirements for tolerance enforcement purposes. The proposed High Performance Liquid Chromatography/Multistage Mass Spectrometer (HPLC/MS-MS) enforcement method, Method 01128, is acceptable for determination of residues of ethiprole and its sulfone metabolite RPA097973 for data collection in plant commodities. The proposed Gas Chromatograph-Electron Capture Device (GC-ECD) method (Report No. B003572) is suitable for determining residues of parent ethiprole and its sulfone metabolite RPA097973 in milk, eggs and tissues. The FDA multiresidue method testing study for ethiprole and its sulfone metabolite RPA097973 is adequate and indicates that PAM multiresidue methods are not suitable for enforcing maximum residue limits (MRLs) due to the thermolability of ethiprole.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov.

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 MRLs established by the Codex Alimentarius Commission (Codex), as required by section 408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. 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, section 408(b)(4) of FFDCA requires that EPA explain the reasons for departing from the Codex level.

There are currently no MRLs established by Codex for ethiprole. The tolerances established in this rule are identical to those being established in Canada.

There are currently no U.S. tolerances or MRLs in Canada for ethiprole and no uses for ethiprole are currently being proposed in the U.S. or Canada. As part of PP 9E7550, Bayer CropScience LP proposed harmonized tolerances/MRLs for ethiprole residues to allow for the importation of ethiprole-treated rice (3.0 ppm) and tea (50 ppm) into the U.S. and Canada. In addition, Bayer CropScience LP proposed tolerances for the combined residues of the insecticide ethiprole in or on various livestock commodities.

Adequate residue data are available from the rice field trials conducted in China, India and Thailand reflecting the critical use pattern for ethiprole on imported rice. The Agency'sGuidance for Setting Pesticide Tolerances Based on Field Trial Datawas utilized for determining appropriate tolerance level for ethiprole residues in or on rice, grain. EPA has determined that these residue data indicate that the tolerance in or on rice, grain should be set at 1.7 ppm.

Adequate residue data are available from the tea field trials conducted in China reflecting the critical use pattern for ethiprole on imported tea. These residue data show that the highest average residues on plucked fresh tea leaves will be 11 ppm. Taking into account data from the tea processing study that shows that combined ethiprole residues concentrate by up to 2.53x in dried tea (green and black), EPA determined that a tolerance of 30 ppm for dried tea would be appropriate.

EPA and PMRA are recommending the same tolerance values for rice and tea. In addition, EPA and PMRA are not establishing tolerances on livestock commodities since ethiprole is not registered in the U.S., and feedstuffs derived from rice are unlikely to be imported into the U.S. and Canada and fed to livestock. Further, based upon review of the available residue data supporting PP 9E7550, EPA has determined that the residue of concern in plant commodities (rice and tea) for both tolerance expression and risk assessment is only ethiprole.

Therefore, permanent tolerances (without U.S. registrations) are being established for residues of the insecticide ethiprole, including its metabolites and degradate, in or on the imported plant commodities listed in this Unit. Compliance with the tolerance levels specified in this Unit is to be determined by measuring only ethiprole [5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(ethyl)-sulfinyl]-1H-pyrazole-3-carbonitrile], in or on the following imported plant commodities: Rice, grain at 1.7 ppm; and tea, dried at 30 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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 isnot subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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:

EPA is publishing this rule as a direct final rule because we view this action as a noncontroversial action and anticipate no adverse comment. Based on the information and data submitted by the petitioner for this site-specific treatment variance and the oversight being provided by the regulatory authorities in the states of Nevada and California, we do not believe that there will be adverse comments on this action. However, in the “Proposed Rules” section of today'sFederal Register, we are publishing a separate document that will serve as a proposed rule should EPA receive adverse comments. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule,seetheADDRESSESsection of this document.

If EPA receives adverse comment, we will publish a timely withdrawal in theFederal Registerinforming the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

If we do not receive adverse comment, the rule will take effect on June 6, 2011. Section 3010(b) of RCRA states that rules implementing subtitle C of RCRA normally take effect six months after promulgation, but that EPA may provide for a shorter effective date for rules with which the regulated community does not need six months to come into compliance. This is such a rule, as the Owens-Brockway Glass Container Company should be able to transport the waste to USEN for treatment and disposal in a much shorter period of time.

This action applies only to U.S. Ecology Nevada located in Beatty, Nevada and to Chemical Waste Management, Inc. located in Kettleman Hills, California.

Under sections 3004(d) through (g) of the Resource Conservation and Recovery Act (RCRA), the land disposal of hazardous wastes is prohibited unless such wastes are able to meet the treatment standards established by EPA. Under section 3004(m) of RCRA, EPA is required to set “levels or methods of treatment, if any, which substantially diminish the toxicity of the waste or substantially reduce the likelihood of migration of hazardous constituents from the waste so that short-term and long-term threats to human health and the environment are minimized.” EPAinterprets this language to authorize treatment standards based on the performance of the best demonstrated available technology (BDAT). This interpretation was upheld by the DC Circuit inHazardous Waste Treatment Councilv.EPA,886 F. 2d 355 (D.C. Cir. 1989).

The Agency recognizes however, that there may be wastes that cannot be treated to the levels specified in the regulations (see40 CFR 268.40) because an individual waste matrix or concentration can be substantially more difficult to treat than those wastes evaluated in establishing the treatment standard (51 FR 40576, November 7, 1986). For such wastes, EPA has a process by which a generator or treater may seek a treatment variance (see40 CFR 268.44). If granted, the terms of the variance establish an alternative treatment standard for the particular waste at issue.

Treatment of selenium poses special difficulties. In particular, it can be technically challenging to treat wastes containing selenium and other metals e.g., cadmium, lead and/or chromium because of their different chemical properties and solubility curves (62 FR 26041, May 12, 1997).

The current treatment standard for a waste exhibiting the toxicity characteristic for selenium (RCRA Hazardous Waste D010) is based upon the performance of stabilization on low concentration selenium wastes. When the Agency developed the treatment standard for selenium, EPA believed that wastes containing high concentrations of selenium were rarely generated and land disposed (59 FR 47980, September 19, 1994). The Agency also stated that it believed that, for most wastes containing high concentrations of selenium, recovery of the selenium would be feasible using recovery technologies currently employed by copper smelters and copper refining operations (Id.). The Agency further stated in 1994, that it did not have any performance data for selenium recovery, but available information indicated that some recovery of elemental selenium out of certain types of scrap material and other wastes was practiced in the United States.1

In 1994, the Agency used performance data from the stabilization of a mineral processing waste that was characteristically hazardous (RCRA Hazardous Waste D010) to set the national treatment standard for selenium. At that time, we determined that this was the most difficult to treat selenium waste. This untreated waste contained up to 700 ppm total selenium and 3.74 mg/L selenium as measured by the Toxicity Characteristic Leaching Procedure (TCLP). The resulting post-treatment levels of selenium in the TCLP leachate were between 0.154 mg/L and 1.80 mg/L, which (after considering the range of treatment process variability) led to EPA establishing a national treatment standard of 5.7 mg/L for D010 selenium nonwastewaters.2 This D010 mineral processing waste also contained other toxic metals (i.e., arsenic, cadmium, and lead) above the characteristic levels. The treatment technology used to establish the selenium levels also resulted in meeting the Land Disposal Restrictions (LDR) treatment standards for these non-selenium metals. The waste to reagent ratios varied from 1:1.3 to 1:2.7 (62 FR 26041).

Thus, in the Phase IV final rule, the Agency determined that a treatment standard of 5.7 mg/L, as measured by the TCLP, continued to be appropriate for D010 nonwastewaters (63 FR 28556, May 26, 1998). The Agency also changed the universal treatment standard (UTS) for selenium nonwastewaters from 0.16 mg/L to 5.7 mg/L TCLP.

On May 26, 1999 (64 FR 28387), EPA granted Chemical Waste Management, Inc. (CWM) in Kettleman Hills, California a site-specific treatment variance from the LDR treatment standards for hazardous selenium-bearing waste generated by the Owens- Brockway Glass Container Company (Owens-Brockway) at their Vernon, California manufacturing facility. Under 40 CFR 268.44(o), CWM was allowed to treat the waste to an alternative treatment standard for selenium of 51 mg/L TCLP with a waste to reagent ratio of 1 to 2.7. Total selenium concentrations in the electrostatic precipitator (ESP) dust generated at the Owens-Brockway facility range from 2,400 mg/kg to 5,700 mg/kg. The untreated waste has a leachable selenium concentration ranging from 228 mg/L to 440 mg/L TCLP. In addition, the untreated waste has a leachable arsenic concentration ranging from 3.3 mg/L to 8.6 mg/L TCLP, a leachable cadmium concentration ranging from 3.9 mg/L to 11.0 mg/L TCLP, and a leachable lead concentration ranging from <0.10 mg/L to 16.3 mg/L TCLP. (For a more detailed discussion of EPA's basis for granting the site-specific treatment variance to CWM,see64 FR 28387, May 26, 1999.)

Under 40 CFR 268.44, facilities can apply for a site-specific treatment variance in cases where a waste that is generated under conditions specific to only one site cannot be treated to the specified LDR treatment standards. In such cases, the generator(s) or the treatment facility may apply to the Administrator, or to EPA's designated representative, (in this case the Assistant Administrator for Solid Waste and Emergency Response) for a site-specific variance from a treatment standard. The applicant for a site-specific variance must demonstrate that, because the physical or chemical properties of the waste differ significantly from the waste analyzed in developing the treatment standard, the waste cannot be treated to the specified levels or by the specified methods. There are other grounds for obtaining variances, but this is the only provision relevant to this action.

On September 16, 2008, U.S. Ecology Nevada (USEN) submitted a petition requesting a site-specific treatment variance from the LDR treatment standards for hazardous selenium-bearing waste generated by Owens-Brockway at their Vernon, California manufacturing facility. USEN requested an alternative treatment standard of 59 mg/L as measured by the TCLP for the selenium contained in the waste. This alternative treatment standard was achieved with a waste to reagent ratio of 1 to 0.45, using 20% ferrous sulfate,15% quick lime and 10% sodium sulfide flakes.3

Owens-Brockway operates a glass manufacturing facility that ESP dust. The ESP dust is generated by the glass furnace air emissions control system and is hazardous due to its high concentrations of leachable arsenic, cadmium, lead, and selenium. The corresponding EPA hazardous waste codes are D004, D006, D008, and D010, respectively. The waste generated by Owens-Brockway does not meet the LDR treatment standards and requires treatment prior to land disposal. As discussed previously, the physical properties and the chemical composition of the ESP dust generated by Owens-Brockway are considerably different from the waste used to establish the current LDR treatment standard for selenium. The Agency set the national treatment standard for nonwastewaters using performance data from the stabilization of a characteristically hazardous mineral processing waste, which the Agency determined at the time to be the most difficult to treat selenium waste.4

According to the petition submitted by USEN, the quantity of ESP dust shipped off-site for management as a hazardous waste ranges from 50 to 100 tons per year.5 The ESP dust, as generated, contains fine particle matter resulting from the combustion of natural gas and particulate matter generated by the dry scrubber used to control SOXemissions. The material is normally returned to the process as a substitute raw material; however, there are circumstances when it cannot be used again due to the high levels of hazardous contaminants, its physical state or excess quantity. In these situations, the ESP dust is managed as a RCRA hazardous waste.

USEN will stabilize the Owens-Brockway ESP dust using a combination of reagents and techniques. These reagents include ferrous sulfate (FeSO4), quick lime (CaO), and sodium sulfide (Na2S). USEN typically uses a combination of hydroxide and sulfide precipitation to treat high concentration wastes. Most often, an alkaline reagent (quick lime) is used to raise the solution pH to lower the solubility of the metal constituents and start the precipitation process.

