Federal Register Vol. 83, No.121,

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Duplin County Airport, Kenansville, NC, to support IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 9822, March 8, 2018) for Docket No. FAA-2016-1238 to amend Class E airspace extending upward from 700 feet above the surface within a 6.8-mile (from a 6.4-mile) at Duplin County Airport, Kenansville, NC, due to the decommissioning of the Kenan NDB, and cancellation of the NDB approach, and adjustment of the geographic coordinates. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Duplin County Airport, Kenansville, NC, due to the decommissioning of the Kenan NDB and cancellation of the NDB approach. These changes are necessary for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport are amended to coincide with the FAA's aeronautical database.

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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the National Airspace System route structure as necessary to preserve the safe and efficient flow of air traffic.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for Docket No. FAA-2017-0724 (82 FR 34272; July 24, 2017). The NPRM proposed to amend VOR Federal airways V-2, V-26, V-84, V-218, and V-510, and to remove V-410, due to the planned decommissioning of the Lansing, MI, and Pontiac, MI, VORTACs. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently published in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 71 by modifying the descriptions of VOR Federal airways V-2, V-26, V-84, V-218, and V-510; and removing V-410, due to the planned decommissioning of the Lansing, MI, and Pontiac, MI, VORTACs. The route changes are described below.

V-2: V-2 extends between the Seattle, WA, VORTAC and the Gardner, MA, VOR/DME, excluding the airspace within Canada. The airway segment between the intersection of the Nodine, MN, 122° and Waukon, IA, 053° radials (WEBYE fix) and the Lansing, MI, VORTAC is removed. The unaffected portions of the airway remain as charted.

V-26: V-26 extends between the Blue Mesa, CO, VOR/DME and the Dryer, OH, VOR/DME, excluding the airspace within Canada. The airway segment between the White Cloud, MI, VOR/DME and the Lansing, MI, VORTAC is removed. The unaffected portions of the airway remain as charted.

V-84: V-84 extends between the Northbrook, IL, VOR/DME and the Flint, MI, VORTAC; and between the Buffalo, NY, VOR/DME and the Syracuse, NY, VORTAC. The airway segment between the Pullman, MI, VOR/DME and the Lansing, MI, VORTAC is removed. The unaffected portions of the airway remain as charted.

V-218: V-218 extends between the Grand Rapids, MN, VOR/DME and the Rockford, IL, VOR/DME; and between the Keeler, MI, VOR/DME and the Lansing, MI, VORTAC. The airway segments between the Waukon, IA, VORTAC and the Rockford, IL, VOR/DME; and between the Keeler, MI, VOR/DME and the Lansing, MI, VORTAC are removed. The unaffected portions of the airway remain as charted.

V-410: V-410 extends between the Pontiac, MI, VORTAC and the London, ON, Canada VOR/DME, excluding the airspace within Canada. The airway is removed in its entirety.

V-510: V-510 extends between the Dickinson, ND, VORTAC and the Dells, WI, VORTAC; between the Oshkosh, WI, VORTAC and the Lansing, MI, VORTAC; and between the Buffalo, NY, VOR/DME and the Rochester, NY, VOR/DME. The airway segment between the Oshkosh, WI, VORTAC and the Lansing, MI, VORTAC is removed. The unaffected portions of the airway remain as charted.

All radials in the route descriptions are stated relative to True north. Additionally, minor punctuation changes were made for clarity.

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 Department of Transportation (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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of modifying five VOR Federal airways and removing one Federal airway qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, Paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). As such, this action is not expected to cause any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Altoona-Blair County Airport, Altoona, PA, to ensure the efficient use of airspace within the National Airspace System.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 11446, March 15, 2018) for Docket No. FAA-2018-0129 to amend Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface at Altoona-Blair County Airport, Altoona, PA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E surface area airspace, and Class E airspace extending upward from 700 feet or more above the surface due to the decommissioning of the Altoona VOR and cancelation of associated approaches at Altoona-Blair County Airport, Altoona, PA.

The Class E surface area airspace is amended to within a 4.7-mile (from a 4-mile) radius of the airport, with a segment 1.0-mile each side of the 026° bearing from the airport to 8.7 miles northeast. The Altoona VOR segment is removed.

The Class E airspace area extending upward from 700 feet above the surface is amended to within an 11.2-mile (from a 6.5-mile) radius of the airport. These changes enhance the safety and management of IFR operations at the airport.

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. Therefore, this regulation: (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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends existing restricted area R-5601F by subdividing it into R-5601F and R-5601J, and updates the using agency information for each of the restricted areas at Fort Sill, OK.

R-5601F is an irregularly shaped restricted area in the Fort Sill, OK, restricted area complex used to contain hazardous activities. It connects the Military Operations Areas located to the north with the R-5601 gunnery ranges located to the south and stretches the entire length of the Fort Sill restricted area complex laterally from west to east, from 500 feet above ground level (AGL) to Flight Level 400 in altitude. The United States (U.S.) Army normally trains in the eastern restricted areas, R-5601A, R-5601B, and R-5601F, while the U.S. Air Force normally trains in the western areas, R-5601C, R-5601D, R-5601E, R-5601F, and R-5601G. When the using agency only requires the eastern areas to support its hazardous training activities, it results in the R-5601F restricted area being activated across the entire northern boundary of the restricted areas being activated, and creates a 14-mile extension of restricted area airspace that is not needed for the training activities being conducted.

The activation of R-5601F, and the unintended consequences of the 14-mile extension of restricted area airspace extending westward beyond the eastern Fort Sill restricted areas, primarily impacts the high altitude commercial air carriers inbound to the Dallas-Fort Worth metroplex area. Routing aircraft to overfly the R-5601F restricted area results in descent delays that take aircraft off their optimized descent profiles, and vectoring aircraft to circumnavigate the R-5601F restricted area laterally to the west adds miles and flight time to each aircraft. Additionally, these mitigations to overcome the unneeded extension of the R-5601F restricted area when only the eastern Fort Sill restricted areas are required also increases air traffic complexity and controller workload.

In December 2017, the FAA supported a U.S. Army laser air defense exercise conducted at Fort Sill, OK, using existing permanent restricted areas and two temporary restricted areas established overhead the Fort Sill restricted area complex. As part of a lessons learned review of the exercise, the FAA determined that subdividing the existing R-5601F restricted area laterally into two restricted areas, activated independently, would lessen aeronautical impacts to air traffic operating in the central United States.

Further, subdividing the existing R-5601F laterally into two separate restricted areas enhances the efficient use of the National Airspace System by providing for activation of the minimum amount of restricted area airspace needed for hazardous military training activities and releases unneeded restricted areas for access by other airspace users.

Lastly, while staffing this airspace action to subdivide R-5601F laterally, the FAA also determined that one geographic point in the R-5601G boundary information needed to be adjusted and the using agency information needed to be updated in all of the restricted areas in the R-5601 complex. The minor R-5601G boundary point change was deemed necessary to ensure the accuracy of the shared boundaries with the two new subdivided restricted areas and the using agency editorial updates was necessary for clarity and standardization in all of the restricted areas in the R-5601 complex.

This action amends 14 CFR part 73 by subdividing restricted area R-5601F in the Fort Sill, OK, restricted area complex into two subareas, R-5601F (amended) and R-5601J (new), divided laterally by a shared boundary extending from lat. 34°45′03″ N, long. 98°29′44″ W to lat. 34°43′30″ N, long. 98°35′40″ W. The subarea portion of the current R-5601F established west of the shared boundary will continue to be designated R-5601F, and the subarea portion established east of the shared boundary will be designated R-5601J. This action does not alter the existing lateral or vertical boundaries of the restricted area airspace or the operations currently conducted in that airspace. The subdivision of the current R-5601F restricted area minimizes impacts to high altitude commercial air carriers inbound to the Dallas-Fort Worth metroplex area unnecessarily when only the eastern R-5601 complex restricted areas are required for training by the using agency at Fort Sill, OK.

This action also makes a minor change to one geographic point in the boundaries information listed in the R-5601G description due to improved digital charting capabilities. This change ensures the accuracy of the shared boundaries between restricted areas R-5601F and R-5601J with R-5601G, and that all three restricted areas meet at the same shared boundary point.

Additionally, this action makes editorial changes to the using agency information listed in each of the Fort Sill restricted area descriptions for clarity and standardization. The using agency is unchanged, but simply amended in the descriptions to reflect the military unit responsible for ensuring the restricted areas are used for their designated purpose, scheduling the restricted areas, and coordinating the restricted area airspace use with the controlling agency. The Fort Sill using agency concurs with this editorial update.

These modifications do not change the current lateral boundaries, designated altitudes, times of designation, or activities conducted within the Fort Sill restricted area complex; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

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 Department of Transportation (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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of amending the internal subdivision of restricted area R-5601F within the Fort Sill, OK, complex qualifies for categorical exclusion under the National Environmental Policy Act and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.d, “Modification of the technical description of special use airspace (SUA) that does not alter the dimensions, altitudes, or times of designation of the airspace (such as changes in designation of the controlling or using agency, or correction of typographical errors).” This airspace action is an administrative change to the internal subdivision of an existing restricted area within the Fort Sill, OK, restricted area complex. It does not alter the dimensions, altitudes, time of designation, or use of the airspace. Therefore, this airspace action is not expected to result in any significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or an environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows:

Section 14(a) of the Consumer Product Safety Act (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires that manufacturers of products subject to a consumer product safety rule or similar rule, ban, standard, or regulation enforced by the CPSC, must certify that the product complies with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products, children's toys, and child care articles, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body (laboratory). Id. Public Law 112-28 (August 12, 2011) directed the CPSC to seek comment on “opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” Public Law 112-28 also authorized the Commission to issue new or revised third party testing regulations if the Commission determines “that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” Id. 2063(d)(3)(B).

Section 101 of the CPSIA has two requirements associated with lead in children's products. 15 U.S.C. 1278a. First, no accessible part of a children's product may contain more than 100 parts per million (ppm) lead content. Second, paint or other surface coatings on children's products and furniture intended for consumer use may not contain lead in concentrations greater than 90 ppm. Manufacturers of children's products must certify, based on third party testing, that their products comply with all relevant children's product safety rules. Thus, products subject to the lead content or paint/surface coating limits require passing test results from a CPSC-accepted third party laboratory for the manufacturer to issue a children's product certificate (CPC), before the products can be entered into commerce.

To alleviate some of the third party testing burdens associated with lead in the accessible component parts of children's products, the Commission determined that certain materials, including gemstones, precious metals, wood, paper, CMYK process printing inks, textiles, and specified stainless steel, do not exceed the 100 ppm lead content limit under section 101 of the CPSIA. Based on this determination, these materials do not require third party testing for the lead content limits. The determinations regarding lead content for certain materials are set forth in 16 CFR 1500.91.

Section 106 of the CPSIA provides that the provisions of ASTM International Consumer Safety Specifications for Toy Safety (ASTM F963) shall be considered to be consumer product safety standards issued by the Commission.1 15 U.S.C. 2056b. The Commission has issued a rule that incorporates by reference the relevant provisions of ASTM F963.2 16 CFR part 1250. Thus, children's toys subject to ASTM F963 must be tested by a CPSC-accepted third party laboratory and demonstrate compliance with all applicable CPSC requirements for the manufacturer to issue a CPC before the children's toys can be entered into commerce.3

Section 4.3.5 of ASTM F963 requires that surface coating materials and accessible substrates of children's toys that can be sucked, mouthed, or ingested 4 must comply with the solubility limits of eight elements listed in Table 1 of the toy standard. The materials and their solubility limits are shown in Table 1. We refer to these eight elements as “ASTM F963 elements.”

The third party testing burden could be reduced only if all elements listed in section 4.3.5 have concentrations below their solubility limits. Because third party laboratories typically run one test for all of the ASTM F963 elements, no testing burden reduction would be achieved if any one of the elements requires testing.

To alleviate some of the third party testing burdens associated with the ASTM F963 elements in the accessible component parts of children's toys, the Commission determined that certain unfinished and untreated trunk wood does not contain ASTM F963 elements that would exceed the limits specified in section 106 of the CPSIA. Based on this determination, unfinished and untreated trunk wood would not require third party testing for the ASTM F963 elements. The determinations regarding the ASTM F963 elements limits for certain materials is set forth in 16 CFR 1251.2.

Section 108(a) of the CPSIA permanently prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any “children's toy or child care article” that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate (BBP). 15 U.S.C. 2057c(a). The CPSIA required the Commission to appoint a Chronic Hazard Advisory Panel (CHAP) to “study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” 15 U.S.C. 2057c(b)(2). The CHAP issued its report in July 2014.6 On October 27, 2017, the Commission published a final rule in the Federal Register, “Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates,” 82 FR 49938, prohibiting children's toys and child care articles containing concentrations greater than 0.1 percent of:

These restrictions apply to any plasticized component part of a children's toy or child care article or any other component part of a children's toy or child care article that is made of other materials that may contain phthalates. The phthalates prohibitions are set forth in 16 CFR part 1307.

Tests for phthalate concentration are among the most expensive certification tests to conduct on a product, and each accessible component part subject to section 108 of the CPSIA must be tested.7 Third party testing burden reductions can occur only if each phthalate's concentration is below 0.1 percent (1000 ppm). Because laboratories typically run one test for all of the specified phthalates, no testing burden reduction likely is achieved if any one of the phthalates requires compliance testing.

To alleviate some of the third party testing burdens associated with plastics in the accessible component parts of children's toys and child care articles, the Commission determined that products made with general purpose polystyrene (GPPS), medium-impact polystyrene (MIPS), high-impact polystyrene (HIPS), and super high-impact polystyrene (SHIPS) with specified additives do not exceed the phthalates content limits under section 108 of the CPSIA. 82 FR 41163 (August 30, 2017). Based on this determination, materials used in children's toys and child care articles that use these specified plastics and additives would not require third party testing for the phthalates content limits. The plastics determinations are set forth in the Commission's regulations at 16 CFR part 1308.

On October 13, 2017, the Commission published a notice of proposed rulemaking (NPR) in the Federal Register for the engineered wood determinations. (80 FR 47645). The Commission proposed determinations that untreated and unfinished EWPs (particleboard, hardwood plywood, and medium-density fiberboard) made from virgin wood or pre-consumer wood waste, do not contain lead, or any of the specified elements in ASTM F963 in concentrations greater than their specified solubility limits. In addition, with the exception of hardwood plywood that contains PVAc adhesive formulations, the Commission proposed a determination that these specified EWPs do not contain any of the specified phthalates in concentrations greater than 0.1 percent. The comments to the NPR are addressed in section C of this preamble.

CPSC contracted with the Toxicology Excellence for Risk Assessment (TERA),8 who authored literature review reports on the content issues related to certain natural materials, plastics, and EWPs. The following reports produced by TERA formed the basis for the proposed EWP determinations: Task 9, Concentrations of Selected Elements in Unfinished Wood and Other Natural Materials; Task 11, Exposure Assessment: Composition, Production, and Use of Phthalates; and Task 14, Final Report for CPSC Task 14, which summarized the available information on the production of the EWPs.

In the Task 9 Report, TERA conducted a literature search on whether unfinished wood and other natural materials could be determined not to contain any of the ASTM F963 elements in concentrations greater than the ASTM F963 solubility limits.9 The materials researched included unfinished woods (ash, beech, birch, cherry, maple, oak, pine, poplar, and walnut); bamboo; beeswax; undyed and unfinished fibers and textiles (cotton, wool, linen, and silk); and uncoated or coated paper (wood or other cellulosic fiber).

To assess the presence of the ASTM F963 elements' concentrations in the materials, TERA looked at several factors. The factors reviewed included the presence and concentrations of the elements in the environmental media (e.g., soil, water, air), and in the base materials for the textiles and paper; whether processing has the potential to introduce any of the ASTM F963 elements into the material under study; and the potential for contamination after production, such as through packaging. From this report, the Commission determined that untreated and unfinished woods from tree trunks do not contain any of the elements in ASTM F963 in concentrations greater than their respective solubility limits, and thus, they are not required to be third party tested to ensure compliance with the specified solubility test.10 TERA relied on this information in TERA Task Report 14 to determine that the virgin wood material used in the manufacture of EWPs does not, and will not, contain any of the elements in ASTM F963 in concentrations greater than their respective solubility limits.

In the Task 11 Report, TERA conducted a literature search on the production and use of 11 specified phthalates in consumer products.11 The 11 phthalates researched by TERA were based on the recommendations made in the CHAP report. The 11 phthalates included the eight prohibited phthalates that are subject to the final rule prohibiting children's toys and child care articles containing specified phthalates issued in October 2017 and codified in 16 CFR part 1307. (82 FR 49938). Table 2 lists the phthalates researched by TERA. TERA's research focused on the following factors:

• The raw materials used in the production of the specified phthalates;

• The manufacturing processes used worldwide to produce the specified phthalates;

• Estimated annual production of the specified phthalates;

• Physical properties of the specified phthalates (e.g., vapor pressure, flashpoint, water solubility, temperature at which chemical breakdown occurs);

• Applications for phthalates use in materials and consumer and non-consumer products; and

• Other potential routes by which phthalates can be introduced into an otherwise phthalates-free material (e.g., migration from packaging, recycling, reuse, product breakdown).

In the Task 14 Report, TERA conducted a literature search on the production of three EWPs: Particleboard, hardwood plywood, and medium-density fiberboard.13 TERA first researched authoritative sources, such as reference books and textbooks, along with internet resources, for general information about EWPs, adhesives, raw materials, manufacturing processes, and the potential use of recycled materials. TERA used this information and consulted technical experts to identify key words for searching the literature. These key words were then used to conduct primary literature searches for research studies and publications. In addition, TERA searched for Safety Data Sheets (SDS) for information on raw materials. TERA researched the possibility of the raw materials or finished products in the three EWPs to contain:

• Lead in concentrations exceeding 100 ppm;

• Any of the specified elements that are included in the safety standard for children's toys, ASTM F963, Standard Consumer Safety Specification for Toy Safety, in concentrations exceeding specified solubility limits; or

• Any of 10 specified phthalates in concentrations greater than 0.1 percent (1000 ppm), listed in Table 3.14

TERA reviewed the literature to assess whether the specified EWPs might contain lead or one or more of the other elements at levels that exceed the ASTM solubility limits, or any of the specified phthalates in concentrations greater than the specified limits. TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than their limits in particleboard, hardwood plywood, or medium-density fiberboard, that are unfinished and untreated, and made from virgin wood or pre-consumer wood waste.

In the Task 14 Report, TERA described an unfinished EWP as one that does not have any surface treatments applied at manufacture, such as factory-applied coatings. An untreated EWP is one that does not have any additional finishes applied at manufacture, such as flame retardants or rot-resistant finishes. TERA described “virgin wood” as wood logs, fibers, chips, or layers that have not been recycled from a previous use. TERA described “pre-consumer wood waste” as wood materials that have been recycled from an industrial process before being made available for consumer use. Examples of this type of waste include trimmings from EWP panel manufacturing, sawdust from cutting logs, or remaining wood pieces from sawing a log into framing lumber.

The TERA report highlighted the potential for lead, the ASTM F963 elements, or the specified phthalates to be present in concentrations greater than those specified through the use of contaminated recycled material in EWPs made from recycled wood waste or EWPs that have post-manufacturing treatments or finishes. Recycled wood waste may be made from reclaimed or post-consumer wood waste. “Post-consumer wood waste” is described as wood waste that is comprised of materials that are recovered from their original use and subsequently used in a new product. Examples of this type of waste include recycled demolition wood, packaging materials, such as pallets and crates, used wood from landscape care (i.e., from urban and highway trees, hedges, and gardens), discarded furniture, and wood waste from industrial, construction, and commercial activities.

The three types of EWPs reviewed by TERA are discussed below.

Particleboard is a composite of wood chips, adhesives, and other additives pressed into a board. Adhesive formulations are used to bond wood chips, which are then formed into mats that are layered to create uniform boards in a range of dimensions. Particleboard is used widely in furniture making and other interior (or nonstructural) uses. The constituent parts of particleboard reported by TERA can include (by weight):

• Wood (60-99+ percent);

• Adhesive formulation (0-17 percent, with 5-11 percent most common);

• Phenol-formaldehyde (uncommon but potential for use), urea-formaldehyde, melamine-urea-formaldehyde, polymeric methylene-diphenyl-diisocyanate (pMDI);

• Waxes (0.3-1 percent);

• Other additives (up to 2 percent); or

• Scavengers or additional unspecified materials.

TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates, in concentrations greater than their specified limits in particleboard. TERA identified little information on measurements of lead and the ASTM F963 elements in particleboard, and found no studies that measured the specified phthalates. TERA identified two references where particleboard made from both untreated and copper chromate arsenic-(CCA) treated wood chips was tested. Arsenic and chromium were undetected in the particleboards made from virgin wood chips. However, the particleboard composed of 25 percent wood chips from reclaimed CCA-treated wood products contained 895 and 832 ppm of arsenic and chromium, respectively, without adversely affecting the mechanical performance of the board. Another study that discussed “recycled particleboard” was identified as wood waste obtained from a wood recycling plant.

Apart from the studies on particleboard made from wood waste that may contain post-consumer wood waste or post-manufacturing treatments, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished particleboard.

Plywood is a layered board of wood veneers, where the layers have alternating, perpendicular wood grain directions. Less commonly, the board might have a core of other EWPs with wood veneers as the outer layers. Hardwood plywood, addressed in this report, is a type of plywood that is composed of angiosperms (i.e., “hardwoods,” such as oak or maple) and used primarily in furniture and for other interior (nonstructural) purposes, as well as in playground equipment, sports equipment, and musical instruments. The constituent parts of hardwood plywood reported by TERA can include (by weight):

• Wood (75-99+ percent);

• Adhesive formulation (0.02-20 percent, with 1 percent to 5 percent most common);

• Phenol-formaldehyde or phenol-resorcinol-formaldehyde (likely for use in structural plywood but potential for application to hardwood plywood), urea-formaldehyde, melamine-formaldehyde, or melamine-urea-formaldehyde, or polyvinyl acetate (PVAc); or

• Other additives (less than 2 percent).

TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than those specified in hardwood plywood. TERA identified only one study that measured lead and the ASTM F963 elements in plywood, and found no studies that measured the specified phthalates. Concentrations of cadmium, chromium, and lead were all less than the solubility limits in “plain” plywood. In addition, because hardwood plywood is made from sheets of wood veneer, it is less likely to contain recycled wood content, unless it incorporates a core of some other EWPs, such as particleboard or medium-density fiberboard.

Aside from the studies on recycled wood waste that may contain post-consumer wood waste or post-manufacturing treatments in a particleboard, medium-density fiberboard, or other EWP core, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished hardwood plywood. However, TERA identified research that indicated that polyvinyl acetate (PVAc) can be used as an adhesive system for hardwood plywood, as discussed in section (d) below.

Medium-density fiberboard (MDF) is a composite of wood fibers, an adhesive formulation, and other additives pressed into a board. MDF is a product similar to particleboard, differing mostly due to the use of fiber rather than chips. It is used primarily in furniture and for other interior (nonstructural) purposes. The constituent parts of MDF reported by TERA can include (by weight):

• Wood (73-99+ percent);

• Adhesive formulation (0-25 percent with most common 5-12 percent);

• Phenol-formaldehyde (uncommon, but potentially used for moisture resistance), urea-formaldehyde (most commonly identified), methylene-diphenyl-diisocyanate (pMDI), melamine-formaldehyde, or melamine-urea-formaldehyde;

• Waxes (less than 1 percent); or

• Other additives (10-30 percent).

TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than those specified in MDF. TERA did not identify any references that reported the presence of lead, the ASTM F963 elements, or the specified phthalates in MDF made with virgin wood.

Aside from the studies on recycled wood waste that may contain post-consumer wood waste or post-manufacturing treatments, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished MDF.

Because few references were found directly addressing lead, the ASTM F963 elements, and the specified phthalates in EWPs, TERA also researched the constituent parts that could be used to manufacture EWPs, including wood and adhesives.

According to the manufacturing process information provided by TERA, virgin wood and wood residues are the main sources of wood fiber used in North America to manufacture EWPs. Typically, these sources include low-value logs, industrial wood residues, or scraps and trim from furniture and EWP production. For example, hardwood plywood requires the trunks of trees to obtain the thin layers of veneer used to construct a sheet. TERA relied on the Task 9 Report and Commission findings on unfinished and untreated wood (80 FR 78651 (Dec. 17, 2015)) to determine that untreated and unfinished wood from the trunks of trees do not contain lead or the ASTM F963 elements in concentrations greater than the specified solubility limits. TERA also noted that, although phthalates can be taken up by trees and plants, the concentrations are negligible and less than the specified limit (0.1 percent).

Although TERA reported that the majority of EWPs are manufactured with virgin wood or pre-consumer wood waste fiber or chips, the wood component also can originate from recycled material. For EWPs made from recycled wood waste that may contain post-consumer wood waste, the TERA report highlighted the potential for lead, the ASTM F963 elements, or the specified phthalates to be present in concentrations greater than those specified through the use of contaminated recycled material. The TERA report cited multiple examples of the use of reclaimed or post-consumer wood material used to produce EWPs, both domestically and internationally. Specifically, TERA found studies showing that reclaimed lumber and wood waste could contain a myriad of contaminants, such as surface treatments (e.g., paints, stains), metals, glues and adhesives, glass, paper, plastic, rubber and chemical treatments. Metals and organic materials may be present in paints, stains, varnishes, and polishes that are used on wood products (e.g., furniture, window frames) and nails, screws, and other metal hardware might be attached to the recycled and recovered wood. These contaminants are intimately attached to the wood, and therefore, some contaminants may pass through cleaning systems, contaminating the entire recovered wood stream.

TERA also reviewed another study, based in Italy, which evaluated the “recyclability” of used wood, by conducting elemental analysis of wood residues from wood recycling plants using a handheld fast energy dispersive X-ray fluorescence spectroscopy (ED-XRF) device. TERA found that the study provided some indication of the types and levels of contamination in various kinds of post-consumer wood waste. Elemental analysis results were compared to EU Community Ecolabel limits.15 For all wood products tested, 16 percent exceeded one or more of the Ecolabel limits, with the highest concentrations from lead, chromium, chlorine, copper, cadmium, and mercury. No samples had levels of arsenic over the 25 ppm limit (except a CCA-treated utility pole). Barium and lead were found in 10 percent to 20 percent of the samples, chromium and cadmium in 3 percent to 4 percent, and antimony, mercury, and arsenic ranged from 0.3 percent to 1.2 percent of samples. The sources most contaminated with non-wood content were from furniture and building materials, while pallets and shipping containers were least likely to be contaminated.16

TERA concluded that, with an increased interest and use of post-consumer recycled materials in EWP production, potential contamination by the specified elements and phthalates must be considered. To ensure that EWPs made from used wood fibers do not contain ASTM F963 elements or phthalates that exceed the specified limits, TERA indicated that the materials would need to be sorted carefully and tested to ensure that they are not contaminated.

Adhesive formulations hold together the wood chips, layers, or fibers to make EWP mats and sheets. Some of the formulations use a metal catalyst during the curing process. TERA identified a number of references describing the presence of the ASTM F963 elements in adhesive formulations. However, TERA found very few references that would implicate EWPs. Although the use of barium was noted in multiple references, only one study appeared to be relevant to EWPs. This study suggested that barium, when used as a catalyst in an adhesive, could result in an EWP that exceeded the ASTM solubility level for barium.17 However, this method does not appear to be used currently in EWP production. TERA also noted studies that indicate the possible use of chromium as a catalyst in phenol formaldehyde resin, as well as the possible use of antimony or arsenic in a drier formulation for certain polymeric coatings. However, no references included information on concentrations or appeared to be relevant to EWPs.

Although many different adhesive formulations may be used in hardwood plywood, TERA noted that PVAc can be used as an adhesive system for hardwood plywood. The report cited sources (The Handbook of Adhesive Technology, USDA), which mentioned the use of some of the specified phthalates in PVAc adhesive formulations.18 TERA also identified research papers that included the use of DBP and DEHP in PVAc at concentrations greater than 0.1 percent.

The CPSC received seven comments in response to the NPR. Five of the comments did not address any matters regarding EWPs. These comments addressed environmental regulation issues concerning alternative energy, electric cars, and greenhouse gas emissions, among other topics. None of these comments addressed EWPs. Accordingly, these comments do not fall within the scope of the current rulemaking. Two comments addressed the proposed determinations for EWPs.

Comment 1: A commenter states that the use of third party testing and “verification of testing” for lead is important for ensuring product safety and that any change to the testing and verification requirements is “antithetical” to public safety.

Response 1: The commenter does not provide any data or information about EWPs that would support a testing requirement for lead for certain untreated and unfinished EWPs. Nor does the commenter address the data and information the Commission relied upon to demonstrate that certain untreated and unfinished EWPs do not contain lead above the limits specified by the lead content requirements. The Commission's proposed EWP determinations only apply to EWPs that have not been treated or adulterated with materials that could result in the addition of lead, the ASTM elements, or the specified phthalates at concentrations greater than their specified solubility limits. EWPs that do not meet the provisions of the rule would still be subject to applicable testing requirements.

Comment 2: A commenter expresses concern regarding the language of the proposed rule's determination, which states: “Accessible component parts of children's products, children's toys, and child care articles made with engineered wood products not listed in paragraphs (a)-(c) of this section are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.” The commenter asserts that the language negates the flexibility of the Commission's 2009 Statement of Policy. The commenter requests a revision of the language to state: “Accessible component parts of children's products, children's toys, and child care articles made with engineered wood products not listed in paragraphs (a)-(c) of this section must still be comprised of compliant materials pursuant to section 108 of CPSIA, Public Law 110-314 as amended by H.R. 2714, Public Law 112-28.”

Response 2: The proposed EWP determinations do not negate the flexibility of the Commission's 2009 Statement of Policy. 19 That policy was intended to give general guidance on the types of materials that may contain phthalates. Section 108 of the CPSIA is limited to plasticized component parts and other materials that may contain phthalates. The Commission has already identified in the proposed rule the potential use of phthalates in polyvinyl acetate (PVAc) adhesive in hardwood plywood that would result in an EWP with phthalate concentrations greater than 0.1 percent. However, to make it clear that only products that are subject to one or more of the requirements for lead, ASTM elements, and the specified phthalates, or that contain post-consumer wood waste, must be third party tested, the Commission is revising the proposed language in section 1252.3(e). That section now states that accessible component parts of children's products, children's toys, and child care articles made with engineered wood products other than the specified EWPs listed in the rule, or that contain post-consumer wood waste, are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107 and sections 101, 106, or 108 of the CPSIA, as applicable.

In addition, to reflect the current list of prohibited phthalates in section 108 of the CPSIA, as required in the Commission's final rule issued on October 27, 2017, § 1252.1(c) is revised to include all of the permanently prohibited phthalates in any children's toy or child care article that contains concentrations of more than 0.1 percent of DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP.

As noted above, section 14(a)(2) of the CPSA requires third party testing for children's products that are subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Children's products must comply with the lead limits in section 101 of the CPSIA. 15 U.S.C. 1278a. Children's toys must comply with the solubility limits for elements under the ASTM toy standard in section 106 of the CPSIA. 15 U.S.C. 2056b. Children's toys and child care articles must comply with the phthalates prohibitions in section 108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction, the Commission has investigated approaches that would reduce the burden of third party testing while also assuring compliance with CPSC requirements. As part of that endeavor, the Commission has considered whether certain materials used in children's products, children's toys, and child care articles would not require third party testing.

To issue a determination that an EWP does not require third party testing, the Commission must have sufficient evidence to conclude that the product consistently complies with the CPSC's requirements to which the EWP is subject, so that third party testing is unnecessary to provide a high degree of assurance of compliance. Under 16 CFR part 1107, section 1107.2 defines “a high degree of assurance” as “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”

For accessible component parts of children's products, children's toys, and child care articles subject to sections 101, 106, and 108 of the CPSIA, compliance to the specified content limits is always required, irrespective of any testing exemptions. Thus, a manufacturer or importer who certifies a children's product, children's toy or child care article, must ensure the product's compliance. The presence of lead, the ASTM F963 elements, or the specified phthalates do not have to be intended to require compliance. The presence of these chemicals, whether for any functional purpose, as a trace material, or as a contaminant, must be in concentrations less than the specified content or solubility limits for the material to be compliant. Additionally, the manufacturer or importer must have a high degree of assurance that the product has not been adulterated or contaminated to an extent that would render it noncompliant. For example, if a manufacturer or importer is relying on a determination that an EWP does not contain lead, ASTM F963 elements, or specified phthalates in concentrations greater than the specified limits in a children's product, children's toy, or child care article, the manufacturer must ensure that the EWP is one on which a determination has been made.

