Management of Empty Warfarin Containers or Acutely Hazardous Waste Pharmaceuticals  William Kulas, MBA., Vaiyapuri Subramaniam, PharmD., John Lechman, CIH, CHMM                                         Abstract: Objective:  The proper management of empty acutely hazardous waste pharmaceutical containers is a challenge to the healthcare industry including pharmacies, nursing homes, medical centers and hospitals.  This study (1) Solicited comments from the Environmental Protection Agency (EPA) to assist in the regulatory interpretation of empty Coumadin(R) (Warfarin) containers; (2) Quantified residual Warfarin in "empty" containers; (3) Developed a process to determine the weight of the residue generated and; (4) Analyzed the percentage of Warfarin in the residue to ensure proper waste characterization.   Practice Description:  EPA regulates the residue remaining in empty containers of acutely hazardous waste found in pharmaceutical operations as a hazardous waste.  Facilities count the container weight and the remaining residue in their calculation to determine hazardous waste generator status.  This calculation frequently results in the facility being classified as a large quantity generator.   Practice Innovation:  The Warfarin residue was quantified and found to be miniscule.  A practical method of quantifying residue was developed to ensure the empty Warfarin containers are properly classified and managed.    The percent of Warfarin in the residue was analyzed to determine if the residue would meet the definition of "p" listed waste or "u" listed waste in the hazardous waste regulations.   Conclusion:  Implementing proper management controls for empty Warfarin containers can result in the determination of proper generator status for health care facilities, pharmacies and other areas that dispense Warfarin.  Many of these facilities are small quantity generators of hazardous waste versus large quantity generators of hazardous wastes when proper management controls are in place. Introduction The Department of Veterans Affairs (VA) Veterans Health Administration (VHA), has sought regulatory guidance for empty containers that previously held or contained pharmaceuticals that are on the "p" list of commercial chemical products identified in 40 CFR §261.33(e).  "P" listed wastes are acutely hazardous wastes when discarded.  This study focused solely on Warfarin due to the volume of prescriptions in the VA for it.  When a facility generates or accumulates more than 1 kg of acute hazardous waste per month, the generator is subject to the increased regulatory burden as a large quantity generator (40 CFR 262-270).  This study sought a regulatory interpretation of how empty containers of "p" listed materials count towards the generator status of a facility, to quantify the warfarin residue in the different sized containers, strengths and formulations used in the VA and to  determine the percentage of Warfarin  in the residue to enable proper characterization of this waste stream.   Objectives This study reports the results of a quantitative analysis of the amount Warfarin residue in empty containers.  The steps taken were as follows:  (1) Review the regulations concerning the management of empty "p" listed containers, (2) Request letters of interpretation where the regulations were not clear, (3) Quantify the amount of residue left in empty containers to provide a conservative determination of generator status, and (4) Quantify the percentage of Warfarin in the residue to determine if it meets the characteristics of a "p" listed or "u" listed waste. Methods The VHA requested EPA's interpretation  on the proper management of empty Warfarin stock bottles on August 10, of 2011.  Specifically, clarification was requested on the following questions:    * Should empty Warfarin stock bottles be managed as a hazardous waste?    * Is the weight of the Warfarin stock bottle or only the warfarin residue therein counted toward monthly generator status?    * Is the volume of the Warfarin stock bottle or only the warfarin residue therein counted toward the one quart limit for acutely hazardous waste at a satellite accumulation area? Answers to those questions were provided on October 19, 2011, by EPA Region I and again on November 4, 2011, by EPA Headquarters. Both interpretation letters stated that it is the residue's weight and not the container's weight that is regulated and counted towards generator status.  In the interpretation letter from EPA Region I, it recommended that a process should be developed to accurately and readily determine the amount of residues in such bottles.  Based upon the interpretation from the EPA the next part of this study was to quantify the amounts of residue left in various container sizes and doses to ensure that accurate monthly generator status calculations can be made.    The "p" listing for warfarin is unusual in that it is concentration-based.  Warfarin and its salts at a concentration of >0.3 % are listed as a P001 in 40 CFR 261.33 (e) while warfarin salts at a concentration of <0.3% is listed as U248 in 40 CFR 261.33 (f).  The final part of the study was to analyze the percentage of Warfarin in the residue to determine if the residue remaining in these containers would carry the "p" listing or the "u" listing as hazardous wastes An environmental lab, Bureau Veritas, was chosen to analyze the samples.  Seventeen different combinations of empty Warfarin containers with different dose and bottle sizes were collected from the VHA Pharmacy Benefits Management (PBM) Services' Consolidated Mail Outpatient Pharmacies (CMOPs).  Since all the potential warfarin containers generated by the VHA were not tested, the samples were weighted towards high count (1000 pill bottles) or high dose to the extent feasible.  Five or six replicates of each bottle size and dose were submitted to the laboratory from different CMOP locations between February 28, 2013 and May 24, 2013 to enable a statistical analysis. Results Regulatory Interpretation The EPA issued a  regulatory interpretation in a Regional Letter on October 19, 2011, and a national letter on November 4, 2011.  It highlighted the regulatory status of Commercial Chemical Product residues that is specifically addressed in 40 CFR § 261.33 which states: 	"The following materials or items are hazardous wastes if and when they are discarded or intended to be discarded.... 	(c) Any residue remaining in a container or in an inner liner removed from a container that has held any commercial chemical product or manufacturing chemical intermediate having the generic name listed in paragraphs (e ) or (f) of this section, unless the container is empty as defined in § 261.7(b) The letter reiterates that it is only the residue in the non RCRA (Resource Conservation and Recovery Act) empty container that is considered a P-listed waste; the container itself is not a "p" listed hazardous waste.  Thus only the weight of the residue in the container needs to be counted towards generator status. The interpretation letter from EPA Region I, however, further states that: 	"In order to determine the amount of P-listed hazardous waste or residue remaining in empty stock bottles for the purpose of monthly generator status determinations, the generator would need to develop a process by which the amount of waste or residue remaining in such bottles can be accurately and readily determined.  The process should adequately address how the amounts of waste or residue from different size bottles/containers of specific P-listed hazardous waste and form is determined so that the amount of waste residues generated from collected bottles/containers, possibly of various sizes, can be readily determined.... to ensure that accurate monthly generator status calculations are made.   Based upon the EPA's interpretation, this study developed a process to quantify the amount of residue remaining in bottles/containers of various  sizes and dosage strengths. The EPA Headquarters letter also stated that they "do not have, nor have we received, data regarding the concentration of warfarin in the residue remaining in fully dispensed containers of warfarin.  Generators have indicated that some doses of warfarin pills contain concentrations high enough to meet the "p" listing.  But if a generator conducted analysis on the warfarin residues remaining in a fully dispensed container and the concentration of the residues is <0.3 % warfarin, then the residues ..... would be regulated as U248 hazardous waste."  The last part of the study investigated the concentrations of warfarin in the residues to determine if a "p" or "u" listing was the most appropriate.  Mass of Total Residue per Bottle

Five or six samples of seventeen different products in either 100 or 1000 pill containers  were evaluated to determine the total residue of Warfarin.  Each bottle was triple rinsed with deionized water to remove any residue and to render the container "RCRA empty". The rinsates were combined in a weighed glass beaker and evaporated to dryness in a low temperature oven. The beaker was re weighed again to calculate the mass of total residue in each container. Results for total residue are reported in Table 1 as the average mass of residue per product code and bottle type in milligrams. The one sided 95% upper confidence limit was calculated (milligrams) and used to provide a conservative figure for Warfarin residue.  The results show that the most residue left in a 1000 pill empty container was the 85 mg found in the 6 mg dose of Product Code W0051.  A one sided, 95% upper confidence limit for the residue (mg) was calculated to be 125 mg.  The most residue left in a 100 pill container was 7.8 mg in the 10 mg dose of Product Code W0037.  A one sided, 95% upper confidence limit for the residue (mg) was calculated to be 16 mg.

Mass of Warfarin per Bottle

Each bottle type was then evaluated for concentration of Warfarin in the residue to determine if the residue met the definition of  a "p" listed or "u" listed material.  Residues from three replicates of each bottle type were evaluated for Warfarin concentration. The residue was extracted in a 1:1 solution of methanol and water, and the extracts were analyzed using high pressure liquid chromatography (HPLC).  The results of the Warfarin analysis are reported as an average mass of Warfarin per bottle (milligrams), and as the average concentration of Warfarin in the total residue (percentage).  As all percentages are greater than 0.3% the "p" listing at P001 is the appropriate waste characterization. Table 1

                              Sample Information                               Total Residue (n=6)                                 Warfarin (n=3) Product Code  Warfarin Dose  Tablet Count  Average Mass  (mg)  One sided 95% upper confidence limit for the residue (mg)  Average Mass  (mg)  Mass Warfarin per Mass Total Residue  (%)  W0051  6 mg  1000  85  125  3.7  5.1%  W0050  5 mg  1000  48  74  1.8  4.1%  W0049  4 mg  1000  68  109  2.4  3.0%  W0048  3 mg  1000  55  69  1.2  2.1%  W0046  2 mg  1000  60  81  0.7  1.1%  W0044  2.5 mg  1000  50  60  0.5  1.0%  W0039  1 mg  1000  67  80  0.5  0.8%  W0038  7.5 mg  100  7.8  15  0.1  1.4%  W0037  10 mg  100  7.7  16  0.2  2.7%  W0017  3 mg  100  3.4  12  0.02  0.5%  W0013  4 mg  100  4.8  6.6  0.1  1.7%  W0009  1 mg  1000  42  70  0.4  0.7%  W0005*  7.5 mg  100  5.0  7.1  0.2  3.9%  W0004  5 mg  1000  61  91  2.4  3.9%  W0003  2 mg  1000  33  43  0.6  1.7%  W0002  2.5 mg  1000  44  57  0.9  1.9%  W0001  10 mg  100  4.2  6.5  0.2  4.4%  * Five replicates (n=5) for total residue for sample W0005

Quality Control Samples

The method was evaluated by weighing duplicate known amounts of Warfarin sodium into a bottle. The bottle was triple rinsed, and the rinsates were combined in a weighed glass beaker and evaporated to dryness. The dried residue was extracted in a 1:1 solution of methanol and water and analyzed using HPLC. The results are reported in table 2 below.

Table 2

                            Quality Control Sample                          Mass of Warfarin Sodium (mg)                            Warfarin Recovery by HPLC Laboratory Control Spike                                      1.40                                       99% Laboratory Control Spike Duplicate                                      1.73                                      107%

Estimation of Bottle Accumulation to EPA Waste Rules

We estimated, using the 95% confidence limit for the residue and the highest doses available, that it would take 7,602 empty warfarin 1000 pill containers or 60,320 empty warfarin 100 pill containers to meet the EPA regulatory limit of 2.2 pounds or 1 kg of warfarin residue.   We estimated the number of 55 gallon drums that could be filled with empty Warfarin bottles without exceeding the EPA threshold of 1 kilogram of total residue.  A facility could generate in any one month or accumulate at any one time 14 standard sized 55 gallon drums of 1000 pill empty containers or 26 standard sized 55 gall drums of 100 pill empty containers.  (See attachment 1 for the calculations)

Discussion VHA Healthcare facilities and Consolidated Mail Order Pharmacies (CMOP) have been counting the weight of the container of empty "p" listed pharmaceuticals containers in calculating their generator status because there has not been a process developed that can accurately and readily determine the amount of residue that is found in the various sizes and dosages of collected bottles and containers.  Many of these facilities have exceeded the 1 kilogram threshold monthly generation/accumulation rate or total accumulation rate and have become Large Quantity Generators.  By developing a systematic process based upon test results of residues in bottles/containers of various sizes and dosages, healthcare and CMOP facilities now have data to quantify the amount of "p" listed residues that are generated.  In many cases this will allow the facility to change their regulatory status from Large Quantity Generator to Small or Conditionally Exempt Small Quantity Generator as  defined in 40 CFR 261.5.   The results of this study will enable processes to be developed that can be used to calculate the actual amount of Warfarin remaining in empty containers, the actual amounts generated in any one month, or the actual amounts accumulated at any one time. This study demonstrates that a facility can either generate or accumulate 7,602 containers or 14 (55 gallon) drums of empty Warfarin 1000 pill containers or 60,320 containers or 26 (55 gallon) drums of empty Warfarin 100 pill containers before reaching the 1 kg limit of a Small Quantity Generator.  It is beneficial to the facility to manage these containers so that the facility does not reach these amounts at any time.   Facilities are required to calculate their generator status on a monthly basis.  By using the actual results of the warfarin remaining in empty pill containers facilities can potentially keep the facility under the limit of 1 kilogram.  A management option would be to separate the 1000 and 100 pill container sizes into separate drums and use 0.068 kg and 0.037 kg respectively for the amount of Warfarin contained in a 55 gallon drum.  The Warfarin residue carries the "p" listing and not the "u" listing based upon the concentration of Warfarin found in the residue.

Limitations Facilities may generate other acute hazardous wastes that, when combined with the "p" listed container residues, would cause the facility to exceed the 1 kg monthly threshold.  Facilities need to be aware of all wastes generated at the facility before the generator determination is made.   Conclusion Many Healthcare facilities and Consolidated Mail Order Pharmacies that have previously reported their generator status as Large Quantity Generator can now file as a Small Quantity Generator using the information provided in this study. Accurate monthly generator status calculations are required.  The one-kilogram generation and accumulation threshold for P-listed acutely hazardous wastes may affect the regulatory status of many facilities.  Exceeding these thresholds subjects these generators to the large quantity generator requirements.  Documentation of the process used to make this determination should be maintained on site and be readily available for inspection. Article Notes Disclaimer:  The opinions expressed are those of the authors and do not represent the views of the Department of Veterans Affairs (VA).  No official support or endorsement by the VA is intended or should be inferred.

Attachment 1: A standard 55 gallon drums has an inner dimensions of about 22.5 inches in diameter (11.25 inches in radius) and 33.5 inches in height, for an approximate volume of 13,320 cubic inches.   Volume of a cylinder = PI r ²  x h, where r = radius and h = height

Volume a 55 gallon drum = PI x (11.25 inches) ² x 33.5 inches = 13,320 inches³

1000 Tablet Bottles

There were two types of 1000 tablet bottles. The calculations are based on the smaller of the two bottles to present a worst-case scenario.

The dimensions of the bottle were measured. The radius, r, was approximately 1.25 inches and the height, h, was 5 inches. The estimation of the volume was calculated in square inches, according to the calculation below.

Estimated Volume = PI r²  x h = PI x (1.25 inches) ²  x 5 inches = 24.5 inches³/bottle

The maximum number of bottles that could fit into a 55 gallon drum was calculated by dividing the volume of a 55 gallon drum by the volume of a bottle.

      13,320 inches³     x       Bottle       =     543 bottle/drum                   Drum                     24.5 inches

The total amount of pill residue in a 55 gallon drum filled with empty 1000 tablet Warfarin bottles was calculated by multiplying the maximum number of bottles per drum with the largest mass (one sided upper confidence limit) of pill residue (W0051) in a 1000 tablet bottle and converting to kilograms. The one sided upper limit of the largest mass was used to present a worst-case scenario.

	543 bottles	x	125 mg residue		x	1kg	         =0.068 kg residue/drum                  Drum                                 bottle                             1,000,000 mg

Based on these calculations, 14 (55 gallon) drums of empty 1000 tablet Warfarin bottles could be stored on site without exceeding the limit of 1 kg of total residue.

100 Tablet Bottles

The same calculations were done for the 100 tablet bottles. There were two types of 100 tablet bottles. The calculations are based on the smaller of the two bottles to present a worst-case scenario.

The dimensions of the bottle were measured. The radius, r, was approximately 0.75 inches and the height, h, was 3.25 inches. An estimation of the volume of the bottle was calculated in square inches, according to the calculation below.

Estimated Volume = PI r ²   x h = PI x (0.75 inches) ²   x 3.25 inches =5.74 inches³/bottle

The maximum number of 100 tablet bottles that could fit into a 55 gallon drum was calculated by dividing the volume of a 55 gallon drum by the volume of a bottle.

          13,320 inches³    x       bottle               =          2,320 bottles/drum                  Drum                5.74 inches³

The total amount of pill residue in a 55 gallon drum filled with empty 100 tablet Warfarin bottles was calculated by multiplying the maximum number of bottles per drum with the largest mass (one sided upper confidence limit) of pill residue in a 100 tablet bottle (W0037) and converting to kilograms. The one sided upper limit of the largest mass was used to present a worst-case scenario.

    2,320 bottles     x     16 mg residue     x          1 kg          =     0.037 kg of residue/drum           Drum                         bottle                  1,000,000

Based on these calculations, 26 (55 gallon) drums of empty 100 tablet Warfarin bottles could be stored on site without exceeding the limit of 1 kg of total residue.

References    1.  Memorandum from Suzanne Rudzinksi, Director of Environmental Protection Agency Office of Resource Conservation and Recovery dated November 4, 2011 to RCRA Division Directors, EPA Regions 1-10.    2.  Memorandum from Mary Sanderson, Chief Remediation and Restoration II Branch, Office of Site Remediation and Restoration (OSRR07-2), United States Environmental Protection Agency, Region 1, dated October 19, 2011 entitled Empty Warfarin Container Interpretation (warfarin stock bottles)    3.  40CFR . § 261.7(b)    4.  40 CFR § 261.33


[Federal Register Volume 86, Number 85 (Wednesday, May 5, 2021)]
[Notices]
[Pages 23957-23958]
[FR Doc No: 2021-09520]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2242-125]

Eugene Water and Electric Board; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amended Recreation and Aesthetics Management
Plan.
    b. Project No: 2242-125.
    c. Date Filed: January 8, 2021.
    d. Applicant: Eugene Water and Electric Board.
    e. Name of Project: Carmen-Smith Hydroelectric Project.
    f. Location: The project is located on the McKenzie River in Lane
and Linn counties, Oregon and occupies 624.56 acres of federal lands
administered by the U.S. Forest Service.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Scarlett Philibosian, Eugene Water and
Electric Board, 500 East 4th Avenue, Eugene, OR 97440; telephone (541)
685-7120; or email<EMAIL_ADDRESS>    i. FERC Contact: Mark Ivy,<PHONE_NUMBER>, or<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: June 1, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-2242-125. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensees filed an amended
Recreation and Aesthetics Management Plan (plan) which incorporates
changes requested by the U.S. Forest Service to align the plan with
current agency management strategies and proposes additional
modifications, for Commission approval. The recreation facilities
available at many recreation sites would

be revised to match existing conditions, the existing and planned
recreation facilities accessible to persons with disability would be
updated, the implementation schedule for developing recreation
facilities would be modified, and the public would no longer be
notified of planned high flow releases in the bypass reaches.
    l. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659. Agencies may obtain copies of the application directly
from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: April 29, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-09520 Filed 5-4-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Page 1411]
[FR Doc No: 2016-00404]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2484-000]

Gresham Municipal Utilities; Notice of Authorization for
Continued Project Operation

    On November 22, 2010, Gresham Municipal Utilities, licensee for the
Gresham Hydroelectric Project, filed an Application for a New License
pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Gresham Hydroelectric Project is located on
the Red River in Shawano County, Wisconsin.
    The license for Project No. 2484 was issued for a period ending
December 31, 2015. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2484 is issued to
the licensee for a period effective January 1, 2016 through December
31, 2016 or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
December 31, 2016, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, Gresham Municipal Utilities is
authorized to continue operation of the Gresham Hydroelectric Project,
until such time as the Commission acts on its application for a
subsequent license.

    Dated: January 6, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-00404 Filed 1-11-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Rules and Regulations]
[Pages 58405-58407]
[FR Doc No: 2016-20307]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R02-OAR-2016-0088; FRL-9951-24-Region 2]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Virgin Islands; Sewage Sludge Incinerators

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve the Clean Air Act (CAA) section 111(d)/129
negative declaration for the Government of the United States Virgin
Islands, for existing sewage sludge incinerator (SSI) units. This
negative declaration certifies that existing SSI units subject to
sections 111(d) and 129 of the CAA do not exist within the jurisdiction
of United States Virgin Islands. The EPA is accepting the negative
declaration in accordance with the requirements of the CAA.

DATES: This direct final rule will be effective October 24, 2016,
without further notice, unless the EPA receives adverse comment by
September 26, 2016. If EPA receives adverse comment, we will publish a
timely withdrawal of the direct final rule in the Federal Register
informing the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R02-
OAR-016-0088), to http://www.regulations.gov. Follow the online
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.

FOR FURTHER INFORMATION CONTACT: Edward J. Linky, Environmental
Protection Agency, Air Programs Branch, 290 Broadway, New York, New
York 10007-1866 at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to the EPA. This section provides additional information
by addressing the following:

I. Background
II. Analysis of State Submittal
III. Statutory and Executive Order Reviews

I. Background

    The Clean Air Act (CAA) requires that state \1\ regulatory agencies
implement the emission guidelines and compliance times using a state
plan developed under sections 111(d) and 129 of the CAA.
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    \1\ Section 302(d) of the CAA includes the Virgin Islands in the
definition of the term ``State.''
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    The general provisions for the submittal and approval of state
plans are codified in 40 CFR part 60, subpart B and 40 CFR part 62,
subpart A. Section 111(d) establishes general requirements and
procedures on state plan submittals for the control of designated
pollutants.
    Section 129 requires emission guidelines to be promulgated for all
categories of solid waste incineration units, including SSI units.
Section 129 mandates that all plan requirements be at least as
protective and restrictive as the promulgated emission guidelines. This
includes fixed final compliance dates, fixed compliance schedules, and
Title V permitting requirements for all affected sources. Section 129
also requires that state plans be submitted to

the EPA within one year after the EPA's promulgation of the emission
guidelines and compliance times.
    States have options other than submitting a state plan in order to
fulfill their obligations under CAA sections 111(d) and 129. If a State
does not have any existing Sewage Sludge Incineration (SSI) units for
the relevant emissions guidelines, a letter can be submitted certifying
that no such units exist within the State (i.e., negative declaration)
in lieu of a state plan.
    The negative declaration exempts the State from the requirements of
subpart B that would otherwise require the submittal of a CAA section
111(d)/129 plan.
    On March 21, 2011 (76 FR 15372), the EPA established emission
guidelines and compliance times for existing SSI units. The emission
guidelines and compliance times are codified at 40 CFR 60, subpart
MMMM.
    In order to fulfill obligations under CAA sections 111(d) and 129,
the Government of the United States Virgin Islands (USVI) Department of
Planning and Natural Resources (DPNR) submitted a negative declaration
letter to the EPA on December 1, 2015. As the USVI-DPNR has certified
by letter that no SSI units exist, the submittal of this declaration
exempts the Territory from the requirement to submit a state plan for
existing SSI units.

II. Analysis of State Submittal

    In this Direct Final action, the EPA is amending part 62 to reflect
receipt of the negative declaration letter from the USVI-DPNR,
certifying that there are no existing SSI units subject to 40 CFR part
60, subpart MMMM, in accordance with section 111(d) of the CAA.
    If a designated facility (i.e., existing SSI unit) is later found
within USVI-DPNR's jurisdiction after publication of this Federal
Register action, then the overlooked facility will become subject to
the requirements of the Federal plan for that designated facility,
including the compliance schedule. The Federal plan will no longer
apply, if we subsequently receive and approve the section 111(d)/129
plan from the jurisdiction with the overlooked facility.
    The EPA is publishing this direct final rule without a prior
proposed rule because we view this as a noncontroversial action and
anticipate no adverse comment. However, in the ``Proposed Rules''
section of this Federal Register, we are publishing a separate document
that will serve as the proposed rule to approve the negative
declaration if adverse comments are received on this direct final rule.
We will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document. If the EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that
this direct final rule will not take effect. We will address all public
comments in any subsequent final rule based on the proposed rule.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a 111(d)/
129 plan submission that complies with the provisions of the Act and
applicable Federal regulations. 40 CFR 62.04.
    Thus, in reviewing 111(d)/129 plan submissions, the EPA's role is
to approve state choices, provided that they meet the criteria of the
CAA. Accordingly, this action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under
the provisions of the Paperwork Reduction Act (44 U.S.C. Sec.  3501
et seq.);
     Is certified as not having a significant economic
impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. Sec.  601 et seq.);
     does not contain any unfunded mandate or significantly
or uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. Sec.  104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62
FR 19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
Sec.  272 note) because application of those requirements would be
inconsistent with the Clean Air Act; and
     does not provide EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16,
1994).

    This action does not have tribal implications as specified by
Executive Order 13175. The section 111(d)/129 plan is not approved to
apply on any Indian reservation land or in any other area where the EPA
or an Indian tribe has demonstrated that a tribe has jurisdiction.
Thus, Executive Order 13175 does not apply to this section.
    The Congressional Review Act, 5 U.S.C. Sec.  801 et seq., as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. The EPA will submit a report containing
this action and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the rule in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. Sec.  804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 24, 2016.
    Filing a petition for reconsideration by the Administrator of this
final rule does not affect the finality of this action for the purposes
of judicial review nor does it extend the time within which a petition
for judicial review may be filed, and shall not postpone the
effectiveness of such rule or action. This action may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Administrative
practice and procedure, Intergovernmental relations, Reporting and
recordkeeping requirements, Sewage sludge incinerators.

    Dated: August 8, 2016.
Judith A. Enck,
Regional Administrator, Region 2.

    For the reasons stated in the preamble, EPA amends 40 CFR part 62
as set forth below:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart CCC--Virgin Islands

0
2. Add an undesignated center heading and Sec.  62.13357 to subpart CCC
to read as follows:

Air Emissions From Existing Sewage Sludge Incineration Units
Constructed on or Before October 14, 2010

Sec.  62.13357  Identification of plan--negative declaration.

    Letter from the Virgin Islands Department of Planning and Natural
Resources, submitted December 1, 2015 to EPA Regional Administrator
Judith A. Enck, certifying that there are no existing Sewage Sludge
Incinerator units in the Territory of the United States Virgin Islands
subject to 40 CFR part 60, subpart MMMM.

[FR Doc. 2016-20307 Filed 8-24-16; 8:45 am]
 BILLING CODE 6560-50-P