As noted previously, (see64 FR 28387, May 26, 1999), EPA concluded that it is difficult, if not impossible, to optimize the treatment for selenium when other metals are being treated, because the selenium solubility curve differs from that of most other metals. Thus, successfully stabilizing other metals generally means that treatment for selenium cannot be optimized. As further pointed out in the petition submitted by USEN, selenium's minimum solubility is in the range of 6.5 to 7.5, while other characteristic metals have a minimum solubility in the pH range of 8 to 12. In simple terms, if you maximize the stabilization treatment recipe to treat arsenic, cadmium, and lead, the selenium becomes soluble and will not meet the treatment standard (i.e., fail the TCLP). If you maximize the recipe to treat selenium, the other metals will not meet the treatment standard.

USEN has been unsuccessful in developing a treatment recipe that can achieve all the LDR treatment standards applicable to this waste (e.g., arsenic, chromium, lead, and selenium). USEN tested and submitted performance data on 135 treatment recipes on five different ESP dust samples using a combination of reagents and concentrations of reagents. USEN was unable to achieve the LDR treatment standard of 5.7 mg/L selenium using any of the 135 treatment recipes. The average post treatment selenium TCLP value achieved was 47 mg/L TCLP, which is approximately a 90% reduction in soluble selenium. The treatment to an average of 47 mg/L TCLP was the result of a recipe with a waste to reagent ratio of 1:0.45. With a variability factor applied to the average TCLP selenium value, the final treatment standard would be 59 mg/L TCLP.6

With the data and information provided to the Agency as part of their site-specific treatment variance petition, EPA was able to perform an analysis which shows that the USEN treatment process would generate a lower volume of waste material, post treatment, coupled with a lower potential for selenium being released to the environment. Mass balance calculations performed by the Agency indicated that the treatment conducted by USEN has the potential to release between 3.88 to 7.76 kilograms (8.54 to 17.1 pounds) of selenium per year to the environment. This range is a result of Owens-Brockway generating between 50 and 100 tons of waste annually. (As we discuss in the next section, CWM, even with a lower alternative treatment standard, has the potential to release greater amounts of selenium per year to the environment. This is due to the higher waste to reagent ratio used to stabilize the waste material.7 ) As such, the Agency has determined that USEN has optimized its stabilization recipe by reducing the amount of selenium potentially released to the environment and minimizing the amount of reagent that must be used to achieve this result.

EPA has reviewed USEN's petition for a site-specific treatment variance from the LDR treatment standards for hazardous selenium-bearing waste generated by Owens-Brockway and is granting a variance from the selenium treatment standard from 5.7 mg/L TCLP to an alternative treatment standard of 59 mg/L TCLP, with the condition that USEN does not exceed a waste to reagent ratio of 1:0.45. Concurrently, EPA is withdrawing the site-specific variance granted to CWM that established an alternative treatment standard of 51 mg/L TCLP for this same waste (69 FR 6567, February 11, 2004).

EPA has determined that USEN, despite having a higher selenium treatment standard based on selenium concentration, does, in fact, have the potential to release less selenium in a land disposal environment by utilizing a much more environmentally favorable waste to reagent ratio. As such, the Agency believes that the treatment performed by USEN is the best treatment available for this waste. CWM uses a waste to reagent ratio of 1:2.7, while USEN uses a waste to reagent ration of 1:0.45. Consequently, the Agency has determined that a treatment standard of 59 mg/L TCLP for this selenium-bearing waste is more protective of human health and the environment, due to the fact that it generates a lower volume of waste material, with a much lower leaching potential. In particular, the treatment process employed by CWM has the potential to release between 8.56 to 17.11 kilograms (18.8 to 37.69 pounds) of selenium per year to the environment, whereas USEN has the potential to release 3.88 to 7.76 kilograms (8.54 to 17.1 pounds) of selenium per year to the environment. Furthermore, utilizing the waste to reagent ratio of 1:2.7 would dispose of between 185 and 370 tons of waste to land disposal per year, whereas utilizing the waste to reagent ratio of 1:0.45 would dispose of only 72.5 to 145 tons of waste to land disposal per year.

Based on the foregoing, the Agency is granting USEN's petition for a site-specific treatment variance for the ESP dust generated at the Owens-Brockway glass manufacturing plant in Vernon, California. We are also withdrawing the portion of CWM's site-specific treatment variance that pertains to its management of the Owens-Brockway waste, i.e., 51 mg/L TCLP for selenium-bearing D010 waste.

Technology-based treatment standards, whether adopted by generally applicable rule or through a variance to the generally applicable rule, serve as the measure of when threats posed by land disposal of the hazardous waste are “minimized,” as required by RCRA section 3004(m).See55 FR 6640 (February 26, 1990). Thus, EPA has typically limited the standards adopted by a variance to a single standard.See70 FR 44505 (August 3, 2005). We are continuing this practice here by rescinding the current variance granted to CWM (69 FR 6567, February 11, 2004). The Agency has determined that the existing treatment standard is less stringent than the standard we would now be granting, both with respect to potential concentrations of selenium released to the environment and also the waste to reagent ratios. Under these circumstances, EPA believes that threats posed by land disposal are minimized by use of the treatment process utilized by USEN.

Please note that the waste already disposed of pursuant to the standard established in the original treatment variance granted to CWM would be lawfully disposed, and would not have to be retreated if the standard in the variance were altered or lapsed. This variance results in amending 40 CFR 268.44(o) to allow hazardous selenium-bearing waste generated by Owens-Brockway in Vernon, California, with the RCRA hazardous waste identification code of D010, to be treated to an alternate treatment standard of 59 mg/L TCLP by USEN with the condition that the waste to reagent ratio not exceed 1:0.45.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.

This action does not impose any new information collection burden. This action does two things: (1) Grants a site-specific treatment variance to USEN for the treatment of hazardous selenium-bearing waste under RCRA's LDR program; and (2) withdraws an existing site-specific treatment variance to CWM. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations at 40 CFR 268.42 and .44 under the provisions of thePaperwork Reduction Act,44 U.S.C. 3501et seq.and has assigned OMB control number 2050-0085. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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

This site-specific treatment variance does not create any new requirements. Rather, it establishes an alternative treatment standard for a specific waste that applies to only one facility, USEN located in Beatty, Nevada and withdraws an existing site-specific treatment variance for the same waste at CWM located in Kettleman Hills, California. Therefore, we hereby certify that this rule will not add any new regulatory requirements to small entities. This rule, therefore, does not require a regulatory flexibility analysis.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. This action imposes no enforceable duty on any State, local or tribal governments or the private sector. This action would not impose any new duties on the State's hazardous waste program. EPA has determined, therefore, that this rule would not contain regulatory requirements that might significantly or uniquely affect small governments in that the authority for this action exists with the Federal government. Therefore, this action is not subject to the requirements of sections 202 or 205 of the UMRA.

This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.

This action does not have federalism implications. 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. This action does two things: (1) Grants a site-specific treatment variance applicable to one facility, and (2) withdraws a site-specific treatment variance for that same waste at another facility. Thus, Executive Order 13132 would not apply to this action.

States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because ofchanges to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273, and 279.

We conclude that Oklahoma's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Oklahoma Final authorization to operate its hazardous waste program with the changes described in the authorization application. Oklahoma has responsibility for permitting treatment, storage, and disposal facilities within its borders. Also section 10211(a) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Statute 1144 (August 10, 2005) provides the State of Oklahoma opportunity to request approval from EPA to administer RCRA subtitle C in Indian Country and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Oklahoma including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in Oklahoma subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Oklahoma has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

• Do inspections, and require monitoring, tests, analyses, or reports;

• enforce RCRA requirements and suspend or revoke permits; and

• take enforcement actions after notice to and consultation with the State.

This action does not impose additional requirements on the regulated community because the regulations for which Oklahoma is being authorized by today's action is already effective under State law, and are not changed by today's action.

The EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today'sFederal Registerwe are publishing a separate document that proposes to authorize the State program changes.

If the EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in theFederal Registerbefore the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified in this document. TheFederal Registerwithdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Oklahoma initially received final Authorization on January 10, 1985 (49 FR 50362-50363) published December 27, 1984 to implement its base hazardous waste management program. We authorized the following revisions: Oklahoma received authorization for revisions to its program with publication dates: April 17, 1990 (55 FR 14280-14282), effective June 18, 1990; September 26, 1990 (55 FR 39274) effective November 27, 1990; April 2, 1991 (56 FR 13411-13413) effective June 3, 1991; September 20, 1991 (56 FR 47675-47677) effective November 19, 1991; September 29, 1993 (58 FR 50854-50856) effective November 29, 1993; October 12, 1993 (58 FR 52679-52682) effective December 13, 1993; October 7, 1994 (59 FR 51116-51122) effective December 21, 1994; January 11, 1995 (60 FR 2699-2702) effective April 27, 1995; October 9, 1996 (61 FR 52884-52886) effective December 23, 1996; Technical Correction March 14, 1997 (62 FR 12100-12101) effective March 14, 1997; September 22, 1998 (63 FR 50528-50531) effective November 23, 1998; March 29, 2000 (65 FR 16528-16532) effective May 30, 2000; May 10, 2000 (65 FR 29981-29985) effective June 10, 2000; January 2, 2001 (66 FR 28-33) effective March 5, 2001; April 9, 2003 (68 FR 17308-17311) effective June 9, 2003 and February 4, 2009 (74 FR 5994-6001). The authorized Oklahoma RCRA program was incorporated by reference into the CFR published on December 9, 1998 (63 FR 67800-67834) effective February 8, 1999, August 26, 1999 (64 FR 46567-46571) effective October 25, 1999, August 27, 2003 (68 FR 51488-51492) effective October 27, 2003 and August 27, 2010 (75 FR 36546) June 28, 2010. On March 26, 2010, and January 18, 2011, Oklahoma submitted a final complete program revision application seeking authorization of its program revision in accordance with 40 CFR 271.21.

The Oklahoma Hazardous Waste Management Act (“OHWMA”) provides the ODEQ with the authority to administer the State Program, including the statutory and regulatory provisions necessary to administer the provisions of RCRA Cluster XVIII, and designates the ODEQ as the State agency to cooperate and share information with EPA for purpose of hazardous waste regulation. The Oklahoma Environmental Quality Code (“Code”), at 27A O.S. Sections establishes an EQB to be the rulemaking body for the DEQ, specifically charged with the responsibility of promulgating rules to implement the duties and responsibilities of the DEQ. The EQB consists of 13 members appointed by the Governor with the advice and consent of the State senate. The Code, 27A O.S. Section 2-2-201, also establishes a Hazardous Waste Management Advisory Council (“Council”) with the authority to recommend rules to the Board on behalf of the ODEQ.

The Environmental Quality Act, at 27A O.S. Section 1-3-101(E), grants the Oklahoma Corporation Commission (“OCC”) authority to regulate certain aspects of the oil and gas production and transportation industry in Oklahoma, including certain wastes generated by pipelines, bulk fuel sales terminals and certain tank farms, as well as underground storage tanks. To clarify areas of environmental jurisdiction, theODEQ and OCC developed an ODEQ/OCC Jurisdictional Guidance Document to identify respective areas of jurisdiction. The current ODEQ/OCC jurisdictional Guidance Document was amended and signed on January 27, 1999. The revisions to the State Program necessary to administer Cluster XVIII and Checklist 220 in RCRA Cluster XIX will not affect the jurisdictional authorities of the ODEQ or OCC.

The Board adopted RCRA Cluster XVIII amendments on November 18, 2008 and became effective on July 1, 2009 and also adopted RCRA Cluster XIX which is part of Checklist 220 on March 24, 2010 with an effective date July 11, 2010. The rules were also codified at OAC 252:205 et seq, Subchapter.

