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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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REGION 8
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1595 Wynkoop Street
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Denver, CO   80202-1129
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Phone<PHONE_NUMBER>
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www.epa.gov/region8

Ref: 8ARD-PM

Mr. Mike Natchees
Director, Air Quality Program
Energy and Minerals Division
Ute Indian Tribe
P.O. Box 70
Fort Duchesne, Utah  84026

Dear Mr. Natchees:

The U.S. Environmental Protection Agency Region 8 is proposing to issue a synthetic minor permit for the KGH Operating Company (KGH), Bonanza State 20-15H Compressor Station on the Uintah and Ouray Indian Reservation. As requested by KGH, this permit would incorporate enforceable requirements for the installation and operation of two field gas fired, 4-stroke, rich-burn compressor engines using catalytic emissions control systems. KGH also requested enforceable requirements to install and operate two flares to control volatile organic compounds from the two separators and six storage tanks on site, as well as a throughput limit on flared gas. This permit is only intended to incorporate requested emission limits and provisions from the permit application for existing emissions units operating at the facility.

A public comment period for the proposed permit will begin on August 6, 2019, and end on September 4, 2019.

We have enclosed a CD and paper copy containing the proposed permit and supporting documentation, and we ask that you please make this material available for public review until the end of the public comment period. Comments may be submitted by mail, via email to<EMAIL_ADDRESS>or through regulations.gov (Docket ID #EPA-R08-OAR-2018-0342). In addition, we have provided copies of the bulletin board public notice announcement and would appreciate it if you would post this announcement in prominent locations in your area. All of these documents will also be available for review in electronic format on our website at: https://www.epa.gov/caa-permitting/caa-permit public-comment-opportunities-region-8.

If you have any questions concerning the enclosed proposed permit or technical support documents, please contact Patrick Wauters, of my staff, at<PHONE_NUMBER>.

                                       Sincerely,

                                 	   Carl Daly
                                    Acting Director
                                      Air and Radiation Division

Enclosures


 1 March 15, 2005 MEMORANDUM From: William H. Maxwell CG/ ESD ( C439 01)

To: CAMR docket OAR 2002 0056 Subject: Analysis of operating oil fired electric utility steam generating units In EPA's February 1998 " Study of Hazardous Air Pollutant Emissions from Electric Utility Steam Generating Units: Final Report to Congress" ( RtC; A 92 55, I A 90), we stated that the majority of the 137 oil fired plants in operation at that time were estimated to pose inhalation cancer maximum individual risks ( MIR) less than one in a million ( 1 x 10 6). However, up to 11 of the 137 oil fired plants were estimated to potentially present inhalation MIR for cancer above 1 x 10 6. As shown in the tables below ( 1 and 2), Ni was the largest contributor to these cancer risks ( see RtC at p. ES 12 and OAR 2002 0056 0173).

Table 1. Summary of high end inhalation cancer risk estimates based on local analysis for oil fired utilities for the year 1990. ( from Table ES 4 in RtC)

HAP Highest MIR a Population with lifetime risk > 1 x 10 6 Number plants with MIR > 1 x 10 6 Nickel b 5 x 10 5 110,000 11 Total c ( aggregate) 6 x 10 5 110,000 11 a Estimated lifetime MIR due to inhalation exposure for the " highest risk" oil fired plant. Based on an uncertainty analysis, these estimates are considered reasonable high end estimates ( see RtC at section ES. 7.4 for discussion). b The estimates for Ni and total HAP are based on the assumption that the mix of Ni compounds is 50 percent as carcinogenic as Ni subsulfide. c Estimated risk due to inhalation of the aggregate of HAP assuming additivity of risk for 14 individual carcinogenic HAP. 2 Table 2. Summary of plant specific risk information for 11 oil fired plants with MIR potentially above 1 x 10 6 based on local analysis for oil fired utilities for the year 1990 ( See OAR 2002 0056 0173)

Plant City State Maximum predicted risk Nickel a Waiau Pearl City HI 4.8E 05 Honolulu Honolulu HI 1.1E 05 New Boston South Boston MA 5.3E 06 Astoria Astoriak NY 2.1E 06 Mystic Everett MA 1.8E 06 T. G. Smith Lake Worth FL 1.8E 06 Bryan Bryan TX 1.7E 06 Riviera Riviera Beach FL 1.7E 06 Devon Millford CT 1.5E 06 Alamitos Long Beach CA 1.4E 06 East River New York NY 1.3E 06 a Assumes cancer potency equals 50 percent that of Ni subsulfide.

Since issuance of the February 1998 Report to Congress, we have learned that a number of the 11 plants have reduced or eliminated their Ni emissions through unit closures or fuel switching ( OAR 2002 0056 2046; OAR 2002 0056 5998). Of the 42 units that made up the 11 plants, 12 units have permanently ceased operation or are out of service ( OAR 2002 0056 2046 at pp. 12  13; OAR 2002 0056 5998). Six units have reported to the U. S. Department of Energy ( DOE) that their fuel mix now includes natural gas, which was not reported in the earlier data ( OAR 2002 0056 5998). An additional five units report using a mix of natural gas and distillate oil ( rather than residual oil) in 2003 ( OAR 2002 0056 5998). Five units have changed their fuel mixture to natural gas exclusively since the data for the February 1998 report were obtained ( OAR 2002 0056 2046 at pp. 12  13; OAR 2002 0056 5998). Finally, 2 units fire a residual oil/ natural gas mixture and have limited their residual oil use through permit restrictions to no greater than 10 percent of the fuel consumption between April 1 and November 15, with natural gas being used for at least 90 percent of total fuel consumption ( OAR 2002 0056 2046 at p. 13). These changes mean that 30 of the original 42 units have taken steps to reduce or eliminate their Ni emissions; only 2 of the original 11 plants, both in Hawaii, have units that appear not to have taken any actions that would result in reduced Ni emissions. Of the 12 units that appear to not have taken steps to reduce or eliminate their Ni emissions, only the eight units at the two Hawaiian plants report using only oil. The remaining four units report firing both oil and natural gas ( as was also reported in the RtC). The 11 plants, along with their fuel mix and operational status in 1994 and 2003, are provided in Table 3. 3 4 Table 3. Summary of information for 11 oil fired plants listed in previous table.

Plant Unit City State Fuel mix/ operational status a 1994 b 2003 c Waiau Waiau 3 Pearl City HI Oil RFO Waiau Waiau 4 Pearl City HI Oil RFO Waiau Waiau 5 Pearl City HI Oil RFO Waiau Waiau 6 Pearl City HI Oil RFO Waiau Waiau 7 Pearl City HI Oil RFO Waiau Waiau 8 Pearl City HI Oil RFO Honolulu Honolulu 8 Honolulu HI Oil RFO Honolulu Honolulu 9 Honolulu HI Oil RFO New Boston New Boston 1 South Boston MA NG/ Oil NG New Boston New Boston 2 South Boston MA Oil Not operating Astoria Astoria 1 Astoriak NY NG/ Oil Not operating Astoria Astoria 2 Astoriak NY NG/ Oil NG Astoria Astoria 3 Astoriak NY Oil RFO/ NG Astoria Astoria 4 Astoriak NY NG/ Oil RFO/ NG Astoria Astoria 5 Astoriak NY Oil RFO/ NG Mystic Mystic 4 Everett MA Oil Not operating Mystic Mystic 5 Everett MA Oil Not operating Mystic Mystic 6 Everett MA Oil Not operating Mystic Mystic 7 Everett MA NG/ Oil RFO/ NG T. G. Smith T. G. Smith S1 Lake Worth FL Oil NG/ RFO T. G. Smith T. G. Smith S2 Lake Worth FL Oil Out of service T. G. Smith T. G. Smith S3 Lake Worth FL Oil NG/ RFO T. G. Smith T. G. Smith S4 Lake Worth FL Oil Out of service Bryan Bryan 3 Bryan TX Oil NG/ DFO Bryan Bryan 4 Bryan TX Oil NG/ DFO Bryan Bryan 5 Bryan TX Oil NG/ DFO Bryan Bryan 6 Bryan TX NG/ Oil NG/ DFO Bryan Bryan 7 Bryan TX Oil NG/ DFO Riviera Riviera 3 Riviera Beach FL NG/ Oil RFO/ NG Riviera Riviera 4 Riviera Beach FL NG/ Oil RFO/ NG Devon Devon 3 Millford CT Oil Not operating Devon Devon 4 Millford CT Oil Not operating Devon Devon 5 Millford CT Oil Not operating Devon Devon 6 Millford CT Oil Not operating Devon Devon 7 Millford CT Oil RFO/ NG Devon Devon 8 Millford CT Oil RFO/ NG Alamitos Alamitos 2 Long Beach CA NG/ Oil NG Alamitos Alamitos 4 Long Beach CA NG/ Oil NG Alamitos Alamitos 5 Long Beach CA NG/ Oil NG 5 East River East River 5 New York NY Oil Not operating East River East River 6d New York NY Oil RFO/ NG East River East River 7d New York NY Oil RFO/ NG a RFO  Residual fuel oil DFO  Distillate fuel oil NG  Natural gas b RtC; OAR 2002 0056 0173 c Existing Generating Units in the United States by State, Company and Plant, 2003; existing generating units as of January 1, 2004 ( OAR 2002 0056 5998) d Agreement limits fuel oil use to less than 10 percent of fuel consumption between April 1 and November 15. Natural gas used for at least 90 percent of fuel consumption ( OAR 2002 0056 2046)

It is likely that this same mix of unit retirements and fuel mixture changes have been occurring throughout the oil fired segment of the electric utility industry in the past decade. The number of operational oil fired electric utility units has declined substantially between 1994 and 2003. The risk determination reported in February 1998 was based on 309 units at 137 plants ( RtC; OAR 2002 0056 0173); the inventory of oil fired units in 2003 has decreased to 142 units ( 18 of which are listed as being either " out of service" or " on standby" and some of which may not meet the definition of an " electric utility steam generating unit") at 74 plants ( OAR 2002 0056 5998). This decreasing trend in the number of oil fired units is expected to continue. The latest DOE/ EIA projections ( OAR 2002 0056 5999) estimate no new utility oil fired generating capacity and decreasing existing oil fired generating capacity through 2025, with an additional 29.2 gigawatts of combined oil and natural gas fired existing capacity being retired by 2025.

Further, during the public comment period, a number of commenters ( OAR 2002 0056 2046,  2910,  2912,  5282,  5284) provided EPA with information indicating that the level of sulfidic Ni ( the form of nickel considered to have greatest carcinogenic potency) emissions from oil fired utility units is less than had been estimated in the RtC.

In summary, at the time of the RtC, MIR estimates for Ni emissions at 11 coal fired utilities were greater than 1 x 10 6, with the highest plant MIR being 5 x 10 5. Many of these 11 units now either no longer operate or currently use natural gas, from which there are negligible Ni emissions. As for the remaining units, available projections indicate a continued decrease in generating capacity ( with some uncertainty as the projections include oil and gas fired units in the same category), a lack of new capacity, and the increasing retirement of units.

Because of ( 1) the dramatic reductions in the total nationwide inventory of oil fired electric utility steam generating units ( more so than we had envisioned previously); ( 2) the changing fuel mixtures being used at the remaining units; and ( 3) the reduced levels of sulfidic Ni likely being emitted from oil fired utility units, current levels of oil fired utility Ni emissions are believed to pose substantially lower risk than the 1998 analysis ( RtC) had concluded.


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4186-4188]
[FR Doc No: 2023-01286]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1079]

Cannabis and Cannabis-Derived Compounds: Quality Considerations
for Clinical Research; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Cannabis
and Cannabis-Derived Compounds: Quality Considerations for Clinical
Research.'' This guidance outlines FDA's current thinking on several
topics relevant to the development of cannabis and cannabis-derived
human drugs, including the source of cannabis for clinical research;
general quality considerations for developing human drugs that contain
cannabis and cannabis-derived compounds; and calculation of percent
delta-9 tetrahydrocannabinol (THC) in botanical raw materials,
intermediates, drug substances, and drug products to determine their
control status. This guidance is being issued to support clinical
research for development of cannabis and cannabis-derived human drugs.
This guidance finalizes the draft guidance of the same title issued on
July 22, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on January 24, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2020-D-1079 for ``Cannabis and Cannabis-Derived Compounds: Quality
Considerations for Clinical Research.'' Received comments 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,<PHONE_NUMBER>.
     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 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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Zuk, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6684, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Cassandra Taylor, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4150,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Cannabis and Cannabis-Derived Compounds: Quality
Considerations for Clinical Research.'' This guidance outlines FDA's
current thinking on several topics relevant to the development of human
drugs containing cannabis and cannabis-derived compounds, including the
source of cannabis for clinical research; general quality
considerations for developing human drugs that contain cannabis and
cannabis-derived compounds; and calculation of percent delta-9 THC in
botanical raw materials, intermediates, drug substances, and drug
products to determine their status as a controlled substance. This
guidance is being issued to support clinical research for development
of human drugs containing cannabis and cannabis-derived compounds.
    Cannabis and cannabis-derived compounds (i.e., compounds that occur
naturally in the Cannabis sativa L plant) have been the subject of
interest from consumers, industry, researchers, the public, and
regulators. The Agriculture Improvement Act of 2018 (Pub. L. 115-334)
(often called the 2018 Farm Bill) changed certain Federal authorities
relating to the production of cannabis and cannabis-derived compounds.
Among other things, the 2018 Farm Bill removed hemp, defined as
cannabis and derivatives or extracts of cannabis having not more than
0.3 percent delta-9 THC by dry weight, from Schedule I controls in the
Controlled Substances Act (CSA). The 2018 Farm Bill also explicitly
preserved FDA's authority to regulate products containing cannabis or
cannabis-derived compounds under the Federal Food, Drug, and Cosmetic
Act and section 351 of the Public Health Service Act (42 U.S.C. 262).
Accordingly, consistent with the 2018 Farm Bill, drugs that contain
cannabis and cannabis-derived compounds are subject to the same
authorities and requirements as FDA-regulated products containing any
other substance, regardless of whether the products fall within the
definition of hemp under the 2018 Farm Bill.
    The Drug Enforcement Administration (DEA) is the lead Federal
Agency for regulating controlled substances. Activities related to
growing and manufacturing cannabis for use as an investigational drug
for research must comply with CSA and DEA requirements if the cannabis
is a controlled substance (i.e., it exceeds the threshold of 0.3
percent delta-9 THC by dry weight). Sponsors and investigators are
encouraged to contact DEA with questions regarding Schedule I cannabis
or the CSA. FDA does not enforce the CSA or other laws within DEA's
jurisdiction.
    Many sponsors initiating clinical research for drugs containing
cannabis and cannabis-derived compounds may be unclear regarding, or
unfamiliar with, applicable drug quality expectations. Early
interaction with FDA may prevent clinical hold issues and aid sponsors
in developing a complete investigational new drug (IND) application.
    In general, drugs containing cannabis and cannabis-derived
compounds are subject to the same authorities and requirements as drugs
containing any other substance. Drugs intended for human use are
evaluated by FDA's Center for Drug Evaluation and

Research \1\ to help ensure that drugs marketed in the United States
are safe and effective for their intended uses and will be manufactured
in a manner that ensures quality.
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    \1\ FDA's Center for Biologics Evaluation and Research also has
regulatory responsibilities with respect to the review of human
drugs.
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    The recommendations in this guidance are intended to address the
legal definitions and regulatory controls related to cannabis, and to
address certain questions raised about drugs containing cannabis. The
guidance also introduces key FDA regulatory concepts to stakeholders
who may be less familiar with FDA or our authorities than other drug
developers.
    This guidance finalizes the draft guidance entitled ``Cannabis and
Cannabis-Derived Compounds: Quality Considerations for Clinical
Research'' issued on July 22, 2020 (85 FR 44305). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include clarifying sources
of cannabis for clinical research (including Schedule I sources),
adding resources that explain expectations for INDs in various stages
of drug development, and providing guidance on quality considerations
for INDs. The final guidance also lists applicable U.S. Pharmacopeia
chapters on quality testing, including the assessment of leachables
from packaging and delivery systems. Further, the guidance addresses
the calculation of delta-9 THC content, which is relevant to determine
control status for cannabis and cannabis-derived compounds. In
addition, editorial changes were made to improve clarity, including
better explaining FDA's authority to regulate human drugs and renaming
subsection III.C to emphasize that this section relates to control
status considerations under the CSA.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cannabis and Cannabis-Derived Compounds:
Quality Considerations for Clinical Research.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 312 and 314 for submission and approval
of applications for investigational drugs and new drugs have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collections of information pertaining to current good
manufacturing practices for finished pharmaceuticals as outlined in 21
CFR parts 210 and 211 have been approved under OMB control number 0910-
0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01286 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P