The Commission finds, based on the staff's review of TERA's Task 14 report regarding reclaimed or post-consumer waste assessment in EWPs, that EWPs with post-consumer wood content and post-manufacturing waste could contain unwanted contaminants, such as paint or stains, metals from nails or fasteners, or adhesive formulations. Additionally, based on staff's review of the Task 11 and Task 14 reports, the Commission finds that PVAc used as an adhesive formulation in the manufacture of EWPs could contain at least one of the specified phthalates in hardwood plywood manufacturing that could result in the EWP exceeding the allowable levels of the specified phthalates. Accordingly, the Commission concludes that there is not a high degree of assurance that EWPs made from post-consumer wood waste or post-manufacturing treatments or finishes are compliant with sections 101, 106, or 108 of the CPSIA, or that hardwood plywood that contain PVAc are compliant with 108 of the CPSIA.

Based on the information provided in the TERA Task reports, staff's review of TERA's source references in the Task reports, and with the additional clarification that only products that are subject to one or more of the requirements for lead, ASTM elements, and the specified phthalates must be third party tested, the Commission determines that untreated and unfinished EWPs (particleboard, hardwood plywood, and medium-density fiberboard) made from virgin wood or pre-consumer wood waste, do not contain lead, or any of the specified elements in ASTM F963 in concentrations greater than their specified solubility limits. In addition, with the exception of hardwood plywood that contains PVAc adhesive formulations, the Commission determines that the specified EWPs do not contain any of the specified phthalates in concentrations greater than 0.1 percent. The Commission's determinations on EWPs are limited to unfinished and untreated EWPs made from virgin wood or pre-consumer wood waste. Children's products, children's toys, and child care articles made from post-consumer wood waste, or from EWPs that have other materials that are applied to or added on to the EWP after it is manufactured, such as treatments and finishes, would be subject to third party testing requirements, unless the component part has a separate determination which does not require third party testing for certification purposes.

Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, sec. 3, Aug. 14, 2008. Section 14 of the CPSA, which was amended by the CPSIA, requires third party testing for children's products subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by Public Law 112-28, gives the Commission the authority to “prescribe new or revised third party testing regulations if it determines that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” Id. 2063(d)(3)(B). These statutory provisions authorize the Commission to issue a rule determining that certain EWPs would not be concentrations greater than their specified limits, and thus, are not required to be third determined to contain lead, the ASTM F963 elements, and the specified phthalates in party tested to ensure compliance with sections 101, 106, and 108 of the CPSIA.

The determinations for the specified EWPs would relieve children's product certifiers from third party testing burdens, while assuring compliance with sections 101, 106, and 108 of the CPSIA for component parts made from the specified EWPs. However, the determinations would only relieve the manufacturers' obligation to have the specified EWPs tested by a CPSC-accepted third party laboratory. Children's products, children's toys, and child care articles must still comply with the substantive content limits in sections 101, 106, and 108 of the CPSIA, regardless of any relief on third party testing requirements. Finally, even if a determination is in effect and third party testing is not required, a certifier must still issue a certificate.

This rule creates a new part 1252 for Children's Products, Children's Toys, and Child Care Articles: Determinations Regarding Lead, ASTM F963 elements, and Phthalates for Engineered Wood Products.

• Section 1252.1(a) of the rule explains the statutorily created requirements that limit lead in children's products under the CPSIA and the third party testing requirements for children's products.

• Section 1252.1(b) of the rule explains the statutorily created requirements for limiting the ASTM F963 elements in children's toys under the CPSIA and the third party testing requirements for children's toys.

• Section 1252.1(c) of the rule explains the statutorily created requirements limiting phthalates for children's toys and child care articles under the CPSIA and the third party testing requirements for children's toys and child care articles. This section is revised to reflect the final rule issued on phthalates that permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). In addition, in accordance with section 108(b)(3) of the CPSIA, 16 CFR part 1307 prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate (DCHP).

• Section 1252.2 of the rule provides definitions that apply to part 1252.

• Section 1252.3(a) of the rule establishes the Commission's determinations that specified EWPs do not exceed the lead content limits with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.

• Section 1252.3(b) of the rule establishes the Commission's determinations that specified EWPs do not exceed the solubility limits for ASTM F963 elements with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.

• Section 1252.3(c) of the rule establishes the Commission's determinations that specified EWPs do not exceed the phthalates content limits, with the exception of hardwood plywood containing PVAc, with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.

• Section 1252.3(d) of the rule provides that accessible component parts of children's products, children's toys, and child care articles made with the specified EWPs, are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.

• Section 1252.3(e) of the rule is clarified to state that accessible component parts of children's products, children's toys, and child care articles made with engineered wood products not listed in paragraphs (a)-(c) of this section, or with post-consumer wood waste, are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107 and sections 101, 106, or 108 of the CPSIA, as applicable.

The Administrative Procedure Act (APA) generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the final rule provides relief from existing testing requirements under the CPSIA, the Commission concludes that 30 days is sufficient. Thus, the effective date is July 23, 2018.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to consider the impact of proposed and final rules on small entities, including small businesses. Section 604 of the RFA requires that agencies prepare a final regulatory flexibility analysis (FRFA) when promulgating final rules, unless the head of the agency certifies that the rule will not have a significant impact on a substantial number of small entities. The FRFA must describe the impact of the rule on small entities. CPSC staff prepared a FRFA, which is summarized below.

CPSC staff's review shows that comprehensive estimates of the number of children's products, children's toys, and child care articles that contain component parts made from the specified engineered woods are not available. However, based on the number of domestic producers and sellers of these products, staff believes that a substantial number of small entities could be impacted by this regulation. Staff's review indicates that there are approximately 81,505 small firms that manufacture or distribute children's products, children's toy or child care articles (6,976 manufacturers + 26,124 wholesalers + 48,405 retailers). Even if only a small proportion of these firms manufacture or sell products using the EWPs of interest, staff finds that a substantial number would benefit from the reduced testing burden. The impact of the determinations on small businesses would be to reduce the burden of third party testing for firms and are expected to be entirely beneficial. The current cost of testing, on a per-test basis, is reflective of the expected cost reductions that would result from the determinations, and are as follows:

• Lead—The cost of lead testing ranges from $50 to more than $100 per component through Inductively Coupled Plasma (ICP) testing. If one uses X-ray fluorescence (XRF) spectrometry, which is an acceptable method for certification of third party testing for lead content, the costs can be greatly reduced to approximately $5 per component. If a component part made with one of the specified engineered woods is painted, the component part would be exempt from the third party testing requirement, but the paint would still require lead testing.

• ASTM F963 Elements—Based on published invoices and price lists, the cost of a third party test for the ASTM F963 elements ranges from around $60 in China, up to around $190 in the United States, using ICP. This cost can be greatly reduced with the use of high definition X-ray fluorescence spectrometry (HDXRF), which is an acceptable method for certification of third party testing for the presence of the ASTM elements. The cost can be reduced to about $40 per component part. It should be noted that lead is one of the ASTM elements, so this testing would also cover the cost of lead testing for component parts.

• Phthalates—The cost of phthalate testing is relatively high: between about $125 and $350 per component, depending upon where the testing is conducted and any discounts that are applicable. Because one product might have multiple components that require testing, the cost of testing a single product for phthalates could exceed $1,000 in some cases. Moreover, more than one sample might have to be tested to provide a high degree of assurance of compliance with the requirements for testing.

To the extent that small businesses have lower production or lower sales volume than larger businesses, these determinations would be expected to have a disproportionately beneficial impact on small businesses. This beneficial impact is due to spreading the costs of the testing over fewer units. However, small entities that need fewer third party tests may not qualify for discounts that some laboratories may offer their larger customers. In addition, the possible benefits associated with the determinations might be somewhat lower to the extent that firms were already taking advantage of component part testing as allowed by 16 CFR part 1109. Additionally, some firms have reduced their testing costs by using XRF or HDXRF technology, which is less expensive than ICP, and would reduce the marginal benefit of these determinations.

The determinations would not impose any new reporting, recordkeeping, or other compliance requirements on small entities. In fact, because the rule would eliminate a testing requirement, there would be a small reduction in some of the recordkeeping burden under 16 CFR parts 1107 and 1109 because manufacturers would no longer have to maintain records of third party tests for the component parts manufactured from these engineered woods for lead, the ASTM F963 elements, or the specified phthalates. Based on staff's review, the Commission finds that the burden reduction from this determination rule could potentially result in significant benefits for a substantial number of manufacturers, importers, or retailers of the relevant product categories.

Under section 604 of the Regulatory Flexibility Act, a FRFA should include a “statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.” The final rule is itself, the result of CPSC's efforts to reduce third party testing costs consistent with assuring compliance with all applicable consumer product safety rules. Therefore, CPSC considered few alternatives, other than expanding the list of engineered woods for which determinations could be made. CPSC staff identified these three types of EWPs for study, based on stakeholder feedback, the likelihood of being used in products subject to children's product, children's toy, or child care article certification requirements, and available resources. However, the Commission did not receive any other comments or other information on any additional engineered wood materials for further burden-reduction activities.

The Commission's regulations provide a categorical exclusion for most Commission rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. The Commission's regulations state that safety standards for products normally have little or no potential for affecting the human environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that expectation.

On August 9, 2007, we issued an interim final rule permitting some attorney advisors to conduct certain prehearing proceedings and issue fully favorable decisions when the documentary record warrants doing so. 72 FR 44763. We instituted this practice to provide more timely service to the increasing number of applicants for Social Security disability benefits and Supplemental Security Income payments based on disability. We considered the public comments we received on the interim final rule, and on March 3, 2008, we issued a final rule without change. 73 FR 11349. Under this rule, some attorney advisors may develop claims and, in appropriate cases, issue fully favorable decisions before a hearing.

We originally intended the attorney advisor program to be a temporary modification to our procedures. Therefore, we included in sections 404.942(g) and 416.1442(g) of the interim final rule a provision that the program would end on August 10, 2009, unless we decided to either terminate the rule earlier or extend it beyond that date by publication of a final rule in the Federal Register. Since that time, we have periodically extended the sunset date (see 74 FR 33327 extending to August 10, 2011; 76 FR 18383 extending to August 9, 2013; 78 FR 45459 extending to August 7, 2015; 80 FR 31990 extending to August 4, 2017; and 82 FR 34400 extending to February 5, 2018). As we noted above, the current sunset date for the program is August 3, 2018. 83 FR 711.

We published the final rule to adopt without change the interim final rule that we published on August 9, 2007. We stated our intent to monitor the program closely and to modify it if it did not meet our expectations. 73 FR 11349.

We explained in the 2008 final rule that the number of requests for hearings had increased significantly in recent years. From 2008 to the present, the number of pending hearing requests has continued to remain at a high level, and we anticipate that we will receive several hundred thousand hearing requests in fiscal year 2018 and in fiscal year 2019.1 We are extending the program at this time while we continue to consider our options with respect to the program.

To preserve the maximum degree of flexibility and manage our hearings-level workloads effectively, we have decided to extend the attorney advisor rule until August 2, 2019. As before, we reserve the authority to end the program earlier, to extend it by publishing a final rule in the Federal Register, or to discontinue it altogether.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when developing regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest. We have determined that good cause exists for dispensing with the notice and public comment procedures for this rule. 5 U.S.C. 553(b)(B). Good cause exists because this final rule only extends the expiration date of an existing rule. It makes no substantive changes to the rule. The current regulations expressly provide that we may extend or terminate this rule. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this rule as a final rule.

In addition, because we are not making any substantive changes to the existing rule, we find that there is good cause for dispensing with the 30-day delay in the effective date of a substantive rule provided by 5 U.S.C. 553(d)(3). To ensure that we have uninterrupted authority to use attorney advisors to address the number of pending cases at the hearing level, we find that it is in the public interest to make this final rule effective on the date of publication.

We consulted with the Office of Management and Budget (OMB) and although we do not believe that this will be a significant regulatory action under Executive Order (E.O.) 12866, as supplemented by E.O. 13563, OMB has reviewed this final rule.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.

For the reasons stated in the preamble, we are amending subpart J of part 404 and subpart N of part 416 of Chapter III of title 20 of the Code of Federal Regulations as set forth below:

I. Background

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

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

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

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

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

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

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

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

On September 25, 2017, Memorial Sloan-Kettering Cancer Center Department of Pathology submitted a request for De Novo classification of the MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets). FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on November 15, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.6080. We have named the generic type of device next generation sequencing (NGS) based tumor profiling test, and it is identified as a qualitative in vitro diagnostic test intended for NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals.

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

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

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collection of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collection of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.

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

I. Background on the Alabama Plan II. Submission of the Amendment III. OSMRE's Findings IV. Summary and Disposition of Comments V. OSMRE's Decision VI. Procedural Determinations I. Background on the Alabama Plan

The Abandoned Mine Land Reclamation Program was established by Title IV of the Act, (30 U.S.C. 1201 et seq.) in response to concerns over extensive environmental damage caused by past coal mining activities. The program is funded by a reclamation fee collected on each ton of coal that is produced. The money collected is used to finance the reclamation of abandoned coal mines and for other authorized activities. Section 405 of the Act allows States and Indian tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary of the Interior for approval, a program (often referred to as a plan) for the reclamation of abandoned coal mines. Background information on the Alabama Plan, including the Secretary's findings, the disposition of comments, and the approval of the Plan, is found in the May 20, 1982, Federal Register (47 FR 22057). Later actions concerning the Alabama Plan and amendments to the Plan, are found at 30 CFR 901.20 and 901.25.

By letter dated June 7, 2016 (Administrative Record No. AL-0670), Alabama sent OSMRE an amendment to its Plan under SMCRA (30 U.S.C. 1201 et seq.) at its own initiative.

We announced receipt of the proposed amendment in the April 7, 2017, Federal Register (82 FR 16975). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on May 8, 2017. We did not receive any public comments.

During OSMRE's review, several minor deficiencies were noted, including section numbering inconsistencies and the lien language in the “Reclamation of Private Land” section. By letter dated July 17, 2017 (Administrative Record No. AL-0670-02), OSMRE requested that Alabama address these minor deficiencies. Because these requested changes were minor, Alabama was given the option to either incorporate the changes or withdraw the amendment and resubmit the Plan amendment at a later date. By letter dated July 28, 2017 (Administrative Record No. AL-0670-03), Alabama returned a revised Plan amendment correcting the deficiencies and the amendment process resumed.

We are approving the amendment as described below. The following are the findings we made concerning Alabama's amendment under SMCRA and the Federal regulations at 30 CFR 884.14 and 884.15. Any revisions that we do not specifically discuss below concerning non-substantive wording or editorial changes can be found in the full text of the Plan amendment available at www.regulations.gov.

Alabama included a 1979 letter from the Governor designating the Alabama Department of Industrial Relations, now known as the Alabama Department of Labor (ADOL), as the agency responsible for the abandoned mine lands reclamation program in the state of Alabama. This letter was submitted and approved as part of the original proposed reclamation plan and is consistent with the Federal requirements of 30 CFR 884.13(a)(1). Therefore, we are approving its inclusion.

Alabama included a 1981 legal opinion from the Attorney General of Alabama authorizing the Alabama Department of Industrial Relations, under the legal authority of Alabama law, to conduct its reclamation program in accordance with the requirements of Title IV of the Act. This legal opinion was submitted and approved as part of the original proposed reclamation plan and is consistent with the Federal requirements of 30 CFR 884.13(a)(2). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(3)(i) of the Plan, stated that the goal of its AMLR Plan is to amend those adverse effects of past coal mining conducted prior to August 3, 1977, which impact public health, safety, or general welfare, and cause environmental degradation. The stated objectives of the AMLR Plan are to identify and prioritize these adverse impacts, provide planning procedures, and affect their ultimate reclamation. Alabama also stated that, although the primary purpose of the program is the reclamation of coal mine lands, any non-coal AML issues will be dealt with in accordance with OSMRE policies. ADOL elected to set aside up to the maximum amount allowed by OSMRE of each year's allocation of AML funds into a separate fund for the abatement of the causes and treatment of the effects of acid mine drainage. These funds are used in accordance with all applicable State and Federal regulations and are used to achieve the priorities of SMCRA. The program purpose, goals, and objectives are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(i). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(3)(ii) of the Plan, described the priority system and the specific criteria for identifying and ranking all sites eligible for reclamation under Title IV of the Act. Examples of eligible site problems include: Open and unprotected mine entries; open shafts; hazardous highwalls and other steep embankments; hazardous mine structures; underground mine subsidence; trash dumps on mine lands; water bodies adversely affected by coal mine drainage; dangerous impoundments; and any other mine related danger. The sites given highest priority are those exhibiting extreme danger to public health, safety, and property from adverse effects of coal mining practices. The sites given the second highest priority are those exhibiting adverse effects of coal mining practices that may impact public health and safety. The sites given third priority for restoration are those land and water resources previously degraded by adverse effects of coal mining, including measures for the conservation and development of soil, water, woodland, fish and wildlife, recreational resources, and agricultural productivity. The three priority categories described are consistent with Section 403(a) of SMCRA. Alabama also describes ADOL's data acquisition procedures in determining site eligibility, which include the review of past mining records (available in the OSMRE's Abandoned Mine Land Inventory System (e-AMLIS)), site inventories, field investigations, and public input. Alabama states that site priority will be determined for all eligible sites, regardless of resource recovery potential, and that any resource recovery will be undertaken in accordance with Federal rules. Any remined sites will remain eligible for AML reclamation. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(ii). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(3)(iii) of the Plan, described ADOL's coordination with other agencies. The ADOL AML Program coordinates with other State divisions such as the Alabama Department of Environmental Management (ADEM), the State Historic Preservation Office (SHPO), and the Alabama Department of Conservation and Natural Resources (ADCNR), to review proposed reclamation projects, provide assistance, and offer expertise to ensure that reclamation activities restore adversely impacted land and water to a productive state while protecting natural and historic/cultural resources. ADOL maintains an annual cooperative agreement with a non-profit organization, the Walker County Soil and Water Conservation District Board (WCB), which funds and oversees a reclamation group that performs reclamation and maintenance on AML sites and responds to AML emergencies. Historically, several major and minor tribes occupied Alabama; however, no tribal reservations were historically or are currently located in the areas where AML reclamation presently takes place within the Alabama Coal Region. Consultations concerning potential cultural resource impacts are conducted through the SHPO's Alabama Historical Commission through the NEPA review process. Alabama also describes the purpose of its AML Emergency Program, which is to stabilize the emergency aspects of an AML problem by eliminating the immediate danger to public health, safety, or general welfare. The AML Emergency Program is discussed further in Section 8, “Rights of Entry.” This description of agency coordination is consistent with the Federal requirements of 30 CFR 884.13(a)(3)(iii). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(3)(iv) of the Plan, stated that ADOL may acquire, manage, and dispose of lands that have been adversely affected by coal mining activity, if deemed necessary, pursuant to Section 407 of SMCRA, 30 U.S.C. 1237, and Code of Alabama Section9-16-127. These acquisition, management, and disposition policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(iv). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(3)(v) of the Plan, described its policies and procedures for reclamation on private land. Under its Plan, the ADOL State Programs Administrator has the authority to place or waive a lien against private property if the owner has consented to, participated in, or exercised control over the mining operation, and if reclamation will result in a significant increase in property value. If an initial evaluation suggests an increase in property value of $25,000 or more, the land appraisal may be conducted by an independent appraiser. The Administrator will determine whether to place or waive a lien based on both the independent appraisal findings and other relevant facts, in accordance with Code of Alabama Section 9-16-129. During OSMRE's review, it was noted that this section of the Plan, as well as the referenced Alabama state law (Code of Alabama Section 9-16-129), fails to address the full requirements of 30 CFR 882.13(b) in regard to notifying the landowner of the proposed lien and allowing the landowner a reasonable time to pay that amount in lieu of filing the lien. On July 17, 2017 (Administrative Record No. AL-0670-02), OSMRE requested that Alabama add this lien language to its proposed Plan. On July 28, 2017, Alabama returned a revised Plan which incorporated the additional lien language. These revised policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(v) and 882.13(b). Therefore, we are approving this inclusion.

Alabama, in section 884.13(a)(3)(vi) and (iii) of the Plan, stated its policies and procedures regarding rights of entry to lands or property. Pursuant to Code of Alabama Section 9-16-126, ADOL will take all reasonable actions to obtain advance written consent from the property owner for the purposes of reclamation. In the event that permission cannot be obtained on properties where reclamation is needed and there is an immediate danger to public health, safety, or general welfare, police power entry is authorized under the AML Emergency Program. If police power entry is necessary, a written notice must be mailed to the property owner at least 30 days prior to entry. If the property owner's address is not known, the notice must be posted on the property and advertised in the newspaper. These policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(vi). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(3)(vii) of the Plan, described its public participation policies in the development and operation of its Plan. The ADOL encourages the public to contact its office with any questions or concerns regarding mining related problems or the AML program, or to visit the ADOL Inspections Division Abandoned Mine Lands Program Office. For future projects, ADOL distributes notifications to Federal, State, and local elected officials, and publishes public notices to news outlets within the county where the proposed activity is located. If sufficient public response is received, a public meeting may be scheduled to provide information on proposed activities and address the concerns of the citizens. Additional public involvement in the preparation of any revisions or amendments to the AML Plan will be coordinated and executed by OSMRE during the public comment and review period. These policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(vii). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(4)(i) of the Plan, described the organization of ADOL and its relationship to other State organizations that may become involved in its reclamation program. ADOL also attached an updated organizational chart. The Inspections Division of ADOL reports to the Commissioner, via the State Programs Administrator. The Commissioner for ADOL reports directly to the Governor. The ADOL AML Program also coordinates with other State divisions such as the ADEM, SHPO, and the ADCNR to review proposed reclamation projects, provide assistance, and offer expertise to ensure that reclamation activities restore adversely impacted land and water to a productive state while protecting natural and historic/cultural resources. This description of agency organization is consistent with the Federal requirements of 30 CFR 884.13(a)(4)(i). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(4)(ii) of the Plan, described the personnel staffing policies that will govern the assignment of personnel to its reclamation program. The program's staff is selected on the basis of applicable academic and professional experience. ADOL will be responsible for complying with all pertinent Federal and State laws. This description of agency personnel policies is consistent with the Federal requirements of 30 CFR 884.13(a)(4)(ii). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(4)(iii) of the Plan, stated that the purchasing and procurement systems used by ADOL will be in accordance with the requirements of Office of Management and Budget (OMB) Circular A-102, Attachment 0. Purchasing and procurement program staff is trained in all applicable State and Federal regulations and larger transactions are reviewed, if necessary, by the Alabama Department of Finance, the State Attorney General, the Alabama Department of Examiners of Public Accounts, and the State Auditor. Alabama also described its AML Applicant/Violator System (AVS), which ensures that no company owners, directors, or major shareholders bidding on AML Federally funded projects have any Federal coal mining violations or state cessation orders that would render them ineligible. Emergency program contractors are also required to meet AVS clearance requirements, unless an overriding need to proceed is determined. These systems are consistent with the Federal requirements of 30 CFR 884.13(a)(4)(iii). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(4)(iv) of the Plan, described the ADOL's accounting system, including procedures for the operation of the State Abandoned Mine Reclamation Fund. The ADOL Finance Division is responsible for the proper accounting of Federal draws, income, and expenses, including the maintenance of records for annual audits conducted by the Alabama Department of Examiners of Public Accounts. AML projects, including administrative, operational, and construction costs, are grant-funded and detailed financial records are maintained for auditing purposes, in accordance with 30 CFR part 886 and OMB Circular A-102, Attachment 0. This system description is consistent with the Federal requirements of 30 CFR 884.13(a)(4)(iv). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(5) and (a)(5)(i) of the Plan, included a list of documents and data sources offering general descriptions of known or suspected eligible lands and waters within the State of Alabama which potentially required reclamation at the time of publication. Alabama also included a list of counties, in order of significance which have either reported coal mining prior to 1978, currently have conditions associated with past surface mining practices, or currently have physical hazards or environmental conditions associated with past underground mining practices. Alabama also included a mine map repository showing the general location of known or suspected eligible lands and waters within the State which require reclamation. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(5) and (a)(5)(i). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(5) through (a)(5)(iii) of the Plan, described the problems occurring on known or suspected lands and waters which require reclamation, including a table expressing the percentage of total abandoned mine lands affected by each problem or source. Examples of such problems include: Open shafts and portals; subsidence; highwalls; abandoned structures and equipment; insect or vermin vectors; water impoundments; waste banks; mine-related fires; landslide and flood hazards; pollution of domestic water supplies; erosion; sedimentation; reduced land potential; and aesthetic disamenities. Reclamation techniques to restore the site to an environmentally stable condition will be based on ADOL's site specific assessments, current industry construction standards, and the reclamation cost estimate procedures outlined in OSMRE Directive AML-1. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(5)(ii) and (iii). Therefore, we are approving their inclusion.

Alabama, in section 884.13(a)(6)(i) of the Plan, described the economic base for the state's primary coal producing region, including population size, market accessibility, economic activities, such as agricultural products and manufacturing, and available mining resources. This description is consistent with the Federal requirements of 30 CFR 884.13(a)(6)(i). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(6)(ii) of the Plan, described the aesthetic, historic, and recreational values of Alabama. Alabama stated that, to ensure that all potential impacts of the reclamation process are mitigated, ADOL's Planning and Maintenance Branch will consult with the SHPO's Alabama Historical Commission. This statement is consistent with the Federal requirements of 30 CFR 884.13(a)(6)(ii). Therefore, we are approving its inclusion.

Alabama, in section 884.13(a)(6)(iii) of the Plan, stated that, during the planning stages of proposed AML reclamation projects, evaluations are conducted by the Planning and Maintenance Branch to determine the presence of wetlands, endangered species, and other environmental concerns. Recommendations are provided to enhance or improve wildlife habitat, and to preserve wetlands and other critical wildlife habitat during construction. During this process, ADOL consults with the U.S. Fish and Wildlife Service to determine whether the project will adversely affect any Federally-listed threatened or endangered species and to develop appropriate mitigation measures and minimize disturbance, if necessary. ADOL also coordinates with the ADCNR and reviews the Outdoor Alabama Watchable Wildlife database to determine whether any important natural features are recorded at or near the proposed reclamation project. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(6)(iii). Therefore, we are approving their inclusion.

Alabama included a mine map repository showing the general location of known or suspected eligible lands and waters within the State which require reclamation. This map repository is consistent with the Federal requirements of 30 CFR 884.13(a)(5)(i). Therefore, we are approving its inclusion.

We asked for public comments on the amendment but did not receive any.

On June 27, 2016, under 30 CFR 884.14(a), we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Alabama plan (Administrative Record No. AL-0670). We did not receive any comments.

Under 30 CFR 884.14(a)(2), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On June 27, 2016, we requested comments on Alabama's amendment (Administrative Record No. AL-0670), but neither the SHPO nor ACHP responded to our request.

Based on the above findings, we approve the revised amendment Alabama sent us on July 28, 2017 (Administrative Record No. AL-0670-03).

To implement this decision, we are amending the Federal regulations at 30 CFR part 901, that codify decisions concerning the Alabama Plan. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 405 of SMCRA requires that each state with an abandoned mine reclamation program must have an approved State regulatory program pursuant to Section 503 of the Act. Section 503(a) of the Act requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires consistency of State and Federal standards.

This rulemaking does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

Pursuant to Office of Management and Budget (OMB) guidance, dated October 12, 1993, the approval of state program amendments is exempted from OMB review under Executive Order 12866.

The Department of the Interior has reviewed this rule as required by Section 3 of Executive Order 12988. The Department determined that this Federal Register document meets the criteria of Section 3 of Executive Order 12988, which is intended to ensure that the agency reviews its legislation and proposed regulations to eliminate drafting errors and ambiguity, that the agency write its legislation and regulations to minimize litigation, and that the agency's legislation and regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because Section 3 focuses on the quality of Federal legislation and regulations, the Department limited its review under this Executive Order to the quality of this Federal Register document and to changes to the Federal regulations. The review under this Executive Order did not extend to the language of the State AML program or to the Plan amendment that the State of Alabama drafted.

This rule is not a “[p]olicy that [has] Federalism implications” as defined by Section 1(a) of Executive Order 13132 because it does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Instead, this rule approves an amendment to the Alabama Plan submitted and drafted by that State. OSMRE reviewed the submission with fundamental federalism principles in mind as set forth in Sections 2 and 3 of the Executive Order and with the principles of cooperative federalism as set forth in SMCRA. See, e.g., 30 U.S.C. 1201(f). As such, pursuant to Section 503(a)(1) and (7) (30 U.S.C. 1253(a)(1) and (7)), OSMRE reviewed the plan amendment to ensure that it is “in accordance with” the requirements of SMCRA and “consistent with” the regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rulemaking on Federally-recognized Indian tribes and have determined that the rulemaking does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. The basis for this determination is that our decision is on a State AML program and does not involve Federal regulations involving Indian lands.

Executive Order 13211 of May 18, 2001, requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rulemaking does not require an environmental impact statement because it falls within a categorical exclusion within the meaning of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). It is documented in the DOI Departmental Manual, 516 DM 13.5(B)(29), that agency decisions on approval of state reclamation plans for abandoned mine lands do not constitute major Federal Actions.

This rulemaking does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq.).

The Department of the Interior certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rulemaking would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rulemaking is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rulemaking: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rulemaking.

This rulemaking will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 901 is amended as set forth below:

It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing a duplicative CFR part.

Removal of this part does not add or reduce the burden or cost on the public in any way. The cost of disposal of surplus property will remain the same with removal of the part.

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

The North Carolina Department of Transportation, owner and operator of the U.S. Route 76 (Cape Fear Memorial) Bridge across the Cape Fear River, mile 26.8, in Wilmington, NC, has requested a temporary deviation from the current operating schedule to accommodate routine maintenance.

Under this temporary deviation, the bridge will require a four hour advanced notice to open from 12:01 a.m. on June 15, 2018, to 5 p.m. on November 30, 2018. The current operating schedule is set out in 33 CFR 117.822.

The Cape Fear River is used by a variety of vessels including small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully considered the restrictions with waterway users in publishing this temporary deviation.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by this temporary deviation.

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

The Coast Guard will enforce a safety zone for the Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration in 33 CFR 165.801, Table 1, Line 45, from 9 p.m. through 11 p.m. on July 4, 2018, with a rain date of July 5, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the Monongahela River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration, which covers a one-mile stretch of the Monongahela River. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessel shall comply with the instructions of the COTP or designated representative.

In addition to this notice of enforcement in the Federal Register, the COTP or a designated representative will inform the public through Broadcast Notice to Mariners (BNMs), Local Notices to Mariners (LNMs), Marine Safety Information Bulletins (MSIBs), and/or through other means of public notice as appropriate at least 24 hours in advance of each enforcement.

The Coast Guard will enforce a safety zone for the Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration in 33 CFR 165.801, Table 1, Line 68, from 9:30 p.m. through 11 p.m. on July 4, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration, which covers a one-mile stretch of the Ohio River. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessel shall comply with the instructions of the COTP or designated representative.

In addition to this notice of enforcement in the Federal Register, the COTP or a designated representative will inform the public through Broadcast Notice to Mariners (BNMs), Local Notices to Mariners (LNMs), Marine Safety Information Bulletins (MSIBs), and/or through other means of public notice as appropriate at least 24 hours in advance of enforcement.

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Corpus Christi DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it would be impracticable. This safety zone must be established by June 30, 2018 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone until after the scheduled date of the fireworks and compromise public safety.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is necessary to respond to the potential safety hazards associated with the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the fireworks display occurring on June 30, 2018 will be a safety concern for anyone within a 500-foot radius of the fireworks display. This rule is necessary to ensure the safety of life before, during, and after the scheduled firework displays.

This rule establishes a temporary safety zone from 7:30 p.m. through 9:30 p.m. on June 30, 2018. The safety zone will cover all navigable waters within 500 feet of the fireworks launch location at Point Comfort Bayfront Park in the approximate position 28°40′52.93″ N, 096°33′47.723″ W, Point Comfort, TX. The duration of the zone is intended to protect the public from the fireworks display before, during, and after the scheduled fireworks display. The duration of the zone is intended to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays.

Entry of vessels or persons into this zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Corpus Christi. Persons or vessels seeking to enter the safety zone must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450. All persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small designated area of Lavaca Bay for about two hours on one evening when vessel traffic is normally low. Moreover, the Coast Guard will issue BNMs (via VHF-FM marine channel 16), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), about the zone. In addition, the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting two hours that would prohibit entry within 500 feet of the fireworks launch location. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

The Coast Guard will enforce a safety zone for the EQT 4th of July Celebration in 33 CFR 165.801, Table 1, Line 47, from 9 p.m. through 11 p.m. on July 4, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on navigable waters of the Ohio, Allegheny, and Monongahela Rivers during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the EQT 4th of July Celebration, which covers a less than one-mile stretch of the Ohio, Allegheny, and Monongahela Rivers. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter the safety zone must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

In addition to this notice of enforcement in the Federal Register, the COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), Marine Safety Information Bulletins (MSIBs), and/or through other means of public notice as appropriate at least 24 hours in advance of enforcement.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Since the Coast Guard received notice of this event on May 26, 2018, notice and comment procedures would be impracticable in this instance.

For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) San Francisco has determined that potential hazards associated with the planned fireworks display on June 22, 2018, will be a safety concern for anyone within a 100-foot radius of the fireworks barge and anyone within a 700-foot radius of the fireworks firing site. This rule is needed to protect spectators, vessels, and other property from hazards associated with pyrotechnics.

This rule establishes a temporary safety zone during the loading and transit of the fireworks barge, until after completion of the fireworks display. During the loading of the pyrotechnics onto the fireworks barge, scheduled to take place from 11:00 a.m. to 5:00 p.m. on June 22, 2018, at Pier 50 in San Francisco, CA, the safety zone will encompass the navigable waters around and under the fireworks barge within a radius of 100 feet.

The fireworks barge will remain at Pier 50 until the start of its transit to the display location. Towing of the barge from Pier 50 to the display location is scheduled to take place from 8:30 p.m. to 9:00 p.m. on June 22, 2018, where it will remain until the conclusion of the fireworks display.

At 9:30 p.m. on June 22, 2018, 30 minutes prior to the commencement of the 15-minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 700 feet in approximate position 37°46′36″ N, 122°22′56″ W (NAD 83) for the San Francisco Giants Fireworks Display. The safety zone shall terminate at 10:45 p.m. on June 22, 2018.

The effect of the temporary safety zone is to restrict navigation in the vicinity of the fireworks loading, transit, and firing site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the fireworks firing sites to ensure the safety of participants, spectators, and transiting vessels.

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

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

This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.

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

This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Broadcast Notice to Mariners.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register LNM Local Notice to Mariners NPRM Notice of proposed rulemaking RNA Regulated Navigation Area § Section U.S.C. United States Code II. Background Information and Regulatory History

On May 1, 2018, Amtrak sent the U.S. Coast Guard a letter describing work it would be conducting to remove and replace the moveable portion of the Spuyten Duyvil Railroad Bridge over the Harlem River at mile 7.9. On May 7, 2018, the U.S. Coast Guard District One Bridge Administration notified Amtrak, the bridge owner, that it had no objections to the proposed project.

From May 27 to September 29, 2018, Amtrak will be repairing the Spuyten Duyvil Railroad Bridge. This repair project includes the removal and reinstallation of the swing span of the bridge.

During the removal of the swing span a crane barge and support vessels will be staged near the bridge. The swing span will be lifted from the bridge by a heavy lift crane barge and then secured to another barge. The barge with the swing span will then be towed away and moored west of the bridge, in the Hudson River. These operations, from preparing for the removal of the swing span, removing and securing the swing span to the waiting barge, to mooring the barge with the secured swing span in the Hudson River, will take approximately 72 hours. Amtrak anticipates this work will be conducted over a three-day period between June 12 and June 17, 2018.

During the reinstallation of the swing span a barge and support vessels will again be staged near the bridge. The swing span will be lifted from a support barge by a heavy lift crane barge and reinstalled. The preparation for and reinstallation of the swing span will take approximately 72 hours. Amtrak anticipates this work will be conducted over a three-day period between July 15 and July 28, 2018.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA)(5 U.S.C. 553(b)(B). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the schedule for the removal and reinstallation of the swing span was only recently finalized and provided to the Coast Guard, and timely action is needed to respond to the potential safety hazards associated with this bridge project. The schedule for the repairs and notification to the Coast Guard was delayed by the late finalization of project details, including coordinating the two heavy lift operations with the schedules of known waterway users, and writing a Maintenance of Waterway Traffic Plan. It is impracticable and contrary to the public interest to publish an NPRM because we must establish this RNA and safety zone by June 12, 2018, to allow for timely repairs to the bridge's swing span and promote the safety of the public.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because timely action is needed to respond to the potential safety hazards associated with repairs to the swing span of the bridge.

The First District Commander has determined that potential hazards associated with the bridge swing span removal and reinstallation will be a safety concern for anyone within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge. The RNA and safety zone are needed to ensure the safety of personnel, vessels, and the marine environment from hazards associated with the removal and replacement of Spuyten Duyvil Railroad Bridge. The Coast Guard anticipates that crane lifting operations may create the potential for falling debris into the waterway. The RNA is needed to limit vessel speed and wake of all vessels operating in the Hudson River in the vicinity to minimize the unexpected or uncontrolled movement of water. Construction operations utilizing a crane barge are sensitive to water movement and wake from passing vessels could pose significant risk of injury or death to construction workers.

This rule establishes a RNA and safety zone from noon on Monday, June 12, 2018, to 11:59 p.m. on Sunday, September 30, 2018.

The RNA covers all waters of the Hudson River, approximately 500 yards upstream, and downstream, of the Spuyten Duyvil Railroad Bridge from surface to bottom bound by the following approximate positions starting south of a line drawn from 40°53′15.67″ N, 073°56′29.22″ W, thence to 40°52′56.48″ N, 073°55′21.57″ W, and all waters north of a line drawn from 40°52′47.97″ N, 073°56′42.85″ W, thence to 40°52′31.58″ N, 073°55′45.06″ W (NAD 83), excluding the portion of the safety zone surrounding the Spuyten Duyvil Railroad Bridge as discussed in the following paragraph.

The safety zone covers all waters of the Hudson River and Harlem River within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge, from surface to bottom, bound by the following approximate positions starting on the Manhattan side of Spuyten Duyvil Railroad Bridge with position 40°52′38.20″ N, 073°55′36.70″ W, thence to 40°52′39.96″ N, 073°55′43.75″ W, thence to 40°52′46.34″ N, 073°55′36.90″ W, thence to 40°52′43.98″ N, 073°55′29.83″ W, thence along the Bronx shoreline to the Henry Hudson Bridge at mile 7.2 of the Harlem River, thence south across the Harlem River following along the Henry Hudson Bridge to the Manhattan side, thence along the Manhattan shoreline to the point of origin (NAD 83). For illustrations of the RNA and the safety zone, please refer to the docket.

During operations involving the removal and reinstallation of the swing span a safety zone will prohibit the transit of vessels in the Hudson River and Harlem River within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge. This safety zone will protect personnel, vessels, and the marine environment from potential hazards created by the Spuyten Duyvil Railroad Bridge swing span removal and reinstallation project.

Additionally, during the removal and reinstallation of the swing span all vessels transiting the Hudson River within the regulated navigation area (RNA) will be required to follow a “Slow-No Wake” speed limit. When this RNA is enforced, no vessel may produce a wake nor attain speeds greater than five (5) knots unless a higher minimum speed is necessary to maintain bare steerageway. The heavy lift operations involving the removal and reinstallation of the bridge swing span are currently scheduled to take place in June and July 2018. The Coast Guard is publishing this rule to be effective, and enforceable, through September 30, 2018, in case the project is delayed due to unforeseen circumstances.

We anticipate enforcing the RNA and safety zone during the two periods of heavy lift operations, one occurring between June 12 and approximately June 17, 2018 and the other between approximately July 15 and July 28, 2018. The RNA and safety zone is expected to be enforced for approximately two 72-hour periods when vessels are preparing for, and conducting, the swing span removal and reinstallation operations. The duration of enforcement for both the RNA and safety zone is intended to protect personnel, vessels, and the marine environment in these waters while the bridge span is being removed and reinstalled. During the enforcement periods, all vessels and persons must obtain permission from the First District Commander or a designated representative before entering the safety zone.

The Coast Guard will notify the public and local mariners of this RNA and safety zone through the Local Notice to Mariners (LNM) and Broadcast Notice to Mariners via VHF-FM marine channel 16 in advance of any enforcement period. The regulatory text we are enforcing appears at the end of this document.

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

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

This regulatory action determination is based on the following reasons: (1) The RNA and safety zone only impact a small designated area of the Harlem and Hudson Rivers; (2) the RNA and safety zone will only be enforced during heavy lift operations tentatively scheduled to occur between June 12-17, 2018, for the swing span removal, and between July 15-28, 2018, for the swing span reinstallation; (3) persons or vessels may transit the RNA at any time, subject to a speed restriction during any periods of enforcement; (4) persons or vessels desiring to enter the safety zone may do so when the heavy lift operations are not in progress; (5) the Coast Guard previously published the approximate project dates in the LNM #18-2018 dated May 2, 2018, LNM #19-2018 dated May 9, 2018, LNM #20-2018 dated May 17, 2018, LNM #21-2018 dated May 23, 2018, LNM #22 dated May 30, 2018, and also requested impacted mariners to contact the contractor to discuss their schedules and receive email schedule updates; (6) the contractor contacted known waterway users to discuss the project and waterway impacts. Although the heavy lift operations will result in two periods of enforcement of a safety zone, closing the Harlem River in the vicinity of the Spuyten Duyvil Railroad Bridge, these operations are scheduled to accommodate sight-seeing vessels and marine events to the greatest extent possible.

The Coast Guard will also notify the public of the enforcement of this rule via appropriate means, such as the LNM and Broadcast Notice to Mariners.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the creation of an RNA and a safety zone, both of which are expected to be enforced for two periods each lasting approximately 72 hours. The RNA is will restrict the speed of vessels transiting the Hudson River within approximately 500 yards upstream and downstream of the Spuyten Duyvil Railroad Bridge while heavy lift operations are conducted. The safety zone will prohibit vessels on the Hudson and Harlem Rivers from coming within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge during heavy lift operations. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination will be available in the docket where indicated under ADDRESSES.

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

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

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

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. It is impracticable to publish an NPRM because we must enforce this safety zone starting June 14, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is also contrary to the public interest as it would delay the safety measures necessary to protect persons, vessels, and the marine environment from the potential hazards associated with the detonation of unexploded ordnance.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule is contrary to public interest because it would delay the safety measures necessary to protect persons, vessels, and the marine environment from the potential hazards associated with the detonation of unexploded ordnance.

The United States Army Corps of Engineers is conducting a Remedial Investigation/Feasibility Study for the Fort Pickens Munitions Response Site 01—Range Complex, located in Escambia County, Florida. The site, which is located along the western tip of Santa Rosa Island and extends south into the Gulf of Mexico, was used for coastal defense from before the Civil War until after World War II. There is a potential that the marine investigation may encounter munitions that will require in-water detonation to address potential explosive hazards. The safety zone will encompass a 1,000 yard square area detonation area surrounded by a 1,200 yard buffer area. The United States Army Corps of Engineers will be responsible for the detonation of ordnance within the safety zone.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the detonation of unexploded ordnance beginning on June 14, 2018 will be a safety concern for any vessels or persons on the Gulf of Mexico near Fort Pickens in Pensacola, FL. This rule is necessary to protect persons, vessels, and the marine environment from the potential hazards associated with the detonation of unexploded ordnance.

This rule establishes a temporary safety zone from June 14, 2018 through June 30, 2018. The safety zone will cover all navigable waters of the Gulf of Mexico within the approximate positions 30°17′47.65″ N, 87°21′36.5″ W; 30°17′47.65″ N, 87°19′39.8″ W; 30°16′6.35″ N, 87°19′39.8″ W; and 30°16′6.35″ N, 87°21′36.5″ W near Fort Pickens in Pensacola, FL. The safety zone will encompass a 1,000 yard square area detonation area surrounded by a 1,200 yard buffer area. A chart depicting the area is included in the docket where indicated under ADDRESSES.

The duration of this safety zone is intended to protect persons, vessels, and the marine environment, and will only be enforced if and when the detonation of unexploded ordnance is necessary. No person or vessel will be permitted to enter or transit within the safety zone during periods of enforcement unless authorized by the COTP or a designated representative. The periods of enforcement will be one hour prior to, during, and after any ordnance exploding operations. The Coast Guard was informed that the operations would take place during daylight hours only. A law enforcement vessel will coordinate all vessel traffic during the enforcement periods. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) at least 3 hours in advance of each enforcement period.

Entry into the temporary safety zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Mobile. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM channel 16 or by telephone at 251-441-5976. The COTP or a designated representative will inform the public of the enforcement periods of this safety zone through BNMs, LNMs, and/or MSIBs as appropriate.

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

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

This regulatory determination is based on the size, location, and duration of the temporary safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small designated area of the Gulf of Mexico only as necessary for the detonation of ordnance during a two and half week period. Moreover, the Coast Guard will issue a BNMs via VHF-FM marine channel 16 about the zone, and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone that will prohibit entry on a small designated area of the Gulf of Mexico near Fort Pickens in Pensacola, FL only as necessary for the detonation of ordnance. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev.01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

You may be potentially affected by this action if you work in or employ persons working in crop production agriculture where pesticides are applied. 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:

• Agricultural Establishments (NAICS code 111000), e.g., establishments or persons, such as farms, orchards, groves, greenhouses, and nurseries, primarily engaged in growing crops, plants, vines, or trees and their seeds.

• Nursery and Tree Production (NAICS code 111421), e.g., establishments or persons primarily engaged in (1) growing nursery products, nursery stock, shrubbery, bulbs, fruit stock, sod, and so forth, under cover or in open fields and/or (2) growing short rotation woody trees with a growth and harvest cycle of 10 years or less for pulp or tree stock.

• Timber Tract Operations (NAICS code 113110), e.g., establishments or persons primarily engaged in the operation of timber tracts for the purpose of selling standing timber.

• Forest Nurseries and Gathering of Forest Products (NAICS code 113210), e.g., establishments or persons primarily engaged in (1) growing trees for reforestation and/or (2) gathering forest products, such as gums, barks, balsam needles, rhizomes, fibers, Spanish moss, ginseng, and truffles.

• Farm Workers (NAICS codes 11511, 115112, and 115114), e.g., establishments or persons primarily engaged in providing support activities for growing crops; establishments or persons primarily engaged in performing a soil preparation activity or crop production service, such as plowing, fertilizing, seed bed preparation, planting, cultivating, and crop protecting services; and establishments or persons primarily engaged in performing services on crops, subsequent to their harvest, with the intent of preparing them for market or further processing.

• Pesticide Handling on Farms (NAICS code 115112), e.g., establishments or persons primarily engaged in performing a soil preparation activity or crop production service, such as seed bed preparation, planting, cultivating, and crop protecting services.

• Farm Labor Contractors and Crew Leaders (NAICS code 115115), e.g., establishments or persons primarily engaged in supplying labor for agricultural production or harvesting.

• Pesticide Handling in Forestry (NAICS code 115310), e.g., establishments or persons primarily providing support activities for forestry, such as forest pest control.

• Pesticide Manufacturers (NAICS code 325320), e.g., establishments primarily engaged in the formulation and preparation of agricultural and household pest control chemicals (except fertilizers).

• Farm Worker Support Organizations (NAICS codes 813311, 813312, and 813319), e.g., establishments or persons primarily engaged in promoting causes associated with human rights either for a broad or specific constituency; establishments or persons primarily engaged in promoting the preservation and protection of the environment and wildlife; and establishments primarily engaged in social advocacy.

• Farm Worker Labor Organizations (NAICS code 813930), e.g., establishments or persons primarily engaged in promoting the interests of organized labor and union employees.

• Crop Advisors (NAICS codes 115112, 541690, 541712) e.g., establishments or persons who primarily provide advice and assistance to businesses and other organizations on scientific and technical issues related to pesticide use and pest pressure.

On November 2, 2015, EPA published a final rule making changes to the WPS, 40 CFR part 170, referred to as the “2015 revised WPS” (80 FR 67496) (FRL-9931-81). The WPS is a regulation primarily intended to reduce the risks of injury or illness resulting from agricultural workers' and handlers' use of and contact with agricultural pesticides on farms, forests, nurseries and greenhouses. The rule primarily seeks to protect workers (those who perform hand-labor tasks on pesticide-treated crops, such as harvesting, thinning or pruning) and handlers (those who mix, load and apply pesticides). The 2015 revised WPS requirements retained many of the 1992 WPS requirements, while increasing the stringency of some standards and adding new requirements.

Sections 170.401 and 170.501 of the 2015 revised WPS allowed employers to omit certain topics from training materials until 180 days after EPA publishes in the Federal Register a notification of availability of new WPS training materials. EPA is announcing the availability of new training materials covering the expanded training content for both workers and handlers. These materials, developed through a cooperative agreement with the Pesticide Education Resources Collaborative (PERC), are available at http://pesticideresources.org/. These materials have been approved by EPA and contain the content required by the 2015 revised WPS. There are also new training materials developed by other organizations that have been approved by EPA and contain the content required by the 2015 revised WPS; some of these materials are available on the PERC website and others are proprietary.

EPA is currently reconsidering three requirements of the 2015 revised WPS and plans to solicit comments on potential changes to the designated representative provision, the minimum age for handlers and early-entry workers, and the application exclusion zone. If those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.

The publication of this notification of availability of the training materials specified in 40 CFR 170.401(c)(3) and 170.501(c)(3) commences the 180-day period provided in those provisions. Per §§ 170.401(c)(3) and 170.501(c)(3), WPS training programs must include all of the topics specified in §§ 170.401(c)(3)(i)-(xxiii) and 170.501(c)(3)(i)-(xiv) no later than December 19, 2018.

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-2018-0071 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0071, 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 April 11, 2018 (83 FR 15528) (FRL-9975-57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11112) filed by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Solvay USA Inc., 504 Carnegie Center Princeton, NJ 08540. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether (CAS Reg. No. 2112825-11-1). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. No relevant comments were received on the notice of filing.

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

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown 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(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6)

Additionally, the polymer also meets as required the following exemption criteria: Specified in 40 CFR 723.250(e):

The polymer's number average MW of polymer's number average MW is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer contains only reactive functional groups listed in 40 CFR 723.250(e)(1)(ii)(A).

Thus, oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether.

For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether is 1900 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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 oxirane,2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether to share a common mechanism of toxicity with any other substances, and oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether 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) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether.

There are no existing exemptions from a tolerance for oxirane,2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether polymers.

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.

Accordingly, EPA finds that exempting residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether from the requirement of a tolerance will be safe.

This action establishes 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0235 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0235, 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 February 27, 2018 (83 FR 8408) (FRL-9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8533) by Monsanto Company, 1300 I Street NW, Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180.470 (a) General., be amended by establishing tolerances for residues of the herbicide acetochlor,(2-chloro-2′-methyl-6′-ethyl-N-ethoxymethylacetanilide), and its metabolites containing either the 2-ethyl-6-methylaniline (EMA) or the 2-(1-hydroxyethyl)-6-methyl-aniline (HEMA) moiety, to be expressed as acetochlor equivalents, resulting from applications to soil or growing crops, in or on Alfalfa, forage at 8 parts per million (ppm), Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an exception in the description of the commodities as follows: Animal feed, nongrass, group 18, except alfalfa, forage, and Animal feed, nongrass, group 18, except alfalfa, hay. That document referenced a summary of the petition prepared by Monsanto Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed 8 ppm tolerance for alfalfa forage to 8.0 ppm. The reason for this change is explained in Unit IV.D.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Acetochlor has low acute toxicity by the oral, dermal, and inhalation routes of exposure and is minimally irritating to the eyes. A dermal irritation study indicates that it is a severe skin irritant. Acetochlor is also a strong dermal sensitizer. Evidence of neurotoxicity was observed in acute and subchronic neurotoxicity screening studies in rats, developmental toxicity studies in rats, and subchronic and chronic studies in dogs. In addition to the nervous system, the major target organs affected in subchronic and chronic studies in rats, dogs, and mice exposed to acetochlor are the liver, thyroid (secondary to liver), kidney, testes, and erythrocytes. Species-specific target organs include the nasal olfactory epithelium in rats and the lungs in mice.

There is no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring to acetochlor exposure in the developmental and reproduction toxicity studies in rats and rabbits. In two developmental toxicity studies in rats, fetal effects (increased early resorptions, post-implantation loss, and decreased fetal weight) occurred at doses that also resulted in maternal toxicity (mortality, clinical signs of toxicity, and decreased maternal body weight). In two rabbit developmental toxicity studies, there were no adverse fetal effects at the highest doses tested (190 mg/kg/day and 300 mg/kg/day); whereas maternal toxicity (body weight loss) was seen at 190 mg/kg/day in one study. In three reproduction toxicity studies in rats, offspring effects (decreased pup weights in the first two studies; decreased pup weights, decreased F2 litter size at birth, and focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study) occurred at the same or higher doses than those resulting in parental toxicity (decreased body weight or weight gain in the first two studies; focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study). There was no evidence of reproductive toxicity observed at any dose tested in two of the three reproductive toxicity studies in rats. The third reproduction study in rats showed a decreased number of implantations at the highest dose tested of 216 mg/kg/day.

There was evidence of carcinogenicity in studies conducted with acetochlor in rats and mice. A 23-month mouse carcinogenicity study showed weak evidence for increased benign lung tumors in females, and a 78-week study showed weak evidence for increased benign lung tumors in males. The increases were considered equivocal, based on increases in benign tumors only, inconsistent dose-responses between the two studies, inconsistencies in the responses of males and females between the two studies, lack of pre-neoplastic lung lesions in the 23-month study (while the 78-week study showed an increase in bronchiolar hyperplasia), and the variable incidence of lung tumors known to occur in older mice.

Two carcinogenicity studies in rats showed an increase in nasal epithelial tumors and thyroid follicular cell tumors. Thyroid tumor incidence was relatively low, and there was evidence that the tumors were due to disruption of thyroid-pituitary homeostasis. There are acceptable mode of action data for the rat tumors (nasal olfactory epithelial tumors and thyroid follicular cell tumors) which are adequate to support a non-linear, margin of exposure (MOE), approach for assessment of cancer risk. The data show that, like the related compounds, alachlor and butachlor, tumor formation is dependent upon local cytotoxicity secondary to oxidative damage by a reactive quinone imine intermediate. The mechanistic data on nasal tumorigenesis of acetochlor in the rat, when considered together with the mutagenicity data on acetochlor and consistent findings in mechanistic and mutagenicity studies on the closely related compound alachlor, are considered adequate to demonstrate a cytotoxic, non-mutagenic mode of tumor induction.

Because a clear mode of action was demonstrated for the rat tumors, EPA based the cancer classification on the data from the mouse. EPA classified acetochlor as “Suggestive Evidence of Carcinogenic Potential” based on weak evidence for benign lung tumors in male and female mice and histiocytic sarcomas in female mice, and determined that linear quantification of carcinogenic potential would not be appropriate for the mouse tumors. The rat nasal tumors, with a point of departure (POD) of 10 mg/kg/day, are the most sensitive effect for cancer risk. The chronic population adjusted dose (cPAD), based on the no observed adverse effect level (NOAEL) of 2.0 mg/kg/day from the chronic dog study, will be protective of both non-cancer and cancer effects, including rat nasal tumors, thyroid tumors, and mouse tumors.

Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Acetochlor: Human Health Risk Assessment for Proposed New Use on Alfalfa and Related Animal Commodities at [insert page number] in docket ID number EPA-HQ-OPP-2017-0235.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for acetochlor used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of January 22, 2014 (79 FR 3512) (FRL-9904-19).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acetochlor, EPA considered exposure under the petitioned-for tolerances as well as all existing acetochlor tolerances in 40 CFR 180.470. EPA assessed dietary exposures from acetochlor in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for acetochlor. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues except for livestock commodities where anticipated residues were used, and 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, anticipated residues from field trial data and livestock feeding studies were used, while 100% crop treated assumptions (including feed items) were made for all commodities.

iii. Cancer. Based on the results of carcinogenicity studies in rats and mice summarized in Unit III.A., EPA classified acetochlor as having “Suggestive Evidence of Carcinogenic Potential” but determined that the chronic risk assessment will be protective of both non-cancer and cancer effects. Therefore, a separate exposure assessment to evaluate cancer risk is unnecessary.

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of acetochlor for acute exposures are estimated to be 74.9 parts per billion (ppb) for surface water and 129 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 4.84 ppb for surface water and 82.6 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 129.0 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value of 82.6 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Acetochlor is not registered for any specific use patterns that would result in residential exposure.

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.”

The chloroacetanilides have been evaluated by the Agency and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) as a related group of chemicals for this purpose. Acetochlor is included in a Cumulative Assessment Group of chloroacetanilide pesticides. For purposes of a cumulative risk assessment, it was determined that the common mechanism of toxicity group consists of alachlor, acetochlor, and butachlor. Butachlor is excluded from the group for risk assessment purposes at present because there are no registered uses or tolerances for this chemical in the U.S. The group was selected based on common endpoints of:

i. Nasal turbinate tumors in rats, and a known mechanism of toxicity for development of these tumors.

ii. Induction of hepatic uridine diphosphate-glucuronosyl transferase (UDPGT), which results in increased incidence of thyroid follicular cell tumors secondary to disruption of pituitary-thyroid homeostasis.

Thyroid effects were not included in the final cumulative assessment of the chloroacetanilide herbicides because they were determined to occur at excessively toxic dose levels, and therefore were not considered relevant to human risk assessment. Nasal tumors represent the most sensitive endpoint for both compounds.

A cumulative risk assessment of the chloroacetanilide pesticides acetochlor and alachlor was conducted in April 2007 and did not identify any cumulative risks of concern. A revised quantitative cumulative assessment was not conducted because the proposed new use on alfalfa would not affect the cumulative risk results. The new use on alfalfa is not anticipated to affect the cumulative risk results for the following reasons: The major risk driver in the cumulative assessment was alachlor in drinking water, domestic alachlor uses are being phased out (tolerances are being maintained for imported foods), cumulative dietary exposure was not of concern when accounting for the contribution from alachlor, acetochlor is a very minor contributor to chloroacetanilide cumulative risk when compared to alachlor, and acetochlor is less toxic than alachlor. No further cumulative evaluation is necessary for acetochlor use on alfalfa.

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

2. Prenatal and postnatal sensitivity. No increase in susceptibility was seen in developmental toxicity studies in rats and rabbits or in three multi-generation reproductive toxicity studies in rats. Toxicity to offspring was observed at dose levels which were the same or greater than those causing maternal or parental toxicity. Based on the results of developmental and reproductive toxicity studies, there is no concern for increased qualitative and/or quantitative susceptibility of the young following exposure to acetochlor.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for acute dietary, chronic dietary, and dermal. That decision is based on the following findings:

i. The toxicity database for acetochlor is complete for the purpose of evaluating this tolerance petition.

ii. Evidence of neurotoxicity from exposure to acetochlor was observed in several oral studies. However, these effects were typically observed at high doses. The points of departure selected for risk assessment are protective of the potential neurotoxicity observed in the database.

iii. There is no evidence that acetochlor results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction studies.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acetochlor in drinking water. The acute dietary exposure analysis used tolerance level residues except for livestock commodities where anticipated residues were used and 100 PCT. The chronic dietary exposure analysis used anticipated residues from field trial data and livestock feeding studies, while 100% crop treated assumptions (including feed items) were made for all commodities and 100 PCT. These assessments will not underestimate the exposure and risks posed by acetochlor.

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

1. Acute risk. In examining acute aggregate risk, the only pathway of exposure relevant to the acute time frame is dietary exposure. Therefore, the acute aggregate risk is comprised of exposures to acetochlor residues in food and drinking water and is equivalent to the acute dietary risk estimates. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acetochlor will occupy 1.6% of the aPAD for infants <1-year old, the population group receiving the greatest exposure.

2. Chronic risk. In examining chronic aggregate risk, the only pathway of exposure relevant to the chronic time frame is dietary exposure. Therefore, the chronic aggregate risk is comprised of exposures to acetochlor residues in food and drinking water and is equivalent to the chronic dietary risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acetochlor from food and water will utilize 26% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for acetochlor.

3. Short- and intermediate-term aggregate risk. Short-term and intermediate-term aggregate exposure take into account short-term or intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Acetochlor is not registered for any use patterns that would result in residential exposure. Therefore, the short-term or intermediate-term aggregate risk is the sum of the risk from exposure to acetochlor through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. The Agency has concluded that assessments using a non-linear approach (e.g., a chronic RfD-based approach) will adequately protect for all chronic toxicity, including carcinogenicity that could result from exposure to acetochlor. Chronic aggregate risk estimates are below the Agency's level of concern; therefore, cancer risk is also below the Agency's level of concern.

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

An Enforcement Analytical Method is available to enforce the proposed tolerances. The method is a high performance liquid chromatography/oxidative coulometric electrochemical detector (HPLC/OCED) method and is listed as Method I in the Pesticide Analytical Manual (PAM) Vol. II (§ 180.470).

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for acetochlor on alfalfa commodities, but there are Codex MRLs established for livestock commodities at 0.02 ppm. The tolerances established in this rulemaking are harmonized with the Codex MRLs for livestock commodities, except for the U.S. kidney tolerances, which are being established at 0.03 ppm.

EPA has revised the 8 ppm tolerance for alfalfa forage to 8.0 ppm, in accordance with policy. No other revisions were needed.

Therefore, tolerances are established for residues of acetochlor, in or on Alfalfa, forage at 8.0 ppm, Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an exception in the description of the commodities as follows: Animal feed, nongrass, group 18, except alfalfa, forage, and Animal feed, nongrass, group 18, except alfalfa, hay.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0448 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0448, 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 March 6, 2018 (83 FR 9471) (FRL-9973-27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F8583) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that the existing wheat, forage tolerance in 40 CFR 180.645 for residues of the herbicide thiencarbazone-methyl, methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonyl] amino]sulfonyl]-5-methyl-3-thiophenecarboxylate, be amended from 0.10 parts per million (ppm) to 0.15 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. No comments related to this tolerance action were received on the notice of filing.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Thiencarbazone-methyl has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Thiencarbazone-methyl is not an eye nor a skin irritant and it is not a skin sensitizer.

The most toxicologically significant effect of thiencarbazone-methyl occurs in the urothelial system including the kidney, bladder, and urinary tract. Across species, the dog is more sensitive than the rat or the mouse. Common effects observed throughout the database included sulfonamide crystals in the urine, eosinophilic urolithiasis (kidney, ureter and bladder stones), pelvic dilation, thickening of the kidney, bladder, or ureter, collecting duct hyperplasia, urothelial hyperplasia, submucosal inflammatory cell infiltration, bladder hemorrhage, inflammation, and ulceration.

There is no evidence of susceptibility in the thiencarbazone-methyl database. Offspring effects occurred at the same doses as those which caused maternal toxicity. In rats, maternal toxicity was indicated by decreased body and placenta weight and yellowish sediment in the urinary bladder. Developmental toxicity was indicated by delayed ossification of several locations. In rabbits, maternal toxicity consisted of decreased body weight, deaths, reduced food consumption and sediment in the kidney and urinary bladder. Developmental toxicity consisted of more runt fetuses and lower body weight in female offspring. There were no effects on reproductive parameters in either males or females in a reproductive study in rats. Systemically, there were effects on the urothelial system at the high dose in the parents and decreases in body weight in females toward the end of lactation. There was also evidence of reduced absolute and relative liver weight in males in the high dose F1 group. The pups also demonstrated evidence of urothelial effects as indicated by the presence of stones in the kidneys and urinary bladder in a few F2 weanlings at the highest dose tested.

There is no evidence of immunotoxicity, neurotoxicity, or mutagenicity in the thiencarbazone-methyl database. There were no treatment-related increases in neoplasia in the rat carcinogenicity study. In mice, calculi in the urothelial system as well as transitional cell epithelium tumors in the urinary bladder (1 male/3 females) and in the prostatic urethra (1 male) were observed at the highest dose tested (599 mg/kg/day in males and 758 mg/kg/day in females). Since the neoplasia occurred only in the high dose group, thiencarbazone-methyl was classified as “not likely to be a carcinogen to humans at doses that do not cause urothelial cytotoxicity.” The formation of the tumors is considered to be related to the secondary effects of the urothelial toxicity (irritation) and regenerative proliferation associated with the formation of urinary tract crystals/calculi.

Specific information on the studies received and the nature of the adverse effects caused by thiencarbazone-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, Thiencarbazone-methyl Human Health Risk Assessment, at pages 39-42 in docket ID number EPA-HQ-OPP-2017-0448.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for thiencarbazone-methyl used for human risk assessment is shown in Table 1 of this unit.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0167 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0167, 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 July 26, 2017 (82 FR 34664) (FRL-9963-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8542) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.686 be amended by establishing tolerances for residues of the fungicide benzovindiflupyr (N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide), in or on grasses grown for seed, forage at .15 parts per million (ppm); grasses grown for seed, hay at 7 ppm; and grasses grown for seed, straw at 6 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. Although one commenter requested that this petition be denied, no basis or information was provided to support a denial of this petition.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The rat is the most sensitive species tested, and the target organs of benzovindiflupyr are the liver, thyroid, and kidneys in rats. Hepatotoxicity was manifested as changes in liver weights, liver hypertrophy, and decreased triglycerides. The kidney effects were tubular cell pigment deposits, changes in the tubular basophilia, and increased urea. Enlargement and focal c-cell hyperplasia of the thyroid were observed. An increased incidence of cell hypertrophy in the pituitary pars distalis was noted in the F1 generation males and females in the 2-generation reproductive toxicity rat study. Mouse studies revealed distended large intestines, soft feces and hyperplasia of the colon and caecum. Indications of general malaise including decreased body weight and food consumption, decreased activity, decreased grip strength, piloerection, decreased response to stimulus, hunched posture, gait changes and/or ataxia were reported in the rat and mouse studies. In several studies, females tended to be more sensitive than males, and effects were generally seen at lower doses with gavage dosing than with dietary dosing.

There are no concerns for developmental or reproductive toxicity following benzovindiflupyr exposure. Decreased fetal weight and ossification in the rat developmental toxicity studies occurred at maternally toxic doses. There were no maternal or fetal adverse effects in the rabbit developmental study. In rat reproduction studies, offspring effects (decreased body weight, liver and pituitary effects) occurred at doses higher than those causing parental effects, thus there was no quantitative increase in sensitivity in rat pups. There were no single-dose developmental effects identified in the developmental toxicity studies in rats or rabbits. Although decreases in growing follicle counts were noted in the 2-generation reproduction toxicity study, this effect did not result in reduced fertility in the rat. Furthermore, the antral follicle counts at a later stage in development were not decreased, so the decreased growing follicle count effect is not considered adverse.

No evidence of specific neurotoxicity was observed in the acute oral (gavage) and sub-chronic oral (dietary) neurotoxicity (ACN and SCN) studies in rats, conducted on the benzovindiflupyr technical product. Although benzovindiflupyr caused decreased activity and decreased grip strength in the neurotoxicity studies, there was no supportive neuro-histopathology in any study to indicate a specific neurotoxic effect.

The mouse immunotoxicity study was negative by the T-cell Dependent Antigen Response (TDAR) assay in the mouse.

No systemic effects were noted at the limit dose of 1000 mg/kg/day in the 28-day dermal rat study.

The Agency classified benzovindiflupyr as showing “Suggestive Evidence of Carcinogenic Potential” based on the presence of granular cell tumors of the brain in male rats only at the highest dose tested. The Agency concluded that a non-genotoxic mode of action for thyroid tumors observed in male rats has been established as a result of upregulation of uridine diphosphate glucuronyltransferase (UDPGT), increased clearance of T3 and T4 hormones, and increased TSH levels, resulting in increased thyroid cell proliferation, which progress to form thyroid tumors. There was no evidence of carcinogenicity in female rats or in male or female mice. In addition, there is no concern for mutagenicity. The Agency has determined that using a non-linear approach (i.e., RfD; reference dose) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to benzovindiflupyr.

Specific information on the studies received and the nature of the adverse effects caused by benzovindiflupyr as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled Benzovindiflupyr. Human Health Risk Assessment for the Proposed Use on Grasses Grown for Seeds on pages 30-36 in docket ID number EPA-HQ-OPP-2017-0167.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for benzovindiflupyr used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 14, 2017 (82 FR 52669) (FRL-9967-33).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benzovindiflupyr, EPA considered exposure under the petitioned-for tolerances as well as all existing benzovindiflupyr tolerances in 40 CFR 180.686. EPA assessed dietary exposures from benzovindiflupyr in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for benzovindiflupyr. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a non-linear approach (i.e., RfD) adequately accounts for all chronic toxicity, including carcinogenicity, that could result from exposure to benzovindiflupyr. A separate cancer assessment was not performed.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for benzovindiflupyr. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for benzovindiflupyr in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of benzovindiflupyr. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the estimated drinking water concentrations (EDWCs) of benzovindiflupyr for acute exposures are estimated to be 8.41 parts per billion (ppb) for surface water and 0.14 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 5.41 ppb for surface water and 0.14 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 8.41 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 5.41 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Benzovindiflupyr is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: The residential uses of benzovindiflupyr will result in short-term residential handler and post-application exposure in residential settings. Only residential handler inhalation and post-application incidental oral exposure scenarios have been quantitatively assessed since no dermal hazard was identified. Residential handler short-term inhalation MOEs are well above the LOC of 100 for all scenarios assessed and are not of concern (inhalation MOEs are ≥180,000). Residential post-application (incidental oral) MOEs for children ranged from 8,000 to 3,600,000 on the day of application, using default input values, and are not of concern.

The residential scenarios for the benzovindiflupyr aggregate assessments are as follows: Adults: Inhalation exposures from treating ornamentals with a manually pressurized hand-wand or backpack sprayer; children 1 to <2 years old: Post-application hand-to-mouth exposures from treated turf. These scenarios resulted in the highest residential exposures and are considered protective of other exposure scenarios.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 benzovindiflupyr to share a common mechanism of toxicity with any other substances, and benzovindiflupyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benzovindiflupyr 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There was no evidence of quantitative or qualitative susceptibility in fetuses or offspring in the rat and rabbit developmental studies or in the 2-generation rat reproduction study. Benzovindiflupyr produced effects in rat fetuses (i.e., decreased fetal weight and ossification) in developmental toxicity studies at maternally toxic doses. In the rabbit developmental study, there were no adverse effects in either the does or the fetuses at the highest dose tested. In reproduction studies, offspring effects occurred at doses higher than those causing parental effects; thus, there was no quantitative increase in sensitivity in rat pups. The LOAELs and NOAELs for the rat developmental and rat reproduction studies were clearly defined.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for benzovindiflupyr is complete.

ii. There is no indication that benzovindiflupyr is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that benzovindiflupyr results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzovindiflupyr in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzovindiflupyr.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to benzovindiflupyr will occupy 43% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benzovindiflupyr from food and water will utilize 19% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of benzovindiflupyr is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Benzovindiflupyr is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to benzovindiflupyr.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2100 for adults and 510 for children. Because EPA's LOC for benzovindiflupyr is an MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

An intermediate-term adverse effect was identified; however, benzovindiflupyr is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for benzovindiflupyr.

5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. Based on the results of the chronic risk assessment, which accounts for all chronic toxicity, including carcinogenicity, EPA does not expect any cancer risk to the U.S. population from aggregate exposure to benzovindiflupyr.

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

An adequate analytical method is available to enforce the proposed tolerances for benzovindiflupyr in the specified grass commodities. A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009) was developed for the determination of residues of benzovindiflupyr via liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for benzovindiflupyr.

The registrant petitioned for the use of benzovindiflupyr in or on grasses grown for seed, forage at 0.15 parts per million (ppm), grasses grown for seed, hay at 7 ppm and grasses grown for seed, straw at 6 ppm. The Agency has not established a crop group for “grasses grown for seed” or otherwise defined what commodities are included in the category of “grasses grown for seed”. The closest group tolerance to the commodity category requested is a crop group tolerance on grasses (i.e., “grass, forage, fodder and hay, group 17”), although this group includes all grasses, whether grown for seed or not. Sufficient representative commodity residue data were not submitted to support establishing a crop group 17 tolerances; therefore, the Agency is establishing tolerances for the individual grasses for which residue data were submitted: Bluegrass, bromegrass, fescue, orchardgrass, and ryegrass.

Therefore, tolerances are established for residues of benzovindiflupyr, including its metabolites and degradates, in or on bluegrass, forage at 0.15 ppm, bluegrass, hay at 7.0 ppm, bluegrass, straw at 6.0 ppm, bromegrass, forage at 0.15 ppm, bromegrass, hay at 7.0 ppm, bromegrass, straw at 6.0 ppm, fescue, forage at 0.15 ppm, fescue, hay at 7.0 ppm, fescue, straw at 6.0 ppm, orchardgrass, forage at 0.15 ppm, orchardgrass, hay at 7.0 ppm, orchardgrass, straw at 6.0 ppm, and ryegrass, forage at 0.15 ppm, ryegrass, hay at 7.0 ppm, and ryegrass, straw at 6.0 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

NFS part 1802, Definitions of Words and Terms, contains the following definitions that affect only the internal Agency administrative procedures and have no cost or administrative impact on contractors or prospective contractors: Administrator, Contracting activity, Head of the agency or agency head, Head of the contracting activity (HCA), NASA Acquisition internet Service (NAIS), Procurement officer, and Senior Procurement Executive. Pursuant to Executive Order 13563, Improving Regulation and Regulatory Review, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, NASA is continually reviewing existing regulations with the objective of reducing or removing any unnecessary, outdated and burdensome requirements that have outlived their intended purpose. Because the definitions affect only the internal Agency administrative procedures they can be removed from the regulatory section of the NFS.

NASA does not anticipate opposition to the changes or significant adverse comments. However, if the Agency receives significant adverse comment, it will withdraw this final rule by publishing a document in the Federal Register. A significant adverse comment is one that explains: (1) Why the final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the final rule will be ineffective or unacceptable without change. In determining whether a comment necessitates withdrawal of this final rule, NASA will consider whether it warrants a substantive response in a notice and comment process.

Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations that has no impact on contractors or prospective offerors as the definitions being removed affect only the internal Agency administrative procedures.

Executive Orders (E.O.s) 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 is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.

The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, require that whenever the words “establish” and “establishment” are used in clause 52.227-17, Rights in Data, those words shall be construed to mean “assert” and “assertion”, respectively. In 2007, 52.227-17 was modified. As a result of the modification, the words “establish” and “establishment” no longer appear in the clause. With the modification of 52.227-17, the requirement for NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, is rendered unnecessary. Pursuant to Executive Order 13563, Improving Regulation and Regulatory Review, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, NASA is continually reviewing existing regulations with the objective of reducing or removing any unnecessary, outdated and burdensome requirements that have outlived their intended purpose, NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, were reviewed and recommended for removal from the NFS since they are no longer applicable under any circumstance.

NASA does not anticipate opposition to the changes or significant adverse comments. However, if the Agency receives significant adverse comment, it will withdraw this final rule by publishing a document in the Federal Register. A significant adverse comment is one that explains: (1) Why the final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the final rule will be ineffective or unacceptable without change. In determining whether a comment necessitates withdrawal of this final rule, NASA will consider whether it warrants a substantive response in a notice and comment process.

Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or from, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations. The rule merely removes from the NFS policy and an associated clause that are outdated.

Executive Orders (E.O.s) 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 is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.

The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Accordingly, 48 CFR parts 1827 and 1852 are amended as follows:

NFS subpart 1843.71, Shared Savings, and associated clause 1852.243-71, Shared Savings, were added to the NFS in 1997. The intent of the clause was to provide an incentive for contractors to identify and implement significant cost reduction programs. In return, they would be eligible for a share of the realized savings which resulted from those cost-cutting projects once they were approved by the contracting officer. Pursuant to Executive Order 13563, Improving Regulation and Regulatory Review, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, NASA is continually reviewing existing regulations with the objective of reducing or removing any unnecessary, outdated and burdensome requirements that have outlived their intended purpose, NFS 1843.71, Shared Savings, and associated clause 1852.243-71, Shared Savings were reviewed and recommended for removal from the NFS since they are duplicative of the FAR part 48, Value Engineering Change Proposal (VECP) program and associated clauses implemented under OMB Circular A-131, Value Engineering. The FAR VECP clauses provide the same incentive to contactors as the NFS Shared Savings clause.

NASA does not anticipate opposition to the changes or significant adverse comments. However, if the Agency receives significant adverse comment, it will withdraw this final rule by publishing a document in the Federal Register. A significant adverse comment is one that explains: (1) Why the final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the final rule will be ineffective or unacceptable without change. In determining whether a comment necessitates withdrawal of this final rule, NASA will consider whether it warrants a substantive response in a notice and comment process.

Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations that has minimal impact on contractors or offerors as there are value engineering proposal clauses prescribed in FAR part 48 that may be utilized in lieu of the NFS clause. The rule merely removes from the NFS policy and an associated clause that is outdated and redundant to policy that is already provided for in the FAR.

Executive Orders (E.O.s) 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 is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.

The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Accordingly, 48 CFR parts 1843 and 1852 are amended as follows:

The Gulf reef fish fishery includes mutton snapper and gag and is managed under the FMP. The FMP was prepared by the Council and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Steven Act) (16 U.S.C. 1801, et seq.).

On February 15, 2018, NMFS published a proposed rule for the framework action and requested public comment (83 FR 6830). The proposed rule and framework action outlined the rationale for the actions contained in this final rule. A summary of the management measures described in the framework action and implemented by this final rule is provided below.

For mutton snapper, this final rule revises the stock ACL (given in round weight), the commercial and recreational minimum size limits, and the recreational bag limit. This final rule also revises the gag commercial minimum size limit.

This final rule sets the Gulf mutton snapper stock ACL at 134,424 lb (60,974 kg) for the 2018 fishing year, 139,392 lb (63,227 kg) for the 2019 fishing year, and 143,694 lb (65,179 kg) for the 2020 fishing year and subsequent fishing years. The ACLs are consistent with the current apportionment between the Gulf and South Atlantic and are equal to the Gulf's portion of the acceptable biological catch recommended by the Council's Scientific and Statistical Committee (SSC).

This final rule reduces the recreational bag limit applicable to the Gulf EEZ to 5 mutton snapper per person per day within the 10-snapper aggregate bag limit to be consistent with the Florida state bag limit and South Atlantic EEZ bag limit. NMFS and the Council expect consistent mutton snapper recreational bag limits across the Gulf and South Atlantic EEZs and Florida state waters to improve regulatory compliance and decrease the burden for law enforcement.

This final rule revises the mutton snapper commercial and recreational minimum size limits to 18 inches (45.7 cm), total length (TL), in the Gulf EEZ to be consistent with the state of Florida and South Atlantic EEZ minimum size limits. As with the change to the recreational bag limit, this revision increases regulatory consistency to improve compliance and decrease the burden for law enforcement.

Because more than 95 percent of mutton snapper landings from the Gulf are from the commercial sector and 95 percent of the commercially landed mutton snapper are larger than 20 inches (50.8 cm), NMFS expects little effect on the spawning population and harvest rates as a result of this change.

This final rule increases the Gulf gag commercial minimum size limit to 24 inches (60.9 cm), TL, to make the commercial minimum size limit consistent with the Gulf EEZ recreational minimum size limit, as well as consistent with the South Atlantic EEZ and state of Florida commercial and recreational size limits. Over 98 percent of Gulf commercial gag landings come from waters adjacent to Florida and 94.5 percent of commercially harvested gag in the Gulf waters are at least 24 inches. Therefore, NMFS and the Council expect increasing the commercial minimum size limit to improve compliance and decrease the burden for law enforcement by increasing regulatory consistency, but do not expect an increase in regulatory discards of gag.

NMFS received three comments related to the proposed rule for the framework action. These comments either agreed with the proposed changes or suggested additional modifications to management measures such as prohibiting commercial harvest of gag or modifying the recreational closed seasons, which were beyond the scope of the proposed rule. No changes were made to this final rule based on public comment.

The Regional Administrator for the NMFS Southeast Region has determined that this final rule is consistent with the framework action, the FMP, the Magnuson-Stevens Act, and other applicable law.

This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under E.O. 12866.

In compliance with section 604 of the Regulatory Flexibility ACT (RFA), NMFS prepared a final regulatory flexibility analysis (FRFA) for this final rule. The FRFA follows.

The Magnuson-Stevens Act provides the statutory basis for this final rule. A description of the final rule, why it is being considered, and the objectives of, and legal basis for this final rule are contained in the SUMMARY and SUPPLEMENTARY INFORMATION sections of the preamble. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule. Accordingly, this final rule does not implicate the Paperwork Reduction Act.

No public comments were received relating to the socio-economic implications and potential impacts on small business entities, therefore no changes to this final rule were made in response to public comments. No comments were received from the Office of Advocacy for the Small Business Administration.

NMFS agrees that the Gulf Council's preferred alternatives will best achieve their objectives for the framework action while minimizing, to the extent practicable, the adverse effects on fishers, support industries, and associated communities.

NMFS expects this final rule to directly affect all commercial vessels that harvest Gulf mutton snapper and/or gag under the FMP. Changes to ACLs, recreational minimum size limits, or recreational bag limits in this framework and final rule will not directly apply to or regulate charter vessel and headboat (for-hire) businesses. Any impact to the profitability or competitiveness of for-hire fishing businesses will be the result of changes in for-hire angler demand and will therefore be indirect in nature. The RFA does not consider recreational anglers, who will be directly affected by this final rule, to be small entities, so they are outside the scope of this analysis and only the effects on commercial vessels were analyzed. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

As of April 5, 2018, there were 842 vessels with valid or renewable Federal Gulf reef fish commercial vessel permits. From 2010 through 2015, an average of 119 vessels per year landed mutton snapper in state and Federal waters of the Gulf. These vessels, combined, averaged 429 trips per year in the Gulf on which mutton snapper were landed and 1,594 other trips taken in the Gulf on which no mutton snapper were landed or were taken in the South Atlantic. The average annual total dockside revenue (2015 dollars) was approximately $0.22 million from mutton snapper, approximately $4.34 million from other species co-harvested with mutton snapper (on the same trips), and approximately $12.10 million from other trips by these vessels in the Gulf on which no mutton snapper were harvested or occurred in the South Atlantic. Total average annual revenue from all species harvested by vessels harvesting mutton snapper in the Gulf was approximately $16.66 million, or approximately $138,764 per vessel. For the same period, an average of 375 vessels per year landed gag in the Gulf. These vessels, combined, averaged 2,936 trips per year in the Gulf, on which gag were landed and 2,416 trips taken either in the Gulf on which gag were not harvested or trips taken in the South Atlantic. The average annual total dockside revenue (2015 dollars) for these 375 vessels was approximately $2.39 million from gag, approximately $25.32 million from other species co-harvested with gag (on the same trips in the Gulf), and approximately $17.06 million from the other trips taken by these vessels. The total average annual revenue from all species harvested by these 375 vessels was approximately $44.77 million, or approximately $120,238 per vessel. Based on the foregoing revenue information, all commercial vessels affected by the final rule may be assumed to be small entities.

Because all entities expected to be directly affected by this final rule are assumed to be small entities, NMFS has determined that this final rule will affect a substantial number of small entities; however, the issue of disproportionate effects on small versus large entities does not arise in the present case.

Relevant to commercial vessels, the final rule modifies the 2018-2020, and subsequent years', ACLs for the Gulf apportionment of mutton snapper; increases the minimum size limit for commercial mutton snapper in the Gulf to 18 inches (45.7 cm) TL; and, increases the commercial minimum size limit for gag in the Gulf to 24 inches (60.9 cm) TL.

Modifying the ACLs for mutton snapper will result in ACL reductions each year from 2018 through 2020. Vessel revenue reductions corresponding to these reduced ACLs will be approximately $166,000 in 2018, $154,000 in 2019, and $143,000 in 2020, or an annual average of approximately $160,000 for the four-year period. If distributed equally among the 119 vessels, average annual revenue loss will be approximately $1,350 per vessel. This annual revenue loss per vessel will be approximately 1 percent of average per vessel revenues from all species.

Increasing the Gulf mutton snapper minimum size limit from 16 inches (40.6 cm), TL, to 18 inches (45.7 cm), TL, affects approximately 0.2 percent of commercial landings, or approximately $495 annually in total vessel revenues. This revenue reduction is minimal, and it is also unlikely to be in addition to the estimated revenue losses from the reductions in ACLs, because NMFS expects fishermen to catch the full amount of the ACLs even with an increase in the minimum size limit for mutton snapper.

Increasing the commercial gag minimum size limit in the Gulf from 22 inches (55.8 cm), TL, to 24 inches (60.9 cm), TL, could potentially reduce commercial gag landings by 12,207 lb (5,537 kg) annually, or approximately $61,890 in total vessel revenues. These landings and revenue loss, however, appear unlikely because gag are managed under an individual fishing quota (IFQ) program, and IFQ participants will likely adjust their trip level catch composition throughout the year or sell a portion of their annual gag allocation to other fishers, rather than suffer a loss in revenues.

The following discussion analyzes the alternatives that were considered by the Council, including those that were not selected as preferred by the Council.

Three alternatives, including the preferred alternative described in this final rule, were considered for establishing ACLs for Gulf mutton snapper. The first alternative, the no-action alternative, would maintain the current economic benefits to all participants in the mutton snapper component of the reef fish fishery. This alternative, however, would be inconsistent with the best scientific information available and would allow more harvest than is recommended by the SSCs based on the most recent stock assessment.

The second alternative, which is the preferred alternative, includes two options, one of which is the preferred option. The non-preferred option would apply the Gulf's ACL/annual catch target (ACT) control rule, with the resultant ACT being 12 percent less than the ACL. Because the ACT is not currently used for management purposes, the economic effects of this option would be the same as that of the preferred option.

The third alternative would establish ACLs that would be lower than the ACLs in the preferred alternative, and thus would be expected to result in larger revenue losses than the preferred alternative.

Three alternatives, one of which includes the preferred alternative described in this final rule, were considered for modifying the mutton snapper minimum size limit. The first alternative, the no-action alternative, would maintain the 16-inch (40.6 cm), TL, minimum size limit for commercial and recreational mutton snapper, and thus would not be expected to change the economic benefits from fishing for mutton snapper. However, this alternative would not achieve one of the stated goals of changing the minimum size limit, which is to establish consistent size limit regulations between the Gulf EEZ, the South Atlantic EEZ, and Florida state waters.

The second alternative would increase the minimum size limit for commercial and recreational mutton snapper to 20 inches (50.8 cm), TL. This alternative would be expected to result in larger revenue reductions to commercial vessels than the preferred alternative.

Two alternatives, including the preferred alternative described in this final rule, were considered for modifying the commercial gag minimum size limit. The only alternative to the preferred action is the no-action alternative which would retain the 22-inch (55.8 cm), TL, minimum size limit for gag. However, this alternative would not establish consistent size limit regulations between the Gulf EEZ, the South Atlantic EEZ, and Florida state waters. Furthermore, although the preferred alternative is expected to reduce vessel revenues by approximately $61,890 relative to the no-action alternative, as previously noted, such revenue reduction is deemed unlikely under an IFQ program.

For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

The spiny lobster fishery of the Gulf and the South Atlantic is managed under the FMP. The FMP was prepared by the Councils and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1801 et seq.).

On February 2, 2018, NMFS published a proposed rule for Regulatory Amendment 4 in the Federal Register and requested public comment (83 FR 4890). Regulatory Amendment 4 and the proposed rule outline the rationale for the actions contained in this final rule. A summary of the management measures described in Regulatory Amendment 4 and implemented by this final rule is provided below.

This final rule modifies the stock ACL and annual catch target (ACT) for spiny lobster and prohibits the use of traps for the recreational harvest of spiny lobster in the South Atlantic EEZ.

This final rule revises the stock ACL and ACT based on the new acceptable biological catch (ABC) recommendation provided by the Councils' Scientific and Statistical Committees (SSCs). This final rule sets the ACL equal to the recommended ABC of 9.60 million lb (4.35 million kg), which is based on the mean landings from the years 1991/1992-2015/2016 plus 1.5 standard deviations. This final rule sets the ACT at 8.64 million lb (3.92 million kg), which is 90 percent of the ACL. As established in Amendment 10 to the FMP (Amendment 10), the optimum yield (OY) equals the ACT. NMFS does not expect the increase in the ACT and ACL to result in negative biological effects on the stock because current fishing effort is limited by several variables. These variables include the number of trap tags issued by the state of Florida, commercial and recreational bag and possession limits in the Gulf and South Atlantic EEZ, and the duration of the fishing season, which varies depending on the area where spiny lobsters are harvested.

This final rule prohibits the use of traps for recreational harvest of spiny lobster in all of the South Atlantic EEZ.

The Councils are concerned that using these traps for recreational harvest may become more popular and result in potential negative impacts on essential fish habitat and an increase in the use of vertical lines that may interact with protected species, for example, by creating entanglement issues, continuing to fish after a trap is lost, or creating bycatch.

As established in Amendment 10, the maximum sustainable yield (MSY) proxy and maximum fishing mortality threshold (MFMT) are equal to the OFL, which was set at 7.9 million lb (3.58 million kg). Consistent with Amendment 10, Regulatory Amendment 4 would modify the MSY proxy and MFMT values, so that they are equal to the revised OFL of 10.46 million lb (4.74 million kg).

In addition to implementing the measures associated with Regulatory Amendment 4, this final rule corrects regulatory language that was mistakenly included in the final rule implementing Amendment 10. This final rule changes 50 CFR 622.407(c) to remove the phrase “whichever is greater” and the first occurrence of a duplicative sentence. This final rule also makes a minor wording revision to more directly state that the total number of undersized spiny lobster allowed on-board a vessel is 50 plus 1 per trap.

A total of 14 comments were received on the proposed rule to implement Regulatory Amendment 4. Comments that were beyond the scope of the proposed rule and comments that agreed with the proposed actions are not responded to in this final rule. Other comments that relate to the actions contained in Regulatory Amendment 4 and the proposed rule are grouped as appropriate and summarized below, followed by NMFS' respective responses.

Comment 1: The ACL for spiny lobster should not be increased. The ACL should remain at its current level for another 5 years to allow the spiny lobster populations to increase.

Response: NMFS disagrees. The new ACL is consistent with a new ABC recommendation by the Councils' SSCs. The prior ABC recommendation was based on a time period when landings were historically low. The new ABC and the corresponding increase in the ACL are based on a longer time period (1991/1992 through 2015/2016) to better capture the dynamics of the fishery that are influenced by factors beyond spiny lobster biology and harvest, such as environmental, economic, and social conditions. As described in Regulatory Amendment 4, increasing the ACL is not expected to negatively affect the spiny lobster population because fishing effort is not expected to increase. Current fishing effort is limited by such measures as the number of commercial trap tags issued by the state of Florida, commercial and recreational bag and possession limits in the South Atlantic and Gulf EEZ, and the duration of the fishing seasons, which varies based on location. Further, maintaining the current ACL for 5 years would not necessarily allow for the spiny lobster populations to increase in U.S. waters. Spiny lobster is widely distributed throughout the western Atlantic Ocean from as far north as North Carolina to as far south as Brazil, including Bermuda, The Bahamas, Caribbean, and Central America. Genetic studies show that most larval recruits in U.S. waters are from elsewhere in the Caribbean, with only 10-40 percent locally spawned larvae retained in U.S. waters.

Comment 2: The timeframe used to specify catch limits for spiny lobster should be continuously updated to incorporate periods of low and high landings, natural disasters such as hurricanes, and to allow for accurate estimates of the stock OFL and ABC.

Response: NMFS agrees that is appropriate to reevaluate the ABC, which is used to set the catch limit, when relevant new information becomes available. That is what occurred through the process leading to up to the Council proposing Regulatory Amendment 4. As explained above, the current OFL and ABC for spiny lobster were established using the mean of the most recent 10 years of landings at that time (i.e., fishing years 2000/2001 through 2009/2010). The Councils' SSCs reevaluated this approach in 2016 in response to a recommendation from a review panel, which was convened as required by the accountability measures when landings exceeded the ACT. The SSCs agreed with the review panel's recommendation to use a longer time series of landings (i.e., fishing years 1991/1992 through 2015/2016) to re-specify the OFL and ABC for spiny lobster. This resulted in the increase in the ACL and ACT implemented through this final rule. Regulatory Amendment 4 also states that a review panel should be convened if there are 2 consecutive years of low landings (below 5.3 million lb). Thus, there are mechanisms in place to respond to changes in harvest and update the ACL as appropriate.

Comment 3: The increase in spiny lobster ACL and prohibition of recreational harvest using traps will allow more commercial harvest of spiny lobster. This will have an economic impact on small business entities and therefore, as a result of increased commercial harvest, NMFS should prepare an initial regulatory flexibility act analysis (IRFA) to better address the economic impacts of these actions.

Response: NMFS disagrees that it is necessary to prepare an IRFA. As stated in the Classification section of the proposed rule and again in this final rule, the increase in the ACL and ACT for spiny lobster will have no impact on small commercial fishing businesses because the AMs do not require a closure or otherwise limit commercial landings of spiny lobster taken from Federal waters if landings reach or exceed the ACL or ACT. Further, the majority of commercial harvest of spiny lobster occurs off Florida, and effort is limited by the number of trap tags issued by the state of Florida, commercial limits, and the length of the fishing season. Therefore, any reduction in the use of traps for recreational harvest is not expected to increase commercial harvest.

Comment 4: NMFS should not prohibit the use of traps for recreational harvest in the EEZ off North Carolina. To avoid interaction of traps with whales, it would be better to close the recreational fishing season for spiny lobster in the EEZ off North Carolina during the whale migration period.

Response: NMFS does not agree that a season restriction on the use of traps for recreational harvest is appropriate. Potential interactions between traps and protected species was one issue the Councils considered in deciding to prohibit the use of traps for recreational harvest in the EEZ off all of the South Atlantic states. However, the Councils were also concerned about bycatch and damage to habitat. Therefore, the Councils did not consider seasonal restrictions for recreational harvest of spiny lobster in RegulatoryAmendment 4.

Comment 5: NMFS should allow the use of traps for recreational harvest in the EEZ off Florida to make current spiny lobster regulations consistent in the EEZ off all the states in the South Atlantic region. The proposed rule did not include any evidence that the recreational sector is harming the resource or its habitat as a result of trap use.

Response: NMFS disagrees that consistency in the regulations related to recreational harvest by traps should be achieved by allowing the use of traps in the EEZ off Florida. Consistency was not the basis for the Councils' decision to prohibit the use of this gear. Although current recreational harvest using traps in the EEZ outside Florida is likely minimal, the Councils were concerned that there could be an increase in the use of recreational traps and associated negative impacts. As discussed in Regulatory Amendment 4, trap gear can negatively affect the bottom substrate, entangle protected species, and continue ghost fishing when the trap is lost. Because the majority of spiny lobster harvest occurs in the EEZ off Florida, opening this area to recreational traps would be expected to increase these negatives impacts. In addition, because spiny lobsters are larger in the EEZ off Georgia, South Carolina, and North Carolina than in Florida, traps in those areas would require larger mouths (entrances) that would likely increase bycatch. Recreational harvest is still permitted with dive and snorkel gears, which are the predominant gears used by the recreational sector, and these gears do not have the same impact on habitat and other species as traps do.

Comment 6: Commercial harvest of spiny lobster has fluctuated, while recreational harvest, a small part of overall harvest, has remained consistent. In order to protect the resource, there should be restrictions on both the commercial and recreational sectors.

Response: Restrictions are already in place for spiny lobster in place for both the commercial and recreational sectors, and this final rule will not remove these restrictions. Commercial and recreational bag and possession limits, and fishing seasons for spiny lobster are in place to control harvest. Any person who commercially fishes for and sells spiny lobster caught in either the Gulf or South Atlantic EEZ, except off Florida, must have a Federal spiny lobster vessel permit. Any person who commercially fishes for spiny lobster caught in the EEZ off Florida, or sells spiny lobster in Florida must have the permits and licenses required by Florida (http://www.myfwc.com/fishing/saltwater/commercial/spiny-lobster/). There are also requirements related to gear and vessel identification, and trap construction.

This final rule revises a reference to a boundary point coordinate for the Tortugas shrimp sanctuary in 50 CFR 622.55(c)(2)(iii), which incorrectly refers to paragraph (d)(1) rather than paragraph (c)(1).

The Regional Administrator, Southeast Region, NMFS has determined that this final rule is consistent with Regulatory Amendment 4, the FMP, the Magnuson-Stevens Act, and other applicable law.

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

The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this final rule would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination was published in the proposed rule and is not repeated here.

One public comment (Comment 3) stated that the increase in commercial harvest would have an economic impact on small entities and therefore an IRFA analysis must be prepared. As stated in the Classification section of the proposed rule, although the rule would increase the ACL and ACT, there would be no impact on small commercial fishing businesses because there are no AMs that can either close the Federal season early or otherwise limit commercial landings of spiny lobster taken from Federal waters if landings reach or exceed the ACL or ACT.

No changes were made to the final rule in response to public comments, and NMFS has not received any new information that would affect its previous determination. As a result, a final regulatory flexibility analysis is not required and none was prepared.

The Assistant Administrator for NOAA Fisheries finds that with respect to the change to 50 CFR 622.55(c)(2)(iii) there is good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary. Such procedures are unnecessary because the rule implementing the provision has been subject to notice and comment and the revision corrects only a typographical error.

For the reasons set out in the preamble, 50 CFR parts 600 and 622 are amended as follows: