Background

The 2018 Farm Bill (Pub. L. 115-334) reauthorized DIPP and requires establishment of regulations for the DMC Program. The changes for each of the programs are explained below.

Section 1402 of the 2018 Farm Bill amends 7 U.S.C. 4553 to reauthorize DIPP through 2023, and does not make any other changes to DIPP.

The purpose of DIPP is to indemnify dairy farmers and manufacturers of dairy products who, through no fault of their own, suffer income losses with respect to milk or milk products that were removed from commercial markets because such milk or milk products contained certain harmful pesticide residues, chemicals, or toxic substances, or were contaminated by nuclear radiation or fallout.

This rule is adding a specific timeframe that will limit the period of time that a dairy claimant under DIPP is eligible to receive indemnification. This is a discretionary change. Current DIPP rules indemnify losses until such time as the dairy is reinstated to the commercial market by a State regulatory agency. The large majority of claims for indemnification to affected farmers under DIPP typically range from 2 to 10 days for which their milk has been removed from the commercial market before such milk has been reinstated by a State regulatory agency. However, some claims submitted for indemnification could span the course of several months. In these circumstances, FSA will limit indemnification for the same loss to a period not to exceed 18 months. The current regulation does not have a limit on the time period for which an eligible dairy can receive DIPP payments for the same contaminating event. Accordingly, discretionary changes are being made to DIPP to limit indemnification to not extend past the time period that the impacted dairy cows in the dairy herd are no longer lactating or impacted dairy cows in gestation have delivered a calf and are no longer lactating from its most immediately preceding birth after the contaminating event, not to exceed 18 months. Claims for milk from the affected farmer not reinstated to the commercial markets after the impacted dairy cows in the herd are dry and no longer producing milk from its most immediately preceding birth after the contaminating event, or have exceeded the 18-month period will not be eligible for indemnification for their milk any further, in order to prevent continued indemnification to an affected farmer for the removal of milk based upon the same contaminating event, however long that contaminating event or activity lasts. The 18-month period is based on a 10-month lactation period after the calf is born, overlapping breeding period, and a remaining 6-month pregnancy term. The 18-month period also accounts for approximately 2 months of the 18-month period the cow may not be producing milk during the dry period between lactations. At any time when the impacted dairy cows are dry from lactating from its most immediately preceding birth after the contaminating event the occurrence will no longer be eligible for indemnification. Limiting indemnification of a contaminating event to the maximum 18-month period, during which such dairy cow could be affected, was determined a fair and reasonable time frame to limit claims. Otherwise, any indemnification payment beyond this specified time period would be for milk from cows that have already completed the gestation period prior to the contaminating event and lactation period following birth, or from cows that were conceived after the initial contaminating event that caused the milk to be removed from the market. Once the dairy is required to remove their milk from the commercial market, such dairy producer knows or has reason to know the presence of contamination and it is reasonable that such dairy should take such actions as to not allow their cows to be further exposed to such contamination. Claimants will be required to provide inventory of dairy cows bred and lactating as of the contamination event to determine eligible livestock producing milk during the contamination period for which DIPP assistance is provided. Further, once the contaminating event has occurred and the dairy has been directed to remove their milk from the commercial market, any subsequently purchased or bred animals are not eligible for assistance under DIPP. The limitation will prevent a claimant from receiving indemnification in perpetuity for the same contaminating event. Therefore, this rule specifies a timeframe for which dairies are eligible to be indemnified for the same contaminating event or activity under DIPP. Dairy producers that have exceeded the specified timeframe established by FSA before June 18, 2019 will be allowed to submit one additional claim after June 18, 2019, since this new provision is being implemented as of June 18, 2019 and some producers may have already exceeded the specified timeframe.

This rule establishes a new subpart in the regulations in 7 CFR part 1430 to establish the new DMC Program for dairy producers as authorized by Subtitle D of Title I of the 2018 Farm Bill. The DMC Program regulation is in effect from June 18, 2019, through December 31, 2023; however, the DMC Program is retroactive back to January 1, 2019, as specified in the 2018 Farm Bill.

DMC replaces MPP-Dairy (7 CFR part 1430 subpart A). The 2018 Farm Bill authorizes retroactive provisions that open eligibility for certain producers previously determined ineligible under MPP-Dairy and for MPP-Dairy participants when the total premiums paid exceeded the total payments received during each of the applicable years of MPP-Dairy. This rule amends the MPP-Dairy regulations to make these changes. MPP-Dairy will only remain in effect until retroactive provisions have been administered and concluded.

The DMC Program is based on a similar framework to MPP-Dairy, with some changes. The purpose of DMC is to provide eligible dairy producers risk protection against low margins resulting from a combination of low milk prices and high feed costs. DMC and MPP-Dairy both provide for payments to dairy operations that are calculated based on producer elected margins when the difference between the national “all-milk” price of milk and the national average cost of feed falls below that producer elected margin. However, revisions were made, including changes to premium rates, additional coverage levels, and a premium discount option for locking in coverage levels for a 5-year period. FSA will announce the date on which the DMC Program registration will begin. Under the 2018 Farm Bill, the DMC Program ends December 31, 2023.

The 2018 Farm Bill expands on the modifications made to MPP-Dairy by the Bipartisan Budget Act of 2018. DMC is a voluntary program for producers involving fees and coverage-based premiums at most levels that provides payments when the calculated national margin for a month falls below the producer's selected margin trigger. The “margin” is the difference between the average national price of one hundred pounds (cwt) of milk and the national average price of the feed components (corn, soymeal, and hay) needed to produce that milk. For example, if the average price of milk is $20.00 a cwt and the average cost of soybean meal, corn, and hay needed to produce that milk is $12.00 a cwt, the margin is $8.00 a cwt. A factored hay price determined by FSA by averaging the prices of “premium and supreme” alfalfa hay and conventional alfalfa hay will be used in the feed cost calculations for DMC. Section 1401(c) of the 2018 Farm Bill required the National Agricultural Statistics Service to revise monthly price survey reports to include prices for high-quality (premium and supreme) alfalfa hay in the top 5 milk producing states and to publish that data no later than 120 days after passage of the 2018 Farm Bill. There is no mandate for USDA to use that data in the DMC feed cost calculation. However, there are indications that this higher quality alfalfa hay price would better reflect the quality of hay purchased by dairy operations. Since not all dairy producers feed high quality hay, a factored price, which assumes that 50 percent of alfalfa hay that is fed to dairy cows is “premium and supreme,” will more closely reflect the prices paid by dairy producers.

As authorized by the 2018 Farm Bill, DMC is available for participating dairy operations. A dairy operation can have one or more producers and each of the producers on the operation must share in the risk of production, and must contribute capital, land, labor, equipment, or management to the operation commensurate with their share of the proceeds. However, all producers do not have to participate. Producer payments and premiums will be reduced according to the non-participating producer's percentage share in the dairy operation. However, all participating producers in the dairy operation must unanimously agree to the elected coverage levels and any non-participating producers from that same dairy operation cannot independently or separately apply for DMC.

The production history for each dairy operation will be established in the same manner as MPP-Dairy, using the highest of the operation's annual milk marketings in any one of 2011, 2012, or 2013 calendar years. Under DMC, dairy operations that were not in operation prior to January 1, 2014, and have more than 1 year of production history but have not previously established a production history under MPP-Dairy, will establish production history from annual milk marketings during any 1 calendar year, as specified in this rule. However, dairy operations with less than a full calendar year of production history will establish production history using the same options established in MPP-Dairy, based on either an extrapolation from actual production data for the first calendar year with at least 1 full month of production history, adjusted for a seasonality index, or by estimating annual production based on the herd size of the dairy operation relative to the national rolling herd average production data.

For DMC, the production history, once established for an operation, does not change, even for changes in the herd size of the dairy operation. MPP-Dairy previously allowed for an annual upward adjustment to established production history that was based on the national annual increase in milk production. However, under DMC, production history will be adjusted only for 2019 for certain dairies to reflect any increase in the national average milk production relative to calendar year 2017. FSA determined the national average milk production relative to calendar year 2017 based on the milk production history increase from April 2016 through March 2017 and applied that adjustment at a factor of 1.0186 to participating dairy operations under MPP-Dairy for coverage year 2018. Dairy operations participating in DMC that had production history previously established under MPP-Dairy but elected not to participate in MPP-Dairy are not eligible for the production history adjustment. Additionally, dairy operations that first participated in MPP-Dairy in 2018, are not eligible for a production history adjustment and will maintain that same production history. However, dairy operations that did not previously establish their production history for the purpose of MPP-Dairy and, consequently did not participate in MPP-Dairy, will have the same adjustment factor of 1.0186 applied to their established production history upon registration in the DMC Program. However, unlike in MPP-Dairy, no additional production history adjustments will be made to the established production history in subsequent years of participation in DMC, per changes made by the 2018 Farm Bill.

Provisions regarding production history remain largely unchanged from MPP-Dairy to DMC. The production history is established for the participating dairy operation, and is assigned to that operation, not to an individual producer or to the facility location.

The 2018 Farm Bill does not permit a producer to adjust the proportion of their share of the dairy operation for the production history that is covered by the premium rate schedule in Tier I and Tier II, from what is covered for the dairy operation. For example, a participating dairy operation with two equal partners, each with a 50 percent ownership share in a 20 million pound production history that elects 60 percent coverage (20,000,000 × 60% = 12,000,000) under DMC, must cover the full 12,000,000 pounds, as applicable in the premium rate schedules. If one partner in that operation decides not to participate, the participating partner is not allowed to only cover their 50 percent share of the production history, 10 million pounds in this example, at the 60 percent election.

In some instances for MPP-Dairy, production history was tied to the facility location if the dairy operation was under a lease agreement. As such, transfers of production history to a different location and successions-in-interest of production history to another owner were not allowed. Similarly, when transfers were allowed for a relocation of the dairy operation from another facility location of a dairy operation that previously had MPP-Dairy established production history, the relocating dairy operation was allowed to merge the two histories together.

Under new DMC provisions, that in effect untie the production history from the facility location, the dairy operation, regardless of who established the production history, will be allowed to transfer the production history to another dairy operation, as specified by FSA, when there is no relative break in the continuity in the operation of the dairy being transferred. FSA has determined that based on its experience in administering MPP-Dairy that production history of a dairy operation should remain with the operation rather than with the facility because production is naturally tied to the animals that produce the dairy, not the facility; therefore, production should move with the dairy operation that established the production history. Although not a provision required by the 2018 Farm Bill, the provisions for transferring production histories will be implemented using FSA's discretionary authority to untie production history from the facility location in all cases as specified in this rule.

The DMC Program eligibility requirements remain the same as MPP-Dairy, except that producers that participate in the Livestock Gross Margin for Dairy (LGM-Dairy) insurance program administered by the USDA Risk Management Agency (RMA) on behalf of the Federal Crop Insurance Corporation, who under MPP-Dairy could only participate in either LGM-Dairy or MPP-Dairy, are now eligible to receive benefits from both LGM-Dairy and the DMC Program, as specified by the 2018 Farm Bill.

The 2018 Farm Bill also authorizes those producers with LGM-Dairy coverage in 2018, who were previously ineligible to enroll for MPP-Dairy coverage, the ability to retroactively enroll in MPP-Dairy for 2018. FSA has announced a period for eligible LGM-Dairy producers to make application and retroactive 2018 coverage elections to qualify for the payments that triggered in 2018 during the months of February through August and also December (no other months resulted in MPP-Dairy payments). The retroactive 2018 MPP-Dairy signup is only for dairy producers with 2018 LGM-Dairy coverage who produced and commercially marketed milk in 2018 but did not obtain full year MPP-Dairy coverage. FSA will notify eligible producers of the retroactive application signup period.

The 2018 Farm Bill makes significant changes from MPP-Dairy to DMC in the area of coverage levels. Both the previous MPP-Dairy and the new DMC Program require the dairy operation to select a margin trigger and a percentage of production history that will be covered. Coverage level thresholds under MPP-Dairy ranged from $4 per cwt for basic catastrophic (CAT) level coverage to an $8 per cwt maximum, in 50 cent increments. A dairy operation could elect coverage on anywhere from 25 percent to 90 percent of the operation's established production history. Under DMC, CAT level coverage remains at $4, however, higher levels of coverage at the $8.50, $9.00, and $9.50 threshold levels have been added under Tier I. Tier II coverage level thresholds under DMC remain the same as those under MPP-Dairy ranging from $4 to $8 and at the same $0.50 increments. However, the percentage of production history that can be covered also changed. Under MPP-Dairy, coverage was available from 25 percent to 90 percent, in 5 percent increments, whereas under DMC, coverage is available from 5 percent up to 95 percent, in 5 percent increments.

MPP-Dairy required producers to select one margin trigger level and one percentage of production history for both Tier I and Tier II, however, the new DMC Program allows for a second election of a coverage level threshold in Tier II that can be different than what the dairy operation elects under Tier I, but only if the DMC participating dairy operation elects a Tier I coverage level threshold of $8.50, $9.00, or $9.50. For example, a dairy operation with a 12 million pound production history elects to cover 50 percent of the operations' production history, which is 6 million pounds in this example. The dairy operation can cover 5 million pounds at $9.00, then can elect to cover 1 million pounds under Tier II at the $5 margin trigger, or any other level in Tier II, from $4 to $8. This option was not previously available under MPP-Dairy and only allows for a second election of a coverage level threshold, not a different coverage percentage, as specified in this rule.

As part of the annual coverage election process, the dairy operation is required to select the levels of coverage and pay an administrative fee, unless waived for a qualifying exemption, and if applicable, pay a premium based on the level of coverage (margin trigger) elected. Premium rates have changed from MPP-Dairy to DMC. The annual premium rates are specified in the 2018 Farm Bill. The premium for each participating dairy operation will be determined based on the dairy operation's election of each of the margin trigger and percentage of coverage. The method to calculate the premium due for participating dairy operations selecting coverage above CAT level, are the same in MPP-Dairy and the new DMC Program, and must be paid by a date determined by FSA, as specified in this rule.

For DMC, just as in MPP-Dairy, the coverage level threshold and coverage percentage must be elected by the dairy operation during the annual coverage election period announced by FSA for the applicable coverage year. MPP-Dairy required producers to make annual coverage elections and participate in the program for the duration of the 2014 Farm Bill. However, under DMC, annual participation is not mandatory. A dairy operation can decide annually during the coverage election period for the applicable year of coverage if they would like to participate.

To be eligible for DMC, a dairy operation must be in the business of producing and commercially marketing milk at the time of application during each annual coverage election period. Because section 1401(m) of the 2018 Farm Bill requires that the DMC Program take effect on January 1, 2019, for the 2019 coverage year only, those dairy operations that have stopped producing and commercially marketing milk before the coverage election signup period for 2019 begins, may apply for 2019 coverage and applicable payments for only the months the operation was still producing and commercially marketing milk in 2019. These dairy operations are not eligible for the premium rate discount, however, premiums will be prorated based on the months such dairy was in operation for 2019, as such the last marketing statement for the dairy operation, or other documentation deemed appropriate by FSA will be required at the time of application.

Payment of a $100 administrative fee is still required under DMC for each year of participation, unless the dairy operation qualifies for a waiver exemption based on the dairy operations qualifying status for socially disadvantaged, limited resource, beginning farmer or rancher, and veteran farmer or rancher.

DMC also provides an option during the 2019 coverage election period to make a 1-time election of coverage level and percentage of coverage, “locking-in” those elections for a 5-year period beginning January 2019 and ending December 2023. After the 2019 coverage election period, the lock-in option is not available to dairy operations participating in DMC, except as specified for dairy operations that have not established a production history. All dairy operations that elect the lock-in option are required to participate in the DMC Program at the same elected premium coverage levels for a 5-year period beginning in January 2019. DMC participating dairy operations locking in elections for the 5-year period will receive a premium discount of 25 percent off the premium rate per cwt in each applicable Tier table. For example, a dairy operation elects to lock-in coverage levels at $7 and 70 percent (5.6 million pounds) of the operation's 8 million pound production history. The applicable premium rate for a $7 margin trigger is $0.08 per cwt, discounted by 25 percent of the applicable premium rate will be $0.06, for the first 5 million pounds covered under Tier I (50,000 cwt × $0.06 = $3,000 premium). Likewise, in Tier II, the applicable premium rate for a $7 margin trigger is $1.107, discounted by 25 percent, the applicable premium rate of $0.83025 per cwt will be applied to the remainder of the covered pounds (5,600,000−5,000,000 = 600,000) above 5 million pounds that fall under Tier II (6,000 cwt × $0.83025 = $4,981.50). Therefore, in this example, the dairy operation will pay the same premium for each coverage year 2019 through 2023, in the amount of $7,981.50 (Tier I $3,000 + Tier II $4,981.50).

New dairy operations will be eligible for the premium rate discount for locking in coverage for the period beginning with the first available calendar year and ending in December 2023. Operations that are determined to be “new dairy operations” under this rule are dairy operations that have never established a production history under MPP-Dairy, and have begun producing and commercially marketing milk within 60 calendar days prior to registering to participate in DMC.

If there are producers in an operation that want to be considered new and are also part of another dairy operation participating in DMC, FSA must determine that the dairy operation is separate and distinct from the other DMC participating dairy operation. Under MPP-Dairy, separate participation by a new dairy operation that was purchased or acquired was subject to an affiliation test, however, under DMC, the affiliation test will no longer apply. The 2018 Farm Bill specifies that the Secretary may not make DMC payments to a dairy operation that is determined by FSA to have reorganized the structure of such operation for the sole purpose of qualifying as a new dairy operation.

Section 1407(f) of the 2014 Farm Bill, as amended by Section 1401(i) of the 2018 Farm Bill, specifies that dairy operations that participated in MPP-Dairy during any of calendar years 2014 through 2017 that submit an application on an approved form may receive a repayment in an amount equal to the difference between the total amount of premiums paid by the dairy operation for each applicable calendar year of coverage and the total amount of payments made to the MPP-Dairy participating dairy operation for that applicable calendar year. Coverage years that result in payments that exceeded premiums paid for that coverage year will yield a $0 calculation for that calendar year. The 2018 Farm Bill further specifies that a dairy operation that is eligible to receive the calculated repayment must elect to receive the repayment in either an amount that is equal to:

(1) 75 percent of the calculated repayment as a credit that may be used by the dairy operation towards DMC premiums; or

(2) 50 percent of the calculated repayment as a direct cash repayment.

FSA will determine the calculated repayment amounts for each year for each dairy operation that participated in MPP-Dairy. Adequate proof must be provided by the dairy operation, to the satisfaction of FSA, for any repayment amounts calculated by FSA under dispute. FSA will specify the time and manner to make a MPP-Dairy repayment request.

Once the choice of cash or credit is made by the dairy operation and approved by FSA, that choice cannot be changed. Dairy operations that elect the credit option can only use that credit in the DMC Program. If the entire credit is not used, for any reason, it cannot be applied as credit to any other USDA program and will have zero cash value and cannot be redeemed for any purpose.

Both cash and credit elections may be transferred to a dairy operation that succeeded to the dairy operation through a succession-in-interest transfer under MPP-Dairy and the successor is currently participating in DMC. Otherwise, the repayment election is not transferrable.

Dairy operations that give up their right to elect a premium repayment option or do not timely make application on a form specified by FSA are not eligible to receive a cash or credit benefit for premiums paid under MPP-Dairy.

Dairy operations eligible for the MPP-Dairy premium that elect the cash repayment option will have cash repayments issued in the same name as the entity that participated in the MPP-Dairy.

This rule includes provisions for MPP-Dairy in 7 CFR part 1430, subpart D, specifically to allow eligibility for LGM-Dairy producers for 2018 and allow for the MPP-Dairy premium repayments. These two provisions are the final actions for MPP-Dairy.

As specified in 7 U.S.C. 9091, the regulations to implement the provisions of Title I and the administration of Title I of the 2018 Farm Bill are exempt from:

• The Paperwork Reduction Act (44 U.S.C. chapter 35), and

• The notice and comment provisions of 5 U.S.C. 553.

In addition, 7 U.S.C. 9091(c)(3) directs the Secretary to use the authority provided in 5 U.S.C. 808, which provides that when an agency finds for good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, that the rule may take effect at such time as the agency determines. Due to the nature of the rule, the mandatory requirements of the 2018 Farm Bill, and the need to implement the dairy regulations expeditiously to provide assistance to dairy producers, FSA and CCC find that notice and public procedure are contrary to the public interest. Therefore, even though this rule is a major rule for purposes of the Congressional Review Act of 1996, FSA and CCC are not required to delay the effective date for 60 days from the date of publication to allow for Congressional review. Therefore, this rule is effective on the date of publication in the Federal Register.

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” established a federal policy to alleviate unnecessary regulatory burdens on the American people.

The Office of Management and Budget (OMB) designated this rule as economically significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has reviewed this rule. The costs and benefits of this rule are summarized below. The full cost benefit analysis is available on regulations.gov.

As a transfer rule, per OMB guidance, this rule is not covered by Executive Order 13371, “Reducing Regulation and Controlling Regulatory Costs.”

DMC provides a greater subsidized margin protection to producers compared to the expired MPP-Dairy, which is expected to lead to greater participation. DMC expands options for dairy operations to buy higher coverage for margins up to $9.50 per cwt, at incremental premium increases of $0.50 per cwt. The coverage limit under MPP-Dairy was $8.00 per cwt. In addition, the premium structure of the DMC Program favors high coverage levels for Tier I production history. Further, dairy operations are now able to cover as little as 5 percent of their production history compared to 25 percent minimum for MPP-Dairy. Dairy operations are allowed to participate concurrently in DMC and Livestock Gross Margin Insurance for Dairy (LGM-Dairy), which also has the potential to increase DMC participation. Finally, operations that were excluded from participating in MPP-Dairy during 2018 because they were participating in LGM-Dairy can sign up for 2018 MPP-Dairy coverage retroactively.

As a result of these changes, payments to producers from DMC are expected to be greater than for MPP-Dairy. USDA projections as of early 2019 indicate that, over the 10-year baseline period, DMC payments will be triggered frequently. With national feed costs expected to average about $9.14 over the life of the DMC Program, margins are expected to average $8.50 per cwt through 2023, even as milk prices recover from 2018 lows. DMC payments are less likely to trigger in the second half of the baseline period, 2024-2029, assuming lower feed prices and higher milk prices bring annual average margins near $10.29 per cwt.

Stochastic modelling results indicate that DMC would trigger significant outlays under current baseline projections. Allowing variation around the means for milk prices and feed ingredient costs in a stochastic model generates annual gross estimates averaging to $1.3 billion per year and collection of $89 million per year in fees and premiums paid by dairy program participants. For the 5-year life of the DMC Program, net expenditures through 2023 are projected to average $1.2 billion annually.

The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by Small Business Regulatory Enforcement Fairness Act, generally requires an agency to prepare a regulatory flexibility analysis of any rule whenever an agency is required by the Administrative Procedure Act or any other law to publish a proposed rule, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This rule is not subject to the Regulatory Flexibility Act because FSA and CCC are not required by any law to publish a proposed rule for this rulemaking initiative.

The environmental impacts of this final rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and the FSA regulations for compliance with NEPA (7 CFR part 799). FSA has determined that the provisions identified in this final rule are administrative in nature, intended to clarify the mandatory requirements of the programs, as defined in the 2018 Farm Bill, and do not constitute a major Federal action that would significantly affect the quality of the human environment, individually or cumulatively. The few discretionary features of the rules include establishing deadlines, determinations of eligibility and prices, and have been selected largely based on pre-existing USDA programs and continuation with clarification of duration of existing indemnifiation payments. Accordingly, these discretionary aspects are covered by the Categorical Exclusion, in § 799.31(b)(6)(iii), that applies to price support programs, and no Extraordinary Circumstances (§ 799.33) exist. Therefore, as this rule presents only administrative clarifications of mandatory requirements, FSA will not prepare an environmental assessment or environmental impact statement for this regulatory action; this rule serves as documentation of the programmatic environmental compliance decision for this federal action.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive Order are to foster an intergovernmental partnership and a strengthened Federalism, by relying on State and local processes for State and local government coordination and review of proposed federal financial assistance and direct federal development. For reasons specified in the final rule related notice regarding 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), the programs and activities in this rule are excluded from the scope of Executive Order 12372.

This rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” This rule will not preempt State or local laws, regulations, or policies unless they represent an irreconcilable conflict with this rule. This rule has retroactive effect for MPP-Dairy for calendar year 2018. Also, coverage for dairy operations that register during the 2019 re-enrollment period will be retroactive to January 1, 2019. Before any judicial actions may be brought regarding the provisions of this rule, the administrative appeal provisions of 7 CFR parts 11 and 780 are to be exhausted.

This rule has been reviewed under Executive Order 13132, “Federalism.” The policies contained in this rule do not have any substantial direct effect on States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, except as required by law. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.

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

The USDA's Office of Tribal Relations (OTR) has assessed the impact of this rule on Indian Tribes and determined that this rule has Tribal implications that required Tribal consultation under Executive Order 13175. Tribal consultation for this rule was included in the 2018 Farm Bill Tribal consultation held on May 1, 2019, at the National Museum of the American Indian, in Washington, DC. The portion of the Tribal consultation relative to this rule was conducted by Bill Northey, USDA Under Secretary for the Farm Production and Conservation mission area, as part of the Title I session. There were no specific comments from Tribes on the dairy rule during the Tribal consultation. If a Tribe requests additional consultation, FSA will work with OTR to ensure meaningful consultation is provided where changes, additions, and modifications identified in this rule are not expressly mandated by legislation.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) requires federal agencies to assess the effects of their regulatory actions of State, local, or Tribal governments or the private sector. Agencies generally must prepare a written statement, including cost benefits analysis, for proposed and final rules with federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no federal mandates as defined by Title II of UMRA for State, local, or Tribal governments, or the private sector. In addition, CCC is not required to publish a notice of proposed rulemaking for this rule. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The titles and numbers of the Federal assistance programs in the Catalog of Federal Domestic Assistance to which this rule applies are:

CCC and FSA are 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.

For the reasons discussed above, FSA and CCC amend the regulations in 7 CFR parts 760 and 1430 as follows:

On November 18, 2014, CCC published a Final Rule in the Federal Register (79 FR 68589) revising and amending the regulations that administer the Export Credit Guarantee (GSM-102) Program. On September 22, 2016, CCC published a Final Rule in the Federal Register (81 FR 65510) revising and amending the regulations that administer the Facility Guarantee Program (FGP). Both of these final rules incorporated certifications required of U.S. exporters, U.S. sellers, U.S. financial institutions and foreign financial institutions applying to participate in these programs. The certifications for the GSM-102 program are found at 7 CFR 1493.60, and those for the FGP at 7 CFR 1493.250. The certifications are, in part, based on Government-wide requirements related to suspension and debarment found at 2 CFR part 180 and prohibitions barring delinquent debtors from obtaining Federal loans, insurance and guarantees (31 CFR part 285). Certain certifications (at 7 CFR 1493.60(a)(1) through (4) and 7 CFR 1493.250(a)(1) through (4)) require the applicant to certify with respect to the applicant itself, as well as its “principals” and “affiliates” (as defined in 2 CFR part 180).

FAS is eliminating the requirement for applicants to make these certifications with respect to “affiliates,” for several reasons. First, there is no Government-wide or Department of Agriculture requirement to make these certifications with respect to “affiliates.” Neither the government-wide suspension and debarment regulations at 2 CFR part 180 nor the Department of Agriculture's form AD-1047 (“Certification Regarding Debarment, Suspension, and Other Responsibility Matters”) include affiliates. Second, FAS has determined that the affiliates of program participants generally do not have a relationship to the applicant's participation in CCC export credit guarantee programs. Third, the “affiliate” certification is burdensome on U.S. exporters, sellers, and U.S. and foreign financial institution participants that are large, and often diverse, organizations with many affiliates. This change will therefore reduce the burden on program applicants and participants.

In general, the Administrative Procedure Act (5 U.S.C. 553) requires that a notice of proposed rulemaking be published in the Federal Register and interested persons be given an opportunity to participate in the rulemaking through submission of written data, views, or arguments, except when the rule involves a matter relating to public property, loan, grants, benefits or contracts. The Administrative Procedure Act also states notice of proposed rulemaking is not required “when the agency for good cause finds . . . that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” Because this rule involves two loan guarantee programs, the regulations for this program are exempt from the notice and comment provisions of 5 U.S.C. 553. Additionally, the agency has determined that because this amendment will make the existing rules at 7 CFR part 1493 consistent with U.S. Government and Departmental certification requirements and will reduce burden on participants, notice of proposed rulemaking is unnecessary. It is in the public interest to implement these changes as soon as possible; therefore, this final rule is effective when published in the Federal Register .

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. This proposed rule has been determined to be not significant and was not reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

This rule has been reviewed for compliance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments, proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal government and Indian tribes. FAS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to the knowledge of FAS, have tribal implications that required tribal consultation under Executive Order 13175. If a tribe requests consultation, FAS will work with USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress.

Executive Order 13771 directs agencies to reduce regulation and control regulatory costs and provides that for every new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

Accordingly, for the reasons stated in the preamble, 7 CFR part 1493 is amended as follows:

This final rule is exempt from the Office of Management and Budget (OMB) review for purposes of Executive Order 12866 and, therefore, has not been reviewed by OMB.

This final rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. A notice of final rule entitled “Department Programs and Activities Excluded from Executive Order 12372,” (50 FR 47034) exempted the Rural Utilities Service loans and loan guarantees from coverage under this order.

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

This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this final rule does not have sufficient federalism implications to require preparation of a Federalism Assessment.

The Rural Utilities Service has been determined that the Regulatory Flexibility Act is not applicable to this rule since USDA Rural Utilities Service is not required by 5 U.S.C. 551 et seq. or any other provision of the law to publish a notice of proposed rulemaking with request to the subject matter of this rule.

This final rule contains no new reporting or recordkeeping burdens under OMB control number 0572-0076 that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended).

The program described by this final rule is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.850, Rural Electrification Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800.

This final rule contains no Federal Mandates (under the regulatory provision of title II of the Unfunded Mandates Reform Act of 1995 [2 U.S.C. chapter 25]) for State, local, and tribal governments or the private sector. Thus, this final rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.

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

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights in any program or activity conducted or funded by the Department. (Not all prohibited basis will apply to all programs and/or employment activities.) Remedies and complaint filing deadlines vary by program or incident. Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form (PDF), found online at http://www.ascr.usda.gov/complaint_filing_cust.html, or at any USDA office, or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992 to request the form. Submit your completed complaint form or letter to USDA by: (1) Mail at U.S. Department of Agriculture, Office of Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410, by Fax (202) 690-7442 or Email at program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

The Rural Utilities Service maintains bulletins that contain construction standards and specifications for materials and equipment. These standards and specifications apply to systems constructed by electric and telecommunications borrowers in accordance with the loan contract, and contain standard construction units, materials, and equipment units used on electric and telecommunications borrowers' systems. The following bulletins establish standards for the manufacture and inspection of wood utility poles, crossarms and pole keys: Bulletin 1728F-700, “RUS Specification for Wood Poles, Stubs and Anchor Logs” (incorporated by reference at § 1728.97); 7 CFR 1728.201 “Bulletin 1728H-701, Specification for Wood Crossarms (Solid and laminate), Transmission Timbers, and Pole Keys;” and 7 CFR 1728.202 “Bulletin 1728H- 702, Specification for Quality Control and Inspection of Timber Products.”

The Agency is affording the public an opportunity to comment on the following changes to standards and specifications as applied to systems constructed by electric and telecommunications borrowers:

1. Changes relevant to Bulletin 1728F-700 (incorporated by reference at § 1728.97), 7 CFR 1728.201, Bulletin 1728H-701, and 7 CFR 1728.202, Bulletin 1728H-702:

(a) Significantly limit the number of individual AWPA standards contained in the reference section of the current RUS specifications.

RUS references several other national standards/specifications in the wood products specifications. For the RUS standards to keep current with each of these referenced documents, RUS would basically have to change their wood product specifications to some degree every year. The AWPA standards referenced in RUS specifications could best be kept current by simply referencing two broad AWPA standards, AWPA Standard U1, User Specification for Treated Wood and AWPA Standard T1, Processing and Treatment Standard, rather than listing each individual AWPA standard that is currently referenced in the RUS wood product specifications. All the information contained in the long list of individual AWPA standards now found in the RUS wood product specifications is found somewhere in either of these two AWPA standards.

(b) Add language to the specifications requiring that all third-party agencies involved in the inspection of RUS products must, on an annual basis, provide RUS Technical Standards Committee “A” with proof that the agency does have: (1) The required insurance coverage, and (2) the required, fully equipped laboratory capable of running each of the referee methods of analysis.

While these two requirements themselves are not new, providing proof of such to RUS on an annual basis is new. The reason for making this change is that in recent years, there apparently have been several instances where third-party agencies involved in RUS inspection did not have the required insurance or the required lab facilities. Given that RUS currently does not have the ability to provide an active overview of these third-party agencies, this change simply provides RUS with a method for checking the basic legitimacy of any company involved in the inspection of RUS treated wood products. It also provides both RUS and the cooperative borrower with some possible source of fiscal recovery if problems with product service in line can be traced back to performance issues involving the third-party agency being utilized.

(c) Addition of language that clearly defines the different function of plant quality control versus the function of third-party inspection.

This is a small but important change, in that over the past 30-40 years there has been a deliberate ongoing attempt by many former and some current inspection agencies to blur the distinction between the two functions to promote their inspection services. It is extremely important that the cooperative utilities using these RUS specifications understand exactly what the different function of plant quality control and of third-party inspectors are, that these two are separate and distinct functions, and that each has very specific requirements. Clarifying the two will make it clear that the responsibility for product quality does and always has rested with the producer, eliminating the widespread fallacy that the responsibility for product quality lies with the third-party inspector.

(2) Changes relevant only to Bulletin 1728F-700, (7 CFR 1728.97, Incorporation by reference of electric standards and specifications, (incorporation approved for 7 CFR 1728.98) and 7 CFR 1728.202, Bulletin 1728H-702:

Addition of language listing the referee methods of analysis for each of the major types of preservatives used to treat RUS poles and crossarms.

Over the last couple of decades, much of the wet chemistry that was previously used to run retention analyses on treated wood poles and crossarms has shifted to more modern and efficient methods, such as X-ray fluorescence. This addition simply notes the current referee methods for plant quality control labs and for the laboratories that must be maintained by any third-party inspection agency involved in the inspection of RUS treated wood products.

(3) Changes relevant only to Bulletin 1728F-700, “Specification for Wood Poles, Stubs and Anchor Logs (incorporated by reference at § 1728.97):”

(a) Eliminate northern white cedar as an acceptable pole species, and eliminate any reference to it.

No manufacturer has produced a northern white cedar pole in over four decades. Given the availability of many other far superior species of trees for use as poles and crossarms, northern white cedar will not be used for poles again. Removing it from the specification does not affect a single producer.

(b) Change the restriction on the defect known as shelling to match the shelling restrictions recently adopted by ANSI in their O5.1 pole specification.

RUS currently restricts shelling to no more than one inch deep at any point on a pole's surface. That used to match the ANSI restriction for the same defect. Knowing this is a very dangerous defect that can cause utilities a lot of problems, several years ago ANSI decided to add an additional restriction to their shelling allowance. The current ANSI O5.1 language on shelling restrictions reads “Shelling on the surface of the pole shall be limited to no more than one inch in depth nor exceed 1/3 of the pole's circumference at the point of shelling.” Manufacturers are already operating under the current ANSI shelling restriction, so RUS adopting it in their specification will have no impact on the industry while providing a better overall product for cooperatives.

(c) Modify the language in the RUS specification dealing with rate of growth requirements for poles.

RUS has always had a rate of growth requirement (ring count requirement) to ensure that the trees used for poles have adequate strength characteristics. Given that ring count is a critical component in determining the strength of an individual pole, the proposed language modification to denote a “referee” method for determining ring count is a very important improvement to the current RUS specifications. This change will have no impact on the way ring count is currently determined, just provides clarification about how any difference of opinion over ring count in an individual pole is to be determined if there is a difference of opinion on the issue between two parties.

(d) Modify the language that “no pole treated with an oil-borne preservative (penta and copper naphthenate) or with creosote can be shipped to a RUS borrower more than two years after its original treatment date” to also include poles treated with water-borne preservatives such as CCA or ACZA.

The language modification is to make this two-year restriction applicable to all RUS poles, regardless of type of treatment. This change will bring all of the major preservatives under the same restriction. Given that both oil-borne preservatives and creosote do migrate over time to the low side of stored poles, it prevented potential problems with pole service life due to possibly significantly lower preservative content on the top side of poles held in a producer's treated stock for an extended period. This two year “drop-dead” requirement also encouraged manufacturers to rotate their stock on a reasonably short basis, meaning they could provide their cooperative customers with the “new” fresher poles that utilities expected when they made pole purchases.

(e) Addition of a specific listing in Table 10 in Appendix A of Bulletin 1728F-700, the pole specification, that allows for the treatment Alaska Yellow Cedar with copper naphthenate.

Normally when cedar poles are produced, the vast bulk of the cedar itself is one species, western red cedar. However, a small amount of that volume might also be Alaska yellow cedar. The two species are quite similar in the way they look and treat. Apparently at least one large producer in the western region has developed a significant supply of Alaska yellow cedar that they wanted to produce and treat with copper naphthenate on a full charge basis. The species is a very good pole species, but there was no allowance for treating full charges composed of only Alaska yellow cedar in RUS Table 10. This change will add that allowance to Table 10. Overall, it will have a negligible impact on the industry because of the relatively scarcity of pure stands of Alaska yellow cedar.

(4) The following changes in the rule making are relevant only to 7 CFR 1728.201, RUS Bulletin 1728H-701, “Specification for Wood Crossarms (Solid and Laminated), Transmission Timbers and Pole Keys.”

(a) Eliminate the allowance for producing thermal non-pressure treated crossarms.

The last thermal dip treating facility for crossarms was closed over 35 years ago. All of the crossarms produced today, whether Douglas-fir or southern pine, are pressure treated. Pressure treatment provides a much more uniform treatment and a far better product.

(b) Slight modification of the language contained in the one-year warranty for RUS crossarms to address the fact that no crossarms are sold directly from a crossarm producer to a cooperative, but rather are sold only through distributorships.

The current language in the crossarm warranty states “If any crossarm is determined to be defective within 1 year after delivery to the borrower, it shall be replaced as promptly as possible by the producer.” The modification simply replaces the word “producer” with the word “supplier”. The term “supplier” is already properly defined elsewhere in the specification.

(5) The following changes in the rule making are relevant only to 7 CFR 1728.202, Bulletin 1728H-702, “Specification for Quality Control and Inspection of Timber Products.”

(a) Remove the Insured Warranty Program (IW) as a purchase plan for poles.

The IW program was started back in the late 60's as another option for cooperative borrowers to use for inspection of RUS treated poles they were purchasing. The IW program ended in the mid 70's. Given that insurance premiums on a natural product like a wood pole or crossarm are very expensive (if an agency will even provide the coverage at all), and that there are other effective purchase plans available to cooperatives, and that IW hasn't been used in over 40 years, it needs to be removed from the specifications.

(b) Relocation of appendix A (formerly located in § 1728.202).

Appendix A, Inspector's Qualifications, was formerly located in § 1728.202. It is relocated to new § 1728.203, Inspector's qualifications, to comply with the codification requirements in 1 CFR chapter I.

Bulletin 1728F-700, RUS Specification for Wood Poles, Stubs and Anchor Logs. This specification describes the minimum acceptable quality of wood poles, stubs, telephone pedestal stubs, and anchor logs (hereinafter called poles, except where specifically referred to as stubs or anchor logs) purchased by or for RUS borrowers. The requirements of this specification implement contractual provisions between RUS and borrowers receiving financial assistance from RUS.

RUS provides free online public access to view and download copies of Bulletin 1728-F 700. The RUS website to view and download this bulletin is: https://www.rd.usda.gov/publications/regulations-guidelines/bulletins/electric.

AITC 200-2009, Manufacturing Quality Control Systems Manual for Structural Glued Laminated Timber, details requirements for quality control in accordance with the ANSI/AITC A190.1-1992. Laminators quality control system and inspection of plant quality control system by AITC Inspection Bureau are detailed. Topics addressed are personnel, equipment and facilities, quality control of production operations, testing and inspection requirements, test procedures, AITC tests, definitions and annexes. Recommended for manufacturers of glued laminated timber, third party testing and inspection agencies, and quality assurance agencies.

AITC Publications may be available for a fee by calling 503-639-0651, or as a free download online at their web address: https://www.aitc-glulam.org/index.asp. The AITC 200-2009 standard is reasonably available for a fee.

ANSI O5.2-2012, Structural Glued Laminated Timber for Utility Structures, covers requirements for manufacturing and quality control of structural glued laminated timber of Southern Pine, Coastal Region Douglas Fir, Hem Fir and other species of similar treatability for electric power and communication structures.

ANSI 05.3-2015, Solid Sawn Wood Crossarms & Braces: Specifications & Dimensions, consists of specifications covering solid sawn-wood crossarms and braces manufactured from coastal Douglas-fir and from dense Southern pine. The specifications are intended to cover communications crossarms, power crossarms, heavy-duty crossarms, and heavy-duty braces.

ANSI standards are reasonably available to obtain by calling 212-642-4980 or by online access at their web address: https://webstore.ansi.org/ for a fee. ANSI O5.2-2012 and ANSI O5.3-2015 are also available for a fee in ANSI O5.—Wood Poles Package.

AWPA A6-15, Method for the Determination of Oil-Type Preservatives and Water in Wood. This method is suitable for the determination of creosote, petroleum, and their solutions in treated wood when the sample contains at least 5.0 grams of wood and one gram of oil.

Additives, such as copper naphthenate or pentachlorophenol, may not be quantitatively extracted by this method. The method can also be used for the determination of water in treated or untreated wood, but when it is so used, the directions on handling the sample in Standard M2 must be followed carefully.

AWPA A9-18, Standard Method for Analysis of Treated Wood and Treating Solutions By X-Ray Spectroscopy. This method provides for the non-destructive analysis of treated wood and treating solutions by X-ray fluorescence spectroscopy and is applicable to the determination of elements of atomic number 5 or higher that are present in significant quantity in the wood (usually above 0.05%). The elements covered in this method are specified for use in preservative and fire-retardant treatment of wood.

AWPA A15-18, Referee Methods. Referee methods are given to assist in the resolution of disputes over the acceptability of the active(s) in treated wood products.

AWPA A83-18, Standard Method for Determination of Chloride for Calculating Pentachlorophenol in solution or Wood. The Methods, commonly called the “lime ignition” method, describes the chemical analysis of treating solutions which contain pentachlorophenol, of pentachlorophenol concentrates, and of wood treated with pentachlorophenol.

AWPA M2-16, Standard for the Inspection of Preservative Treated Products for Industrial Use. This Standard provides procedures for inspection at wood preserving plants of industrial products including but not limited to poles, crossarms, piling, ties, timbers, round posts and composite wood products. This Standard also contains detailed procedures and test methods for determining the conformance of treated wood products with specified standards or other written product quality specifications.

AWPA M3-16, Standard for the Quality Control of Preservative Treated Products for Industrial Use. This Standard provides procedures for quality control at wood preserving plants of industrial products, including but not limited to poles, crossarms, piling, ties, timbers, round posts and composite wood products. This standard contains minimum requirements for the treating plant quality control to monitor the treating plant and process, sample treated products and determine conformance to the applicable portions of Standards U1 and T1 or other written product quality specifications.

AWPA T1-18, Use Category System: Processing and Treatment Standard This Processing and Treatment Standard contains the minimum requirements and process limitations for treating wood products under the AWPA Standards. This includes conditioning of material for treatment, treatment processes and limitations, end-results of treatment, post treatment handling, and quality control applicable to all commodities treated under the AWPA Use Category System.

AWPA U1-18, Use Category System: User Specification for Treated Wood. The Use Category System (UCS) of the American Wood Protection Association (AWPA) designates what preservative systems and retentions have been determined to be effective in protecting wood products under specified exposure conditions.

AWPA standards are reasonably available to obtain for a fee by calling 1-855-999-9870 or by online access at the web address: https://www.techstreet.com/standards/awpa-a9-18?product_id=2017417 for a fee. AWPA standards are also available for a fee in 2018 AWPA Book of Standards at http://www.awpa.com/standards/index.asp.

Standard Grading Rules for Southern Pine Lumber, 2014 Edition. Standard definitions and classifications of the most common characteristics and causes for grade limitation for Southern Pine lumber are provided. Also provided are descriptions of the characteristics allowed in southern pine lumber and other information such as general grade characteristics, definitions of lumber for different uses, moisture content, claim procedures and significant classes of lumber. The Inspection and Shipping Provisions of the Standard Grading Rules for Southern Pine Lumber represents customary usage and fair-trade practice.

This standard is reasonably available to obtain by online access at the web address for a fee by an order form: https://www.spib.org/docs/litorderform.pdf for a fee. Order forms can be emailed to spib@spib.org or faxed to 850-434-1290.

Standard No. 17, Grading Rules for West Coast Lumber. These rules apply to lumber species manufactured from timber grown in the West Coast region which includes the summit area of the Cascade Mountains and west to the Pacific Ocean in the states of Washington and Oregon, and in the entire state of California, and to those species of foreign origin specifically listed in these rules.

This standard is reasonably available by online access at the web address: https://www.wclib.org/publications/rules-17/ for a free download or purchase for a fee.

For reasons set forth in the preamble, chapter XVII of title 7 of the Code of Federal Regulations is amended as follows:

On March 25, 2019, we published in the Federal Register (84 FR 11170-11196, Docket No. APHIS-2007-0127) a final rule that amended the regulations in parts 54 and 79 by changing the requirements for records needed to trace animals, and by adding provisions to link official individual animal identification applied by persons other than the flock owner to the flock of origin in the National Scrapie Database rather than just the person who applied the official identification. As part of this change, we added some paragraphs to § 79.6(a) and redesignated others. Specifically, § 79.6(a)(10)(i) was redesignated as § 79.6(a)(12). However, in § 79.2(a)(1), footnote 4 refers to the identification requirements in § 79.6(a)(10)(i), and we did not update the reference in the footnote to reflect that change. This document corrects that error.

Accordingly, we are amending 9 CFR part 79 as follows:

Correction

In the preamble to the final rule published on March 5, 2019 (84 FR 7793) FHFA stated that data on servicer performance is included in quarterly PMRs. Actually, data on servicer performance is not included in quarterly PRMs.

In FR Doc. 2019-03934 appearing on page 7793 in the Federal Register of Tuesday, March 5, 2019, make the following correction in the SUPPLEMENTARY INFORMATION section. On page 7798, in the left column, on lines 7 through 11, correct the sentence “FHFA currently receives and monitors data that include information on servicer performance, and publishes that information in quarterly PMRs” to read “FHFA currently receives and monitors data that include information on servicer performance.”

The FAA learned of five commanded IFSD events that occurred on certain CFM LEAP-1B model turbofan engines beginning in August 2018. CFM's investigations identified debris on the TGB scavenge screen, A-sump screen, and other screens. Subsequently, CFM determined that these IFSD events were the result of inadequate oil flow to the RDS bearing, which caused the RDS bearing cage to fail. This condition, if not addressed, could result in failure of one or more engines, loss of thrust control, and loss of the airplane. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA reviewed CFM Service Bulletin (SB) LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019. The SB describes procedures for inspections of TGB scavenge screens and borescope inspection (BSI) of the RDS bearing. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA reviewed CFM SB LEAP-1B-72-00-0256-01A-930A-D, Issue 003, dated May 17, 2019. The SB describes procedures for an optional BSI of the RDS bearing. CFM has cancelled this SB and transferred its content to CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019.

The FAA is issuing this AD because it evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires initial and repetitive inspections of the TGB scavenge screens and, depending on the results of the inspection, possible removal of the engine from service.

The FAA considers this AD interim action. The manufacturer is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, the FAA might consider additional rulemaking.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule. The affected CFM LEAP-1B model turbofan engines experienced multiple RDS bearing cage failures in the last five months resulting in five IFSDs. The TGB scavenge screens must be inspected before accumulating between 100-250 flight hours since new on the RDS bearing or within 50 FHs after the effective date of this AD to prevent the failure of the RDS bearing, which could lead to in-flight shutdown of both engines, loss of thrust control, and loss of the airplane. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2019-0414 and Product Identifier 2019-NE-15-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 136 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

This AD will not have federalism implications under Executive Order 13132. This AD will not have 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Congress enacted the CPSIA (Pub. L. 110-314, 122 Stat. 3016), including the Danny Keysar Child Product Safety Notification Act, on August 14, 2008. Section 104(b) of the CPSIA requires the Commission to: (1) Examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts; and (2) issue consumer product safety standards for durable infant or toddler products. 15 U.S.C. 2056a(b)(1). Any standard the Commission adopts under this mandate must be “substantially the same as” the voluntary standard, or more stringent than the voluntary standard if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product. Id. Section 104(f)(1) of the CPSIA defines the term “durable infant or toddler product” as “a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years,” and lists SACs as a durable infant or toddler product. Id. 2056a(f).

On June 19, 2018, the Commission issued a notice of proposed rulemaking (NPR), proposing to incorporate by reference the voluntary standard for SACs, ASTM F2012-18 ε 1 , without modifications. 83 FR 28390. ASTM F2012-18 ε 1 is still the current version of the standard.

In this final rule, the Commission incorporates by reference ASTM F2012-18 ε 1 , with no modifications, as the mandatory safety standard for SACs. CPSC staff consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and the public to develop this standard, largely through the ASTM standard-development process. In addition, this final rule amends the list of NORs in 16 CFR part 1112 to include the standard for SACs. This rule is based on information in CPSC staff's briefing package, “Staff's Draft Final Rule for Stationary Activity Centers Under the Danny Keysar Child Product Safety Notification Act,” which is available on CPSC's website.

ASTM F2012-18 ε 1 defines a SAC as “a freestanding product intended to remain stationary that enables a sitting or standing occupant whose torso is completely surrounded by the product to walk, rock, play, spin or bounce, or all of these, within a limited range of motion.” ASTM F2012-18 ε 1 , section 3.1.12. This definition does not include doorway jumpers.

SACs are intended for children who are not yet able to walk, but who are able to hold up their heads unassisted. SACs vary in style and design complexity, but typically consist of a seat that is suspended from a frame by springs or supported from the bottom by a fixed base. ASTM F2012-18 ε 1 defines three types of SACs: Closed-base SACs, open-base SACs, and spring-supported SACs. The standard defines each of these terms, as follows:

• A closed-base SAC is “a stationary activity center that does not allow the occupant's feet to contact the floor when the product is in any manufacturer's recommended use position” (section 3.1.1.);

• an open-base SAC is “a stationary activity center that allows the occupant's feet to contact the floor” (section 3.1.7); and

• a spring-supported SAC is “a stationary activity center in which the sitting or standing platform is supported from below or suspended from above by springs (or equivalent resilient members)” (section 3.1.10).

SACs typically range in price from $40 to $150, with spring-supported SACs typically ranging from $70 to $150. Some manufacturers produce multiple models, and several produce models that are similar in design, but with different accessories. SACs typically accommodate children who weigh less than 25 pounds and have a maximum height of 32 inches.

There were approximately 7.5 million  1 SACs in U.S. households with children under 5 years old in 2013, according to CPSC's 2013 Durable Nursery Product Exposure Survey. However, only about 4.1 million of these SACs were actually in use. 2

CPSC staff identified 11 domestic firms that currently supply SACs to the U.S. market. These firms primarily specialize in manufacturing children's products. According to the U.S. Small Business Administration's (SBA) standards, 3 7 of the 11 firms are small businesses. All seven firms manufacture SACs; staff did not identify any small domestic importers of SACs. Of the seven small manufacturers, three produce spring-supported SACs. The Juvenile Products Manufacturers Association (JPMA) certifies the SACs of all seven firms, which indicates that these SACs comply with the ASTM standard and undergo third party testing.

CPSC receives data about product-related injuries from several sources. One source is the National Electronic Injury Surveillance System (NEISS), from which CPSC may obtain estimates based on a probability sample, determined by sampling weights from NEISS hospitals projected to national estimates. Other sources include reports from consumers and others through the Consumer Product Safety Risk Management System (which also includes some NEISS data) and reports from retailers and manufacturers through CPSC's Retailer Reporting System—CPSC refers to these sources collectively as Consumer Product Safety Risk Management System data (CPSRMS).

CPSC staff reviewed the NEISS and CPSRMS databases for incidents involving SACs. For the NPR, staff reviewed incident data reported to have occurred between January 1, 2013 and September 30, 2017. For the final rule, staff updated this review to include incident data received from October 1, 2017 through February 20, 2019. This updated review includes additional incident data reported to have occurred between January 1, 2013 and September 30, 2017, as well as new incidents that occurred between October 1, 2017 and February 20, 2019. Because reporting is ongoing, the number of reported incidents may change. For both the NPR and updated data periods, the number of injuries associated with SACs treated in U.S. EDs was insufficient for staff to derive reportable national estimates. 4 For this reason, staff has not provided injury estimates. However, injuries associated with SACs treated in U.S. EDs are included in the total count of reported incidents presented below.

CPSC is not aware of any fatalities associated with SACs that occurred between January 1, 2013 and February 20, 2019.

CPSC is aware of 4,035 nonfatal incidents related to SACs that reportedly occurred between January 1, 2013 and February 20, 2019. CPSC had received reports of 3,488 of these incidents at the time of the NPR; since the NPR, CPSC received 547 additional reports of SAC incidents that reportedly occurred between January 1, 2013 and February 20, 2019. Of the 4,035 total incidents, 359 reportedly resulted in injuries (CPSC had received reports of 304 of these injury incidents at the time of the NPR, and received 55 additional injury reports since the NPR). The remaining 3,676 incidents either did not result in injuries, or did not include sufficient information to determine whether an injury occurred (CPSC had received reports of 3,184 of these incidents at the time of the NPR, and received 492 additional reports since the NPR). Although these reports did not indicate that an injury occurred, many of the incident descriptions indicated the potential for a serious injury.

Of the 304 incidents that had reportedly resulted in injuries at the time of the NPR, 24 of the injured children were treated and released from a U.S. ED. A majority of the injured children suffered a fall, resulting in head injuries, limb fractures, and contusions. A few children treated in U.S. EDs suffered foot, leg, or pelvic bruising, or fractures or swelling while jumping in the product. One child had an allergic reaction to the product's finish or materials, and the limbs of two children became entrapped in the product. Among the remaining 280 injury reports, some identified the type of injury sustained, while others only mentioned an injury, but provided no specifics about the injury. Some of the commonly reported injuries were fractures, head injuries, concussions, teeth injury, abrasions, contusions, and lacerations.

Of the 55 injury incidents reported since the NPR, there were reports of head contusions; arm and leg contusions, abrasions, and lacerations; hand contusions, abrasions, lacerations, and blisters; finger entrapments; mouth lacerations; torso abrasions; a nose contusion; a torso abrasion; a leg fracture; and a skull fracture. Three children suffered allergic reactions to the product finish or material, and one child experienced a choking episode. Three children suffered multiple injuries.

The majority of reported incidents and injuries involved children between 6 months old and 11 months old. Of the 4,035 total incidents, 13 percent involved children under 6 months old; 60 percent involved children between 6 and 11 months old; 7 percent involved children between 12 and 17 months old; 1 percent involved children between 18 and 23 months old; and 18 percent did not report the age of the victim. 5 Of the 359 incidents that reportedly resulted in injuries, 20 percent involved children under 6 months old; 60 percent involved children between 6 and 11 months old; 6 percent involved children between 12 and 17 months old; 1 percent involved children between 18 and 23 months old; and 12 percent did not report the age of the victim. 6

The hazards reported in the new incidents are consistent with the hazard patterns staff identified in the incidents presented in the NPR. Table 1 lists the number and percentage of the 4,035 total reported incidents within each hazard pattern.

Spring issues. These incidents involved problems with the springs that attach the seat of the SAC to the frame. A total of 1,756 incident reports CPSC received between January 1, 2013 and February 20, 2019 involved spring issues (CPSC received 1,617 of these reports before the NPR and 139 after the NPR). Thirty of these incidents reportedly resulted in injuries, including 1 injury treated in a U.S. ED (CPSC received 27 of these reports before the NPR and 3 after the NPR).

Problems with toy accessories. These incidents involved problems with the toy accessories attached to SACs, including detached small parts posing a choking hazard, toys striking children in the face, toys pinching or entrapping children's fingers, and laceration hazards caused by sharp edges or surfaces. A total of 1,166 incident reports CPSC received between January 1, 2013 and February 20, 2019 involved toy accessory issues (CPSC received 1,075 of these before the NPR and 91 after the NPR). Of these 1,166 incidents, 169 reportedly resulted in injuries, including 15 injuries treated in U.S. EDs (CPSC received 156 of these reports before the NPR and 91 after the NPR).

Strap issues. These incidents involved torn, fraying, twisted, or detached straps. Typically, the strap system on a SAC is attached to a support spring and serves as the primary means of support for most spring-supported SACs. If the strap fails, the SAC may be unsupported on one side and often results in a child falling. A total of 513 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved strap issues (CPSC received 306 of these before the NPR and 207 after the NPR). Of these 513 incidents, 42 reportedly resulted in injuries, including one injury treated in a U.S. ED (CPSC received 30 of these reports before the NPR and 12 after the NPR).

Structural integrity problems. These incidents involved a problem with structural components, such as frame tube damage, broken battery cover tabs, loose screws or small parts, broken activity bars, and problems with locks, which led to product collapse, detachment of the top and bottom parts of the SAC, or failure of the height adjustment mechanism. A total of 166 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved structural integrity issues (CPSC received 158 of these before the NPR and 8 after the NPR). Twelve of these incidents reportedly resulted in injuries (CPSC received all 12 of these reports before the NPR).

Problems with seats or seat pads. These incidents included stitching on the seat pad fraying or tearing; tabs used to attach the pad to the seat frame breaking, tearing, or separating; attachments disassembling and causing the seat pad to fall; inadequately constrictive leg openings; seat fabric detaching from pegs; ripped seat pads; and rough seat pad material. A total of 136 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved seat or seat pad issues (CPSC received 122 of these before the NPR and 214 after the NPR). Thirteen of these incidents reportedly resulted in injuries (CPSC received 12 of these reports before the NPR and 1 after the NPR).

Stability issues. These incidents involved SACs leaning to one side, lifting off the floor, or tipping over during use. A total of 112 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved stability issues (CPSC received 76 of these before the NPR and 36 after the NPR). Thirteen of these incidents reportedly resulted in injuries, including two injuries treated in U.S. EDs (CPSC received four of these reports before the NPR and nine after the NPR).

Design issues. These incidents involved problems with the design of the SAC, such as entrapment of limbs or extremities, failure of the seat to contain a child, placement of structural components that made it easier for a child to get hurt during routine use, mold buildup in a wire compartment, the base of the product disassembling while a child jumped in it, and straps that loosen when a baby kicks them. A total of 59 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved design issues (CPSC received 32 of these before the NPR and 27 after the NPR). Of these 59 incidents, 26 reportedly resulted in injuries, including two injuries treated in U.S. EDs (CPSC received 20 of these reports before the NPR and six after the NPR).

Electrical problems. These incidents involved melting, leaking, or corroded batteries, or failure of the circuit board on the product. A total of 38 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved electrical issues (CPSC received 36 of these before the NPR and 2 after the NPR). Two of these incidents reportedly resulted in injuries (CPSC received both of these reports before the NPR).

Miscellaneous or other problems. These incidents involved the product falling from an elevated surface; a rough surface, sharp edges, or protrusions; problems with the paint or finish; problems with the product packaging; allergic reactions to the product; and a loose unraveling string. A total of 31 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved miscellaneous or other issues (CPSC received 22 of these before the NPR and 9 after the NPR). Eighteen of these incidents reportedly resulted in injuries, including five injuries treated in U.S. EDs (CPSC received 13 of these reports before the NPR and 5 after the NPR).

Multiple problems. These incidents involved more than one of the hazard patterns listed above. CPSC staff could not determine the priority of the hazard patterns involved. A total of 32 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved multiple issues (CPSC received 20 of these before the NPR and 12 after the NPR). Nine of these incidents reportedly resulted in injuries (CPSC received five of these reports before the NPR and four after the NPR).

Unspecified or unknown problems. These reports provided incomplete or unclear descriptions of the incident. A total of 26 incident reports CPSC received between January 1, 2013 and February 20, 2019, involved unspecified or unknown issues (CPSC received 24 of these before the NPR and 2 after the NPR). Twenty-five of these incidents reportedly resulted in injuries, mostly resulting from falls, and included 17 injuries treated in U.S. EDs (CPSC received 23 of these reports before the NPR and 2 after the NPR).

In the preamble to the NPR, the Commission reported that one consumer-level recall between January 2013 and March 2018, involved a SAC. 8 The hazard that prompted the recall was a toy attachment on the SAC, which posed an impact hazard when it rebounded. The firm received 100 reports of incidents, including 61 reported injuries. The injuries included bruises and lacerations to the face, a 7-month-old child who sustained a lineal skull fracture, and an adult who sustained a chipped tooth. The recall involved 400,000 units in the United States. There have not been any additional consumer-level recalls of SACs since the NPR.

ASTM F2012 addresses the hazard patterns associated with SACs. ASTM first approved and published the standard in 2000, as ASTM F2012-00, Standard Consumer Safety Specification for Stationary Activity Centers. ASTM has revised the standard several times since then. In the NPR, the Commission proposed to incorporate by reference the then-current version of the standard, ASTM F2012-118 ε 1 , with no modifications. ASTM approved ASTM F2012-18 ε 1 on March 1, 2018, and published it in March 2018. ASTM F2012-18 ε 1 is still the current version of the standard.

ASTM F2012-18 ε 1 adequately addresses the risk of injuries and deaths associated with SACs. The standard addresses multiple hazards, including the hazard patterns that make up the majority of incidents and injuries in the SAC incident data. ASTM F2012-18 ε 1 includes requirements to address the following hazards:

• Sharp edges and points;

• small parts;

• latching or locking mechanisms to prevent unintentional folding;

• openings;

• scissoring, shearing, and pinching;

• exposed coil springs;

• toy accessories sold with SACs;

• protective components;

• spring failures on spring-supported SACs;

• structural integrity;

• leg openings;

• stability (including tip overs and seat tilt); and

• motion resistance.

The standard also includes requirements for warning labels and instructional literature. On-product warning labels inform caretakers of the risks of strangulation and occupants falling from SACs; the potential severity of resulting injuries; and how to avoid these hazards. The instructions that accompany SACs also include these warnings, as well as developmental criteria to explain when to begin using the product and when to discontinue use.

ASTM F2012-18 ε 1 addresses the four primary hazard patterns associated with SACs in the incident data. These are: (1) Spring issues (44 percent of incidents); (2) problems with toy accessories (29 percent of incidents); (3) strap issues (13 percent of incidents); and (4) structural integrity problems (4 percent of incidents). This section discusses how ASTM F2012-18 ε 1 addresses each of these hazard patterns.

Spring issues. Spring issues typically involve SACs in which the activity tray and child hang from springs at multiple points. These incidents often involve one or more parts of the spring system failing, which can result in the child falling out of the SAC when it tilts, tips, topples, or leans from the manufacturer's recommended-use position. ASTM F2012-18 ε 1 addresses this hazard with a performance requirement that support springs withstand 100 drops from a 33-pound weight from a height of at least 1 inch. In addition, based on input from CPSC staff, ASTM F2012-18 ε 1 requires a secondary support for load-bearing springs, so that there is a redundant system to prevent the seat from falling if a spring fails. CPSC concludes that these requirements adequately address the spring issues indicated in the incident data.

Problems with toy accessories. The majority of reported problems with toy accessories involve detached small parts causing choking or gagging, toys striking children in the face, pinch or entrapment points created by small gaps, and lacerations from sharp edges. ASTM F2012-18 ε 1 addresses these hazards by requiring toy accessories for SACs, and their means of attachment, to meet relevant requirements in ASTM F963-17, Standard Consumer Safety Specification for Toy Safety (ASTM F963). ASTM F963 includes requirements that address the hazards evident in the injury data, including choking, ingestion, and inhalation hazards from small objects; sharp edges, hazardous points, and hazardous projections; folding mechanisms and hinges; and entanglement and strangulation hazards from cords, straps, and elastics. CPSC concludes that ASTM F963 adequately addresses the majority of hazards related to toy accessories on SACs.

Strap issues. The strap system on a SAC supports the occupant's weight and allows the occupant to bounce. The strap system is the primary means of support for most spring-supported SACs. A typical spring-supported SAC includes a strap system that connects at the top to the frame structure, and at the bottom to the side or underside of the carrier, to support the occupant. The length of the strap system typically consists of an upper segment that serves as the frame support strap, a lower segment that serves as the occupant support strap, and a middle section that consists of a spring to allow the occupant to bounce. Because the strap system serves as the primary means of support for most spring-supported SACs, if the strap fails, the SAC may be unsupported on one side, resulting in a child falling. Incidents involving strap issues include torn, fraying, twisted, or detached straps.

To address this hazard, ASTM F2012-18 ε 1 requires dynamic and static loading at the seat of the product to evaluate the durability of the support structures for the seat. This testing also stresses the structural integrity components of the product, such as straps. The standard requires that the product show no failure of seams, material breakage, or changes of adjustments that could cause the product to not fully support the child. CPSC staff concludes that these provisions adequately address the strap issues indicated in the incident data.

As the NPR discussed, while preparing the NPR, CPSC staff learned of one product in which the occupant support strap frayed and broke because the strap rubbed against a metal buckle during normal use. The support structure durability requirements in ASTM F2012-18 ε 1 do not address this scenario. On April 27, 2018, CPSC staff requested that ASTM address this hazard scenario, and ASTM created a task group to review the issue. The NPR requested comments about this issue, but CPSC received none. CPSC staff is participating in the ASTM task group, and the task group is making progress toward developing a requirement to address fraying straps. In this final rule, the Commission is not adopting an additional requirement to address this hazard because: (1) The ASTM task group has made progress toward developing a requirement to address fraying straps; (2) CPSC is aware of only one product that involved this issue; and (3) the one product has been redesigned with parts that will not cause the strap to fray.

Structural integrity problems. Incidents involving structural integrity problems include frame tube damage; loose screws; broken activity bars; and problems with locks that lead to the product collapsing, the top and bottom parts of the product detaching, or the height adjustment mechanism failing. To address these issues, ASTM F2012-18 ε 1 requires dynamic and static loading at the seat of the SAC to evaluate the durability of the support structures for the seat. This testing also stresses the structural integrity components of the SAC. The standard requires that the product show no failure of seams, material breakage, or changes of adjustments that could cause the product to not fully support the occupant. CPSC concludes that these requirements are adequate to address the structural integrity issues indicated in the incident data.

CPSC received two comments in response to the NPR. The comments are available in the docket for this rulemaking, CPSC-2018-0015, at: www.regulations.gov.

The first comment, from JPMA (a national non-profit trade association that represents producers, importers, and distributors of childcare articles), expressed support for the proposed rule and CPSC staff's collaboration with ASTM. The second comment also expressed general support for the proposed rule, but stated that there should be oversight of small manufacturers and importers. It appears that the commenter misunderstood the Regulatory Flexibility Act (RFA) analysis to mean that the rule would not apply to small entities; this is incorrect. The rule applies to all manufacturers and importers of SACs sold in the United States.

The Office of the Federal Register (OFR) has regulations regarding incorporation by reference. 1 CFR part 51. These regulations require the preamble to a final rule to summarize the material the agency is incorporating by reference, discuss how the material is reasonably available to interested parties, and explain how to obtain the material. 1 CFR 51.5(b). This section summarizes ASTM F2012-18 ε 1 , and describes how to obtain a copy of the standard.

ASTM F2012-18 ε 1 contains test methods and requirements regarding:

• Sharp edges or points;

• small parts;

• latching or locking mechanisms to prevent unintentional folding;

• openings;

• scissoring, shearing, or pinching;

• exposed coil springs;

• toy accessories sold with SACs;

• protective components;

• spring failures on spring-supported SACs;

• structural integrity;

• leg openings;

• stability (including tip overs and seat tilt);

• motion resistance;

• warnings and labels; and

• instructional literature.

Interested parties may obtain a copy of ASTM F2012-18 ε 1 from ASTM, through its website ( http://www.astm.org ), or by mail from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428. Alternatively, interested parties may inspect a copy of the standard at CPSC's Division of the Secretariat.

Section 1238.2 of the final rule requires SACs to comply with ASTM F2012-18 ε 1 and incorporates the standard by reference. Section VII of this preamble describes the OFR requirements for incorporating material by reference. To comply with those requirements, section VII summarizes ASTM F2012-18 ε 1 , explains how the standard is reasonably available to interested parties, and indicates how to obtain a copy of the standard.

The final rule also amends 16 CFR part 1112 to add a new § 1112.15(b)(48) that lists 16 CFR part 1238, Safety Standard for Stationary Activity Centers, as a children's product safety rule for which the Commission has issued an NOR. Section XV of this preamble provides additional information about certifications and NORs.

The Administrative Procedure Act (5 U.S.C. 551-559) generally requires that agencies set an effective date for a final rule that is at least 30 days after the Federal Register publishes the final rule. Id. 553(d). The NPR proposed that the final rule for SACs, and the amendment to part 1112, would take effect 6 months after publication. CPSC did not receive any comments about this timeline. Six months is generally enough time for firms to modify their products to meet a new standard, it is consistent with other CPSIA section 104 rules, and JPMA typically allows six months for products in its certification program to shift to a new standard. For these reasons, this rule will take effect 6 months after publication in the Federal Register , and will apply to products manufactured or imported on or after that date.

This rule contains information collection requirements that are subject to public comment and Office of Management and Budget (OMB) review under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501-3521). Under the PRA, CPSC must estimate the “burden” associated with each “collection of information.” 44 U.S.C. 3506(c).

In this rule, section 8 of ASTM F2012-18 ε 1 contains labeling requirements that meet the definition of “collection of information” in the PRA. Id. 3502(3). In addition, section 9 of ASTM F2012-18 ε 1 requires instructions be provided with SACs; however, CPSC staff believes this requirement can be excluded from the PRA burden estimate. OMB allows agencies to exclude from the PRA burden estimate any “time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities,” if the disclosure activities required to comply are “usual and customary.” 5 CFR 1320.3(b)(2). CPSC staff is not aware of SACs that require use or assembly instructions but lack such instructions, so staff believes that providing instructions with SACs is “usual and customary.” For this reason, the burden estimate includes only the labeling requirements.

The preamble to the NPR discussed the information collection burden of the proposed rule and requested comments on the accuracy of CPSC's estimates. 83 FR 28395. CPSC did not receive any comments about the information collection burden of the proposed rule. The information collection burden has not changed since the NPR. The estimated burden of this collection of information is as follows:

CPSC staff is aware of 11 suppliers of SACs to the U.S. market. This estimated reporting burden assumes that all 11 suppliers may need to modify their labels to comply with the final rule. CPSC staff estimates that it will take about one hour per model to make these modifications and, based on staff's evaluation of product lines, that each firm supplies an average of four models of SACs. Therefore, CPSC staff estimates that the burden associated with the labeling requirements is: 11 entities × 1 hour per model × 4 models per entity = 44 hours. CPSC staff estimates that the hourly compensation for the time required to create and update labels is $34.50 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” Dec. 2018, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/ncs/ ). Therefore, the estimated annual cost associated with the labeling requirements is: $34.50 per hour × 44 hours = $1,518. CPSC staff does not expect there to be operating, maintenance, or capital costs associated with this information collection.

As the PRA requires, CPSC has submitted the information collection requirements of this final rule to OMB. 44 U.S.C. 3507(d). OMB has assigned control number 3041-0179 to this information collection.

The RFA (5 U.S.C. 601-612) requires agencies to consider the potential economic impact of a proposed and final rule on small entities, including small businesses. An agency must prepare and publish a final regulatory flexibility analysis (FRFA) when it issues a final rule, unless the head of the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 604(a), 605(b). If, rather than publishing a FRFA, the head of the agency makes the above certification, the agency must publish the certification and a statement of the factual basis for it in the Federal Register with the final rule. Id. 605(b).

The Commission made the above certification in the NPR because staff found that the cost of modifying products to meet the standard would not be significant, and the SACs of all seven small manufacturers were JPMA certified. JPMA certification indicates that the products comply with the ASTM standard and undergo third party testing. The Commission does not have any new information that would change that conclusion. Therefore, the Commission certifies that this rule, incorporating by reference ASTM F2012-18 ε 1 as a CPSC standard, will not have a significant economic impact on a substantial number of small entities involved in manufacturing or importing SACs.

CPSC did not receive any comments addressing the RFA analysis or from the Chief Counsel for Advocacy of the SBA, but did receive one comment regarding small entities. The commenter stated that there should be oversight of small manufacturers or importers if the rule does not apply to them. It appears that the commenter misunderstood the RFA analysis to mean that the rule would not apply to small entities; this is not correct. The rule applies to all manufacturers and importers of SACs sold in the United States.

The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that, before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must indicate whether the rule is a “major rule.” The CRA states that the Office of Information and Regulatory Affairs (OIRA) determines whether a rule qualifies as a “major rule.”

Pursuant to the CRA, OIRA designated this rule as not a “major rule,” as defined in 5 U.S.C. 804(2). In addition, to comply with the CRA, the Office of the General Counsel will submit the required information to each House of Congress and the Comptroller General.

CPSC's regulations list categories of agency actions that “normally have little or no potential for affecting the human environment.” 16 CFR 1021.5(c). Such actions qualify as “categorical exclusions” under the National Environmental Policy Act (42 U.S.C. 4321-4370m-12), which do not require an environmental assessment or environmental impact statement. One categorical exclusion listed in CPSC's regulations is for rules or safety standards that “provide design or performance requirements for products.” 16 CFR 1021.5(c)(1). Because the final rule for SACs creates design or performance requirements, the rule falls within the categorical exclusion.

Under section 26(a) of the CPSA, no state or political subdivision of a state may establish or continue in effect a requirement dealing with the same risk of injury as a Federal consumer product safety standard under the CPSA unless the state requirement is identical to the Federal standard. 15 U.S.C. 2075(a). However, states or political subdivisions of states may apply to CPSC for an exemption, allowing them to establish or continue such a requirement if the state requirement “provides a significantly higher degree of protection from [the] risk of injury” and “does not unduly burden interstate commerce.” Id. 2075(c).

Section 104 of the CPSIA requires the Commission to issue consumer product safety standards for durable infant or toddler products. As such, consumer product safety standards that the Commission creates under CPSIA section 104 are covered by the preemption provision in the CPSA. Therefore, the preemption provision in section 26 of the CPSA applies to the mandatory safety standard for SACs.

Section 14(a) of the CPSA requires the manufacturer or private labeler of a children's product that is subject to a children's product safety rule to certify that, based on a third party conformity assessment body's ( i.e., third party laboratory's) testing, the product complies with the relevant children's product safety rule. 15 U.S.C. 2063(a)(2)(A), 2063(a)(2)(B). The Commission must publish an NOR for a third party laboratory to obtain accreditation to assess conformity with a children's product safety rule. 15 U.S.C. 2063(a)(3)(A).

Effective June 10, 2013, the Commission adopted 16 CFR part 1112, which sets out the general requirements and criteria concerning third party laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112 includes procedures for CPSC to accept a third party laboratory's accreditation and lists the children's product safety rules for which the Commission has published NORs. When the Commission issues a new NOR, it must amend part 1112 to include that NOR.

Because this final rule is a children's product safety rule, the Commission is amending part 1112 to include an NOR for the SACs standard. Third party laboratories that apply for CPSC acceptance to test SACs for compliance with the new SAC rule will have to meet the requirements in part 1112. When a laboratory meets the requirements of a CPSC-accepted third party conformity assessment body, the laboratory can apply to CPSC to include 16 CFR part 1238, Safety Standard for Stationary Activity Centers, in the laboratory's scope of accreditation of CPSC safety rules listed on the CPSC website at: www.cpsc.gov/labse arch.

As the RFA requires, CPSC staff prepared a FRFA for the Commission's part 1112 rulemaking. 78 FR 15836, 15855 (Mar. 12, 2013). The FRFA concluded that the accreditation requirements would not have a significant economic impact on a substantial number of small laboratories because no requirements applied to laboratories that did not intend to provide third party testing services. The only laboratories CPSC expected to provide such services were those that anticipated receiving sufficient revenue from the mandated testing to justify accepting the requirements as a business decision.

For the same reasons, adding an NOR for the SACs standard to part 1112 will not have a significant economic impact on small test laboratories. Because only a small number of laboratories in the United States have applied for accreditation to test for conformance to existing juvenile product standards, CPSC expects that only a few laboratories will seek accreditation to test for compliance with the SACs standard. Of those that seek accreditation, CPSC expects that most already will have accreditation to test for conformance to other juvenile product standards. The only costs to those laboratories will be the cost of adding the SACs standard to their scopes of accreditation. For these reasons, CPSC certifies that amending 16 CFR part 1112 to include an NOR for the SACs standard will not have a significant economic impact on a substantial number of small entities.

For the reasons discussed in the preamble, the Commission amends 16 CFR chapter II as follows:

Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), where the Drug Enforcement Administration (DEA) receives notification from the Department of Health and Human Services (HHS) that the Secretary has indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act (FDCA), the DEA is required to issue an interim final rule, with opportunity for public comment and to request a hearing, controlling the drug not later than 90 days after receiving such notification from HHS and subsequently to issue a final rule. 21 U.S.C. 811(j). When controlling a drug pursuant to section 811(j), the DEA must apply the scheduling criteria of subsections 811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3).

On August 26, 2016, the DEA published an interim final rule with request for comments [81 FR 58834] to make thiafentanil (including its salts) a schedule II controlled substance(s). See 21 CFR 1308.12(c)(29) (DEA Controlled Substance Code 9729).

Over time, alternative chemical names have been used to describe this same specific substance. In the preamble to the interim final rule, the DEA provided “4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2-(thienyl)ethyl]piperidine”  1 as the chemical name for thiafentanil. However, the DEA believes it is more accurate to use “methyl 4-(2-methoxy- N -phenylacetamido)-1-(2-(thiophen-2-yl)ethyl)piperidine-4-carboxylate)”  2 in the preamble of this final rule. It bears emphasis that the chemical that is the subject of this final rule is the same substance that was the subject of the interim final rule. The DEA simply is using an alternative chemical description to refer to that same substance in this preamble.

Thiafentanil, a potent opioid, is an analogue of fentanyl. In June 2016, the Food and Drug Administration (FDA) reviewed and determined that the product Thianil (thiafentanil oxalate, a salt form of thiafentanil) met the requirements for addition to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) (21 U.S.C. 360ccc-1) as set forth by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). 3 As discussed in the preamble to the interim final rule, the HHS provided the requisite notification to DEA that HHS/FDA added Thianil (thiafentanil oxalate) to the Index (Minor Species Index File (MIF) 900000) under section 572 of the FDCA.

The DEA based its scheduling decision, and issuance of the interim final rule, on 21 U.S.C. 811(j), the HHS's November 2011 scientific and medical evaluation and scheduling recommendation, the HHS's March 2016 supplemental analysis, the MUMS Act indication by the HHS/FDA, and the DEA's determination. The interim final rule provided an opportunity for interested persons to file written comments, as well as a request for hearing or waiver of hearing, on or before September 26, 2016.

The DEA received one comment from the American Veterinary Medical Association supporting the interim final rule to control thiafentanil as a schedule II substance of the CSA.

DEA Response. The DEA appreciates the support for this rulemaking.

The DEA did not receive any requests for hearing or waiver of hearing. Based on the rationale set forth in the interim final rule, the DEA adopts the interim final rule, without change.

As indicated above, thiafentanil has been a schedule II controlled substance for more than two years by virtue of the interim final rule issued by the DEA in 2016. Thus, this final rule does not alter the regulatory requirements applicable to handlers of thiafentanil that have been in place since that time. Nonetheless, for informational purposes, we restate here those requirements. Thiafentanil is subject to the CSA's schedule II regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule II substances, including the following:

1. Registration. Any person who desires to handle thiafentanil (manufacture, distribute, reverse distribute, dispense, import, export, engage in research, or conduct instructional activities or chemical analysis with, or possess), must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Quota. Only registered manufacturers are permitted to manufacture thiafentanil in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

3. Disposal of stocks. Upon obtaining a schedule II registration to handle thiafentanil, and if subsequently, any person who does not desire or is not able to maintain a schedule II registration must surrender all quantities of currently held thiafentanil, or may transfer all quantities of currently held thiafentanil to a person registered with the DEA in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws.

4. Security. Thiafentanil is subject to schedule II security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71-1301.93.

5. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of thiafentanil must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. In addition, thiafentanil is subject to additional labeling requirements provided by the FDA. Thiafentanil must be labeled, distributed, and promoted in accordance with the Index entry of the new animal drug and the FDA may remove a new animal drug from the Index if the conditions and limitations of use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G); (f)(l)(F). The labeling of an indexed new animal drug must prominently state that the extra-label use of the product is prohibited. 21 U.S.C. 360ccc-l(h).

6. Inventory. Every DEA registrant who desires to possess any quantity of thiafentanil must take an inventory of thiafentanil on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

Any person who becomes registered with the DEA to handle thiafentanil must take an initial inventory of all stocks of controlled substances (including thiafentanil) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

7. Records and Reports. Every DEA registrant must maintain records and submit reports for thiafentanil, or products containing thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312 and 1317.

8. Orders for thiafentanil. Every DEA registrant who distributes thiafentanil is required to comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.

9. Prescriptions and other dispensing. All prescriptions for thiafentanil or products containing thiafentanil must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C. Moreover, given that thiafentanil is not the subject of an approved new drug application under the FDCA, and that it is only allowed under the MUMS Act amendments to the FDCA to be marketed for extremely limited use in minor species, DEA would not consider any dispensing of thiafentanil for human use to be for a legitimate medical purpose within the meaning of the CSA. Likewise, DEA would not consider any dispensing of thiafentanil for animal use beyond the scope of the drug's labeling authorized under the MUMS Act amendments to the FDCA to be for a legitimate medical purpose within the meaning of the CSA.

10. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule II controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of thiafentanil may only be for the legitimate purposes consistent with the drug's labeling authorized under the MUMS Act, or for research activities authorized by the FDCA and CSA.

11. Importation and Exportation. All importation and exportation of thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

12. Liability. Any activity involving thiafentanil not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

This final rule adopts, without change, the amendments made by the interim final rule that are already in effect. Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, Public Law 114-89, which was signed into law in 2015, amended 21 U.S.C. 811 to provide that in cases where a new drug is (1) approved or indexed by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II-V, the DEA shall issue an interim final rule scheduling the drug within 90 days. This action was taken August 26, 2016. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause.

In accordance with Public Law 114-89, this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

This final rule is not an Executive Order 13771 regulatory action pursuant to Executive Order 12866 and OMB guidance. 4

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This final rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the above discussion regarding applicability of the Administrative Procedure Act, the DEA was not required to publish a general notice of proposed rulemaking prior to this final rule. Consequently, the RFA does not apply.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, the DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.

Background

This document contains final amendments to the Income Tax Regulations (26 CFR part 1) under sections 641 and 1361 of the Internal Revenue Code (Code).

Section 13541(a) of the Tax Cuts and Jobs Act, Public Law 115-97, 131 Stat. 2054, 2154 (TCJA) amended section 1361(c)(2)(B)(v) of the Code to allow NRAs to be PCBs of ESBTs. As amended, section 1361(c)(2)(B)(v) provides that NRA PCBs will not be taken into account for purposes of the S corporation shareholder-eligibility requirement that otherwise prohibits NRA shareholders. See section 1361(b)(1)(C).

On April 19, 2019, the Department of the Treasury (Treasury Department) and the IRS published a notice of proposed rulemaking (REG-117062-18) in the Federal Register (84 FR 16415) proposing regulations under sections 641 and 1361 (proposed regulations). No comments addressing the proposed regulations were received in response to the notice of proposed rulemaking. As no request for a public hearing was received, no hearing was held.

This document adopts the proposed regulations with no change as final regulations. Where an NRA is a deemed owner of a grantor trust that has elected to be an ESBT, the final regulations ensure that such ESBT's S corporation income will continue to be subject to U.S. Federal income tax. Specifically, the final regulations modify the allocation rules under § 1.641(c)-1 to require that the S corporation income of the ESBT be included in the S portion of the ESBT if that income otherwise would have been allocated to an NRA deemed owner under the grantor trust rules. Accordingly, such income will be taxed to the domestic ESBT by providing that, if the deemed owner is an NRA, the grantor portion of net income must be reallocated from the grantor portion of the ESBT to the ESBT's S portion.

The final regulations also implement Congress' amendment to section 1361(c)(2)(B)(v) by making conforming revisions to § 1.1361-1(m). For example, the final regulations update the description of PCBs in § 1.1361-1(m)(4)(i) to reflect the ability of NRAs to be PCBs of ESBTs. The final regulations similarly update other provisions in § 1.1361-1(m) to reflect that ability.

Section 7805(b)(1)(A) and (B) of the Code generally provide that no temporary, proposed, or final regulation relating to the internal revenue laws may apply to any taxable period ending before the earliest of (A) the date on which such regulation is filed with the Federal Register , or (B) in the case of a final regulation, the date on which a proposed or temporary regulation to which the final regulation relates was filed with the Federal Register . However, section 7805(b)(2) provides that regulations filed or issued within 18 months of the date of the enactment of the statutory provision to which they relate are not prohibited from applying to taxable periods prior to those described in section 7805(b)(1). Furthermore, section 7805(b)(3) provides that the Secretary may provide that any regulation may take effect or apply retroactively to prevent abuse.

Accordingly, to prevent abuse of sections 641 and 1361, and the final regulations thereunder, the final regulations apply to all ESBTs after December 31, 2017.

The final regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (April 11, 2018) between the Treasury Department and the Office of Management and Budget regarding review of tax regulations.

The final regulations do not impose a collection of information on any entities, including small entities. Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that the final regulations would not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that the final regulations would primarily affect sophisticated ownership structures involving ESBTs that have NRAs as PCBs.

Pursuant to section 7805(f), the proposed regulations preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.

The principal author of the final regulations is Cynthia Morton of the Office of Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing 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 regatta 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 . Waiting for a 30-day effective period to run is impracticable and contrary to the public interest for the reasons discussed in the preceding paragraph.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with the regatta from 8 a.m. on June 28, 2019 through 7 p.m. on June 29, 2019 will be a safety concern to anyone within waters of the Maumee River, Toledo, OH where the regatta is being held. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the regatta occurs.

This rule establishes a safety zone from 8 a.m. on June 28, 2019 through 7 p.m. on June 29, 2019. The safety zone will encompass all U.S. navigable waters of the Maumee River, Toledo, OH from the Martin Luther King Jr. Memorial Bridge at river mile 4.30 to a line drawn from a point at 41°38′44.6″ N 83°31′51.8″ W east to a point at 41°38′45.1″ N 83°32′02.2″ W. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

The Coast Guard will patrol the regatta area under the direction of the Captain of the Port Detroit (COTP), or a designated representative. A designated representative may be a Coast Guard Patrol Commander. Vessels desiring to transit the regulated area may do so only with prior approval of the COTP or a designated representative and when so directed by that officer. Vessels will be operated at a no wake speed to reduce the wake to a minimum, in a manner which will not endanger participants in the event or any other craft and remain vigilant for event participants and safety craft. Additionally, vessels must yield right-of-way for event participants and event safety craft and must follow directions given by the COTP or a designated representative. The rules contained in the above two sentences do not apply to participants in the event or vessels of the patrol operating in the performance of their assigned duties. Commercial vessels will have right-of-way over event participants and event safety craft. The races will stop for oncoming freighter or commercial traffic and will resume after the vessel has completed its passage through the regulated area. The COTP or a designated representative may direct the anchoring, mooring, or movement of any boat or vessel within the regatta area. A succession of sharp, short signals by whistle or horn from vessels patrolling the area under the direction of the COTP or a designated representative shall serve as a signal to stop. Vessels so signaled must stop and comply with the orders of the COTP or a designated representative. Failure to do so may result in expulsion from the area, citation for failure to comply, or both. The COTP or a designated representative may establish vessel size and speed limitations and operating conditions and may restrict vessel operation within the regatta area to vessels having particular operating characteristics. The COTP or a designated representative may terminate the marine event or the operation of any vessel at any time it is deemed necessary for the protection of life and property.

Patrol Commander means a Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP to monitor a regatta area, permit entry into the regatta area, give legally enforceable orders to persons or vessels within the regatta area, and take other actions authorized by the COTP. The Patrol Commander will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Patrol Commander may be contacted on VHF-FM Marine Channel 16 by the call sign “Coast Guard Patrol Commander.”

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

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 regulated area. Vessel traffic will be able to safely transit around this regulated area, which will impact a small designated area of the Maumee River in Toledo, OH for a period of 35 hours. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM Marine Channel 16 about the regulated area and the rule allows vessels to seek permission to enter the regulated area.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The 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. Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this temporary rule on small entities. While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation interval lasting for a period of 35 hours that will prohibit entry within specified waters of the Maumee River, Toledo, OH. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. 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 100 as follows:

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 the requested safety zone with sufficient time for a comment period to run before the start of the fireworks display. Thus, delaying this rule to wait for a notice and comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect the public from the potential hazards associated with the fireworks display.

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 . For the same reasons discussed in the preceding paragraph, a 30 day notice period would be impracticable.

The legal basis for this final rulemaking is found at 46 U.S.C 70034; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

On June 26th 2019 from 9:30 p.m. through 10:30 p.m., Mackinac Island will have a fireworks display at position 45°50′48.44″ N, 084°37′40.06″ W. The maximum sized shell to be used is six inches and requires a temporary safety zone of at least 420 feet. The State of Michigan regulates fireworks displays. This action is only for the temporary safety zone.

The Captain of the Port Sault Sainte Marie has determined that potential hazard associated with fireworks from 9:30 p.m. to 10:30 p.m. on June 26, 2019 will be a safety concern to anyone within a 420-foot radius of the launch site. Such hazards include premature and accidental detonations, falling and burning debris, and collisions among spectator vessels. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the temporary safety zone while the fireworks are being displayed.

This rule establishes a temporary safety zone from 9:30 p.m. through 10:30 p.m. on June 26, 2019. This rule is necessary to protect the safety of spectators and vessels during the aforementioned display. The temporary safety zone will encompass all U.S. waters of Lake Huron within a 420 feet radius from 45°50′48.44″ N, 084°37′40.06″ W. The rule will be enforced to mitigate risks associated with the display.

The duration of the zone is intended to protect the safety of life and property in these navigable waters during the scheduled fireworks display. No vessel or person will be permitted to enter the temporary safety zone without obtaining permission from the Captain of the Port or a designated representative. The Captain of the Port or a designated representative may be contacted via VHF Channel 16 or at 906-635-3237.

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-day for this temporary safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact small designated area of Lake Huron near Mackinac Island for 1 hour. Moreover, the Coast Guard will issue Broadcast Notice to Mariners 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 temporary 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 would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and 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 temporary safety zone lasting one hour that will prohibit entry into a designated area. Normally such actions are categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. 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 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 26, 2019 the Captain of the Port (COTP) Buffalo published a notice of proposed rulemaking (NPRM), Docket Number USCG-2019-0121, to include safety zones for annual events into a final rule. This event was included in that 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 public comments, which ended on May 28, 2019. As such, it is unnecessary to publish a separate NPRM for this event, as the public previously had the opportunity to comment on it, and no comments were received.

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 final publication in the Federal Register because doing so would be impracticable and contrary to the public interest. Delaying the effective date of this rule to wait for final publication would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a stand up paddleboard race.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that a large-scale paddle craft event on a navigable waterway will pose a significant risk to participants and the boating public. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the Blazing Paddles Race is happening.

This rule establishes a safety zone from 7:45 a.m. through 2:30 p.m. on June 22, 2019. The safety zone will cover all navigable waters at the start point at position 41°29′36″ N and 081°42′13″ W to the turnaround point at position 41°28′52″ N and 081°40′33″ W and returning to the starting point on the Cuyahoga River; Cleveland, OH. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 8:00 a.m. through 2:00 p.m. Paddleboard Race. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the COTP or a designated on-scene representative. The COTP or a 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 characteristics of the safety zone. The safety zone created by this rule will be relatively small and is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. In addition, the safety zone will have built in times to allow vessels to travel through when races are not being held. 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 COTP.

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.

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 Environmental Planning COMDTINST 5090.1 (series), 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 establishment of a safety zone. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. 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. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Upper Mississippi River DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section USACE United States Army Corps of Engineers 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 it is impracticable. It is impracticable because we must establish this safety zone immediately and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone and compromise public safety.

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 this rule would be contrary to public interest because immediate action is necessary to respond to the potential safety hazards associated with floodwaters threatening to overtop levees along the river.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP in consultation with the United States Army Corps of Engineers (USACE) Kansas City District has determined that potential hazards associated with flood waters threaten to damage or overtop flood control levees along the river. This rule is necessary to ensure the safety of persons, vessels, and the marine environment on these navigable waters due to the flood impacts to levees.

On June 2, 2019, the USACE Kansas City District contacted the Coast Guard to report floodwaters approaching the tops of levees along the Missouri River between Mile Marker (MM) 0 and MM 734.8 and requested a river closure to ensure the safety of persons, vessels, and the marine environment that would be significantly impacted if floodwaters overtop the levees. This rule establishes a temporary safety zone from June 2, 2019 until July 2, 2019, or until cancelled by the Captain of the Port Sector Upper Mississippi River (COTP). The safety zone will be enforced on all navigable waters of the Missouri River from MM 0 to MM 734.8, unless reduced in scope by the COTP as flood conditions warrant.

No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Upper Mississippi River. To seek permission to enter, contact the COTP or a designated representative via VHF-FM channel 16, or through USCG Sector Upper Mississippi River at 314-269-2332. Persons and vessels permitted to enter the safety zone must comply with all lawful orders or directions issued by the COTP or designated representative. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement, as well as reductions in size of the safety zone as flood conditions improve, through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.

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 emergency nature of the action and after consultation with representatives of the shipping industries that use this reach of river indicate that the many shipping companies have already made arrangements to avoid this area. Moreover, the Coast Guard will issue a BNM via VHF-FM marine channel 16 about the zone, and the rule allows vessels to seek permission to enter the zone on a case-by-case basis.

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 temporary 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 temporary safety zone prohibiting entry on a 734-mile stretch of the Missouri River that is experiencing significant flooding that is impacting levees. It is categorically excluded from further review under paragraph L60 (d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination will be made 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. 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 46 U.S.C. 70034. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 9:30 p.m. on July 12, 2019 through 11 p.m. on July 14, 2019 will be a safety concern to anyone within a 200-yard 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 9:30 p.m. on July 12, 2019 through 11 p.m. on July 14, 2019. The safety zone will encompass all U.S. navigable waters of Lake Huron, Harbor Beach, MI, within a 200-yard radius of position 43°50.77′ N, 082°38.63′ W (NAD 83). 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 Lake Huron from 9:30 p.m. on July 12, 2019 through 11 p.m. on July 14, 2019. 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 Environmental Planning COMDTINST 5090.1 (series), 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 and a half hours on two nights that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. 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:

VA published a proposed rule in the Federal Register at 84 FR 1678 on February 5, 2019, to amend 38 CFR 4.88a and 4.88b, the portion of the VASRD dealing with infectious diseases, immune disorders, and nutritional deficiencies. VA provided a 60-day public comment period, and interested persons were invited to submit written comments on or before April 8, 2019. VA received 32 comments.

One commenter supported VA's intent to eliminate obsolete terminology and substitute the most up-to-date terms and definitions for conditions such as Chronic Fatigue Syndrome. The commenter noted that this rule would help to achieve the important public policy goal of clear, effective communication among veterans, their health care providers, and the Department. Additionally, the commenter observed that it is important that what appears to be “catch-all” language appended to the respective disease evaluation categories be correctly phrased to minimize the likelihood that deserving patients will be excluded from care. The commenter suggested that VA should consider identifying the “residual effects” categories explicitly so the rating decisions and appeals would be most favorable to the veterans seeking care. The commenter further suggested that VA consider expressly recognizing that any ambiguity in the rules regarding covered residual effects should be resolved in the veteran's favor. VA makes no changes based on these comments. The proposed diagnostic codes provided examples of common residuals of specific diseases, but also made clear that the instruction to rate “any residual disability” from a disease “includes, but is not limited to” the listed examples. We believe this language is sufficiently clear and broad to ensure that any residuals identified in individual cases may be appropriately evaluated. We do not believe it is necessary or advisable to seek to list in these regulations all of the conditions that may be found to be residuals of diseases in specific cases. Further, because these rules do not restrict the conditions that may be found in individual cases to be residuals of a disease, we do not believe the regulation is restrictive or ambiguous on that issue. We note also that the principle of resolving reasonable doubt in favor of veterans is established in 38 CFR 3.102 and 4.3.

One commenter expressed an opinion that this regulatory update can be viewed as a bureaucratic move to disenfranchise veterans eligible for unspecified services. The commenter did not offer any specific recommendations and did not propose any actions. VA makes no changes based on this comment.

One commenter stated that vector-borne diseases (VBD) are of major importance to human health both locally and globally. In addition, the commenter highlighted that the precise diagnoses of many of these diseases remains a major challenge because of the lack of comprehensive data available on accurate and reliable diagnostic methods, specifically for borreliosis (Lyme disease). The commenter did not offer a specific recommendation or a course of action. VA makes no changes based on this comment.

Two commenters were concerned that by implementing a General Rating Formula (GRF) for infectious diseases, VA would drastically change veterans' ratings from 100 percent to zero percent, dependent upon whether the disease is deemed active or resolved based upon a laboratory test. Commenters noted that there is considerable evidence that laboratory tests may not always be deemed reliable and that each laboratory may have differing references ranges leading to improper reading of results. However, VA's proposed GRF did not alter the rating principles for infectious diseases, which currently provide—in individual diagnostic codes rather than a GRF—for evaluation of active diseases and residuals. Instead, we updated the format of the rating schedule to indicate that the GFR for infectious diseases would be consistent for rating these conditions and also be similar to the use of a GFR in other sections of the VASRD, such as in 38 CFR 4.97, 4.116, 4.130, and others. Currently, VA assigns a 100-percent evaluation for each specific infectious disease during an active period; thereafter, any residual functional impairment from the infectious disease determines the level of disability. VA pointed out that its proposed GFR would be a familiar concept for Veterans Benefits Administration (VBA) employees and minimize the risk for error by providing one criterion applicable to multiple diagnostic codes (DCs). Additionally, VA did not propose any laboratory testing in its GFR, but instead we proposed to confirm the recurrence of active infection for certain conditions (DCs 6301, 6304, 6311, 6312, 6316) with overlapping clinical symptoms such as pallor, fever and hepatosplenomegaly. By adding a specific reference to laboratory testing for each infection, we made an effort to distinguish one infection from another. VA makes no changes based on this comment.

Additionally, commenters were concerned that the proposed GRF would not consider veterans' ability to maintain gainful employment because many infectious diseases, even after negative laboratory test results, can cause long-lasting residual symptoms that may last up to eight weeks or longer and that lingering, residual symptoms would adversely affect a veteran's normal functioning and his/her ability to maintain gainful employment. The proposed GRF is designed to assess permanent functional impairment that resulted from long-lasting residual symptoms rather than rely solely on a specific laboratory test. The proposed GFR directs rating personnel to rate any residual effect of acute and/or chronic infection and to determine the degree of disability within the appropriate body system using the same principles as they exist in the current rating schedule. VA's disability compensation benefits are based on the extent of average impairment of earning capacity from the service-connected injury or disease and this focus is reflected throughout the rating schedule. Therefore, VA makes no changes based on this comment.

One commenter expressed concern regarding West Nile Virus infection, stating infected individuals could experience headaches, body aches, joint pains, vomiting, diarrhea, or rash during an acute phase of the disease and that the residual symptoms could last for an extended period. The commenter specifically noted a severe complication of the West Nile Virus infection that affects the central nervous system in its acute phase and that such complications could become clinically permanent. The commenter proposed to list specific neuroinvasive diseases such as meningitis and encephalitis as residuals of West Nile Virus in § 4.88b and to be rated under the applicable DC code(s). The commenter further interpreted the note under DC 6335 that VA would rate West Nile virus infection residuals and residuals listed in § 3.317 together and was concerned that this approach would cause confusion and limit this DC to only a subset of Persian Gulf veterans who served in the Southwest Asia Theater of Operations and are entitled to presumptive service connection. VA clarifies that the note under DC 6335 concerning § 3.317 is intended solely to serve as a reference that provides guidance to the adjudicator in rating a disease under this DC. The reference to § 3.317 is not intended nor can it be read to restrict application of DC 6335 to veterans with Southwest Asia service. As West Nile infection and other similar infectious diseases have complex disability pictures that are not commonly seen by VA adjudicators, the inclusion of the § 3.317(d) reference under DC 6335 is specifically meant to assist our adjudicators in understanding the nature of the disease and, most critically, the usual residual disabilities of the disease. Referencing § 3.317(d) in the note for infectious diseases like the West Nile virus serves to impart understanding to VA adjudicators that such infectious diseases may result in various residuals or complications with physical, functional, or cognitive effects and enables adjudicators to accurately rate veterans with these diseases. In response and in order to minimize any confusion, VA has removed the notes that reference 38 CFR 3.317(d) from the Infectious Diseases rating criteria for DCs 6301, 6304, 6316, 6330, 6331, 6333-6335. VA has added the reference to 38 CFR 3.317(d) as a note in a new introductory paragraph before the rating schedule for infectious diseases, immune disorders, and nutritional deficiencies in 38 CFR 4.88b.

Additionally, commenters expressed a concern that the proposed GRF will negatively affect veterans' care and treatment. VA appreciates commenters' concerns; however, VA's Rating Schedule for Disabilities does not regulate veterans' access to clinical care. Further, as explained above, the provisions in the proposed GRF for rating active diseases and residuals are consistent with the existing provisions under individual diagnostic codes in § 4.88b and will not significantly change how VA evaluates these conditions. VA makes no changes based on these comments.

One commenter supported the need for greater simplification of the rating schedule and disability determination process and was concerned that this proposed update to the schedule for infectious disease, immune disorders and nutritional deficiencies excludes nurse practitioners and their patients. Specifically, the commenter noted that the proposed criteria for determining incapacitation related to systemic exertion intolerance disease (SEID)/chronic fatigue syndrome (CFS) require bed rest and treatment prescribed by a licensed physician and that a physician who administered diagnostic tests ruled out ongoing exertion or other medical conditions associated with fatigue. The commenter requested that the Veterans Health Administration (VHA) revise this proposed rating schedule update and add “or nurse practitioner” after the word “physician” in all sections. The commenter also asked that, in future revisions of the rating schedule, VHA recognize that thousands of veterans receive care from nurse practitioners and to include nurse practitioners in the language of the rating schedule. VA clarifies that this rulemaking pertains to the Veterans Benefits Administration (VBA) and addresses disability evaluations due to the functional impairment related to service-connected health conditions. This rulemaking does not address the scope of clinical practice for nurse practitioners. However, VBA will assess whether amendments to the list of qualifying heath care providers are necessary and such amendments, if any, will be addressed in a future proposal. VA makes no changes based on this comment.

One commenter stated that it is unfair that a National Guard soldier who was called to active duty and then immediately released upon return from the Middle East has to have manifested one of the infectious diseases listed in § 3.317 within one year from separation (aside from three exceptions), whereas an active duty solider who redeploys from Iraq or Afghanistan and serves several more years on active duty only has to show the disease within a year after separation, which may be several years after service in Iraq or Afghanistan. This comment relates to the time period prescribed in 38 CFR 3.317(c)(3) for applying the presumption of service connection for infectious diseases in veterans who served in the Southwest Asia theater of operations during the Persian Gulf War. The proposed rules pertained only to the criteria for evaluating the severity of service-connected infectious diseases, immune disorders, and nutritional deficiencies. They did not propose to address matters concerning the establishment of service connection or the operation of presumptions of service connection for any diseases. Accordingly, the comment is beyond the scope of this rulemaking. VA makes no changes based on this comment.

Multiple commenters including individual veterans, Veterans Advocacy Organizations, Veterans Service Organizations, and other professional organizations expressed a wide range of concerns regarding the proposed changes to the definition of chronic fatigue syndrome (CFS) under § 4.88a and the name change for DC 6354. Commenters thought the name change of Chronic Fatigue Syndrome (CFS) to Systemic Exertion Intolerance Disease/Chronic Fatigue Syndrome (SEID/CFS) was unwarranted and that it would create unnecessary confusion among medical providers, including non-VA medical providers. Commenters also stated that that the new name, Systemic Exertion Intolerance Disease (SEID), has not been adopted by any federal agency, nor by researchers and clinicians and that the CDC, National Institutes of Health (NIH), research publications, and materials for patients and health care providers all use the term ME/CFS. Commenters felt that VA's use of the term SEID/CFS would introduce confusion among medical providers and patients at VA and reduce VA's ability to coordinate with other federal agencies.

Commenters expressed that the proposed changes to the definition of CFS does not conform to the Kansas Criteria (2000), the Centers for Disease Control (CDC) Chronic Multisymptom Illness (CMI) criteria, and to those used in VA-funded research into Gulf War Illness (GWI) and that the proposed definition is not compatible with the department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) for CMI. Commenters stated that VA's proposed combination of the Institute of Medicine (IOM) reevaluation of CFS as SEID with the 1994 Fukuda criteria for CFS presents an amalgamation that is not based in evidence nor discussed in any publications. The commenters expressed concern that VA did not follow any recommendations from the IOM, the Gulf War Research Advisory Committee (RAC), CDC, or other agencies and this combination is for an entirely new entity that is not known by World Health Organization, International Classification of Diseases, Tenth Revision (ICD-10) or other medical classification system and that the VA proposed definition is not compatible with the one mandated by DoD's CDMRP for CMI and the Kansas Criteria to qualify for GWI research funding.

Commenters noted that VA did not consult the RAC on these proposed changes and stated that the RAC is responsible for understanding the definitions and entirety of the condition. Commenters also were concerned that the proposed changes would leave those Gulf War veterans who receive care and services for CFS, vulnerable to VA manipulation of their care and services. The commenters suggested that CFS should be studied by the Gulf War research community, the veteran community, CFS researchers, the RAC, and independent medical professionals and that VA rely on the recommendations from these parties as a guide for new criteria updates and to ascertain if these changes are even warranted. Commenters also stated that VA would be directly and negatively impacting more than 300,000 Gulf War veterans suffering from Gulf War Illness by not relying on the studies from these parties and by combining, in whole or in part, the 2015 Systemic Exertion Intolerance Disease (SEID) and the 1994 Fukuda CDC criteria for Chronic Fatigue Syndrome (CFS) into what would be called SEID/CFS.

Commenters felt that VA's adoption of the Fukuda criteria is a step backwards that will perpetuate diagnostic inaccuracy and cause harm to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients served by the VA. Commenters referenced the 2015 IOM Report to state that the Fukuda criteria were overly broad because they do not require the hallmark symptom of post-exertional malaise and should not be used because of the possibility of misdiagnosing patients with other conditions. Commenters believed that VA's reliance on outdated Fukuda diagnostic criteria would cause harm to veterans with ME/CFS through misdiagnosis and cause a mismatch with the diagnostic criteria in use elsewhere. Commenters suggested that VA adopt ME/CFS or ME/CFS/SEID title for the illness to stay in alignment with the greater ME/CFS community, to include patients, doctors, and researchers. Commenters felt that VA's proposed revisions were based on financial reasons in order to revoke benefits from existing veterans and prevent other veterans from receiving this combined diagnosis of SEID/CFS.

Commenters also provided questions and recommended that VA adopt ME/CFS instead of SEID/CFS; reject the Fukuda criteria; and adopt the IOM diagnostic criteria.

Another recommendation was for VA to revise § 4.88a to more closely mirror the diagnostic standard endorsed by the IOM and CDC and eliminate the listed exclusions to allow the veterans' examining and/or treating physician to make a final determination as to the appropriate diagnosis for veterans. In addition, commenters recommended that VA should broaden the group of medical professionals authorized to prescribe bed rest and treatment to meet the incapacitation standard.

While VA received some support for updating its definition of CFS, VA considered these comments and concerns and concluded that this proposed update to § 4.88a is premature and that additional research is needed to provide a more comprehensive way to determine the disabling effects of CFS and associated conditions. Therefore, VA is withdrawing its proposal to amend § 4.88a Chronic Fatigue Syndrome. To ensure that the full range of relevant factors is adequately addressed, VA intends to establish a work group to specifically address this condition. Upon assessment of the work group's findings, VA will determine whether amendments to § 4.88a are necessary and such amendments, if any, will be addressed in a future proposal.

VA makes one clarifying change to the criteria for a 10 percent disability rating under DC 6351, HIV-related illness. In the proposed rule, VA proposed to replace the phrase “definite medical symptoms” with “HIV-related constitutional symptoms” but stated that we would otherwise make no change to the criteria for a 10 percent evaluation. The prior criteria for a 10 percent evaluation read: “Following development of definite medical symptoms, T4 cells of 200 or more and less than 500, and on approved medication(s), or with evidence of depression or memory loss with employment limitations.” We proposed to revise this to read: “Following development of HIV-related constitutional symptoms; T4 cell count between 200 and 500, and use of approved medication(s); or with evidence of depression or memory loss with employment limitations.” In its review of the final rule, VA realized that the prior text for a 10 percent disability rating was unclear because it listed four criteria, separated by commas, but used “and” between the second and third criteria, while using “or” between the third and fourth criteria. The proposed text listed three criteria, separated by semicolons, with the second of those criteria encompassing both the second and third criteria of the prior text, joined by the word “and”. We recognize that the combination of punctuation and conjunctions in both the prior and the propsed text could create confusion. Accordingly, VA revises the text for a 10 percent disability rating to read: “Following development of HIV-related constitutional symptoms; T4 cell count between 200 and 500; use of approved medication(s); or with evidence of depression or memory loss with employment limitations.” This clarifies that the text includes four separate criteria, consistent with the prior text, but will eliminate the potential confusion caused by the term “and” between two of those criteria. This will ensure that the provision is implemented in the manner most consistent with VA's intent and most favorable to veterans. VA appreciates the comments submitted in response to the proposed rule. Based on the rationale stated in the proposed rule and in this document, the proposed rule is adopted as a final rule with the changes noted above.

VBA personnel utilize the Veterans Benefit Management System for Rating (VBMS-R) to process disability compensation claims that involve disability evaluations made under the VASRD. In order to ensure that there is no delay in processing veterans' claims, VA must coordinate the effective date of this final rule with corresponding VBMS-R system updates. As such, this final rule will apply effective August 11, 2019, the date VBMS-R system updates related to this final rule will be complete.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 through FYTD. This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will not affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Catalog of Federal Domestic Assistance program numbers and titles for this rule are 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.105, Pension to Veterans, Surviving Spouses, and Children; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

The Secretary of Veterans Affairs approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on May 20, 2019, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 4 as set forth below:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0560 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 19, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0560, 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 May 18, 2018 (83 FR 23247) (FRL-9976-87), EPA issued a Notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8620) by Andermatt Biocontrol AG, Stahlermatten 6, CH-6146 Grossdietwil, Switzerland (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the fungicide Bacillus amyloliquefaciens subspecies plantarum strain FZB42 in or on all food commodities. That Notice referenced a summary of the petition prepared by the petitioner Andermatt Biocontrol AG and available in the docket via http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit III.C.

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

EPA evaluated the available toxicity and exposure data on Bacillus amyloliquefaciens subspecies plantarum strain FZB42 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Bacillus amyloliquefaciens subspecies plantarum strain FZB42” (Safety Determination). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

The available data demonstrated that, with regard to humans, Bacillus amyloliquefaciens subspecies plantarum strain FZB42 is not toxic, pathogenic, or infective via any route of exposure. Although there may be some exposure to residues when Bacillus amyloliquefaciens subspecies plantarum strain FZB42 is used on food commodities in accordance with label directions and good agricultural practices, dietary exposure to such residues presents no concern for adverse effects. EPA also determined that a Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Bacillus amyloliquefaciens subspecies plantarum strain FZB42. These findings are discussed in more detail in the Safety Determination.

Based upon its evaluation in the Safety Determination, 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 Bacillus amyloliquefaciens subspecies plantarum strain FZB42. Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus amyloliquefaciens subspecies plantarum strain FZB42 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Three comments were received in response to the notice of filing. EPA reviewed the comments and determined that they are irrelevant to the tolerance exemption in this action.

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, 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 (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 (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 (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:

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

In the Aleutian Islands subarea, the portion of the 2019 pollock total allowable catch (TAC) allocated to the Aleut Corporation's directed fishing allowance (DFA) is 14,700 metric tons (mt) as established by the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019).

As of June 12, 2019, the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that 14,600 mt of Aleut Corporation's DFA in the Aleutian Islands subarea will not be harvested. Therefore, in accordance with § 679.20(a)(5)(iii)(B)( 4 ), NMFS reallocates 14,600 mt of Aleut Corporation's DFA from the Aleutian Islands subarea to the 2019 Bering Sea subarea allocations. The 14,600 mt of pollock in the Bering Sea subarea is apportioned to the AFA Inshore sector (50 percent), AFA catcher/processor sector (40 percent), and the AFA mothership sector (10 percent). The 2019 Bering Sea subarea pollock incidental catch allowance remains at 46,520 mt. As a result, the 2019 harvest specifications for pollock in the Aleutian Islands subarea included in the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019 and 84 FR 9976, March 19, 2019) are revised as follows: 100 mt to Aleut Corporation's DFA. Furthermore, pursuant to § 679.20(a)(5), Table 4 of the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019 and 84 FR 9976, March 19, 2019) is revised to make 2019 pollock allocations consistent with this reallocation.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Aleutian Islands pollock. Since the pollock fishery opened January 20, 2019, it is important to immediately inform the industry as to the final Bering Sea subarea pollock allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery; allow the industry to plan for the fishing season and avoid potential disruption to the fishing fleet as well as processors; and provide opportunity to harvest increased seasonal pollock allocations while value is optimum. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of June 11, 2019.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.