[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38657-38658]
[DOCID:fr04au09-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0501]

Paul H. Kornak: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Paul H. Kornak from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Paul H. Kornak was convicted of
three felonies under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product, and for conduct otherwise relating to the
regulation of a drug product under the act. After being given notice of
the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation, Mr. Kornak
failed to request a hearing. Mr. Kornak's failure to request a hearing
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective August 4, 2009.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert L. Hummel, Sr., Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product. Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct otherwise relating
to the regulation of any drug product under the act.
    On January 18, 2005, the U.S. District Court for the Northern
District of New York accepted Mr. Kornak's plea of guilty and entered
judgment against Mr. Kornak for one count of making and using a
materially false statement, one count of mail fraud, and one count of
criminally negligent homicide, federal felony offenses under 18 U.S.C.
1001(a)(3), 1341 and 1346, and 13, respectively. The actions underlying
these convictions were committed while Mr. Kornak was employed by the
Department of Veterans Affairs as the coordinator of several clinical
studies of drug products. Mr. Kornak participated in a scheme to
defraud the sponsors of these studies by repeatedly submitting false
documentation and enrolling and causing to be enrolled persons as study
subjects who did not qualify under particular study protocols. Mr.
Kornak admitted to submitting a case report form with regard to a study
subject knowing the document contained

materially false laboratory entries and altered information from a
radiology display report, which were critical factors in determining
whether the individual was eligible to participate in the clinical
study. He also admitted to knowingly and willfully misrepresenting the
results of a blood chemistry analysis related to the participation of a
study subject who would not otherwise have met the criteria for that
study. The subject was administered chemotherapeutic drugs in
connection with the clinical study and died as a result thereof. Mr.
Kornak's failure to perceive a substantial and unjustifiable risk that
death would occur when he knowingly and willingly made and used such
false documents constituted a gross deviation from the standard of care
that a reasonable person would observe in the situation. Mr. Kornak
further admitted to knowingly and willfully using interstate mail for
the purpose of executing the aforesaid scheme and artifice to defraud,
deprive, and obtain money and property.
    As a result of these convictions, FDA sent Mr. Kornak by certified
mail on May 4, 2009, a notice proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(A) and (a)(2)(B) of the act, that Mr. Kornak
was convicted of felonies under Federal law for conduct relating to the
development or approval of a drug product, and for conduct otherwise
relating to the regulation of a drug product under the act. The
proposal also offered Mr. Kornak an opportunity to request a hearing,
providing him 30 days from the date of receipt of the letter in which
to file the request, and advised him that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Mr. Kornak did not request a
hearing and has, therefore, waived his opportunity for a hearing and
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the
act, and under authority delegated to the Acting Director (Staff Manual
Guide 1410.35), finds that Mr. Kornak has been convicted of felonies
under Federal law for conduct relating to the development of approval
of a drug product and conduct otherwise relating to the regulation of a
drug product under the act.
    As a result of the foregoing finding, Mr. Kornak is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21
U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), and 321(dd)). Any person with
an approved or pending drug product application who knowingly employs
or retains Mr. Kornak as a consultant or contractor, or otherwise uses
in any capacity the services of Mr. Kornak during Mr. Kornak's
permanent debarment, will be subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Kornak, during his
period of debarment, provides services in any capacity to a person with
an approved or pending drug product application, he will be subject to
civil money penalties (section 307(a)(7) of the act). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Mr. Kornak during his period of
debarment (section 306(c)(1)(B) of the act).
    Any application by Mr. Kornak for special termination of debarment
under section 306(d)(4) of the act should be identified with Docket No.
2007-N-0501 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 20, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-18619 Filed 8-3-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Proposed Rules]
[Pages 64055-64058]
[FR Doc No: 2011-26765]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OAR-2009-0924; FRL-9479-7]

Special Rules Governing Certain Information Obtained Under the
Clean Air Act: Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to correct an erroneous reference in
EPA's procedures for handling data collected under the Mandatory
Greenhouse Gas Reporting Rule, which are provided in the Special Rules
Governing Certain Information Obtained under the Clean Air Act. The
proposed correction would not change any requirements for entities
regulated under the Mandatory Greenhouse Gas Reporting Rule or the
final confidentiality determinations EPA has made for such data. In the
``Rules and Regulations'' section of this Federal Register, we are
making this correction as a direct final rule without a prior proposed
rule. If we receive no adverse comment, we will not take further action
on this proposed rule.

DATES: Written comments must be received on or before November 16,
2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0924, by mail to Environmental Protection Agency, EPA Docket
Center (EPA/DC), Mailcode 6102T, Attention Docket ID No. EPA-HQ-OAR-
2009-0924, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Please
include a total of two copies. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Carole Cook, Climate Change Division,
Office of Atmospheric Programs (MC-6207J), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>For technical information and implementation
materials, please go to the Web site http://www.epa.gov/climatechange/emissions/ghgrulemaking.html. To submit a question, select Rule Help
Center, then select Contact Us.

SUPPLEMENTARY INFORMATION:

I. Why is EPA issuing this proposed rule?

    This document proposes to correct an erroneous reference in special
rules governing certain information obtained under the Clean Air Act
(40 CFR part 2, subpart B). We have published a direct final rule
making this correction in the ``Rules and Regulations'' section of this
Federal Register because we view this as a noncontroversial action and
anticipate no adverse comment. We have explained our reasons for this
action in the preamble to the direct final rule.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If the EPA receives adverse comment, we will
withdraw the direct final rule and it will not take effect. We would
address all public comments in any subsequent final rule based on this
proposed rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so by the comment
deadline listed in the DATES section of this document. For further
information, please see the information provided in the ADDRESSES
section of this document.

II. Does this action apply to me?

    Regulated Entities. Entities potentially affected by this proposed
action include those listed in Table 1 of this preamble:

           Table 1--Examples of Affected Entities by Category
------------------------------------------------------------------------
                                                   Examples of affected
            Category                  NAICS             facilities
------------------------------------------------------------------------
General Stationary Fuel          ...............  Facilities operating
 Combustion Sources.                               boilers, process
                                                   heaters,
                                                   incinerators,
                                                   turbines, and
                                                   internal combustion
                                                   engines.
                                             211  Extractors of crude
                                                   petroleum and natural
                                                   gas.
                                             321  Manufacturers of
                                                   lumber and wood
                                                   products.
                                             322  Pulp and paper mills.
                                             325  Chemical
                                                   manufacturers.
                                             324  Petroleum refineries,
                                                   and manufacturers of
                                                   coal products.

                                   316, 326, 339  Manufacturers of
                                                   rubber and
                                                   miscellaneous plastic
                                                   products.
                                             331  Steel works, blast
                                                   furnaces.
                                             332  Electroplating,
                                                   plating, polishing,
                                                   anodizing, and
                                                   coloring.
                                             336  Manufacturers of motor
                                                   vehicle parts and
                                                   accessories.
                                             221  Electric, gas, and
                                                   sanitary services.
                                             622  Health services.
                                             611  Educational services.
Electricity Generation.........           221112  Fossil-fuel fired
                                                   electric generating
                                                   units, including
                                                   units owned by
                                                   Federal and municipal
                                                   governments and units
                                                   located in Indian
                                                   Country.
Adipic Acid Production.........           325199  Adipic acid
                                                   manufacturing
                                                   facilities.
Aluminum Production............           331312  Primary Aluminum
                                                   production
                                                   facilities.
Ammonia Manufacturing..........           325311  Anhydrous and aqueous
                                                   ammonia manufacturing
                                                   facilities.
Cement Production..............           327310  Portland Cement
                                                   manufacturing plants.
Electronics Manufacturing......           334111  Microcomputers
                                                   manufacturing
                                                   facilities.
                                          334413  Semiconductor,
                                                   photovoltaic (solid-
                                                   state) device
                                                   manufacturing
                                                   facilities.
                                          334419  LCD unit screens
                                                   manufacturing
                                                   facilities.
                                 ...............  MEMS manufacturing
                                                   facilities.
Ferroalloy Production..........           331112  Ferroalloys
                                                   manufacturing
                                                   facilities.
Fluorinated Gas Production.....           325120  Industrial gases
                                                   manufacturing
                                                   facilities.
Glass Production...............           327211  Flat glass
                                                   manufacturing
                                                   facilities.
                                          327213  Glass container
                                                   manufacturing
                                                   facilities.
                                          327212  Other pressed and
                                                   blown glass and
                                                   glassware
                                                   manufacturing
                                                   facilities.
HCFC-22 Production and HFC-23             325120  Chlorodifluoromethane
 Destruction.                                      manufacturing
                                                   facilities.
Hydrogen Production............           325120  Hydrogen manufacturing
                                                   facilities.
Iron and Steel Production......           331111  Integrated iron and
                                                   steel mills, steel
                                                   companies, sinter
                                                   plants, blast
                                                   furnaces, basic
                                                   oxygen process
                                                   furnace shops.
Lead Production................           331419  Primary lead smelting
                                                   and refining
                                                   facilities.
                                          331492  Secondary lead
                                                   smelting and refining
                                                   facilities.
Lime Manufacturing.............           327410  Calcium oxide, calcium
                                                   hydroxide, dolomitic
                                                   hydrates
                                                   manufacturing
                                                   facilities.
Magnesium Production...........           331419  Primary refiners of
                                                   nonferrous metals by
                                                   electrolytic methods.
                                          331492  Secondary magnesium
                                                   processing plants.
Nitric Acid Production.........           325311  Nitric acid
                                                   manufacturing
                                                   facilities.
Petroleum and Natural Gas                 486210  Pipeline
 Systems.                                          transportation of
                                                   natural gas.
                                          221210  Natural gas
                                                   distribution
                                                   facilities.
                                             211  Extractors of crude
                                                   petroleum and natural
                                                   gas.
                                          211112  Natural gas liquid
                                                   extraction
                                                   facilities.
Petrochemical Production.......            32511  Ethylene dichloride
                                                   manufacturing
                                                   facilities.
                                          325199  Acrylonitrile,
                                                   ethylene oxide,
                                                   methanol
                                                   manufacturing
                                                   facilities.
                                          325110  Ethylene manufacturing
                                                   facilities.
                                          325182  Carbon black
                                                   manufacturing
                                                   facilities.
Petroleum Refineries...........           324110  Petroleum refineries.
Phosphoric Acid Production.....           325312  Phosphoric acid
                                                   manufacturing
                                                   facilities.
Pulp and Paper Manufacturing...           322110  Pulp mills.
                                          322121  Paper mills.
                                          322130  Paperboard mills.
Silicon Carbide Production.....           327910  Silicon carbide
                                                   abrasives
                                                   manufacturing
                                                   facilities.
Soda Ash Manufacturing.........           325181  Alkalies and chlorine
                                                   manufacturing
                                                   facilities.
                                          212391  Soda ash, natural,
                                                   mining and/or
                                                   beneficiation.
Electrical Transmission and               221121  Electric bulk power
 Distribution Equipment Use.                       transmission and
                                                   control facilities.
Titanium Dioxide Production....           325188  Titanium dioxide
                                                   manufacturing
                                                   facilities.
Underground Coal Mines.........           212113  Underground anthracite
                                                   coal mining
                                                   operations.
                                          212112  Underground bituminous
                                                   coal mining
                                                   operations.
Zinc Production................           331419  Primary zinc refining
                                                   facilities.
                                          331492  Zinc dust reclaiming
                                                   facilities,
                                                   recovering from scrap
                                                   and/or alloying
                                                   purchased metals.
Municipal Solid Waste Landfills           562212  Solid waste landfills.
                                          221320  Sewage treatment
                                                   facilities.
Industrial Wastewater Treatment           322110  Pulp mills.
                                          322121  Paper mills.
                                          322122  Newsprint mills.
                                          322130  Paperboard mills.
                                          311611  Meat processing
                                                   facilities.
                                          311411  Frozen fruit, juice,
                                                   and vegetable
                                                   manufacturing
                                                   facilities.
                                          311421  Fruit and vegetable
                                                   canning facilities.
                                          325193  Ethanol manufacturing
                                                   facilities.
Suppliers of Coal Based Liquid            211111  Coal liquefaction at
 Fuels.                                            mine sites.
Suppliers of Petroleum Products           324110  Petroleum refineries.

Suppliers of Natural Gas and              221210  Natural gas
 NGLs.                                             distribution
                                                   facilities.
                                          211112  Natural gas liquid
                                                   extraction
                                                   facilities.
Suppliers of Industrial                   325120  Industrial gas
 Greenhouse Gases.                                 manufacturing
                                                   facilities.
Suppliers of Carbon Dioxide               325120  Industrial gas
 (CO2).                                            manufacturing
                                                   facilities.
Importers and Exporters of                423730  Air-conditioning
 Fluorinated Greenhouse Gases                      equipment (except
 in Pre-charged Equipment or                       room units) merchant
 Closed-Cell Foams.                                wholesalers.
                                          333415  Air-conditioning
                                                   equipment (except
                                                   motor vehicle)
                                                   manufacturing.
                                          336391  Motor vehicle air-
                                                   conditioning
                                                   manufacturing.
                                          423620  Air-conditioners,
                                                   room, merchant
                                                   wholesalers.
                                          443111  Household appliance
                                                   stores.
                                          423730  Automotive air-
                                                   conditioners merchant
                                                   wholesalers.
                                          326150  Polyurethane foam
                                                   products
                                                   manufacturing.
                                          335313  Circuit breakers,
                                                   power, manufacturing.
                                          423610  Circuit breakers
                                                   merchant wholesalers.
Geologic Sequestration of                    N/A  CO2 geologic
 Carbon Dioxide.                                   sequestration
                                                   projects.
Electrical Equipment                       33531  Power transmission and
 Manufacture or Refurbishment.                     distribution
                                                   switchgear and
                                                   specialty
                                                   transformers
                                                   manufacturing
                                                   facilities.
Industrial Waste Landfills.....           562212  Solid waste landfills.
                                          221320  Sewage treatment
                                                   facilities.
                                          322110  Pulp mills.
                                          322121  Paper mills.
                                          322122  Newsprint mills.
                                          322130  Paperboard mills.
                                          311611  Meat processing
                                                   facilities.
                                          311411  Frozen fruit, juice,
                                                   and vegetable
                                                   manufacturing
                                                   facilities.
                                          311421  Fruit and vegetable
                                                   canning facilities.
Injection of Carbon Dioxide....              211  Oil and gas extraction
                                                   projects using CO2
                                                   enhanced oil and gas
                                                   recovery.
                                       211111 or  Projects that inject
                                          211112   acid gas containing
                                                   CO2 underground.
------------------------------------------------------------------------

    Table 1 of this preamble is not intended to be exhaustive, but
rather provides a guide for readers regarding facilities likely to be
affected by this action and 40 CFR part 98. Table 1 of this preamble
lists the types of facilities that the EPA is now aware could be
potentially affected by this action. Other types of facilities not
listed in the table could also be affected. To determine whether your
facility is affected by this action, you should carefully examine the
applicability criteria found in 40 CFR part 98, subpart A, and other
subparts as necessary. If you have questions regarding the
applicability of this action to a particular facility, consult the
person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Table of Contents

I. Why is EPA issuing this Proposed Rule?
II. Does this action apply to me?
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    The correction to 40 CFR part 2 would not impose any information
collection burden.

C. Regulatory Flexibility Act (RFA)

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions. For purposes of assessing the impacts of
the amendments on small entities, small entity is defined as: (1) A
small business as defined by the Small Business Administration's
regulations at 13 CFR 121.201; (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's proposed correction
to the citation in 40 CFR part 2 on small entities, I certify that this
action would not have a significant economic impact on a substantial
number of small entities. In determining whether a rule has a

significant economic impact on a substantial number of small entities,
the impact of concern is any significant adverse economic impact on
small entities, since the primary purpose of the regulatory flexibility
analyses is to identify and address regulatory alternatives ``which
minimize any significant economic impact of the rule on small
entities.'' 5 U.S.C. 603 and 604. Thus, an agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, or
otherwise has a positive economic effect on all of the small entities
subject to the rule.
    This proposed rule would not impose any new requirement on small
entities that are not currently required by Part 98. The amendment to
40 CFR part 2 is administrative in nature. Therefore, this rule would
not have a significant economic impact on a substantial number of small
entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or Tribal governments or the private
sector. The action would impose no enforceable duty on any state, local
or Tribal governments or the private sector. Therefore, this action is
not subject to the requirements of sections 202 or 205 of the UMRA.
This action is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. The correction in
this proposed rule revises a citation reference in one section of 40
CFR part 2, subpart B to confirm the original intention of the
reference by correcting the citation to statutory authority.

E. Executive Order 13132: Federalism

    This proposed change to 40 CFR part 2 would not have federalism
implications. It would not have substantial direct effects on the
states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132.
However, for a more detailed discussion about how Part 98 relates to
existing state programs, please see Section II of the preamble to the
final part 98 rule (74 FR 56266).
    The correction to 40 CFR part 2 is administrative in nature and
would apply to data reported under Part 98 by facilities that directly
emit GHGs or supply fuel or chemicals that may emit GHGs when used.
Part 98 does not apply to governmental entities unless the government
entity owns a facility that directly emits GHGs above threshold levels
such as large stationary combustion sources or landfills, so relatively
few government facilities would be affected. The change to 40 CFR part
2 also would not limit the power of states or local governments to
collect GHG data or regulate GHG emissions. Thus, Executive Order 13132
does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action is not expected to have Tribal implications, as
specified in Executive Order 13175 (65 FR 67249, November 9, 2000),
because this action is administrative in nature and would not impose
any new requirements on Tribes. Thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying only to those regulatory actions that concern health
or safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it would not
establish an environmental standard intended to mitigate health or
safety risks.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. The amendments to 40 CFR part 2 are
administrative in nature and therefore would not have any adverse
impacts on energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note)
directs the EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs the EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This proposed change to 40 CFR part 2 is administrative in nature
and would not involve technical standards. Therefore, the EPA did not
consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    The EPA has determined that the proposed action would not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because the correction
noted would not affect the level of protection provided to human health
or the environment. The change to 40 CFR part 2 is administrative in
nature and therefore would not affect the level of protection provided
to human health or the environment.

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure,
Reporting and recordkeeping requirements.

    Dated: October 11, 2011.
Lisa P. Jackson,
Administrator.
[FR Doc. 2011-26765 Filed 10-14-11; 8:45 am]
BILLING CODE 6560-50-P


Date: 	2/1/10

To: 	EPA-HQ-OAR-2005-0161

Subject:	Petroleum Indirect Impacts Analysis

I. Overview

Per the statutory requirements of Section 201 of the Energy Independence
and Security Act (EISA), EPA was required to establish a baseline based
on the “average lifecycle greenhouse gas emissions, as determined by
the Administrator, after notice and opportunity for comment, for
gasoline or diesel (whichever is being replaced by the renewable fuel)
sold or distributed as transportation fuel in 2005.” This baseline is
used to determine whether certain renewable fuel pathways are able to
meet the GHG reduction thresholds also mandated in Section 201 of EISA.

In the preamble to the proposed Renewable Fuel Standard (RFS2)
regulation, we acknowledged that it was possible that renewable fuels
may actually displace fuels which on the margin had higher lifecycle GHG
emissions than the average petroleum fuel baseline.  Furthermore, we
took comment “on whether-strictly for purposes of assessing the
benefits of the rule (and not for purposes of determining whether
certain renewable fuel pathways meet the GHG reduction thresholds set
forth in EISA), we should assess benefits based on a marginal
displacement approach and, if so, what assumptions we should use for the
marginal displacements.”  We also received numerous comments that
urged us to assess the indirect impacts of petroleum use.

For this final RFS2 rulemaking, we carried out an analysis of the
indirect impacts of petroleum, employing the Department of Energy’s
(DOE) Energy Technology Perspectives (ETP) model.  The ETP model is a
MARKAL-based model that was developed by the International Energy Agency
and was modified and updated by DOE.   It is a partial equilibrium model
that incorporates a representation of the physical energy system and
represents the flow of energy carriers through the physical
infrastructure from the resource base through the various energy
conversion technologies to the end user.  The MARKAL modeling framework
allows for a full “well-to-wheels” comparison.

The main objective of our study was to understand the sources of
marginal crude oil that would be displaced by renewable fuels in 2022.
This would give us insight into whether the lifecycle GHG emissions for
marginal crude in 2022 would differ significantly from the 2005 average
petroleum baseline established by this rule.

II. Model Background

The ETP model consists of fifteen world regions. These are broken out
into: the United States; Canada; Mexico; IEA Europe; Japan; South Korea;
Australia/New Zealand; Central and South America; Eastern Europe; Former
Soviet Union; Middle East; China; India; Other Developing Asia; and
Africa.  All major energy sources are covered, including coal, oil,
natural gas, nuclear power, and renewable energy. Energy conversion
processes include power generation and refinery operations and other
non-conventional processes such as coal-to-liquids and
biomass-to-liquids. Demand is represented through industrial,
commercial, residential, and transportation sectors. The model runs
through 2050 in five year increments.  For this study, ETP has been
benchmarked and updated using the Energy Information Administration’s
(EIA) Annual Energy Outlook (AEO).

III. Scenario Description

The purpose of this study was to isolate the impact of petroleum use on
total energy sector greenhouse gas emissions.  Thus, we created a
“demand boost case”, which was a domestic gasoline demand increase
of one million barrels per day.  The boost was phased in beginning in
2012 with annual 200,000 barrel per day increments over a five year
period. The increase in demand could be met by both foreign and domestic
refined products.

IV. Assumptions and Limitations

There are a number of economic assumptions in the ETP model.  For this
scenario, the ETP projected demand-driven perturbations from the AEO oil
price path.  Thus, alternative oil price paths could affect the market
share and energy consumption results anticipated by the model.

In addition, the global oil market is not modeled as fully competitive.
It is assumed that the Middle East members of OPEC have significant
market power and act as a dominant firm. In this representation, the
Middle East OPEC countries set world oil prices, and other countries and
regions produce up until the point where their marginal cost of
production equals the world oil price.

In ETP, the oil price consists of five different components: finding
costs; production costs; transportation costs; oil company profits; and
government revenues. Government revenues in the Middle East are the main
lever used to set oil prices. A high oil price case is thus one where
Middle East producers restrict supply, which pushes prices higher and
allows them to extract a higher economic rent on each barrel of oil
produced. In ETP, this “rent seeking” is the variable used to
calibrate to a given oil price path. For the purposes of this study, the
Middle East rent seeking is set to the level that is implicit in the AEO
2009 oil price path, given the production cost of Middle East producers.
This level of rent seeking is held constant between scenarios.

The ETP model is driven by exogenously specified demands for energy
services (e.g. light-duty vehicle miles traveled, ton-miles of rail
freight, etc.). The U.S. petroleum demand base case was calibrated to
the AEO 2009 projections by adjusting these service demands to the
levels forecasted by the EIA.  Demands were derived from AEO trends for
the model years after the AEO forecast period ends.

Overall oil resources are based on IEA (2008) ETP data for conventional
and unconventional resources. Unconventional resources include
ultra-deepwater crude, Canadian oil sands, Venezuelan extra-heavy crude,
and coal-to-liquids. Canadian oil sands production rates were
endogenously determined based on the price of other competing resources.
Within ETP, data are limited for other unconventional resources;
however, the completed scenario suggests that other unconventional
production would not play a large role in meeting the boosted demand.

V. Description of Results

In 2022, ETP predicted a 0.73 million barrels of oil equivalent (MMboe)
per day increase in conventional oil production and a 0.04 MMboe per day
increase in oil sands/bitumen production.   The increase in petroleum
production came mainly from the Middle East (0.46 MMboe per day, 59%),
with no other region accounting for more than 8% of the total increase
in production.  Oil sands/bitumen, where production was split between
Canada and Central/South America, accounted for less than 5% of the
total increase in production.  The ETP results show a considerably
different production distribution for the 2022 marginal crude mix versus
the 2005 average crude mix used for the final rule.

Comparison of 2022 marginal crude mix from ETP run to 2005 crude mix
used for RFS2 petroleum baseline calculation

VI. Discussion of Results

Using estimates of well-to-tank GHG emissions for crudes produced in
various countries, we calculated the well-to-tank GHG emissions for the
marginal crude mix.  As ETP did not have data for specific countries,
emissions for regions were estimated by taking the straight average
emissions rate for countries in that region.  For example, well-to-tank
values for Africa were estimated by taking the average of the values for
Nigeria, Angola, and Algeria.  However, there were some regions, such as
the “Former Soviet Union”, where well-to-tank estimates were not
available.  In these cases, the value for “Other Imports” was used
as a default value.

Well-to-tank GHG emissions for domestic diesel production by crude
source

Country of Origin	Well-to-Tank Values

(kg CO2e/MMBtu LHV)

Canada Oil Sands	34.0

Venezuela Bitumen	30.8

Nigeria	29.7

Mexico	24.1

Angola	23.0

Kuwait	19.6

Iraq	18.7

Venezuela Conventional	18.6

Canada Conventional	18.0

Ecuador	17.8

Saudi Arabia	17.4

Other Imports	17.3

U.S.	13.5

Algeria	12.4

These calculations yielded a well-to-tank value for the marginal crude
mix of 19.0 kg/MMBtu.  This value was slightly higher than the
well-to-tank value used for the 2005 average petroleum baseline in the
final rule.  When combined with the tailpipe emissions, this yielded a
well-to-wheels value of 98.0 kg/MMBtu, about 0.6% larger than the
average petroleum baseline value.

One area we examined in more detail was the use of the “Other
Imports” value as a default.  Overall, the default value was used for
18% of the marginal crude mix.  To test the sensitivity of this value in
the overall calculations, we considered a range of default values for
conventional crude oil, from 12.4-29.7 kg/MMBtu.  Utilizing this range
of default values, we find that, for the marginal crude mix, this
yielded well-to-tank values from 18.1-21.2 kg/MMBtu and well-to-wheels
values from 97.1-100.2 kg/MMBtu.  The marginal well-to-wheels values
ranged from being 0.3% less to 2.9% greater than the average 2005
petroleum baseline value used in the final rule depending on the default
value used.

VII. Conclusions

We created a scenario with increased domestic demand for gasoline and
used DOE’s ETP model to analyze how the increased demand would be met
in 2022.  The model indicated that crude oil production would increase,
with close to 60% of the increase in production occurring in the Middle
East and less than 5% of the increase in production coming from oil
sands/bitumen.  Overall, well-to-wheels emissions for the marginal crude
oil were virtually the same as the average well-to-wheels emissions
calculated for the 2005 petroleum baseline.

 The ETP model operates in energy units on a lower heating value basis.
The energy equivalent of 1 million barrels/day was obtained by using the
lower heating value energy content of conventional motor gasoline as
reported in EIA’s Annual Energy Review 2008 (approximately 4.90
MMBtu/barrel).  The 1 million barrels/day converts on an annual basis to
about 1.78 quads of gasoline.

 The marginal value is higher than the average because low-GHG domestic
crudes are replaced by Middle East crudes, and there is a slightly
higher amount of oil sands.

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