Federal Register Vol. 83, No.115,

This final rule is issued under the Rules of Practice governing MOMA (7 CFR part 900) and R&P (7 CFR part 1200) overseen by USDA's AMS to include a definition of the term “mail”. Currently, MOMA and R&P regulations generally use the term “mail” but do not define it. This action creates a definition of “mail” that clarifies that it includes not only transmittal of information through a postal or other delivery system, but also through electronic mail. Without this broader definition of mail, the business activities of the boards, councils, and committees that administer the programs under AMS oversight, as well as federal milk marketing order administrative activities, will be restricted to using the traditional system of physical transportation of letters and parcels.

USDA believes that an expansive definition of “mail” will create greater effectiveness and cost savings for MOMA and R&P programs. This aligns with the Secretary's goal for greater use of technology in the Department to deliver the most effective, efficient and customer-focused programs. For this reason, USDA is amending the regulations at 7 CFR part 900 and 7 CFR part 1200 to reflect “mail” as both electronic mail and postal (or otherwise delivered) mail. One of the first initiatives under this amendment is to allow for electronic voting as an option in required implementation and continuance referenda on R&P programs.

In addition, this rule will further modify authority citations for 7 CFR part 1200 to correct the current citations as some authority cites are not currently included.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

Section 11 of the Beef Promotion and Research Act of 1985 (7 U.S.C. 2910) provides that it shall not preempt or supersede any other program relating to beef promotion organized and operated under the laws of the United States or any State. Section 524 of the Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

Section 121 of the Dairy Production Stabilization Act of 1983 (7 U.S.C. 4512(a)) provides that nothing in this Act may be construed to preempt or supersede any other program relating to dairy product promotion organized and operated under the laws of the United States or any State.

Section 1212(c) of the Hass Avocado Promotion, Research and Information Act of 2000 (7 U.S.C. 7811) provides that nothing in this Act may be construed to preempt or supersede any program relating to Hass avocado promotion, research, industry information, and consumer information organized and operated under the laws of the United States or of a State.

Section 1930 of the Mushroom Promotion, Research, and Consumer Information Act of 1990 (7 U.S.C. 6109) provides that nothing in this Act may be construed to preempt or supersede any other program relating to mushroom promotion, research, consumer information or industry information organized and operated under the laws of the United States or any State.

Section 580 of the Popcorn Promotion, Research, and Consumer Information Act (7 U.S.C. 7489) provides that nothing in this Act preempts or supersedes any other program relating to popcorn promotion organized and operated under the laws of the United States or any State.

Section 1628 of the Pork Promotion, Research, and Consumer Information Act of 1985 (7 U.S.C. 4817) states that the statute is intended to occupy the field of promotion and consumer education involving pork and pork products and of obtaining funds thereof from pork producers. The regulation of such activity (other than a regulation or requirement relating to a matter of public health or the provision of State or local funds for such activity) that is in addition to or different from the Pork Act may not be imposed by a State.

Additionally, section 1974 of the Soybean Promotion, Research, and Consumer Information Act (7 U.S.C. 6309) provides, with certain exceptions, that nothing in the Soybean Act may be construed to preempt or supersede any other program relating to soybean promotion, research, consumer information, or industry information organized under the laws of the United States or any State.

According to the following authorizing acts, administrative proceedings must be exhausted before parties may file suit in court: Agricultural Marketing Agreement Act of 1937 (7 U.S.C. 601-674); Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7411-7425); Cotton Research and Promotion Act of 1966 (7 U.S.C. 2101-2118); Dairy Production Stabilization Act of 1983 (7 U.S.C. 4501-4514); Egg Research and Consumer Information Act of 1974 (7 U.S.C. 2701-2718); Fluid Milk Promotion Act of 1990 (7 U.S.C. 6401-6417); Hass Avocado Promotion, Research, and Information Act of 2000 (7 U.S.C. 7801-7813); Mushroom Promotion, Research, and Consumer Information Act of 1990 (7 U.S.C. 6101-6112); Popcorn Promotion, Research, and Consumer Information Act of 1996 (7 U.S.C. 7481-7491); Pork Promotion, Research, and Consumer Information Act of 1985 (7 U.S.C. 4801-4819); Potato Research and Promotion Act of 1971 (7 U.S.C. 2611-2627); Soybean Promotion, Research, and Consumer Information Act (7 U.S.C. 6301-6311); and Watermelon Research and Promotion Act (7 U.S.C. 4901-4916).

Under those acts, any person subject to an order may file a petition with the Secretary stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. The petitioner is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary will make a ruling on the petition. The acts provide that the district courts of the United States in any district in which the person is an inhabitant, or has his principal place of business, has the jurisdiction to review the Secretary's rule, provided a complaint is filed within 20 days from the date of the entry of the ruling. There are no administrative proceedings that must be exhausted prior to any judicial challenge under the provision of the Beef Promotion and Research Act of 1985 (7 U.S.C. 2901-2911).

This final rule establishes agency rules of practice and procedure. Under the Administrative Procedure Act (APA), prior notice and opportunity for comment are not required for the promulgation of agency rules of practice and procedure. 5 U.S.C. 553 (b)(3)(A). Only substantive rules require publication 30 days prior to their effective date. 5 U.S.C. 553 (d). Therefore, this final rule is effective upon publication in the Federal Register.

Under 5 U.S.C. 804, this rule is not subject to Congressional review under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. In addition, because prior notice and opportunity for comment are not required to be provided for this final rule, this rule is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Furthermore, we have determined that the addition of a definition for the term “mail” to 7 CFR parts 900 and 1200 will not impact the current information collection burden for approved OMB forms.

Accordingly, 7 CFR parts 900 and 1200 are amended as follows:

This final rule affecting the Peanut Promotion, Research, and Information Order (order) at 7 CFR part 1216 is authorized under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act)(7 U.S.C. 7411-7425).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

In addition, this final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order may file a written petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and request a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of USDA's final ruling.

This rule changes the assessment rate computation under the Peanut Promotion, Research, and Information Order. Part 1216 is administered by the Board with oversight by USDA. This rule changes the basis for assessment under the program from value to volume (per ton). Two rates of assessment are established instead of using the formula currently specified in this part. The assessment rates will be $3.55 per ton for Segregation 1 peanuts and $1.25 per ton for lower quality Segregation 2 and 3 peanuts. This action was unanimously recommended by the National Peanut Board (Board) and will help facilitate program operations by providing a more predictable revenue stream for the Board. This rule also updates the definition for fiscal year specified in the part to reflect current practices.

The Peanut Promotion, Research, and Information Order regulations took effect in 1999. Under the regulations, the Board administers a nationally-coordinated program of promotion, research, and information designed to strengthen the position of peanuts in the market place and to develop, maintain, and expand the demand for U.S. peanuts.

Section 1216.48(m) provides authority for the Board to recommend to the Secretary amendments to the regulations as the Board considers appropriate.

Section 1216.51 specifies that the funds necessary to pay for programs and other authorized costs shall be acquired by levying assessments upon producers in a manner prescribed by the Secretary. The assessments are collected by first handlers from producers and remitted to the Board no later than 60 days after the last day of the month in which the peanuts were marketed. Paragraph (c) of that section currently states that assessments shall be levied based on value at a rate of one percent of the price paid for all farmers stock peanuts sold. As defined in § 1216.9, “farmers stock peanuts” means picked or threshed peanuts produced in the United States which have not been changed (except for removal of foreign material, loose shelled kernels and excess moisture) from the condition in which picked or threshed peanuts are customarily marketed by producers, plus any loose shelled kernels that are removed before farmers stock peanuts are marketed.

For producers who place their peanuts in a USDA loan program,1 assessments are levied at a rate of one percent of the loan value. The loan value is equivalent to the national loan rate for peanuts established by Congress and currently averages $355 per ton.2 The loan rate will vary depending upon the quality of the peanuts (e.g., Segregation 1, 2, and 3). For peanuts placed under loan, USDA deducts from the loan paid to the producer one percent of the loan value and remits this to the Board. This computes to an average assessment rate of $3.55 per ton.

Over the three year period (2014-2016), about $8.6 million in assessments has been collected under the program annually. Assessments collections totaled $7,284,050 3 in 2014, $8,811,444 4 in 2015, and $9,670,889 5 in 2016.

In recent years, the Board has discussed the merits of modifying the formula for calculating assessments in order to receive a more predictable revenue stream for the program. A reduction in value (producer price or the loan rate) could reduce Board revenue to the point where the Board would have to drastically curtail its promotional and research activities. Producer prices declined 24 percent from 2013-2016 while production increased. According to USDA's National Agricultural Statistics Service (NASS), the producer price was $0.249 per pound (or $498 per ton) in 2013 6 and $0.189 (or $378 per ton) in 2016.7 Production in 2013 was 4.174 billion pounds 8 and 5.685 billion pounds in 2016.9 For 2017, production is estimated at 7.429 billion pounds, up 31 percent from 2016.10

The Board met on April 4, 2017, and unanimously recommended changing the basis for assessment under the order from value to volume (per ton). Two rates of assessments will be established for farmers stock peanuts, depending upon their quality as defined in the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States (Standards) codified in 7 CFR part 996.11 Under the authority of section 517(d) of the 1996 Act, a board may recommend to the Secretary one or more rates of assessment under an order. The Board specifically recommended to set the assessment rates at $3.55 per ton for Segregation 1 peanuts and $1.25 per ton for lower quality Segregation 2 and 3 peanuts.

Pursuant to § 996.13(b) of the Standards, “Segregation l peanuts” means farmers stock peanuts with not more than 3.49 percent damaged kernels nor more than l.00 percent concealed damage caused by rancidity, mold, or decay and which are free from visible Aspergillus flavus. Pursuant to § 996.13(c), “Segregation 2 peanuts” means farmers stock peanuts with more than 3.49 percent damaged kernels or more than l.00 percent concealed damage caused by rancidity, mold, or decay and which are free from visible Aspergillus flavus. Pursuant to § 996.13(d), “Segregation 3 peanuts” means farmers stock peanuts with visible Aspergillus flavus.

This action will help facilitate program operations by providing a more predictable revenue stream for the Board to carry out its mission. Section 1216.51 is revised accordingly.

This rule references §§ 996.13(b), 996.13(c) and 996.13(d) of the Standards which define the terms Segregation 1 peanuts, Segregation 2 peanuts, and Segregation 3 peanuts, respectively.

Further, this rule revises § 1216.11 regarding the term `fiscal year' from the 12-month period beginning August 1 of any year and ending July 31 of the following year to the 12-month period beginning November 1 of any year and ending October 31 of the following year to reflect current industry practices. That section also defines the term crop year to mean the same as fiscal year. The term crop year is not referenced elsewhere in part 1216 and is thus not necessary. This rule removes that term from § 1216.11. Section 1216.11 is revised accordingly.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of the final rule on small entities. Accordingly, AMS has considered the economic impact of this action on such entities.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The Small Business Administration (SBA) defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (handlers) as those having annual receipts of no more than $7.5 million.

According to the Board, there are approximately 7,600 producers and 33 handlers of peanuts who are required to pay assessments under the program.

Most producers would be classified as small businesses under the criteria established by the SBA. USDA's NASS reports that the farm value of the peanuts produced in the top 11 States in 2016 was $1.077 billion.12 Dividing the 2016 crop value by 7,600 producers yields an average peanut sales per producer estimate of approximately $142,000. This is well below the threshold level of $750,000 in annual sales, indicating that most peanut producers would be classified by the SBA as small businesses.

Dividing the 2016 crop value by 33 handlers yields an average peanut crop value per handler of about $33 million. This is many times larger than the $7.5 million SBA threshold and is thus an indication that most of the handlers would not be classified as small businesses.

U.S. peanut production from the 11 major peanut-producing States in 2016 was 5.685 billion pounds.13 Georgia was the largest producer (49 percent of U.S. production), followed by Alabama (11 percent), Texas (10 percent), Florida (10 percent), South Carolina (6 percent), North Carolina (6 percent), Mississippi (3 percent), Arkansas (2 percent), Virginia (1 percent), Oklahoma (1 percent) and New Mexico (less than 1 percent). According to the 2012 Census of Agriculture,14 small amounts of peanuts were also grown in seven other States.

If the number of peanut producers (7,600) is divided into total 2016 U.S. production (5.685 billion pounds), the resulting average peanut production per producer is approximately 748,000 pounds.

This rule revises § 1216.51 to change the basis for assessment from value to volume (per ton). The program is administered by the Board with oversight by USDA. Two rates of assessment will be established instead of using a formula currently specified in the regulations. The assessment rates will be $3.55 per ton for Segregation 1 peanuts and $1.25 per ton for lower quality Segregation 2 and 3 peanuts. This action was unanimously recommended by the Board and will help facilitate program operations by providing a more predictable revenue stream for the Board based only on volume for assessment. Authority for this action is provided in § 1216.48(m) and section 517 of the 1996 Act. This rule also updates the definition for fiscal year specified in § 1216.11 to reflect current practices. That section provides authority for the Board, with approval of the Secretary, to change the fiscal year.

Regarding the economic impact of this rule on affected entities, this action changes the basis of assessment from value to volume (per ton). The rates of assessment recommended by the Board are comparable to the rates that have been in effect since the inception of the program.15 While assessments impose additional costs on producers, the costs are minimal and uniform on all. The costs would also be offset by the benefits derived from the operation of the program. (The update to § 1216.11 regarding the fiscal year is administrative in nature.)

Regarding the impact of the peanut program on the industry, the program has been successful in helping to build demand and improve producer returns. A 2014 economic study shows that the program helped to increase demand by 15 percent from 2007-2013, and that each dollar invested in Board activities over the period returned $8.87 to the producer.16

With regard to alternatives, the Board has been considering revising the assessment rate computation for a number of years. The Board considered revising the assessment rate to equal a weighted average of the value of Segregation 1, 2, and 3 peanuts as reported by the NASS for the prior year. However, this would still link the assessment rate to value. Another option would be to maintain the status quo. After review and deliberation, the Board unanimously recommended revising the basis for assessment under the program from value to volume as described herein.

To calculate the percentage of producer revenue represented by the assessment rate, the proposed assessment rates are divided by the average producer price. The proposed assessment rates are $3.55 per ton ($0.001775 per pound) for Segregation 1 peanuts and $1.25 per ton ($0.000625 per pound) for Segregation 2 and 3 peanuts. According to NASS, the average producer price ranged from $0.193 per pound in 2015 to $0.189 per pound in 2016.17 Thus, the proposed assessment rates as a percentage of producer price could range from 0.92 to 0.94 percent for Segregation 1 peanuts and from 0.32 to 0.33 percent for Segregation 2 and 3 peanuts.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are imposed by the program have been approved previously under OMB control number 0581-0093. This final rule will not result in a change to the information collection and recordkeeping requirements previously approved and will impose no additional reporting and recordkeeping burden on peanut producers or first handlers.

As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

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

In regard to outreach efforts, Board members have been conducting outreach to educate industry members about the need for changing the basis of assessment since January 2016. The issue has been discussed at Board meetings over the past few years. The Board has also conducted outreach to the major peanut associations and has received positive feedback. All of the Board's meetings are open to the public and interested persons are invited to participate and express their views.

A proposed rule concerning this action was published in the Federal Register on March 30, 2018 (83 FR 13700). The Board sent the proposed rule directly to the peanut producer associations, Board members, and assessment payers. In addition, the Board disseminated the proposed rule via the internet by providing the links to the proposal in its industry newsletter and website. The proposal was also made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending April 30, 2018, was provided to allow interested persons to submit comments.

Thirteen comments were received in response to the proposed rule. Of those 13 comments, 12 comments were in favor of the proposed flat computation of the two assessment rates (one favorable comment was a duplicate and only counted once), and one comment was outside the scope of the review.

Ten commenters stated the change in the assessment computation would allow for a more consistent revenue stream for the Board to carry out its mission. Of these commenters, one commenter stated the computation change is not an increase or decrease in producer assessments. It stated that this change is a proactive business move to create an assessment rate which will not fluctuate downward rapidly. The proposed computation will allow the Board to plan long term without a disruption to its income flow. Another commenter in favor of the proposed change stated that it will be less confusing and easier for USDA to administer the assessment rate.

After consideration of all relevant matters presented, including the information and recommendation submitted by the Board and other available information, it is hereby found that this rule, as hereinafter set forth, is consistent with and will effectuate the purposes of the 1996 Act.

For the reasons set forth in the preamble, 7 CFR part 1216 is amended as follows:

This rule amends Title 14 of the Code of Federal Regulations, part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

The BLBA, 30 U.S.C. 901-944, provides for the payment of benefits to coal miners and certain of their dependent survivors on account of total disability or death due to coal workers' pneumoconiosis. 30 U.S.C. 901(a); Usery v. Turner Elkhorn Min. Co., 428 U.S. 1, 5 (1976). A miner who is entitled to disability benefits under the BLBA is also entitled to medical benefits. 33 U.S.C. 907, as incorporated by 30 U.S.C. 932(a); 20 CFR 725.701. Those medical benefits entitle a miner to medical, surgical, and other treatment—including hospital services, medicine, equipment, and supplies—for his or her pneumoconiosis and related disability. 20 CFR 725.701(b). The rules governing the payment of medical benefits are contained in 20 CFR part 725, subpart J.

Benefits are paid by either a “responsible” coal mine operator (or its insurance carrier), or the Trust Fund. Director, OWCP v. Bivens, 757 F.2d 781, 783 (6th Cir. 1985); see 20 CFR 725.495 (criteria for determining a responsible operator). OWCP pays medical benefits from the Trust Fund in three instances: (1) If no responsible operator can be identified as the party liable for a claim, and the Trust Fund is liable as a result (see 20 CFR 725.701(b)); (2) when the identified responsible operator declines to pay benefits pending final adjudication of a claim (see 20 CFR 725.522, 725.708(b)); and (3) when the responsible operator fails to meet its payment obligations on an effective award (see 20 CFR 725.502). For interim payments made pending final adjudication, OWCP seeks reimbursement from the operator after the claim is finally awarded. 20 CFR 725.602(a). Likewise, OWCP seeks reimbursement for payments made when an operator fails to meet its obligations on an effective award. 20 CFR 725.601.

Although the current regulations provide that medical services and supplies be paid at the rate prevailing in the community where the physician, medical facility or supplier is located, they do not address how the prevailing community rate should be determined. See 20 CFR 725.706(c). OWCP currently bases Trust Fund payments for professional medical services, medical equipment, and inpatient and outpatient medical services and treatments on internally-derived payment formulas. For prescription medications, OWCP uses a payment formula similar to that employed by the three other workers' compensation programs that it administers.

On January 4, 2017, the Department issued a Notice of Proposed Rulemaking (NPRM), proposing a revised Subpart J. 82 FR 739-770 (Jan. 4, 2017). Specifically, the Department proposed to base Trust Fund payments for all medical services and treatments rendered on or after the effective date of the rule on payment formulas derived from those used by CMS under the Medicare program. Id. at 740. The proposed payment formulas were similar to those used by other OWCP programs, but were tailored to the specific geography, medical conditions, and needs of black lung program stakeholders. See id. at 767 (proposed § 725.707).

The Department chose these payment formulas for several reasons. The proposed formulas more accurately reflected prevailing community rates for authorized treatments and services than did OWCP's internally-derived formulas. Id. at 740. In addition, because responsible operators and their insurance carriers utilize payment formulas or fee schedules that are substantially similar to the proposed payment formulas, use of such formulas would more likely lead operators to reimburse fully the Trust Fund for the payments the Trust Fund makes on an interim basis. Id. Thus, the proposed rule would control the health care costs associated with the BLBA, conserve the Trust Fund's limited resources, and provide greater clarity and certainty with respect both to fees paid to providers and reimbursements sought from operators and carriers. The rule would also ensure more consistent payment policies across all of the programs administered by OWCP. Id.

The public comment period closed on March 6, 2017. The Department has fully evaluated these comments and has determined that proceeding with a final rule is in the best interests of the stakeholders and the program's administration.

Section 426(a) of the BLBA, 30 U.S.C. 936(a), authorizes the Secretary of Labor to prescribe rules and regulations necessary for the administration and enforcement of the BLBA. The Secretary is also explicitly empowered to promulgate regulations addressing medical fees and charges, including determining the prevailing community rate. 33 U.S.C. 907(g), as incorporated by 30 U.S.C. 932(a).

The Department received eleven comments on the proposed regulations. Most of these comments focus on a few substantive issues. Some commenters generally supported OWCP's efforts to modernize the medical payment formulas and no commenters expressed overall objections to the promulgation of these rules. Several commenters applauded the technical changes made to several rules to simplify and clarify the language, such as replacing the term “Office” with “OWCP.” No negative comments were received on the following revised or new regulations: §§ 725.308, 725.701, 725.702, 725.703, 725.704, 725.706, 725.708, 725.711, 725.712, and 725.714-725.720. Thus, the Department is promulgating these regulations as proposed. The Department received one negative comment on the substantive provisions of § 725.705 (titled “Is prior authorization for medical services required?”), but the Department proposed only technical changes to this rule and did not open it for substantive comment. Thus, the Department is promulgating § 725.705 as proposed.

In addition to comments received on specific sections of the proposed rules (discussed below in the Section-by-Section Explanation), a few commenters offered more general comments. One suggested that the medical bill payment rules should contain provisions allowing the Director to sue operators who fail to properly reimburse the Trust Fund for medical benefit payments made on their behalf. The BLBA incorporates various provisions of the and Harbor Workers' Compensation Act, 33 U.S.C. 918(a), 921(d), as incorporated by 30 U.S.C. 932(a), that already provide the Department with authority to undertake such suits. See generally 20 CFR 725.601-725.605 (regulations implementing enforcement of liability against operators). The implementing regulations clarify that these enforcement tools may be used when an operator fails to reimburse the Trust Fund for medical benefits. 20 CFR 725.602(a). Thus, the Department does not believe that any additional authority is necessary.

Another commenter requested that the Department specify when OWCP will exercise its discretion to modify or change payment formulas or parts thereof as provided in several proposed regulations. See proposed §§ 725.707, 725.708, 725.709, 725. 710, 725.711. The vast majority of payments for medical services and treatments will be determined under the payment formulas set out in these regulations. The provisions giving OWCP discretion to modify or change payment formulas are intended to allow OWCP to respond quickly to unique or novel medical, technological, or financial circumstances that arise in implementing the payment formulas both initially and over time. The Department cannot predict when that might occur, and thus cannot specify when OWCP would take such discretionary actions.

Finally, the Department has determined that a two-phase implementation of this rule will be more efficient and cost-effective, allow sufficient time to update and improve its computer processes, and result in less disruption, than implementing the entire rule at once. Except for §§ 725.708(a) and (b) and 725.710, all provisions of this rule (including the payment formulas for medical equipment, prescription drugs and inpatient medical services) will apply to services and treatments rendered after the effective date of the rule, August 31, 2018. The Department can apply these regulations immediately because they either codify existing practices or require easily implemented modifications to current payment processes. The provisions of §§ 725.708(a) and (b) and 725.710 (governing the payment of professional medical services and outpatient medical services) will apply to services and treatments rendered after November 30, 2019. Both regulations would require extensive modifications to the existing computer processes for full implementation. The Department is currently transitioning to a new computer system and will realize cost-savings by building the new payment methodologies into that system rather than modifying the existing one. The Department has revised three provisions (§§ 725.707, 725.708 and 725.710) to reflect the two-phase implementation. The changes to each provision are discussed in the Section-by-Section Explanation.

(a) Section 725.707 is a new provision that sets out general rules governing the payment of compensable medical bills by the Trust Fund. It provides that the Trust Fund will pay no more than the prevailing community rate for medical services, treatments, drugs or equipment, and that the prevailing community rate for various types of treatments and services will generally be determined under the provisions of §§ 725.708-725.711. Where the provisions of §§ 725.708-725.711 cannot be used to determine the prevailing community rate, the rule permits OWCP to determine the prevailing community rate based on other payment formulas or evidence. This section also requires OWCP to review the payment formulas in §§ 725.708-725.711 annually, and permits OWCP to adjust, revise or replace any formula (or its components) when needed.

(b) Four commenters express concern that the proposed payment formulas may have a negative impact on miners' access to care. This concern stems from the fact that reduced payments will result in some circumstances under the proposed rules. One commenter believes that rural Appalachia would feel the greatest impact.

The Department agrees that maintaining miners' access to care is of paramount importance in implementing the payment formulas for various services and treatments. In fact, OWCP made access to care a primary consideration during the development of the proposed rules. Although the text of proposed § 725.707 does not directly address impact on access to care, the NPRM's preamble makes repeated reference to this concern and expresses OWCP's intent to continually review the payment formulas to ensure that they do not adversely impact access to care. In particular, the rule requires OWCP to review the payment formulas at least annually and revise them if needed, § 725.707(e), and the preamble to this provision makes clear that it is intended to allow OWCP to quickly make changes to the formulas if they “are adversely impacting miners' access to care, or are otherwise not appropriate.” 82 FR 742; see also id. at 740, 746, 748, 749, 752. These changes could include adjustments for particular geographic areas.

Nonetheless, the commenters' general concern is important and the Department agrees that maintaining access to care should be codified in the regulation. Thus, the Department has revised § 725.707(e) in the final rule to specifically require that OWCP consider and ensure miners' access to care in its annual review of the payment formulas in §§ 725.708-.725.711. The Department believes that this clarification of its intent will prevent miners' access to care from being negatively affected by the new payment formulas.

(c) Finally, the Department has revised § 725.707(f) to reflect the phased implementation of this rule. This paragraph now provides that the provisions of the rule apply to all medical services or treatments rendered after the effective date of the rule (August 31, 2018), except as otherwise noted in the rule. A different application date for the payment formulas for professional medical services and outpatient medical services is now provided in §§ 725.708 and 725.710. These regulations apply to services and treatments rendered after November 30, 2019.

Section 725.708 is a new provision governing payment for professional medical services and medical equipment. No comments were received on this provision. The Department, however, has revised the provision to reflect the phased implementation of this rule. The Department has added a new paragraph (c), which states that the provisions of paragraphs (a) and (b) apply to professional medical services rendered after November 30, 2019. This later applicability date does not apply to payments for medical equipment, which are instead governed by the general applicability date in § 725.707(f). The Department has also renumbered paragraph (c) of the proposed rule (dealing with payment for medical equipment) as paragraph (d).

(a) Section 725.709 is a new provision governing payment for compensable prescription drugs. The regulation codifies existing policy and does not change current payment practice. It is also consistent with the payment practices of the other programs that OWCP administers. Section 725.709 generally provides for payment for prescribed medication at a percentage of the national average wholesale price (or another baseline price designated by OWCP) for a particular medication, plus a flat-rate dispensing fee. It also provides that OWCP may, in its discretion, require the use of specific providers for certain medications.

(b) One commenter asks OWCP to specify when miners will be required to use specific providers for certain medications. The comment also requests clarification of whether OWCP will directly negotiate with drug manufacturers, presumably with respect to the cost of medications.

The Department declines to revise the regulation in response to this comment. OWCP does not currently require the use of specific providers for any medication under the BLBA. The provision in § 725.709 gives OWCP the option of doing so in the future if it would be in the best interests of both the agency and the program's stakeholders. It is not possible to predict or specify when OWCP might use this option. OWCP, however, would advise miners and providers before any such requirement were implemented. With respect to negotiating drug prices with drug manufacturers, OWCP is a third-party payer and does not directly purchase medications or distribute them to miners.

(a) Section 725.710 is a new provision governing payment for compensable outpatient medical services. As proposed, it provides that, where appropriate, OWCP will utilize the Outpatient Prospective Payment System (OPPS) devised by CMS for the Medicare program. The proposed rule also states that where outpatient services cannot be assigned or priced appropriately under the OPPS system, payment will be based on fee schedules and other pricing formulas utilized by OWCP.

(b) One commenter requested clarification of the proposed rules with respect to payments that would be made to Critical Access Hospitals (CAHs) for outpatient hospital services. CAHs are small hospitals (generally 25 beds or less) in isolated rural areas (35 miles or more from another hospital, 15 or more miles in mountainous areas) that provide emergency services and offer short-term (generally less than 96 hours) inpatient services. See 42 U.S.C. 1395i-4, 1395x; 42 CFR 485.601-485.647. Medicare uses different payment formulas for services and treatments at CAHs than those used to pay other hospitals. In particular, Medicare excludes CAHs from both its inpatient and outpatient prospective payment systems. The commenter notes that under proposed § 725.711 (inpatient hospital services), services at facilities (such as CAHs) that are excluded from Medicare's Inpatient Prospective Payment System will be paid under fee schedules or other pricing formulas. The commenter requests clarification of whether a similar policy will be applied for outpatient services, given that CAHs are excluded from Medicare's OPPS. The commenter also requests that the Department consider undertaking additional economic analysis of applying the OPPS to CAHs.

During the development of the proposed rules, OWCP determined that CAHs would be exempt from the new outpatient and inpatient prospective payment systems generally applicable to other hospitals, as CAHs are excluded from Medicare's prospective payment systems. While this determination was codified in the inpatient regulation (§ 725.711), it was omitted from the outpatient regulation (§ 725.710). The Department agrees with the commenter that § 725.710 should be revised to clarify that the outpatient payment formula described in paragraph (a) of the provision does not apply to services at facilities (such CAHs) that are excluded from Medicare's OPPS. Thus, the Department has revised § 725.710(b) in the final rule to provide that services at such facilities will be paid “based on fee schedules or other pricing formulas utilized by OWCP for outpatient services.” This revision mirrors the inpatient rule and is consistent with Medicare's exclusion of CAHs from its OPPS. Since the Department has revised § 725.710 to exclude CAHs from the general payment formula, there is no need to analyze the economic impact of that formula on CAHs.

(c) Finally, the Department has revised § 725.710 to reflect the phased implementation of this rule. The Department has added a new paragraph (d), which states that the provisions of this section apply to outpatient medical services rendered after November 30, 2019.

(a) Section 725.713 is a new provision addressing reductions in requested fees. The proposed regulation provides that if a billed fee has been reduced (i.e., only paid in part) in accordance with the provisions of Subpart J, providers may not recover any additional amount from the miner. It, thus, prohibits the practice of “balance billing,” which occurs when providers receive only a portion of their submitted charges from third-party payers and seek to recover the “balance” from the patient.

(b) Three commenters request that the proposed rule be extended to prohibit balance billing where OWCP makes no payment for a treatment or service, as well as where the agency makes partial payment. The commenters also request that the principle that disabled miners and their families should never have to make any payments for covered treatments and services under the BLBA be explicitly stated in the rule.

It is OWCP's longstanding position and practice that miners should not be subject to balance billing for treatments and services that are covered under these regulations. To make this clear, the Department has revised § 725.713 in the final rule to explicitly state that providers cannot bill miners for, and that miners are not required to pay, any remaining balance for any treatments or services provided pursuant to this subpart (i.e., that are for a miner's disabling pneumoconiosis) after OWCP makes partial payment for such treatments and services. See also discussion at § 725.717 (noting similar revision). OWCP, however, has no legal authority to pay bills for services or treatments not covered under the BLBA (i.e., that are unrelated to a miner's disabling pneumoconiosis), or to regulate the payment and collection of such bills. Thus, the Department declines to extend § 725.713 to situations where OWCP denies payment entirely for noncovered services or treatments.

(a) Section 725.717 is a new provision setting time limits on the submission of bills by providers and reimbursement requests by miners. Bills and reimbursement requests must be submitted within one year of either (1) the end of the calendar year in which the service or treatment was provided or (2) the end of the calendar year in which the miner's entitlement to benefits was finally adjudicated, whichever is later. OWCP may waive these time limits for good cause shown.

(b) As discussed under § 725.713, several commenters asked the Department to clarify in the regulations that miners are not required to pay for covered treatments and services. The Department agrees with the commenters' point. Thus, in addition to revising § 725.713, the Department has revised the title and text of § 725.717 to clarify that a provider may not seek reimbursement from a miner when OWCP denies an otherwise-compensable bill due to late submission.

The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., and its implementing regulations, 5 CFR part 1320, require that the Department consider the impact of paperwork and other information collection burdens imposed on the public. A federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the Office of Management and Budget (OMB) under the PRA and displays a current, valid OMB Control Number. In addition, no person may generally be subject to penalty for failing to comply with an information collection that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.

Although the medical benefit payment rules in Subpart J contain collections of information within the meaning of the PRA (see §§ 725.715-725.716), these collections are not new. They are currently approved for use in the black lung program and other OWCP-administered compensation programs by OMB under Control Numbers 1240-0007 (OWCP-915 Claim for Medical Reimbursement); 1240-0019 (OWCP-04 Uniform Billing Form); 1240-0021 (OWCP-1168 Provider Enrollment Form); 1240-0037 (OWCP-957 Medical Travel Refund Request); and 1240-0044 (OWCP-1500 Health Insurance Claim Form). The requirements for completion of the forms and the information collected on the forms do not change under this rule. Since no changes are being made to the collections, the overall burdens imposed by them also will not change.

While the Department has determined that the rule does not affect the general terms of the information collections or their associated burdens, consistent with requirements codified at 44 U.S.C. 3506(a)(1)(B), (c)(2)(B) and 3507(a)(1)(D); 5 CFR 1320.11, the Department submitted a series of Information Collection Requests (ICRs) to OMB for approval concurrent with the NPRM to update the information collections to reflect this rulemaking and provide interested parties a specific opportunity to comment under the PRA. The NPRM specifically invited comments regarding the information collection and notified the public of their opportunity to file such comments with both OMB and the Department. 82 FR 742. On March 6, 2017, OMB concluded its review of the ICRs by asking the Department to submit updated ICRs at the final rule stage after considering any public comments regarding the information collection requirements in the rule. While the Department received comments on the substance of the proposed rule, which are addressed in the Section-by-Section Explanation above, it received no comments about the information collection burdens.

The Department submitted updated ICRs to OMB for the information collections in this final rule. See ICR Reference Numbers 1240-0007: 201805-1240-0006; 1240-0019: 201805-1240-0005; 1240-0021: 201805-1240-0004; 1240-0037: 201805-1240-0003; and 1240-0044: 201805-1240-0002. A copy of these requests (including supporting documentation) may be obtained free of charge from the Reginfo.gov website at www.Reginfo.gov or by contacting Michael A. Chance, Director, Division of Coal Mine Workers' Compensation, Office of Workers' Compensation Programs, U.S. Department of Labor, 200 Constitution Avenue NW, Suite N-3464, Washington, DC 20210. Telephone: (202) 693-0978 (this is not a toll-free number). TTY/TDD callers may dial toll-free 1-800-877-8339. Concurrent with its approval of this rule, OMB also approved the updated ICRs.

The information collections in this rule are summarized as follows. The number of responses and burden estimates listed are not specific to the black lung program; instead, the estimates are cumulative for all OWCP-administered compensation programs that collect this information.

1. Title of Collection: Claim for Medical Reimbursement Form (OWCP-915).

OMB Control Number: 1240-0007.

Total Estimated Number of Responses: 34,564.

Total Estimated Annual Time Burden: 5,738 hours.

Total Estimated Annual Other Costs Burden: $59,450.

2. Title of Collection: Uniform Billing Form (OWCP-04).

OMB Control Number: 1240-0019.

Total Estimated Number of Responses: 259,865.

Total Estimated Annual Time Burden: 29,466 hours.

Total Estimated Annual Other Costs Burden: $0.

3. Title of Collection: Provider Enrollment Form (OWCP-1168).

OMB Control Number: 1240-0021.

Total Estimated Number of Responses: 64,325.

Total Estimated Annual Time Burden: 8,555 hours.

Total Estimated Annual Other Costs Burden: $33,449.

4. Title of Collection: Medical Travel Refund Request (OWCP-957).

OMB Control Number: 1240-0037.

Total Estimated Number of Responses: 333,528.

Total Estimated Annual Time Burden: 55,366 hours.

Total Estimated Annual Other Costs Burden: $173,435.

5. Title of Collection: Health Insurance Claim Form (OWCP-1500).

OMB Control Number: 1240-0044.

Total Estimated Number of Responses: 3,381,232.

Total Estimated Annual Time Burden: 321,455 hours.

Total Estimated Annual Other Costs Burden: $0.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It also instructs agencies to review “rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them.” The Department has considered the final rule with these principles in mind and has determined that the regulated community will benefit from this regulation.

The Department addressed these issues in the NPRM. 82 FR 745-752. The Department comprehensively analyzed the potential economic impact of the new payment formulas and determined that they would not have a significant impact on either the economy as a whole or on firms that provide black lung-related health care to entitled miners. 82 FR 745-751. Comparing Trust Fund medical benefit payments for Fiscal Year 2014 with payment amounts that would be made under the proposed regulations for the same services, the Department estimated an aggregate $3,154,297 annual reduction in Trust Fund payments under the proposed payment formulas. 82 FR 751. Further analysis revealed that even for negatively affected providers, the proposed rule would not have significant impact on individual firms. Id.

The Department also noted the rule's multiple advantages that serve the interests of stakeholders. 82 FR 752. The proposed formulas would bring Trust Fund payments in line with industry standards, help protect the Trust Fund from inaccurate and excessive payments, ease recouping of medical benefits paid by the Trust Fund on a liable operator's behalf, and conserve the Trust Fund's limited resources. Id. Additionally, the new formulas would decrease administrative costs, reduce disparities in provider reimbursements, shorten the time period providers must wait for reimbursement, and provide all stakeholders with greater clarity and certainty regarding the black lung medical benefit payment process. Id.

The Department received one comment suggesting that the economic analysis in the NPRM improperly focused solely on the nation-wide impacts of the proposed rules. This is incorrect. In addition to considering the overall impact of the proposed rules, the analysis addressed the impact of the proposed payment formulas on a state-by-state basis. See 82 FR 746-751.

The same commenter takes issue with a statement in the NPRM's economic analysis that any decline in the number of entitled claimants may result in a decline in payments by the Trust Fund, even apart from any change in payments resulting from the new payment formulas. See 82 FR 751. The commenter suggests that claims filed by miners with complicated pneumoconiosis, a more serious form of the disease, are in fact increasing in certain areas. The Department did not mean to suggest that miners would be less likely to contract pneumoconiosis in the future or that the number of claims filed could not fluctuate from year to year. Rather, the Department was simply noting that there had been a long-term decline in both the number of beneficiaries covered, and medical benefit payments made, by the Trust Fund. See id., n.17.

The Department received no other comments calling its cost-benefit analysis into question. Thus, the Department continues to believe that the cost savings and other benefits of this rule support its promulgation.

The Office of Information and Regulatory Affairs of the Office of Management and Budget has determined that this rule is a “significant regulatory action” under section 3(f)(4) of Executive Order 12866 and has reviewed it.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601 et seq., and Executive Order 13272 require agencies to review proposed and final rules to assess their impact on small entities. The agency must determine whether a proposed rule may have a “significant” economic impact on a “substantial” number of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions. See 5 U.S.C. 603. If the agency estimates that a proposed rule would have a significant impact on a substantial number of small entities, then it must prepare an initial regulatory flexibility analysis as described in the RFA. Id. The RFA also requires agencies to prepare a final regulatory flexibility analysis when promulgating a final rule. 5 U.S.C. 604. However, the RFA does not require a regulatory flexibility analysis if the agency certifies that the proposed or final rule will not have a significant economic impact on a substantial number of small entities and provides the factual basis for the certification. 5 U.S.C. 605. The Department has determined that a final regulatory flexibility analysis is not required for this rulemaking.

The Department conducted an initial regulatory flexibility analysis to aid understanding of the impact of the proposed rule and invited comments on all aspects of the costs and benefits of the proposed rule, with particular attention to the effects of the rule on small entities. See 82 FR 752-765. To determine whether the rule would have a significant impact on a small entity, the Department used as its standard whether the rule would impose costs that equal or exceed 3% or more of the entity's annual revenue. 82 FR 752. Applying this standard, the Department considered whether the rule would significantly impact 15% or more of the small entities in the relevant industry. 82 FR 752-53. The Department separately examined the rule's impact on small entities of each provider type (non-hospital health care services providers, hospitals providing outpatient services, and hospitals providing inpatient services) affected by the rule. 82 FR 753-764. The Department estimated that the rule will not have a significant impact on any small entity providing non-hospital health care services. 82 FR 759. The Department estimated that one small hospital entity providing outpatient services and two providing inpatient services will be significantly impacted, but these entities do not constitute a substantial number of the total number of negatively affected small hospitals providing either outpatient or inpatient services. 82 FR 761, 763. The Department noted that its analysis likely overstated the impact of the rule on negatively affected small entities. 82 FR 765. The Department therefore concluded that the rule, if adopted, would not have a significant impact on a substantial number of small entities. Id.

No comments were received that raise a significant issue regarding the initial regulatory flexibility analysis or that provide a basis for departing from the conclusion reached in the analysis. Significantly, with the exception of CAHs, no commenter or interested small business brought forth any information that contradicts the Department's assumptions or conclusions in the initial regulatory flexibility analysis, despite the Department's specific request for comments about adverse effects on small businesses. And the Department's determination, as explained in the Section-by-Section Explanation above, to exclude CAHs from the new payment formulas renders the request to analyze the impact of those formulas on CAHs moot.

Based on these facts, the Department certifies for the purposes of 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. Accordingly, it has not prepared a final regulatory impact analysis. The Department will provide the Chief Counsel for Advocacy of the Small Business Administration with a copy of this certification. See 5 U.S.C. 605.

This final rule is not subject to the requirements of Executive Order 13771 because this final rule addresses transfer costs and does not impose any new requirements apart from the transfers. OMB's interim guidance on E.O. 13771 (Para II, Q2) (February 2, 2017) and OMB additional guidance on E.O. 13771 (Para III, Q13) (April 5, 2017); see also 82 FR 746, 748-49 (recognizing rules as implicating transfer costs).

Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq., directs agencies to assess the effects of Federal Regulatory Actions on State, local, and tribal governments, and the private sector, “other than to the extent that such regulations incorporate requirements specifically set forth in law.” 2 U.S.C. 1531. For purposes of the Unfunded Mandates Reform Act, this rule does not include any Federal mandate that may result in increased expenditures by State, local, tribal governments, or increased expenditures by the private sector of more than $100,000,000.

The Department has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule will not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Id.

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a report, which includes a copy of the rule, to each House of Congress and to the Comptroller General of the United States. OWCP will report this rule's promulgation to each House of Congress and the Comptroller General simultaneously with publication of the rule in the Federal Register. The report will state that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set forth in the preamble, the Department of Labor amends 20 CFR part 725 as follows:

I. Background

Upon request, FDA has classified the brain trauma assessment test as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On August 28, 2017, Banyan Biomarkers, Inc., submitted a request for De Novo classification of the Banyan BTI. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on February 14, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.5830. We have named the generic type of device brain trauma assessment test, and it is identified as a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks intable 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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 establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. 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 the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA has classified the endoscopic electrosurgical clip cutting system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807), respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s. As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 11, 2016, Ovesco Endoscopy AG submitted a request for De Novo classification of the remOVE System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on December 22, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.4310. We have named the generic type of device endoscopic electrosurgical clip cutting system, and it is identified as a prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection. The system includes instruments that are then used to remove the fragmented clips from the digestive tract.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks intable 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, endoscopic electrosurgical clip cutting systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

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 establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. 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 the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing DoD internal policies and procedures that are publically available on the Department's issuance website.

This part contains internal DoD requirements and thus, does not fiscally impact parties outside of DoD. DoD's internal DoD Instruction 5240.05, “Technical Surveillance Countermeasures (TSCM),” remains in effect exclusively for the management of TSCM in DoD and is available at http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/524005_2014.pdf.

This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.

Consolidated Rail Corporation, the owner of the bridge, requested a temporary deviation from the normal operating schedule to facilitate A-Frame sheave bearing repairs. The Lehigh Valley Bridge across the Newark Bay, mile 4.3, at Newark, New Jersey is a lift bridge with a vertical clearance in the closed position of 35 feet at mean high water and 39 feet at mean low water. The existing bridge operating regulations are listed at 33 CFR 117.5 and 117.735.

Under this temporary deviation, the Lehigh Valley Bridge shall remain in the closed position from 6 a.m. on July 15, 2018, to 6 p.m. on July 16, 2018. Should inclement weather occur, the following rain dates may be used: (1) From 6 a.m. on July 22, 2018, to 6 p.m. on July 23, 2018; (2) from 6 a.m. on July 29, 2018, to 6 p.m. on July 30, 2018; or (3) from 6 a.m. on August 5, 2018, to 6 p.m. on August 6, 2018.

The waterway users are seasonal recreational boaters and commercial vessels of various sizes. Coordination with waterway users indicated no objections to this temporary deviation. Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local 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.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA)(5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” On April 19, 2018, the Captain of the Port (COTP) Buffalo published a notice of proposed rulemaking (NPRM), Docket Number USCG-2017-1112, to make temporary safety zones for annual events a final rule. This event was included in the NPRM. Its purpose was to mitigate potential threats to personnel, vessels, and the marine environment in the navigable waters within the specified safety zones. The NPRM addressed these concerns, and invited the public to comment during the comment period, which ended on May 21, 2018. As such, it is unnecessary to publish an NPRM for this temporary rule because the public had opportunity to comment on it and no comments were received concerning this event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register because doing so would be impracticable and contrary to the public interest. This safety zone will be included in a final rule, Docket Number USCG-2017-1112, which is awaiting publication. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels in vicinity of the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a fireworks display presents significant risks to the public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display takes place.

This rule establishes a safety zone on June 15, 2018, from 9:45 p.m. until 10:45 p.m. The safety zone will encompass all waters of the Vermillion River, Vermillion, OH contained within a 420-foot radius of: 41°25′45″ N, 082°21′54″ W.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the conclusion that this rule is not a significant regulatory action. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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

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

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 establishes a temporary safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

The Coast Guard will enforce the safety zones listed in 33 CFR 165.941, Safety Zones; Annual Events in the Captain of the Port Detroit Zone, at the following dates and times for the following events:

(1) Washington Township Summerfest Fireworks, Toledo, OH. The safety zone listed in § 165.941(a)(2), will be enforced from 9 p.m. to 11 p.m. on June 23, 2018. In the case of inclement weather on June 23, 2018, this safety zone will be enforced from 9 p.m. to 11 p.m. on June 24, 2018.

(2) Put-In-Bay Fourth of July Fireworks, Put-In-Bay, OH. The safety zone listed in § 165.941(a)(5) will be enforced from 9 p.m. to 11 p.m. on July 4, 2018. In the case of inclement weather on July 4, 2018, this safety zone will be enforced from 9 p.m. to 11 p.m. on July 5, 2018.

Under the provisions of § 165.23, entry into, transiting, or anchoring within these safety zones during the enforcement period is prohibited unless authorized by the Captain of the Port Detroit or his designated representative. Vessels that wish to transit through the safety zones may request permission from the Captain of the Port Detroit or his designated representative. Requests must be made in advance and approved by the Captain of Port before transits will be authorized. Approvals will be granted on a case by case basis. The Captain of the Port may be contacted via U.S. Coast Guard Sector Detroit on channel 16, VHF-FM or by calling (313) 568-9564. The Coast Guard will give notice to the public via Local Notice to Mariners and VHF radio broadcasts that the regulation is in effect.

This document is issued under authority of § 165.941 and 5 U.S.C. 552(a). If the Captain of the Port determines that any of these safety zones need not be enforced for the full duration stated in this document, he may suspend such enforcement and notify the public of the suspension via a Broadcast Notice to Mariners.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA)(5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause find that those procedures are “impracticable, unnecessary, or contrary to public interest.” On April 19, 2018, the Captain of the Port (COTP) Buffalo published a notice of proposed rulemaking (NPRM), Docket Number USCG-2017-1112, to make temporary safety zones for annual events a final rule. This event was included in the NPRM. Its purpose was to mitigate potential threats to personnel, vessels, and the marine environment in the navigable waters within the specified safety zones. The NPRM addressed these concerns, and invited the public to comment during the comment period, which ended on May 21, 2018. As such, it is unnecessary to publish an NPRM for this temporary rule because the public had opportunity to comment on it and no comments were received concerning this event.

Under 5 U.S.C 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The Coast Guard intends to establish a permanent safety zone in the future under Docket Number USCG-2017-1112. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels in the vicinity of the planned event.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined the Hope Chest Buffalo Niagara Dragon Boat Festival presents significant risks to the public safety and property. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the event takes place.

This rule establishes a safety zone on June 16, 2018, from 8:00 a.m. until 5:30 p.m. The safety zone will encompass all waters of the Buffalo River, Buffalo, NY starting at position 42°52′12.60″ N, 078°52′17.0″ W then Southeast to 42°52′03.0″ N, 078°52′12.0″ W then East to 42°52′03.0″ N, 078°52′10.0″ W then Northwest to 42°52′13.0″ N, 078°52′16.0″ W then returning to the point of origin.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the conclusion that this rule is not a significant regulatory action. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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

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

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

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

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 establishes a temporary safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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.

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Detroit 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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA)(5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this fireworks display in time to publish an NPRM. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 10 p.m. on June 30, 2018 through 11 p.m. on July 1, 2018 will be a safety concern to anyone within a 280-foot radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being displayed.

This rule establishes a safety zone from 10 p.m. on June 30 through 11 p.m. on July 1, 2018. The safety zone will encompass all U.S. navigable waters of Detroit River, Grosse Ile, MI, within a 280-foot radius of position 42°05.390′ N, 083°09.065′ W (NAD 83). The safety zone will be enforced from 10 p.m. to 11 p.m. on June 30, 2018. In the case of inclement weather on June 30, 2018, this safety zone will be enforced from 10 p.m. to 11 p.m. on July 1, 2018. No vessel or person will be permitted to enter the safety zone 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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Detroit River from 10 p.m. on June 30, 2018 through 11 p.m. on July 1, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 safety zone lasting one hour that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0565 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0565, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of January 26, 2018 (83 FR 3658) (FRL-9971-46), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F8504) by Gowan Company LLC, P.O. Box 5569, Yuma, AZ 85366-5569. The petition requested that 40 CFR 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the biochemical fungicide Extract of Swinglea glutinosa in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner, Gowan Company LLC, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.” FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

EPA evaluated the available toxicity and exposure data on Extract of Swinglea glutinosa and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Extract of Swinglea glutinosa is extracted from the leaves of Swinglea glutinosa. Commonly known as Tabog, the plant is found in southeast Asian and South American countries and is also commercially cultivated for ornamental purposes. As a pesticidal active ingredient, Extract of Swinglea glutinosa is intended for use as a fungicide on growing crops and ornamentals in agricultural, greenhouse, turf, recreational, and commercial landscape use sites to control fungal diseases such as powdery mildew and sour rot. The antifungal mode of action (MOA) of Extract of Swinglea glutinosa is likely cell membrane disruption, attributable to the terpene constituents in the essential oil of the extract. This mode of action is similar to that observed in other essential oils that are considered biopesticides, such as tea tree oil, rosemary oil and thyme oil. The constituent compounds in Extract of Swinglea glutinosa are ubiquitous in fruits and vegetables and are regularly consumed by humans as part of a normal diet. The constituent compounds are also biodegradable; and the active ingredient is highly soluble in water and will degrade rapidly in aqueous environments.

Based on the data submitted in support of this petition and the dietary risk assessment conducted by the Agency, EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to Extract of Swinglea glutinosa, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is not acutely toxic, subchronically toxic, mutagenic, or developmentally toxic via repeat oral exposure. As such, the Agency has not identified any endpoints of concern for Extract of Swinglea glutinosa and has conducted a qualitative assessment of exposure. The Agency has also determined that residues Extract of Swinglea glutinosa in drinking water are not expected to be significant when products are used according to label instructions. The active ingredient is applied at low concentrations, is very soluble in water, and degrades rapidly in aqueous solutions. Non-occupational exposures are not expected since Extract of Swinglea glutinosa is only intended for commercial agricultural and landscaping use. A full explanation of the data upon which EPA relied and its dietary risk assessment based on those data can be found within the April 10, 2018, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Extract of Swinglea glutinosa.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

Based upon its evaluation, EPA concludes that Extract of Swinglea glutinosa is not toxic. No toxic endpoints were established for oral toxicity, dermal toxicity or inhalation toxicity. Exposure to Extract of Swinglea glutinosa via pesticidal use is not expected to exceed any levels of concern. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary due to the lack of threshold effects.

Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Extract of Swinglea glutinosa. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of Extract of Swinglea glutinosa when applied pre-harvest in accordance with label directions and good agricultural practices.

An analytical method is not required for enforcement purposes due to the lack of concern about safety for Extract of Swinglea glutinosa at any exposure level.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

The small-mesh multispecies fishery is managed by the New England Fishery Management Council within the Northeast Multispecies Fishery Management Plan (FMP). The fishery is composed of five stocks of three species of hakes: Northern silver hake; southern silver hake; northern red hake; southern red hake; and offshore hake. Southern silver hake and offshore hake are often grouped together and collectively referred to as “southern whiting.” Amendment 19 to the FMP (78 FR 20260; April 4, 2013) established a process and framework for setting catch specifications for the small-mesh fishery. The FMP requires the specification of an overfishing limit (OFL), acceptable biological catch (ABC), annual catch limit (ACL), and total allowable landings (TAL) for each stock within the fishery for up to three years at a time, based on the most recent stock projections for upcoming years. This action implements the Council's recommended small-mesh multispecies specifications for the 2018 fishing year, announces projected 2019 and 2020 specifications as recommended by the Council, and makes a minor regulatory correction.

The proposed rule for this action published in the Federal Register on April 12, 2018 (83 FR 15780), and comments were accepted through April 27, 2018. Additional background information regarding the development of these specifications was provided in the proposed rule (83 FR 15780; April 12, 2018) and is not repeated here.

This action implements the final 2018 and projected 2019-2020 small-mesh multispecies specifications as proposed (Table 1). All other management measures in the small-mesh multispecies fishery (such as possession limits) will remain unchanged. By providing projected quotas for 2019 and 2020, NMFS hopes to assist fishery participants in planning ahead. The Council will review these specifications annually, and NMFS will provide notice prior to each fishing year to announce any necessary changes for 2019 and 2020. For more information on the Council's recommendations and decision-making process, please see the proposed rule (83 FR 15780).

This action also corrects regulatory text specifying the red hake possession limits in the southern small-mesh exemption areas (Southern New England and Mid-Atlantic Exemption Areas). In the 2015-2017 specifications for this fishery (May 28, 2015; 80 FR 30379), we implemented a new 3,000-lb (1,361-kg) red hake possession limit for the northern exemption areas, but we did not specify that the possession limit in the southern areas would remain 5,000 lb (2,268 kg). This action revises the regulations to specify the 5,000-lb (2,268-kg) possession limit for red hake harvested in the southern small-mesh exemption areas, as originally intended by the Council.

The public comment period for the proposed rule ended on April 27, 2018. We received three comments from the public on this rule. One commenter asked how the input of the active fishing community contributed to the development of these specifications. These specifications were developed through the Council process, which involved multiple discussions at public Council meetings (such as meetings on June 20, 2017, in Portland, ME; on September 26, 2017, in Gloucester, MA; and on December 7, 2017, in Newport, RI) where concerns and interests of the active fishing community were considered. Active members of the fishing community also sit on the Small-Mesh Multispecies (Whiting) Advisory Panel, which makes recommendations on management of the fishery to the Council and its Small-Mesh Multispecies Committee. The public comment period announced by the proposed rule was another opportunity for fishermen to offer suggestions and improvements to the specifications. The other two comments were not relevant either to this action or to fisheries in general and did not warrant a response. No changes to the proposed specifications were made as a result of these comments.

There are no substantive changes from the proposed rule.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the Small-Mesh Multispecies FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

This action does not contain a collection of information requirement for purposes of the Paperwork Reduction Act.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in the date of effectiveness for this rule, to ensure that the final specifications are in place as close as practicable to the start of the 2018 small-mesh multispecies fishing year, which began on May 1, 2018. This action establishes the final specifications (i.e., annual catch limits) for the small-mesh multispecies fishery for the 2018 fishing year. A delay in effectiveness well beyond the start of the 2018 fishing year would be contrary to the public interest, as it could create confusion and potential economic harm to the commercial small-mesh multispecies industry. Additionally, it could compromise the effectiveness of the new specifications in achieving optimal yield and preventing overfishing.

This rule is being issued at the earliest possible date. Preparation of the proposed rule was dependent on the submission of the EA, in support of the specifications, that is developed by the Council. A complete specifications document and accompanying EA was received by NMFS in late January 2018. Documentation in support of the Council's recommended specifications is required for NMFS to provide the public with information from the environmental and economic analyses, as required in rulemaking, and to evaluate the consistency of the Council's recommendation with the Magnuson-Stevens Act and other applicable law. The proposed rule published on April 12, 2018, with a 15-day comment period ending April 27, 2018.

Although the specifications from 2017 are carried into 2018 until the new catch limits are implemented, the Council has recommended changes based on the most recent assessment of the four main small-mesh multispecies stocks that should be in place as soon as possible. Harvest occurring within the first weeks of the fishing year based on old catch limits could be detrimental to southern hake stocks, including southern red hake, which is experiencing overfishing.

Furthermore, this action increases the northern silver hake quota by 33 percent and increases northern red hake quota by 128 percent, providing federally permitted vessels additional harvest opportunity for the 2018 fishing year. The timely implementation of these specifications will help to ensure that the industry has the opportunity to achieve optimal yield in the fishery, and to access the increased quotas for the northern stocks. It is also important to implement the lower southern stock catch limits as soon as possible to avoid the potential for overfishing. The commercial whiting industry has been involved in the development of these specifications and is anticipating this rule. Therefore, there would be no benefit to delaying the implementation of these specifications. For these reasons, we find that there is good cause to waive the 30-day delay in the date of effectiveness.

The final regulatory flexibility analysis (FRFA) included in this final rule was prepared consistent with 5 U.S.C. 604(a), and incorporates the initial regulatory flexibility analysis (IRFA) and a summary of analyses completed to support the action. A public copy of the environmental assessment/IRFA is available from the Council (see ADDRESSES). The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here.

NMFS did not receive any comments in response to the IRFA or regulatory flexibility analysis (RFA) process. Refer to the “Comments and Responses” section of this rule's preamble for more detail on the public comments that were received. No changes to the proposed rule were required to be made as a result of public comment.

This final rule affects small entities engaged in commercial fishing operations within the small-mesh multispecies fishery that is a subset of the northeast multispecies fishery. For the purposes of the RFA analysis, the ownership entities (or firms), not the individual vessels, are considered to be the regulated entities. Because of this, some vessels with northeast multispecies permits may be considered to be part of the same firm because they may have the same owners. In terms of RFA, a business primarily engaged in commercial fishing activity is classified as a small business if it has combined annual gross receipts not in excess of $11 million (NAICS 11411) for all its affiliated operations worldwide. To identify these small and large firms, vessel ownership data from the permit database were grouped according to common owners and sorted by size. The current ownership data set used for this analysis is based on calendar year 2016 (the most recent complete year available) and contains average gross sales associated with those permits for calendar years 2014 through 2016.

The small-mesh exempted fishery allows vessels to harvest species in designated areas using mesh sizes smaller than the minimum mesh size required by Regulated Mesh Area (RMA) regulations. To participate in the small-mesh multispecies exempted fishery, vessels must possess either a limited access multispecies permit (categories A, C, D, E or F) or an open access multispecies permit (category K). Limited access multispecies permit holders can target small-mesh multispecies with different possession limit requirements depending on fishing region and mesh size used. Open access, Category K permit holders may fish for small-mesh multispecies when participating in an exempted fishing program. Therefore, entities holding one or more multispecies permits (permit type A, C-F, K) are the entities that have the potential to be directly impacted by this action. According to the commercial database, there were 853 distinct ownership entities, based on entities' participation during the 2014-2016 time-period, that could potentially target small-mesh multispecies. This includes entities that could not be classified into a business type because they did not earn revenue from landing and selling fish in 2014-2016 and thus are considered to be small. Of the 853 total firms, 844 are categorized as small business entities and nine are categorized as large businesses.

While 853 commercial entities have the potential to be impacted by the proposed action, not all of these entities actively land small-mesh multispecies for commercial sale. There are 406 distinct entities that commercially sold small-mesh multispecies from 2014-2016 and may be directly affected by the proposed action. Of those, 404 are categorized as small businesses.

No additional reporting, recordkeeping, or other compliance requirements are included in this final rule.

Specification of commercial catch limits is constrained by the conservation objectives of in the FMP and implemented at 50 CFR part 648 under the Magnuson-Stevens Act. This action implements final 2018 and projected 2019-2020 commercial catch specifications for the small-mesh multispecies fishery based on the most recent stock assessment update. The Council also considered taking no action, where the same catch limits and specifications from 2017 would continue into 2018 with no change. Only these two alternatives were considered by the Council. The alternative status quo specifications do not address the overfishing and overfished designations raised by the 2017 stock assessment update, and thus do not meet the Magnuson-Stevens Act requirements. The specifications implemented by this final rule minimize the economic impacts on small entities to the extent practicable while adhering to the conservation requirements of the Magnuson-Stevens Act. As described in the proposed rule for this action, we do not anticipate these specifications to have a significant impact on those small entities to which this final rule would apply.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide was prepared and will be sent to all holders of Federal permits issued for the small-mesh multispecies fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS at the following website: www.greateratlantic.fisheries.noaa.gov.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:

Precious corals (also called deep-sea corals) include black, pink, red, bamboo, and gold corals, and are harvested for use in high quality jewelry. NMFS and the Council manage the fishery for precious corals in the U.S. Pacific Islands under fishery ecosystem plans (FEP) for American Samoa, Hawaii, the Mariana Archipelago (Guam and the Northern Mariana Islands), and the Pacific Remote Islands Area. The U.S. fishery for gold corals in the Pacific Islands has been dormant since 2001.

In 2008, the Council recommended, and NMFS implemented, a five-year moratorium on the harvest of gold corals in the Pacific Islands Region (73 FR 47098, August 13, 2008). The measure was a precautionary response to research that suggested that gold coral growth rates and recruitment were much lower than previously known.

The Council considered additional research in 2012 that included refined gold coral growth rates and the identification of previously unknown habitat requirements. Based on that information, in 2013 the Council recommended that NMFS extend the moratorium for five years, which the agency did in May 2013 (78 FR 32181, May 29, 2013).

The current moratorium is scheduled to expire on June 30, 2018, but the Council continues to be concerned about uncertainties related to slow gold coral growth rates, taxonomy, and complex habitat requirements. Extending the moratorium another five years will provide additional time for further research and for the Council to develop sustainable management measures for gold corals. Based on the Council's concerns, NMFS is extending the moratorium on harvesting gold corals for five years, through June 30, 2023.

Additional background information on this action is in the preamble to the proposed rule (83 FR 18260, April 26, 2018).

On April 26, 2018, NMFS published a proposed rule and request for public comments (83 FR 18260). The comment period ended May 11, 2018. NMFS received input from four commenters, all generally in support of the rule. We respond below to specific comments.

Comment 1: Additional research on gold coral growth rates would help develop sustainable catch levels in the future.

Response: NMFS agrees research is needed on the biology of gold corals to quantify the impacts of possible future harvesting on these coral species. Extending the moratorium may stimulate this needed research.

Comment 2: NMFS should reduce harvest effort gradually until the long-term optimal level is achieved and gold corals are allowed to recover.

Response: Prior to the implementation of the first moratorium in 2008, the gold coral fishery was regulated by an annual harvest quota of 240 kg. This quota was divided between two coral beds located in the main Hawaiian Islands (20 kg each), and two coral beds located in the Northwestern Hawaiian Islands (33.5 and 66.5 kg). The Council considered a range of new management alternatives in 2008, including a moratorium and 50 percent reduction in quota at each coral bed. NMFS analyzed the effect of a 50 percent reduction in quota and found that the potential risk of overfishing gold corals would be reduced, but not eliminated. If gold coral growth rates are as low as indicated, reducing the current quota by 50 percent may result in unsustainable harvest. Furthermore, given the high operating costs and associated safety risks, harvest at low levels may not be economically viable.

Comment 3: NMFS should conduct an economic analysis on the effects of the moratorium.

Response: NMFS assessed the costs and benefits of the proposed action and other alternatives pursuant to Executive Order 12866. Gold coral harvesting has occurred infrequently during the past 50 years, with only 2 entities ever harvesting gold corals commercially in the region. The fishery was dormant for the seven years prior to the implementation of the moratorium in 2008. If the moratorium expires, consumers and fishermen might gain in the short term in being able to trade in gold corals. However, if such harvests are unsustainable, consumers and fishermen may face negative impacts from potential fishery closures in the long term.

Comment 4: NMFS should extend the moratorium for ten years.

Response: The five-year moratorium provides time for researchers to conduct gold coral research and share their results with managers. This time period provides the impetus for the research to be conducted so that the fishery can be re-opened as soon as possible, if the research indicates that the fishery could be sustainable. After five years, the Council would review the best available scientific information and recommend appropriate management actions.

Comment 5: Why do gold corals need conservation relative to other precious corals?

Response: While all precious corals grow slowly and have low rates of mortality and recruitment, gold corals grow more slowly and live longer than other precious corals in the region. For example, whereas pink and black coral colonies may be less than 100 years old, gold coral colonies may be several hundred to several thousand years old. Slower growth rates and longer lives make gold corals more vulnerable to overfishing than other precious corals. Thus, gold corals require different conservation and management measures than other precious corals.

This final rule contains no changes from the proposed rule.

The Administrator, Pacific Islands Region, NMFS, determined that this action is necessary for the conservation and management of the gold coral fishery and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. As a result, a regulatory flexibility analysis was not required and none was prepared.

For the reasons set out in the preamble, NMFS amends 50 CFR part 665 as follows: