Federal Register Vol. 80, No.146,

On July 22, 2015 (80 FR 43301), the Office of Management and Budget (OMB) issued a number of changes to Title 2 of the Code of Federal Regulations (2 CFR 180 and 2 CFR 200). These changes provided guidance to Federal agencies to implement Section 872 of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009. As section 872 required, OMB and the General Services Administration (GSA) have established an integrity and performance system that includes governmentwide data with specified information related to the integrity and performance of entities awarded Federal grants and contracts. This document is to advance the effective date to July 30, 2015 for the Guidance for Reporting and Use of Information Concerning Recipient Integrity and Performance final rule.

This final rule is issued under the general regulations for federal marketing agreements and orders (7 CFR part 900), effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” This action adds a new § 900.202 (Restrictions applicable to Committee personnel) under “Subpart—Miscellaneous Regulations” to accentuate the applicability of U.S. antitrust laws to marketing order program activities.

The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule implements an amendment to the general regulations for federal fruit, vegetable, and specialty crop marketing agreements and marketing orders that would accentuate the applicability of U.S. antitrust laws to marketing order programs' domestic and foreign activities. This action advises marketing order board and committee members and personnel of the restrictions, limitations, and liabilities imposed by those laws.

Federal marketing order boards and committees have always been subject to U.S. antitrust laws. These boards and committees work with USDA in administering marketing order programs which, among other things, authorizes them, with approval of the Secretary, to establish and promote a program's domestic and foreign marketing activities. The Act immunizes board and committee members and employees from prosecution under U.S. antitrust laws so long as their conduct is authorized by the Act or provisions of a marketing order. This rule accentuates the applicability of U.S. antitrust laws to marketing order board and committee members and personnel in light of changing global marketing and production trends as well as advises boards and committees of the restrictions, limitations, and liabilities of those laws. Under the antitrust laws, Committee members and employees may not engage in any unauthorized agreement or concerted action that unreasonably restrains United States domestic or foreign commerce. Failing to adhere to these laws may lead to prosecution under the antitrust laws by the United States Department of Justice and/or suit by injured private persons seeking treble damages, and may also result in expulsion of members from the Committee or termination of employment with the Committee.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 1,090 handlers who are subject to regulation under the 28 federal marketing order programs and approximately 33,100 producers in the regulated areas. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201). USDA estimates that many of these handlers and producers may be classified as small entities. This rule accentuates the applicability of U.S. antitrust laws to marketing order programs' domestic and foreign activities. This action also advises marketing order board and committee members and personnel of the restrictions, limitations, and liabilities imposed by those laws.

This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

AMS has discussed the changes to the regulations with all marketing order board and committee staff that it oversees. Moreover, AMS conducted refresher training on antitrust laws for marketing order board and committee staff and officers at the Marketing Order Management Conference on September 23-24, 2014.

A proposed rule concerning this action was published in the Federal Register on May 6, 2015 (80 FR 25969). The rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending June 5, 2015, was provided to allow interested persons to respond to the proposal. No comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Jeffrey Smutny at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because AMS is simply updating the regulations to reemphasize the applicability of U.S. antitrust laws.

For the reasons set forth in the preamble, 7 CFR part 900 is amended as follows:

Executive Order 12866

This rule has been determined to be significant and was reviewed by the Office of Management and Budget under Executive Order 12866. In accordance with Executive Order 12866, an Economic Impact Analysis was completed, outlining the costs and benefits of implementing this program in rural America. The complete analysis is available from the Agency upon request. The following is the discussion of the Economic Benefits section of the Analysis.

Bringing broadband services to rural areas does present some challenges. Because rural systems must contend with lower household density than urban systems, the cost to deploy fiber-to-the-home (FTTH) and 4G LTE systems in urban communities is considerably lower on a per household basis, making urban systems more economical to construct. Depending upon the technology deployed it can be more expensive to provide service to rural customers than to customers located in urban areas. Other associated rural issues, such as environmental challenges or providing wireless service through mountainous areas, also can add to the cost of deployment.

Areas with low population size, locations that have experienced persistent population loss and an aging population, or places where population is widely dispersed over demanding terrain generally have difficulty attracting broadband service providers. These characteristics can make the fixed cost of providing broadband access too high, or limit potential demand, thus depressing the profitability of providing service. Clusters of lower service exist in sparsely populated areas, such as the Dakotas, eastern Montana, northern Minnesota, and eastern Oregon. Other low-service areas, such as the Missouri-Iowa border and Appalachia, have aging and declining numbers of residents. Nonetheless, rural areas in some States (such as Nebraska, Kansas, and Vermont) have higher-than expected broadband service, given their population characteristics, suggesting that policy, economic, and social factors can overcome common barriers to broadband expansion.

In general, rural America has shared in the growth of the Internet economy. Online course offerings for students in primary, secondary, post-secondary, and continuing education programs have improved educational opportunities, especially in small, isolated rural areas. Interaction among students, parents, teachers, and school administrators has been enhanced via online forums, which is especially significant given the importance of ongoing parental involvement in children's education.

Telemedicine and telehealth have been hailed as vital to health care provision in rural communities, whether simply improving the perception of locally provided health care quality or expanding the menu of medical services. More accessible health information, products, and services confer real economic benefits on rural communities, reducing transportation time and expenses, treating emergencies more effectively, reducing time missed at work, increasing local lab and pharmacy work, and providing savings to health facilities from outsourcing specialized medical procedures.

Most employment growth in the U.S. over the last several decades has been in the service sector, a sector especially conducive for broadband applications. Broadband allows rural areas to compete for low- and high-end service jobs, from call centers to software development. Rural businesses have been adopting more e-commerce and Internet practices, improving efficiency and expanding market reach. Some rural retailers use the Internet to satisfy supplier requirements. The farm sector, a pioneer in rural Internet use, is increasingly comprised of farm businesses that purchase inputs and make sales online. Farm household characteristics such as age, education, presence of children, and household income are significant factors in adopting broadband Internet use, whereas distance from urban centers is not a factor. Larger farm businesses are more apt to use broadband in managing their operation; the more multifaceted the farm business, the more the farm uses the Internet.

The Catalog of Federal Domestic Assistance (CFDA) number assigned to this program is 10.886, Rural Broadband Access Loans and Loan Guarantees. The Catalog is available on the Internet and the General Services Administration's (GSA's) free CFDA Web site at http://www.cfda.gov. The CFDA Web site also contains a PDF file version of the Catalog that, when printed, has the same layout as the printed document that the Government Publishing Office (GPO) provides. GPO prints and sells the CFDA to interested buyers. For information about purchasing the Catalog of Federal Domestic Assistance from GPO, call the Superintendent of Documents at 202-512-1800 or toll free at 866-512-1800, or access GPO's online bookstore at http://bookstore.thefederalregister.org.

This rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require a consultation with State and local officials. See the final rule related notice entitled, “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034).

The agency has reviewed this regulation pursuant to E.O. 13563, issued on January 18, 2011 (76 FR 3281, January 21, 2011). E.O. 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in E.O. 12866. To the extent permitted by law, agencies are required by E.O. 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, 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 specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the RUS invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested. These requirements have been approved by emergency clearance under OMB Control Number 0572-0130.

Comments must be received by September 28, 2015.

Comments are invited on (a) whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of burden including the validity of the methodology and assumption used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques on other forms of information technology.

Title: 7 CFR 1738, Rural Broadband Loan and Loan Guarantee Program.

OMB Control Number: 0572-0130.

Type of Request: Extension of an existing collection.

Abstract: The Rural Utilities Service is authorized under Title VI of the Rural Electrification Act of 1936, as amended (RE Act), to provide loans and loan guarantees to fund the cost of construction, improvement, or acquisition of facilities and equipment for the provision of broadband service in eligible rural areas in States and Territories of the United States. In conjunction with this interim rulemaking, RUS is submitting an information collection package to OMB as required by the Paperwork Reduction Act of 1995. The information collection package for 7 CFR 1738 includes the estimated burden related to the application process for the Rural Broadband Loan and Loan Guarantee Program. Since the inception of the program in 2003, the Agency has tried to accurately determine the burden to respondents applying for a Rural Broadband Loan, including soliciting comments from the public. The items covered by this collection include forms and related documentation to support a loan application, including Form 532 and its supporting schedules.

The 2014 Farm Bill requires that the Agency be more transparent when identifying entities that are applying for funding, set the definition of unserved areas, address defaulted loans, and provide incentives for applicants to provide service in the most remote unserved rural areas. To accomplish the goals above, the Agency has: (1) Established a process for prioritizing applications; (2) set a minimum acceptable level of broadband service; (3) established a percentage of unserved households to receive broadband service; (4) provided additional details on the contents of applications; and (5) added additional incentives for reaching unserved areas.

The Agency has addressed these issues as follows:

Prioritizing Applications: To ensure that the priority requirements of the 2014 Farm Bill and this regulation are effectuated, a minimum of two evaluation periods will be established for ranking applications. At present, the Agency expects that evaluations will be conducted in March and September, but a notice in the Federal Register will be published, announcing the opening of each window and the deadlines for applications.

Broadband Service: With the growing need for bandwidth in the medical and business environments, as well as for the average user, the 2014 Farm Bill established a minimum acceptable level of broadband service at 4 megabits downstream and 1 megabit upstream, which the Agency will use as the benchmark for determining whether broadband service exists in an area. However, with respect to minimum standards for applications requesting funding, the Agency will be continuing its practice of a Broadband Lending Speed, which will require applicants to make available a minimum amount of bandwidth to all premises in the proposed funded service area. As with the prior broadband program, that standard will be updated from time to time in the Federal Register.

The definitions for Broadband Service and the Broadband Lending Speed are integral parameters for the administration of this program and the determination of what entities are eligible to apply for funds. Although the minimum level for Broadband Service is established by statute in the 2014 Farm Bill, this regulation allows for the standard to be raised as the need for additional bandwidth is required by the public. Therefore, we are requesting and encouraging commenters to this regulation to make recommendations on the bandwidth requirements for both Broadband Service and the Broadband Lending Speed. The level for Broadband Service will be used to determine eligibility of a service area for funding and the level for the Broadband Lending Speed will set the bandwidth requirement that a proposed system must be able to provide to every customer in the service area.

With the development of new applications and the need for greater bandwidth, the Agency strongly suggests that applicants applying for funding under this program consider system designs that will allow for 25 megabits downstream and 3 megabits upstream. Building to these requirements will ensure that facilities that are constructed today will also be able to handle the needs of the future.

Application Transparency: To ensure transparency for the Broadband Loan Program, the Agency's mapping tool will be modified to include the following information for each application:

For all applications that are approved, an additional report will be posted that includes the name of the company receiving funding, type of funding received and the purposes of the funding.

Additionally, in accordance with 2014 Farm bill requirements, a requirement has been added to require borrowers to submit semi-annual reports for three years after the completion of construction. It is anticipated that this reporting requirement will not become effective until approximately three years from the effective date of this rulemaking. At that time the agency will need to revise the information collection package associated with reporting requirements for the Broadband Loan Program (0572-0031). Information collected will consist of the following items;

1. The number and location of residences and businesses that will receive service at or greater than the broadband lending speed;

2. The types of facilities constructed and installed;

3. The speed of the broadband services being delivered;

4. The average price of the broadband services being delivered in each proposed service area;

5. The broadband adoption rate for each proposed service territory, including the number of new subscribers generated from the facilities funded;

This information will be used to analyze the effectiveness of the funding provided and will allow the Agency to track adoption rates as new and improved broadband services are being provided.

The Agency seeks comments on its estimate of burden related to the application process for the Rural Broadband Program and welcomes comments related to further reducing application paperwork and costs. Specifically, comments should address the estimation of hour and cost burden associated with each component of RUS Form 532, available on the agency's Web site. Burden on respondents is considered to include the time, effort, and financial resources expended to generate, maintain, retain, disclose, or provide information to or for a Federal Agency. The Agency is also interested in determining the information that Broadband applicants would have on hand in a format that could be readily provided for the loan application and which items would be prepared by parties outside the applicant's organization. Comments may be sent to Michele Brooks, Director, Program Development and Regulatory Analysis, Rural Development, U.S. Department of Agriculture, 1400 Independence Ave. SW., Stop 1522, Room 5159 South Building, Washington, DC 20250-1522 or via email to: [email protected].

Estimate of Burden: Public reporting for this collection of information is estimated to average 425.5 hours per response.

Respondents: Businesses and Not-for-profit institutions.

Estimated Number of Respondents: 5.

Estimated Total Annual Burden on Respondents: 2094.5 hours.

Copies of this information collection can be obtained from Michele Brooks, Program Development and Regulatory Analysis, at (202) 690-1078.

All responses to this information collection and recordkeeping notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Administrator has determined that this rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.). Therefore, this action does not require an environmental impact statement or assessment.

It has been determined that the Regulatory Flexibility Act is not applicable to this rule because the Agency is not required by 5 U.S.C. 553 or any other provision of law to publish a notice of proposed rulemaking with respect to the subject matter of this rule.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. The Agency has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted, no retroactive effort will be given to this rule, and, in accordance with Sec. 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. Sec. 6912(e)), administrative appeal procedures, if any, must be exhausted before an action against the Department or its agencies may be initiated.

This rule contains no Federal mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of section 202 and 205 of the Unfunded Mandates Reform Act of 1995.

The policies contained in this rule do not have any 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. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the States is not required.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

Rural Development has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. However, since deploying broadband infrastructure throughout Indian Country presents unique challenges, the Agency commits to provide at least one Tribal Consultation focused on those unique challenges (and potential solutions) prior to the implementation of this rule. If a Tribe requests consultation, Rural Development will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress. If a tribe would like to engage in consultation with Rural Development on this rule, please contact Rural Development's Native American Coordinator at (720) 544-2911 or [email protected].

The Agency is committed to the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. The Agency is currently developing an online application system that will replace the existing manual process for submitting applications.

The Agency improves the quality of life in rural America by providing investment capital for deployment of rural telecommunications infrastructure. In order to achieve the goal of increasing economic opportunity in rural America, the Agency finances infrastructure that enables access to a seamless, nationwide telecommunications network. With access to the same advanced telecommunications networks as its urban counterparts, especially those designed to accommodate distance learning, telework, and telemedicine, rural America will eventually see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. The Agency shares the assessment of Congress, State and local officials, industry representatives, and rural residents that broadband service is a critical component to the future of rural America. The Agency is committed to ensuring that rural America will have access to affordable, reliable, broadband services and to provide a healthy, safe, and prosperous place to live and work.

On May 13, 2002, the Farm Security and Rural Investment Act of 2002, Public Law 107-171 (2002 Farm Bill) was signed into law. The 2002 Farm Bill amended the Rural Electrification Act of 1936 to include Title VI, the Rural Broadband Access Loan and Loan Guarantee Program (Broadband Loan Program), to be administered by the Agency. Title VI authorized the Agency to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. Under the 2002 Farm Bill, the Agency was directed to promulgate regulations without public comment. Implementing the program required a different lending approach for the Agency than it employed in its earlier telephone program because of the unregulated, highly competitive, and technologically diverse nature of the broadband market. Those regulations were published on January 30, 2003, at 68 FR 4684.

In an attempt to enhance the Broadband Loan Program and to acknowledge growing criticism of funding competitive areas, the Agency proposed to amend the program's regulations on May 11, 2007, at 72 FR 26742. As the Agency began analysis of the public comments it received on the proposed regulations, the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) was working its way through Congress. On March 14, 2011, the Agency published an interim rule implementing the requirements of the 2008 Farm Bill and started accepting applications. The Agency did not receive any significant comments to the interim rule and published a final rule on February 6, 2013. With the enactment of the Agricultural Act of 2014 (2014 Farm Bill) Section 6104, Public Law 113-79 (Feb. 7, 2014), additional requirements were added to the Broadband Loan Program, including the prioritization of approving applications, a minimum benchmark of broadband service, a more transparent public notice requirement, and the first statutorily required reporting standards, all of which are implemented in this rule.

On March 23, 2015, a Presidential Memorandum was issued for Expanding Broadband Deployment and Adoption by Addressing Regulatory Barriers and Encouraging Investment and Training. The memorandum states that it shall be the policy of the Federal Government for executive departments and agencies having statutory authorities applicable to broadband deployment (agencies) to use all available and appropriate authorities to: Identify and address regulatory barriers that may unduly impede either wired broadband deployment or the infrastructure to augment wireless broadband deployment; encourage further public and private investment in broadband networks and services; promote the adoption and meaningful use of broadband technology; and otherwise encourage or support broadband deployment, competition, and adoption in ways that promote the public interest. In addition to assist in this effort, there is established the Broadband Opportunity Council (Council), to be co-chaired by the Secretaries of Commerce and Agriculture, or their designees. In addition to the Co-Chairs, the Council shall include the heads, or their designees, of:

i. The Department of Defense;

ii. the Department of State;

iii. the Department of the Interior;

iv. the Department of Labor;

v. the Department of Health and Human Services;

vi. the Department of Homeland Security;

vii. the Department of Housing and Urban Development;

viii. the Department of Justice;

ix. the Department of Transportation;

x. the Department of the Treasury;

xi. the Department of Energy;

xii. the Department of Education;

xiii. the Department of Veterans Affairs;

xiv. the Environmental Protection Agency;

xv. the General Services Administration;

xvi. the Small Business Administration;

xvii. the Institute of Museum and Library Services;

xviii. the National Science Foundation;

xix. the Council on Environmental Quality;

xx. the Office of Science and Technology Policy;

xxi. the Office of Management and Budget;

xxii. the Council of Economic Advisers;

xxiii. the Domestic Policy Council;

xxiv. the National Economic Council;

xxv. the National Security Council staff; and

xxvi. such other Federal agencies or entities as determined appropriate pursuant to subsection (c) of this section.

The following summarizes the substantive changes introduced in this rule. The changes are presented in the order in which they appear within the interim rule.

Broadband service—This definition was modified to incorporate the 2014 Farm Bill's requirement that the minimum level of broadband service be initially set to 4 megabits downstream and 1 megabit upstream, and reviewed by the Agency at least once every 2 years, and adjusted as necessary through a notice published in the Federal Register, in order to ensure that high quality, cost-effective broadband service is being provided to rural areas. This definition will be used to determine if a rural area is eligible for funding.

Incumbent service provider—This definition was modified so as not to automatically eliminate an existing service provider from being counted as an incumbent service provider if the provider did not respond to the public notice filing for new applications.

The 2014 Farm Bill requires that the Agency use all means available to determine if an incumbent service provider is present in a proposed funded service area. As a result, only in cases where the Agency is unable to make an incumbent determination without input from the provider, will a provider not be counted as an incumbent for not responding to a request for information. The determination of incumbent service providers is critical to whether a loan is eligible for the broadband program.

Interim financing—This definition was modified to make only construction started after a loan has been offered as eligible for reimbursement, as opposed to the prior rule which allowed for construction started after an application was deemed “complete” to be eligible for reimbursement. Because of the new requirement to prioritize applications within at least two evaluation periods, and not process applications on a first-come, first-served basis, applications which are feasible, but not the highest priority, may never be funded. As a result, the Agency has changed its policy on when construction is eligible for reimbursement.

Unserved household or unserved area—The 2014 Farm Bill removed the definition for underserved and introduced the definition of unserved. All proposed funded service areas must include a minimum of fifteen percent unserved households.

In March of 2012, the Agency published 7 CFR part 1700 as a final rule instituting eligibility requirements for classifying an area as a Substantially Underserved Trust Area and making certain considerations available for those areas that qualify. The changes to this section incorporate this regulation by reference and allow for applicants to seek classification as a Substantially Underserved Trust Area and associated benefits of this classification.

Section 1738.51(b)—A statement was added to this section to clarify that if an Indefeasible Right to Use (IRU) agreement qualifies as a capital lease, the entire cost of the lease will be amortized over the life of the lease and that only the first three years of the amortization period can be funded.

Section 1738.101(b)(2)—The existing regulations require that facilities be constructed within three years from the time loan funds are made available. Given the many factors affecting when loan funds are available, the Agency has decided to simplify this requirement by making funds available 120 days after the date of the loan contract, which is the time allotted for closing a loan. The three-year construction period will commence 120 days after the date of the loan contract. This uniform change will bring clarity to applicants and assist their budgeting of time.

Section 1738.102(c)—This section was added to address the new 2014 Farm Bill requirement that the Agency determine if there are incumbent service providers in a proposed funded service area. In addition to the current use of the public notice process, the Agency will now utilize the National Broadband Map and any other data that may be available detailing service provider information in the affected area to make this determination. This process will assist the Agency in identifying ineligible areas, despite any non-responses from existing service providers.

Section 1738.155—Most areas in the U.S. that still do not have broadband service are areas with low population densities or very tough geographic conditions which impede construction. Under these conditions, it is very difficult to develop a feasible business plan that the Agency can fund. To assist and encourage companies to venture into difficult rural areas, the 2014 Farm Bill permitted modifications to the standard lending terms. As a result, the Agency, at its discretion, may consider the following for applications that propose to serve areas that contain a minimum of 50 percent unserved households and that request special terms: (1) An extension of the standard 2-year principal deferral period up to a maximum of 4 years; (2) an extension of the maturity period beyond economic life of the assets; and (3) a modification to the security arrangements for the loan. These three options individually or together may assist in the development of a successful business by reducing the initial debt service payments and allowing borrowers more time to develop operations and positive cash flow. Special terms are only authorized to the extent they are necessary to achieve financial feasibility and long-term sustainability of these projects.

Section 1738.203—In accordance with 2014 Farm Bill requirements, this section has been modified to require applications to be evaluated and prioritized no less than twice a year, based on the number of unserved household proposed to receive service at the broadband lending speed. This process will ensure that the maximum number of unserved residents and businesses receive broadband service.

National and State reserves will be established based on the amount of funding provided for any given fiscal year. Please note that depending on the amount of funding provided, it may not be appropriate to establish State reserves.

Section 1738.204—To better inform the public of the applications that are being submitted for financial assistance, the public notice that the Agency publishes through the use of the Agency's mapping tool will now include the following additional information: (1) Amount and type of funding requested; (2) status of the review of the application; (3) the number of unserved households in the application; and (4) a list of census block groups to be served. In addition, for all approved applications, an additional notice will be published on the Agency Web page that includes the name of the entity being funded, the type of funding received, and the purpose of the assistance. All applicants that are approved for funding will also be required to submit semiannual reports that will be published on the Web page. This information will better allow the public to understand where taxpayer dollars are being spent and what is being accomplished.

Section 1738.254—In accordance with 2014 Farm Bill requirements, an additional requirement has been added to this section that requires borrowers to submit semi-annual reports for three years after the completion of construction. The report must include the purpose of the financing, number and location of the premises served, speed of the broadband service being delivered, average price of the services and the adoption rate of the services being provided. This report will allow the Agency to better track the progress of the loan and validate that the funds are being used for the purposes in the application.

The Agency urges all interested parties to provide comments. Please see instructions on how to do so in the ADDRESSES section of this document.

The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.

If you wish to file an employment complaint, you must contact your agency's EEO Counselor (PDF) within 45 days of the date of the alleged discriminatory act, event, or in the case of a personnel action. Additional information can be found online at http://www.ascr.usda.gov/complaint_filing_file.html.

If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at http://www.ascr.usda.gov/complaint_filing_cust.html, or at any USDA office, or call (866) 632-9992 to request the form. You may also write a letter containing all of the information requested in the form. Send your completed complaint form or letter to us by mail at U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, by fax (202) 690-7442 or email at [email protected].

Individuals who are deaf, hard of hearing or have speech disabilities and you wish to file either an EEO or program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).

Persons with disabilities who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (e.g., Braille, large print, audiotape, etc.) please contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Accordingly, chapter XVII, title 7, Code of Federal Regulations is amended by revising part 1738 to read as follows:

Table of Contents I. The Petition II. Public Comments on the Petition III. Discussion IV. Reasons for Denial V. Conclusion I. The Petition

Section 2.802 of Title 10 of the Code of Federal Regulations (10 CFR), “Petition for rulemaking,” provides an opportunity for any interested person to petition the Commission to issue, amend, or rescind any regulation. The NRC received a petition from Motti Slodowitz on behalf of CampCo dated December 2, 2011 (ADAMS Accession No. ML12132A332). The petition requests that the NRC amend certain regulations concerning exemptions from licensing for products containing byproduct material to include illumination tritium markers.

On July 5, 2012 (ADAMS Accession No. ML121580046), the NRC requested supplemental information to further clarify the request. On September 18, 2012 (ADAMS Accession No. ML13112B010), the petitioner responded to the NRC's request and submitted supplemental information clarifying that the petitioner is requesting the NRC to amend paragraph (b) of 10 CFR 32.22, “Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer;” paragraph (c) of 10 CFR 30.19, “Self-luminous products containing tritium, krypton-85, or promethium-147;” and 10 CFR 30.15, “Certain items containing byproduct material.” The petitioner also provided a dose assessment for the purpose of showing that the tritium markers would result in acceptably low doses.

The petitioner requests that the NRC amend 10 CFR 32.22(b) to include an additional requirement stating that an applicant cannot be denied a device registration or distribution license if it has adequately demonstrated that the criteria in applicable regulations have been met. The petitioner contends that the statement in 10 CFR 32.22(b), that “the Commission may deny an application for a specific license if the end uses of the product cannot be reasonably foreseen,” is a subjective statement without specific criteria and that it is unfair to deny applications based upon subjective statements where the criteria are not codified in the regulations. The petitioner references a Memorandum on Scientific Integrity issued by President Obama on March 9, 2009, which states that “[s]cience and the scientific process must inform and guide decisions of [the] Administration on a wide range of issues, including improvement of public health.” The petitioner notes that the NRC has previously denied approval of products because end uses of the products could not reasonably be foreseen. The petitioner also states that the term “frivolous use,” as used in the NRC's policy statement on consumer products (30 FR 3462; March 16, 1965, proposed revision 76 FR 63957; October 14, 2011) and in the NRC's guidance for materials licenses (NUREG-1556, Volume 3, Revision 1, “Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration” (ADAMS Accession No. ML041340618)), is not clearly defined and that there are no detailed criteria used to make determinations. The petitioner asserts that the potential misuse of a tritium marker as a toy should not result in the product being banned outright.

The petitioner requests that the NRC also amend 10 CFR 30.19(c) to add that tritium markers used to label equipment are not considered to be toys or adornments and shall not be sold as such.

The petitioner also requests that the NRC amend 10 CFR 30.15 to add a specific exemption for tritium markers with a maximum activity of 25 millicuries (925 mBq) of tritium. The petitioner believes an exemption is warranted because of the usefulness of the tritium markers and the low dose potential. The petitioner states that the markers would not be a frivolous use of radioactive material, and that “the potential radiation doses to members of the public under normal use and accident conditions...are within regulatory limits.” The petitioner also states that the markers are sold in other countries and have practical benefit such as helping military personnel recover lost items, helping first responders locate tagged equipment at night, assisting hunters in finding lost items, and helping lost campers find their tents.

The notice of receipt published in the Federal Register (78 FR 41720; July 11, 2013), invited interested persons to submit comments. The comment period closed on September 24, 2013. The NRC received one public comment opposing the petition. The commenter states:

Although the NRC is denying the petition, the NRC disagrees with the commenter that the presence of tritium in approved consumer products would negatively affect law enforcement efforts to track illegal weapons.

The NRC regulates consumer products containing byproduct material without imposing regulatory controls on the consumer-user. Those who manufacture or distribute products containing byproduct material, including consumer products, must have a license issued under 10 CFR part 32. Exemptions for users of products containing byproduct material appear in 10 CFR part 30. These exemptions are either product-specific or class exemptions.

A class exemption covers a class of products, for which a person who wishes to manufacture or distribute a specific product within that class may submit a license application. An applicant must provide safety information about the product and demonstrate that the product meets a number of safety criteria. Exemption of a product under a class exemption is dependent on approval under the applicable regulations for the distributor.

Section 30.19 is a class exemption for the receipt, possession, use, transfer, ownership, or acquisition of self-luminous products containing certain radionuclides, including tritium. This exemption does not apply to persons who manufacture, process, produce, or initially transfer such products for sale or distribution. Paragraph (c) in 10 CFR 30.19 states that the exemption for products containing tritium, krypton-85, or promethium-147 does not apply to products primarily for frivolous purposes or in toys or adornments. Those who wish to intially transfer for sale or distribution self-luminous products covered by the 10 CFR 30.19 class exemption must first apply for and receive a specific license under 10 CFR 32.22 and must have the product registered under 10 CFR 32.210. Applicants for licenses under 10 CFR 32.22 must also demonstrate that the product is designed and manufactured in accordance with the safety criteria in 10 CFR 32.23. Paragraph 32.22(b) further indicates that the Commission may deny an application for a specific license if the end uses of the product cannot be reasonably foreseen.

Section 30.15 provides a list of product-specific exemptions for certain products containing byproduct material, subject to certain limits including specific radionuclide quantity limits. The receipt, possession, use, transfer, ownership, and acquisition of these products, which includes self-luminous timepieces, hands, and dials, are exempt from licensing requirements. Persons wishing to apply or incorporate byproduct material into these products or initially transfer them for sale or distribution must apply for a specific license under 10 CFR 32.14. Unlike products covered by the 10 CFR 30.19 class exemption, specific products listed in 10 CFR 30.15 do not need to be registered under 10 CFR 32.210 in order for one to obtain a specific license for distribution.

The NRC's Consumer Product Policy Statement (CPPS or policy) (79 FR 2907; January 16, 2014) provides the Commission's policy with respect to approval of the use of byproduct, source, and special nuclear material in products intended for use by the general public (consumer products) without the imposition of regulatory controls on the consumer-user. The revision of the consumer product policy statement was finalized after the petition was filed.

The petitioner requests that the NRC amend 10 CFR 32.22(b) to include a statement that an applicant cannot be denied a device registration or distribution license if it has adequately demonstrated that the criteria in the applicable regulations have been met.

Paragraph 32.22(b) allows the NRC to exercise its judgment in denying a license application when the end use of a product cannot be reasonably foreseen. The requested amendment would affect all future applications for a license under this section and would limit the NRC's ability to deny an applicant based on whether a practice (in this case, the distribution of certain products for use by the general public) is justified. Furthermore, this suggested revision would make 10 CFR 32.22(b) internally inconsistent and essentially would nullify it.

Such a revision would be inconsistent with the NRC's CPPS, revised in January 2014. In response to a public comment that discussed the ability to foresee the end uses of products, the Commission explicitly stated the importance of evaluating products “on a case-by-case basis,” listing a number of considerations such as likely doses, the probability and severity of accidents and misuse, and the benefits to be obtained from the product, noting that these cannot be reasonably evaluated if the ultimate uses of the product are not known (79 FR 2910). The Commission addressed the importance of this particular regulatory criterion that allows the denial of a distribution license for a product whose end uses cannot be reasonably foreseen, stating “[s]elf-luminous products in particular have a wide range of potential applications and might easily be widely used for purposes other than those originally intended if not clearly designed for a specific use. This criterion also ensures that the uses . . . of radioactive material in products are justified.” Id. Therefore, it is important for the NRC to be able to exercise its judgment in denying a license application when the end use of a product cannot be reasonably foreseen.

The petitioner requests that the NRC amend 10 CFR 30.19(c) to add that tritium markers used to label equipment are not considered to be toys or adornments and shall not be sold as such.

The requested amendment stating that the tritium markers “shall not be sold” as toys or adornments would not further control whether these products can be distributed as such. Additionally, there is no need to expressly designate products that are or are not “toys or adornments” for purposes of 10 CFR 30.19(c) because NRC staff can apply the normal dictionary definition of such terms to individual products on a case-by-case basis. Paragraph 30.19(c) also addresses self-luminous products generally, which makes references to specific products inappropriate. Moreover, including a reference to tritium markers used for labeling purposes would prejudge the product as covered by the exemption, contrary to the intent of the regulatory framework and the CPPS, which stresses the importance of case-by-case determinations.

The petitioner requests that the NRC amend 10 CFR 30.15 to add a specific exemption for tritium markers with a maximum activity of 25 millicuries (925 mBq) of tritium.

The NRC is choosing not to include a new specific exemption for these tritium markers at this time, consistent with the guiding principles within the CPPS. The exempt products in 10 CFR 30.15, such as timepiece hands or dials containing specified quantities of byproduct material including tritium, or marine compasses containing tritium, are designed for specific uses. As previously indicated, the Commission has stated that “[s]elf-luminous products in particular have a wide range of potential applications and might easily be widely used for purposes other than those originally intended if not clearly designed for a specific use” (79 FR 2910). Based on the small size (1.8 cm long by 0.8 cm diameter by 0.2 cm thick) and the design of the tritium markers, the tritium markers have potential uses beyond those intended by the petitioner, including as decorations on zipper pulls on clothing or as jewelry. The lack of a clear design for a specific use creates greater potential for unintended uses (such as the ones specifically excluded from the exemption in 10 CFR 30.19), which outweighs the product's beneficial uses. Because of the potential for widespread use, careful consideration of justification of practice is important.

Also, the size and glow-in-the-dark nature of the tritium markers would appeal to and be accessible to children. Creating a new specific exemption for these tritium markers would be inconsistent with the CPPS, in particular, paragraph four (79 FR 2912), which requires that products subject to mishandling, especially by children, require an unusual degree of safety and utility. This criterion is unchanged from the original 1965 version of the policy. The tritium markers do not meet this criterion as they do not provide an unusual degree of utility. The unique benefits as compared to other alternatives are relatively limited. For example, the uses of the tritium markers asserted by the petitioner can be achieved by other products on the market, such as battery-powered products. While the use of tritium presents a particular benefit by staying illuminated continuously without having to be turned on when needed, the amount of light created using the 25 mCi of tritium suggested for the new exemption is limited. Also, self-luminous products containing tritium light sources incorporated into products with clear end uses can provide some of the same benefits.

The petitioner stated that the tritium markers are sold in other countries. The discussion in the CPPS recognizes that it is unavoidable that there will be some differences made in judgments concerning justification of practice. Generally, international standards, such as the International Atomic Energy Agency's “Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards,” suggest that this product should not be exempted. However, individual countries' regulatory bodies make their own judgments.

The NRC is denying the petition because the petitioner fails to demonstrate that a specific exemption is warranted or that the existing regulatory framework for self-luminous products is inappropriate. The tritium markers do not meet the regulatory criteria for the use of self-luminous products under an exemption from licensing. In addition, the self-luminous product class exemption was set up to eliminate the need to evaluate numerous PRMs for a wide variety of self-luminous products and the need to conduct a separate rulemaking to add individual exemptions for each acceptable one. This provision is needed to ensure that the use of radioactive material in a product is justified.

For the reasons cited in this document, the NRC is denying PRM-32-8. The petition fails to present any significant new information or arguments that would warrant the requested amendments.

The Coast Guard will enforce the Seattle Seafair Unlimited Hydroplane Race Special Local Regulation in 33 CFR 100.1301 from 8:00 a.m. on July 30, 2015 through 11:59 p.m. on August 2, 2015.

Under the provisions of 33 CFR 100.1301, the Coast Guard will restrict general navigation in the following area: All waters of Lake Washington bounded by the Interstate 90 (Mercer Island/Lacey V. Murrow) Bridge, the western shore of Lake Washington, and the east/west line drawn tangent to Bailey Peninsula and along the shoreline of Mercer Island.

The regulated area has been divided into two zones. The zones are separated by a line perpendicular from the I-90 Bridge to the northwest corner of the East log boom and a line extending from the southeast corner of the East log boom to the southeast corner of the hydroplane race course and then to the northerly tip of Ohlers Island in Andrews Bay. The western zone is designated Zone I, the eastern zone, Zone II. (Refer to NOAA Chart 18447).

The Coast Guard will maintain a patrol consisting of Coast Guard vessels, assisted by Coast Guard Auxiliary vessels, in Zone II. The Coast Guard patrol of this area is under the direction of the Coast Guard Patrol Commander (the “Patrol Commander”). The Patrol Commander is empowered to control the movement of vessels on the racecourse and in the adjoining waters during the periods this regulation is in effect. The Patrol Commander may be assisted by other federal, state and local law enforcement agencies.

Only vessels authorized by the Patrol Commander may be allowed to enter Zone I during the hours this regulation is in effect. Vessels in the vicinity of Zone I shall maneuver and anchor as directed by the Patrol Commander.

During the times in which the regulation is in effect, the following rules shall apply:

(1) Swimming, wading, or otherwise entering the water in Zone I by any person is prohibited while hydroplane boats are on the racecourse. At other times in Zone I, any person entering the water from the shoreline shall remain west of the swim line, denoted by buoys, and any person entering the water from the log boom shall remain within ten (10) feet of the log boom.

(2) Any person swimming or otherwise entering the water in Zone II shall remain within ten (10) feet of a vessel.

(3) Rafting to a log boom will be limited to groups of three vessels.

(4) Up to six (6) vessels may raft together in Zone II if none of the vessels are secured to a log boom. Only vessels authorized by the Patrol Commander, other law enforcement agencies or event sponsors shall be permitted to tow other watercraft or inflatable devices.

(5) Vessels proceeding in either Zone I or Zone II during the hours this regulation is in effect shall do so only at speeds which will create minimum wake, seven (7) miles per hour or less. This maximum speed may be reduced at the discretion of the Patrol Commander.

(6) Upon completion of the daily racing activities, all vessels leaving either Zone I or Zone II shall proceed at speeds of seven (7) miles per hour or less. The maximum speed may be reduced at the discretion of the Patrol Commander.

(7) A succession of sharp, short signals by whistle or horn from vessels patrolling the areas under the direction of the Patrol Commander shall serve as signal to stop. Vessels signaled shall stop and shall comply with the orders of the patrol vessel; failure to do so may result in expulsion from the area, citation for failure to comply, or both.

The Captain of the Port may be assisted by other federal, state and local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 100.1301 and 5 U.S.C. 552(a). If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

We encourage you to submit comments (or related material) on this temporary final rule. We will consider all submissions and may adjust our final action based on your comments. Comments should be marked with docket number USCG-2015-0568 and should provide a reason for each suggestion or recommendation. You should provide personal contact information so that we can contact you if we have questions regarding your comments; but please note that all comments will be posted to the online docket without change and that any personal information you include can be searchable online (see the Federal Register Privacy Act notice regarding our public dockets, 73 FR 3316, Jan. 17, 2008).

Mailed or hand-delivered comments should be in an unbound 81/2 x 11 inch format suitable for reproduction. The Docket Management Facility will acknowledge receipt of mailed comments if you enclose a stamped, self-addressed postcard or envelope with your submission.

Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following the Web site's instructions. You can also view the docket at the Docket Management Facility (see the mailing address under ADDRESSES) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

The San Diego Maritime Museum Festival of Sail is an annual reoccurring event listed in 33 CFR 100.1101 (table 1, item 15) for Southern California annual marine events for the San Diego Captain of the Port Zone. Special local regulations exist for the marine event to allow for use of the San Diego Bay waterway to allow for three days of events. For 2015, the event is occurring over four days. This temporary final rule is therefore necessary to ensure that the same measures normally provided are in place for all four days.

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.”

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. The publishing of an NPRM would be impracticable since immediate action is needed to minimize potential danger to the participants and the public during the event. The danger posed by the volume of commercial, public and private recreational marine traffic in San Diego bay makes special local regulations necessary to provide for the safety of participants, event support vessels, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is important to have these regulations in effect during the event. The area covered by the special local regulation should have negligible impact on vessel movement. The Coast Guard will issue a broadcast notice to mariners (BNM) to advise vessel operators of navigational restrictions. In addition, Coast Guard will also advertise notice of the event and event date changes via local notice to mariners (LNM) report. For the same reasons, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date would be contrary to the public interest, because immediate action is needed to ensure the safety of the event. However, notifications will be made to users of the affected area near San Diego Bay, San Diego, California via marine information broadcast and a local notice to mariners.

Furthermore, we are providing an opportunity for subsequent public comment and, should public comment show the need for modifications to the special local regulations during the 2015 event, we may make those modifications and will provide actual notice of those modifications to the affected public.

The legal basis and authorities for this rule are found in 33 U.S.C. 1233, which authorize the Coast Guard to establish, and define special local regulations. The Captain of the Port San Diego is establishing a special local regulation for the waters of San Diego Bay, San Diego, California to protect event participants, spectators and transiting vessels. Entry into this area is prohibited unless specifically authorized by the Captain of the Port San Diego or designated representative.

The San Diego Maritime Museum Tall Ship Festival of Sail is an annual event held in the early part of September on San Diego Bay, San Diego, California.

The regulation listing annual marine events within the San Diego Captain of the Port Zone and special local regulations is 33 CFR 100.1101. Table 1 to § 100.1101 identifies special local regulations within the COTP San Diego Zone. Table 1 to § 100.1101 at item “15” describes the enforcement date and regulated location for this marine event.

The date listed in the Table 1 to § 100.1101 has the marine event occurring over three days in September. However, this temporary rule changes the marine event date to September 4 through September 7, 2015 to reflect the actual four days of the event.

The Coast Guard is establishing a temporary special local regulation for a marine event on San Diego Bay that will be effective from 9 a.m. on September 4, 2015 through 7 p.m. September 7, 2015 and will be enforced daily from 9 a.m. to 7 p.m. on September 4 through September 7, 2015.

The Coast Guard will temporarily suspend the regulation listed in Table 1 to § 100.1101 item “15”, and insert this temporary regulation in Table 1 to § 100.1101, at item “19”. This change is needed to accommodate the sponsor's event plan. No other portion of Table 1 to § 100.1101 or other provisions in Table 1 to § 100.1101 shall be affected by this regulation.

The special local regulations are necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway for this event that will consist of a tall ship parade and mock cannon battle demonstrations. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within this regulated waterway unless authorized by the Coast Guard Captain of the Port (COTP), or his designated representative, during the proposed times. Before the effective period, the Coast Guard will publish information on the event in the weekly LNM.

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. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. This determination is based on the size, location, and the limited duration of the marine event and associated special local regulations. Optional waterway routes exist to allow boaters to transit around the marine event area, without impacting the festival. Additionally, to the maximum extent practicable, the event sponsor will assist with the movement of boaters desiring to transit the area throughout the four days.

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 rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the impacted portion of San Diego Bay, California from 9 a.m. to 7 p.m. on September 4 through September 7, 2015.

This special local regulation will not have a significant economic impact on a substantial number of small entities for the following reasons. Although the special local regulations would apply to a broad portion of San Diego, traffic would be allowed to pass around the zone or through the zone with the permission of the COTP, or his designated representative. The event sponsor will also be advertising the event. Before the effective period, the Coast Guard will publish event information on the internet in the weekly LNM marine information report and will provide a BNM via marine radio during the event.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not 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 rule involves establishment of marine event special local regulations on the navigable waters of San Diego Bay. This rule is categorically excluded from further review under paragraph 34(h) 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 100 as follows:

The Coast Guard is issuing this 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), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the State Street Bridge and the Railroad Bridge, that once required draw operations in 33 CFR 117.761, were replaced by fixed bridges in 1992 and 1970, respectively. Therefore, the regulation is no longer applicable and shall be removed. It is unnecessary to publish an NPRM because this regulatory action does not place any restrictions on mariners but rather removes a restriction that has no further use or value.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. The bridges have been a fixed bridge for 23 and 45 years, respectively, and this rule merely requires an administrative change to the Federal Register, in order to omit a regulatory requirement that is no longer applicable or necessary. The modifications have already taken place and the removal of these regulations will not affect mariners currently operating on this waterway. Therefore, a delayed effective date is unnecessary.

The State Street Bridge across Woodbridge Creek, mile 0.5, was removed and replaced in 1992 with a fixed bridge. The Railroad Bridge, mile 0.6, was converted to a fixed bridge in 1970. It has come to the attention of the Coast Guard that the governing regulation for these drawbridges were not removed subsequent to the replacement and conversion of these bridges. The elimination of these drawbridges necessitates the removal of the drawbridge operation regulation, 33 CFR 117.761, pertaining to the former drawbridges.

The purpose of this rule is to remove the paragraph of 33 CFR 117.761 that refers to the State Street Bridge and the Railroad Bridge at mile 0.5 and mile 0.6, respectively, from the Code of Federal Regulations because it governs bridges that no longer open.

The Coast Guard is changing the regulation in 33 CFR 117.761 by removing restrictions and the regulatory burden related to the draw operations for these bridges that are no longer drawbridges. The change removes the section 117.761 of the regulation which governs the State Street Bridge and the Railroad Bridge. This Final Rule seeks to update the Code of Federal Regulations by removing language that governs the operation of the State Street Bridge and the Railroad Bridge, which are in fact no longer drawbridges. This change does not affect waterway or land traffic.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 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 does not consider this rule to be “significant” under that Order because it is an administrative change and does not affect the way vessels operate on the waterway.

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.

This rule will have no effect on small entities since these drawbridges have been replaced, converted with fixed bridges and the regulation governing draw operations for these bridges is no longer applicable. There is no new restriction or regulation being imposed by this rule; therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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 have determined that it 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 might 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 guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded 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 rule involves the removal of a drawbridge operation regulation that is no longer necessary. This rule is categorically excluded, under figure 2-1, paragraph (32) (e), of the Instruction.

Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

On April 17, 2015, the Department published a notice in the Federal Register (80 FR 21196) proposing an extension of project period and a waiver of 34 CFR 75.250 and 34 CFR 75.261(c)(2) (proposed waiver and extension) in order to—

(1) Enable the Secretary to provide additional funds to the National Center for an additional 12-month period, from September 30, 2015, through September 30, 2016; and

(2) Invite comments on the proposed waiver and extension.

There are no substantive differences between the proposed waiver and extension and this final waiver and extension.

Public Comment: In response to our invitation in the proposed waiver and extension, one party submitted comments.

Analysis of Comments and Changes: An analysis of the comments received in response to the proposed waiver and extension and of any changes in the waiver and extension since publication of the proposed waiver and extension follows.

Comment: One commenter supported extending the National Center's project period for one year to avoid the loss of the invaluable assistance provided to the Regional Centers and the deaf consumers whom they support.

Discussion: We appreciate the commenter's support.

Changes: None.

In the proposed waiver and extension, we discuss the background and purposes of the National Center and our reasons for proposing the waiver and extension. For the reasons discussed there, we conclude that it would be contrary to the public interest to have a lapse in the provision of the training currently provided by the National Center. Allowing funding to lapse before a new interpreter education delivery system can be implemented would leave individuals who are deaf or hard of hearing and individuals who are deaf-blind without necessary supports in the event that critical needs arise.

The Secretary waives the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, and the requirements in 34 CFR 75.261(c)(2), which limit the extension of a project period if the extension involves the obligation of additional Federal funds. This will allow the current National Center to request and continue to receive Federal funding through September 30, 2016. With this waiver and extension of the project period, the National Center will be required to develop a plan to demonstrate how it will continue to carry out activities during the year of the continuation award consistent with the scope, goals, and objectives of the grantee's application as approved in the 2010 competition. This plan must be submitted to RSA for review and approval by September 1, 2015.

The Administrative Procedure Act requires that a substantive rule must be published at least 30 days before its effective date, except as otherwise provided for good cause (5 U.S.C. 553(d)(3)). We have not made any substantive changes to the proposed waiver and extension. The Secretary has therefore determined to waive the delayed effective date to ensure a timely continuation grant to the current National Center and continuation of the valuable services the National Center provides.

The Secretary certifies that this final waiver and extension of the project period will not have a significant economic impact on a substantial number of small entities. The only entity that will be affected is the current grantee receiving Federal funds to serve as the National Center and any other potential applicants.

The Secretary certifies that the final waiver and extension will not have a significant economic impact on this entity because the extension of an existing project period imposes minimal compliance costs, and the activities required to support the additional year of funding will not impose additional regulatory burdens or require unnecessary Federal supervision.

This final waiver and extension of the project period does not contain any information collection requirements.

This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. However, under 34 CFR 79.8(a), we waive intergovernmental review in order to make an award by the end of FY 2015.

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 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 17, 2015, the Department published a notice in the Federal Register (80 FR 21195) proposing an extension of the project period and a waiver of 34 CFR 75.250 and 34 CFR 75.261(c)(2) (proposed waiver and extension) in order to—

(1) Enable the Secretary to provide additional funds to the Regional Centers for an additional 12-month period, from September 30, 2015, through September 30, 2016; and

(2) Invite comments on the proposed waiver and extension.

There are no substantive differences between the proposed waiver and extension and this final waiver and extension.

Public Comment: In response to our invitation in the proposed waiver and extension, two parties submitted comments.

Analysis of Comments and Changes: An analysis of the comments received in response to the proposed waiver and extension and of any changes in the waiver and extension since publication of the proposed waiver and extension follows.

Comment: Two commenters supported extending the Regional Centers' project period for one year to avoid the loss of an essential source of training and training materials tailored to the needs of the five regions served.

Discussion: We appreciate the commenters' support.

Changes: None.

In the proposed waiver and extension, we discuss the background and purposes of the Regional Centers and our reasons for proposing the waiver and extension. For the reasons discussed there, we conclude that it would be contrary to the public interest to have a lapse in the provision of the training currently provided by the Regional Centers. Allowing funding to lapse before a new interpreter education delivery system can be implemented would leave individuals who are deaf or hard of hearing and individuals who are deaf-blind without necessary supports in the event that critical needs arise.

The Secretary waives the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, and the requirements in 34 CFR 75.261(c)(2), which limits the extension of a project period if the extension involves the obligation of additional Federal funds. This will allow the five current grantees to request and continue to receive Federal funding through September 30, 2016. With this waiver and extension of the project period, each Regional Center will be required to develop a plan to demonstrate how it will continue to carry out activities during the year of the continuation award consistent with the scope, goals, and objectives of the grantee's application as approved in the 2010 competition. These plans must be submitted to RSA for review and approval by September 1, 2015.

The Administrative Procedure Act requires that a substantive rule must be published at least 30 days before its effective date, except as otherwise provided for good cause (5 U.S.C. 553(d)(3)). We have not made any substantive changes to the proposed waiver and extension. The Secretary has therefore determined to waive the delayed effective date to ensure timely continuation grants to the entities affected and continuation of the valuable services the Regional Centers provide.

The Secretary certifies that this final waiver and extension of the project period will not have a significant economic impact on a substantial number of small entities. The only entities that will be affected are the five current grantees receiving Federal funds to serve as the Regional Centers and any other potential applicants.

The Secretary certifies that the waiver and extension will not have a significant economic impact on these entities because the extension of an existing project period imposes minimal compliance costs, and the activities required to support the additional year of funding will not impose additional regulatory burdens or require unnecessary Federal supervision.

This final waiver and extension of the project period does not contain any information collection requirements.

This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. However, under 34 CFR 79.8(a), we waive intergovernmental review in order to make awards by the end of FY 2015.

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 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.

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) to support projects that provide training, traineeships, and 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.

Program Authority: 29 U.S.C. 772(a)(1).

Applicable Program Regulations: 34 CFR part 385.

We published a notice of proposed priority for this competition in the Federal Register on May 15, 2015 (80 FR 27868). That notice contained background information and our reasons for proposing the particular priority. There are differences between the proposed priority and this final priority, and we explain those differences in the Analysis of Comments and Changes section of this notice.

Public Comment: In response to our invitation in the notice of proposed priority, three parties submitted comments on the proposed priority.

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 since publication of the notice of proposed priority follows.

Comment: One commenter suggested that the Vocational Rehabilitation Technical Assistance Center—Youth with Disabilities (VRTAC-Y) include as a focus of the training and TA to be provided by the Center best practices for improving services and supports for children with disabilities who are home schooled as well as children with disabilities in foster care. In addition, the commenter noted that, like youth without disabilities, youth with disabilities need support in obtaining work experience in intermediate jobs while they are still being encouraged to seek careers requiring postsecondary education or training. The commenter also suggested that the VRTAC-Y consult with adults with disabilities who are successful in order to identify practices they found to be helpful. Finally, the commenter suggested that best practices include mentoring programs pairing youth with disabilities and individuals with disabilities who have been successful in their chosen careers.

Discussion: The focus of this priority is to provide TA to State VR agencies to improve services to and outcomes for: (1) Students with disabilities, as defined in section 7(37) of the Rehabilitation Act, who are in school and who are not receiving services under the Individuals with Disabilities Education Act (IDEA); and (2) youth with disabilities, as defined in section 7(42) of the Rehabilitation Act, who are no longer in school and who are not employed, often referred to as dropouts. Thus, an applicant could propose to include as a focus of its TA students with disabilities who are home schooled or in foster care and who are not receiving services under the IDEA, and youth with disabilities in foster care who are between the ages of 14 and 24 and who are dropouts, if such a focus is consistent with the TA needs identified by the Center under this priority.

Similarly, nothing in this priority as currently written precludes the grantee from providing TA to help students and youth with disabilities to obtain intermediate jobs as they pursue their long-term career goals. In addition, an applicant may employ or otherwise consult with adults with disabilities to identify best practices in serving students and youth with disabilities, and an applicant may propose this strategy as one of its TA activities. Finally, we agree that developing supportive mentoring relationships can help to improve employment outcomes for youth with disabilities, and we have added language to the priority under topic area (c) to address this comment.

Changes: We have added mentoring services under topic area (c) as an example of a collaborative and coordinated service strategy that is designed to increase the number of students and youth with disabilities who obtain competitive integrated employment.

Comment: Given the potential for overlap with TA and materials provided by other TA centers on related topics, one commenter suggested that applicants for the VRTAC-Y describe their plans to coordinate with other previously established TA centers. The commenter also questioned the requirement to review current VR agency State Plans while State agencies are in the midst of developing Unified or Combined State Plans with WIOA core programs and updating relevant interagency agreements, suggesting that review of these State Plans that were developed before the implementation of WIOA might not yield current information on which to base selection of intensive TA sites or the measurement of TA impact on performance.

Discussion: Coordinating responsibilities between the VRTAC-Y and existing TA centers is required under Coordination Activities, section (b), and Application Requirements, section (b)(1)(iii), and we believe the commenter's concerns are adequately addressed in those sections.

While we recognize that State VR agencies are working with WIOA partners to develop Unified or Combined State Plans, including updating relevant interagency agreements, we expect that review of current State Plans will still provide valuable information for TA purposes. The review of State Plans is only one source of information the VRTAC-Y will consider in its knowledge development activities. In addition to reviewing State-reported data and other information, the VRTAC-Y will conduct a survey of relevant stakeholders and VR service providers to identify TA needs. Finally, the applicant is required to describe how it will determine the effectiveness of the TA, including any proposed standards or targets for determining effectiveness, and its progress toward achieving intended outcomes, which at a minimum must include data on a number of variables.

Changes: None.

Comment: One commenter suggested that the Technical Assistance and Dissemination Activities section of this priority could be strengthened by specifically identifying service providers as partners of the State VR agency in these activities in section (a)(1). The commenter suggested using the phrase “public and community-based” to better describe the service systems discussed under section (a)(2) (how to access and leverage partnerships across agencies and public and community-based service delivery systems to increase the number of students and youth with disabilities provided with relevant and accessible information regarding services available through the State VR agency) and under section (b)(1) (a curriculum guide for developing partnerships). The commenter also suggested that work experience opportunities and programs be included in section (b)(3) (a curriculum guide for developing training and work experience programs).

Discussion: Service providers are included in the term “relevant stakeholders,” which already is used in the priority, so we do not believe it is necessary to mention them specifically. We agree that the phrase “public and community-based” is most inclusive of potential partners in serving students and youth with disabilities. We also agree that the addition of work opportunities to the curriculum guide on developing training and work experience programs is consistent with the individualized nature of customized training that is included in this curriculum guide description.

Changes: We have added the phrase “public and community-based” in sections (a)(2)(i) and (ii) and (b)(1) under Technical Assistance and Dissemination Activities in order to better describe coordination among service systems. Under section (b)(3), we have added the words “career pathways” and “work opportunities” in the description of the curriculum guide.

Comment: None.

Discussion: In reviewing the NPP, we recognized that we had overlooked an obvious but important set of training programs to which students and youth with disabilities should have access.

Changes: We have added language under paragraph (3)(iii) of the Technical Assistance and Dissemination Activities section. We clarify that TA on assisting students and youth with disabilities to access training that is directly responsive to employer needs and hiring requirements may include training offered by providers under the WIOA core programs.

Final Priority:

The purpose of this priority is to fund a cooperative agreement to establish a Vocational Rehabilitation Technical Assistance Center—Youth with Disabilities (VRTAC-Y). The focus of this priority is to provide technical assistance (TA) to State vocational rehabilitation (VR) agencies to improve services to and outcomes of: (1) Students with disabilities, as defined in section 7(37) of the Rehabilitation Act, who are in school and who are not receiving services under the IDEA; and (2) youth with disabilities, as defined in section 7(42) of the Rehabilitation Act, who are no longer in school and who are not employed, often referred to as dropouts. For purposes of this priority, “Students and youth with disabilities” refers to these two groups.

The VRTAC-Y is designed to achieve, at a minimum, the following outcomes:

(a) Assist State VR agencies to identify and meet the VR needs of students and youth with disabilities consistent with section 101(a)(15) of the Rehabilitation Act;

(b) Improve the ability of State VR agencies to develop partnerships with State and local agencies, service providers, or other entities to ensure that students and youth with disabilities are referred for VR services and have access to coordinated supports, services, training, and employment opportunities, including: (1) Increasing the number of referrals and applications received by State VR agencies from agencies, service providers and others serving students and youth with disabilities; and (2) increasing the number of students and youth with disabilities receiving VR services;

(c) Improve the ability of VR personnel to develop individualized plans for employment that ensure the successful transition of students and youth with disabilities and the achievement of post-school goals; and

(d) Increase the number of students and youth with disabilities served by VR agencies (particularly dropouts and youth involved in the foster care and correctional systems) who are engaged in education and training programs leading to the attainment of postsecondary educational skills and credentials needed for employment in high-demand occupations.

Under this priority, the VRTAC-Y must develop and provide training and TA to State VR agency staff and related rehabilitation professionals and service providers in the following topic areas:

(a) Developing and maintaining formal and informal partnerships and relationships with relevant stakeholders (including, but not limited to, school systems, institutions of higher education (IHEs), State and local service agencies, community rehabilitation programs, correctional facilities and programs, and employers) to increase referral of students and youth with disabilities to the State VR system for the supports and services they need to achieve competitive integrated employment;

(b) Developing and implementing outreach policies and procedures using evidence-based and promising practices that ensure that students and youth with disabilities in the State are located, identified, and evaluated for services; and

(c) Developing and implementing collaborative and coordinated service strategies, such as mentoring services; higher education and training services; and internship, apprenticeship, and other work experience services designed to increase the number of students and youth with disabilities who are served by the State VR agency who obtain competitive integrated employment.

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

(a) In the first year, collect information from the literature and from existing Federal, State, and other programs on evidence-based and promising practices relevant to the work of the VRTAC-Y and make this information publicly available in a searchable, accessible, and useful format. The VRTAC-Y must review, at a minimum:

(1) State VR agency State Plan descriptions of outreach plans and procedures, coordination and collaboration with other agencies, and coordination and collaboration with education officials relating to students and youth with disabilities;

(2) State VR agency formal interagency agreements with SEAs for the coordination of transition services, including the provision of pre-employment transition services;

(3) The results of State VR agency monitoring conducted by RSA, when available;

(4) State VR agency program and performance data; and

(5) Information on promising practices and VR needs of students and youth with disabilities from TA centers that serve relevant public and private non-profit agencies, as well as existing RSA and Office of Special Education Programs (OSEP) TA centers and RSA and OSEP Parent Training and Information Centers.

(b) In the first year, conduct a survey of relevant stakeholders and VR service providers to identify TA needs that the VRTAC-Y can meet and develop a process by which TA solutions can be offered to State VR agencies and their partners. The VRTAC-Y must survey, at a minimum:

(1) State VR agency staff;

(2) Relevant RSA staff;

(3) Grantees of the National Institute on Disability, Independent Living, and Rehabilitation Research that are researching topics related to the work of the VRTAC-Y; and

(4) Educators or other professionals conducting research on topics related to the work of the VRTAC-Y.

(a) Over the five-year grant period, provide intensive TA to a minimum of 10 State VR agencies and their associated rehabilitation professionals and service providers in the topic areas set out in this priority.1 In each of the second, third, fourth, and fifth years of the project, the VRTAC-Y must provide intensive TA to at least two different State VR agencies. Applicants must clearly describe the application process and selection criteria for the State VR agencies that would receive intensive TA. Such TA must include:

(1) For topic area (a)—

(i) Identification of relevant stakeholders in the State or region who can improve the State VR agency's ability to perform outreach activities and meet the employment and training needs of students and youth with disabilities;

(ii) Effective marketing and outreach to school and community services personnel, such as how best to present information about VR supports, training, and programming for students and youth with disabilities; and

(iii) How to develop formal and informal service and outreach agreements with relevant stakeholders to meet the employment and training needs of students and youth with disabilities.

(2) For topic area (b)—

(i) How to conduct an analysis and assessment of outreach strategies to determine gaps between public and community-based service delivery systems, as well as the need for coordinated services and supports across service systems for students and youth with disabilities;

(ii) How to access and leverage partnerships across agencies and public and community-based service delivery systems to increase the number of students and youth with disabilities provided with relevant and accessible information regarding services available through the State VR agency.

(3) For topic area (c)—

(i) Evidence-based and promising practices in the development and implementation of vocational services to meet the employment and training needs of students and youth with disabilities;

(ii) How to incorporate students and youth with disabilities into training programs in which they have been historically underrepresented; and

(iii) How to assist students and youth with disabilities in accessing customized vocational, occupational, or certification training or other career training that is directly responsive to employer needs and hiring requirements, including, but not limited to, training offered by providers under the WIOA core programs, Carl D. Perkins Career and Technical Education Improvement Act, H-1B Ready to Work Partnership Grants, and Trade Adjustment Assistance Community College and Career Training Grants, including two-year and four-year IHEs.

(b) In the first year, develop and refine a minimum of five curriculum guides for VR staff training in topics related to the work of the VRTAC-Y, which must include:

(1) Partnership development across public and community-based service delivery systems for purposes of leveraging resources and coordinating supports, services, training, and employment opportunities for students and youth with disabilities;

(2) Development, implementation, and dissemination of effective model outreach strategies, policies, and procedures to improve access for students and youth with disabilities to VR services and supports;

(3) Development of customized training, career pathways, other career training, work opportunities and work experience programs for students and youth with disabilities;

(4) Development and delivery of support services to providers of career training programs that facilitate completion of training and result in competitive integrated employment for students and youth with disabilities; and

(5) Delivery of support services to employers who hire students and youth with disabilities from customized or career training programs or who offer internships and work experience opportunities.

(c) Provide a range of targeted and general TA products and services on the topic areas in this priority. Such TA must include, at a minimum, the following activities:

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

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

(3) Providing a minimum of four Webinars or video conferences on each of the topic areas in this priority to describe and disseminate information about emerging and promising practices in each area.

(a) Establish a community of practice for all interested State VR agencies that will act as a vehicle for communication, exchange of information among State VR agencies and partners, and a forum for sharing the results of TA projects that are in progress or have been completed. Such community of practice must be focused on partnerships across service systems, outreach and identification strategies for students and youth with disabilities, and the development and provision of vocational services and vocational training to students and youth with disabilities.

(b) Communicate and coordinate, on an ongoing basis, with other Department-funded projects and those supported by the Departments of Labor and Commerce; and

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

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

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

(1) Address State VR agencies' capacity to meet the employment and training needs of students and youth with disabilities. To meet this requirement, the applicant must:

(i) Demonstrate knowledge of emerging and best practices in conducting outreach and providing VR services to students and youth with disabilities;

(ii) Demonstrate knowledge of current applicable Federal statutes and regulations, current RSA guidance, and State and Federal initiatives designed to improve employment outcomes for students and youth with disabilities; and

(iii) Present information about the difficulties that State VR agencies and service providers have encountered in developing and implementing effective outreach and service delivery plans for students and youth with disabilities; and

(2) Result in increases in both the number of students and youth with disabilities receiving services from State VR agencies and related agencies and the number and quality of employment outcomes in competitive integrated employment for students and youth with disabilities;

(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, advocates for students and youth with disabilities, RSA partners such as the Council of State Administrators of Vocational Rehabilitation (CSAVR), the National Council of State Agencies for the Blind (NCSAB), 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. To meet this requirement, the applicant must describe—

(i) The current research on emerging, promising, and evidence-based practices in the topic areas in this priority;

(ii) How the current research about adult learning principles and implementation science will inform the proposed TA; and

(iii) How the proposed project will incorporate current research and evidence-based practices in the development and delivery of its products and services;

(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. To address this requirement, the applicant must describe—

(i) Its proposed activities to identify or develop the knowledge base on emerging and promising practices in the topic areas in this priority;

(ii) Its proposed approach to universal, general TA; 2

(iii) Its proposed approach to targeted, specialized TA,3 which must identify—

(A) The intended recipients of the products and services under this approach; and

(B) Its proposed approach to measure the readiness of State VR agencies to work with the proposed project, assessing, at a minimum, their current infrastructure, available resources, and ability to effectively respond to the TA, as appropriate;

(iv) Its proposed approach to intensive, sustained TA, which must identify—

(A) The intended recipients of the products and services under this approach;

(B) Its proposed approach to measure the readiness of the State VR agencies to work with the proposed project including the State VR agencies' commitment to the TA initiatives, appropriateness of the initiatives, current infrastructure, available resources, and ability to respond effectively to the TA, as applicable;

(C) Its proposed plan for assisting State VR agencies to build training systems that include professional development based on adult learning principles and coaching; and

(D) Its proposed plan for developing intensive TA agreements with State VR agencies to provide intensive, sustained TA. The plan must describe how the intensive TA agreements will outline the purposes of the TA, the intended outcomes of the TA, and the measurable objectives of the TA that will be evaluated;

(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 each TA activity from State VR agencies, partners, or other sources, as appropriate; and

(ii) Analyzing data and determining the effectiveness of each TA activity, including any proposed standards or targets for determining effectiveness. At a minimum, the VRTAC-Y must analyze data on school and service system referrals to State VR agencies and employment outcomes of students and youth with disabilities, including type of employment, wages, hours worked, weeks of employment, and public benefits received;

(2) Collect and analyze data on specific and measurable goals, objectives, and intended outcomes of the project, including measuring and tracking the effectiveness of the TA provided. To address this requirement, the applicant must describe—

(i) Its proposed evaluation methodologies, including instruments, data collection methods, and analyses;

(ii) Its proposed standards or targets for determining effectiveness;

(iii) How it will use the evaluation results to examine the effectiveness of its implementation and its progress toward achieving the intended outcomes; and

(iv) How the methods of evaluation will produce quantitative and qualitative data that demonstrate whether the project and individual TA activities achieved their intended outcomes;

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

(1) The proposed project will encourage applications for employment from persons who are members of groups that have historically been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

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

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

(4) 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 that 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)).

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

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 this final priority only on a reasoned determination that its benefits justify its 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. This priority will better prepare State VR agency personnel to assist the students and youth with disabilities who are the focus of this priority 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.

The 2014 Interim Patent Eligibility Guidance, prepared for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101, was published in the Federal Register on December 16, 2014. See 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74618 (Dec. 16, 2014). The USPTO also sought public comment on the 2014 Interim Patent Eligibility Guidance, along with additional suggestions on claim examples for explanatory example sets.

The USPTO received over sixty comments from the public. The public comments include the following six major themes: (1) requests for additional examples, particularly for claims directed to abstract ideas and laws of nature; (2) further explanation of the markedly different characteristics analysis; (3) further information regarding how examiners identify abstract ideas; (4) discussion of the prima facie case and the role of evidence with respect to eligibility rejections; (5) information regarding application of the 2014 Interim Patent Eligibility Guidance in the Patent Examining Corps; and (6) explanation of the role of preemption in the eligibility analysis, including a discussion of the streamlined analysis.

The USPTO has produced a July 2015 Update: Subject Matter Eligibility responding to each of the six major themes from the public comments. The July 2015 Update: Subject Matter Eligibility includes three appendices. The first appendix (Appendix 1) provides new examples that are illustrative of major themes from the comments. The second appendix (Appendix 2) is a comprehensive index of examples for use with the 2014 Interim Patent Eligibility Guidance, including new and previously issued examples. The third appendix (Appendix 3) lists and discusses selected eligibility cases from the Supreme Court and the U.S. Court of Appeals for the Federal Circuit. The July 2015 Update: Subject Matter Eligibility is intended to assist examiners in applying the 2014 Interim Patent Eligibility Guidance during the patent examination process.

The July 2015 Update: Subject Matter Eligibility, including the appendices, are available to the public on the USPTO's Internet Web site. The USPTO is now seeking public comment on the July 2015 Update: Subject Matter Eligibility.

On June 10, 2015, the EPA proposed to find that Washington adequately addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2006 24-hour PM2.5 NAAQS (80 FR 32870). An explanation of the CAA requirements, a detailed analysis of the submittal, and the EPA's reasons for approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on July 10, 2015. The EPA received no comments on the proposal.

The EPA has determined that the Washington SIP meets the CAA section 110(a)(2)(D)(i)(I) interstate transport requirements for the 2006 24-hour PM2.5 NAAQS.

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, the 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 Orders 12866 (58 FR 51735, October 4, 1993) 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 this action does not involve technical standards; and

• Does not provide the 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 in Washington except as specifically noted below and is also not approved to apply in any other area where the 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Washington's SIP is approved to apply on non-trust land within the exterior boundaries of the Puyallup Indian Reservation, also known as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and local agencies in Washington authority over activities on non-trust lands within the 1873 Survey Area.

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. The 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 September 28, 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. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

Throughout this document, wherever “we”, “us” or “our” are used, it is intended to refer to the EPA.

The EPA is approving the limited maintenance plan submitted by the State of Oregon (the State) on April 22, 2015, for the Grants Pass Urban Growth Boundary. The plan addresses maintenance of the PM10 National Ambient Air Quality Standard for a second 10-year period through 2025.

The EPA identified the Grants Pass, Oregon, Urban Growth Boundary as a “Group I” area of concern due to measured violations of the newly promulgated 24-hour PM10 National Ambient Air Quality Standard (NAAQS) on August 7, 1987 (52 FR 29383). On November 15, 1990, the Clean Air Act (CAA) Amendments under section 107(d)(4)(B), designated Grants Pass Group I area as nonattainment for PM10 by operation of law. The EPA published a Federal Register document announcing all areas designated nonattainment for PM10 on March 15, 1991 (56 FR 11101). The Oregon Department of Environmental Quality (ODEQ) worked with the community of Grants Pass to develop a plan for attainment of the PM10 NAAQS. Control measures focused on reducing smoke emissions with PM10 control measures for wood stoves, open forestry burning, as well as industrial growth controls and other strategies. The EPA proposed approval of the plan on March 10, 1993 (58 FR 13230), and approved it on December 17, 1993 (58 FR 65934). On November 5, 1999, Oregon submitted a complete rule renumbering and relabeling package to the EPA for approval into the SIP. On January 22, 2003, the EPA approved the recodified version of Oregon's rules to remove and replace the outdated numbering system (68 FR 2891). The EPA approved ODEQ's maintenance plan to ensure continued compliance with the PM10 NAAQS for ten years on October 27, 2003 (68 FR 61111).

In addition to approving ODEQ's maintenance plan for the area, the EPA also approved ODEQ's request to redesignate the Grants Pass nonattainment area to attainment on October 27, 2003 (68 FR 61111). The purpose of the submitted limited maintenance plan is to fulfill the second 10-year planning requirement of CAA section 175A(b) to ensure compliance through 2025.

Section 110(a)(2) of the CAA requires that each SIP revision offer a reasonable opportunity for notice and public hearing. This must occur prior to the revision being submitted by the State to the EPA. The State provided notice and an opportunity for public comment from December 16, 2014 until January 26, 2015 with no comments received. ODEQ also held a public hearing on January 22, 2015 in Grants Pass. This SIP revision was submitted by the Governor's designee and was received by the EPA on April 22, 2015. The EPA evaluated ODEQ's submittal and determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA.

On August 9, 2001, the EPA issued guidance on streamlined maintenance plan provisions for certain moderate PM10 nonattainment areas (Memo from Lydia Wegman, Director, Air Quality Standards and Strategies Division, entitled “Limited Maintenance Plan Option for Moderate PM10 Nonattainment Areas” (limited maintenance plan option memo). The limited maintenance plan option memo contains a statistical demonstration that areas meeting certain air quality criteria will, with a high degree of probability, maintain the standard ten years into the future. Thus, the EPA provided the maintenance demonstration for areas meeting the criteria outlined in the memo. It follows that future year emission inventories for these areas, and some of the standard analyses to determine transportation conformity with the SIP, are no longer necessary.

To qualify for the limited maintenance plan option, the State must demonstrate the area meets the criteria described below. First, the area should have attained the PM10 NAAQS. Second, the most recent five years of air quality data at all monitors in the area, called the 24-hour average design value, should be at or below 98 µg/m3. Third, the State should expect only limited growth in on-road motor vehicle PM10 emissions (including fugitive dust) and should have passed a motor vehicle regional emissions analysis test. Lastly, the memo identifies core provisions that must be included in all limited maintenance plans. These provisions include an attainment year emissions inventory, assurance of continued operation of an EPA-approved air quality monitoring network, and contingency provisions.

The transportation conformity rule and the general conformity rule (40 CFR parts 51 and 93) apply to nonattainment areas and areas covered by an approved maintenance plan. Under either conformity rule, an acceptable method of demonstrating a Federal action conforms to the applicable SIP is to demonstrate that expected emissions from the planned action are consistent with the emissions budget for the area.

While qualification for the limited maintenance plan option does not exempt an area from the need to affirm conformity, conformity may be demonstrated without submitting an emissions budget. Under the limited maintenance plan option, emissions budgets are treated as essentially not constraining for the length of the maintenance period because it is unreasonable to expect that the qualifying areas would experience so much growth in the period that a violation of the PM10 NAAQS would result. For transportation conformity purposes, the EPA would conclude that emissions in these areas need not be capped for the maintenance period and therefore a regional emissions analysis would not be required. Similarly, Federal actions subject to the general conformity rule could be considered to satisfy the “budget test” specified in 40 CFR 93.158(a)(5)(i)(A) for the same reasons that the budgets are essentially considered to be unlimited.

As discussed above, the limited maintenance plan option memo outlines the requirements for an area to qualify. First, the area should be attaining the NAAQS. The EPA determined the Grants Pass area attained the PM10 NAAQS based on monitoring data from 1988 through 1990 and approved the State's maintenance plan and request to redesignate the area from nonattainment to attainment on October 27, 2003 (68 FR 61111). The area has been in continued compliance with the PM10 NAAQS since that time.

Second, the average design value for the past five years of monitoring data must be at or below the critical design value of 98 μg/m3 for the 24-hour PM10 NAAQS. The critical design value is a margin of safety in which an area has a one in ten probability of exceeding the NAAQS. Using the most recently available Federal Reference Method (FRM) monitoring data for the years 2004-2008, the State's analysis demonstrated that Grants Pass average design value was 49 μg/m3, well below the 98 μg/m3 threshold. An FRM monitor is one that has been approved by the EPA under 40 CFR part 58 to measure compliance with the NAAQS. As discussed later in this proposal, ODEQ also calculated average design values using a linear regression analysis technique for the period 2009 to 2013. This more recent monitoring data shows that PM10 levels continue to be well below the standard with an average design value of 49 μg/m3. The EPA reviewed the data provided by ODEQ and finds that Grants Pass meets the design value criteria outlined in the limited maintenance plan option memo.

Third, the area must meet the motor vehicle regional emissions analysis test described in attachment B of the limited maintenance plan option memo. ODEQ submitted an analysis showing that growth in on-road mobile PM10 emissions sources was minimal and would not threaten the assumption of maintenance that underlies the limited maintenance plan policy. Using the EPA's methodology, ODEQ calculated a regional emissions analysis margin of safety of 52 μg/m3, easily meeting the threshold of 98 μg/m3. The EPA reviewed the calculations in the State's limited maintenance plan submittal and concurs with this conclusion.

Lastly, the limited maintenance plan option memo requires all controls relied on to demonstrate attainment remain in place for the area to qualify. The area's first 10-year maintenance plan relied on measures addressing residential wood combustion, open burning, road dust from motor vehicles and a major new source review program for industry. EPA approved the rules into the SIP on October 27, 2003 (68 FR 61111).

As described above, Grants Pass meets the qualification criteria set forth in the limited maintenance plan option memo. Under the limited maintenance plan option, the State will be expected to determine on an annual basis that the criteria are still being met. If the State determines that the limited maintenance plan criteria are not being met, it should take action to reduce PM10 concentrations enough to requalify. One possible approach the State could take is to implement contingency measures. Section V. I. provides a description of contingency provisions included as part of the limited maintenance plan submittal.

Pursuant to the limited maintenance plan option memo, the State's approved attainment plan should include an emissions inventory which can be used to demonstrate attainment of the NAAQS. The inventory should represent emissions during the same five-year period associated with air quality data used to determine whether the area meets the applicability requirements of the limited maintenance plan option.

ODEQ's Grants Pass limited maintenance plan submittal includes an emissions inventory based on EPA's 2011 National Emissions Inventory (NEI) data for Josephine County. The 2011 base year represents the most recent emissions inventory data available and is consistent with the data used to determine applicability of the limited maintenance plan option. This approach is also consistent with the 1993 emission inventory developed for the first maintenance plan. Historically, exceedances of the 24-hr PM10 standard in Grants Pass have occurred during the winter months, between November 1 and the end of February. As such, in addition to annual emissions, typical season day and worst-case season day emissions are included in the inventory. The term “worst-case day” describes the maximum activity/emissions that have occurred or could occur on a season day, for each emissions source. Worst-case day emissions are summed for all sources/categories, i.e. assumed to occur on the same day. This assumption is the basis for what would be needed to cause an exceedance of the 24-hr standard. The unit of measure for annual emissions is in tons per year (tpy), while the unit of measure for season day emissions is in pounds per day (lb/day). In addition, the county-wide emissions inventory data was spatially allocated to the Grants Pass Urban Growth Boundary, and to buffers around the boundary or monitor, depending on emissions category.

The submitted emissions inventory included the following categories: permitted point sources, area sources (including open burning, small stationary fossil fuel combustion, residential wood combustion, wildfires and prescribed burning, fugitive dust), nonroad (aircraft and airport related, locomotives, marine vessels, nonroad vehicles and equipment), and onroad mobile (exhaust/brake/tire, re-entrained road dust). The EPA has reviewed the emissions inventory data and methodology and finds that the data support ODEQ's conclusion that the control measures contained in the original attainment plan will continue to protect and maintain the PM10 NAAQS.

The state of Oregon began monitoring in the Grants Pass area in 1987, with many changes to the monitoring technology and requirements since. From 2006 through 2008, the State collocated a PM2.5 monitor with the existing PM10 Federal Reference Method (FRM) monitor to establish correlation data and confirm that PM10 levels could be accurately predicted using PM2.5 concentrations for the areas. Due to the high level of correlation between the PM2.5 and PM10 monitors, ODEQ developed a report on their findings and asserted that PM2.5 monitoring was an accurate predictor of PM10 levels for purposes of determining continued maintenance of the PM10 standard in Grants Pass, and asked to discontinue the PM10 monitor. EPA approved this request in the Annual Network Plan Approval letter, dated January 6, 2012. Both the ODEQ report and the EPA approval letter are included in the materials of this docket.

A full description of the correlation data and the estimation model is included in the State's submittal. The EPA is approving the use of PM2.5 monitoring data to estimate PM10 concentrations for the second 10-year maintenance plan period in Grants Pass and finds that it meets the relevant requirements at 40 CFR 58.14(c). This estimation method is a reproducible approach to representing air quality in the area, and the area continues to meet the applicable Appendix D requirements evaluated as part of the annual network approval process.

In order to continue to qualify for the limited maintenance plan option, the State must calculate the PM10 design value estimate annually from PM2.5 monitoring data to confirm the area continues to meet the PM10 NAAQS.

CAA section 175A states that a maintenance plan must include contingency provisions, as necessary, to ensure prompt correction of any violation of the NAAQS which may occur after redesignation of the area to attainment. The first Grants Pass maintenance plan contained contingency measures that would be implemented under two scenarios—if the official PM10 monitor registers a value of 120 μg/m3 or higher, or if a violation of the 24-hr PM10 standard were to occur. These two contingency scenarios are continued under the limited maintenance plan.

Under the limited maintenance plan option, emissions budgets are treated as essentially not constraining for the maintenance period because it is unreasonable to expect that qualifying areas would experience so much growth in that period that a NAAQS violation would result. While areas with maintenance plans approved under the limited maintenance plan option are not subject to the budget test, the areas remain subject to the other transportation conformity requirements of 40 CFR part 93, subpart A. Thus, the metropolitan planning organization (MPO) in the area or the State must document and ensure that:

(a) Transportation plans and projects provide for timely implementation of SIP transportation control measures (TCMs) in accordance with 40 CFR 93.113;

(b) transportation plans and projects comply with the fiscal constraint element as set forth in 40 CFR 93.108;

(c) the MPO's interagency consultation procedures meet the applicable requirements of 40 CFR 93.105;

(d) conformity of transportation plans is determined no less frequently than every three years, and conformity of plan amendments and transportation projects is demonstrated in accordance with the timing requirements specified in 40 CFR 93.104;

(e) the latest planning assumptions and emissions model are used as set forth in 40 CFR 93.110 and 40 CFR 93.111;

(f) projects do not cause or contribute to any new localized carbon monoxide or particulate matter violations, in accordance with procedures specified in 40 CFR 93.123; and

(g) project sponsors and/or operators provide written commitments as specified in 40 CFR 93.125.

In the June 24, 2015 adequacy finding for the Grants Pass PM10 limited maintenance plan, EPA determined that Grants Pass met the criteria to be exempt from regional emissions analysis for PM10. However, other transportation conformity requirements such as consultation, transportation control measures, and project level conformity requirements would continue to apply to the area. With approval of the LMP, the area continues to be exempt from performing a regional emissions analysis but must meet project-level conformity analyses as well as the transportation conformity criteria mentioned above.

Upon approval of the Grants Pass PM10 limited maintenance plan, the area is exempt from performing a regional emissions analysis, but must meet project-level conformity analyses as well as the transportation conformity criteria mentioned above.

For Federal actions required to address the specific requirements of the general conformity rule, one set of requirements applies particularly to ensuring that emissions from the action will not cause or contribute to new violations of the NAAQS, exacerbate current violations, or delay timely attainment. One way that this requirement can be met is to demonstrate that the total of direct and indirect emissions from the action (or portion thereof) is determined and documented by the state agency primarily responsible for the applicable SIP to result in a level of emissions which, together with all other emissions in the nonattainment area, would not exceed the emissions budgets specified in the applicable SIP (see 40 CFR 93.158(a)(5)(i)(A)).

The decision about whether to include specific allocations of allowable emissions increases to sources is one made by the State air quality agencies. These emissions budgets are different than those used in transportation conformity. Emissions budgets in transportation conformity are required to limit and restrain emissions. Emissions budgets in general conformity allow increases in emissions up to specified levels. The State has not chosen to include specific emissions allocations for Federal projects that would be subject to the provisions of general conformity.

Oregon Revised Statute 468.126, prohibits ODEQ from imposing a penalty for violation of an air, water or solid waste permit, unless the source has been provided five days advanced written notice of the violation, and has not come into compliance or submitted a compliance schedule within that five-day period. By its terms, the statute does not apply to Oregon's Title V program, or to any program if application of the notice provision would disqualify the program from Federal delegation. Oregon has previously confirmed that, because application of the notice provision would preclude EPA approval of the Oregon SIP, no advance notice is required for violation of SIP requirements.

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, the 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 Orders 12866 (58 FR 51735, October 4, 1993) 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 this action does not involve technical standards; and

• does not provide the 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 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. The 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 September 28, 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 the Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 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 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-2014-0889 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 September 28, 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-2014-0889, 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 January 28, 2015 (80 FR 4525) (FRL-9921-55), 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 4F8290) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The petition requested to amend the tolerances in 40 CFR 180.418 for residues of the insecticide zeta-cypermethrin, S-cyano (3-phenoxyphenyl) methyl (±))(cis-trans 3-(2-2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate, in or on corn, field, forage from 0.2 parts per million (ppm) to 9.0 ppm; corn, field, stover from 3.0 ppm to 30.0 ppm; and corn, pop, stover from 3.0 ppm to 30.0 ppm. That document referenced a summary of the petition prepared by FMC Corporation, 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.

Instead of the proposed tolerances in field corn stover (30.0 ppm) and popcorn stover (30.0 ppm), the Agency is establishing the tolerances at 30 ppm. The Agency establishes tolerances using whole numbers for tolerances of 10 ppm or more, per the OECD's User Guide ENV/JM/MONO (2011)2 for the OECD tolerance calculation procedure.

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 zeta-cypermethrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with zeta-cypermethrin follows.

Zeta-cypermethrin is an enriched isomer of the pyrethroid insecticide cypermethrin. In addition, alpha-cypermethrin is also an enriched isomer of cypermethrin. Although cypermethrin, zeta-cypermethrin, and alpha-cypermethrin are separate active ingredients with different end-use products, they are included together in the hazard evaluation for the purpose of human health risk assessment. The toxicology database for the cypermethrins includes studies with cypermethrin and both of its enriched isomers, and is considered complete for the purpose of risk assessment.

The aggregate risk assessment for zeta-cypermethrin must consider potential exposure from all cypermethrins (i.e., cypermethrin, zeta-cypermethrin, and alpha-cypermethrin), since the three active ingredients are considered to be essentially the same from the mammalian toxicity perspective. The revised tolerances are associated with decreased pre-harvest intervals (PHIs) for field corn and popcorn—from 30 days for grain and stover and 60 days for forage to 7 days for all these commodities—and have no impact on the existing dietary exposure assessment for the cypermethrins. Corn forage and stover are livestock feed items and are not directly entered into the dietary exposure assessment, and EPA has determined that the existing tolerances for livestock commodities are adequate to support the changed use pattern. The existing zeta-cypermethrin use on corn was included in previous dietary exposure assessments. Decreasing the PHI and increasing the zeta-cypermethrin tolerances for field corn forage, field corn stover, and popcorn stover will have no impact on the dietary risk estimates, as they are already covered in the existing dietary assessment.

In the final rule published in the Federal Register of December 7, 2012 (77 FR 72975) (FRL-9371-7), EPA established tolerances for residues of zeta-cypermethrin in multiple commodities. Since the publication of that final rule, the toxicity profile of zeta-cypermethrin has not changed, and since the revised tolerances associated with decreased PHIs for field corn and popcorn have no impact on the existing dietary and aggregate risk determinations, the risk assessments that supported the establishment of the zeta-cypermethrin tolerances published in the December 7, 2012 Federal Register final rule remain valid. Therefore, EPA is relying on those risk assessments in order to support the revised tolerances for zeta-cypermethrin in field corn forage, field corn stover, and popcorn stover.

An updated aggregate risk assessment was not needed to support the proposed increased tolerances for residues in field corn forage, field corn stover, and popcorn stover, and the increased tolerances will not result in a change in the previously estimated dietary (food and water) or residential exposure estimates for zeta-cypermethrin. For a detailed discussion of the aggregate risk assessments and determination of safety, refer to the December 7, 2012 Federal Register final rule and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0472. EPA is relying on those supporting risk assessments and findings to support this final rule.

Based on the risk assessments and information described in this unit, 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 zeta-cypermethrin residues. Additional information can be found in the document: “Zeta-Cypermethrin—Human Health Risk Assessment for a Petition to Amend (Increase) the Established Tolerances for the Insecticide in Field Corn and Popcorn Stover, and in Field Corn Forage,” available in docket ID number EPA-HQ-OPP-2014-0889.

Adequate tolerance enforcement methods are available in Pesticide Analytical Manual (PAM) Volume II for determining residues of alpha-cypermethrin, cypermethrin, and zeta-cypermethrin in plant (Method I) and livestock (Method II) commodities. Both methods are gas chromatographic methods with electron-capture detection (GC/ECD), and have undergone successful Agency petition method validations (PMVs). These methods are not stereospecific; thus no distinction is made between residues of cypermethrin (all 8 stereoisomers), alpha-cypermethrin (enriched in 2 isomers), and zeta-cypermethrin (enriched in 4 isomers). The January 1994 Food and Drug Administration (FDA) PESTDATA database (PAM Volume I) indicates that residues of cypermethrin are completely recovered (>80%) using multi-residue method sections 302 (Luke), 303 (Mills, Onley, and Gaither), and 304 (Mills fatty food).

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.

There are no Codex MRLs for cypermethrin, which includes both alpha- and zeta-cypermethrin, established in corn forage or stover.

One comment was received from the general public, urging the Agency to deny the request. The commenter particularly addressed toxicity to bees and other insects, and human toxicological and reproductive effects.

The Agency understands the commenter's concerns, and recognizes that some individuals believe that certain pesticide chemicals should not be permitted in food. Regarding effects to bees and other insects, the safety standard for approving tolerances under section 408 of FFDCA focuses on potential harms to human health and does not permit consideration of effects on other species or the environment. The existing legal framework provided by section 408 of 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. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency, as is required by Section 408 of FFDCA, estimates the risk of the potential exposure to these residues by performing an aggregate risk assessment. Such a risk assessment integrates the individual assessments that are conducted for food, drinking water, and residential exposures. Additionally, the Agency, as is further required by Section 408 of the FFDCA, considers available information concerning what are termed the cumulative toxicological effects of the residues of that pesticide and of other substances having a common mechanism of toxicity. Therefore, these assessments consider both exposure and toxicological effects—including information concerning the reproductive effects of the pesticide—in reaching a conclusion as to whether or not the reasonable certainty of no harm decision can be made. The Agency has concluded after this assessment that there is a reasonable certainty that no harm will result from exposure to the residues of zeta-cypermethrin. Therefore, the proposed tolerances are found to be acceptable.

Therefore, tolerances are established for residues of zeta-cypermethrin, S-cyano (3-phenoxyphenyl) methyl (±))(cis-trans 3-(2-2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate, in or on corn, field, forage at 9.0 ppm; corn, field, stover at 30 ppm; and corn, pop, stover at 30 ppm.

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:

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-2013-0138 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 September 28, 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-2013-0138, 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 June 5, 2013 (78 FR 33785) (FRL-9386-2), 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 3F8142) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2-thiophenecarboxamide in or on almond at 0.02 parts per million (ppm); almond, hulls at 0.2 ppm; lettuce, head at 6.0 ppm; lettuce, leaf at 7.0 ppm; low growing berry crop subgroup 13-07G at 4.0 ppm; rapeseed, crop subgroup 20A at 0.04 ppm; and small fruit vine climbing crop subgroup 13-07F at 3.0 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that additional tolerances are necessary; revised some of the proposed tolerances; and corrected some commodity definitions for the tolerances. The reasons for these changes are explained in Unit IV.C.

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

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 isofetamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with isofetamid follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicology database is complete for isofetamid. In repeated dose studies, the liver was the primary target organ in the rat, mouse, and dog, as indicated by increased liver weights, changes in the clinical chemistry values, and liver hypertrophy. A second target organ was the thyroid in the rat and dog, as indicated by changes in thyroid weights and histopathology. Adrenal weight changes were observed in the subchronic rat and dog studies. In the rat and dog, the dose levels where toxicity was observed were similar or higher in the chronic studies compared with the respective subchronic studies, showing an absence of progression of liver toxicity with time. There was no evidence of carcinogenicity in the rat or mouse cancer studies; the mutagenicity battery was negative. There are no genotoxicity, neurotoxicity, or immunotoxicity concerns observed in the available toxicity studies. Developmental toxicity was not observed in the rat or rabbit, and offspring effects such as decreased body weight were seen only in the presence of parental toxicity in the multi-generation rat study. Isofetamid is classified as “Not Likely to be Carcinogenic to Humans” based on the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and mice. Isofetamid is not acutely toxic; it is classified as Toxicity Category III for acute oral and dermal exposure, and Toxicity Category IV for inhalation exposure. Furthermore, it is not irritating to the eye or skin, and it is not a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by isofetamid 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 Isofetamid. Aggregate Human Health Risk Assessment for the Proposed New Uses of the New Active Fungicide, including Agricultural Uses on Almonds, Lettuce, Small Vine Climbing Fruits (Crop Subgroup 13-07F), Low Growing Berries (Crop Subgroup 13-07G), and Rapeseed (Crop Subgroup 20A); and Uses on Turfgrass (including Golf Courses, Sod Farms, Seed Farms, Recreational Fields, and Commercial/Residential Lawns) at pages 12-18 in docket ID number EPA-HQ-OPP-2013-0138.

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

1. Dietary exposure from food and feed uses. EPA assessed dietary exposures from isofetamid 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 isofetamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the 2003-2008 food consumption data from the USDA's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). A partially refined chronic (food and drinking water) dietary assessment was conducted assuming mean field trial residues of the combined residues of parent and GPTC for all proposed crops and 100% CT. Empirical and default processing factors were used as available.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isofetamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use PCT information in the dietary assessment for isofetamid. Mean field trial residues of the combined residues of parent and GPTC were used.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for isofetamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of isofetamid. 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 Flooded Application Model and the Pesticide Root Zone Model Ground Water (PRZM GW) the estimated drinking water concentrations (EDWCs) of isofetamid for chronic exposures for non-cancer assessments are estimated to be 110 ppb for surface water and 43 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 110 ppb was used to assess the contribution from 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).

Isofetamid is currently under review for registering the following uses that could result in residential exposures: Foliar and systemic fungicide for control in turfgrass including golf courses, residential lawns, and recreational turfgrass. Since there may be residential use sites, residential handler exposure and risk estimates were calculated for all possible residential exposure scenarios. Including all possible residential exposure scenarios provides a conservative and health protective assessment for the potential for homeowners to use the professionally labeled products on residential use sites. Since there is no dermal toxicity endpoint, the residential handler assessment only includes the inhalation route of exposure. Residential handler exposure is expected to be short-term in duration as a maximum of eight applications are allowed per year. Thus, intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Unit exposure values and estimates for area treated or amount handled were taken from the Agency's 2012 Residential SOPs 1 (Lawns/Turf). The algorithms used to estimate exposure and dose for residential handlers can be found in the 2012 Residential SOPs 2 (Lawns/Turf). Risk estimates of all possible scenarios are not of concern. Short-term inhalation MOEs range from 850,000 to 18,000,000. 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 isofetamid to share a common mechanism of toxicity with any other substances, and isofetamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isofetamid 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 is no evidence of developmental toxicity or reproductive susceptibility, and there are no residual uncertainties concerning pre- or post-natal toxicity or exposure.

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

i. The toxicity database for isofetamid is complete.

ii. There is no indication that isofetamid 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 isofetamid 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 average (mean) field trial residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isofetamid 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 isofetamid.

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, isofetamid 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 isofetamid from food and water will utilize <1% 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 isofetamid 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). Isofetamid 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 isofetamid.

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 24,000 and 3,900 for adults and children (1-2 years old) respectively. Because EPA's level of concern for isofetamid 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, isofetamid 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 isofetamid.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, isofetamid 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 isofetamid residues.

Adequate enforcement methodology liquid chromatography with tandem mass spectrometry (LC-MS/MS) method (Document Number JSM0119; MRID 49011967) is available to enforce the tolerance expression.

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 any MRLs for isofetamid. Canada is concurrently establishing tolerances for all of the same commodities identified in this document except almond hulls because Canada does not set tolerances on livestock feed commodities. Canada's recommended tolerance levels for these commodities are the same as the U.S. established tolerance levels. The tolerance expression for the U.S. and Canada is the same, with isofetamid as the residue of concern for primary crops.

The Agency has made revisions to some of the petitioned-for tolerance levels based on the following reasons:

1. Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures;

2. The parent only is the residue of concern for primary crop tolerances rather than parent and the metabolite GPTC; and

3. The concentration of residues in two processed commodities.

Since all residues of isofetamid (parent) were nondetectable (<0.01 ppm) in almond nutmeat and hulls, the proposed tolerances of 0.02 ppm for almond (nutmeat) and 0.2 ppm for almond hulls will both be reduced to 0.01 ppm, the limit of quantitation of the analytical method.

Based on the OECD tolerance calculation procedures, the proposed tolerance for head lettuce of 6.0 ppm will be reduced to 5.0 ppm. Based on the OECD tolerance calculation procedures, the proposed tolerance for the rapeseed subgroup 20A of 0.04 ppm will be reduced to 0.015 ppm.

The petitioner did not propose tolerances for the processed commodities, canola oil and raisins. Since residues concentrate significantly in canola oil and raisins, tolerances will be established at 0.03 ppm for canola, refined oil, and 5.0 ppm for grape, raisin. These Agency recommendations are based on the highest average field trial (HAFT) residues for canola seed and grape and the processing factors for canola oil and raisins. The petitioner did not propose tolerances for flaxseed oil, mustard seed oil, or sesame oil. However, flaxseed, mustard seed, and sesame are members of the rapeseed subgroup 20A, with canola as the representative crop, and treated commodities could be processed to produce sesame oil, mustard seed oil and flaxseed oil. Therefore, the Agency is also establishing tolerances for residues in flaxseed oil, mustard seed oil, and sesame oil. Tolerances are being established at 0.03 ppm, the same level as for refined canola oil.

Additionally, some of the requested tolerances have been corrected. Almond has been revised from 0.02 ppm to 0.01 ppm; almond, hulls from 0.2 ppm to 0.01 ppm; lettuce, head from 6.0 ppm to 5.0 ppm; and rapeseed, subgroup 20A from 0.04 ppm to 0.015 ppm. The Agency is setting tolerances on some processed commodities that were not proposed by the petitioner including canola, refined oil at 0.03 ppm; flax, seed, oil at 0.03 ppm; grape, raisin at 5.0 ppm; mustard, seed, oil at 0.03 ppm and sesame, oil at 0.03 ppm.

Therefore, tolerances are established for residues of isofetamid, in or on almond at 0.01 ppm; almond, hulls at 0.01 ppm; canola, refined oil at 0.03 ppm; flax, seed, oil at 0.03 ppm; grape, raisin at 5.0 ppm; lettuce, head at 5.0 ppm; lettuce, leaf at 7.0 ppm; berry, low growing, subgroup 13-07G at 4.0 ppm; mustard, seed, oil at 0.03 ppm; rapeseed subgroup 20A at 0.015 ppm; sesame, oil at 0.03 ppm; and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm.

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:

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. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0714 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 September 28, 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-2013-0714, 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 21, 2014 (79 FR 9870) (FRL-9904-98), 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 3E8162) by Technology Sciences Group on behalf of Isagro S.p.A., 1150 18th Street NW., Suite 1000, Washington, DC 20036. The petition requested that 40 CFR part 180 be amended by establishing import tolerances for residues of the fungicide benalaxyl-M in or on grape at 1.1 parts per million (ppm); grape juice at 1.1 ppm; grape wine at 1.1 ppm; grape raisin at 2.2 ppm; tomato at 0.25 ppm; and tomato processed at 0.25 ppm. That document referenced a summary of the petition prepared by Technology Sciences Group on behalf of Isagro S.p.A., the registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted.

Based upon review of the data supporting the petition, EPA is establishing tolerances as follows: 3.0 ppm for grapes and 0.20 ppm for tomato. The reasons for these changes are explained in Unit IV.C.

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

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

Benalaxyl-M has no significant acute toxicity via oral, dermal or inhalation route of exposure. It is not a skin irritant and does not cause skin sensitization.

The liver and thyroid are the primary target organs for benalaxyl-M. In rats, increased liver weights, clinical chemistry changes indicative of liver toxicity, hepatocellular hypertrophy, and thyroid follicular cell hypertrophy were seen following subchronic and chronic exposure. In mice, increased liver weight and microscopic lesions in the liver (hepatocellular hypertrophy, necrosis, eosinophilic foci) were observed following subchronic and chronic exposure. Additionally, chronic exposure in rats and mice led to increases in the incidence of liver (rat, mouse) and thyroid (rat) tumors. In dogs, increased liver weight, changes in clinical chemistry indicative of liver toxicity, and hepatocellular hypertrophy were observed following subchronic exposure via the diet, whereas clinical chemistry changes indicative of liver toxicity, fat vacuolation in the liver, and thyroid follicular cell hypertrophy were observed following chronic exposure via capsules.

No evidence of increased quantitative or qualitative susceptibility was seen in the benalaxyl-M hazard database following in utero exposure with rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. No evidence of maternal toxicity or developmental effects was observed in the developmental toxicity studies in rabbits or rats. There is no reproductive concern. No neurotoxic effects were observed in the acute and subchronic neurotoxicity studies in rats, and no immunotoxic effects were observed in the immunotoxicity study in rats.

Benalaxyl-M was classified as “Likely to be Carcinogenic to Humans”. This determination was based on the treatment-related liver tumors observed in male mice, liver tumors observed in male and female rats; and thyroid follicular cell tumors observed in female rats. No treatment-related tumors were observed in female mice. A linear low-dose extrapolation model (Q*1) was used to estimate cancer risk, based on the male mouse liver tumor rates. There is no mutagenicity concern from the in vivo or in vitro genetic toxicity assays.

Specific information on the studies received and the nature of the adverse effects caused by benalaxyl-M 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 “Benalaxyl-M. Human-Health Risk Assessment for Tolerances in/on Imported Grape and Tomato” on pages 10 through 20 in docket ID number EPA-HQ-OPP-2013-0714.

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 benalaxyl-M used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benalaxyl-M, EPA assessed dietary exposures from benalaxyl-M in food as follows:

i. Acute exposure. No such effects were identified in the toxicological studies for benalaxyl-M; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 CSFII. As to residue levels in food, EPA used tolerance-level residues and 100% crop treated.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or 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 benalaxyl-M should be classified as “Likely to be Carcinogenic to Humans” and a linear approach has been used to quantify cancer risk. Cancer risk was quantified using the same 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 benalaxyl-M. Tolerance level residues and/or 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. An assessment of residues in drinking water is not required for this assessment because there is no drinking water exposure in the U.S. associated with the establishment of an import tolerance.

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

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

EPA has not found benalaxyl-M to share a common mechanism of toxicity with any other substances, and benalaxyl-M does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benalaxyl-M 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. No evidence of increased quantitative or qualitative susceptibility was seen following in utero exposure to benalaxyl-M with rats or rabbits in the prenatal developmental toxicity studies or in young rats in the 2-generation reproduction study. The 2-generation reproduction study resulted in no effects on reproductive function or fertility. The offspring effects occurred at the same dose that caused parental effects. No evidence of developmental delay or developmental toxicity was observed in developmental toxicity studies in rabbits or in rats.

The rabbit was tested at the limit dose (1000 mg/kg/day), and no maternal or developmental toxicity was observed. No significant developmental or maternal toxicity occurred at the highest dose level tested in the rat study, but the limit dose was not tested. It is not necessary to require the submission of an additional rat study since a study at higher dose levels would not result in a lower NOAEL and the point of departure is already 10-fold lower than the NOAEL in the rat study.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were retained at 10×. That decision is based on the following findings:

i. The toxicity database for benalaxyl-M is complete for purposes of assessing the exposures from the use of benalaxyl-M on imported grapes and tomatoes. However, there remains some uncertainty regarding the potential for benalaxyl-M effects on thyroid. Thyroid toxicity was seen following subchronic and chronic exposures to adult rats. There are, however, no data regarding the potential effects of benalaxyl-M on thyroid homeostasis in the young animals. This lack of characterization creates uncertainty with regards to potential life stage sensitivities due to exposure to benalaxyl-M. For future uses with higher exposure potential, the Agency will require a comparative thyroid assay in rats to assess the potential impact of benalaxyl-M exposure on thyroid function in the young given the pivotal role of thyroid hormones in brain development.

ii. There is no indication that benalaxyl-M 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 benalaxyl-M 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 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, benalaxyl-M 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 benalaxyl-M from food will utilize 1.4% of the cPAD for the general U.S. population and all population sub-groups. The most highly exposed population subgroup was children 1-2 years old with an estimated risk of 7.1% cPAD.

3. Aggregate cancer risk for U.S. population. The cancer dietary assessment made use of the same input assumptions as the chronic analysis. Benalaxyl-M has been classified as “Likely to be Carcinogenic to Humans”. A linear low-dose extrapolation model (Q1*) was used to estimate cancer risk, with a Q1* = 5.90 × 10−3 (mg/kg/day) −1. The cancer risk estimate to the U.S. population is 1.7 × 10−6. EPA generally considers cancer risks in the range of 10−6 or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3 × 10−7 and 3 × 10−6 are expressed as risks in the range of 10−6. Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above in this unit, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10−6 until the calculated risk exceeds approximately 3 × 10−6. This is particularly the case where some conservatism is maintained in the exposure assessment.

4. Determination of safety. There are no existing or proposed US registrations of benalaxyl-M and the only route of exposure is via dietary ingestion from imported grape and tomato commodities. Therefore, aggregate exposure and risk estimates are equivalent to the dietary exposures and risk estimates. 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 benalaxyl-M residues.

Adequate enforcement methodology (RA.09.01, a high-performance liquid chromatography method with tandem mass spectrometry detection (HPLC/MS/MS) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [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 benalaxyl-M at 0.3 and 0.2 ppm in or on grape and tomato, respectively. As a result, the EPA recommendations will result in harmonization of the U.S. tolerance with the Codex MRL for tomato, but not for grape since benalaxyl-M residues from the grape trials in Argentina were significantly higher than the Codex MRL.

The requested tolerance levels differ from those being established by EPA. The petitioner used the NAFTA calculator to propose tolerance levels while EPA used OECD MRL calculation procedures. Additionally, for determination of the grape and tomato tolerance levels, the petitioner included the results from all trials. In contrast, EPA included only those data that matched the critical Good Agricultural Practice (cGAP). The tolerance for grape, raisin was not recommended because it is covered by the grape tolerance. No separate tolerances are needed for grape juice, grape wine, or processed tomato products as processing studies showed that residues of benalaxyl-M do not concentrate in these processed commodities.

Therefore, tolerances are established for residues of benalaxyl-M, in or on grape and tomato at 3.0 and 0.20 ppm, respectively.

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: