[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7586-7587]
[FR Doc No: 2012-3233]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Draft Guidance for Industry on Bioequivalence Recommendation for
Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/
Sublingual Products; 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 two draft guidances for industry entitled
``Bioequivalence Recommendations for Nitroglycerin,'' one for
nitroglycerin metered spray/sublingual products and one for
nitroglycerin metered aerosol/sublingual products. The recommendations
provide specific guidance on the design of bioequivalence (BE) studies
to support abbreviated new drug applications (ANDAs) for these
products. The draft guidances are revised versions of previously
published draft guidances on the subject.

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 the
draft guidances before it begins work on the final versions of the
guidances, submit either electronic or written comments on the draft
guidances by April 13, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidances 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. 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access to the draft guidance documents.
    Submit electronic comments on the draft guidances 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: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register sof June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry, ``Bioequivalence
Recommendations for Specific Products,'' which explained the process
that would be used to make product-specific BE recommendations
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that guidance, FDA adopted this process as a means to
develop and disseminate product-specific BE recommendations and provide
a meaningful opportunity for the public to consider and comment on
those recommendations. This document announces the availability of two
revised draft BE recommendations, one for nitroglycerin metered spray/
sublingual products and one for nitroglycerin metered aerosol/
sublingual products.
    Nitrolingual Pumpspray (nitroglycerin lingual spray), approved by
FDA in October 1985, is a metered dose spray indicated for acute relief
of an attack or prophylaxis of angina pectoris due to coronary artery
disease. Nitromist (nitroglycerin lingual aerosol), approved by FDA in
November 2006, is another metered dose spray indicated for acute relief
of an attack or acute prophylaxis of angina pectoris due to coronary
artery disease. Nitrolingual Pumpspray and Nitromist are designated as
reference listed drugs (RLDs), and therefore any ANDAs for generic
nitroglycerin lingual spray or generic nitroglycerin lingual aerosol
must demonstrate BE to the relevant RLD prior to approval. There are no
approved ANDAs for these products.
    In February 2010, FDA posted on its Web site a draft guidance for
industry on the Agency's recommendations for BE studies to support
ANDAs for nitroglycerin metered spray/sublingual products (Draft
Nitroglycerin Spray BE Recommendations of February 2010). In that draft
guidance, FDA recommended three studies to demonstrate BE of generic
nitroglycerin metered spray/sublingual products: An in vivo fasting
study, an in vitro study of unit dose and uniformity of unit dose, and
an in vitro study of priming and tail off.
    In March 2010, FDA posted on its Web site a draft guidance for
industry on the Agency's recommendations for BE studies to support
ANDAs for nitroglycerin metered aerosol/sublingual products (Draft
Nitroglycerin Aerosol BE Recommendations of March 2010). In that draft
guidance, FDA recommended three studies to demonstrate BE of generic
nitroglycerin metered aerosol/sublingual products: An in vivo fasting
study, an in vitro study of unit dose and uniformity of unit dose, and
an in vitro study of priming and tail off.
    FDA has reconsidered the recommendations for both of these draft
guidances and has decided to revise them. In November 2011, FDA
withdrew the Draft Nitroglycerin Spray BE Recommendations of February
2010 and the Draft Nitroglycerin Aerosol BE Recommendations of March
2010. FDA is now issuing revised draft guidances for industry on BE
recommendations for nitroglycerin metered spray/sublingual products
(Revised Draft Nitroglycerin Spray BE Recommendations) and
nitroglycerin metered aerosol/sublingual products (Revised Draft
Nitroglycerin Aerosol BE Recommendations). In these revised draft
guidances, FDA recommends one

study (an in vivo fasting study) to demonstrate BE of generic
nitroglycerin metered spray/sublingual products and generic
nitroglycerin metered aerosol/sublingual products. In both of the
revised draft guidances, FDA notes that even though we have not
requested comparative in vitro studies, in vitro studies outlined in
the 2002 guidance for industry, ``Nasal Spray and Inhalation Solution,
Suspension, and Spray Drug Products--Chemistry, Manufacturing, and
Controls Documentation,'' should still be submitted for chemistry,
manufacturing, and controls evaluation.
    In December 2010, G. Pohl-Boskamp GmbH and Company KG (Pohl),
manufacturer of the RLD Nitrolingual Pumpspray, filed a citizen
petition challenging FDA's Draft Nitroglycerin Spray BE Recommendations
of February 2010 (Docket No. FDA-2010-P-0648). FDA is reviewing the
issues raised in the petition and will consider any comments on the
Revised Draft Nitroglycerin Spray BE Recommendations before responding
to Pohl's citizen petition and finalizing its BE recommendation for
nitroglycerin metered spray/sublingual products.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the Agency's current thinking on the
design of BE studies to support ANDAs for nitroglycerin metered spray/
sublingual products and nitroglycerin metered aerosol/sublingual
products. They do not create or confer any rights for or on any person
and do 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. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3233 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P


A.	Justification

1.	Necessity of Information Collection

On January 21, 2009, President Obama signed a memorandum on Transparency
and Open Government.  The memorandum directed Departments and Agencies
to promote transparency by using new technologies, by increasing
opportunities to participate in policymaking, and by expanding
collaboration among Agencies, across governments, and with external
groups and individuals.

The eRulemaking Program, an inter-agency program led by the
Environmental Protection Agency and authorized under Section 206 of the
Electronic Government Act of 2002, operates   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  .  Regulations.gov is
a citizen-focused website that provides the public the ability to find,
view, download, bookmark, receive email alerts, establish RSS feeds, and
submit comments on proposed rulemakings and other federal actions that
solicit public comment.  Regulations.gov currently provides access to
more than 2 million documents, supports 32 partner Departments and
Agencies which promulgate more than 90% of the federal government’s
annual rulemakings, and receives millions of hits and tens of thousands
of comments each month.  Since September 2005, Regulations.gov has
received more than 250 million hits and received more than 750,000
public comments.

In response to the Presidential memorandum, the eRulemaking Program
plans to launch the Regulations.gov ‘feedback exchange’ web site in
May 2009.  This interactive web site will showcase new technologies
being considered for Regulations.gov.   The ‘feedback exchange’ will
serve as an online environment for open government and transparency, as
it enables the public to provide direct input on future improvements to
the Regulations.gov interface, promotes innovation and collaboration,
and ensures that the eRulemaking Program can efficiently manage federal
resources by testing new tools before they are launched.

What will it do?   The Regulations.gov ‘feedback exchange’ website
will provide the public with a preview of new technologies being
considered for Regulations.gov.   It will also enable the public to
provide feedback on these technologies.  Technologies that could be
considered for the Regulations.gov ‘feedback exchange’ include: User
Profiles; Comment Threads and Wikis; Ratings, Polls, and Tagging; an
interactive Educational Tool; and an Information Export capability.
These technologies would be deployed iteratively, with components
deployed upon the site’s release in May 2009 and during subsequent
upgrades to the web site.   User profiles enable the public to register
on the site and pre-load submitter information for later use as well as
save their own personalized searches, RSS feeds, and email alerts
without the use of persistent cookies.  Comment Threads allow the public
to enter into virtual conversations with one another about a topic.
Wikis enable the public to collaboratively develop and modify narrative
descriptions about a topic.   Ratings and Polls allow the public to
indicate a preference for a topic or issue via the selection of stars or
thumbs up / thumbs down icons which graphically provide an at-a-glance
indication of public sentiment and can simplify navigation.   Tagging
provides the public with the ability to tag or label information they or
someone else has posted to the site to ease navigation and to promote
the formation of common interest categories.   The Educational Tool will
inform the public about the Federal rulemaking process through
interactive text and images.  The Data Export capability enables the
public to download and review the contents of a rulemaking docket as
well as mix and match such information with other information in a new
way (also known as a “mash-up”).  The Regulations.gov “feedback
exchange” will rely on feedback from Government, Industry, Academia
and Citizenry to improve Regulations.gov as time goes on.

What are the Benefits?  As part of the president's pledge to make the
government more open and transparent, the Regulations.gov “feedback
exchange” web site will be the citizen's back stage pass to shape and
drive the evolution of the federal government’s premier public access
rulemaking web site.  Citizens will be able to participate in an open
dialogue on the design, format, and functionality of Regulations.gov.
Sitting in the director’s chair, the public will be able to clearly
identify and see other ideas on the kinds of new Internet technologies
it would like Regulations.gov to use to access, participate in, and
understand federal rulemaking.

The ‘feedback exchange’ also can serve as a laboratory to explore
the statutory and policy impacts of emerging Internet technologies on
the federal rulemaking process, fostering innovative approaches to
involve citizens in federal decision-making.   Enhancing access to
rulemaking information through new forms of communication and
collaboration can help transform government and realize the vision of
and open and transparent government by "democratizing" regulatory
decisions.  The site will be continuously operated and maintained to
freely interact and solicit feedback with the Public to promote
innovation through engagement.

Finally, the Regulations.gov ‘feedback exchange’ will conserve
taxpayer resources through a low-cost, controlled approach to pilot and
evaluate new technologies before they are deployed on the live
Regulations.gov web site.

What information collections are needed?  This information collection
request is being submitted in order to fulfill the citizen engagement
and feedback aspects of this important initiative.  The end users will
be provided opportunities to provide information feedback and ratings in
fulfillment of the President’s open government and transparency
agenda.  This information collection request will enable these
capabilities to be included on the Regulations.gov ‘feedback
exchange’.  The four elements addressed in this information collection
request are a five star rating system, a request for user email and URL
address on the registration section, support for the ability of users to
tag or label content on the site, and support/oppose functionalities
that are proposed by the federal government for Regulations.gov.

Rating  The rating system seeks to give visitors the ability to identify
which topics or functionalities and user comments visitors found most
useful and interesting.  The ability to provide ratings on Internet
sites is commonplace and routine for web sites that provide information,
allow public browsing, support public interaction, and enable
categorization. Ratings provided by users would not be in response to
specific questions, but rather would solicit the users’ reaction to a
topic or specific functionality.  A rating of 1 star would indicate a
low priority or preference for a topic or functionality while a rating
of 5 stars would indicate a high priority or preference for a topic or
functionality.   Site visitors could then view the top rated topics or
system functionalities ranked by other users (for example, a visitor
could view the top five highest rated functionalities or the top five
highest rated visitor comments).

Registration  The web site registration capability seeks to give
visitors the ability to establish ‘profiles’ on the site to support
user-defined tailoring of information and features to meet his or her
needs.  Registration is common and routine for web sites that provide
information, allow public browsing, support public interaction, and
enable categorization.  For the Regulations.gov ‘feedback exchange’,
visitors will be able to voluntarily register on the site by providing
their email address, user name, and relative URLs.

Tagging  The tagging or labeling capability seeks to give visitors the
ability to self-identify information about themselves (e.g.,
Professional Category, such as ‘Academic / Professor”) or to label
or categorize information they provided or others provided.  Tagging is
common and routine for web sites that provide information, allow public
browsing, support public interaction, and enable categorization. For the
Regulations.gov ‘feedback exchange’, visitors will be able to
voluntarily select tags or labels about themselves and create tags about
information they have submitted or others have submitted.

Support or Oppose Comment Form  The ‘support or oppose’ comment form
seeks to give visitors the ability to enter comments that are
categorized as ‘support’ or ‘oppose’. These fields enable
categorization of comments.  For the Regulations.gov ‘feedback
exchange’, visitors will be able to voluntarily enter text in comment
fields labeled ‘support’, ‘oppose’ or ‘general’ and which
are viewable by other visitors as such.

2.	Needs and Uses

The ratings information collected from the public will help the
eRulemaking Program, the Office of Management and Budget, and the
Program’s partner Agencies understand how potential features presented
on the Regulations.gov ‘feedback exchange’ are valued by
respondents.  It is the intention of the eRulemaking Program team to
leverage the rating responses to provide feedback to the public as to
how the possible new functionalities and tools are collectively viewed
by those choosing to rate them.  The information will not be used to
generalize to all users or potential users.

The email address collection on the Registration section is part of the
registration process to enable site visitors to provide comments, rate
content, or tag information. The email address field is required for
registration. During the system registration and user profile set-up
process, to satisfy security requirements, users receive a dynamic,
temporary URL to link back to the system and complete the user profile
registration. This security feature is required in order to log-in to
the system and use the user profile, due to the fact that federal
government websites cannot utilize persistent cookies. Users have the
option to sign up for e-mail notifications. The e-mail address required
for system registration is used for e-mail notifications only if the
user chooses to receive e-mail notifications. Topic discussions and
comments can still be viewed by those users who choose not to register.
The URL collection on the Registration section is also part of the
registration process to enable site visitors to provide access to
supplemental or related information. The URL address field is optional
for registration.

The information collected for tagging or the support / oppose comments
will be used by registered users to further categorize comments when
viewing information in the system. When users self-identify themselves,
it enables the eRulemaking Program to stratify and better understand the
needs of different user groups.  This is a common method to gauge and
understand customer feedback, for example, the American Customer
Satisfaction Index.

3.	Efforts to Minimize Burden

To limit respondent burden, the rating questions are short, require only
a response of one star through five stars or a thumbs up / thumbs down,
and are purely voluntary.  The public is not required to provide its
ratings.  For those in the public who decide to participate, the
abbreviated list of questions and potential responses simplifies their
participation.

To limit the public’s burden on the site, users only need to provide
their email address to be able to submit comments, rate content, and tag
information and receive e-mail notifications.  The public is not
required to provide relative URL addresses.

Participation on the ‘favor or oppose’ comment form is not required
and can be completed on a voluntary basis.  Additionally, the form is
defined as a single field brief and makes use of selection boxes to
minimize the amount of text required to be entered for submission.

Participation on the tagging or labeling functionality is not required
and can be completed on a voluntary basis.  Additionally, the form makes
use of selection boxes to minimize the amount of text required to be
entered for submission.

4.	Efforts to Identify Duplication

Ratings relate specifically to possible new functionalities and tools
considered for   HYPERLINK "http://www.regulations.gov"
www.regulations.gov  and do not duplicate what other agencies are doing.
 This is a new capability that does not exist within any other
inter-agency rulemaking and public notice and comment portals.  The
email and URL address fields on the Registration section enabling users
to create a user account is a new capability that does not exist within
any other rulemaking and public notice and comment portals.   Similarly,
the tagging or labeling functionality and the ‘favor or opposed’
comment form are new capabilities that do not exist within any other
inter-agency rulemaking and public notice and comment portals.

5.	Minimizing Burden on Small Businesses

Small businesses are not specific targets of the Regulations.gov
‘feedback exchange’ rating efforts or information collection
efforts.  However, if they visit the Regulations.gov ‘feedback
exchange’ website they will be presented with the opportunity to
provide ratings, register on the site, submit narrative statement
feedback in favor of or opposed to a topic, and tag or label information
about themselves or a topic.  We ensure that rating questions and icons,
registration form, and tagging and labeling capabilities are not
redundant and include only requests for information relevant to the
specific data sets on the ‘feedback exchange’.

6.	Consequences of Less Frequent Collection

This clearance involves establishing a single type of rating to be used
for possible functionalities and tools on Regulations.gov, email and URL
address fields on the Registration section, fields allowing the public
to submit feedback in favor or opposed to a topic, and fields enabling
the public to tag or label information about themselves or a topic.  The
voluntary responses to these information collection opportunities will
determine the frequency of the information collection.

7.	Consistency with OMB Guidelines

The Environmental Protection Agency, as managing partner of the
inter-agency eRulemaking Program, will collect the information in a
manner that complies with OMB guidelines.

8.	Consultation Outside the Agency

The inter-agency eRulemaking Program has conferred with the Office of
Management and Budget, its 32 partner Departments and Agencies,
including the Program’s managing partner, to determine that the
ratings approach is desired, within scope of the Regulations.gov
‘feedback exchange’ project, and in alignment with the
Administration’s transparency and open government memorandum.

The eRulemaking Program also has conferred with the Office of Management
and Budget and its 32 partner Departments and Agencies to determine that
the email/URL address fields on the Registration section, fields
allowing the public to submit feedback in favor or opposed to a topic,
and fields enabling the public to tag or label information about
themselves or a topic are all desired, within scope of the
Regulations.gov ‘feedback exchange’, and will provide value to the
public.

9.	Paying Respondents

The federal government will not provide payment or other forms of
remuneration to respondents to its Regulations.gov ‘feedback
exchange’ information collections.

10.	Assurance of Confidentiality

The Regulations.gov ‘feedback exchange’ website will not provide
visitors with any assurance of confidentiality.

11.	Justification for Sensitive Questions

Questions are carefully composed and structured to avoid being sensitive
in nature to respondents.

12.	Estimate of Hour Burden

For the ratings, it is estimated that 5,000 ratings will be submitted,
on an annualized basis.  Each of the ratings is estimated to take 5
seconds and therefore it is anticipated that 417 minutes per year will
be required to submit the data set ratings.  Approximately 7 annual
burden hours are requested based on these estimations.  Based upon
similar ratings methods, we believe that this is an accurate estimate.

For the email and URL address fields on the Registration form, it is
estimated that 1,000 user profiles will be created each year.  It is
estimated that completing the email address field on the contact form
will take 10 seconds and therefore it is anticipated that 167 minutes
per year will be required to submit the email address field on the
contact form.  Approximately 3 annual burden hours are requested based
on these estimations.  Based upon similar contact form methods, we
believe that this is an accurate estimate.

For the tagging of content, it is estimated that 1,000 tags will be
submitted each year.  It is estimated that completing the tag will take
30 seconds and therefore it is anticipated that 500 minutes per year
will be required to submit the nomination form.  Approximately 8 annual
burden hours are requested based on these estimations.  Based upon
similar form methods, we believe that this is an accurate estimate.

For the submission of support or oppose comments, it is estimated that
1,000 support or oppose comments will be submitted each year.  It is
estimated that completing the nomination form will take 1 minute and
therefore it is anticipated that 1,000 minutes per year will be required
to submit the nomination form.  Approximately 17 annual burden hours are
requested based on these estimations.  Based upon similar form methods,
we believe that this is an accurate estimate.

Therefore the total burden for this ICR is 35 hours (7 hours for
ratings, 3 hours for email address, 8 hours for tagging content, and 17
hours for completing support or oppose comments).  The total number of
respondents is 1,000 and the total number of responses is 7,000.

13.	Estimate of Cost Burden

We do not expect respondents to incur any costs other than that of
their time expended.  The information requested is of the type and scope
normally provided online and without additional research time required.
Therefore, respondents are not expected to incur any costs or burden for
responding to this voluntary rating procedure.

14.	Cost to Federal Government

Electronic surveys are virtually cost-free.  The Environmental
Protection Agency is incurring no additional costs for hosting the
information collection forms and will incur no additional costs for
storing the anticipated responses.  It is estimated that one federal
staff person will spend two hours a week to review and monitor the
comments posted on the site or total of 104 hours a year. The system
automatically categorizes comments and users.  This information will be
integrated into the existing framework that the eRulemaking Program
utilizes to analyze public feedback.  The average annual Agency cost is
estimated to be $4,600.  This is based on the average hourly labor rate
for a GS-12, step 1 of $44.24.  (This rate is from the Office of
Personnel Management “2008 General Schedule” which excludes locality
rates of pay).

15.	Reason for Change in Burden

There is no change in burden.

16.	Project Schedule

The Environmental Protection Agency released the Regulations.gov
‘feedback exchange’ to the public in May 2009.

17.	Request to Not Display Expiration Date

The Regulations.gov ‘feedback exchange’ requests not displaying the
expiration date since this will be an on-going website.

18.	Exceptions to the Certification

There are no exceptions.

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[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29449-29450]
[FR Doc No: 2012-11948]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0058; Notice 3]

Toyota Motor Corporation, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Grant of Petition.

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SUMMARY: Toyota Motor North America, Inc., on behalf of Toyota Motor
Corporation,\1\ and Toyota Manufacturing, Indiana, Inc.\2\
(collectively referred to as ``Toyota''), has determined that certain
model year 2011 Toyota Sienna multipurpose passenger vehicles (MPV)
manufactured between January 3, 2011 and February 11, 2011, do not
fully comply with paragraph S9.5(a)(3) of Federal Motor Vehicle Safety
Standard (FMVSS) No. 225, Child restraint anchorage systems. Toyota
filed an appropriate report dated March 17, 2011, pursuant to 49 CFR
Part 573 Defect and Noncompliance Responsibility and Reports.
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    \1\ Toyota Motor Corporation is a Japanese corporation that
manufacturers and imports motor vehicles.
    \2\ Toyota Manufacturing, Indiana, Inc., is an Indiana
corporation that manufactures motor vehicles.
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    Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule
implementing those provisions at 49 CFR Part 556, Toyota has petitioned
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety. Notice of receipt of the
petition was published, with a 30-day public comment period, on June
16, 2011 in the Federal Register (76 FR 35271). No comments were
received. To view the petition and all supporting documents log onto
the Federal Docket Management System (FDMS) Web site at: http://www.regulations.gov/. Then follow the online search instructions to
locate docket number ``NHTSA-2011-0058.''
    For further information on this decision contact Mr. Ed Chan,
Office of Vehicle Safety Compliance, the National Highway Traffic
Safety Administration (NHTSA), telephone<PHONE_NUMBER>, facsimile
(202) 366-7002.
    Vehicles involved: Affected are approximately 9,122 model year 2011
Toyota Sienna MPV's that were manufactured between January 3, 2011 and
February 11, 2011.
    Noncompliance: Toyota explains that the noncompliance is that the
label identifying the location of the lower child restraint anchorages
in some of the second row seats of the affected vehicles are located
slightly outside the limits as stated within the requirements of
paragraph S9.5(a)(3) of FMVSS No. 225.
    Specifically, Toyota also explains that ``the potential deviation
of the label location outside the requirement is very small. Toyota
observed that in a detailed survey of a randomly selected subset
involving 18 of these vehicles in which it found a deviation, the mean
deviation was approximately +1.4 mm (i.e. 26.4 mm from the centerline);
the maximum deviation observed was +2.5 mm (i.e. 27.5 mm from the
centerline); and the standard deviation was only 0.5 mm. While a survey
carried out by the seat supplier also supports Toyota's assertions that
the potential deviation of the label location from the specified
requirements is very small. In the supplier's survey of 240 labels on
120 seats, 3 labels were outside of the specifications of FMVSS No.
225. All 3 of those labels were measured at +1 mm beyond the
specification, or 26 mm from the centerline.''

Summary of Toyota's Analysis and Arguments

    Toyota stated its belief that although the lower child anchorage
labels are outside the specified limits of this requirement that the
noncompliance is inconsequential to motor vehicle safety for the
following reasons:
    (1) The measured deviations are very minor, and such a slight
deviation is not noticeable to consumers and would not impair a
consumer's ability to locate the lower anchorages.
    (2) Paragraph S9.1 of FMVSS No. 225 requires that the length of the
straight portion of the lower anchorage bar be a minimum of 25 mm. In
the affected vehicles the length is 30 mm; the total length including
the curved portions is 54 mm. As a result, even with greater deviations
than noted above in label location, some part of the label would be
over some part of the bar, making the bar easy to locate.
    (3) The regulatory history of the provision allowing a 25 mm lateral tolerance for the location of the center of the
circular label further supports the argument that this noncompliance
has no adverse safety consequences. As originally adopted, FMVSS No.
225 would have limited the lateral tolerance to 12 mm. In
response to a petition for reconsideration from vehicle manufacturers
concerned that such a low tolerance would be difficult to meet due to
process limitations and seat design features, NHTSA amended the
standard to allow the current 25 mm tolerance. 69 Fed Reg.
48818 (August 11, 2004). In doing so, The agency stated:

    ``* * * Moreover, the agency believes that increasing the
tolerance to 25 mm will not significantly affect the consumers'
ability to find the LATCH anchorages. While anchor bars are
permitted to be as short as 25 mm in the straight portion of the
bar, most are considerably longer. Even if a 25 mm bar were used,
with a 25 mm tolerance from the center of the bar, the circle will
be, at farthest, tangent to a longitudinal vertical plane tangent to
the side of the anchorage bar. If a person were to probe the seat
bight in the area directly under the marking circle, his or her
finger would easily contact the bar. For bars that are greater than
25 mm in length, with a 25 mm tolerance a portion of the marking
circle will always be over some part of the bar. In either
situation, marking the circle with a 25 mm tolerance will adequately
provide a visual reminder to consumers that the LATCH system is
present and will help users locate and use the bars. Adopting the 25
mm tolerance will also

harmonize FMVSS No. 225 with the comparable Transport Canada
requirement.''

    (4) The seat design is such that only one label at a seating
position can be noncompliant. As the seat cover is constructed, the
labels are secured to the fabric a specified distance apart that
reflects the location of each pair of anchorages, and the labels are
designed to be within the lateral tolerance of the standard.
    (5) Information provided in the vehicle owner's manual further
reduces any possibility of confusion when installing a child restraint.
The instructions clearly advise the installer to recline the second row
seat and widen the gap between the seat cushion and the seatback to
expose the lower anchorages.
    (6) The label locations are correct for the LATCH anchorage system
located at the third row center seating position.\3\
---------------------------------------------------------------------------

    \3\ Toyota indicated that this LATCH anchorage is not required
by the standard, but was voluntarily installed by Toyota.
---------------------------------------------------------------------------

    (7) There have been no customer complaints, injuries, or accidents
related to the deviation of the child restraint label location being
slightly outside the limits of the requirement.
    In addition, Toyota stated that the model year 2011 Sienna is sold
by Toyota in both the United States and Canada and the subject
noncompliance was reported to both NHTSA and Transport Canada at the
same time. (In Canada, the applicable standard is CMVSS 210.2; it
contains the same requirements as FMVSS No. 225). Transport Canada
responded on March 23, indicating it concurs that ``there is no real or
implied degradation to motor vehicle safety,'' and that no further
action in Canada will be required.
    In summation, Toyota believes that the described noncompliance of
the subject vehicles is inconsequential to motor vehicle safety, and
that its petition, to exempt from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.

NHTSA Decision

    Requirement Background: The purpose for the locational requirements
for the label identifying the location of the lower child restraint
anchorage is to assure that the installer of a child restraint system
is readily able to locate the appropriate lower child restraint
anchorages.

NHTSA's Analysis of Toyota's Reasoning

    After review of the subject petition NHTSA agrees with Toyota that
the location of the subject lower child restraint anchorage is in-line
with the nonconforming location of the lower child restraint anchorage
label, and the Owner's manual provided with the vehicles includes a
description of the location of the anchorages in sufficient detail to
allow the person installing a child seat to readily locate the
anchorage.

NHTSA Conclusions

    NHTSA agrees with Toyota's assessment that while the location of
the subject lower child restraint anchorage label is outside of the
allowable tolerance relative to the location of the anchorage that this
would not prevent the installer of a child restraint system from being
readily able to locate the lower child restraint anchorage.

Decision

    In consideration of the foregoing, NHTSA has decided that Toyota
has met its burden of persuasion that the FMVSS No. 225 noncompliance
in the vehicles identified in Toyota's Noncompliance Information Report
is inconsequential to motor vehicle safety. Accordingly, Toyota's
petition is granted and the petitioner is exempted from the obligation
of providing notification of, and a remedy for, that noncompliance
under 49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the vehicles that Toyota no longer controlled at the
time that it determined that a noncompliance existed in the subject
vehicles.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8)

    Issued on: May 10, 2012.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2012-11948 Filed 5-16-12; 8:45 am]
BILLING CODE 4910-59-P


The Human DDVP Data Do Provide Sufficient Scientifically Sound Information to Warrant Reduction of the 10X Interspecies Factor Thomas B. Starr, PhD & Principal TBS Associates, Raleigh NC USA EPA Human Studies Review Board Meeting 5 April 2006   Arlington VA Our DDVP Analysis for Non Pregnant Adults ° Makes Use of Comprehensive Data Base NOT Just One Study or Dose at a Time ° Lab Animals: 138 Dose Duration Data Points ° Humans: 77 Dose Duration Data Points ° RBC Cholinesterase Activity Expressed as % of Control Activity ° % Inhibition Classified into 3 Categories:

< 10%   10% to < 20%   20% Figure 1 Percent Inhibition of Red Blood Cell Cholinesterase in Adult Laboratory Animals ( Mice, Rats, Dogs, Monkeys)

0.0001 0.001 0.01 0.1 1 10 100 0.01 0.1 1 10 100 1000 Days Dose (

mg/

kg) Inhibition < 10%

Inhibition 10 20%

Inhibition > 20%

DDVP Lab Animal Data: Non Pregnant Adults Figure 2 Percent Inhibition of Red Blood Cell Cholinesterase in Adult Humans 0.0001 0.001 0.01 0.1 1 10 100 0.01 0.1 1 10 100 1000 Days Dose (

mg/

kg) Inhibition < 10%

Inhibition 10 20%

Inhibition > 20%

DDVP Human Data: Actual Non Pregnant Adults Figure 2a Percent Inhibition of Red Blood Cell Cholinesterase in Adult Humans IF they are 10X More Sensitive than Animals 0.0001 0.001 0.01 0.1 1 10 100 0.01 0.1 1 10 100 1000 Days Dose (

mg/

kg) Inhibition < 10%

Inhibition 10 20%

Inhibition > 20%

DDVP Human Data: IF 10X More Sensitive Conclusions ° Non Pregnant Adult Humans are NOT 10X More Sensitive than Non Pregnant Adult Animals to RBC Cholinesterase Inhibiting Effects of DDVP ° Humans Appear NO MORE Sensitive than Animals ° 1X Interspecies Factor is Scientifically Warranted ° Not Scientifically Defensible to Exclude these Data and their Implications from Full and Fair Consideration


Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 1 1 The twelve NERC regions presented are: ASCC ( Alaska Systems Coordinating Council), ECAR ( East Central Area Reliability Coordination Agreement), ERCOT ( Electric Reliability Council of Texas), FRCC ( Florida Reliability Coordinating Council), HI ( Hawaii), MAAC ( Mid Atlantic Area Council), MAIN ( Mid America Interconnected Network, Inc.), MAPP ( Mid Continent Area Power Pool), NPCC ( Northeast Power Coordination Council), SERC ( Southeastern Electricity Reliability Council), SPP ( Southwest Power Pool), and WSCC ( Western Systems Coordinating Council). Memorandum Date March 12, 2003 To The Record From Lynne Tudor, OW/ EPA, and Antje Siems, Dan Rosenfeld, and Janet Larson, Abt Associates Inc.

Subject Supporting Documentation of Changes to Economic Impacts in Support of the Section 316( b) Phase II NODA This memorandum provides more detailed information supporting the " other economic analyses"

discussed in Section VI of the Section 316( b) Phase II Notice of Data Availability ( NODA). These analyses include: ( 1) an analysis of total national costs; ( 2) a cost to revenue analysis at the facility and firm levels; ( 3) an analysis of compliance costs per household at the North American Electric Reliability Council ( NERC) level; and ( 4) an analysis of compliance costs relative to electricity price projections,

also at the NERC level. 1 These four measures are provided in addition to the impact measures based on the Integrated Planning Model ( IPM ® ) analyses ( see Section V of the Notice). These measures are used to assess the magnitude of compliance costs; they are not used to predict closures or other types of economic impacts on facilities subject to Phase II regulation.

For this NODA, EPA analyzed changes to the preferred option and the " Intake Capacity Commensurate with Closed Cycle, Recirculating Cooling System based on Waterbody Type/ Capacity" Option ( hereafter the " waterbody/ capacity based" option). This memo therefore only addresses these two regulatory options. For a discussion of the original methodology used by EPA for the proposal analysis, please refer to the chapters in Part B of the Economic and Benefits Analysis ( EBA) document in support of the proposed rule at http:// www. epa. gov/ waterscience/ 316b/ econbenefits/ ( DCN 4 0002).

It should be noted that the results of the preferred option and the waterbody/ capacity based option cannot Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 2 2 For example, compliance requirements in NERC regions without estuarine/ tidal river or ocean facilities ( i. e., ECAR, MAIN, MAPP, and SPP) are identical under the two options. For this NODA analysis, all facilities in these regions would have had identical compliance costs under the two options, were it not for the difference in base case assumptions.

3 EPA's 2000 Section 316( b) Industry Survey identified 540 facilities that are subject to the preferred rule. EPA applied sample weights to the 540 facilities to account for non sampled facilities and facilities that did not respond to the survey. The 540 analyzed facilities represent 551 facilities in the industry. be directly compared to each other. EPA used two different demand growth assumptions for the IPM base cases of the preferred option ( EPA electricity demand assumption) and the waterbody/ capacity based option ( AEO electricity demand assumption, upon request by the Department of Energy). Since EPA is using IPM base case data in its estimate of the cost of installation downtime, the cost of the energy penalty, and revenues, the results presented in this section could vary between the two options, even for facilities or NERC regions with identical compliance requirements under the two options. 2 1. National Costs The costs in this section are based on 551 facilities with steam electric generators which EPA identified as being subject to Section 316( b) Phase II regulation. 3 The costs include all facility incurred costs associated with compliance with the two analyzed options: one time technology costs, one time cost of installation downtime, annual operating and maintenance costs, cost of the energy penalty incurred by facilities estimated to upgrade to a recirculating cooling tower system, and permitting costs ( including initial permit costs, annual monitoring costs, and repermitting costs). Not included in this analysis are costs of administering the rule incurred by permitting authorities and the federal government.

Table 1 below summarizes different measures of national, facility incurred compliance costs developed for the NODA analyses for the preferred option and the waterbody/ capacity based option. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 3 Table 1: Summary of National Costs ($ 2002; million)

Preferred Option Waterbody/ Capacity Based Option All Phase II Facilities Number of Phase II facilities 551 551 Total pre tax facility cost $ 416 $ 1,280 Total post tax facility cost $ 269 $ 797 Phase II Facilities Excluding Baseline Closures Number of Phase II facilities 543 544 Total pre tax facility cost $ 410 $ 1,273 Total post tax facility cost $ 265 $ 793 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 4 EPA estimates that the total annual post tax facility compliance cost of the preferred option for the 551 in scope facilities is $ 269 million annually. Table 2 below presents annualized facility compliance costs by cost category and NERC region for the preferred option. The annualized cost by NERC region ranges from approximately $ 0.4 million for facilities located in ASCC to $ 48.9 million for facilities located in ECAR.

Table 2: Private ( Post Tax) Annualized Facility Compliance Costs by NERC Region for the Preferred Option ( in millions, $ 2002)

NERC Region One Time Costs Recurring Costs Total Capital Technology Connection Outage Initial Permit Application Pilot Study O& M Monitoring,

Record Keeping &

Reporting Energy Penalty Permit Renewal ASCC $ 0.1 $ 0.0 $ 0.1 $ 0.0 $ 0.0 $ 0.1 $ 0.0 $ 0.1 $ 0.4 ECAR $ 23.9 $ 7.1 $ 3.8 $ 0.4 $ 4.8 $ 6.1 $ 0.0 $ 2.9 $ 48.9 ERCOT $ 3.4 $ 0.0 $ 1.9 $ 0.1 $ 4.9 $ 3.3 $ 0.0 $ 1.4 $ 15.2 FRCC $ 10.5 $ 0.7 $ 1.3 $ 0.2 $ 1.9 $ 2.1 $ 0.0 $ 1.0 $ 17.7 HI $ 2.6 $ 1.0 $ 0.1 $ 0.2 $ 0.1 $ 0.2 $ 0.0 $ 0.1 $ 4.2 MAAC $ 11.2 $ 3.2 $ 1.6 $ 0.3 $ 2.1 $ 2.5 $ 0.0 $ 1.3 $ 22.2 MAIN $ 10.5 $ 2.0 $ 1.8 $ 0.3 $ 3.7 $ 3.0 $ 0.0 $ 1.4 $ 22.7 MAPP $ 2.7 $ 1.1 $ 2.0 $ 0.1 $ 1.4 $ 2.8 $ 0.0 $ 1.5 $ 11.7 NPCC $ 20.0 $ 5.2 $ 2.7 $ 0.4 $ 0.5 $ 3.6 $ 0.0 $ 2.1 $ 34.4 SERC $ 18.4 $ 6.8 $ 3.8 $ 0.7 $ 6.1 $ 5.8 $ 0.0 $ 2.9 $ 44.5 SPP $ 2.7 $ 0.6 $ 1.0 $ 0.1 $ 2.3 $ 2.0 $ 0.0 $ 0.8 $ 9.4 WSCC $ 26.9 $ 3.4 $ 1.5 $ 0.3 $ 2.7 $ 2.1 $ 0.0 $ 1.2 $ 38.1 Total $ 132.9 $ 31.1 $ 21.5 $ 3.1 $ 30.5 $ 33.6 $ 0.0 $ 16.6 $ 269.3 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 5 Table 3 presents total annual facility compliance costs by cost category and steam plant type for the preferred option. Costs are presented both on a pre tax and post tax basis. Annual post tax compliance costs range from approximately $ 2.4 million ($ 4.0 million pre tax) for " other steam" ( primarily non fossil waste) steam facilities to $ 126.2 million ($ 191.2 million pre tax) for coal steam facilities.

Table 3: Private Annualized Facility Compliance Costs by Steam Plant Type for the Preferred Option ( in millions, $ 2002)

Plant Type One Time Costs Recurring Costs Total Capital Technology Connection Outage Initial Permit Application Pilot Study O& M Monitoring,

Record Keeping &

Reporting Energy Penalty Permit Renewal Pre Tax Compliance Costs Coal Steam $ 77.7 $ 30.1 $ 16.9 $ 2.0 $ 25.0 $ 26.5 $ 0.0 $ 13.0 $ 191.2 Combined Cycle $ 2.2 $ 0.6 $ 0.9 $ 0.1 $ 0.4 $ 1.6 $ 0.0 $ 0.7 $ 6.4 Nuclear $ 79.0 $ 11.7 $ 2.9 $ 1.6 $ 5.0 $ 5.4 $ 0.0 $ 2.2 $ 107.7 O/ G Steam $ 50.4 $ 7.2 $ 10.6 $ 1.2 $ 14.1 $ 15.6 $ 0.0 $ 8.1 $ 107.0 Other Steam $ 1.5 $ 0.1 $ 0.7 $ 0.0 $ 0.4 $ 0.9 $ 0.0 $ 0.5 $ 4.0 Total $ 210.7 $ 49.6 $ 31.9 $ 4.8 $ 44.8 $ 49.9 $ 0.0 $ 24.5 $ 416.4 Post Tax Compliance Costs Coal Steam $ 50.3 $ 19.3 $ 11.5 $ 1.3 $ 16.8 $ 18.1 $ 0.0 $ 8.9 $ 126.2 Combined Cycle $ 1.4 $ 0.4 $ 0.6 $ 0.0 $ 0.2 $ 1.1 $ 0.0 $ 0.5 $ 4.3 Nuclear $ 48.1 $ 7.0 $ 1.8 $ 1.0 $ 3.4 $ 3.4 $ 0.0 $ 1.4 $ 66.1 O/ G Steam $ 32.2 $ 4.3 $ 7.1 $ 0.8 $ 9.9 $ 10.5 $ 0.0 $ 5.4 $ 70.3 Other Steam $ 0.9 $ 0.0 $ 0.4 $ 0.0 $ 0.2 $ 0.5 $ 0.0 $ 0.3 $ 2.4 Total $ 132.9 $ 31.1 $ 21.5 $ 3.1 $ 30.5 $ 33.6 $ 0.0 $ 16.6 $ 269.3 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 6 Tables 4 and 5 below present the same information as Tables 2 and 3 for the waterbody/ capacity based option.

Table 4: Private ( Post Tax) Annualized Facility Compliance Costs by NERC Region for the Waterbody/ Capacity Based Option ( in millions, $ 2002)

NERC Region One Time Costs Recurring Costs Total Capital Technology Connection Outage Initial Permit Application Pilot Study O& M Monitoring,

Record Keeping &

Reporting Energy Penalty Permit Renewal ASCC $ 0.1 $ 0.0 $ 0.1 $ 0.0 $ 0.0 $ 0.1 $ 0.0 $ 0.1 $ 0.4 ECAR $ 23.9 $ 8.0 $ 3.8 $ 0.4 $ 4.8 $ 6.1 $ 0.0 $ 2.9 $ 49.9 ERCOT $ 6.3 $ 0.3 $ 1.8 $ 0.1 $ 8.5 $ 3.3 $ 1.1 $ 1.3 $ 22.7 FRCC $ 36.6 $ 13.0 $ 1.1 $ 0.2 $ 35.4 $ 2.1 $ 10.7 $ 0.8 $ 99.7 HI $ 5.8 $ 0.8 $ 0.0 $ 0.0 $ 5.7 $ 0.2 $ 2.6 $ 0.0 $ 15.1 MAAC $ 59.5 $ 13.2 $ 1.2 $ 0.1 $ 48.2 $ 2.5 $ 16.6 $ 0.9 $ 142.3 MAIN $ 10.5 $ 2.1 $ 1.8 $ 0.3 $ 3.7 $ 3.0 $ 0.0 $ 1.4 $ 22.8 MAPP $ 2.7 $ 1.2 $ 2.0 $ 0.1 $ 1.4 $ 2.8 $ 0.0 $ 1.5 $ 11.7 NPCC $ 40.6 $ 11.2 $ 2.2 $ 0.3 $ 26.9 $ 3.6 $ 17.0 $ 1.7 $ 103.6 SERC $ 43.4 $ 16.8 $ 3.4 $ 0.5 $ 31.8 $ 5.8 $ 10.1 $ 2.6 $ 114.4 SPP $ 2.7 $ 0.6 $ 1.0 $ 0.1 $ 2.3 $ 2.0 $ 0.0 $ 0.8 $ 9.5 WSCC $ 98.5 $ 25.9 $ 1.0 $ 0.1 $ 53.2 $ 2.1 $ 22.8 $ 0.8 $ 204.4 Total $ 330.6 $ 93.0 $ 19.4 $ 2.2 $ 221.8 $ 33.6 $ 80.9 $ 14.9 $ 796.5 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 7 Table 5: Private ( Post Tax) Annualized Facility Compliance Costs by Steam Plant Type for the Waterbody/ Capacity Based Option ( in millions, $ 2002)

Plant Type One Time Costs Recurring Costs Total Capital Technology Connection Outage Initial Permit Application Pilot Study O& M Monitoring,

Record Keeping &

Reporting Energy Penalty Permit Renewal Pre Tax Compliance Costs Coal Steam $ 145.5 $ 37.1 $ 15.7 $ 1.7 $ 110.2 $ 26.5 $ 39.5 $ 12.1 $ 388.3 Combined Cycle $ 17.0 $ 0.9 $ 0.7 $ 0.0 $ 18.3 $ 1.6 $ 1.9 $ 0.6 $ 41.0 Nuclear $ 244.2 $ 100.2 $ 2.3 $ 0.8 $ 124.0 $ 5.4 $ 39.9 $ 1.8 $ 518.6 O/ G Steam $ 125.4 $ 13.6 $ 9.3 $ 0.8 $ 103.9 $ 15.6 $ 50.2 $ 7.0 $ 325.8 Other Steam $ 2.0 $ 0.2 $ 0.5 $ 0.0 $ 1.7 $ 0.9 $ 0.4 $ 0.4 $ 6.1 Total $ 534.0 $ 152.0 $ 28.5 $ 3.3 $ 358.2 $ 49.9 $ 131.9 $ 21.9 $ 1,279.8 Post Tax Compliance Costs Coal Steam $ 91.7 $ 23.8 $ 10.8 $ 1.1 $ 68.9 $ 18.1 $ 24.1 $ 8.3 $ 246.7 Combined Cycle $ 10.5 $ 0.5 $ 0.5 $ 0.0 $ 11.3 $ 1.1 $ 1.2 $ 0.4 $ 25.6 Nuclear $ 147.3 $ 60.3 $ 1.5 $ 0.5 $ 75.2 $ 3.4 $ 24.0 $ 1.2 $ 313.5 O/ G Steam $ 79.9 $ 8.3 $ 6.3 $ 0.5 $ 65.4 $ 10.5 $ 31.4 $ 4.8 $ 207.1 Other Steam $ 1.2 $ 0.1 $ 0.3 $ 0.0 $ 1.0 $ 0.5 $ 0.2 $ 0.2 $ 3.6 Total $ 330.6 $ 93.0 $ 19.4 $ 2.2 $ 221.8 $ 33.6 $ 80.9 $ 14.9 $ 796.5 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 8 Compliance Schedule The following three tables present EPA's updated assumptions with respect to the compliance schedule for the Phase II regulation ( see also discussion in Section III of the Notice). Table 6 presents the anticipated compliance years for technologies other than recirculating systems and for facilities upgrading to recirculating systems, respectively, based on the year of the facility's last NPDES permit. Tables 7 and 8 present the number of Phase II facilities by their anticipated compliance year and NERC region for the preferred option and the waterbody/ capacity based option, respectively.

Table 6: Compliance Schedule for Facilities Costed with Cooling Towers Year of Last NPDES Permit Compliance Period Year of First Post

Promulgation Permit Compliance Year for Technologies Other than Recirculating Systems Range of Compliance Years for Recirculating Systems 1995 or 2000 2005 2005 2006  2009 1996 or 2001 2006 2006 2007  2010 1997 or 2002 2007 2007 2008  2011 1998 or 2003 2008 2008 2009  2012 1999 or 2004 2009 2009 2010  2013 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 9 Table 7: Number of Phase II Facilities by Anticipated Compliance Year and NERC Region for the Preferred Option NERC Region Compliance Year Total 2005 2006 2007 2008 2009 ASCC 1     1 ECAR 16 26 29 17 14 102 ERCOT 12 6 4 14 16 52 FRCC 10 3 2 7 8 30 HI     3 3 MAAC 11 12 11 4 6 44 MAIN 16 11 7 7 10 51 MAPP 11 11 10 9 3 44 NPCC 13 18 12 9 10 61 SERC 21 20 29 11 15 96 SPP 11 3 5 9 4 32 WSCC 16 7 4 1 5 34 Total 138 116 114 88 95 551 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 10 Table 8: Number of Phase II Facilities by Anticipated Compliance Year and NERC Region for the Waterbody/ Capacity Based Option NERC Region Compliance Year Total 2005 2006 2007 2008 2009 2010 2011 2012 ASCC 1        1 ECAR 16 26 29 17 14    102 ERCOT 11 7 4 13 17    52 FRCC 9 3 2 7 8   1 30 HI     1 2   3 MAAC 7 15 9 7 4 2   44 MAIN 16 11 7 7 10    51 MAPP 11 11 10 9 3    44 NPCC 13 14 13 8 9 5   61 SERC 18 21 29 13 15    96 SPP 11 3 5 9 4    32 WSCC 11 9 7 2 5    34 Total 123 120 115 92 90 9  1 551 Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 11 Installation Downtime EPA also changed its assumptions about facility downtime as a result of technology installation ( see also discussion in Section III of the Notice). Table 9 presents the total number of weeks of downtime for compliance technology installation estimated by EPA for the preferred option and the waterbody/ capacity based option.

Table 9: Number of Downtime Weeks for Phase II Facility by NERC Region NERC Region Preferred Option Waterbody/ Capcity Based Option ASCC 4 4 ECAR 102 106 ERCOT  8 FRCC 10 52 HI 6 8 MAAC 50 99 MAIN 23 23 MAPP 20 20 NPCC 59 111 SERC 67 111 SPP 8 8 WSCC 20 96 Total 369 645 2. Cost to Revenue Ratio The " cost to revenue ratio" is used to assess the magnitude of compliance costs relative to revenues. This test is commonly used to evaluate the economic practicability of regulatory requirements. The cost

torevenue measure is a useful test because it compares the cost of reducing adverse environmental impact from the operation of the facility's cooling water intake structure ( CWIS) with the economic value ( i. e.,

revenue) of the facility's economic activities. EPA conducted this test at the facility and firm levels.

Depending on the policy option analyzed, annualized compliance costs include all capital costs, O& M costs, administrative costs, energy penalty costs ( where applicable), and plant outage costs of compliance with Phase II regulation. O& M costs include the cost of auxiliary power requirements as a result of the Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 12 4 This annualization methodology is different from the one conducted for the national cost estimate presented in Chapter B1 of the EBA and used in Section 1 of this memo. For the national cost estimate, the present value was determined as of the first year the Phase II rule will take effect ( 2004). In contrast, for the impact analysis, the present value was determined as of the first year of compliance of each facility ( 2005 to 2013).

5 EPA used 2008 rather than 2010 baseline revenues for this analysis because 2008 is the first model run year specified in the IPM analyses. EPA used the first model run year because it more closely resembles the current operating conditions of in scope facilities than later run years ( over time, facilities may be increasingly affected by factors other than a Phase II regulation). operation of recirculating cooling towers. To derive the constant annual value of the capital costs and the value of the cooling tower construction and/ or connection plant outage, EPA annualized these values over 30 years, using a seven percent discount rate. The costs of condenser upgrades were annualized over 20 years. Other capital costs, which include fine mesh traveling screens with and without fish handling as well as fish handling and return systems, were annualized over 10 years. EPA then added the annualized capital and connection outage costs to annual O& M costs, administrative costs, and the cost of the energy penalty to derive each facility's total annual cost of complying with the Phase II rule. 4 For a detailed analysis of the compliance cost components developed for this analysis, see Chapter B1 of the EBA and the Section 316( b) Technical Development Document ( DCN 4 0004), both in support of the proposed rule.

EPA compared the annualized compliance costs to the estimated facility and firm revenues on both the facility and firm levels. This analysis uses thresholds of one and three percent.

Facility Level Analysis EPA examined the annualized post tax compliance costs of the preferred option and the waterbody/ capacity based option as a percentage of baseline annual revenues, for each of the 551 facilities subject to Phase II of the Section 316( b) regulation. This measure allows for a comparison of compliance costs incurred by each facility with its revenues in the absence of Phase II regulation. The revenue estimates are facility specific baseline projections from the IPM base case for 2008 ( see Section V of this Notice for a discussion of EPA's analyses using the IPM). 5 If IPM revenues were not available,

EPA used facility specific electricity generation and firm specific wholesale prices as reported to the Energy Information Administration ( EIA) to calculate the cost to revenue ratio.

Tables 10 and 11 below present the results of the facility level cost to revenue measure, by facility ownership type and fuel type, for the preferred option and the waterbody/ capacity based option,

respectively. For each facility type and fuel type, the tables present ( 1) the total number of facilities; ( 2) Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 13 the number of facilities with a cost to revenue ratio of less than 0.5 percent, between 0.5 and one percent,

between one and three percent, and greater than three percent; and ( 3) the minimum and maximum ratios.

Table 10 shows that the vast majority of facilities subject to the preferred option, 404 out of 551 ( 73 percent), would incur annualized costs of less than one percent of revenues. Of these, 292 facilities would incur compliance costs of less than 0.5 percent of revenues. Ninety seven facilities ( 18 percent)

would incur costs of between one and three percent of revenues, and 41 facilities ( seven percent) would incur costs of greater than three percent. Eight facilities are estimated to be baseline closures, and for one facility, revenues are unknown. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 14 Table 10: Facility Level Cost to Revenue Measure for the Preferred Option Facility Type Total Number of Facilities Number of Facilities with a Ratio of Minimum Ratio Maximum Ratio < 0.5% 0.5 1% 1 3% > 3% Baseline Closure n/ a By Ownership Type Investor Owned Utility 316 189 73 37 13 3 1 0.01% 102.6%

Nonutility ( former utility) 120 61 28 23 3 4  0.01% 8.3%

Nonutility ( original) 15 3  7 5   0.03% 16.8%

Federal Utility 14 13  1    0.07% 2.2%

State Owned Utility 6 3 1 1 1   0.04% 4.1%

Political Subdivision 8 4  1 2 1  0.06% 22.8%

Municipality & Municipal Marketing Authority 47 11 5 17 14   0.03% 62.9%

Rural Electric Cooperative 25 7 5 10 3   0.04% 10.4%

Totala 551 292 112 97 41 8 1 0.01% 102.6%

By Fuel Type Coal Steam 300 176 74 38 11   0.01% 20.3%

Combined Cycle 17 10 2 3 2   0.02% 5.7%

Nuclear 58 40 1 9 1 7  0.01% 3.1%

Oil/ Gas Steam 167 66 34 42 24 1  0.03% 102.6%

Other Steam 9  1 5 2  1 0.50% 4.0%

Totala 551 292 112 97 41 8 1 0.01% 102.6%

a Individual numbers may not add up due to independent rounding.

Source: IPM analysis: Section 316( b) NODA base case ( EPA electricity demand); U. S. EPA analysis, 2003.

Table 11 shows that out of the 551 facilities subject to this option, 382 ( 69 percent) would incur annualized costs of less than one percent of revenues. Of these, 281 ( 51 percent) would incur annualized costs of less than 0.5 percent of revenues. One hundred and two facilities ( 19 percent) would incur costs of between one and three percent of revenues, and 58 facilities ( 11 percent) would incur costs of greater than three percent. EPA estimates that seven facilities would be baseline closures, and for one facility, Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 15 6 For the waterbody/ capacity based option, IPM revenues for 2008 were not available for seven facilities estimated to be baseline closures, ten facilities not modeled by the IPM, and two facilities projected to have zero baseline revenues. EPA used facility specific electricity generation and firm specific wholesale prices as reported to the Energy Information Administration ( EIA) to calculate the cost to revenue ratio for the 12 non baseline closure facilities with missing information. The revenues for one of these facilities remained unknown. revenues are unknown. 6 Table 11: Facility Level Cost to Revenue Measure for the Waterbody/ Capacity Based Option Facility Type Total Number of Facilities Number of Facilities with a Ratio of Minimum Ratio Maximum Ratio < 0.5% 0.5 1% 1 3% > 3% Baseline Closure n/ a By Ownership Type Investor Owned Utility 316 190 63 38 22 2 1 0.01% 15.7%

Nonutility ( former utility) 120 50 24 26 16 4  0.01% 12.9%

Nonutility ( original) 15 3  7 5   0.03% 16.8%

Federal Utility 14 13  1    0.07% 2.1%

State Owned Utility 6 3  2 1   0.03% 4.5%

Political Subdivision 8 4  1 2 1  0.06% 22.8%

Municipality & Municipal Marketing Authority 47 10 9 18 10   0.03% 63.3%

Rural Electric Cooperative 25 8 5 9 3   0.03% 10.5%

Totala 551 281 101 102 58 7 1 0.01% 63.3%

By Fuel Type Coal Steam 300 171 68 42 18   0.01% 18.9%

Combined Cycle 17 9  6 2   0.02% 13.0%

Nuclear 58 36  7 8 7  0.01% 12.9%

Oil/ Gas Steam 167 64 33 42 28   0.03% 63.3%

Other Steam 9 1  5 2  1 0.40% 14.6%

Totala 551 281 101 102 58 7 1 0.01% 63.3%

a Individual numbers may not add up due to independent rounding.

Source: IPM analysis: Section 316( b) NODA base case ( AEO electricity demand); U. S. EPA analysis, 2003.

Firm Level Analysis EPA also conducted a firm level analysis to evaluate the potential impacts on firms that own multiple Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 16 7 EPA used EIA data if D& B data were not available for privately owned facilities, and D& B data if EIA data were not available for facilities owned by other entities. If neither EPA nor EIA data were available, EPA used data from the Section 316( b) Survey. facilities subject to Section 316( b) Phase II regulation. Impacts experienced at the firm level may be higher for firms that own multiple facilities subject to the rule. The firm level analysis is based on the aggregated post tax compliance costs for each facility owned by the 128 parent entities to the firm's total sales revenue. EPA identified 70 entities, out of the 128 unique domestic parent entities, that own more than one facility subject to the proposed Phase II rule.

EPA did not update its determination of the domestic parent entities of Phase II facilities for this NODA.

The only change to the parent entity determination since proposal was due to the change in the universe of Phase II facilities: Six facilities have been added to the Phase II analysis since proposal; these six facilities are owned by five entities which all own other Phase II facilities and were therefore already part of the Phase II proposal universe. Conversely, five facilities have been dropped since proposal; these five facilities are owned by five entities. Three of these entities do not own other Phase II facilities and are no longer part of Phase II regulation. As a result of these changes, the number of domestic parent entities decreased from 131 at proposal to 128 for this NODA analysis. For a detailed description of how EPA identified domestic parent entities at proposal, see Chapter B4 of the EBA in support of the proposed Phase II rule.

EPA updated and modified the revenues used for the firm level analysis for the NODA. At proposal,

EPA used Dun and Bradstreet ( D& B) sales data for any parent entity listed in the database. If D& B data were not available, EPA used the EIA database or the Section 316( b) Survey. For the NODA analysis,

EPA used the D& B database for privately owned entities only. For other entities, EPA used the EIA database. 7 In addition, EPA updated the average Form EIA 861 data used for this analysis from 1996 to 1998 ( used at proposal) to 1997 to 1999 ( used for the NODA).

Tables 12 and 13 below summarize the cost to revenue ratios for the 128 entities owning in scope electric generating facilities by the parent entity type for the preferred option and the waterbody/ capacity based option, respectively. For each entity type the tables present ( 1) the total number of facilities owned; ( 2)

the total number of firms; ( 3) the number of firms with a cost to revenue ratio of less than 0.5 percent,

between 0.5 and one percent, between one and three percent, greater than three percent; and ( 4) the minimum and maximum ratio. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 17 For the preferred option, EPA estimates that of the 128 unique entities, only two entities would incur compliance costs of greater than three percent of revenues; 11 entities would incur compliance costs of between one and three percent of revenues; eight entities would incur compliance costs of between 0.5 and one percent of revenues; and the remaining 107 entities would incur compliance costs of less than 0.5 percent of revenues. The highest estimated cost to revenue ratio for this NODA analysis is 7.4 percent of the entities' annual sales revenue. The compliance cost estimates used for this firm level analysis include costs for all Phase II facilities, including facilities estimated to be baseline closures.

Table 12: Firm Level Cost to Revenue Measure by Entity Type for the Preferred Option Entity Type Total Number of Facilities Total Number of Firms Number of Firms with a Ratio of Minimum Ratio Maximum Ratio < 0.5% 0.5 1% 1  3% > 3%

Private 450 70 68 1 1  0.00% 1.07%

Federal 14 1 1    0.16% 0.16%

State 7 4 4    0.02% 0.32%

Political Subdivision 8 4 3  1  0.11% 1.32%

Municipality &

Municipal Marketing Authority 47 34 17 6 9 2 0.04% 7.36%

Rural Electric Cooperative 25 15 14 1   0.18% 0.69%

Totala 551 128 107 8 11 2 0.00% 7.36%

a Individual numbers may not add up to totals due to independent rounding.

Source: IPM analysis: Section 316( b) NODA base case ( EPA electricity demand); U. S. EPA analysis, 2003.

EPA estimates that under the waterbody/ capacity based option only two of the 128 unique entitieswould incur compliance costs of greater than three percent of revenues the; 15 entities would incur compliance costs of between one and three percent of revenues; 16 entities would incur compliance costs of between 0.5 and one percent of revenues; and the remaining 95 entities would incur compliance costs of less than 0.5 percent of revenues. The highest estimated cost to revenue ratio for this NODA analysis is 7.4 percent of the entities' annual sales revenue. The compliance cost estimates used for this firm level analysis include costs for all Phase II facilities, including facilities estimated to be baseline closures. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 18 8 The number of residential consumers reported in Form EIA 861 is based on the number of utility meters. This is a proxy for the number of households but can differ slightly due to bulk metering in some multi family housing. Table 13: Firm Level Cost to Revenue Measure by Entity Type for the Waterbody/ Capacity Based Option Entity Type Total Number of Facilities Total Number of Firms Number of Firms with a Ratio of Minimum Ratio Maximum Ratio < 0.5% 0.5 1% 1  3% > 3%

Private 450 70 58 7 5  0.00% 2.20%

Federal 14 1 1    0.16% 0.16%

State 7 4 3 1   0.02% 0.63%

Political Subdivision 8 4 3  1  0.11% 1.32%

Municipality &

Municipal Marketing Authority 47 34 16 7 9 2 0.04% 7.36%

Rural Electric Cooperative 25 15 14 1   0.18% 0.71%

Totala 551 128 95 16 15 2 0.00% 7.36%

a Individual numbers may not add up to totals due to independent rounding.

Source: IPM analysis: Section 316( b) NODA base case ( AEO electricity demand); U. S. EPA analysis, 2003.

3. Cost per Household EPA also conducted an analysis that evaluates the potential cost per household, 8 if Phase II facilities were able to pass compliance costs on to their customers. This analysis estimates the average compliance cost per household for each NERC region, using two data inputs: ( 1) the average annual compliance cost per megawatt hour ( MWh) of sales and ( 2) the average annual MWh of electricity sales per household. Both data elements were calculated by NERC region using the following approach.

Average annual compliance cost per MWh of sales: EPA compiled data on total electricity sales ( including residential, commercial, industrial, public street highway and lighting, and other sales) from the 2000 Form EIA 861 database. Utility level sales were aggregated by NERC region to derive each region's total electricity sales in 2000. In addition, EPA aggregated the national pre tax compliance costs by the NERC region in which the 551 Phase II facilities are located. The average compliance cost per Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 19 MWh of electricity sales is calculated by dividing total electricity sales by total pre tax compliance costs for each region.

Average annual electricity sales per household: Form EIA 861 differentiates electricity sales by customer type and also presents the number of customers that account for the sales. The average annual electricity sales per household is therefore calculated by dividing the MWh of residential sales by the number of households. This calculation was again done by NERC region.

For both the preferred option and the waterbody/ capacity based option, EPA calculated the annual compliance cost per household by multiplying the average annual compliance cost per MWh of sales by the average annual electricity sales per household. This analysis assumes that power generators pass costs on to consumers, on a dollar to dollar basis, and that each sector ( i. e., residential, industrial, commercial,

public street highway and lighting, and other) bears an equal burden of compliance costs per MWh of electricity.

Table 14 shows the results of this analysis for the preferred option. The cost per residential household would average $ 1.30, and range from $ 0.55 per year in ASCC to $ 5.69 per year in HI. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 20 Table 14: Annual Compliance Cost per Residential Consumer by NERC Region in 2000 for the Preferred Option ($ 2002)

NERC Region Total Electricity Sales ( MWh) Total National Pre Tax Compliance Cost Annualized Pre

Tax Compliance Cost ($ / MWh Sales) Residential Electricity Sales ( MWh) Number of Households Annual Residential Sales/

Household ( MWh) Annual Compliance Cost/

Household ASCC 5,309,970 $ 365,651 $ 0.07 1,854,968 230,534 8.05 $ 0.55 ECAR 522,187,334 $ 76,948,607 $ 0.15 158,037,771 15,626,013 10.11 $ 1.49 ERCOT 285,347,453 $ 21,670,672 $ 0.08 103,478,697 7,021,590 14.74 $ 1.12 FRCC 182,848,371 $ 27,154,034 $ 0.15 92,391,451 6,721,120 13.75 $ 2.04 HI 9,271,676 $ 6,922,457 $ 0.75 2,627,203 344,882 7.62 $ 5.69 MAAC 229,193,120 $ 37,371,992 $ 0.16 82,890,271 8,982,600 9.23 $ 1.50 MAIN 247,759,377 $ 36,585,689 $ 0.15 72,946,752 8,188,189 8.91 $ 1.32 MAPP 139,246,194 $ 15,352,411 $ 0.11 47,997,755 4,848,274 9.90 $ 1.09 NPCC 256,382,568 $ 56,165,133 $ 0.22 85,806,190 12,650,908 6.78 $ 1.49 SERC 764,593,949 $ 63,832,839 $ 0.08 282,503,216 20,192,159 13.99 $ 1.17 SPP 171,473,599 $ 12,324,949 $ 0.07 59,902,473 4,909,350 12.20 $ 0.88 WSCC 599,645,124 $ 61,665,308 $ 0.10 201,895,024 22,010,686 9.17 $ 0.94 U. S. 3,413,258,735 $ 416,359,743 $ 0.12 1,192,331,771 111,726,305 10.67 $ 1.30 Source: U. S. DOE, 2000; EPA analysis, 2003.

Table 15 shows the results of this analysis for the waterbody/ capacity based option. The cost per household would average $ 4.00, and range from $ 0.55 per year in ASCC to $ 20.41 per year in HI. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 21 9 The Annual Energy Outlook does not include two NERC regions, ASCC and HI. Table 15: Annual Compliance Cost per Residential Consumer by NERC Region in 2000 for the Waterbody/ Capacity Based Option ($ 2002)

NERC Region Total Electricity Sales ( MWh) Total National Pre Tax Compliance Cost Annualized Pre Tax Compliance Cost ($ / MWh Sales) Residential Electricity Sales ( MWh) Number of Households Annual Residential Sales/

Household ( MWh) Annual Compliance Cost/ Houshold ASCC 5,309,970 $ 365,795 $ 0.07 1,854,968 230,534 8.05 $ 0.55 ECAR 522,187,334 $ 78,527,538 $ 0.15 158,037,771 15,626,013 10.11 $ 1.52 ERCOT 285,347,453 $ 33,805,805 $ 0.12 103,478,697 7,021,590 14.74 $ 1.75 FRCC 182,848,371 $ 160,722,241 $ 0.88 92,391,451 6,721,120 13.75 $ 12.08 HI 9,271,676 $ 24,838,714 $ 2.68 2,627,203 344,882 7.62 $ 20.41 MAAC 229,193,120 $ 236,666,387 $ 1.03 82,890,271 8,982,600 9.23 $ 9.53 MAIN 247,759,377 $ 36,778,203 $ 0.15 72,946,752 8,188,189 8.91 $ 1.32 MAPP 139,246,194 $ 15,449,356 $ 0.11 47,997,755 4,848,274 9.90 $ 1.10 NPCC 256,382,568 $ 172,926,197 $ 0.67 85,806,190 12,650,908 6.78 $ 4.57 SERC 764,593,949 $ 175,494,912 $ 0.23 282,503,216 20,192,159 13.99 $ 3.21 SPP 171,473,599 $ 12,428,707 $ 0.07 59,902,473 4,909,350 12.20 $ 0.88 WSCC 599,645,124 $ 331,813,043 $ 0.55 201,895,024 22,010,686 9.17 $ 5.08 U. S. 3,413,258,735 $ 1,279,816,898 $ 0.37 1,192,331,771 111,726,305 10.67 $ 4.00 Source: U. S. DOE, 2000; EPA analysis, 2003.

4. Electricity Price Analysis EPA also considered potential effects of the Phase II regulation on electricity prices. EPA used three data inputs in this analysis: ( 1) total pre tax compliance cost incurred by facilities subject to the Phase II regulation; ( 2) total electricity sales, based on the Annual Energy Outlook ( AEO) 2002; and ( 3) prices by consumer type ( residential, commercial, industrial, and transportation), also from the AEO 2002. All three data elements were calculated by NERC region. 9 Table 16 presents the annualized costs of complying with the preferred option, total electricity sales ( in MWh), and the cost in cents per kilowatt hour ( KWh) of total electricity sales by NERC region. The Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 22 costs per KWh sales range from 0.007 cents in SPP to 0.020 cents in NPCC.

Table 16: Compliance Cost per KWh of Sales by NERC Region for the Preferred Option NERC Region Annualized Pre Tax Compliance Costs ( National; $ 2002) Total Electricity Sales ( MWh; 2000) Annualized Pre Tax Compliance Cost ( Cents /

KWh Sales)

ASCC $ 365,651     ECAR $ 76,948,607 517,730,286 0.015 ¢ ERCOT $ 21,670,672 269,072,083 0.008 ¢ FRCC $ 27,154,034 182,241,013 0.015 ¢ HI $ 6,922,457     MAAC $ 37,371,992 246,302,490 0.015 ¢ MAIN $ 36,585,689 231,949,219 0.016 ¢ MAPP $ 15,352,411 153,681,397 0.010 ¢ NPCC $ 56,165,133 279,294,891 0.020 ¢ SERC $ 63,832,839 759,772,644 0.008 ¢ SPP $ 12,324,949 171,100,266 0.007 ¢ WSCC $ 61,665,308 627,001,373 0.010 ¢ U. S. $ 416,359,743 3,418,263,184 0.012 ¢ Source: U. S. DOE, 2001; U. S. EPA analysis, 2003.

To determine potential effects of these compliance costs on electricity prices, EPA compared the compliance costs per KWh of sales to baseline electricity prices. This analysis assumes that power generators fully recover compliance costs from consumers and that each sector ( i. e., residential,

commercial, industrial, and transportation) bears an equal burden of compliance costs per MWh of purchased electricity.

Table 17 below shows the annualized pre tax compliance cost in cents per KWh of electricity sales for the preferred option and the AEO electricity prices for 2000 by consumer type. In addition, the table presents the price increase by consumer type that would result from the rule. Under the preferred option, the largest potential increase in electricity prices would be 0.36 percent for an industrial facility in NPCC.

The average increase in electricity prices would be between 0.14 percent for residential customers ( 0.012/ 8.84) and 0.25 percent for industrial customers ( 0.012/ 4.90). Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 23 Table 17: Estimated Price Increase as a Percent of 2000 Pricesa by Consumer Type and NERC Region for the Preferred Option ($ 2002)

Region Annualized Pre Tax Compliance Cost ( Cents /

KWh Sales) Residential Commercial Industrial Transportation All Sectors Average Price %

Change Price %

Change Price %

Change Price %

Change Price %

Change ECAR 0.015 8.07 0.18% 7.45 0.20% 4.64 0.32% 7.10 0.21% 6.46 0.23%

ERCOT 0.008 8.37 0.10% 7.43 0.11% 4.36 0.18% 6.56 0.12% 6.82 0.12%

FRCC 0.015 8.33 0.18% 7.20 0.21% 5.33 0.28% 6.52 0.23% 7.62 0.20%

MAAC 0.015 10.46 0.14% 9.22 0.16% 7.12 0.21% 9.16 0.17% 9.14 0.17%

MAIN 0.016 9.12 0.17% 7.62 0.21% 5.05 0.31% 7.58 0.21% 7.15 0.22%

MAPP 0.010 8.30 0.12% 6.85 0.15% 4.64 0.22% 6.78 0.15% 6.45 0.15%

NPCC 0.020 11.46 0.18% 8.42 0.24% 5.54 0.36% 8.36 0.24% 8.95 0.22%

SERC 0.008 7.36 0.11% 6.54 0.13% 4.21 0.20% 5.65 0.15% 6.10 0.14%

SPP 0.007 7.16 0.10% 6.10 0.12% 4.05 0.18% 5.16 0.14% 5.88 0.12%

WSCC 0.010 9.20 0.11% 8.05 0.12% 5.09 0.19% 6.86 0.14% 7.61 0.13%

U. S. 0.012 8.84 0.14% 8.03 0.15% 4.90 0.25% 7.91 0.15% 7.33 0.17%

a Prices are in cents per KWh.

Source: EPA analysis, 2003.

Table 18 presents the annualized cost of complying with the waterbody/ capacity based option, total electricity sales ( MWh), and the cost in cents per kilowatt hour ( KWh) of total electricity sales by NERC region. The costs per KWh sales range from 0.007 cents in SPP to 0.096 cents in MAAC. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 24 Table 18: Compliance Cost per KWh of Sales by NERC Region for the Waterbody/ Capacity Based Option NERC Region Annualized Pre Tax Compliance Costs ( National; $ 2002) Total Electricity Sales ( MWh; 2000) Annualized Pre Tax Compliance Cost ( Cents /

KWh Sales)

ASCC $ 365,795     ECAR $ 78,527,538 517,730,286 0.015 ¢ ERCOT $ 33,805,805 269,072,083 0.013 ¢ FRCC $ 160,722,241 182,241,013 0.088 ¢ HI $ 24,838,714     MAAC $ 236,666,387 246,302,490 0.096 ¢ MAIN $ 36,778,203 231,949,219 0.016 ¢ MAPP $ 15,449,356 153,681,397 0.010 ¢ NPCC $ 172,926,197 279,294,891 0.062 ¢ SERC $ 175,494,912 759,772,644 0.023 ¢ SPP $ 12,428,707 171,100,266 0.007 ¢ WSCC $ 331,813,043 627,001,373 0.053 ¢ U. S. $ 1,279,816,898 3,418,263,184 0.037 ¢ Source: U. S. DOE, 2001; U. S. EPA analysis, 2003.

Table 19 below shows the annualized pre tax compliance cost in cents per KWh of electricity sales for the waterbody/ capacity based option and the AEO electricity prices for 2000 by consumer type. In addition,

the table presents the price increase by consumer type that would result from the rule. Under this option,

the largest potential increase in electricity prices would be 1.66 percent for an industrial facility in FRCC.

The average increase in electricity prices would only be between 0.42 percent for residential customers and 0.76 percent for industrial customers. Supporting Documentation of Changes to Economic Impacts March 12, 2003 Page 25 Table 19: Estimated Price Increase as a Percent of 2000 Pricesa by Consumer Type and NERC Region for the Waterbody/ Capacity Based Option ($ 2002)

Region Annualized Pre Tax Compliance Cost ( Cents /

KWh Sales) Residential Commercial Industrial Transportation All Sectors Average Price %

Change Price %

Change Price %

Change Price %

Change Price %

Change ECAR 0.015 8.07 0.19% 7.45 0.20% 4.64 0.33% 7.10 0.21% 6.46 0.23%

ERCOT 0.013 8.37 0.15% 7.43 0.17% 4.36 0.29% 6.56 0.19% 6.82 0.18%

FRCC 0.088 8.33 1.06% 7.20 1.23% 5.33 1.66% 6.52 1.35% 7.62 1.16%

MAAC 0.096 10.46 0.92% 9.22 1.04% 7.12 1.35% 9.16 1.05% 9.14 1.05%

MAIN 0.016 9.12 0.17% 7.62 0.21% 5.05 0.31% 7.58 0.21% 7.15 0.22%

MAPP 0.010 8.30 0.12% 6.85 0.15% 4.64 0.22% 6.78 0.15% 6.45 0.16%

NPCC 0.062 11.46 0.54% 8.42 0.73% 5.54 1.12% 8.36 0.74% 8.95 0.69%

SERC 0.023 7.36 0.31% 6.54 0.35% 4.21 0.55% 5.65 0.41% 6.10 0.38%

SPP 0.007 7.16 0.10% 6.10 0.12% 4.05 0.18% 5.16 0.14% 5.88 0.12%

WSCC 0.053 9.20 0.58% 8.05 0.66% 5.09 1.04% 6.86 0.77% 7.61 0.70%

U. S. 0.037 8.84 0.42% 8.03 0.47% 4.90 0.76% 7.91 0.47% 7.33 0.51%

a Prices are in cents per KWh.

Source: EPA analysis, 2003.


Comment Info: =================

General Comment:A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.

This is a harm minimization product, the people you intend to rule against are not bankrolled and have millions of people across the world addicted to their products.

By Deeming that these products are tobacco products, and by restricting them in such a way, you will drive a whole industry underground, cutting corners and potentially putting lives at risk.

By ruling against these products - you will hand ALL of the power to Big Tobacco.

There has to be a better way.