Federal Register Vol. 80, No.137,

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -315 airplanes. The NPRM published in the Federal Register on August 18, 2014 (79 FR 48703).

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2007-32R2, dated June 27, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Bombardier, Inc. Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -315 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0570-0002.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 48703, August 18, 2014) or on the determination of the cost to the public.

Since the NPRM (79 FR 48703, August 18, 2014) was published, the information in Bombardier Temporary Revision (TR) AWL-110, dated August 31, 2007, to Part 2, “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, Product Support Manual PSM 1-8-7, has been merged in Subject 5-FSL of Section 5, “Fuel System Limitations,” of the “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, PSM 1-8-7, Revision 18, dated February 23, 2012. We have removed paragraph (g)(1) of the proposed AD that referred to Bombardier TR AWL-110, dated August 31, 2007, to Part 2, “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, Product Support Manual PSM 1-8-7, and we have redesignated paragraph (g)(2) of the proposed AD as paragraph (g)(1) of this AD. We have also added new paragraph (g)(5) of this AD to refer to Subject 5-FSL of Section 5, “Fuel System Limitations,” of the “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, PSM 1-8-7, Revision 18, dated February 23, 2012.

We have included a new paragraph (j) in this AD to provide credit for accomplishing the revision to the maintenance or inspection program, as applicable, to incorporate new limitations for fuel tank systems before the effective date of this AD using Bombardier TR AWL-110, dated August 31, 2007, to Part 2, “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, Product Support Manual PSM 1-8-7. The subsequent paragraphs have been redesignated accordingly.

Since the NPRM (79 FR 48703, August 18, 2014) was published, we also received Bombardier TR AWL 2-47, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 200 Maintenance Program Manual, PSM 1-82-7, which supersedes Bombardier TR AWL 2-43, dated August 31, 2007, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 200 Maintenance Program Manual, PSM 1-82-7. We have added paragraph (g)(2) of this AD to refer to Bombardier TR AWL 2-47, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 200 Maintenance Program Manual, PSM 1-82-7, as an appropriate source of service information to accomplish the revision required by paragraph (g) of this AD.

Furthermore, we also received Bombardier TR AWL 3-117, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 300 Maintenance Program Manual, PSM 1-83-7, which supersedes Bombardier TR AWL 3-109, dated August 31, 2007, to Part 2, “Airworthiness Limitations,” of Bombardier Dash 8 Series 300 Maintenance Program Manual, PSM 1-83-7. We have added paragraph (g)(4) of this AD to refer to Bombardier TR AWL 3-117, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 300 Maintenance Program Manual, PSM 1-83-7, as an appropriate source of service information to accomplish the revision required by paragraph (g) of this AD.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 48703, August 18, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 48703, August 18, 2014).

Bombardier, Inc. has issued the following service information:

• Bombardier Temporary Revision AWL 2-43, dated August 31, 2007, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 200 Maintenance Program Manual, PSM 1-82-7.

• Bombardier Temporary Revision AWL 2-47, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 200 Maintenance Program Manual, PSM 1-82-7.

• Bombardier Temporary Revision AWL 3-109, dated August 31, 2007, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 300 Maintenance Program Manual, PSM 1-83-7.

• Bombardier Temporary Revision AWL 3-117, dated February 16, 2011, to Part 2, “Airworthiness Limitations,” of the Bombardier Dash 8 Series 300 Maintenance Program Manual, PSM 1-83-7.

• Subject 5-FSL of Section 5, “Fuel System Limitations,” of the “Airworthiness Limitations List,” of the Bombardier Dash 8 Series 100 Maintenance Program Manual, PSM 1-8-7, Revision 18, dated February 23, 2012.

The service information describes revising the maintenance or inspection program to incorporate new limitations for fuel tank systems. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

We estimate that this AD affects 122 airplanes of U.S. registry.

We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $10,370, or $85 per product.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0570; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 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, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. Pub. L. 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.” In response to Pub. L. 112-28, the Commission published in the Federal Register a Request for Comment (“RFC”). See http://www.cpsc.gov//PageFiles/103251/3ptreduce.pdf. As directed by the Commission, staff submitted a briefing package to the Commission that described opportunities that the Commission could pursue to potentially reduce the third party testing costs consistent with assuring compliance. See http://www.cpsc.gov/PageFiles/129398/reduce3pt.pdf.

In addition to soliciting and reviewing comments as required by Pub. L. 112-28, the Commission published in the Federal Register on April 16, 2013 a Request for Information (“RFI”) on four potential opportunities to reduce testing burdens. See http://www.thefederalregister.org/fdsys/pkg/FR-2013-04-16/pdf/2013-08858.pdf. In February 2014, the Commission also published a notice in the Federal Register of a CPSC workshop on potential ways to reduce third party testing costs through determinations consistent with assuring compliance. See http://www.thefederalregister.org/fdsys/pkg/FR-2014-02-27/pdf/2014-04265.pdf. The workshop was held on April 3, 2014.

As discussed further in this preamble, if the Commission determines that, due to the nature of a particular material, children's products made of that material will comply with CPSC's requirements with a high degree of assurance, manufacturers do not need to have those materials tested by a third party conformity assessment body.

Section 106 of the CPSIA states that the provisions of ASTM International (“ASTM”), Consumer Safety Specifications for Toy Safety (“ASTM F963” or “toy standard”), “shall be considered to be consumer product safety standards issued by the Commission under section 9 of the CPSA (15 U.S.C. 2058).” 1 Thus, toys subject to ASTM F963-11, the current mandatory version of the standard, must be tested by a CPSC-accepted third party conformity assessment body and demonstrate compliance with all applicable CPSC requirements for the manufacturer to issue a Children's Product Certificate (“CPC”) before the toys can be entered into commerce.

The toy standard has numerous requirements. Among them, section 4.3.5 requires that surface coating materials and accessible substrates of toys 2 that can be sucked, mouthed, or ingested, comply with the solubility limits on eight heavy elements. (We refer to these elements as the “ASTM heavy elements.”) One of the eight ASTM heavy elements is lead. The Commission previously determined that certain materials do not exceed lead content limits, and therefore, those materials do not require third party testing when used in children's products (including toys). 16 CFR 1500.91. Thus, CPSC staff focused its work on the remaining seven ASTM heavy elements. The eight ASTM heavy elements and their solubility limits are shown below.

For some materials, the concentrations of all the listed heavy elements might always be below their respective solubility limits due to biological, manufacturing, or other constraints. For example, one of the specified elements may be sequestered in a portion of a plant, such as the roots, that is not used in textile manufacturing. Additionally, a manufacturing process step may remove a specified element, if the element is present, from the material being processed. For these materials, compliance with the limits stated in section 4.3.5 of ASTM F963-11 is assured without requiring third party testing because the material is intrinsically compliant.

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

CPSC hired a contractor to conduct a literature search to assess whether the Commission potentially could determine that wood and other natural materials do not contain any of the seven specified heavy elements in concentrations above the ASTM F963-11 maximum solubility limits (excluding the eighth element, lead which is already subject to a determination). The contractor researched the following materials:

• Unfinished and untreated wood (ash, beech, birch, cherry, maple, oak, pine, poplar, and walnut);

• Bamboo;

• Beeswax;

• Undyed and untreated fibers and textiles (cotton, wool, linen, and silk); and

• Uncoated or coated paper (wood or other cellulosic fiber).

Staff chose these materials for research because they met two criteria:

• Materials the Commission previously determined not to contain lead in concentrations above 100 ppm; and

• Materials more likely to be used in toys subject to the ASTM F963-11 solubility limits.

The contractor's report is available on the Commission's Web site at: http://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Toys/TERAReportASTMElements.pdf. CPSC staff reviewed the contractor's report and prepared a briefing package providing recommendations to the Commission. The staff's briefing package is also available on the Commission's Web site. http://www.cpsc.gov//Global/Newsroom/FOIA/CommissionBriefingPackages/2015/DFRandNPRDeterminationsontheASTMElementsUnfinishedWoods%20June302015.pdf.

In conducting this research, the contractor considered the following factors:

• The concentrations of the seven heavy elements in the material under study;

• 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 seven heavy elements into the material under study; and

• The potential for contamination after production, such as through packaging.

The contractor examined secondary sources and reviewed articles to identify the available data regarding the elements' concentrations in the materials listed above. The contractor summarized the relevant data on bioavailability and presence/concentrations in environmental media (i.e., soil, air, and water) from the most recent Agency for Toxic Substances and Disease Registry (“ATSDR”) 4 toxicological profile, supplemented with more recent authoritative reviews. The contractor conducted a literature search for data on concentrations of the chemical elements in each of the specific materials. Potentially relevant papers for information on concentrations of chemical elements in each product were identified and reviewed. The contractor used the references from reviewed articles to identify other articles to examine and used the references in those articles to find other sources recursively, to uncover relevant cited references.5 The literature screening was to examine whether there is a potential for an ASTM heavy element to be present in the natural material at levels above its solubility limit. When the contractor determined there was sufficient information to indicate the potential for an ASTM heavy element to be present, the contractor stopped that particular line of inquiry and reported the results.

As discussed in the staff's briefing package, the contractor's report does not support a Commission determination for any material other than unfinished and untreated wood. The literature reviewed by the contractor did not provide sufficient information to determine that any of the reviewed materials, other than unfinished and untreated wood, do not contain the heavy elements in concentrations above the limits stated in the toy standard.

Of the materials reviewed, the contractor identified the most studies for wood. Although the contractor could not examine every study concerning wood, the contractor reported that the studies examined constitute a representative sample of studies. The contractor studied measurements taken from trees in natural settings, samples from trees grown on contaminated soils, hydroponically grown 6 seedlings, experimental studies with seedlings grown in pots in which the soil had some of the elements intentionally added, and seedlings soaked in solutions containing one or more of the ASTM heavy elements.

The contractor examined measurements on roots, shoots, bark, trunks, branches, and leaves (or needles, for evergreens). Not every study conducted measurements on each part of the tree. Many studies showed concentrations of the ASTM heavy elements at levels below their solubility limits.

Antimony. For antimony, the studies examined showed that roots, shoots, branches, and leaves contained antimony in concentrations greater than the ASTM solubility limit of 60 ppm. No tree trunks showed antimony concentrations above the ASTM solubility limit. One study's measurements of tree trunks showed that the trunks were nearly free of antimony.

Arsenic. For arsenic, trunks, roots shoots, leaves, stems, bark, and branches of trees were characterized. An experimental study showed roots with more than 25 ppm arsenic. A study at a contaminated mining site showed roots, branches, leaves/needles, and shoots with arsenic concentrations above the ASTM solubility limit. However, no tree trunk measurement showed arsenic in concentrations above 25 ppm. In the two tested cases, tree trunks contained only trace levels of arsenic (levels well below the solubility limit).

One study measured levels of arsenic in sawdust sampled from 15 sawmill locations in the Sapele metropolis (a port city in Nigeria). The highest arsenic concentration measured was 93.0 ppm. The study's authors did not specify what types of trees or wood were processed at the sawmills. However, the authors noted that a major industry in the study area is Africa Timber Plywood Industry and mentioned that arsenic and chromium are used as wood preservatives. Plywood is a manufactured wood and could contain materials not found in natural wood. The authors did not report what woods these sawmills were processing. Therefore, we cannot draw any conclusions from this study.

Barium. For barium, measurements of leaves, leaf litter, wood, and sawdust all showed barium concentrations below the ASTM solubility limit of 1,000 ppm.

Cadmium. For cadmium, the studies examined showed cadmium in tree core samples and wood at levels below the ASTM solubility limit of 75 ppm. Studies that measured cadmium in hydroponic samples showed cadmium levels in root, stem bark, stem wood, and leaf parts above 75 ppm. In a similar manner, shoots grown in pots containing varying amounts of cadmium added, showed cadmium concentrations above the ASTM solubility limit in leaves, stems, and roots.

Chromium. For chromium, one study at a chromate-contaminated site found chromium concentrations above the ASTM solubility limit of 60 ppm in roots, but measurements were below the detection limit for leaves, wood, and bark. Hydroponic studies by the same researcher showed that tree roots can concentrate chromium, but translocation (the movement of a material from one place to another) of chromium from the roots to other parts of the tree, is very low.

Mercury. For mercury, the contractor reviewed studies that measured mercury uptake in the roots, shoots, leaves, bark, trunks, limbs, fruits, branches, stems, and nuts of trees. The studies included both experimental tests and trees sampled from natural areas. Only an experimental study with seedlings grown in pots, to which either mercuric nitrate, methyl mercury chloride, or both, had been added, showed mercury in concentrations above the ASTM solubility limit in shoots and leaves of sycamore seedlings. The other studies did not show mercury levels above the ASTM solubility limit of 60 ppm in samples, even at contaminated sites.

Selenium. For selenium, one study showed measured concentrations of 1.4 ppm selenium in tree rings growing in contaminated soil. Other studies showed selenium at concentrations of 10 ppm or less, well below the ASTM solubility limit of 500 ppm. Only an experimental study with tree cuttings grown hydroponically in either sodium selenate or sodium selenite for 6 days, showed root concentrations above the ASTM solubility limit. All other parts of the cuttings had selenium levels below the ASTM solubility limit.

Conclusions. The contractor's report provides sufficient information for the Commission to determine that unfinished and untreated wood from tree trunks does not contain the ASTM heavy elements in concentrations above their respective solubility limits, and are, therefore, not required to be third party tested to assure compliance with the ASTM F963-11 solubility test. The studies examined multiple species of trees grown on several continents. No study examined by the contractor found any of the ASTM heavy elements in tree trunks at concentrations beyond the element's solubility limit.

The contractor's report indicates that heavy elements could be present in wood from other portions of the tree: The roots, bark, leaves, or fruit. The studies examined by the contractor showed high levels of one or more of the ASTM heavy elements in portions of trees other than trunks. However, commercial timber harvesting involves the process of “delimbing” The tree to create logs that can be transported and cut at a sawmill or lumberyard.7 Often, the sawmill creates uniform-length planks from the delivered logs. These planks are sold to wood wholesalers or retailers, and are bought by wooden toy and other manufacturers. Because commercial practice creates logs from only the trunks of harvested trees, the wood available for use in toys and other wooden objects is sourced from these logs, or trunks of trees, and not the other parts of trees that could contain the ASTM elements above the limits in the toy standard.8

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). Toys must comply with the toy standard, including the specified limits on heavy elements. 15 U.S.C. 2056b. 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 toys would not require third party testing.

To issue a determination that a material does not require third party testing, the Commission must have sufficient evidence to conclude that the material would consistently comply with the CPSC requirement that the material is subject to so that third party testing is unnecessary to provide a high degree of assurance of compliance. 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 a material determination, a high degree of assurance of compliance means that the material will comply with the specified chemical limits due to the nature of the material, or due to a processing technique (e.g., harvesting, smelting, cleaning, filtering, sorting) that reduces the chemical concentration below its limit. For materials determined to comply with a chemical limit, the material must continue to comply with that limit if it is used in a children's product subject to that requirement. A material on which a determination has been made cannot be altered or adulterated to render it noncompliant and then used in a children's product.

Based on the information discussed in section B of this preamble, the Commission determines that unfinished and untreated trunk wood complies with the solubility requirements for the heavy elements in section 4.3.5 of ASTM F963-11 with a high degree of assurance. This determination means that third party testing for compliance to the solubility requirements is not required for certification purposes for unfinished and untreated trunk wood. The Commission makes this determination to reduce the third party testing burden on children's product certifiers while continuing to ensure compliance.

CPSC staff assessed the burden reduction that could result from a determination that unfinished and untreated trunk wood does not require third party testing for compliance with the limits on heavy elements in the toy standards. Testing the soluble concentration of the ASTM heavy elements requires placing the toy (or component part of the toy) in a solution of hydrochloric acid for 2 hours. After 2 hours, the solids are separated from the solution, and the solution is analyzed for the presence of any of the ASTM F963-11 heavy elements using atomic spectroscopy. The cost of this testing can vary by factors such as geography and the volume of testing that a manufacturer obtains from a testing laboratory. Based on published invoices and price lists, the cost of a third party test for the ASTM heavy elements ranges from around $60 in China, up to around $190 in the United States.

Staff cannot estimate with any certainty what the total potential burden reduction would be from a determination that unfinished and untreated wood will not contain concentrations of antimony, arsenic, barium, cadmium, mercury, and selenium in excess of the limits in ASTM F963-11. Most of the approximately 80,000 kinds of toys on the market 9 probably do not contain any wood components. If we assume that 10 percent of the approximately 80,000 different kinds of toys on the market have at least one wood component that requires third party testing, and we also assume that the average cost of a third party test is about $125 (representing the approximate midpoint of the range for the test's cost), then the potential total burden reduction from a determination for unfinished and untreated wood from tree trunks would be about $1 million annually. This estimate assumes that only one type of wood was used in a product so that the manufacturer would not have to test each individual unfinished and untreated wood component part in a product, as allowed by the component part testing rule (16 CFR part 1109). The estimated benefits could be lower if some manufacturers certify that their wood components comply with the ASTM F963-11 heavy elements requirements, based on third party tests of their raw materials instead of the finished product, as allowed by the component part testing rule. Moreover, the assumption that 10 percent of the toys have wood components is intended only to illustrate the potential benefits; the assumption is not based on any formal study of the toy market.

Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, § 3, Aug. 14, 2008. As noted previously, section 14 of the CPSA, which was amended by the CPSIA, 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). 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 this rule determining that unfinished and untreated trunk wood will not exceed the limits for heavy elements stated in the toy standard, and therefore, unfinished and untreated trunk wood does not require third party conformity assessment body testing to assure compliance with the heavy elements limits stated in the toy standard.

This determination relieves unfinished and untreated trunk wood from the third party testing requirement of section 14 of the CPSA for purposes of supporting the required certification. However, if the unfinished and untreated wood is altered so that the material exceeds the heavy elements limits of ASTM F963, the determination is not applicable to that material. The changed or altered material or product must then be tested and meet the heavy element requirements of ASTM F963.

The determination only lifts the obligation to have unfinished and untreated trunk wood tested by a third party conformity assessment body. The underlying requirement that products subject to the toy standard must comply with the toy standard's limits on heavy elements remains in place.

This rule creates a new Part 1251 for “Toys; Determination Regarding Heavy Elements Limits for Unfinished and Untreated Wood.” Section 1251.1 of the rule explains the statutorily-created requirements for toys under ASTM F963 and the third party testing requirements for children's products.

Section 1251.2(a) of the rule establishes the Commission's determination that unfinished and untreated trunk wood does not exceed the limits for the heavy elements established in section 4.3.5 of the toy standard with a high degree of assurance as that term is defined in 16 CFR part 1107. The determination only applies if the material has not been treated or adulterated with the addition of any materials that could result in the addition of any of the heavy elements listed in the toy standard at levels above their respective solubility limits. In section 1251.2(b) of the rule, unfinished and untreated trunk wood means wood harvested from trees with no added surface coatings (e.g., varnish, paint, shellac, polyurethane) and no materials added to the wood substrate (e.g., stains, dyes, preservatives, antifungals, insecticides). Because commercial practice creates wood from only the trunks of harvested trees, unfinished and untreated wood as used in the rule means wood that is generally commercially available. Unfinished and untreated wood does not include manufactured or engineered woods such as pressed wood, plywood, particle board, or fiberboard.

The Commission is issuing this rule as a direct final rule (“DFR”). The Administrative Procedure Act (“APA”) generally requires notice and comment rulemaking 5 U.S.C. 553(b). In Recommendation 95-4, the Administrative Conference of the United States (“ACUS”) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule because we believe the determination will not be controversial. The rule will not impose any new obligations, but will relieve companies from the requirement of having toys (or materials that are component parts of toys) tested by a third party conformity assessment body if the toys or materials are made of unfinished and untreated wood. We expect that the determination will be supported by stakeholders. The determination responds to the desire expressed by numerous stakeholders and Congress that the Commission provide relief from the burdens of third party testing while also ensuring that products will comply with all applicable children's product safety rules. The rule establishes a discrete determination that a specific material (unfinished and untreated wood) in a particular type of product (toys) will always comply with the toy standard's limits on heavy elements. We expect that this focused action will not engender any significant adverse comments.

Unless we receive a significant adverse comment within 30 days, the rule will become effective on September 15, 2015. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why the rule would be inappropriate, including an assertion challenging the rule's underlying premise or approach, or a claim that the rule would be ineffective or unacceptable without change.

Should the Commission receive a significant adverse comment, the Commission will withdraw this direct final rule. A notice of proposed rulemaking (“NPR”), providing an opportunity for public comment, is also being published in this same issue of the Federal Register.

The 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 effective date is September 15, 2015. However, as discussed in section D of the preamble, if the Commission receives a significant adverse comment the Commission will withdraw the DFR and proceed with the NPR published in this same issue of the Federal Register.

The Regulatory Flexibility Act (“RFA”) generally requires that agencies review proposed and final rules for the rules' potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604.

The rule would relieve toy manufacturers and importers of the responsibility of obtaining third party tests for compliance with the limits on the ASTM elements for components of toys consisting of unfinished and untreated wood. Although the impact will be to reduce testing costs, we expect that the rule would have only limited impact on toy manufacturers and importers for two reasons. First, the rule will affect only those companies that manufacture or import toys that contain unfinished and untreated wood components. We expect that relatively few of the approximately 80,000 toys on the market contain any unfinished and untreated wood components. Therefore this rule would be expected to impact only a small number of manufacturers and importers or at most, a small portion of the toys in the market.

Second, manufacturers of toys containing unfinished and untreated wood components still would be required to test to other aspects of the ASTM toy standard, so the impact of this rule relative to production costs for most firms should be small. Due to the small number of entities affected and the limited scope of the impact, the Commission certifies that this rule will not have a significant impact on a substantial number of small entities pursuant to section 605(b) of the RFA, 5 U.S.C. 605(b).

The Commission's regulations provide a categorical exclusion for 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.

Accordingly, 16 CFR part 1251 is added to read as follows:

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.

Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated her scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of the Administrator's intention to temporarily place a substance into schedule I of the CSA.1 The Administrator transmitted the notice of intent to place acetyl fentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated April 7, 2015. The Assistant Secretary responded to this notice by letter dated April 29, 2015 (received by the DEA on May 05, 2015), and advised that based on review by the FDA, there are currently no investigational new drug applications or approved new drug applications for acetyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acetyl fentanyl into schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Acetyl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acetyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the scheduling of acetyl fentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule acetyl fentanyl was published in the Federal Register on May 21, 2015. 80 FR 29227.

To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): the substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for acetyl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA analysis is available in its entirety under the tab “Supporting and Related Material” of the public docket of this action at www.regulations.gov under Docket Number DEA-413F.

Clandestinely produced substances structurally related to the schedule II opioid analgesic fentanyl were trafficked and abused on the West Coast in the late 1970s and 1980s. These clandestinely produced fentanyl-like substances were commonly known as designer drugs, and recently, there has been a reemergence in the trafficking and abuse of designer drug substances, including fentanyl-like substances. Alpha-methylfentanyl, the first fentanyl analogue identified in California, was placed into schedule I of the CSA in September 1981. Following the control of alpha-methylfentanyl, the DEA identified several other fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl, beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl, beta-hydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in submissions to forensic laboratories. These substances were temporarily controlled under schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed into schedule I of the CSA.

The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by State and local forensic laboratories across the country. The first laboratory submission of acetyl fentanyl was recorded in Maine in April 2013 according to NFLIS. NFLIS registered eight reports containing acetyl fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio, Oregon, Pennsylvania, and Virginia.

The System to Retrieve Information from Drug Evidence (STRIDE) is a database of drug exhibits sent to DEA laboratories for analysis. Exhibits from this database are from the DEA, other Federal agencies, and some local law enforcement agencies. Acetyl fentanyl was first reported to STRIDE in September 2013 from exhibits obtained through a controlled purchase in Louisiana. In October 2013, an exhibit collected from a controlled purchase of suspected oxycodone tablets in Rhode Island contained acetyl fentanyl as the primary substance. In 2014, STARLiMS (a Web-based, commercial laboratory information management system that is in transition to replace STRIDE) and STRIDE reported eight additional seizures in Colorado, Florida, Georgia, and Washington.

In August 2013, the Centers for Disease Control and Prevention published an article in its Morbidity and Mortality Weekly Report documenting a series of 14 fatalities related to acetyl fentanyl that occurred between March and May 2013. In December 2013, another fatality associated with acetyl fentanyl was reported in Rhode Island for a total of 15 fatalities. In February 2014, the North Carolina Department of Health and Human Services issued a health advisory related to acetyl fentanyl following at least three deaths related to this synthetic drug. Toxicologists at the North Carolina Office of the Chief Medical Examiner detected acetyl fentanyl in specimens associated with deaths that occurred in January 2014 in Sampson, Person, and Transylvania counties. In July and August 2014, four additional fatalities involving acetyl fentanyl were reported for a total of seven fatalities in North Carolina. Deaths involving acetyl fentanyl have also been reported in California (1), Louisiana (14), Oregon (1) and Pennsylvania (1).

A significant seizure of acetyl fentanyl occurred in April 2013 during a law enforcement investigation in Montreal, Canada. Approximately three kilograms of acetyl fentanyl in powder form and approximately 11,000 tablets containing acetyl fentanyl were seized. Given that a typical dose of acetyl fentanyl is in the microgram range, a three kilogram quantity could potentially produce millions of dosage units. In the United States, tablets that mimic pharmaceutical opioid products have been reported in multiple states, including Colorado, Florida, Georgia, Rhode Island, and Washington. Recent reports indicate that acetyl fentanyl in powder form is available over the Internet and has been imported to addresses within the United States.

Evidence also suggests that the pattern of abuse of fentanyl analogues, including acetyl fentanyl, parallels that of heroin and prescription opioid analgesics. For example, seizures of acetyl fentanyl have been encountered both in powder and in tablet form. It is also known to have caused many fatal overdoses, in which intravenous routes of administration and histories of drug abuse are documented.

The DEA is currently aware of at least 39 fatalities associated with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six states including California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases capturing drug evidence information from DEA forensic laboratories, have a total of 10 drug reports in which acetyl fentanyl was identified in six cases for analyzed drugs submitted from January 2010—December 2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and Washington. It is likely that the prevalence of acetyl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported since standard immunoassays cannot differentiate acetyl fentanyl from fentanyl.

The population likely to abuse acetyl fentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use history documented in acetyl fentanyl fatal overdose cases. Because abusers of acetyl fentanyl are likely to obtain the drug through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to its abusers. This risk is particularly heightened by the fact that acetyl fentanyl is a highly potent opioid (15.7 fold more potent than that of morphine as tested in mice using an acetic acid writhing method). Thus small changes in the amount and purity of the substance could potentially lead to overdose and death.

Acetyl fentanyl exhibits a pharmacological profile similar to that of fentanyl and other opioid analgesic compounds, and it is a potent opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7 times as potent as morphine in mice tested in an acetic acid writhing method. In addition, studies also showed that the range between the effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is narrower than that of morphine and fentanyl, increasing the risk of fatal overdose. Thus, its abuse is likely to pose quantitatively greater risks to the public health and safety than abuse of traditional opioid analgesics such as morphine.

Based on the above pharmacological data, the abuse of acetyl fentanyl at least leads to the same qualitative public health risks as heroin, fentanyl, and other opioid analgesic compounds. The public health risks attendant to the abuse of heroin and opioid analgesics are well established. The abuse of opioid analgesics has resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.

Acetyl fentanyl has been associated with numerous fatalities. At least 39 overdose deaths due to acetyl fentanyl abuse have been reported in six states in 2013 and 2014, California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that acetyl fentanyl poses an imminent hazard to public safety.

Based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of acetyl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for acetyl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 7, 2015, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into schedule I.

In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), into schedule I of the CSA, and finds that placement of this synthetic opioid into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into schedule I to avoid an imminent hazard to the public safety, this final order temporarily scheduling acetyl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).

The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

Upon the effective date of this final order, acetyl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional activities, and possession of schedule I controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, conducts instructional activities with, or possesses), or who desires to handle, acetyl fentanyl must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of July 17, 2015. Any person who currently handles acetyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acetyl fentanyl as of July 17, 2015, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after July 17, 2015 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA.

2. Security. Acetyl fentanyl is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July 17, 2015.

3. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acetyl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of July 17, 2015. Current DEA registrants shall have 30 calendar days from July 17, 2015, to comply with all labeling and packaging requirements.

4. Inventory. Every DEA registrant who possesses any quantity of acetyl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand as of July 17, 2015, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including acetyl fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

5. Records. All DEA registrants must maintain records with respect to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA registrants authorized to handle acetyl fentanyl shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.

6. Reports. All DEA registrants who manufacture or distribute acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015.

7. Order Forms. All DEA registrants who distribute acetyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of July 17, 2015.

8. Importation and Exportation. All importation and exportation of acetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of July 17, 2015.

9. Quota. Only DEA registered manufacturers may manufacture acetyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of July 17, 2015.

10. Liability. Any activity involving acetyl fentanyl not authorized by, or in violation of the CSA, occurring as of July 17, 2015, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

Further, the DEA believes that this temporary scheduling action final order is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking.

Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).

This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Pursuant to the Congressional Review Act, “any rule for which an agency for good cause finds . . . that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to schedule these substances immediately because they pose a public health risk. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place this substance into schedule I because it poses an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, in accordance with 5 U.S.C. 808(2), this order shall take effect immediately upon its publication.

For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under ADDRESSES. Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

On March 25, 2015 we published a Notice of Proposed Rulemaking (NPRM) with a request for comments entitled, “Safety Zone; Big Foot TLP, Walker Ridge 29, Outer Continental Shelf on the Gulf of Mexico” in the Federal Register (80 FR 15703). We received no comments on the NPRM. Before publication of the final rule, Chevron North America (Chevron) notified the Coast Guard of specific challenges during the Big Foot Tension Leg Platform's (TLP) construction phase. Specifically, multiple tendon failures occurred while the Big Foot TLP was going through installation operations. These tendon failures resulted in losing a buoyancy can, which went adrift. Subsequently, the construction operation was put on hold but the remaining tendons and construction/attending vessels and equipment remain on site. The Coast Guard decided to expand the original proposed safety zone to include the construction site as part of the facility for purposes of an interim safety zone during the construction phase. Under 33 CFR 147.1, a safety zone may be established around OCS facilities being constructed, maintained, or operated for safety of life and property. And, under 33 CFR 147.15, a safety zone may extend up to a maximum of 500 meters around an OCS facility measuring from the facility's outer most edge or from its construction site. While the remaining tendons and construction vessels and equipment remain on site and during construction of the Big Foot TLP, this interim rule is necessary to establish the safety zone as extending 500 meters from the construction site to protect persons and vessels from hazards inherent to construction of this type of platform on the OCS. Once the Big Foot TLP facility is constructed, a final rule will revise the safety zone to extend from the constructed facility's outer most edges.

