This document makes nomenclature changes to subpart headings in 7 CFR parts 300, 301, 318, 319, 330, 340, and 355 to bring the headings into conformance with the Office of the Federal Register (OFR) requirements. These changes will ensure that all subheadings in the listed parts of title 7 are consistent with OFR nomenclature and formatting conventions. We are also making related changes within the regulations where subparts are referenced.

In addition to the changes set forth above, we are updating the authority citations for parts 319 and 330 to reflect a U.S. Code citation that has been redesignated. In the authority citations for parts 319 and 330, 7 U.S.C. 450 will be changed to 7 U.S.C. 1633.

Lastly, we are redesignating footnote 4 as footnote 3 in § 319.75-7. In an interim rule published in the Federal Register on December 29, 2014, (79 FR 77839-77841), we removed footnote 3 from § 319.75-2. When we removed footnote 3, we should have redesignated footnote 4 as footnote 3. In this document, we are making that change.

This rule relates to internal agency management and makes various nonsubstantive changes to the regulations in title 7, Code of Federal Regulations to reflect minor edits, updates to authority citations, and formatting changes to bring language into conformance with the Office of Federal Register requirements. Because the changes contained in this rule are nonsubstantive in nature, notice and other public procedure on this rule are unnecessary and contrary to the public interest. Therefore, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity to comment are not required, and this rule may be made effective less than 30 days after publication in the Federal Register . Further, since this rule relates to internal agency management, it is exempt from the provisions of Executive Orders 12866, 12988, and 13771. Finally, this action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 501) and, thus, is exempt from the provisions of that Act.

This final rule contains no new reporting, recordkeeping, or third party disclosure requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, we are amending 7 CFR parts 300, 301, 318, 319, 330, 340, and 355 as follows:

Background

On May 16, 2018, FSIS proposed (83 FR 22604) to amend the Federal meat inspection regulations by removing from the post-mortem inspection regulations requirements for the cleaning of hog carcasses before incision for inspection or evisceration (9 CFR 310.11). FSIS noted that regulations on sanitation and standard operating procedures (9 CFR parts 304, 416), hazard analysis and critical control point (HACCP) systems (9 CFR part 417), and another post-mortem inspection regulation (9 CFR 310.18) require sanitary conditions for the handling of carcasses. The regulation at 9 CFR 310.18, in particular, addresses the prevention and removal of contamination from carcasses (before or after incision), organs, and other parts. The regulation requires the removal of any contamination remaining or occurring post-incision or post-evisceration.

After reviewing comments on the proposed rule, FSIS is finalizing it without changes.

FSIS received nine comment letters on the proposed rule from industry and consumer-advocacy groups, as well as from individuals. The issues raised in the comments and the Agency responses are summarized below.

Comment: A group advocating humane treatment of livestock stated that other current regulations do not obviate the need for 9 CFR 310.11. According to the comment, this is the only regulation that addresses pre-incision cleaning, which is integral to preventing contamination of pig carcasses. Similarly, the comment stated that studies show that pre-incision cleaning is necessary to ensure food safety, and FSIS provides no evidence to the contrary. Pig carcasses are relatively smooth compared to beef and potentially more susceptible to external contamination. For this reason, pre-evisceration cleaning is even more necessary and more effective in removing bacteria from pig carcasses. Eliminating this requirement, therefore, does not have a scientific basis, would endanger food safety, and is arbitrary and capricious.

Response: The regulations at 9 CFR 310.10, which remain, require the washing and cleaning of hide-on or skin-on livestock carcasses before incision for removal of any parts or for evisceration. Additionally, establishments commonly scald, dehair, and singe hog carcasses after bleed-out, before inspection. And, as explained elsewhere in this document, the removal of other trim defects on hog carcasses, such as hair, scurf, nails, and hooves, which 9 CFR 310.11 addressed, is still required under 310.18 and can be completed in a different manner and at different points in the slaughter process. This can be done without creating insanitary conditions and before the product enters commerce. Under this final rule, an establishment will have to handle its carcasses and parts in a sanitary manner to prevent their contamination with hair, dirt, or foreign matter. The establishment will have to carry out all carcass dressing and further processing activities in a manner consistent with its Sanitation SOPs, other prerequisite programs, and its HACCP plan.

Comment: Comments from consumer advocacy groups, an animal welfare organization, and individuals argued that the proposal would yield no public health benefits, just efficiency, and that industry efficiency is not a goal of the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq. ). The animal welfare group went farther and argued that the proposed rule is arbitrary and capricious under the Administrative Procedure Act (APA, 5 U.S.C. Subchapter II) because, in constructing and making the proposal, the Agency relied on factors Congress did not intend it to consider, failed to consider an important aspect of the problem, and offered an implausible explanation running counter to evidence and not based on differences in expertise or viewpoints. According to the animal welfare group, the Agency proposed the rule to ensure the efficiency of establishment operations, but ensuring this efficiency is not a responsibility of FSIS. Therefore, according to the comment, the Agency relied on factors Congress did not intend it to consider, making the proposed regulation arbitrary and capricious. One consumer advocacy argued that the cost-benefit analysis was flawed because it did not address potential public health implications of removing 9 CFR 310.11.

Response: Congress, through the FMIA, requires the Agency and its inspection program to address and prevent the distribution in commerce of meat and meat food products that are adulterated (21 U.S.C. 602). Congress empowered the Agency to promulgate regulations for the efficient execution of the Federal Meat Inspection Act (21 U.S.C. 621). The elimination of unnecessary regulations creates efficiencies for both FSIS inspection and industry.

Specifically, since FSIS made final its HACCP regulations in 1996, appropriately shifting the full responsibility for producing safe meat and poultry products to the regulated industry, the Agency has revised many of its prescriptive food safety regulations to give industry more flexibility to customize processes under HACCP. This flexibility often results in greater efficiencies for regulated establishments, but also allows them to fully employ HACCP to better ensure the production of safe meat and poultry products. The proposal to remove the requirements for hog carcass cleaning before incision for evisceration is part of these continuing efforts and was promulgated in accordance with the APA procedures.

Removing a regulation that other requirements for sanitation and the prevention of adulteration have made redundant, will make the enforcement of the Act more efficient. This change will not negatively affect public health because, as explained above, establishments are still required to remove contamination from carcasses and to produce products that are safe, wholesome, and not adulterated.

Comment: A consumer advocacy organization, an animal welfare organization, and an individual stated that the proposal assumes the implementation of the new swine inspection system.

Response: The scurf proposal cites the future implementation of the new swine inspection system as more support for eliminating § 310.11, “if finalized” (83 FR 22605).

Comment: One consumer advocacy group stated that FSIS inspection program personnel (IPP) are still issuing noncompliance records (NRs) for 9 CFR 310.11 violations; hence, the regulation is not redundant.

Response: In the proposal, the Agency explained that the requirement in 9 CFR 310.11 is not needed because compliance with other regulations and accompanying procedures achieve its objective, i.e., clean hog carcasses and parts. Further, that this prescriptive regulation is cited in NRs does not show that it is in fact needed to ensure to ensure the production of safe food.

Comment: Comments from consumer advocacy groups stated that the Agency seems to be basing the proposal on the five regulatory waivers granted to a major processor. The commenters were concerned that FSIS was relying on a small sample to justify removing 9 CFR 310.11.

Response: Information from establishments that operated under waivers from this specific regulation shows that they operated without jeopardizing food safety and supports the removal of the specific requirement.

Comment: Comments from consumer advocacy groups stated that HACCP plans are doubtful substitutes for the requirements of 9 CFR 310.11.

Response: Based on FSIS and establishment testing data, HACCP has proven to be an effective system for reducing or eliminating food safety hazards, and establishments may elect to clean hog carcasses before incision as a part of a HACCP system. Establishments also may elect to clean hog carcasses through a Sanitation SOP or other prerequisite program. And, notably, establishments must continue to comply with the regulations at 9 CFR 310.18, which require that livestock carcasses be cleaned of contamination to the satisfaction of FSIS.

Comment: One consumer advocacy organization stated that the proposed rule is without adequate support in the Trump Administration. According to the commenter, at a June 27, 2018, House Oversight and Government Reform Committee hearing on the proposed Government reorganization, a Member asked an OMB official about the Agency's proposed repeal of the hog carcass cleaning regulation and how this deregulation would protect consumers or whether it was proposed at the behest of slaughterhouse operators. The OMB official said she was unfamiliar with the proposed rule.

Response: This rulemaking has been listed in the Unified Agenda of Regulatory and Deregulatory Actions, reviewed and published by OMB, since Fall 2017.

Comment: One consumer advocacy organization remarked that, according to the 1995 HACCP notice of proposed rulemaking, “Science-based process control . . . and appropriate performance standards are inextricably intertwined in the Agency's regulatory strategy for improving food safety” (60 FR 6774, 6786; Feb. 3, 1995). The commenter also stated that the 1996 HACCP final rule established Salmonella performance standards for pork carcasses, but in 2011 FSIS stopped testing to ensure compliance with the standard, reasoning that violation rates were too low to justify the effort. The commenter questioned the wisdom of the Agency's decision, noting that the performance standards of the 1990's were intended to be a first step toward broader reliance on pathogen-specific performance standards. The commenter recommended that FSIS update the performance standards for whole carcasses, develop alternative standards for pork parts, or implement other performance standards to reduce Salmonella in pork products.

Response: The Government Accountability Office (GAO), in a recent review of FSIS efforts to control pathogens in meat and poultry products, 1 recommended that the Agency set timeframes for determining what pathogen standards or additional policies might be needed to address pathogens in beef carcasses, ground beef, port cuts, and ground pork. As indicated in the GAO's review report, FSIS concurred with the recommendation and is continuing its sampling and testing raw pork cuts and pork comminuted products for Salmonella under its exploratory study.

As FSIS stated in its response to GAO, in 2019, the Agency will use the data from the exploratory study to determine whether standards or additional policies ( e.g., training, guidance to industry, or instructions to field personnel) are needed to address Salmonella in pork products. If the Agency decides to institute new standards, it will collect and evaluate data to determine whether establishments meet the standards.

Executive Orders (E.O.) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated as a “non-significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget under E.O. 12866.

FSIS is adopting the preliminary regulatory impact analysis (PRIA) published in the proposed rule as the final regulatory impact analysis (FRIA) in this final rule, without change.

This final rule is expected to reduce swine slaughter labor costs by approximately $11.81 million annually. These savings are due to industry's practice of dedicating labor pre-incision, solely to comply with 9 CFR 310.11. Under the final rule, this labor will no longer be needed because the work can be accomplished by existing labor located post-incision. FSIS's labor cost savings estimate assumes that the labor affected by the final rule is equivalent to that in the Bureau of Labor Statistics' (BLS's) slaughtering and meat-packing occupational category, for which the industry annual wage is $27,140. 2 The Agency sought, but did not receive, comment on this assumption. Applying a benefits-and-overhead factor of 2 brings this occupation's total annual labor costs per position to $54,280 ($27,140 × 2).

The number of positions affected at each establishment depends on the establishment's size, slaughter volume, number of lines and shifts it operates, and days of operation. Large  3 swine establishments are thought to dedicate from one to three full-time positions per line and per shift to comply with 9 CFR 310.11; while small  4 high-volume  5 establishments dedicate between one and two positions for the same purpose. Small low-volume and very small  6 establishments are thought to dedicate between one quarter-time and one full-time position to comply with this regulation. The Agency sought, but did not receive, comment on these labor-demand estimates.

According to data from the Agency's electronic Public Health Information System (PHIS), 479 very small establishments, 54 small low-volume establishments, 51 small high-volume establishments, and 23  7 large swine establishments will be affected by this rule. This analysis takes into consideration the fact that some large and small high-volume establishments operate multiple lines and multiple shifts. This analysis assumes that all other establishments operate one line and one shift per day. Data from PHIS also show that, on average, large establishments annually operate 266 days, small high-volume establishments 239 days, small low-volume establishments 95 days, and very small establishments 67 days. The final rule is expected to lead to a reduction in industry positions at these establishments; see table 1. Table 2 provides the estimated labor cost savings from the final rule, given the expected labor costs, number of positions, and days of operation. The annual cost savings range from $5.27 million to $19.03 million, with a mid-point of $11.81 million.

The final rule has no expected costs associated with it.

The FSIS Administrator certifies that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not have a significant impact on a substantial number of small entities in the United States. The expected labor cost reductions associated with the final rule are not likely to be large enough to significantly impact an entity. Further, the final rule does not have any cost increases.

Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has estimated that this final rule will yield cost savings. Therefore, this final rule is an E.O. 13771 deregulatory action.

No new paperwork requirements are associated with this final rule.

This final rule has been reviewed under E.O. 12988, Civil Justice Reform. Upon the effective date of this final rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) No retroactive effect will be given to this rule; and (3) Administrative proceedings will not be required before parties may file suit in court challenging this rule.

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq. ) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register.

FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

No agency, officer, or employee of the USDA, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, shall exclude from participation in, deny the benefits of, or subject to discrimination, any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410, Fax: (202) 690-7442.

Email: program.intake@usda.gov.

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

For the reasons set out in the preamble, FSIS is amending 9 CFR part 310 as follows:

Congress passed the FCPIAA in 1990 to allow for regular adjustment for inflation of civil monetary penalties, maintain the deterrent effect of such penalties and promote compliance with the law, and improve the collection of civil monetary penalties by the Federal government (Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note). Pursuant to this authority, and as amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-34, 110 Stat. 1321-373), the NRC increased, via rulemaking, the penalty amounts for violations of the AEA (codified at § 2.205 of title 10 of the Code of Federal Regulations (10 CFR)) and Program Fraud Civil Remedies Act (codified at § 13.3) on four occasions between 1996 and 2008. 1

On November 2, 2015, Congress amended the FCPIAA through the 2015 Improvements Act (Sec. 701, Pub. L. 114-74, 129 Stat. 599). The 2015 Improvements Act required that the head of each agency perform an initial “catch-up” adjustment via rulemaking, adjusting the civil monetary penalties enforced by that agency according to the percentage change in the Consumer Price Index (CPI) between the month of October 2015 and the month of October of the calendar year when the penalty amount was last established by Congress. The NRC performed this catch-up rulemaking on July 1, 2016 (81 FR 43019).

The 2015 Improvements Act also requires that the head of each agency continue to adjust penalty amounts, rounded to the nearest dollar, on an annual basis. Specifically, each civil monetary penalty is to be adjusted based on the percentage change between the CPI for the previous month of October, and the CPI for the month of October in the year preceding that. The NRC most recently adjusted its civil penalties for inflation according to this statutory formula on January 12, 2018 (83 FR 1515). This year's adjustment is based on the percentage change between the CPI for October 2018 and October 2017.

Section 234 of the AEA limits civil penalties for violations of the AEA to $100,000 per day, per violation (42 U.S.C. 2282). However, as discussed in Section I, “Background,” of this document, the NRC has increased this amount several times since 1996 per the FCPIAA, as amended. Using the formula in the 2015 Improvements Act, the $290,875 amount last established in January 2018 will increase by 2.522 percent, resulting in a new penalty amount of $298,211. This is based on the percentage change between the October 2018 CPI (252.885) and the October 2017 CPI (246.663). Therefore, the NRC is amending § 2.205 to reflect a new maximum civil monetary penalty under the AEA in the amount of $298,211 per day, per violation. This represents an increase of $7,336.

Monetary penalties under the Program Fraud Civil Remedies Act were established in 1986 at $5,000 per claim (Pub. L. 99-509, 100 Stat. 1938; 31 U.S.C. 3802). The NRC has also adjusted this amount (currently set at $11,181) multiple times pursuant to the FCPIAA, as amended, since 1996. Using the formula in the 2015 Improvements Act, the $11,181 amount last established in January 2018 will also increase by 2.522 percent, resulting in a new civil monetary penalty amount of $11,463. Therefore, the NRC is amending § 13.3 to reflect a new maximum penalty amount of $11,463 per claim or statement. This represents an increase of $282.

As permitted by the 2015 Improvements Act, the NRC may apply these increased penalty amounts to any penalties assessed by the agency after the effective date of this rulemaking (February 7, 2019), regardless of whether the associated violation occurred before or after this date (Pub. L. 114-74, 129 Stat. 600; 28 U.S.C. 2461 note). The NRC assesses civil penalty amounts for violations of the AEA based on the class of licensee and severity of the violation, in accordance with the NRC Enforcement Policy (ADAMS Accession No. ML18138A138).

The 2015 Improvements Act expressly exempts this final rule from the notice and comment requirements of the Administrative Procedure Act, by directing agencies to adjust civil monetary penalties for inflation “notwithstanding section 553 of title 5, United States Code” (Pub. L. 114-74, 129 Stat. 599; 28 U.S.C. 2461 note). As such, this final rule is being issued without prior public notice or opportunity for public comment, with an effective date of February 7, 2019.

This final rule revises paragraph (j) by replacing “$290,875” with “$298,211”.

This final rule revises paragraphs (a)(1)(iv) and (b)(1)(ii) by replacing “$11,181” with “$11,463”.

This final rule adjusts for inflation the maximum civil monetary penalty amounts the NRC may assess under the AEA and under the Program Fraud Civil Remedies Act of 1986. The formula for determining the amount of the adjustment is mandated by Congress in the FCPIAA, as amended by the 2015 Improvements Act (codified at 28 U.S.C. 2461 note). Congress passed this legislation on the basis of its findings that the power to impose monetary civil penalties is important to deterring violations of Federal law and furthering the policy goals of Federal laws and regulations. Congress has also found that inflation diminishes the impact of these penalties and their effect. The principal purposes of this legislation are to provide for adjustment of civil monetary penalties for inflation, maintain the deterrent effect of civil monetary penalties, and promote compliance with the law. Therefore, these are the anticipated impacts of this rulemaking. Direct monetary impacts fall only upon licensees or other persons subjected to NRC enforcement for violations of the AEA and regulations and orders issued under the AEA (§ 2.205), or those licensees or persons subjected to liability pursuant to the provisions of the Program Fraud Civil Remedies Act of 1986 (31 U.S.C. 3801-3812) and the NRC's implementing regulations (10 CFR part 13).

The Regulatory Flexibility Act does not apply to regulations for which a Federal agency is not required by law, including the rulemaking provisions of the Administrative Procedure Act, 5 U.S.C. 553(b), to publish a general notice of proposed rulemaking (5 U.S.C. 604). As discussed in this document under Section III., “Rulemaking Procedure,” the NRC has determined that this final rule is exempt from the requirements of 5 U.S.C. 553(b) and notice and comment need not be provided. Accordingly, the NRC also determines that the requirements of the Regulatory Flexibility Act do not apply to this final rule.

The NRC has not prepared a backfit analysis for this final rule. This final rule does not involve any provision that would impose a backfit, nor is it inconsistent with any issue finality provision, as those terms are defined in 10 CFR chapter I. As mandated by Congress, this final rule increases penalty amounts for violations of already-existing NRC regulations and requirements. This final rule does not modify any licensee systems, structures, components, designs, approvals, or procedures required for the construction or operation of any facility.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

The NRC has determined that this final rule is the type of action described as a categorical exclusion in § 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain a collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995.

This final rule is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; 28 U.S.C. 2461 note; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 2 and 13:

I. Background

The test procedure established for furnace fans specifies that the applicable rating metric of FER must be expressed in terms of watts per 1000 cubic feet per minute (“Watts/1000 cfm”). 79 FR 500, 523 (Jan. 3, 2014); 10 CFR 430.23(cc). In the July 2014 final rule, DOE established energy conservation standards for furnace fans using the FER metric. 79 FR 38130 (July 3, 2014). Consistent with the test procedure, the certification requirements established in the July 2014 final rule require reporting of FER in terms of Watts/1000 cfm. 79 FR 38130, 38208 (July 3, 2014); 10 CFR 429.58(b)(2). Additionally, the preamble to the July 2014 final rule generally presents the units for the FER metric as Watts/1000 cfm. 79 FR 38130, 38138, 38201, 38202 (July 3, 2014). However, in a number of places in the July 2014 final rule preamble and regulatory text, the units for FER are improperly written as “Watts/cfm” instead of “Watts/1000 cfm.” This document identifies and corrects these typographical errors. DOE notes that the energy conservation standards and related equations adopted in the July 3, 2014 final rule are correct as published and do not require substantive revision.

As published, the adopted energy conservation standards text may result in confusion due to incorrect unit reference. Because this final rule would simply correct errors in the text without making substantive changes in the energy conservation standards, the changes addressed in this document are technical in nature. Accordingly, DOE finds that there is good cause under 5 U.S.C. 553(b)(B) to not issue prior notice to solicit public comment on the changes contained in this document. Issuing a separate document to solicit public comment would be unnecessary and contrary to the public interest.

DOE has concluded that the determinations made pursuant to the various procedural requirements applicable to the July 3, 2014 final rule remain unchanged for this final rule technical correction. These determinations are set forth in the July 3, 2014 final rule. 79 FR 38130, 38203-38208.

In the Federal Register of July 3, 2014, in FR Doc. 2014-15387, the following corrections are made:

1. On page 38131, in Table I.1—Energy Conservation Standards for Covered Residential Furnace Fans, correct the second column header to read: FER* (Watts/1000 cfm).

2. On page 38152, in the second column, in the first paragraph, replace all instances of “watts/cfm” with “Watts/1000 cfm.”

3. On page 38157, in the third column, in the first paragraph, replace “watts/cfm” with “Watts/1000 cfm.”

4. On page 38209, in Table 1—Energy Conservation Standards for Covered Residential Furnace Fans, correct the second column header to read: FER** (Watts/1000 cfm).

For the reasons stated in the preamble, DOE amends part 430 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations as set forth below:

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act)  1 to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The Inflation Adjustment Act provides for the regular evaluation of CMPs and requires FCSIC, and every other Federal agency with authority to impose CMPs, to ensure that CMPs continue to maintain their deterrent values. 2

FCSIC must enact regulations that annually adjust its CMPs pursuant to the inflation adjustment formula of the amended Inflation Adjustment Act and rounded using a method prescribed by the Inflation Adjustment Act. The new amounts will apply to penalties assessed on or after the effective date of this rule. Agencies do not have discretion in choosing whether to adjust a CMP, by how much to adjust a CMP, or the methods used to determine the adjustment.

First, section 5.65(c) of the Farm Credit Act, as amended (Act), provides that any insured Farm Credit System bank that willfully fails or refuses to file any certified statement or pay any required premium shall be subject to a penalty of not more than $100 for each day that such violations continue, which penalty FCSIC may recover for its use. 3 Second, section 5.65(d) of the Act provides that, except with the prior written consent of the Farm Credit Administration, it shall be unlawful for any person convicted of any criminal offense involving dishonesty or a breach of trust to serve as a director, officer, or employee of any System institution. 4 For each willful violation of section 5.65(d), the institution involved shall be subject to a penalty of not more than $100 for each day during which the violation continues, which FCSIC may recover for its use.

FCSIC's current § 1411.1 provides that FCSIC can impose a maximum penalty of $205 per day for a violation under section 5.65(c) and (d) of the Act.

The 2015 Act requires agencies to make annual adjustments for inflation. Annual inflation adjustments are based on the percent change between the October Consumer Price Index for all Urban Consumers (CPI-U) preceding the date of the adjustment, and the prior year's October CPI-U. Based on theCPI-U for October 2018, not seasonally adjusted, the cost-of-living adjustment multiplier for 2019 is 1.02522. 5 Multiplying 1.02522 times the current penalty amount of $205, after rounding to the nearest dollar as required by the 2015 Act, results is a new penalty amount of $210.

In accordance with the 2015 Act, Federal agencies shall adjust civil monetary penalties “notwithstanding” Section 553 of the Administrative Procedures Act. This means that public procedure generally required for agency rulemaking—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.

For the reasons stated in the preamble, part 1411 of chapter XIV, title 12 of the Code of Federal Regulations is amended as follows:

We have received reports from Boeing of warpage of internal engine fire handle components, which can cause binding and prevent proper operation. A latently failed engine fire handle could prevent the fire extinguishing agent from being able to be released. In the event of certain engine fires, the potential exists for an engine fire to be uncontrollable. This unsafe condition, if not addressed, could result in the inability to extinguish an engine fire that, if uncontrollable, could lead to wing failure.

We are issuing this AD because we 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 revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations.

Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (j) of this AD.

We consider this AD interim action. The manufacturer is currently developing a terminating action that will address the unsafe condition identified in this AD. Once this terminating action is developed, approved, and available, we 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 because warpage of internal engine fire handle components can cause binding and prevent proper operation. A latently failed engine fire handle could prevent the fire extinguishing agent from being able to be released. In the event of certain engine fires, the potential exists for an engine fire to be uncontrollable, which could lead to wing failure. Additionally, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find 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, we invite 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-2019-0015 and Product Identifier 2018-NM-179-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

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

We estimate that this AD affects 120 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

We have determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

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.

We are 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 transport category airplanes and associated appliances to the Director of the System Oversight 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,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Background

The Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410; 28 U.S.C. 2461), as amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-134), provided for agencies' adjustments for inflation to CMPs to ensure that CMPs continue to maintain their deterrent value and that CMPs due to the Federal Government were properly accounted for and collected.

A CMP is defined as any penalty, fine, or other sanction that:

1. Is for a specific monetary amount as provided by Federal law, or has a maximum amount provided for by Federal law; and,

2. Is assessed or enforced by an agency pursuant to Federal law; and,

3. Is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts.

On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701 of Pub. L. 114-74) further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 to improve the effectiveness of CMPs and to maintain their deterrent effect. This amendment (1) required agencies to adjust the CMP levels in effect as of November 2, 2015, with initial catch up adjustments for inflation through a final rulemaking to take effect no later than August 1, 2016; and (2) requires agencies to make subsequent annual adjustments for inflation to CMPs that shall take effect not later than January 15. The Department of Commerce's 2018 adjustments for inflation to CMPs were published in the Federal Register on January 8, 2018, and the new CMP levels became effective January 15, 2018.

The Department of Commerce's 2019 adjustments for inflation to CMPs apply only to CMPs with a dollar amount, and will not apply to CMPs written as functions of violations. These 2019 adjustments for inflation to CMPs apply only to those CMPs, including those whose associated violation predated such adjustment, which are assessed by the Department of Commerce after the effective date of the new CMP level.

This regulation adjusts for inflation CMPs that are provided by law within the jurisdiction of the Department of Commerce. The actual CMP assessed for a particular violation is dependent upon a variety of factors. For example, the National Oceanic and Atmospheric Administration's (NOAA) Policy for the Assessment of Civil Administrative Penalties and Permit Sanctions (Penalty Policy), a compilation of NOAA internal guidelines that are used when assessing CMPs for violations for most of the statutes NOAA enforces, will be interpreted in a manner consistent with this regulation to maintain the deterrent effect of the CMPs. The CMP ranges in the Penalty Policy are intended to aid enforcement attorneys in determining the appropriate CMP to assess for a particular violation. The Penalty Policy is maintained and made available to the public on NOAA's Office of the General Counsel, Enforcement Section website at: http://www.gc.noaa.gov/enforce-office.html.

The Department of Commerce's 2019 adjustments for inflation to CMPs set forth in this regulation were determined pursuant to the methodology prescribed by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires the maximum CMP, or the minimum and maximum CMP, as applicable, to be increased by the cost-of-living adjustment. The term “cost-of-living adjustment” is defined by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. For the 2019 adjustments for inflation to CMPs, the cost-of-living adjustment is the percentage for each CMP by which the Consumer Price Index for the month of October 2018 exceeds the Consumer Price Index for the month of October 2017.

Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701(b)) requires agencies to make annual adjustments for inflation to CMPs notwithstanding section 553 of title 5, United States Code. Additionally, the methodology used for adjusting CMPs for inflation is given by statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The Department of Commerce is charged only with performing ministerial computations to determine the dollar amounts of adjustments for inflation to CMPs. Accordingly, prior public notice and an opportunity for public comment are not required for this rule.

The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this rule because there are no new or revised recordkeeping or reporting requirements.

E.O. 12866, Regulatory Review

This rule is not a significant regulatory action as that term is defined in Executive Order 12866.

Because notice of proposed rulemaking and opportunity for comment are not required pursuant to 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility act (5 U.S.C. 601, et seq. ) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

On June 29, 2010, the DEA designated ANPP as an immediate precursor for the Schedule II controlled substance fentanyl under the definition set forth in 21 U.S.C. 802(23). 75 FR 37295 (Jun. 29, 2010). ANPP is the immediate chemical intermediary in the synthesis process used by clandestine laboratory operators for the illicit manufacture of the Schedule II controlled substance fentanyl.

In the rulemaking, the DEA inadvertently introduced an error into the drug name. This rulemaking is intended to correct that ministerial error.

Both the notice of proposed rulemaking and the final rule referenced the chemical name as “4-anilino-N-phenethyl-4-piperidine (ANPP)” and “CASRN 21409-26-7” (Chemical Abstract Service Registry Number). 1 73 FR 19175, 19176 (Apr. 9, 2008); 75 FR 37295, 37296 (Jun. 29, 2010). While the abbreviation ANPP and the Chemical Abstract Service Registry Number 21409-26-7 correctly identified the compound, the name “4-anilino-N-phenethyl-4-piperidine” is incorrect and is without meaning. The correct name is “4-anilino-N-phenethylpiperidine”.

There is no existing chemical compound named “4-anilino-N-phenethyl-4-piperidine.” While chemists understood which compound was being controlled by the DEA due to the abbreviation ANPP and specific CASRN number, DEA is now correcting the listing in the Code of Federal Regulations (CFR) by revising 21 CFR 1308.12 to provide the correct name.

The Administrative Procedure Act (APA) generally requires that agencies, prior to issuing a new rule, publish a notice of proposed rulemaking in the Federal Register . The APA also provides, however, that agencies may be exempt from this requirement when “the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”  2

The name “4-anilino-N-phenethyl-4-piperidine” is without meaning and no substance exists by that chemical name. The inclusion of the “-4” in the middle of the name is nonsensical. Because the correct Chemical Abstract Service Registry Number and abbreviation “ANPP” were given in the original rulemaking, chemists have understood which compound has been (and remains) controlled by DEA. There is no change as to what substance is controlled. Public notice and comment is thus unnecessary.

For the same reasons that the DEA has determined that public notice and comment is unnecessary, the DEA also finds good cause to adopt an effective date that would be less than 30 days after the publication in the Federal Register pursuant to the APA. 5 U.S.C. 553(d). Accordingly, this amendment will be effective as of the date of publication in the Federal Register .

For the reasons set out above, 21 CFR part 1308 is amended as follows:

Pursuant to section 2(x)(6) of the Veterans Appeals Improvement and Modernization Act of 2017 (AMA), the Department of Veterans Affairs (VA) is providing notice that the effective date of the new VA appeals system is February 19, 2019. The Secretary of Veterans Affairs transmitted to Congress the certification required under AMA section 2(x)(1) on January 18, 2019. On that same date, the final rule setting forth the implementing regulations was published in the Federal Register . 84 FR 138 (Jan. 18, 2019). Because the thirtieth day from January 18, 2019, falls on a non-business day, the effective date was set on the next business day of February 19, 2019.

I. Background

In a rulemaking published on August 17, 2018 (83 FR 41035), the EPA proposed approval of various revisions to Colorado's Regulation Number 11 that the State submitted to the EPA on February 20, 2015, and on May 14, 2018. Most of the revisions involve minor updates to several sections of Regulation Number 11 and the deletion of obsolete language. The August 17, 2018 notice gives a detailed description of each revision.

In this rulemaking the EPA is taking final action to approve the proposed revisions, which are listed in section III below. The reasons for our approval are provided in the proposed rule.

The EPA received one anonymous comment on the proposed SIP amendments to Colorado's Regulation Number 11. After reviewing the comment, the EPA has determined that the comment is outside the scope of our proposed action. We note the EPA is not removing or relaxing any emissions standards in this action. The comment that we received on this action is available for review in the docket for this rulemaking. This rule will be finalized as proposed without revisions.

For the reasons expressed in the proposed rule, the EPA is approving the two SIP submittals to Regulation Number 11 as submitted by the State of Colorado on February 20, 2015, and on May 14, 2018. These revisions were discussed in our August 17, 2018 proposed rule and are as follows:

a. Addition of a definition of “Tampering” to Part A.II.

b. Revisions to Part B.IV.B to require span gases to be labelled in accordance with Attachment VI of Appendix A.

c. Revisions to Part A.II.16 and Part C.XII. (A.3 and C.2) to increase clean screening efficiency by removing the requirement that two qualifying clean screen observations must be made on different days or at different locations.

d. Revisions to Part C.II.B.4 to remove incomplete and obsolescent qualifying criteria for certain vehicles that are unable to be tested on the IM240 chassis dynamometer.

e. Revisions to Part C.II.C to allow self-inspecting gasoline vehicle fleets to utilize the more effective and more convenient OBDII testing procedure on all 1996 model year and newer vehicles.

f. Revisions to Part C.II.C.3 regarding acceptable readiness criteria for OBD sensors and monitors.

g. Revisions to Part C.II.C.9 and C.10 regarding I/M240 tests and tampering associated with OBD tests.

h. Revisions to Part C.VIII and IX to clarify and modernize provisions for issuance of emissions repair, diagnostic and economic hardship waivers.

i. Revisions to Part D.I.B. 5, 6, and 7 to remove obsolete language regarding dwell meters, timing lights, and idle adjustment.

j. Revisions to Part F.VI.B, the roadside remote sensing clean screen LEI, to allow for greater utilization of this component of the I/M program.

k. Revisions to Part F.VII regarding OBD testing criteria.

l. Revisions to Appendix A, Technical Specifications; Introduction, Section 2.11; Attachment IV, Section 2.0; Attachment V; Attachment VI, and the deletion of Appendix B in its entirety to remove obsolete specifications and procedures for vehicle inspection analyzer calibration gasses.

m. Corrections of typographical, grammatical, and formatting errors throughout Regulation Number 11.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Colorado's Regulation Number 11 described in the amendments set forth to 40 CFR part 52, below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this final action merely approves some state law as meeting federal requirements; this final action does not impose additional requirements beyond those imposed by state law. For that reason, this final action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, Feb. 2, 2017) regulatory action because actions such as approving SIPs are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

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

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

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

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

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, Feb. 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 8, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

40 CFR part 52 is amended to read as follows:

The contents of this preamble are listed in the following outline:

Entities potentially affected by this final action are fuel producers and distributors who do business in the Northern Kentucky Area.

The above table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. The table lists the types of entities of which EPA is aware that potentially could be affected by this final action. Other types of entities not listed on the table could also be affected. To determine whether your organization could be affected by this final action, you should carefully examine the regulations in 40 CFR part 80, subpart D—Reformulated Gasoline. If you have questions regarding the applicability of this action to a particular entity, see the FOR FURTHER INFORMATION CONTACT section of this preamble.

EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2018-0114. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information may not be publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through www.regulations.gov.

The reformulated gasoline (RFG) opt-out regulations (40 CFR 80.72—Procedures for opting out of the covered areas) provide the process and criteria for a reasonable transition out of the federal RFG program if a state decides to opt-out. 2 These opt-out regulations provide that the governor of the state must submit a petition to the Administrator requesting to opt-out of the federal RFG program. The petition must include specific information on how, if at all, the state has relied on RFG in a proposed or approved state implementation plan (SIP) or plan revision and, if RFG is relied upon, how the SIP will be revised to reflect the state's opt-out from RFG. The opt-out regulations also provide that EPA will notify the state in writing of the Agency's action on the petition and the date the opt-out becomes effective ( i.e., the date RFG is no longer required in the affected area) when the petition is approved. The opt-out regulations also provide that EPA will publish a Federal Register document announcing the approval of any opt-out petition and the effective date of such opt-out. If a SIP revision is required, the effective date of EPA's approval of the opt-out can be no less than 90 days from the effective date of EPA's approval of the revision to the SIP that removes RFG as a control measure. See 40 CFR 80.72(c)(7).

In 1995, Kentucky voluntarily opted Boone, Campbell, and Kenton Counties (the Northern Kentucky Area), into the federal RFG program. Kentucky also opted its portion of the Louisville ozone area (Jefferson County and parts of Bullitt and Oldham Counties) into the federal RFG program; however, this action does not affect the use of RFG in the Kentucky portion of the Louisville ozone area. A current listing of the RFG covered areas and a summary of RFG requirements can be found at 40 CFR 80.70 and on EPA's website at: https://www.epa.gov/gasoline-standards/reformulated-gasoline.

On April 18, 2017, Kentucky submitted a petition to the EPA Administrator requesting to opt-out from the federal RFG program for the Northern Kentucky Area. 3 In order to fulfill the requirements of the RFG opt-out regulations and to support its initial request, on September 13, 2017, Kentucky submitted a revision to its maintenance plan for the Northern Kentucky Area to remove the emissions reductions associated with the use of RFG in this area and to demonstrate that the RFG opt-out would not interfere with the area's ability to attain or maintain the 2008 ozone National Ambient Air Quality Standard (NAAQS) and any other NAAQS as required by Clean Air Act (CAA) section 110(l). ( See 40 CFR 80.72(b)). EPA published a proposed approval of the SIP revision on February 14, 2018 (83 FR 6496) and a final approval of the SIP revision on April 2, 2018 (83 FR 13872). The final approval of the maintenance plan revision was effective upon publication, on April 2, 2018.

By letter dated April 30, 2018, EPA informed Kentucky of the grant of its petition as required by the RFG Opt-Out Rule. EPA also indicated that the effective date of the RFG opt-out for the Northern Kentucky Area would be July 1, 2018, which is 90 days after the effective date of EPA's approval of the maintenance plan revision and CAA section 110(l) analysis, as required by 40 CFR 80.72(c)(7). On May 16, 2018, EPA published the Federal Register document required by the RFG Opt-Out Rule that informed the public of the July 1, 2018 effective date and indicated that EPA would publish a final rule later to remove the Northern Kentucky Area from the list of RFG covered areas in 40 CFR 80.70 after the effective date of the opt-out (83 FR 22595). The July 1, 2018 opt-out effective date is the date for the removal of the prohibition on the sale of conventional gasoline in the Northern Kentucky Area and applies to retailers, wholesale purchasers-consumers, refiners, importers, and distributors of gasoline.

In this rule, EPA is amending 40 CFR 80.70(j) to reflect that the Northern Kentucky Area (Boone, Campbell, and Kenton counties) is no longer a federal RFG covered area. This final rule merely conforms the applicable regulations with EPA's prior approval of the Kentucky petition.

EPA is issuing this final action without prior notice and comment. The rulemaking procedures provided in CAA section 307(d) do not apply when the Agency for good cause finds that notice-and-comment procedures are impracticable, unnecessary, or contrary to the public interest pursuant to section 553(b)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(B). This is a ministerial action that amends 40 CFR 80.70 to reflect the prior EPA approval of Kentucky's opt-out petition, which was based on criteria in EPA regulations for opting out of the federal RFG program. In the RFG opt-out regulations, EPA established a petition process that would address, on a case-by-case basis, future individual state requests to opt-out of the RFG program. The regulations established clear and objective criteria for EPA to apply that include criteria for when a state's petition is complete and the appropriate transition time for opt-out of the RFG program. Further, at the time of promulgation of those regulations, EPA had explained that the application of these regulatory criteria on a case-by-case basis to individual opt-out requests would not require notice-and-comment rulemaking, either under CAA section 307(d) or the Administrative Procedure Act.

Here, and as explained in the approval action, EPA is simply revising the list of RFG covered areas in 40 CFR 80.70 to conform with EPA's prior approval of Kentucky's request, which was effective on July 1, 2018 (83 FR 22595). That approval was a separate action, which was based on criteria in EPA's regulations for opting out of the federal RFG program and is not the subject of this rule. For these reasons, EPA finds that notice-and-comment procedures under CAA section 307(d)(1) are unnecessary.

This final rule is effective immediately upon publication. Section 553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1), provides that final rules shall not become effective until 30 days after publication in the Federal Register “except . . . a substantive rule which grants or recognizes an exemption or relieves a restriction.” The purpose of this provision is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when the agency finalizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the affect is not adverse. EPA has determined that the finalized rule does not change any regulatory obligations and merely revises the list of covered areas in 40 CFR 80.70 to reflect EPA's prior action on May 16, 2018 which relieved a restriction (the requirement of the federal RFG program) in the Northern Kentucky Area. For these reasons, this rule will be effective immediately upon publication.

This action is not a significant regulatory action and therefore was not submitted to the Office of Management and Budget (OMB) for review.

This action is considered an Executive Order 13771 deregulatory action. This final rule and EPA's earlier approval of Kentucky's request to opt the three counties in the Northern Kentucky Area out of the federal RFG program provide meaningful burden reduction because it removes the requirements of the federal RFG program for gasoline sold in the Northern Kentucky Area and, as a result, fuel suppliers will no longer be required to sell gasoline that meets the federal RFG standards. Removing the federal RFG requirements will also be beneficial because this action can improve the fungibility of gasoline sold in the State of Kentucky by allowing gasoline sold in the Northern Kentucky Area to be identical to fuel sold in most of Kentucky.

This action does not impose any information collection burden under the PRA, because it does not contain any information collection activities.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. The small entities subject to the requirements of this action are refiners, importers or blenders of gasoline that choose to produce or import gasoline that meets the federal RFG program requirements for sale in the Northern Kentucky Area, and gasoline distributers and retail stations in the Northern Kentucky Area. EPA previously approved Kentucky's request to opt the three counties in the Northern Kentucky Area out of the federal RFG program remove the federal RFG requirements for gasoline sold in the Northern Kentucky Area as of July 1, 2018. This action merely amends the regulation at 40 CFR 80.70 to reflect the Northern Kentucky Area is no longer a covered area. This action does not impose any requirements or create impacts on small entities beyond those, if any, already required by or resulting from the CAA section 211(k) federal RFG program. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This final rule does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. EPA previously approved Kentucky's request to opt the three counties in the Northern Kentucky Area out of the federal RFG program removed a requirement for the sale of federal RFG in the area as provided for in CAA section 211(k) and EPA's regulations at 40 CFR 80.72. This action merely amends the regulation at 40 CFR 80.70 to reflect the Northern Kentucky Area is no longer a covered area.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. EPA's earlier approval of Kentucky's request to opt the three counties in the Northern Kentucky Area out of the federal RFG program affected only those refiners, importers or blenders of gasoline that chose to produce or import gasoline that met federal RFG program requirements for sale in the Northern Kentucky Area and gasoline distributers and retail stations in the Area. This action merely amends the regulation at 40 CFR 80.70 to reflect the Northern Kentucky Area is no longer a covered area. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. EPA has no reason to believe that this action will disproportionately affect children since Kentucky has provided evidence that opt-out from the federal RFG gasoline program will not interfere with its attainment of the ozone NAAQS, or any other applicable CAA requirement. By separate action, EPA has approved Kentucky's non-interference demonstration regarding its maintenance plan for the 2008 ozone NAAQS, and that Kentucky's opt-out from the federal RFG gasoline program in the Northern Kentucky Area will not interfere with any other NAAQS or CAA requirement.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the applicable ozone NAAQS which establish the level of protection provided to human health or the environment. EPA previously approved Kentucky's request to opt the three counties in the Northern Kentucky Area out of the federal RFG program removes the federal RFG gasoline program requirements for the Northern Kentucky Area. EPA has concluded that the federal RFG opt-out will not cause a measurable increase in ozone concentrations that would result in a violation of any ozone NAAQS including the 2008 ozone NAAQS and the more stringent 2015 ozone NAAQS. Therefore, disproportionately high and adverse human health or environmental effects on minority or low-income populations are not an anticipated result. The results of this evaluation are contained in EPA's proposed and final rules for Kentucky's non-interference demonstration. A copy of Kentucky's April 12, 2017 letter requesting that EPA relax the gasoline RVP standard, and Kentucky's September 13, 2017 letter that included additional technical analysis demonstrating that the opt-out from the federal RFG program would not interfere with continued maintenance of the 2008 ozone NAAQS in the Northern Kentucky Area, or with any other applicable CAA requirement, has been placed in the public docket for this action. This action merely amends the regulation at 40 CFR 80.70 to reflect the Northern Kentucky Area is no longer a covered area.

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The statutory authority for this action is granted to EPA by sections 211(k) and 301(a) of the Clean Air Act, as amended; 42 U.S.C. 7545(h) and 7601(a).

For the reasons set forth in the preamble, EPA amends 40 CFR part 80 as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2018-0163 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 April 8, 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-2018-0163, 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 document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11101) by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Fine Agrochemicals Ltd. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of glycine betaine (CAS Reg. No. 107-43-7) when used as an inert ingredient (plant nutrient) in pesticide formulations applied to growing crops. That document referenced a summary of the petition prepared by SciReg, Inc., on behalf of Fine Agrochemicals Ltd., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance 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. The FFDCA requires EPA to consider the factors in subparagraphs (b)(2)(C) and (D) when making this safety determination. 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for glycine betaine including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with glycine betaine follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by glycine betaine as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Glycine betaine is naturally present in numerous foods including beets, spinach, grains, seafood, and eggs. Its presence has also been reported in bacteria, animals, and plants. It is produced in the human body from choline and the amino acid glycine and acts as a methyl group donor and osmolyte.

Glycine betaine has low acute oral toxicity. Acute dermal, inhalation, and dermal irritation studies for glycine betaine were not submitted. Glycine betaine was shown to be non-irritating to the eyes. In skin sensitization studies in mice, glycine betaine was not skin sensitizer. Although a dermal irritation study is not available, studies have shown that glycine betaine is found in human skin cell and sweat excreted from the body indicating that the chance for dermal irritation is minimal. In addition, a percutaneous dermal absorption study showed that only 0.1% of the applied dose permeated through the epidermis. This would make dermal toxicity unlikely.

Repeat dose oral toxicity studies on glycine betaine in rats include: Two 28-day studies, a 90-day study, and a combined chronic toxicity/carcinogenicity study. No adverse effects of treatment were seen in any of the studies up to the limit dose of 1000 Milligrams/kilograms/day (mg/kg/day). Some effects ( e.g., increased liver weights, hepatocellular vacuolation, and increased Gamma Glutamyl Transferase (GGT) levels) were seen at varying dose levels, but only at extremely high doses (≥4000 mg/kg/day) were these effects seen in combination and therefore, considered a potential effect of treatment. One of the 28-day rat oral toxicity studies included a 28-day reversal period where animals were fed the control diet and evaluated on day 56. The study showed that after the reversal period the liver weights were comparable to control and the vacuoles were gone.

The full study reports for studies referenced above were not available and therefore, the Agency could not determine if these effects ( e.g., increased liver weights, hepatocellular vacuolation, and increased GGT levels) were a true result of toxicity from the subject chemical or if they were within normal range of historical controls of the test animal or an effect of the excessive dosing. According to the summaries provided through the European Chemicals Agency (ECHA) database as part of the Registration, Evaluation, Authorization, and Restrictions of Chemical (REACH) program and the Cosmetic Ingredient Review (CIR) on betaine, betaine is tolerated at very high levels and its effects are reversible. This was also the finding of an article in Food and Chemical Toxicology which reviewed the two 28-day studies and the 90-day study. Although the study reviews did not treat these effects as adverse, and determined the NOAEL to be the highest dose tested in each case (4000-7143 mg/kg/day), in the absence of confirmatory data, the Agency has taken the conservative approach and treated these as an effect of treatment. The target organ in these studies appeared to be the liver.

While no developmental or reproductive studies were conducted with glycine betaine, it was seen to be beneficial in preventing neural tube defects and has been used in children as young as 24 days old as a treatment for homocystinuria. There was no evidence of carcinogenicity in any of the studies presented including the combined chronic/carcinogenicity study and studies on mutagenicity and cytotoxicity. In addition, no neuropathological changes or effects were reported in any of the studies. The Agency does not believe glycine betaine will be carcinogenic or neurotoxic.

Available toxicity studies on glycine betaine indicate that it has a very low acute, subchronic, and chronic toxicity. No adverse effects were seen in any of the studies presented at the limit dose of 1000 mg/kg/day, effects seen above the limit dose level are not used for endpoint selection; therefore, no endpoint of concern has been selected for acute, subchronic, or chronic toxicity.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to glycine betaine, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from glycine betaine in food as follows:

Dietary exposure to glycine betaine may occur from eating foods naturally containing glycine betaine and foods treated with pesticide formulations containing glycine betaine as an inert ingredient. Because, at the limit dose, no endpoint of concern was identified, a quantitative dietary exposure assessment for glycine betaine was not conducted.

2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted, although exposures may be expected from use of pesticide formulations containing glycine betaine on food crops.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Glycine betaine may be used as inert ingredient in pesticide products that are registered for specific uses that may result in indoor or outdoor residential. Additional non-dietary exposure may occur from use of glycine betaine in pharmaceutical products and cosmetics. However, since there are no toxicological effects of concern at the limit dose in available studies, a quantitative assessment of residential (non-occupational) exposures and risks is not necessary.

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

EPA has not found glycine betaine to share a common mechanism of toxicity with any other substances, and glycine betaine does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that glycine betaine does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) requires EPA to retain an additional tenfold margin of safety in the case of threshold effects 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. As noted in Unit IV.B., there is no indication of threshold effects being caused by glycine betaine at the limit dose. Therefore, due to the lack of any toxicological endpoints of concern at the limit dose, EPA is conducting a qualitative assessment of glycine betaine which does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Taking into consideration all available information on glycine betaine EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to glycine betaine under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of glycine betaine when used as an inert ingredient in pesticide formulations applied to growing crops, is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for glycine betaine (CAS Reg. No. 107-43-7) when used as an inert ingredient (plant nutrient) in pesticide formulations applied to growing crops only.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

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

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

Therefore, 40 CFR chapter I is amended as follows:

This rule adjusts the civil monetary penalties assessable by the Commission in accordance with the 2015 Act, which became effective on November 2, 2015, § 701 of Public Law 114-74. The 2015 Act further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), Public Law 101-410, 104 Stat. 890 (codified as amended at 28 U.S.C. 2461 note), in order to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect.

The 2015 Act requires agencies to adjust civil monetary penalties under their jurisdiction by January 15 each year, based on changes in the consumer price index (CPI-U) using data from October in the previous calendar year. On December 14, 2018, the Office of Management and Budget published guidance stating that the CPI-U multiplier for October 2018 is 1.02522. 1 In order to complete the adjustment for January 2019, the Commission must multiply the most recent civil penalty amounts in 46 CFR part 506.

Adjustments under the FCPIAA, as amended by the 2015 Act, are not subject to the procedural rulemaking requirements of the Administrative Procedure Act (APA) (5 U.S.C. 553), including the requirements for prior notice, an opportunity for comment, and a delay between the issuance of a final rule and its effective date. 2 As noted above, the 2015 Act requires that the Commission adjust its civil monetary penalties no later than January 15 of each year.

The rule is not a “major rule” as defined by the Congressional Review Act, codified at 5 U.S.C. 801 et seq. The rule will not result in: (1) An annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies. 5 U.S.C. 804(2).

The Regulatory Flexibility Act (codified as amended at 5 U.S.C. 601-612) provides that whenever an agency promulgates a final rule after being required to publish a notice of proposed rulemaking under the APA (5 U.S.C. 553), the agency must prepare and make available a final regulatory flexibility analysis (FRFA) describing the impact of the rule on small entities. 5 U.S.C. 604. As indicated above, this final rule is not subject to the APA's notice and comment requirements, and the Commission is not required to prepare an FRFA in conjunction with this final rule.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before collecting information from the public. 44 U.S.C. 3507. The agency must submit collections of information in rules to OMB in conjunction with the publication of the notice of proposed rulemaking. 5 CFR 1320.11. This final rule does not contain any collections of information, as defined by 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).

The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda, available at: http://www.reginfo.gov/public/do/eAgendaMain.

For the reasons stated in the preamble, part 506 of title 46 of the Code of Federal Regulations is amended as follows:

This document announces that, on January 28, 2019, OMB approved, for a period of three years, the information collection requirements relating to the pole attachment complaint rules contained in the Commission's Accelerating Wireline Broadband Deployment by Removing Barriers to Infrastructure Investment, Third Report and Order and Declaratory Ruling, FCC 18-111, published at 83 FR 46812, September 14, 2018. The OMB Control Number is 3060-0392. The Commission publishes this document as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW, Washington, DC 20554. Please include the OMB Control Number, 3060-0392, in your correspondence. The Commission also will accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approval on January 28, 2019 for the information collection requirements contained in the modifications to the Commission's pole attachment complaint rules in 47 CFR 1.1413.

Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0392.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the affected respondents are as follows:

OMB Control Number: 3060-0392.

OMB Approval Date: January 28, 2019.

OMB Expiration Date: January 31, 2022.

Title: 47 CFR part 1, subpart J—Pole Attachment Complaint Procedures.

Form Number: N/A.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 1,775 respondents; 1,791 responses.

Estimated Time per Response: 10-14 hours.

Frequency of Response: On occasion reporting and third-party disclosure requirements.

Obligation to Respond: Required to obtain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 224.

Total Annual Burden: 3,149 hours.

Total Annual Cost: $486,000.

Nature and Extent of Confidentiality: No questions of a confidential nature are asked. However, respondents may request that materials or information submitted to the Commission in a complaint proceeding be withheld from public inspection under 47 CFR 0.459.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: The Commission received OMB approval for a revision to an existing information collection. OMB Collection No. 3060-0392, among other things, tracks the burdens associated with utilities defending against complaints brought by incumbent local exchange carriers (LECs) related to unreasonable rates, terms, and conditions for pole attachments. In Accelerating Wireline Broadband Deployment by Removing Barriers to Infrastructure Investment, Third Report and Order and Declaratory Ruling, FCC 18-111, the Commission, among other things, revised 47 CFR 1.1413 to establish a presumption that an incumbent LEC is similarly situated to an attacher that is a telecommunications carrier or a cable television system providing telecommunications services for purposes of obtaining comparable pole attachment rates, terms, or conditions. The Commission also established a presumption that an incumbent LEC may be charged no higher than the Commission-defined pole attachment rate for telecommunications carriers, as determined in accordance with 47 CFR 1.1406(d)(2). To rebut these presumptions, the utility must demonstrate by clear and convincing evidence that the incumbent LEC receives benefits under its pole attachment agreement with a utility that materially advantages the incumbent LEC over other telecommunications carriers or cable television systems providing telecommunications services on the same poles. As a result, now there is an incremental paperwork burden on utilities should they elect to challenge the presumption that incumbent LECs are entitled to rates, terms, and conditions of similarly-situated telecommunications attachers. None of the other paperwork burdens as set forth in the 2018 renewal of OMB Collection No. 3060-0392 will change. The Commission will use the information collected under this revision to 47 CFR 1.1413 to hear and resolve pole attachment complaints brought by incumbent LECs and to determine the merits of the complaints.

This is a summary of the Commission's Order, DA 18-1272, adopted and released on December 19, 2018. The document is available for download at https://www.fcc.gov/document/annual-adjustment-civil-monetary-penalties-reflect-inflation . The complete text of this document is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554.

The Bipartisan Budget Act of 2015 included, as Section 701 thereto, the Inflation Adjustment Act, which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), to improve the effectiveness of civil monetary penalties and maintain their deterrent effect. Under the Inflation Adjustment Act, agencies are required to make annual inflationary adjustments by January 15 each year, beginning in 2017. The adjustments are calculated pursuant to Office of Management and Budget (OMB) guidance. OMB issued guidance on December 14, 2018, and this Order follows that guidance. The Commission therefore updates the civil monetary penalties for 2019, to reflect an annual inflation adjustment based on the percent change between each published October's CPI-U; in this case, October 2018 CPI-U (252.885)/October 2017 CPI-U (246.663) = 1.02522. The Commission multiplies 1.02522 by the most recent penalty amount and then rounds the result to the nearest dollar.

This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:

This document announces that, on January 28, 2019, OMB approved the information collection requirements contained in the Commission's Second R&O and Third R&O, FCC 17-152 and FCC 18-73, published at 83 FR 37 and 83 FR 34478, January 2, 2018 and July 20, 2018. The OMB Control Number is 3060-1215. The Commission publishes this document as an announcement of the effective date of the information collection requirements.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on November 6, 2018, for the information collection requirements contained in the Commission's rules.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1215.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1215.

OMB Approval Date: January 28, 2019.

OMB Expiration Date: January 31, 2022.

Title: Use of Spectrum Bands Above 24 GHz for Mobile Radio Services.

Form Number: Not applicable.

Respondents: Business or other for-profit entities, state, local, or tribal government and not for profit institutions.

Number of Respondents and Responses: 280 respondents; 280 responses.

Estimated Time per Response: 0.5-10 hours.

Frequency of Response: On occasion reporting requirement; third party disclosure requirement; upon commencement of service, or within 3 years of effective date of rules; and at end of license term, or 2024 for incumbent licensees.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection are contained in sections 1, 2, 3, 4, 5, 7, 10, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, and 336 of the Communications Act of 1934, 47 U.S.C. 151, 152, 153, 154, 155, 157, 160, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, 336, Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302.

Total Annual Burden: 615 hours.

Annual Cost Burden: $450,000.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information. The information to be collected will be made available for public inspection. Applicants may request materials or information submitted to the Commission be given confidential treatment under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The Federal Communications Commission (Commission or FCC) adopted Use of Spectrum Bands Above 24 GHz for Mobile Radio Services in a Second Report and Order (“Second R&O”), GN Docket No. 14-177, IB Docket No. 15-256, WT Docket No. 10-112 and IB Docket No. 97-95, FCC 17-152, on November 16, 2017, published in 83 FR 37 on January 2, 2018. The Commission also adopted Use of Spectrum Bands Above 24 GHz for Mobile Radio Services in the Third R&O, GN Docket No. 14-177, WT Docket No. 10-112, on June 7, 2018, FCC 18-73, published in 83 FR 34478 on July 20, 2018. In the Second and Third R&Os, the Commission amended § 25.136 by revising the section heading and paragraphs (a) introductory text, (a)(4), (b), (c), and (d) and adding paragraphs (e), (f) and (g). The Commission added the 24 GHz band (24.75-25.25 GHz) and 47 GHz band (47.2-48.2 GHz) to the bands that are subject to the framework for sharing between the Upper Microwave Flexible Use Service (UMFUS) and the Fixed-Satellite Service (FSS) established in that rule. Therefore, the Commission expanded the scope of the rules to include additional bands. In turn, since the rules now apply in additional bands, the number of respondents, the annual number of responses, annual burden hours and annual costs will increase for this collection. In addition, the Commission modified the sharing criteria between UMFUS and FSS to facilitate deployment of FSS earth stations in smaller markets and decrease the possibility of conflicts between UMFUS and FSS. The other rule sections previously approved under OMB Control Number 3060-1215 have not changed.

Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.110. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102, and the initial 2018 allocations were published on December 22, 2017 (82 FR 60682), and corrected January 30, 2018 (83 FR 4165).

The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan, as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider the criteria in § 648.102(c)(2)(i)(A) through (C) in the evaluation of requests for quota transfers or combinations.

North Carolina is transferring 5,000 lb (2,268 kg) of 2018 summer flounder commercial quota to Virginia through mutual agreement of the states. This transfer was requested to repay landings made by a North Carolina-permitted vessel in Virginia under a safe harbor agreement. Based on the initial quotas published in the 2018 Summer Flounder, Scup, and Black Sea Bass Specifications and subsequent adjustments and transfers, the revised summer flounder quotas for calendar year 2018 are now: North Carolina, 1,747,145 lb (792,492 kg); and Virginia, 1,356,972 lb (615,512 kg).

The 2018 fishing year ended December 31, 2018. The revised 2018 quotas will be used by NMFS in the ongoing quota accounting that is finalized in late 2019. These transfers were requested as a result of unforeseeable late-season events. Specifically, a landing event where a vessel were granted safe harbor too late in the year to publish notice in 2018.

This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.