Federal Register Vol. 81, No.140,

I. Background

The Administrative Procedure Act (APA) requires that each agency give interested persons the right to petition the agency for the issuance, amendment, or repeal of a rule. 5 U.S.C. 553(e). Such a petition is known as a “rulemaking petition.” DHS is adopting this rule to describe its procedures for receiving and responding to rulemaking petitions. Other federal agencies have adopted similar petition procedures. See, e.g., 49 CFR 5.11, 5.13 (Department of Transportation); 24 CFR 10.20 (Department of Housing and Urban Development).

Two components of DHS have component-specific regulations governing rulemaking petitions. See 33 CFR 1.05-20 (U.S. Coast Guard); 44 CFR 1.17, 1.18 (Federal Emergency Management Agency (FEMA)). This rule leaves those regulations in place. This rule, however, will cover petitions related to all other components of the Department.

The discussion below provides a section-by-section description of the rule's provisions.

This section includes definitions that apply throughout the rule.

This section describes the applicability of this rule. Interested persons who wish to submit a rulemaking petition to DHS 1 must use the process outlined in this rule, except as follows:

(1) Interested persons who wish to submit a rulemaking petition on a matter related to the U.S. Coast Guard must submit their request to the U.S. Coast Guard pursuant to 33 CFR 1.05-20.

(2) Interested persons who wish to submit a rulemaking petition on a matter related to FEMA must submit their request to FEMA pursuant to 44 CFR 1.18.

In summary, the procedures described in this rule cover rulemaking petitions related to the rulemaking functions of all Department components, except for the U.S. Coast Guard and FEMA. Accordingly, the procedures described in this rule are the exclusive procedures for submitting a rulemaking petition related to the programs and authorities of U.S. Citizenship and Immigration Services, U.S. Customs and Border Protection (except for customs-revenue functions retained by the Department of the Treasury under sections 412 and 415 of the Homeland Security Act and Treasury Department Order No. 100-16 2 ), U.S. Immigration and Customs Enforcement, the National Protection and Programs Directorate, and the Transportation Security Administration (TSA) among other Department components.

This section provides instructions for how to submit a rulemaking petition to the Department. The petitioner must clearly mark the rulemaking petition itself as a rulemaking petition. In addition, the petitioner must provide essential contact information—including a name and mailing address—so that the Department is able to reply to the petitioner. A petitioner may also submit additional information, such as telephone numbers, a fax number, and/or an email address.

The Department will accept petitions by mail (no courier service accepted) to the address(es) designated in the regulation. The Department will accept most petitions for rulemaking at a single address, however, petitioners may also submit petitions related to TSA-specific authorities directly to TSA, at the address in the regulation.

Section 3.5 contains the minimum procedural requirements for formatting and submitting a rulemaking petition under this regulation. In the interest of efficiency and sound public administration, DHS may decline to accept as a rulemaking petition any correspondence that does not meet these basic requirements.

This section discusses the substantive content of a rulemaking petition. DHS encourages petitioners to submit rulemaking petitions that clearly explain what the petitioner is requesting, identify specific regulations, and include actionable data. DHS is better positioned to understand and respond to a rulemaking petition if it describes with reasonable particularity the rule that the petitioner is asking DHS to issue, amend, or repeal, as well as the factual and legal basis for the petition. The regulatory text highlights some items that would help DHS to understand and respond to a petition. DHS may deny the petition if it does not adequately describe what the petition is requesting and provide adequate support for the request.

The regulation describes DHS's process for responding to rulemaking petitions. This section states that DHS, in its discretion, may solicit public comment on a rulemaking petition. Following appropriate consideration of a rulemaking petition, DHS responds to the petition by letter or by Federal Register publication. The responsible official may grant or deny the petition, in whole or in part. Granting the petition means that DHS is initiating regulatory action.

By contrast to the final disposition outcomes described immediately above, DHS may also deny or summarily dismiss without prejudice any petition that is moot, premature, repetitive, frivolous, or which plainly does not warrant further consideration.

This is a rule of agency organization, procedure, or practice under the Administrative Procedure Act, 5 U.S.C. 553(b)(A). Although the Administrative Procedure Act does not require DHS to provide a period of advance notice and opportunity for public comment, DHS invites public comment on this rule.

Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a significant regulatory action for the purposes of Executive Order 12866, as amended, and therefore review by the Office of Management and Budget is not necessary.

This rule describes how to petition DHS to issue, amend, or repeal a rule. The rule's qualitative benefits include additional transparency and accountability for the public. The rule imposes no additional costs on the public or the government.

This rule does not require a general notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.

This rule does not contain or modify any collections of information under the Paperwork Reduction Act. See 44 U.S.C. 3501 et seq.

For the reasons set forth in the preamble, DHS amends 6 CFR chapter I by adding part 3 to read as follows:

Authority for This Rulemaking History

The Federal Register published a final rule (81 FR 40165, June 21, 2016) Docket No. FAA-2015-7203, establishing Class D airspace at Destin Executive Airport, Destin, FL; and Duke Field Eglin AFB, FL; removing Class D airspace at Eglin AF Aux No 3 Duke Field; and amending Class D and Class E airspace at Eglin Air Force Base, FL. Further review revealed one comment was received, but not addressed. This action corrects that error.

Class D and E airspace designations are published in paragraphs 5000, 6002, and 6005, respectively, of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Accordingly, pursuant to the authority delegated to me, in the Federal Register of June 21, 2016 (81 FR 40165) FR Doc. FAA-2015-7203, Establishment of Class D Airspace: Destin, FL; Duke Field, Eglin AFB, FL; Revocation of Class D Airspace; Eglin AF Aux No 3 Duke Field, FL; and Amendment of Class D and E Airspace; Eglin Air Force Base, FL; Eglin Hurlburt Field, FL; and Crestview, FL, is corrected as follows:

On page 40165, column 3, on line 37, Remove the following text: “July 21” and in its place, “November 10”.

On page 40166, column 1, beginning on line 47, remove the following text: “No comments were received” and in its place add, “One comment was received, from the Aircraft Owners and Pilots Association, in support of the rulemaking. The commenter requested the FAA make clear all publications, so as to relay the proper information concerning this airspace to the flying public. ”

In the Federal Register of April 4, 2016 (81 FR 19033), FDA solicited comments concerning the direct final rule for a 75-day period ending June 20, 2016. FDA stated that the effective date of the direct final rule would be on August 17, 2016, no later than 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

On June 14, 2016, the Department published a final rule on Indian Child Welfare Act proceedings, in implementation of ICWA. See 81 FR 38778. To help those affected by the final rule—in particular States courts, State agencies, Tribes, private agencies—to prepare for the December 12, 2016, effective date of the final rule, the Department is offering several training sessions on the final rule.

The following chart shows the current schedule for training sessions. Please check the following Web site for updates: http://www.bia.gov/WhoWeAre/BIA/OIS/HumanServices/index.htm. This Web site also includes the training materials and the full text of the regulation.

At the on-site sessions, trainers will present material during the morning hours, to allow sufficient additional time for discussion.

Each session is open to Tribes, State child welfare agency personnel, and State court personnel. Separate training sessions are being planned for others interested in the new rule and will be announced at a later date. Because space is limited, we ask that you RSVP to [email protected] for each session you plan to attend by submitting your name and the location (or webinar) you plan to attend. Please also note that some on-site locations are at government facilities that may include security screening, and plan accordingly.

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary of the Treasury has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013 (superseding Treasury Order 120-01, dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these laws.

Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

TTB received a petition from the Straits Area Grape Growers Association, on behalf of winery and vineyard owners in the northern portion of Michigan's Lower Peninsula, proposing the establishment of the “Tip of the Mitt” AVA. The proposed AVA contains approximately 2,760 square miles, and there are 41 commercially-producing vineyards covering a total of 94 acres distributed throughout the proposed AVA, along with 8 wineries. According to the petition, an additional 48 acres of vineyards and 4 new wineries are planned for the near future. The proposed Tip of the Mitt AVA is not located within any established AVA. According to the petition, the distinguishing features of the proposed Tip of the Mitt AVA include its climate and soils.

The proposed AVA is bordered by Grand Traverse Bay, Little Traverse Bay, and Lake Michigan to the west; the Straits of Mackinac to the north; and Lake Huron to the east. The presence of large bodies of water on three sides of the proposed AVA has a moderating effect on the climate, providing slightly warmer annual high temperatures than are found south of the proposed AVA. The proposed Tip of the Mitt AVA also has fewer days with high temperatures below both 0 and 32 degrees Fahrenheit than the region to the south, meaning that temperatures do not drop low enough to cause severe damage to cold-hardy grape varietals such as Marechal Foch and Leon Millot. The proposed AVA also has a longer growing season and higher growing degree day accumulations than the region to the south, providing ample time for mid-to-late season grape varietals such as Frontenac to ripen.

With respect to soils, the proposed Tip of the Mitt AVA predominately contains coarse-textured glacial till and Lacustrine sand and gravel. Soils that contain either glacial outwash sand or ice-contact sand and gravel are present only in small amounts within the proposed AVA and are more common in the region to the south. The soils within the proposed AVA have high levels of organic matter, which prevents nutrients from leaching rapidly. The soils also have high water-holding capacities, so vineyard owners take steps to reduce moisture accumulation, such as planting cover crops between rows to absorb excess water. By contrast, the soils in the region south of the proposed AVA have lower levels of organic matter and lower water-holding capacities. Finally, the soils within the proposed AVA do not heat as quickly in the spring as soils that contain high levels of sand and gravel, so bud-break is naturally delayed until the risk of late spring frosts has passed.

TTB published Notice No. 155 in the Federal Register on August 6, 2015 (80 FR 46883), proposing to establish the Tip of the Mitt AVA. In the notice, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The notice also compared the distinguishing features of the proposed AVA to the features of the surrounding areas. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed AVA, and for a detailed comparison of the distinguishing features of the proposed AVA to the surrounding areas, see Notice No. 155.

In Notice No. 155, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. The comment period closed on October 5, 2015. TTB received 14 comments in response to Notice No. 155. All 14 commenters supported the establishment of the proposed AVA. Commenters included self-identified local winery and vineyard owners and operators; members of the Straits Area Grape Growers Association; the Corporate and Community Education Training Coordinator for North Central Michigan College in Petoskey, MI; an Agricultural Innovation Counselor with Michigan State University's Product Center; and several individuals who did not describe any affiliation with the wine industry. Many of the commenters stated that the region's climate and the ability to grow a variety of cold-hardy grape varietals distinguish the proposed AVA from the region to the south. Several of the commenters supported the proposed AVA as a way to showcase the region's wines and promote tourism to the region. TTB did not receive any comments opposing the establishment of the proposed AVA.

One commenter (comment 6) supported the establishment of the proposed AVA but did not support the proposed name. The commenter stated that he believed “Tip of the Mitt” was a “whimsical” name that is “Michigan slang” and “doesn't provide the public with an accurate geographical description” of where the proposed AVA is located. The commenter suggested “The Straits” or “Little Traverse” as alternate names for the proposed AVA, but did not provide any evidence to support the alternative AVA names.

Section 9.12(a)(1) of TTB regulations requires, among other things, that: (1) A proposed AVA name be currently and directly associated with an area in which viticulture exists; (2) the proposed name apply to all of the area within the proposed AVA; and (3) the region of the proposed AVA be known nationally or locally by the proposed name. Although “Little Traverse” and “The Straits” both refer to geographical features within the proposed AVA, the commenter did not provide evidence to show that the entire region of the proposed AVA is known locally or nationally by either of those names. Additionally, “The Straits” could apply to any of the numerous straits in the United States and is therefore unsuitable as an AVA name without a geographical modifier. Therefore, TTB does not believe that either “Little Traverse” or “The Straits” meets the regulatory requirements for an AVA name.

TTB believes that the petition to establish the Tip of the Mitt AVA provided sufficient evidence to demonstrate that the name “Tip of the Mitt” is widely used throughout the proposed AVA to describe the region. The petition included names of local businesses and organizations and regional events that use the phrase in their names. Therefore, TTB has determined that “Tip of the Mitt” meets the regulatory requirements for an AVA name as set forth in § 9.12(a).

After careful review of the petition and the comments received, TTB finds that the evidence provided by the petitioner supports the establishment of the Tip of the Mitt AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Tip of the Mitt” AVA in the northern portion of Michigan's Lower Peninsula, effective 30 days from the publication date of this document.

See the narrative description of the boundary of the AVA in the regulatory text published at the end of this final rule.

The petitioner provided the required maps, and they are listed below in the regulatory text.

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of this AVA, its name, “Tip of the Mitt,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations (27 CFR 4.39(i)(3)). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Tip of the Mitt” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin.

The establishment of the Tip of the Mitt AVA will not affect any existing AVA. The establishment of the Tip of the Mitt AVA will allow vintners to use “Tip of the Mitt” as an appellation of origin for wines made primarily from grapes grown within the Tip of the Mitt AVA if the wines meet the eligibility requirements for the appellation.

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

On May 27, 2016, the Contract Drilling and Blasting representative submitted a CG-4260 to the Coast Guard for blasting operations that would take place from May 31, 2016 to August 1, 2016 during the demolition of the B.B. Comer Bridge on the Tennessee River at mile marker 386.0. The blasting operations will take place at various times and dates determined by environmental factors. The Captain of the Port Ohio Valley (COTP) has determined that this safety zone is necessary to protect persons, property, and infrastructure before, during, and after blasting operations.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard was informed of this project in early May, but full details of blasting operations on or over a Navigable Waterway were not provided until May 27, 2016 with a start date of May 31, 2016. The notification of blasting requirements were made only a few days before the project is scheduled to begin. Immediate action is needed to respond to potential safety hazards related to blasting operations on or over this navigable waterway. It is impracticable to publish an NPRM because we must establish this safety zone by May 31, 2016.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to establish a safety zone to protect persons, property, and infrastructure whenever blasting operations take place on the B.B. Comer Bridge from May 31, 2016 until August 1, 2016.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Ohio Valley (COTP) has determined the need to protect persons, property, and infrastructure during the blasting operations taking place on the B.B. Comer Bridge on the Tennessee River at mile marker 386.0. This rule is needed to protect personnel, vessels, and these navigable waters before, during, and after blasting operations take place.

The Captain of the Port Ohio Valley is establishing this safety zone from May 31, 2016 through August 1, 2016, for all waters of the Tennessee River beginning at mile marker 385.0 and ending at mile marker 387.0. The periods of enforcement will be 30 minutes prior to, during, and 30 minutes after any blasting operation that takes place on the B.B. Comer Bridge. The Coast Guard was informed that there would be between 9 and 12 blasting operations that will take place during daylight hours and will last approximately one hour on each occurrence. Safety zone enforcement times will be announced via Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNM), or through other public notice and at least 12-24 hour notice will be provided before each enforcement period. Any deviation from this rule are prohibited unless specifically authorized by the COTP Ohio Valley, or a designated representative. Deviations requests will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7465 or can be reached by VHF-FM channel 16.

The duration of each safety zone enforcement period is intended to protect persons, property, and infrastructure from safety hazards associated with blasting operations. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are establishing appears at the end of this document.

We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone.

This safety zone prohibits transit on the Tennessee River from mile 385.0 to mile 387.0, 30 minutes prior to, during, and 30 minutes after blasting operations on the B.B. Comer bridge from May 31, 2016 through August 1, 2016. Broadcast Notices to Mariners and Local Notices to Mariners will also inform the community of the safety zone enforcement periods through BNM, LNM and other forms of public notice so that they may plan accordingly for each short enforcement period restricting transit. Vessel traffic may request permission from the COTP Ohio Valley or a designated representative to enter the restricted area.

The Regulatory Flexibility Act of 1980, 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.

While some owners or operators of vessels intending to transit the safety zone area may be small entities, for the reasons stated in section V.A above this rule would not have a significant economic impact on any vessel owner or operator.

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 section.

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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 (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 area safety zone that would prohibit entry to unauthorized vessels. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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.

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

On January 2, 2016, the Coast Guard received notification of a dielectric oil release from a submerged power cable in the Hudson River in the vicinity Edgewater, NJ. In response, on February 5, 2016, the Coast Guard published a temporary final rule at 33 CFR 165-T01.0028 (81 FR 246181) establishing a safety zone to be enforced until July 9, 2016 or until completion of cleanup and cable repairs. On May 29, 2016, the Coast Guard received notification that cleanup operations and cable repairs were completed. The Coast Guard received notification of another dielectric oil release from a submerged power cable in the Hudson River in the vicinity of Edgewater, NJ on June 28, 2016.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. Waiting for a notice and comment period to run would inhibit the Coast Guard from protecting the public and vessels from the possible hazards associated with this dielectric oil leak and the hazards associated with the cable repairs.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. For the same reasons as discussed in the preceding paragraph, waiting for a 30 day notice and comment period to run would be impracticable.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port New York (COTP) has determined that a temporary safety zone is necessary to ensure the safety of vessels from the hazards associated with this dielectric oil leak and power cable repairs.

This rule establishes a safety zone from July 10, 2016 through July 10, 2017. The safety zone will cover all navigable waters of the Hudson River extending 1700 feet from the New Jersey shoreline and approximately 460 feet on either side of the charted power cable between Edgewater, NJ and W 110th Street, Manhattan, NY.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the COTP or a designated representative. Vessel operators must contact the COTP or an on-scene representative to obtain permission to transit through this safety zone. The COTP or an on-scene representative may be contacted by VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, and will not adversely alter the budget of any grant or loan recipients. Vessel traffic will be able to safely transit around this safety zone. This safety zone only affects a small-designated area of the Hudson River waterway. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 and publish the information in the Local Notice to Mariners.

The Regulatory Flexibility Act of 1980, 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.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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 section.

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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 (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 the establishment of a safety zone that will prohibit entry within the dielectric oil spill, cleanup, and power cable repair area, and is therefore categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be 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.

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.

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

Purpose of Program: The purpose of the Technical Assistance on State Data Collection program is to improve the capacity of States to meet the Individuals with Disabilities Education Act (IDEA) data collection and reporting requirements. Funding for this program is authorized under section 611(c)(1) of IDEA, which gives the Secretary the authority to reserve funds appropriated under Part B of the IDEA to provide technical assistance activities authorized under section 616(i) of IDEA. Section 616(i) of IDEA requires the Secretary to review the data collection and analysis capacity of States to ensure that data and information determined necessary for implementation of IDEA section 616 are collected, analyzed, and accurately reported to the Secretary. It also requires the Secretary to provide technical assistance, where needed, to improve the capacity of States to meet the data collection requirements under IDEA Parts B and C, which include the data collection and reporting requirements in sections 616 and 618 of IDEA.

Program Authority: 20 U.S.C. 1411(c) and 1416(i).

Applicable Program Regulations: 34 CFR 300.702.

We published a notice of proposed priority and requirements for this program in the Federal Register on March 23, 2016 (81 FR 15491). That notice contained background information and our reasons for proposing the particular priority and requirements.

Public Comment: In response to our invitation in the notice of proposed priority and requirements, we did not receive any comments on the proposed priority and requirements. However, as a result of our further review of the proposed priority and requirements since publication of the notice of proposed priority and requirements, we have made changes as follows:

Analysis of Comments and Changes:

Comment: None.

Discussion: As a result of our further review, we realized that a few items in the priority could benefit from further clarification. First, we have changed the title of the priority to be more descriptive. Second, we clarified that references to “assessment” in the priority include both formative and summative assessments. Third, to clarify how we intend for applicants to address logic models, we deleted some references to “logic model” and instead included a note directing the reader to additional information on the meaning of the term.

Changes: We have changed the title of the priority to: “Targeted and Intensive Technical Assistance to States on the Analysis and Use of Formative and Summative Assessment Data to Support Implementation of States' Identified Measurable Result(s).” We have modified, as appropriate, references to assessment describing “formative and summative” assessments, deleted references to “logic model” and inserted a note directing the reader to additional information on the meaning of the term, and made other technical changes.

FINAL PRIORITY: Targeted and Intensive Technical Assistance to States on the Analysis and Use of Formative and Summative Assessment Data to Support Implementation of States' Identified Measurable Result(s).

Priority: The purpose of this priority is to (1) assist States in analyzing and using assessment data to better achieve the States' Identified Measurable Result(s) (SIMR) as described in their IDEA Part B State Systemic Improvement Plans (SSIPs), and (2) assist State efforts to provide technical assistance (TA) to local educational agencies (LEAs) in analyzing and using State and districtwide assessment data to better achieve the SIMR, as appropriate.

The Center must achieve, at a minimum, the following expected outcomes:

(a) Increased capacity of State educational agency (SEA) personnel to analyze and use assessment data to better achieve the SIMR described in the IDEA Part B SSIP, including using assessment data to evaluate and improve educational policy, inform instructional programs, and improve instruction for students with disabilities; and

(b) Increased capacity of SEA personnel to provide TA to LEAs in the analysis and use of State and districtwide assessment data to improve instruction of students with disabilities and better achieve the SIMR.

Types of Priorities:

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

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

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

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

FINAL REQUIREMENTS: The Assistant Secretary establishes the following requirements for this program. We may apply these requirements in any year in which this program is in effect.

Requirements: Applications that:

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

(1) Address the needs of SEAs and LEAs to analyze and use formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities. To meet this requirement the applicant must—

(i) Present applicable national, State, and local data demonstrating the needs of SEAs and LEAs to analyze and use formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities;

(ii) Demonstrate knowledge of current educational issues and policy initiatives related to analyzing and using formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities;

(iii) Describe the current level of implementation related to analyzing and using formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities.

(2) Improve the analysis and use of formative and summative assessment data to improve teaching and learning for students with disabilities.

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

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the needs of the intended recipients for TA and information; and

(ii) Ensure that products and services meet the needs of the intended recipients (e.g., by creating materials in formats and languages accessible to the stakeholders served by the intended recipients);

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

(i) Measurable intended project outcomes; and

(ii) The logic model by which the proposed project will achieve its intended outcomes;

(3) 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;

Note: While section 77.1(c) of the Education Department General Administrative Regulations (EDGAR) contains a definition for “logic model,” the Office of Special Education Programs (OSEP), based upon its experience in this area, has been using the above definition as standard language for the OSEP Technical Assistance and Dissemination (TA&D) program priorities. OSEP's definition establishes a difference between logic models and conceptual frameworks whereas 34 CFR 77.1(c) considers the model to be one and the same. The following Web sites provide more information on logic models: www.osepideasthatwork.org/logicModel and www.osepideasthatwork.org/resources-grantees/program-areas/ta-ta/tad-project-logic-model-and-conceptual-framework.

(4) Be based on current research and make use of practices supported by evidence. To meet this requirement, the applicant must describe—

(i) The current research on the effectiveness of analyzing and using formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities; and

(ii) How the proposed project will incorporate current practices supported by evidence in the development and delivery of its products and services;

(5) 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) How it proposes to identify or develop the knowledge base on analyzing and using formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities;

(ii) Its proposed approach to universal, general TA,1 which must identify the intended recipients of the products and services under this approach;

(iii) Its proposed approach to targeted, specialized TA,2 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 potential TA recipients to work with the project, assessing, at a minimum, their current infrastructure, available resources, and ability to build capacity at the local level; and

(iv) Its proposed approach to intensive, sustained TA,3 which must identify—

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

(B) Its proposed approach to measure the readiness of SEA and LEA personnel to work with the project, including their commitment to the initiative, alignment of the initiative to their needs, current infrastructure, available resources, and ability to build capacity at the SEA and LEA levels;

(C) Its proposed plan for assisting SEAs (and LEAs, in conjunction with SEAs) to build training systems that include professional development based on adult learning principles and coaching; and

(D) Its proposed plan for working with appropriate levels of the education system (e.g., SEAs, regional TA providers, LEAs, schools, and families) to ensure that there is communication between each level and that there are systems in place to support the collection, analysis, and use of formative and summative assessment data in instructional decision-making to improve teaching and learning for students with disabilities;

(E) Its proposed plan for collaborating and coordinating with Department-funded TA investments and the Institute of Education Sciences (IES) research and development investments, where appropriate, in order to align complementary work and jointly develop and implement products and services to meet the purposes of this priority;

(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—

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

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

(iii) How the proposed project will use non-project resources to achieve the intended project outcomes.

(c) In the narrative section of the application under “Quality of the Evaluation Plan,” include an evaluation plan for the project as described in the following paragraphs. The evaluation plan must describe: Measures of progress in implementation, including the extent to which the project's products and services have reached its target population; and measures of intended outcomes or results of the project's activities in order to assess the effectiveness of those activities.

In designing the evaluation plan, the project must—

(1) Designate, with the approval of the OSEP project officer, a project liaison staff person with sufficient dedicated time, experience in evaluation, and knowledge of the project to work in collaboration with the Center to Improve Project Performance (CIPP),4 the project director, and the OSEP project officer on the following tasks:

(i) Revise, as needed, the logic model submitted in the grant application to provide for a more comprehensive measurement of implementation and outcomes and to reflect any changes or clarifications to the model discussed at the kick-off meeting;

(ii) Refine the evaluation design and instrumentation proposed in the grant application consistent with the logic model (e.g., preparing evaluation questions about significant program processes and outcomes, developing quantitative or qualitative data collections that permit both the collection of progress data, including fidelity of implementation, as appropriate, and progress toward achieving intended outcomes, selecting respondent samples if appropriate, designing instruments or identifying data sources, and identifying analytic strategies); and

(iii) Revise, as needed, the evaluation plan submitted in the grant application such that it clearly—

(A) Specifies the measures and associated instruments or sources for data appropriate to the evaluation questions, suggests analytic strategies for those data, provides a timeline for conducting the evaluation, and includes staff assignments for completion of the plan;

(B) Delineates the data expected to be available by the end of the second project year for use during the project's intensive review for continued funding described under the heading Fourth and Fifth Years of the Project; and

(C) Can be used to assist the project director and the OSEP project officer, with the assistance of CIPP, as needed, to specify the performance measures to be addressed in the project's Annual Performance Report;

(2) Cooperate with CIPP staff in order to accomplish the tasks described in paragraph (1) of this section; and

(3) Dedicate sufficient funds in each budget year to cover the costs of carrying out the tasks described in paragraphs (1) and (2) of this section and implementing the evaluation plan.

(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 traditionally 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 carry out the proposed activities and 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 will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(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 families, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(f) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, a logic model that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project. A logic model communicates how a project will achieve its intended outcomes and provides a framework for both the formative and summative evaluations of the project.

(2) Include, in Appendix A, a conceptual framework for the project;

(3) Include, in Appendix A, person-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(4) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period.

Note: Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer and the grantee's project director or other authorized representative;

(ii) A two and a half day project directors' meeting in Washington, DC, during each year of the project period;

(iii) Three trips annually to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP; and

(iv) A one-day intensive 3 + 2 review meeting in Washington, DC, during the last half of the second year of the project period;

(5) Include, in the budget, a line item for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with OSEP.

Note: With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period; and

(6) Maintain a Web site that meets government or industry-recognized standards for accessibility.

Fourth and Fifth Years of the Project: In deciding whether to continue funding the project for the fourth and fifth years, the Secretary will consider the requirements of 34 CFR 75.253(a), as well as—

(a) The recommendation of a review team consisting of experts selected by the Secretary. This review will be conducted during a one-day intensive meeting that will be held during the last half of the second year of the project period;

(b) The timeliness and effectiveness with which all requirements of the negotiated cooperative agreement have been or are being met by the project; and

(c) The quality, relevance, and usefulness of the project's products and services and the extent to which the project's products and services are aligned with the project's objectives and likely to result in the project achieving its intended outcomes.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The benefits of the TA projects have been well-established over the years in that other TA projects have been completed successfully. The priority announced in this notice will improve the capacity of States to meet the IDEA data collection and reporting requirements, including (1) increased capacity of SEA personnel to analyze and use assessment data to better achieve the SIMR described in the IDEA Part B SSIP through means such as the use of formative and summative assessment data to evaluate and improve educational policy, inform instructional programs and improve instruction for students with disabilities; and (2) increased capacity of SEA personnel to provide TA to LEAs in the analysis and use of State and districtwide assessment data to improve instruction of students with disabilities and better achieve the SIMR.

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 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.

Throughout this document, “we,” “us,” and “our” refer to the EPA.

Table 1 lists the plan addressed by this action with the date that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

On April 21, 2016, the EPA determined that EDCAQMD's Ozone Emergency Episode Plan submittal met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

There are no previous versions of this plan adopted by EDCAQMD or approved by EPA in the SIP.

The CAA requires the EPA to establish National Ambient Air Quality Standards (NAAQS) for Ozone and five other pollutants that are harmful to public health and the environment. Each state is required to submit to the EPA, within three years after the promulgation of a primary or secondary NAAQS, or any revision thereof, an infrastructure SIP revision that provides for the implementation, maintenance, and enforcement of such NAAQS. CAA section 110(a)(2) describes the contents required of such a plan that constitute the “infrastructure” of a state's air quality management program. The EDCAQMD Ozone Emergency Episode Plan is intended to fulfill the CAA § 110(a)(2)(G) infrastructure SIP requirement.

SIPs must be enforceable (see CAA section 110(a)(2)) and SIP revisions are restricted in how they can relax approved SIPs. This plan must also meet the infrastructure SIP requirements of CAA section 110(a)(2)(G) and EPA's implementing regulations found in 40 CFR part 51, subpart H (51.150 through 51.153).

Guidance that we used to evaluate section 110(a)(2) CAA requirements includes: “Guidance Document for Infrastructure State Implementation Plan Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2)”, EPA (September 2013).

We believe this plan is consistent with the relevant policy and guidance regarding enforceability, SIP relaxations and infrastructure SIPs. The EPA's technical support document (TSD) has more information about this plan and our evaluation.

As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted plan because we believe it fulfills all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted plan. If we receive adverse comments by August 22, 2016, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 19, 2016. This will incorporate the plan into the federally enforceable SIP.

Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this plan and if that provision may be severed from the remainder of the plan, the EPA may adopt as final those provisions of the plan that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the EDCAQMD plan described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available electronically through www.regulations.gov and in hard copy at U.S. Environmental Protection Agency Region IX (AIR4), 75 Hawthorne Street, San Francisco, CA, 94105-3901.]

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 application of those requirements would be inconsistent with the Clean Air Act; 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).

In addition, the SIP is not approved to apply on any Indian reservation land or 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that 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)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we,” “us,” and “our” refer to the EPA.

The California Air Resources Board (CARB) submitted Riverside County Air Pollution Control District (RCAPCD) and San Bernardino County Air Pollution Control District (SBCAPCD) Rules 213, 213.1, and 213.2, which address Clean Air Act (CAA) requirements for New Source Review (NSR) programs, to the EPA on June 6, 1977 for inclusion in the California SIP. The EPA approved RCAPCD Rules 213, 213.1, and 213.2 and SBCAPCD Rules 213, 213.1, and 213.2 into the SIP on November 9, 1978 (43 FR 52237). The area under the jurisdiction of RCAPCD and SBCAPCD at the time these rules were submitted is now under the jurisdiction of the Mojave Desert Air Quality Management District (MDAQMD) and the South Coast Air Quality Management District (SCAQMD). More information about the jurisdictional history of this area is found in the EPA's Technical Support Document (TSD) accompanying this rulemaking.

CARB has since submitted and the EPA has approved into the California SIP a series of NSR rules for MDAQMD and SCAQMD referred to as Regulation XIII. These rules supersede, among other rules, Rules 213, 213.1, and 213.2. This rulemaking action clarifies the applicable NSR rules for the Mojave Desert air district by removing from the Mojave Desert portion of the California SIP RCAPCD Rules 213, 213.1, and 213.2 and SBCAPCD Rules 213, 213.1, and 213.2.

RCAPCD Rules 203.1, 203.2, and 213.3 and SBCAPCD Rules 203.1, 203.2, and 213.3 also address NSR requirements. However, we can find no evidence that RCAPCD Rules 203.1, 203.2, and 213.3 and SBCAPCD Rules 203.1, 203.2, and 213.3 were ever submitted for SIP approval. Consequently, we are taking no action on the rescission of RCAPCD Rules 203.1, 203.2, and 213.3 and SBCAPCD Rules 203.1, 203.2, and 213.3.

MDAQMD rescinded Rules 203.1, 203.2, 213, 213.1, 213.2, and 213.3 on April 28, 2008, and CARB submitted the rescissions adopted by MDAQMD as a revision to the California SIP on October 20, 2008. As noted above, these rules had originally been adopted by RCAPCD and SBCAPCD and approved by the EPA as part of the California SIP. More than a decade later, when MDAQMD was established, MDAQMD adopted the rules that had been adopted by the previous air pollution control district as part of that agency's initial set of rules and regulations. MDAQMD's submittal of the rescissions to CARB for submittal to the EPA make it clear that the rescissions relate to the corresponding SIP rules from which the corresponding MDAQMD rules derive. As such, CARB's submittal of the rescission of MDAQMD Rules 203.1, 203.2, 213, 213.1, 213.2, and 213.3 constitutes the rescission of the corresponding SIP rules, i.e., RCAPCD Rules 203.1, 203.2, 213, 213.1, 213.2, and 213.3 and SBCAPCD Rules 203.1, 203.2, 213, 213.1, 213.2, and 213.3. Table 1 lists these rules, along with SIP approval dates (if any).

On November 18, 2008, we determined that CARB's October 20, 2008 SIP revision met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal review by the EPA.

SBCAPCD and RCAPCD rules 203.1, 203.2, 213, 213.1, 213.2, and 213.3 have been superseded by MDAQMD Regulation XIII and SCAQMD Regulation XIII. CARB has requested that these SBCAPCD and RCAPCD rules be rescinded from the SIP for the purpose of clarifying the SIP and to avoid confusion as to the SIP status of these rules. This action represents an administrative change and does not result in changes to SIP approved Regulation XIII that contains the current NSR program. A more detailed discussion of these rules is found in the TSD accompanying this rulemaking.

The EPA is evaluating the rules submitted for rescission by CARB to determine whether they were ever approved in the relevant portion of the SIP, and if they had been approved in the SIP, whether they have been superseded by approval of subsequent rules by the EPA.

The provisions contained in RCAPCD Rules 213, 213.1, and 213.2 and SBCAPCD Rules 213, 213.1, and 213.2 have been superseded by MDAQMD Regulation XIII, Rules 1300-1306 (61 FR 58133) and SCAQMD Regulation XIII, Rules 1301-1306, 1309-1310, 1313, and 1325 (50 FR 3906, 61 FR 64291, 64 FR 13514, 71 FR 35157, 80 FR 24821). The rescission of superseded rules is consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. We can find no evidence that RCAPCD Rules 203.1, 203.2, and 213.3 and SBCAPCD Rules 203.1, 203.2, and 213.3 were ever approved into the SIP, therefore no action is necessary to remove them. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the CAA, the EPA is fully approving the rescission of RCAPCD Rules 213, 213.1, and 213.2 and SBCAPCD Rules 213, 213.1, and 213.2 because we have concluded that they were superseded years ago by approval by the EPA of subsequent rules and thus are no longer part of the applicable California SIP, and because rescission of them will clarify the contents of the MDAQMD portion of the SIP and avoid confusion as the SIP status of these rules. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted rule rescissions. If we receive adverse comments by August 22, 2016, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 19, 2016. This action will rescind specific rules from the federally enforceable SIP.

Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 (Public Law 104-4);

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that 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)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0646 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 19, 2016. 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-2015-0646, 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 October 21, 2015 (80 FR 63731) (FRL-9935-29), 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 5F8358) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.532 be amended by establishing tolerances for residues of the fungicide cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on vegetable, tuberous and corm, subgroup 1C at 0.01 parts per million (ppm) and potato, wet peel at 0.03 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the Notice of Filing.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyprodinil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyprodinil 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 major target organs of cyprodinil are the liver and the kidney. Liver effects were consistent among male and female rats and mice in both sub-chronic and chronic studies and typically included increased liver weights along with increases in serum clinical chemistry parameters associated with adverse effects on liver function (i.e., increased cholesterol and phospholipid levels). Microscopic lesions in rats and mice included hepatocyte hypertrophy and hepatocellular necrosis. In the kidneys, adverse effects were seen as chronic tubular lesions and chronic kidney inflammation following sub-chronic exposure of male rats. Chronically, cyprodinil caused increased kidney weights and progressive nephropathy in male rats. Chronic effects in dogs were limited to decreased body-weight gain, decreased food consumption and decreased food efficiency; liver toxicity was not seen in the dog. Although increases in thyroid weight and/or hypertrophy of thyroid follicular cells were observed at higher doses in the rat 28-day oral-toxicity studies and in the 90-day oral-toxicity study in rats, treatment related changes in thyroid weights or gross/microscopic observations were not observed in the chronic rat study or in other studies.

A 28-day dietary immunotoxicity study in mice resulted in no apparent suppression of the humoral component of the immune system. The only effect attributed to cyprodinil treatment was higher mean absolute, relative (to body weight), and adjusted liver weights for the 5,000 ppm group. There were no treatment-related effects on absolute, adjusted, or relative spleen or thymus weights; no effects on specific activity or total activity of splenic Immunoglobulin M antibody-forming cells to the T cell-dependent red blood cell antigens. No dermal or systemic toxicity was seen following repeated dermal application at the highest dose in a 21-day dermal toxicity study in rabbits.

An acute neurotoxicity study indicated systemic toxicity with signs of induced hunched posture, piloerection, and reduced responsiveness to sensory stimuli and reduced motor activity. Females were slightly more affected than males per daily clinical observations, which disappeared by day 3 to 4. A dose-related reduction in body temperature was seen in all treated animals, thus hypothermia is considered a compound-related effect in the highest dose tested and was found to be statistically significant, whereas the lower dosed animals was not or only marginally significant and was fully reversible in all groups. Clinical signs, hypothermia, and changes in motor activity were found to all be reversible by day 8. There were no histopathological findings to support evidence of damage to the central nervous system, eyes, optic nerves, or skeletal muscles. A sub-chronic neurotoxicity study showed no treatment related effects on mortality, clinical signs, or gross or histological neuropathology. Functional observational battery and motor activity testing revealed no treatment related effects up to the highest dose tested.

There was no evidence of increased susceptibility in the developmental rat or rabbit study following in utero exposure or in the two-generation reproduction study following pre- and post-natal exposure. Fetal toxicity, manifested as significantly lower fetal weights and an increased incidence of delayed ossification in the rat and a slight increase in litters showing extra ribs (13th) in the rabbit, was reported in developmental toxicity studies. In a rat two-generation reproduction study, significantly lower pup weights for F 1 and F 2 offspring were observed. However, each of these fetal/neonatal effects occurred at the same dose levels at which maternal toxicity (decreased body weight gain) was observed and were considered to be secondary to maternal toxicity.

Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to the carcinogenic potential, cyprodinil was classified as “not likely to be carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by cyprodinil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Human Health Risk Assessment for Registration Review and New Use Risk Assessment to Support the Registration of Proposed Use on Crop Subgroup 1C” in docket ID number EPA-HQ-OPP-2015-0646.

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 the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for cyprodinil used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of August 17, 2012 (77 FR 49732) (FRL-9359-7).

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

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for cyprodinil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA utilized the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16 default processing factors and tolerance-level residues and 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA dietary survey conducted from 2003 to 2008. As to residue levels in food, EPA tolerance-level residues were used for most commodities, and average field trial residues were used for pome fruit, head lettuce, leaf lettuce, spinach, tomato, and grapes. 100 PCT assumptions were used for all commodities. DEEM default and empirical processing factors were used to modify the tolerance values.

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

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyprodinil and CGA 249287 in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyprodinil and CGA 249287. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI-GROW) models and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of cyprodinil and CGA 249287 for acute exposures are estimated to be 34.8 parts per billion (ppb) for surface water and 2.05 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 24.7 ppb for surface water and 1.80 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 34.8 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 24.7 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyprodinil is currently registered for the following uses that could result in residential exposures: Ornamental plants. EPA assessed residential exposure using the following assumptions: Only short-term inhalation exposures to adult residential handlers from application to ornamental plants. Though there may be short-term dermal exposures to handlers, this was not assessed since no dermal endpoint was identified. Post-application exposures to adults and children are not expected. Intermediate or chronic exposures are not expected. 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 cyprodinil to share a common mechanism of toxicity with any other substances, and cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyprodinil does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. In a rat developmental toxicity study, there were significantly lower mean fetal weights in the high-dose group compared to controls as well as a significant increase in skeletal anomalies in the high-dose group due to abnormal ossification. The skeletal anomalies/variations were considered to be a transient developmental delay that occurs secondary to the maternal toxicity noted in the high-dose group. In the rabbit study, the only treatment related developmental effect was indication of an increased incidence of a 13th rib at maternally toxic doses. Signs of fetal effects in the two-generation reproductive toxicity study included significantly lower F1 and F2 pup weights in the high-dose group during lactation, which continued to be lower than controls post-weaning and after the pre-mating period in the F1 generation only. Reproductive effects were seen only at doses that also caused parental toxicity.

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 for non-inhalation routes of exposure and retained at 10X for inhalation exposure scenarios for all population groups. That decision is based on the following findings:

i. The toxicity database for cyprodinil is complete, except for a 90-day inhalation toxicity study required to reduce uncertainty associated with the use of an oral POD for assessing risk via the inhalation route. In the absence of a route-specific inhalation study, a 10x FQPA SF factor for residential scenarios will be retained for risk assessments involving inhalation exposure.

ii. As indicated by an acute neurotoxicity study in mice, clinical signs, hypothermia, and changes in motor activity were all found to be reversible and no longer seen at day 8. There were no treatment related effects on mortality, gross or histological neuropathology. Reduced motor activity, induced hunched posture, piloerection and reduced responsiveness to sensory stimuli were observed and disappeared in all animals by day 3 to 4. In a sub-chronic neurotoxicity study in rats, there were no treatment related effects on mortality, clinical signs, or gross or histological neuropathology. No clinical signs suggestive of neurobehavioral alterations or evidence of neuropathological effects were observed in the available oral-toxicity studies. Based on this evidence, there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. In the prenatal developmental rat and rabbit studies and in the two-generation reproduction rat study, toxicity to the fetuses/offspring, when observed, occurred at the same doses at which effects were observed in maternal/parental animals. All of these fetal effects were considered to be secondary to maternal toxicity. There is no evidence that cyprodinil results in increased susceptibility in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary assessment was conservative and based on 100 PCT and tolerance level residues as well as DEEM default and empirical processing factors. The chronic dietary assessment was partially refined with average field trial residues for some commodities and tolerance-level residues for the remaining commodities. DEEM default and empirical processing factors were also incorporated into the chronic dietary assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyprodinil in drinking water. Based on the discussion in Unit III.C.3, postapplication exposure of children as well as incidental oral exposure of toddlers is not expected. These assessments will not underestimate the exposure and risks posed by cyprodinil.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyprodinil will occupy 8.6% of the aPAD for children one to two years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyprodinil from food and water will utilize 86% of the cPAD for children one to two 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 cyprodinil 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). Cyprodinil 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 cyprodinil. Using the exposure assumptions described in this unit for short-term exposures, EPA has estimated the short-term food, water, and residential exposures. For adults, oral dietary and inhalation estimates were combined using the total aggregate risk index (ARI) methodology since the levels of concern (LOC) for oral and dietary exposure (LOC = 100) and inhalation (LOC 1,000) are different. The short-term ARI for adults is 70 which is greater than 1 and is therefore, 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, cyprodinil 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 cyprodinil.

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

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

Adequate enforcement methodology (AG-631 and AG-631B) are 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 not established a MRL for cyprodinil in/on potato, wet peel and vegetable, tuberous and corm, subgroup 1C.

Therefore, tolerances are established for residues of cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin, in or on potato, wet peel at 0.03 and vegetable, tuberous and corm, subgroup 1C at 0.01ppm.

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 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(g), 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-2014-0329 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 19, 2016. 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-2014-0329, 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 August 1, 2014 (79 FR 44729) (FRL-9911-67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 3F8193) by Technology Sciences Group, Inc., 1150 18th St., NW., Suite 1000, Washington, DC 20036 (on behalf of Novozymes BioAg, Inc., 13100 W. Lisbon Rd., Suite 600, Brookfield, WI 53005). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Isaria fumosoroseus strain FE 9901 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner Novozymes BioAg, Inc., which is available in the docket via http://www.regulations.gov. There were no comments received in response to this notice of filing.

Based upon a tolerance exemption that EPA established for a different strain of this microbe in 2011 and a review of public literature, EPA revised the active ingredient name from “Isaria fumosoroseus strain FE 9901” to “Isaria fumosorosea strain FE 9901.” The reason for this change is explained in Unit III.C.

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

EPA evaluated the available toxicity and exposure data on Isaria fumosorosea strain FE 9901 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the April 11, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that Isaria fumosorosea strain FE 9901 is not toxic, is not pathogenic, and is not infective. Although there may be some exposure to residues when used as an insecticide on food, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor (SF) was not necessary as part of the qualitative assessment conducted for Isaria fumosorosea strain FE 9901.

Based on its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Isaria fumosorosea strain FE 9901. Therefore, an exemption from the requirement of a tolerance is established for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method is not required for enforcement purposes for the reasons contained in the April 11, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901” and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

One modification has been made to the requested tolerance exemption. When Novozymes BioAg, Inc. first submitted this petition in 2013, it described the active ingredient as “Paecilomyces fumosoroseus strain FE 9901.” After conducting an initial review of this petition, EPA asked Novozymes BioAg, Inc. to revise the genus name of the active ingredient from “Paecilomyces” to “Isaria” based upon what it believed to be current, acceptable taxonomy. Novozymes BioAg, Inc. responded to EPA's request by representing the active ingredient as “Isaria fumosoroseus strain FE 9901” instead of “Paecilomyces fumosoroseus strain FE 9901” in its petition. After recently reviewing a tolerance exemption established in 2011 for a different strain of this microbe (40 CFR 180.1306 for Isaria fumosorosea Apopka strain 97) and public literature, EPA realizes that it should have also asked Novozymes BioAg, Inc. to change the species name of the active ingredient from “fumosoroseus” to “fumosorosea” to align completely with current, acceptable taxonomy (Refs. 1, 2, and 3). Use of Isaria fumosorosea strain FE 9901 throughout this document is supported by public literature, is consistent with a previous tolerance exemption that EPA established for a different strain of this microbe, and should assist in preventing confusion with regard to the proper nomenclature for this particular active ingredient in the future. EPA does not believe the change from “fumosoroseus” to “fumosorosea” will cause confusion among the public as there is a clear history linking the first term to the second and because the names refer to the same microbe.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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:

EPA issued a final rule in the Federal Register of June 13, 2016 (81 FR 38104) amending its hazardous chemical regulations due to the changes in the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS). The final rule inadvertently omitted the hazard “serious eye damage or eye irritation” in § 370.66 under the definition of “health hazard”. This action is being issued to correct the omitted hazard in 40 CFR 370.66, which contains the definitions of the key words used in 40 CFR part 370. Specifically, under the definition of “hazard category,” EPA inadvertently omitted the hazard, “serious eye damage or eye irritation” under the definition of “health hazard.” This document corrects this error by adding the hazard, “serious eye damage or eye irritation” in 40 CFR 370.66 under the definition of “health hazard.”

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is corrected as follows:

In FR Doc. 2016-12857 appearing on page 40004 in the Federal Register of Monday, June 20, 2016, the following corrections are made: