Chapter 858:	UNIVERSAL WASTE RULES
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                               TABLE OF CONTENTS

                                                                           Page

                                                           l.	Legal Authority	2
                                                                  2.	Preamble	2
3.	Incorporation by Reference	2
4.	Definitions	.2
                                                             5.	Prohibitions.	6
6.	Household Hazardous Waste	6
                                                      7.	Generator Standards	.6
8.	Central Accumulation Facility	14
9.	Consolidation Facility	15
10.	Green Light and Thermometer Collection Programs	17
                                                     11.	Alternate Standards	17
12.	Special Requirements for Certain Batteries	17

Chapter 858:	STANDARDS FOR UNIVERSAL WASTE

SUMMARY: This rule establishes standards and requirements for all universal waste.

      l.	Legal Authority. This rule is authorized by and adopted under 38 M.R.S. §1301 et seq.

      2.	Preamble. It is the purpose of the Department of Environmental Protection, consistent with legislative policy, to provide effective controls for the management of hazardous waste. Universal waste is a subset of hazardous waste. This rule provides for one of these controls by establishing certain standards which must be met by generators, and facilities managing universal waste.

      3.	Incorporations by Reference. Portions of this rule refer to specific federal regulations of the United States Environmental Protection Agency (EPA). Federal regulations referenced are those regulations revised as of July 1, 2001, as they appeared in volume 40 of the Code of Federal Regulations (C.F.R.). Where specifically stated, the terms of a referenced federal regulation are hereby adopted as terms of this rule, except that in regulations incorporated thereby, "EPA" shall mean "the Maine Department of Environmental Protection (DEP)"; "Administrator", "Regional Administrator" and "Director" shall mean "the Commissioner", and the phrase "treat, store, and/or dispose" shall mean "handle". In addition, where the terms of federal regulations hereby incorporated by reference differ from or are inconsistent with other terms of this Chapter or Chapters 850-860, the more stringent of the requirements shall apply. Other changes to regulations incorporated hereby are as expressly made in this rule.

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NOTE: Other requirements for generators, transporters, and facilities appear in other rules of the Department dealing with specific aspects of hazardous waste management, including universal waste. See, for example, Chapter 857, Hazardous Waste Manifest Requirements; Chapter 856, Licensing of Hazardous Waste Facilities; Chapter 854, Standards for Hazardous Waste Facilities; and Chapter 853, Licensing of Transporters of Hazardous Waste.

4.	Definitions. For the purposes of this rule, terms not defined in this section shall have the meaning given them in Chapter 850, or in 38 M.R.S. §§ 361-A, 1303-C.

       Architectural Paint. Architectural paint means interior and exterior architectural coatings sold in containers of 5 gallons or less that is unused but intended for painting components of houses or other buildings. For the purposes of this Chapter, architectural paint only includes materials defined as a hazardous waste by characteristic or that contains a listed hazardous waste in accordance with Chapter 850, Section 3, that are generated by a person or entity that generates less than 100 kilograms in a calendar month (approximately 27 gallons or less) and accumulates no more than 55 gallons of hazardous waste at any one time in aggregate, including hazardous wastes other than architectural paints, or acutely hazardous waste in amounts less than or equal to those amounts specified in Chapter 850, Section 3(A)(5)(c). Architectural paint does not include industrial, original equipment or specialty coatings, ignitable or F-listed paint thinners, mineral spirits or solvents used for cleaning paint-related equipment, or other ignitable or F-listed paint thinners or solvents contaminated with architectural paint. Architectural paint also does not include: aerosol paints (spray cans), arts and crafts paints, adhesives and caulking compounds, epoxies, glues, automotive and marine paints, 2-component coatings, deck cleaners, industrial maintenance (IM) coatings, original equipment manufacturer (OEM) paints and finishes (shop applications), paint additives, colorants, tints, resins, roof patch and repair, tar, asphalt and bitumen based products, traffic and road marking paints, and wood preservatives. Architectural Paint may only be managed as universal waste if an approved Stewardship plan is also in place.

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      NOTE: Latex, water- based, and acrylic interior and exterior paints are not generally hazardous waste.

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      NOTE: Household hazardous wastes that are also a type of universal waste may be managed through the universal waste program.

       Ballast. Ballast means a device that electronically controls light fixtures and includes a capacitor containing 0.1 kg or less of dielectric.

       Cathode Ray Tubes. Cathode Ray Tubes (CRTs) means a product video display component of televisions, computer displays, military and commercial radar, and other display devices.

             Central Accumulation Facility. Central Accumulation Facility means a facility where:

            (1)	A generator combines its own universal wastes from the generator's various facilities;
            (2)	A licensed solid waste transfer station or recycling center where universal waste generators may take their universal wastes;
            (3)	A facility where less than 200 universal waste items are collected from generators that are serviced by the facility; or
            (4)	For architectural paints, a paint retailer including paint, hardware and home improvement stores that accepts architectural paint from consumers as defined by 38 M.R.S. §2144.

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      NOTE: Section D(3) above allows sign service companies, electricians, and other service companies that service a generator's lights, and other universal waste, to take these waste back to their facilities by using a log, store them for a period of time and then transport them to an instate Consolidation facility. The instate consolidator would then take the log information and submit a Quarterly Report to the Department.

       Collection Container. Collection container means a container that is designed to store more than one universal waste item, and for architectural paint, a reusable plastic or metal tote or drum. For a one or two day collection event of paint waste, a plastic lined cardboard gaylord box or lined roll off box may be used.

       Consolidation Facility. Consolidation Facility means a facility where universal waste is consolidated and temporarily stored while awaiting shipment to a recycling, treatment or disposal facility. This facility is typically where a central accumulation facility will send its waste initially.

       Hazardous Waste Management Rules. Hazardous Waste Management Rules means Chapters 850 through 858 inclusive.

             Lamp. Lamp means a bulb or tube portion of an electric lighting device. A lamp is specifically designed to produce radiant energy, most often in the ultraviolet, visible, and infra-red regions of the electromagnetic spectrum. Examples of lamps are fluorescent lamps, high intensity discharge lamps, neon lamps, mercury vapor lamps, high pressure sodium lamps and metal halide lamps. Lamp includes both lamps that fail the Toxicity Characteristic Leaching Procedure (TCLP) and those that contain mercury but pass the TCLP.

       Mercury Device. Mercury Device means a manufactured item that has mercury added. Examples of mercury devices are mercury thermometers, mercury manometers, sphygmomanometers, and mercury switches. The term does not include a motor vehicle mercury switch.

       Mercury Switch. Mercury Switch means a mercury added manufactured item that uses metallic mercury to measure, control or regulate the flow of gas, fluids or electricity.

             Mercury Thermostat. Mercury Thermostat means a temperature control device that contains metallic mercury in an ampule attached to a bimetal sensing element.

             Motor Vehicle Mercury Switch. Motor Vehicle Mercury Switch means a mercury switch used in a motor vehicle. It includes mercury light switches used to turn a light bulb or lamp on and off and a mercury switch used in anti-lock braking systems.

       Recycling Center. "Recycling Center" means a publicly owned or publicly contracted facility that primarily handles municipal recyclables and that receives pre-separated, uncontaminated, unwanted paper, cardboard, glass, plastic, metal, and universal wastes. A recycling center is not a recycling facility.

             Recycling Facility. "Recycling Facility" means a facility where universal wastes are dismantled, hazardous constituents recovered, reclaimed or separated for reuse.

       Small Universal Waste Generator. Small Universal Waste Generator means a person or entity that generates in any calendar month or accumulates on site at any one time no more than:

            (1)	200 universal waste items, including batteries as described in Section 12, or
            (2)	4,000 motor vehicle mercury switches, or
            (3)	40 tons of cathode ray tubes.

            The total weight of all universal waste including batteries must be no more than 5,000 kg.

            A one-time generation of lamps under a Green Lights or other similar energy conversion program that is completed within six months or a mercury thermometer collection event, is exempt from the 200 item count provided no more than 5,000 kg of universal waste are generated and the waste is managed in accordance with the standards for a Green Lights Program or mercury thermometer collection event in Section 10 of this chapter.

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            NOTE: 5,000 kg approximately equals 20,000 lamps.
            40 tons of Cathode Ray Tubes (CRT's) approximately equals 4,000 CRT's.
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            An anti-lock brake system is considered one universal waste unit even though it may contain up to three mercury switches per unit.

             Universal Wastes. Universal wastes are those wastes determined by the Department to meet the criteria in Chapter 850, Section 3(D). These universal wastes are:

                   Architectural paint;

                   Cathode ray tubes;

                   Lamps;

                   Mercury Devices;

                   Mercury thermostats;

                   Motor Vehicle Mercury Switches;

                   Totally enclosed, non-leaking polychlorinated biphenyl (PCB) ballast.

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            NOTE: Only mercury-containing lamps or lamps otherwise hazardous are included as universal wastes.
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            NOTE: Batteries are managed as universal waste in accordance with Section 12.

 Prohibitions. Generators, owners or operators of any central accumulation or consolidation facility, and transporters of universal wastes are prohibited from conducting the following activities:

 Disposing, diluting or treating universal wastes.

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      NOTE: The intentional breaking of universal wastes including Cathode Ray Tubes is a form of treatment, and is therefore prohibited at locations other than the recycling facility.

 Sending a universal waste to any facility other than:

             a central accumulation facility;
             a consolidation facility for universal waste;
             an approved recycling facility for universal wastes; or
                  (4)	an approved disposal or treatment facility authorized to handle PCB ballasts, the residues from mercury spill kits, or architectural paint that cannot be recycled.

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            NOTE: Generators that self-transport waste must comply with universal waste transporter requirements, as provided in Section 7D of this chapter.

 Household Hazardous Waste. Household hazardous waste (or household universal waste), which meets the description of universal waste in Section 4P but which is exempt under Chapter 850, Section 3A(4)(a)(vii), when combined or mixed with non-household universal or hazardous wastes is no longer exempt and must be managed either in accordance with the universal waste requirements of this chapter or the Hazardous Waste Management Rules, Chapter 850 through 857.

 Generator Standards. All generators of universal wastes must comply with either the full Hazardous Waste Management Rules, Chapter 850 through 857 or the following alternative generator standards.

             Determine whether the waste generated is hazardous in accordance with Section 5 of Chapter 851 and, pursuant to 38 M.R.S. §1663 determine that all mercury containing lamps are a universal waste; and

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            NOTE: All mercury containing lamps are universal wastes as required by statute, regardless of TCLP test results.

             Determine whether the waste is a universal waste under Section 4P;

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            NOTE: If a hazardous waste is not eligible for regulation under the universal waste rules, then the full hazardous waste management rules apply, Chapter 850 through 857.

             Properly track the universal waste via a manifest, Recyclable Hazardous Material Uniform Bill of Lading, or the log system in accordance with Chapter 857;

             Utilize a licensed transporter in accordance with Section 7 of Chapter 851 or a common carrier in accordance with Section 10(B) of Chapter 853;

             Transport or offer for transport, universal waste only to a facility authorized to handle the waste under a state program, and which is authorized to handle the waste under the federal hazardous waste regulatory program, if applicable, and which is one of the types of facilities named in Section 5B above;

             Store all universal waste in containers. Containers must not show evidence of leakage, spillage or damage that could cause leakage under reasonably foreseeable conditions. The containers must be closed, structurally sound, compatible with the content of the waste, and must not be leaking, spilling, dented or damaged such that it could cause leakage under reasonably foreseeable conditions;

             Immediately contain and transfer all releases of waste and residues resulting from spills or leaks from broken or ruptured universal waste to a container that meets the requirements of the Maine Hazardous Waste Management Rules, Chapter 850 through 857, except that waste and residues from incidental breakage may still be managed as a universal waste;

             Determine by testing, or handle as hazardous, clean up residues resulting from spills or leaks from events other than incidental breakage of lamps or CRTs in accordance with Maine Hazardous Waste Management Rules, Chapter 850 through 857, including generator accumulation time limit, storage and disposal standards, and count this waste toward the determination of hazardous waste generator status;

             Train all employees and contractors who handle or have responsibility for managing universal wastes on proper handling and emergency procedures. Maintain the documentation of employee and contractor training. The documentation shall include the name of the person receiving the training, the date of the training and the information covered during the training;

             Conduct weekly inspections of universal waste storage areas and maintain a written inspection log to document the inspections. The log must include the name of the inspector, date of inspection, number and condition of waste containers and descriptions of actions taken to address any problem discovered during the inspection. The number of universal wastes (i.e.: number of lamps, thermostats, individual architectural paint original containers) must be maintained onsite;

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            NOTE: The generator may find the inspection log to be the easiest way to keep track of the number of universal wastes onsite.

             Store universal waste in a secured area which can be locked when not in use;

             Label each universal waste container or collection container with an accumulation start date and the date the container becomes full;

             Store universal wastes for no more than one year from the date the waste is first placed in the container or collection container. A generator may store waste for more than one year only if the generator stores the waste for no more than 90 days from the date the container or collection container becomes full when the activity is solely for the purposes of accumulation of such quantities of universal waste as necessary to facilitate proper recovery, treatment or disposal. The handler bears the burden of proving that such activity was solely for the purposes of accumulation of such quantities as necessary to facilitate proper recovery, treatment or disposal. For the purposes of the accumulation of the following waste in collection containers no larger than the following capacities, the accumulation time of 90 days from the collection container full date is deemed "necessary to facilitate proper recovery, treatment or disposal:"

(1)	Architectural paint  -  container of 5 gallons or less;

(2)	Cathode Ray Tubes - no larger than a single gaylord container;

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            NOTE:	A gaylord container is typically a 4'x4'x4' container that will typically contain 24 CRTs.

(3)	Lamps - no larger than 190 bulb size container;

(4)	Mercury Thermostats - container of no larger than 30 gallons;

(5)	Mercury Devices - containers of no larger than 55 gallons;

(6)	Motor Vehicle Mercury Switches - containers of no larger than 5 gallons.

Motor Vehicle Mercury Switches must be shipped off site at least every three years regardless of whether the size limit identified in (6) in this paragraph is reached.

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                  NOTE: This universal waste in storage will not be considered part of your hazardous waste accumulation for the purpose of your generation status.

             Store universal waste containers or collection containers, with adequate aisle space to be able to inspect the condition of the containers and collection containers and determine the accumulation start dates and container and collection container full dates;

             Comply with the export and import requirements of Chapter 857, Section 7(D);

             Generators that accumulate more than 4,000 motor vehicle mercury switches or 200 other items of universal wastes at any one time or in any given month must notify the Maine Department of Environmental Protection of the handling of universal wastes and must receive an EPA Identification Number, unless the generator has previously notified and the site has been assigned an EPA Identification Number. Alternatively generators that handle less than 40 tons of cathode ray tubes or 5,000 kg of other universal wastes are required to notify but may notify the Department on a state waste notification form provided by the Department in lieu of notifying EPA using the EPA form. This notification shall include the specific type of universal wastes handled by the generator. The requirement of an EPA Identification Number for those that generate or accumulate only universal waste is intended as a registration provision and does not make other sections of the hazardous waste rules applicable unless other hazardous wastes are generated or accumulated.

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            NOTE: A generator may obtain an EPA identification number by applying to the Department of Environmental Protection, Bureau of Remediation and Waste Management, State House Station #17, Augusta, Maine 04333-0017 using EPA form 8700-12.

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            NOTE: A generator or central accumulation facility that meets the threshold in paragraph P but is not required to obtain an EPA identification number is required to notify the Department of its activities by submitting either a Notification of State Universal Waste Activities form or an EPA 8700-12 form to the Department of Environmental Protection at the above address.

             Reduced requirements for small universal waste generators

             A small universal waste generator may log information at the Central Accumulation facility or instate Consolidation facility in accordance with Section 13(A) of Chapter 857;

                   In lieu of 7(J) above, a small universal waste generator must keep track of the number of universal waste items onsite (i.e.: number of lamps, thermostats);

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NOTE: The Department recommends that the universal waste area is inspected when placing wastes in the area to ensure that the area is in compliance with the rules and to minimize exposures to toxic releases.

             A small universal waste generator is not required to notify the Department of this activity, as provided in 7(P);

             A small universal waste generator must maintain a copy of the log or a certificate of receipt from the receiving facility if transporting and using a log; and

             Records related to personnel training may be retained by the instate consolidation facility in lieu of a small universal waste generator as provided in 7(T).

             Ship universal waste

(1)	Whole, intact, and unbroken except as authorized by the Department as incidental breakage;

(2)	In proper packaging that includes closed containers that are compatible for the type and amount of waste and that meet the US DOT standards;

(3)	Accompanied by a Recyclable Hazardous Material Uniform Bill of Lading, manifest, or log (as applicable); and

(4)	Via a common carrier or licensed hazardous waste transporter, or if operating as a small universal waste generator, the small universal waste generator may self-transport its universal waste in accordance with the universal waste transporter requirements of 06-096 C.M.R. ch. 853 §11;

             Comply with the Recyclable Hazardous Material Uniform Bill of Lading, manifest or log requirements of Chapter 857;

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NOTE: An instate small universal waste generator and an instate central accumulation facility are allowed to use the log in lieu of the manifest or bill of lading provided they are transporting to an instate consolidation facility.

             Retain the following records at the generator facility, the central accumulation facility, and the consolidation facility (where applicable);

(1)	Inspection logs for at least one year from generator's shipment or facility's receipt of the universal waste;

(2)	Documentation of employee or contractor training for at least three years from the date of generator shipment or facility receipt of the universal waste or for the length of employee service whichever is greater. An instate consolidation facility may maintain the record of training for small universal waste generators and central accumulation locations on behalf of these entities; and

(3)	Recyclable Hazardous Materials Uniform Bill of Lading, or manifest, or log for at least three years from the date of shipment or receipt of the universal waste.

             Submit the following information to the Department:

(1)	The original Recyclable Hazardous Materials Uniform Bill of Lading or proper manifest copies within 7 days of shipment.

(2)	The quarterly universal waste report from the consolidation facility in accordance with the provisions of Chapter 857, Section 13(C)(2).

             In addition to 5, 6, and 7(A) through (U) above, cathode ray tubes (CRT) must also be managed in accordance with the following requirements:

(1)	Pack CRT in containers, boxes, gaylord, or another acceptable container method approved by the Department that will contain any breakage. CRTs must have packing materials adequate to prevent breakage during storage, handling and transportation;

(2)	Seal securely, such as with tape, around the box openings of all full boxes and immediately if incidental breakage should occur;

(3)	Do not stack containers or boxes of CRT's more than five feet in height;

(4)	Store CRT's in an inside, dry area not exposed to weather;

(5)	Mark the container or box with the words "Waste Cathode Ray Tube";

(6)	Designate each waste CRT storage area by a clearly marked sign which states. "Waste Cathode Ray Tube Storage" or Universal Hazardous Waste Storage;"

             In addition to 5, 6 and 7(A) through (U) above, lamps must also be managed in accordance with the following requirements:

(1)	Pack lamps in containers or boxes with packing materials adequate to prevent breakage during storage, handling, and transportation;

(2)	Seal securely, such as with tape, around the box openings of all full boxes and immediately if incidental breakage should occur;

(3)	Do not stack containers or boxes of lamps more than five feet in height;

(4)	Store lamps in an inside, dry area not exposed to weather;

(5)	Mark the container with the words "Waste Lamps";

(6)	Designate each waste lamp storage area by a clearly marked sign which states "Waste Lamp Storage" or "Universal Hazardous Waste Storage";

             In addition to 5, 6 and 7(A) through (U) above, mercury devices must also be managed in accordance with the following requirements:

            (1)	Pack mercury devices in rigid, sealable containers with packing materials adequate to prevent breakage during storage, handling, and transportation;

            (2)	Store mercury devices in an inside, dry area not exposed to weather;

            (3)	Mark the containers with the words "Waste Mercury Devices";

            (4)	Designate each mercury device storage area by a clearly marked sign which states "Waste Mercury Device Storage" or "Universal Hazardous Waste Storage";

             In addition to 5, 6 and 7(A) through (U) above, mercury thermostats must also be managed in accordance with the following requirements:

            (1)	 Pack mercury thermostats in rigid, sealable containers with packing materials adequate to prevent breakage during storage, handling, and transportation;

            (2)	Store mercury thermostats in an inside, dry area not exposed to weather;

            (3)	Mark each container with the words "Waste Mercury Thermostats";

            (4)	Designate each waste thermostat area by a clearly marked sign which states "Waste Mercury Thermostat Storage" or "Universal Hazardous Waste Storage";

             In addition to 5, 6 and 7(A) through (U) above, motor vehicle mercury switches must also be managed in accordance with the following requirements:

            (1)	Pack switches in rigid, sealable containers with packing material adequate to prevent breakage during storage, handling, and transportation;

            (2)	Store switches in an inside, dry area not exposed to the weather;

            (3)	Mark the container with the words "Waste Motor Vehicle Switches";

            (4)	Designate each waste motor vehicle mercury switch storage area by a clearly marked sign which states "Waste Motor Vehicle Switch Storage" or "Universal Hazardous Waste Storage";

            (5)	A motor vehicle switch generator may accumulate 4,000 motor vehicle mercury switches before becoming a large universal waste generator. The 200 item limit would continue to apply to all other universal waste items;

            (6)	In addition to 7M above, a motor vehicle switch generator must ship off its motor vehicle mercury switches at least every three years whether or not the container is full;

             In addition to 5, 6 and 7(A) through (U) above, totally enclosed, non-leaking PCB ballast must also be managed in accordance with the following requirements:

            (1)	Pack ballasts in rigid, sealable containers with packing materials adequate to prevent breakage during storage, handling, and transportation;

            (2)	Store ballasts in an inside, dry area not exposed to the weather;

            (3)	Mark containers with the words "Waste PCB Ballasts";

                  (4)	Designate each waste ballast storage area by a clearly marked sign which states "Waste PCB Ballast Storage " or "Universal Hazardous Waste Storage";

             In addition to 5, 6 and 7(A) through (U) above, architectural paint must also be managed in accordance with the following requirements:

            (1)	Store the paint in its original closed non-leaking container of 5 gallons or less in size;

            (2)	Store container or collection container in an inside, dry area not exposed to the weather;

            (3)	Store the securely closed original paint containers within secondary containment to contain liquids in the event of a leak, and store away from storm drains and floor drains, and away from ignition sources;

            (4)	Mark collection containers with the words "Waste Paint" or designate each waste storage area or container by a clearly marked sign which states "Waste Paint Storage" or "Universal Hazardous Waste Storage."
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      NOTE:	In addition to the requirements contained in this rule, Architectural Paint will also be subject to any requirements in an approved stewardship program plan.
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 Central Accumulation Facility. The owner or operator of a central accumulation facility must comply with the following requirements:

 Sections 5, 6, and 7, excluding 7(J), (L), (M) and (P);

 Conduct weekly inspections of universal waste storage areas and maintain a written inspection log to document the inspections. The log must include the name of the inspector, date of inspection, number, and condition of original waste containers and collection containers, and descriptions of actions taken to address any problem discovered during the inspection;

 Obtain an EPA ID number as outlined in Subsection 7(P) or if handling less than 5,000 kg notify the Department on a waste notification form provided by the Department;

 Ship to a consolidation facility for universal waste or a properly approved recycling facility for universal waste, or in the case of ballasts, residues from mercury spill kits, and architectural paint which cannot be recycled ship to a properly approved disposal or treatment facility within one year of receipt of the waste;

 Mark each container with the date the universal waste is received at the facility; or mark each collection container with the date the first universal waste item is placed into collection container and the date the collection container is full;

 Maintain an inventory system on-site that identifies the date and manifest or Uniform Bill of Lading number or log information i.e. name of generator, log, date, type and number of universal waste items (if applicable) for each universal waste container or group of containers that is received at the facility and the date and manifest or Uniform Bill of Lading number (if applicable) for each waste container or group of containers that is shipped from the facility;

 For architectural paint, pack original securely closed containers completely in the collection container, keep the collection container closed except when adding containers of architectural paint, and label the collection container with the words "Waste Paint;" and

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            NOTE: This universal waste in storage as part of a take back program will not be considered part of the facility's hazardous waste accumulation for the purpose of the facility's hazardous waste generation status.

 When the facility no longer accepts universal wastes, remove all universal waste and any residues from the universal wastes to a facility licensed to handle the wastes. Provide written notice to the Department within ten (10) days of ceasing acceptance of each type of universal waste.

 Consolidation Facility. The owner or operator of a consolidation facility must comply with the following requirements:

             Sections 5, 6, and 7, excluding 7(J), (L), (M) and (P);

             Conduct weekly inspections of universal waste storage areas and maintain a written inspection log to document the inspections. The log must include the name of the inspector, date of inspection, number, and condition of original waste containers and collection containers, and descriptions of actions taken to address any problem discovered during the inspection;

             Ship to a properly approved recycling facility for universal waste, or in the case of ballasts, the residues from mercury spill kits, and architectural paint which cannot be recycled to a properly approved treatment or disposal facility within one year of receipt of waste;

             Obtain an EPA ID number as outlined in Section 7(P);

             Mark each container with the date the universal waste is received at the facility; or mark each collection container with the date the first universal waste item is placed into the collection container and the date the collection container is full;

             Maintain an inventory system on-site that identifies the date and manifest or Uniform Bill of Lading number or log information i.e. name of generator, log date, and type and number of universal waste items (if applicable) for each universal waste container or group of containers that is received at the facility and the date and manifest or Uniform Bill of Lading number for each waste container or group of containers that is shipped from the facility;

             For architectural paint where paint will be transferred out of the original container for consolidation in another container, consolidators must:

            (1)	Make hazardous waste determinations for paint including any unidentified architectural paint in accordance with Chapter 851, Section 5;

            (2)	Separate any characteristic or listed hazardous waste paint containers from other paint containers and only consolidate hazardous waste paints with other hazardous waste paints in the same containers;

            (3)	Identify and separate any waste or containers which do not meet the criteria of architectural paint pursuant to Chapter 858, Section 4(A). Manage any of these wastes and containers identified as hazardous waste in accordance with the applicable standards for hazardous waste of Chapters 850 through 857, including labeling with the words "hazardous waste" and disposal through a licensed hazardous waste transporter;

                  (4)	Conduct all transfer and consolidation activities over secondary containment;

            (5)	Empty individual architectural paint containers by draining the emptied container for at least thirty (30) seconds after the steady flow of paint has ceased and individual droplets are clearly evident. Then perform that procedure two more times, or crush the can using a commercially available crusher that collects vapors, liquids, and is explosion proof;

            (6)	Place empty containers in a collection container that is closed except when adding or removing containers and that will prevent the release of any residue or vapors that remains after complying with subsection (5) above;

            (7)	Remove and cleanup all discharges of hazardous waste to the Department's satisfaction;

            (8)	Ship all architectural paint on a hazardous waste manifest or uniform bill of lading;

            (9)	Submit for Department review and approval a closure plan with financial assurance sufficient for a third party to conduct the closure activities. The closure plan and financial assurance shall be in accordance with 06-096 CMR 854(6)(C)(15) and (16) and shall be updated annually in accordance with the rules;

            (10)	Submit quarterly reports on a form approved by the Department that identifies the number of individual containers and volume of architectural paint received, the number of individual containers and volume determined not to meet the definition of architectural paint, the name and location of all facilities where architectural paint and non-hazardous paint waste has been shipped, and the number of individual containers and volumes remaining on site at the end of the reported quarter;

            (11)	Submit proof of liability insurance; and

            (12)	Submit an environmental monitoring plan.

             For architectural paint, pack original securely closed containers directly into collection containers, keep the collection container closed except when adding containers of paint, label the container with the words "Waste Paint."

             Conduct closure of the facility in accordance with Chapter 851, Section 11.

       Green Light and Thermometer Collection Programs. A small universal waste generator that generates greater than 200 lamps or thermometers per month or at any one time under (i) a Green Lights Program or other similar energy conversion program that is completed within a six month period; or (ii) a single short term event of a maximum of five consecutive days per year for the collection of mercury thermometers, or such other period of time approved by the Department, must comply with the following requirements:

      A.	Ship the lamps or thermometers directly to a properly approved recycling facility for universal waste on a manifest or Recyclable Hazardous Materials Uniform Bill of Lading; and

      B.	Comply with all other requirements for a small universal waste generator. A small universal waste generator conducting a Green Lights or thermometer collection event of 200 items or more under this Section is not required to obtain an EPA ID Number or notify the Department on a state waste notification form pursuant to Section 7(P) of this chapter.

       Alternate Standards. Notwithstanding 7, 8 and 9 above, the Department may on a case by case basis approve alternative standards for tracking and reporting universal waste, in the case of a manufacturer's sponsored product take back program, also known as a "product stewardship" program or other similar manufacturer sanctioned collection program. A criteria of any approval under this subsection must include an annual report from the manufacturer on the amount of the particular product collected through this program in the state and the program must meet the federal universal waste requirements of 40 C.F.R. 273. The operator of such a program must file a request with the Department and identify the regulatory tracking and reporting elements for which the operator is seeking alternative approval.

 Special Requirements For Certain Batteries

      Batteries that are described in 40 C.F.R. 273.2, must be managed in accordance with 40 C.F.R. 273, except that references to 40 C.F.R. Parts 260 through 272 shall mean 850 through 857 of the Maine Hazardous Waste Management Rules and except that 40 C.F.R. 273.8(a)(2) is not adopted, and instead, batteries handled by federally conditionally exempt small quantity generators are regulated as small quantity handlers pursuant to 40 C.F.R. 273 Subpart B. In addition, instead of 40 C.F.R. 273.2(c), a battery becomes a waste on the date that it becomes useless, unwanted, or intended for disposal, and spent lead acid batteries described in 40 C.F.R. 273.2(a)(2) and 273.2(b)(1) are regulated under 850 through 858 instead of 40 C.F.R. part 266, subpart G.

STATUTORY AUTHORITY: 38 M.R.S. §1319-O(1) and § 2144

EFFECTIVE DATE:
      March 11, 2015  -  filing 2015-031

NON-SUBSTANTIVE CORRECTIONS:
	April 28, 2017  -  formatting and numbering

AMENDED:
	June 11, 2018  -  filing 2018-101


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Proposed Rules]
[Pages 20073-20077]
[FR Doc No: 2019-09476]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1995-0005; FRL-9993-38-Region 4]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Tennessee Products Superfund
Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; notice of intent.

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SUMMARY: The Environmental Protection Agency Region 4 is issuing a
Notice of Intent to Delete the Tennessee Products Superfund Site (Site)
located in Chattanooga, Tennessee, from the National Priorities List
(NPL) and requests public comments on this proposed action. The NPL,
promulgated pursuant to section 105 of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) of 1980, as amended,
is an appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). The EPA and the State of Tennessee (State),
through the Tennessee Department of Environment and Conservation
(TDEC), have determined that all appropriate response actions under
CERCLA, other than Five-Year Reviews, have been completed. However,
this deletion does not preclude future actions under Superfund.

DATES: Comments must be received by June 7, 2019.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1995-0005, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
     Email<EMAIL_ADDRESS>     Mail: Craig Zeller, Remedial Project Manager, U.S. EPA
Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303,
     Hand delivery: U.S. EPA Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303. Such deliveries are accepted only during the
Docket's normal hours of operation (Monday through Friday, 9:00 a.m. to
5:00 p.m.), and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1995-0005. 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 website is
an ``anonymous access'' system, which means 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 EPA without
going through http://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, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, 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.
    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 material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:

U.S. EPA Region 4, Superfund Division, 61 Forsyth Street SW, Atlanta,
Georgia 30303. Hours: Monday through Friday, 9:00 a.m. to 5:00 p.m.
Tennessee Department of Environment and Conservation Division of
Remediation, 1301 Riverfront Parkway, Suite 206, Chattanooga, Tennessee
37402. Hours: Monday through Friday, 8:00 a.m. to 4:30 p.m. Phone: 423-
634-5745

FOR FURTHER INFORMATION CONTACT: Craig Zeller, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW, Atlanta, Georgia 30303; phone:<PHONE_NUMBER>; email:
[email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Site Deletion

I. Introduction

    EPA Region 4 announces its intent to delete the Tennessee Products
Superfund Site from the National Priorities List (NPL) and requests
public comment on this proposed action. The NPL constitutes Appendix B
of 40 CFR part 300, which is the National Oil and Hazardous Substances
Pollution Contingency Plan (NCP), which EPA promulgated pursuant to
section 105 of the Comprehensive Environmental Response, Compensation
and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL
as the list of sites that appear to present a significant risk to
public health, welfare, or the environment. Sites on the NPL may be the
subject of remedial actions financed by the Hazardous Substance
Superfund (Fund). As described in 40 CFR 300.425(e)(3) of the NCP,
sites deleted from the NPL remain eligible for Fund-financed remedial
actions if future conditions warrant such actions.
    EPA will accept comments on the proposal to delete this site for
thirty (30) days after publication of this document in the Federal
Register.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the Tennessee Products Superfund
Site and demonstrates how it meets the deletion criteria.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
     Responsible parties or other persons have implemented all
appropriate response actions required;
     All appropriate Fund-financed response under CERCLA has
been implemented, and no further response action by responsible parties
is appropriate; or
     The remedial investigation has shown that the release
poses no significant threat to public health or the environment and,
therefore, the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts Five-
Year Reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure (see Operation and Maintenance and Five-Year Review section
below). EPA conducts such Five-Year Reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    A. EPA consulted with the State before developing this Notice of
Intent to Delete;
    B. EPA has provided to the State 30 working days for review of this
notice prior to publication of it today;
    C. In accordance with the criteria discussed above, EPA has
determined that no further response is appropriate;
    D. The State, through its Department of Environment and
Conservation, has concurred with deletion of the Site from the NPL
(letter to EPA dated May 21, 2018);
    E. Concurrently with the publication of this Notice of Intent to
Delete in the Federal Register, a notice is being published in a major
local newspaper, The Chattanooga Times Free Press. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent to Delete the site from the NPL; and
    F. The EPA placed copies of documents supporting the proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    If comments are received within the 30-day public comment period on
this document, EPA will evaluate and respond appropriately to the
comments before making a final decision to delete. If necessary, EPA
will prepare a Responsiveness Summary to address any significant public
comments received. After the public comment period, if EPA determines
it is still appropriate to delete the Site, the Regional Administrator
will publish a final Notice of Deletion in the Federal Register. Public
notices, public submissions and copies of the Responsiveness Summary,
if prepared, will be made available to interested parties and in the
site information repositories listed above.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Intended Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL.

A. Site Background and History

    The Tennessee Products Superfund Site (TPS) is located in south
Chattanooga, Hamilton County, Tennessee and is defined as 2.5-mile
section of Chattanooga Creek that contained sediments contaminated
primarily with polycyclic aromatic hydrocarbons (PAHs). During the
early decades of the 20th Century, a coal carbonization (Coke) plant
complex (named Tennesee Products) was responsible for waste disposal
practices that led to the contamination of Chattanooga Creek sediments.
Numerous discharges of contaminated water to Chattanooga Creek via
tributaries, were documented. Results of previous investigations and
subsequent evaluations indicated that existing conditions posed a
potential unacceptable risk to human health, if exposure to the
contaminated sediments were to occur.
    The TPS Site was proposed for inclusion on the NPL in January 1994
(59 FR 2568) after completion of a multi-media investigation of
Chattanooga Creek by the EPA and the issuance of a Health Advisory by
the Agency for Toxic Substances and Disease Registry (ATSDR) in 1993.
The Health Advisory concluded that ``the presence of the coal tar in-
and-around the creek poses a health and safety hazard.'' The TPS Site
was placed on the NPL on September 29, 1995 (60 FR 50435). The EPA
CERCLIS ID Number for this Site is TND071516959.
    Based on the ATSDR Health Advisory, the EPA initiated a non-time-
critical removal of the most accessible coal tar deposits along the
upper reach of the Creek and behind the former Southern Coke and
Chemical plant site (the Coke Plant area). On September 26, 1996, the
EPA issued an Action Memorandum approving a non-time-critical removal
action (Phase I removal action) as described in the 1996 Engineering
Evalaution/Cost Analysis (EE/CA). The Action Memorandum was amended on
September 24, 1997, and on December 5, 1998, authorizing the
expenditure of additional funding to address a larger volume of
contaminated sediments in the Creek than previously estimated. Over the
course of the eighteen months of the Phase I removal action, a total of
4,235 linear feet of Chattanooga Creek was excavated, along with three
isolated tar pits located in the flood plain and adjacent to the former
coke plant. The total material excavated was 25,350 cubic yards, of
which 22,934 cubic yards came from the excavation of Chattanooga Creek.
The removal action was completed in December, 1998.

B. Remedial Investigation and Feasibility Study (RI/FS)

    The purpose of a remedial investigation is to determine the nature
and extent of contamination at a site and the threat to public health
and the environment from a release, or potential release of hazardous
substances from a site. The remedial investigation for the TPS Site
included reviewing historical information and collecting samples from
the air, water, soil, sediment and waste. The remedial investigation
focused on the plant site, although a number of samples were also
collected from areas surrounding the creek. EPA decided not to collect
many creek sediment samples for this investigation because the EPA had
conducted a comprehensive study of the creek in 1992 (Chattanooga Creek
Sediment Profile Study).
    The purpose of the Feasibility Study was to determine the best
cleanup remedy. The EPA conducted a Feasibility Study focused on
cleanup alternatives for the portion of the contaminated creek not
addressed during the Phase I Removal. Other much smaller areas in the
flood plain that were contaminated with coal-tar and its related
chemicals were also addressed with the creek sediments.
    The former plant property was not considered in the cleanup
strategy for the Site, because the property was removed from the
Tennessee Products NPL listing by Federal Courts. See the November 12,
1996, decision of the U.S. Court of Appeals for the D.C. Circuit in
Mead Corporation v. Browner (No. 5-1610). Therefore, no remedy was
proposed for the plant property. The plant property was addressed
through the State Superfund program (TCA 68-212-201). After the court
ruling, the NPL listing for the Site included only 2.5 miles of the
creek.
    Based on the remedial investigation and the risk assessment, the
remedy objectives were:
     Prevent human exposure to contaminated soil along the
Northeast Tributary and contaminated sediment in Chattanooga Creek;
and,
     Eliminate risks to aquatic life in Chattanooga Creek from
exposure to contaminated sediment.
    Six remedial action alternatives were considered for evaluation in
the Focused Feasibility Study Report. They were: (1) Taking no action;
(2) Re-routing the creek and encapsulating (solidifying) the
contaminated sediment; (3) Excavating contaminated sediment and
disposing of it in an on-site landfill; (4) Excavating contaminated
sediment and treatment with on-site thermal desorption; (5) Excavating
with on-site incineration; and (6) Excavating with off-site disposal
and recycling.

C. The Selected Remedy

    In September 2002, EPA Region 4 issued the Final Record of Decision
(ROD) for the TPS Site. The ROD selected the remedial action for the
Middle Reach of Chattanooga Creek and a portion of the Northeast
Tributary. The Middle Reach includes the bed and banks of Chattanooga
Creek beginning 1,354 feet north of the 38th Street Bridge and
extending to the confluence of Chattanooga Creek and Dobbs Branch, an
approximate 1.9-mile section (the previous Non-Time Critical Removal
Action addressed the upstream portion of the creek). Remediation of a
dredged spoil pile located along the Northeast Tributary was also
included in the ROD. The six remedial alternatives, including the no
action alternative, were evaluated using nine criteria for remedy
selection. Based on this evaluation, the EPA determined that excavating
with off-site disposal and recycling (Alternative 6) was its preferred
alternative for the Site. It provided the best balance of tradeoffs
among the nine evaluation criteria and met the remedial goals by
preventing future human contact with the coal-tar constituents and
contaminated sediment in Chattanooga Creek. This remedy was used during
the first phase of the cleanup (Non-Time Critical Removal) and was
proven to be effective and efficient. Also, this was the only
alternative considered to completely remove the waste material from the
site. The remedy selected involved excavating coal-tar constituent
waste and contaminated sediment beginning where the Phase 1 Cleanup
ended (at 38th Street), to the confluence with Dobbs Branch. All of the
contaminated sediment and waste in this segment of the creek was
removed from the creek sides and bottom. Since the coal-tar
contamination was easily identified by visual inspection, it was
unnecessary to establish numerical cleanup standards. The cleanup was
confirmed after a visual inspection of the work areas of the creek was
performed. The scope of the remedy did not include groundwater, soil
(other than specific areas containing tar waste), or surface water. The
RI did not find contamination in those media requiring a remedial
action.

D. Explanation of Significant Difference

    In August of 2004, the EPA issued an Explanation of Significant
Difference (ESD) to explain a change to a portion of the selected
remedy. The remedy selected in the ROD was excavating with off-site
disposal and recycling. The ESD changed the remedy to off-site disposal
at the Bradley County Landfill. The recycling component of the remedy
was eliminated due to the remedy encountering a larger volume of waste
and the accompanying increase in costs.

E. The Remedial Action

    The remedial action was implemented by dividing the creek into five
segments, or creek channel reaches. In general, excavation of
contaminated sediment and restoration activities occurred starting at
the upstream segment and working downstream. The strategy for removal
of sediments in the work area involved excavation in the dry. The creek
dewatering process included installation of temporary coffer dams and
pumping systems (large pumps and pipes) to route the creek water around
the active reaches of excavation. The dams were constructed of clay
and/or clean fill. The pumping systems were maintained twenty-four
hours per day, seven days per week to keep the work areas dewatered.
Contact between creek water and contaminated sediments in an active
reach of excavation was minimized. However, water within the active
stream reach that came in contact with excavated sediment was treated
using an oil/water separator prior to discharge back into the creek.
    Contaminated sediment from the creek channel was excavated until
the remaining sediments were visually clean. Excavation activities
began in October 2005 in Reach 1. Contaminated sediment was excavated
from bank-to-bank, which was defined as the vegetative line at the edge
of the creek; and, since limestone bedrock was not always present to
define the vertical extent, all visual signs of sediment contamination
were removed, and test pits were excavated to confirm that no other
visual contamination existed. Where visible contamination extended
beyond the creek bank, a maximum of three feet was removed horizontally
from the original bank. The bank was then backfilled with clean fill
and stabilized. When these efforts were completed, the EPA, or the
designated representative, inspected the work area and verified that
the performance standard was achieved. The excavated reach was then
approved by the EPA before restoration activities were completed and
water was pumped back into that portion of the creek.
    Excavation of the contaminated creek sediments was conducted in a
manner to minimize handling and to contain the contaminated sediment
within the creek before direct transfer to trucks for transport to a
drying bed for stabilization. Typically, two excavators were in the
creek reach working to transport sediment to a common area for load-
out. Lime kiln dust (LKD) was added to the sediment in the creek to
stabilize sediment that contained significant free liquids prior to
loading into the truck. The mixture was allowed to cure for a period of
time that was sufficient to promote drying before the sediment was
loaded in trucks. These activities were performed as necessary to
reduce spillage during loading of the trucks. The excavated sediments
were then transported to drying beds located on the former Southern
Wood Piedmont facility. Additional LKD was mixed into the sediment
prior to transport to the Bradley County, Tennessee, landfill for final
disposal. Approval by the TDEC Division of Solid Waste Management was
required for disposal of special waste (contaminated sediment mixed
with lime kiln dust) at the Bradley County Landfill. Disposal of the
special waste from the Site was approved on October 10, 2005.
Recertifications for the 2006 and 2007 construction seasons were
submitted and approved as well.
    During excavation of a portion of the creek oxbow in January 2006,
a black liquid was observed infiltrating the bottom of the excavation.
Twelve inches of clay was placed in the first 250-foot section of the
oxbow in an attempt to seal off the liquid. The seal did not work. This
section of the creek is on property owned by Southern Wood Piedmont
Company, which treated railroad cross-ties with creosote from 1924 to
1988. The black liquid resembled creosote and differed in physical
characteristics from the coal-tar impacted sediments that were
encountered in the upper reaches of the creek channel remediation.
While the project was temporarily shut down because of high water
conditions, the EPA performed a field investigation in March 2006
within and adjacent to Chattanooga Creek to evaluate this Non Aqueous
Phase Liquid (NAPL). The general objectives of the investigation were
to:
     Determine the horizontal and vertical extent of the NAPL
in the oxbow section;
     Evaluate whether the presence of NAPL in the oxbow creates
a potential for re-contamination;
     Assess NAPL transport pathways and potential sources of
NAPL; and
     Evaluate the potential risks to human health and the
environment posed by the NAPL.
    The results of the EPA investigation were presented in a June 2006
document titled Chattanooga Creek NAPL Assessment, Chattanooga,
Tennessee. Based on results of the investigation, the EPA determined
that the Statement of Work and related work plans should be modified to
address the changed site conditions encountered. The EPA determined
that these modifications were necessary to achieve the Performance
Standards and to maintain the effectiveness of the remedy. In June
2006, the Statement of Work was modified to include design and
installation of a protective isolation barrier in those sections of
Chattanooga Creek where NAPL was encountered. This modification is
consistent with the scope of the selected remedy, which included
``stabilizing creek banks where necessary to minimize erosion or
prevent contamination buried in the creek bank from re-entering the
creek,'' as described in the Statement of Work. The objective of the
protective isolation barrier was to minimize the potential for NAPL to
recontaminate the restored creek channel.
    The design for the isolation barrier included the use of
AquaBlok[supreg], which is a patented solid aggregate that is coated
with a clay polymer that expands when hydrated. For the isolation
barrier, a minimum 12-inch prepared subgrade soil layer was placed over
the creek bed and banks to a level that was a minimum of three feet
above the highest point of observed NAPL intrusion. The creek banks
were graded or maintained at a maximum 3:1 slope. The protective
isolation barrier was placed from where the creek crosses the Southern
Wood Piedmont property to the confluence of Dobbs Branch, or
approximately 5,750 linear feet of restored creek channel. A total of
308,878.3 square feet of isolation barrier, or approximately 7.1 acres,
was installed. A combination of placing riprap and seeding was
performed for creek bank stabilization. Restoration was consistent with
the previous removal action at the upper reach of Chattanooga Creek.
Areas of the creek bank where excavation of the bank had occurred or
potential eroding locations (specifically on outer radius of curves)
were stabilized by one of two methods. The first method included
placement of a 6-oz non-woven geotextile covered by 6-inch riprap. The
riprap was obtained from the temporary coffer dams or imported as
required. Other locations requiring stabilization were seeded for a

more natural restoration method, as feasible.
    A final total of 107,292 tons of contaminated sediment and debris
were transported to the landfill for disposal over the course of the
project in a total of 4,338 truck loads. The last load of stabilized
sediment was transported from the Site to the landfill on September 4,
2007. Discarded tires found in the creek were removed and pressure
washed. A total of 15.01 tons of tires were sent to a recycler in
Nashville, Tennessee.
Operation and Maintenance and Five-Year Reviews (FYRs)
    No long-term operation and maintenance or monitoring activities
under CERCLA are required by the ROD or the RD/RA Consent Decree.
Discretionary Five-Year Reviews will be conducted by the EPA to assess
whether the protective isolation barrier continues to function as an
effective engineering control to isolate the creek from the nearby NAPL
source in the oxbow area. Operation and Maintenance and monitoring are
the responsibility of the Southern Wood Piedmont facility under the
Resource Conservation and Recovery Act (RCRA) through the Final RCRA
Post-Closure Permit for the Southern Wood Piedmont facility, which is
delegated to the TDEC. The triggering date for the discretionary Five-
Year Review is five years from the formal authorization to proceed on
October 12, 2005. There have been two FYRs in 2011 and 2016. EPA is
conducting Discretionary Five-Year Reviews because a protective
isolation barrier was installed to isolate the CERCLA remedy from
adjacent areas where hazardous substances, pollutants or contaminants
could remain above levels that allow for unlimited use and unrestricted
exposure as defined by CERCLA. The most recent Five-Year Review was
completed on September 26, 2016, and reported no issues or
recommendations. The 2016 Five-Year Review concluded that the remedy at
the Tennessee Products Site remains protective of human health and the
environment, both in the short term and long term. The site inspections
and sampling events concluded that the AquaBlok[supreg] cap is
functioning as intended. These reviews will continue until the NAPL
under the creek is addressed through the September 2005 RCRA Post-
Closure Permit for the Southern Wood Piedmont facility. No
institutional controls were required by the ROD.
Community Involvement
    Community involvement activities were conducted throughout the Non-
Time Critical Removal and Remedial Action. Public notices and meetings
were routinely held. An administrative record and information
repository was placed in the community to provide accessible
information about the activities at the Site. An advertisement will be
placed in the Chattanooga Times Free Press announcing the deletion of
the Site during the comment period. The community proposed a public
park (greenway) along the bank of the creek during the remedial action,
but no future plans for the development of the Site have been
determined.
Determination That the Site Meets the Criteria for Deletion in the NCP
    Region 4 has followed the procedures required by 40 CFR 300.425(e),
and the implemented remedy achieves the degree of cleanup specified in
the ROD for all pathways of exposure. The EPA confirmed that the
sediment remedial action objectives and performance criteria were
achieved. All cleanup actions specified in the ROD have been
implemented. All selected remedial and removal action objectives and
associated cleanup levels are consistent with agency policy and
guidance, and are summarized in the Final Close-Out Report. This Site
meets all the site completion requirements as specified in Office of
Solid Waste and Emergency Response (OSWER) Directive 9320.22, Close-Out
Procedures for National Priorities List Sites. A Final Close-Out Report
was issued by the EPA on September 26, 2008. A supplemental Final
Close-Out Report was also issued by the EPA on March 4, 2019,
confirming that the remedy was complete and met the remedial action
goals of the ROD. No further Superfund response is needed to protect
human health and the environment. The EPA, with concurrence of the
State of Tennessee, has determined that all appropriate response
actions under CERCLA have been completed. Therefore, the EPA intends to
delete the Site from the NPL.

List of Subjects in 40 CFR Part 300

    Environmental protection, Chemicals, Hazardous substances,
Hazardous waste, Intergovernmental relations, Reporting and
recordkeeping requirements, Superfund, Water pollution control.

    Authority:  33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

    Dated: April 22, 2019.
 Mary S. Walker,
Acting Regional Administrator.
[FR Doc. 2019-09476 Filed 5-7-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Proposed Rules]
[Pages 64224-64227]
[FR Doc No: 2011-26625]

Vol. 76

Monday,

No. 200

October 17, 2011

Part III

Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Part 870

Cardiovascular Devices; Reclassification of External Pacemaker Pulse
Generator Devices; Draft Guidance for Industry and Food and Drug
Administration Staff; Class II Special Controls Guidance Document:
External Pacemaker Pulse Generator; Availability; Proposed Rule and
Notice

Federal Register / Vol. 76 , No. 200 / Monday, October 17, 2011 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]

Cardiovascular Devices; Reclassification of External Pacemaker
Pulse Generator Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the external pacemaker pulse generator preamendments class
III device into class II (special controls). FDA is proposing this
reclassification on its own initiative based on new information. FDA is
taking this action under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Medical Device Amendments of 1976 (the
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food
and Drug Administration Modernization Act of 1997 (FDAMA), and the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

DATES: Submit either electronic or written comments by January 17,
2012. Please see section XIII of this document for the effective date
of any final rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0650 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and docket number and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1538, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended by the 1976 amendments (Pub. L. 94-295),
the SMDA (Pub. L. 101-629), FDAMA (Pub. L. 105-115), MDUFMA (Pub. L.
107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-
214), and the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), establish a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
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).
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA issues a final regulation under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) requiring premarket approval.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' FDA
can initiate a reclassification under section 513(e) or an interested
person may petition FDA to reclassify a preamendments device. The term
``new information,'' as used in section 513(e) of the FD&C Act,
includes information developed as a result of a reevaluation of the
data before the Agency when the device was originally classified, as
well as information not presented, not available, or not developed at
that time. (See, e.g., Holland Rantos v. United States Department of
Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act
(21 U.S.C. 360c(a)(3)) and 21 CFR 860.7(c)(2). (See, e.g., General
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc.
v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).

    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by
FDAMA, provides that FDA may use, for reclassification of a device,
certain information in a PMA 6 years after the application has been
approved. This includes information from clinical and preclinical tests
or studies that demonstrate the safety or effectiveness of the device
but does not include descriptions of methods of manufacture or product
composition and other trade secrets.
    FDAMA added a new section 510(m) to the FD&C Act. New section
510(m) of the FD&C Act provides that a class II device may be exempted
from the premarket notification requirements under section 510(k) of
the FD&C Act, if the Agency determines that premarket notification is
not necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    In the preamble to the proposed rule (44 FR 13284, March 9, 1979
and 44 FR 13372, March 9, 1979), the Cardiovascular Devices Panel
recommended that external pacemaker pulse generators be classified into
class III because the device provided temporary life-support and that
certain kinds of failures could cause this device to emit inappropriate
electrical signals, which could cause cardiac irregularities and death.
The panel indicated that general controls alone would not be sufficient
and that there was not enough information to establish a performance
standard. Consequently, the panel believed that premarket approval was
necessary to assure the safety and effectiveness of the device. In
1980, FDA classified external pacemaker pulse generators into class III
after receiving no comments on the proposed rule. In 1987, FDA
published a clarification by inserting language in the codified
language stating that no effective date had been established for the
requirement for premarket approval for external pacemaker pulse
generator devices (52 FR 17732, May 11, 1987).
    In 2009, FDA published an order for the submission of information
on external pacemaker pulse generators by August 7, 2009 (74 FR 16214,
April 9, 2009). In response to that order, FDA received
reclassification petitions from three device manufacturers who all
recommended that external pacemaker pulse generators be reclassified to
class II. The manufacturers stated that safety and effectiveness of
these devices may be assured by design and maintenance (special
controls), consideration of risks involved with the device, and an
independent verification that appropriate standard operating procedures
are in place and being followed.

III. Device Description

    An external pacemaker pulse generator is a device that has a power
supply and electronic circuits that produce a periodic electrical pulse
to stimulate the heart. This device, which is used outside the body, is
used as a temporary substitute for the heart's intrinsic pacing system
until a permanent pacemaker can be implanted, or to control irregular
heartbeats in patients following cardiac surgery or a myocardial
infarction. The device may have adjustments for impulse strength,
duration, R-wave sensitivity, and other pacing variables.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposal be
reclassified from class III to class II. FDA believes that the
identified special controls would provide reasonable assurance of
safety and effectiveness. Therefore, in accordance with sections 513(e)
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information
with respect to the devices, FDA, on its own initiative, is proposing
to reclassify this preamendments class III device into class II. The
Agency has identified special controls that would provide reasonable
assurance of their safety and effectiveness. FDA has considered
external pacemaker pulse generators in accordance with the reserved
criteria and determined that the device does require premarket
notification. The Agency does not intend to exempt this proposed class
II device from premarket notification (510(k)) submission as provided
for under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering the information from the reports and
recommendations of the advisory committees (panels) for the
classification of these devices along with information submitted in
response to the 515(i) order and any additional information that FDA
has encountered, FDA has evaluated the risks to health associated with
the use of external pacemaker pulse generators and determined that the
following risks to health are associated with its use:
    1. Failure to pace--A failure of the electronic circuitry can cause
failure to pace the patient's heart;
    2. Improper pacing leading to high rate--Electric failure,
electromagnetic interference, or improper programming can cause
sustained high rate pacing, which can lead to arrhythmias such as
pulseless ventricular tachycardia;
    3. Improper pacing leading to unwanted stimulation--Pacing during
vulnerable periods of the cardiac cycle or at higher than programmer
amplitude can induce cardiac arrhythmias; and
    4. Micro/macro shocks--Uncontrolled leakage currents or patient
auxiliary currents can cause an electric shock resulting in an
arrhythmia or cardiac tissue damage.

VI. Summary of Reasons for Reclassification

    FDA believes that external pacemaker pulse generators should be
reclassified into class II because special controls, in addition to
general controls, can be established to provide reasonable assurance of
the safety and effectiveness of the device. In addition, there is now
adequate effectiveness information sufficient to establish special
controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    Since 1980 when FDA classified external pacemaker pulse generators
into class III, sufficient evidence has been developed to support a
reclassification to class II with special controls. The effectiveness
and acceptability of pacing for the treatment of various cardiac
arrhythmias has been demonstrated in extensive clinical studies and is
summarized in the American College of Cardiology/American Heart
Association Guidelines for implantable cardiac pulse generators.
Several key performance standards have been developed and used to
support marketing applications over the years, which address various
aspects of design and performance and have been determined to be
sufficient in the establishment of requirements for market entry.

VIII. Proposed Special Controls--Related Documents

    FDA believes that the special controls described in the guidance
document ``Class II Special Controls Guidance Document: External
Pacemaker Pulse Generator'' are sufficient to mitigate the risks to
health described in section V of

this document. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of a draft guidance document that, when
finalized, would serve as a special control, if FDA reclassifies this
device. If adopted, following the effective date of a final rule
classifying the device, any firm submitting a 510(k) premarket
notification for the device would need to address the issues covered in
the special control guidance. However, the firm would need to show only
that its device meets the recommendations of the guidance or in some
other way provides equivalent assurances of safety and effectiveness.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule will not introduce new
requirements for manufacturers of external pacemaker pulse generators,
the Agency proposes to certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This rule proposes to reclassify external pacemaker pulse generator
devices into class II with special controls from its current
classification as preamendment class III. Manufacturers of new or
modified external pacemaker pulse generators would continue to be
subject to premarket notification requirements as they have already
been marketed through premarket notification procedures. The rule would
require compliance with the proposed special controls, in addition to
general controls. As described in the special controls guidance
document, however, the standards for labeling, safety, and performance
testing for these devices reflect current FDA requirements for
marketing clearance.
    The information and data requirements for 510(k) submissions remain
unchanged. Thus, there would be no additional manufacturer costs
associated with this proposed rule. While reclassification is unlikely
to result in any procedural changes in how the affected devices are
reviewed, the proposed rule will ensure that manufacturers understand
the requirements by clarifying FDA's expectations for premarket
submissions in the special controls guidance document.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. According to FDA's Registration and Listing
database, there are seven establishments that currently market external
pacemaker pulse generator devices. Because this proposed rule would
impose no additional regulatory burdens, the Agency proposes to certify
that this proposed rule would not have a significant economic impact on
a substantial number of small entities.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain state requirements ``different from or
in addition to'' certain Federal requirements applicable to devices.
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic, Inc. v.
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999
(2008)). If this proposed rule is made final, the special controls
established by the final rule would create ``requirements'' for
specific medical devices under 21 U.S.C. 360(k), even though product
sponsors have some flexibility in how they meet those requirements (Cf.
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997)).

XII. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information found in 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 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in part
807, subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814, subpart B have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

XIII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.

XIV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

XV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Gregoratos G., Cheitlin, M.D., Conill A., et al., ``ACC/AHA
Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia
Devices: Executive Summary--A Report of the American College of
Cardiology/American Heart Association Task Force on Practice
Guidelines (Committee on Pacemaker Implantation),'' Circulation
1998; 97; 1325-35.
    2. Class II Special Controls Guidance Document: External
Pacemaker Pulse Generator.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

    1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

    2. Section 870.3600 is amended by revising paragraph (b) and
removing paragraph (c) to read as follows:

Sec.  870.3600  External pacemaker pulse generator.

* * * * *
    (b) Classification. Class II. The special control for this device
is the FDA guidance document entitled ``Class II Special Controls
Guidance Document: External Pacemaker Pulse Generator.''

    Dated: October 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-26625 Filed 10-13-11; 8:45 am]
BILLING CODE 4160-01-P