Federal Register Vol. 81, No.74,

This final rule is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

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

This final rule continues in effect the provisions of the interim rule that revised the exemption provisions prescribed under the order. The interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. The interim rule also revised the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. These changes were unanimously recommended by the Board at its meeting on June 25, 2015.

Section 930.59 of the order authorizes handler diversion. When volume regulation is in effect, handlers may fulfill any restricted percentage requirement in full or in part by acquiring diversion certificates or by voluntarily diverting cherries or cherry products in a program approved by the Board, rather than placing cherries in an inventory reserve.

Section 930.159 of the order's administrative rules specifies methods of handler diversion, including using cherries or cherry products for exempt purposes prescribed under § 930.162. Section 930.162 establishes the terms and conditions of exemption that must be satisfied for handlers to receive diversion certificates for exempt uses. Section 930.162(b) defines the activities which qualify for exemptions under new market development and market expansion and the period for which they are eligible for diversion credit. New market development and market expansion activities include, but are not limited to, sales of cherries into markets that are not yet commercially established, product line extensions, or segmentation of markets along geographic or other definable characteristics.

Section 930.162(d) establishes a Board-appointed subcommittee to review the applications for exemption or renewal of exemption and to either approve or deny the exemption. Prior to this change, this section specified that the subcommittee consist of three members, including the Board manager, or a Board member acting in the manager's stead, the public member, and one industry person who is not on the Board.

The order provides for the use of volume regulation to stabilize prices and improve grower returns during periods of oversupply. At the beginning of each season, the Board examines production and sales data to determine whether a volume regulation is necessary and, if so, announces free and restricted percentages to limit the volume of tart cherries on the market. Free percentage cherries can be used to supply any available market, including domestic markets for pie filling, water packed, and frozen tart cherries. Restricted percentage cherries can be placed in reserve or be used to earn diversion credits as prescribed in §§ 930.159 and 930.162 of the order's administrative rules. These activities include, in part, the development of new products, new market development and market expansion, the development of export markets, and charitable contributions.

In 2012, the Board made a series of changes to the volume control provisions to facilitate the marketing of tart cherries and to help lower restrictions during seasons when volume control is implemented. One of these changes was to decrease the number of years that new market development and market expansion projects are eligible for handler diversion credit from three years to one year. The Board thought this decrease would continue to encourage new market development and market expansion projects while reducing the impact these credits had on volume restriction calculations. At that time, new market and market expansion sales were not included in the average sales figure used to determine optimum supply for volume regulation. The Board anticipated the change would shift more volume to sales, helping to reduce the calculated surplus and lower the restricted percentage.

In revisiting this change, the Board recognized that the underlying rationale for having reduced the duration of diversion credit for new market development and market expansion was no longer an issue. Since that change, the method for calculating average sales for the purpose of volume regulation has been adjusted so that only export sales are excluded from the average sales calculation. Consequently, all sales from market development and market expansion activities are now included as sales when calculating a restriction. Therefore, increasing the number of years new market development and market expansion projects are eligible to receive diversion credit from one year to three years will not significantly impact the calculations for free and restricted percentages.

Further, since limiting these activities to one year, participation in new market development and market expansion activities has dropped dramatically. In years prior to changing from three years to one year, applications for new market activities numbered around 20 to 25 a season. During the 2014-15 season, the first season with volume regulation under the one-year limitation, applications dropped to eight. Handlers stated that it was not worth the time and effort to develop one of these projects if the benefit was only for a single year. It was reported that the shortened time frame did not allow handlers to recoup the resources needed to establish one of these projects.

The Board affirmed its support for new market development and market expansion diversion credit programs. Accordingly, the Board voted unanimously to change the exemption provisions applicable to handler diversion activities by increasing the number of years that new market development and market expansion activities are eligible for diversion credit back to three years. The Board also noted that projects approved for the 2014-15 season would be allowed to continue and be subject to the new three-year cycle.

This action also continues in effect a revision to the composition of the subcommittee appointed to review exemption applications. The subcommittee was formed to assist Board staff members in reviewing and granting exemptions. The subcommittee reviews applications to use restricted cherries for activities related to new product development, new market development and market expansion, the development of export markets, and for experimental purposes. Prior to this change, the previous provisions (§ 930.162(d)) stated that the subcommittee consists of the manager of the Board or a Board member acting in their stead, the public member, and one industry member who is not on the Board. The Board recommended changing the composition of the subcommittee to help ensure impartiality so that no one affiliated with a handler was part of the review process.

Consequently, the Board recommended revising the subcommittee to consist of three members, all of whom are not affiliated with a handler but have industry knowledge. One of these members shall be the public member or the alternate public member, if available to serve. The subcommittee will also include a similarly qualified alternate should one of the other members be unable to serve.

The Board made several other recommendations for changes to the regulations under the order at its June 25, 2015, meeting. These changes are being considered under a separate action.

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

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

There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000 and small agricultural service firms have been defined as those having annual receipts of less than $7,500,000 (13 CFR 121.201).

According to the National Agricultural Statistics Service and Board data, the average annual grower price for tart cherries during the 2014-15 season was $0.35 per pound, and total utilization was around 300 million pounds. Therefore, average receipts for tart cherry producers were around $175,800, well below the SBA threshold for small producers. In 2014, The Food Institute estimated an f.o.b. price of $0.96 per pound for frozen tart cherries, which make up the majority of processed tart cherries. Using this data, average annual handler receipts were about $6.9 million, which is also below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.

This final rule continues in effect the action that revised § 930.162 of the regulations regarding exemptions by changing the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. This rule also continues in effect the revision to the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. The authority for these actions is provided in § 930.59 of the order.

It is not anticipated that this action will impose additional costs on handlers or growers, regardless of size. Rather, this should help handlers receive better returns on their new market development and market expansion projects by providing additional time for the handlers to receive diversion credit for those activities. This should provide more opportunity for them to recoup the time and resources required to establish these projects.

In addition, changing the number of years that these projects are eligible for diversion credits may provide additional incentive for handlers to develop these programs and may facilitate additional sales, which could improve returns for growers and handlers. Further, the Board does not believe that this change significantly impacts the calculations for free and restricted percentages.

The change in composition of the subcommittee is administrative in nature and is not expected to result in any additional costs.

This rule is expected to benefit the industry. The effects of this rule are not expected to be disproportionately greater or less for small handlers or producers than for larger entities.

The Board discussed alternatives to these changes, including not changing the number of years that new market development and market expansion projects were eligible for diversion credit. The Board agreed that increasing the number of years that new market development and market expansion projects are eligible for diversion credit from one year to three years provides handlers with more incentive to utilize these programs while not impacting the calculations for free and restricted percentages.

Another alternative considered was maintaining the previous composition of the subcommittee responsible for reviewing exemption requests. However, the Board wanted to specify that the subcommittee be composed of members who are not affiliated with any handler. Therefore, for the reasons mentioned above, these alternatives were rejected.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule. Further, the public comment received concerning the proposal did not address the initial regulatory flexibility analysis.

In addition, the Board's meeting was widely publicized throughout the tart cherry industry, and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 25, 2015, meeting was a public meeting, and all entities, both large and small, were able to express views on this issue.

An interim rule concerning this action was published in the Federal Register on November 5, 2015, (80 FR 68424) and was effective November 6, 2015. Copies of the rule were sent via email to all Board members and tart cherry handlers. Finally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending January 4, 2016, was provided to allow interested persons to respond to the proposal.

One comment was received during the comment period in response to the interim rule. The commenter, a producer, supported part of the action but offered an alternative to the membership of the subcommittee.

The commenter supported the expansion of handler diversion credits for new market development and market expansion projects from one year to three years. The commenter agreed with the Board's finding that it will encourage growth in the industry.

Regarding the change to the membership of the approval subcommittee, the commenter suggested that membership should be further modified to include cherry growers that are not also handlers. However, the Board's intent in making the revision to the subcommittee requirements was, in part, to ensure impartiality. Consequently, the Board recommended that the subcommittee be composed of members who are not affiliated with any handler. Even growers who are not handlers themselves have a business relationship with the handlers to which they sell.

The additional points in the comment were not relevant to the interim rule. Accordingly, no changes will be made to the interim rule, based on the comment received. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule, without change.

To view the interim rule and the comment that was received, go to: http://www.regulations.gov/#!docketDetail;D=AMS-FV-15-0046.

This action also affirms information contained in the interim rule concerning Executive Orders 12866, 12988, 13175, and 13563; the Paperwork Reduction Act (44 U.S.C. Chapter 35); and the E-Gov Act (44 U.S.C. 101).

After consideration of all relevant material presented, it is found that finalizing the interim rule, without change, as published in the Federal Register (80 FR 68424, November 5, 2015) will tend to effectuate the declared policy of the Act.

SCBGP is authorized under the Specialty Crop Competitiveness Act of 2004 (7 U.S.C. 1621 note).

AMS published 7 CFR part 1290, as a Final rule, in the Federal Register on September 11, 2006 (71 FR 53307), to establish regulations for SCBGP. SCBGP is a noncompetitive grant program that makes funds available to eligible entities for projects to solely enhance the competitiveness of specialty crops. The rule established SCBGP eligibility and application requirements, review and approval processes, and grant administration procedures for SCBGP for the fiscal years 2006 to 2008.

The grant agreements that 7 CFR part 1290 affected have expired and the regulations are now obsolete. Therefore, the AMS is rescinding and removing the regulation implementing the SCBGP from 2006 to 2008 in its entirety.

Table of Contents I. Statutory Authority II. Current Rulemaking Process III. Proposed Definition IV. Evaluation of Portable ACs as a Covered Product Subject to Energy Conservation Standards A. Coverage Necessary or Appropriate To Carry Out Purposes of EPCA B. Average Household Energy Use V. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act of 1999 I. Review Under Executive Order 12630 J. Review Under the Treasury and General Government Appropriations Act of 2001 K. Review Under Executive Order 13211 L. Review Under the Information Quality Bulletin for Peer Review I. Statutory Authority

Title III of the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6291 et seq.), sets forth various provisions designed to improve energy efficiency. Part A of Title III of EPCA (42 U.S.C. 6291-6309) established the “Energy Conservation Program for Consumer Products Other Than Automobiles.” 1 EPCA authorizes the Secretary of Energy to classify additional types of consumer products not otherwise specified in Part A as covered products. For a type of consumer product to be classified as a covered product, the Secretary must determine that:

(1) Classifying the product as a covered product is necessary for the purposes of EPCA; and

(2) The average annual per-household energy use by products of such type is likely to exceed 100 kilowatt-hours (kWh) per year. (42 U.S.C. 6292(b)(1))

For the Secretary to prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) for covered products added pursuant to 42 U.S.C. 6292(b)(1), he must also determine that:

(1) The average household energy use of the products has exceeded 150 kWh per household for a 12-month period;

(2) The aggregate 12-month energy use of the products has exceeded 4.2 terawatt-hours (TWh);

(3) Substantial improvement in energy efficiency is technologically feasible; and

(4) Application of a labeling rule under 42 U.S.C. 6294 is unlikely to be sufficient to induce manufacturers to produce, and consumers and other persons to purchase, covered products of such type (or class) that achieve the maximum energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(l)(1))

Portable ACs are movable units typically designed to provide 8,000-14,000 British thermal units (Btu) per hour (hr) of cooling capacity 2 for a single room. In contrast to room ACs, a covered product that provides consumers with a similar function, portable ACs are not permanently installed on the wall or in a window. DOE has determined that portable ACs meet the statutory requirements under 42 U.S.C. 6292(b)(1), and therefore classifies portable ACs as a covered product. Separately, DOE is conducting rulemakings to consider test procedures and energy conservation standards for portable ACs. DOE will determine if portable ACs satisfy the provisions of 42 U.S.C. 6295(l)(1) during the course of the energy conservation standards rulemaking.

DOE has not previously conducted an energy conservation standards rulemaking for portable ACs. On July 5, 2013, DOE published in the Federal Register a notice of proposed determination of coverage (NOPD) in which it tentatively determined that portable ACs satisfy the provisions of 42 U.S.C. 6292(b)(1). 78 FR 40403. After considering public comments on the NOPD (see sections III and IV of this notice), DOE is issuing this final determination of coverage for portable ACs and is evaluating in separate rulemakings both test procedures and energy conservation standards for portable ACs.

With respect to the test procedure rulemaking, DOE initially published a notice of data availability (NODA) on May 9, 2014, in which it discussed various industry test procedures and presented results from its investigative testing. 79 FR 26639. In the NODA, DOE evaluated existing methodologies and alternate approaches adapted from these methodologies that could be incorporated in a future DOE test procedure for portable ACs.

After reviewing comments and information received on the NODA, DOE published a test procedure notice of proposed rulemaking (NOPR) on February 25, 2015, in which it proposed to establish test procedures for portable ACs that would measure the energy efficiency, energy use, and estimated annual operating cost of portable ACs during a representative average use period and that would not be unduly burdensome to conduct, as required under 42 U.S.C. 6293(b)(3)). 80 FR 10211. The proposed test procedures were based upon industry methods to determine energy consumption in active modes, standby modes, and off mode, with certain modifications to ensure the test procedures would be repeatable and representative. Based on comments from interested parties on the NOPR, DOE subsequently published a supplemental notice of proposed rulemaking (SNOPR) on November 27, 2015, in which it proposed revisions to the test procedure proposed in the NOPR to improve repeatability, reduce test burden, and ensure that the test procedure is representative of typical consumer usage. 80 FR 74020.

With respect to the energy conservation standards rulemaking, DOE published a notice of public meeting and notice of availability of a preliminary technical support document (TSD) for portable ACs on February 27, 2015. 80 FR 10628. The TSD describes the details of DOE's preliminary analysis. DOE held a public meeting to discuss and receive comments on the preliminary analysis it conducted. The meeting covered the analytical framework, models, and tools that DOE used to evaluate potential standards; the results of preliminary analyses performed by DOE for this product; the potential energy conservation standard levels derived from these analyses that DOE could consider for this product; and other issues relevant to the development of energy conservation standards for portable ACs.

After considering comments and information submitted on the preliminary analysis, DOE expects to complete a full analysis of both the burdens and benefits of potential energy conservation standards in a NOPR, pursuant to 42 U.S.C. 6295(o). Because DOE is classifying portable ACs as a covered product under 42 U.S.C. 6292(b)(1), DOE will also consider as part of any energy conservation standard NOPR whether portable ACs satisfy the requirements of 42 U.S.C. 6295(l)(1). After the publication of the standards NOPR, DOE will afford interested parties an opportunity during a period of not less than 60 days to provide oral and written comment. After receiving and considering the comments on the NOPR and not less than 90 days after the publication of the NOPR, DOE will issue the final rule prescribing any new energy conservation standards for portable ACs.

In the NOPD, DOE proposed the following definition of “portable air conditioner” to determine the potential scope of which products would potentially be regulated as a covered product. The proposed definition also provided clarity for interested parties with respect to the test procedure and energy conservation standards rulemakings as DOE continued its analyses. DOE initially proposed that a portable AC was:

DOE noted that this proposed definition would be mutually exclusive to the current definition for a room AC, which is “designed as a unit for mounting in a window or through the wall.” (10 CFR 430.2) Id.

In response to the NOPD, DOE received several comments from interested parties regarding the kinds of products that would be included under the proposed definition of a portable AC. DOE addressed these comments in the test procedure NOPR and proposed a revised definition to further refine the definition and exclude other similar products. Specifically, DOE proposed the definition:

DOE received multiple comments from interested parties in response to the proposed definition in the test procedure NOPR, focusing on the distinction between portable ACs intended for consumer versus commercial applications.

DENSO Products and Services Americas, Inc. (DENSO) noted that portable ACs are used in both residential and commercial settings, and that the typical distinction between the two settings is the use of single-phase versus three-phase power. However, DENSO expressed concern about the proposed definition because some portable ACs with single-phase power may be used in commercial or industrial applications. (DENSO, TP Public Meeting Transcript, No. 13 at pp. 21-22) 3

I. Background

FHFA is responsible for ensuring that the regulated entities operate in a safe and sound manner, including the maintenance of adequate capital and internal controls, that their operations and activities foster liquid, efficient, competitive, and resilient national housing finance markets, and that they carry out their public policy missions through authorized activities. See 12 U.S.C. 4513. These Orders are being issued under 12 U.S.C. 4516(a), which authorizes the Director of FHFA to require by Order that the regulated entities submit regular or special reports to FHFA and establishes remedies and procedures for failing to make reports required by Order. The Orders, through the accompanying Summary Instructions and Guidance, prescribe for the regulated entities the scenarios to be used for stress testing. The Summary Instructions and Guidance also provides to the regulated entities advice concerning the content and format of reports required by the Orders and the rule.

For the convenience of the affected parties and the public, the text of the Orders follows below in its entirety. You may access these Orders and the Summary Instructions and Guidance from FHFA's Web site at http://www.fhfa.gov/SupervisionRegulation/DoddFrankActStressTests. The Orders and Summary Instructions and Guidance also will be available for public inspection and copying at the Federal Housing Finance Agency, Eighth Floor, 400 Seventh St. SW., Washington, DC 20219. To make an appointment call (202) 649-3804.

The text of the Orders is as follows:

Whereas, section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) requires certain financial companies with total consolidated assets of more than $10 billion, and which are regulated by a primary Federal financial regulatory agency, to conduct annual stress tests to determine whether the companies have the capital necessary to absorb losses as a result of adverse economic conditions;

Whereas, FHFA's rule implementing section 165(i)(2) of the Dodd-Frank Act is codified as 12 CFR 1238 and requires that “[e]ach regulated entity must file a report in the manner and form established by FHFA.” 12 CFR 1238.5(b);

Whereas, The Board of Governors of the Federal Reserve System issued stress testing scenarios on January 28, 2016 and supplemented on February 4, 2016; and

Whereas, section 1314 of the Safety and Soundness Act, 12 U.S.C. 4514(a) authorizes the Director of FHFA to require regulated entities, by general or specific order, to submit such reports on their management, activities, and operation as the Director considers appropriate.

Now Therefore, it is hereby Ordered as follows:

Each regulated entity shall report to FHFA and to the Board of Governors of the Federal Reserve System the results of the stress testing as required by 12 CFR 1238, in the form and with the content described therein and in the Summary Instructions and Guidance, with Appendices 1 through 12 thereto, accompanying this Order and dated March 2, 2016.

It Is So Ordered, this the 2nd day of March, 2016.

This Order is effective immediately.

Signed at Washington, DC, this 2nd day of March, 2016.

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

Also, FDA is amending the regulations to reflect the approval of several minor supplemental applications that revised classes of food-producing animals in indications and in food safety warnings for decoquinate and robenidine in medicated feeds. A food safety precautionary statement has also been revised for use of monensin in medicated chicken feed.

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

Also, Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.

In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.

FDA has noticed that it failed to amend all necessary regulations to reflect the change of sponsorship of an oxytetracycline soluble powder (80 FR 13226, March 13, 2015). At this time, we are amending 21 CFR 529.1660 to include the drug labeler code for the new sponsor. This action is being taken to improve the accuracy of the regulations.

FDA has also noticed that in § 558.355 (21 CFR 558.355) use of bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination with monensin in broiler and replacement chicken feeds was codified in error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time, § 558.355 is amended by removing paragraphs (f)(1)(xxx) and (f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous technical amendment (79 FR 10963, February 27, 2014), is also being removed. We have also noticed that certain paragraphs describing approved conditions of use were removed in error from § 558.355 during codification of a supplemental application to NADA 138-456 that increased the dose range for monensin used in combination with bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554, February 26, 1992). At this time, § 558.355 is amended by adding paragraphs (f)(1)(xxiv)(a) and (b). These actions are being taken to improve the accuracy of the regulations.

FDA has noticed that in error we removed the approved conditions of use for gleptoferron, an injectable iron used to prevent anemia in young piglets. At this time, 21 CFR 522.1055 is being added. This action is being taken to improve the accuracy of the regulations.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 524, 529, 556, and 558 are amended as follows:

I. Background—Regulatory Authorities

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device under that section from rulemaking to an administrative order.

Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify an eligible device type. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).) FDA relies upon “valid scientific evidence” in the reclassification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order to reclassify a device under that section. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act and (3) consideration of comments to a public docket. FDA published a proposed order to reclassify EPPG and PSA devices in the Federal Register of September 15, 2014 (79 FR 54927) (the “proposed order”). On September 11, 2013, FDA held a meeting of a device classification panel described in section 513(b) to discuss reclassification of EPPG and PSA devices (the “2013 Panel”). FDA has also received and considered comments on the proposed order as discussed in section III. Therefore, FDA has satisfied the requirements for issuing a final order under section 513(e)(1) of the FD&C Act.

As noted in the proposed order, on March 9, 1979, the Agency published a proposed rule for the classification of EPPG devices into class III (44 FR 13284). FDA subsequently published a final rule classifying EPPG devices into class III under §  870.3600 (21 CFR 870.3600) after receiving no comments on the March 9, 1979, proposed rule (45 FR 7904, February 5, 1980). In 1987, FDA published a final rule to codify language clarifying that no effective date had been established for the requirement for premarket approval for EPPG devices (52 FR 17732, May 11, 1987). In 2009, FDA published an order (the “515(i) Order”) requiring manufacturers of remaining class III devices for which regulations requiring PMAs had not been issued, including EPPGs, to submit a summary of information concerning those devices by August 7, 2009 (74 FR 16214, April 9, 2009). On October 17, 2011, FDA published a proposed rule proposing the reclassification of EPPG devices from class III to class II (76 FR 64224), which the Agency subsequently withdrew on September 15, 2014 (79 FR 54927). FDA withdrew the proposed rule in response to the new process for reclassifications under section 513(e) of the FD&C Act, as amended by FDASIA, and new information, including new information discussed during the 2013 Panel meeting.

Single and dual chamber PSAs have historically been classified with EPPG devices. Single and dual chamber PSAs combine the functionality of a single or dual chamber EPPG, which is currently a class III device, and the functionality of a pacemaker electrode function tester, which is regulated as a class II device under § 870.3720 (21 CFR 870.3720). Single and dual chamber PSA devices have been found substantially equivalent to EPPG devices through the 510(k) process. TCPSA devices have not been determined to be substantially equivalent to a predicate device through the 510(k) process and, because TCPSAs were not on the market before May 28, 1976, TCPSAs have been reviewed through the PMA process as postamendments class III devices. This order creates a new classification regulation for single, dual, and triple chamber PSA devices, which combine the functionality of an EPPG and the functionality of a pacemaker electrode function tester.

As discussed in the proposed order, FDA considered the available information on these devices (EPPG and PSA devices) and concluded that reclassifying these devices to class II, subject to the identified special controls, would provide reasonable assurance of their safety and effectiveness. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss whether EPPG and PSA devices should be reclassified or remain in class III on September 11, 2013 (78 FR 49272). The reclassification of EPPG and PSA devices was supported by the 2013 Panel. The 2013 Panel recommended that EPPG devices (including single and dual chamber PSAs) be reclassified to class II with special controls when intended for cardiac rate control or prophylactic arrhythmia prevention. In addition, the 2013 Panel agreed that EPPG devices are life-supporting and, per § 860.93 (21 CFR 860.93), explained that its rationale for recommending that EPPG devices be reclassified to class II was based on the proposed special controls FDA presented, which the 2013 Panel believed were adequate (along with general controls) to mitigate the risks of the device.

The 2013 Panel also recommended that TCPSA devices be reclassified to class II with special controls when intended for use during the pulse generator implant procedure. The 2013 Panel acknowledged that TCPSA devices are life-supporting devices and provided the following rationale per § 860.93 for recommending that TCPSA devices be reclassified to class II: (1) These devices are used only during the implant procedure where backup monitoring is continuous, hazards can be recognized and treated immediately, and where there is a reasonable expectation that users are adequately trained; (2) these devices are not intended to provide the long-term hemodynamic benefit of biventricular pacing or cardiac resynchronization therapy; and (3) the recommended special controls will mitigate the health risks associated with the device. The 2013 Panel transcript and other meeting materials are available on FDA's Web site (Ref. 1). Since the 2013 Panel meeting, FDA has not become aware of new information that would provide a basis for a device classification panel to make a different recommendation or different findings.

In response to the September 15, 2014, proposed order to reclassify EPPG and PSA devices (79 FR 54927), FDA received two comments. FDA previously received three sets of comments on the October 17, 2011, proposed rule to reclassify EPPG devices that was subsequently withdrawn (79 FR 54927). The Agency has considered all of these comments in drafting this final order.

The comments and FDA's responses to the comments are summarized in this section. Certain comments are grouped together under a single number because the subject matter of the comments is similar. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted.

(Comment 1) Four comments suggested that EPPG devices are life-sustaining and should be subject to premarket approval to provide better assurance of safety and effectiveness; as such, the comments asserted that EPPG devices should remain in class III. Further, one comment indicated that the proposed special controls are not sufficient to mitigate the risks associated with EPPG devices. Three other comments also discussed the risks associated with these devices and the need for adequate mitigation through premarket approval.

(Response 1) These comments were considered by FDA in drafting this final order. Per 21 CFR 860.3(c)(3), a device is in class III if two conditions are met: (1) Insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in 21 CFR 860.3(c)(2) would provide such assurance, and (2) the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA has concluded that for EPPG devices, special controls will provide reasonable assurance of safety and effectiveness to appropriately mitigate risks to health. Therefore, these life-supporting devices can be reclassified into class II. As discussed in section II, the 2013 Panel agreed with FDA's recommendation of class II for EPPG and TCPSA devices.

EPPG devices are therapeutic devices designed to be used temporarily and in a controlled clinical setting. The expected presence of clinical support and physician monitoring mitigates many potential complications. Specifically, EPPG devices are used exclusively in hospital environments with the patients supervised by qualified medical personnel. The environment of care for EPPG devices includes resuscitation equipment, hospital level monitoring of heart rhythm, and patient vital status by other devices with alarm functions. The special controls require labeling for EPPG devices to “clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use.” Further, the non-clinical performance testing and labeling special controls appropriately mitigate the risks for EPPG devices by helping to ensure adequate device performance/pacing, as well as proper maintenance of the device.

(Comment 2) Three comments referenced the number of medical device reports (MDRs) associated with EPPG devices and suggested that MDR data support keeping EPPG devices in class III. Two of those comments also discussed the number of MDR reports for malfunctions associated with EPPG devices and suggested that this shows the performance standards that have been developed and used to support EPPG marketing applications are insufficient to provide reasonable assurance of safety and effectiveness.

(Response 2) Increased premarket regulatory requirements cannot be assumed to result in fewer MDRs, nor are MDRs necessarily an indicator of poor device performance. FDA performed multiple analyses of MDRs for EPPG devices in the Manufacturer and User Facility Device Experience (MAUDE) database. The Agency's analysis of the available data shows that over 85 percent of reports had either no patient involvement or no known consequences to the patient. These types of malfunction reports were generally discovered during routine servicing, which may be anticipated for reusable electrical devices. FDA's MDR analyses were conducted multiple times during the reclassification process and showed trends of increased reporting, but with an associated sharp decline in the relative number of death and injury reports over the last several years (i.e., the increased reporting was largely for device malfunctions). FDA believes these trends are indicative of tighter adherence to MDR requirements and a related change in reporting practices rather than a change in device performance. FDA's detailed review of MDRs for EPPG devices also did not suggest design or functional issues that would be decreased by requiring premarket approval for EPPG devices.

FDA also reviewed device recalls for EPPGs over the past 15 years and did not find evidence indicating the need for class III premarket approval regulation of these devices. FDA presented its analysis of MDR and recall data to the 2013 Panel that ultimately recommended reclassification of EPPG devices from class III to class II (special controls). The 2013 Panel identified no new or different risks for EPPG devices based on that information. Therefore, FDA believes that the identified special controls provide adequate mitigation of the health risks posed by the EPPG device.

(Comment 3) One comment suggested that EPPG devices remain in class III and require PMAs because FDA failed to identify new information on which to base the reclassification recommendation, specifically noting: (1) Performance standards developed in support of PMAs are not publicly available, and (2) FDA used information submitted in response to the 515(i) Order that was not publicly available in the Agency's analysis of risks to health for EPPG devices.

(Response 3) FDA's presentation to the 2013 Panel included a summary of the available safety and effectiveness information for EPPG devices, including FDA's analysis of adverse event reports from FDA's MAUDE database and available literature. The 2013 Panel agreed with FDA's conclusion that the available scientific evidence is adequate to support reasonable assurance of the safety and effectiveness of EPPG devices and to reclassify EPPG devices to class II. While the 2013 Panel agreed with the identified risks to health presented at the September 11, 2013, meeting, it recommended that FDA consider rewording some of the language for clarity and also to ensure that certain hazards, such as asynchronous pacing and arrhythmia induction, are included in the risks to health. FDA agreed with the 2013 Panel's recommendations and modified the risks to health accordingly as outlined in section V of the 2014 proposed order. The Agency identified in the proposed order special controls, including non-clinical performance testing data and labeling that, together with general controls (including prescription use), would provide reasonable assurance of the safety and effectiveness of EPPG devices. Since the 2013 Panel, FDA has not become aware of new information that would provide a basis for a different recommendation or finding for these devices.

Information submitted in response to the 2009 515(i) Order that FDA used in its reclassification determination was incorporated in what the Agency presented to the 2013 Panel (see Ref. 1). In addition, that information was listed in the September 15, 2014, proposed order and is publicly available through other sources. The information presented to the 2013 Panel and discussed in the 2014 proposed order also identified and provided information regarding the two recognized consensus standards that address various aspects of design and performance of EPPG devices (IEC 60601-1 and IEC 60601-2-31). The information provided by these consensus standards is particularly important as design control measures and aided in forming part of the basis for FDA's reclassification determination. Therefore, the information that forms the basis for FDA's reclassification determination has been made publicly available.

(Comment 4) One comment suggested that PSA devices remain in class III because the special controls rely heavily on labeling to mitigate risks, and expressed doubt that labeling would be sufficient to protect the health of patients.

(Response 4) It should be noted that labeling is not the only mitigation that is proposed to reasonably assure safety and effectiveness of PSAs. Further, neither FDA nor the 2013 Panel believed that clinical performance testing was necessary to provide reasonable assurance of safety or effectiveness. The environment of care for PSAs is limited to the surgical implant suite, which must have backup pacing, defibrillation and resuscitation equipment, and capabilities including intensive care level monitoring of heart rhythm and patient vital signs. Therefore, FDA believes that the non-clinical performance testing and labeling special controls, in addition to general controls, can be established to mitigate the identified risks and provide reasonable assurance of the safety and effectiveness of PSA devices when indicated for use during the implant procedure of pacemakers and defibrillators for the evaluation of the placement and integrity of pacing leads to determine the appropriate pacing parameters for the implanted device. Furthermore, the 2013 Panel agreed that the special controls would mitigate the health risks associated with the PSA devices.

Based on the information discussed in the preamble to the proposed order (79 FR 54927, September 15, 2014), the comments received, a review of the MAUDE database and recall data, a review of current scientific literature, and the 2013 Panel deliberations (see the 2013 Panel transcript (Ref. 1)), FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of EPPG and PSA devices. Under sections 513(e) and 513(f) of the FD&C Act, FDA is adopting its findings, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify EPPG devices from class III to class II (special controls), as well as to create a separate classification regulation for PSA devices and reclassify PSA devices into class II (special controls). As noted in the proposed order, FDA is also making a slight modification to the identification for EPPG devices in §  870.3600 to clarify that these are prescription devices.

Following the effective date of this final order, firms marketing an EPPG or PSA device must comply with the applicable mitigation measures set forth in the codified special controls. Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date of this final order, or models (if any) that have been marketed but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of EPPG and PSA devices for their intended uses, and therefore, these device types are not exempt from premarket notification requirements.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously promulgated regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, pursuant to section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in §  870.3600 related to the classification of EPPG devices as class III devices, and codifying the reclassification of EPPG and PSA devices into class II (special controls).

The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

I. Background

The FDA Food Safety Modernization Act (Pub. L. 111-353, 124 Stat. 3885), was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C) to add section 1012, 21 U.S.C. 399d, which provides protection to employees against retaliation by an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food for engaging in certain protected activities. Section 1012 protects employees against retaliation because they provided or are about to provide to their employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of, any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C; testified or are about to testify in a proceeding concerning such violation; assisted or participated, or are about to assist or participate, in such a proceeding; or objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee reasonably believed to be in violation of any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C.

Section 1012 became effective upon enactment on January 4, 2011. Although the Food and Drug Administration of the U.S. Department of Health and Human Services (FDA) generally administers the FD&C, the Secretary of Labor is responsible for enforcing the employee protection provision set forth in section 1012 of the FD&C. These rules establish procedures for the handling of whistleblower complaints under section 1012 of the FD&C. Throughout this rule, FSMA refers to section 402 of the FDA Food Safety Modernization Act, codified as section 1012 of the Federal Food, Drug and Cosmetic Act. See 21 U.S.C. 399d.

FSMA's whistleblower provisions include procedures that allow a covered employee to file, within 180 days of the alleged retaliation, a complaint with the Secretary of Labor (Secretary). Upon receipt of the complaint, the Secretary must provide written notice to the person or persons named in the complaint alleged to have violated the FSMA (respondent) of the filing of the complaint, the allegations contained in the complaint, the substance of the evidence supporting the complaint, and the rights afforded the respondent throughout the investigation. The Secretary must then, within 60 days of receipt of the complaint, afford the complainant and respondent an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation.

The statute provides that the Secretary may conduct an investigation only if the complainant has made a prima facie showing that the protected activity was a contributing factor in the adverse action alleged in the complaint and the respondent has not demonstrated, through clear and convincing evidence, that it would have taken the same adverse action in the absence of that activity (see section 1987.104 for a summary of the investigation process). OSHA interprets the prima facie case requirement as allowing the complainant to meet this burden through the complaint as supplemented by interviews of the complainant.

After investigating a complaint, the Secretary will issue written findings. If, as a result of the investigation, the Secretary finds there is reasonable cause to believe that retaliation has occurred, the Secretary must notify the respondent of those findings, along with a preliminary order that requires the respondent to, where appropriate: Take affirmative action to abate the violation; reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages to the complainant, as well as all costs and expenses (including attorney fees and expert witness fees) reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

The complainant and the respondent then have 30 days after the date of the Secretary's notification in which to file objections to the findings and/or preliminary order and request a hearing before an administrative law judge (ALJ) at the Department of Labor. The filing of objections under FSMA will stay any remedy in the preliminary order except for preliminary reinstatement. If a hearing before an ALJ is not requested within 30 days, the preliminary order becomes final and is not subject to judicial review.

If a hearing is held, the statute requires the hearing to be conducted “expeditiously.” The Secretary then has 120 days after the conclusion of any hearing in which to issue a final order, which may provide appropriate relief or deny the complaint. Until the Secretary's final order is issued, the Secretary, the complainant, and the respondent may enter into a settlement agreement that terminates the proceeding. Where the Secretary has determined that a violation has occurred, the Secretary, where appropriate, will assess against the respondent a sum equal to the total amount of all costs and expenses, including attorney and expert witness fees, reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the Secretary issued the order. The Secretary also may award a prevailing employer reasonable attorney fees, not exceeding $1,000, if the Secretary finds that the complaint is frivolous or has been brought in bad faith.

Within 60 days of the issuance of the final order, any person adversely affected or aggrieved by the Secretary's final order may file an appeal with the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit where the complainant resided on the date of the violation.

FSMA permits the employee to seek de novo review of the complaint by a United States district court in the event that the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination. The court will have jurisdiction over the action without regard to the amount in controversy, and the case will be tried before a jury at the request of either party.

FSMA also provides that nothing therein preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law. Finally, FSMA states that nothing therein shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement, and the rights and remedies in FSMA may not be waived by any agreement, policy, form, or condition of employment.

On February 13, 2014, OSHA published in the Federal Register an interim final rule (IFR) establishing rules governing the whistleblower provisions of 402 of the FDA Food Safety Modernization Act. 79 FR 8619. OSHA provided the public an opportunity to comment on the IFR by April 14, 2014.

In response, OSHA received comments that were responsive to the rule from two organizations. Comments were received from the Roll Law Group (Roll), on behalf of Paramount Farming Company LLC, Paramount Farms International LLC, Pom Wonderful LLC, and Paramount Citrus Holdings LLC, and; Kalijarvi, Chuzi, Newman & Fitch, P.C. (Kalijarvi). OSHA also received one comment that was not responsive to the rule.

OSHA has reviewed and considered the comments and now adopts this final rule with minor revisions. The following discussion addresses the comments and OSHA's responses. The provisions in the IFR are adopted and continued in this final rule, unless otherwise noted below. The regulatory provisions in this part have been written and organized to be consistent with other whistleblower regulations promulgated by OSHA to the extent possible within the bounds of the statutory language of FSMA. Responsibility for receiving and investigating complaints under FSMA has been delegated to the Assistant Secretary for Occupational Safety and Health (Assistant Secretary). Secretary of Labor's Order No. 1-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012). Hearings on determinations by the Assistant Secretary are conducted by the Office of Administrative Law Judges, and appeals from decisions by ALJs are decided by the ARB. Secretary of Labor's Order No. 2-2012 (Oct. 19, 2012), 77 FR 69378 (Nov. 16, 2012).

Roll commented that OSHA should “ensure that the rules not only protect employee rights and promote food safety, but uphold equality and fairly address the concerns of both parties involved in these types of matters.” OSHA agrees, and notes that its procedures are designed to ensure a fair process for both parties.

Kalijarvi commented that “Congress passed the FSMA to protect people from getting sick and dying. When Congress passes a law to accomplish a remedial purpose, that purpose should be central to decisions about interpretation and application of the law.” Kalijarvi elaborated that decisions under FSMA should be made with an eye towards furthering the statute's remedial purpose. In addition, Kalijarvi commented that OSHA's discussion of the reasonable belief doctrine serves as a helpful reminder that “a complainant's whistleblower activity will be protected when it is based on a reasonable belief that any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C, has been violated.” OSHA believes that, generally, support for the remedial nature of the FSMA is found in the statute itself.

This section describes the purpose of the regulations implementing FSMA and provides an overview of the procedures covered by these regulations. No comments were received on this section, and no changes were made to it.

This section includes general definitions from the FD&C, which are applicable to the whistleblower provisions of FSMA. The FD&C states that the term “person” includes an individual, partnership, corporation, and association. See 21 U.S.C. 321(e). The FD&C also defines the term “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” See 21 U.S.C. 321(f). No comments were received on this section, and no changes were made to it.

This section describes the activities that are protected under FSMA, and the conduct that is prohibited in response to any protected activities. Under FSMA, an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may not retaliate against an employee because the employee “provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter.” 21 U.S.C. 399d(a)(1). FSMA also protects employees who testify, assist or participate in proceedings concerning such violations. See 21 U.S.C. 399d(a)(2) and (3). Finally, FSMA prohibits retaliation because an employee “objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.” 21 U.S.C. 399d(a)(4). References to “this chapter” refer to the FD&C, which is chapter 9 of title 21. 21 U.S.C. 301 et seq. Although an entity must therefore be engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food in order to be covered by FSMA, a complainant's whistleblower activity will be protected when it is based on a reasonable belief that any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C, has been violated.

In order to have a “reasonable belief” under FSMA, a complainant must have both a subjective, good faith belief and an objectively reasonable belief that the complained-of conduct violated the FD&C or any order, rule, regulation, standard, or ban under the FD&C. See Sylvester v. Parexel Int'l LLC, ARB No. 07-123, 2011 WL 2165854, at * 11-12 (ARB May 25, 2011) (discussing the reasonable belief standard under analogous language in the Sarbanes-Oxley Act whistleblower provision for employees, 18 U.S.C. 1514A). The requirement that the complainant have a subjective, good faith belief is satisfied so long as the complainant actually believed that the conduct complained of violated the relevant law. See id. The objective “reasonableness” of a complainant's belief is typically determined “based on the knowledge available to a reasonable person in the same factual circumstances with the same training and experience as the aggrieved employee.” Id. at * 12 (internal quotation marks and citation omitted). However, the complainant need not show that the conduct complained of constituted an actual violation of law. Pursuant to this standard, an employee's whistleblower activity is protected where it is based on a reasonable, but mistaken, belief that a violation of the relevant law has occurred. Id. at * 13.

No comments were received on this section, and no changes were made to it.

This section explains the requirements for filing a retaliation complaint under FSMA. According to section 1012(b)(1) of the FD&C, a complaint must be filed within 180 days of when the alleged violation occurs. Under Delaware State College v. Ricks, 449 U.S. 250, 258 (1980), this is considered to be when the retaliatory decision has been both made and communicated to the complainant. In other words, the limitations period commences once the employee is aware or reasonably should be aware of the employer's decision to take an adverse action. See Equal Emp't Opportunity Comm'n v. United Parcel Serv., Inc., 249 F.3d 557, 561-62 (6th Cir. 2001). The time for filing a complaint may be tolled for reasons warranted by applicable case law. For example, OSHA may consider the time for filing a complaint to be tolled if a complainant mistakenly files a complaint with an agency other than OSHA within 180 days after an alleged adverse action.

Complaints filed under FSMA need not be in any particular form. They may be either oral or in writing. If the complainant is unable to file the complaint in English, OSHA will accept the complaint in any language. With the consent of the employee, complaints may be filed by any person on the employee's behalf.

OSHA notes that a complaint of retaliation filed with OSHA under FSMA is not a formal document and need not conform to the pleading standards for complaints filed in federal district court articulated in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009). See Sylvester, 2011 WL 2165854, at * 9-10 (holding whistleblower complaints filed with OSHA under analogous provisions in the Sarbanes-Oxley Act need not conform to federal court pleading standards). Rather, the complaint filed with OSHA under this section simply alerts OSHA to the existence of the alleged retaliation and the complainant's desire that OSHA investigate the complaint. Upon receipt of the complaint, OSHA is to determine whether the “complaint, supplemented as appropriate by interviews of the complainant” alleges “the existence of facts and evidence to make a prima facie showing.” 29 CFR 1987.104(e). As explained in section 1987.104(e), if the complaint, supplemented as appropriate, contains a prima facie allegation, and the respondent does not show clear and convincing evidence that it would have taken the same action in the absence of the alleged protected activity, OSHA conducts an investigation to determine whether there is reasonable cause to believe that retaliation has occurred. See 21 U.S.C. 399d(b)(2)(A), 29 CFR 1987.104(e).

No comments were received on this section, and no changes were made to it.

This section describes the procedures that apply to the investigation of complaints under FSMA. Paragraph (a) of this section outlines the procedures for notifying the parties and the FDA of the complaint and notifying the respondent of its rights under these regulations. Paragraph (b) describes the procedures for the respondent to submit its response to the complaint. Paragraph (c) describes OSHA's procedures for sharing a party's submissions during a whistleblower investigation with the other parties to the investigation. Paragraph (d) of this section discusses confidentiality of information provided during investigations.

Paragraph (e) of this section sets forth the applicable burdens of proof. FSMA requires that a complainant make an initial prima facie showing that protected activity was “a contributing factor” in the adverse action alleged in the complaint, i.e., that the protected activity, alone or in combination with other factors, affected in some way the outcome of the employer's decision. The complainant will be considered to have met the required burden if the complaint on its face, supplemented as appropriate through interviews of the complainant, alleges the existence of facts and either direct or circumstantial evidence to meet the required showing. The complainant's burden may be satisfied, for example, if he or she shows that the adverse action took place within a temporal proximity of the protected activity, or at the first opportunity available to the respondent, giving rise to the inference that it was a contributing factor in the adverse action. See, e.g., Porter v. Cal. Dep't of Corrs., 419 F.3d 885, 895 (9th Cir. 2005) (years between the protected activity and the retaliatory actions did not defeat a finding of a causal connection where the defendant did not have the opportunity to retaliate until he was given responsibility for making personnel decisions).

If the complainant does not make the required prima facie showing, the investigation must be discontinued and the complaint dismissed. See Trimmer v. U.S. Dep't of Labor, 174 F.3d 1098, 1101 (10th Cir. 1999) (noting that the burden-shifting framework of the Energy Reorganization Act of 1974 (ERA), which is the same framework now applicable to FSMA, serves a “gatekeeping function” that “stem[s] frivolous complaints”). Even in cases where the complainant successfully makes a prima facie showing, the investigation must be discontinued if the employer demonstrates, by clear and convincing evidence, that it would have taken the same adverse action in the absence of the protected activity. Thus, OSHA must dismiss a complaint under FSMA and not investigate further if either: (1) The complainant fails to meet the prima facie showing that protected activity was a contributing factor in the adverse action; or (2) the employer rebuts that showing by clear and convincing evidence that it would have taken the same adverse action absent the protected activity.

Assuming that an investigation proceeds beyond the gatekeeping phase, the statute requires OSHA to determine whether there is reasonable cause to believe that protected activity was a contributing factor in the alleged adverse action. A contributing factor is “any factor which, alone or in connection with other factors, tends to affect in any way the outcome of the decision.” Marano v. Dep't of Justice, 2 F.3d 1137, 1140 (Fed. Cir. 1993) (internal quotation marks, emphasis and citation omitted) (discussing the Whistleblower Protection Act, 5 U.S.C. 1221(e)(1)); see also Addis v. Dep't of Labor, 575 F.3d 688, 689-91 (7th Cir. 2009) (discussing Marano as applied to analogous whistleblower provision in the ERA); Clarke v. Navajo Express, Inc., ARB No. 09-114, 2011 WL 2614326, at * 3 (ARB June 29, 2011) (discussing burdens of proof under analogous whistleblower provision in the Surface Transportation Assistance Act (STAA)). For protected activity to be a contributing factor in the adverse action, “a complainant need not necessarily prove that the respondent's articulated reason was a pretext in order to prevail,” because a complainant alternatively can prevail by showing that the respondent's “ `reason, while true, is only one of the reasons for its conduct,' ” and that another reason was the complainant's protected activity. See Klopfenstein v. PCC Flow Techs. Holdings, Inc., ARB No. 04-149, 2006 WL 3246904, at * 13 (ARB May 31, 2006) (quoting Rachid v. Jack in the Box, Inc., 376 F.3d 305, 312 (5th Cir. 2004)) (discussing contributing factor test under the Sarbanes-Oxley whistleblower provision), aff'd sub nom. Klopfenstein v. Admin. Review Bd., U.S. Dep't of Labor, 402 F. App'x 936, 2010 WL 4746668 (5th Cir. 2010).

If OSHA finds reasonable cause to believe that the alleged protected activity was a contributing factor in the adverse action, OSHA may not order relief if the employer demonstrates by clear and convincing evidence that it would have taken the same action in the absence of the protected activity. See 21 U.S.C. 399d(b)(2)(C). The “clear and convincing evidence” standard is a higher burden of proof than a “preponderance of the evidence” standard. Clear and convincing evidence is evidence indicating that the thing to be proved is highly probable or reasonably certain. Clarke, 2011 WL 2614326, at * 3.

Paragraph (f) describes the procedures OSHA will follow prior to the issuance of findings and a preliminary order when OSHA has reasonable cause to believe that a violation has occurred.

Roll commented that this section of the IFR did not explicitly state that the respondent has the right to receive copies of the substantive evidence provided by the complainant, and Roll states that it is “essential that both parties receive equal access to all documents throughout the entire matter.” OSHA agrees that the input of both parties in the investigation is important to ensure that OSHA reaches the proper outcome during its investigation. In fact, OSHA's current policy is to request that each party provide the other parties with a copy of all submissions to OSHA that are pertinent to the whistleblower complaint. Where the parties do not provide each other such submissions, OSHA will ensure that each party is provided with such information after redacting the submissions as appropriate. OSHA has revised paragraph (c) to clarify these policies regarding information sharing during the course of an investigation. Further information regarding OSHA's nonpublic disclosure and information sharing policies also may be found in the Whistleblower Investigations Manual, available at, http://www.whistleblowers.gov/regulations_page.html.

Roll also commented that the IFR did not provide the complainant and the respondent equal opportunity to respond to the each other's submissions to OSHA. OSHA has revised paragraph (c) to clarify that OSHA will ensure that each party is provided with an opportunity to respond to the other party's submissions.

Apart from the changes to paragraph (c) described above, OSHA has reworded paragraphs (a) and (f) slightly to clarify the paragraphs without changing their meaning.

This section provides that, on the basis of information obtained in the investigation, the Assistant Secretary will issue, within 60 days of the filing of a complaint, written findings regarding whether or not there is reasonable cause to believe that the complaint has merit. If the findings are that there is reasonable cause to believe that the complaint has merit, the Assistant Secretary will order appropriate relief, including preliminary reinstatement, affirmative action to abate the violation, back pay with interest, and compensatory damages. The findings and, where appropriate, preliminary order, advise the parties of their right to file objections to the findings of the Assistant Secretary and to request a hearing. The findings and, where appropriate, preliminary order, also advise the respondent of the right to request an award of attorney fees not exceeding $1,000 from the ALJ, regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. If no objections are filed within 30 days of receipt of the findings, the findings and any preliminary order of the Assistant Secretary become the final decision and order of the Secretary. If objections are timely filed, any order of preliminary reinstatement will take effect, but the remaining provisions of the order will not take effect until administrative proceedings are completed.

As explained in the IFR, in ordering interest on back pay under FSMA, the Secretary has determined that interest due will be computed by compounding daily the Internal Revenue Service interest rate for the underpayment of taxes, which under 26 U.S.C. 6621 is generally the Federal short-term rate plus three percentage points. 79 FR 8623. The Secretary has long applied the interest rate in 26 U.S.C. 6621 to calculate interest on backpay in whistleblower cases. Doyle v. Hydro Nuclear Servs., ARB Nos. 99-041, 99-042, 00-012, 2000 WL 694384, at *14-15, 17 (ARB May 17, 2000); see also Cefalu v. Roadway Express, Inc., ARB No. 09-070, 2011 WL 1247212, at *2 (ARB Mar. 17, 2011); Pollock v. Cont'l Express, ARB Nos. 07-073, 08-051, 2010 WL 1776974, at *8 (ARB Apr. 10, 2010); Murray v. Air Ride, Inc., ARB No. 00-045, slip op. at 9 (ARB Dec. 29, 2000). Section 6621 provides the appropriate measure of compensation under FSMA and other DOL-administered whistleblower statutes because it ensures the complainant will be placed in the same position he or she would have been in if no unlawful retaliation occurred. See Ass't Sec'y v. Double R. Trucking, Inc., ARB No. 99-061, slip op. at 5 (ARB July 16, 1999) (interest awards pursuant to § 6621 are mandatory elements of complainant's make-whole remedy). Section 6621 provides a reasonably accurate prediction of market outcomes (which represents the loss of investment opportunity by the complainant and the employer's benefit from use of the withheld money) and thus provides the complainant with appropriate make-whole relief. See EEOC v. Erie Cnty., 751 F.2d 79, 82 (2d Cir. 1984) (“[s]ince the goal of a suit under the [Fair Labor Standards Act] and the Equal Pay Act is to make whole the victims of the unlawful underpayment of wages, and since [§ 6621] has been adopted as a good indicator of the value of the use of money, it was well within” the district court's discretion to calculate prejudgment interest under § 6621); New Horizons for the Retarded, 283 N.L.R.B. No. 181, 1987 WL 89652, at *2 (NLRB May 28, 1987) (observing that “the short-term Federal rate [used by § 6621] is based on average market yields on marketable Federal obligations and is influenced by private economic market forces”). Similarly, as explained in the IFR, daily compounding of the interest award ensures that complainants are made whole for unlawful retaliation in violation of FSMA. 79 FR 8623.

As explained in the IFR, in ordering back pay, OSHA will require the respondent to submit the appropriate documentation to the Social Security Administration (SSA) allocating the back pay to the appropriate calendar quarters. Requiring the reporting of back pay allocation to the SSA serves the remedial purposes of FSMA by ensuring that employees subjected to retaliation are truly made whole. See 79 FR 8623; see also Don Chavas, LLC d/b/a Tortillas Don Chavas, 361 NLRB No. 10, 2014 WL 3897178, at *4-5 (NLRB Aug. 8, 2014).

Finally, as noted in the IFR, in limited circumstances, in lieu of preliminary reinstatement, OSHA may order that the complainant receive the same pay and benefits that he or she received prior to termination, but not actually return to work. See 79 FR 8623. Such “economic reinstatement” is akin to an order for front pay and frequently is employed in cases arising under section 105(c) of the Federal Mine Safety and Health Act of 1977, which protects miners from retaliation. 30 U.S.C. 815(c); see, e.g., Sec'y of Labor ex rel. York v. BR&D Enters., Inc., 23 FMSHRC 697, 2001 WL 1806020, at *1 (ALJ June 26, 2001). Front pay has been recognized as a possible remedy in cases under the whistleblower statutes enforced by OSHA in limited circumstances where reinstatement would not be appropriate. See, e.g., Luder v. Cont'l Airlines, Inc., ARB No. 10-026, 2012 WL 376755, at *11 (ARB Jan. 31, 2012), aff'd, Cont'l Airlines, Inc. v. Admin. Rev. Bd., No. 15-60012, slip op. at 8, 2016 WL 97461, at *4 (5th Cir. Jan. 7, 2016) (unpublished) (under Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, “front-pay is available when reinstatement is not possible”); Moder v. Vill. of Jackson, ARB Nos. 01-095, 02-039, 2003 WL 21499864, at *10 (ARB June 30, 2003) (under environmental whistleblower statutes, “front pay may be an appropriate substitute when the parties prove the impossibility of a productive and amicable working relationship, or the company no longer has a position for which the complainant is qualified”).

Roll commented on the discussion in the IFR of “economic reinstatement” and front pay and suggested that OSHA should include specific guidelines pertaining to front pay awards. Roll noted that the IFR provided examples of situations where front pay might be appropriate, but the rules themselves do not explicitly state that front pay is an available remedy, which could be “misleading.” Further, Roll questioned whether OSHA has authority to order front pay as a remedy.

OSHA declines to adopt specific guidelines pertaining to front pay awards in these rules. As explained in the IFR, the appropriateness of “economic reinstatement” or front pay as an alternative to the default statutory remedy of reinstatement has long been recognized. OSHA believes that relevant case law more appropriately addresses the parameters for issuing an award of front pay in lieu of reinstatement. See, e.g., Luder, ARB No. 10-026, slip op. at *11. (holding that front pay must be awarded according to reasonable parameters such as the amount of the proposed award, the length of time the complainant expects to be out of work, and the applicable discount rate) (internal quotation marks and citations omitted), front pay award modified, Luder v. Cont'l Airlines, Inc., ARB No. 13-009, 2014 WL 6850012 (ARB Nov. 2014), aff'd, Cont'l Airlines, Inc. v. Admin. Review Bd., No. 15-60012, slip op. at 8, 2016 WL 97461, at *4 (5th Cir. Jan. 7, 2016) (unpublished).

Kalijarvi requested that the rule include a reference to Blackburn v. Martin, 982 F.2d 125 (4th Cir. 1992) to inform the public that emotional distress damages may be awarded without the testimony of expert witnesses. A number of ARB decisions have awarded such damages without the testimony of expert witnesses in appropriate circumstances. See e.g., Lockheed Martin Corp. v. Admin. Review Bd., 717 F.3d 1121, 1138 (10th Cir. 2013) (upholding an award of $75,000 for emotional pain and suffering without requiring the testimony of expert witnesses); Menendez v. Halliburton, Inc., ARB Nos 09-002, 09-003 2013 WL 1282255, at *11-12 (ARB Mar. 15, 2013) (upholding award of $30,000 for emotional distress and reputational harm without requiring expert testimony) aff'd sub nom. Halliburton, Inc. v. Admin. Review Bd., 771 F.3d 254 (5th Cir. 2014). OSHA believes that these cases adequately serve to notify the public that emotional distress damages may be awarded without the testimony of expert witnesses.

For these reasons, OSHA has made no changes to the text of this section.

To be effective, objections to the findings of the Assistant Secretary must be in writing and must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, within 30 days of receipt of the findings. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of the filing; if the objection is filed in person, by hand-delivery or other means, the objection is filed upon receipt. The filing of objections also is considered a request for a hearing before an ALJ. Although the parties are directed to serve a copy of their objections on the other parties of record, as well as the OSHA official who issued the findings and order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards, the failure to serve copies of the objections on the other parties of record does not affect the ALJ's jurisdiction to hear and decide the merits of the case. See Shirani v. Calvert Cliffs Nuclear Power Plant, Inc., ARB No. 04-101, 2005 WL 2865915, at *7 (ARB Oct. 31, 2005).

The timely filing of objections stays all provisions of the preliminary order, except for the portion requiring reinstatement. A respondent may file a motion to stay the Assistant Secretary's preliminary order of reinstatement with the Office of Administrative Law Judges. However, such a motion will be granted only based on exceptional circumstances. The Secretary believes that a stay of the Assistant Secretary's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief, i.e., irreparable injury, likelihood of success on the merits, a balancing of possible harms to the parties, and the public interest favors a stay. If no timely objection to the Assistant Secretary's findings and/or preliminary order is filed, then the Assistant Secretary's findings and/or preliminary order become the final decision of the Secretary not subject to judicial review.

No comments were received on this section, and no changes were made to it.

This section adopts the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges as set forth in 29 CFR part 18 subpart A. This section provides that the hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo, on the record. As noted in this section, formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.

No comments were received on this section, and no changes were made to it.

The Assistant Secretary, at his or her discretion, may participate as a party or amicus curiae at any time in the administrative proceedings under FSMA. For example, the Assistant Secretary may exercise his or her discretion to prosecute the case in the administrative proceeding before an ALJ; petition for review of a decision of an ALJ, including a decision based on a settlement agreement between the complainant and the respondent, regardless of whether the Assistant Secretary participated before the ALJ; or participate as amicus curiae before the ALJ or in the ARB proceeding. Although OSHA anticipates that ordinarily the Assistant Secretary will not participate, the Assistant Secretary may choose to do so in appropriate cases, such as cases involving important or novel legal issues, multiple employees, alleged violations that appear egregious, or where the interests of justice might require participation by the Assistant Secretary. The FDA, if interested in a proceeding, also may participate as amicus curiae at any time in the proceedings.

No comments were received on this section, though minor changes were made as needed to clarify the provision without changing its meaning.

This section sets forth the requirements for the content of the decision and order of the ALJ, and includes the standard for finding a violation under FSMA. Specifically, the complainant must demonstrate (i.e., prove by a preponderance of the evidence) that the protected activity was a “contributing factor” in the adverse action. See, e.g., Allen v. Admin. Review Bd., 514 F.3d 468, 475 n.1 (5th Cir. 2008) (“The term `demonstrates' [under identical burden-shifting scheme in the Sarbanes-Oxley whistleblower provision] means to prove by a preponderance of the evidence.”). If the employee demonstrates that the alleged protected activity was a contributing factor in the adverse action, the employer, to escape liability, must demonstrate by “clear and convincing evidence” that it would have taken the same action in the absence of the protected activity. See 21 U.S.C. 399d(b)(2)(C).

Paragraph (c) of this section further provides that OSHA's determination to dismiss the complaint without an investigation or without a complete investigation under section 1987.104 is not subject to review. Thus, section 1987.109(c) clarifies that OSHA's determinations on whether to proceed with an investigation under FSMA and whether to make particular investigative findings are discretionary decisions not subject to review by the ALJ. The ALJ hears cases de novo and, therefore, as a general matter, may not remand cases to OSHA to conduct an investigation or make further factual findings.

Paragraph (d) notes the remedies that the ALJ may order under FSMA and, as discussed under section 1987.105 above, provides that interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and that the respondent will be required to submit appropriate documentation to the SSA allocating any back pay award to the appropriate calendar quarters. Paragraph (e) requires that the ALJ's decision be served on all parties to the proceeding, OSHA, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. Paragraph (e) also provides that any ALJ decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the ARB. If no timely petition for review is filed with the ARB, the decision of the ALJ becomes the final decision of the Secretary and is not subject to judicial review.

No comments were received on this section, and no changes were made to it.

Upon the issuance of the ALJ's decision, the parties have 14 days within which to petition the ARB for review of that decision. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing of the petition; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt.

The appeal provisions in this part provide that an appeal to the ARB is not a matter of right but is accepted at the discretion of the ARB. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. The ARB has 30 days to decide whether to grant the petition for review. If the ARB does not grant the petition, the decision of the ALJ becomes the final decision of the Secretary. If a timely petition for review is filed with the ARB, any relief ordered by the ALJ, except for that portion ordering reinstatement, is inoperative while the matter is pending before the ARB. If the ARB accepts a petition for review, the ALJ's factual determinations will be reviewed under the substantial evidence standard.

Kalijarvi submitted several comments related to this section of the rule. Kalijarvi requested the removal of the portion of the rule stating that objections not raised in the petition for review to the ARB may be considered waived. Instead, Kalijarvi requested that the provision be altered to instruct parties to identify in their petitions for review the legal conclusions or orders to which they object so that the ARB may determine whether the review presents issues worthy of full briefing. OSHA declines to revise the rule as Kalijarvi has proposed. OSHA notes that the IFR used the phrase “may” be deemed waived, indicating that the parties are not necessarily barred from subsequently raising grounds in addition to those included in the initial petition. Further, OSHA's inclusion of this provision is not intended to limit the circumstances in which parties can add additional grounds for review as a case progresses before the ARB; rather, the rules include this provision to put the public on notice of the possible consequences of failing to specify the basis of an appeal to the ARB. OSHA recognizes that, while the ARB has held in some instances that an exception not specifically urged may be deemed waived, the ARB also has found that the rules provide for exceptions to this general rule.

Kalijarvi also requested that the deadline for filing a petition for review with the ARB be extended past 14 days, and for this section to allow explicitly for the parties to file a motion to extend the time for submitting a petition for review. Kalijarvi further requested that OSHA explain how the current text of the section furthers FSMA's remedial purpose. OSHA declines to extend the time limit to petition for review because the shorter review period is consistent with the practices and procedures followed in OSHA's other whistleblower programs. Furthermore, as Kalijarvi acknowledges in its comment, parties may file a motion for extension of time to appeal an ALJ's decision, and the ARB has discretion to grant such extensions. OSHA believes that mentioning a motion for an extension of time in these rules, where no other motions are mentioned, could lead the public to mistakenly conclude that the 14 day deadline may be waived as a matter of right, where such is not the case.

OSHA believes that this section furthers the remedial purpose of FSMA by informing the public of the option of requesting ARB review of ALJ decisions as well as the deadlines associated with such review.

This section also provides that, based on exceptional circumstances, the ARB may grant a motion to stay an ALJ's preliminary order of reinstatement under FSMA, which otherwise would be effective, while review is conducted by the ARB. The Secretary believes that a stay of an ALJ's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief, i.e., irreparable injury, likelihood of success on the merits, a balancing of possible harms to the parties, and the public interest favors a stay.

If the ARB concludes that the respondent has violated the law, it will order the respondent to take appropriate affirmative action to abate the violation, including reinstatement of the complainant to that person's former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of employment, and compensatory damages. At the request of the complainant, the ARB will assess against the respondent all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and the respondent will be required to submit appropriate documentation to the Social Security Administration (SSA) allocating any back pay award to the appropriate calendar quarters. If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney fee, not exceeding $1,000, to be paid by the complainant.

No changes were made to this section, and other than the comments discussed above, no additional comments were received on this section.

This section provides the procedures and time periods for withdrawal of complaints, the withdrawal of findings and/or preliminary orders by the Assistant Secretary, and the withdrawal of objections to findings and/or orders. It permits complainants to withdraw their complaints orally and provides that, in such circumstances, OSHA will confirm a complainant's desire to withdraw in writing. It also provides for approval of settlements at the investigative and adjudicative stages of the case.

Roll commented that this provision should state explicitly that settlements may be conducted in a confidential manner and outside of the administrative proceedings. Because the IFR did not plainly provide such assurances, Roll expressed concern that “the lack of confidentiality will work as a disincentive for both parties . . . [and] will ultimately lead to fewer out-of-court settlements. . . .” Roll further commented that this section should include guidelines regarding when the Secretary will approve or disapprove a settlement agreement, as well as an explanation regarding the settlement options that are available to the parties.

OSHA is not making any changes to the rule in response to this comment. This section implements FSMA's statutory provision that “[a]t any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.” 21 U.S.C. 399(b)(3)(A). However, OSHA notes that the Secretary has always recognized that parties may efficiently resolve cases in negotiations between themselves. The Secretary's policy is to approve privately negotiated settlements, provided that each settlement is reviewed by the Secretary to ensure that the terms are fair, adequate, reasonable, and consistent with the purpose and intent of the relevant whistleblower statute and the public interest. See, e.g. , Macktal v. Sec'y of Labor, 923 F.2d 1150, 1154 (5th Cir. 1991) (agreeing that the Secretary may “enter into” a settlement by approving a settlement negotiated and agreed to by the parties); see also OSHA's Whistleblower Investigations Manual, pp. 6-18 to 6-21 (Apr. 21, 2015) available at http://www.whistleblowers.gov/regulations_page.html. OSHA believes that paragraphs (d)(1) and (2) adequately explain that a settlement agreement reached between the parties will settle a pending whistleblower case so long as the agreement is reviewed and approved by OSHA, an ALJ, or the ARB. The resources listed above provide more detailed guidance on when OSHA, an ALJ or the ARB will approve or disprove a settlement agreement, and OSHA thus believes it unnecessary to add such additional details to the regulatory text.

As to Roll's confidentiality concerns, OSHA, an ALJ or the ARB will not approve an agreement that states or implies that any of these entities, or DOL more generally, is party to a confidentiality agreement. Moreover, as noted in paragraph (e) of this section, any settlement approved by OSHA, the ALJ, or the ARB will constitute the final order of the Secretary, and as such, an approved agreement is an official government record that is subject to applicable public disclosure rules. See, e.g. , Gonzalez v. J.C. Penny Corp., Inc., ARB No. 10-148, 2012 WL 4753923, at *6 (ARB Sept. 28, 2012) (describing the public interest supporting the Secretary's review of settlement agreements); McGuire v. B.P. Prods. N. Am., Inc., 2014-TSC-0001, slip op. at 6-11 (ALJ Jan. 17, 2014) (describing public disclosure interests relating to whistleblower settlements and some of the provisions that the Secretary may not approve in a whistleblower settlement). Thus, for example, while parties may negotiate the terms of a settlement agreement in confidence and may indicate to OSHA, an ALJ or the ARB that they believe a settlement contains information exempt from disclosure under the Freedom of Information Act (FOIA) and that they should receive pre-disclosure notification of a request for disclosure, the Secretary must make his own determination of whether the contents of a settlement may be withheld in response to a request from a member of the public. See, e.g. , Vannoy v. Celanese Corp., ARB No. 09-118, 2013 WL 5872048, at *2 (ARB Sept. 27, 2013) (describing the application of FOIA to a whistleblower settlement).

This section describes the statutory provisions for judicial review of decisions of the Secretary and requires, in cases where judicial review is sought, the ALJ or the ARB to submit the record of proceedings to the appropriate court pursuant to the rules of such court. No comments were received on this section, and no changes were made to it.

This section describes the Secretary's power under FSMA to obtain judicial enforcement of orders and the terms of settlement agreements. FSMA expressly authorizes district courts to enforce orders, including preliminary orders of reinstatement, issued by the Secretary. See 21 U.S.C. 399d(b)(6) (“Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order.”). Specifically, reinstatement orders issued at the close of OSHA's investigation are immediately enforceable in district court pursuant to 21 U.S.C. 399d(b)(6) and (7). FSMA provides that the Secretary shall order the person who has committed a violation to reinstate the complainant to his or her former position. See 21 U.S.C. 399d(b)(3)(B)(ii). FSMA also provides that the Secretary shall accompany any reasonable cause finding that a violation occurred with a preliminary order containing the relief prescribed by subsection (b)(3)(B), which includes reinstatement where appropriate, and that any preliminary order of reinstatement shall not be stayed upon the filing of objections. See 21 U.S.C. 399d(b)(2)(B) (“The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order.”). Thus, under FSMA, enforceable orders include preliminary orders that contain the relief of reinstatement prescribed by 21 U.S.C. 399d(b)(3)(B). This statutory interpretation is consistent with the Secretary's interpretation of similar language in the whistleblower provisions of the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, 49 U.S.C. 42121, and Section 806 of the Corporate and Criminal Fraud Accountability Act of 2002, Title VIII of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1514A. See Brief for the Intervenor/Plaintiff-Appellee Secretary of Labor, Solis v. Tenn. Commerce Bancorp, Inc., No. 10-5602 (6th Cir. 2010); Solis v. Tenn. Commerce Bancorp, Inc., 713 F. Supp. 2d 701 (M.D. Tenn. 2010); but see Bechtel v. Competitive Techs., Inc., 448 F.3d 469 (2d Cir. 2006); Welch v. Cardinal Bankshares Corp., 454 F. Supp. 2d 552 (W.D. Va. 2006) (decision vacated, appeal dismissed, No. 06-2295 (4th Cir. Feb. 20, 2008)). FSMA also permits the person on whose behalf the order was issued to obtain judicial enforcement of the order. See 21 U.S.C. 399d(b)(7).

No comments were received on this section. OSHA has revised this section slightly to more closely parallel the provisions of the statute regarding the proper venue for an enforcement action.

This section sets forth provisions that allow a complainant to bring an original de novo action in district court, alleging the same allegations contained in the complaint filed with OSHA, under certain circumstances. FSMA permits a complainant to file an action for de novo review in the appropriate district court if there has been no final decision of the Secretary within 210 days of the filing of the complaint, or within 90 days after receiving a written determination. “Written determination” refers to the Assistant Secretary's written findings issued at the close of OSHA's investigation under section 1987.105(a). See 21 U.S.C. 399d(b)(4). The Secretary's final decision is generally the decision of the ARB issued under section 1987.110. In other words, a complainant may file an action for de novo review in the appropriate district court in either of the following two circumstances: (1) A complainant may file a de novo action in district court within 90 days of receiving the Assistant Secretary's written findings issued under section 1987.105(a), or (2) a complainant may file a de novo action in district court if more than 210 days have passed since the filing of the complaint and the Secretary has not issued a final decision. The plain language of 21 U.S.C. 399d(b)(4), by distinguishing between actions that can be brought if the Secretary has not issued a “final decision” within 210 days and actions that can be brought within 90 days after a “written determination,” supports allowing de novo actions in district court under either of the circumstances described above.

However, the Secretary believes that FSMA does not permit complainants to initiate an action in federal court after the Secretary issues a final decision, even if the date of the final decision is more than 210 days after the filing of the complaint or within 90 days of the complainant's receipt of the Assistant Secretary's written findings. The purpose of the “kick-out” provision is to aid the complainant in receiving a prompt decision. That goal is not implicated in a situation where the complainant already has received a final decision from the Secretary. In addition, permitting the complainant to file a new case in district court in such circumstances conflicts with the parties' right to seek judicial review of the Secretary's final decision in the court of appeals. See 21 U.S.C. 399d(b)(5)(B) (providing that an order with respect to which review could have been obtained in the court of appeals shall not be subject to judicial review in any criminal or other civil proceeding).

Under FSMA, the Assistant Secretary's written findings become the final order of the Secretary, not subject to judicial review, if no objection is filed within 30 days. See 21 U.S.C. 399d(b)(2)(B). Thus, a complainant may need to file timely objections to the Assistant Secretary's findings, as provided for in § 1987.106, in order to preserve the right to file an action in district court.

This section also requires that, within seven days after filing a complaint in district court, a complainant must provide a file-stamped copy of the complaint to OSHA, the ALJ, or the ARB, depending on where the proceeding is pending. In all cases, a copy of the complaint also must be provided to the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. This provision is necessary to notify the agency that the complainant has opted to file a complaint in district court. This provision is not a substitute for the complainant's compliance with the requirements for service of process of the district court complaint contained in the Federal Rules of Civil Procedure and the local rules of the district court where the complaint is filed. This section also incorporates the statutory provisions which allow for a jury trial at the request of either party in a district court action, and which specify the remedies and burdens of proof in a district court action.

In response to the IFR preamble's statement that the purpose of the “kick-out” provision is to “aid the complainant in receiving a prompt decision,” Kalijarvi commented that the kick-out provision offers additional benefits to complainants, such as an opportunity to receive a jury determination of damages. Indeed, Paragraph (a) of this section provides that an action brought under this section is entitled to trial by jury. OSHA appreciates Kalijarvi's comment, but has left the text of the rule unchanged.

This section provides that in circumstances not contemplated by these rules or for good cause the ALJ or the ARB may, upon application and notice to the parties, waive any rule as justice or the administration of FSMA requires. No comments were received on this section, and no changes were made to it.

This rule contains a reporting provision (filing a retaliation complaint, Section 1987.103) which was previously reviewed and approved for use by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The assigned OMB control number is 1218-0236.

The notice and comment rulemaking procedures of section 553 of the Administrative Procedure Act (APA) do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This is a rule of agency procedure, practice, and interpretation within the meaning of that section, since it provides procedures for the Department's handling of retaliation complaints. Therefore, publication in the Federal Register of a notice of proposed rulemaking and request for comments are not required for these regulations. Although this rule is not subject to the notice and comment procedures of the APA, the Assistant Secretary sought and considered comments to enable the agency to improve the rules by taking into account the concerns of interested persons.

Furthermore, because this rule is procedural and interpretative rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule is effective 30 days after publication in the Federal Register is inapplicable. The Assistant Secretary also finds good cause to provide an immediate effective date for this rule. It is in the public interest that the rule be effective immediately so both parties may know what procedures are applicable to pending cases.

The Department has concluded that this rule is not a “significant regulatory action” within the meaning of section 3(f)(4) of Executive Order 12866, as reaffirmed by Executive Order 13563, because it is not likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866. Therefore, no regulatory impact analysis under Section 6(a)(3)(C) of Executive Order 12866 has been prepared.

For this reason, and because no notice of proposed rulemaking has been published, no statement is required under Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq. Finally, this rule does not have “federalism implications.” The rule does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government” and therefore is not subject to Executive Order 13132 (Federalism).

The notice and comment rulemaking procedures of Section 553 of the APA do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). Rules that are exempt from APA notice and comment requirements are also exempt from the Regulatory Flexibility Act (RFA). See SBA Office of Advocacy, A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act 9 (May 2012); also found at: http://www.sba.gov/sites/default/files/rfaguide_0512_0.pdf. This is a rule of agency procedure, practice, and interpretation within the meaning of that section; therefore, the rule is exempt from both the notice and comment rulemaking procedures of the APA and the requirements under the RFA.

This document was prepared under the direction and control of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health.

Accordingly, for the reasons set out in the preamble, 29 CFR part 1987 is revised to read 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 December 7, 2015, Powerboat P1-USA, LLC notified the Coast Guard that it will conduct a series of high speed boat races in the Atlantic Ocean, offshore from Daytona Beach, FL from April 22 through 24, 2016. In response, on February 4, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Special Local Regulation, Daytona Beach Grand Prix of the Seas; Daytona Beach, FL (81 FR 5967). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this boat race. During the comment period that ended March 7, 2016, we received 3 comments.

Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the Federal Register. The Coast Guard finds that good cause exists for making this rule effective starting April 22, 2016 because the public was notified of this event well in advance through a proposed rule to regulate waterway activities published on February 4, 2016 [81 FR 5967]. Designated representatives will be on scene to assist the public with compliance during the nine hours per day that the regulation will be enforced.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP Jacksonville determined that potential hazards associated with high speed boat races necessitate the establishment of a special local regulation. The purpose of this rulemaking is to ensure the safety of life on the navigable waters of the United States by prohibiting all vessels and persons not participating in the event from entering the regulated area.

As noted above, we received three comments on the NPRM published February 4, 2016. Two comments received were in support of the rule. The third comment received was opposed to the rule. The comment opposed to the rule disputed the following items: (1) The Coast Guard's position that this high speed boat race poses an extra hazard to the safety of life on the navigable waters surrounding the event, (2) the need to establish a special local regulation to mitigate the hazards associated with this event, (3) the need for Coast Guard presence to enforce the rule (due to monetary cost to taxpayers), and (4) the determination that this rule is not a “significant regulatory action.” In regard to significant regulatory action, the commenter stated that this rule “encroaches on rights of mariners to be in a public area.”

A marine event is defined as an organized event of limited duration on the navigable waters of the United States conducted according to a prearranged schedule which presents an extra or unusual hazard to the safety of human life that cannot be protected by existing navigation. Prior to taking any regulatory action and to considering the establishment of a special local regulation, the Coast Guard utilizes a risk-informed decision making process to determine if an event meets the definition of a marine event as outlined in 33 CFR 100.05 and is likely to introduce an extra or unusual hazard to the safety of human life. The primary risk factors for determining that this is a marine event included: (1) The expected involvement of an unusually large concentration of traffic on the water that may interfere with routine navigation and (2) the event includes an inherently hazardous competition where craft are expected to travel at high speeds. Once the Coast Guard made the marine event determination, we proposed a safety risk-mitigation tool. In this case, it is the establishment of a special local regulation. Based on an analysis of the factors addressed above, the commenter's position that this race is not a marine event justifying Coast Guard action is not supportable.

For the enforcement of this rule, the Coast Guard does not need to be on scene. As stated in the regulatory text at the end of this document, the COTP may utilize Federal, state, and local officers (designated representatives) for the enforcement of the regulated area.

A “significant regulation” under Executive Order 12866, is one that has an impact on the economy of more than $100 million or one that adversely affects in a material way the economy or a sector of the economy; creates a serious inconsistency or interferes with another agency; materially alters the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients; or raises a novel issue of law or policy. For the reasons stated in section V.A below, the Coast Guard determines that this rule is not a significant regulatory action. It is one of a category of regulations considered “routine and frequent” by the Office of Management and Budget.

This rule establishes a special local regulation for the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. The regulated area includes the waters of the Atlantic Ocean offshore from Daytona Beach, Florida and will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. Approximately 90 high-speed personal watercraft are anticipated to participate in the races. The regulated area would encompass an approximated offshore area that is 1,350 yards wide extending 600 yards south of the Daytona Beach pier to 1,900 yards north of the pier. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.

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.

The Coast Guard has determined that this temporary final rule is not a significant regulatory action for the following reasons: (1) The special local regulation would be enforced for a total of only 27 hours over the course of three days; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the COTP Jacksonville or a designated representative, they would be able to operate in the surrounding area during the enforcement period; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the COTP Jacksonville or a designated representative; and (4) the Coast Guard would provide advance notification of the special local regulation to the local maritime community via Broadcast Notice to Mariners or by on-scene designated representative.

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 received no comments from the Small Business Administration on this rulemaking. 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 regulated area 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.

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 a special local regulation that would prohibit persons and vessels from transiting through a 2,500 yard by 1,350 yard regulated area during a three day racing event lasting nine hours daily. It is categorically excluded from further review under paragraphs 34(h) and 35(a) 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 Coast Guard amends 33 CFR part 100 as follows:

The OC Tri-Running Sports, on behalf of the Maryland State Highway Administration, who owns the US 50 (Harry W. Kelly Memorial) Bridge has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.559, to facilitate the 2016 “Island 2 Island” Half Marathon.

Under this temporary deviation, the bridge will be closed to navigation from 8 a.m. to 10:30 a.m. on April 30, 2016. The closure has been requested to ensure the safety of the increased volumes of runners and spectators that will be participating in the “Island 2 Island” Half Marathon on April 30, 2016.

The bridge is a Double Bascule bridge and has a vertical clearance in the closed position of 13 feet above mean high water. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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