Federal Register Vol. 80, No.157,

The NRC published a final rule in the Federal Register on June 12, 2015 (80 FR 33987), effective July 13, 2015, amending its regulations in part 71 of Title 10 of the Code of Federal Regulations (10 CFR) for the packaging and transportation of radioactive material. These amendments made conforming changes to the NRC's regulations based on the International Atomic Energy Agency's 2009 standards for the international transportation of radioactive material and maintain consistency with the DOT's regulations. The final rule contained minor editorial errors in the definition of Contamination that was added to 10 CFR 71.4, “Definitions,” and contained outdated information for the contact for the rule and for examining the materials that are incorporated by reference. This document corrects the final rule by revising the calculation contained in the definition of Contamination, and updates the contact information in the FOR FURTHER INFORMATION CONTACT section of the final rule's preamble. This document also updates the examination information by referencing the NRC Technical Library in Section XVII, Incorporation by Reference under 1 CFR part 51—Reasonable Availability to Interested Parties, of the final rule's preamble. Similarly, the new 10 CFR 71.70, “Incorporations by reference,” is corrected to reference the NRC Technical Library.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(3)(B), the NRC finds good cause to waive notice and opportunity for comment on the amendments because they will have no substantive impact and are of a minor and administrative nature dealing with corrections to certain CFR sections related only to management, organization, procedure, and practice. Specifically, these amendments are to correct editorial errors. These amendments do not require action by any person or entity regulated by the NRC. Also, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC. Accordingly, for the reasons stated, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make this rule effective upon publication.

In FR Doc. 2015-14212 appearing on page 33987 in the Federal Register of Friday, June 12, 2015, the following corrections to the preamble are made:

1. On page 33988, in the second column, the FOR FURTHER INFORMATION CONTACT section is corrected to read as follows:

FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-3781; email: [email protected].

2. On page 34010, in the third column, last paragraph, in Section XVII, Incorporation by Reference under 1 CFR part 51—Reasonable Availability to Interested Parties, the first sentence is corrected to read as follows:

The two ISO standards incorporated by reference into 10 CFR 71.75 may be examined, by appointment, at the NRC's Technical Library, which is located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301-415-7000; email: [email protected].

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following correcting amendments to 10 CFR part 71:

The Dodd-Frank Wall Street Reform and Consumer-Protection Act (the “Dodd-Frank Act”) was enacted on July 21, 2010.1 Section 1075 of the Dodd-Frank Act amends the Electronic Fund Transfer Act (“EFTA”) (15 U.S.C. 1693 et seq.) to add a new section 920 regarding interchange transaction fees and rules for payment card transactions.2 EFTA section 920(a)(2) provides that the amount of any interchange transaction fee that an issuer receives or charges with respect to an electronic debit transaction must be reasonable and proportional to the cost incurred by the issuer with respect to the transaction.3 Section 920(a)(3) requires the Board to establish standards for assessing whether an interchange transaction fee is reasonable and proportional to the cost incurred by the issuer with respect to the transaction. Without limiting the full range of costs that the Board may consider, section 920(a)(4)(B) requires the Board to distinguish between two types of costs when establishing standards under section 920(a)(3). In particular, section 920(a)(4)(B) requires the Board to distinguish between “the incremental cost incurred by an issuer for the role of the issuer in the authorization, clearance, or settlement of a particular electronic debit transaction,” which the statute requires the Board to consider, and “other costs incurred by an issuer which are not specific to a particular electronic debit transaction,” which the statute prohibits the Board from considering.

Under EFTA section 920(a)(5), the Board may allow for an adjustment to the amount of an interchange transaction fee received or charged by an issuer if (1) such adjustment is reasonably necessary to make allowance for costs incurred by the issuer in preventing fraud in relation to electronic debit card transactions involving that issuer, and (2) the issuer complies with fraud-prevention standards established by the Board. Those standards must, among other things, require issuers to take effective steps to reduce the occurrence of, and costs from, fraud in relation to electronic debit transactions, including through the development and implementation of cost-effective fraud-prevention technology.

The Board promulgated its final rule implementing standards for assessing whether interchange transaction fees meet the requirements of section 920(a) in July 2011. (Regulation II, Debit Card Interchange Fees and Routing, “Final Rule,” codified at 12 CFR part 235).4 Among the provisions of the Final Rule was one relating to transactions-monitoring costs. Transactions-monitoring costs are costs incurred by the issuer during the authorization process to detect indications of fraud or other anomalies in order to assist in the issuer's decision to authorize or decline the transaction. The Board included transactions-monitoring costs as part of the interchange fee standard called for in section 920(a)(3)(A) (costs incurred by an issuer for the issuer's role in the authorization of a particular transaction) based on the Board's determination that these costs are incurred in the course of effecting a particular transaction and an integral part of the authorization of a specific electronic debit transaction.

The Board amended Regulation II on August 3, 2012 to implement the fraud-prevention cost adjustment permitted by EFTA section 920(a)(5).5 Fraud-prevention costs included in that adjustment included costs associated with research and development of new fraud technologies, card reissuance due to fraudulent activity, data security, and card activation.6 These costs are not incurred during the transaction as part of the authorization process.

On March 21, 2014, the Court of Appeals for the District of Columbia Circuit upheld the Board's Final Rule relating to the interchange fee standard. NACS v. Board of Governors of the Federal Reserve System, 746 F.3d 474 (D.C. Cir. 2014).7 The Court of Appeals held, however, that one aspect of the rule—the Board's treatment of transactions-monitoring costs—required further explanation from the Board, and remanded the matter for further proceedings. The Court of Appeals agreed with the Board's position that “transactions-monitoring costs can reasonably qualify both as costs `specific to a particular transaction' (section 920(a)(4)(B)) and as fraud-prevention costs (section 920(a)(5)).” 746 F.3d at 492. The Court held, however, that the Board had not adequately articulated its reasons for including transactions-monitoring in the interchange fee standard rather than in the fraud-prevention adjustment.

In the Final Rule, the Board identified the types of costs that could not be included in the interchange fee standard under section 920(a)(4)(B)(ii) (other costs “not specific to a particular transaction”) on the basis of whether those costs are “incurred in the course of effecting” transactions.8 Costs that were “not incurred in the course of effecting any electronic debit transaction” were determined to be outside of the allowable ambit of the interchange fee standard, but the standard could include “any cost that is not prohibited—i.e., any cost that is incurred in effecting any electronic debit transaction.” 9 Thus, for example, the costs of equipment, hardware, software, and labor associated with transactions processing were properly included in the interchange fee standard because no particular transaction can occur without incurring these costs, and thus these costs are “specific to a particular transaction.” 10 In upholding the rule, the Court of Appeals found this to be “reasonable line-drawing.” 11

The same rationale supports including transactions-monitoring costs in the interchange fee standard. Transactions-monitoring systems, such as neural networks and fraud-risk scoring systems, assist in the authorization process by providing information needed by the issuer in deciding whether the issuer should authorize the transaction before the issuer decides to approve or decline the transaction. Like other authorization steps, such as confirming that a card is valid and authenticating the cardholder, transactions-monitoring is integral to an issuer's decision to authorize a specific transaction.12 In fact, most costs of the authorization process (which are costs Congress required to be considered in determining the interchange fee) assist in preventing some type of fraud. Steps in the authorization process may include ensuring that the transaction is not against an account that has been closed, checking to be sure the card has not been reported lost or stolen, checking that there is an adequate balance, and authenticating the cardholder. Like transactions-monitoring, these authorization steps are all “specific to a particular transaction” in the sense that they occur in connection with each transaction that is authorized or declined. Because the statute requires the Board to consider incremental authorization costs in setting the interchange fee standard, the Board concluded that that it should consider the costs of all activities that are integral to authorization, even if those costs are also incurred for the dual purpose of helping to prevent fraud.

By contrast, fraud-prevention costs that the Board used to calculate the separate fraud-prevention adjustment authorized under section 920(a)(5) were not necessary to effect a particular transaction and were not part of the authorization, clearing, or settlement process, and thus a particular electronic debit transaction could occur without the issuer incurring these costs. As the Board stated in the Final Rule, the types of fraud-prevention activities considered in connection with the fraud-prevention adjustment were those activities designed to prevent debit card fraud at times other than when the issuer is authorizing, settling, or clearing a transaction.13 For example, in setting the fraud-prevention adjustment, the Board considered costs associated with research and development of new fraud prevention technologies, card reissuance due to fraudulent activity, data security, and card activation.14

As noted above, section 920(a)(4)(B) specifically directs the Board to consider in establishing the interchange fee standard the costs “incurred by the issuer for the role of the issuer in the authorization, clearance or settlement of a particular transaction.” Transactions monitoring is an integral part of the authorization process, so that the costs incurred in that process are part of the authorization costs that the Board is required by the statute to consider when establishing the interchange fee standard. In addition, the statutory language of section 920(a)(5), which differs in important respects from section 920(a)(4)(B), supports the Board's decision to include transactions-monitoring costs in the interchange fee standard rather than in the separate fraud prevention adjustment. The costs considered in section 920(a)(5)(A)(i) are those of preventing fraud “in relation to electronic debit transactions,” rather than costs of “a particular electronic debit transaction” referenced in section 920(a)(4)(B). Congress's elimination of the word “particular” and its use of the more general phrase “in relation to,” along with its use of the plural “transactions,” indicates that the fraud-prevention adjustment may take into account an issuer's fraud prevention costs over a broad spectrum of transactions that are not linked to a particular transaction.

Moreover, section 920(a)(5) permits the Board to adopt a separate adjustment “to make allowance for costs incurred by the issuer in preventing fraud in relation to electronic debit transactions involving that issuer” if certain standards are met, and directs that those standards include that the issuers take steps to “reduce the occurrence of, and costs from, fraud in relation to electronic debit transactions,” including “development and implementation of cost-effective fraud prevention technology.” Section 920(a)(5)(A)(i), (A)(ii)(II) (emphasis supplied). The use of the general phrase “fraud in relation to electronic debit transactions” and the specific reference to developing fraud prevention technology suggest a Congressional intent to use the fraud prevention adjustment to encourage issuers to develop and adopt programmatic improvements to address fraud outside of the context of particular transactions that incur costs for authorization, clearance, or settlement. The types of costs the Board included in the separate fraud prevention adjustment are programmatic costs, such as researching and developing new fraud prevention technologies and data security, and other costs that encourage enhanced fraud prevention that are not necessary to effect particular transactions.

The Board is publishing this explanation in accordance with the opinion of the Court of Appeals.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D and Class E airspace at Santa Rosa, CA.

The FAAs Aeronautical Information Services identified that the airport reference point (ARP) was not coincidental with the FAA's aeronautical database. This action makes these corrections. Accordingly, since this action merely adjusts the geographic coordinates of the airport, notice and public procedure under 553(b) are unnecessary.

Class D and E airspace designations are published in paragraphs 5000 and 6004, respectively, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR part 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Y, airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class D airspace and Class E airspace designated as an extension at Charles M. Schulz-Sonoma County Airport, Santa Rosa, CA. The airport's geographic coordinates are adjusted to be in concert with the FAA's aeronautical database. This is an administrative change and does not affect the dimensions or operating requirements of the airspace area.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The Department of State (the Department) administers the Exchange Visitor Program pursuant to the Mutual Educational and Cultural Exchange Act of 1961, as amended (22 U.S.C. 2451, et. seq.), also known as the Fulbright-Hays Act (the Act). The purpose of the Act is to increase mutual understanding between the people of the United States and the people of other countries, including through educational and cultural exchanges. The Department's implementing regulations for the Exchange Visitor Program are set forth at 22 CFR part 62.

In accordance with 22 CFR 62.1(c), the Department's Assistant Secretary for Educational and Cultural Affairs has waived 22 CFR 62.25(c) with respect to an educational and cultural exchange program established pursuant to an arrangement between the Government of the United States of America and the Government of the Republic of Yemen. The program, which begins in August 2015, is for approximately thirty students from the Republic of Yemen currently in the United States on the Kennedy-Lugar Youth Exchange & Study Program (YES). This waiver of 22 CFR 62.25(c), which imposes a one-year maximum program duration for secondary school participants, will allow those students to receive continued educational and cultural programming offered by the Department for a period of one additional year.

PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for September 2015.1

The September 2015 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for August 2015, these interest assumptions represent a decrease of 0.25 percent in the immediate annuity rate and are otherwise unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during September 2015, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

The Smith Point Bridge, mile 6.1, across Narrow Bay, has a vertical clearance in the closed position of 18 feet at mean high water and 19 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(d).

The waterway is transited by seasonal recreational vessels of various sizes.

The Community Family Literacy Project, Inc. requested a temporary deviation from the normal operating schedule to facilitate the 5K Run for Literacy.

Under this temporary deviation the Smith Point Bridge may remain in the closed position for one hour between 9 a.m. and 10 a.m. on Saturday September 12, 2015.

There are no alternate routes for vessel traffic; however, vessels that can pass under the closed draws during this closure may do so at all times. The bridge may be opened in the event of an emergency.

The Coast Guard will inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Southport (SR 27) Bridge, mile 0.7, across the Townsend Gut has a vertical clearance in the closed position of 10 feet at mean high water and 19 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.537.

Maine Department of Transportation requested this temporary deviation from the normal operating schedule to facilitate essential bridge repairs.

Under this temporary deviation, the Southport Bridge (SR 27) may remain in the closed position from 7 a.m. on October 5, 2015 through 7 a.m. on October 6, 2015.

The bridge will be able to open in the event of an emergency. There is no alternate route for vessel traffic; however, vessels that can pass under the closed draws during this closure may do so at any time.

The Coast Guard will inform the users of the waterway through our Local Notice to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Coast Guard is issuing this final rule after publication of NPRM USCG-2015-0563 (80 FR 42072; Jul. 16, 2015) which received no comments.

The legal basis for the rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.

The purpose of this safety zone is to protect mariners and spectators from the hazards associated with the fireworks display, such as accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris.

The Captain of the Port, Delaware Bay, is establishing a safety zone on specified waters that will encompass all waters of Indian River Bay, within a 200 foot radius of the fireworks barge in approximate position 38-36.58 N., 075-09.00 W., adjacent to Millsboro, Delaware. The safety zone will be effective from 8:45 p.m. to 10:15 p.m. on August 22 and September 26, 2015, unless cancelled earlier by the Captain of the Port. Should inclement weather require cancellation of the fireworks display on the above scheduled dates, the safety zone will be effective from 8:45 p.m. to 10:15 p.m. on August 23 and September 27, 2015, respectively.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Delaware Bay, or his designated representative. The Captain of the Port, Delaware Bay, or his representative may be contacted via VHF channel 16 or at 215-271-4807.

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

This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this regulation will restrict access to the regulated area, the effect of this rule will not be significant because: (i) The Coast Guard will make extensive notification of the Safety Zone to the maritime public via maritime advisories so mariners can alter their plans accordingly; (ii) vessels may still be permitted to transit through the safety zone with the permission of the Captain of the Port on a case-by-case basis; and (iii) the size and duration of the zone are relatively limited in scope.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities.

This proposed rule would affect the following entities, some of which may be small entities: The owners or operators of vessels intending to anchor or transit along Indian River Bay, adjacent to Millsboro, Delaware, on August 22 and September 26, 2015, from 8:45 p.m. until 10:15 p.m., unless cancelled earlier by the Captain of the Port.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reason: vessel traffic will be allowed to pass through the zone with permission of the Coast Guard Captain of the Port, Delaware Bay, or his designated representative and the safety zone is limited in size and duration. The Coast Guard will issue maritime advisories widely available to users of Indian River Bay.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves implementation of regulations within 33 CFR part 165, applicable to safety zones on the navigable waterways. This zone will temporarily restrict vessel traffic from anchoring or transiting a portion of Indian River Bay near Millsboro, Delaware, in order to protect the safety of life and property on the waters while a fireworks display is conducted. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Table of Acronyms COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking NAD 83 North American Datum 1983 A. Regulatory History and Information

This rulemaking establishes six safety zones for six fireworks displays. Each event and its corresponding regulatory history are discussed below.

Sag Harbor Fire Department Fireworks is a first time marine event with no regulatory history.

Sebonack Golf Club Fireworks is a reoccurring marine event with regulatory history and is cited in 33 CFR 165.151(7.44). This event has been included in this rule due to deviation from the date and location in this cite.

Wood Family Celebration Fireworks is a first time marine event with no regulatory history.

Baker Annual Summer Celebration is a recurring marine event with regulatory history. A safety zone was established for this event on August 16, 2014 via a temporary final rule entitled, “Safety Zones; Marine Events in Captain of the Port Long Island Zone”. This rule was published on August 18, 2014 in the Federal Register (79 FR 48685).

Clinton Chamber of Commerce Fireworks is a first time marine event with no regulatory history.

Old Black Point Beach Fireworks is a reoccurring marine event with regulatory history and is cited in 33 CFR 165.151(8.3). This event has been included in this rule due to deviation from the location in this cite.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. There is insufficient time to publish an NPRM and solicit comments from the public before these events take place. Thus, waiting for a comment period to run would inhibit the Coast Guard's ability to fulfill its mission to keep the ports and waterways safe.

Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The legal basis for this temporary rule is 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5 and Department of Homeland Security Delegation No. 0170.1 which collectively authorize the Coast Guard to define regulatory safety zones.

Six fireworks displays will take place in the Coast Guard Sector LIS COTP Zone between August 7, 2015 and August 23, 2015. The COTP Sector LIS has determined that the six safety zones established by this temporary final rule are necessary to provide for the safety of life on navigable waterways during those events.

Sag Harbor Fire Department Fireworks will be held at a land launch at Havens Beach, Sag Harbor, NY.

Sebonack Golf Club Fireworks will be held on Peconic Bay, Southampton, NY.

Wood Family Celebration Fireworks will be held on Peconic Bay, Jamesport, NY.

Baker Annual Summer Celebration will be held on Flanders Bay, Southampton, NY.

Clinton Chamber of Commerce Fireworks will be held at a land launch at Clinton Town Beach, Clinton, CT.

Old Black Point Beach Fireworks will be held at a land launch at Old Black Point Beach, Niantic, CT.

This rule establishes six safety zones for six fireworks displays. The location of these safety zones are as follows:

These fireworks displays will launch pyrotechnics from either a landsite near a waterway or from a barge on a waterway. Regulated areas, specifically safety zones, are required for these fireworks displays to protect both spectators and participants from the safety hazards created by the fireworks displays, including unexpected pyrotechnics detonation and burning debris.

This rule prevents vessels from entering, transiting, mooring, or anchoring within areas specifically designated as a safety zone and restricts vessel movement around the location of the marine event to reduce the safety risks associated with them during the periods of enforcement unless authorized by the COTP or designated representative.

The Coast Guard will notify the public and local mariners of these safety zones through appropriate means, which may include, but are not limited to, publication in the Federal Register, the Local Notice to Mariners, and Broadcast Notice to Mariners.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) The enforcement of these safety zones will be relatively short in duration; (2)persons or vessels desiring to enter a safety zone may do so with permission from the COTP Sector LIS or a designated representative; (3) these safety zones are designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterways not designated as a safety zone; and (4) the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners to increase public awareness of these safety zones.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This temporary final rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit, anchor, or moor within a safety zone during the periods of enforcement, from August 7, 2015 to August 23, 2015. However, this temporary final rule will not have a significant economic impact on a substantial number of small entities for the same reasons discussed in the Regulatory Planning and Review section.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves the establishment of safety zones. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zones listed in 33 CFR 165.160 on the specified dates and times as indicated in Table 1 below. This regulation was published in the Federal Register on November 9, 2011 (76 FR 69614).

Under the provisions of 33 CFR 165.160, vessels may not enter the safety zones unless given permission from the COTP or a designated representative. Spectator vessels may transit outside the safety zones but may not anchor, block, loiter in, or impede the transit of other vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 165.160(a) and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide mariners with advanced notification of enforcement periods via the Local Notice to Mariners and marine information broadcasts.

If the COTP determines that a safety zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the safety zone.

Purpose of Program: Under the Rehabilitation Act of 1973 (Rehabilitation Act), as amended by the Workforce Innovation and Opportunity Act (WIOA), the Rehabilitation Services Administration (RSA) makes grants to States and public or nonprofit agencies and organizations (including institutions of higher education (IHEs)) to support projects that provide training, traineeships, and technical assistance (TA) designed to increase the numbers of, and improve the skills of, qualified personnel, especially rehabilitation counselors, who are trained to provide vocational, medical, social, and psychological rehabilitation services to individuals with disabilities; assist individuals with communication and related disorders; and provide other services authorized under the Rehabilitation Act.

Applicable Program Regulations: 34 CFR part 385.

We published a notice of proposed priority and definitions (NPP) for this competition in the Federal Register on June 26, 2015 (80 FR 36736). That notice contained background information and our reasons for proposing the particular priority and definitions. Other than minor, technical revisions, there are no differences between the proposed priority and definitions and the final priority and definitions.

Public Comment: In response to our invitation in the NPP, three parties submitted comments.

Generally, we do not address technical and other minor changes.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priority and definitions since publication of the NPP follows.

Comment: One commenter suggested that consideration be given under paragraph (c) of the Application Requirements, “Quality of the Evaluation Plan,” to plans that have a strong qualitative evaluation component, such as measuring outcomes that include a focus on positive deviance and those factors associated with successful employment outcomes.

Discussion: We agree with the commenter that qualitative evaluation components should be an important aspect of the evaluation plan for the priority. We believe that the requirements in the priority sufficiently address any concern about strong qualitative evaluation. We decline to require applicants to propose an evaluation plan with a focus on the specific qualitative components that the commenter suggests, as we want applicants to have the flexibility to propose an evaluation plan that is tailored to the applicants' specific proposed projects. However, nothing in the priority precludes applicants from including in their evaluation plan the components suggested by the commenter.

Changes: None.

Comment: One commenter suggested we include in the definition of “high-leverage groups with national applicability” a category for individuals with disabilities of employable age who are living in institutional or similar settings. The commenter noted that there are many individuals living in such settings who are waiting for long periods to receive community and employment supports, but who would want or need to work.

Discussion: We agree that providing community living and employment supports to individuals who are living in institutional or similar settings addresses an important problem, but the priority is not intended to address the lack of community-based supports for individuals residing in these types of settings. Rather, the priority is designed to improve VR participation and employment outcomes for individuals who are living in low-income communities, and for whom poverty creates additional barriers to VR participation. Of course, there may be some overlap with individuals with disabilities who live in community group homes or similar situations in low-income areas. To the extent that these overlaps exist, the individuals highlighted by the commenter would directly benefit from this priority.

Changes: None.

Comment: One commenter recommended that a mix of rural and urban settings be considered in selecting the targeted communities because resources, employment options, and other characteristics differ greatly between urban and rural settings.

Discussion: We agree that the issues facing individuals with disabilities living in rural areas often differ from issues facing individuals with disabilities in urban areas. Residents of rural and remote areas are included in the definition of “high-leverage groups with national applicability,” and therefore could be addressed in the TA provided by the VRTAC-TC. Additionally, in reviewing the TA proposals from the VRTAC-TC, RSA will ensure that the selected targeted communities reflect a wide variety of communities.

Changes: None.

Comment: One commenter recommended that we include the analysis of findings and best practices available from the PROMISE (Promoting Readiness of Minors in Social Security Income) grant sites as a first-year activity for the VRTAC, because PROMISE grant sites also seek to establish collaborative, wrap-around services, though for children receiving Supplemental Security Income (SSI).

Discussion: Nothing in the priority would preclude an applicant from including the review of available information from PROMISE projects in its proposed knowledge development activities. However, please note that while such projects may be able to provide valuable information on lessons learned in the implementation of collaborative service strategies during the first year of the VRTAC-TC, it is unlikely that new findings on best practices will be available during this time period.

Changes: None.

Comment: One commenter indicated a concern about the lack of regionally based TA that was formerly provided by the Regional Technical Assistance and Continuing Education (TACE) centers.

Discussion: We recognize the commenter's concern, and it is one that was raised and addressed in the notice of final priority for the Job-Driven Vocational Rehabilitation Technical Assistance Center (79 FR 48983). The VRTAC-TC is not intended to provide comprehensive TA to State VR agencies in the way that the TACE centers were intended to do. Instead, the VRTAC-TC will focus on addressing the long-term and systemic issues facing persistently under-served communities across the Nation (including in eight of the nine Census divisions). While we intend that the communities chosen and the strategies developed for responding to their needs will have national applicability, not all State VR agencies will be able to use all of the tools or resources developed by the VRTAC-TC. However, we believe that across RSA's suite of TA investments, the varying needs of State VR agencies will be adequately met, despite RSA's decision not to continue support for the TACE program.

Changes: None.

Final Priority:

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for a cooperative agreement to establish a Vocational Rehabilitation Technical Assistance Center for Targeted Communities (VRTAC-TC) to provide technical assistance (TA) and training to upgrade and increase the competency, skills, and knowledge of vocational rehabilitation (VR) counselors and other professionals to assist economically disadvantaged individuals with disabilities (as defined in this notice) to achieve competitive integrated employment outcomes.

The VRTAC-TC will facilitate linkages for the State VR agencies through substantial outreach to partner agencies within targeted communities (as defined in this notice) to increase the resources and key partnerships needed to address the daily living stressors that often result in unsuccessful VR case closures, including childcare needs, homelessness, hunger, safety concerns, interpersonal issues, and lack of transportation, basic or remedial education services, and literacy services.

The VRTAC-TC must, at a minimum, develop and provide training, TA, and opportunities for ongoing discussion in each of the following areas to rehabilitation professionals and staff from both (1) the State VR agencies and partner agencies who are serving the targeted communities, and (2) diverse service providers throughout the Nation, including State VR agency staff, who work with high-leverage groups with national applicability (as defined in this notice) in other economically disadvantaged communities similar to the targeted communities that are the focus of this priority:

(a) Developing and maintaining formal and informal partnerships and relationships with relevant stakeholders (including, but not limited to, State and local social service and community development agencies, correctional facilities, community rehabilitation programs (CRPs), school systems, and employers) for the following coordinated activities:

(1) Increasing referrals to the State VR system for economically disadvantaged individuals with disabilities from at least two high-leverage groups with national applicability residing in each of the targeted communities; and

(2) Facilitating the provision of support services by stakeholders to VR consumers and applicants from at least two high-leverage groups with national applicability residing in each of the targeted communities;

(b) Developing and implementing outreach policies and procedures based on evidence-based and promising practices that ensure that consumers with disabilities from each of the targeted communities are located, identified, and evaluated for services; and

(c) Developing and implementing collaborative and coordinated service strategies designed to increase the number of consumers with disabilities from targeted communities who are served by the State VR agencies, receive support services from other stakeholders, and obtain, maintain, regain, or advance in competitive integrated employment.

Project Activities:

To meet the requirements of this priority, the VRTAC-TC must, at a minimum, conduct the following activities:

(a) Within the first year, survey each of the 80 State VR agencies regarding the action steps, including emerging, promising, and evidence-based practices utilized, that the VR agencies have previously used to address substandard participation levels and performance outcomes achieved by residents of targeted communities within their States;

(b) Within the first year, conduct a literature review of emerging, promising, and evidence-based practices relevant to the work of the VRTAC-TC. The review should include, at a minimum, research on place-based interventions and the particular needs of economically disadvantaged individuals with disabilities;

(c) By the end of the first year, post on its Web site the results of its survey and literature review; and

(d) Categorize, analyze, and provide an opportunity for interactive commentary by VR professionals about all information posted on its Web site in order to identify the workforce participation challenges and resources that underserved individuals with disabilities (as defined in this notice) from economically disadvantaged communities tend to have in common and to identify examples of the types of VR services that have been used to address their employment and training needs. This interactive process should facilitate both evaluating and adjusting the ongoing and planned interventions within the targeted communities and the development of effective practices for the nationwide VR community.

(a) In the first year, survey each of the 80 State VR agencies to identify two or more groups of underserved individuals with disabilities from one or more targeted communities in each of their respective States. All identified targeted communities in each State must meet the eligibility requirements for designation as an Empowerment Zone under either 24 CFR 598.100 or 7 CFR 25.100;

(b) Develop intensive TA (as defined in this notice) proposals for at least 20 targeted communities to present to the Rehabilitation Services Administration (RSA). The proposals must:

(1) Include communities that reflect national diversity with respect to State, region, and culture. Communities must be situated in at least 12 States and territories located within no fewer than eight of the nine Census Divisions (State groupings) defined by the U.S. Census Bureau (For more information on Census Divisions, see www.census.gov/geo/reference/gtc/gtc_census_divreg.html). No more than two targeted communities may be located within any one State or territory, and no more than four may be located within any one Census Division; and

(2) Include the following information for each targeted community recommended:

(A) A map that shows the targeted community's boundaries and relevant demographic characteristics, including poverty concentration;

(B) Documentation that within the targeted community's boundaries:

(i) The median household income is below 200 percent of the Federal poverty level; and

(ii) The rate of unemployment is at or above the national annual average rate;

(C) A performance chart of State VR agency data that documents substandard participation levels and performance outcomes achieved by VR consumers and applicants from high-leverage groups with national applicability from the targeted communities in comparison to the State's overall performance that includes the following for all relevant groups:

(i) The number of applicants and percentage of the overall population;

(ii) The number and percentage of individuals determined eligible;

(iii) The number and percentage of individuals receiving VR services pursuant to an individualized plan for employment;

(iv) The number and percentage of individuals whose service records were closed without employment; and

(v) The number and percentage of individuals whose service records were closed after achieving employment;

(D) A brief (one or two pages) overview by the State VR agency addressing the following for high-leverage groups with national applicability from the targeted communities:

(i) The factors that the agency believes have contributed to the substandard performance outlined in the chart; and

(ii) Action steps that the VR agency has previously taken to address these performance gaps;

(E) A two- or three-page proposed intensive TA work plan by the VRTAC-TC that addresses:

(i) The performance gaps summarized in the chart required by paragraph (b)(2)(C) of this section;

(ii) The barriers to employment described in the State VR agency's overview statement required by paragraph (b)(2)(D) of this section;

(iii) The strategies being proposed to remediate the identified barriers in the targeted community;

(iv) The potential replicability of the strategies in the work plan for targeted communities in other parts of the State; and

(v) The potential to replicate the strategies in the work plan for targeted communities in other States; and

(F) Letters of support from the State VR agency and partners in the community (e.g., employers, secondary and post-secondary educational institutions, and community leaders) stating their intent to work cooperatively with the VRTAC-TC should the targeted community be chosen as a recipient of intensive TA.

(a) By the end of the first year, provide RSA with, at minimum, 10 proposals (as described in paragraph (b) of the “Targeted Community Selection and Development” section of this priority) from which RSA will select six to receive intensive TA from the VRTAC-TC;

(b) By no later than the third quarter of the second year provide RSA with, at minimum, 10 proposals (as described in paragraph (b) of the “Targeted Community Selection and Development” section of this priority) in addition to the proposals described in paragraph (a) of this section, from which RSA will select six to receive intensive TA from the VRTAC-TC;

(c) By no later than the first quarter of the second year, begin providing intensive TA to VR staff, CRPs, employers, education and training entities, and community leaders, as appropriate, in at least three of the targeted communities approved by RSA in the first year;

(d) By no later than the third quarter of the second year, be providing intensive TA to VR staff, CRPs, employers, education and training entities, and community leaders, as appropriate, in all targeted communities approved by RSA in the first year;

(e) By no later than the first quarter of the third year, begin providing intensive TA to VR staff, CRPs, employers, education and training entities, and community leaders, as appropriate, in at least three of the targeted communities approved by RSA in the second year; and

(f) By no later than the third quarter of the third year, be providing intensive TA to VR staff, CRPs, employers, education and training entities, and community leaders, as appropriate, to all targeted communities approved by RSA in the second year.

(a) At a minimum, provide intensive TA that is aligned with the proposals described in paragraph (b) of the “Targeted Community Selection and Development” section of this priority to the VR agency within each of the targeted communities on the following topic areas, as appropriate:

(1) Using labor market data and occupational information to provide individuals with disabilities from high-leverage groups with national applicability who reside in targeted communities with information about job demand, skills matching, supports, education, training, and career options;

(2) Providing disability-related consultation and services to employers about competitive integrated employment of economically disadvantaged individuals with disabilities from high-leverage groups with national applicability;

(3) Building and maintaining relationships in targeted communities with industry leaders, employer associations, and prospective employers of economically disadvantaged individuals with disabilities from high-leverage groups with national applicability;

(4) Building and maintaining relationships with secondary and post-secondary institutions and CRPs that serve to support transition activities and leverage programs and providers of basic education, remedial learning, and literacy services to the targeted communities and are committed to providing individualized wrap-around VR services that are attuned to the remedial and ongoing support services needed by economically disadvantaged individuals with disabilities;

(5) Building and maintaining alliances with schools, community organizations, and business leaders with a heightened understanding of the acculturation and assimilation issues within the targeted communities regarding culture, religion, language, dialect, and socioeconomic status that might be impeding full participation of the economically disadvantaged individuals with disabilities from high-leverage groups with national applicability; and

(6) Developing services for providers of customized training and other types of training that are directly responsive to employer needs and hiring requirements for economically disadvantaged individuals with disabilities from high-leverage groups with national applicability;

(b) By the end of the first year, post on its Web site State agency overview statements specific to high-leverage groups with national applicability along with related VR research studies identified by the VRTAC-TC;

(c) Establish no fewer than two communities of practice with the following areas of focus:

(1) One community of practice should be designed to specifically support State VR agency and related agency staff and management serving targeted communities; and

(2) One community of practice should be designed to be open to all staff and management serving economically disadvantaged communities nationwide and to address the employment needs of individuals with disabilities in those communities;

(d) Ensure that the communities of practice described in paragraph (c) of this section focus on partnerships across service systems designed to develop, implement, adjust, support, and evaluate VR processes and strategies for promoting competitive integrated employment for high-leverage groups with national applicability from targeted communities; and

(e) Develop and make available to State VR agencies and their associated rehabilitation professionals and service providers a range of targeted TA and general TA products and services designed to increase VR participation levels and outcomes achieved by individuals with disabilities from targeted communities. This TA must include, at a minimum, the following activities:

(1) Developing and maintaining a state-of-the-art information technology (IT) platform sufficient to support Webinars, teleconferences, video conferences, and other virtual methods of dissemination of information and TA; and

(2) Ensuring that all TA products are sent to the National Center for Rehabilitation Training Materials, including course curricula, audiovisual materials, Webinars, and examples of emerging and best practices related to this priority;

(f) During the fourth quarter of both the second year and the fourth year, develop and implement year-end national State VR agency forums dedicated to discussing the progress and lessons learned from the targeted communities; and

(g) During the fourth quarter of the fifth year, present a national results meeting to State VR agencies to review the data collected, best practices developed, and lessons learned from the intensive intervention sites served within the 12 targeted communities, as well as the communities of practice described in paragraph (c) of this section.

(a) Facilitate communication and coordination on an ongoing basis with other Federal agencies, State agencies, and local government workforce development partners, as well as private and nonprofit social service agencies and other VR TA centers funded by RSA, in order to:

(1) Maximize existing individual and community assets to effectively address socioeconomic issues that impact employment and overall well-being;

(2) Create a mechanism for partner organizations and community members to participate in the VR program planning process, including brainstorming and vetting new ideas and approaches to VR service provision;

(3) Create an active online community of practice that addresses the needs of participants;

(4) Organize the online community of practice to address both general barriers to employment faced by individuals with disabilities from targeted communities, and barriers to employment faced by individuals with disabilities from diverse high-leverage groups with national applicability including, but not limited to, adjudicated adults and youth, persons with multiple disabilities, and high school dropouts; and

(5) Provide greater access for targeted communities to culturally relevant VR services provided by State VR agency personnel with the support of VRTAC-TC staff and community partners;

(b) Communicate and coordinate, on an ongoing basis, with the communities of practice described in paragraph (c) of the “Technical Assistance Activities” section of this priority; and

(c) Maintain ongoing communications with the RSA project officer.

Application Requirements:

To be funded under this priority, applicants must meet the following application requirements. RSA encourages innovative approaches to meet these requirements, which are:

(a) Demonstrate, in the narrative section of the application, under “Significance of the Project,” how the proposed project will—

(1) Recruit State VR agencies to identify targeted communities with intensive TA needs to take part in the services supported by this priority, including a detailed description of the primary factors and processes proposed to facilitate the identification and selection of these communities;

(2) Address State VR agencies' capacity to meet the employment and training needs of individuals with disabilities from high-leverage groups with national applicability from targeted communities. To meet this requirement, the applicant must:

(i) Demonstrate knowledge of emerging and best practices in conducting outreach and providing VR services to applicants and consumers from economically disadvantaged communities; and

(ii) Demonstrate knowledge of emerging and best practices in conducting outreach and providing VR services to high-leverage groups with national applicability that are frequently reported as underserved or achieving substandard employment outcomes in statewide comprehensive needs assessments, VR-related research studies, or monitoring reports prepared by RSA pursuant to periodic onsite monitoring visits; and

(3) Result in increases both in the number of individuals with disabilities from high-leverage groups with national applicability receiving services from State VR agencies within targeted communities and the number and quality of employment outcomes in competitive integrated employment achieved by these individuals;

(b) Demonstrate, in the narrative section of the application, under “Quality of Project Services,” how the proposed project will—

(1) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes;

(ii) A plan for how the proposed project will achieve its intended outcomes; and

(iii) A plan for communicating and coordinating with key staff in State VR agencies, State and local partner programs, RSA partners such as the Council of State Administrators of Vocational Rehabilitation and the National Council of State Agencies for the Blind, and other TA Centers and relevant programs within the Departments of Education, Labor, and Commerce;

(2) Use a conceptual framework to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

(3) Be based on current research and make use of evidence-based and promising practices;

(4) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project;

(5) Develop products and implement services to maximize the project's efficiency. To address this requirement, the applicant must describe—

(i) How the proposed project will use technology to achieve the intended project outcomes; and

(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;

(c) Demonstrate, in the narrative section of the application under “Quality of the Evaluation Plan,” how the proposed project will—

(1) Measure and track the effectiveness of the TA provided. To meet this requirement, the applicant must describe its proposed approach to—

(i) Collecting data on the effectiveness of the TA activity from State VR agencies, partners, or other sources, as appropriate; and

(ii) Analyzing data and determining the effectiveness of the TA provided for at least two high-leverage groups with national applicability residing in each of the 12 targeted communities. This process includes evaluation of the effectiveness of current practices within the selected targeted communities throughout the project period, with a goal of demonstrating substantial progress towards achieving outcome parity for the high-leverage groups and other targeted groups with the State VR agency's overall performance with respect to number of applications received and processed, eligibility assessments completed, and both the number and quality of employment outcomes achieved;

(2) Conduct an evaluation of progress made by all of the targeted communities on an annual basis. At the end of the final year of the project, the VRTAC-TC will submit a final report on the project performance to detail the outcomes of individuals with disabilities in the targeted communities. The evaluation will utilize multiple data points as evidence of progress as compared to the baseline established at the beginning of the project, including State VR agency reported data, changes in State policies and procedures, customer surveys, and State personnel input, as well as any other relevant stakeholder input; and

(3) Collect and analyze preliminary quantitative and qualitative data of VR services facilitated and the outcomes achieved by economically disadvantaged individuals with disabilities in at least one other part of the State in which a targeted community is located. State VR personnel from the targeted communities approved by RSA within the first year will serve as trainers for colleagues in other parts of the State by applying or modifying the strategies learned from the VRTAC-TC;

(d) Demonstrate, in the narrative section of the application under “Adequacy of Project Resources,” how—

(1) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to provide TA to State VR agencies and their partners for each of the activities in this priority and to achieve the project's intended outcomes;

(2) The applicant and any key partners have adequate resources to carry out the proposed activities; and

(3) The proposed costs are reasonable in relation to the anticipated results and benefits;

(e) Demonstrate, in the narrative section of the application under “Quality of the Management Plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes, including an assurance that such personnel will have adequate availability to ensure timely communications with stakeholders and RSA;

(3) The proposed management plan will ensure that the products and services provided are of high quality; and

(4) The proposed project will benefit from a diversity of perspectives, including those of State and local personnel, TA providers, researchers, and policy makers, among others, in its development and operation.

Types of Priorities:

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

Final Definitions:

The Assistant Secretary announces the following definitions for this program. We may apply one or more of these definitions in any year in which this program is in effect.

Economically disadvantaged individuals with disabilities means individuals with disabilities who are from a household with a median household income below 200 percent of the Federal poverty level; individuals receiving Federal financial assistance through Temporary Assistance to Needy Families (TANF), Social Security Disability Insurance (SSDI), or Supplemental Security Income (SSI); or individuals residing in public housing and participating in the Section 8 housing-choice voucher program.

General technical assistance (TA) means TA and information provided to independent users through their own initiative, resulting in minimal interaction with TA center staff and including one-time, invited or offered conference presentations by TA center staff. This category of TA also includes information or products, such as newsletters, guidebooks, or research syntheses, downloaded from the TA center's Web site by independent users. Brief communications by TA center staff with recipients, either by telephone or email, are also considered universal, general TA.

High-leverage groups with national applicability means groups of individuals with disabilities who are frequently identified by State VR agencies throughout the Nation in their statewide comprehensive needs assessments as groups comprised of individuals that are either underserved or who have achieved substandard performance. Examples of these groups include, but are not limited to, the following populations:

(A) Residents of rural and remote communities;

(B) Adjudicated adults and youth;

(C) Youth with disabilities in foster care;

(D) Individuals with disabilities receiving Federal financial assistance through TANF;

(E) Culturally diverse populations, e.g., African Americans, Native Americans, and non-English speaking populations;

(F) High school dropouts and functionally illiterate consumers;

(G) Persons with multiple disabilities, e.g., deaf-blindness, HIV/AIDS-substance abuse; and

(H) SSI and SSDI recipients, including subminimum-wage employees.

Intensive technical assistance (TA) means TA services often provided on-site and requiring a stable, ongoing relationship between the VRTAC-TC staff and the TA recipient. Intensive TA should result in changes to policy, programs, practices, or operations that support increased recipient capacity or improved outcomes at one or more systems levels.

Targeted community means any economically disadvantaged community that qualifies as an Empowerment Zone under either 24 CFR 598.100 or 7 CFR 25.100, and in which (a) the median household income is below 200 percent of the Federal poverty level; (b) the unemployment rate is at or above the national average; and (c) as a group, individuals with disabilities have historically sought, been determined eligible for, or received VR services from a State VR agency at less than 65 percent of the average rate for the State VR agency, or who have achieved competitive integrated employment outcomes subsequent to receiving VR services at 65 percent or less of the State VR agency's overall employment outcome level.

Targeted technical assistance (TA) means TA services based on needs common to multiple recipients and not extensively individualized. A relationship is established between the TA recipient and one or more TA center staff. This category of TA includes one-time, labor-intensive events, such as facilitating strategic planning or hosting regional or national conferences. It can also include episodic, less labor-intensive events that extend over a period of time, such as facilitating a series of conference calls on single or multiple topics that are designed around the needs of the recipients. Facilitating communities of practice can also be considered targeted, specialized TA.

Underserved individuals with disabilities means individuals with disabilities who, because of disability, place of residence, geographic location, age, race, gender, or socioeconomic status, have not historically sought, been determined eligible for, or received VR services at a rate of 65 percent or more of the State's overall service level groups. Underserved individuals include, but are not limited to, subminimum wage employees; adjudicated youth and adults; culturally diverse populations such as African Americans, Native Americans, and non-English speaking persons; individuals living in rural areas; and persons with multiple disabilities such as deaf-blindness.

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Note: This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register.

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

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

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing the final priority and definitions only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

The benefits of the Rehabilitation Training program have been well established over the years through the successful completion of similar projects. The priority and definitions would better prepare State VR agency personnel to assist individuals with disabilities living in targeted communities to achieve competitive integrated employment in today's challenging labor market.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program. Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

On April 14, 2015, at 80 FR 19914, the U.S. Postal Service proposed to adopt a new USPS STD 7C, to replace USPS STD 7B which currently governs the design of city and rural curbside mailboxes. Pursuant to the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®) 508.3.2.1, USPS STD 7 applies to mailboxes manufactured to be erected at the edge of a roadway or curbside of a street and to be served by a carrier from a vehicle on any city route, rural route, or highway contract route. Copies of USPS STD 7, or other information about the manufacture of curbside boxes may be obtained from USPS Engineering, 8403 Lee Highway, Merrifield, VA 22082-8101 (see DMM 608.8.0). We proposed this action because the current standard, effective February 8, 2001 (66 FR 9509-9522), prescribes designs that in several respects are no longer ideal for the operational requirements of the Postal Service. As detailed in our proposal, the design and performance requirements for new versions of both locking and non-locking curbside mailboxes were included in the proposed USPS STD 7C. As proposed, the new STD 7C most notably:

• Provided design parameters for a new version of locked and non-locked mailbox designs that can accommodate the insertion and removal of a test gauge measuring 7 inches high by 13 inches wide by 16 inches deep.

• To thwart quick-strike attacks, introduced the requirement that the new locked mailbox designs must pass a 3-minute physical security test of the customer access door (using commonly available hand and pry tools) and a 3-minute manual test to ensure that no mail item can be removed through the front carrier access door.

• Reaffirmed the prohibition of any style of locks, locking devices, or inserts that require the carrier to use a key or restrict or reduce the interior opening of the mailbox, once the front door has been fully opened for any approved non-locked curbside mailbox. (To assure the effectiveness of the new minimum parcel capacity requirement under USPS STD 7C, internal obstructions that prevent this requirement from being met would result in a suspension of service when the situation is identified.)

• Introduced minimal door catch and signal flag force tests to ensure those components meet prescribed limits.

• Updated the provisions regarding Application Requirements and Approval or Disapproval to establish a new 180-day time limit for the submission of a mailbox for security testing (if applicable), and final review after the manufacturer has received approval of a design upon preliminary review.

• Provided updated quality requirements in a new section exclusively concerned with Quality Management System Provisions.

• Introduced provisions concerning the use of both USPS and third-party intellectual property, including the requirement that manufacturers agree not to use USPS marks without USPS approval, have sole responsibility for acquiring all necessary licenses for the use of third-party intellectual property, and bear all liability concerning the use of third-party intellectual property regarding any USPS approved mailboxes.

We believe that instituting these mailbox design options will allow for improvement in the Postal Service's capacity for this mode of delivery as vendors choose to produce these curbside mailboxes, and the mailboxes come into widespread use.

As a further matter, we note that the addition of these new design options would not have any impact on any currently approved USPS STD 7B product. Any mailbox manufacturer wishing to seek approval for either or both of the new locked and non-locked design options introduced by USPS STD 7C would follow the process detailed in the new standard.

We received comments from two firms involved in the manufacture of mailboxes. One set of comments focused on the security tests proposed for the new locked, large-capacity designs. The other set of comments covered a broader range of topics, including the timeframe established for the mailbox review process, the number and type of drawings required to accompany a mailbox submitted for approval, certain unintentional errors in the mailbox design figures, the dimensions and color of the mailbox flag, the design and dimensions of the slot for locked mailbox designs, and the need to provide information regarding how to obtain permission for the use of proprietary USPS marks. Our response to these comments is as follows.

With regard to the security testing requirements for locked, large capacity mailboxes set forth in section 4.12 of the proposed standard, one set of comments suggested that we should further standardize the testing process by providing a specific list of “pry tools, defined even by specific brands and model available in the marketplace,” to be used in the tests. We declined to accept this suggestion, in the belief that the current, more generic description of “tools such as screwdrivers, flat plates, knives, pry bars, vise grips, pliers, chisels, and punches'' was adequate for testing purposes.

The same set of comments also suggested that the maximum length of pry tools used for testing should be reduced from 18 inches to reflect the more typical dimensions of such instruments (as well as establish a more reasonable balance between security and cost), and that the manual test for removal of items through an opened carrier access door should specify that no tools were to be used. These suggestions were accepted. The maximum length of pry tools for testing purposes was reduced to 12 inches, and it is specified that no tools were to be used in the manual test.

The second set of comments questioned certain aspects of the mailbox review process in section 6.1 of the proposed standard, including the 180-day time limit for submitting a mailbox for final review after receiving preliminary approval, and the requirement that two paper drawing sets be provided. These comments addressed the timeframe required to move from a conceptual design to a production unit that can be released for tooling, as well as complete the third-party testing process. The comments also questioned the reliance on 2-D paper drawings, in view of the growing reliance on 3-D electronic drawings for the manufacturing process. These suggestions were accepted. The 180-day time limit was extended to one year, and the requirement for two paper drawings has been replaced by a requirement for one paper drawing set and one electronic drawing set.

This set of comments also questioned the width of the mailbox door handles shown in design Figure 5 of the proposed standards, and suggested that they reflected a change from the current standards of USPS STD 7B. No such dimensional changes were intended, and Figure 5 has been reworked accordingly.

These comments also suggested the need for clarification of the requirements concerning the flag dimension for traditional mailboxes in Figure 1A, and more specificity regarding the requirement in section 3.9 that the color of the flag present a “clear contrast” with the predominant color of the mailbox. These suggestions were not accepted. We believe that such changes to longstanding requirements for boxes already approved under former STD 7B would not be appropriate in this context.

These comments further questioned the requirement in section 3.1.2.1 that the slot for a locked mailbox measure at least 1.75 inches high by 10 inches wide, suggesting that other shapes (such as a modified trapezoid) that allowed the insertion of the test gauges should be acceptable. This change was not accepted. We believe that the dimensions as proposed will facilitate the delivery of mail to the new boxes by simplifying the carrier's task.

With regard to the rules concerning the use of intellectual property in section 3.14 of the proposed standard, these comments also inquired how a manufacturer might obtain a “license” to use USPS marks. In response, we have included the online address of the Postal Service's Rights and Permissions information in a footnote to that section.

For these reasons, the Postal Service has determined to replace USPS STD 7B with USPS STD 7C as set forth in the Appendix to this document.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1. Accordingly, for the reasons stated in the preamble, 39 CFR part 111 is amended as follows:

I. Background

The SIP is a living document which the state revises as necessary to address the unique air pollution problems in the state. Therefore, EPA from time to time must take action on SIP revisions containing new and/or revised regulations to make them part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference Federally-approved SIPs, as a result of consultations between EPA and the Office of Federal Register. The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997, Federal Register document.

On February 12, 1999, EPA published a document in the Federal Register (64 FR 7091) beginning the new IBR procedure for Iowa. On September 23, 2004 (69 FR 56942), and on July 29, 2009, (74 FR 37556) EPA published an update to the IBR material for Iowa.

In this document, EPA is publishing an updated set of tables listing the regulatory (i.e., IBR) materials in the Iowa SIP taking into account the additions, deletions, and revisions to those materials previously submitted by the state agency and approved by EPA. We are removing the EPA Headquarters Library from paragraph (b)(3), as IBR materials are no longer available at this location. In addition, EPA has found errors in certain entries listed in 40 CFR 52.820(c), as amended in the published IBR update actions listed above, and is correcting them in this document. Table (c) revisions include:

• Adding the inadvertent omission of the following explanation to the explanation column for 567.22.1 (Permits Required for New or Existing Stationary Sources): In 22.1(3) the following sentence regarding electronic submission is not SIP approved. The sentence is “Alternatively, the owner or operator may apply for a construction permit for a new or modified stationary source through the electronic submittal format specified by the department”.

• Adding the inadvertent omission of the following explanation to the explanation column for 567-22.3 (Issuing Permits): Subrule 22.3(6) has not been approved as part of the SIP. Subrule 22.3(6), Limits on Hazardous Air Pollutants, has been approved under Title V and section 112(l). The remainder of the rule has not been approved pursuant to Title V and section 112(l).

• 567.22.105 (Title V Permit Applications): Correcting the state effective date, correcting the EPA approval date column to the correct date and Federal Register citation, and adding the inadvertent omission of the following explanation to the explanation column: In 22.105(1) Duty to apply the last sentence “Alternatively, an owner or operator may submit a complete and timely application through the electronic submittal format specified by the department.” is not approved. In 22.105(1) “a” new subparagraph (9) is not approved.

• Adding the inadvertent omission of the following explanation to the explanation column for 567-23.1 (Emission Standards): Sections 23.1(2)-(5) are not approved in the SIP. Section 23.1(5) is approved as part of the 111(d) plan.

Table (e) revisions include:

• Adding text in the explanation column for (4)-(39).

In this action, EPA is doing the following:

A. Announcing the update to the IBR material as of December 31, 2014;

B. Revising the entry in paragraph 52.820(b) to reflect the update and corrections;

C. Revising certain entries in paragraph 52.820 (c) as described above;

D. Correcting the date format in the “State effective date” or “State submittal date” and “EPA approval date” columns in paragraphs 52.820 (c), (d) and (e). Dates are numerical month/day/year without additional zeros;

E. Modifying the Federal Register citation in paragraphs 52.820 (c), (d) and (e) to reflect the beginning page of the preamble as opposed to the page number of the regulatory text.

EPA has determined that today's rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3), which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). Today's rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by providing notice of the updated Iowa SIP compilation.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Iowa regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, 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 Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the Iowa SIP compilations previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” reorganization update action for the State of Iowa.

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 52 as set forth below: Chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Particle pollution, or particulate matter, is a mixture of solid particles and liquid droplets found in the air. Particle pollution includes “inhalable coarse particles,” with diameters larger than 2.5 micrometers and smaller than 10 micrometers and “fine particles,” with diameters that are 2.5 micrometers and smaller. Due to their small size, these particles often contribute to adverse health effects. EPA is required to set National Ambient Air Quality Standards (NAAQS) under the authority of the CAA, for the purpose of controlling particle pollution. The first NAAQS for PM2.5 were established on July 16, 1997 (62 FR 38652). EPA promulgated an annual standard at a level of 15 micrograms per cubic meter (μg/m3), based on a three-year average of annual mean PM2.5 concentrations (the 1997 annual PM2.5 standard). In the same rulemaking action, EPA promulgated a 24-hour standard of 65 μg/m3, based on a three-year average of the 98th percentile of 24-hour concentrations.

EPA published air quality area designations for the 1997 PM2.5 standards on January 5, 2005. In its rulemaking action, EPA designated the Washington, DC-MD-VA Area as nonattainment for the 1997 annual PM2.5 standard. The Washington, DC-MD-VA area (Washington Area) is composed of the District of Columbia; Arlington, Fairfax, Loudoun, and Prince William Counties and the cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park in Virginia (the Northern Virginia area); and Charles, Frederick, Montgomery, and Prince George's Counties in Maryland.

The District of Columbia Department of the Environment (DDOE), the Maryland Department of the Environment (MDE), and the Virginia Department of Environmental Quality (VADEQ), (collectively, the States), collaborated to develop redesignation requests and maintenance plans for the Washington Area for the 1997 annual PM2.5 NAAQS. EPA received the 1997 annual PM2.5 redesignation requests and maintenance plans for the Washington Area from DDOE on June 3, 2013, from MDE on July 10, 2013, and from VADEQ on June 3, 2013. The Washington Area maintenance plan included motor vehicle emissions budgets (MVEBs) for PM2.5 and nitrogen oxides (NOX) for the Washington Area for the 1997 annual PM2.5 standard, which EPA approved for transportation conformity purposes. The emissions inventories included in the Washington Area maintenance plans were subsequently supplemented by the States to provide for emissions estimates of volatile organic compounds (VOC) and ammonia. The supplemental inventories were submitted to EPA on July 22, 2013 by DDOE, on July 26, 2013 by MDE, and on July 17, 2013 by VADEQ.

On October 6, 2014 (79 FR 60081), the EPA approved the States' redesignation requests and maintenance plans for the Washington Area, including Northern Virginia, for the 1997 annual PM2.5 standard. Therefore, the designation of the Northern Virginia area, as part of the Washington Area, was changed from nonattainment to attainment. Subsequently, Virginia changed its lists of areas in nonattainment and maintenance within its regulations, located in 9 VAC5 Chapter 20, to reflect EPA's redesignation of the Washington Area.

On June 1, 2015, the Commonwealth of Virginia submitted a formal revision to its SIP. The SIP revision consists of a regulatory change that moves the Northern Virginia area (Counties of Arlington, Fairfax, Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park), which was part of the Washington Area, from the list of nonattainment areas found in regulation 9 VAC 5-20-204 to the list of maintenance areas found in regulation 9 VAC 5-20-203.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code § 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the proposed regulatory amendment which moves the localities in Northern Virginia (Counties of Arlington, Fairfax, Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park) from the list of nonattainment areas found in regulation 9 VAC 5-20-204 to the list of maintenance areas found in regulation 9 VAC 5-20-203. EPA finds this revision to the SIP is in accordance with CAA requirements, including sections 107 and 110 of the CAA.

EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on October 13, 2015 without further notice unless EPA receives adverse comment by September 14, 2015. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rulemaking action, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of changes to 9 VAC5 Chapter 20, specifically 9VAC5-20-203 and 9VAC5-20-204, described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (See the ADDRESSES section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP revision applies to Northern Virginia and does not apply in Indian country, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 13, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action. This action, which moves the localities in Northern Virginia within the Washington Area (Counties of Arlington, Fairfax, Loudoun, and Prince William; Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park) from the list of nonattainment areas found in regulation 9 VAC 5-20-204 to the list of maintenance areas found in regulation 9 VAC 5-20-203, may not be challenged later in proceedings to enforce its requirements. (See 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:

This rulemaking addresses infrastructure SIP submissions from the Indiana Department of Environmental Management (IDEM) submitted on January 15, 2013, for the 2010 NO2 NAAQS and on May 22, 2013, for the 2010 SO2 NAAQS. This rulemaking also addresses infrastructure SIP submissions from the Ohio Environmental Protection Agency (OEPA) submitted on June 7, 2013, for the 2010 SO2 NAAQS.

Under sections 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure that their SIPs provide for implementation, maintenance, and enforcement of the NAAQS. These submissions must contain any revisions needed for meeting the applicable SIP requirements of section 110(a)(2), or certifications that their existing SIPs for NO2 and SO2 already meet those requirements.

EPA has highlighted this statutory requirement in multiple guidance documents, including the most recent guidance document entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under CAA Sections 110(a)(1) and (2)” issued on September 13, 2013.

EPA is acting upon Indiana and Ohio's SIP submissions that address the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2010 SO2 NAAQS and also the 2010 NO2 NAAQS for Indiana. The requirement for states to make SIP submissions of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.

This rulemaking will not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction (“SSM”) at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (collectively referred to as “director's discretion”); and, (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each one of these substantive areas in separate rulemaking. A detailed rationale, history, and interpretation related to infrastructure SIP requirements can be found in our May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” (see 79 FR 27241 at 27242-27245).

In addition, EPA is not acting on section 110(a)(2)(D)(i)(I), interstate transport significant contribution and interference with maintenance for the Indiana and Ohio 2010 SO2 submittals, a portion of section 110(a)(2)(D)(i)(II) with respect to visibility, and 110(a)(2)(J) with respect to visibility for the 2010 NO2 and SO2 submittals for Indiana and the 2010 SO2 submittal for Ohio, and portions of 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J) with respect to PSD for Ohio's 2010 SO2 submittal. EPA has already taken action on the portion related to PSD for Ohio's 2010 SO2 infrastructure submittal in the February 27, 2015 rulemaking (see 80 FR 10591). EPA is also not acting on section 110(a)(2)(I)—Nonattainment Area Plan or Plan Revisions Under Part D, in its entirety. The rationale for not acting on elements of these requirements was included in EPA's August 19, 2013, proposed rulemaking or is discussed below in today's response to comments.

EPA received one comment letter from the Sierra Club regarding its July 25, 2014, proposed rulemaking (79 FR 43338) on Ohio's 2010 SO2 NAAQS Infrastructure SIP submittal. EPA did not receive any comments on its February 27, 2015, proposed rulemaking (80 FR 10644) on Indiana's 2010 NO2 NAAQS Infrastructure SIP, but did receive one comment from the Sierra Club relevant to the SO2 submittal. The majority of the SO2-related comments from the Sierra Club for Indiana and Ohio are identical. The comments are summarized and responded to together; however, the few differences in the comments are explicitly pointed out.

Comment 1: Sierra Club contends that the plain language of section 110(a)(2)(A) of the CAA and the legislative history of the CAA require the inclusion of enforceable emission limits in an infrastructure SIP to prevent NAAQS exceedances in areas not designated nonattainment. Sierra Club also asserts that the Ohio and Indiana 2010 SO2 infrastructure SIP revisions did not revise the existing SO2 emission limits in response to the 2010 SO2 NAAQS and failed to comport with CAA requirements for SIPs to establish enforceable emission limits that are adequate to prohibit NAAQS exceedances in areas not designated nonattainment.

The Sierra Club states that, on its face, the CAA “requires I-SIPs to be adequate to prevent exceedances of the NAAQS.” In support, the Sierra Club quotes the language in section 110(a)(1) which requires states to adopt a plan for implementation, maintenance, and enforcement of the NAAQS, and the language in section 110(a)(2)(A) which requires SIPs to include enforceable emissions limitations as may be necessary to meet the requirements of the CAA and which Sierra Club claims include the maintenance plan requirement. Sierra Club notes the CAA definition of emission limit and reads these provisions together to require “enforceable emission limits on source emissions sufficient to ensure maintenance of the NAAQS.”

Response 1: EPA disagrees that section 110 is clear “on its face” and must be interpreted in the manner suggested by Sierra Club. Section 110 is only one provision that is part of the complicated structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be interpreted in the context of not only that structure, but also of the historical evolution of that structure. In light of the revisions to section 110 since 1970 and the later-promulgated and more specific planning requirements of the CAA, EPA interprets the requirement in section 110(a)(2)(A) that the plan provide for “implementation, maintenance and enforcement” to mean that the infrastructure SIP must contain enforceable emission limits that will aid in attaining and/or maintaining the NAAQS and that the state demonstrate that it has the necessary tools to implement and enforce a NAAQS, such as adequate state personnel and an enforcement program. With regard to the requirement for emission limitations, EPA has interpreted this to mean, for purposes of section 110, that the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. As EPA stated in “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),” dated September 13, 2013 (Infrastructure SIP Guidance), “[t]he conceptual purpose of an infrastructure SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS, whether by establishing that the SIP already contains the necessary provisions, by making a substantive SIP revision to update the SIP, or both. Overall, the infrastructure SIP submission process provides an opportunity . . . to review the basic structural requirements of the air agency's air quality management program in light of each new or revised NAAQS.” Infrastructure SIP Guidance at p. 2.

The Sierra Club makes general allegations that Ohio and Indiana do not have sufficient protective measures to prevent SO2 NAAQS exceedances. EPA addressed the adequacy of Ohio and Indiana's infrastructure SIPs for 110(a)(2)(A) purposes to meet applicable requirements of the CAA in the proposed rulemakings and explained why the SIPs include enforceable emission limitations and other control measures necessary for maintenance of the 2010 SO2 NAAQS throughout the state. For Ohio, these limits are found in Chapter 3745-18, Sulfur Dioxide Limitations, of Ohio's SIP. For Indiana, these limits are found in 326 Indiana Administrative Code (IAC) 7-1.1, 326 IAC 7-4, and 326 IAC 7-4.1. As discussed in the proposed rulemakings, EPA finds that these provisions adequately address section 110(a)(2)(A) to aid in attaining and/or maintaining the applicable NAAQS, and finds that Ohio and Indiana have demonstrated that they have the necessary tools to implement and enforce these NAAQS.

Comment 2: The Sierra Club cites 40 CFR 51.112(a), providing that each plan “must demonstrate that the measures, rules and regulations contained in it are adequate to provide for the timely attainment and maintenance of the [NAAQS].” It asserts that this regulation requires all SIPs to include emissions limits necessary to ensure attainment of the NAAQS. The Sierra Club states that “[a]lthough these regulations were developed before the Clean Air Act separated infrastructure SIPs from nonattainment SIPs—a process that began with the 1977 amendments and was completed by the 1990 amendments—the regulations apply to I-SIPs.” It relies on a statement in the preamble to the 1986 action restructuring and consolidating provisions in part 51, in which EPA stated that “[i]t is beyond the scope of th[is] rulemaking to address the provisions of Part D of the Act . . . .” 51 FR 40656, 40656 (November 7, 1986).

Response 2: The Sierra Club's reliance on 40 CFR 51.112 to support its argument that infrastructure SIPs must contain emission limits “adequate to prohibit NAAQS exceedances” and adequate or sufficient to ensure the maintenance of the NAAQS is not supported. As an initial matter, EPA notes and the Sierra Club recognizes that this regulatory provision was initially promulgated and “restructured and consolidated” prior to the CAA Amendments of 1990, in which Congress removed all references to “attainment” in section 110(a)(2)(A). In addition, it is clear on its face that 40 CFR 51.112 applies to plans specifically designed to attain the NAAQS. EPA interprets these provisions to apply when states are developing “control strategy” SIPs such as the detailed attainment and maintenance plans required under other provisions of the CAA, as amended in 1977 and again in 1990, such as sections 175A, 182, and 192. The Sierra Club suggests that these provisions must apply to section 110 SIPs because in the preamble to EPA's action “restructuring and consolidating” provisions in part 51, EPA stated that the new attainment demonstration provisions in the 1977 Amendments to the CAA were “beyond the scope” of the rulemaking. It is important to note, however, that EPA's action in 1986 was not to establish new substantive planning requirements, but merely to consolidate and restructure provisions that had previously been promulgated. EPA noted that it had already issued guidance addressing the new “Part D” attainment planning obligations. Also, as to maintenance regulations, EPA expressly stated that it was not making any revisions other than to re-number those provisions. 51 FR at 40657.

Although EPA was explicit that it was not establishing requirements interpreting the provisions of the new “Part D” of title I of the CAA, it is clear that the regulations being restructured and consolidated were intended to address control strategy plans. In the preamble, EPA clearly stated that 40 CFR 51.112 was replacing 40 CFR 51.13 (“Control strategy: SOX and PM (portion)”), 51.14 (“Control strategy: CO, HC, OX and NO2 (portion)”), 51.80 (“Demonstration of attainment: Pb (portion)”), and 51.82 (“Air quality data (portion)”). Id. at 40660. Thus, the present-day 40 CFR 51.112 contains consolidated provisions that are focused on control strategy SIPs, and the infrastructure SIP is not such a plan.

Comment 3: The Sierra Club references two prior EPA rulemaking actions where EPA disapproved or proposed to disapprove SIPs, and claims that they were actions in which EPA relied on section 110(a)(2)(A) and 40 CFR 51.112 to reject infrastructure SIPs. It first points to a 2006 partial approval and partial disapproval of revisions to Missouri's existing plan addressing the SO2 NAAQS (71 FR 12623). In that action, EPA cited section 110(a)(2)(A) of the CAA as a basis for disapproving a revision to the state plan on the basis that the State failed to demonstrate the SIP was sufficient to ensure maintenance of the SO2 NAAQS after revision of an emission limit and cited to 40 CFR 51.112 as requiring that a plan demonstrates the rules in a SIP are adequate to attain the NAAQS. Second, Sierra Club cites a 2013 disapproval of a revision to the SO2 SIP for Indiana, where the revision removed an emission limit that applied to a specific emissions source at a facility in the State (78 FR 78721). In its proposed disapproval, EPA relied on 40 CFR 51.112(a) in proposing to reject the revision, stating that the State had not demonstrated that the emission limit was “redundant, unnecessary, or that its removal would not result in or allow an increase in actual SO2 emissions.” EPA further stated in that proposed disapproval that the State had not demonstrated that removal of the limit would not “affect the validity of the emission rates used in the existing attainment demonstration.”

The Sierra Club also asserts that EPA stated in its 2013 infrastructure SIP guidance that states could postpone specific requirements for start-up shutdown, and malfunction (SSM), but did not specify the postponement of any other requirements. The commenter concludes that emissions limits ensuring attainment of the standard cannot be delayed.

Response 3: EPA does not agree that the two prior actions referenced by the Sierra Club establish how EPA reviews infrastructure SIPs. It is clear from both the final Missouri rulemaking and the proposed and final Indiana rulemakings that EPA was not reviewing initial infrastructure SIP submissions under section 110 of the CAA, but rather revisions that would make an already approved SIP designed to demonstrate attainment of the NAAQS less stringent. EPA's partial approval and partial disapproval of revisions to restrictions on emissions of sulfur compounds for the Missouri SIP addressed a control strategy SIP and not an infrastructure SIP. The Indiana action provides even less support for the Sierra Club's position. The review in that rule was of a completely different requirement than the section 110(a)(2)(A) SIP. In that case, the State had an approved SO2 attainment plan and was seeking to remove from the SIP provisions relied on as part of the modeled attainment demonstration. EPA proposed that the State had failed to demonstrate under section 110(l) of the CAA why the SIP revision would not result in increased SO2 emissions and thus interfere with attainment of the NAAQS. Nothing in that rulemaking addresses the necessary content of the initial infrastructure SIP for a new or revised NAAQS. Rather, it is simply applying the clear statutory requirement that a state must demonstrate why a revision to an approved attainment plan will not interfere with attainment of the NAAQS.

EPA also does not agree that any requirements related to emission limits have been postponed. As stated in a previous response, EPA interprets the requirements under 110(a)(2)(A) to include enforceable emission limits that will aid in attaining and/or maintaining the NAAQS and that the state demonstrate that it has the necessary tools to implement and enforce a NAAQS, such as adequate state personnel and an enforcement program. With regard to the requirement for emission limitations, EPA has interpreted this to mean, for purposes of section 110, that the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. Emission limits providing for attainment of a new standard are triggered by the designation process and have a different schedule in the CAA than the submittal of infrastructure SIPs.

As discussed in detail in the proposed rules, EPA finds that the Ohio and Indiana SIPs meet the appropriate and relevant structural requirements of section 110(a)(2) of the CAA that will aid in attaining and/or maintaining the NAAQS, and that the States have demonstrated that they have the necessary tools to implement and enforce a NAAQS.

Comment 4: Sierra Club also discusses several cases applying the CAA which it claims support its contention that courts have been clear that section 110(a)(2)(A) requires enforceable emissions limits in infrastructure SIPs to prevent violations of the NAAQS. Sierra Club first cites to language in Train v. NRDC, 421 U.S. 60, 78 (1975), addressing the requirement for “emission limitations” and stating that emission limitations “are specific rules to which operators of pollution sources are subject, and which if enforced should result in ambient air which meet the national standards.” Sierra Club also cites to Pennsylvania Dept. of Envtl. Resources v. EPA, 932 F.2d 269, 272 (3d Cir. 1991) for the proposition that the CAA directs EPA to withhold approval of a SIP where it does not ensure maintenance of the NAAQS, and to Mision Industrial, Inc. v. EPA, 547 F.2d 123, 129 (1st Cir. 1976), which quoted section 110(a)(2)(B) of the CAA of 1970. The Sierra Club contends that the 1990 Amendments do not alter how courts have interpreted the requirements of section 110, quoting Alaska Dept. of Envtl. Conservation v. EPA, 540 U.S. 461, 470 (2004), which in turn quoted section 110(a)(2)(A) of the CAA and also stated that “SIPs must include certain measures Congress specified” to ensure attainment of the NAAQS. The Commenter also quotes several additional opinions in this vein. Mont. Sulphur & Chem. Co. v. EPA, 666 F.3d 1174, 1180 (9th Cir. 2012) (“The Clean Air Act directs states to develop implementation plans—SIPs—that `assure' attainment and maintenance of [NAAQS] through enforceable emissions limitations”); Hall v. EPA 273 F.3d 1146, 1153 (9th Cir. 2001) (“Each State must submit a [SIP] that specif[ies] the manner in which [NAAQS] will be achieved and maintained within each air quality control region in the State”); Conn. Fund for Env't, Inc. v. EPA, 696 F.2d 169, 172 (D.C. Cir. 1982) (CAA requires SIPs to contain “measures necessary to ensure attainment and maintenance of NAAQS”). Finally, the commenter cites Mich. Dept. of Envtl. Quality v. Browner, 230 F.3d 181 (6th Cir. 2000) for the proposition that EPA may not approve a SIP revision that does not demonstrate how the rules would not interfere with attainment and maintenance of the NAAQS.

Response 4: None of the cases the Sierra Club cites support its contention that section 110(a)(2)(A) requires that infrastructure SIPs must include detailed plans providing for attainment and maintenance of the NAAQS in all areas of the state, nor do they shed light on how section 110(a)(2)(A) may reasonably be interpreted. With the exception of Train, none of the cases the Commenter cites concerned the interpretation of CAA section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 CAA). Rather, the courts reference section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 CAA) in the background sections of decisions in the context of challenges to EPA actions on revisions to SIPs that were required and approved as meeting other provisions of the CAA or in the context of an enforcement action.

In Train, 421 U.S. 60, the Court was addressing a state revision to an attainment plan submission made pursuant to section 110 of the CAA, the sole statutory provision at that time regulating such submissions. The issue in that case concerned whether changes to requirements that would occur before attainment was required were variances that should be addressed pursuant to the provision governing SIP revisions or were “postponements” that must be addressed under section 110(f) of the CAA of 1970, which contained prescriptive criteria. The Court concluded that EPA reasonably interpreted section 110(f) to not restrict a state's choice of the mix of control measures needed to attain the NAAQS and that revisions to SIPs that would not impact attainment of the NAAQS by the attainment date were not subject to the limits of section 110(f). Thus, the issue was not whether a section 110 SIP needs to provide for attainment or whether emissions limits are needed as part of the SIP; rather the issue was which statutory provision governed when the state wanted to revise the emission limits in its SIP if such revision would not impact attainment or maintenance of the NAAQS. To the extent the holding in the case has any bearing on how section 110(a)(2)(A) might be interpreted, it is important to realize that in 1975, when the opinion was issued, section 110(a)(2)(B) (the predecessor to section 110(a)(2)(A)) expressly referenced the requirement to attain the NAAQS, a reference that was removed in 1990.

The decision in Pennsylvania Dept. of Envtl. Resources was also decided based on the pre-1990 provision of the CAA. At issue was whether EPA properly rejected a revision to an approved plan where the inventories relied on by the state for the updated submission had gaps. The Court quoted section 110(a)(2)(B) of the pre-1990 CAA in support of EPA's disapproval, but did not provide any interpretation of that provision. Yet, even if the Court had interpreted that provision, EPA notes that it was modified by Congress in 1990; thus, this decision has little bearing on the issue here.

At issue in Mision Industrial, 547 F.2d 123, was the definition of “emissions limitation,” not whether section 110 requires the state to demonstrate how all areas of the state will attain and maintain the NAAQS as part of their infrastructure SIPs. The language from the opinion the Sierra Club quotes does not interpret but rather merely describes section 110(a)(2)(A). Sierra Club does not raise any concerns about whether the measures relied on by the state in the infrastructure SIP are “emissions limitations,” and the decision in this case has no bearing here.1

In Mont. Sulphur & Chem. Co., 666 F.3d 1174, the Court was reviewing a Federal implementation plan (FIP) that EPA promulgated after a long history of the state failing to submit an adequate SIP in response to EPA's finding under section 110(k)(5) that the previously approved SIP was substantially inadequate to attain or maintain the NAAQS, which triggered the state's duty to submit a new SIP to show how it would remedy that deficiency and attain the NAAQS. The Court cited generally sections 107 and 110(a)(2)(A) of the CAA for the proposition that SIPs should assure attainment and maintenance of NAAQS through emission limitations, but this language was not part of the Court's holding in the case, which focused instead on whether EPA's finding of SIP inadequacy, disapproval of portions of the state's responsive SIP and attainment demonstration, and adoption of a remedial FIP were lawful.

The Sierra Club suggests that Alaska Dept. of Envtl. Conservation, 540 U.S. 461, stands for the proposition that the 1990 CAA Amendments do not alter how courts interpret section 110. This claim is inaccurate. Rather, the Court quoted section 110(a)(2)(A), which, as noted previously, differs from the pre-1990 version of that provision, and the Court makes no mention of the changed language. Furthermore, the Sierra Club also quotes the Court's statement that “SIPs must include certain measures Congress specified,” but that statement specifically referenced the requirement in section 110(a)(2)(C), which requires an enforcement program and a program for the regulation of the modification and construction of new sources. Notably, at issue in that case was the state's “new source” permitting program, not its infrastructure SIP.

Two of the cases the Sierra Club cites, Mich. Dept. of Envtl. Quality, 230 F.3d 181, and Hall, 273 F.3d 1146, interpret CAA section 110(l), the provision governing “revisions” to plans, and not the initial plan submission requirement under section 110(a)(2) for a new or revised NAAQS, such as the infrastructure SIP at issue in this instance. In those cases, the courts cited section 110(a)(2)(A) solely for the purpose of providing a brief background of the CAA.

Finally, in Conn. Fund for Env't, Inc. v. EPA, 696 F.2d 169 (D.C. Cir. 1982), the D.C. Circuit was reviewing EPA action on a control measure SIP provision which adjusted the percent of sulfur permissible in fuel oil. The D.C. Circuit focused on whether EPA needed to evaluate effects of the SIP revision on one pollutant or effects of change on all possible pollutants; therefore, the D.C. Circuit did not address required measures for infrastructure SIPs, and nothing in the opinion addressed whether infrastructure SIPs needed to contain measures to ensure attainment and maintenance of the NAAQS.

Comment 5: Citing section 110(a)(2)(A) of the CAA, Sierra Club contends that EPA may not approve the proposed infrastructure SIPs because they do not include enforceable one hour SO2 emission limits for sources that show NAAQS exceedances through modeling. Sierra Club asserts the proposed infrastructure SIPs fail to include enforceable one hour SO2 emissions limits or other required measures to ensure attainment and maintenance of the SO2 NAAQS in areas not designated nonattainment as required by section 110(a)(2)(A). Sierra Club asserts that emission limits are especially important for meeting the 2010 SO2 NAAQS because SO2 impacts are strongly source-oriented. Sierra Club states that coal-fired electric generating units (EGUs) are large contributors to SO2 emissions but contends that Ohio and Indiana did not demonstrate that emissions allowed by the proposed infrastructure SIPs from such large sources of SO2 will ensure compliance with the 2010 SO2 NAAQS.

For Ohio, the Sierra Club claims that the proposed infrastructure SIP would allow major sources to continue operating with present emission limits. Sierra Club then refers to air dispersion modeling it conducted for three coal-fired EGUs in Ohio including the Cardinal Power Plant (Brilliant), the Sammis Station (Stratton), and the Zimmer Plant (Moscow). Sierra Club asserts that the results of the air dispersion modeling it conducted employing EPA's AERMOD program for modeling used the plants' allowable and actual emissions, and showed that the plants could cause exceedances of the 2010 SO2 NAAQS with either allowable emissions at all three facilities or actual emissions at the Zimmer Plant.2

For Indiana, the Sierra Club also claims that the proposed infrastructure SIP would allow major sources to continue operating with present emission limits. Sierra Club then refers to air dispersion modeling it conducted for three coal-fired EGUs in Indiana, including the A.B. Brown Plant (Mount Vernon), the Clifty Creek Plant (Madison), and the Gibson Plant (Owensville). Sierra Club asserts that the results of the air dispersion modeling it conducted employing EPA's AERMOD program for modeling used the plants' allowable and actual emissions, and showed the plants could cause exceedances of the 2010 SO2 NAAQS with either allowable or actual emissions at all three facilities.

Based on the modeling, Sierra Club asserts that the Ohio and Indiana SO2 infrastructure SIP submittals authorize these EGUs to cause exceedances of the NAAQS with allowable and actual emission rates, and therefore that the infrastructure SIP fails to include adequate enforceable emission limitations or other required measures for sources of SO2 sufficient to ensure attainment and maintenance of the 2010 SO2 NAAQS. As a result, Sierra Club claims EPA must disapprove Ohio and Indiana's proposed SIP revisions. In addition, Sierra Club asserts that additional emission limits should be imposed on the plants that ensure attainment and maintenance of the NAAQS at all times.

Response 5: EPA believes that section 110(a)(2)(A) of the CAA is reasonably interpreted to require states to submit SIPs that reflect the first step in their planning for attainment and maintenance of a new or revised NAAQS. These SIP revisions, also known as infrastructure SIPs, should contain enforceable control measures and a demonstration that the state has the available tools and authority to develop and implement plans to attain and maintain the NAAQS. In light of the structure of the CAA, EPA's long-standing position regarding infrastructure SIPs is that they are general planning SIPs to ensure that the state has adequate resources and authority to implement a NAAQS in general throughout the state and not detailed attainment and maintenance plans for each individual area of the state. As mentioned above, with regard to the requirement for emission limitations, EPA has interpreted this to mean that states may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit.

EPA's interpretation that infrastructure SIPs are more general planning SIPs is consistent with the CAA as understood in light of its history and structure. When Congress enacted the CAA in 1970, it did not include provisions requiring states and the EPA to label areas as attainment or nonattainment. Rather, states were required to include all areas of the state in “air quality control regions” (AQCRs) and section 110 set forth the core substantive planning provisions for these AQCRs. At that time, Congress anticipated that states would be able to address air pollution quickly pursuant to the very general planning provisions in section 110 and could bring all areas into compliance with a new NAAQS within five years. Moreover, at that time, section 110(a)(2)(A)(i) specified that the section 110 plan provide for “attainment” of the NAAQS and section 110(a)(2)(B) specified that the plan must include “emission limitations, schedules, and timetables for compliance with such limitations, and such other measures as may be necessary to insure attainment and maintenance [of the NAAQS].” In 1977, Congress recognized that the existing structure was not sufficient and that many areas were still violating the NAAQS. At that time, Congress for the first time added provisions requiring states and EPA to identify whether areas of a state were violating the NAAQS (i.e., were nonattainment) or were meeting the NAAQS (i.e., were attainment) and established specific planning requirements in section 172 for areas not meeting the NAAQS. In 1990, many areas still had air quality not meeting the NAAQS, and Congress again amended the CAA and added yet another layer of more prescriptive planning requirements for each of the NAAQS. At that same time, Congress modified section 110 to remove references to the section 110 SIP providing for attainment, including removing pre-existing section 110(a)(2)(A) in its entirety and renumbering subparagraph (B) as section 110(a)(2)(A). Additionally, Congress replaced the clause “as may be necessary to insure attainment and maintenance [of the NAAQS]” with “as may be necessary or appropriate to meet the applicable requirements of this chapter.” Thus, the CAA has significantly evolved in the more than 40 years since it was originally enacted. While at one time section 110 of the CAA did provide the only detailed SIP planning provisions for states and specified that such plans must provide for attainment of the NAAQS, under the structure of the current CAA, section 110 is only the initial stepping-stone in the planning process for a specific NAAQS. In addition, more detailed, later-enacted provisions govern the substantive planning process, including planning for attainment of the NAAQS, depending upon how air quality status is judged under other provisions of the CAA, such as the designations process under section 107.

As stated in response to a previous comment, EPA asserts that section 110 of the CAA is only one provision that is part of the complicated structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be interpreted in the context of not only that structure, but also of the historical evolution of that structure. In light of the revisions to section 110 since 1970 and the later-promulgated and more specific planning requirements of the CAA, EPA reasonably interprets the requirement in section 110(a)(2)(A) of the CAA that the plan provide for “implementation, maintenance and enforcement” to mean that the infrastructure SIP must contain enforceable emission limits that will aid in attaining and/or maintaining the NAAQS and that the state must demonstrate that it has the necessary tools to implement and enforce a NAAQS, such as an adequate monitoring network and an enforcement program. As discussed above, EPA has interpreted the requirement for emission limitations in section 110 to mean that the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. Finally, as EPA stated in the Infrastructure SIP Guidance which specifically provides guidance to states in addressing the 2010 SO2 NAAQS, “[t]he conceptual purpose of an infrastructure SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS, whether by establishing that the SIP already contains the necessary provisions, by making a substantive SIP revision to update the SIP, or both.” Infrastructure SIP Guidance at p. 2.

On April 12, 2012, EPA explained its expectations regarding the 2010 SO2 NAAQS infrastructure SIPs via letters to each of the states. EPA communicated in the April 2012 letters that all states were expected to submit SIPs meeting the “infrastructure” SIP requirements under section 110(a)(2) of the CAA by June 2013. At the time, the EPA was undertaking a stakeholder outreach process to continue to develop possible approaches for determining attainment status with the SO2 NAAQS and implementing this NAAQS. EPA was abundantly clear in the April 2012 letters to states that EPA did not expect states to submit substantive attainment demonstrations or modeling demonstrations showing attainment for potentially unclassifiable areas in infrastructure SIPs due in June 2013, as EPA had previously suggested in its 2010 SO2 NAAQS preamble based upon information available at the time and in prior draft implementation guidance in 2011 while EPA was gathering public comment. The April 2012 letters to states recommended states focus infrastructure SIPs due in June 2013, such as Ohio and Indiana's SO2 infrastructure SIP, on “traditional infrastructure elements” in section 110(a)(1) and (2) rather than on modeling demonstrations for future attainment for potentially unclassifiable areas.3

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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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 at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0496 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 October 13, 2015. 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0496, by one of the following methods:

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

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

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

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

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8272) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide fludioxonil [4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on the raw agricultural commodity carrot at 7.0 ppm, and by changing the existing entry for “fruit, stone, group 12 at 5.0 ppm” to “fruit, stone, group 12-12 at 5.0 ppm.” That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov.

In the Federal Register of October 24, 2014 (79 FR 63594) (FRL-9916-03), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8277) by Syngenta Crop Protection, LLC, 410 Swing Rd., Greensboro, NC 27419. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide fludioxonil in or on the rapeseed subgroup 20A, except flax seed at 0.01 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov.

Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fludioxonil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fludioxonil 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 all species tested, the effects in the fludioxonil database are indicative of toxicity to the liver and kidney. The hematopoietic system was also a target in dogs. There were also decreased body weights and clinical signs throughout the database. Fludioxonil was non-toxic through the dermal route, and there was no evidence of immunotoxicity when tested up to and including the limit dose. Fludioxonil was not mutagenic in the tests for gene mutations.

In a rat developmental toxicity study, fludioxonil caused an increase in fetal incidence and litter incidence of dilated renal pelvis at the limit dose (1,000 mg/kg/day). These effects are known to occur spontaneously in the rat, in addition to being transient and reversible which is consistent with the fludioxonil hazard database (not seen in offspring in the 2-generation reproductive study). Under current policy, the agency considers classification of these effects as treatment-related but conservative and not indicative of increased fetal susceptibility. Maternal toxicity occurred at the same dose and manifested as body weight decrements. In the 2-generation reproduction study, parental and offspring effects occurred at the same dose and consisted of decreased body weights in parental and offspring animals, as well as increased clinical signs in parental animals.

There was no evidence of carcinogenicity in male or female CD-1 mice and male Sprague-Dawley rats following dietary administration at doses that were adequate for assessing the carcinogenic potential of fludioxonil. In female Sprague-Dawley rats, there was a statistically significant increase in tumor incidence only when hepatocellular adenomas and carcinomas were combined (not for individual tumor types). The pairwise increase for combined tumors was significant at p=0.03, which is not a strong indication of a positive effect. Further, statistical significance was only found when liver adenomas were combined with liver carcinomas. Finally, the increase in these tumors was within, but at the high-end, of the historical controls. Based on these findings and in accordance with the Agency's 1986 “Guidelines for Carcinogen Risk Assessment,” fludioxonil was classified as a Group D carcinogen; therefore, there is no need for a quantitative cancer risk assessment.

Specific information on the studies received and the nature of the adverse effects caused by fludioxonil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Fludioxonil. Section 3 Registration for Use on Carrots, Stone Fruit, Group 12-12, and Rapeseed, Subgroup 20A. Human Health Risk Assessment” at page 28 in docket ID number EPA-HQ-OPP-2014-0496.

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 fludioxonil used for human risk assessment is shown in Table 1 of this unit. Since the last assessment in 2012, (August 15, 2012) (77 FR 48907) (FRL-9357-5), the Agency has reevaluated the toxicological endpoints. Based upon current policy, it was determined that an acute dietary assessment was no longer necessary for fludioxonil. This decision was based upon the following weight of evidence: (1) After re-evaluation of the hazard database, it was determined that there were no effects that could be attributed to single dose and (2) the fetal effects in the developmental rat study occurred only at the limit dose (1,000 mg/kg/day). Additionally, though the same study is being used to assess chronic dietary risk, the NOAEL and LOAEL have been reclassified. Further, the remaining endpoints for short-term incidental oral toxicity and short-term inhalation toxicity have changed as well.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fludioxonil, EPA considered exposure under the petitioned-for tolerances as well as all existing fludioxonil tolerances in 40 CFR 180.516. EPA assessed dietary exposures from fludioxonil 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 fludioxonil; 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 U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, an unrefined chronic dietary exposure and risk assessment was performed assuming tolerance-level residues, 100 percent crop treated (PCT) estimates, and DEEM (ver. 7.81) default processing factors.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has classified fludioxonil as a group D carcinogen. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fludioxonil for chronic exposures are estimated to be 38.5 parts per billion (ppb) for surface water and 0.2 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 38.5 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).

Fludioxonil is currently registered for the following uses that could result in residential exposures: parks, golf courses, athletic fields, residential lawns, ornamentals, and greenhouses. To assess residential handler exposure, the Agency used the short-term inhalation exposure to adults from mixing/loading/applying a wettable powder in water-soluble packaging with hose end sprayer (both for turf and gardens). To assess post-application exposure, the Agency used short-term incidental oral exposures (hand-to-mouth) to children 1<2 years old from exposure to outdoor treated turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://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 fludioxonil to share a common mechanism of toxicity with any other substances, and fludioxonil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fludioxonil 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 at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There was no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits or following pre-/postnatal exposure. In a rat developmental toxicity study, fludioxonil caused an increase in fetal incidence and litter incidence of dilated renal pelvis at the limit dose (1,000 mg/kg/day). Maternal toxicity occurred at the same dose and manifested as body weight decrements. Fludioxonil was not developmentally toxic in rabbits. In the 2-generation reproduction study, parental and offspring effects occurred at the same dose and consisted of decreased body weights in parental and offspring animals, as well as increased clinical signs in parental animals.

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 fludioxonil is complete.

ii. The only potential indicator of neurotoxicity for fludioxonil was convulsions in mice following handling in the mouse carcinogenicity study at the mid- and high-doses. The concern is low however since there was no supportive neuropathology, the effect was not seen at similar doses in a second mouse carcinogenicity study, there were no other signs of potential neurotoxicity observed in the database, and selected endpoints are protective of the effect seen in mice. Therefore, there is no residual uncertainty concerning neurotoxicity and no need to retain the FQPA 10X safety factor.

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

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fludioxonil in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fludioxonil.

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 from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fludioxonil 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 fludioxonil from food and water will utilize 71% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fludioxonil 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).

Fludioxonil 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 fludioxonil.

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 81,000 for adults and 4,800 for children 1-2 years old. Because EPA's level of concern for fludioxonil 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).

An intermediate-term adverse effect was identified; however, fludioxonil is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for fludioxonil.

5. Aggregate cancer risk for U.S. population. Based on the discussion contained in Unit III.A., fludioxonil 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 fludioxonil residues.

Adequate high-performance liquid chromatography/ultraviolet (HPLC/UV) methods (Methods AG-597 and AG-597B) are available for enforcing tolerances for fludioxonil on plant commodities. An adequate liquid chromatography, tandem mass spectrometry (LC-MS/MS) method (Analytical Method GRM025.03A) is available for enforcing tolerances for residues of fludioxonil in or on livestock commodities.

The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has established MRLs for fludioxonil in or on multiple stone fruit commodities (peaches, apricots, etc.) at 5.0 ppm. These MRLs are the same as the tolerances established for fludioxonil in the United States.

The Codex has established an MRL for fludioxonil in or on carrot roots at 0.7 ppm. This MRL is different than the tolerance established for fludioxonil in the United States because it is based on a foliar use, whereas the U.S. use is based on a post-harvest use. Harmonization with the Codex MRL is likely to result in tolerance exceedances when fludioxonil is applied to carrots in accordance with the label.

The Codex has established an MRL for fludioxonil in or on rape seed at 0.02 ppm. This MRL is different than the 0.01 ppm tolerance established for fludioxonil on the rapeseed subgroup 20A in the U.S., which is aligned with the existing Canadian MRL on rapeseed. In their petition, Syngenta requested to remain aligned with Canada at 0.01 ppm for rapeseed in order to prevent NAFTA trade barriers.

Several comments were received in response to the Notice of Filing regarding adverse impacts to bees but did not reference any specific active ingredient. The commenters by and large stated this action should be denied due to toxicity to bees and that all use of chemicals should be stopped. The comments primarily appear directed to the registration of the pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). One comment referenced the establishment of a tolerance for an unnamed Syngenta pesticide, so to the extent that comment is directed at the present tolerance action, the Agency understands the commenters' concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The comment appears to be directed at the underlying statute and not EPA's implementation of it; no contentions have been made that EPA has acted in violation of the statutory framework. As to bees the EPA considers impacts to the environment and non-target species under the authority of the (FIFRA).

Therefore, tolerances are established for residues of fludioxonil, (4-(2,2- difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile), in or on carrots at 7.0 ppm; fruit, stone, group 12-12 at 5.0 ppm; and the rapeseed subgroup 20A, except flax seed at 0.01 ppm. In addition, upon establishment of these tolerances, the existing tolerance for rapeseed, seed is removed as unnecessary since it is part of the rapeseed subgroup 20A.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the Federal Register. This action 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0793 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 October 13, 2015. 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0793, by one of the following methods:

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

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

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

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

In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition inert ingredient (IN-10766) by Technology Sciences Group, Inc. (1150 18th Street, Suite 1000 Washington, DC 20036), on behalf of West Agro, Inc. (11100 Congress Ave., Kansas City, MO 64153). The petition requested that 40 CFR 180.940(b) and (c) be amended by modifying an exemption from the requirement of a tolerance for residues of acetic acid (CAS Reg No. 64-19-7) when used as an inert ingredient to promote the active ingredient in antimicrobial pesticide formulations applied to dairy-processing equipment, food-processing equipment, and utensils to increase the use limitation from 686 parts per million (ppm) to 1,200 ppm. That document referenced a summary of the petition prepared by Technology Sciences Group, Inc. on behalf of West Agro, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of filing.

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

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

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 acetic acid including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with acetic acid follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by acetic acid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Acetic acid is of low acute dermal and inhalation toxicity in rats. It causes dermal irritation in mice and is corrosive in rabbits. It was also irritating in the eyes of rabbits. Although, reduced body weight was observed at 390 milligrams/kilograms/day (mg/kg/day) in a 90-day oral toxicity study in the rat, the reduction in weight gain was likely attributed to reduced appetite and food consumption observed in the study. Therefore, this is not considered an adverse effect. Fetal susceptibility was not observed in developmental studies in rats, mice and rabbits. It is not genotoxic, mutagenic, carcinogenic or neurotoxic. Although, increased spleen weight and increased levels of iron stored in the spleen were observed in a toxicity study via inhalation in rats, these effects are not considered an immunotoxic response, but are due to the destruction of red blood cells; therefore, there is no concern for potential immunotoxicity.

Acetic acid undergoes dissociation to the acetate anion and the H+ cations in aqueous media at pHs commonly found in the environment. Also, it is a naturally-occurring substance in plants and animals. In aerobic metabolism, acetic acid (as acetate) is a metabolite that combines with Co-enzyme A to form acetyl Co-A which subsequently enters into the Citric Acid Cycle, a common metabolic pathway in which food molecules are broken down to form energy. A major function of the Citric Acid Cycle is the oxidation of acetate. In animals, acetate is obtained from the breakdown of glucose molecules.

Specific information on the studies received and the nature of the adverse effects caused by acetic acid as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Acetic Acid; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2014-0793.

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.

Based on the widespread presence of acetic acid in human foods, and the fact that acetic acid is a normal metabolite in humans and animals and its status as a substance that is considered Generally Recognized as Safe (GRAS) by the Food and Drug Administration, toxicological endpoints of concern relevant to human exposures have not been identified for acetic acid. Thus, due to its low potential hazard and lack of hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate. Instead, the Agency's assessment of the risk from acetic acid is qualitative.

1. Dietary exposure from food and feed uses and drinking water. In evaluating dietary exposure to acetic acid, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from acetic acid in food as follows:

Acetic acid is currently used as a biochemical pesticide post-harvest on grains, hays for animal feed, and as a herbicide. Under this exemption from the requirement of a tolerance, residues of this chemical also may be found on foods that come in contact with treated dairy and food-processing equipment and utensils. However, a quantitative dietary exposure assessment was not conducted since an endpoint for risk assessment was not identified.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Acetic acid may be used in pesticide products and nonpesticide products that may be used around the home. Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for acetic acid was not conducted.

3. 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 acetic acid to share a common mechanism of toxicity with any other substances, and acetic acid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acetic acid 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 at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA 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.

As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of acetic acid and its chemical properties, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.

Because no toxicological endpoints of concern were identified, EPA concludes that aggregate exposure to residues of acetic acid will not pose a risk to the U.S. population, including infants and children, and that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acetic acid residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance. EPA is establishing a limitation on the amount of acetic acid that may be used in pesticide formulations.

The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any antimicrobial pesticide formulation used on dairy processing equipment or food-processing equipment and utensils for sale or distribution containing acetic acid at ready for use end-use concentrations exceeding 1,200 parts per million.

Therefore, the exemption from the requirement of a tolerance for acetic acid when used as an inert ingredient in antimicrobial pesticide formulations used on dairy-processing equipment, food-processing equipment, and utensils under 40 CFR 180.940(b) and (c) are amended by an increase in the use limitation from 686 ppm to 1,200 ppm.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the Federal Register. This action 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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 at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0804 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 October 13, 2015. 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0804, by one of the following methods:

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

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

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

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

In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8315) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition requested that 40 CFR 180.448 be amended by establishing tolerances for residues of the insecticide hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, in or on wheat, forage at 6.0 parts per million (ppm); wheat, hay at 30 ppm; wheat, grain at 0.02; and wheat, straw at 8.0 ppm. That document 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.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for 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 associated with toxicity of the liver and adrenals following subchronic and chronic exposure to dogs, rats and mice, with the dog being the most sensitive species. The prenatal developmental studies in rabbits and rats and the 2-generation reproduction study in rats showed no indication of increased susceptibility to in utero or postnatal exposure to hexythiazox. Reproductive toxicity was not observed. There is no concern for immunotoxicity or neurotoxicity following exposure to hexythiazox. The toxicology database for hexythiazox does not show any evidence of treatment-related effects on the immune system. Hexythiazox is classified as “likely to be carcinogenic to humans”; however, the evidence as a whole is not strong enough to warrant a quantitative estimation of human cancer risk. Since the effects seen in the study that serves as the basis for the chronic RfD occurred at doses substantially below the lowest dose that induced tumors, the chronic RfD is considered protective of all chronic effects including potential carcinogenicity.

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 at http://www.regulations.gov in document: Hexythiazox. Human Health Risk Assessment to Support New Uses on Wheat and Pepper/Eggplant Subgroup 8-10B in docket ID number EPA-HQ-OPP-2014-0804.

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

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 U.S. Department of Agriculture's 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance level residues, assumed 100 percent crop treated (PCT), and incorporated Dietary Exposure Evaluation Model (DEEM) default processing factors when processing data were not available.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to 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 level water 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 at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Surface Water Concentration Calculator (SWCC), the estimated drinking water concentrations (EDWCs) of hexythiazox for chronic exposures for non-cancer assessments are estimated to be 4.3 ppb for surface water. Since groundwater residues are not expected to exceed surface water residues, 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 currently registered for the following uses that could result in residential exposures: ornamental plantings, turf, and fruit and nut trees in residential settings. EPA assessed residential exposure using the following assumptions: Residential handler exposures are expected to be short-term (1 to 30 days) via either the dermal or inhalation routes of exposures. Since a quantitative dermal risk assessment is not needed for hexythiazox, handler MOEs were calculated for the inhalation route of exposure only. Both adults and children may be exposed to hexythiazox residues from contact with treated lawns or treated residential plants. Post application exposures are expected to be short-term (1 to 30 days) and intermediate-term (1 to 6 months) in duration. Adult postapplication exposures were not assessed since no quantitative dermal risk assessment is needed for hexythiazox and inhalation exposures are typically negligible in outdoor settings. The exposure assessment for children included incidental oral exposure resulting from transfer of residues from the hands or objects to the mouth, and from incidental ingestion of soil. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

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 at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicology data base indicates no increased susceptibility of rats or rabbits to in utero and/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 complete.

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 in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground 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 from a 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 81% 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).

Hexythiazox 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 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 1291 for children and 8626 for adults. 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).

Hexythiazox is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to 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 1474 for children and 8808 for adults. 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. This method is listed in the U.S. EPA Index of Residue Analytical Methods under hexythiazox as method AMR-985-87.

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

The Codex has not established a MRL for hexythiazox in/on wheat, therefore, there are no harmonization issues associated with this action.

Therefore, tolerances are established for residues of hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, as petitioned.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction

The EPA Region 4 is publishing this direct final Notice of Deletion of the Redwing Carriers, Inc. (Saraland) Superfund Site from the NPL. The NPL constitutes Appendix B of 40 CFR part 300 which is the NCP, which the EPA promulgated pursuant to section 105 of the CERCLA of 1980, as amended. The EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in the Section 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if future conditions warrant such actions.

Section II of this document explains the criteria to delete sites from the NPL. Section III discusses procedures that the EPA is using for this action. Section IV discusses the Site and demonstrates how it meets the deletion criteria. Section V discusses the EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that the EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), the EPA will consider, in consultation with the State, whether any of the following criteria have been met:

i. responsible parties or other persons have implemented all appropriate response actions required;

ii. all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. the remedial investigation has shown that the release poses no significant threat to public health or the environment, and, therefore, the taking of remedial measures is not appropriate.

The following procedures apply to deletion of the Site:

(1) The EPA consulted with the State of Alabama prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the “Proposed Rules” section of the Federal Register.

(2) The EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through ADEM, has concurred on the deletion of the site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Deletion, a notice of the availability of the parallel Notice of Intent to Delete is being published in a major local newspaper, The Mobile Press Register. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this deletion action, the EPA will publish a timely notice of withdrawal of this direct final Notice of Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter the EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist the EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides the EPA's rationale for deleting the Site from the NPL:

Redwing Carriers, Inc. (Saraland) Superfund Site, (EPA ID: ALD980844385) is located at 527 U.S. Highway 43, Saraland, Mobile County, Alabama. The Site is 5.1 acres and bounded to the east by U.S. Highway 43 and a skating rink. To the north it is bounded by a United Gas Pipe Line easement and a mobile home community, to the south by a residential development, and to the west by an undeveloped lot. The Site was the former location of the Saraland Apartment Complex (Apartments) that has since been demolished to allow for the complete remediation of the Site. From 1961 to 1971, Redwing Carriers, Inc. (Redwing), a trucking company, owned and operated the Site as a terminal for cleaning, repairing and parking its fleet of trucks. The company transported a variety of substances, including asphalt, diesel fuel, chemicals and pesticides from local plants. Redwing discharged untreated hazardous substances to the ground during the cleaning of tanker trucks, creating a tar-like sludge and contaminating Site soils. The tar-like sludge was composed predominately of polycyclic aromatic hydrocarbon compounds together with lesser amounts of pesticides, herbicides and volatile organic compounds. These operations resulted in contamination of soils, groundwater and sediment.

In 1973, Saraland Apartments Ltd. purchased the Site and built a U.S. Housing and Urban Development (HUD) subsidized apartment complex on the Site. During construction, the sludge and contaminated soils were covered with up to 5 feet of clean soil. When completed, the complex consisted of 60 apartment units located in 12 buildings, and at one time housed approximately 160 residents, including 80 to 90 preschool-age or elementary school-age children.

In 1984, ADEM investigated apartment residents' complaints about the tar-like sludge seeping to the surface at numerous locations at the Site. In 1985, under Superfund removal authority, the EPA conducted initial studies in which high concentrations of 1, 2, 4-trichlorobenzene and naphthalene were detected in the soil and in leachate coming from the sludge. On July 8, 1985, the EPA and Redwing entered into a removal Administrative Order on Consent (AOC) that required Redwing to, among other things, conduct a limited sludge and contaminated soil removal action. Redwing was required to periodically inspect the Site and remove any visible sludge on the surface. The Site was proposed for the NPL on June 24, 1988 (53 FR 23988) and finalized on the NPL February 21, 1990 (55 FR 6154) due to the potential for consumption of contaminated groundwater.

On July 2, 1990, the EPA and Redwing entered into an AOC wherein Redwing agreed to conduct the Site RI/FS. Redwing, under the EPA's oversight, began field activities for the first phase of the remedial investigation in January 1991. The RI/FS was completed in July of 1992. During the investigation, 39 soil borings were collected with a total of 123 separate soil samples being analyzed. The substances found most frequently at concentrations above risk-based cleanup levels fall into three major categories: pesticides and herbicides; volatile organic compounds (VOCs) and Polycyclic Aromatic Hydrocarbons (PAHs). These substances were found in soils, ditch sediments, and groundwater across the Site. The highest levels of contamination were detected in the southern and eastern portions (the location of the former containment levee used by Redwing) and across areas of former terminal operations. Inorganic substances, which may occur in nature at significant levels, were also detected in soils, sludge, and groundwater. During this investigation, the EPA determined that the contaminants at the Site presented an unacceptable risk to human health by future groundwater consumption.

The EPA's Record of Decision (ROD) was signed on December 15, 1992, and the State of Alabama concurred with the selected remedy. The selected alternative included the following:

• Excavation of sludge, sediments, and contaminated soils.

• Off-site treatment/disposal of contaminated soils, sediments, and sludge at an approved disposal facility as determined appropriate by Resource Conservation and Recovery Act (RCRA) criteria and the waste sampling results from Toxicity Characterization Leaching Procedure (TCLP) testing.

• Regrading and backfill of excavations using clean, compacted-fill material.

• Temporary and possibly permanent relocation of residents with the potential demolition of selected apartment units.

• On-site treatment of contaminated groundwater in the surficial aquifer. Monitoring and possible withdrawal and treatment of groundwater in the alluvial aquifer. Treatment of groundwater for discharge to a Publicly Owned Treatment Works, or if unavailable, to a nearby surface water body.

While the ROD did not explicitly state Remedial Action Objectives (RAOs), the selected remedy was intended to address unacceptable risk presented by the Site, described in the risk assessment. The risk assessment summary for the Site indicated several areas of risk for mitigation as indicated below.

• Health risk posed at the Site is primarily from the future use of groundwater in both surficial and alluvial aquifers as a potable source.

• Surface soils and sediments are subject to contamination from continual leaching of contaminants from the sludge as it percolates to the surface.

The 1992 ROD was subsequently amended on June 14, 2000 with an Amended ROD (AROD). The RAOs for the Site remained unaltered but the major components of the amended remedy were as follows:

• Development of a phased approach to implement the amended remedy during the Remedial Design (RD).

• Demolition, removal, and off-site disposal to an approved facility of all buildings, foundations, concrete walkways, asphalt driveways and parking areas.

• Excavation, off-site treatment and disposal of the remaining source material (sludge, sediments and contaminated soils) at an approved disposal facility as determined appropriate by RCRA criteria and the waste sampling results from TCLP testing to aid in restoring and protecting groundwater quality.

• Reconstitution of the groundwater monitoring program at the Site after the backfilling and regrading of excavated areas had been completed.

• Postponement of the 1992 ROD requirement for on-site extraction and treatment of contaminated groundwater and compliance monitoring. Implementation was to be contingent upon the results of the baseline groundwater sampling and evaluation of the quarterly groundwater monitoring data. The groundwater response action would be revaluated to consider new groundwater monitoring data collected after the source removal action completion and determine whether or not the groundwater restoration could be achieved using Monitored Natural Attenuation (MNA).

On September 25, 2007, the EPA issued an ESD for the Redwing Site. In the ESD, the EPA revised the 1992 ROD subsurface soil cleanup levels for Acetone, Aldrin, Alpha-BHC, and Dieldrin. The remedy at the Site is protective of human health and the environment because the surface soil, subsurface soil, sediment and groundwater at the Site met performance standards established in the ROD, AROD, and the ESD.

Redwing continued periodic removal of surface seeps until 1994, when they discontinued work at the Site. On July 5, 1995, the EPA issued a Unilateral Administrative Order (UAO) to Redwing and Saraland Apartments, Ltd. directing them to conduct a removal of tar seeps at the Site. When both parties declined to comply with the order, the EPA undertook the removal action. The removal action consisted of the removal and off-site disposal of 288 55-gallon drums of investigation derived waste, approximately 5 cubic yards of stockpiled soil and approximately 10 gallons of “tar like material” (TLM) from 13 tar seeps.

During the spring of 1996, the tar seeps returned, and on July 12, 1996, the EPA issued a UAO to Redwing and Saraland Apartments, Ltd. directing them to remove the source of the tar seeps. When both parties refused to comply with the order, the EPA conducted a removal action, which consisted of temporarily relocating 57 families living in the complex and excavating and transporting off-site for disposal approximately 20,724 tons of sludge, contaminated soil, and debris. These contaminated materials were transported as nonhazardous waste, after passing TCLP sampling analysis, to the Browning-Ferris Industries' Falcon Incinerator in Brewton, Alabama. Trucks were lined prior to filling to prevent further contamination and utilized fabric covers during transport to prevent soils from leaving the vehicle during transport. Once received at the disposal site, the materials were emptied into a covered shed to await thermal treatment in the primary incinerator with a minimum temperature of 700 °F. After the removal was completed, air monitoring conducted in the Apartments detected unacceptable levels of benzene and the pesticide, Aldrin, in some of the Apartments. Based on this monitoring, the EPA determined that the residents could not return to live in the Apartments. Working together, the EPA and HUD relocated the residents to comparable permanent housing.

In July 1997, the EPA collected soil, sediment and water samples from 23 properties adjacent to the Redwing Site. The purpose of this sampling was to address community concerns about possible releases from the Site. Based on a risk evaluation of the analytical results of these samples, the EPA determined that there is no unacceptable health risk or hazard in the neighborhood adjacent to the Site.

The Redwing PRP conducted the remedial action pursuant to the February 26, 2002 RD/Remedial Action (RA) Consent Decree. Site demolition activities started in March 2004 and were completed in June 2004. During the demolition, 5,700 cubic yards of demolition debris was transported off-site for disposal and 3,915 cubic yards of asphalt and concrete were transported off-site for recycling. All debris was visually inspected and any debris found with visually questionable materials were sampled prior to transport to ensure that none of the debris failed RCRA criteria and waste sampling results from TCLP testing. None of the construction debris failed RCRA criteria and waste sampling results from TCLP, and as a result, all debris was transported to Jarrett Rd. Landfill in Pritchard, Alabama, a RCRA permitted construction debris facility, as required by the ROD.

The EPA approved the Final RD Report on June 28, 2007. The Site RA started in mid-December 2007 and was completed in June 2008. The excavation of TLM-contaminated soil was executed by the removal of blocks of soil to predetermined depths based on analytical results from the pre-design investigation. Additional TLM-contaminated soil was removed laterally based on visual inspection and presence on excavated sidewalls. Additional soil was excavated from the bottom of pre-determined excavation block depths based on confirmation analysis. Specifically, five-point composite samples were collected at the bottom of each excavation block and analyzed for the contaminants of concern (COC) established in the ROD. If the concentration of any constituent resulted in an exceedance of the 90% Upper Confidence Limit (UCL) average concentration for the Site, then additional soil was excavated and the deeper block bottom was again sampled.

The large majority of the soils excavated from the site contained TLM and were thus removed from the Site based on that criterion. The removal of the TLM-contaminated soils resulted in the need to only remove a small amount of additional soils to meet the 90% UCL average concentration requirement for soil constituent impacts. It should be noted that carbon tetrachloride, while retained as a COC for remediation, was only found in a single surface soil sample location, which was removed during the first removal action. The COC was retained due to the risk posed for ingestion and dermal contact. The subsurface excavation pits were not sampled for carbon tetrachloride since the risk posed was related to the surface soils which had already been removed.

During the RA, a total of 25,114 cubic yards of soil was excavated. Of this amount, approximately 21,375 cubic yards were sampled to assess for TCLP and subsequently transported off-site for disposal at Macland Disposal Center in Moss Point, Mississippi, a RCRA permitted non-hazardous waste facility, as no materials failed TCLP. The remaining soil that lacked visual signs for TLM and passed confirmation sampling, was mixed together with clean fill brought in from off-site and was used to backfill and regrade excavated areas of the Site. After regrading and seeding activities were completed, six monitoring wells were installed on-site and groundwater samples were collected in September 2008 and December 2008. The sampling detected Vernolate in one monitoring well (MW-16) at a concentration above the ROD groundwater cleanup level. The monitoring wells were resampled in March 2009, and Vernolate was again detected in MW-16 while none of the other groundwater monitoring wells were found to contain any ROD COC above their respective cleanup goals. In response to the 2008-2009 groundwater sampling, three monitoring wells were installed on adjacent property in early April 2009 to determine if contaminated groundwater had migrated off-site. No contamination was detected in these wells during the sampling event.

The June 14, 2000 AROD delayed the implementation of the 1992 ROD requirement for groundwater extraction and treatment to allow for evaluation of the groundwater monitoring data that would be collected after the source removal action completion. During this evaluation, degradation rates for each of the groundwater contaminants of concern were determined along with a prediction of future decreases in contaminant. After this evaluation, it was determined that further groundwater remediation would not be required since it was anticipated that the groundwater cleanup levels would be achieved within a short time frame as a result of natural attenuation after the removal of the source material. The EPA approved the Final RA Report dated July 2014 in September 2014.

Long-term, post-remediation groundwater monitoring was initiated after the completion of the RA in 2008 and was ongoing until late 2012. This monitoring program began with the installation of six new monitoring wells (MW-14, MW-15, MW-16, MW-17, MW-18 and MW- 19) on-site and included two monitoring wells that existed prior to the remediation (MW-12U and MW-13U). These eight wells were sampled in September 2008, December 2008 and March 2009 for the following constituents: Sulfate, Chloride, Beryllium (total and dissolved), Total Chromium (total and dissolved), Nickel (total and dissolved), Vanadium (total and dissolved), Total Organic Carbon, Methylene Chloride, Acetone, Carbon Disulfide, Chloroform, Bis(2-ethylhexyl)phthalate, Vernolate, Lindane, Alpha-BHC, 4,4-DDT, Dieldrin and Aldrin. Only a few minor exceedances of the ROD cleanup goals were observed with the exception of Vernolate in MW-16.

During the March 2009 sampling event, it was determined by the EPA that the groundwater cleanup goals had been met for all COCs with the exception of Vernolate. Due to the persistent exceedances of Vernolate in MW-16, three additional monitoring wells were installed off-site (MWOS-01, MWOS-02 and MWOS-03). Some members of the community were concerned with the proximity of MW-16 to the property line. All monitoring wells except MW-16 and the three off-site monitoring wells were abandoned in 2010. Monitoring continued on these three off-site wells and on-site MW-16 for Vernolate until the groundwater cleanup level was achieved in MW-16. No Vernolate was ever detected in the off-site monitoring wells.

From September 2009 to August 2012, groundwater samples were collected quarterly from MW-16 and the three off-site monitoring wells. After reviewing the results of the Vernolate groundwater sampling, ADEM and the EPA determined that the cleanup goals specified in the 1992 ROD, 2000 AROD and 2007 ESD had been met and abandonment of the remaining monitoring wells for the Site was approved.

The first five-year review (FYR) was completed on September 25, 2014. This review concluded that the selected remedy remains protective of human health and the environment pursuant to CERCLA section 121(c), 42 U.S.C. 9601 et seq. Per the EPA's 2001 FYR guidance, “Five-year reviews may no longer be needed when no hazardous substances, pollutants or contaminants remain on-site above levels that allow for unlimited use or unrestricted exposure” (UU/UE). Since the Site is UU/UE and has met the requirements established by the ROD, it is not necessary to conduct another FYR. The EPA has a policy that at least one FYR must be conducted after initiation of remedial action at the Site to ensure that the remedy is protective of human health and the environment. This policy FYR was conducted in 2014, and it concluded that the selected remedy at the Site is protective of human health and the environment because the surface soil, subsurface soil, sediment and groundwater at the Site met performance standards established in the 1992 ROD, subsequent 2000 AROD and subsequent 2007 ESD. The policy requirement for the five-year review has been met, and accordingly, the Site FYR requirement has been discontinued.

Throughout the removal and remedial process, the EPA has kept the public informed of the activities being conducted at the Site by way of public meetings, progress fact sheets, and the announcement through local newspaper advertisement on the availability of documents such as the RI/FS, Risk Assessment, ROD, Proposed Plan, AROD, ESD and FYRs.

Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k) and CERCLA Section 117, 42 U.S.C. 9617. Documents in the deletion docket, which the EPA relied on for recommendation of the deletion from the NPL, are available to the public in the information repositories identified above.

This Site meets all the site completion requirements as specified in Office of Solid Waste and Emergency Response (OSWER) Directive 9320.22, Close-Out Procedures for National Priorities List Sites. Specifically, confirmatory soil and groundwater sampling verifies that the Site has achieved the ROD cleanup standards, and that all cleanup actions specified in the ROD, AROD and ESD have been implemented.

The EPA, with concurrence of the State of Alabama through ADEM, has determined that all appropriate response actions under CERCLA have been completed. Therefore, the EPA is deleting the Site from the NPL.

Because the EPA considers this action to be noncontroversial and routine, the EPA is taking it without prior publication. This action will be effective September 28, 2015 unless the EPA receives adverse comments by September 14, 2015. If adverse comments are received within the 30-day public comment period, the EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion, and it will not take effect. The EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

For the reasons set out in this document, 40 CFR part 300 is amended as follows:

In order to carry out its mission, the Legal Services Corporation (“LSC” or “Corporation”) is authorized under the LSC Act to issue binding federal regulations with the force of law. The United States Court of Appeals for the District of Columbia Circuit has described LSC as possessing “general rulemaking authority.” Texas Rural Legal Aid, Inc., et al. v. Legal Services Corporation, 940 F.2d 685, 692 (D.C. Cir. 1991); see 42 U.S.C. 2996e. The LSC Act specifies, however, that the Corporation “shall not be considered a department, agency, or instrumentality, of the Federal Government.” 42 U.S.C. 2996d(e). Consequently, the Corporation's regulatory process is not statutorily tied to the Administrative Procedure Act (APA, 5 U.S.C. Ch. 5 et seq.), which binds federal agencies. Instead, Congress has required more specifically that LSC “shall afford notice and reasonable opportunity for comment to interested parties prior to issuing rules, regulations, and guidelines, and it shall publish in the Federal Register at least 30 days prior to their effective date all its rules, regulations, guidelines, and instructions.” 42 U.S.C. 2996g(e). The scope of LSC's Rulemaking Protocol encompasses “rules” and “regulations,” which are interpreted as essentially synonymous and which result in codified federal regulations.

Although the APA does not bind LSC, the Corporation has identified the broad purposes of that statute—public participation and reasoned, orderly, decision-making based on high-quality information—as consistent with its own statutory requirements and the general goals of regulation. LSC is also guided by other best practices broadly adopted by federal agencies, which include Executive Orders 12866 (1993) and 13563 (2011) and Office of Management and Budget Circular A-4 (2003).

Collectively, these documents suggest that regulation should proceed by demonstrating why action is needed and should be justified by a consideration of the costs and benefits of the regulatory approach chosen. Costs and benefits may be qualitative or quantitative and include outcomes related to the widespread distribution of “equity, human dignity, [and] fairness,” 1 which is in accord with the goals of the LSC Act. In addition, these federal best practices remind us to maintain regulatory flexibility where possible by specifying objectives rather than detailed rules, and also to engage in a regular examination of existing regulations to identify those that are redundant, unnecessary, or in need of modification.

LSC intends that an important source of new rulemaking activity and agenda items will be an ongoing retrospective review of its existing regulations. LSC's regulations are not voluminous, and to the extent they can be improved, they should be, as time and resources allow. In particular, LSC will examine its regulations to identify those where costs and burdens can be lessened without compromising effectiveness, or where effectiveness can be increased without increasing cost. It also will identify, with the input of the Office of Inspector General, regulations that are outdated or otherwise no longer useful or manageable, and those rules implicated by LSC's Strategic Plan. In order to maintain this process of continuous improvement, however, LSC anticipates the need for assistance from the regulated community, which is in the best position to highlight unanticipated problems that have arisen from particular regulatory provisions.

Similarly, existing nonregulatory guidance, including Program Letters and External Opinions, may often be a basis for agenda items. For a variety of reasons, it may be useful to codify successful guidance following a notice and comment process. In other cases, LSC may identify this guidance as founded in outdated regulation and as problematic in practice; revision of the underlying regulations would then be called for. Because of these important relationships between guidance and regulation, LSC's commitment to retrospective review extends to its guidance documents, as does its reliance on the communicated experience of the public and regulated community.

The purpose of this protocol is to explain the procedures used by LSC in the development, modification, rescission, and promulgation of its regulations, currently codified beginning at 45 CFR part 1600. The regulatory principles guiding LSC are intended to advance its overall mission as an organization: To provide financial support for legal assistance in civil matters to persons financially unable to afford legal assistance in a manner consistent with the LSC Act and other statutory directives of Congress. See 42 U.S.C. 2996b(a). LSC, in particular, is asked “to insure that grants and contracts are made so as to provide the most economical and effective delivery of legal assistance to persons” eligible for LSC-funded services. 42 U.S.C. 2996f(a)(3).

LSC first developed a formal rulemaking protocol in 2000. The rulemaking protocol was revised in 2002. The Board of Directors of LSC (“Board”) at that time believed that while there was no legal requirement for rulemaking procedures to be formalized in a written protocol, it was appropriate for LSC to produce such a document. As an independent entity not bound by the Administrative Procedure Act, LSC does not follow precisely the standardized regulatory processes of federal agencies, and in the interests of conducting its business in an open and fair way, LSC should make its rulemaking procedure generally known. The Board issuing this Protocol has determined these views to be sensible and has also determined that further revisions would be useful. This 2015 revision reflects more than a decade's worth of experience in rulemaking under the prior protocol and in addition incorporates certain trends in regulations, such as the emphasis on outcomes and on cost-benefit analysis.

It should be noted that because this Protocol is a statement of LSC internal procedure and is not itself a “rule, regulation, guideline or instruction,” LSC is not required by law to publish this Protocol or seek public comment. LSC is choosing to publish this Protocol in the Federal Register (and has also posted it on the LSC Web site at http://www.lsc.gov) in furtherance of LSC's general policy of transparency.2 The Protocol begins with an overview of the rulemaking process as usually conducted and then proceeds to a more detailed discussion of the steps involved and certain variations that may occur.

The Operations and Regulations Committee (“Committee”) is responsible for identifying rulemaking priorities for the Corporation in consultation with LSC management (“Management”) and LSC's Office of Inspector General (“OIG”), and for laying the groundwork for the Board's initial consideration of a regulatory change. The usual vehicle for the Committee's work will be a Rulemaking Agenda (“Agenda”), revised at least annually. Through the Agenda, Management will propose a prioritized list of regulatory actions that the Committee will consider for action and presentation to the Board. The Agenda will serve as a work plan for the Committee and LSC staff.

As items from the Rulemaking Agenda come up for Committee consideration, LSC staff will produce a written statement describing the need for regulatory action. This document, termed a Justification Memorandum (“Memorandum”), is intended to be flexible in character, and will be of a length and scope appropriate to the issue. The Memorandum will contain a recommendation from Management regarding whether or not to authorize rulemaking.

Final authority over LSC rulemaking policies and actions rests with the Board. Under the LSC Act, the Board has the legal authority to initiate, terminate, or otherwise direct a rulemaking at any duly authorized meeting. Under normal circumstances, the Board will take three votes on a rulemaking:

Prior to each of these votes, the Committee normally will engage in public deliberation on the rulemaking, and the meeting or meetings at which such deliberations occur will include an opportunity for public comment. Upon concluding its deliberations, the Committee will vote on and issue a recommendation to the Board.

The initial impetus for a rulemaking may come from a variety of sources, including:

• New studies or other evidence;

• Initiatives arising from the Corporation's Strategic Plan;

• Retrospective review of the Corporation's regulations;

• Congressional directives;

• Board or Committee decisions;

• Requests from Management, the OIG, or individual members of the Board or Committee; or

• Petitions or recommendations from the regulated community and general public.

Management is responsible for compiling and conveying these possibilities, together with its views, for Committee consideration. At minimum, this will occur annually during revision of the Rulemaking Agenda.3 It may, however, occur at any time as circumstances dictate or if a potential rulemaking is time-sensitive. From the possibilities presented by Management, the Committee will determine which items to include or exclude from further consideration for the coming year and will also indicate general priorities among the items included.

The annual preparation of the Agenda (and any significant revisions) will be reported to the Board at its Spring quarterly meeting. The Committee normally will develop the Agenda without Board action, but rather in consultation with Management and the OIG. The Board may specifically act to place (or remove) items on the Agenda. During the course of the year, the Committee may authorize LSC to undertake rulemakings that were not placed on the Rulemaking Agenda.

Generally, Management will work on items on the Rulemaking Agenda in the order of priority established by the Committee. Management will present each item to the Committee at a public meeting. Prior to that meeting, Management will prepare a Justification Memorandum discussing the potential rulemaking for the Committee and the Board. This Memorandum will discuss the need for the regulatory action and Management's views on whether action is necessary or desirable. The Memorandum represents Management's considered view on the initiation of rulemaking and is developed in consultation with the OIG. OIG's views may be incorporated in the Memorandum submitted by Management, or OIG may submit them to the Committee independently.

Beyond these elements, the format of the Memorandum will be determined by the characteristics of each particular proposed rulemaking. Often, the focus at this early stage of the rulemaking will be simply on whether some change is warranted, rather than an assessment of any specific changes or routes by which they could be achieved. The Memorandum may discuss and evaluate:

• The effects of acting or not acting on a particular rulemaking proposal;

• The costs and benefits of engaging in rulemaking, compared to the status quo;

• Whether LSC needs additional information from the public before it can proceed with drafting an NPRM; and

• The suitability of particular processes, such as fact-gathering through a rulemaking workshop with stakeholders.

In other circumstances, where rulemaking is needed to conform the rule to statutory or regulatory changes, none of these analyses may be necessary.

Management may provide the Committee and the Board with privileged advice related to a proposed rulemaking. That advice may be provided in writing, as well as in a closed session of the Committee or Board's meeting, as permitted by the Government in the Sunshine Act.

The Committee will consider the Memorandum at a public meeting, and a copy of the Memorandum (but not any privileged material) will be publicly available, either physically or online, at the time of the meeting. The Committee will then provide an independent recommendation to the Board on the advisability of initiating rulemaking. Instead of issuing a recommendation, the Committee may also choose to request further work by Management on particular issues and development of a revised Memorandum, which the Committee will consider at future public meeting.

If the Committee makes a recommendation to the Board, it is asking the Board to take the first of its votes on a particular rulemaking. The Board also has the option of requesting further work and a revised Memorandum before acting on the Committee's recommendation. If the Board votes to not initiate rulemaking without further instruction, it is effectively removing the rulemaking from the Rulemaking Agenda. If the Board votes to initiate rulemaking, it may attach to its vote further instructions regarding the scope of the rulemaking, particular changes desired, or processes to be used in developing the rule.

In certain circumstances, including time-sensitive matters that are relatively straightforward and anticipated to be uncontroversial, an accelerated process may be employed that combines Step 2 and Step 3 (discussed below). This would involve Management's preparation, with the concurrence of the Committee, of a Memorandum and a draft of an NPRM. If the Committee votes to recommend rulemaking, it could then proceed at the same meeting to consider a recommendation regarding the draft NPRM, and then present both recommendations in a combined motion to the Board. The Board could then choose to authorize both the opening of rulemaking and the publication of the NPRM for comment. In these circumstances, the Memorandum should contain a separate justification for the use of this accelerated process.

Once the Board votes to open rulemaking, Management and the Committee will work together to oversee the process of developing the rule. For relatively straightforward rules, this may involve simply converting the Memorandum into the preamble of a draft NPRM, accompanied by proposed regulatory changes.

More complex rulemakings, especially those with different alternatives for regulating a particular issue, may call for public engagement at an early stage. The Committee, after consulting with Management, may vote at a public meeting to authorize preliminary information-gathering actions. Should the Committee use these methods, it will regularly report its actions and the results of its efforts to the Board.

In particular, rulemaking may be enhanced in some cases by the issuance of an Advanced Notice of Proposed Rulemaking (“ANPRM”) or a Request for Information (“RFI”) that solicits comments on certain issues or requests certain factual information at an early stage of the rulemaking process. An ANPRM or RFI may also be useful in collecting public views on the scope of the proposed rulemaking and on what issues to include or exclude from the proposed rule. In addition, if the costs and benefits associated with the rulemaking are unclear, LSC may use an ANPRM or an RFI to request that public input and data be provided to help understand the costs and benefits more clearly and accurately.

Alternatively, LSC may choose to seek public input through Rulemaking Workshops. Rulemaking Workshops consist of one or more publicly noticed meetings of the Committee with the participation of Management, invited stakeholder representatives, and other interested and well-informed parties. Workshops are open discussions designed to elicit information about problems or concerns with the regulation (or certain aspects thereof) and provide an opportunity for sharing ideas regarding how to address those issues. Using whatever electronic and online methods are feasible, the Workshop should be open to observation by, and input from, the general public, including those not physically present with the Committee. The Workshop is not generally intended to develop detailed alternatives or to obtain consensus on regulatory proposals, and the primary anticipated role of Committee members would be to engage other participants with relevant questions rather than issue immediate decisions.

A Negotiated Rulemaking 4 is another alternative to develop an NPRM for a particular item. If the Committee determines this is the best approach, it will work with Management to designate a group of external representatives that will then meet with Management over an extended period, under supervision of a professional facilitator, in order to develop consensus regarding particular regulatory alternatives and the form of a draft NPRM.

The above mechanisms do not exhaust the ways LSC may develop its proposed rules. Where appropriate, LSC may publish general or specific requests for comment or surveys or use social media to seek public input on a proposed rule.

After gathering the necessary input, and as directed by the Committee, LSC staff will be responsible for drafting the NPRM in consultation with the OIG. LSC staff will submit the draft for review and approval or revision by the President of LSC. Once approved, Management will submit the draft NPRM to the Committee for consideration at a public meeting.

Management will provide the draft NPRM to the Committee sufficiently in advance of the meeting to allow adequate time for consideration. The draft also will be made available both electronically in advance of the meeting and in physical form at the meeting. LSC will publish in the Federal Register a notice of the meeting announcing the placement of the draft NPRM on the Committee agenda and the availability of the draft NPRM on LSC's Web site. At the Committee meeting, Management will present the draft NPRM, and the Committee will provide a designated opportunity for public comment prior to a vote of the Committee to recommend publication. The Committee will then deliberate and decide whether to recommend that the Board publish the NPRM, recommend that the Board terminate the rulemaking, or make no recommendation to the Board, but instead return the draft to Management for further development.

If the Board authorizes by its vote publication of the NPRM, Management will make any necessary technical revisions to the document and submit it to the Federal Register for publication. The comment period will be at least 30 days, but may be longer at the discretion of the Committee and Management, or at the direction of the Board.

LSC will accept comments submitted in either physical or electronic form by the closing date stated in the NPRM published in the Federal Register. LSC will publish the notice and the NPRM on LSC's Web site.

Copies of all comments received during the designated comment period will be provided to the Committee and made available to other Board Members upon request. Copies of all comments will also be placed in a public docket available for inspection and copying in the FOIA Reading Room at the Corporation's offices, as well as in an electronic docket accessible from LSC's Web site.

In addition to comments received during the comment period, any relevant public comments made to the Committee during its public meetings on the rulemaking—including written comments submitted in conjunction with oral presentations—will be considered part of the administrative record of the rulemaking and included in LSC's docket. LSC will not consider or respond to comments submitted outside of the public comment period or the relevant Committee meetings for a particular rulemaking. In the event a comment submitted outside the time periods described above raises significant substantive or procedural questions that LSC believes are likely to affect the outcome of the rulemaking, LSC may provide another opportunity for the submitter to provide the comment to LSC in a public forum or by reopening the rulemaking.

In some circumstances, LSC may determine that publication of a revised (or “further”) NPRM (“FNPRM”) or a supplemental NPRM is necessary. These notices may be used to request comment on specific issues, on revisions to discrete parts of an NPRM, to clarify or add missing information to an existing NPRM, or in other instances where LSC wishes to obtain from or share information with the public. Such instances may include times when LSC makes material changes to the rule text proposed in the NPRM. With notice to the Board, the Committee may authorize an FNPRM or a supplemental NPRM at a public meeting, designating an additional period of public comment for no less than 30 days. The Committee may also authorize an extension or re-opening of the comment period on an existing NPRM.

Upon the close of the comment period, and upon determination that no further comment periods are needed, Management will draft the Final Rule in consultation with the OIG. Management will submit the draft Final Rule to the Committee for consideration at a public meeting. The draft also will be made available both electronically in advance of the meeting and in physical form at the meeting. LSC will publish in the Federal Register a notice of the meeting announcing the placement of the draft Final Rule on the Committee agenda and the availability of the draft Final Rule on LSC's Web site. At the Committee meeting, Management will present the draft Final Rule, and the Committee will provide a designated opportunity for public comment prior to a vote of the Committee to recommend publication. The Committee will then deliberate and decide whether to recommend that the Board adopt the Final Rule as a federal regulation, recommend that the Board terminate the rulemaking, or make no recommendation to the Board, but instead return the draft to Management for further development.

If the Board authorizes by its vote adoption of the Final Rule (as amended, if it chooses to do so), Management will make any necessary minor revisions to the document submitting it to the Federal Register. Any changes to LSC's regulations will also be reflected on LSC's Web site. In accordance with the LSC Act, any regulatory change will not be operative for at least 30 days after publication as a Final Rule, and this period may be extended at the discretion of the Committee and Management, or at the direction of the Board.