[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74722-74723]
[FR Doc No: 2012-30270]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68401; File No. SR-CME-2012-42]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Order Approving Proposed Rule Change Regarding the Valuation of
Securities on Deposit

December 11, 2012.

I. Introduction

    On October 10, 2012, Chicago Mercantile Exchange Inc. (``CME'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change SR-CME-2012-42 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on October 30, 2012.\3\ The Commission received no
comment letters regarding this proposal. For the reasons discussed
below, the Commission is granting approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 34-68093 (October
24, 2012), 77 FR 65730 (October 30, 2012).
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II. Description

    CME is proposing to issue an Advisory Notice that announces certain
changes to the way CME will value securities on deposit. Under the
proposed changes, CME will begin using the current market value, plus
accrued interest, to value securities on deposit. CME currently
excludes accrued interest from the value of securities on deposit.
Therefore, with this adjustment, accrued interest will now be included
in the market value of the security. The purpose of the adjustment is
to harmonize valuations with existing industry conventions. CME
initially

planned to implement these changes beginning on December 3, 2012; \4\
however, CME has delayed the implementation date and will notify its
Clearing Members of the new implementation date in a subsequent notice
to its members.\5\
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    \4\ See supra note 3.
    \5\ Telephone conversation among Tim Elliott, Executive Director
and Associate General Counsel, CME; Gena Lai, Senior Special
Counsel, SEC; Justin Byrne, Attorney-Adviser, SEC; December 4, 2012.
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III. Discussion

    Section 19(b)(2)(C) of the Act \6\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization. Section 17A(b)(3)(F) of the Act \7\
requires, among other things, that the rules of a clearing agency are
designed to promote the prompt and accurate clearance and settlement of
securities transactions and, to the extent applicable, derivative
agreements, contracts, and transactions, and to assure the safeguarding
of securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.
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    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Commission believes that these changes are consistent with the
requirements of Section 17A(b)(3)(F) of the Act \8\ and the rules and
regulations thereunder applicable to CME. These changes would use the
current market value, plus accrued interest, for securities on deposit
at CME, which will better align CME's practices with the marketplace
and expectations of its participants. The changes will therefore
promote the prompt and accurate clearance and settlement of securities
transactions and, to the extent applicable, derivative agreements,
contracts, and transactions, and assure the safeguarding of securities
and funds which are in the custody or control of the clearing agency or
for which it is responsible.
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    \8\ 15 U.S.C. 78q-1(b)(3)(F).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \9\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (File No. SR-CME-2012-42) be,
and hereby is, approved.\11\
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    \10\ 15 U.S.C. 78s(b)(2).
    \11\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Kevin M. O'Neill,
Deputy Secretary.
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    \12\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2012-30270 Filed 12-14-12; 8:45 am]
BILLING CODE 8011-01-P


Page 1 of 4 FIFRA SCIENTIFIC ADVISORY PANEL Revised Charge Questions SESSION TITLE: A MODEL COMPARISON: DIETARY AND AGGREGATE EXPOSURE IN CALENDEX, CARES, AND LIFELINE FIFRA SAP MEETING DATE: April 29  30, 2004, Holiday Inn Hotel, Arlington, Virginia.

SUGGESTED QUESTIONS FOR THE SAP:

1. General Approach of Approximating Models:

A. While the three probabilistic risk assessment models described in this SAP presentation each project pesticide exposure for the ` US population', they differ in their basic design in a number of ways. EPA has identified and investigated four model design features associated with these models, as follows:

! ` Reference Population':

" DEEM Calendex is based on the CSFII survey design " CARES is based on the US Census PUMs " Lifeline is based on the NCHS Natality database ! ` Binning food diaries' to generate longitudinal consumption profiles:

" DEEM Calendex draws from the individuals' two day diaries " CARES uses the Gower dissimilarity index " Lifeline ` bins' food diaries based on age and season ! ` Model weights' to project simulated exposure days up to the modeled ( US) population " DEEM Calendex uses the CSFII survey weights.

" CARES uses weights developed from its stratified sampling design, and " Lifeline weights each person equally.

! ` Body weight'

" DEEM Calendex assigns food consumption values to each individual on the basis of the grams food/ kg body weight as reported by the CSFII respondents.

" CARES also assigns food consumption values to each individual on the basis of the grams food/ kg body weight as reported by the CSFII respondents. However, since the CARES body weights are different from the CSFII Body weights, CARES adjusts the amount of food consumed to reflect the CARES body weight. Page 2 of 4 " Lifeline uses a reported consumption value for each individual on the basis of the grams food as reported in CSFII) and estimates the individual's body weight based on physiometric growth models developed for various demographic groups ( based on gender, race and ethnicity) using NHANES data.

Question 1.1 The SAP is asked to please comment on whether the above cited model design features reflect those most likely to result in differences in dietary [ food and water] exposure estimates based on identical data sets. If not, what other model design features are likely to cause different dietary exposure estimates?

B. In an attempt to further elucidate differences between predicted exposures among the three models ( DEEM Calendex, CARES and LifeLine) , OPP developed SAS approximation models. These SAS approximation models permit the isolation of factors related to the Reference Population, Binning Procedures, Sampling Weights, and individual Body Weights which cannot be isolated by running the individual models. Section IV of the background document, provided to the SAP, describes the development of these SAS approximation models and some analyses performed by the Agency using these SAS approximation models to compare and contrast model design features of DEEM Calendex, CARES, and LifeLine. Based on these analyses the Agency concluded that the SAS approximation models track actual model results very closely for single Raw Agricultural Commodity ( RAC) analyses, and reasonably well for the multi RAC analyses.

Question 1.2 The SAP is asked to please comment on the approach taken by the Agency to develop and use SAS approximation models ( see Section IV of the background document) to attribute differences in model predictions from differences in model designs. Please suggest possible improvements or refinements to these SAS approximation models and to alternative methods for comparing model predictions.

2. Reference Population & Model Weights:

The DEEM Calendex program uses the CSFII survey respondents as its reference population; as such, the DEEM Calendex model estimates use the CSFII specific sample ( or model) weights to estimate exposures. Each simulated day is weighted to project that exposure day to represent a group of similar individuals from the U. S. population. CARES and Lifeline use alternative data sources ( i. e., U. S. Census PUMS, and NCHS Natality) to generate their respective Reference populations. The CARES model developed its Reference Population by taking a stratified random sample of 100,000 persons from the US Census PUMS. The stratified sampling design enabled CARES to over represent sub populations of interest ( e. g., 20,003 Infants) in its reference population which are subsequently downweighted to permit projection to the U. S. Page 3 of 4 population. The Lifeline model uses the Natality data to generate its Reference population. Lifeline provides the option of using CSFII survey weights to affect the probability of selecting diaries from each of the dietary bins. If this option is not selected, Lifeline will weight each modeled individual equally since these modeled lives are drawn randomly from the Natality statistics.

Question 2.1 The SAP is asked to please comment on the different approaches used by the three models in developing their Reference Populations and model weights.

3. Binning Design & Frequencies of using CSFII diaries:

These models differ in the expected ( or actual) frequencies that each CSFII diary is used in the probabilistic risk assessment. DEEM Calendex uses only the individuals that provided two days of food diaries in its reference population, and sets aside approximately 1,000 one day food diaries in estimating dietary exposure. CARES employs a Gower dissimilarity index in its algorithm to generate longitudinal consumption profiles for its Reference Population. The result is use of some CSFII diaries much more often than other diaries in simulating exposure ( as much as 4,000 times for certain diaries versus once for others). Approximately 1,000 CSFII diaries are not included in the CARES Food Match table. The Lifeline model uses a very general bin based on age and season, such that all food diaries within a particular bin have the same expected frequency of being used in its exposure assessment. In order to evaluate the effect of these differing frequencies and modeling weights, EPA approximated all three models using the Lifeline recipes ( i. e., keeping recipes constant).

Question 3.1 The SAP is asked to please comment on the frequency that CSFII diaries are used by the various models. Are there any potential biases that may arise in the respective dietary exposure estimates for these models as a result of how they used CSFII records? Considering Lifeline's current dietary bin design ( age, season), please comment with respect to the use of the CSFII survey weight option. Is either Lifeline option ( CSFII weighted or not) generally more appropriate than the other or are there circumstances in which one might be preferable to the other?

4. Commodity Exposure Contribution Analyses:

An important aspect of any dietary risk assessment is the ability to identify significant contributors at the upper percentiles of exposure. The CARES and DEEM models both include an output report option known as the Critical Exposure Contribution ( CEC) analysis. A comparable report option is expected to be developed for the LifeLine model in the near future. These CEC reports quantify the contribution of specific food commodities ( RAC FF) to the total exposure at the upper percentiles ( e. g., top 0.2%) of the exposure distribution. An alternate or complementary approach ( frequency Page 4 of 4 exceeded), also used by various model developers, tabulates the frequency that a particular commodity ( RAC FF) causes exposure to exceed some level of concern . As was the case with predictive exposure estimates, model design can affect the outcome of commodity exposure contribution analyses. Section IV. G of the background document describes the CEC and ` frequency exceeded' approaches for identifying significant contributors at the upper end of the exposure distribution. Tables 13 and 14 show CEC reports and ` frequency of occurrence' data for DEEM FCID and CARES analyses for 3  5 year olds and 20  49 year olds, respectively. Tables 15 and 16 show SAS approximations for the model CEC reports and ` number of occurrences > aPAD' for these same age groups. Although there is certainly a degree of similarity between model results and between the model results and the SAS approximation results, differences do occur.

Question 4.1 The SAP is asked to please comment on the relative merits of the two approaches described above ( CEC and frequency exceeded) for identifying significant contributors ( RAC FF) to exposure at the upper percentiles of exposure. Are there other methods or techniques which the Panel might recommend for accomplishing this important part of the dietary exposure assessment?


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Page 72227]
[FR Doc No: 2011-30190]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Federal Register Citation of Previous Announcement: [76 FR 70781,
November 15, 2011].

STATUS:  Closed Meeting.

PLACE:  100 F Street, NW., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING:  November 17, 2011 at 2
p.m.

CHANGE IN THE MEETING:  Deletion of Item.
    The following item was not considered during the Closed Meeting on
Thursday, November 17, 2011: adjudicatory matter.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 17, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-30190 Filed 11-18-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16344-16345]
[FR Doc No: 2014-06471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0250]

Draft Guidance for Industry on Labeling for Human Prescription
Drug and Biological Products Approved Under the Accelerated Approval
Regulatory Pathway; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Labeling for
Human Prescription Drug and Biological Products Approved Under the
Accelerated Approval Regulatory Pathway.'' This draft guidance
discusses FDA's recommendations for developing the indication and usage
statements in the prescribing information for drugs approved under the
accelerated approval regulatory pathway (hereafter ``accelerated
approval''). The guidance also discusses labeling considerations for
indications approved under accelerated approval when clinical benefit
has been verified and FDA terminates the conditions of accelerated
approval, or when FDA withdraws accelerated approval of an indication
while other indications for the drug remain approved.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 27, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,

Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and
Development (HFM-40), Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ann Marie Trentacosti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-
796-2901; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Labeling for Human Prescription Drug and Biological Products
Approved Under the Accelerated Approval Regulatory Pathway.'' Labeling
must conform to the content and format requirements delineated in
Sec. Sec.  201.56(d) and 201.57 (21 CFR 201.56(d) and 201.57). Special
provisions exist for older drug labeling under Sec. Sec.  201.56(e) and
201.80. Labeling for drugs approved under the accelerated approval
process is fundamentally the same as for drugs approved under the
traditional pathway; however, for drugs approved under accelerated
approval there are additional labeling requirements as described in
Sec.  201.57(c)(2)(i)(B) and recommended elements for consideration.
    This draft guidance discusses FDA's recommendations for developing
the indication and usage statements in the prescribing information for
drugs approved under accelerated approval as defined in 21 CFR part
314, subpart H (for new drug applications) and 21 CFR part 601, subpart
E (for biologics license applications) when the approval is based on an
effect on a surrogate endpoint that is reasonably likely to predict
clinical benefit, or an effect on a clinical endpoint that can be
measured earlier than an effect on irreversible morbidity or mortality,
that is reasonably likely to predict an effect on irreversible
morbidity or mortality or other clinical benefit. The guidance also
discusses labeling considerations for indications approved under
accelerated approval when clinical benefit has been verified and FDA
terminates the conditions of accelerated approval under 21 CFR 314.560
or 21 CFR 601.46, or when FDA withdraws accelerated approval of an
indication while other indications for the drug remain approved.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on labeling for
human prescription drug and biologic products approved under
accelerated approval. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in Sec. Sec.  201.56 and 201.57
have been approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/biologicsbloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm, or
http://www.regulations.gov.

    Dated: March 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06471 Filed 3-24-14; 8:45 am]
BILLING CODE 4160-01-P


intended to remedy repairable problems to bring the vehicle into
compliance; however, if there is no demonstrable, repairable problem
that could be remedied to bring the vehicles into compliance, the
manufacturer must submit an alternative plan for to address the
noncompliance. For example, manufacturers may need to calculate a
correction to its emission credit balance based on the GHG emissions of
the actual number of vehicles produced. EPA may void credits originally
calculated from noncompliant vehicles, unless traded, and will adjust
debits. In the case of traded credits, EPA will adjust the selling
manufacturer's credit balance to reflect the sale of such credits and
any resulting credit deficit. Manufacturers may voluntarily recall
vehicles to remedy such a noncompliance and submit a voluntary recall
report as described in 40 CFR part 85, subpart T.
    (4) The manufacturer may request a hearing under 40 CFR part 1068,
subpart G, regarding any voiding of credits or adjustment of debits
under paragraph (j)(3) of this section. Manufacturers must submit such
a request in writing describing the objection and any supporting data
within 30 days after we make a decision.
    (5) Each manufacturer must comply with the applicable
CO2 fleet average standard on a production-weighted average
basis, at the end of each model year. Use the procedure described in
paragraph (i) of this section for passenger automobiles and light
trucks (including MDPV). Use the procedure described in Sec.  86.1819-
14(d)(9)(iv) for non-MDPV heavy-duty vehicles.
    (6) Each manufacturer must comply on an annual basis with the fleet
average standards as follows:
    (i) Manufacturers must report in their annual reports to the Agency
that they met the relevant corporate average standard by showing that
the applicable production-weighted average CO2 emission
levels are at or below the applicable fleet average standards; or
    (ii) If the production-weighted average is above the applicable
fleet average standard, manufacturers must obtain and apply sufficient
CO2 credits as authorized under paragraph (k)(8) of this
section. A manufacturer must show that they have offset any exceedance
of the corporate average standard via the use of credits. Manufacturers
must also include their credit balances or deficits in their annual
report to the Agency.
    (iii) If a manufacturer fails to meet the corporate average
CO2 standard for four consecutive years, the vehicles
causing the corporate average exceedance will be considered not covered
by the certificate of conformity (see paragraph (k)(8) of this
section). A manufacturer will be subject to penalties on an individual-
vehicle basis for sale of vehicles not covered by a certificate.
    (iv) EPA will review each manufacturer's production to designate
the vehicles that caused the exceedance of the corporate average
standard. EPA will designate as nonconforming those vehicles in test
groups with the highest certification emission values first, continuing
until reaching a number of vehicles equal to the calculated number of
noncomplying vehicles as determined in paragraph (k)(8) of this
section. In a group where only a portion of vehicles would be deemed
nonconforming, EPA will determine the actual nonconforming vehicles by
counting backwards from the last vehicle produced in that test group.
Manufacturers will be liable for penalties for each vehicle sold that
is not covered by a certificate.
* * * * *
0
78. Amend Sec.  86.1866-12 by revising paragraphs (a) and (c)(3) to
read as follows:

Sec.  86.1866-12   CO2 credits for advanced technology vehicles.

* * * * *
    (a) Electric vehicles, plug-in hybrid electric vehicles, and fuel
cell vehicles that are certified and produced for sale in the states
and territories of the United States may use a value of zero grams
CO2 per mile to represent the proportion of electric
operation of a vehicle that is derived from electricity generated from
sources that are not onboard the vehicle.
* * * * *
    (c) * * *
    (3) Multiplier-based credits for model years 2022 through 2024 may
not exceed credit caps, as follows:
    (i) Calculate a nominal annual credit cap in Mg using the following
equation, rounded to the nearest whole number:
[GRAPHIC] [TIFF OMITTED] TP05MY23.048

Where:

Pauto = total number of certified passenger automobiles the
manufacturer produced in a given model year for sale in any state or
territory of the United States.
Ptruck = total number of certified light trucks (including MDPV) the
manufacturer produced in a given model year for sale in any state or
territory of the United States.

    (ii) Calculate an annual g/mile equivalent value for the
multiplier-based credits using the following equation, rounded to the
nearest 0.1 g/mile:

[GRAPHIC] [TIFF OMITTED] TP05MY23.049

Where:

annual credits = a manufacturer's total multiplier-based credits in
a given model year from all passenger automobiles and light trucks
as calculated under this paragraph (c).

    (iii) Calculate a cumulative g/mile equivalent value for the
multiplier-based credits in each year by adding the annual g/mile
equivalent values calculated under paragraph (c)(3)(ii) of this
section.
    (iv) The cumulative g/mile equivalent value may not exceed 10.0 in
any year.
    (v) For every year of certifying with multiplier-based credits, the
annual credit report must include the calculated values for the nominal
annual credit cap in Mg and the cumulative g/mile equivalent value.
0
79. Amend Sec.  86.1867-12 by revising the introductory text to read as
follows:

Sec.  86.1867-12   CO2 credits for reducing leakage of air conditioning
refrigerant.

    Through model year 2026, manufacturers may generate credits
applicable to the CO2 fleet average program described in
Sec.  86.1865-12 by implementing specific air conditioning system
technologies designed to reduce air conditioning refrigerant leakage
over the useful life of their passenger automobiles and/or light trucks
(including MDPV); only the provisions of paragraph (a) of this section
apply for non-MDPV heavy-duty vehicles. Credits shall be calculated
according to this section for each air conditioning system that the
manufacturer is using to generate CO2 credits. Manufacturers
may no longer generate credits under this section starting in model
year 2027.
* * * * *
0
80. Amend Sec.  86.1868-12 by:
0
a. Revising the introductory text.
0
b. Removing paragraph (a)(1).
0
c. Redesignating paragraph (a)(2) as paragraph (a).
0
d. Revising the redesignated paragraph (a).
0
e. Adding a heading to the table in newly redesignated paragraph (a).
0
f. Revising paragraph (b).
0
g. Removing and reserving paragraphs (e) and (f).
0
h. Revising paragraph (g) introductory text.
    The revisions and addition read as follows:

Sec.  86.1868-12   CO2 credits for improving the efficiency of air
conditioning systems.

    Manufacturers may generate credits applicable to the CO2
fleet average program described in Sec.  86.1865-12 by implementing
specific air conditioning system technologies designed to reduce air
conditioning-related CO2 emissions over the useful life of
their passenger automobiles and light trucks (including MDPV). The
provisions of this section do not apply for non-MDPV heavy-duty
vehicles. Credits shall be calculated according to this section for
each air conditioning system that the manufacturer is using to generate
CO2 credits. Manufacturers must validate credits under this
section based on testing as described in paragraph (g) of this section.
Starting in model year 2027, manufacturers may generate credits under
this section only for vehicles propelled by internal combustion
engines.
    (a) Air conditioning efficiency credits are available for the
following technologies in the gram per mile amounts indicated for each
vehicle category in the following table:

Table 1 to Paragraph (a)

* * * * *
    (b) Air conditioning efficiency credits are determined on an air
conditioning system basis. For each air conditioning system that is
eligible for a credit based on the use of one or more of the items
listed in paragraph (a) of this section, the total credit value is the
sum of the gram per mile values for the appropriate model year listed
in paragraph (a) for each item that applies to the air conditioning
system. The total credit value for an air conditioning system may not
be greater than 5.0 grams per mile for any passenger automobile or 7.2
grams per mile for any light truck.
* * * * *
    (g) AC17 validation testing and reporting requirements.
Manufacturers must validate air conditioning credits by using the AC17
Test Procedure in 40 CFR 1066.845 as follows:
* * * * *
0
81. Amend Sec.  86.1869-12 by revising the introductory text and
paragraph (b)(2) to read as follows:

Sec.  86.1869-12   CO2 credits for off-cycle CO2 reducing technologies.

    This section describes how manufacturers may generate credits for
off-cycle CO2-reducing technologies through model year 2030.
The provisions of this section do not apply for non-MDPV heavy-duty
vehicles, except that Sec.  86.1819-14(d)(13) describes how to apply
paragraphs (c) and (d) of this section for those vehicles.
Manufacturers may no longer generate credits under this section
starting in model year 2027 for vehicles deemed to have zero tailpipe
emissions and in model year 2031 for all other vehicles. Manufacturers
may no longer generate credits under paragraphs (c) and (d) of this
section for any type of vehicle starting in model year 2027.
* * * * *
    (b) * * *
    (2) The maximum allowable decrease in the manufacturer's combined
passenger automobile and light truck fleet average CO2
emissions attributable to use of the default credit values in paragraph
(b)(1) of this section is specified in paragraph (b)(2)(v) of this
section. If the total of the CO2 g/mi credit values from
paragraph (b)(1) of this section does not exceed the specified off-
cycle credit cap for any passenger automobile or light truck in a
manufacturer's fleet, then the total off-cycle credits may be
calculated according to paragraph (f) of this section. If the total of
the CO2 g/mi credit values from paragraph (b)(1) of this
section exceeds the specified off-cycle credit cap for any passenger
automobile or light truck in a manufacturer's fleet, then the gram per
mile decrease for the combined passenger automobile and light truck
fleet must be determined according to paragraph (b)(2)(ii) of this
section to determine whether the applicable limitation has been
exceeded.
    (i) Determine the gram per mile decrease for the combined passenger
automobile and light truck fleet using the following formula:
[GRAPHIC] [TIFF OMITTED] TP05MY23.050

Where:

Credits = The total of passenger automobile and light truck credits,
in Megagrams, determined according to paragraph (f) of this section
and limited to those credits accrued by using the default gram per
mile values in paragraph (b)(1) of this section.
ProdC = The number of passenger automobiles produced by
the manufacturer and delivered for sale in the U.S.
ProdT = The number of light trucks produced by the
manufacturer and delivered for sale in the U.S.

    (ii) If the value determined in paragraph (b)(2)(i) of this section
is greater than the off-cycle credit cap specified in paragraph
(b)(2)(v) of this section, the total credits, in Megagrams, that may be
accrued by a manufacturer using the default gram per mile values in
paragraph (b)(1) of this section shall be determined using the
following formula:
[GRAPHIC] [TIFF OMITTED] TP05MY23.051

Where:

cap = the off-cycle credit cap specified in paragraph (b)(2)(v) of
this section.
ProdC = The number of passenger automobiles produced by
the manufacturer and delivered for sale in the U.S.
ProdT = The number of light trucks produced by the
manufacturer and delivered for sale in the U.S.

    (iii) If the value determined in paragraph (b)(2)(i) of this
section is not greater than the off-cycle credit cap specified in
paragraph (b)(2)(v) of this section, then the credits that may be
accrued by a manufacturer using the default gram per mile values in
paragraph (b)(1) of this section do not exceed the allowable limit, and
total credits may be determined for each category of vehicles according
to paragraph (f) of this section.
    (iv) If the value determined in paragraph (b)(2)(i) of this section
is greater than the off-cycle credit cap specified in paragraph
(b)(2)(v) of this section, then the combined passenger automobile and
light truck credits, in Megagrams, that may be accrued using the
calculations in paragraph (f) of this section must not exceed the value
determined in paragraph (b)(2)(ii) of this section. This limitation
should generally be done by reducing the amount of credits attributable
to the vehicle category that caused the limit to be exceeded such that
the total value does not exceed the value determined in paragraph
(b)(2)(ii) of this section.
    (v) The manufacturer's combined passenger automobile and light
truck fleet average CO2 emissions attributable to use of the
default credit values in paragraph (b)(1) of this section may not
exceed the specific values as described in this paragraph (b)(2)(v).
Starting in model year 2027, adjust the credit contribution from PHEVs
in the fleet-average calculation by dividing the PHEV off-cycle credit
value by the utility factor established under 40 CFR 600.116-12(c)(1)
or (c)(10)(iii) (weighted 55 percent city, 45 percent highway). For
example, if a PHEV has utility factor of 0.3 and an off-cycle credit of
3.0, count it as having a credit value of 10 (3/0.3) for calculating
the fleet average value. The following maximum values apply for off-
cycle credits:

------------------------------------------------------------------------
                                                             Off-cycle
                       Model year                         credit cap (g/
                                                               mile)
------------------------------------------------------------------------
(A) 2023-2026...........................................              15
(B) 2027................................................              10
(C) 2028................................................             8.0
(D) 2029................................................             6.0
(E) 2030................................................             3.0
------------------------------------------------------------------------

* * * * *

Sec.  86.1871-12   [Removed]

0
82. Remove Sec.  86.1871-12.

PART 600--FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF
MOTOR VEHICLES

0
83. The authority citation for part 1036 continues to read as follows:

    Authority:  49 U.S.C. 32901--23919q, Pub. L. 109-58.

0
84. Amend Sec.  600.007 by revising paragraph (b)(4) introductory text
to read as follows:

Sec.  600.007   Vehicle acceptability.

* * * * *
    (b) * * *
    (4) Each fuel economy data vehicle must meet the same exhaust
emission standards as certification vehicles of the respective engine-
system combination during the test in which the fuel economy test
results are generated. This may be demonstrated using one of the
following methods:
* * * * *
0
85. Amend Sec.  600.113-12 by revising the introductory text and
paragraph (n) to read as follows:

Sec.  600.113-12   Fuel economy, CO2 emissions, and carbon-related
exhaust emission calculations for FTP, HFET, US06, SC03 and cold
temperature FTP tests.

    The Administrator will use the calculation procedure set forth in
this section for all official EPA testing of vehicles fueled with
gasoline, diesel, alcohol-based or natural gas fuel. The calculations
of the weighted fuel economy and carbon-related exhaust emission values
require input of the weighted grams/mile values for total hydrocarbons
(HC), carbon monoxide (CO), and carbon dioxide (CO2); and,
additionally for methanol-fueled automobiles, methanol
(CH3OH) and formaldehyde (HCHO); and, additionally for
ethanol-fueled automobiles, methanol (CH3OH), ethanol
(C2H5OH), acetaldehyde
(C2H4O), and formaldehyde (HCHO); and
additionally for natural gas-fueled vehicles, non-methane hydrocarbons
(NMHC) and methane (CH4). For manufacturers selecting the
fleet averaging option for N2O and CH4 as allowed
under Sec.  86.1818 of this chapter the calculations of the carbon-
related exhaust emissions require the input of grams/mile values for
nitrous oxide (N2O) and methane (CH4). Emissions
shall be determined for the FTP, HFET, US06, SC03, and cold temperature
FTP tests. Additionally, the specific gravity, carbon weight fraction
and net heating value of the test fuel must be determined. The FTP,
HFET, US06, SC03, and cold temperature FTP fuel economy and carbon-
related exhaust emission values shall be calculated as specified in
this section. An example fuel economy calculation appears in Appendix
II of this part.
* * * * *
    (n) Manufacturers may use a value of 0 grams CO2 and
CREE per mile to represent the emissions of fuel cell vehicles and the
proportion of electric operation of a electric vehicles and plug-in
hybrid electric vehicles that is derived from electricity that is
generated from sources that are not onboard the vehicle.
* * * * *
0
86. Amend Sec.  600.116-12 by revising paragraphs (c)(1), (c)(2)(i) and
(iii), and (c)(5) and (10) and adding paragraph (c)(11) to read as
follows:

Sec.  600.116-12   Special procedures related to electric vehicles and
hybrid electric vehicles.

* * * * *
    (c) * * *
    (1) To determine CREE values to demonstrate compliance with GHG
standards, calculate composite values representing combined operation
during charge-depleting and charge-sustaining operation using the
following utility factors, except as otherwise specified in this
paragraph (c):

                  Table 1 to Paragraph (c)(1)--Fleet Utility Factors for Urban ``City'' Driving
----------------------------------------------------------------------------------------------------------------
                                           Model year 2026 and earlier            Model year 2027 and later
   Schedule range for UDDS phases,   ---------------------------------------------------------------------------
                miles                   Cumulative UF      Sequential UF      Cumulative UF      Sequential UF
----------------------------------------------------------------------------------------------------------------
3.59................................              0.125              0.125              0.062              0.062
7.45................................              0.243              0.117              0.125              0.062
11.04...............................              0.338              0.095              0.178              0.054
14.90...............................              0.426              0.088              0.232              0.053
18.49...............................              0.497              0.071              0.278              0.046
22.35...............................              0.563              0.066              0.324              0.046
25.94...............................              0.616              0.053              0.363              0.040
29.80...............................              0.666              0.049              0.403              0.040
33.39...............................              0.705              0.040              0.437              0.034
37.25...............................              0.742              0.037              0.471              0.034
40.84...............................              0.772              0.030              0.500              0.029
44.70...............................              0.800              0.028              0.530              0.029
48.29...............................              0.822              0.022              0.555              0.025
52.15...............................              0.843              0.021              0.580              0.025
55.74...............................              0.859              0.017              0.602              0.022
59.60...............................              0.875              0.016              0.624              0.022
63.19...............................              0.888              0.013              0.643              0.019
67.05...............................              0.900              0.012              0.662              0.019
70.64...............................              0.909              0.010              0.679              0.017
----------------------------------------------------------------------------------------------------------------

                     Table 2 to Paragraph (c)(1)--Fleet Utility Factors for Highway Driving
----------------------------------------------------------------------------------------------------------------
                                           Model year 2026 and earlier            Model year 2027 and later
   Schedule range for HFET, miles    ---------------------------------------------------------------------------
                                        Cumulative UF      Sequential UF      Cumulative UF      Sequential UF
----------------------------------------------------------------------------------------------------------------
10.3................................              0.123              0.123              0.168              0.168
20.6................................              0.240              0.117              0.303              0.136
30.9................................              0.345              0.105              0.414              0.110
41.2................................              0.437              0.092              0.503              0.090
51.5................................              0.516              0.079              0.576              0.073
61.8................................              0.583              0.067              0.636              0.060
72.1................................              0.639              0.056              0.685              0.049
----------------------------------------------------------------------------------------------------------------

    (2) * * *
    (i) For vehicles that are not dual fueled automobiles, determine
fuel economy using the utility factors specified in paragraph (c)(1) of
this section for model year 2026 and earlier vehicles. Do not use the
petroleum-equivalence factors described in 10 CFR 474.3.
* * * * *
    (iii) For 2016 and later model year dual fueled automobiles, you
may determine fuel economy based on the following equation, separately
for city and highway driving:
[GRAPHIC] [TIFF OMITTED] TP05MY23.052

Where:

UF = The appropriate utility factor for city or highway driving
specified in paragraph (c)(1) of this section for model year 2026
and earlier vehicles.
* * * * *
    (5) Instead of the utility factors specified in paragraphs (c)(1)
through (3) of this section, calculate utility factors using the
following equation for vehicles whose maximum speed is less than the
maximum speed specified in the driving schedule, where the vehicle's
maximum speed is determined, to the nearest 0.1 mph, from observing the
highest speed over the first duty cycle (FTP, HFET, etc.):

[GRAPHIC] [TIFF OMITTED] TP05MY23.053

Where:

UFi = the utility factor for phase i. Let UF0 = 0.
J = a counter to identify the appropriate term in the summation
(with terms numbered consecutively).
K = the number of terms in the equation (see Table 5 of this
section).
di = the distance driven in phase i.
ND = the normalized distance. Use 399 for both FTP and HFET
operation for fleet values CAFE, and for GHG through model year
2026. Use 583 for both FTP and HFET operation for GHG fleet values
starting in model year 2027. Use 399 for both FTP and HFET operation
for multi-day individual value for labeling.
Cj = the coefficient for term j from the following table:

                 Table 5 to Paragraph (c)(5)--City/Highway Specific Utility Factor Coefficients
----------------------------------------------------------------------------------------------------------------
                                                    Fleet values for I, and for    Fleet values      Multi-day
                                                        GHG through MY 2026           for GHG       individual
                                                 -------------------------------- starting in MY     value for
                   Coefficient                                                         2027          labeling
                                                                                -------------------------------
                                                       City           Highway         City or         City or
                                                                                highway         highway
----------------------------------------------------------------------------------------------------------------
1...............................................           14.86             4.8           10.52            13.1
2...............................................           2.965              13          -7.282           -18.7
3...............................................          -84.05             -65          -26.37            5.22
4...............................................           153.7             120           79.08            8.15
5...............................................          -43.59         -100.00          -77.36            3.53
6...............................................          -96.94           31.00           26.07           -1.34
7...............................................           14.47  ..............  ..............           -4.01
8...............................................           91.70  ..............  ..............           -3.90
9...............................................          -46.36  ..............  ..............           -1.15
10..............................................  ..............  ..............  ..............            3.88
----------------------------------------------------------------------------------------------------------------
n = the number of test phases (or bag measurements) before the vehicle reaches the end-of-test criterion.

* * * * *
    (10) The utility factors described in this paragraph (c) and in
Sec.  600.510 are derived from equations in SAE J2841. You may
alternatively calculate utility factors from the corresponding
equations in SAE J2841 as follows:
    (i) Calculate utility factors for labeling directly from the
equation in SAE J2841 Section 6.2 using the Table 2 MDIUF Fit
Coefficients (C1 through C10) and a normalized distance (norm_dist) of
399 miles.
    (ii) Calculate utility factors for fuel economy standards from the
equation in SAE J2841 Section 6.2 using the Table 5 Fit Coefficients
for city/Hwy Specific FUF curves weighted 55 percent city, 45 percent
highway and a normalized distance (norm_dist) of 399 miles.
    (iii) Starting in model year 2027, calculate utility factors for
GHG compliance with emission standards from the equation in SAE J2841
Section 6.2 using the Table 2 FUF Fit Coefficients (C1 through C6) and
a normalized distance (norm_dist) of 583 miles. For model year 2026 and
earlier, calculate utility factors for compliance with GHG emission
standards as described in paragraph (c)(10)(ii) of this section.
    (11) The following methodology is used to determine the useable
battery energy (UBE) for a PHEV using data obtained during either the
UDDS Full Charge Test (FCT) or the HFET Full Charge Test as described
in SAE J1711:
    (i) Perform the measurements described in SAE J1711 Section
<IP_ADDRESS>.d. Record initial and final SOC of the RESS for each cycle in
the FCT.
    (ii) Calculate utility factors for fuel economy standards from the
equation in SAE J2841 Section 6.2 using the Table 5 Fit Coefficients
for city/Hwy Specific FUF curves (weighted 55 percent city, 45 percent
highway) and a normalized distance (norm_dist) of 399 miles.
    (iii) Determine average RESS voltage during each cycle of the FCT
by averaging the results of either the continuous voltage measurement
or by averaging the initial and final voltage measurement.
    (iv) Determine the DC discharge energy for each cycle of the FCT by
multiplying the change in SOC of each cycle by the average voltage for
the cycle. You may instead use a DC wideband power analyzer meeting the
requirements of SAE J1711 Section 4.2.a. to directly measure the DC
discharge energy of the RESS during each cycle of the FCT.
    (v) After completing the FCT, determine the cycles comprising the
Charge-Depleting Cycle Range (Rcdc) as described in SAE J1711 Section
3.1.13. Rcdc includes the transitional cycle or cycles where the
vehicle may have operated in both charge-depleting and charge-
sustaining modes. Do not include charge-sustaining cycles in Rcdc.
    (vi) Determine the UBE of the PHEV by summing the measured DC
discharge energy for each cycle comprising Rcdc. Following the charge-
depleting cycles and during the transition to charge-sustaining
operation, one or more of the transition cycles may involve vehicle
charging without discharging the RESS. Include these negative discharge
results in the summation.
* * * * *
0
87. Revise Sec.  600.117 to read as follows:

Sec.  600.117   Interim provisions.

    (a) The following provisions apply instead of other provisions
specified in this part through model year 2026:
    (1) Except as specified in paragraphs (a)(5) and (6) of this
section, manufacturers must demonstrate compliance with greenhouse gas
emission standards and determine fuel economy values using E0 gasoline
test fuel as specified in 40 CFR 86.113-04(a)(1), regardless of any
testing with E10 test fuel specified in 40 CFR 1065.710(b) under
paragraph (a)(2) of this section.

    (2) Manufacturers may demonstrate that vehicles comply with
emission standards for criteria pollutants as specified in 40 CFR part
86, subpart S, during fuel economy measurements using the E0 gasoline
test fuel specified in 40 CFR 86.113-04(a)(1), as long as this test
fuel is used in fuel economy testing for all applicable duty cycles
specified in 40 CFR part 86, subpart S. If a vehicle fails to meet an
emission standard for a criteria pollutant using the E0 gasoline test
fuel specified in 40 CFR 86.113-04(a)(1), the manufacturer must retest
the vehicle using the E10 test fuel specified in 40 CFR 1065.710(b) (or
the equivalent LEV III test fuel for California) to demonstrate
compliance with all applicable emission standards over that test cycle.
    (3) If a manufacturer demonstrates compliance with emission
standards for criteria pollutants over all five test cycles using the
E10 test fuel specified in 40 CFR 1065.710(b) (or the equivalent LEV
III test fuel for California), the manufacturer may use test data with
the same test fuel to determine whether a test group meets the criteria
described in Sec.  600.115 for derived 5-cycle testing for fuel economy
labeling. Such vehicles may be tested over the FTP and HFET cycles with
the E0 gasoline test fuel specified in 40 CFR 86.113-04(a)(1) under
this paragraph (a)(3); the vehicles must meet the emission standards
for criteria pollutants over those test cycles as described in
paragraph (a)(2) of this section.
    (4) Manufacturers may perform testing with the appropriate gasoline
test fuels specified in 40 CFR 86.113-04(a)(1), 86.213(a)(2), and
1065.710(b) to evaluate whether their vehicles meet the criteria for
derived 5-cycle testing under Sec.  600.115. All five tests must use
test fuel with the same nominal ethanol concentration.
    (5) For IUVP testing under 40 CFR 86.1845, manufacturers may
demonstrate compliance with greenhouse gas emission standards using a
test fuel meeting specifications for demonstrating compliance with
emission standards for criteria pollutants.
    (6) Manufacturers may alternatively demonstrate compliance with
greenhouse gas emission standards and determine fuel economy values
using E10 gasoline test fuel as specified in 40 CFR 1065.710(b).
However, manufacturers must then multiply measured CO2
results by 1.0166 and round to the nearest 0.01 g/mile and calculate
fuel economy using the equations appropriate equation for testing with
E10 test fuel.
    (7) If a vehicle uses an E10 test fuel for evaporative emission
testing and E0 is the applicable test fuel for exhaust emission
testing, exhaust measurement and reporting requirements apply over the
course of the evaporative emission test, but the vehicle need not meet
the exhaust emission standards during the evaporative emission test
run.
    (b) Manufacturers may certify model year 2027 through 2029 vehicles
to greenhouse gas emission standards using data with E0 test fuel from
testing for earlier model years, subject to the carryover provisions of
40 CFR 86.1839. In the case of the fleet average CO2
standard, manufacturers must divide the measured CO2 results
by 1.0166 and round to the nearest 0.01 g/mile.

PART 1036--CONTROL OF EMISSIONS FROM NEW AND IN-USE HEAVY-DUTY
HIGHWAY ENGINES

0
88. The authority citation for part 1036 continues to read as follows:

    Authority:  42 U.S.C. 7401-7671q.

0
89. Add Sec.  1036.635 to read as follows:

Sec.  1036.635   Certification requirements for high-GCWR medium-duty
vehicles.

    This section describes provisions that apply for engines certified
under this part for installation in vehicles at or below 14,000 pounds
GVWR that have GCWR above 22,000 pounds.
    (a) Engines that will be installed in complete vehicles must meet
the criteria pollutant emission standards specified in Sec.  1036.104.
Those engines are exempt from the greenhouse gas emission standards in
Sec.  1036.108, but engine certification under this part 1036 depends
on the following conditions:
    (1) The vehicles in which the engines are installed must meet the
following vehicle-based standards under 40 CFR part 86, subpart S:
    (i) Evaporative and refueling emission standards as specified in 40
CFR 86.1813-17.
    (ii) Greenhouse gas emission standards as specified in 40 CFR
86.1819-14.
    (iii) For electric vehicles, battery durability standards in 40 CFR
86.1815.
    (2) Additional provisions related to greenhouse gas emission
standards from 40 CFR part 86, subpart S, apply for certifying engines
under this part, as illustrated in the following examples:
    (i) The engine's emission control information label must state that
the vehicle meets evaporative and refueling emission standards under 40
CFR 86.1813-17 and greenhouse gas emission standards under 40 CFR
86.1819-14.
    (ii) The application for certification must include the information
related to complying with evaporative, refueling, and greenhouse gas
emission standards.
    (iii) We may require you to perform testing on in-use vehicles as
specified in 40 CFR 86.1845-04 and 86.1846-01.
    (iv) Demonstrate compliance with the fleet average CO2
standard as described in 40 CFR 86.1865-12 by including vehicles
certified under this section in the compliance calculations as part of
the averaging set for medium-duty vehicles certified under 40 CFR part
86, subpart S.
    (3) State in the application for certification that you are using
the provisions of this section to meet the fleet average CO2
standard in 40 CFR 86.1819-14 instead of meeting the standards of Sec.
1036.108 and instead of certifying the vehicle to standards under 40
CFR part 1037.
    (b) The provisions of this section are optional for engines
installed in incomplete vehicles at or below 14,000 pounds GVWR that
have GCWR above 22,000 pounds.

PART 1037--CONTROL OF EMISSIONS FROM NEW HEAVY-DUTY MOTOR VEHICLES

0
90. The authority citation for part 1037 continues to read as follows:

    Authority:  42 U.S.C. 7401-7671q.

0
91. Amend Sec.  1037.150 by revising paragraph (l) to read as follows:

Sec.  1037.150  Interim provisions.

* * * * *
    (l) Optional certification to GHG standards under 40 CFR part 86.
The greenhouse gas standards in 40 CFR part 86, subpart S, may apply
instead of the standards of Sec.  1037.105 as follows:
    (1) Complete or cab-complete vehicles may optionally meet
alternative standards as described in 40 CFR 86.1819-14(j).
    (2) Complete high-GCWR vehicles must meet the greenhouse gas
standards of 40 CFR part 86, subpart S, as described in 40 CFR
1036.635.
    (3) Incomplete high-GCWR vehicles may meet the greenhouse gas
standards of 40 CFR part 86, subpart S, as described in 40 CFR
1036.635.
* * * * *

PART 1066--VEHICLE-TESTING PROCEDURES

0
92. The authority citation for part 1066 continues to read as follows:

    Authority:  42 U.S.C. 7401-7671q.

0
93. Amend Sec.  1066.801 by revising the introductory text and
paragraphs (c) and (e) to read as follows:

Sec.  1066.801  Applicability and general provisions.

    This subpart I specifies how to apply the test procedures of this
part for light-duty vehicles, light-duty trucks, and heavy-duty
vehicles at or below 14,000 pounds GVWR that are subject to chassis
testing for exhaust emissions under 40 CFR part 86, subpart S. For
these vehicles, references in this part 1066 to the standard-setting
part include this subpart I.
* * * * *
    (c) This subpart covers the following test procedures:
    (1) The Federal Test Procedure (FTP), which includes the general
driving cycle. This procedure is also used for measuring evaporative
emissions. This may be called the conventional test since it was
adopted with the earliest emission standards.
    (i) The FTP consists of one Urban Dynamometer Driving Schedule
(UDDS) as specified in paragraph (a) of appendix I of 40 CFR part 86,
followed by a 10-minute soak with the engine off and repeat driving
through the first 505 seconds of the UDDS. Note that the UDDS
represents about 7.5 miles of driving in an urban area. Engine startup
(with all accessories turned off), operation over the initial UDDS, and
engine shutdown make a complete cold-start test. The hot-start test
consists of the first 505 seconds of the UDDS following the 10-minute
soak and a hot-running portion of the UDDS after the first 505 seconds.
The first 505 seconds of the UDDS is considered the transient portion;
the remainder of the UDDS is considered the stabilized (or hot-
stabilized) portion. The hot-stabilized portion for the hot-start test
is generally measured during the cold-start test; however, in certain
cases, the hot-start test may involve a second full UDDS following the
10-minute soak, rather than repeating only the first 505 seconds. See
Sec. Sec.  1066.815 and 1066.820.
    (ii) Evaporative emission testing includes a preconditioning drive
with the UDDS and a full FTP cycle, including exhaust measurement,
followed by evaporative emission measurements. In the three-day diurnal
test sequence, the exhaust test is followed by a running loss test
consisting of a UDDS, then two New York City Cycles as specified in
paragraph (e) of appendix I of 40 CFR part 86, followed by another
UDDS; see 40 CFR 86.134. Note that the New York City Cycle represents
about 1.18 miles of driving in a city center. The running loss test is
followed by a high-temperature hot soak test as described in 40 CFR
86.138 and a three-day diurnal emission test as described in 40 CFR
86.133. In the two-day diurnal test sequence, the exhaust test is
followed by a low-temperature hot soak test as described in 40 CFR
86.138-96(k) and a two-day diurnal emission test as described in 40 CFR
86.133-96(p).
    (iii) Refueling emission tests for vehicles that rely on integrated
control of diurnal and refueling emissions includes vehicle operation
over the full FTP test cycle corresponding to the three-day diurnal
test sequence to precondition and purge the evaporative canister. For
non-integrated systems, there is a preconditioning drive over the UDDS
and a refueling event, followed by repeated UDDS driving to purge the
evaporative canister. The refueling emission test procedures are
described in 40 CFR 86.150 through 86.157.
    (2) The US06 driving cycle is specified in paragraph (g) of
appendix I of 40 CFR part 86. Note that the US06 driving cycle
represents about 8.0 miles of relatively aggressive driving.
    (3) The SC03 driving cycle is specified in paragraph (h) of
appendix I of 40 CFR part 86. Note that the SC03 driving schedule
represents about 3.6 miles of urban driving with the air conditioner
operating.
    (4) The hot portion of the LA-92 driving cycle is specified in
paragraph (c) of appendix I of 40 CFR part 86. Note that the hot
portion of the LA-92 driving cycle represents about 9.8 miles of
relatively aggressive driving for commercial trucks. This driving cycle
applies for heavy-duty vehicles above 10,000 pounds GVWR and at or
below 14,000 pounds GVWR only for vehicles subject to Tier 3 standards.
    (5) The Highway Fuel Economy Test (HFET) is specified in appendix I
of 40 CFR part 600. Note that the HFET represents about 10.2 miles of
rural and freeway driving with an average speed of 48.6 mi/hr and a
maximum speed of 60.0 mi/hr. See Sec.  1066.840.
    (6) Cold temperature standards apply for CO and NMHC emissions when
vehicles operate over the FTP at a nominal temperature of -7 [deg]C.
See 40 CFR part 86, subpart C, and subpart H of this part.
    (7) Emission measurement to determine air conditioning credits for
greenhouse gas standards. In this optional procedure, manufacturers
operate vehicles over repeat runs of the AC17 test sequence to allow
for calculating credits as part of demonstrating compliance with
CO2 emission standards. The AC17 test sequence consists of a
UDDS preconditioning drive, followed by emission measurements over the
SC03 and HFET driving cycles. See Sec.  1066.845.
    (8) The mid-temperature intermediate soak FTP is specified as the
procedure for Partial Soak Emission Testing in Section E4.4 of CARB's
PHEV Test Procedures for plug-in hybrid electric vehicles, in Part II
Section I.7 of CARB's LMDV Test Procedures for other hybrid electric
vehicles, and in Part II, Section B.9.1 and B.9.3 of CARB's LMDV Test
Procedures for other vehicles (both incorporated by reference, see
Sec.  1066.1010).
    (9) The early driveaway FTP is specified as the procedure for Quick
Drive-Away Emission Testing in Section E4.5 of CARB's PHEV Test
Procedures for plug-in hybrid electric vehicles, in Part II Section I.8
of CARB's LMDV Test Procedures for other hybrid electric vehicles, and
in Part II, Section B.9.2 and B.9.4 of CARB's LMDV Test Procedures for
other vehicles (both incorporated by reference, see Sec.  1066.1010).
    (10) The high-load PHEV engine starts US06 is specified in Section
E7.2 of CARB's PHEV Test Procedures using the cold-start US06 Charge-
Depleting Emission Test (incorporated by reference, see Sec.
1066.1010).
* * * * *
    (e) The following figure illustrates the FTP test sequence for
measuring exhaust and evaporative emissions:

Figure 1 to Paragraph (e)

[GRAPHIC] [TIFF OMITTED] TP05MY23.054

0
94. Amend Sec.  1066.805 by revising paragraph (c) to read as follows:

Sec.  1066.805  Road-load power, test weight, and inertia weight class
determination.

* * * * *
    (c) For FTP, US06, SC03, New York City Cycle, HFET, and LA-92
testing, determine road-load forces for each test vehicle at speeds
between 9.3 and 71.5 miles per hour. The road-load force must represent
vehicle operation on a smooth, level road with no wind or calm winds,
no precipitation, an ambient temperature of approximately 20 [deg]C,
and atmospheric pressure of 98.21 kPa. You may extrapolate road-load
force for speeds below 9.3 mi/hr.
0
95. Revise Sec.  1066.830 to read as follows:

Sec.  1066.830  Supplemental Federal Test Procedures; overview.

    Sections 1066.831 and 1066.835 describe the detailed procedures for
the Supplemental Federal Test Procedure (SFTP). This testing applies
for Tier 3 vehicles subject to the SFTP standards in 40 CFR 86.1811-17
or 86.1816-18. The SFTP test procedure consists of FTP testing and two
additional test elements--a sequence of vehicle operation with more
aggressive driving and a sequence of vehicle operation that accounts
for the impact of the vehicle's air conditioner. Tier 4 vehicles
subject to 40 CFR 86.1811-27 must meet standards for each individual
driving cycle.
    (a) The SFTP standard applies as a composite representing the three
test elements. The emission results from the aggressive driving test
element (Sec.  1066.831), the air conditioning test element (Sec.
1066.835), and the FTP test element (Sec.  1066.820) are analyzed
according to the calculation methodology and compared to the applicable
SFTP emission standards as described in 40 CFR part 86, subpart S.
    (b) The test elements of the SFTP may be run in any sequence that
includes the specified preconditioning steps.
0
96. Amend Sec.  1066.831 by revising paragraph (e)(2) to read as
follows:

Sec.  1066.831  Exhaust emission test procedures for aggressive
driving.

* * * * *
    (e) * * *
    (2) Operate the vehicle over the full US06 driving schedule, with
the following exceptions that apply only for Tier 3 vehicles:
    (i) For heavy-duty vehicles above 10,000 pounds GVWR, operate the
vehicle over the Hot LA-92 driving schedule.
    (ii) Heavy-duty vehicles at or below 10,000 pounds GVWR with a
power-to-weight ratio at or below 0.024 hp/pound may be certified using
only the highway portion of the US06 driving schedule as described in
40 CFR 86.1816.
* * * * *
0
97. Amend Sec.  1066.1001 by removing the definition of ``SFTP'' and
adding a definition of ``Supplemental FTP (SFTP)'' in alphabetical
order.
    The addition reads as follows:

Sec.  1066.1001  Definitions.

* * * * *
    Supplemental FTP (SFTP) means the collection of test cycles as
given in 1066.830.
* * * * *
0
98. Amend Sec.  1066.1010 by adding paragraph (c) to read as follows:

Sec.  1066.1010  Incorporation by reference.

* * * * *
    (c) California Air Resources Board. The following documents are
available from the California Air Resources Board, 1001 I Street,
Sacramento, CA 95812,<PHONE_NUMBER>, or http://www.arb.ca.gov:

    (1) California 2026 and Subsequent Model Year Criteria Pollutant
Exhaust Emission Standards and Test Procedures for Passenger Cars,
Light-Duty Trucks, And Medium-Duty Vehicles (``CARB's LMDV Test
Procedures''); adopted August 25, 2022; IBR approved for Sec.
1066.801(c).
    (2) California Test Procedures for 2026 and Subsequent Model Year
Zero-Emission Vehicles and Plug-In Hybrid Electric Vehicles, in the
Passenger Car, Light-Duty Truck and Medium-Duty Vehicle Classes
(``CARB's PHEV Test Procedures''); adopted August 25, 2022; IBR
approved for Sec.  1066.801(c).

[FR Doc. 2023-07974 Filed 5-4-23; 8:45 am]
BILLING CODE 6560-50-P


to the development of the current systems for animal production.
Use of AFA caters for high stocking rates which from an economic point
of view is favourable but from a disease point of view raises serious
questions about disease control. Examples of situations where animal density
create problems are the control of outbreaks of epizootic diseases (e.g. swine
fever), zoonotic diseases (e.g. salmonella) and production diseases (e.g.
swine dysentery). Only certain diseases in the latter group are prevented by
AFA usage. These high density production systems have also been
questioned from the point of view of animal ethics and animal welfare.
Neither animal welfare nor animal health are created through administration
of antibacterials. A sound approach from an animal welfare point of view is
to rear animals employing management strategies and animal care of high
standard. A modern Animal Welfare Act is also an Animal Health Act.
AFA are considered to be part of a production model in which productivity
is over-emphasised. Clearly, a development towards more health-orientated
production systems is needed.
Agriculture must, as all other sectors, aim towards a sustainable
development. This means the development of production systems that meet
the need of the present without compromising the ability of future
generations to meet their own needs. In essence, sustainable development is a
process of change in which the exploitation of resources, the direction of

SOU 1997:132
8. Assessment
217
investments, the orientation of technological development, and institutional
change are all in harmony and enhance both current and future potential to
meet human needs and aspirations.
In view of the above, it is questionable whether continued reliance on
usage of AFA favours a sustainable development of animal production
systems. Non-usage of AFA in a region or a country would contribute to an
innovative and dynamic climate for finding measures to raise healthy animals
in the absence of AFA without compromising the efficiency of the
production.
The future of the Common Agricultural Politics was addressed by Mr.
Jacques Santer, President of the European Commission, in a speech to the
European Parliament on February 18, 1997. He made the following
statement:

4HE½STARTING½POINT½FOR½THE½REFORM½WILL½BE½THE½IDEA½THAT½THERE½MUST½BE½A
GREATER½FOCUS½IN½%UROPEAN½AGRICULTURE½ON½QUALITY½PROTECTION½OF½THE
ENVIRONMENT½ANIMAL½WELFARE½A½RETURN½TO½MORE½NATURAL½PRODUCTION½METHODS
AND½A½SIMPLIFICATION½OF½#OMMUNITY½LAW

8.6.3
The risks
The main hazard associated with use of AFA is increased resistance of
commensals and pathogens. The consequence of this might be impairment of
therapy in both animals and man. Transmission of resistance genes between
animal and man can and does occur. The risk for loss of effectiveness of
therapeutical drugs has been estimated to be far from negligible. The
estimate is uncertain due to the complexity of the problem and to lack of
pertinent data. Consequently, the magnitude of the risk can presently not be
fully established. In order to reduce some of the uncertainties, the following
information needs to be on hand:
%XPOSURE
·
exposure of animals to AFA
·
exposure of animals to therapeutic antimicrobials
·
exposure of man to therapeutic antimicrobials
·
prevalence of relevant resistance genes in animals
·
prevalence of relevant resistance genes in animal products
·
prevalence of relevant resistance genes in the environment
·
prevalence of relevant resistance genes in man
·
dose response relationship between antimicrobial use and prevalence of
resistant genes

8. Assessment
SOU 1997:132
218
4RANSMISSIONEPIDEMIOLOGY
·
identification of relevant resistance genes
·
identification of transfer mechanisms of relevant resistance genes
·
transfer rates of relevant resistance genes between animal and human
bacteria in realistic settings
·
transfer rates of relevant resistance genes between animal and
environmental bacteria in realistic settings
·
transfer rates of relevant resistance genes between human and
environmental bacteria in realistic settings
·
persistence of relevant resistant genes in human or animal hosts in the
absence and presence of a selective pressure
#ONSEQUENCES
·
incidence of co-transfer of resistance and other relevant genes
·
probability of acquiring an infection caused by a bacterium carrying the
relevant resistance gene
·
probability of the infection above requiring therapy with the relevant
substance
Needless to say the above information is required for each resistance gene
and for each antimicrobial substance. The minimum time required to
undertake this research would be 5-10 years. Whenever the conditions
change or new information or techniques become available parts of the above
given studies will have to be repeated and the risk assessment updated.
The economic benefits of AFA in livestock production in EU has been
estimated to 2 billion ECU annually. In view of this it is surprising that the
data necessary for a risk assessment of the most controversial hazard are still
lacking as information on the level of risk is essential for the consumer. A
search through scientific databases shows that the number of publications
available on performance enhancing effects of AFA is more than 10-fold the
sum of publications on microbiological effects. At the present stage it is
impossible to fully quantify the risk.
Risk-assessment of environmental effects of AFA is hampered by the fact
that the information necessary is not publicly accessible. Based on available
information, the usage of most AFA does not appear to be associated with
major risk for the environment.
Other hazards that can be identified for some AFA and medicinal feed
additives (MFA) are toxic effects. Halofuginone and the quinoxalines have
toxic effects on the respective target species. In addition, many AFA and
MFA are potent allergens and thereby present an occupational hazard and
possibly a consumer hazard. The risk for the latter is assumed to be very
small.
Quinoxalines and nitroimidazoles are potentially genotoxic. The use of
such substances in animal production is highly questionable. The primary

SOU 1997:132
8. Assessment
219
risk group is persons handling the substances including feedingstuffs. The
nitroimidazoles have been banned as veterinary drugs for food-producing
animals through listing in annex IV of Council Directive 2377/90/EEC. This
lack of coherence between regulations is also associated with a risk of losing
public credibility.
8.6.4
Conclusions
It is the overall opinion of this commission that the benefits of antibacterial
feed additives do not outweigh the risks. With regard to coccidiostats and
other medicinal substances, they are specifically used to prevent disease and
therefore they should be treated as pharmaceutical specialities, i.e. as
medicated feed. Our opinion can be summarised as follows:
·
Antibacterial feed additives have favourable economic effects on livestock
production, but from a long term perspective these are questionable,
especially regarding animal welfare and animal health. AFA can, at levels
permitted in feedingstuffs, be used for treatment or prevention of animal
diseases, which is in violation of Council Directive 70/524EEC.
·
Further, the quinoxalines and the nitroimidazoles are potentially genotoxic
thereby posing an occupational hazard.
·
Halofuginone and the quinoxalines are toxic for target species. This is
deleterious for the well being of the animals.
·
The risk for increased resistance associated with the general use of
antibacterials as feed additives is far from negligible and the potential
consequences are serious for both animal and human health. Antibacterials
that are not yet used as therapeuticals in human or veterinary medicine are
valuable templates for future drugs. As emergence of resistance is
considered to be a threat to animal and human health, all AFA should be
restricted to medical and veterinary purposes only.
8.6.5
Considerations for risk management decisions
Although it is somewhat beyond the scope of this assignment, some
preliminary ideas relating to possible actions to mitigate the risks involved
have been noted for consideration.
As the risks involved are of uncertain magnitude, the decisions on risk
management are particularly difficult. The risk can obviously not be
excluded with certainty, nor can it be determined as acceptable. Scientists
may declare that the information is inadequate for decision making, but for
the policymakers, failure to take action is not a neutral position but represents
a positive decision to do nothing. In a climate of uncertainty it is preferable
to show caution.

8. Assessment
SOU 1997:132
220
The determination of what level of risk is acceptable is established by the
public, not by scientists. Communication on the subject of risk, in form of a
two-way exchange of information between scientists, decision-makers and
consumers, is essential in order to establish the level of acceptance. In
general, the risk acceptance tends to increase considerably if there is a
possibility of control (i.e. choice) involved compared to a situation were one
can not actively avoid the risk.
Another important aspect on risk management is to decide on who is to
bear the cost - the risk maker or the risk taker. In the event of an over-
cautious decision, the risk maker may suffer a cost through reduced benefits.
On the other hand, inadequate risk management may lead to a cost for the
risk taker.
In terms of risk management, a range of measures involving various
degrees of intervention are available. Since AFA, like coccidiostats, are
medical products they should be approved and used as pharmaceutical
specialities and not as feed additives. Dual authorisations are not acceptable.
A single system would reduce the administrative burdens. Further, the
transparency of the system would increase. It is understood that animal
production would need time to adjust to the situation, allowing for
knowledge on appropriate changes in management and feeding practices to
expand and to be implemented. Countries which today have restrictions in
the use of AFA should be allowed to maintain these until the regulatory
system can be fully harmonised.

SOU 1997:132
8. Assessment
221
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9OUNG¹'!¹5NDERDAHL¹,*¹3UMPTON¹,*¹0EO¹,3¹/LSEN¹'7¹+ELLY¹$"


[Federal Register: January 29, 2009 (Volume 74, Number 18)]
[Notices]
[Page 5193]
[DOCID:fr29ja09-103]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59171; File No.
SR-ISE-2008-98]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change to Fee Changes

Correction

    In notice document E8-31351 beginning on page 482 in the issue of
Tuesday, January 6, 2009 make the following corrections:
    1. On page 482, the department docket number is corrected to read
as set forth above.
    2. On page 483, in the second column, in the last line of the last
paragraph, ``January 26, 2009'' should read ``January 27, 2009''.

[FR Doc. Z8-31351 Filed 1-28-09; 8:45 am]

BILLING CODE 1505-01-D