Pursuant to OAC 252:205-3-2, the State's incorporation of Federal regulations does not incorporate prospectively future changes to the incorporated sections of the 40 CFR, and no other Oklahoma law or regulation reduces the scope of coverage or otherwise affects the authority provided by these incorporated-by-reference provisions. Further, Oklahoma interprets these incorporated provisions to provide identical authority to the Federal provisions. Thus, OAC Title 252, Chapter 205 provides equivalent and no less stringent authority than the Federal Subtitle C program in effect July 1, 2009 and July 11, 2010. The State of Oklahoma incorporate by reference the provisions of 40 Code of Federal Regulations (CFR) parts 124 of 40 CFR that are required by 40 CFR 271.14 (with the addition of 40 CFR 124.19(a) through (c), 124.19(e), 124.31, 124.32, 124.33 and Subpart G); 40 CFR parts 260-268 [with the exception of 260.21, 261.(b)(18), 262 subparts E and H, 264.1(f), 264.1(g)(12), 264.149, 264.150, 264.301(1), 264.1030(d), 264.1050(g), 264.1080(e), 264.1080(f), 264.1080(g), 265.1(c)(4), 265.1(g)12), 265.149, 265.150, 265.1030(c), 265.1050(f) 265.1080(e), 265.1080(f), 265.1080(g), 268.5, 268.6, 268.13, 268.42(b), and 268.44(a) through (g)]; 40 CFR part 270 [with the exception of 270.1(c)(2)(ix and 270.14(b)(18)]; 40 CFR part 273; and 40 CFR part 279.

The OHWMA provides the DEQ with the authority to administer the State Program, including the statutory and regulatory provisions necessary to administer the provisions of RCRA Cluster XVIII and Checklist 220 in RCRA Cluster XIX, designates the DEQ as the State agency to cooperate and share information with the EPA for the purpose of hazardous waste regulation.

Pursuant to 27A O.S. Section 2-7-104, the Executive Director has created the Land Protection Division (“LPD”) to be responsible for implementing the State Program. The LPD is staffed with personnel that have the technical background and expertise to effectively implement the provisions of the State program subtitle C Hazardous Waste Management program.

On March 26, 2010, and January 11, 2011, the State of Oklahoma submitted final complete program applications, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of written comments that oppose this action that the State of Oklahoma's hazardous waste program revision satisfies all of the requirements necessary to qualify for final authorization. The State of Oklahoma revisions consist of regulations which specifically govern Federal Hazardous Waste revisions promulgated from July 1, 2007 through December 31, 2008 (RCRA Cluster XVIII and Checklist 220 in RCRA Cluster XIX). Oklahoma requirements are included in a chart with this document.

The only clarification in this FR notice is at OAC 252:205-3-2(c)(3) states “in 261.31(a) the listing for F019, at the end: “Zinc phosphate sludges meeting exemption conditions remain subject to regulations as hazardous waste characteristic” This statement is consistent with EPA's interpretation of its rule and was added by way of clarification.

Oklahoma will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue toadminister any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Oklahoma is not yet authorized.

The State of Oklahoma Hazardous Program is not being authorized to operate in Indian Country.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart LL for this authorization of Oklahoma's program changes until a later date. In this authorization application the EPA is not codifying the rules documented in thisFederal Registernotice.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. The reference to Executive Order 13563 (76 FR 3821, January 21, 2011) is also exempt from review under Executive orders 12866 (56 FR 51735, October 4, 1993). This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on 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.

Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.). 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. The EPA will submit a report containing this document 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 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). This action will be effective June 6, 2011.

Inspection of Public Comments:All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:http://regulations.gov.Follow the search instructions on that Web site to view public comments.

Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

On August 12, 2010, we published a final rule (75 FR 49030 through 49214) in theFederal Register, entitled “Medicare Program; End-Stage Renal Disease Prospective Payment System”, hereinafter, referred to as the CY 2011 ESRD PPS final rule. In the CY 2011 ESRD PPS final rule, we implemented a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis services furnished beginning January 1, 2011, in accordance with the statutory provisions set forth in section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

Section 1881(b)(14) of the Social Security Act (the Act) requires a case-mix adjusted bundled ESRD PPS for renal dialysis services furnished by ESRD facilities beginning January 1, 2011, which replaces the basic case-mix adjusted composite payment system. Section 1881(b)(14)(E)(i) of the Act requires the Secretary to provide a “four-year phase-in” of the payments under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011. For the purposes of this interim final rule with comment, the term “transition” will be used to describe the timeframe during which payments are based on the blend of the payment rates under the basic case-mix adjusted composite payment system and the ESRD PPS. Section 1881 (b)(14)(E)(ii) of the Act permits an ESRD facility to make a one-time election prior to January 1, 2011, in a form and manner specified by the Secretary of the Department of Health and Human Services (the Secretary), to be excluded from the transition and be paid entirely based on the payment amount under the ESRD PPS.

As specified in regulations at 42 CFR 413.239(b)(1), ESRD facilities were required to notify their fiscal intermediary or Medicare administrative contractor (FI/MAC) of their election choice to either be included or excluded from the 4-year transition period in a manner established by the FI/MAC no later than November 1, 2010. In addition, § 413.239(b)(1) provides that once a decision is made, the election to be excluded from the 4-year transition cannot be rescinded. As required under § 413.239(b)(3), ESRD facilities that became certified for Medicare participation and began to furnish dialysis services on November 1, 2010 through December 31, 2010, must have notified their FI/MAC of their election decision at the time of enrollment. For ESRD facilities that failed to make an election by November 1, 2010, § 413.239(b)(2) requires that payment be based on the blended payment during the transition. Further, under § 413.239(c), ESRD facilities that are certified for Medicare participation and begin furnishing renal or home dialysis services on or after January 1, 2011, are paid under the ESRD PPS.

Section 1881(b)(14)(E)(iii) of the Act requires that we make an adjustment to payments for renal dialysis services provided by ESRD facilities during the transition so that the estimated total amount of payments under the ESRD PPS, including payments under the transition, equal the estimated total amount of payments that would otherwise occur under the ESRD PPS without a transition. We refer to this provision as the transition budget-neutrality adjustment. As described in the CY 2011 ESRD PPS final rule (75 FR49082), the transition budget-neutrality adjustment is comprised of two parts. The first part created a payment adjustment under the basic case-mix adjusted composite payment system portion of the blended rate during the transition. The second part created a factor that would make the estimated total amount of payments under the ESRD PPS, including payments under the transition, equal the estimated total amount of payments that would otherwise occur without such a transition. In this interim final rule with comment, we are addressing the second part of the transition budget-neutrality adjustment finalized in the CY 2011 ESRD PPS final rule.

In the CY 2011 ESRD PPS final rule (75 FR 49082), we explained that section 1881(b)(14)(E)(iii) of the Act requires that we make an adjustment to payments for renal dialysis services furnished by the ESRD facilities during the transition so that the estimated total amount of payments under the ESRD PPS, including payments under the transition, equals the estimated total amount of payments that would otherwise occur under the ESRD PPS without such a transition. In calculating the transition budget-neutrality adjustment, we first determined the estimated increases in payments under the transition and then determined an offset factor, based on certain assumptions of which facilities would choose to opt out of the transition (74 FR 49946). We explained that using estimates of simulated payments under the basic case-mix adjusted composite payment and under the ESRD PPS by facility, we estimated that 43 percent of the 4,951 ESRD facilities would choose to be excluded from the transition and that 57 percent of those ESRD facilities would choose to be paid the blended rate during the transition. As a result, we estimated that during the first year of the transition, total payments would exceed the estimated payments under the ESRD PPS in the absence of the transition (75 FR 49083).

In order to maintain the 98 percent budget-neutrality requirement in section 1881 (b)(14)(A)(ii) of the Act during the initial year of the transition period, we finalized the reduction of all payments to ESRD facilities in CY 2011 by a factor that is equal to 1 minus the ratio of estimated payments under the ESRD PPS if there were no transition, to the total estimated payments under the transition, or 3.1 percent. This approach resulted in a 3.1 percent reduction in all payments to ESRD facilities (that is, the 3.1 percent adjustment would be applied to both the blended payments made under the transition and payments made 100 percent under the ESRD PPS). We stated that we believed that because the application of the 3.1 percent reduction to all payments would evenly distribute the effect of the transition adjustment, it would not have affected the decision of ESRD facilities when choosing whether or not to opt out of the transition.

In the CY 2011 ESRD PPS final rule (75 FR 49082 through 49083), we acknowledged that the transition budget-neutrality adjustment may not reflect the actual choices made by the ESRD facilities regarding whether or not to opt out of the ESRD PPS transition. We also indicated that we were not able to wait until November 1, 2010, when ESRD facilities were to notify their respective FI/MACs, to establish the transition budget-neutrality adjustment. We explained that we based the final budget-neutrality adjustment on our best projections of how ESRD facilities would fare under the ESRD PPS compared to the basic case-mix adjusted composite payment system. We stated that we believed that ESRD facilities would choose to be excluded from the blended payment if payment under the ESRD PPS provided financial benefits. We also indicated that the transition budget-neutrality adjustment would be updated each year of the transition to reflect the appropriate blend of the PPS and composite rate payments. Finally, we noted that given that the transition budget-neutrality adjustment applies in each transition year, we would consider whether we would prospectively correct for an over or understatement of the number of facilities that chose to opt out of the transition when we updated the adjustment for CY 2012.

The simulation (resulting in the 3.1 percent reduction) was based on determining which payment approach (that is, blended payments or 100 percent ESRD PPS payments) would financially benefit an ESRD facility. However, based upon analysis of the elections submitted by ESRD facilities, we found that the decision to receive payment under the blend or under the ESRD PPS did not appear to be based solely on which payment approach would be more financially advantageous. Rather than 43 percent of ESRD facilities electing to receive 100 percent payment under the ESRD PPS as was determined by simulating 2007 payments, 87 percent of ESRD facilities elected to opt out of the transition and elected to receive full payment under the ESRD PPS. We received elections from 5,645 ESRD facilities. Of the 5,645 elections received, 5,068 (or 90 percent) opted to receive payment under the ESRD PPS. We matched the 5,645 elections received in 2010 from ESRD facilities to the 4,951 facilities in 2007 that were used in the simulation. Of the 4,951 facilities, we received terminations for three facilities and therefore, we removed those three facilities from our computation. In addition, we did not receive an election for 210 facilities. As § 413.239(b)(2) requires that payment be made under the blend during the transition for facilities that fail to make an election by November 1, 2010, we considered the 210 facilities to have elected the transition. Therefore, after matching the 5,645 elections to the 4,951 facilities in 2007 (including 3 terminations and 210 assumptions), we determined that 4,324 of the 4,951 ESRD facilities in 2007 (or 87 percent) elected to receive payment under the ESRD PPS for CY 2011.

In this interim final rule with comment, we are revising the ESRD transition budget-neutrality adjustment finalized in the CY 2011 ESRD PPS final rule (75 FR 49030 through 49214). We believe that this updated adjustment better reflects the actual elections made by ESRD facilities with regard to the transition because there is a significant difference between the projected and the actual number of ESRD facilities that elected to receive full payment under the ESRD PPS.

Subsequent to the publication of the CY 2011 ESRD PPS final rule, we received numerous comments from stakeholders including ESRD facilities and major ESRD associations requesting that we not defer reconciling any discrepancies between the estimated simulated election decisions with the actual decisions made by ESRD facilities. These stakeholders cited many negative outcomes that would result from a 3.1 percent transition budget-neutrality adjustment reduction, including limiting or reducing renal dialysis services which would result in individuals with ESRD experiencing difficulties in accessing vital and life-sustaining dialysis services. Additionally, these stakeholders cited that as a result of the 3.1 percent transition budget-neutrality adjustment reduction, they would have difficulty recruiting and retaining staff, staff to patient ratios would decrease, and renal dialysis services could be limited.

We find these requests compelling specifically because the number of ESRD facilities electing to receive full payment under the ESRD PPS issubstantially greater than the number of facilities that we estimated would elect to receive full payment under the ESRD PPS and therefore, the assumption used in the simulation to calculate the transition budget-neutrality adjustment was understated. We believe that rather than provide for a prospective adjustment in CY 2012, it is important to revise the transition budget-neutrality adjustment at this time for services furnished on April 1, 2011 through December 31, 2011.

As discussed in detail below, in this interim final rule with comment, we are revising the transition budget-neutrality adjustment by using the actual number of ESRD facilities that elected to receive 100 percent payment under the ESRD PPS. We believe that revising the transition budget-neutrality adjustment and eliminating the 3.1 percent reduction to payments in CY 2011, as discussed below, will mitigate difficulties cited above in patient access to renal dialysis services that could result from ESRD facilities limiting renal dialysis services due to the reduction in payments.

We are revising the transition budget-neutrality adjustment by re-calculating the transition budget-neutrality adjustment based on the actual elections received by the FI/MACs using the same methodology as described in the CY 2011 ESRD PPS proposed and final rules. This results in a zero percent adjustment. The zero percent adjustment is equal to 1 minus the ratio of the estimated payments under the ESRD PPS were there no transition (that is, 98 percent of total estimated payments that would have been made under the basic case-mix adjusted composite payment) to the total estimated payments under the transition.

Therefore, in this interim final rule with comment, the revised transition budget-neutrality adjustment of zero percent will apply prospectively to renal dialysis services furnished April 1, 2011 through December 31, 2011. As discussed earlier, we are not changing the application of the transition budget-neutrality adjustment factor. We are applying the zero percent transition budget-neutrality adjustment to both the blended payments under the transition and payments under the ESRD PPS.

We note that in the analysis of the 2010 ESRD facility elections and in our computation of the revised transition budget-neutrality adjustment using actual facility elections that we are finalizing in this interim final rule with comment, we did not change the methodology that was described in the CY 2011 ESRD PPS proposed rule (75 FR 49944 through 49947) published on September 29, 2009, and finalized in the CY 2011 ESRD PPS final rule (75 FR 49030 through 49214) for determining the revision to the transition budget-neutrality adjustment that will apply to renal dialysis services furnished on April 1, 2011 through December 31, 2011; rather, we are merely changing the number of ESRD facilities that elected to opt out of the transition that was used in the transition budget-neutrality calculation to reflect the actual rather than projected elections. All other provisions finalized in the CY 2011 ESRD PPS final rule remain unchanged.

We ordinarily publish a notice of proposed rulemaking in theFederal Registerin accordance with 5 U.S.C. section 553(b) of the Administrative Procedure Act (APA) and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

In addition, we ordinarily provide a 30-day delay in the effective date of the provisions of an interim final rule with comment. Section 553(d) of the APA (5 U.S.C. section 553(d)) ordinarily requires a 30-day delay in the effective date of final rules after the date of their publication in theFederal Register. This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the finding and its reasons in the rule issued. In addition, similar notice-and-comment procedures and a 30-day delay in effective date are required, but can be waived under section 1871 of the Act.

We find good cause that it is unnecessary to undertake notice-and-comment rulemaking to revise the ESRD transition budget-neutrality adjustment by updating estimated figures with actual figures, because we are not changing our underlying methodology for computing or applying the transition budget-neutrality adjustment. The numbers we are updating pertain to elections made by ESRD facilities with regard to participation in the transition. Because we are not attempting to further project how ESRD facilities would behave and are instead using the actual number of the facilities that opted out of the transition, we find notice and the opportunity for public comment unnecessary.

In addition, we also find good cause to waive these procedures with regard to revising the transition budget-neutrality adjustment because it would be contrary to the public interest to maintain the adjustment finalized in the CY 2011 ESRD PPS final rule for the remainder of CY 2011. In particular, we believe that delaying the revision of the transition budget-neutrality adjustment until the CY 2012 rulemaking in order to allow ESRD facilities an opportunity to comment on the revised adjustment that converts a 3.1 percent payment reduction to zero percent payment adjustment, could further decrease renal dialysis services to a vulnerable population that relies on these services to maintain their lives. For example, stakeholders have informed us that as a result of the 3.1 percent transition budget-neutrality adjustment reduction based on CMS' estimation of the ESRD facilities that would elect to receive full payment under the ESRD PPS, they will have difficulty recruiting and retaining staff, staff to patient ratios could decrease, and services could decrease due to decreases in staff and supplies. Therefore, we believe that delaying this revision could result in difficulties in access of care. We believe that revising the transition budget-neutrality adjustment in the way we discussed above and applying it without delay will mitigate these concerns and difficulties, and therefore, we find good cause to waive notice and comment rulemaking.

Also, for the reasons above, we believe that it is unnecessary and it is contrary to the public interest to delay the application of the revised transition budget-neutrality adjustment factor in order to provide for the required 30-day delay in the effective date of this interim final rule with comment. Delaying the effective date for an additional 30 days would further delay revising the adjustment (and therefore, the underestimation of how ESRD facilities would elect to receive payment under the ESRD PPS) and would continue to place a financial burden on ESRD facilities.

Therefore, for the reasons stated above, we believe there is good cause to waive not only notice-and-comment procedures but also the 30-day delay in the effective date for this interim final rule with comment.

This interim final rule with comment does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

Because of the large number of public comments we normally receive onFederal Registerdocuments, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in theDATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

We have examined the impact of this interim final rule with comment period as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This is not a significant rule and we have determined that this interim final rule with comment does not have a significant economic impact. Therefore, we have not prepared an RIA.

With regards to the ESRD transition budget-neutrality adjustment, we believe that with a zero percent adjustment we are budget-neutral for payments made for renal dialysis services furnished on April 1, 2011 through December 31, 2011. The zero percent transition budget-neutrality adjustment applied to payments made to ESRD facilities for renal dialysis services furnished on April 1, 2011 through December 31, 2011 will increase payments to providers as compared to payments they would receive with a 3.1 percent transition budget-neutrality adjustment reduction. This will benefit all providers.

The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $34.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. All ESRD facilities will receive a zero percent budget-neutrality adjustment to their payment for renal dialysis services furnished April 1, 2011 through December 31, 2011, instead of a 3.1 percent reduction, including small dialysis facilities. We are not preparing an analysis for the RFA because the Secretary has determined that this interim final rule with comment will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Social Security Act (the Act) requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because the Secretary has determined this rule does not have a substantial impact on small rural hospitals. Most dialysis facilities are free standing and we have determined that that this interim final rule with comment will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This rule will have no consequential effect on State, local, or Tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services are revising the 3.1 percent transition budget-neutrality adjustment reduction to a zero percent transition budget-neutrality adjustment for renal dialysis services furnished on April 1, 2011 through December 31, 2011.

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001et seq.;unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in theFederal Register.

In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act.This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act.The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification.This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism.This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform.This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act.This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501et seq.

Accordingly, 44 CFR part 64 is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below of the modified BFEs for each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001et seq.,and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in those buildings. The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act.This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act.As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification.This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism.This final rule involves no policies that have federalism implications under Executive Order 13132, Federalism.

Executive Order 12988, Civil Justice Reform.This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 65 is amended to read as follows:

This is a synopsis of the Commission's Second Report and Order and First Order on Reconsideration (Second R&O), FCC 11-28, adopted and released March 3, 2011. The full text of the Second R&O is available for inspection and copying during regular business hours in the FCC Reference Center, 445 Twelfth Street, SW., Room CY-A257, Portals II, Washington, DC 20554, and may also be purchased from the Commission's copy contractor, BCPI, Inc., Portals II, 445 Twelfth Street, SW., Room CY-B402, Washington, DC 20554. Customers may contact BCPI, Inc. via their Web site,http://www.bcpi.com,or call 1-800-378-3160. This document is available in alternative formats (computer diskette, large print, audio record, and Braille). Persons with disabilities who need documents in these formats may contact the FCC by e-mail:FCC504@fcc.govor phone: 202-418-0530 or TTY: 202-418-0432.

This Second R&O adopts new or revised information collection requirements, subject to the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13, 109 Stat 163 (1995) (codified in 44 U.S.C. 3501-3520)). These information collection requirements will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. The Commission will publish a separate notice in theFederal Registerinviting comment on the new or revised information collection requirements adopted in this document. The requirements will not go into effect until OMB has approved them and the Commission has published a notice announcing the effective date of the information collection requirements. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,see44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

1. In the Second R&O, the Commission addressed one of the issues set forth in the Further Notice of Proposed Rule Making (FNPRM) that accompanied the First Report and Order in this proceeding (75 FR 9797, March 4, 2010, FCC 10-24, rel. Feb. 23, 2010) (First R&O), and additionally addressed those issues set forth in the Notice of Proposed Rule Making in this proceeding, 24 FCC Rcd 5239 (2009) (Rural NPRM) that were not addressed in the First R&O. It set forth a waiver standard for Native American Tribes and Alaska Native Villages (Tribes) seeking to avail themselves of the Tribal Priority adopted in the First R&O, but that do not have Tribal Lands as defined by the Commission. The Tribal Priority as adopted requires that a Tribe or Tribal-owned entity proposing a new radio station qualifying for the Tribal Priority must show that 50 percent or more of the proposed station's signal covers Tribal Lands. Not all Tribes possess reservations or other Tribal Lands, however. Because the record was not fully developed on this issue, rather than set forth an alternate coverage standard, the Commission stated it would be receptive to requests to waive the requirement of Tribal Land coverage, setting forth various factors that would be considered probative in a determination of the functional equivalent of Tribal Lands. The Second R&O also adopted some of the changes proposed in the Rural NPRM in the Commission's procedures for awarding new channel allotments and assignments under section 307(b) of the Communications Act, 47 U.S.C. 307(b); adopted a rule prohibiting FM translator applicants from proposing to change channels from the non-reserved to reserved bands and vice-versa; and codified existing standards for determining nighttime mutual exclusivity between applications to provide AM service that are filed in the same window.

2. In the FNPRM, the Commission noted the concern of some commenters that the Tribal Priority, as originally adopted in the First R&O, would benefit only those Tribes possessing Tribal Lands, as the Commission defined that term in the First R&O. The requirement that at least 50 percent of the proposed station's principal community contour cover Tribal Lands was designed to ensure that a facility qualifying for the Tribal Priority is primarily used for its intended purpose, namely, to assist Tribes in their mission of promulgating Tribal language and culture, promoting Tribal self-governance, and serving the specific needs of Tribal communities. Commenters noted, however, that while there are 563 Tribes in the United States, there are only 312 reservations, with some Tribes occupying more than one reservation. Thus, not all Tribes could avail themselves of the Tribal Priority as adopted.

3. The record on this issue was not as well-developed as the Commission anticipated. Commenters noted that the situations of different Tribes are extremely varied and are likely to require different showings, necessitating flexible standards. The Commission thus decided against adopting a specific standard for defining a functional equivalent of Tribal Lands. Rather than modify the Tribal Priority at this time,the Commission encouraged Tribes lacking Tribal Lands to seek waiver in appropriate cases of the tribal coverage requirements of the Tribal Priority. Because, as noted in the First R&O, approximately two-thirds of all Tribal citizens do not live on Tribal Lands, the Commission recognized the potential need for the availability of a Tribal Priority in such circumstances, and will accordingly be receptive to waiver requests that demonstrate waiver would serve the goals of the Tribal Priority—to enable the Tribe to provide radio service uniquely devoted to the needs, language, and culture of the Tribal community—because a majority of the proposed service would cover the functional equivalent of Tribal Lands.

4. A waiver of the tribal coverage provisions of the Tribal Priority should be formally requested by an official of a federally recognized Tribe who has proper jurisdiction and is empowered to speak for the Tribe. Beyond that requirement, as is the case with any waiver request, an applicant seeking to establish eligibility for the Tribal Priority may submit any evidence probative of a connection between a defined community or area and the Tribe itself. Such a waiver showing should explain that the communities or areas associated with the Tribe do not fit the definition of Tribal Lands set forth in the First R&O. A waiver showing should also detail how a proposed service to the area would aid the Tribe in serving the needs and interests of its citizens in that community, and thus further the goals of the Tribal Priority. Factors probative of a geographically identifiable Tribal population grouping might include, for example, evidence of an area to which the Tribe delivers services to its citizens, or evidence of an area to which the federal government delivers services to Tribal members, for example, federal service areas used by the Indian Health Service, Department of Energy, or Environmental Protection Agency. Probative evidence might also include evidence of Census Bureau-defined tribal service areas, used by agencies such as the Department of Housing and Urban Development. Evidence that a Tribal government has a defined seat, such as a headquarters or office, in combination with evidence that Tribal citizens live and/or are served by the Tribal government in the immediate environs of such a governmental seat, would also be probative of a nexus between that community and the Tribe. Further, absent a physical seat of Tribal government, a Tribe might, for example, provide evidence that a majority of members of the Tribal council or board live within a certain radius of the proposed station (similar to 47 CFR 73.7000, under which an applicant for a noncommercial educational radio station may qualify for a “local applicant” credit by establishing that it is physically headquartered, has a campus, or has 75 percent of its governing board living within 25 miles of the reference coordinates of the proposed community of license). An applicant might also provide a showing under the standard enunciated in 25 CFR 83.7(b)(2)(i), that more than 50 percent of Tribal members live in a geographical area exclusively or almost exclusively composed of members of the Tribe. Additionally, tribes might provide other indicia of community, such as Tribal institutions (e.g., hospitals or clinics, museums, businesses) or activities (e.g., conferences, festivals, fairs).

5. Regardless of the waiver showing provided, an applicant seeking to take advantage of the Tribal Priority must set forth a defined area for the functional “Tribal Lands” to be covered, and the community on those lands that would be considered the community of license. This showing is necessary to duplicate, as closely as possible, the Tribal Land coverage provisions of the Tribal Priority, and also to make determinations such as community coverage. Additionally, the showing should demonstrate the predominantly Tribal character of the coverage area sought, and that such area does not include regions so non-Native in their character or location as to defeat the shared purposes of both the Commission and the Tribes, namely, to enable Tribes to serve their citizens, to perpetuate Tribal culture, and to promote self-government. The Commission found that the use of waivers to establish the equivalent of Tribal Lands will serve the public interest by affording maximum flexibility to Tribes in non-landed situations, particularly given that the circumstances of such Tribes are so varied. In evaluating such waiver requests, the Commission noted that it will delineate the “Tribal Lands” equivalent as narrowly as possible, viewing most favorably those proposals that seek facilities narrowly designed, to the extent feasible under technical and geographic constraints, to provide service to Tribal citizens rather than to non-Tribal members living in adjacent areas or communities.

6. In the Rural NPRM, the Commission observed that new allotments for FM channels and, especially, awards for new AM stations were being made based on either (a) dispositive 47 U.S.C. 307(b) (section 307(b)) preferences under Priority (3) of the Commission's allotment priorities, to proponents for first local transmission service, at communities located in or very near large Urbanized Areas, or (b) dispositive preferences under Priority (4), “other public interest matters,” based solely upon the differential in raw population totals to be served under the proposal. This has led to a disproportionate number of new FM allotments and AM construction permits being awarded as additional services to already well-served urbanized areas, in some cases at the expense of smaller communities or rural areas that received fewer services. The Commission noted that the vast majority of mutually exclusive groups of applications for new AM stations were being resolved under section 307(b), rather than through competitive bidding, pursuant to 47 U.S.C. 309(j) (section 309(j)). The Commission expressed the same concerns with regard to moves of stations (i.e., changes of community of license) from smaller communities and rural areas toward urbanized areas, because the same section 307(b) criteria are used to compare the applicant's former and new community and/or service areas.

7. Accordingly, the Commission tentatively concluded that it should modify its policies to more equitably distribute radio service among urban and rural areas, and to promote the resolution of mutual exclusivity through competitive bidding where section 307(b) principles do not dictate a preference among communities. First, the Commission tentatively concluded that it should establish a rebuttable presumption that an FM allotment or AM new station proponent seeking to locate at a community in an urbanized area, or that would cover or could be modified to cover 50 percent or more of an urbanized area, was in fact proposing a service to the entire urbanized area, and that accordingly it would not award such an applicant a preference for providing first local transmission service under Priority (3) of the FM allotment priorities to a small community within that area. Second, in the case of applicants for new AM stations, the Commission tentatively concluded that it should change its application of Priority (4)—other public interest matters—and sought comment on alternative proposals in this regard. The alternatives included ceasing treating Priority (4) as a dispositive section 307(b) criterion, or a more narrowly defined application of Priority(4), under which no dispositive preference would be awarded if the population in 75 percent of the proposed station's principal community contour already receives five or more aural services, and the proposed community of license already has more than five transmission services, except where the applicant can make a successful showing as set forth in the case ofGreenup, Kentucky and Athens, Ohio,2 FCC Rcd 4319 (MMB 1987) (Greenup). An applicant whose proposed contour did not meet the five reception/five transmission service criteria would proceed to a modified Priority (4) analysis. The Commission suggested that, as part of this modified analysis, a Greenup showing, involving calculation of a Service Value Index (SVI), which takes into account both population and the number of reception services, could be useful. The Commission tentatively concluded that, in such a situation, it would award a dispositive section 307(b) preference under Priority (4) if the SVI difference was 50 percent or greater. Otherwise, the application would proceed to competitive bidding. Third, the Commission proposed an “underserved listeners” preference, that would be co-equal with Priorities (2) and (3), under which it would grant a section 307(b) preference to an applicant proposing to provide third, fourth, or fifth aural reception service to a substantial portion of its covered population.

8. With regard to proposed community of license change applications, the Commission tentatively concluded that there should be an absolute bar on proposals that would leave populations with no or only one reception service. The Commission also proposed to apply the same Priority (3) standards to community of license changes as it proposed for new FM allotment and AM applications, when determining whether a proposed community change represents a preferential arrangement of allotments. Finally, the Commission sought comment on a number of other proposals: whether to disallow community changes that would remove third, fourth, or fifth reception service to a significant population; whether to bar removal of a second local transmission service at a community; and whether provision of service to underserved listeners should outweigh a proposal of first local transmission service, in both the community change and new station/allotment contexts.

9. Many commenters opposed these changes, arguing that they were unnecessary. They contended that 80 percent of the U.S. population lived in urbanized areas, and that locating radio stations where most people live was the most efficient use of spectrum and of distributing radio service. Some commenters also objected that the Commission's proposed changes would have a disproportionate effect on minorities and radio stations owned by and programming to minorities, as most of their audiences live in urbanized areas. The Commission observed that section 307(b)'s purpose was to ensure that all Americans, whether living in large urbanized areas or small communities or rural areas, had access to a variety of radio services, to the extent that demand exists to provide such service. The limited goal of the Rural NPRM was to provide greater opportunities for those applicants who propose such service with the expectation that it would be viable, to the extent that they are mutually exclusive with applicants proposing yet more service to urbanized areas whose residents already have an abundance of radio listening choices. The Commission further rejected the contention that its proposals would disproportionately affect minority broadcasters and listeners, noting that while most members of minority groups live in urbanized areas, most Americans generally live in such areas, and in roughly the same proportions. The same considerations apply in rural and smaller communities, that also have minority populations that are equally deserving of radio service. The Commission thus stated that the speculative benefit of additional service in urban areas did not outweigh its concern that the current priorities fail to promote new service, or the retention of existing service, at less well-served communities and that the current allocation priorities do not realistically reflect broadcasters' actual economic incentives. The Commission also took into account a commenter's analysis showing that, in many cases, the community of license of a station represented a small percentage of the total population covered by the station, and often was not the largest community served by the station. It concluded that awards of section 307(b) preferences should take into account the totality of a station's service, not merely the community of license designated by the applicant or proponent.

10. The Commission adopted its proposals, in somewhat modified form, noting that the procedural changes would take place in three related, but distinct, contexts: (1) Applications for new AM stations; (2) proposals for new commercial FM allotments; and (3) applications to change the community of license of an existing radio station (in which the moving station's new facilities are compared to its existing facilities under section 307(b), for a determination of whether the new community constitutes a preferential arrangement of allotments).

11. With regard to applications for new AM radio stations, the Commission noted its Congressional mandate to use competitive bidding as the primary means of awarding new service. As a threshold matter, the Commission will restrict the award of dispositive section 307(b) preferences among mutually exclusive AM applications to those situations where there is a significant difference between the proposals. First, with regard to proposals for first local transmission service under Priority (3), it adopted its tentative conclusion that any new AM station proposal for a community located within an urbanized area, that would place a daytime principal community signal over 50 percent or more of an urbanized area, or that could be modified to provide such coverage, will be presumed to be a proposal to serve the urbanized area rather than the proposed community. This is the standard the Commission has heretofore used in determining whether an applicant for a new AM station must provide a showing underFaye and Richard Tuck,3 FCC Rcd 5374, 5376 (1988) (Tuck). Recognizing the possibility that the majority of a proposed station's daytime principal community contour could cover part of an urbanized area without necessarily triggering the urbanized area service presumption—for example, when the proposed contour covers only 45 percent of an urbanized area, but urbanized area coverage constitutes well over half of the contour—the Commission stated its willingness to entertain challenges, at the appropriate stage of the application or allotment proceeding, detailing the reasons the proposal should nonetheless be treated as one to serve the urbanized area rather than the named community of license. For AM facilities, the determination of whether a proposed facility “could be modified” to cover 50 percent or more of an urbanized area will be limited to a consideration of rule-compliant minor modifications to the proposal, without changing the proposed antenna configuration or site, and spectrum availability as of the close of the filing window.

12. The urbanized area service presumption may be rebutted by a compelling showing (1) That the proposed community is truly independent of the urbanized area, (2)of the community's specific need for an outlet for local expression separate from the urbanized area and (3) the ability of the proposed station to provide that outlet. The required compelling showing may be based on the existing three-prongedTucktest (see Tuck,3 FCC Rcd at 5378). However, theTuckfactors, especially the eight-part test of independence, will be more rigorously scrutinized than has sometimes been the case in the past. For example, an applicant should submit actual evidence of the number of local residents who work in the community, not merely extrapolations from commute times or observations that there are businesses where local residents could work if they so chose.1 Similarly, the record should include actual evidence that the community's residents perceive themselves as separate and distinct from the urbanized area, rather than merely self-serving statements to that effect from town officials or business leaders. Moreover, certain of theTuckindependence factors have become increasingly anachronistic, and accordingly will not be given as much weight. For example, as local telephone companies have started to discontinue routine distribution of telephone directories, factor five is less meaningful than it once was. Similarly, with the closing of even major city newspapers, the lack of a local newspaper should not necessarily be fatal to a finding of independence, though it is still a relevant factor. However, the mere existence of a city- or town-posted site on the World Wide Web is not a substitute for evidence of independent media also covering a community, as a means of demonstrating a community's independence from an urbanized area. In addition to demonstrating independence, a compelling showing sufficient to rebut the urbanized area service presumption must also include evidence of the community's need for an outlet for local expression. For example, an applicant may rely on factors such as the community's rate of growth; the existence of substantial local government necessitating coverage; and/or physical, geographical, or cultural barriers separating the community from the remainder of the urbanized area. An applicant will be afforded wide latitude in attempting to overcome the presumption, but a compelling showing will be required.

13. The Commission did not believe it necessary or desirable to eliminate completely an applicant's ability to make its public interest case for additional service at a community under Priority (4), other public interest matters. It nonetheless found that large service population differentials between competing proposals should not suffice, in and of themselves, for a dispositive section 307(b) preference under Priority (4), especially when the proposed new population is already abundantly served. Such a preference often unfairly disadvantages those who would provide additional media voices to those needing them most. The Commission thus adopted, in modified form, the proposal to emphasize underserved populations, that is, those receiving fewer than five aural services, under Priority (4). Accordingly, a new AM applicant proposing third, fourth, and/or fifth reception service to at least 25 percent of the population in the proposed primary service area, as defined in 47 CFR 73.182(d), where the proposed community of license has two or fewer local transmission services, may receive a dispositive section 307(b) preference under Priority (4). For purposes of this analysis, “community of license” will be considered to be the entire urbanized area if the proposed community of license is subject to the urbanized area service presumption.