This interim rule follows an NPRM that received no comments. The Coast Guard is issuing this interim rule without further notice 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 when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” As stated above, an NPRM proposing a safety zone around the Big Foot TLP facility was published in March and no comments were received. The NPRM provided prior notice and opportunity to comment. This interim rule provides additional opportunity to comment. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not providing additional notice with respect to this interim rule establishing the safety zone as extending from the construction site rather than from the facility location. Construction and installation operations are expected to resume promptly and immediate action is necessary to establish this interim OCS safety zone during the Big Foot TLP's construction phase to protect life and property from the hazards associated with and resulting from the construction operations.

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

The legal basis and authorities for this rule are found in 14 U.S.C. 85; 43 U.S.C. 1333; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define OCS safety zones.

Because of construction and installation complications, the Coast Guard explored establishing the safety zone proposed in the NPRM published in March 2015 (80 FR 15703) as an interim rule, rather than a final rule at this time, extending from the construction site during the construction phase. Chevron also requested that the Coast Guard establish the interim OCS safety zone around the Big Foot TLP construction site located in the deepwater area of the Gulf of Mexico on the OCS. Placing a safety zone around the construction site will significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the environment.

The construction and installation complications pose significant safety hazards to vessels and mariners operating in the area. The Coast Guard is issuing this interim rule during construction which Chevron anticipates continuing for at least six months. Establishing the OCS safety zone to extend 500 meters (1640.4 feet) from the outside of the 1/2 x 1/2 square mile construction site is necessary to maintain navigational safety during the anticipated six month construction phase.

The Coast Guard is establishing an interim OCS safety zone extending 500 meters (1640.4 feet) from the outer edges of the Big Foot TLP's 1/2 mile by 1/2 mile construction site. The construction site outermost points are located at:

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This rule is not a significant regulatory action due to the location of the Big Foot TLP—on the Outer Continental Shelf—and its distance from both land and safety fairways. Vessel traffic can pass safely around the safety zone using alternate routes. Deviation to transit through the safety zone may be requested. Such requests will be considered on a case-by-case basis and may be authorized by the Commander, Eighth Coast Guard District or a designated representative.

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 would not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in Walker Ridge Block 29, where this safety zone is now established.

This safety zone will not have a significant economic impact or a substantial number of small entities for the following reasons: Vessel traffic can pass safely around the safety zone using an alternate route. Use of an alternate route may cause minimal delay in reaching a final destination, depending on other traffic in the area and vessel speed. Vessels may request deviation from this rule to transit through the safety zone. Such requests will be considered on a case-by-case basis and may be authorized by the Commander, Eighth Coast Guard District or a designated representative. Therefore, the Coast Guard expects any impact of this rulemaking establishing a safety zone around an OCS facility to be minimal, with no significant economic impact on small entities.

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, above.

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 determined that this rule does not have implications for federalism.

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 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.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination 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 establishment of a safety zone around an OCS Facility to protect life, property and the marine environment. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. The environmental analysis checklist supporting this determination and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 147 as follows:

The Coast Guard will enforce the Safety Zone; Chicago Air and Water Show listed as item (f)(10) in Table 165.929 of 33 CFR 165.929. Section 165.929 lists many annual events requiring safety zones in the Captain of the Port Lake Michigan zone. This safety zone encompasses all waters and adjacent shoreline of Lake Michigan and Chicago Harbor bounded by a line drawn from 41°55.900′ N at the shoreline, then east to 41°55.900′ N, 087°37.200′ W, then southeast to 41°54.000′ N, 087°36.000′ W, then southwestward to the northeast corner of the Jardine Water Filtration Plant, then due west to the shore. This zone will be enforced on August 13, 2015, through August 18, 2015, from 8:30 a.m. until 5:00 p.m. on each day.

All vessels must obtain permission from the Captain of the Port Lake Michigan, or a designated on-scene representative to enter, move within, or exit this safety zone. Requests must be made in advance and approved by the Captain of the Port before transits will be authorized. Approvals will be granted on a case by case basis. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port Lake Michigan, or his or her on-scene representative.

This document is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port Lake Michigan, or a designated on-scene representative may be contacted via VHF Channel 16 during the event.

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM would be impracticable since the regulation is immediately necessary to help ensure the safety of all waterway users including the specified vessels and those individuals that desire to exercise their First Amendment rights and holding a notice and comment period at this time would delay regulatory implementation beyond the departure of the last Shell contracted vessel and expected First Amendment activities regarding Shell's operations, thereby increasing the safety risk to all waterways users.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. For reasons identical to those described above, delaying the effective date until 30 days after publication would be impracticable since the regulation is immediately necessary to help ensure the safety of all waterway users.

The legal basis for this rule is the Coast Guard's authority to establish limited access areas: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

Shell is planning Arctic oil drilling and exploration operations for the spring and summer of 2015. In preparation for those operations, it is staging a large number of vessels in the Puget Sound area. There has been a significant amount of First Amendment activity related to Shell's operations in the Puget Sound during the last month including the formation of a “kayak flotilla” used to exercise the participating individuals First Amendment rights regarding Shell's operations in the region. Among other activities, the “kayak flotilla” attempted to block the POLAR PIONEER's departure from Seattle, Washington. Also, Greenpeace International members conducted an unauthorized boarding of a Shell contracted vessel on the high seas. Draft restrictions, vessel maneuvering characteristics, and geographic/environmental conditions may constrain the ability of large commercial vessels (the Shell-contracted vessels) to maneuver in close quarters with other vessels, particularly small craft piloted by recreational operators. Intentional close-in interaction of these vessels will create an increased risk of collision, grounding, or personal injury for all parties. Furthermore, while moored or at anchor the vessels will have ongoing operations occurring onboard, some of which could pose a safety risk to other maritime traffic. The myriad of potential safety risks to all parties and the port itself is best addressed by mandating a minimum zone of separation. For these reasons, the Coast Guard believes that safety zones around the Shell-contracted vessels are necessary to ensure the safety of all waterways users.

Additionally, the Coast Guard believes that given the nature of the First Amendment activity expected and the likely type of vessels used by individuals desiring to express their First Amendment rights, namely kayaks and other small vessels, a regulated navigation area designating a Voluntary First Amendment Area is necessary to ensure the safety of those vessels and persons. The regulated navigation area encompassing the Voluntary First Amendment Area would do so by establishing it as a “no wake” area, which is particularly important for small boats such as kayaks, to better enable persons and vessels to congregate and exercise their First Amendment rights safely and without interference from or interfering with other maritime traffic.

This rule is extending the rule established at 33 Code of Federal Regulations (CFR) § 165.T13-289 as published in the Federal Register (80 FR 23445) due to the fact that the departure from the Puget Sound of several of the vessels associated with Shell's planned Arctic oil drilling and exploration operations have been delayed.

In this rule, the Coast Guard is extending the temporary safety zones and regulated navigation area established at 33 CFR 165.T13-289 as published in the Federal Register (80 FR 23445).

The safety zones are established in subsection (a) of this temporary regulation. Per subsection (a)(1)(i), while transiting, the safety zone around each of the vessels will encompass all waters within 500 yards of the vessel in all directions. Per subsection (a)(1)(ii), while moored or anchored, the safety zone around each of the vessels will encompass all waters within 100 yards of the vessel in all directions. Persons and/or vessels that desire to enter these safety zones must request permission to do so from the Captain of the Port, Puget Sound by contacting the Joint Harbor Operations Center at 206-217-6001, or the on-scene Law Enforcement patrol craft, if any, via VHF-FM CH 16.

The Coast Guard is also establishing a regulated navigation area to ensure the safety of individuals that desire to exercise their First Amendment rights related to Shell's activities in subsection (b) of this regulation. The Voluntary First Amendment Area is being established in an area where we believe individuals will be able to effectively communicate their message, without posing an undue risk to maritime safety, after analyzing maritime traffic patterns and other environmental factors as well as meeting with some groups who have expressed a desire to exercise their First Amendment rights. The regulated navigation area encompassing the Voluntary First Amendment Area will ensure the safety of small boats by establishing it as a “no wake” area for persons and/or vessels to congregate and exercise their First Amendment rights safely and without interference from or interfering with other maritime traffic. The “no wake” provisions will ensure all interactions between vessels within the area occur at a low rate of speed, thereby reducing risk of collision and personal injury. Likewise, the designation of a Voluntary First Amendment Area will help to ensure that a large congregation of vessels does not impede or endanger other commercial and recreational users who are not associated with Shell's arctic drilling and exploration operations or the associated First Amendment activity.

These provisions are particularly vital given the expected presence of the “kayak flotilla” described above. Persons or vessels desiring to exercise their First Amendment rights to free speech regarding Shell's Arctic drilling and exploration operations may enter the regulated navigation area at any time. All other persons or vessels are advised to avoid the regulated navigation area. When inside the regulated navigation area, all vessels must proceed at “no wake” speed and with due regard for all other persons and/or vessels inside the regulated navigation area.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This rule is not a significant regulatory action as the safety zones and regulated navigation area are limited in both size and duration and any person and/or vessel needing to transit through the safety zones or regulated navigation area may be allowed to do so in accordance with the regulatory provisions.

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 will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the affected waterways when the safety zones and regulated navigation areas are in effect. The safety zones and regulated navigation areas will not have a significant economic impact on a substantial number of small entities, however, because the safety zones and regulated navigation area are limited in both size and duration and any person and/or vessel needing to transit through the safety zones or regulated navigation area may be allowed to do so in accordance with the regulatory provisions.

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, above.

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 determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of all individuals. This regulation establishes a regulated navigation area to create a Voluntary First Amendment Area so that persons and vessels can congregate and exercise their First Amendment free speech rights safely and without interference from or interfering with other maritime traffic. Of particular note, large vessels operating in restricted waters cannot maneuver freely, nor can they stop immediately. As such, any First Amendment activity taking place in immediate proximity to such vessels can quickly result in extremis. The Voluntary First Amendment Area has been located to allow individuals a meaningful opportunity to be heard. Individuals that desire to exercise their First Amendment rights are asked utilize the designated area to the extent possible, however, its use is voluntary. Individuals that desire to exercise their First Amendment rights outside the designated area are requested to contact the person listed in the FOR FURTHER INTFORMATION CONTACT section to coordinate their activities so that their message can be heard, without jeopardizing the safety or security of people, places, or vessels.

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.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (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 establishment of temporary safety zones and a regulated navigation area to deal with an emergency situation that is one week or longer in duration. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

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

On April 23, 2015, the United States Postal Service published a proposed rule to amend 39 CFR part 501 to support the automated revenue assurance program currently in development. (See, 80 FR 22661). Comments were received from two industry stakeholders. The first comment generally supported the proposed rule as written. The second comment suggested that the proposed rule should be clarified to apply only to PC Postage systems, and not postage meters. Further, it suggested that the proposal inadequately addressed the cost burden that would be imposed on PC Postage providers, and should provide additional detail regarding account suspension processes, adjustments for overpayment of postage, and the role of the PC Postage provider in the dispute resolution process.

The Postal Service believes that the rule as proposed is appropriately written to encompass all postage evidencing systems. While initial automated collection efforts will be facilitated by PC Postage vendors, all customers should pay postage accurately, regardless of the postage technology they elect to use. As automated solutions become available for the various postage evidencing systems USPS will coordinate implementation plans with the parties concerned. Current manual efforts employed by the Postal Service to collect proper postage are costly and inefficient. An automated approach will reduce costs and improve overall recovery efforts. The costs of program administration will be acknowledged and considered as the USPS establishes operative recovery thresholds and certain other program related business rules. Account suspension, however, is already specifically addressed in postal regulations not modified by this proposal (see, 39 CFR 501.6), and we see no current need for further clarifications in these regulations. We further believe that the proposed rule as written (in conjunction with current 39 CFR 501.11 and 501.12) appropriately discusses PC Postage provider participation in the dispute process. The Postal Service is working diligently to ensure the quality and accuracy of postage evidencing data using automated process controls, and may elect to make such adjustments to our rules in the future as are required to achieve that end. At this time, however, we believe it is appropriate to publish this final rule.

Accordingly, for the reasons stated, 39 CFR part 501 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

Indiana's SIP rules for lead are contained in two separate parts of the State's regulations. The first is Article 15, which EPA approved on August 17, 1989 (See 54 FR 33894). This provision addresses lead-bearing emissions from processes and fugitive dust from several facilities in Indiana.

The second regulatory provision is 326 IAC 20-13, which EPA approved on January 15, 2008 (77 FR 2248). This section contains a partial incorporation by reference of EPA's June 13, 1997, NESHAP for secondary lead smelting at 40 CFR part 63, subpart X (62 FR 32209). This includes: 1) 326 IAC 20-13-1(c) [incorporation by reference of 40 CFR part 63, subpart X, NESHAP (June 13, 1997; 62 FR 32209), with exceptions]; 2) 326 IAC 20-13-2(a) [source-specific lead emission limits and filter requirements for secondary lead smelter, Quemetco Incorporated (Quemetco)]; and 3) 326 IAC 20-13-6 [compliance testing requirements].

On January 5, 2012 (77 FR 556), EPA published amendments to the NESHAP for secondary lead smelting. The final rule revised the standards for secondary lead smelters based on the residual risk and technology reviews required under section 112(f) of the Clean Air Act (CAA), 42 U.S.C. 7412(f). In addition to revising the emission limits for lead compounds, the amendments to the NESHAP included: Revisions to standards for fugitive emissions; addition of total hydrocarbon, dioxin, and furans emission limits for reverberatory and electric arc furnaces; modification and addition of testing and monitoring, recordkeeping and reporting requirements.

On March 14, 2013, and supplemented on November 17, 2014, IDEM submitted a request to revise the SIP to update its lead rule at 326 IAC 15. IDEM published several newspaper notices informing the public of the revisions to 326 IAC 15 and 326 IAC 20. A public hearing on these revisions was held on November 7, 2012. There were no comments received.1

Below is a discussion of Indiana's rules, including an identification of any significant changes from the previously approved SIP lead rules.

IDEM made several administrative revisions to Article 15 to clarify the language in the rule. In section 2 of this rule, IDEM removed obsolete rule language for sources no longer in operation.

In section 3 of this rule, “Control of fugitive lead dust,” IDEM made minor revisions by removing unnecessary language. For instance, the language in this section of the rule instructs sources listed section 2 to submit their fugitive dust control program to “the department of environmental management, office of air management.” IDEM deleted the words “of environmental management, office of air management” in the revised rule language to simply direct the sources to submit its fugitive dust control programs to “the department.”

In section 4 of this rule, “Compliance,” IDEM made a revision to correct the citation for the appropriate source sampling procedures. Previously, the SIP the source sampling procedures were in 326 IAC 3-2. IDEM has relocated these to 326 IAC 3-6.

EPA finds these administrative changes approvable in Indiana's SIP.

Consistent with amendments to the NESHAP, Indiana added 326 IAC 20-13.1, which incorporates portions of this rule. More specifically, it contains standards for process and fugitive sources at secondary lead smelters, test methods, fugitive dust control, standard operating procedures for baghouses, and monitoring and recordkeeping requirements, which are covered by other portions of 326 IAC 20-13. When IDEM adopted rule 326 IAC 20-13.1, it did not include any exclusions to the rule that would exempt secondary lead smelters from complying with any operating and testing requirements consistent with the NESHAP. Thus, the secondary lead smelter rule at 326 IAC 20-13.1 provides clarity to the applicability, operating, and testing requirements for secondary lead smelters.

Second, the revisions to the NESHAP revised the lead emission limits that apply to process and process fugitive, and stacks venting fugitive dust emissions. The lead emission limit from process and process fugitive sources was revised from 2.0 milligrams of lead/dry standard cubic meter (mg/dscm) to 1.0 mg/dscm. The lead emission limit for stacks venting fugitive dust emissions was revised from 2.0 mg/dscm to 0.5 mg/dscm.

In the current SIP, EPA approved source-specific lead emission limits that apply to the secondary lead smelting facility owned and operated by Quemetco. Quemetco is located in Indianapolis, Indiana. For Quemetco, the lead emission limits that apply to a specific process and process fugitive dust, and stacks venting fugitive dust emissions are already as stringent as the NESHAP. IDEM has relocated these limits to 326 IAC 20-13.1-4.

In addition to lead emission limits for Quemetco, IDEM included source-specific lead emission limits for the Muncie (Delaware County), Indiana secondary lead smelting facility owned and operated by Exide Technologies (Exide) at 326 IAC 20-13.1-3. The rule contains lead emission limits for specific processes and process fugitive dust lead emissions at Exide. These emission limits are at levels as stringent as the NESHAP.

When revising the NESHAP for secondary lead smelting, EPA established a facility-wide, flow weighted average, lead emissions limit from stacks of 0.20 mg/dscm. IDEM incorporated this emission limit into 326 IAC 20-13.1-5.

Indiana has requested that EPA approve all portions of 326 IAC 20-13.1 into the SIP, with the following exceptions:

(A.) All provisions related to dioxins, furans, total hydrocarbons, in the following provisions:

(1) 326 IAC 20-13.1-5(d); (2) 326 IAC 20-13.1-5(f); (3) 326 IAC 20-13.1-5(g); (4) 326 IAC 20-13.1-5(i); (5) 326 IAC 20-13.1-5(j); (6) 326 IAC 20-13.1-10(e); (7) 326 IAC 20-13.1-11(d); (8) 326 IAC 20-13.1-11(e); (9) 326 IAC 20-13.1-12(b); (10) 326 IAC 20-13.1-12(c); (11) 326 IAC 20-13.1-12(d); (12) 326 IAC 20-13.1-12(e); (13) 326 IAC 20-13.1-14(e)(2); and (14) 326 IAC 20-13.1-14(e)(3), related to total hydrocarbon.

(B.) certain “General Provisions” and notification provisions under the Federal NESHAP, identified in 326 IAC 20-13.1-1(d); 326 IAC 20-13.1-13(a),2

(C.) 326 IAC 20-13.1-15, concerning the affirmative defense to civil penalties for an exceedance of the emissions limit during malfunctions.3

IDEM decided that the changes to 326 IAC Article 20 required the removal of any duplicate or conflicting emission limits or other requirements that presently exist in 326 IAC 20-13 in the transition to the new requirements in 326 IAC 20-13.1, and thus, repealed 326 IAC 20-13.

EPA finds the lead emission limits for secondary lead smelters in 326 IAC 20-13.1 are more stringent than and will thus strengthen Indiana's current lead SIP. As such, they are approvable.

EPA is approving Indiana's March 14, 2013, SIP revision request, as supplemented on November 17, 2014, which addresses lead sources in the state. The submission consists of updates and clarifications to Indiana's lead SIP rule at 326 IAC Article 15. It also amends 326 IAC Article 20, to incorporate some of the provisions of EPA's NESHAP for secondary lead smelters at 326 IAC 20-13.1. EPA will take no action on the provision of this rule related to (1) dioxins, furans, and total hydrocarbons, (2) identified NESHAP requirements, and (3) the affirmative defense to civil penalties for an exceedance of the emissions limit during malfunctions. It should be noted that this action in no way affects the continued enforceability of the NESHAP at 40 CFR part 63, subpart X.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective September 15, 2015 without further notice unless we receive relevant adverse written comments by August 17, 2015. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective September 15, 2015.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 15, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2015-0396 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 September 15, 2015. 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-2015-0396, 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.

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for the combined residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) in or on pea, succulent shelled at 0.02 parts per million (ppm). This time-limited tolerance expires on December 31, 2018.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The emergency exemption to treat pea seed with thiabendazole was requested by the State of Idaho (Applicant) because the seed will be treated in Idaho. However, the seed is being planted in Minnesota, Illinois, and Wisconsin, where the emergency conditions exist. Pea growers in these states are faced with a new complex of pea root and foliar disease pathogens that current cultural practices, varieties, and seed treatments do not manage. Pea crop failure in commercial fields has become a severe problem and growers have experienced rapidly increasing yield losses within the pea production area each year for several years.

The Applicant asserts that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and has utilized a crisis exemption under FIFRA section 18 to allow the use of thiabendazole on as a seed treatment on succulent peas in Idaho for control of Fusarium and Ascochyta blight in Minnesota, Illinois, and Wisconsin.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of thiabendazole in or on succulent peas. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2018, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on succulent peas after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether thiabendazole meets FIFRA's registration requirements for use on succulent peas or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of thiabendazole by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Idaho to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for thiabendazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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 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 expected as a result of this emergency exemption request and the time-limited tolerance for combined residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) on succulent shelled peas at 0.02 ppm.

EPA recently updated its dietary risk assessment in connection with a Federal Register rule on September 25, 2014 (79 FR 57450) (FRL-9915-78) establishing permanent tolerances for residues of thiabendazole in or on multiple commodities, and has evaluated the potential increase in exposure resulting from the Section 18 emergency exemption use of thiabendazole on succulent shelled peas (Pisum spp., including English pea, garden pea, and green pea). Based on the supporting residue chemistry data, the combined residues of thiabendazole and benzimidazole in/on succulent shelled peas (Pisum spp., including English pea, garden pea, and green pea) are estimated at 0.01 ppm (i.e., 1/2 limit on quantitation (LOQ) for each analyte) for the Section 18 emergency exemption use. To estimate the contribution to drinking water residues resulting from the emergency seed treatment use on succulent shelled peas, EPA relied on the drinking water residue estimates for the currently registered seed treatment use on wheat at 0.20 lbs. active ingredient/acre (ai/A), which is higher than the 0.083 lbs. ai/A maximum seed treatment use allowed under the emergency exemption. The addition of the emergency use on succulent shelled peas and the assumption of 100% of succulent shelled peas treated did not change the findings of the most recent dietary exposure and risk assessment which are discussed in the Federal Register of September 25, 2014. The Agency's exposure and risk assessment for the emergency use on succulent shelled peas is discussed in greater detail in “Section 18 Emergency Exemption for the Use of Thiabendazole as a Seed Treatment on Succulent Peas in Bonneville and Latah Counties in Idaho,” May 14, 2015, available in docket at the address provided under ADDRESSES.

Because the Section 18 emergency use of thiabendazole on succulent shelled peas will result in negligible increases in dietary exposure to all subgroups relative to the safety findings reached in the September 25, 2014 Federal Register Notice, 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 thiabendazole residues.

Acceptable enforcement analytical methods are available for thiabendazole and benzimidazole in plant commodities. Four spectrophoto fluoro metric methods for the determination of thiabendazole are published in the Pesticide Analytical Manual (PAM) Vol. II, and a high performance liquid chromatography (HPLC) method with fluorescence detection (FLD) for the determination of benzimidazole (free and conjugated) is identified in the U.S. EPA Index of Residue Analytical Methods under thiabendazole as Study No. 93020.

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 thiabendazole in or on the requested commodity.

Therefore, a time-limited tolerance is established for residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated), calculated as the stoichiometric equivalent of thiabendazole, in or on pea, succulent shelled at 0.02 ppm. This tolerance expires on December 31, 2018.

This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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 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-2012-0585 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 September 15, 2015. 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-2012-0585, 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, 2013 (78 FR 13295) (FRL-9380-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 2E8049) by Wagner Regulatory Associates, P.O. Box 640, 7217 Lancaster Pike, Suite A, Hockessin, DE 19707 on behalf of Pennzoil-Quaker State Company, 700 Milam Street, Houston, TX 77002. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear (CAS Reg. No. 848301-69-9) when used as an inert ingredient as a solvent, diluent and/or dust suppressant in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That document referenced a summary of the petition prepared by Wagner Regulatory Associates on behalf of the Pennzoil-Quaker State Company, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(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. . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear (also known as GTL petroleum distillates) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The acute oral lethal dose (LD)50 is 5,000 milligrams/kilograms (mg/kg) in rats. An acute dermal toxicity study was not conducted. There were no available dermal irritation data. It is not irritating to the rabbit eye. It is not a skin sensitizer in the guinea pig.

In a 90-day oral toxicity study, GTL petroleum distillates administered by gavage resulted in a statistically significant increase in the incidence and severity of alveolar macrophage accumulations and increased vacuolation of alveolar macrophages in the lung in rats at the lowest observed adverse effect level (LOAEL) 200 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) was 50 mg/kg/day.

In a 2-generation reproductive toxicity study via gavage in rats, GTL petroleum distillates caused maternal and offspring toxicity at 1,000 mg/kg/day. Toxicity was manifested as chronic interstitial/alveolus inflammation in the lungs. The NOAEL for parental toxicity was 50 mg/kg/day since animals in the mid dose (250 mg/kg/day) group were not analyzed. The reproduction NOAEL was 1,000 mg/kg/day, the highest dose tested.

Based upon subsequent studies conducted to evaluate the lung effects, the Agency determined that the effects observed in the 90-day oral toxicity study and 2-generation reproductive toxicity study were caused by gavage administration error and were not test material (dose) related. In a 28-day oral feeding study in rats at doses up to 1,256 mg/kg/day, no adverse effects were observed. In a prenatal developmental toxicity study in the rat (by oral gavage) at doses up to 1,000 mg/kg/day, no adverse toxicological effects were seen. The results of these two more recent studies alleviated the Agency's concern for the lung effects seen in the 90-day oral toxicity study and the 2-generation reproduction study.

GTL petroleum distillates were evaluated for mutagenic potential using the Ames test, micronucleus assay, and gene mutation in mammalian cells. These studies were negative for the induction of mutations and aberrations. Therefore, GTL petroleum distillates are considered non-mutagenic.

A neurotoxicity study was not conducted with GTL petroleum distillates. However, signs of neurotoxicity were not observed in acute toxicity tests at doses up to 5,000 mg/kg body weight (bw)/day. Evidence of neurotoxicity was not observed in the 90-day oral toxicity study in rats and in the 28-day oral feeding study in rats.

An immunotoxicity study was not conducted with GTL petroleum distillates. However, alveolar macrophage accumulations and increased vacuolation of alveolar macrophages in the lung was observed in rats at >200 mg/kg/day in both the 90-day oral and 2-generation reproduction toxicity studies. However, these effects were determined to be caused by gavage technique error rather than effects attributable to the test substance.

There are no data specific to the absorption, metabolism, distribution and elimination of GTL petroleum distillates, however, the absorption of other mixtures of normal, branched and cyclic petroleum derived hydrocarbons is inversely related to carbon chain length and is independent of isomeric form, preparation process or type of product. Consequently, when administered orally, Fischer-Tropsch derived hydrocarbons in the range of C18-C50 are likely to be unabsorbed and excreted in the feces.

Carcinogenicity studies with GTL petroleum distillates are not available for review. However, based on the lack of carcinogenicity of related linear, branched, and cyclic alkanes and the negligible absorption of GTL petroleum distillates, lack of systemic toxicity at the limit dose, lack of mutagenic concerns, GTL petroleum distillates are not expected to be carcinogenic.

There were no adverse effects in repeat dose toxicity, reproductive, and developmental studies with GTL petroleum distillates at or above limit dose levels to either parental animals or their offspring. Thus, due to the low potential hazard and lack of hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate for GTL petroleum distillates.

1. Dietary exposure from food and feed uses and drinking water. In evaluating dietary exposure to GTL petroleum distillates, EPA considered exposure under the proposed exemption from the requirement of a tolerance. Dietary exposure to GTL petroleum distillates can occur when eating food treated with pesticide formulation containing this inert ingredient. Since an endpoint for risk assessment was not identified, a quantitative dietary exposure assessment for GTL petroleum distillates was not conducted.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

GTL petroleum distillates may be used as an inert ingredient in agricultural pesticide products that could result in short- and intermediate-term residential exposure. Residential exposure can occur via dermal and inhalation routes of exposure to residential applicator. Dermal and inhalation exposure can occur from the use of consumer products and foods/food additives containing GTL petroleum distillates. Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for GTL petroleum distillates was not conducted.

3. 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 distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear to share a common mechanism of toxicity with any other substances, and the category does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear do 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 Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10×) 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10×, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

At this time, there is no concern for potential sensitivity to infants and children resulting from exposures to GTL petroleum distillates. There is no reported quantitative or qualitative evidence of increased susceptibility of rat fetuses to in utero exposure to GTL petroleum distillates in developmental toxicity studies in rats. No quantitative or qualitative evidence of increased susceptibility has been reported following the pre/postnatal exposure to rats in 2-generation reproduction toxicity studies in rats. Given the lack of adverse toxicological effects at limit dose levels, a safety factor analysis has not been used to assess the risk. For these reasons the additional tenfold safety factor is unnecessary.

In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, and non-occupational pesticide exposures. Dietary (food and drinking water) and non-dietary (residential) exposures of concern are not anticipated for GTL petroleum distillates because of its low toxicity based on animal studies showing toxicity at or above the limit dose of 1,000 mg/kg/day. Taking into consideration all available information on GTL petroleum distillates, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to GTL petroleum distillates under reasonably foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 for residues of GTL petroleum distillates when used as an inert ingredient (solvent, diluent and/or dust suppressant) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest is safe under FFDCA section 408.

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

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 distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180. 910 for distillates, (Fischer-Tropsch), heavy, C18-C50, branched, cyclic and linear (CAS Reg. No. 848301-69-9) when used as an inert ingredient (solvent, diluent and/or dust suppressant) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.

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:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

Background

HHS is publishing this rule to comply with a requirement of the Defense Production Act Reauthorization of 2009 (Pub. L. 111-67) (the “DPAR”). The Defense Production Act Reauthorization of 2009 required that HHS, and all other agencies that previously have been delegated authority to issue rated orders under Executive Order 13603, publish regulations providing standards and procedures for prioritization of contracts and orders and for allocation of materials, services, and facilities to promote the national defense under both emergency and non-emergency conditions. HHS's regulation, along with regulations promulgated by other agencies, will become part of the Federal Priorities and Allocations System.

The HRPAS is part of the Federal Priorities and Allocations System. The HRPAS has two principal components: priorities and allocations. Under the priorities component, certain contracts between the government and private parties or between private parties for the production or delivery of industrial resources are required to be given priority over other contracts to facilitate expedited delivery in promotion of the U.S. national defense. Under the allocations component, materials, services, and facilities may be allocated to promote the national defense. For both components, the term “national defense”' is defined broadly and can include critical infrastructure protection and restoration, emergency preparedness and response, and recovery from natural and man-made disasters. Priorities authorities (and other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation) may be re-delegated by the Secretary. The Secretary retains the authority for allocations.

On September 30, 2009, Congress amended the DPA through the Defense Production Act Reauthorization of 2009 (Pub. L. 111-67) (the “DPAR”). The DPAR directed, all agencies to which the President has delegated priorities and allocations authority under E.O. 13603, publish final rules establishing standards and procedures by which that authority will be used to promote the national defense in both emergency and nonemergency situations. The DPAR also required all such agencies to consult as appropriate and to the extent practicable to develop a consistent and unified Federal priorities and allocations system. This rule is one of several rules to be published to implement the provisions of the DPAR. The final rules of the agencies with DPAR authorities, which are the Departments of Commerce, Energy, Transportation, Health and Human Services, Defense, and Agriculture, will comprise the Federal Priorities and Allocations System (“FPAS”). HHS is publishing this interim final rule in compliance with the provision of the DPAR noted above. HHS's HRPAS provisions are consistent with the FPAS regulations being issued by other agencies. The specific proposals in this rule are more fully described below.

Section 101.1 states the purpose of the HRPAS in general terms, as providing guidance and procedures for use of the Defense Production Act (DPA) priorities and allocations authority with respect to health resources necessary or appropriate to promote the national defense.

Section 101.2 provides guidance and procedures for the use of the DPA priorities and allocation authority with respect to health resources necessary or appropriate to promote the national defense.

Section 101.3 provides an overview of the HRPAS program eligibility.

This section describes briefly aspects of the HRPAS, including the certain programs for military and health resources under the DPA.

The “Definitions” section appears in § 101.20 and provides definitions for the relevant regulatory terms.

Section 101.30, “Delegation of Authority,” describes fully the President's delegations to HHS. It also describes, in general terms, the items subject to HHS's jurisdiction. This provision facilitates public understanding of the role that each delegate agency plays in the overall priorities and allocations system.

Section 101.31, “Priority ratings,” describes the two possible levels of priority and program identification symbols used when rating an order.

Section 101.32, “Elements of a rated order,” describes in detail what each rated order must include, consisting of the appropriate priority rating, delivery date information, signatures and required language. HHS seeks comment specifically on the text of this provision.

Section 101.33, “Acceptance and rejection of rated orders,” details when orders placed by HHS may or must be accepted or rejected, and what the procedures are for both, including customer notification requirements and certain exceptions for emergency preparedness conditions. Specifically, persons must accept or reject rated orders for emergency response-related approved programs within fifteen (15) working days (or ten (10) working days, depending on the circumstance). HHS requires the shorter time limit in for the recipient to respond to a rated order issued in connection with an emergency response because such orders would require a shorter time frame to ensure delivery in time to provide disaster assistance, emergency response or similar activities. HHS believes that the exigent circumstances inherent in such activities justify requiring a shorter response time.

Section 101.34, “Preferential scheduling,” details procedures in cases where a person receives two or more conflicting rated orders. If a person is unable to resolve such a conflict, this section refers them to special priorities assistance as provided in §§ 101.40 through 101.44.

Section 101.35, “Extension of priority ratings,” requires a person to use rated orders with suppliers to obtain items or services needed to fill a rated order. This allows the priority rating to “extend” from contractor to subcontractor to supplier throughout the entire procurement chain.

Section 101.36, “Changes or cancellations of priority ratings and rated orders,” provides procedures for changing or cancelling a rated order, both by HHS or other persons who placed the order.

Section 101.37, “Use of rated orders,” lists what items must be rated. It also introduces the use of certain program identification symbols used when rated orders may be combined, and details the procedures for combining two or more rated orders, as well as rated and unrated orders.

Section 101.38, “Limitations on placing rated orders,” prohibits the use of rated orders in a list of specific circumstances. This section also specifically excludes the use of rated orders for resources within the resource jurisdiction of agencies other than HHS with DPA priorities and allocations authority.

Section 101.40, “General provisions” illustrates when and how HHS can provide special priorities assistance, and provides specific HHS points of contact and the form to be used for requesting such assistance. Special priorities assistance may generally be requested for any reason.

Section 101.41, “Requests for priority rating authority,” directs persons to the Department of Commerce to request rating authority for production or construction equipment. This section also identifies circumstances in which HHS may authorize a person to place a priority rating on an order to a supplier in advance of the issuance of a rated prime contract, and lists factors HHS will consider in deciding whether to grant this authority.

Section 101.42, “Examples of assistance,” provides a number of examples of when special priorities assistance may be provided, although it may generally be provided for any reason.

Section 101.43 lists the criteria for granting assistance, and § 101.44 lists instances in which assistance may not be provided (i.e., to secure a price advantage).

Sections 101.50 through 101.52 describe allocations and contain procedures for the use of allocation orders. Specifically, allocation orders will be used only if priorities authority will not provide a sufficient supply of material, services or facilities for national defense requirements, or when use of priorities authority will cause a severe and prolonged disruption in the supply of resources available to support normal U.S. economic activities. Allocation orders will not be used to ration materials or services at the retail level. Allocation orders will be distributed equitably among the suppliers of the resource(s) being allocated and will not require any person to relinquish a disproportionate share of the civilian market. The standards set forth in §§ 101.50 through 101.52 provide reasonable assurance that allocation orders will be used only in situations where the circumstances justify such orders.

Section 101.53 describes the three types of allocation orders that HHS might issue. The types of allocation orders are a set-aside, an allocation directive, and an allotment. A set-aside is an official action that will require a person to reserve resource capacity in anticipation of receipt of rated orders. An allocation directive is an official action that will require a person to take or refrain from taking certain actions in accordance with its provisions (an allocation directive can require a person to stop or reduce production of an item, prohibit the use of selected items, divert supply of one type of product to another, or to supply a specific quantity, size, shape, and type of an item within a specific time period). An allotment is an official action that will specify the maximum quantity of an item authorized for use in a specific program or application. HHS is requiring these three types of allocation orders because it believes that, collectively, they describe the types of actions that might be taken in any situation in which allocation is justified.

Section 101.54, “Elements of an allocation order,” sets forth the minimum elements of an allocation order. Those elements are:

• A detailed description of the required allocation action(s);

• Specific start and end calendar dates for each required allocation action;

• The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of the Secretary of Health and Human Services or his/her designee, which certifies that the order is authorized under this regulation and that the order is consistent with requirements of the regulation;

• A statement that reads in substance: This is an allocation order certified for national defense use. [Insert the legal name of the person receiving the order] is required to comply with this order, in accordance with the provisions of the Health Resources Priorities and Allocations System regulation (45 CFR 101.1), which is part of the Federal Priorities and Allocations System; and

• A current copy of the HRPAS.

HHS rquires these elements because it believes that they provide a proper balance between the need for standards to permit the public to recognize and understand an allocation order if one is issued, and the expectation that any actual allocation orders will have to be tailored to meet unforeseeable circumstances. The language of § 101.54 precludes HHS from including additional information in an allocation order if circumstances warrant doing so.

Section 101.55, “Mandatory acceptance of allocation orders,” requires that an allocation order must be accepted if a person is capable of fulfilling the order. If a person is unable to comply fully with the required actions specific in an allocation order, the person must notify HHS immediately, explain the extent to which compliance is possible, and give reasons why full compliance is not possible. This section also states that a person may not discriminate against an allocation order in any manner, such as by charging higher prices or imposing terms and conditions different than what the person imposed on contracts or orders for the same resource(s) that were received prior to receiving the allocation order. Section 101.55 makes it clear to the public that the limited circumstances and emergency situations that trigger issuance of an allocation order require immediate response from the public in order to address the situation in an expedient fashion.

Section 101.56, “Changes or cancellations of an allocation order” provides that an allocation order may be changed or cancelled by HHS.

Section 101.60, “General Provisions”, provides HHS and overview regarding implementation of this subpart.

Section 101.61, “Rating Authorizations,” defines a rating authorization as an official action granting specific priority rating authority, and refers persons to § 101.21 to request such priority rating authority.

Section 101.62, “Directives,” defines a directive as an official action that requires a person to take or refrain from taking certain actions in accordance with its provisions. This section details directive compliance for the public.

Section 101.63, “Letters and Memoranda of Understanding,” defines a letter or memorandum of understanding as an official action that may be issued in resolving special priorities assistance cases to reflect an agreement reached by all parties, and explains its use.

Section 101.70, “General Provisions” details the official actions which may be taken by HHS to enforce or administer the DPA and other applicable statutes.

Section 101.71, “Audits and investigations,” details the procedures for official examinations of books, records, documents, and other writings and information to ensure that the provisions of the DPA and other applicable statutes, this regulation, and official actions have been properly followed. An audit or investigation may also include interviews and a systems evaluation to detect problems or failures in the implementation of this regulation.

Section 101.72, “Compulsory process,” provides that if a person refuses to permit a duly authorized HHS representative to have access to necessary information, HHS may seek the institution of appropriate legal action, including ex parte application for an inspection warrant, in any forum of appropriate jurisdiction.

Sections 101.73 and 101.74 both provide procedures for notification of failure to comply with the DPA, these regulations, or HHS official actions, and describe the resulting penalties and remedies.

Section 101.75, “Compliance Conflicts,” requires that persons immediately contact HHS should compliance with the DPA, these regulations, or an official action prevent a person from filling a rated order or from complying with another provision of the DPA and other applicable statutes, this regulation, or an official action.

Section 101.80, “Adjustments, Exceptions, and Appeals,” reflects the procedures necessary to request an adjustment or exception to the provisions of these regulations.

Section 101.81, “Appeals,” provides the procedures, timing and contact information for appealing a decision made on a request for relief in the previous section.

Section 101.90, “Protection against claims,” provides that a person shall not be held liable for damages or penalties for any act or failure to act resulting directly or indirectly from compliance with any part of this regulation or an official action.

Section 101.91, “Records and reports,” requires that persons are required to make and preserve for at least three years, accurate and complete records of any transaction covered by this regulation or an official action. Various requirements and procedures regarding such records are provided in this section. The confidentiality provisions of the DPA governing the submission of information pursuant to the DPA and these regulations are also set forth.

Section 101.92, “Applicability of this regulation and official actions,” provides the jurisdictional applicability of this regulation and official actions.

Section 101.93, “Communications,” provides a HHS point of contact for all communications regarding this regulation.

HHS has examined the impacts of the interim final rule under Executive Order 12866 and Executive Order 13563. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). This rule is not an economically significant regulatory action under Executive Order 12866.

A summary of the cost benefit analysis is provided below.

This rule sets criteria under which HHS (or agencies to which HHS delegates HHS's DPA authority to issue rated orders) will authorize prioritization of certain orders or contracts as well as criteria under which HHS will issue orders allocating resources or production facilities. To date, HHS has minimally exercised its prioritization authority for contracts during the response to H1N1 influenza in 2009 to order ancillary supplies in support of the Centers for Disease Control and Prevention's (CDC) Immunization Program, and not exercised its existing allocations authority.

Under prioritization, HHS or its Delegate Agency designates certain orders as one of two possible priority levels. Once so designated, such orders are referred to as “rated orders.” The recipient of a rated order must give it priority over an unrated order or an order with a lower priority rating. A recipient of a rated order may place orders at the same priority level with suppliers and subcontractors for supplies and services necessary to fulfill the recipient's rated order and the suppliers and subcontractors must treat the request from the rated order recipient as a rated order with the same priority level as the original rated order. The rule does not require recipients to fulfill rated orders if the price or terms of sale are not consistent with the price or terms of sale of similar non-rated orders. The rule provides a defense from any liability for damages or penalties for actions taken in or inactions required for, compliance with the rule.

The impact of HRPAS on private companies receiving priority orders is expected to vary. However, in most cases, there is likely to be no economic impact in filling priority orders because it will generally just be changing the timing in which orders are completed.

HRPAS is expected to have an overall positive impact on the U.S. public and industry by maintaining and restoring the production, processing, storage, and distribution of health resources during times of both emergency and nonemergency conditions to promote national defense and to prevent civilian hardship in the food marketplace. While HHS has not yet administered HRPAS under DPA authority, the continued use of DPAS by the Department of Defense proves the utility of a priorities and allocations system.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. HHS reviewed this interim final rule under the provisions of the Regulatory Flexibility Act and has determined that this rule, if promulgated, will not have a significant impact on a substantial number of small entities.

Small entities include small businesses, small organizations and small governmental jurisdictions. For purposes of assessing the impacts of this interim final rule on small entities, a small business, as described in the Small Business Administration's Table of Small Business Size Standards Matched to North American Industry Classification System Codes (January 2012 Edition), has a maximum annual revenue of $33.5 million and a maximum of 1,500 employees (for some business categories, these number are lower). A small governmental jurisdiction is a government of a city, town, school district or special district with a population of less than 50,000. A small organization is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

This rule sets criteria under which HHS (or agencies to which HHS delegates HHS's DPA authority to issue rated orders) will authorize prioritization of certain orders or contracts as well as criteria under which HHS will issue orders allocating resources or production facilities. Because the rule affects commercial transactions, HHS believes that small organizations and small governmental jurisdictions are unlikely to be affected by this rule. To date, HHS has minimally exercised its prioritization authority for contracts during the response to 2009 H1N1 influenza to order ancillary supplies in support of HHS/CDC's Immunization Program, and not exercised its existing allocations authority. As such, HHS has no basis on which to estimate the number of small businesses that may be affected by this rule.

The interim final rule has two principle components: prioritization and allocation. Under prioritization, HHS, or its Delegate Agency, designates certain orders as one of two possible priority levels. Once so designated, such orders are referred to as “rated orders.” The recipient of a rated order must give it priority over an unrated order or an order with a lower priority rating. A recipient of a rated order may place orders at the same priority level with suppliers and subcontractors for supplies and services necessary to fulfill the recipient's rated order and the suppliers and subcontractors must treat the request from the rated order recipient as a rated order with the same priority level as the original rated order. The rule does not require recipients to fulfill rated orders if the price or terms of sale are not consistent with the price or terms of sale of similar non-rated orders. The rule provides a defense from any liability for damages or penalties for actions taken in or inactions required for, compliance with the rule.

Although rated orders could require a firm to fill one order prior to filling another, they will not necessarily require a reduction in the total volume of orders. The regulations will also not require the recipient of a rated order to reduce prices or provide rated orders with more favorable terms than a similar non-rated order. Under these circumstances, the economic effects on the rated order recipient of substituting one order for another are likely to be mutually offsetting, resulting in no net economic impact.

Allocations could be used to control the general distribution of materials or services in the civilian market. Specific allocation actions that HHS might take are as follows:

Set-aside: an official action that requires a person to reserve resource capacity in anticipation of receipt of rated orders.

Allocations directive: an official action that requires a person to take or refrain from taking certain actions in accordance with its provisions. An allocation directive can require a person to stop or reduce production of an item, prohibit the use of selected items, or divert supply of one type of product to another, or to supply a specific quantity, size, shape, and type of an item within a specific time period.

Allotment: an official action that specifies the maximum quantity of an item authorized for use in a specific program or application.

HHS has not yet taken any actions under its existing allocations authority, and any future allocations actions would be used only in extraordinary circumstances. As required by section 101(b) of the Defense Production Act of 1950, as amended, (50 U.S.C. App. Sec. 2071), hereinafter “DPA,” and by Section 201(a) (3) of Executive Order 13603, HHS may implement allocations only if the Secretary of Health and Human Services makes, and the President approves, and determines that there is a scarcity of critical materials and services essential to the national defense, and that the requirements of the national defense cannot otherwise be met without a significant interruption of normal distribution of these essential materials or services in the civilian marketplace that would cause considerable hardship. “National defense” covers programs for military and health resources production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling, space, and any related activity. Such term includes emergency preparedness activities conducted pursuant to title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195 et seq.) and critical infrastructure protection and restoration.

Any allocation actions taken by HHS must assure that small business concerns shall be accorded, to the extent practicable; a fair share of the materials or services covered by the allocation action in proportion to the share received by small business concerns under normal conditions, giving such special consideration as may be possible to emerging business concerns, 50 U.S.C. App. Sec. 2151(e).

Although HHS cannot determine precisely the number of small entities that will be affected by this rule, HHS believes that the overall impact on such entities will not be significant. In most instances, rated contracts will be fulfilled in addition to other (unrated) contracts and, in some instances might actually increase the total amount of business of the firm that receives a rated contract.

Because allocations can be imposed only after an agency determination confirmed by the President, and because HHS has not yet used its allocations authority that has existed since passage of the Defense Production Act in 1950, one can expect allocations will be ordered only in particular circumstances. Any allocation actions would also have to comply with Section 701(e) of DPA (50 U.S.C. app. 2151(e)), which provides that small business concerns be accorded, to the extent practicable, a fair share of the material, including services, in proportion to the share received by such business concerns under normal conditions, giving such special consideration as may be possible to emerging business concerns.

Therefore, HHS believes that the requirement for a Presidential determination and the provisions of section 701 of the DPA indicate that any impact on small business will not be significant.

Therefore, for the reasons set forth above, the Secretary of the Department of Health and Human Services certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities.

This interim final rule contains a collection-of-information requirement for Request for Special Priorities Assistance, which is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval. Data required will include: name, location, contact information, items for which the applicant is requesting assistance on, quantity, and delivery date. Public reporting burden for submission of a request for special priorities assistance or priority rating authority is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Public comment is sought regarding: whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to (see [email protected], Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 630G, Washington, DC 20201).

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

Title: Request for Special Priorities Assistance for HRPAS.

OMB Control Number: To be provided by OMB.

Type of Request: New Collection.

Abstract: HRPAS will efficiently place priority ratings on contracts or orders of health resources within its authority as specified in the Defense Production Act (DPA) of 1950, as amended, when necessary. Applicants (Government agencies or private individuals with a role in emergency preparedness, response, and recovery functions) will request authorization from HHS to place a rating on a contract for items to support national defense activities. Applicants must supply, at time of request, their name, location, contact information, items for which the applicant is requesting assistance on, quantity, and delivery date. Applicants can submit the request by mail or fax.

Estimate of Burden: Public reporting for this collection of information is estimated to average 30 minutes per response.

Type of Respondents: Individuals, businesses, and Agencies with responsibilities for emergency preparedness and response.

Estimated Number of Respondents: 100.

Estimated Number of Responses per Respondents: 0.95.

Estimated Total Number of Respondents: 95.

Estimate Total Annual Burden Hours on Respondents: 50 hours.

We are requesting comments on all aspects of this information collection to help us: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of HHS, including whether the information will have practical utility; (2) Evaluate the accuracy of HHS's estimate of burden including the validity of the methodology and assumptions used; (3) Enhance the quality, utility and clarity of the information to be collected; (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All comments received in response to this document, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget approval.

HHS reviewed this rule pursuant to Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999), which imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. HHS determined that the rule will not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of Government.

Title II of the Unfunded Mandate Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions on State, local, or Tribal governments or the private sector. Agencies generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any one year for State, local, or Tribal governments, in the aggregate, or to the private sector. This rule contains no Federal mandates as defined by Title II of UMRA for State, local, or Tribal governments or for the private sector; therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The Secretary of Health and Human Services has approved publication of this interim final rule.

For the reasons stated in the preamble, HHS adds part 101 to subchapter A of title 45 of the Code of Federal Regulations to read as follows:

South Atlantic coral is managed under the FMP. The FMP is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

On May 20, 2014, NMFS published a notice of availability for Amendment 8 and requested public comment (79 FR 28880). On July 3, 2014, NMFS published a proposed rule for Amendment 8 and requested public comment (79 FR 31907). Subsequently, NMFS published a correction to the notice of availability (79 FR 37269, July 1, 2014) and the proposed rule (79 FR 37270, July 1, 2014) to correct an error in the size of the Oculina Bank HAPC. The proposed rule and NOA stated that the size of the Oculina Bank HAPC would expand “by 405.42 square miles (1,050 square km), for a total area of 694.42 square miles (1,798.5 square km) . . .” However, this was incorrect. The published corrections explained that the increase in size of the Oculina Bank HAPC would be 343.42 square miles (889.5 square km), for a total area of 632.42 square miles (1,638 square km). The Secretary approved the amendment on August 18, 2014. The proposed rule and Amendment 8 set forth the rationale for the actions contained in this final rule. A summary of the actions implemented by this final rule is provided below.

This final rule expands the boundaries of the Oculina Bank HAPC and allows transit through the Oculina Bank HAPC by fishing vessels with rock shrimp onboard; modifies the VMS requirements for rock shrimp fishermen transiting the Oculina Bank HAPC; expands the boundaries of the Stetson-Miami Terrace CHAPC, the adjacent shrimp fishery access area, and the Cape Lookout CHAPC; and makes a minor administrative change to the names of the shrimp fishery access areas. The purpose of these measures is to provide better protection for deepwater coral ecosystems.

This final rule increases the size of the Oculina Bank HAPC by 343.42 square miles (889.5 square km), for a total area of 632.42 square miles (1,638 square km) and, except for a limited transit provision described below, extends the current prohibitions to the larger area, and increases protection of coral. The prohibitions for the Oculina Bank include the following: It is unlawful to use a bottom longline, bottom trawl, dredge, pot or trap, and if aboard a fishing vessel it is unlawful to anchor, use an anchor and chain, or use a grapple and chain. Additionally, it is unlawful to fish for or possess rock shrimp in or from the Oculina Bank HAPC on board a fishing vessel.

This final rule establishes a transit provision to allow fishing vessels with rock shrimp onboard to transit the Oculina Bank HAPC under limited circumstances. To be considered to be in transit and thus allowed to possess rock shrimp on board a vessel in the Oculina Bank HAPC, a vessel must have a valid commercial permit for rock shrimp, the vessel's gear must be appropriately stowed (i.e., doors and nets are required to be out of water and onboard the deck or below the deck of the vessel), and the vessel must maintain a direct and non-stop continuous course through the HAPC at a minimum speed of 5 knots, as determined by an operating VMS approved for the South Atlantic rock shrimp fishery onboard the vessel. In addition, this rule modifies the VMS requirements to require all vessels with rock shrimp onboard that choose to transit the Oculina Bank HAPC to have a VMS unit that registers a VMS ping (signal) rate of 1 ping per 5 minutes. As discussed in the proposed rule, not all VMS units used on the vessels in the rock shrimp fishery were expected to be able to meet the ping rate requirement. As a result, some vessels were expected to have to reconfigure or upgrade their unit, or purchase a new unit, in order to be able to transit the Oculina Bank HAPC within this exception. However, since publication of the proposed rule, NMFS has determined that all vessels have VMS units that are capable of registering a VMS ping (signal) rate of 1 ping per 5 minutes, however, they will incur higher communication costs for this ping rate if they choose to transit the Oculina Bank HAPC with rock shrimp onboard. These communication costs will be offset by not incurring the costs associated with having to transit around the HAPC to get to or from the fishing grounds. This transit provision allows rock shrimp fishermen with rock shrimp onboard their vessels to travel to and from additional rock shrimp fishing grounds in less time using less fuel than if the fishermen are required to travel around the Oculina Bank HAPC.

This final rule increases the size of the Stetson-Miami Terrace CHAPC by 490 square miles (1,269 square km), for a total area of 24,018 square miles (62,206 square km), and increases the size of the Cape Lookout CHAPC by 10 square miles (26 square km), for a total area of 326 square miles (844 square km), and extends the current CHAPC gear prohibitions to the larger areas to increase protection of deepwater coral ecosystems. The prohibitions for the CHAPCs include the following: It is unlawful to use a bottom longline, trawl (mid-water or bottom), dredge, pot or trap, and if aboard a fishing vessel, it is unlawful to anchor, use an anchor and chain, or use a grapple and chain. Additionally, it is unlawful to fish for or possess coral in or from the CHAPCs on board a fishing vessel.

Additionally, the expansion of the Stetson-Miami Terrace CHAPC provides royal red shrimp fishermen a new zone adjacent to the existing shrimp access area A (renamed “shrimp access area 1”, as discussed in the next section of this preamble) within which they can haul-back fishing gear without drifting into an area where their gear is prohibited. Thus, this rule expands the shrimp fishery access area to include the new haul-back zone.

This rule also revises the names of the shrimp fishery access areas, from “shrimp access area A-D” to “shrimp access area 1-4”, in the regulations implemented through the Comprehensive Ecosystem-Based Amendment 1 (75 FR 35330, June 22, 2010) to more closely match the names in the FMP. This final rule also revises 50 CFR 622.224(c)(3)(i)-(iv), to change the four shrimp fishery access areas titles.

NMFS received a total of 35 comment letters on Amendment 8 and the proposed rule, which include letters from a Federal agency, an environmental organization, private citizens, recreational fishermen, commercial fishermen, and fishing associations. Five letters expressed support for the amendment and three letters were unrelated to the actions in Amendment 8. One comment letter was signed by 257 members of the rock shrimp fishing industry and opposed the implementation of the amendment. The specific comments on the actions contained in Amendment 8 and the proposed rule and NMFS's respective responses, are summarized below.

Comment 1: Amendment 8 is not based upon the best scientific information available because the analysis to determine the location of fishing and the socio-economic impacts of proposed extensions to the HAPCs was based on VMS data. The assumption that each VMS point should be given equal value is incorrect. Amendment 8 should have included trawl track data generated from WinPlotTM software matched up to trip ticket information from the state of Florida. Trawl track data, instead of VMS data, may be more easily correlated with trip ticket information to determine location and value of catches.

Response: NMFS disagrees that Amendment 8 was not based on the best scientific information available. NMFS requires a VMS onboard each rock shrimp fishing vessel to determine where the fishing vessel is fishing and provides this information through VMS generated trawl track data. NMFS does not require trawl track data generated by WinPlotTM or any other proprietary tracking or monitoring system. Thus, VMS data were used in Amendment 8 to determine location of fishing effort and economic impacts, and NMFS has determined that Amendment 8 used the best scientific information available.

WinPlotTM is charting software used by some fishermen in the rock shrimp fishery in addition to the required VMS. It is unknown if all rock shrimp fishermen are using WinplotTM software or if they all are recording the same information for each trawl or trip. Trawl track information from WinPlotTM represents self-reported data for which there are no standardized data elements, and there would be limited utility of trying to use WinPlotTM trawl track data for socio-economic analysis. Instead, the data from the required VMS units were used to determine the socio-economic impacts. The analysis considered the percentage of VMS points on average that occur in the area that would become closed to rock shrimp fishing. Rock shrimp landings information cannot be associated to each VMS data point. As a result, any assessment of the expected effects of the Oculina Bank HAPC expansion requires an assumption of how harvest is expected to be distributed over the area encompassed by the expansion. NMFS has determined that the assumption that the harvest of rock shrimp occurs uniformly across each VMS data point is reasonable.

Comment 2: The rock shrimp industry (vessels, restaurants, processors, fish houses, fuel companies, freight companies, crews, dock workers, etc.) will suffer significant economic impacts if the northern expansion of the Oculina Bank HAPC in Amendment 8 is implemented.

Response: The northern expansion of the Oculina Bank HAPC may have adverse economic effects on some individual businesses associated with the rock shrimp industry; however, NMFS disagrees that the industry will suffer significant economic impacts due to the variable nature of rock shrimp harvest. The average annual revenue from rock shrimp harvest over the period 2007-2012 was $1.92 million (2012 dollars), but ranged from a low of approximately $442,000 in 2007 to a high of approximately $3.89 million in 2008. In 2012, the most recent year for which final data were available at the time of completion of Amendment 8, the rock shrimp revenue was approximately $501,000. Thus, the economic performance of the industry is quite variable and the associated businesses, on average, would be expected to be economically flexible by necessity. For rock shrimp harvesters, this flexibility is demonstrated by the fact that, on average, the majority of annual fishing revenue comes from other species. Over the period 2009, 2010, and 2011, rock shrimp accounted for 27 percent, 22 percent, and 13 percent of the average total fishing revenue per vessel in each year, respectively. Comparable data for more recent years are not available. For rock shrimp harvesters, penaeid shrimp harvested in the South Atlantic was the highest revenue species in each year, ranging from 43 percent in 2011 to 63 percent in 2009. Additionally, although there are an estimated 104 vessels permitted to harvest rock shrimp, the number of vessels that actually harvest rock shrimp in the South Atlantic is substantially less. During 2009, 2010, and 2011, only 31, 19, and 18 vessels harvested rock shrimp in the South Atlantic in these years, respectively, and the production results provided above reflect the estimated average performance of these vessels. These results demonstrate, on average, that although the revenue from rock shrimp comprises a substantial portion of total annual revenue, rock shrimp fishermen are more dependent on other species.

In addition to analyzing the relative importance of rock shrimp revenue within the total fishing revenue, the significance of any economic effects will be determined by the expected reduction in rock shrimp harvest. It is not possible to determine with certainty the reduction in rock shrimp harvest that may occur as a result of the proposed expansion of the Oculina Bank HAPC because available data does not allow for the tabulation of rock shrimp harvest per tow, and the harvest area is recorded by statistical grid (60 nautical miles squared). Additionally, the distribution and abundance of rock shrimp in any area is highly variable from year to year. Although anecdotal information made available through public comment may suggest higher rock shrimp yields in the northern expansion of the Oculina Bank HAPC in 2013, sufficient information is not available to conclude this higher abundance of rock shrimp will persist or that it is more representative of future conditions than the historic average. Further, it has not been shown that the northern expansion of the Oculina Bank HAPC is the source of substantial rock shrimp harvest in years when total rock shrimp harvests have been high. In the absence of harvest data per tow, the assessment of the expected reduction in rock shrimp harvest was based on the assumption that rock shrimp harvest is uniformly distributed over the statistical grid and, thus, the reduction in harvest as a result of the northern expansion of the Oculina Bank HAPC would be proportionate to the amount of area in the expansion relative to the area in the total statistical grid within which harvest is reported. Although this assumption may not capture the actual harvest that has occurred in the expansion area, or the potential higher productivity that may occasionally occur in future years, NMFS has determined this assumption is reasonable.

Comment 3: Does the analysis use all of the existing 678 commercial vessel permits for South Atlantic snapper-grouper, or only the vessel logbooks home ported nearest the Amendment 8 proposed expansions of the Oculina Bank HAPC areas from Fort Pierce north to St. Augustine, Florida, or only the logbooks of the vessels that indicated they fished in that area with landings as a metric of socio-economic impact in this analysis? The minimal impact description to the commercial snapper-grouper fleet contained in Amendment 8 is incorrect.

Response: The assessment of the socio-economic effects of the expansion of the Oculina Bank HAPC was based on the expected average harvest of snapper-grouper species in the area of the expansion over the period 2009-2011, as recorded in all logbooks regardless of where the respective vessels were home-ported. Because harvest is recorded by statistical grid (60 nautical miles squared) and is not available at finer geographic resolution, the expected reduction in snapper-grouper harvest was based on the assumption that snapper-grouper harvest is uniformly distributed over the area in the statistical grid and, thus, the reduction in harvest as a result of the northern expansion of the Oculina Bank HAPC would be proportionate to the amount of area in the expansion relative to the area in the total statistical grid within which harvest is reported. Although this assumption may not capture the actual harvest that has occurred in the proposed expansion area, NMFS has determined this assumption is reasonable.

Comment 4: The $189,464 average annual revenue loss estimate for the proposed northern and western extension to the Oculina Bank HAPC is too low. Rock shrimp abundance and distribution is extremely variable, and only recent information, rather than an average, should be used in the economic analysis. The estimated value of the catches in the area was approximately $1,000,000 for a subset of 6 vessels over a 3-week period in September 2013, which substantially transcends the average annual revenue loss of $189,464 for all vessels in the entire fishery over the entire fishing year, as set forth in Amendment 8.

Response: NMFS disagrees that the average annual revenue loss estimate for the proposed northern and western extension to the Oculina Bank HAPC is too low. Because rock shrimp are so variable over time and space, it is not appropriate to use only the most recent anecdotal information to determine the socio-economic effects of the proposed action. The Council approved Amendment 8 for review by the Secretary of Commerce at its September 2013 meeting. On November 6, 2013, the Council was informed in a letter about high landings of rock shrimp in the proposed northern extension of the Oculina Bank HAPC. Although anecdotal information made available through public comment may suggest higher rock shrimp yields in the northern extension of the Oculina Bank HAPC in 2013, sufficient information is not available for NMFS to conclude a higher abundance will persist and is more representative of future conditions than the historic average as previously discussed.

Comment 5: Amendment 8 is in violation of the National Environmental Policy Act (NEPA) because Action 1 did not consider a reasonable range of alternatives. Alternatives 2 and 3 are completely distinct from each other and modify different boundaries of the HAPC, thus Alternative 3 should be a separate action. Also, Alternative 2 had two sub-alternatives and Alternative 3 did not have any. Furthermore, the Purpose and Need section of Amendment 8 is focused on protection of deepwater coral and does not include any reference to minimizing, to the extent practicable, adverse economic impacts on the rock shrimp fishery.

Response: NMFS disagrees that Amendment 8 is in violation of NEPA. While Alternatives 2 and 3 under Action 1 consider modifications to the northern and western boundaries of the Oculina Bank HAPC, respectively, they fall within the scope of the action which is to “Expand Boundaries of the Oculina Bank HAPC.” Further, NEPA does not require that the Purpose and Need include a reference to minimizing economic impacts. According to NEPA, biological, economic, social and administrative impacts of the proposed actions should be analyzed and considered. These analyses in Amendment 8 used the best scientific information available and are included in Chapter 4 of the amendment, and were considered by the Council. The Council's adoption of a recommendation by their Deepwater Shrimp Advisory Panel for modification of the northern extension of the Oculina Bank HAPC, reduced fishery impacts where traditional fishing activity occurs. NMFS has determined that Amendment 8 and its implementing final rule will be effective in increasing the protection of deepwater coral while minimizing, to the extent practicable, adverse socio-economic impacts, as required by National Standard 8 of the Magnuson-Stevens Act.

Comment 6: The actions in the proposed rule indicate the Council and NMFS may have a misunderstanding of how a shrimp trawl works. The type of trawl used to catch rock shrimp is not designed to work in hard rocky bottom.

Response: A description of the rock shrimp fishing practices, vessels involved, and gear used can be found in Section 3 of Amendment 8. It was discussed at the November 2012 Habitat Advisory Panel and the December 2012 Council meetings that rock shrimp fishermen do not trawl on coral or hard-bottom coral habitat, but instead target rock shrimp on their preferred soft-bottom habitat where coral is not present.

Comment 7: The minutes from the October 2012 Joint Deepwater Shrimp and Coral Advisory Panels meeting were lost. At that meeting, an agreement was made between a scientist, a member of Council staff, and the chair of the Deepwater Shrimp Advisory Panel to develop a new alternative for the northern Oculina Bank HAPC extension for consideration by the Council. Because the minutes from the meeting were lost, there is no documentation of this agreement. An alternative for the northern Oculina Bank HAPC extension alternative was later developed without the input of the Deepwater Shrimp Advisory Panel Chair. Several hours were spent at the October 2012 meeting demonstrating and educating the Coral Advisory Panel about rock shrimping, the equipment used, and the process involved. The Coral Advisory Panel agreed with the Deepwater Shrimp Advisory Panel that rock shrimp trawls were not harming coral or coral habitats.

Response: The Coral and Deepwater Shrimp Advisory Panels met in Cape Canaveral, Florida, on October 18, 2012, and the Chair of the Deepwater Shrimp Advisory Panel presented an overview of the rock shrimp fishery. The verbatim minutes of that joint meeting were partially compromised and are incomplete because the afternoon session of the joint advisory panel meeting was not recorded and transcribed, due to an inadvertent, technical error. A new alternative for the northern Oculina Bank HAPC extension, developed by a Council staff member and a scientist following the October 2012 Joint Coral and Deepwater Shrimp Advisory Panel Meeting, was brought to the Council at their December 2012 meeting, and the Council added this new alternative to Amendment 8 at that meeting. The Chair of the Deepwater Shrimp Advisory Panel also attended the December 2012 Council meeting, and he indicated that some slight adjustments to the new alternative might be needed. During its May 2013 meeting, the Deepwater Shrimp Advisory Panel discussed the new alternative, and made a recommendation to further modify the boundaries to reduce fishery impacts in the area where traditional fishing activity occurs. Recognizing that rock shrimpers do not trawl on coral or hard-bottom habitat, the Council, at its June 2013 meeting, adopted the Deepwater Shrimp Advisory Panel's recommendation for the modified northern Oculina Bank HAPC extension alternative, and chose that alternative as its preferred alternative.

Comment 8: The public was not properly notified that a new and significant revision to the proposed closed area under Action 1, Alternative 2 would be discussed and considered by the Habitat Advisory Panel during its November 2012 meeting. Failure to provide timely notice of this new matter on the agenda for the Habitat Advisory Panel meeting made it difficult for the Chair of the Deepwater Shrimp Advisory Panel and members of the Habitat Advisory Panel to assist in the collection and evaluation of information relevant to the development of the new alternative.

Response: The Habitat and Environmental Protection Advisory Panel Meeting was announced in the Federal Register on October 29, 2012 (77 FR 65536). The announcement stated “Topics to be addressed at the meeting include: A member workshop on developing the South Atlantic Habitat and Ecosystem Atlas and Digital Dashboard, including the new online Ecospecies System; species research and habitat mapping associated with deepwater marine protected areas; deepwater habitat complexes associated with Coral Habitat Areas of Particular Concern (CHAPC) extension proposals; a review of a draft Memorandum of Understanding (MOU) between Atlantic Councils on deepwater coral ecosystem conservation; a review of other regional partner activities supporting the regional move to ecosystem-based management; and consideration of updates to essential fish habitat policy statements as needed.” Specific alternatives for actions in amendments are not usually contained in agendas for Advisory Panel meetings in Federal Register notices. However, a discussion of the actions and alternatives in Amendment 8 fits within the scope of the agenda and topics announced for discussion at the Habitat Advisory Panel meeting. Thus, the public was properly notified about the Habitat Advisory Panel Meeting in accordance with section 302(i)(2)(C) of the Magnuson-Stevens Act, and an additional Federal Register notice was not necessary.

Comment 9: Amendment 8 is not consistent with section 3.2.7 of the Council's Statement of Organization, Practices, and Procedures (SOPPs) because the Deepwater Shrimp Advisory Panel Chairman was denied the opportunity to make a presentation of the issues to be discussed at the November 2012 meeting of the Habitat Advisory Panel, including a new alternative for the northern Oculina Bank HAPC extension for consideration by the Council. This presentation could have been accommodated, at a minimum, during a public comment period during the advisory panel meeting.

Response: Section 3.2.7 of the Council's SOPPs states: “Public testimony will be allowed at Council meetings on all agenda items before the Council for final action and at advisory panel (AP) and Scientific and Statistical Committee (SSC) meetings on all agenda items. If the agenda does not schedule a time for public testimony, the chairperson or presiding officer shall schedule testimony at an appropriate time during the meeting that is consistent with the orderly conduct of business.” Although the Chair of the Deepwater Shrimp Advisory Panel was not provided the opportunity to make a presentation at the Habitat and Environmental Protection Advisory Panel Meeting, that Chair did provide public testimony on issues related to the northern extension of the Oculina Bank HAPC at the Habitat and Environmental Protection Advisory Panel Meeting in accordance with the Council's SOPPs, and with section 302(i)(2)(D) of the Magnuson-Stevens Act.

Comment 10: The SSC did not provide the Council any meaningful scientific advice on the social or economic impacts of the proposed management measures contained in Amendment 8. The SSC was not provided with timely or complete VMS data and other necessary data on the fishery and the proposed management measures.

Response: The SSC reviewed and discussed Amendment 8 at its April 2013 meeting. A report from that meeting states “By consensus the Committee agreed that the proposed actions that modify the CHAPCs succeed in addressing the Purpose and Need of Amendment 8 and, therefore, actions in Amendment 8 are warranted to protect coral in these areas.”

Comment 11: The rock shrimp industry requested that a transit implementation plan be put in place before the proposed northern extension area of the Oculina Bank HAPC is effective, in order to test the transit provision. A serious safety issue will be created for shrimpers working offshore of a closed area that extends from Ft. Pierce to St. Augustine without the ability to transit the area.

Response: The Council and NMFS determined that the expansion of the Oculina Bank HAPC and the establishment of a transit provision needed to be implemented simultaneously. As a result, the final rule will establish a provision to allow fishing vessels with rock shrimp onboard to transit the Oculina Bank HAPC. The expansion of the Oculina Bank HAPC and the transit provision will be effective 30 days after the final rule publishes.

Comment 12: The Council did not consider any other methods to protect deepwater coral habitat in Amendment 8 except to expand the HAPCs.

Response: The Council has protected deepwater coral ecosystems through fishing gear restrictions in HAPCs. The Oculina Bank HAPC was implemented in 1984, and the Stetson-Miami Terrace Coral HAPC and the Cape Lookout Coral HAPC were included in the Coral HAPCs that were implemented in 2010. Within the existing HAPCs, the use of bottom longline, bottom trawl, dredge, pot, or trap, as well as the use of an anchor, anchor and chain, or grapple and chain is prohibited if on board a fishing vessel. Within the Coral HAPCs, the use of a mid-water trawl is also prohibited. Fishing for or possessing rock shrimp or Oculina coral is prohibited within the Oculina Bank HAPC (this rule will allow transit through the Oculina Bank HAPC for rock shrimp fishermen with rock shrimp onboard their vessel), and fishing for or possessing coral is prohibited on board a fishing vessel in the Coral HAPCs. Recent scientific explorations have identified areas of high relief features and hard bottom habitat outside the boundaries of the existing Oculina Bank HAPC and Coral HAPCs. Deepwater coral are extremely fragile and slow growing, and any method to protect deepwater coral must involve restrictions on gear that may impact coral. The Council recommended expansion of existing HAPCs to provide protection to the newly discovered areas of deepwater coral. Other options such as a prohibition to all fishing could have been considered; however, the Council determined that prohibiting the use of gear that may impact coral through the expansion of HAPCs was the most appropriate method for protecting deepwater coral, while minimizing, to the extent practicable, negative socio-economic impacts.

Comment 13: Research dives found only two instances of deepwater coral, yet Amendment 8 proposes to close 267 square miles of historical trawling grounds in the northern extension of Oculina Bank HAPC. The Oculina Bank HAPC should not be expanded westward as there is no Oculina coral in that area. The new information does not justify such a large closure. The Oculina Bank HAPC is sufficiently large to protect deepwater coral ecosystems.

Response: In October 2011, a presentation was provided to the Council's Coral Advisory Panel on two new areas of high-relief Oculina coral mounds and hard bottom habitats that had been discovered north and west of the current boundaries of the Oculina Bank HAPC. The locations of these sites were originally identified from NOAA regional bathymetric charts and later verified with multibeam sonar, a remotely operated vehicle (ROV) and submersible video surveys. The sonar maps and ROV dives confirmed that the high-relief features of the NOAA regional charts were high-relief Oculina coral mounds. Based on bathymetric charts, it is estimated that over 100 mounds exist in this area. Other observations include gentle slopes covered with coral rubble, standing dead coral, and sparse live Oculina coral colonies. Exposed hard bottom with 1 to 2 meter relief ledges was observed at the base of some mounds. Between the mounds and west of the main reef track, the substrate is mostly soft sediment but patchy rock pavement habitat and coral rubble are also present. Multibeam sonar maps made in 2002 and 2005 revealed numerous high-relief coral mounds and hard bottom habitat that are west of the western Oculina Bank HAPC boundary. A few of these mounds are comprised mostly of coral rubble, with live and standing dead Oculina. During its 2011 October meeting, the Coral Advisory Panel recommended the Council revisit the boundaries of the Oculina Bank HAPC, Stetson-Miami Terrace Coral HAPC, and the Cape Lookout Coral HAPC to incorporate these areas of additional deepwater coral habitat that were previously uncharacterized. The Council determined that, based on the information provided, extension of the HAPCs was appropriate. The NMFS Southeast Fisheries Science Center reviewed the amendment and certified that it was based on the best scientific information available. NMFS agrees with that determination.

Comment 14: It is not appropriate for anchors or drag nets to be used in the HAPCs but fishing with hook-and-line gear should be allowed, because research has shown hook-and-line fishing does not create any lasting damage to bottom habitat.

Response: Hook-and-line fishing without anchoring in the HAPCs will not be restricted by this amendment. The management measures contained in this final rule are intended to protect deepwater coral ecosystems from gear than may impact coral. Within the existing HAPCs, the use of bottom longline, bottom trawl, dredge, pot, or trap, as well as the use of an anchor, anchor and chain, or grapple and chain if on board a fishing vessel is prohibited. The use of mid-water trawl gear is also prohibited in the Coral HAPCs. Fishing for or possessing rock shrimp or Oculina coral is also prohibited within the Oculina Bank HAPC (this rule will allow transit through the Oculina Bank HAPC for rock shrimp fishermen with rock shrimp onboard their vessel), and fishing for or possessing coral is prohibited on board a fishing vessel in the Coral HAPCs.

Comment 15: The coordinates (latitude and longitude) published in the proposed rule for the Oculina Bank HAPC extension do not match any of the figures in the amendment used to illustrate the boundaries. The Council has never seen a good illustration of the area where the rock shrimp vessels operate and the historical fishing grounds (indicated by VMS points) that are being eliminated.

Response: The coordinates in the amendment and the rule differ slightly in the way they are listed but do not differ functionally. In the amendment, the latitude and longitude in the figures are in degrees and decimal minutes, and were converted to degrees, minutes, and seconds in the proposed and final rules. This conversion was necessary to remain consistent with the coordinates contained in the regulations for the other CHAPCs. Also, in the amendment, the coordinates listed identify the expanded area rather than the entire Oculina Bank HAPC, while the proposed rule lists the coordinates for the entire Oculina Bank HAPC, including the new expanded area. Figures S-4 and S-6 in Amendment 8 illustrate the northern and western extensions of the Oculina Bank HAPC, and illustrate the VMS points showing fishing by rock shrimp vessels operating in that area. The Council had sufficient information to make its decision when they approved Amendment 8. NMFS will work with the Council to improve the illustrations in future amendments.

Comment 16: Instead of expanding the Oculina Bank HAPC, studies should be done on increased algae growth on the south end of the Oculina Bank.

Response: The purpose of Amendment 8 is to increase protections for deepwater coral based on new information of deepwater coral resources in the South Atlantic. Studies of algae growth in Oculina Bank are outside the scope of this amendment. There is currently no information on increased algae growth in Oculina Bank, however, that is an area for potential research in the future.

Comment 17: It appears that the rock shrimp are moving northward due to changes in climate. The northern expansion of Oculina Bank HAPC will cut off access to historical northern shrimping grounds and will not protect coral.

Response: There are likely many factors that may explain the variability in rock shrimp abundance and distribution, and climate change may be one of the factors. Expansion of the Oculina Bank HAPC may have adverse effects on some individual businesses associated with the rock shrimp industry, but is expected to enhance protection to deepwater corals. The northern expansion of Oculina Bank HAPC is based on recent scientific information, which indicates deepwater coral ecosystems occur in the area. This expansion is expected to reduce historical fishing in the area by about 5 percent based on VMS data from 2007-2012.

Comment 18: Expansion of the Oculina Bank HAPC, Stetson-Miami Terrace Coral HAPC, and Cape Lookout Coral HAPC could have implications for green energy development and exploration in the future.

Response: NMFS has determined that any effects of expansion of the Oculina Bank HAPC, and the Stetson-Miami Terrace or Cape Lookout Coral HAPCs on the development of green energy or exploration would be speculative. The Oculina Bank HAPC, Stetson-Miami Terrace Coral HAPC, and Cape Lookout Coral HAPC have been designated as essential fish habitat (EFH) HAPCs by the Council to warrant special protection. Designation as EFH or an EFH-HAPC would require that Federal agencies consult with the NMFS Habitat Conservation Division, if a Federal agency determines its activity or action may adversely affect EFH or the EFH-HAPC.

Comment 19: There have been many problems with Amendment 8. For example, NMFS published a correction notice in the Federal Register on July 1, 2014, noting an error found in the preamble text for the proposed rule and the notice of availability for the amendment, with regard to the actual size of the proposed expansion of the Oculina HAPC.

Response: As explained in the Supplementary Information above, NMFS published correction notices during the comment period for Amendment 8 and the proposed rule on July 1, 2014 (79 FR 37270 and 79 FR 37269), to correct an inadvertent error regarding the proposed increased size of the Oculina Bank HAPC. The proposed rule and notice of availability for the amendment stated “the proposed rule would increase the size of the Oculina Bank HAPC by 405.42 square miles (1,050 square km), for a total area of 694.42 square miles (1,798.5 square km) . . .” This was incorrect. The correction notices explained that the proposed rule would increase the size of the Oculina Bank HAPC by 343.42 square miles (889.5 square km), for a total area of 632.42 square miles (1,638 square km).

Comment 20: Amendment 8 is not consistent with section 303(b)(2)(C)(iii) of the Magnuson-Steven Act, which requires that for any closed area, NMFS must ensure a timetable is established for review of the closed area's performance, consistent with the purposes of the closed area.

Response: Section 303(b)(2)(C)(iii) of the Magnuson-Steven Act is applicable when a closure prohibits all fishing. Because Amendment 8 does not prohibit all fishing, the requirements of section 303(b)(2)(C)(iii) of the Magnuson-Steven Act are not applicable. Although there are fishing gear restrictions in the existing HAPCs and expanded HAPCs, fishing would continue to be allowed in the HAPCs with the appropriate gear.

Since publication of the proposed rule, NMFS Office for Law Enforcement (OLE) published a final rule to specify requirements related to approved VMS units, which describes the requirements for vendors wishing to provide VMS units for domestic fisheries (70 FR 77399, December 24, 2014). NMFS has now determined that the discussion of the VMS requirements in the proposed rule preamble and economic analysis for Coral Amendment 8 was incorrect. The preamble in the proposed rule stated that the proposed transit provisions would require that some VMS units would need to be replaced or would be required to have software/hardware upgrades to allow transit through the Oculina Bank HAPC with rock shrimp on board. Estimates of the costs of these upgrades were provided in the proposed rule. However, NMFS has since determined that the VMS units currently operating in the fishery are capable of signaling at a rate of at least 1 ping per 5 minutes, as is required by Amendment 8 and this rule.

Therefore, no replacement units or upgrades will likely be necessary for fishing vessels with rock shrimp on board that choose to transit through the Oculina Bank HAPC. As a result, the only costs associated with this final rule may be the increased communication charges if vessels choose to transit through the closed area with rock shrimp onboard. The maximum charge for any of the VMS units is $0.06 per ping, however, the total amount of increased communication charges per vessel cannot be determined because the total cost will depend on how often a vessel transits the Oculina Bank HAPC and the route the vessel chooses to take through the HAPC.

In addition, NMFS fixes a spelling mistake in this final rule. This rule changes the spelling of “Lithotherm” to “Lithoherm” in the name of the CHAPC “Stetson Reefs, Savannah and East Florida Lithoherms, and Miami Terrace Deepwater Coral HAPC” in 50 CFR 622.224(c)(1)(iii).

The Regional Administrator, Southeast Region, NMFS has determined that this final rule is necessary for the conservation and management of deepwater coral resources in the South Atlantic and is consistent with Amendment 8, 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.

NMFS prepared a Final Regulatory Flexibility Analysis (FRFA) for this rule. The FRFA describes the economic impact this rule is expected to have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A copy of the full analysis is available from NMFS (see ADDRESSES). A summary of the analysis follows.

The purpose of this rule is to address recent discoveries of deepwater coral resources and protect deepwater coral ecosystems in the Council's jurisdiction from activities that could compromise their condition. The Magnuson-Stevens Act provides the statutory basis for this rule.

Comments on the proposed rule are addressed in the comments and responses section of this final rule and the changes to the final rule are discussed in the changes from the proposed rule section of this final rule. No changes were made to the rule in response to these comments.

This rule does not include any reporting or record-keeping requirements other than those associated with the VMS requirements discussed below.

This rule is expected to directly apply up to 700 vessels that commercially harvest snapper-grouper species and up to 104 vessels that commercially harvest rock shrimp in the affected areas of the exclusive economic zone (EEZ) in the South Atlantic. Among the vessels that harvest rock shrimp, an estimated 9 vessels also harvest royal red shrimp. Although potentially all vessels in the snapper-grouper commercial sector could potentially be affected, the number of vessels that actually fish in the affected areas is expected to be small, as evidenced by the minimal economic effects expected to occur as a result of this rule (described below). The average vessel involved in commercial snapper-grouper harvest is estimated to earn approximately $28,700 (2012 dollars) in annual gross revenue, and the average vessel permitted to harvest rock shrimp is estimated to earn approximately $20,500 (2012 dollars) in annual rock shrimp gross revenue. The average annual gross revenue for vessels that harvest both rock shrimp and royal red shrimp is estimated to be approximately $113,000 (2012 dollars). However, although there are an estimated 104 vessels permitted to harvest rock shrimp, the number of vessels that actually harvest rock shrimp in the South Atlantic is substantially less. Over the period 2009-2011, only 31, 19, and 18 vessels harvested rock shrimp in the South Atlantic in these years, respectively. Based on sample data from these vessels (10 vessels in 2009, 7 vessels in 2010, and 9 vessels in 2011), the average annual total revenue from all fishing activity during these years was approximately $334,000 (2012 dollars) in 2009, $725,000 in 2010, and $629,000 in 2011. More recent data are not available. NMFS has not identified any other small entities that would be expected to be directly affected by this rule.

The Small Business Administration (SBA) has established size criteria for all major industry sectors in the United States including seafood dealers and harvesters. A business involved in commercial finfish fishing is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $20.5 million (NAICS code 114111, Finfish Fishing). The receipts threshold for a business involved in shrimp fishing is $5.5 million (NAICS code 114112, Shellfish Fishing). Because the average annual gross revenues for the commercial fishing operations expected to be directly affected by this rule are significantly less than the SBA revenue threshold, all these businesses are believed to be small business entities.

This rule contains four separate actions. The first action expands the boundaries of the Oculina Bank HAPC by 343.42 square miles (889.5 square km), for a total area of 632.42 square miles (1,638 square km). Expansion of the Oculina Bank HAPC is expected to affect vessels that harvest snapper-grouper, rock shrimp, and royal red shrimp because some fishermen have historically harvested these species in this area and will be prevented by the expansion from continuing to fish here. The expected maximum potential reduction in total gross revenue from snapper-grouper species as a result of the expansion of the Oculina Bank HAPC is approximately $56,000 (2012 dollars), or less than 0.3 percent of the total average annual revenue received by South Atlantic commercial fishing vessels from snapper-grouper species. The expected maximum potential reduction in revenue from snapper-grouper species is minimal, and fishermen may be able to absorb the reduction or adapt their fishing practices to the expansion of the Oculina Bank HAPC and increase their fishing effort, and harvest, in other locations to mitigate the impact of the reduction. Additionally, fishermen may benefit from spill-over effects (increased total harvest or more cost-efficient harvest) of the enhanced productivity of the protected Oculina Bank HAPC.

All vessels that harvest royal red shrimp are expected to also harvest rock shrimp. Royal red shrimp are not managed in a fishery management plan by the Council, therefore, neither logbooks nor VMS units are required to harvest royal red shrimp. As a result, NMFS cannot determine with available data what portion of the average annual royal red shrimp harvest may be affected by the expansion of the Oculina Bank HAPC. However, the primary effect of the expansion of the Oculina Bank HAPC is expected to be on the harvest of rock shrimp and not the harvest of royal red shrimp. This rule is expected to reduce the total revenue from rock shrimp for all potentially affected rock shrimp fishermen by a maximum of approximately $189,500 (2012 dollars).

Translating this expected reduction in total revenue to an average reduction per vessel is difficult because of the variability in participation in the fishery from year-to-year, as well as variability in revenue. As discussed above, significantly more vessels are permitted to harvest rock shrimp (104 vessels) than harvest rock shrimp (18-31 vessels, 2009-2011). Compared to the performance in each of the years 2009-2011, the expected annual total reduction in revenue from rock shrimp as a result of the Oculina Bank HAPC expansion would be approximately 1.8 percent of the total average annual gross revenue based on 2009 performance (reduction of approximately $6,100 per vessel compared to total average revenue of $334,000; 2012 dollars), 1.4 percent based on 2010 performance (reduction of approximately $10,000 per vessel compared to total average revenue of $725,000; 2012 dollars), and 1.7 percent based on 2011 performance (reduction of approximately $10,500 per vessel compared to total average revenue of $629,000; 2012 dollars). Overall, although the reduction in rock shrimp revenue as a result of the Oculina Bank HAPC expansion may be more than projected, rock shrimp accounted for only 27 percent, 22 percent, and 13 percent of total fishing revenue each year over the period 2009, 2010, and 2011 for vessels harvesting South Atlantic rock shrimp, respectively. Penaeid shrimp were the highest revenue species in each of these years. Thus, on average, although the revenue from rock shrimp comprises a substantial portion of total annual revenue, available data indicate that rock shrimp fishermen are more dependent on other species than rock shrimp. Although the revenue from royal red shrimp also may be affected, the economic effects of the proposed expansion of the Oculina Bank HAPC on vessels that harvest royal red shrimp are expected to be minor.

The second action establishes transit provisions through the Oculina Bank HAPC for a vessel with rock shrimp on board. This rule will allow transit through the Oculina Bank HAPC by a vessel with rock shrimp on board if the vessel maintains a direct and non-stop continuous course at a minimum speed of 5 knots (as determined by an operating VMS approved for the South Atlantic rock shrimp fishery and the VMS onboard the vessel registers a VMS ping (signal) rate of 1 ping per 5 minutes), and the vessel's gear is appropriately stowed (i.e., doors and nets will be required to be out of water and onboard the deck or below the deck of the vessel). At the time of publication of the proposed rule, NMFS expected that this VMS ping rate, which is more frequent than that currently required, would result in increased costs for vessels choosing to transit. These costs would be associated with the purchase of new VMS units for vessels with units unable to ping at the higher rate (22 vessels), upgrade of units that could ping at the higher rate if upgraded (57 vessels), and increased communication costs (all vessels). These increased costs were estimated to range from approximately $2,795 to $3,595 for the purchase and installation of a new VMS unit and approximately $300 per vessel for VMS unit upgrades and associated shipping costs. Increased communication costs were not estimated because they would depend on the frequency of transit and, in some cases, would only increase if the resultant total number of pings exceeded a pre-paid threshold. The maximum communication charge that has been identified is $0.06 per ping and the number of pings per transit should be minimal if a vessel takes the most direct path through the Oculina Bank HAPC.

Subsequent to publication of the proposed rule, however, NMFS determined that all of the VMS units operated by the affected rock shrimp vessels are capable of communicating at the higher ping rate. As a result, no vessel that desires to transit through the Oculina Bank HAPC with rock shrimp on board will be required to purchase a new VMS unit or acquire an upgrade and the only change in costs will be an increase in communication costs. Despite this increase in communication costs, any increase will be voluntarily incurred because the rule will not require that vessels transit the Oculina Bank HAPC with rock shrimp on board. The net economic effect per entity of transiting is expected to be positive. Transit through the Oculina Bank HAPC is expected to reduce operating expenses by allowing a vessel to avoid time-consuming and costly travel around the area with rock shrimp onboard. Also, revenue may be increased if a reduction in travel time allows longer fishing. Overall, a fisherman will only choose to incur the increased VMS communication costs associated with transit if they conclude they will receive a net increase in economic benefits, regardless of the source of these benefits. As a result, this component of the rule is expected to have a direct positive economic effect on all affected small entities.

Combined, the expected effects of the expansion of the Oculina Bank HAPC and transit provisions for vessels with rock shrimp on board are expected to range from a minor short term reduction in the average annual gross revenue from rock shrimp to a net positive economic effect on the average rock shrimp vessel. Although the expansion of the Oculina Bank HAPC is expected to reduce rock shrimp revenue from this area, the transit provisions are expected to reduce operating costs and potentially increase rock shrimp revenue by allowing more time to harvest rock shrimp from other areas, where permitted.

The third action in this rule will expand the boundaries of the Stetson-Miami Terrace CHAPC by 490 square miles (1,269 square km), for a total area of 24,018 square miles (62,206 square km). Fishing for snapper-grouper species does not occur normally in this area and fishing for other finfish or golden crab will not be expected to be affected by the expansion of the Stetson-Miami Terrace CHAPC. This action will also establish a gear haul back/drift zone to accommodate the royal red shrimp fishery that occurs in this area. As a result, this component of the rule is not expected to reduce the revenue of any small entities.

The fourth action will expand the boundaries of the Cape Lookout CHAPC by 10 square miles (26 square km), for a total area of 326 square miles (844 square km). Similar to the expansion of the Stetson-Miami Terrace CHAPC, fishing for snapper-grouper species does not occur normally in this area and fishing for other finfish or golden crab is not expected to be affected because of the small size of the expansion and availability of nearby areas with similar fishable habitat for these species. As a result, this component of the rule is not expected to reduce the revenue of any small entities.

Among the actions in this rule, only the expansion of the Oculina Bank HAPC is expected to directly reduce the revenue of any small entities. Four alternatives, including the no action status quo alternative, were considered for the expansion of the Oculina Bank HAPC. Two of these alternatives are included in this rule. The no action alternative was not adopted because it would not have achieved the objective of increasing the protection of deepwater coral ecosystems in the Council's jurisdiction. The second alternative would have increased the area of expansion and, as a result, would result in a larger reduction in fishing revenue to directly affected small entities than this rule. Because the other actions considered in this rule (actions 2-4) would not be expected to result in any negative economic effects on any directly affected small entities, the issue of significant alternatives to reduce any significant negative effects is not relevant.

This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA), which have been approved by the Office of Management and Budget (OMB) under control number 0648-0205. Since 2003, NMFS has required VMS be installed and maintained on commercially permitted South Atlantic rock shrimp vessels. NMFS estimates the increased VMS ping (signal) rate that would be required would result in increased communication costs for vessels that choose to transit through the Oculina Bank HAPC with rock shrimp onboard. Currently, all vessels actively participating in the rock shrimp fishery have a VMS unit and NMFS has determined that all of those VMS units have the capability to ping at the higher rate. NMFS estimates the increased VMS communications costs for vessels in the rock shrimp fishery that choose to transit through the Oculina Bank HAPC with rock shrimp onboard would be a maximum known cost of $0.06 per ping; however, the total increased communications charges per vessel per year cannot be determined because these costs will depend on how often the vessel transits through the Oculina Bank HAPC. The increased communication costs will be offset by reduced travel costs associated with travel around the HAPC to get to and from the fishing grounds. Allowing transit should increase the amount of time on a trip available for fishing and save on fuel and other vessel maintenance costs. Therefore, there is zero net change in burden costs for this data collection.

These estimates of the public reporting burden include the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection-of-information.

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection-of-information subject to the requirements of the PRA, unless that collection-of-information displays a currently valid OMB control number.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as small entity compliance guides. As part of the rulemaking process, NMFS prepared a fishery bulletin, which also serves as a small entity compliance guide. The fishery bulletin will be sent to all South Atlantic snapper-grouper and South Atlantic rock shrimp vessel permit holders.

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