[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Rules and Regulations]
[Page 68521-68522]
[DOCID:fr28de09-17]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0631; Airspace Docket No. 09-ASW-19]

Establishment of Class E Airspace; Albany, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Albany, TX, to
accommodate Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAPs) at Albany Municipal Airport, Albany, TX. The FAA is
taking this action to enhance the safety and management of Instrument
Flight Rule (IFR) operations at the airport.

DATES: Effective 0901 UTC, April 8, 2010. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On October 14, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class E airspace for Albany
Municipal Airport, Albany, TX (74 FR 52705) Docket No. FAA-2009-0631.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9T signed August 27, 2009, and
effective September 15, 2009, which is incorporated by reference in 14
CFR Part 71.1. The Class E airspace designations listed in this
document will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E airspace extending upward from 700 feet
above the surface to accommodate SIAPs at Albany Municipal Airport,
Albany, TX. This action is necessary for the safety and management of
IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when

promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Albany Municipal Airport,
Albany, TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:
* * * * *

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW TX E5 Albany, TX [New]

Albany Municipal Airport, TX
    (Lat. 32[deg]43'17'' N., long. 99[deg]16'03'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Albany Municipal Airport, and within 4
miles each side of the 178[deg] bearing from the airport extending
from the 6.4-mile radius to 10.6 miles south of the airport, and
within 4 miles each side of the 358[deg] bearing from the airport
extending from the 6.4-mile radius to 10.7 miles north of the
airport.
* * * * *

    Issued in Fort Worth, Texas, on December 8, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-30189 Filed 12-24-09; 8:45 am]

BILLING CODE 4910-13-P


STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 39

HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATORS

Effective 21 August 2000

Last Amended    19 July 2007

AUTHORITY:	These regulations are authorized pursuant to R.I. Gen. Laws
§ 42-17.1-2(s) and 23-23, as amended, and have been promulgated
pursuant to the procedures set forth in the R.I. Administrative
Procedures Act, R.I. Gen. Laws Chapter 42-35.

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION 39

HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATORS

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc168714241"  39.1
Definitions	  PAGEREF _Toc168714241 \h  1

  HYPERLINK \l "_Toc168714242"  39.2	Applicability	  PAGEREF
_Toc168714242 \h  9

  HYPERLINK \l "_Toc168714243"  39.3	Plan Submittals and Compliance
Schedules	  PAGEREF _Toc168714243 \h  10

  HYPERLINK \l "_Toc168714244"  39.4	Pre-construction Requirements
PAGEREF _Toc168714244 \h  14

  HYPERLINK \l "_Toc168714245"  39.5	Emission Limitations	  PAGEREF
_Toc168714245 \h  14

  HYPERLINK \l "_Toc168714246"  39.6	Inspection & Repair Requirements
PAGEREF _Toc168714246 \h  15

  HYPERLINK \l "_Toc168714247"  39.7	Compliance and Performance Testing
Requirements	  PAGEREF _Toc168714247 \h  17

  HYPERLINK \l "_Toc168714248"  39.8	Monitoring Requirements	  PAGEREF
_Toc168714248 \h  24

  HYPERLINK \l "_Toc168714249"  39.9	Reporting and Recordkeeping
Requirements	  PAGEREF _Toc168714249 \h  24

  HYPERLINK \l "_Toc168714250"  39.10	HMIWI Operation, Training, and
Qualification Requirements	  PAGEREF _Toc168714250 \h  28

  HYPERLINK \l "_Toc168714251"  39.11	Inspection and Entry	  PAGEREF
_Toc168714251 \h  31

  HYPERLINK \l "_Toc168714252"  39.12	General Provisions	  PAGEREF
_Toc168714252 \h  32

  HYPERLINK \l "_Toc168714253"  Table 1 (a) .   Emission limits for
HMIWI constructed on or before June 20, 1996	  PAGEREF _Toc168714253 \h
34

  HYPERLINK \l "_Toc168714254"  Table 1(b).    Emission limits for HMIWI
constructed after June 20, 1996	  PAGEREF _Toc168714254 \h  35

  HYPERLINK \l "_Toc168714255"  Table 2.     Toxic Equivalency Factors
PAGEREF _Toc168714255 \h  36

  HYPERLINK \l "_Toc168714256"  Table 3. Operating Parameters to be
Monitored and Minimum Measurement and Recording Frequencies	  PAGEREF
_Toc168714256 \h  37

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION 39

HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATORS

Definitions

Unless otherwise expressly defined in this section, the terms used in
this regulation shall be defined by reference to the Rhode Island Air
Pollution Control General Definitions Regulation. As used in this
regulation, the following terms shall, where the context permits, be
construed as follows:

“Batch HMIWI” means an HMIWI that is designed such that neither
waste charging nor ash removal can occur during combustion.

“Biologicals” means preparations made from living organisms and
their products, including vaccines, cultures, etc., intended for use in
diagnosing, immunizing, or treating humans or animals or in research
pertaining thereto.

“Blood products” means any product derived from human blood,
including but not limited to blood plasma, platelets, red or white blood
corpuscles, and other derived licensed products, such as interferon,
etc.

“Body fluids” means liquid emanating or derived from humans and
limited to blood; dialysate; amniotic, cerebrospinal, synovial, pleural,
peritoneal and pericardial fluids; and semen and vaginal secretions.

“Bypass stack” means a device used for discharging combustion gases
to avoid severe damage to the air pollution control device or other
equipment.

“Chemotherapeutic waste” means waste material resulting from the
production or use of antineoplastic agents used for the purpose of
stopping or reversing the growth of malignant cells.

“Co-fired combustor or co-fired incinerator” means a unit combusting
hospital waste and/or medical/infectious waste with other fuels or
wastes and subject to an enforceable requirement limiting the unit to
combusting a fuel stream, 10 percent or less of the weight of which is
comprised, in aggregate, of hospital waste and medical/infectious waste
as measured on a calendar quarter basis.  For purposes of this
definition, pathological waste, chemotherapeutic waste, and low-level
radioactive waste are considered “other” wastes when calculating the
percentage of hospital waste and medical/infectious waste combusted.

“Continuous emission monitoring system or CEMS” means a monitoring
system for continuously measuring and recording the emissions of a
pollutant from an affected facility.

“Continuous HMIWI” means an HMIWI that is designed to allow waste
charging and ash removal during combustion.

“Dioxins/furans” means the combined emissions of tetra- through
octa-chlorinated dibenzo-para-dioxins and dibenzofurans, as measured by
EPA Reference Method 23.

“Dry scrubber” means an add-on air pollution control system that
injects dry alkaline sorbent (dry injection) or sprays an alkaline
sorbent (spray dryer) to react with and neutralize acid gases in the
HMIWI exhaust stream forming a dry powder material.

“Fabric filter or baghouse” means an add-on air pollution control
system that removes particulate matter (PM) and nonvaporous metals
emissions by passing flue gas through filter bags.

“Facilities manager” means the individual in charge of purchasing,
maintaining, and operating the HMIWI or the owner or operator’s
representative responsible for the management of the HMIWI.  Alternative
titles may include director of facilities or vice president of support
systems.

“High-air phase” means the stage of the batch operating cycle when
the primary chamber reaches and maintains maximum operating
temperatures.

“Hospital” means any facility which has an organized medical staff,
maintains at least six inpatient beds, and where the primary function of
the institution is to provide diagnostic and therapeutic patient
services and continuous nursing care primarily to human patients who are
not related and who stay on average in excess of 24 hours per admission.
 This definition does not includes facilities maintained for the sole
purpose of providing nursing or convalescent care to human patients who
generally are not acutely ill but who require continuing medical
supervision.

“Hospital/medical/infectious waste incinerator or HMIWI or HMIWI
unit” means any device that combusts any amount of hospital waste
and/or medical/infectious waste.

“Hospital/medical/infectious waste incinerator operator or HMIWI
operator” means any person who operates, controls or supervises the
day-to-day operation of an HMIWI.

“Hospital waste” means discards generated at a hospital, except
unused items returned to the manufacturer.  The definition of hospital
waste does not include human corpses, remains, and anatomical parts that
are intended for interment or cremation.

“Infectious agent” means any organism (such as a virus or bacteria)
that is capable of being communicated by invasion and multiplication in
body tissues and capable of causing disease or adverse health impacts in
humans.

“Intermittent HMIWI” means an HMIWI that is designed to allow waste
charging, but not ash removal, during combustion.

“Large HMIWI” means:

An HMIWI whose maximum design waste burning capacity is

more than 500 pounds per hour; or

A continuous or intermittent HMIWI whose maximum charge rate is more
than 500 pounds per hour; or

A batch HMIWI whose maximum charge rate is more than 4,000 pounds per
day.

“Low-level radioactive waste” means waste material which contains
radioactive nuclides emitting primarily beta or gamma radiation, or
both, in concentrations or quantities that exceed applicable federal or
State standards for unrestricted release.  Low-level radioactive waste
is not high-level radioactive waste, spent nuclear fuel, or by-product
material as defined by the Atomic Energy Act of 1954 (42 U.S.C.
2014(e)(2).

“Malfunction” means any sudden, infrequent, and not reasonably
preventable failure of air pollution control equipment, process
equipment, or a process to operate in a normal or usual manner.
Failures that are caused, in part, by poor maintenance or careless
operation are not malfunctions.

“Maximum charge rate” means:

For continuous and intermittent HMIWI, 110 percent of the

lowest 3-hour average charge rate measured during the most recent
performance test demonstrating compliance with all applicable emission
limits.

For batch HMIWI, 110 percent of the lowest daily charge rate

measured during the most recent performance test demonstrating
compliance with all applicable emission limits.

“Maximum design waste burning capacity” means:

For intermittent and continuous HMIWI

C = Pv  x 15,000/8,500

where:

       C =  HMIWI capacity, lb/hr

       Pv =  primary chamber volume, ft3

15,000 = primary chamber heat release factor, Btu/ft3/hr

  8,500 = standard waste heating value, Btu/lb;

For batch HMIWI

C = Pv x  4.5/8

where:

C = HMIWI capacity, lb/hr

Pv = primary chamber volume, ft3

4.5 = waste density, lb/ft3

8 = typical hours of operation of a batch HMIWI, hours.

“Maximum fabric filter inlet temperature” means 110 percent of the
lowest 3-hour average temperature at the inlet to the fabric filter
(taken, at a minimum, once every minute) measured during the most recent
performance test demonstrating compliance with the dioxin/furan emission
limit.

“Maximum flue gas temperature” means 110 percent of the lowest
3-hour average temperature at the outlet from the wet scrubber (taken,
at a minimum, once every minute) measured during the most recent
performance test demonstrating compliance with the mercury (Hg) emission
limit.

“Medical/infectious waste” means any of the following waste that is
generated in the diagnosis, treatment, or immunization of human beings
or animals, in research pertaining thereto, or in the production or
testing of biologicals:

Cultures and stocks of infectious agents and associated biologicals,
including: cultures from medical and pathological laboratories; cultures
and stocks of infectious agents from research and industrial
laboratories;  wastes from the production of biologicals; discarded live
and attenuated vaccines; and culture dishes and devices used to
transfer, inoculate, and mix cultures;

Human pathological waste, including tissues, organs, and body parts and
body fluids that are removed during surgery or autopsy, or other medical
procedures, and specimens of body fluids and their containers;

Human blood and blood products including:

Liquid waste human blood;

Products of blood;

Items saturated and/or dripping with human blood; or

Items that were saturated and/or dripping with human blood that are now
caked with dried human blood; including serum, plasma, and other blood
components, and their containers, which were used or intended for use in
either patient care, testing and laboratory analysis or the development
of pharmaceuticals.  Intravenous bags are also included in this
category;

Sharps that have been used in animal or human patient care or treatment
or in medical, research, or industrial laboratories, including
hypodermic needles, syringes ( with or without the attached needle),
pasteur pipettes, scalpel blades, blood vials, needles with attached
tubing, and culture dishes (regardless of  presence of infectious
agents).  Also included are other types of broken or unbroken glassware
that were in contact with infectious agents, such as used slides and
cover slips;

Animal waste including contaminated animal carcasses, body parts, and
bedding of animals that were known to have been exposed to infectious
agents during research (including research in veterinary hospitals),
production of biologicals or testing of pharmaceuticals;

Isolation wastes including biological waste and discarded materials
contaminated with blood, excretions, exudates, or secretions from humans
who are isolated to protect others from certain highly communicable
diseases, or isolated animals known to be infected with highly
communicable diseases; and

Unused sharps including the following unused, discarded sharps:
hypodermic needles, suture needles, syringes, and scalpel blades.

“Medium HMIWI” means:

Except as provided in paragraph (2);

A HMIWI whose maximum design waste burning capacity is more than 200
pounds per hour but less than or equal to 500 pounds per hour; or

A continuous or intermittent HMIWI whose maximum charge rate is more
than 200 pounds per hour but less than or equal to 500 pounds per hour;
or

A batch HMIWI whose maximum charge rate is more than 1,600 pounds per
day but less than or equal to 4,000 pounds per day.

A HMIWI is not a "Medium HMIWI" if:

Its design waste burning capacity exceeds 500 pounds per hour; or

Its maximum charge rate exceeds 500 pounds per hour for continuous or
intermittent HMIWI or 4,000 pounds per day for batch HMIWI.

“Minimum dioxin/furan sorbent flow” means 90 percent of the highest
3-hour average dioxin/furan sorbent flow rate (taken, at a minimum, once
every hour) measured during the most recent performance test
demonstrating compliance with the dioxin/furan emission limit.

“Minimum mercury (Hg) sorbent flow rate” means 90 percent of the
highest 3-hour average Hg sorbent flow rate (taken, at a minimum, once
every hour) measured during the most recent performance test
demonstrating compliance with the Hg emission limit.

“Minimum hydrogen chloride (HCl) sorbent flow rate” means 90 percent
of the highest 3-hour average HCl sorbent flow rate (taken, at a
minimum, once every hour) measured during the most recent performance
test demonstrating compliance with the HCl emission limit.

“Minimum horsepower or amperage” means 90 percent of the highest
3-hour average horsepower or amperage to the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with all applicable emission limits.

“Minimum pressure drop across the wet scrubber” means 90 percent of
the highest 3-hour average pressure drop across the wet scrubber PM
control device (taken, at a minimum, once every minute) measured during
the most recent performance test demonstrating compliance with the PM
emission limit.

“Minimum scrubber liquor flow rate” means 90 percent of the highest
3-hour average liquor flow rate at the inlet to the wet scrubber (taken,
at a minimum, once every minute) measured during the most recent
performance test demonstrating compliance with all applicable emission
limits.

“Minimum scrubber liquor pH” means 90 percent of the highest 3-hour
average liquor pH at the inlet to the wet scrubber (taken, at a minimum,
once every minute) measured during the most recent performance test
demonstrating compliance with the HCI emission limit.

“Minimum secondary chamber temperature” means 90 percent of the
highest 3-hour average secondary chamber temperature (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the PM, carbon monoxide (CO), or
dioxin/furan emission limits.

“Modification or Modified HMIWI” means any change to an HMIWI unit
after the effective date of this regulation such that:

The cumulative costs of the modifications, over the life of the unit,
exceed 50 percent of the original cost of the construction and
installation of the unit (not including the cost of any land purchased
in connection with such construction or installation) updated to current
costs, or

The change involves a physical change in or change in the method of
operation of the unit which increases the amount of any air pollutant
emitted by the unit for which standards have been established under
section 129 or section 111 of the federal Clean Air Act.

39.1.39	“Operating day” means a 24-hour period between 12:00
midnight and the following midnight during which any amount of hospital
waste or medical/infectious waste is combusted at any time in the HMIWI.

39.1.40	“Operation” means the period during which waste is combusted
in the incinerator excluding periods of startup or shutdown.

39.1.41	“Particulate matter or PM” means the total particulate
matter emitted from an HMIWI as measured by EPA Reference Method 5 or
Reference Method 29.

39.1.42	“Pathological waste” means waste material consisting of only
human or animal remains, anatomical parts, and/or tissue, the
bags/containers used to collect and transport the waste material,  and
animal bedding (if applicable).

39.1.43	“Primary chamber” means the chamber in an HMIWI that
receives waste material, in which the waste is ignited, and from which
ash is removed.

39.1.44	“Pyrolysis” means the endothermic gasification of hospital
waste and/or medical/infectious waste using external energy.

39.1.45	‘’Secondary chamber” means a component of the HMIWI that
receives combustion gases from the primary chamber and in which the
combustion process is completed.

39.1.46	“Shutdown” means the period of time after all waste has been
combusted in the primary chamber.  For continuous HMIWI, shutdown shall
commence no less that 2 hours after the last charge to the incinerator.
For intermittent HMIWI, shutdown shall commence no less that 4 hours
after the last charge to the incinerator.  For batch HMIWI, shutdown
shall commence no less than 5 hours after the high-air phase of
combustion has been completed.

39.1.47	“Small HMIWI” means an HMIWI whose maximum design waste
burning capacity is less than or equal to 200 pounds per hour and which
has a maximum charge rate less than or equal to 200 pounds per hour for
continuous or intermittent HMIWI and less than or equal to 1,600 pounds
per day for batch HMIWI.

39.1.48	“Standard conditions” means a temperature of 20oC and a
pressure of 101.3 kilopascals.

39.1.49	“Startup” means the period of time between the activation of
the system and the first charge to the unit.  For batch HMIWI, startup
means the period of time between activation of the system and ignition
of the waste.

39.1.50	“Wet scrubber” means an add-on air pollution control device
that utilizes an alkaline scrubbing liquor to collect particulate matter
(including nonvaporous metals and condensed organics) and/or to absorb
and neutralize acid gases.

Applicability

Except as provided in subsections 39.2.2 through 39.2.7, the provisions
of this regulation shall apply to all HMIWI.

An incinerator is not subject to sections 39.3 through 39.10 of this
regulation if it is burning only pathological waste, low-level
radioactive waste, and/or chemotherapeutic waste, provided that the
owner or operator of the incinerator:

Has notified the Office of Air Resources, in writing, that it is burning
only pathological, low-level radioactive, and/or chemotherapeutic  waste
and has received a determination in writing from the Office of Air
Resources that it is not subject to those subsections; and

Records continuously, summarizes quarterly, and keeps available for
inspection for a period of five years records of all times when only
pathological waste, low-level radioactive waste, and/or chemotherapeutic
waste is burned.

A co-fired incinerator is not subject to sections 39.3 through 39.10 of
this regulation if the owner or operator of the incinerator:

Has notified the Office of Air Resources, in writing, that it is a
co-fired incinerator, and has received a determination from the Office
of Air Resources that it is not subject to those subsections;

As part of this notification, provides a range of the relative weights
of hospital waste, medical/infectious waste, and other fuels and/or
wastes to be combusted; and

Records continuously, summarizes quarterly, and keeps available for
inspection for a period of five years records of the type and weight of
hospital waste and medical/infectious waste burned, and the weight of
all other fuels and wastes burned at the co-fired incinerator.

Any combustor/incinerator required to have a permit under Section 3005
of the Federal Solid Waste Disposal Act is not subject to this
regulation.

Any combustor/incinerator which meets the applicability requirements
under subpart Cb, Ea, or Eb of 40 CFR Part 60 (standards or guidelines
for certain municipal waste combustors) is not subject to this
regulation.

Any pyrolysis unit, as defined in subsection 39.1.44, is not subject to
this regulation.

Physical or operational changes made to an existing HMIWI unit (those
constructed prior to June 20,1996) solely for the purpose of complying
with the requirements of this regulation shall not be considered a
modification as defined in subsection 39.1.38 and shall not cause the
HMIWI to be subject to the provisions in this regulation for new HMIWI
(those constructed after June 20, 1996).

For any HMIWI, this regulation supercedes Rhode Island Air Pollution
Control Regulation No.12 for those areas where there are overlapping
requirements.  HMIWI must comply with all applicable provisions of this
regulation.

Plan Submittals and Compliance Schedules

The owner or operator of a HMIWI subject to this regulation must submit
a HMIWI Emissions Control Plan (ECP) to the Office of Air Resources for
review and approval by October 20, 2000. If an ECP is not submitted by
October 20, 2000 or if the Department determines the ECP is not
approvable, the HMIWI shall immediately cease operations, and shall not
operate until an ECP is approved.  A HMIWI subject to this regulation
must operate pursuant to an operating permit issued according to the
provisions of RI APC Regulation No. 29, “Operating Permits.”  The
facility's operating permit will be modified upon approval of the ECP to
include all required elements of the ECP.  The ECP must contain the
following information:

The control efficiency, equipment description and specifications, and
standard operating and maintenance procedures for any control equipment
which will be used to comply with this regulation;

A proposed construction schedule and anticipated completion date for any
planned installation or modification of equipment to comply with this
regulation;

Any additional information requested by the Office of Air Resources
regarding the process and control equipment used to comply with this
regulation; and

A Waste Management Plan as specified in subsection 39.3.2; or

A closure plan if the facility plans to permanently cease operations
pursuant to subsection 39.3.5.

The Waste Management Plan must include the following:

A description of waste separation programs to be implemented at the
facility which, to the maximum degree feasible, remove from the waste
stream, prior to incineration, products that contribute to emissions of
hazardous air pollutants from the HMIWI.  The feasibility of removal of
the following products from the waste stream must be evaluated:
mercury-containing products, paper, cardboard, plastics, glass, battery,
metals, and materials that contain polyvinyl chloride (PVC) and/or other
dioxin/furan precursors;

A description of recycling programs to be implemented at the facility,
such as programs to recycle mercury products, paper, cardboard,
plastics, glass, batteries, materials which contain PVC and/or other
dioxin/furan precursors and metals; and/ or purchasing recycled or
recyclable products;

A description of reasonably available additional waste management
measures (for example, product substitution) which will be implemented
at the facility, taking into account the effectiveness of waste
management measures already in place, the costs of additional measures,
the emission reductions expected to be achieved, and any other
environmental or energy impacts associated with such measures;

Measures and milestones towards becoming a mercury free facility by
2003;

Milestones towards reducing PVC in the waste stream by 50% by 2003;

Dates that the programs and measures specified in paragraphs 39.3.2(a),
(b), and (c) will be implemented;

A statement that the HMIWI will require, through a contract or another
legally binding mechanism, that any other facility which generates and
transports hospital/ medical/ infectious waste to the HMIWI  for
incineration has adopted and is complying with a Waste Management Plan
consistent with that adopted by the HMIWI;

All aspects of this Waste Management Plan must be in compliance with the
RI DEM Office of Waste Management’s regulation entitled, “Rules and
Regulations Governing the Generation, Transportation. Storage,
Treatment, Management and Disposal of Regulated Medical Waste in Rhode
Island” (Regulation DEM-DAH-MW-01-92) and other applicable rules and
policies of that Office;

"An Ounce of Prevention: Waste Reduction Strategies for Health Care
Facilities," a 1993 publication by the American Society for Health Care
Environmental Services of the American Hospital Association, Chicago,
Illinois, shall be utilized in the development of the Waste Management
Plan.  This document is available for purchase from the American
Hospital Association (AHA) Service, Inc., Post Office Box 92683,
Chicago, Illinois 60675-2683. Other appropriate publications as they
become available should also be utilized in the development of the Waste
Management Plan; and

The Waste Management Plan may specify different goals or approaches for
different areas or departments at the facility and need not include
waste management goals for every waste stream.

Except as provided in subsections 39.3.4 and 39.3.6, any HMIWI subject
to this regulation must be in full compliance with the applicable
emission limitations specified in Section 39.5 of this regulation or
cease operations by October 20, 2000.

The owner of a HMIWI may apply for an extension to the compliance date
specified in subsection 39.3.3.  This extension request must be
submitted as part of the ECP, by the date specified in subsection
39.3.1, and must include the following information:

Reasons why the facility cannot comply with the requirements of this
regulation by the date specified in subsection 39.3.3.

The date by which contracts will be awarded and/or purchase orders
issued for any air pollution control systems and/or components or for
process modifications to comply with this regulation. All such awards
and orders must be issued by October 20, 2000.

The date that onsite construction or installation of any air pollution
control device(s) or process changes to comply with this regulation will
begin. All such construction or process changes must be initiated by
August 21, 2001.

The expected date of the completion of onsite construction or
installation of control equipment or process changes to comply with this
regulation. All such equipment installation and process changes must be
completed by August 21, 2002.

The date that final compliance with all applicable limitations will be
achieved. Final compliance must be achieved by September 16, 2002.

If the owner of a HMIWI plans to comply with this regulation by
permanently ceasing operation of the HMIWI, the owner or operator of the
HMIWI must submit a closure plan to the Office of Air Resources as part
of its ECP by October 20, 2000.  The closure plan must include the
following information:

The date that the facility will cease operation of the HMIWI.
Operations must cease by February 21, 2001 except as provided in
subsection 39.3.6.

The facility’s plans for disposal of waste previously incinerated in
the HMIWI after the incinerator ceases operation.

The owner or operator of a HMIWI which plans to comply with this
regulation by ceasing operations may apply to the Director for an
extension to the closure date specified in subsections 39.3.3 and
39.3.5(a) by submitting the following information as part of its ECP:

Justification of why an extension is warranted;

A written commitment to enter into an Administrative Consent Order with
the Department by February 21, 2001 which contains enforceable
milestones and commitments towards closure including a date that the
facility will cease operations.  In no case shall operations extend
beyond August 21, 2001.

Pre-construction Requirements

Any HMIWI for which construction commences after August 21, 2000, must
comply with all construction permit requirements in RI APC Regulation
No. 9.

Emission Limitations

Any HMIWI that commenced construction prior to June 20, 1996 must comply
with the emission limitations listed in Table 1(a) and subsection
39.5.1(a) by the applicable dates specified in section 39.3 of this
regulation.

Stack emissions shall not exhibit greater than 10 percent opacity
(6-minute block average).

Any HMIWI that commenced construction on or after June 20, 1996 must
comply with the emission limits listed in Table 1(b) according to the
applicable dates specified in Section 39.3, or upon commencing
operations, whichever is later.

Any HMIWI that commenced construction on or after June 20, 1996 must
also comply with the following fugitive ash emission limits by the
applicable dates specified in section 39.3 or upon start-up, whichever
is later:

Stack emissions shall not exhibit greater than 10 percent opacity
(6-minute block average);

Emissions of combustion ash from ash conveying systems (including
conveyor transfer points) at large HMIWI shall not be visible for more
than 5 percent of an observation period (i.e., 9 minutes per 3-hour
period), as determined by EPA Reference Method 22, except as provided in
paragraphs (c) and (d) of this section;

The emission limit specified in paragraph (b) of this section does not
apply to visible emissions discharged inside buildings or enclosures of
ash conveying systems; however, the emission limit does apply to visible
emissions discharged to the atmosphere from buildings or enclosures of
ash conveying systems; and

The provisions specified in paragraph (b) of this section do not apply
during maintenance and repair of ash conveying systems.  Maintenance
and/or repair shall not occur on more than 10 operating days per
calendar quarter unless the owner or operator obtains written approval
from the Office of Air Resources establishing a date whereby all
necessary maintenance and repairs of ash conveying systems shall be
completed.

The emission limits in subsections 39.5.1, 39.5.2, and 39.5.3 do not
apply during periods of startup or shutdown, provided that no hospital
waste or medical/infectious waste is charged to the HMIWI during those
periods.  During periods of malfunction the operator shall operate
within established parameters as much as possible, and shall continue
monitoring all applicable operating parameters until all waste has been
combusted or until the malfunction ceases, whichever comes first.  In
addition, the malfunction must be reported to the Office of Air
Resources within 24 hours.  A written report must be submitted to the
Office of Air Resources within 7 days, which includes the cause of the
malfunction, any exceedance, and actions taken to prevent reoccurrence.

Any violation of the emission limitations in subsections 39.5.1, 39.5.2,
and 39.5.3 must be reported to the Office of Air Resources within 24
hours.  A written explanation of the cause of the violation, the
magnitude of the exceedance and its duration, as well as actions taken
to prevent a reoccurrence must be submitted to the Office of Air
Resources within 7 calendar days.

Inspection & Repair Requirements

The owner or operator of any HMIWI subject to the emission limits in
Table 1(a) or Table 1(b), must conduct an initial equipment inspection
identifying any necessary repairs by October 20, 2000 and yearly
thereafter. All inspections must include the following:

Inspect all burners, pilot assemblies, and pilot sensing devices for
proper operation; clean pilot flame sensor, as necessary;

Ensure proper adjustment of primary and secondary chamber combustion
air, and adjust as necessary;

Inspect hinges and door latches, and lubricate as necessary;

Inspect dampers, fans, and blowers for proper operation;

Inspect HMIWI door and door gaskets for proper sealing;

Inspect motors for proper operation;

Inspect primary chamber refractory lining; clean and repair/replace
lining as necessary;

Inspect incinerator shell for corrosion and/or hot spots;

Inspect secondary/tertiary chamber and stack and clean as necessary;

Inspect mechanical loader, including limit switches, for proper
operation, if applicable;

Visually inspect waste bed (grates), and repair/seal, as appropriate;

For the burn cycle that follows the inspection, document that the
incinerator is operating properly and make any necessary adjustments;

Inspect air pollution control device(s) for proper operation, if
applicable;

Inspect waste heat boiler systems to ensure proper operation, if
applicable;

Inspect bypass stack components;

Ensure proper calibration of thermocouples, sorbent feed systems and any
other monitoring equipment; and

Generally observe that the equipment is maintained in good operating
condition.

Any equipment deficiencies identified in the inspections as required in
subsection 39.6.1 or as a result of an equipment failure shall be
completed within 10 days upon identification unless the owner or
operator obtains written approval from the Department establishing an
alternative date whereby all corrections of deficiencies shall be
completed.

Compliance and Performance Testing Requirements

Any HMIWI subject to the emissions limitations in Table 1(a) or Table
1(b) must conduct an initial performance test to demonstrate compliance
with those emission limits according to the following schedule:

Except as provided in paragraph (b) of this subsection, initial
performance tests for facilities constructed prior to August 21, 2000
shall be conducted by May 21, 2001.

If a compliance extension request was submitted by a facility according
to the provisions of subsection 39.3.4 and was approved by the Office of
Air Resources, an initial performance test of that HMIWI must be
conducted within 90 days after the equipment or process changes
necessary to comply with this regulation are complete, but not later
than September 16, 2002.

For HMIWI that commence construction on or after August 21, 2000,
initial performance tests must be conducted within 90 days after initial
startup of the HMIWI.

All stack testing must be observed by the Office of Air Resources or its
authorized representatives to be considered acceptable.

A performance test protocol must be submitted for review and approval to
the Office of Air Resources at least 60 days prior to conducting the
initial or repeat performance test.  The use of the bypass stack during
a performance test shall invalidate the performance test.  The initial
performance tests shall be conducted according to the following
specifications:

All performance tests shall consist of a minimum of three test runs
conducted under representative operating conditions;

The minimum sampling time shall be 1 hour per test run unless otherwise
required by the Office of Air Resources;.

EPA Reference Method 1 in appendix A of 40 CFR Part 60 shall be used to
select the sampling location and number of traverse points;

EPA Reference Method 3 or 3A in appendix A of 40 CFR Part 60 shall be
used for gas composition analysis, including measurement of oxygen
concentration.  EPA Reference Method 3 or 3A of appendix A of 40 CFR
Part 60 shall be used simultaneously with each reference method;

The pollutant concentrations shall be adjusted to 7 percent oxygen
using the following equation:

	Cadj = Cmeas (20.9-7)/(20.9-%O2)

			where:

			Cadj =	pollutant concentration adjusted to 7 percent oxygen;

			Cmeas =	pollutant concentration measured on a dry basis

		(20.9-7) =	20.9 percent oxygen - 7 percent oxygen (defined oxygen
correction basis);

			20.9 =	oxygen concentration in air, percent; and

			%O2 =	oxygen concentration measured on a dry basis, percent;

EPA Reference Method 5 or 29 of appendix A of 40 CFR Part 60 shall be
used to measure the particulate matter (PM) emissions;

EPA Reference Method 9 of appendix A of 40 CFR Part 60 shall be used to
measure stack opacity;

EPA Reference Method 10 or 10B of appendix A of 40 CFR Part 60 shall be
used to measure the carbon monoxide (CO) emissions;

EPA Reference Method 23 of appendix A of 40 CFR Part 60 shall be used to
measure total dioxin/furan emissions.  The minimum sampling time shall
be 4 hours per test run.   The following procedures should be used to
demonstrate compliance with the toxic equivalency quotient standards for
dioxins/furans specified in Table 1(a) or 1(b):

Measure the concentration of each dioxin/furan tetra- through
octa-congener emitted using EPA Reference Method 23.

For each dioxin/furan congener measured in accordance with subparagraph
39.7.2(i)1, multiply the congener concentration by its corresponding
toxic equivalency factor, as specified in Table 2 of this regulation.

Sum the products calculated in accordance with subparagraph 39.7.2(i)2
to obtain the total toxic equivalent quotient for dioxins/furans;

EPA Reference Method 26 of appendix A of 40 CFR Part 60 shall be used
to measure hydrogen chloride (HCl) emissions;

 EPA Reference Method 29 of appendix A of 40 CFR Part 60

shall be used to measure lead (Pb), cadmium (Cd), and mercury (Hg)
emissions.

EPA Reference Method 22 of Appendix A of 40 CFR Part 60 shall be used to
determine compliance with the fugitive ash emission limits for HMIWI
that commenced construction on or after June 20, 1996 specified in
subsection 39.5.3.  The minimum observation time shall be a series of
three 1-hour observations.

The owner of a HMIWI shall conduct periodic performance tests to
determine continuing compliance with the emission limits specified in
section 39.5 of this regulation for opacity, PM, CO, and HCl using the
applicable test methods specified in subsection 39.7.2. The use of a
bypass stack during a performance test shall invalidate the performance
test.  Periodic tests shall be conducted according to the following
schedule:

Except as provided in paragraph (b) of this subsection, periodic tests
shall be conducted no more than 12 months after the initial performance
test at the facility and, thereafter, no more than 12 months following
the previous performance test.

If, in a 3-year period, all three annual performance tests demonstrate
compliance with the emission limit for a pollutant (PM, CO, or HCl), the
frequency of testing for that pollutant may be reduced to once in three
years. If any performance test indicates noncompliance with an
applicable emission limit, performance tests for that pollutant shall be
conducted annually until all annual performance tests in a 3-year period
indicate compliance with the emission limit.  In no case shall the
period between performance tests for PM, CO, or HCl be longer than 3
years.

For large HMIWI that commenced construction on or after June 20, 1996,
continuing compliance with the visible emission limits for fugitive
emissions from fly ash/bottom ash storage and handling in paragraph
39.5.3(b) of this regulation must be demonstrated by conducting a
performance test using EPA Reference Method 22 no more than 12 months
after the initial performance test and annually thereafter.

HMIWI may use a CEMS to demonstrate continuing compliance with any of
the applicable emission limits in Table 1(a) or Table 1(b) provided
that:

Compliance with the applicable emission limit(s) is determined using a
12-hour rolling average, calculated each hour as the average of the
previous 12 operating hours (not including startup, shutdown, or
malfunction) and

All CEMS are operated in accordance with the applicable procedures
specified in appendices B and F of 40 CFR Part 60.

The owner or operator of a HMIWI equipped with a dry scrubber followed
by a fabric filter, a wet scrubber, or a dry scrubber followed by a
fabric filter and wet scrubber shall:

During the initial performance test, establish maximum and minimum
values for each of the applicable operating parameters listed in
Table 3 as site-specific operating parameters; and

Following the date on which the initial performance test is completed or
is required to be completed, whichever is earlier, ensure that the HMIWI
does not operate above any of the applicable maximum operating
parameters or below any of the applicable minimum operating parameters,
measured as 3-hour rolling averages (calculated each hour as the average
of the previous 3 operating hours) at all times except during periods of
startup, shutdown and malfunction.  Operating parameter limits do not
apply during performance tests.  Operation above the established maximum
or below the established minimum operating parameter(s) shall constitute
a violation of that operating parameter(s).

Except as provided in subsection 39.7.10, continuous compliance status
for HMIWI equipped with a dry scrubber followed by a fabric filter shall
be determined as follows:

Operation of the HMIWI above the maximum charge rate and below the
minimum secondary chamber temperature (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the CO emission
limit.

Operation of the HMIWI above the maximum fabric filter inlet
temperature, above the maximum charge rate, and below the minimum
dioxin/furan sorbent flow rate (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the dioxin/furan
emission limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum HCl sorbent flow rate (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the HCl emission
limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum Hg sorbent flow rate (each measured on a 3-hour rolling average)
simultaneously shall constitute a violation of the Hg emission limit.

Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.

Except as provided in subsection 39.7.10, continuous compliance status
for HMIWI equipped with a wet scrubber shall be determined as follows:

Operation of the HMIWI above the maximum charge rate and below the
minimum pressure drop across the wet scrubber or below the minimum
horsepower or amperage to the system (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the PM emission
limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum secondary chamber temperature (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the CO emission
limit.

Operation of the HMIWI above the maximum charge rate, below the minimum
secondary chamber temperature, and below the minimum scrubber liquor
flow rate (each measured on a 3-hour rolling average) simultaneously
shall constitute a violation of the dioxin/furan emission limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum scrubber liquor pH (each measured on a 3-hour rolling average)
simultaneously shall constitute a violation of the HCl emission limit.

Operation of the HMIWI above the maximum flue gas temperature and above
the maximum charge rate (each measured on a 3-hour rolling average)
simultaneously shall constitute a violation of the Hg emission limit.

Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.

Except as provided in subsection 39.7.10, continuous compliance status
for HMIWI equipped with a dry scrubber followed by a fabric filter and a
wet scrubber shall be determined as follows:

Operation of the HMIWI above the maximum charge rate and below the
minimum secondary chamber temperature (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the CO emission
limit.

Operation of the HMIWI above the maximum fabric filter inlet
temperature, above the maximum charge rate, and below the minimum
dioxin/furan sorbent flow rate (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the dioxin/furan
emission limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum scrubber liquor pH (each measured on a 3-hour rolling average)
simultaneously shall constitute a violation of the HCl emission limit.

Operation of the HMIWI above the maximum charge rate and below the
minimum Hg sorbent flow rate (each measured on a 3-hour rolling average)
simultaneously shall constitute a violation of the Hg emission limit.

Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.

The owner or operator of a HMIWI  may conduct a repeat performance test
within 30 days of violation of applicable operating parameter(s) to
demonstrate that the affected facility is not in violation of the
applicable emission limit(s).  Repeat performance tests conducted for
this purpose shall be conducted under the identical operating parameters
that indicated a violation under subsections 39.7.7, 39.7.8, or 39.7.9
of this regulation.  All stack testing must be observed by the Office of
Air Resources or its authorized representatives to be considered
acceptable.

The owner or operator of a HMIWI using an air pollution control device
other than a dry scrubber followed by a fabric filter, a wet scrubber,
or a dry scrubber followed by a fabric filter and a wet scrubber to
comply with the applicable emission limits in Table 1(a) or Table 1(b)
shall:

As part of the performance test protocol required in subsection 39.7.2,
the owner or operator must submit to the Director for approval
site-specific operating parameters to be monitored during the initial
performance test and continuously thereafter. The following information
must be included in the submittal:

A description of the facility, including the devices controlled with the
air pollution control device;

The proposed operating parameters to be monitored; and

Technical data and information demonstrating that the operating
parameters submitted to be monitored are sufficient for monitoring
operation of the alternative air pollution control device.

The owner or operator shall not conduct the initial performance test
until after the performance test protocol has been approved by the
Director.

Compliance with operating parameters shall be determined as follows:

During the initial performance test, establish maximum and minimum
values for each of the operating parameters approved by the Director as
site-specific operating parameters; and

Following the date on which the initial performance test is completed or
is required to be completed, ensure that the HMIWI does not operate
above any of the applicable maximum operating parameters or below any of
the applicable minimum operating parameters, measured as 3-hour rolling
averages (calculated each hour as the average of the previous 3
operating hours) at all times except during periods of startup, shutdown
and malfunction.  Operating parameter limits do not apply during
performance tests.  Operation above the established maximum or below the
established minimum operating parameter(s) shall constitute a violation
of that operating parameter(s).

The owner or operator of a HMIWI may conduct a repeat performance test
at any time to establish new values for the operating parameters.  The
Department may request a repeat performance test at any time. All stack
testing must be observed by the Office of Air Resources or its
authorized representatives to be considered acceptable.

Monitoring Requirements

The owner or operator of a HMIWI shall install, calibrate (to
manufacturers' specifications), maintain, and operate devices (or
establish methods) for monitoring and recording the applicable maximum
and minimum operating parameters listed in Table 3 at the frequencies
indicated in that table at all times except during periods of startup
and shutdown.

The owner or operator of a HMIWI shall install, calibrate (to
manufacturers' specifications), maintain, and operate a device or method
for measuring the use of the bypass stack including date, time, and
duration.

The owner or operator of a HMIWI using an air pollution control device
other than a dry scrubber followed by a fabric filter, a wet scrubber,
or a dry scrubber followed by a fabric filter and a wet scrubber to
comply with the emission limits in Table 1(a) or Table 1(b) shall
install, calibrate (to the manufacturers' specifications), maintain, and
operate the equipment necessary to monitor the site-specific operating
parameters established according to the provisions of subsection 39.7.11
of this regulation.

The owner or operator of a HMIWI shall obtain and record monitoring data
at all times during operation of the HMIWI except during periods of
monitoring equipment malfunction, calibration, or repair.  At a minimum,
valid monitoring data shall be obtained for 75 percent of the operating
hours per day and for 90 percent of the operating days per calendar
quarter that the HMIWI is combusting hospital waste and /or
medical/infectious waste.

Reporting and Recordkeeping Requirements

The owner or operator of any HMIWI subject to this regulation shall
maintain records of the following information, as applicable, for a
period of at least 5 years.  The records must be made available for
inspection, upon request by the Department:

Calendar date of each record;

Concentrations of pollutants listed in Table 1(a) or Table 1(b) and
measurements of opacity, as determined by the continuous emission
monitoring system, if applicable;

Results of fugitive emissions tests using EPA Reference Method 22, if
applicable;

HMIWI charge dates, times, and weights and hourly charge rates;

Fabric filter inlet temperatures during each minute of operation, as
applicable;

Amount and type of dioxin/furan sorbent used during each hour of
operation, as applicable;

Amount and type of Hg sorbent used during each hour of operation, as
applicable;

Amount and type of HCl sorbent used during each hour of operation, as
applicable;

Secondary chamber temperatures recorded during each minute of operation;

Liquor flow rate to the wet scrubber inlet during each minute of
operation, as applicable;

Horsepower or amperage to the wet scrubber during each minute of
operation, as applicable;

Pressure drop across the wet scrubber system during each minute of
operation, as applicable;

Temperature at the outlet from the wet scrubber during each minute of
operation, as applicable;

pH at the inlet to the wet scrubber during each minute of operation, as
applicable;

Records of all operating parameter data collected pursuant to subsection
39.8;

Records of each time the bypass stack was used, including date, time and
duration, reason for malfunction, and corrective action taken;

Records of periods for which the monitoring data specified in subsection
39.8 was not obtained, including the date, time, duration, an
identification of the emission rates or operating parameters not
measured, reasons for not obtaining the data, and a description of
corrective actions taken.

Identification of the calendar day, time and duration of any
malfunction, and a description of the malfunction and the corrective
action taken.

Identification of calendar days for which emission rates or operating
parameters exceeded the applicable limits, with a description of the
exceedance, reasons for the exceedance, and corrective actions taken.

The results of initial, annual, and any subsequent performance tests
conducted to determine compliance with the emission limits and/or to
establish operating parameters, as applicable.

All documentation produced to comply with the pre-construction
requirements specified in subsection 39.4;

Records of the names of HMIWI operators who have completed review of the
information specified in subsection 39.10.8, as required in subsection
39.10.9 of this regulation, including the date of the initial review and
all subsequent annual reviews;

Records of the names of HMIWI operators who have completed the operator
training and qualification requirements specified in subsections 39.10.3
through 39.10.7 of this regulation, including documentation of training
received, dates of training and dates of qualification;

Records of installation, calibration, inspection, operation and
maintenance of any monitoring devices used to comply with section 39.8
of this regulation; and

Records of annual equipment inspections, as required in section 39.6 of
this regulation, including required maintenance and repairs, and any
repairs not completed by the dates specified in subsection 39.6.2.

The owner or operator of a HMIWI shall submit the following information
to the Office of Air Resources, signed by the facilities manager, no
later than 60 days following the initial performance test:

Emissions rates, operating parameters, and other applicable data
pertaining to the initial performance test, as specified in paragraphs
(a) through (l) of subsection 39.7.2; and

The maximum and minimum values for the site-specific operating
parameters established pursuant to subsection 39.7.6 or 39.7.11 of this
regulation, as applicable.

The owner or operator of a HMIWI shall submit semiannual reports to the
Office of Air Resources for the reporting periods January1 – June 30
and July 1 – December 31.  The reports must be submitted no later than
60 days following the ending of the semiannual reporting period in which
the data were collected. The first semiannual reporting period ends
either June 30 or December 31, whichever comes first, following the
submission of information in subsection 39.9.2 of this regulation.  All
reports shall be signed by the facilities manager and all applicable
information and records in this report must be maintained for 5 years.
The report must include the following information:

Any information recorded under subsections 39.9.1(q) through 39.9.1(s)
of this regulation.

The maximum and minimum values for the site-specific operating
parameters established pursuant to subsection 39.7.6 or 39.7.11, as
applicable;

The highest and lowest values recorded for each applicable operating
parameter during the reporting period and during the calendar year of
the period being reported and the previous calendar year, as applicable;

Any information recorded pursuant to paragraphs (p) through (s) of
subsection 39.9.1of this regulation for the reporting period, the
calendar year being reported and the previous calendar year, as
applicable;

If no exceedances or malfunctions were reported under subsections
39.9.1(q) through 39.9.1(s) of this regulation for the reporting period,
a statement that no exceedance occurred during the reporting period; and

If a performance test was conducted during the reporting period, the
results of that test.

All records specified under subsection 39.9.1 of this regulation shall
be maintained onsite in either paper copy or computer-readable format,
unless an alternative format is approved by the Director. Records must
be signed by the facilities manager.

HMIWI Operation, Training, and Qualification Requirements

No owner or operator of an affected facility shall allow the facility to
operate at any time unless a fully trained and qualified HMIWI operator
is at the facility at all times that the HMIWI is operating.  The
trained and qualified HMIWI operator may operate the HMIWI directly or
be the direct supervisor of one or more HMIWI operators.

HMIWI operator training and qualification shall be obtained and
maintained according to the specifications in subsections 39.10.3
through 39.10.7 of this regulation.

HMIWI operator training shall be obtained by completing and passing an
HMIWI operator training course that includes, at a minimum, the
following elements:

24 hours of training on the following subjects:

Environmental concerns, including pathogen destruction and types of
emissions;

Basic combustion principles, including products of combustion;

Operation of the type of incinerator to be used by the operator,
including proper startup, waste charging, and shutdown procedures;

Combustion controls and monitoring;

Operation of air pollution control equipment and factors affecting
performance, if applicable;

Methods to monitor pollutants (i.e. continuous emission monitoring
systems and monitoring of HMIWI and air pollution control device
operating parameters) and equipment calibration procedures, where
applicable;

Inspection and maintenance of the HMIWI, air pollution control devices,
and continuous emission monitoring systems;

Actions to correct malfunctions or conditions that may lead to
malfunction;

Bottom and fly ash characteristics and handling procedures;

Applicable Federal, State, and local regulations;

Work safety procedures;

Pre-startup inspections; and

Recordkeeping requirements;

An examination designed and administered by the instructor; and

Reference material distributed to the attendees covering the course
topics.

HMIWI operator qualification shall be obtained by:

Completing and passing a training course that satisfies the criteria
listed in subsection 39.10.3 of this regulation; and

Either 6 months experience as an HMIWI operator, 6 months experience
as a direct supervisor of an HMIWI operator, or completion of at least
two burn cycles under the observation of two qualified HMIWI operators.

HMIWI operator qualification is valid for 1 year from the date on which
the examination specified in subsection 39.10.3 of this regulation is
passed, or the completion of the required experience specified in
subsection 39.10.4 of this regulation, whichever is later.

The trained and qualified HMIWI operator must maintain and renew
qualification yearly by completing and passing an annual review or
refresher course of at least 4 hours covering, at a minimum, the
following:

Applicable regulations;

Incinerator operation, including startup and shutdown procedures;

Inspection and maintenance;

Responses to malfunctions or conditions that may lead to malfunction;
and

Discussion of operating problems encountered by attendees.

A lapsed qualification for a HMIWI operator may be renewed by one of the
following methods:

For a lapse of less than 3 years, the HMIWI operator shall complete and
pass a standard annual refresher course described in subsection 39.10.6
of this regulation.

For a lapse of 3 years or more, the HMIWI operator shall complete and
pass a training course with the minimum criteria described in subsection
39.10.3 of this regulation.

The owner or operator of an affected facility shall maintain the
following documentation at the facility:

A summary of applicable Federal, State, and local regulations;

A description of basic combustion theory applicable to an HMIWI;

Procedures for receiving, handling, and charging waste;

HMIWI startup, shutdown, and malfunction procedures;

Procedures for maintaining proper combustion air supply levels;

Procedures for operating the HMIWI and associated air pollution control
systems according to the requirements of this regulation;

Procedures for responding to periodic malfunction or conditions that may
lead to malfunction;

Procedures for monitoring HMIWI emissions;

Reporting and recordkeeping procedures; and

Procedures for handling ash.

The owner or operator of an affected facility shall review the
information listed in subsection 39.10.8 of this regulation
semi-annually with each HMIWI operator according to the following
schedule:

The initial review of the information listed in subsection 39.10.8 of
this regulation shall be conducted by February 21, 2001 or prior to the
operator’s assumption of responsibilities affecting HMIWI operation,
whichever date is later.

Subsequent reviews of the information listed in subsection 39.10.8 of
this regulation shall be conducted annually (no later than 12 months
after the previous review).

The information listed in subsection 39.10.8 of this regulation shall be
kept in a readily accessible location for all HMIWI operators.  This
information, along with records of training, shall be available for
inspection by the Department or EPA upon request.

  Inspection and Entry

Employees of the Office of Air Resources and its authorized
representatives shall be allowed to enter any facility subject to this
regulation at all reasonable times for the purpose of:

Having access to and copying any applicable records to determine
compliance with this regulation;

Inspecting any equipment, practices, or operations required in this
regulation;

Sampling or monitoring substances or parameters for the purpose of
assuring compliance with this regulation or other applicable
requirements; and

Any other areas or operations the Director deems necessary.

Nothing in this regulation shall limit the ability of EPA to inspect or
enter the premises of a HMIWI under the provisions of the Clean Air Act.

No person shall obstruct, hamper, or interfere with any such authorized
representative while in the process of carrying out his/her official
duties.

General Provisions

Purpose

The purpose of this regulation is to limit emissions from hospital,
medical and infectious waste incinerators.

Authority

These regulations are authorized pursuant to R.I. Gen. Laws §
42-17.1-2(s) and 23-23, as amended, and have been promulgated pursuant
to the procedures set forth in the R.I. Administrative Procedures Act,
R.I. Gen. Laws Chapter 42-35

Application

The terms and provisions of this regulation shall be liberally construed
to permit the Department to effectuate the purposes of state law, goals
and policies.

Severability

If any provision of this regulation or the application thereof to any
person or circumstance, is held invalid by a court of competent
jurisdiction, the validity of the remainder of the regulation shall not
be affected thereby.

Effective Date

The foregoing regulation, "Hospital/Medical/Infectious Waste
Incinerators”, as amended, after due notice, is hereby adopted and
filed with the Secretary of State this ___29th__ day of ____June_______,
2007_ to become effective twenty (20) days thereafter, in accordance
with the provisions of Chapters 23-23, 42-35, 42-17.1, 42-17.6, of the
General Laws of Rhode Island of 1956, as amended.

W. Michael Sullivan, PhD., Director

Department of Environmental Management

Notice Given on:	February 21, 2007

Public Hearing held:	   March 23, 2007

Filing Date:	June 29, 2007

Effective Date:       July 19, 2007

Table 1 (a) .   Emission limits for HMIWI constructed on or before June
20, 1996

Pollutant

Units (7 percent oxygen, dry basis)

Emission limits

HMIWI size

	Small

	Medium

	Large

Particulate matter

milligrams per dry standard cubic meter (grains per dry standard cubic
foot)

115

(0.05)

69

(0.03)

34

(0.015)

Carbon monoxide

parts per million by volume

40

40

40

Dioxins/furans

either:

total dioxins/furans

nanograms per dry standard cubic meter

(grains per billion dry standard cubic feet), or

total dioxin/furan TEQ

 nanograms per dry standard cubic meter

(grains per billion dry standard cubic feet)

125

(55)

2.3

(1.0)

125

(55)

2.3

(1.0)

125

(55)

2.3

(1.0)

Hydrogen chloride

parts per million by volume

100

100

100

Sulfur dioxide

parts per million by volume

55

55

55

Nitrogen oxides

parts per million by volume

250

250

250

Lead

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

1.2

(0.52)

1.2

(0.52)

1.2

(0.52)

Cadmium

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

0.16

(0.07)

0.16

(0.07)

0.16

(0.07)

Mercury

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

0.055

(0.024)

0.055

(0.024)

0.055

(0.024)

Table 1(b).    Emission limits for HMIWI constructed after June 20, 1996

Pollutant

Units (7 percent oxygen, dry basis)

Emission limits

HMIWI size

	Small

	Medium

	Large

Particulate matter

milligrams per dry standard cubic meter (grains per dry standard cubic
foot)

69

(0.03)

34

(0.015)

34

(0.015)

Carbon monoxide

parts per million by volume

40

40

40

Dioxins/furans

either:

total dioxins/furans

nanograms per dry standard cubic meter

(grains per billion dry standard cubic feet), or

total dioxin/furan TEQ

 nanograms per dry standard cubic meter

(grains per billion dry standard cubic feet)

125

(55)

2.3

(1.0)

25

(11)

0.6

(0.26)

25

(11)

0.6

(0.26)

Hydrogen chloride

parts per million by volume

15

15

15

Sulfur dioxide

parts per million by volume

55

55

55

Nitrogen oxides

parts per million by volume

250

250

250

Lead

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

1.2

(0.52)

0.07

(0.03)

0.07

(0.03)

Cadmium

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

0.16

(0.07)

0.04

(0.02)

0.04

(0.02)

Mercury

milligrams per dry standard cubic meter (grains per thousand dry
standard cubic feet)

0.055

(0.024)

0.055

(0.024)

0.055

(0.024)

Table 2.     Toxic Equivalency Factors

Dioxin/furan congener	Toxic Equivalency

Factor

2,3,7,8-tetrachlorinated dibenzo-p-dioxin	1

1,2,3,7,8-pentachlorinated dibenzo-p-dioxin	0.5

1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin	0.1

1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin	0.1

1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin	0.1

1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin	0.01

octachlorinated dibenzo-p-dioxin	0.001

2,3,7,8-tetrachlorinated dibenzofuran	0.1

2,3,4,7,8-pentachlorinated dibenzofuran	0.5

1,2,3,7,8-pentachlorinated dibenzofuran	0.05

1,2,3,4,7,8-hexachlorinated dibenzofuran	0.1

1,2,3,6,7,8-hexachlorinated dibenzofuran	0.1

1,2,3,7,8,9-hexachlorinated dibenzofuran	0.1

2,3,4,6,7,8-hexachlorinated dibenzofuran	0.1

1,2,3,4,6,7,8-heptachlorinated dibenzofuran	0.01

1,2,3,4,7,8,9-heptachlorinated dibenzofuran	0.01

octachlorinated dibenzofuran	0.001

Table 3. Operating Parameters to be Monitored and Minimum Measurement
and Recording Frequencies

Operating parameters to be monitored	Minimum frequency	Control system

	Data measurement 	Data recording 	Dry scrubber followed by fabric
filter	Wet scrubber	Dry scrubber followed by fabric filter and wet
scrubber

Maximum operating parameters

Maximum charge rate	continuous	1 per hour	(	(	(

Maximum fabric filter inlet temperature 	continuous	1 per minute	(

(

Maximum flue gas temperature	continuous	1 per minute

 (

Minimum operating parameters

Minimum secondary chamber temperature	continuous	1 per minute	 (	 (	 (

Minimum dioxin/furan sorbent flow rate	hourly	1 per hour	(

(

Minimum HCl sorbent flow rate	hourly	1 per hour	 (

(

Minimum mercury (Hg) sorbent flow rate	hourly	1 per hour	 (

 (

Minimum pressure drop across the wet scrubber or minimum horsepower or
amperage to wet scrubber	continuous	1 per minute

 (	(

Minimum scrubber liquor flow rate	continuous	1 per minute

 (	(

Minimum scrubber liquor pH	continuous	1 per minute

 (	(

 Total dioxin/furan is the sum of the emissions of all tetra- through
octa-chlorinated dibenzo-p-dioxins and dibenzofurans, as measured by EPA
Reference Method 23. To calculate Toxic Equivalent Quantity (TEQ),
emissions of those congeners are weighted according to international
toxic equivalency factors and then summed.

 Total dioxin/furan is the sum of the emissions of all tetra- through
octa-chlorinated dibenzo-p-dioxins and dibenzofurans, as measured by EPA
Reference Method 23. To calculate Toxic Equivalent Quantity (TEQ),
emissions of those congeners are weighted according to international
toxic equivalency factors and then summed.

Page   PAGE  37  of 37


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43350-43351]
[FR Doc No: 2017-19564]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-486-000]

National Fuel Gas Supply Corporation; Notice of Application

    On August 22, 2017, National Fuel Gas Supply Corporation (National
Fuel), 6363 Main Street, Williamsville, New York 14221, filed an
application pursuant to section 7(c) of the Natural Gas Act (NGA) and
the Federal Energy Regulatory Commission's (Commission) regulations
seeking for a certificate of public convenience and necessity
authorizing the use of Well 7451 on an interim basis for up to three
years in order to withdraw storage gas to test the extent of
communication between the Beech Hill Storage Field located in Allegany
County, New York, and the Shongo Field, all as more fully set forth in
the application, which is open to the public for inspection. The filing
may also be viewed on the Web at http://www.ferc.gov using the eLibrary
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions regarding the National Fuel application should be
directed to Alice A. Curtiss, Deputy General Counsel for National Fuel,
6363 Main Street, Williamsville, New York 14221, or by phone (716) 857-
7949.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental

Review will serve to notify federal and state agencies of the timing
for the completion of all necessary reviews, and the subsequent need to
complete all federal authorizations within 90 days of the date of
issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on September 27, 2017.

    Dated: September 6, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-19564 Filed 9-14-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7734-7735]
[FR Doc No: 2018-03610]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0940]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LYMPHOSEEK

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for LYMPHOSEEK and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
23, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 21, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-0940 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; LYMPHOSEEK.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the

actual amount of extension that the Director of USPTO may award (for
example, half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product LYMPHOSEEK
(technetium (Tc 99m) tilmanocept). LYMPHOSEEK is indicated for
lymphatic mapping with a hand-held gamma counter to assist in the
localization of lymph nodes draining a primary tumor site in patients
with breast cancer or melanoma. Subsequent to this approval, the USPTO
received a patent term restoration application for LYMPHOSEEK (U.S.
Patent No. 6,409,990) from Navidea Biopharmaceuticals, Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated November 4,
2015, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of LYMPHOSEEK
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
LYMPHOSEEK is 4,398 days. Of this time, 3,816 days occurred during the
testing phase of the regulatory review period, while 582 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: February 28, 2001. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on February 28, 2001.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: August 10,
2011. FDA has verified the applicant's claim that the new drug
application (NDA) for LYMPHOSEEK (NDA 202207) was initially submitted
on August 10, 2011.
    3. The date the application was approved: March 13, 2013. FDA has
verified the applicant's claim that NDA 202207 was approved on March
13, 2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and under 21
CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03610 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P