[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11572-11574]
[FR Doc No: 2016-04712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0321]

Risk Assessment of Foodborne Illness Associated With Pathogens
From Produce Grown in Fields Amended With Untreated Biological Soil
Amendments of Animal Origin; Request for Scientific Data, Information,
and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and
information.

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SUMMARY: The Food and Drug Administration (FDA or we) is requesting
scientific data, information, and comments that would assist the Agency
in its plan to develop a risk assessment for produce grown in fields or
other growing areas amended with untreated biological soil amendments
of animal origin (including raw manure). The risk assessment will
evaluate and, if feasible, quantify the risk of human illness
associated with consumption of produce grown in fields or other growing
areas amended with untreated biological soil amendments of animal
origin that are potentially contaminated with enteric pathogens, such
as Escherichia coli O157:H7 or Salmonella. The risk assessment also
will evaluate the impact of certain interventions, such as use of a
time interval between application of the soil amendment and crop
harvest, on the predicted risk. The risk assessment is intended to
inform policy decisions with regard to produce safety.

DATES: Submit either electronic or written comments and scientific data
and information by May 3, 2016.

ADDRESSES: You may submit comments and scientific data and information
as follows:

Electronic Submissions

    Submit electronic comments and scientific data and information in
the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments and
scientific data and information submitted electronically, including
attachments, to http://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 and scientific data and information, that
information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments and scientific data and
information submitted to the Division of Dockets Management, 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-2016-N-0321 for ``Risk Assessment of Foodborne Illness Associated
with Pathogens from Produce Grown in Fields Amended with Untreated
Biological Soil Amendments of Animal Origin; Request for Comments,
Scientific Data, and Information''. Received comments and scientific
data and information will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments and scientific data and information 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 and
scientific data and information. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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 scientific data and information 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 and scientific data and information to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments and scientific data and
information received, go to http://

www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. What are the food safety concerns related to untreated biological
soil amendments of animal origin?

    Biological soil amendments of animal origin (BSAAO) can be a source
of contamination of produce with pathogens that can cause human
illness. Human pathogens in BSAAO, once introduced to the growing
environment, may be inactivated at a rate that is dependent upon a
number of environmental, regional, and other agricultural and
ecological factors. The rate of pathogen population decline over time
is also influenced by the types of BSAAO and application methods.
Furthermore, the types of produce and whether or not BSAAO may come
into contact with a harvestable portion of the crop influences the
likelihood of pathogen transfer from the amended soil to produce (Ref.
1).
    Some produce farms use untreated BSAAO for various reasons,
including that they are inexpensive, readily available, and rich
nutrient sources for growing crops. Whether it is feasible for a farm
to use untreated BSAAO as a principal nutrient source depends on
numerous factors, including whether there is a required time interval
between application and harvest and the length of such an interval
(which may affect the nutrients retained or available from BSAAO), and
crop nutrient demand (i.e., the nutrients needed to support crop
growth). Typical examples of untreated BSAAO are raw cattle manure,
poultry litter, swine slurry, and horse manure. FDA acknowledges that
required application intervals for certain uses of untreated BSAAO
could influence the number of crop cycles a farm is able to undertake
each year and/or the choices farms make regarding which type of
amendment to apply (e.g., raw manure, composted manure, or other
nutrient sources).

B. How did FDA's rule on produce safety address BSAAO?

    In January 2013, based in part upon authority provided by the FDA
Food Safety Modernization Act, we published a proposed Produce Safety
Rule entitled ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption'' (78 FR 3504, January 16,
2013). Among other provisions related to BSAAO, the proposed rule
included at Sec.  112.56(a)(1)(i) (21 CFR 112.56(a)(1)(i)) a 9-month
minimum application interval for untreated BSAAO applied in a manner
that does not contact covered produce during application and minimizes
the potential for contact with covered produce after application (78 FR
3504 at 3637). In response to public comments, we withdrew this
proposed 9-month minimum application interval in a supplemental
proposed rulemaking that we published on September 29, 2014 (79 FR
58434 at 58457 through 58461). In the supplemental proposed rule, we
acknowledged the limited body of currently available scientific
evidence relating to the proposed 9-month interval and the need for
additional research in this area, and described our planned risk
assessment and research agenda (79 FR 58434 at 58460 through 58461).
Accordingly, we deferred our decision on an appropriate minimum
application interval.
    On November 27, 2015, we published a final Produce Safety Rule
entitled ``Standards for the Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption,'' (80 FR 74354). The final rule is
now codified at 21 CFR part 112. In the preamble to the final rule, we
restated our decision with respect to the appropriate minimum BSAAO
application interval (80 FR 74354 at 74463). We reserved one of the
provisions in the final rule's Subpart F (Biological Soil Amendments of
Animal Origin and Human Waste) because we continue to believe that a
quantitative application interval standard is necessary and anticipate
locating such a future standard in that provision. As finalized, the
Produce Safety Rule establishes that there is no minimum application
interval required when untreated BSAAO are applied in a manner that
does not contact covered produce during or after application (Sec.
112.56(a)(1)(ii)), and the minimum application interval is [reserved]
when applied in a manner that does not contact produce during
application and minimizes the potential for contact with produce after
application (Sec.  112.56(a)(1)(i)).

II. FDA's Risk Assessment

    FDA, in consultation with the U.S. Department of Agriculture, is
conducting a risk assessment to evaluate the risk of human illness
associated with the consumption of produce grown in growing areas
amended with untreated BSAAO that are potentially contaminated with
enteric pathogens such as E. coli O157:H7 or Salmonella. The risk
assessment will evaluate the impact of different agricultural and
ecological conditions and certain interventions, such as use of a time
interval or intervals between application of untreated BSAAO and crop
harvest, on the predicted risk. The risk assessment will take into
account available data and information on relevant steps in the produce
food safety continuum including: The initial prevalence and levels of
pathogens in untreated BSAAO; the methods used to apply untreated BSAAO
to soils; pathogen survival (and growth) in untreated BSAAO and soils
amended with untreated BSAAO; pathogen transfer to produce grown in
amended soils; pathogen survival and growth on produce; and pathogen
survival, growth, and cross-contamination during storage and other
steps in the supply chain (e.g., washing). The risk assessment will
include characterization of the variability and uncertainty of pathogen
survival and growth under different agricultural and ecological
conditions (e.g., soil types, application methods, or geographic
locations/climatic factors) and time intervals between application of
untreated BSAAO and crop harvest. The risk assessment is intended to
inform policy decisions with regard to produce safety.

III. Issues for Consideration

    FDA is requesting comments and scientific data and other
information relevant to this risk assessment. We are particularly
interested in scientific data and information concerning, but not
limited to, the following factors that may affect the risk of human
illness associated with the consumption of produce grown in fields or
other growing areas amended with untreated BSAAO (including raw
manure):
    1. Data on the prevalence and levels of pathogens.
    a. The frequency of detecting the presence of pathogens in
untreated BSAAO and soil amended with BSAAO, such as Salmonella in
poultry litter, and E. coli O157:H7 and other pathogenic Shiga-toxin
producing E. coli in cattle manure. Samples may be obtained at
different stages of untreated BSAAO storage prior to application, or
after

application. If available, for each data point, we also invite
information regarding the following:
    [ssquf] The type of untreated BSAAO (e.g., animal origin and
content);
    [ssquf] how the untreated BSAAO, including raw manure, was sampled
and handled prior to analysis;
    [ssquf] the size of the analytical unit (i.e., detection limit) and
test method;
    [ssquf] the number of positives, the total number of samples, and
the time period in which the testing was conducted; and
    [ssquf] sampling protocol (e.g., simple random, stratified random,
targeted).
    b. The pathogen concentration, i.e., the number of pathogen cells
per amount (unit volume or weight), in contaminated untreated BSAAO or
soil amended with untreated BSAAO, especially cattle manure and poultry
litter. If available, for each data point, we ask that the data be
provided in unaggregated form and that Most Probable Number (MPN)
patterns as well as raw data (e.g., number of positive and negative
tubes per serial dilution) be provided.
    2. Data and information on survival of pathogens (e.g., Salmonella,
E. coli O157:H7), and pathogen transfer to produce.
    a. Kinetic data that describe the survival (or inactivation) or
growth of pathogens in untreated BSAAO, especially cattle manure and
poultry litter;
    b. Kinetic data that describe the survival (or inactivation) or
growth of pathogens in soil amended with untreated BSAAO, especially
cattle manure and poultry litter, as influenced by soil type, untreated
BSAAO type, application method, geographic locations/climatic factors
(e.g., temperature, days of sunlight, intensity of solar irradiation,
moisture, rainfall) and other factors;
    c. The mechanisms for pathogen transfer from soils to specific
types or categories of produce, such as leafy greens, or to produce
generally, and associated transfer coefficients, including irrigation
and rain water splash, direct contact between produce and soil,
machinery or people or animals contaminated by soil and directly
contacting produce during growth and harvest of produce;
    d. Pathogen transfer rates (i.e., transfer coefficients) from
amended soils to specific types or categories of produce, such as leafy
greens, or to produce generally, as influenced by soil type, untreated
BSAAO type, application method, climate factors, commodity type or any
other pertinent factors not listed here;
    e. The survival of pathogens on produce in the field or other
growing area before harvest; and
    f. The variability in the survival of different Salmonella
serotypes, different subtypes of E. coli O157:H7, or other pathogens of
public health significance in amended soils under field, greenhouse, or
laboratory conditions.
    3. On-farm practices with regard to the use of untreated BSAAO,
including, but not limited to, the following aspects.
    a. The extent to which untreated BSAAO are used in different
regions in the United States, as well outside the United States in
regions that export produce to the United States;
    b. The types of untreated BSAAO and the soil type, and associated
physical and chemical parameters (including but not exclusive to
nutrient content, moisture and pH); and the crops typically grown in
each BSAAO-amended soil type;
    c. Characterization of the proportion of produce farms that have
one or more soil types per geographical location;
    d. The amount of untreated BSAAO applied per unit surface (e.g.,
per acre) or the ratio of untreated BSAAO/soil, including typical ratio
and variability by commodity type, including, for example, row crops
such as leafy greens;
    e. The time of year, number of applications, and amount of
untreated BSAAO that are applied;
    f. The method of application (e.g., surface, incorporated), and
whether or not the amended soil is covered (e.g., with plastic mulch);
    g. Produce commodity type and cropping cycles;
    h. Climate conditions and irrigation practices after soil is
amended, before and after planting; and
    i. The crop density (e.g., the number of rows per bed, and the
distance between adjacent rows in a bed), distance between two crop
beds (furrow width), and the influence of such factors on pathogen
transfer.
    4. Harvesting, handling, and storage conditions that may affect
pathogen detection and levels, survival, growth, or inactivation
between harvest and retail sale along the farm-to-fork continuum.
    a. The harvesting practices and the average conditions as well as
the range of climactic conditions prior to harvesting (e.g., time and
temperature, rain events) under which produce is handled in the field
and in packing operations;
    b. The survival, growth, or inactivation of pathogens on produce
(including, for example, specific commodities or categories such as
leafy greens, or produce generally) during transportation and storage;
    c. Typical storage conditions (e.g., time, temperature) for produce
(including, for example, specific commodities or categories, such as
leafy greens, or produce generally), from harvest until consumer
purchase and whether and how those storage conditions affect pathogen
levels; and
    d. The types and concentration of antimicrobial chemicals or other
treatments, if any, applied to the water used for wash or transport of
produce during farm or other distribution operations prior to retail,
and the efficacy of these treatments in reducing pathogen levels, as
well as the likelihood of cross-contamination during wash or transport.
    5. Storage conditions such as times and temperatures that may
affect pathogen growth and/or survival during transportation and
storage of produce in the consumer's home, and consumer handling
practices with respect to produce after purchase, including data and
information on consumer washing practices.
    We are also interested in other comments concerning, but not
limited to, the types of untreated BSAAO, produce commodities, relevant
agricultural and ecological conditions, and appropriate mitigation
strategies that the Agency should consider in the risk assessment.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Food and Drug Administration, 2015. ``Final Qualitative
Assessment of Risk to Public Health from On-Farm Contamination of
Produce.'' Available at: http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM470780.pdf. Accessed
January 20, 2016.

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04712 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 17, 2010 (Volume 75, Number 158)]
[Notices]
[Page 50784]
[DOCID:fr17au10-83]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0123.
Extension: Form 5; OMB Control No. 3235-0362; SEC File No. 270-323.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Under Section 16(a) of the Securities Exchange Act of 1934
(``Exchange Act'') (15 U.S.C. 78a et seq.) every person who is directly
or indirectly the beneficial owner of more than 10 percent of any class
of any equity security (other than an exempted security) which
registered pursuant to Section 12 of the Exchange Act, or who is a
director or an officer of the issuer of such security (collectively
``reporting persons''), must file statements setting forth their
security holdings in the issuer with the Commission. Form 5 (17 CFR
249.105) is an annual statement of beneficial ownership of securities.
Approximately 9,000 reporting persons file Form 5 annually and we
estimate that it takes approximately one hour to prepare the form for a
total of 9,000 annual burden hours.
    Written comments are invited on: (a) Whether this proposed
collections of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collections of information
on respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, Virginia 22312; or send an e-mail to:
PRA--Mailbox @sec.gov.

    Dated: August 10, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-20257 Filed 8-16-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9916-9923]
[FR Doc No: 2012-3793]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9633-7]

California State Motor Vehicle and Nonroad Engine Pollution
Control Standards; Mobile Cargo Handling Equipment Regulation at Ports
and Intermodal Rail Yards; Notice of Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of decision granting an authorization and waiver of
preemption for California's mobile cargo handling equipment regulation
at ports and intermodal rail yards.

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SUMMARY: Pursuant to section 209(e) of the Clean Air Act (Act), 42
U.S.C. 7543(e), EPA is granting California its request for
authorization to enforce it emission standards and other requirements
for its mobile cargo handling equipment regulation. To the extent that
the mobile cargo handling equipment regulation pertains to the control
of emissions from new motor vehicles or new motor vehicle engines

EPA is, pursuant to section 209(b) of the Act, 42 U.S.C. 7543(b),
granting California its request for a waiver of preemption.

DATES: Under 307(b)(1) of the Act, judicial review of this final action
may be sought only in the United States Court of Appeals for the
District of Columbia Circuit. Petitions for review must be filed by
April 23, 2012. Under 307(b)(2) of the Act, judicial review of this
final action may not be obtained in subsequent enforcement proceedings.

ADDRESSES: EPA has established a docket for this action under Docket ID
EPA-HQ-OAR-2010-0862. All documents relied upon in making this
decision, including those submitted to EPA by CARB, and public
comments, are contained in the public docket. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy at the Air and Radiation Docket in
the EPA Headquarters Library, EPA West Building, Room 3334, located at
1301 Constitution Avenue NW., Washington, DC 20460. The public reading
room is open to the public on all federal government work days between
8 a.m. and 4:30 p.m.; generally, it is open Monday through Friday,
excluding holidays. The telephone number for the Reading Room (202)
566-1744. The Air and Radiation Docket and Information Center's Web
site is http://www.epa.gov/oar/docket.html. The electronic mail (email)
address for the Air and Radiation Docket is<EMAIL_ADDRESS>
the telephone number is<PHONE_NUMBER>, and the fax number is (202)
566-9744. An electronic version of the public docket is available
through the federal government's electronic public docket and comment
system. You may access EPA dockets at http://www.regulations.gov. After
opening the www.regulations.gov Web site, enter EPA-HQ-OAR-2010-0862 in
the ``Enter Keyword or ID'' fill-in box to view documents in the record
of CARB's mobile cargo handling equipment waiver and authorization
request. Although a part of the official docket, the public docket does
not include Confidential Business Information (``CBI'') or other
information whose disclosure is restricted by statute.
    EPA's Office of Transportation and Air Quality (``OTAQ'') maintains
a Web page that contains general information on its review of
California waiver requests. Included on that page are links to prior
waiver Federal Register notices, some of which are cited in today's
notice; the page can be accessed at http://www.epa.gov/otaq/cafr.htm.

FOR FURTHER INFORMATION CONTACT: David Dickinson, Attorney-Advisor,
Compliance and Innovative Strategies Division, Office of Transportation
and Air Quality, U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue (6405J) NW., Washington, DC 20460. Telephone: (202)
343-9256. Fax:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Chronology

    In a letter dated January 29, 2007, the California Air Resources
Board (CARB) submitted to EPA its waiver and authorization request
pursuant to section 209 of the Clean Air Act (CAA or Act), regarding
its regulations for Mobile Cargo Handling Equipment at Ports and
Intermodal Rail yards (Mobile Cargo Handling Equipment or CHE).\1\
CARB's CHE regulations were adopted at CARB's December 8, 2005 public
hearing (by Resolution 05-62) and were subsequently modified after
making the regulation available for supplemental public comment by
CARB's Executive Officer through Executive Order R-06-007 on June 2,
2006. The CHE regulations are codified at title 12, California Code of
Regulations section 2479.\2\
---------------------------------------------------------------------------

    \1\ See CARB's January 29, 2007 request at EPA-HQ-OAR-2010-0862-
0001 (CARB's Request). EPA's review of CARB's mobile source
standards relating to the control of emissions for new motor
vehicles and new motor vehicle engines conducted under section
209(b) of the Act are treated as ``waiver'' requests from CARB.
EPA's review of CARB's regulations relating to standards and other
requirements relating to the control of emissions from nonroad
vehicles and nonroad engines conducted under section 209(e) of the
Act are treated as ``authorization'' requests from CARB.
    \2\ The CHE regulation is designed to use best available control
technology (BACT) to reduce diesel PM and NOX emissions
from mobile cargo handling equipment at ports and intermodal rail
yards. Mobile cargo handling equipment is any engine-propelled
vehicle used to handle cargo at ports and intermodal rail facilities
and vehicles used to perform maintenance and repair activities and
includes, but is not limited to, yard trucks, top handlers, rubber-
tired gantry (RTG) cranes, forklifts, dozers, and loaders.
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    EPA published a Federal Register notice for public hearing and
comment on CARB's request on February 1, 2011.\3\ No hearing request
was received and thus no hearing took place. EPA received a total of
three written comments from BNSF Railway Company and Union Pacific
Railway Company, SSAT Terminal Pier A (SSAT), and Ports America
Equipment Services (Ports America).\4\ EPA also received supplemental
comment from CARB.\5\
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    \3\ 76 FR 5586 (February 1, 2011).
    \4\ See EPA-HQ-OAR-2010-0862-0024.1, EPA-HQ-OAR-2010-0862-
0025.1, and EPA-HQ-OAR-2010-0862-0026.1, respectively.
    \5\ See EPA-HQ-OAR-2010-0862-0028, CARB's comments submitted on
March 17, 2011; and EPA-HQ-OAR-0862-0029, CARB's comments submitted
on May 2, 2011.
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    CARB has requested that EPA grant a waiver of preemption or grant a
new authorization for certain portions of its CHE regulations. For
other portions of its CHE regulation, CARB has requested that EPA find
the requirements fall within the scope of a previously granted waiver
or authorization, or in the alternative grant a new waiver of
preemption or authorization. Finally, for one portion of its CHE
regulation, CARB has requested that EPA find the requirements are not
preempted by section 209 of the Clear Air Act, that if EPA finds they
are preempted, the requirements fall within the scope of a previously
granted waiver or, in the alternative, EPA grant a new waiver of
preemption.\6\
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    \6\ CARB's initial waiver and authorization request submitted on
January 29, 2007 (which full set forth the requisite information to
support the granting of a full waiver and authorization), in
combination with supplemental comments submitted by CARB on March
17, 2011, make clear CARB's intent to receive a full waiver and
authorization to the extent that EPA deems a within the scope
determination is inappropriate. As explained below, EPA finds that
due to the new application of CARB's standards a full waiver and
authorization is necessary.
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B. CARB Mobile Cargo Handling Equipment Regulations

    CARB's CHE regulations set performance standards for engines
equipped in newly purchased, leased, or rented (collectively known as
``newly acquired''), as well as in-use, mobile cargo handling equipment
used at ports or intermodal rail yards in California. The standards
vary depending on the type of vehicle, whether the engine is used in
off-road equipment or a vehicle registered as an on-road motor vehicle,
and whether they are newly acquired or already in-use.\7\
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    \7\ CARB normally uses the term ``off-road'' while EPA uses the
term ``nonroad.'' Similarly, CARB uses the term ``on-road'' while
EPA uses the term ``on-highway'' or ``motor vehicles.''
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    Yard trucks and other mobile cargo handling equipment registered to
operate on California highways acquired after January 1, 2007 must be
equipped with engines that are certified to the on-road engine emission
standards for the model year in which they are acquired.
    Any yard truck not registered for on-road operation (off-road yard
trucks) acquired after January 1, 2007 must be equipped either with an
engine certified to the on-road emission standards for the model year
in which it is acquired or the final Tier-4 off-road emission

standard applicable to the engine's rated power.
    Engines in newly acquired CHE other than yard trucks that are not
registered for on-road operation (non-yard trucks) must--if technically
feasible and available for purchase, lease, or rental--meet one of two
certification standards: (1) The on-road engine certification standards
or (2) the off-road Tier 4 certification standards for the model year
and rated power of the engine. Alternatively, if neither of the options
is feasible or available, a newly acquired non-yard truck must be
equipped with an engine that is certified to the most stringent off-
road engine emission standards for the type of vehicle and application
for the model year in which it is acquired. In addition, under this
alternative, within one year of acquiring the vehicle, the owner or
operator must install the highest level verified diesel emission
control strategy (VDECS) that is approved by CARB and available for
that engine. If no VDECS is verified by CARB and available by the end
of the one-year period, the owner or operator must install the highest
level VDECS within six months after one becomes available.
    For in-use yard trucks, whether on-road or off-road, the
regulations require they meet one of three compliance options: such
vehicles must (1) be certified to the 2007 or later model year on-road
engine standards; (2) be certified to Tier 4 off-road standards; or (3)
apply VDECS that reduce emissions to levels that comply with diesel PM
and NOx emissions of a certified final Tier 4 off-road diesel engine
for the same power rating.
    The date by which each in-use yard truck in an owner or operator's
fleet must be brought into compliance depends on the number of trucks
in the fleet, the model year of the trucks, whether the trucks are
equipped with on-road or off-road engines, and whether the engines were
equipped with VDECS by December 31, 2006.
    For in-use non-yard trucks, the regulations identify and establish
separate requirements for three categories or vehicles: Basic cargo
handling equipment, bulk cargo handling equipment and rubber-tired
gantry (RTG) cranes. Basic cargo handling equipment consists of top
handlers, side handlers, reach stackers, forklifts, straddle carriers
and any other type of equipment (other than RTG cranes) that handles
cargo containers. Bulk cargo handling equipment consists of dozers,
loaders, excavators, mobile cranes, sweepers, railcar movers, aerial
lifts and any other type of equipment (except forklifts) that handles
non-containerized or bulk cargo.
    For all three categories of in-use non-yard trucks, vehicles can be
brought into compliance using any of three options. Option 1 is the
same for all three categories: Use of an engine or power system--
including diesel, alternative fueled, or heavy-duty pilot ignition
engine--certified to the 2007 or later model year on-road or Tier 4
off-road engine standards for the rated power and model year of the
engine.
    Option 2 two is identical for basic cargo handling equipment and
bulk cargo handling equipment, but varies slightly for RTG cranes.
Basic cargo handling equipment and bulk cargo handling equipment must
comply by installing a pre-2007 model year certified on-road engine or
a certified Tier 2 or Tier 3 off-road engine and applying the highest
level VDECS that is certified for the specific engine family and model
year. However, if no Level 2 or higher VDECS is available, the engine
must be upgraded to either a certified Tier 4 off-road engine or a
Level 3 VDECS must be installed by December 31, 2015.
    Under option 2, RTG cranes use a certified Tier 2 or Tier 3 off-
road engine and the highest VDECS available but, in contrast to basic
and bulk cargo handling equipment, need not upgrade, regardless of
whether or not the highest VDECS available was Level 2 or below.
    Option 3 is similar for both basic and bulk cargo handling
equipment. Basic cargo handling equipment may comply using a pre-Tier 1
or a Tier 1 off-road engine equipped with the highest level VDECS
available. However, if the highest level VDECS available is not Level 3
or higher, the engine must be upgraded to either a certified Tier 4
off-road engine or a Level 3 VDECS by December 31, 2015. For bulk cargo
handling equipment, the requirements of this option are the same except
an upgrade is required if no Level 2 or higher VDECS is initially
available. Lastly, under the option 3, RTG cranes may comply using a
pre Tier 1 or certified Tier 1 off-road engine equipped with the
highest level VDECS available. However, if no VDECS is available or the
highest level VDECS is a Level 1 or 2, then the RTG crane engine must
be replaced with a Tier 4 certified off-road engine or a Level 3 VDECS
must be installed by the later of December 31, 2015 or December 31st of
the model year of the initially compliant engine plus 12 years.
    The date by which each in-use non-yard truck in an owner or
operator's fleet must be brought into compliance depends on the size
and model-year composition of the in-use non-yard trucks in the fleet

C. Previously Granted Waivers and Authorizations

    By letter dated July 26, 2004, CARB requested that EPA grant
California a waiver of federal preemption for its 2007 California Heavy
Duty Diesel Engines Standards, which primarily align California's
standards and test procedures with the federal standards and test
procedures for 2007 and subsequent model year heavy-duty motor vehicles
and motor vehicle engines.\8\ After offering an opportunity for hearing
and public comment, on August 26, 2005 EPA granted California's request
for waiver.\9\
---------------------------------------------------------------------------

    \8\ 70 FR 50322 (August 26, 2006)
    \9\ Id.
---------------------------------------------------------------------------

    On July 18, 2008, CARB notified EPA of additional regulations and
amendments to its new nonroad compression ignition engine regulations.
EPA determined that a portion of those regulations fell within the
scope of the previously granted authorization and granted a new
authorization for the remainder of the regulations.\10\
---------------------------------------------------------------------------

    \10\ 75 FR 8056 (February 23, 2010). EPA previously granted an
authorization for California's new heavy-duty off-road diesel-cycle
engines greater than 130 kW at 60 FR 48981 (September 21, 1995) and
subsequently confirmed that amendments to those standards were
within the scope of the prior authorization at 69 FR 38958 (June 29,
2004).
---------------------------------------------------------------------------

D. Clean Air Act Waivers of Preemption and Authorizations

    Section 209(a) of the Clean Air Act preempts states and local
governments from setting emission standards for new motor vehicles and
engines. It provides:

    No State or any political subdivision thereof shall adopt or
attempt to enforce any standard relating to the control of emissions
from new motor vehicles or new motor vehicle engines subject to this
part. No state shall require certification, inspection or any other
approval relating to the control of emissions from any new motor
vehicle or new motor vehicle engine as condition precedent to the
initial retail sale, titling (if any), or registration of such motor
vehicle, motor vehicle engine, or equipment.

Through operation of section 209(b) of the Act, California is able to
seek and receive a waiver of section 209(a)'s preemption. Section
209(b)(1) requires a waiver to be granted for any State that had
adopted standards (other than crankcase emission standards) for the
control of emissions from new motor vehicles or new motor vehicle
engines prior to March 30, 1966,\11\ if the State

determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as applicable Federal standards
(this is known as California's ``protectiveness determination'').
However, no waiver is to be granted if EPA finds that: (A) California's
``protectiveness determination'' is arbitrary and capricious \12\; (B)
California does not need such State standards to meet compelling and
extraordinary conditions \13\; or (C) California's standards and
accompanying enforcement procedures are not consistent with section
202(a) of the Act.\14\ Regarding consistency with section 202(a), EPA
reviews California's standards for technological feasibility and
evaluates testing and enforcement procedures to determine whether they
would be inconsistent with federal test procedures (e.g., if
manufacturers would be unable to meet both California and federal test
requirements using the same test vehicle).\15\
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    \11\ Because California was the only state to have adopted
standards prior to 1966, it is the only state that is qualified to
seek and receive a waiver. See S.Rep. No. 90-403 at 632 (1967).
    \12\ CAA section 209(b)(1)(A).
    \13\ CAA section 209(b)(1)(B).
    \14\ CAA section 209(b)(1)(C).
    \15\ See, e.g., 74 FR at 32767 (July 8, 2009); see also Motor
and Equip. Mfrs Assoc. v. EPA, 627 F.2d 1095 (D.C. Cir. 1979)
(``MEMA I'').
---------------------------------------------------------------------------

    If California amends regulations that were previously granted a
waiver of preemption, EPA can confirm that the amended regulations are
within the scope of the previously granted waiver if three conditions
are met. These conditions for confirming a within-the-scope request are
discussed below.
    Section 209(e)(1) of the Act permanently preempts any State, or
political subdivision thereof, from adopting or attempting to enforce
any standard or other requirement relating to the control of emissions
for certain new nonroad engines or vehicles. Section 209(e)(2) of the
Act requires the Administrator to grant California authorization to
enforce its own standards for new nonroad engines or vehicles which are
not listed under section 209(e)(1), subject to certain restrictions. On
July 20, 1994, EPA promulgated a rule that sets forth, among other
things, the criteria, as found in section 209(e)(2), which EPA must
consider before granting any California authorization request for new
nonroad engine or vehicle emission standards. On October 8, 2008, the
regulations promulgated in that rule were moved to 40 CFR part 1074,
and modified slightly. The applicable regulations, 40 CFR Sec.
1074.105, provide:
    (a) The Administrator will grant the authorization if California
determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as otherwise applicable
federal standards.
    (b) The authorization will not be granted if the Administrator
finds that any of the following are true:
    (1) California's determination is arbitrary and capricious.
    (2) California does not need such standards to meet compelling
and extraordinary conditions.
    (3) The California standards and accompanying enforcement
procedures are not consistent with section 209 of the Act.
    (c) In considering any request from California to authorize the
state to adopt or enforce standards or other requirements relating
to the control of emissions from new nonroad spark-ignition engines
smaller than 50 horsepower, the Administrator will give appropriate
consideration to safety factors (including the potential increased
risk of burn or fire) associated with compliance with the California
standard.

As stated in the preamble to the section 209(e) rule, EPA has
historically interpreted the section 209(e)(2)(iii) ``consistency''
inquiry to require, at minimum, that California standards and
enforcement procedures be consistent with section 209(a), section
209(e)(1), and section 209(b)(1)(C) (as EPA has interpreted that
subsection in the context of section 209(b) motor vehicle waivers).\16\
---------------------------------------------------------------------------

    \16\ See 59 FR 36969 (July 20, 1994).
---------------------------------------------------------------------------

    In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. To be consistent with section
209(e)(1), California's nonroad standards and enforcement procedures
must not attempt to regulate engine categories that are permanently
preempted from state regulation under section 209(e)(1). To determine
consistency with section 209(b)(1)(C), EPA typically reviews nonroad
authorization requests under the same ``consistency'' criteria that are
applied to motor vehicle waiver requests. Pursuant to section
209(b)(1)(C), the Administrator shall not grant California a motor
vehicle waiver if she finds that California ``standards and
accompanying enforcement procedures are not consistent with section
202(a)'' of the Act. Previous decisions granting waivers and
authorizations have noted that state standards are inconsistent with
section 202(a) if: (1) There is inadequate lead time to permit the
development of the necessary technology giving appropriate
consideration to the cost of compliance within that time, or (2) the
federal and state testing procedures impose inconsistent certification
requirements.
    EPA can confirm that amended regulations are within the scope of a
previously granted waiver of preemption or authorization if three
conditions are met. First, the amended regulations must not undermine
California's determination that its standards, in the aggregate, are at
least as protective of public health and welfare as applicable federal
standards. Second, the amended regulations must not undermine our
previous determination with respect to consistency with section 202(a)
of the Act. Third, the amended regulations must not raise any new
issues affecting EPA's prior waiver determinations.

E. Burden of Proof

    In MEMA I, the U.S. Court of Appeals stated that the
Administrator's role in a section 209 proceeding is to:

Consider all evidence that passes the threshold test of materiality
and * * * thereafter assess such material evidence against a
standard of proof to determine whether the parties favoring a denial
of the waiver have shown that the factual circumstances exist in
which Congress intended a denial of the waiver.\17\
---------------------------------------------------------------------------

    \17\ MEMA I, 627 F.2d at 1122.v
---------------------------------------------------------------------------

The court in MEMA I considered the standards of proof under section 209
for the two findings related to granting a waiver for an ``accompanying
enforcement procedure'' (as opposed to the standards themselves): (1)
Protectiveness in the aggregate and (2) consistency with section 202(a)
findings. The court instructed that ``the standard of proof must take
account of the nature of the risk of error involved in any given
decision, and it therefore varies with the finding involved. We need
not decide how this standard operates in every waiver decision.'' \18\
---------------------------------------------------------------------------

    \18\ Id.
---------------------------------------------------------------------------

    The court upheld the Administrator's position that, to deny a
waiver, there must be `clear and compelling evidence' to show that
proposed procedures undermine the protectiveness of California's
standards.\19\ The court noted that this standard of proof also accords
with the congressional intent to provide California with the broadest
possible discretion in setting regulations it finds protective of the
public health and welfare.\20\
---------------------------------------------------------------------------

    \19\ Id.
    \20\ Id.
---------------------------------------------------------------------------

    With respect to the consistency finding, the court did not
articulate a standard of proof applicable to all proceedings, but found
that the opponents of the waiver were unable to meet their burden of
proof even if the standard were a mere preponderance of the evidence.
Although MEMA I did not

explicitly consider the standards of proof under section 209 concerning
a waiver request for ``standards,'' as compared to accompanying
enforcement procedures, there is nothing in the opinion to suggest that
the court's analysis would not apply with equal force to such
determinations. EPA's past waiver decisions have consistently made
clear that: ``[E]ven in the two areas concededly reserved for Federal
judgment by this legislation--the existence of `compelling and
extraordinary' conditions and whether the standards are technologically
feasible--Congress intended that the standards of EPA review of the
State decision to be a narrow one.'' \21\
---------------------------------------------------------------------------

    \21\ See, e.g., 40 FR 21102-103 (May 28, 1975).
---------------------------------------------------------------------------

    Opponents of the waiver bear the burden of showing that the
criteria for a denial of California's waiver request have been met. As
found in MEMA I, this obligation rests firmly with opponents of the
waiver in a section 209 proceeding:

[t]he language of the statute and its legislative history indicate
that California's regulations, and California's determinations that
they must comply with the statute, when presented to the
Administrator are presumed to satisfy the waiver requirements and
that the burden of proving otherwise is on whoever attacks them.
California must present its regulations and findings at the hearing
and thereafter the parties opposing the waiver request bear the
burden of persuading the Administrator that the waiver request
should be denied.\22\
---------------------------------------------------------------------------

    \22\ MEMA I, 627 F.2d at 1121.

The Administrator's burden, on the other hand, is to make a reasonable
evaluation of the information in the record in coming to the waiver
decision. As the court in MEMA I stated: ``Here, too, if the
Administrator ignores evidence demonstrating that the waiver should not
be granted, or if he seeks to overcome that evidence with unsupported
assumptions of his own, he runs the risk of having his waiver decision
set aside as `arbitrary and capricious.' '' \23\ Therefore, the
Administrator's burden is to act ``reasonably.'' \24\
---------------------------------------------------------------------------

    \23\ Id. at 1126.
    \24\ Id. at 1126.
---------------------------------------------------------------------------

F. EPA's Consideration of CARB's Request

    EPA sought comment on a range of issues, including whether certain
or all of CARBs CHE regulation should be evaluated under the within the
scope criteria or under the criteria for a full authorization and
waiver of preemption. EPA did not receive any comments contending that
any portions of the CHE regulations should be subjected to full waiver
or authorization analysis.
    CARB maintains that its requirements for newly acquired on-highway
yard and non-yard trucks are covered by a waiver granted by EPA for
2007 and later model year (MY) on-highway heavy-duty diesel engines, or
conversely its requirements are within the scope of that waiver
decision.\25\
---------------------------------------------------------------------------

    \25\ 70 FR 50322 (August 26, 2005).
---------------------------------------------------------------------------

    CARB also maintains that its requirements for newly acquired off-
road yard trucks should be analyzed under the within the scope criteria
since the compliance options involve either the use of a 2007 and later
MY on-highway heavy-duty diesel engine (and thus the same within the
scope rationale noted above) or the use of an engine meeting the final
Tier 4 off-road engine standards which EPA previously authorized.\26\
Similarly, for the requirements associated with newly acquired off-road
non-yard trucks CARB also states that options 1 and 2 should be
considered within the scope of the prior waiver and authorization noted
above, and that option 3 (the VDECS option) should be granted a full
authorization.
---------------------------------------------------------------------------

    \26\ 75 FR 8056 (February 23, 2010).
---------------------------------------------------------------------------

    In addition to the requirements associated with newly acquired
mobile cargo handling equipment, the CHE regulations also set forth in-
use performance standards applicable to non-new yard and non-yard
trucks. To the extent the in-use standards apply to yard and non-yard
trucks registered on-road, CARB maintains such requirements are not
preempted by section 209(a) of the Act and therefore do not require a
waiver from EPA. To the extent the in-use standards apply to non-new
off-road yard and non-yard trucks (those not registered for on-road
operation) CARB requests a full authorization from EPA.
    Despite CARB's contentions, EPA has determined that California's
CHE regulations to the extent they apply to nonroad engines require a
full authorization and to the extent they apply to new motor vehicles
or new motor vehicle engines require a full waiver of preemption. While
CARB acknowledges their CHE requirements are standards relating to the
control of emissions they nevertheless suggest that such standards have
either been previously waived or authorized by EPA. However, the
analysis does not end there. The United States Supreme Court's
interpretation of ``standard relating to the control of emissions from
new motor vehicles or new motor vehicle engines'' in Engine
Manufacturers Association v. South Coast Air Quality Management
District, 541 U.S. 246 (2004) supports the conclusion that
``standards'' not merely be limited to a design or performance standard
relating to the production of certain vehicles that meet particular
emission characteristics but also that the means of enforcing the
emission limits is pertinent. California's new engine requirements
should be considered as standards relating to the control of emissions.
As the Court noted, ``Manufacturers (or purchasers) can be made
responsible for ensuring that vehicles comply with emission standards,
but the standards themselves are separate from those enforcement
techniques. While standards target vehicles or engines, standard-
enforcement efforts that are proscribed by Sec.  209 can be directed to
manufacturers or purchasers.'' \27\ In this instance, while the
underlying standards as applied toward the production of new heavy-duty
diesel highway engines or new nonroad diesel engines have either
previously been waived or authorized by EPA, CARB is newly applying the
standards to operators at ports and rail yards and requiring them to
acquire CHE with specific emission characteristics to the exclusion of
other CHE.
---------------------------------------------------------------------------

    \27\ Engine Manufacturers Association v. South Coast Air Quality
Management District, 541 U.S. 246,253 (2004).
---------------------------------------------------------------------------

    Therefore, with respect to newly acquired yard and non-yard trucks
EPA will evaluate such requirements under the full waiver criteria.
Similarly, for newly acquired off-road yard and non-yard trucks EPA
will evaluate such requirements under the full authorization criteria.
    In addition to the extent the CHE in-use standards apply to yard
and non-yard trucks registered on-road EPA agrees with CARB's
assessment that such requirements are not preempted by section 209(a)
of the Act (which only applies to ``new'' motor vehicles and ``new''
motor vehicle engines) and therefore do not require a waiver from EPA.
Lastly, to the extent the in-use standards apply to non-new off-road
yard and non-yard trucks (those not registered for on-road operation)
EPA will evaluate such requirements under the full authorization
criteria as requested by CARB.

II. Discussion

A. California's Protectiveness Determination

    Section 209(b)(1)(A) of the Act requires EPA to deny a waiver if
the Administrator finds that California was

arbitrary and capricious in its determination that its State standards
will be, in the aggregate, at least as protective of public health and
welfare as applicable Federal standards. When evaluating California's
protectiveness determination, EPA compares the stringency of the
California and Federal standards at issue in a given waiver request.
That comparison is undertaken within the broader context of the
previously waived California program, which relies upon protectiveness
determinations that EPA previously found were not arbitrary and
capricious.
    Similarly, section 209(e)(2)(i) of the Act instructs that EPA
cannot grant an authorization if the Administrator finds that CARB was
arbitrary and capricious in its determination that its standards are,
in the aggregate, at least as protective of public health and welfare
as applicable federal standards.
    EPA previously found that CARBs regulations establishing emission
standards for 2007 and subsequent model year heavy duty on-road diesel
engines are as protective of the public health and welfare as
comparable federal standards.\28\ CARB has found that to the extent the
CHE regulations permit newly acquired on-road yard trucks, newly
acquired on-road non-yard trucks and in-use yard trucks to comply by
using current model year certified on-road diesel engines, they do not
undermine the board's previous determination that its emission
standards, in the aggregate, are at least as protective of public
health and welfare as comparable federal standards.\29\
---------------------------------------------------------------------------

    \28\ 70 FR 50322 (August 26, 2005).
    \29\ See CARB Resolution 05-62.
---------------------------------------------------------------------------

    EPA previously found that CARB's regulations for new nonroad Tier 4
engines are at least as protective of the public health and welfare as
comparable federal standards.\30\ CARB has found that to the extent the
CHE regulations permit newly acquired off-road yard trucks, newly
acquired off-road non-yard trucks and in-use yard trucks to comply by
using Tier 4 off-road CI emission standards engines, they do not
undermine the board's previous determination that its emission
standards, in the aggregate, are at least as protective of public
health and welfare as comparable federal standards.\31\
---------------------------------------------------------------------------

    \30\ 75 FR 8056 (February 23, 2010).
    \31\ See CARB Resolution 05-62.
---------------------------------------------------------------------------

    No commenter expressed an opinion or presented any evidence
suggesting that CARB was arbitrary and capricious in making its above-
noted protectiveness findings. Therefore, based on the record, EPA
cannot find that California was arbitrary and capricious in its
findings that California's CHE requirements are, in the aggregate, at
least as protective of public health and welfare as applicable Federal
standards.

B. Compelling and Extraordinary Conditions

    Under section 209(b)(1)(B) of the Act, EPA cannot grant a waiver if
California ``does not need such State standards to meet compelling and
extraordinary conditions.'' To evaluate this criterion, EPA considers
whether California needs a separate motor vehicle emissions program to
meet compelling and extraordinary conditions.
    Similarly, section 209(e)(2)(ii) of the Act instructs that EPA
cannot grant an authorization if the Administrator finds that
California does not need such standards to meet compelling and
extraordinary conditions. This criterion restricts EPA's inquiry to
whether California needs its own mobile source pollution program to
meet compelling and extraordinary conditions, and not whether any given
standards are necessary to meet such conditions.\32\
---------------------------------------------------------------------------

    \32\ See 74 FR 32744, 32761 (July 8, 2009); 49 FR 18887, 18889-
18890 (May 3, 1984).
---------------------------------------------------------------------------

    Over the past forty years, CARB has repeatedly demonstrated the
need for its motor vehicle emissions program to address compelling and
extraordinary conditions in California.\33\ In Resolution 05-62, CARB
affirmed its longstanding position that California continues to need
its own motor vehicle and engine program to meet its serious air
pollution problems. Likewise, EPA has consistently recognized that
California continues to have the same ``geographical and climatic
conditions that, when combined with the large numbers and high
concentrations of automobiles, create serious pollution problems.''
\34\ Furthermore, no commenter has presented any argument or evidence
to suggest that California no longer needs a separate motor vehicle
emissions program to address compelling and extraordinary conditions in
California. Therefore, EPA has determined that we cannot deny
California a waiver or authorization for its CHE requirements under
section 209(b)(1)(B) or section 209(e)(2)(ii), respectively.
---------------------------------------------------------------------------

    \33\ See, e.g., Approval and Promulgation of State
Implementation Plans; California--South Coast, 64 FR 1770, 1771
(January 12, 1999). See also 69 FR 23858, 23881-90 (April 30, 2004)
(designating 15 areas in California as nonattainment for the federal
8-hour ozone national ambient air quality standard).
    \34\ 49 FR 18887, 18890 (May 3, 1984); see also 76 FR 34693
(June 14, 2011), 74 FR 32744, 32763 (July 8, 2009), and 73 FR 52042
(September 8, 2008).
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C. Consistency With Section 202(a) and 209 of the Clean Air Act

    Under section 209(b)(1)(C) of the Act, EPA must deny a California
waiver request if the Agency finds that California standards and
accompanying enforcement procedures are not consistent with section
202(a) of the Act. The scope of EPA's review under this criterion is
narrow. EPA has stated on many occasions that the determination is
limited to whether those opposed to the waiver have met their burden of
establishing that California's standards are technologically
infeasible, or that California's test procedures impose requirements
inconsistent with federal test procedures. Previous waivers of federal
preemption have stated that California's standards are not consistent
with section 202(a) if there is inadequate lead time to permit the
development of technology necessary to meet those requirements, giving
appropriate consideration to the cost of compliance within that time.
California's accompanying enforcement procedures would be inconsistent
with section 202(a) if the federal and California test procedures
conflict, i.e., if manufacturers would be unable to meet both the
California and federal test requirements with the same test vehicle.
    Similarly, Section 209(e)(2)(iii) of the Act instructs that EPA
cannot grant an authorization if California's standards and enforcement
procedures are not consistent with section 209. As described above, EPA
has historically evaluated this criterion for consistency with sections
209(a), 209(e)(1), and 209(b)(1)(C).
1. Consistency With Section 209(a)
    As noted above, EPA considers CARB's nonroad authorization requests
under certain criteria including whether CARB's requirements are
consistent with section 209(a) of the Act (to be consistent with
section 209(a) of the Clean Air Act, California's requirements must not
apply to new motor vehicles or engines). However, in this instance
California's CHE requirements affect both new motor vehicles and
engines along with affecting nonroad vehicles and engines. To the
extent the CHE requirements do affect motor vehicles and engines (CHE
motor vehicle requirements) CARB explicitly requests a waiver of
preemption under section 209(b) rather than an authorization under
section 209(e)(2). EPA is evaluating the CHE motor vehicle requirements
under section 209(b). The

purpose of section 209(b) is to waive the preemption otherwise created
by section 209(a). To the extent the CHE requirements affect nonroad
vehicles and engines (CHE nonroad requirements) CARB explicitly
requests an authorization under section 209(e)(2). By logical extension
and definition such CHE nonroad requirements only pertain to nonroad
vehicles and engines and are thus not motor vehicles under section
209(a).
    No commenter presented otherwise; therefore, EPA cannot deny
California's authorization request on the basis that California's CHE
requirements are not consistent with section 209(a).
2. Consistency With Section 209(e)(1)
    To be consistent with section 209(e)(1) of the Clean Air Act,
California's CHE nonroad requirements must not affect new farming or
construction vehicles or engines that are below 175 horsepower, or new
locomotives or their engines. CARB presents that CHE equipment is not
used in farm and construction equipment or vehicles or engines used in
locomotives.\35\ No commenter presented otherwise; therefore, EPA
cannot deny California's request on the basis that California's APS
requirements are not consistent with section 209(e)(1).\36\
---------------------------------------------------------------------------

    \35\ CARB's waiver and authorization request letter at p. 21,
citing section 2479(e)(1)(B) of its regulations.
    \36\ BNSF Railway Company and Union Pacific Railroad Company
note that they are currently complying with the CHE regulation in
their efforts to work with the state and to reduce emissions from
rail operations. Further, they state that ``Regardless of whether or
not EPA issues a waiver for the retrofit component of the CHE rule,
the Railroads are not waiving any aspect of preemption or setting
any precedent as to preemption or voluntary compliance with other
rules or agreements.'' EPA's decision granting a waiver and
authorization for CARB's CHE regulations addresses only the specific
criteria set forth in sections 209(b) and (e) of the Clean Air Act.
It does not address ancillary issues related to harmonizing CAA
authority with other federal preemptions, such as Interstate
Commerce Commission Termination Act (ICCTA), that restrict the
authority of local governments to regulate railroads.
---------------------------------------------------------------------------

3. Consistency With Section 209(b)(1)(C) and Section 202(a)
    As noted above, EPA's evaluation of CARB nonroad authorization
requests (e.g. the CHE nonroad requirements) includes consideration of
whether their requirements are consistent with section 209(b)(1)(C) of
the Act. In addition, EPA's evaluation of CARB waiver requests (e.g.,
the CHE motor vehicle requirements) includes consideration of whether
their requirements are consistent with section 209(b)(1)(C). Under
section 209(b)(1)(C) of the Act, EPA must deny a California request if
the Agency finds that California standards and accompanying enforcement
procedures are not consistent with section 202(a) of the Act. The scope
of EPA's review under this criterion is narrow. EPA has stated on many
occasions that the determination is limited to whether those opposed to
the waiver have met their burden of establishing that California's
standards are technologically infeasible, or that California's test
procedures impose requirements inconsistent with federal test
procedures. Previous waivers of federal preemption have stated that
California's standards are not consistent with section 202(a) if there
is inadequate lead time to permit the development of technology
necessary to meet those requirements, giving appropriate consideration
to the cost of compliance within that time. California's accompanying
enforcement procedures would be inconsistent with section 202(a) if the
federal and California test procedures conflict, i.e., if manufacturers
would be unable to meet both the California and federal test
requirements with the same test vehicle.
    CARB states that the CHE regulations are consistent with section
202(a). CARB states that the technological feasibility of the emission
requirements related to yard trucks registered for operation on-road is
not disputed since such vehicles need only meet the 2007 on-road
engines standards previously waived by EPA. CARB's CHE regulations do
not change the underlying test procedures for on-road engines. CARB
notes that newly acquired non-yard trucks registered for operation on-
road are similar to yard trucks noted above in terms of applicable
emission standards and test procedures.
    With respect to off-road yard and non-yard trucks CARB notes that
the applicable emission standards (either the 2007 on-road standards
previously waived by EPA or the Tier 4 nonroad standards previously
authorized by EPA) are technologically feasible. CARB also notes that
to the extent operators use option 3 (the use of a lower tier engine if
option 1 and 2 are not available, and the subsequent installation of
VDECS) it is feasible given the number of VDECS verified to date.
    EPA received comment from SSAT noting problems with ``post 07 yard
truck issues'' and challenges associated with non-yard trucks and
VDECs. With respect to the yard truck issue it appears that SSAT is
concerned that it is only able to use a certain manufacturer's engine
and such engine has exhaust gas leak issues that includes disabling the
EGR system. SSAT contends that it is dealing with a 25% failure rate.
CARB notes in response that the exact nature of the failure rate at the
terminals is unclear and its conclusions seem to be based on opinion
rather than any data in the record. CARB surmises the problem may be
associated with maintenance or operational practices. SSAT provided no
further explanation as to why the engine it identified is the only
usable engine. Based on the limited information submitted by SSAT, and
as CARB notes the fact that 38 other terminals have voluntarily
acquired new yard trucks equipped with new on-road CI engines with none
reporting EGR problems and none submitting comment to EPA, we find that
opponents of the waiver have not met their burden of proof to
demonstrate that the new yard truck emission standards are infeasible
or otherwise inconsistent with section 202(a).
    With regard to non-yard trucks EPA received comment from SSAT and
Ports America regarding the use of VDECS for compliance.\37\ The
commenters' comments include: VDECS become plugged and do not operate
properly; the compliance extension provisions are ambiguous, forcing
fleet owners to undergo an arduous and expensive process; and the VDECS
are expensive.
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    \37\ Similar to SSAT's comments on yard trucks it is unclear
whether the commenters are raising concerns with newly acquired non-
yard trucks or in-use non-yard trucks. EPA notes that in-use
requirements for on-road vehicles are not preempted by section 209
of the Act.
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    CARB provides several responses to concerns of improper operating
and plugging VDECS. CARB notes that nine Level 3 emission control
devices have been verified for non-yard truck applications and that at
least 77 VDECS have been installed on a wide-variety of vehicle
applications. CARB understands that while excess soot may plug some
VDECS there is strong evidence to suggest that fleet owners are not
properly performing manual regeneration or that improper sizing of
VDECS with engines may be occurring. This coupled with a lack of
concrete information and data from the commenters causes CARB to
suggest that a showing of infeasibility had not been shown.
    CARB also notes that to the extent the use of VDECS is not
available its compliance extension provisions provide ample opportunity
for fleet operators to comply with the CHE regulations. CARB responds
to the commenters' suggestion that the compliance extension provisions
are

ambiguous (extensions are granted by CARB if the VDECS are ``not
available'' and ``not feasible'') by pointing to its initial request to
EPA for a waiver and authorization where CARB discussed compliance
flexibility and relief.\38\ CARB maintains that nothing in the comments
contradicts CARB's reasons for the provisions or that the terms of the
provisions are illusory. CARB notes that to date SSAT has never
requested an extension and Ports America has requested and received an
extension. CARB also provides an accounting of 88 compliance extension
requests it has received with no indication of any problems. In
addition, CARB provides a detailed explanation of its administrative
process for handling such requests.
---------------------------------------------------------------------------

    \38\ See CARB's January 29, 2007 request at pp. 11-12, and 34
where CARB sets out 5 different types of extensions (e.g., a one
year extension if an engine is within one year of retirement, a two-
year extension if no VDECS is available, etc.).
---------------------------------------------------------------------------

    Based on the lack of concrete evidence from the commenters that it
has incurred unreasonable delays or other difficulties making its
compliance with the CHE regulations infeasible, EPA cannot deny CARB's
request based on the infeasibility of CARB's compliance provisions.
    Finally, with regard to the costs associated with VDECS the
commenters note ``The cost of [VDECS] typically cost 40k each dropped
50% on `some' systems when the economy took a down turn. We are looking
at spending millions of dollars to one or two vendors who charge
whatever they feel they can get away with.'' CARB replies by noting
that nowhere do the commenters assert that the costs make the CHE
regulation infeasible. CARB notes that the nature or port terminals and
intermodal railroads make them multimillion-dollar businesses with
highly polluting equipment. Without hard evidence from the commenters
as to why the costs render the regulations infeasible, CARB suggests
that costs are a policy question for CARB to consider when adopting the
regulation and that EPA should follow its historical practice of
deference.
    EPA notes that it is required to closely examine costs when making
a determination of whether there is evidence in the record to support a
finding that CARB's regulations are technologically infeasible. In this
instance there is insufficient evidence in the record to demonstrate
why the costs of VDECS are inappropriately high when compared to the
costs of the underlying vehicles or why the costs are otherwise
inappropriately prohibitive. Therefore, based on the record, EPA cannot
make a finding that CARB's CHE regulations are inconsistent with
section 202(a) based on considerations of costs.
    As noted above, EPA's consideration of the consistency with section
202(a) includes a review of whether California's test procedures impose
requirements inconsistent with federal test procedures. Because CARB's
test procedures are incorporated in previously waived and authorized
regulations (e.g., the Tier 4 nonroad standards and the 2007 heavy-duty
diesel engine regulations) and such regulations harmonize their test
procedures with applicable federal test procedures CARB maintains there
is no test procedure inconsistency. We have received no comments
presented otherwise; therefore, based on the record before me I cannot
deny CARB's request based on a lack of test procedure consistency.

III. Decision

    EPA's analysis finds that the criteria for granting a full
authorization and a full waiver of preemption have been met for CARB's
CHE regulations.
    The Administrator has delegated the authority to grant California a
section 209(b) waiver to enforce its own emission standards for new
motor vehicles and engines and to grant California a section 209(e)
authorization to enforce its own emission standards for nonroad engines
and equipment to the Assistant Administrator for the Office of Air and
Radiation. Having given consideration to all the material submitted for
this record, and other relevant information, I find that I cannot make
the determinations required for a denial of a waiver request pursuant
to section 209(b) of the Act nor can I make the determination required
for a denial of an authorization pursuant to section 209(e) of the Act.
Therefore I grant both a waiver of preemption and authorization to the
State of California with respect to its CHE regulations as set for the
above.
    My decision will affect not only persons in California but also
manufacturers outside the State who must comply with California's
requirements in order to produce engines for sale in California. For
this reason, I determine and find that this is a final action of
national applicability for purposes of section 307(b)(1) of the Act.
    Pursuant to section 307(b)(1) of the Act, judicial review of this
final action may be sought only in the United States Court of Appeals
for the District of Columbia Circuit. Petitions for review must be
filed by April 23, 2012. Judicial review of this final action may not
be obtained in subsequent enforcement proceedings, pursuant to section
307(b)(2) of the Act.
    In addition, this action is not a rule as defined in the Regulatory
Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a
supporting regulatory flexibility analysis addressing the impact of
this action on small business entities.
    Further, the Congressional Review Act, 5 U.S.C. 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, does not apply because this action is not a rule for purposes of
5 U.S.C. 804(3).

    Dated: November 28, 2011.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2012-3793 Filed 2-17-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 17, 2009 (Volume 74, Number 50)]
[Notices]
[Page 11396-11397]
[DOCID:fr17mr09-74]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59556; File No. SR-NYSEArca-2009-17]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change Amending Rule
6.87--Obvious Errors

March 11, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 27, 2009, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the self-regulatory organization. NYSE Arca filed
the proposed rule change as a ``non-controversial'' proposal pursuant
to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 6.87--Obvious Errors. A copy of
this filing is available on the Exchange's Web site at http://
www.nyse.com, at the Exchange's principal office and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE Arca proposes to amend Rule 6.87 pertaining to the
nullification and adjustment of options transactions. Specifically, the
Exchange proposes to adopt a new provision which provides that in the
interest of maintaining a fair and orderly market and for the
protection of investors, the Chief Executive Officer of NYSE Arca Inc.
(``CEO'') or his/her designee (collectively ``Exchange officer''),\5\
may, on his or her own motion or upon request, determine to review any
transaction occurring on the Exchange that is believed to be
erroneous.\6\ A transaction reviewed pursuant to this new provision may
be nullified or adjusted only if it is determined by the Exchange
officer that the transaction is erroneous as provided in Rule
6.87(a)(1)-(5) or Commentary .04 thereof. A transaction would be
adjusted or nullified in accordance with the provision under which it
is deemed an erroneous transaction. The Exchange officer may be
assisted by a Trading Official in reviewing a transaction.
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    \5\ The Exchange represents that a CEO designee will be an
officer of the Exchange, who has also been designated as a Trading
Official, such as the Executive Vice President of Trading Operations
or the Vice President of Trading Services. Exchange officers are
employees of the Exchange, and are not affiliated with OTP Holders
or OTP Firms.
    \6\ In the event a party to a transaction requests that the CEO
or his/her designee review a transaction, the Exchange officer
nonetheless would need to determine, on his or her own motion,
whether to review the transaction.
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    The Exchange officer shall act pursuant to this paragraph as soon
as possible after receiving notification of the transaction, and
ordinarily would be expected to act on the same day as the transaction
occurred. However, because a transaction under review may have occurred
near the close of trading or due to unusual circumstances, the rule
provides that the Exchange officer shall act no later than 9:30 a.m.
(ET) on the next trading day following the date of the transaction in
question. An OTP Holder affected by a determination to nullify or
adjust a transaction pursuant to this new provision may appeal such
determination in accordance with Rule 6.87(a)(6); however, a
determination by an Exchange officer not to review a transaction, or a
determination not to nullify or adjust a transaction for which a review
was requested or conducted, is not appealable. NYSE Arca believes it is
appropriate to limit review on appeal to only those situations in which
a transaction is actually nullified or adjusted.
    This new provision is not intended to replace a party's obligation
to request a review, within the required time periods under Rule
6.87(a)(3), of any transaction that it believes meets the criteria for
an obvious error. And, if a transaction is reviewed and a determination
has been rendered pursuant to Rules 6.87(a)(1)-(5) or Commentary .04
thereof, no additional relief may be granted under this new provision.
Moreover, NYSE Arca does not anticipate exercising this new authority
in every situation in which a party fails to make a timely request for
review of a transaction pursuant to Rule 6.87(a)(3). NYSE Arca believes
this provision will help to protect the integrity of its marketplace by
vesting an Exchange officer with the authority to review a transaction
that may be erroneous, in those situations where a party failed to make
a timely request for a review.
    The Exchange also proposes at this time to revise Rule
6.87(a)(3)(A) in order to clarify that the time period in which a
Market Maker or other OTP Holder must notify the Exchange, when
requesting relief from a possible erroneous transaction, applies to all
transactions that are subject to adjustment or nullification, pursuant
to Rule 6.87(a)(1)-(5).
2. Statutory Basis
    This proposed rule change is designed to allow an Exchange officer
to review a transaction in order to provide the opportunity for
potential relief to a party affected by an obvious error. The Exchange
believes that for these reasons the proposed rule change is consistent
with Section 6(b) of the Act \7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \8\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
NYSE Arca notes that the

Exchange officer can adjust or nullify a transaction under the
authority granted by this new provision only if the transaction meets
the objective criteria for an obvious error under NYSE Arca rules.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

 III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
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    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied the pre-filing requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2009-17. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2009-17 and should
be submitted on or before April 7, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-5716 Filed 3-16-09; 8:45 am]

BILLING CODE 8011-01-P