Cooling Water Intake Structure ( CWIS) Information Data Required Rig Information Rig Name Transocean Rather Transocean Richardson Rig Type Semi Submersible Total Installed Power Generation Capacity 21000 HP ( including emergency generator)

Number of Cooling Water Intake Structures ( CWISs) 4 Brief description of each CWIS ( e. g., sea chest, simple pipe) Sea Chest Rough dimensions of each CWIS and indicate whether onboard CWIS has an existing flange 6 ft. pipe 12" diameter Screen type ( e. g., strainer, wedge wire) with mesh size Simplex Basket Strainers Total Design Specifications for Daily Maximum Water Intake Volume of each CWIS 4,583,302 gal ( 17400 metric tonnes)

Total Daily Water Intake Volume of each CWIS ( Set up/ Drilling) 4,583,302 gal ( 17400 metric tonnes)

Design Specs for Through Screen Velocity of each CWIS ( i. e., Q= V* A) ( Set up/ Drilling) 4.41fps ( 725 metric tonnes/ Hr)

List of Purposes of Cooling Water Intakes ( e. g., cool crude oil, produced water, power generators, drill pipe brakes) Engine cooling, Watermakers,

List of Purposes of Non cooling Water Intakes ( e. g., fire water, hotel loads) Fire Main, Ballast, Sanitary, Pits,

Total Volume of Water Intake for Ballasting, Duration of the Ballast intake, and the Through Screen Velocity of the Ballast intake 3,424,306 gal ( 13000 metric tonnes) Time on location. 4.41 fps. Mitigation Measures for reducing Exotic Species Migration through Ballast water The rig does not carry much ballast water from location to location. It is taken on and dumped at the same location. Mitigation Measures for reducing Impingement and Entrainment of Aquatic Organisms, as well as Bio fouling Prevention Measures Sea chest screens, simplex baskets, cathodic protection for marine growth and corrosion Is the Rig equipped with a Radiator Cooling System for the Main Engines? Alfa Laval plate heat exchangers


1 Date: 13 August 2004 To: James Covington, EPA From: Amy Stillings and Maureen F. Kaplan, ERG Subject: Organic Chemicals, Plastics, and Synthetic Fiber Focus Group 3: Dioxin Dischargers   Industry Profile 1. Introduction EPA published its preliminary effluent guidelines program plan for 2004/ 2005 in December 2003 ( USEPA, 2003). EPA used a four factor approach to review existing guidelines as part of the Agency's responsibilities under Clean Water Act Section 304( m). The first factor is an evaluation of the hazard remaining in an industrial category's discharge. EPA examined discharges by SIC code in the Toxics Release Inventory ( TRI) and Permit Compliance System ( PCS) databases and calculated toxicity weighted pound equivalent discharge as a measure of remaining hazard. Based on the remaining hazard, EPA selected the Organic Chemicals, Plastics, and Synthetic Fibers ( OCPSF) industry for further review. This memorandum provides a profile of this industry.

Sections 2 through 5 focus on the facilities   who they are, who owns them, and who works at them. Section 2 describes the subset of industries within the OCPSF industry that might be considered for further investigation. Section 3 provides facility and company counts as well as a count of facilities belonging to small businesses. Section 4 presents general industry data on employment and payroll expenses. Section 5 reviews the processes used by this group of facilities, products produced, and end uses. Section 6 summarizes trade considerations in terms of imports and exports. Section 7 presents the costs of production and discusses two major cost inputs in detail. Section 8 examines the industry concentration in the chlor alkali industry and what it might imply for an economic analysis. Section 9 discusses trends in the industry.

2. Industries Covered Based on the analysis of TRI and PCS data, as well as information from industry studies, EPA identified a group of facilities whose remaining hazard was driven by dioxin in their discharges ( USEPA, 2004). These facilities manufacture the following products:

Chlor alkali;

Ethylene Dichloride ( EDC)/ Vinyl Chloride Monomer ( VCM);

Polyvinyl Chloride ( PVC); and

Other Organic Chemicals including chlorinated solvents. 2 The manufacturing facilities can be stand alone where chlorine is the primary product and sold as a commodity; a manufacturing facility where chlorine is an intermediate product ( e. g., co located operations); or a stand alone manufacturing facility where chlorine is an input ( e. g., polyvinyl chloride).

The majority of these facilities are classified with the Standard Industrial Code ( SIC) of 2812 Alkalies and Chlorine and North American Industry Classification System ( NAICS) code of 325181 Alkalies and Chlorine Manufacturing. Table 1 provides a list of all the SIC and corresponding NAICS of the identified industries.

Table 1 SIC and NAICS Codes for Facilities in OCPSF Focus Group 3: Dioxin Dischargers SIC NAICS NAICS Description 2612 322121 Paper Mills ( Except Newsprint)

2812 325181 Alkalies and Chlorine Manufacturing 2819 325188 All Other Basic Inorganic Chemical Manufacturing 2821 325211 Plastics Material and Resin Manufacturing 2869 325199 All Other Basic Organic Chemical Manufacturing 2870 325300 Agricultural Chemical Manufacturing 2899 325199 All Other Basic Organic Chemical Manufacturing 3087 325991 Custom Compounding of Purchased Resin 3. Facility and Company Counts EPA identified approximately 61 facilities in OCPSF Focus Group 3: Dioxin Dischargers that are still in operation and still use chlorine in the manufacturing process ( EPA, 2004). Attachment 1 lists the facilities, the company owning the facility, and the corporate parent ( where one exists). These 61 facilities belong to 26 companies/ corporate parents. Six of the companies/ corporate parents are foreign owned.

The Regulatory Flexibility Act ( RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, requires EPA to consider the economic impacts of this regulatory action on small entities. Companies operating chlorine manufacturing plants can be grouped into large or small businesses based on the Small Business Administration's ( SBA) general size standard definitions ( SBA, 2002). Table 2 lists the NAICS codes and size standards for the companies owning Focus Group 3 facilities. ( There are fewer NAICS codes in Table 2 than in Table 1 because a company will have one NAICS code while it may operate several facilities each of which has a different NAICS code.) 3 Table 2 NAICS Codes and Small Business Size Standards NAICS Codes Size Standard ( Employees) 322121 325181 325188 325199 325211 325991 750 1,000 1,000 1,000 750 500 Source: SBA, 2002.

Four companies in Attachment 1 can be classified as small businesses:

# Ashta Chemicals Inc.

# Kuehne Chemical Company, Inc.

# Pioneer Companies # Veisicol Chemical Corporation.

A total of six facilities belong to four small businesses.

4. Industry Employment EPA does not have facility specific employment information for the facilities listed in Attachment 1. An approximation of the number of employees within this industry segment can be made by examining the Census data collected for NAICS 325181 ( Alkalies and Chlorine Manufacturing). These data do not include employment for facilities in Focus Group 3 that are in other NAICS codes, such as NAICS 322121 ( Paper Mills, except newsprint). Table 3 lists data on employment and payroll for NAICS 325181. The number of employees in the industry fluctuated between 4,900 to 4,700 during 1997 and 2001. The payroll per employee peaked in 2000 and dropped slightly in 2001.

Table 3 Employment and Payroll for NAICS 325181, 1997 2001 Year Total Employees Payroll ($ 1,000) Payroll per Employee ($)

1997 4,859 $ 272,779 $ 56,139 1998 4,899 $ 279,018 $ 56,954 1999 4,878 $ 277,595 $ 56,908 2000 4,891 $ 300,311 $ 61,401 2001 4,693 $ 285,999 $ 60,942 Source: U. S. Census, 2003a. 4 5. Processes and Products This section discusses the following manufacturing processes that have been identified as sources of dioxin in wastewater:

Chlor alkali;

EDC/ VCM; and

PVC.

The section begins with the production of chlorine ( Section 5.1). Chlorine is an input to the manufacture of EDC/ VCM and these, in turn, are inputs to the manufacture of PVC ( Section 5.2).

5.1 Chlor Alkali and Chlorine Production 5.1.1 How Is It Produced?

The chlor alkali process is the most common method for producing chlorine, accounting for more than 95 percent of the world chlorine production ( World Chlorine Council, 2002). Since chlor alkali accounts for the majority of chlorine production, and has been identified as a source of dioxin, this section will focus on the chlor alkali process. The process produces chlorine gas and sodium hydroxide ( caustic) by passing an electric current through a sodium chloride brine solution. Although less common, potassium chloride may also be used as the feed stock to produce chlorine and potassium hydroxide. There are three electrolytic technologies used in the chlor alkali process: mercury cell, asbestos diaphragm cell, and membrane cell. The primary focus of this industry profile is the generation of dioxin in industrial discharges. Hence, it focuses on chlorine and its subsequent use in other products rather than the coproduced sodium hydroxide.

Concerns over mercury emissions in wastewater has caused a shift in the United States to nonmercury processes. The Chlorine Institute reports an 81 percent reduction in mercury usage over a 1990 1995 baseline ( Chlorine Institute, 2003a), partly due to the closure of five mercury cell production facilities. Table 4 lists the chlorine production method utilized in the United States. In 2003, the chlor alkali industry used the mercury cell process for 9.0 percent of the total chlorine produced, while 67.2 percent was made in diaphragm cells, 21.7 percent in ion exchange membrane cells, and 2.1 percent other process ( Chlorine Institute, 2003b). 5 Table 4 Percent of Total Chlorine Production by Method in the United States Year Diaphragm Membrane Cells Mercury Cells All Other 1997 75.8 9.5 12.1 2.6 1998 72.8 12.2 12.4 2.6 1999 70.6 15.6 12.0 1.8 2000 69.0 18.5 10.75 1.75 2001 67.45 19.85 10.35 2.35 2002 67.9 20.7 9.4 2.6 2003 67.2 21.7 9.0 2.1 Source: Chlorine Institute, 2003b.

5.1.2 How Much Is Produced?

Table 5 summarizes the amount of chlorine produced in the United States from 1997 to 2002. The first column are the data as reported by the Chlorine Institute while the second column presents data collected by U. S. Census. Production peaked in 2000 with 14.1 million short tons and declined to 12.7 million short tons in 2002. Regulations to reduce the emission of chlorinated products into the environment explains part of the decreased demand for chlorine. In 1998, EPA promulgated effluent limitations guidelines for bleached papergrade kraft and papergrade sulfite pulp and paper mills ( USEPA, 1998, also known as the Phase I cluster rule because EPA coordinated air emission requirements [ MACT] in the same rulemaking). A technology basis for the limitation was the 100 percent substitution of chlorine by chlorine dioxide for most of the subcategories and sectors and a totally chlorine free basis for a segment of the papergrade sulfite subcategory. The pulp and paper industry accounted for 7 percent of chlorine's demand in 1995, but now accounts for about 1 percent ( Innovation Group, 2003a). Another contributing factor is the general economic slowdown that began in 2001. 6 Table 5 Chlorine Production, 1997 2002 Chlorine Production Year Chlorine Institute ( short tons) Census ( short tons)

1997 13,685,360 12,922,235 1998 13,532,559 12,841,273 1999 13,807,739 13,352,756 2000 14,057,698 13,310,668 2001 12,604,865 12,664,934 2002 12,666,629 12,879,395 Source: Chlorine Institute, 2003a; U. S. Census, 2003b; U. S. Census, 2001a; and U. S. Census, 2000.

5.1.3 Who Uses the Chlorine?

Table 6 summarizes the U. S. Chlorine consumption in 2002. As mentioned earlier, it is used to a lessening degree in the bleaching of paper pulps. Chlorine is also used as a disinfectant in drinking water treatment systems. The primary use of chlorine, however, is an input to the manufacture of other organic and inorganic chemicals. Table 7 indicates that PVC production consumes slightly over one third of the entire U. S. production of chlorine.

While chlorine use is declining in some sectors ( e. g., pulp and paper), the Chlorine Institute predicts a long term growth of 0.5 percent to 1 percent per year, due to the use of chlorine in plastics, electronics, computers, water disinfection, and crop protection ( Dungan, 2002). 7 Table 6 U. S. Chlorine Consumption, 2002 Percent of Total Production Organic Chemicals 77%

PVC Production 36%

Inorganic Chemicals 15%

Pulp and Paper 1%

Water Treatment 4%

Miscellaneous 3%

Source: Innovation Group, 2003a.

5.2 Ethylene Dichloride ( EDC), Vinyl Chloride Monomer ( VCM), and Polyvinyl Chloride ( PVC)

5.2.1 How Is It Produced?

As seen in Table 7, 36 percent of chlorine consumption is its use in the production of PVC. Ethylene dichloride ( EDC) is a major PVC feedstock and is produced either by the direct chlorination of ethylene or oxychlorination, in which ethylene reacts with chlorine in hydrogen chloride. The Innovation group reports that 96 percent of the EDC produced in the United States is consumed in the production of vinyl chloride monomer ( VCM) ( Innovation Group, 2003a). In turn, 98 percent of the VCM produced is consumed in the production of PVC ( Innovation Group, 2003b). The production is a mix of vertically integrated sites that produce chloring, EDC, VCM, and PVC, sites producing EDC, VCM, and PCV, sites that produce only EDC and VCM, and sites that produce only PVC.

5.2.2 What Is It Used For?

PVC is the second most popular plastic type produced. There are two types of PVC products that can be produced: rigid PVC, which are inflexible and hard; and flexible PVC, which contains a large portion of plasticizer to make them soft and stretchable. Table 7 lists the most common PVC uses. 8 Table 7 Use of PVC Use Total PVC Production Construction 74%

Piping and Tubing 46%

Siding 14%

Windows and Doors 6%

Other Construction 8%

Consumer Goods 9%

Packaging Films and Containers 6%

Electrical Fittings and Wire and Cable Coatings 5%

Transportation ( e. g., Automobile Parts) 2%

Home Furnishings ( e. g., Shower Curtains) 2%

Miscellaneous 2%

Source: Innovation Group, 2003c.

6. Trade Considerations   Chlorine Imports and Exports As presented in Table 8, exportation of U. S. production of chlorine was less than one percent, while importation of chlorine into the United States between 1997 to 2002 fluctuated between 3 to 4 percent. 9 Table 8 Importation and Exportation of Chlorine, 1997 2002 ( metric tons)

Year Production Imports Exports 1997 11,722,975 410,731 24,179 1998 11,649,526 374,228 22,456 1999 12,113,620 326,295 21,088 2000 11,912,142 358,015 24,231 2001 11,489,436 358,060 20,964 2002 11,683,992 409,695 18,566 Source: U. S. Census, 2003b; U. S. Census, 2001a; and U. S. Census, 2000. Note U. S. Census changed measurement from short tons to metric tons for this table.

7. Production Costs 7.1 What Are The Major Cost Components?

Energy and raw material costs represent the highest share of chlor alkali production costs. As shown in Table 9, these costs account for approximately 65 percent of total costs. We discuss the major cost components in more detail in the sections below. Labor is also a significant cost in the production of chlorine, representing 21 percent of total production costs.

Table 9 Costs of Production for Chlor Alkali Industry, 1997 Value ( 103) Share of Total Costs Share of Value of Shipments Raw Materials and Supplies $ 537,520 33% 22%

Fuels and Electricity $ 527,228 32% 21%

Labor $ 339,677 21% 14%

Depreciation $ 145,890 9% 6%

Purchased Services $ 62,293 4% 3%

Rental Payments $ 13,862 1% 1%

Total $ 1,626,470 100% 66%

Value of Shipments $ 2,465,183  100%

Source: U. S. Census, 1999. 10 Figure 1 Natural Gas and Electricity Prices, 1999 2003 7.2 Salt The production of chlorine by the chlor alkali process begins with salt or brine ( World Chlorine Council, 2002). As a dominant input, salt prices were examined as a proxy for the cost of raw materials in chlorine production. The cost of salt from 1999 to 2003 increased by $ 0.50 per ton or roughly two percent ( USGS, 2004).

7.3 Energy The U. S. Department of Commerce conducts an annual survey of manufacturers for NAICS code 325181, the alkalies and chlorine manufacturing industry. Based on this available data, changes in energy and labor costs can be examined. Chlorine production is energy intensive, requiring the chlor alkali industry to consume 68 trillion Btu of energy in 1998 ( EIA, 1998). Therefore, the increases in fuel prices impact industrial production costs. In 2001, electricity and fuel costs were $ 624 million, which represents an increase of approximately $ 100 million over industry costs in 1997 ( Census, 2003b) even though chlorine production decreased. According to Joel Saltzman, vice president and general manager for the industrial chemicals division of Old World Industries, the current rate of $ 6 to $ 7/ million Btu rate for natural gas contrasts with the $ 2.5$ 3/ million Btu rates chlor alkali producers have been used to paying, drastically cutting into operating margins ( Graff, 2004). Figure 1 illustrates the change in natural gas and electricity costs between 1999 and 2003. 11 300 350 400 450 500 550 600 1999 2000 2001 2002 2003 Year Electricity, Industrial Price ($ 0.01/ kWh) Natural Gas, Industrial Price ($ 0.01/ ft3) Source: EIA, 2004.

8. Organization of the Chlor Alkali Industry The chlor alkali industry is a highly concentrated industry with only 26 companies in 1997. As shown in Table 10, the four largest companies represent over 80 percent of the value of shipments, and the eight largest companies over 90 percent. Herfindahl Hirschmann indices ( HHI) over 1,800 are considered to be highly concentrated industries, indicating that it is less competitive.

Table 10 Share of Value of Shipments by Number of Companies: Alkalies and Chlorine, 1997 Companies Total Value of Shipments ( 1,000) Percentage Accounted for by Four Largest Companies Percentage Accounted for by Eight Largest Companies Herfindahl Hirschmann Index 26 $ 1,421,798 81.2 93.5 2,558.5 Source: U. S. Census, 2001b.

However, an examination of Attachment 1 in conjunction with the Census data indicates that an economic analysis of the Focus Group 3 facilities will need to address several features of the industry. While the production of chlor alkali is concentrated, it is not necessarily specialized. Most of the larger 12 companies listed in Attachment 1also manufacture other chemicals and/ or have other business segments as well. For this set of companies, economic impacts could affect whether the company decides to keep the facility open, but the existence of the company is unlikely to be endangered.

On the other hand, the set of facilities includes some small companies where it appears that their only operations are in this sector. For these companies, economic impacts from increased pollution control costs might affect both the facilities and the companies that own them.

ERG examined other sources of data to evaluate its financial condition, such as Census ( 2004a) and Standard and Poor's industry surveys. The Quarterly Financial Report for the Manufacturing, Mining, and Trade Corporations provides data for NAICS 3251 and 3252 on a combined basis, that is two 4 digit industries. This level of aggregation makes the information inappropriate for examining what is primarily a single industry defined in NAICS at a 6 digit level. Standard and Poor's industry profile covers all basic chemicals.

9. Trends and Related Parameters The financial health of the industry can be affected on two major fronts   cost of production and demand. We discuss each of these in turn.

9.1 Cost of Production Section 7.3 notes the potential vulnerability of this group of facilities to increases in energy prices. The Chemical Market Associates predicts that demand for chlorine will require additional expansion in the chlor alkali industry, however the high price of natural gas in the United States will likely mean the expansion will occur in Northeast Asia or the Middle East ( CAI, 2004). They also predict that the average price of the feedstock for PVC, including chlorine, will increase by 40 percent over its cost during the 1990s ( Plastic News, 2004). Innovation Group ( 2003c) also notes the high cost of energy could also place the U. S. PVC industry at a disadvantage in the world market. Esposito ( 2004) opines that the profit margin for the PVC industry is expected to increase in the near term, though exports from China, which could become the world's largest PVC maker by 2010, may cause less profitable players to leave the market and create the need for greater consolidation of the U. S. PVC industry. So, although Table 8 indicates that imports are only about 4 percent of domestic production in 2002, the industry might be vulnerable to lower priced imports if energy costs remain high or continue to rise.

9.2 Demand Construction consumes nearly three quarters of PVC production ( see Table 7). Table 11 presents the last 10 years of residential housing start data. Although housing can be cyclical, the demand for residential housing remained strong for the last five years. The Chief Economist for the National Association of Home Builders ( NAHB) recently discussed the annual 3 year revision of the National Income and Product Accounts, a component of the General Domestic Product ( GDP) ( Seiders, 2004). Residential fixed investment ( RFI) was little changed for 2001 and 2002, but revised upwards for 2003. For the first quarter of 2004, RFI averaged 10.7 percent growth and the projection for the second quarter is 13 15.4 percent growth. Some of this strength might be due to locking in the current low interest rates, that is, in expectation of or in reaction to the Federal Reserve Board's quarter point increase in the federal funds rate target on August 11, 2004. That is, housing demand and therefore a major component of PVC demand appears to remain strong in the present and near future economic conditions.

Table 11 Residential Housing Starts 1995 2004 Year Single Family Multi Family Total 1995 1,076,000 278,000 1,354,000 1996 1,161,000 316,000 1,477,000 1997 1,134,000 341,000 1,475,000 1998 1,271,000 346,000 1,617,000 1999 1,303,000 339,000 1,642,000 2000 1,231,000 338,000 1,569,000 2001 1,273,000 330,000 1,603,000 2002 1,364,000 347,000 1,711,000 2003 1,445,000 341,000 1,786,000 2004 1,381,000 319,000 1,700,000 Source: Census, 2004b and NAHB, 2004. 14 10. References Chlorine Institute. 2003a. The Chlorine Institute, Inc., Sixth Annual Report to EPA for the Year 2002, May 12, 2003, available at www. epa. gov/ region5/ air/ mercury/ 6thcl2report. pdf.

Chlorine Institute. 2003b. The Chlorine Institute, Inc., North American Chlor Alkali Industry Plants and Production Data Report  2002, June 2003.

CAI. 2004. Chemical Market Associates, Inc., " CAI Completes 2004 World Chlor Alkali Analysis," January 8, 2004.

Dungan. 2002. Dungan, Arthur, The Chlor Alkali Industry and Mercury Cell Technology, The Chlorine Institute, May 30, 2002, available at www. epa. gov/ ORD/ NRMRL/ Pubs/ 600R02007/ 600R02007. pdf.

EIA. 2004. Energy Information Administration, " Monthly Energy Review," U. S. Department of Energy, available at www. eia. doe. gov/ emeu/ mer/ prices. html, accessed July 28, 2004.

EIA. . 1998. Energy Information Administration, " 1998 Energy Consumption Manufacturing Survey," U. S. Department of Energy, available at www. eia. doe. gov/ emeu/ mecs/ mecs98/ byfuel/ elec98. html, accessed July 28, 2004.

Esposito. 2004. Esposito, Frank, " Aging Population Should Help PVC," Plastic News, April 5, 2004, available at www. plasticsnews. com/ subscriber/ features2. phtml? cat= 2& id= 1081178508.

Graff. 2004. Graff, George, " Surging Natural Gas Rates Will Stem Price Erosion," Purchasing Magazine Online, February 5, 2004, available at www. manufacturing. net.

Innovation Group. 2003a. The Innovation Group, Chemical Profile: Chlorine, June 2003.

Innovation Group. 2003b. The Innovation Group, Chemical Profile: Ethylene Dichloride, November 2003.

Innovation Group. 2003c. The Innovation Group, Chemical Profile: Polyvinyl Chloride, November 2003.

NAHB. 2004. National Association of Home Builders. Housing Facts, Figures and Trends 2004. http:// www. nahb. org/ fileUpload_ details. aspx? contentTypeID= 7& contentID= 20. Downloaded 11 August.

Plastic News. 2004. " Feedstocks Should Blame at CMAI Conference," Plastic News, July 16, 2004, available at www. manufacturing. net.

Seiders. 2004. David F. Seiders. Eye on the Economy 08/ 11/ 2004. http:// www. nahbmonday. com/ eyeonecon/ textonly/ 2004 08 11. html Downloaded 11 August.

SBA. 2002. Small Business Administration. Small Business Size Standards: Size Standards by 2002 North American Industry Classification System. Federal Register 67: 56944. 6 September. 15 U. S. Census. 2004a. Census Bureau. Quarterly Financial Report for the Manufacturing, Mining, and Trade Corporations. QFR/ 04 01. June 2004. http:// www. census. gov/ prod/ 2004pubs/ qfr04q1. pdf U. S. Census. 2004b. Census Bureau. Quarterly Starts and Completions by Purpose and Design. http:// www. census. gov/ const/ www/ quarterly_ starts_ completions. pdf. Downloaded 11 August.

U. S. Census 2003a. U. S. Census Bureau, Statistics for Industry Groups and Industries: 2001, U. S. Department of Commerce, January 2003.

U. S. Census 2003b. U. S. Census Bureau, Inorganic Chemicals: 2002, U. S. Department of Commerce, August 2003, available at www. census. gov/ cir/ www/ 325/ mq325a. html.

U. S. Census 2001a. U. S. Census Bureau, Inorganic Chemicals, U. S. Department of Commerce, July 2001, available at www. census. gov/ cir/ www/ 325/ mq325a. html.

U. S. Census 2001b. U. S. Census Bureau, Concentration Ratios in Manufacturing, U. S. Department of Commerce, January 2001, available at www. census. gov/ prod/ ec97/ m31s cr. pdf.

U. S. Census 2000. U. S. Census Bureau, Inorganic Chemicals, U. S. Department of Commerce, February 2000, available at www. census. gov/ cir/ www/ 325/ mq325a. html.

U. S. Census 1999. U. S. Census Bureau, 1997 Economic Census Manufacturing Industry Series: Alkalies and Chlorine Manufacturing, August 1999, available at www. census. gov/ prod/ ec97/ 97m3251e. pdf.

USEPA. 2004. U. S. Environmental Protection Agency. Organic Chemicals, Plastics, and Synthetic Fibers. Detailed Review Chapter VIII of the Technical Support Document Supporting the 2004/ 2005 Biennial Plan. Draft dated July.

USEPA. 2003. U. S. Environmental Protection Agency. Preliminary Effluent Guidelines Program Plan for 2004/ 2005. Federal Register 68: 75515 75531. 31 December.

USEPA. 1998. U. S. Environmental Protection Agency. 40 CFR Parts 63, 261, and 430. National Emissions Standards for Hazardous Air Pollutants for Source Category: Pulp and Paper Production; Effluent Limitations Guidelines, Pretreatment Standards, and New source Performance Standards: Pulp, Paper, and Paperboard Category; Final Rule. Federal Register 63: 18504 18751. 15 April.

USGS 2004. U. S. Geological Survey, Salt, U. S. Department of the Interior, January 2004, available at http:// minerals. er. usgs. gov/ minerals/ pubs/ commodity/ salt/ saltmcs04. pdf.

World Chlorine Council 2002. Chlorine and Caustic Soda: Chlor alkali manufacturing processes. http:// www. worldchlorine. com/ publications/ pdf/ mfg_ processes. pdf downloaded 11 August 2004. 16 Attachment 1 Facilities Reporting Dioxin Discharges Company Facility Location Corporate Parent Small Business Ashta Ashtabula, OH X Atofina Petrochemicals La Porte, TX Atofina Bayer Baytown, TX Celanese Acetate Narrows, VA Celanese AG Certainteed Corp. Westlake, LA Colorite Specialty Resins Burlington, NJ Tekni Plex Cytec Industries Wallingford, CT Dover Chemical Dover, OH ICC Industries Dow Freeport, TX Plaquemine, LA Texas City, TX DuPont Niagara Falls, NY Deepwater, NJ Formosa Plastics Baton Rouge, LA Delaware City, DE Illiopolis, IL Point Comfort, TX GE Plastics Burkville, AL General Electric Co. Mount Vernon, IN Geismar Vinyls Geismar, LA Westlake Chemical Co. Georgia Gulf Aberdeen, MS Oklahoma City, OK Plaquemine, LA Westlake, LA Georgia Pacific Green Bay, WI Muskogee, OK Rincon, GA Keysor Century Geismar, LA Kuehne Chemical Kearny, NJ X Occidental Chemical Company Convent, LA Delaware City, DE Ingleside, TX Hahnville, LA Mobile, AL Niagara Falls, NY Pottstown, PA Olin Augusta, GA Charleston, TN Company Facility Location Corporate Parent Small Business 17 McIntosh, AL Niagara Falls, NY OxyVinyls Deer Park, TX Occidental/ Polyone LaPorte, TX Louisville, KY Pasadena, TX Pedricktown, NJ Oxychem Muscle Shoals, AL Occidental Chemical Castle Hayne, NC Pioneer Henderson, NV Pioneer Companies X St. Gabriel, LA Tacoma, WA Polyone Corp. Burlington, NJ Henry, IL PPG Industries, Inc. Lake Charles, LA Natrium, WV Sasol North America, Inc. Westlake, LA Sasol Limited Baltimore, MD Shintech Inc. Addis, LA Shin Etsu Chemical ( Japan) Freeport, TX Vulcan Chemicals Geismar, LA Port Edwards, WI Wichita, KS Velsicol Chemical Corp Memphis, TN X Vygen Ashtabula, OH Westlake Monomers Calvert City, KY Westlake Chemical Co. Pensacola, FL Source: EPA 2004.


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Page 34576]
[FR Doc No: 2018-15602]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9980-59--Region 8]

Proposed Administrative Settlement Agreement and Order on
Consent, Black Swan Restoration Reach Good Samaritan Superfund Site,
Boulder County, Colorado

AGENCY: Environmental Protection Agency.

ACTION: Notice of proposed agreement; request for public comment.

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SUMMARY: In accordance with the requirements of section 122 of the
Comprehensive Environmental Response Compensation, and Liability Act of
1980, as amended (``CERCLA''), notice is hereby given of the proposed
administrative settlement under sections 104, 106, 107, and 122 of
CERCLA, between the U.S. Environmental Protection Agency (``EPA'') and
the Fourmile Watershed Coalition and Four Mile Fire Protection District
(``Settling Party''). Pursuant to the terms of the proposed settlement,
the Settling Party will conduct a Removal Action to abate an actual or
threat of release of hazardous substances, pollutants or contaminants
at the Black Swan Restoration Reach Good Samaritan Superfund Site
located in Boulder County, Colorado. In exchange, the EPA will resolve
any potential liability the Settling Party may have under CERCLA. The
State of Colorado was consulted on this settlement regarding applicable
state laws and regulations.

DATES: Comments must be submitted on or before August 20, 2018. For
thirty (30) days following the date of publication of this notice, the
Agency will receive written comments relating to the agreement. The
Agency will consider all comments received and may modify or withdraw
its consent to the agreement if comments received disclose facts or
considerations that indicate that the agreement is inappropriate,
improper, or inadequate.

ADDRESSES: The Agency's response to any comments, the proposed
agreement and additional background information relating to the
agreement is available for public inspection at the EPA Superfund
Record Center, 1595 Wynkoop Denver, Colorado.
    Comments and requests for a copy of the proposed agreement should
be addressed to Maureen O'Reilly, Enforcement Specialist, Environmental
Protection Agency--Region 8, Mail Code 8ENF-RC, 1595 Wynkoop Street,
Denver, Colorado 80202-2466, and should reference the Black Swan
Restoration Reach Good Samaritan Superfund Site, Central City, Gilpin
County, Colorado.

FOR FURTHER INFORMATION CONTACT: Mark Chalfant, Enforcement Attorney,
Legal Enforcement Program, Environmental Protection Agency--Region 8,
Mail Code 8ENF-L, 1595 Wynkoop Street, Denver, Colorado 80202-2466,
(303) 312-6177.

    Dated: June 29, 2018.
Deb Thomas,
Deputy Regional Administrator, U.S. Environmental Protection Agency,
Region VIII.
[FR Doc. 2018-15602 Filed 7-19-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78954-78955]
[FR Doc No: 2013-31113]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2013-0652; FRL-9904-85-OW]

Extension of Comment Period for the Alaska Seafood Processing
Effluent Limitation Guidelines Notice of Data Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of data availability; Extension of comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is extending the
comment period for the Alaska Seafood Processing Effluent Limitation
Guidelines Notice of Data Availability. EPA is extending the comment
period in response to stakeholder requests for an extension.

DATES: Comments must be received on or before March 7, 2014. The
comment period was originally scheduled to end on January 6, 2014.

ADDRESSES: Submit your comments, identified by Docket identification
(ID) No. EPA-HQ-OW-2013-0652, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Water Docket, U.S. Environmental Protection Agency,
Mail code: 4203M, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
Attention Docket ID No. EPA-HQ-OW-2013- 0652. Please include three
copies.
     Hand Delivery: Water Docket, EPA Docket Center, William
Jefferson Clinton Building West Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, Attention Docket ID No. EPA-HQ-OW-2013-0652. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information by calling<PHONE_NUMBER>.
     Instructions: Direct your comments to Docket ID No. EPA-
HQ-OW-2013-0652. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other

contact information in the body of your comment and with any disc you
submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the EPA's public
docket visit the Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available (e.g., CBI or other information
whose disclosure is restricted by statute). Certain other materials,
such as copyrighted material, will be publicly available only in hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the
Office of Water Docket Center, EPA/DC, William Jefferson Clinton
Building West, Room 3334, 1301 Constitution Ave. NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>; the telephone number for the
Office of Water Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Lindsay Guzzo, Office of Water and
Watersheds, NPDES Permit Unit (OWW-130), 1200 Sixth Avenue, Suite 900,
Seattle, WA 98101;<PHONE_NUMBER><EMAIL_ADDRESS>or Meghan
Hessenauer, Engineering and Analysis Division (4303T), U.S. EPA, 1200
Pennsylvania Ave. NW., Washington, DC 20460;<PHONE_NUMBER>;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 7, 2013 the Environmental
Protection Agency (EPA) published the Alaska Seafood Processing
Effluent Limitations Guidelines Notice of Data Availability in the
Federal Register (78 FR 66916). In the notice EPA made available for
public review and comment additional data and information gathered
recently by the EPA from seafood processing facilities in Alaska and
other publicly available sources. These data relate to the
applicability of and discharge requirements for the Alaskan seafood
subcategories of the Canned and Preserved Seafood Processing effluent
limitations guidelines. In the notice EPA provided preliminary results
of analyses of the updated data and preliminary indications of how
these results may be reflected in EPA's final response to petitions
submitted in 1980 by certain members of the Alaskan seafood processing
industry, and in amended effluent limitations guidelines applicable to
certain Alaskan seafood processing discharges which EPA is considering
whether to promulgate in final form (CFR part 408).

    Dated: December 19, 2013.
Nancy K. Stoner,
Acting Assistant Administrator, Office of Water.
[FR Doc. 2013-31113 Filed 12-26-13; 8:45 am]
BILLING CODE 6550-50-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2978-2979]
[FR Doc No: 2013-00686]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-3117-001.
    Applicants: Lea Power Partners, LLC.
    Description: Lea Power Partners, LLC's Updated Market Power
Analysis and Order No. 697 Compliance Filing.
    Filed Date: 1/7/13.
    Accession Number: 20130107-5140.
    Comments Due: 5 p.m. ET 1/28/13.

    Docket Numbers: ER12-72-002.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits tariff
filing per 35: PNM Filing of Former NITSA and NOA with Navopache to be
effective 4/14/2012.
    Filed Date: 1/7/13.
    Accession Number: 20130107-5116.
    Comments Due: 5 p.m. ET 1/28/13.

    Docket Numbers: ER13-717-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3476--Queue Position
R11 to be effective 12/7/2012.
    Filed Date: 1/7/13.
    Accession Number: 20130107-5101.

    Comments Due: 5 p.m. ET 1/28/13.

    Docket Numbers: ER13-719-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: 2509 Eva Wind, LLC GIA to be effective 12/6/2012.
    Filed Date: 1/7/13.
    Accession Number: 20130107-5142.
    Comments Due: 5 p.m. ET 1/28/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 7, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-00686 Filed 1-14-13; 8:45 am]
BILLING CODE 6717-01-P


Lydia Wegman/RTP/USEPA/US

11/08/2007 10:22 AM

To

<EMAIL_ADDRESS> cc

Tricia Crabtree/RTP/USEPA/US@EPA, <EMAIL_ADDRESS> Subject

Fw: Pb:  slides for today's meeting with OMB

Rob,

Here are slide we'll be using in today's meeting on lead.   Some folks from OPEI have asked to join the briefing, so I expect them to join us as well.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 11/08/2007 10:20 AM -----

Deirdre Murphy/RTP/USEPA/US

11/08/2007 10:17 AM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Karen Martin/RTP/USEPA/US@EPA, Zachary Pekar/RTP/USEPA/US@EPA

Subject

Pb:  slides for today's meeting with OMB

Lydia,

Here is the slide package we've prepared for the OMB meeting today.

Deirdre


Comments on Section IV of IAQR SNPR   Page 10: This seems to allow states to opt out of cap and trade program relatively easily. My understanding was that opting out would not be easy. Perhaps you should clarify?   Page 14, 18: If a state caps non EGUs, does that mean that they cannot include their EGUs in the trading program?   Page 18, paragraph 2: This paragraph states that if states choose to include non EGU sources in this program, the states must impose a cap on these sources, or if this is not " practicable," adopt another system to measure if the reductions have been obtained. In general, trying to measure reductions from a baseline and not requiring a cap seems like a bad idea. It opens the system up to the same gaming opportunities. It is also unclear to me why this would ever be necessary  if firms can calculate an appropriate baseline etc., why can't a cap be calculated?   Page 19, paragraph 2: This paragraph suggests that states choose a baseline year between 2002 and 2005 for NOx and Sox emissions from non EGU sources. Requiring the baseline to be an average would lessen the ability of sources to cherry pick the most favorable baseline year.   Page 59: " Based on that modeling, EPA has proposed that if States achieve all of the mandated NOx reductions by including their EGUs in the regionwide, annual NOx capand trade program managed by EPA, EPA will consider the reductions from that program to also meet the ozone season reduction requirements that States were previously achieving from EGUs participating in a regionwide ozone season NOx cap and trade program." Does this mean that if a state's EGUs are part of the new program, then they are absolved of responsibility in the NOx SIP Call? Or does it mean that they count only their reductions from the first program against the second program, thus perhaps still being part of both programs? If the latter, then might this invite restrictions on trading to other states?   Page 60: Non EGUs will have many fewer trading partners. Page 60 61: " EPA considered whether it would be appropriate to allow States to include non EGUs in the annual IAQR trading program and relieve them from the requirements of the ozone season NOx trading program." This seems like a more sensible approach. I can't remember: has this been discussed and dismissed already?


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Notices]
[Pages 16911-16912]
[FR Doc No: 2013-06267]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Request To Release Airport Property

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent to rule on request to release airport property
at the Ankeny Regional Airport, Ankeny, Iowa.

-----------------------------------------------------------------------

SUMMARY: The FAA proposes to rule and invites public comment on the
release of land at the Ankeny Regional Airport, Ankeny, Iowa, under the
provisions of U.S.C.

DATES: Comments must be received on or before April 18, 2013.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Lynn D. Martin, Airports Compliance
Specialist, Federal Aviation Administration, Airports Division, ACE-
610C, 901 Locust Room 364, Kansas City, MO 64106.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to: Polk County Aviation Authority, John Pighetti,
President, C/O Brick Gentry P.C., 6701 Westown Parkway, Suite 100, West
Des Moines, IA 50266,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Lynn D. Martin, Airports Compliance
Specialist, Federal Aviation Administration, Airports Division, ACE-
610C, 901 Locust Room 364, Kansas City, MO 64106,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    The request to release property may be reviewed, by appointment, in
person at this same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release approximately 1.67 acres of airport property at the
Ankeny Regional Airport (IKV) under the provisions of 49 U.S.C.
47107(h)(2). On January 24, 2013, the Airport Authority at the Ankeny
Regional Airport requested from the FAA that approximately 1.67 acres
of

property be released for sale to Lucille M. Johnson and family for use
as a farming operation. On January 31, 2013, the FAA determined that
the request to release property at the Ankeny Regional Airport (IKV)
submitted by the Sponsor meets the procedural requirements of the
Federal Aviation Administration and the release of the property does
not and will not impact future aviation needs at the airport. The FAA
may approve the request, in whole or in part, no sooner than thirty
days after the publication of this Notice.
    The following is a brief overview of the request:
    Ankeny Regional Airport (IKV) is proposing the release of one
parcel, of 1.67 acres, more or less. The release of land is necessary
to comply with Federal Aviation Administration Grant Assurances that do
not allow federally acquired airport property to be used for non-
aviation purposes. The sale of the subject property will result in the
land at the Ankeny Regional Airport (IKV) being changed from
aeronautical to non-aeronautical use and release the lands from the
conditions of the Airport Improvement Program Grant Agreement Grant
Assurances. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii),
the airport will receive fair market value for the property, which will
be subsequently reinvested in another eligible airport improvement
project for general aviation facilities at the Ankeny Regional Airport.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT. In
addition, any person may, upon appointment and request, inspect the
application, notice and other documents determined by the FAA to be
related to the application in person at the Ankeny Regional Airport.

    Issued in Kansas City, MO, on March 12, 2013.
Jim A. Johnson,
Manager, Airports Division.
[FR Doc. 2013-06267 Filed 3-18-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50400-50403]
[FR Doc No: 2021-19289]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34370; 812-15229]

Investment Managers Series Trust and Hamilton Lane Advisors,
L.L.C.; Notice of Application

September 1, 2021.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act, as well as from certain disclosure requirements in rule 20a-1
under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the
Securities Exchange Act of 1934 (``1934 Act''), and sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
    Applicants: Investment Managers Series Trust (the ``Trust''), a
Delaware statutory trust registered under the Act as an open-end
management investment company with multiple series, which include the
361 Domestic Long/Short Equity Fund and the 361 Global Long/Short
Equity Fund (each a ``Fund''), and Hamilton Lane Advisors, L.L.C.
(``Initial Adviser''), a Pennsylvania limited liability company
registered as an investment adviser under the Investment Advisers Act
of 1940 (``Advisers Act'') that serves as an investment adviser to the
Funds (collectively with the Trust, the ``Applicants'').
    Summary of Application: The requested exemption would permit
Applicants to enter into and materially amend subadvisory agreements
with subadvisers without shareholder approval and would grant relief
from the Disclosure Requirements as they relate to fees paid to the
subadvisers.
    Filing Dates: The application was filed on May 7, 2021, and amended
on August 5, 2021, August 13, 2021, and August 31, 2021.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by emailing the Commission's
Secretary at<EMAIL_ADDRESS>and serving applicants with a
copy of the request by email. Hearing requests should be received by
the Commission by 5:30 p.m. on September 26, 2021, and should be
accompanied by proof of service on the applicants, in the form of an
affidavit, or, for lawyers, a certificate of service. Pursuant to rule
0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request notification
by emailing the Commission's Secretary at<EMAIL_ADDRESS>
ADDRESSES: The Commission<EMAIL_ADDRESS>The Trust and the
exception occurred on : 2021-19289.htm
exception occurred on : 2021-19289.htm
Initial Adviser: ca.com">[email protected]ca.com (with a copy to
laurie.dee@morganlewis.com).

FOR FURTHER INFORMATION CONTACT: Erin Loomis Moore, Senior Counsel, at
(202) 551-6721, or Parisa Haghshenas, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number or an Applicant
using the ``Company'' name box, at http://www.sec.gov/search/search.htm
or by calling<PHONE_NUMBER>.

I. Requested Exemptive Relief

    1. Applicants request an order to permit the Adviser,\1\ subject to
the approval of the board of trustees of the Trust (collectively, the
``Board''),\2\ including a majority of the trustees who are not
``interested persons'' of the Trust or the Adviser, as defined in
section 2(a)(19) of the Act (the ``Independent Trustees''), without
obtaining shareholder approval, to: (i) Select investment subadvisers
(``Subadvisers'') for all or a portion of the assets of one or more of
the Funds pursuant to an investment subadvisory agreement with each
Subadviser (each a ``Subadvisory Agreement''); and (ii) materially
amend Subadvisory Agreements with the Subadvisers.
---------------------------------------------------------------------------

    \1\ The term ``Adviser'' means (i) the Initial Adviser, (ii) its
successors, and (iii) any entity controlling, controlled by or under
common control with, the Initial Adviser or its successors that
serves as the primary adviser to a Subadvised Fund (as defined
below). For the purposes of the requested order, ``successor'' is
limited to an entity that results from a reorganization into another
jurisdiction or a change in the type of business organization.
    \2\ The term ``Board'' also includes the board of trustees or
directors of a future Subadvised Fund (as defined below), if
different from the board of trustees of the Trust.
---------------------------------------------------------------------------

    2. Applicants also request an order exempting the Subadvised Funds
(as defined below) from the Disclosure Requirements, which require each
Fund to disclose fees paid to a Subadviser. Applicants seek relief to
permit each Subadvised Fund to disclose (as a dollar amount and a
percentage of the Fund's net assets): (i) The aggregate fees paid to
the Adviser and any Wholly-Owned Subadvisers; and (ii) the aggregate
fees paid to Affiliated and Non-Affiliated Subadvisers (``Aggregate Fee
Disclosure'').\3\ Applicants seek an exemption to permit a Subadvised
Fund to include only the Aggregate Fee Disclosure.\4\
---------------------------------------------------------------------------

    \3\ A ``Wholly-Owned Subadviser'' is any investment adviser that
is (1) an indirect or direct ``wholly-owned subsidiary'' (as such
term is defined in section 2(a)(43) of the 1940 Act) of the Adviser,
(2) a ``sister company'' of the Adviser that is an indirect or
direct ``wholly-owned subsidiary'' of the same company that
indirectly or directly wholly owns the Adviser (the Adviser's
``parent company''), or (3) a parent company of the Adviser. A
``Non-Affiliated Subadviser'' is any investment adviser that is not
an ``affiliated person'' (as defined in the 1940 Act) of a Fund or
the Adviser, except to the extent that an affiliation arises solely
because the Subadviser serves as a subadviser to one or more Funds.
Section 2(a)(43) of the 1940 Act defines ``wholly-owned subsidiary''
of a person as a company 95 per centum or more of the outstanding
voting securities of which are, directly or indirectly, owned by
such a person.
    \4\ Applicants note that all other items required by sections 6-
07(2)(a), (b) and (c) of Regulation S-X will be disclosed.
---------------------------------------------------------------------------

    3. Applicants request that the relief apply to Applicants, as well
as to any future Fund and any other existing or future registered open-
end management investment company or series thereof that intends to
rely on the requested order in the future and that: (i) Is advised by
the Adviser; (ii) uses the multi-manager structure described in the
application; and (iii) complies with the terms and conditions of the
application (each, a ``Subadvised Fund'').\5\
---------------------------------------------------------------------------

    \5\ All registered open-end investment companies that currently
intend to rely on the requested order are named as Applicants. Any
entity that relies on the requested order will do so only in
accordance with the terms and conditions contained in the
application.
---------------------------------------------------------------------------

    4. 361 Capital, LLC (``361 Capital'') previously served as the
investment adviser to the Funds. The Commission

previously issued 361 Capital and the Trust a ``manager of managers''
exemptive order (the ``Previous Order''), granting substantially the
same relief as is sought in the application.\6\ On April 1, 2021, the
Adviser became the investment adviser to the Funds, at which time none
of the Applicants were permitted to rely on the Previous Order.\7\
---------------------------------------------------------------------------

    \6\ See 361 Capital, LLC and Investment Managers Series Trust,
Investment Company Act Rel. Nos. 33323 (December 14, 2018) (notice)
and 33349 (January 29, 2019) (order).
    \7\ In reliance on the Commission staff no-action letter issued
to Innovator Capital Management, LLC, et al. (pub. avail. October 6,
2017) and oral discussions with the Commission staff, the Applicants
intend to rely on the Previous Order as if the Previous Order
extended to the Adviser until the earlier of the receipt of the
Order or 150 days from April 1, 2021, the execution date of the new
investment advisory agreement between the Funds and the Adviser.
During such time, the Adviser will comply with the terms and
conditions in the Previous Order imposed on the Funds' previous
investment adviser as though such terms and conditions were imposed
directly on the Adviser. When and if the Order is granted by the
Commission, the Applicants would then rely on the Order, rather than
continuing to rely on the Previous Order.
---------------------------------------------------------------------------

II. Management of the Subadvised Funds

    5. The Adviser serves or will serve as the investment adviser to
each Subadvised Fund pursuant to an investment advisory agreement with
the Fund (each an ``Investment Advisory Agreement''). Each Investment
Advisory Agreement has been or will be approved by the Board, including
a majority of the Independent Trustees, and by the shareholders of the
relevant Subadvised Fund in the manner required by sections 15(a) and
15(c) of the Act. The terms of these Investment Advisory Agreements
comply or will comply with section 15(a) of the Act. Applicants are not
seeking an exemption from the Act with respect to the Investment
Advisory Agreements. Pursuant to the terms of each Investment Advisory
Agreement, the Adviser, subject to the oversight of the Board, will
provide continuous investment management for each Subadvised Fund. For
its services to each Subadvised Fund, the Adviser receives or will
receive an investment advisory fee from that Fund as specified in the
applicable Investment Advisory Agreement.
    6. Consistent with the terms of each Investment Advisory Agreement,
the Adviser may, subject to the approval of the Board, including a
majority of the Independent Trustees, and the shareholders of the
applicable Subadvised Fund (if required by applicable law), delegate
portfolio management responsibilities of all or a portion of the assets
of a Subadvised Fund to a Subadviser. The Adviser will retain overall
responsibility for the management and investment of the assets of each
Subadvised Fund. This responsibility includes recommending the removal
or replacement of Subadvisers, allocating the portion of that
Subadvised Fund's assets to any given Subadviser and reallocating those
assets as necessary from time to time.\8\ The Subadvisers will be
``investment advisers'' to the Subadvised Funds within the meaning of
section 2(a)(20) of the Act and will provide investment management
services to the Funds subject to, without limitation, the requirements
of sections 15(c) and 36(b) of the Act.\9\ The Subadvisers, subject to
the oversight of the Adviser and the Board, will determine the
securities and other instruments to be purchased, sold or entered into
by a Subadvised Fund's portfolio or a portion thereof, and will place
orders with brokers or dealers that they select.\10\
---------------------------------------------------------------------------

    \8\ Applicants represent that if the name of any Subadvised Fund
contains the name of a subadviser, the name of the Adviser that
serves as the primary adviser to the Fund, or a trademark or trade
name that is owned by or publicly used to identify the Adviser, will
precede the name of the subadviser.
    \9\ The Subadvisers will be registered with the Commission as an
investment adviser under the Advisers Act or not subject to such
registration.
    \10\ A ``Subadviser'' also includes an investment subadviser
that provides or will provide the Adviser with a model portfolio
reflecting a specific strategy, style or focus with respect to the
investment of all or a portion of a Subadvised Fund's assets. The
Adviser may use the model portfolio to determine the securities and
other instruments to be purchased, sold or entered into by a
Subadvised Fund's portfolio or a portion thereof, and place orders
with brokers or dealers that it selects.
---------------------------------------------------------------------------

    7. The Subadvisory Agreements will be approved by the Board,
including a majority of the Independent Trustees, in accordance with
sections 15(a) and 15(c) of the Act. In addition, the terms of each
Subadvisory Agreement will comply fully with the requirements of
section 15(a) of the Act. The Adviser may compensate the Subadvisers or
the Subadvised Funds may compensate the Subadvisers directly.
    8. Subadvised Funds will inform shareholders of the hiring of a new
Subadviser pursuant to the following procedures (``Modified Notice and
Access Procedures''): (a) Within 90 days after a new Subadviser is
hired for any Subadvised Fund, that Fund will send its shareholders
either a Multi-manager Notice or a Multi-manager Notice and Multi-
manager Information Statement; \11\ and (b) the Subadvised Fund will
make the Multi-manager Information Statement available on the website
identified in the Multi-manager Notice no later than when the Multi-
manager Notice (or Multi-manager Notice and Multi-manager Information
Statement) is first sent to shareholders, and will maintain it on that
website for at least 90 days.\12\
---------------------------------------------------------------------------

    \11\ A ``Multi-manager Notice'' will be modeled on a Notice of
internet Availability as defined in Rule 14a-16 under the 1934 Act,
and specifically will, among other things: (a) Summarize the
relevant information regarding the new Subadviser (except as
modified to permit Aggregate Fee Disclosure); (b) inform
shareholders that the Multi-manager Information Statement is
available on a website; (c) provide the website address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that website; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Subadvised Fund. A ``Multi-manager Information
Statement'' will meet the requirements of Regulation 14C, Schedule
14C and Item 22 of Schedule 14A under the 1934 Act for an
information statement, except as modified by the requested order to
permit Aggregate Fee Disclosure. Multi-manager Information
Statements will be filed with the Commission via the EDGAR system.
    \12\ In addition, Applicants represent that whenever a
Subadviser is hired or terminated, or a Subadvisory Agreement is
materially amended, the Subadvised Fund's prospectus and statement
of additional information will be supplemented promptly pursuant to
rule 497(e) under the Securities Act of 1933.
---------------------------------------------------------------------------

III. Applicable Law

    9. Section 15(a) of the Act states, in part, that it is unlawful
for any person to act as an investment adviser to a registered
investment company ``except pursuant to a written contract, which
contract, whether with such registered company or with an investment
adviser of such registered company, has been approved by the vote of a
majority of the outstanding voting securities of such registered
company.''
    10. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires a registered
investment company to disclose in its statement of additional
information the method of computing the ``advisory fee payable'' by the
investment company with respect to each investment adviser, including
the total dollar amounts that the investment company ``paid to the
adviser (aggregated with amounts paid to affiliated advisers, if any),
and any advisers who are not affiliated persons of the adviser, under
the investment advisory contract for the last three fiscal years.''
    11. Rule 20a-1 under the Act requires proxies solicited with
respect to a registered investment company to comply with Schedule 14A
under the 1934 Act. Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and
22(c)(9) of Schedule 14A,

taken together, require a proxy statement for a shareholder meeting at
which the advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fee,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    12. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
a registered investment company to include in its financial statements
information about investment advisory fees.
    13. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such exemption is necessary or appropriate in
the public interest and consistent with the protection of investors and
the purposes fairly intended by the policy and provisions of the Act.
Applicants state that the requested relief meets this standard for the
reasons discussed below.

IV. Arguments in Support of the Requested Relief

    14. Applicants assert that, from the perspective of the
shareholder, the role of the Subadvisers is substantially equivalent to
the limited role of the individual portfolio managers employed by an
investment adviser to a traditional investment company. Applicants also
assert that the shareholders expect the Adviser, subject to review and
approval of the Board, to select a Subadviser who is in the best
position to achieve the Subadvised Fund's investment objective.
Applicants believe that permitting the Adviser to perform the duties
for which the shareholders of the Subadvised Fund are paying the
Adviser--the selection, oversight and evaluation of the Subadviser--
without incurring unnecessary delays or expenses of convening special
meetings of shareholders is appropriate and in the interest of the
Fund's shareholders, and will allow such Fund to operate more
efficiently. Applicants state that each Investment Advisory Agreement
will continue to be fully subject to section 15(a) of the Act and
approved by the relevant Board, including a majority of the Independent
Trustees, in the manner required by section 15(a) and 15(c) of the Act.
    15. Applicants submit that the requested relief meets the standards
for relief under section 6(c) of the Act. Applicants state that the
operation of the Subadvised Fund in the manner described in the
Application must be approved by shareholders of that Fund before it may
rely on the requested relief. Applicants also state that the proposed
conditions to the requested relief are designed to address any
potential conflicts of interest or economic incentives, and provide
that shareholders are informed when new Subadvisers are hired.
    16. Applicants contend that, in the circumstances described in the
application, a proxy solicitation to approve the appointment of new
Subadvisers provides no more meaningful information to shareholders
than the proposed Multi-manager Information Statement. Applicants state
that, accordingly, they believe the requested relief is necessary or
appropriate in the public interest, and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act.
    17. With respect to the relief permitting Aggregate Fee Disclosure,
Applicants assert that disclosure of the individual fees paid to the
Subadvisers does not serve any meaningful purpose. Applicants contend
that the primary reasons for requiring disclosure of individual fees
paid to Subadvisers are to inform shareholders of expenses to be
charged by a particular Subadvised Fund and to enable shareholders to
compare the fees to those of other comparable investment companies.
Applicants believe that the requested relief satisfies these objectives
because the Subadvised Fund's overall advisory fee will be fully
disclosed and, therefore, shareholders will know what the Subadvised
Fund's fees and expenses are and will be able to compare the advisory
fees a Subadvised Fund is charged to those of other investment
companies. In addition, Applicants assert that the requested relief
would benefit shareholders of the Subadvised Fund because it would
improve the Adviser's ability to negotiate the fees paid to
Subadvisers. In particular, Applicants state that if the Adviser is not
required to disclose the Subadvisers' fees to the public, the Adviser
may be able to negotiate rates that are below a Subadviser's ``posted''
amounts. Applicants assert that the relief will also encourage
Subadvisers to negotiate lower subadvisory fees with the Adviser if the
lower fees are not required to be made public.

V. Relief for Affiliated Subadvisers

    18. The Commission has granted the requested relief with respect to
Wholly-Owned and Non-Affiliated Subadvisers through numerous exemptive
orders. The Commission also has extended the requested relief to
Affiliated Subadvisers.\13\ Applicants state that although the
Adviser's judgment in recommending a Subadviser can be affected by
certain conflicts, they do not warrant denying the extension of the
requested relief to Affiliated Subadvisers. Specifically, the Adviser
faces those conflicts in allocating fund assets between itself and a
Subadviser, and across Subadvisers, as it has an interest in
considering the benefit it will receive, directly or indirectly, from
the fee the Subadvised Fund pays for the management of those assets.
Applicants also state that to the extent the Adviser has a conflict of
interest with respect to the selection of an Affiliated Subadviser, the
proposed conditions are protective of shareholder interests by ensuring
the Board's independence and providing the Board with the appropriate
resources and information to monitor and address conflicts.
---------------------------------------------------------------------------

    \13\ See Carillon Series Trust and Carillon Tower Advisers,
Inc., Investment Company Act Rel. Nos. 33464 (May 2, 2019) (notice)
and 33494 (May 29, 2019) (order).
---------------------------------------------------------------------------

    19. With respect to the relief permitting Aggregate Fee Disclosure,
Applicants assert that it is appropriate to disclose only aggregate
fees paid to Affiliated Subadvisers for the same reasons that similar
relief has been granted previously with respect to Wholly-Owned and
Non-Affiliated Subadvisers.

VI. Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Subadvised Fund may rely on the order requested in the
Application, the operation of the Subadvised Fund in the manner
described in the Application will be, or has been, approved by a
majority of the Subadvised Fund's outstanding voting securities as
defined in the Act, or, in the case of a Subadvised Fund whose public
shareholders purchase shares on the basis of a prospectus containing
the disclosure contemplated by condition 2 below, by the initial
shareholder before such Subadvised Fund's shares are offered to the
public.
    2. The prospectus for each Subadvised Fund will disclose the
existence, substance and effect of any

order granted pursuant to the Application. In addition, each Subadvised
Fund will hold itself out to the public as employing the multi-manager
structure described in the Application. The prospectus will prominently
disclose that the Adviser has the ultimate responsibility, subject to
oversight by the Board, to oversee the Subadvisers and recommend their
hiring, termination, and replacement.
    3. The Adviser will provide general management services to each
Subadvised Fund, including overall supervisory responsibility for the
general management and investment of the Subadvised Fund's assets, and
subject to review and oversight of the Board, will (i) set the
Subadvised Fund's overall investment strategies, (ii) evaluate, select,
and recommend Subadvisers for all or a portion of the Subadvised Fund's
assets, (iii) allocate and, when appropriate, reallocate the Subadvised
Fund's assets among Subadvisers, (iv) monitor and evaluate the
Subadvisers' performance, and (v) implement procedures reasonably
designed to ensure that Subadvisers comply with the Subadvised Fund's
investment objective, policies and restrictions.
    4. Subadvised Funds will inform shareholders of the hiring of a new
Subadviser within 90 days after the hiring of the new Subadviser
pursuant to the Modified Notice and Access Procedures.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the selection and nomination of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    6. Independent Legal Counsel, as defined in Rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then-
existing Independent Trustees.
    7. Whenever a Subadviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    8. The Board must evaluate any material conflicts that may be
present in a subadvisory arrangement. Specifically, whenever a
subadviser change is proposed for a Subadvised Fund (``Subadviser
Change'') or the Board considers an existing Subadvisory Agreement as
part of its annual review process (``Subadviser Review''):
    (a) the Adviser will provide the Board, to the extent not already
being provided pursuant to section 15(c) of the Act, with all relevant
information concerning:
    (i) Any material interest in the proposed new Subadviser, in the
case of a Subadviser Change, or the Subadviser in the case of a
Subadviser Review, held directly or indirectly by the Adviser or a
parent or sister company of the Adviser, and any material impact the
proposed Subadvisory Agreement may have on that interest;
    (ii) any arrangement or understanding in which the Adviser or any
parent or sister company of the Adviser is a participant that (A) may
have had a material effect on the proposed Subadviser Change or
Subadviser Review, or (B) may be materially affected by the proposed
Subadviser Change or Subadviser Review;
    (iii) any material interest in a Subadviser held directly or
indirectly by an officer or Trustee of the Subadvised Fund, or an
officer or board member of the Adviser (other than through a pooled
investment vehicle not controlled by such person); and
    (iv) any other information that may be relevant to the Board in
evaluating any potential material conflicts of interest in the proposed
Subadviser Change or Subadviser Review.
    (b) the Board, including a majority of the Independent Trustees,
will make a separate finding, reflected in the Board minutes, that the
Subadviser Change or continuation after Subadviser Review is in the
best interests of the Subadvised Fund and its shareholders and, based
on the information provided to the Board, does not involve a conflict
of interest from which the Adviser, a Subadviser, any officer or
Trustee of the Subadvised Fund, or any officer or board member of the
Adviser derives an inappropriate advantage.
    9. Each Subadvised Fund will disclose in its registration statement
the Aggregate Fee Disclosure.
    10. In the event that the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the Application, the requested order will expire on the effective
date of that rule.
    11. Any new Subadvisory Agreement or any amendment to an existing
Investment Advisory Agreement or Subadvisory Agreement that directly or
indirectly results in an increase in the aggregate advisory fee rate
payable by the Subadvised Fund will be submitted to the Subadvised
Fund's shareholders for approval.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-19289 Filed 9-7-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12518-12519]
[FR Doc No: 2014-04861]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
Meeting.

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SUMMARY: The Federal Emergency Management Agency (FEMA) National
Advisory Council (NAC) will meet in person on March 19, 2014 in
Philadelphia, PA. The meeting will be open to the public.

DATES: The NAC will meet on Wednesday, March 19, 2014, from 8:30 a.m.
to 5:00 p.m. Eastern Daylight Time (EDT). Please note that the meeting
may close early if the NAC has completed its business.

ADDRESSES: The meeting will be held at the FEMA Region III Office
located at 615 Chestnut Street, Philadelphia, PA 19106. All visitors to
the FEMA Region III Office will have to register with FEMA to be
admitted to the building. Photo identification is required to access
the building. Please provide your name, telephone number, email
address, title, and organization by close of business on March 12,
2014, to the contact person listed in FOR FURTHER INFORMATION CONTACT
below.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in For Further Information Contact: below as soon as
possible.
    To facilitate public participation, members of the public are
invited to provide written comments on the issues to be considered by
the NAC (see ``Agenda''). Written comments must be submitted and
received by March 12, 2014, identified by Docket ID FEMA-2007-0008, and
submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket number in
the subject line of the message.
     Fax:<PHONE_NUMBER>.
     Mail: Regulatory Affairs Division, Office of Chief
Counsel, FEMA, 500 C Street SW., Room 8NE, Washington, DC 20472-3100.
    Instructions: All submissions received must include the words
``Federal Emergency Management Agency'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.
    Docket: For access to the docket to read comments received by the
NAC, go to http://www.regulations.gov, and search for the Docket ID
listed above.
    A public comment period will be held during the meeting from 3:15
p.m. to 3:45 p.m. EDT, and speakers are requested to limit their
comments to 3 minutes. Comments should be specifically related to and
addressed to the NAC. Contact the individual listed below to register
as a speaker by March 12, 2014. Please note that the public comment
period may end before the time indicated, following the last call for
comments.

FOR FURTHER INFORMATION CONTACT: Alexandra Woodruff, Alternate
Designated Federal Officer, Office of the National Advisory Council,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472-3100, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, and email
<EMAIL_ADDRESS>The NAC Web site is: http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).
    The NAC advises the FEMA Administrator on all aspects of emergency
management. The NAC incorporates State, local, and tribal government,
and private sector input in the development and revision of FEMA plans
and strategies.
    Agenda: The NAC will engage in open discussion with the FEMA
Administrator. The NAC will receive report outs from its subcommittees
on the following topics: Progress on issues related to Federal
Insurance and Mitigation, Preparedness and Protection, and Response and
Recovery. The NAC will review the information presented on each topic,
deliberate on any recommendations presented in the subcommittees'
reports, and, if appropriate, formulate recommendations for FEMA's
consideration.
    The NAC will also receive briefings from FEMA Executive Staff on
the following topics:
     America's PrepareAthon;
     the FEMA Strategic Plan;
     Disability Inclusive Emergency Management;
     Implementation of the National Preparedness System;
     the Emergency Management Institute;

     the National Preparedness Grant Program; and
     FEMA's Climate Change Adaptation and Resilience
Initiative.
    The full agenda and any related committee documents will be posted
on the NAC Web site at http://www.fema.gov/national-advisory-council.

    Dated: February 26, 2014.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-04861 Filed 3-4-14; 8:45 am]
BILLING CODE 9111-48-P


[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Rules and Regulations]
[Pages 40181-40183]
[FR Doc No: 2016-14627]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2016-N-1318]

Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Gynecologic Laparoscopic Power Morcellation
Containment System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
gynecologic laparoscopic power morcellation containment system into
class II (special controls). The special controls that will apply to
the device are identified in this order and will be part of the
codified language for the gynecologic laparoscopic power morcellation
containment system's classification. The Agency is classifying the
device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective June 21, 2016. The classification was
applicable on April 7, 2016.

FOR FURTHER INFORMATION CONTACT: Veronica Price, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On June 19, 2015, Advanced Surgical Concepts submitted a request
for classification of the PneumoLiner device under section 513(f)(2) of
the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set

forth in section 513(a)(1). FDA classifies devices into class II if
general controls by themselves are insufficient to provide reasonable
assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use. After review of the information submitted in the request,
FDA determined that the device can be classified into class II with the
establishment of special controls. FDA believes these special controls,
in addition to general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
    Therefore, on April 7, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 884.4050.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a gynecologic
laparoscopic power morcellation containment system will need to comply
with the special controls named in this final order.
    The device is assigned the generic name gynecologic laparoscopic
power morcellation containment system and is identified as a
prescription device consisting of an instrument port and tissue
containment method that creates a working space allowing for direct
visualization during a power morcellation procedure following a
laparoscopic procedure for the excision of benign gynecologic tissue
that is not suspected to contain malignancy.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks,
in Table 1.

 Table 1--Gynecologic Laparoscopic Power Morcellation Containment System
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
Infection..............................  Sterilization validation, shelf
                                          life validation, and labeling.
Intraperitoneal tissue dissemination     Non-clinical performance
 (benign or malignant):                   testing (bench and animal),
  Material permeability;          shelf life validation,
                                          labeling, and training.
     Improper function of
     containment device;
     Inadequate material
     strength;
     Physical trauma to liner
     caused by contact with morcellator
     or grasper/tenaculum;
     Damage to liner
     (intentional or accidental) from
     instrument inserted through
     secondary port;
     Tearing during removal
     with loss of contents into
     abdominal cavity; and
     Use error.
Traumatic injury to non-target tissue/   Non-clinical performance
 organ:                                   testing (bench and animal),
  Active end of morcellator or    labeling, and training.
 grasper/tenaculum breaches liner;
     Loss of insufflation;
     Inadequate space to
     perform morcellation;
     Inadequate visualization
     of the laparoscopic instruments
     and tissue specimen relative to
     the external viscera; and
     Use error.
Hernia through abdominal wall incision.  Labeling and training.
Prolongation of procedure and exposure   Labeling and training.
 to anesthesia.
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    A gynecologic laparoscopic power morcellation containment system is
not safe for use except under the supervision of a practitioner
licensed by law to direct the use of the device. As such, the device is
a prescription device and must satisfy prescription labeling
requirements (see 21 CFR 801.109, Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the gynecologic laparoscopic power
morcellation containment system they intend to market.

II. Analysis of Environmental Impact

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

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling, have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also

available electronically at http://www.regulations.gov.

    1. DEN150028: De novo request from Advanced Surgical Concepts,
dated June 19, 2015.

List of Subjects in 21 CFR Part 884

    Medical devices.

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

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  884.4050 to subpart E to read as follows:

Sec.  884.4050  Gynecologic laparoscopic power morcellation containment
system.

    (a) Identification. A gynecologic laparoscopic power morcellation
containment system is a prescription device consisting of an instrument
port and tissue containment method that creates a working space
allowing for direct visualization during a power morcellation procedure
following a laparoscopic procedure for the excision of benign
gynecologic tissue that is not suspected to contain malignancy.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible;
    (2) Device components that are labeled sterile must be validated to
a sterility assurance level of 10-\6\;
    (3) Performance data must support shelf life by demonstrating
continued sterility of the device or the sterile components, package
integrity, and device functionality over the intended shelf life;
    (4) Non-clinical performance data must demonstrate that the device
meets all design specifications and performance requirements. The
following performance characteristics must be tested:
    (i) Demonstration of the device impermeability to tissue, cells,
and fluids;
    (ii) Demonstration that the device allows for the insertion and
withdrawal of laparoscopic instruments while maintaining
pneumoperitoneum;
    (iii) Demonstration that the containment system provides adequate
space to perform morcellation and adequate visualization of the
laparoscopic instruments and tissue specimen relative to the external
viscera;
    (iv) Demonstration that intended laparoscopic instruments and
morcellators do not compromise the integrity of the containment system;
and
    (v) Demonstration that intended users can adequately deploy the
device, morcellate a specimen without compromising the integrity of the
device, and remove the device without spillage of contents;
    (5) Training must be developed and validated to ensure users can
follow the instructions for use; and
    (6) Labeling must include the following:
    (i) A contraindication for use in gynecologic surgery in which the
tissue to be morcellated is known or suspected to contain malignancy;
    (ii) Unless clinical performance data demonstrates that it can be
removed or modified, a contraindication for removal of uterine tissue
containing suspected fibroids in patients who are: Peri- or
postmenopausal, or candidates for en bloc tissue removal, for example,
through the vagina or via a mini-laparotomy incision;
    (iii) The following boxed warning: ``Warning: Information regarding
the potential risks of a procedure with this device should be shared
with patients. Uterine tissue may contain unsuspected cancer. The use
of laparoscopic power morcellators during fibroid surgery may spread
cancer. The use of this containment system has not been clinically
demonstrated to reduce this risk.''
    (iv) A statement limiting use of device to physicians who have
completed the training program; and
    (v) An expiration date or shelf life.

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14627 Filed 6-20-16; 8:45 am]
BILLING CODE 4164-01-P