14. The Commission further adopted the proposal to allow, but not require, new AM applicants not meeting the above-stated 25 percent/two transmission service standard to submit an SVI showing as set forth inGreenup(6 FCC Rcd at 1495) in order to receive a dispositive Priority (4) preference. An applicant opting to present aGreenupanalysis must demonstrate a 30 percent differential in SVI between its proposal and the next-highest ranking proposal before the Commission will award a dispositive section 307(b) preference under Priority (4). The Commission inGreenupfound an 18.8 percent SVI differential to be dispositive in an FM allotment case. Because, unlike in an FM allotment proceeding, an applicant for a new AM station need not receive a section 307(b) preference, but may proceed to auction, a higher SVI differential should be required in this context. A 30 percent SVI differential is sufficiently high to demonstrate that a proposed community merits a dispositive section 307(b) preference, but is not so low as to undermine section 309(j)'s general preference for awarding new commercial stations primarily through competitive bidding. An applicant receiving a dispositive section 307(b) preference under Priority (4) will, of course, be subject to the prohibition on reducing service set forth in the First R&O (25 FCC Rcd at 1598-99) and codified in 47 CFR 73.3571(k)(i).

15. Except under the circumstances outlined above, dispositive section 307(b) preferences will not be granted under Priority (4). Thus, as is currently the practice, mutually exclusive application groups in which no applicant receives a section 307(b) preference will proceed to competitive bidding. These new procedures will not be applied to pending applications for new AM stations and major modifications to AM facilities filed in the 2004 AM Auction 84 filing window, but will only apply to those applications filed after the Second R&O's release date. This is because the AM Auction 84 applications have been pending for many years, and in most cases the applicants have invested considerable resources in technical studies, settlements and technical resolutions, and section 307(b) showings, thus applying the new procedures to such applications would place undue hardship on the applicants.

16. With regard to proposals for new allotments to be added to the FM Table of Allotments (47 CFR 73.202), although the section 307(b) considerations of fair, efficient, and equitable distribution of new radio service in the non-reserved FM band are much the same as they are in the AM band, the mechanism for evaluating the respective section 307(b) merits of competing allotment proposals is quite different, insofar as competing proposals for new FM allotments cannot simply be sent to auction if no dispositive section 307(b) difference can be found. Accordingly, the standards for awarding section 307(b) preferences cannot be as strict or as limited as those set forth above with regard to dispositive section 307(b) preferences for new AM applications.

17. As regards Priority (3) (first local transmission service) preferences, the Commission adopted the same urbanized area service presumption set forth above. The determination of whether a proposed facility “could be modified” to cover 50 percent or more of an urbanized area will be made based on an applicant's certification that there are no existing towers in the area to which, at the time of filing, the applicant's antenna could be relocated pursuant to a minor modification application to serve 50 percent or moreof an Urbanized Area.2 If a proposal does not qualify for a first local transmission service preference, the Commission will consider proposals to provide third, fourth, and/or fifth reception service to more than ade minimispopulation under Priority (4), as is the case now. However, the Commission directed the staff to accord greater weight to service to underserved populations than to the differences in raw population totals, concluding that raw population total differentials should be considered only after other Priority (4) factors that a proponent might present, including the number of reception services available to the proposed communities and reception areas, population trends in the proposed communities of license/reception areas, and/or number of transmission services at the respective communities. Because it is impossible to anticipate every possible competing allotment proposal, the Commission did not eliminate outright any factor, including reception population, for determining dispositive section 307(b) preferences in the FM allotment context. For now, the Commission limited its direction to a determination that, of all considerations in making new FM allotments, raw reception population totals—of whatever magnitude—should receive less weight than other legitimate service-based considerations. These procedures shall not apply to any non-final FM allotment proceeding, including “hybrid” coordinated application/allotment proceedings, in which the Commission has modified a radio station license or granted a construction permit. Although it is well settled that the Commission may apply modified rules to applications that are pending at the time of rule modification, substantial equitable considerations apply to these categories of proceedings. Affected licensees and permittees may have expended considerable sums or entered into agreements following such actions. Moreover, filings and licensing actions subsequent to a license modification could impose significant burdens on parties forced to take steps to protect formerly licensed facilities. The revised procedures will apply, however, to all pending petitions to amend the FM Table of Allotments, and to all other open FM allotment proceedings and non-final FM allotment orders.

18. Licensees and permittees seeking to change community of license differ from applicants in the above two categories insofar as, for section 307(b) purposes, they do not face comparative analysis with respect to communities proposed by competing applicants. Rather, the section 307(b) comparison is between the applicant's present community and the community to which it seeks to relocate (see47 CFR 73.3571(j)(2) and 73.3573(g)(2)). The applicant must demonstrate that the facility at the new community represents a preferential arrangement of allotments (FM) or assignments (AM) over the current facility. In such cases, the Commission adopted certain changes designed to require more specificity on the part of licensees and permittees regarding the actual effects of the proposed moves, while still affording flexibility to propose truly favorable arrangements of radio allotments and assignments. First, it adopted the urbanized area service presumption outlined above, which may be rebutted in the same manner as set forth herein, and will be subject to the same determinations described above as to whether the proposed facility “could be modified” to cover over 50 percent of an urbanized area. Additionally, applicants not qualifying for Priority (3) preferences under this standard will still be able to make a Priority (4) showing that will require them to provide a more detailed explanation of the claimed public interest benefits of the proposed move.

19. With regard to Priority (4) claims, the Commission sought, again, to limit the presumption that raw net population gains, in and of themselves, represent a preferential arrangement of allotments or assignments under section 307(b). It imposed an absolute bar to any facility modification that would create white or gray area. The Commission also stated it would strongly disfavor any change that would result in the net loss of third, fourth, or fifth reception service to more than 15 percent of the population in the station's current protected contour (noting that loss of service to underserved listeners offset by proposed new service to a greater number of underserved listeners would not constitute a “net loss of service” to such listeners, and would be viewed more favorably). Applicants would also be required not only to set forth the size of the populations gaining and losing service under the proposal, but also the numbers of services those populations will receive if the application is granted, and an explanation as to how the proposal advances the revised section 307(b) priorities. For example, an applicant will not only be required to detail that it is providing 500,000 listeners with a 21st reception service, and removing the sixth reception service from 50,000 listeners, but also to provide a rationale to explain how this service change represents a preferential arrangement of allotments or assignments.3 Additionally, the Commission will strongly disfavor any proposed removal of a second local transmission service from a community of substantial size (with a population of 7,500 or greater) when determining whether a proposed community of license change represents a preferential arrangement of allotments or assignments. The Commission retains its presumption against removal of sole transmission service. Finally, as is and has always been the case, under Priority (4) applicants may offer any other information they believe to be pertinent to a public interest showing, including the need for further transmission service at the new community, a drop in population justifying the removal of transmission service at the old community, population growth in areas surrounding the proposed new community that can best be met by a centrally located service, or any other changes in circumstance believed relevant to Commission consideration. These procedures shall apply to any applications to change community of license that are pending as of the release date of the Second R&O.

20. The Commission stated its intent that the changes introduced here will, first, cause applicants to give moreconsideration to the effects of proposed station moves on listeners, both those they would serve at a new community and those from whom they would remove existing service; and second, that a fuller explanation of the claimed benefits of a station move will introduce greater transparency into the community change procedure, both to aid in decision-making and for the benefit of affected listeners. The Commission expects that these procedures will help to achieve a balance between distribution of radio service to the largest populations, on the one hand, and distribution of new service to those most in need of it on the other.

21. In the Rural NPRM, the Commission noted that the current rules permit FM translator stations originally authorized in the non-reserved band (channels 221-300) to modify their authorizations to “hop” into the reserved band (channels 201-220).See47 CFR 74.1233. By making these modifications, translator stations are able to operate under the less restrictive NCE rules, which permit the use of alternative methods of signal delivery, such as satellite and terrestrial microwave facilities. Likewise, FM translators authorized in the reserved band are currently able to file modifications to hop into the non-reserved band. The filing of such band-hopping applications by FM translator stations prior to construction of their facilities wastes staff resources, and potentially precludes the use of those frequencies in future reserved band filing windows for FM translators. The integrity of the window filing process is critical to provide equal opportunity to frequencies for translator applicants across the country. The Commission therefore tentatively concluded that § 74.1233 of the Commission's rules should be modified to require that applications to move into the reserved band from the non-reserved band, or to move into the non-reserved band from the reserved band, may only be filed by FM translator stations that have filed license applications or are licensed, and that have been operating for at least two years. In addition to seeking comment on the proposal, the Commission sought comment on the duration of the proposed holding period.

22. Some commenters opposed the proposal, questioning the extent of the band-hopping problem, or suggesting instead that individual FM translator permits and licenses contain conditions prohibiting band-hopping. Another commenter supported the prohibition but suggested an exception for translator operators who could show that they had been displaced and the only frequencies available were in the other band. The Commission found over 160 translator applicants in the last non-reserved band filing window had “hopped” to the reserved band and were operating there. The Commission concluded that adoption of the prohibition proposed in the Rural NPRM, in conjunction with the two-year holding period, will best preserve the fairness of the window filing process while providing flexibility for translators that have operated long enough to have an established listener base. Even though the Commission did not codify a rule that would permit the filing of non-minor-change displacement proposals, it directed Commission staff to continue to consider such waiver requests on a case-by-case basis.

23. As the Commission observed in the Rural NPRM, the first and most fundamental step in the AM auction process is a staff determination as to which applications filed during the relevant filing window are mutually exclusive with one another. In the context of an AM auction, mutual exclusivity is determined by an evaluation of engineering data provided in conjunction with the FCC Form 175. Applicants must specify a frequency on which they seek to operate in accordance with the Commission's existing interference standards.

24. It is well established that mutual exclusivity arises when grant of one application would preclude grant of a second, and the interference rules and protection requirements are the technical standards used to determine mutual exclusivity. Public notices released prior to an AM auction specifically note that the staff applies 47 CFR 73.37, 73.182, and 73.183(b)(1), among other standards, to make mutual exclusivity determinations. In the AM service, mutual exclusivity may occur during three operational timeframes: daytime, critical hours, and nighttime. There are three classes of nighttime interference contributors: (a) A high-level interferer, defined as a station that contributes to the fifty percent exclusion root-sum-square (RSS) nighttime limit of another station; (b) a mid-level interferer, defined as a station that enters the twenty-five but not fifty percent RSS of another station; and (c) a low-level interferer, defined as a station that does not enter into the twenty-five percent RSS of another station. To combat the extreme levels of interference that have led to a deterioration of the AM service, the Commission established a strict new standard, stating that a new station may be authorized only if it qualifies as a low interferer with respect to any other station on the same or first adjacent channel. The nighttime protection requirements are codified in 47 CFR 73.182. For AM auction window applications, the staff analyzes the daytime, critical hours, and nighttime facilities specified in each application against every other application filed in the window. Two AM applications filed during the same filing window are considered mutually exclusive if either fails to fully protect the other as required by the Commission's technical rules.

25. The Commission tentatively concluded, in the Rural NPRM, to codify its decision inNelson Enterprises, Inc.,18 FCC Rcd 3414 (2003), in which the Commission concluded that the staff properly applied 47 CFR 73.182(k) interference standards to establish mutual exclusivity between window-filed applications, i.e., determined that the rule limits the interference a new station application may cause to another application filed in the same AM window. Because the rule establishes that the RSS methodology should be applied for the calculation of nighttime interference for non-coverage purposes, the Commission concluded that the staff properly relied on the rule for making mutual exclusivity determinations, and found it proper to apply 47 CFR 73.182 in considering the effect of nighttime interference caused and received by simultaneously filed AM auction filing window proposals, as well as existing stations.

26. In the Rural NPRM, the Commission also tentatively concluded that it should modify § 73.3571 of the rules, by explicitly providing that the interference standards in § 73.182(k) of the Commission's rules apply when determining nighttime mutual exclusivity between applications to provide AM service that are filed in the same window. That is, two applications would be deemed to be mutually exclusive if either application would be subject to dismissal because it would enter the twenty-five percent exclusion RSS nighttime limit of the other. Two parties filed comments, arguing that these standards would reduce the number of new AM construction permits awarded in filing windows. The Commission disagreed, noting that several mechanisms in AM new application processing, including technical resolutions and settlements, could lead to multiple grants, that the interference rules and protection requirements are the technical standards used for establishing mutual exclusivity, and that the criteria applied by the staffwere fully consistent with the strict interference limitations established by the Commission. The Commission thus concluded that codifying the applicability of 47 CFR 73.182(k) AM nighttime interference standards to mutually exclusive AM auction applications promotes the integrity of the AM service, and is thus in the public interest.

27.First Order on Reconsideration.In the First R&O, the Commission adopted a Tribal Priority, giving federally recognized Tribes and majority Tribal-owned entities a section 307(b) priority for proposing service, 50 percent or more of which would cover “Tribal Lands,” as defined in the First R&O, as long as the proposals met certain conditions. Two parties called attention to perceived difficulties with the implementation of the Tribal Priority that might inadvertently limit the ability of qualifying entities to receive the Tribal Priority. One party argued that Alaska Native Regional Corporations, created pursuant to the Alaska Native Claims Settlement Act of 1971 (ANCSA) should be allowed to claim the Tribal Priority. The Commission found, however, that such corporations are not sovereign or quasi-sovereign entities, as are Tribes, and because the Tribal Priority was based on the government-to-government relationship between the United States Government and Tribes, the Commission could not extend the Tribal Priority to such corporations.

28. Native Public Media and the National Congress of American Indians (NPM/NCAI) jointly observed that some Tribes have Tribal Lands that are either too small to comprise 50 percent or more of a station's principal community contour, or are so irregularly shaped that 50 percent or more of a station's contour could not cover Tribal Lands. They contended that such Tribes could not qualify for the Tribal Priority under the coverage provisions set forth in the First R&O, therefore an alternative coverage provision was needed. The Commission agreed that an alternative was needed, but sought to craft a standard that would include such Tribes while ensuring that the Tribal Priority would be used for its intended purpose, that is, for Tribes to provide radio service to their members, rather than to primarily non-Tribal areas. Accordingly, a Tribe may claim the Tribal Priority if (a) at least 50 percent of the area within the proposed facility's principal community contour is over that Tribe's Tribal Lands, as set forth in the First R&O, or (b) the proposed principal community contour (i) encompasses 50 percent or more of that Tribe's Tribal Lands, (ii) serves at least 2,000 people living on Tribal Lands, and (iii) the total population on Tribal Lands residing within the station's service contour constitutes at least 50 percent of the total covered population. In neither (a) nor (b) may the applicant claim the priority if the proposed principal community contour would cover more than 50 percent of the Tribal Lands of a non-applicant Tribe. The first and second requirements of the alternative test ensure that the proposed station will serve substantial Tribal Lands and populations. The Commission found that service to fewer than 2,000 people should generally be considered insufficient to claim the Tribal Priority.4 However, a situation could arise where a proposal meets these requirements but the population of the applicant's Tribal Lands represents a relatively small percentage of the total population residing in the coverage area, and in this circumstance a Tribal Priority might potentially deprive the majority, non-tribal population of needed local service. To address this concern, the Tribal Priority cannot be claimed if the combined population on Tribal Lands within the proposed station's service contour constitutes less than 50 percent of the total covered population. This requirement is designed to avoid applying the Tribal Priority to regions and populations that are largely non-Native in character or location, in keeping with the priority's goals. The Commission will entertain waiver requests from applicants proposing Tribal service to service areas in which the population on Tribal Lands is less than 50 percent of the covered population, in appropriate situations.5 Finally, the limitation that the applicant will not cover more than 50 percent of the Tribal Lands of a non-applicant Tribe will avoid exhausting the remaining spectrum in areas where many Tribes have Tribal Lands in close proximity, before all qualifying Tribes have an opportunity to apply. This limitation will also encourage different Tribes whose lands are in close proximity to each other to form consortia to establish radio service serving the various Tribes' needs, as well as share the expense of starting new radio service.

29. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 601-612, an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Rural NPRM. The Commission sought written public comment on the proposals in the Rural NPRM, including comment on the IRFA. The Commission received no comments on the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

30. The Second R&O adopted rule and procedural changes to codify or clarify certain allotment, assignment, auction, and technical procedures. In the Second R&O, the Commission also codified a prohibition against “band hopping” FM translator station applications, and codified standards determining nighttime AM mutual exclusivity among window-filed applications for new AM broadcast stations. In the Second R&O, the Commission also addressed issues raised in the FNPRM released with the First R&O. The Tribal Priority, adopted by the Commission in the First R&O, is available to applicants meeting all of the following eligibility criteria: (1) The applicant is either a federally recognized Tribe or tribal consortium, or an entity 51 percent or more of which is owned or controlled by a Tribe or Tribes, at least part of whose tribal lands (as defined in note 30 of the Rural NPRM) are covered by the principal community contour of the proposed facility; (2) at least 50 percent of the daytime principal community contour of the proposed facilities covers tribal lands; (3) the proposed community of license must be located on tribal lands; and (4) the applicant proposes first aural, second aural, or first local tribal-owned commercial transmission service at the proposed community of license, in the case of proposed commercial facilities, or at least first local tribal-owned noncommercial educational transmission service, in the case of proposed NCE facilities. Although “tribal lands” was given an expansive definition in the First R&O, commenters noted that not all Tribes had reservations or other tribal lands as theCommission defined that term. Thus, in the FNPRM the Commission sought comment on how the Tribal Priority could be applied to Tribes that lacked tribal lands. Additionally, the Commission sought comment on whether, and how, to establish a bidding credit to assist Tribes seeking to establish commercial radio stations, and competing with non-Tribal applicants for such facilities at auction.

31. After considering the few comments filed in response to the FNPRM, the Commission determined that the record did not support the establishment of a specific coverage standard for Tribes without Tribal Lands. Instead, such Tribes may, through a Tribal official with proper jurisdiction, request waiver of the tribal coverage criterion of the Tribal Priority, by making an appropriate showing of a defined geographic area identified with the Tribe. Among the probative factors in such a showing would be evidence of an area to which the Tribe delivers services to its citizens, or evidence of an area to which the federal government delivers services to Tribal members. Probative evidence might also include evidence of Census Bureau-defined tribal service areas, used by agencies such as the Department of Housing and Urban Development. Additionally, if a Tribe were able to provide evidence that its Tribal government had a defined seat, such as a headquarters or office, this in combination with evidence that Tribal citizens lived and/or were served by the Tribal government in the immediate environs of such a governmental seat would provide strong evidence of a nexus between that community and the Tribe. Absent a physical location for Tribal government, a Tribe might also, for example, provide evidence that a majority of members of the Tribal council or board lived within a certain radius of a community. The Commission would also accept a showing under the standard enunciated in 25 CFR 83.7(b)(2)(i), that more than 50 percent of Tribal members live in a geographical area exclusively or almost exclusively composed of members of the Tribe. Other evidence, such as evidence of the existence of Tribal institutions or events in a defined area, would also be considered probative of a geographically identifiable Tribal population grouping. Regardless of the evidence provided, the Tribe must define a reasonable boundary for the “tribal lands” to be covered, and the community on those lands that would be considered the community of license, with an eye toward duplicating as closely as possible the Tribal Land coverage provisions of the Tribal Priority.

32. In the Rural NPRM, the Commission also stated that the procedures and priorities it had been using to allocate radio service had not been completely successful in effecting the fair, efficient, and equitable distribution of radio service mandated by section 307(b) of the Communications Act. Specifically, the Commission noted that current policies had resulted in an inordinate number of new services in large, already well-served urban areas, as well as moves of existing stations from smaller and rural communities into or near to urbanized areas. The Commission further observed that in many cases, the sole determinant in assigning new service was the number of people receiving new service, and that reliance on the differences in populations receiving new service in already abundantly served areas may have an adverse impact on the fair distribution of service in new AM and FM station licensing, and may be inconsistent with statutory and policy goals.

33. In order to address these concerns, the Commission concluded in the Second R&O that it should rectify the policies that it perceived as overwhelmingly favoring proposals in and near urbanized areas at the expense of smaller communities and rural areas. First, the Commission established a rebuttable presumption that an FM allotment or AM new station proponent seeking to locate at a community in an urbanized area, or that would cover or could be modified to cover more than 50 percent of an urbanized area, in fact proposes service to the entire urbanized area, and accordingly will not receive a section 307(b) preference for providing first local transmission service. This urbanized area service presumption may be rebutted by a compelling showing, not only that the proposed community is truly independent of the urbanized area, but also of the community's specific need for an outlet for local expression separate from the urbanized area and the ability of the proposed service to provide that outlet. Additionally, in the case of applicants for new AM stations, the Commission stated that an applicant proposing third, fourth, and/or fifth reception service to at least 25 percent of the population in the proposed primary service area, where the proposed community of license has two or fewer local transmission services, may receive a dispositive section 307(b) preference under Priority (4). An applicant whose proposed contour does not meet the 25 percent/two transmission service criteria may, but is not required to, provide a Service Value Index showing as set forth in theGreenupcase. Such a showing, however, must yield a difference in SVI of at least 30 percent over the next-highest ranking proposal in order to receive a dispositive section 307(b) preference under Priority (4) of the assignment priorities. Absent such a showing, no dispositive section 307(b) preference will be awarded, and the competing applications for new AM stations will proceed to competitive bidding.

34. In the case of new FM allotments, before awarding a dispositive section 307(b) preference to an applicant proposing first local service at a community, the Commission will apply the rebuttable urbanized area service presumption as described in the preceding paragraph. If a proposal does not qualify for a first local transmission service preference, the Commission will consider proposals to provide third, fourth, and/or fifth reception service to more than ade minimispopulation under Priority (4), but directs the staff to accord greater weight to service to underserved populations than to the differences in raw population totals. The Commission concluded that raw population total differentials should be considered only after other Priority (4) factors that a proponent might present, including the number of reception services available to the proposed communities and reception areas, population trends in the proposed communities of license/reception areas, and/or number of transmission services at the respective communities.

35. As noted above, in the Rural NPRM the Commission expressed concern over the movement of radio stations away from smaller and rural communities and toward urbanized areas. In order to change its community of license, a radio station must show that service at the new community constitutes a preferential arrangement of allotments or assignments compared to service at the current community. Currently, a substantial number of such applicants justify the benefits of such moves by setting forth the greater number of listeners who would receive a new service at the new community of license. The Commission sought to limit the presumption that such raw net population gains, in and of themselves, represent a preferential arrangement of allotments or assignments under section 307(b). The Commission adopted its proposal to prohibit any community of license change that would create white or gray area, that is, leave any area with no reception services or only one reception service. As with proposals fornew AM stations and FM allotments, the Commission will apply the rebuttable urbanized area service presumption as described above to an applicant for a change of community of license that proposed to provide the new community with its first local transmission service. An applicant not qualifying for a first local transmission service preference may then make a showing under Priority (4), other public interest matters. Such a showing, however, will require the applicant to provide a more detailed explanation of the claimed public interest benefits of the proposed move than is currently the case. A Priority (4) showing that reveals a net loss of third, fourth, or fifth reception service to more than 15 percent of the population in the station's current protected contour will be strongly disfavored. The Commission will now require applicants not only to set forth the size of the populations gaining and losing service under the proposal, but also to summarize the numbers of services those populations will receive if the application is granted, and an explanation as to how the proposal advances the revised section 307(b) priorities. Additionally, pursuant to the Commission's proposal in the Rural NPRM, it will accord significant weight against any proposed removal of a second local transmission service from a community of substantial size (with a population of 7,500 or greater) when determining whether a proposed community of license change represents a preferential arrangement of allotments or assignments. Applicants may also offer, as part of a Priority (4) showing, any other information they believe to be pertinent to a public interest showing, including the need for further transmission service at the new community.

36. In the Rural NPRM, the Commission also noted that the current rules permit FM translator stations originally authorized in the non-reserved band (channels 221-300) to modify their authorizations to “hop” into the reserved band (channels 201-220). Such modifications enable translator stations to operate under the less restrictive NCE rules, permitting the use of alternative methods of signal delivery, such as satellite and terrestrial microwave facilities. Likewise, FM translators authorized in the reserved band are currently able to file modifications to hop into the non-reserved band. The Commission stated that such band-hopping applications by FM translator stations prior to construction of their facilities wastes staff resources, potentially precludes the use of those frequencies in future reserved band filing windows for FM translators, and diminishes the integrity of the window filing process. The Commission therefore tentatively concluded that 47 CFR 74.1233 should be modified to prohibit this practice. In the Second R&O, the Commission adopted its tentative conclusion, and codified this prohibition.

37. The Commission also tentatively concluded, in the Rural NPRM, that it should modify 47 CFR 73.3571 to codify the Commission's decision inNelson Enterprises, Inc.,18 FCC Rcd 3414 (2003), by explicitly providing that the AM nighttime interference standards found in 47 CFR 73.182(k) should apply in determining nighttime mutual exclusivity between applications to provide AM service that are filed in the same window. The Commission believed this rule change was needed to promote the strict interference standard that the Commission has determined is necessary to revitalize the AM service. In the Second R&O, the Commission adopted its tentative conclusion, and codified these procedures.

38. The Commission also released, with the Second R&O, a First Order on Reconsideration, dealing with two issues raised by commenters with regard to the Tribal Priority. One of these issues concerned whether to extend the Tribal Priority to corporations established pursuant to the Alaska Native Claims Settlement Act of 1971 (ANCSA), 43 U.S.C. 1601et seq.Such regional corporations are established in the ANCSA statutes and are incorporated under Alaska law. These corporations, however, are not themselves Tribes, and their shares are owned by individual Natives rather than the Tribes themselves. The Commission determined that, because the basis for the Tribal Priority was the government-to-government relationship between the Tribes and the federal government, and because the regional corporations established pursuant to ANCSA are not sovereign or quasi-sovereign entities, the Tribal Priority could not be extended to such corporations.

39. The second issue on reconsideration concerned Tribes with small or irregularly shaped tribal lands. As originally established, the Tribal Priority requires that at least 50 percent of the principal community contour of a proposed station cover tribal lands. A commenter noted that some Tribes had tribal lands that, in total, would not comprise 50 percent of even a small radio station's contour, and moreover that some tribal lands were, for example, strips of land following rivers, that would not fit into the generally circular contours of non-directional radio stations. The Commission adopted a modification of the Tribal Priority: A Tribe may claim the Tribal Priority if (a) at least 50 percent of the proposed facility's principal community contour covers that Tribe's Tribal Lands, as set forth in the First R&O, or (b) the proposed principal community contour (i) covers 50 percent or more of that Tribe's Tribal Lands, (ii) serves at least 2,000 people living on Tribal Lands, and (iii) the total population on Tribal Lands residing within the station's service contour constitutes at least 50 percent of the total covered population. In neither (a) nor (b) may the applicant claim the priority if the proposed principal community contour would cover more than 50 percent of the Tribal Lands of a non-applicant Tribe. This is intended to facilitate use of the Tribal Priority by Tribes with small or irregularly shaped lands, while avoiding the problem of certain Tribes claiming the remaining spectrum in certain areas where many Tribes have smaller tribal lands in close proximity before all qualifying Tribes have an opportunity to apply. In such situations, different Tribes, whose lands are in close proximity to each other, might be encouraged to form consortia to establish radio service serving the various Tribes' needs, as well as sharing the expense of starting new radio service. The Commission also determined that Tribes complying with these new criteria might still provide service to very small Tribal populations situated among much larger non-Tribal populations. This is also designed to ensure that the Tribal Priority is used primarily to establish service to Tribal populations and communities, rather than proportionally minimal Tribal populations. The limitations on claiming the Tribal Priority in these situations is subject to waiver requests in appropriate situations (such as proposals covering a number of Tribes, narrowly tailored to minimize non-Tribal coverage, in areas where there is abundant non-Tribal service and no Tribal service).

40. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA.

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

42. The subject rules and policies potentially will apply to all AM and FM radio broadcasting licensees and potential licensees. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. Included in this industry are commercial, religious, educational, and other radio stations. Radio broadcasting stations which primarily are engaged in radio broadcasting and which produce radio program materials are similarly included. However, radio stations that are separate establishments and are primarily engaged in producing radio program material are classified under another NAICS number. The SBA has established a small business size standard for this category, which is: firms having $7 million or less in annual receipts (13 CFR 121.201, NAICS code 515112 (updated for inflation in 2008)). According to BIA Advisory Services, L.L.C., MEDIA Access Pro Database on January 13, 2011, 10,820 (97%) of 11,127 commercial radio stations have revenue of $7 million or less. Therefore, the majority of such entities are small entities. We note, however, that many radio stations are affiliated with much larger corporations having much higher revenue. Our estimate, therefore, likely overstates the number of small entities that might be affected by any ultimate changes to the rules and forms.

43. As described, certain rules and procedures will change, although the changes will not result in substantial increases in burdens on applicants. A question will be modified in FCC Form 340, to reflect the changed tribal coverage provisions for claiming eligibility for the Tribal Priority. These are largely self-identification questions reflecting the applicant's status, although in the case of tribal coverage some geographic analysis may be required, and/or a showing may be needed to establish eligibility for the Tribal Priority in the absence of tribal lands as defined in the First R&O. In certain cases (AM auction filing window applications, FM allotment proceedings, and applications to change community of license), section 307(b) information is already required. In some cases, the procedures set forth in the Second R&O require more stringent analysis of information already requested of such applicants, resulting in little or no increase in burden on those applicants. In other cases, especially with regard to applications to change community of license, applicants may need to perform more analysis than is currently the case, increasing the reporting burden. Also, new showings may be required of certain applicants claiming the Tribal Priority, in order to demonstrate their eligibility for the priority. However, these burdens should be moderate to minimal, and are needed in order to achieve the Commission's statutory mandate of fair, efficient, and equitable distribution of radio service (and, in the case of Tribal Priority claimants, are necessary in order to open up the Tribal Priority to greater numbers of Tribes seeking to establish new radio service). The remaining procedural changes in the Second R&O are either changes in Commission procedures, requiring no input from applicants, or more stringent regulation of existing requirements. For example, AM auction filing window applicants will continue to be evaluated for mutual exclusivity based on the nighttime interference standards set forth in theNelson Enterprises, Inc.case, and any burden will not be increased merely because those standards are now codified. Likewise, codifying a limitation on FM translator “band hopping” applications may require potential applicants to evaluate whether they are eligible to file, but will not require greater reporting burdens.

44. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities (5 U.S.C. 603(c)(1) through (c)(4)).

45. With regard to the proposals in the FNPRM, the Commission did receive and consider two alternative proposals for Tribes without tribal lands wishing to claim the Tribal Priority. The Commission did not adopt either proposal, choosing instead to consider requests for waiver of the tribal coverage criterion of the Tribal Priority. The waiver standard allows requesting parties the flexibility to determine how much or how little information is necessary to overcome the criterion, and thus can be less burdensome than a more rigid standard.

46. In the Rural NPRM, the Commission put forth several alternative proposals for modifications to its section 307(b) evaluation procedures, in an effort to encourage the establishment of new service at smaller and rural communities and prevent stations already serving such communities from moving out. Many of these were ultimately rejected in favor of less burdensome alternatives. For example, the Commission considered not awarding dispositive section 307(b) preferences to AM filing window applicants unless they proposedbona fidefirst transmission service or better, eliminating a Priority (4) “other public interest matters” analysis entirely. After considering comments, the Commission decided that applicants should be afforded the opportunity to demonstrate that they would provide service to underserved populations, and thus that new service at the proposed community fulfilled the objectives underlying section 307(b). The Commission also proposed to require aGreenupService Value Index showing but, due to the expense of such showings, determined that such a showing should be optional but not required. Certain other alternatives, proposed as high priorities or mandatory showings in theRural NPRM,were instead included in Priority (4), other public interest matters or were otherwise downgraded in theSecond R&O.For example, the Commission did not, as proposed, establish a priority for underserved listeners (those who would receive third, fourth, and fifth service), but rather indicated that it would strongly favor such showings under Priority (4); moreover, the Commission did not adopt the proposal to bar absolutely community of license changes that would remove service to underserved listeners, although it indicated it would strongly disfavor such moves. Similarly, the Commission did not adopt a proposal to bar removal of second local transmission service at a community,stating instead that such removals would weigh heavily against such moves in communities of over 7,500 population. These modifications of the Rural NPRM proposals were made based upon comments filed by broadcasters, many of whom are small businesses, and are designed to accommodate their concerns while still rectifying the problems identified by the Commission in making its Rural NPRM proposals. The Commission thus determined that the procedural changes, as adopted, represent the least burdensome means of achieving the stated policy goals.

47. With regard to the proposed rule banning translator “band hopping” applications, the Commission did consider commenter's proposals but decided to adopt the rule as proposed. The alternatives proposed and considered did not, in the Commission's view, fully address the basic unfairness inherent in allowing certain translator permittees and licensees to change frequencies in order to take advantage of different operating rules in another frequency band. Because this practice gives an unfair advantage to a small subset of translator operators, the Commission believed the proposed rule was necessary to make the operating rules uniform for all such operators.

48. The proposed rule applying AM nighttime mutual exclusivity standards to mutually exclusive AM filing window applications merely codifies current procedure established in Commission precedent, and presents no change or new burden on applicants requiring consideration of less burdensome alternatives. The Commission did propose, in the Rural NPRM, to codify certain guidelines for submitting contours using alternate prediction methods. However, in part because commenters identified certain technical difficulties and burdens associated with the proposed guidelines, the Commission declined to adopt the proposal.

49. Finally, the Commission granted on reconsideration a proposal for an alternative tribal coverage provision of the Tribal Priority. As discussed above, Tribes with small tribal lands in some cases could not comply with the Tribal Priority condition that 50 percent or more of the proposed principal community contour cover those tribal lands. Only one proposal was submitted to rectify this problem. While the Commission adopted this proposal, it modified it to provide that the Tribal Priority would not be afforded an applicant who covered more than 50 percent of another, non-applicant Tribe's tribal land. The Commission made this modification to avoid a situation in which Tribes with tribal lands in close proximity raced to be the first to claim limited spectrum in an area. Likewise, on its own motion the Commission determined that proposed service to small Tribal Lands of less than 2,000 population would not be considered significant enough to qualify for the Tribal Priority, and that the Tribal population covered by the proposal is at least 50 percent of the total covered population. This is to avoid the situation in which a relatively small Tribe would gain a priority for service to a potentially much larger non-Tribal population. Thus, while other alternatives were not presented, the Commission considered the problem and arrived at its own modifications in order to avoid potential conflicts among qualified Tribal applicants, and in order to avoid unfairness to non-Tribal applicants at the expense of small Tribes, who nonetheless retain the ability to form consortia to establish new radio service and qualify for the Tribal Priority.

50. The Commission will send a copy of the Second R&O, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801(a)(1)(A)). In addition, the Commission will send a copy of the Second R&O, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the Second R&O, First Order on Reconsideration, and FRFA (or summaries thereof) will also be published in theFederal Register(See5 U.S.C. 604(b)).

51. Accordingly,it is ordered,pursuant to the authority contained in sections 1, 2, 4(i), 303, 307, and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 152, 154(i), 303, 307, and 309(j), that this Second Report and Order, First Order on Reconsideration, and Second Further Notice of Proposed Rule Makingis adopted.

52.It is further orderedthat, pursuant to the authority found in sections 4(i), 303(r), and 628 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), and 548, the Commission's rules are hereby amended as set forth herein.

53.It is further orderedthat the rules adopted herein will become effective May 6, 2011, except for Section 73.7000, which contains information collection requirements that have not been approved by OMB. The Commission will publish a document in theFederal Registerannouncing the effective date.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 73 and 74 to read as follows: