[Federal Register: January 23, 2008 (Volume 73, Number 15)]
[Notices]
[Page 4022-4023]
[DOCID:fr23ja08-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8882; 34-57162; File No. 265-24]

Advisory Committee on Improvements to Financial Reporting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of SEC Advisory Committee on Improvements to
Financial Reporting.

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SUMMARY: The Securities and Exchange Commission Advisory Committee on
Improvements to Financial Reporting is providing notice that it will
hold a public telephone conference meeting on Monday, February 11, 2008
beginning at 2 pm. Members of the public may take part in the meeting
by listening to the webcast accessible on the Commission's Web site at
http://www.sec.gov or by calling telephone number<PHONE_NUMBER> and

using code number 763960. Persons needing special accommodations to
take part because of a disability should notify a contact person listed
below.
    The agenda for the meeting includes: (1) Discussion and
deliberation of a draft progress report with developed proposals,
conceptual approaches and currently identified future considerations
based on the Committee's deliberations of the Draft Decision Memorandum
presented at its January 11, 2008 meeting in the areas of substantive
complexity, standard setting, audit process and compliance and delivery
of financial information; (2) a vote on a proposal to publish the
Committee's draft progress report in final form to the Commission and
for public feedback; and (3) a discussion of next steps and planning
for the next meeting. The public is invited to submit written
statements for the meeting.

DATES: Written statements should be received on or before February 4,
2008.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Comments

     Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number 265-24 on the subject line.

Paper Comments

     Send paper statements in triplicate to Nancy M. Morris,
Federal Advisory Committee Management Officer, Securities and Exchange
Commission,

100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File No. 265-24. This file number
should be included on the subject line if e-mail is used. To help us
process and review your statements more efficiently, please use only
one method. The Commission staff will post all statements on the
Advisory Committee's Web site (http://www.sec.gov/about/offices/oca/acifr.shtml
). Statements also will be available for public inspection

and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: James L. Kroeker, Deputy Chief
Accountant, or Shelly C. Luisi, Senior Associate Chief Accountant, at
(202) 551-5300, Office of the Chief Accountant, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549-6561.

SUPPLEMENTARY INFORMATION: In accordance with Section 10(a) of the
Federal Advisory Committee Act, 5 U.S.C. App. 1, section 10(a), James
L. Kroeker, Designated Federal Officer of the Committee, has approved
publication of this notice.

    Dated: January 16, 2008.
Nancy M. Morris,
Committee Management Officer.
[FR Doc. E8-1053 Filed 1-22-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60911-60913]
[FR Doc No: 2015-25625]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Contact Substance Notification Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with the Food Contact Substance Notification Program.

DATES: Submit either electronic or written comments on the collection
of information by December 7, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0294 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Contact Substance
Notification Program.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing this notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information

is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Food Contact Substance Notification Program--21 CFR 170.101, 170.106,
and 171.1

OMB Control Number 0910-0495--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification
process for food contact substances. Section 409(h)(6) of the FD&C Act
defines a ``food contact substance'' as ``any substance intended for
use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.'' Section 409(h)(3) of the FD&C
Act requires that the notification process be used for authorizing the
marketing of food contact substances except when: (1) We determine that
the submission and premarket review of a food additive petition (FAP)
under section 409(b) of the FD&C Act is necessary to provide adequate
assurance of safety, or (2) we and the manufacturer or supplier agree
that an FAP should be submitted. Section 409(h)(1) of the FD&C Act
requires that a notification include: (1) Information on the identity
and the intended use of the food contact substance, and (2) the basis
for the manufacturer's or supplier's determination that the food
contact substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101
and 170.106) specify the information that a notification must contain
and require that: (1) A food contact substance notification (FCN)
includes Form FDA 3480, and (2) a notification for a food contact
substance formulation includes Form FDA 3479. These forms serve to
summarize pertinent information in the notification. The forms
facilitate both preparation and review of notifications because the
forms will serve to organize information necessary to support the
safety of the use of the food contact substance. The burden of filling
out the appropriate form has been included in the burden estimate for
the notification.
    Currently, interested persons transmit an FCN submission to the
Office of Food Additive Safety in the Center for Food Safety and
Applied Nutrition using Form FDA 3480 whether it is submitted in
electronic or paper format. We estimate that the amount of time for
respondents to complete Form FDA 3480 will continue to be the same.
    In addition to its required use with FCNs, Form FDA 3480 is
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN
according to the items listed on the form. Master Files can be used as
repositories for information that can be referenced in multiple
submissions to FDA, thus minimizing paperwork burden for food contact
substance authorizations. We estimate that the amount of time for
respondents to complete the Form FDA 3480 for these types of
submissions is 0.5 hours.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit in order to: (1) Establish
that the proposed use of an indirect food additive is safe, and (2)
secure the publication of an indirect food additive regulation in parts
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations,'' provides
assistance to manufacturers of food packaging in evaluating processes
for producing packaging from post-consumer recycled plastic. The
recommendations in the guidance address the process by which
manufacturers certify to us that their plastic products are safe for
food contact.
    Description of Respondents: The respondents to this information
collection are manufacturers of food contact substances.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                 Number of       Total       Average
   21 CFR section or other       FDA form No.     Number of    responses per     annual     burden per    Total
           category                              respondents    respondent     responses     response     hours
----------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A).....  FDA 3479........           10               2           20            2        40
170.101 \3 7\ (Category B)...  FDA 3480........            6               1            6           25       150
170.101 \4 7\ (Category C)...  FDA 3480........            6               2           12          120     1,440
170.101 \5 7\ (Category D)...  FDA 3480........           42               2           84          150    12,600
170.101 \6 7\ (Category E)...  FDA 3480........           38               1           38          150     5,700
Pre-notification Consultation  FDA 3480........          190               1          190          0.5        95
 or Master File (concerning a
 food contact substance)\8\.
Amendment to an existing       FDA 3480A.......          100               1          100          0.5        50
 notification (170.101),
 amendment to a Pre-
 notification Consultation,
 or amendment to a Master
 File (concerning a food
 contact substance)\9\.
171.1 Indirect Food Additive   N/A.............            1               1            1       10,995    10,995
 Petitions.
Use of Recycled Plastics in    N/A.............           10               1           10           25       250
 Food Packaging: Chemistry
 Considerations.
                              ----------------------------------------------------------------------------------
    Total....................  ................  ...........  ..............  ...........  ...........    31,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require
  the submission of Form FDA 3479 (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive
  petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.

\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The estimates in table 1 are based on our current experience with
the food contact substance notification program and informal
communication with industry.
    Beginning in row 1, we estimate 10 respondents will submit 2
notifications annually for food contact substance formulations (Form
FDA 3479), for a total of 20 responses. We calculate a reporting burden
of 2 hours per response, for a total of 40 hours. In row 2 we estimate
six respondents. We believe the hourly burden for preparing these
notifications will primarily consist of the manufacturer or supplier
completing Form FDA 3480, verifying that a previous notification is
effective, and preparing necessary documentation. We estimate one
submission for each respondent, for a total of six responses. We
calculate a reporting burden of 25 hours per response, for a total of
150 hours.
    In rows 3, 4, and 5, we identify three tiers of FCNs that reflect
different levels of burden applicable to the respective information
collection items (denoted as Categories C, D, and E). We estimate 6
respondents will submit 2 Category C submissions annually, for a total
of 12 responses. We calculate a reporting burden of 120 hours per
response, for a total burden of 1,440 hours. We estimate 42 respondents
will submit 2 Category D submissions annually, for a total of 84
responses. We calculate a reporting burden of 150 hours per response,
for a total burden of 12,600 hours. We estimate 38 respondents will
submit 1 Category E submission annually, for a total of 38 responses.
We calculate a reporting burden of 150 hours per response, for a total
burden of 5,700 hours.
    In row 6, we estimate 190 respondents will submit information to a
pre-notification consultation or a master file in support of FCN
submission using Form FDA 3480. We calculate a reporting burden of 0.5
hours per response, for a total burden of 95 hours. In row 7 we
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a
substantive or non-substantive request of additional information to an
incomplete FCN submission, an amendment to a pre-notification
consultation, or an amendment to a master file in support of an FCN. We
calculate a reporting burden of 0.5 hours per response, for a total
burden of 50 hours.
    In row 8, we estimate one respondent will submit one indirect food
additive petition under Sec.  171.1, for a total of one response. We
calculate a reporting burden of 10,995 hours per response, for a total
burden of 10,995 hours.
    Finally, in row 9, we estimate 10 respondents will utilize the
recommendations in the guidance document entitled, ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations,'' to develop the
additional information for one such submission annually, for a total of
10 responses. We calculate a reporting burden of 25 hours per response,
for a total burden of 250 hours.

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25625 Filed 10-7-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 193 (Monday, October 6, 2014)]
[Notices]
[Page 60151]
[FR Doc No: 2014-23760]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER14-1594-001; ER14-1596-001.
    Applicants: Lone Valley Solar Park I LLC, Lone Valley Solar Park II
LLC.
    Description: Notice of Non-Material Change in Status of Lone Valley
Solar Park I LLC, et. al.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5165.
    Comments Due: 5 p.m. ET 10/20/14.

    Docket Numbers: ER14-2345-001.
    Applicants: El Paso Electric Company.
    Description: Compliance filing per 35: Compliance Filing of
Housekeeping Updates--OATT to be effective 9/1/2014.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5224.
    Comments Due: 5 p.m. ET 10/20/14.

    Docket Numbers: ER14-2858-001.
    Applicants: Origin Wind Energy, LLC.
    Description: Tariff Amendment per 35.17(b): Origin Wind Energy, LLC
Amendment to MBR Tariff to be effective 9/15/2014.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5225.
    Comments Due: 5 p.m. ET 10/20/14.

    Docket Numbers: ER14-2957-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation of
Original Service Agreement No. 3063; Queue No. W3-078 to be effective
4/26/2012.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5142.
    Comments Due: 5 p.m. ET 10/20/14.

    Docket Numbers: ER14-2958-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 3941; Queue Z2-056 to be effective 8/28/
2014.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5217.
    Comments Due: 5 p.m. ET 10/20/14.

    Docket Numbers: ER14-2959-000.
    Applicants: LWP Lessee, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): LWP
Lessee Market-Based Rate Tariff Revision to be effective 11/29/2014.
    Filed Date: 9/29/14.
    Accession Number: 20140929-5222.
    Comments Due: 5 p.m. ET 10/20/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 29, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-23760 Filed 10-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Pages 28772-28776]
[FR Doc No: 2011-12226]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0037; FRL-8869-8]

Federal Plan for Certification of Applicators of Restricted Use
Pesticides Within Indian Country; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing its intention to implement a Federal program
to certify applicators of restricted use pesticides in Indian country.
The program will be administered by EPA. EPA is soliciting comments on
EPA's intent to implement a Federal certification program in Indian
country where no other EPA-approved or EPA-implemented plan applies and
on its Proposed Federal Plan for Certification of Applicators of
Restricted Use Pesticides within Indian Country (Plan). A separate
proposal and public comment period for a Federal certification plan to
address use of restricted use pesticides in Region 8 Indian country was
recently published in the Federal Register on April 20, 2011.

DATES: Comments must be received on or before July 5, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0037, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket EPA-HQ-OPP-2011-0037.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nicole Zinn, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This notice applies to individuals and businesses who are seeking
certification to apply restricted use pesticides (RUPs) as defined by
EPA in Indian country where no EPA-approved plan or EPA-implemented
plan applies. This action may, however, be of interest to those
involved in agriculture and anyone involved with the distribution and
application of pesticides for agricultural purposes. Others involved
with pesticides in a non-agricultural setting may also be affected.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions

regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    In addition to the sources listed in this unit, you may obtain
copies of the Plan, other related documents, or additional information
by contacting Nicole Zinn at the address listed under FOR FURTHER
INFORMATION CONTACT.

II. What action is the agency taking?

    EPA is announcing its intention to implement a Federal program to
certify applicators of restricted use pesticides (RUPs) in Indian
country and seeks public comment. This Federal certification Plan
describes the process by which EPA will implement a program for the
certification of applicators of RUPs in Indian country based upon the
certification requirements enumerated at 40 CFR part 171. The Plan, in
its entirety, is included in the docket.

III. Introduction

A. What is the background for this plan?

    Under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended, 7 U.S.C. 136 et seq., the Administrator of EPA has
the authority to classify all registered pesticide uses as either
``restricted use'' or ``general use.'' Under FIFRA, pesticides (or the
particular use or uses of a pesticide) that may generally cause,
without additional regulatory restrictions, unreasonable adverse
effects on the environment, including injury to the applicator, shall
be classified for ``restricted use.'' Section 3(d)(1)(C), 7 U.S.C.
136a(d)(1)(C). If the classification is made because of hazards to the
applicator, the pesticide may only be applied by or under the direct
supervision of a certified applicator. 7 U.S.C. 136a(d)(1)(C)(i),
136j(a)(2)(F). If the classification is made because of potential
unreasonable adverse effects on the environment, the pesticide may only
be applied by or under the direct supervision of a certified applicator
or subject to such other restrictions as the Administrator may provide
by regulation. 7 U.S.C. 136a(d)(1)(C)(ii), 136j(a)(2)(F). To be
certified, an individual must be determined to be competent with
respect to the use and handling of pesticides covered by the
certification. 7 U.S.C 136i(a).
    It was the intent of Congress that persons desiring to use
restricted use pesticides should be able to obtain certification under
programs approved by EPA, as reflected in sections 11 and 23 of FIFRA.
7 U.S.C. 136i, 136u. The regulations addressing Tribal and State
development and submission of certification plans to EPA are contained
at 40 CFR part 171. It is EPA's position that Tribal and State plans
are generally best suited to the needs of that particular Tribe or
State and its citizens. Tribes and States, however, are not required to
develop their own plans. Where EPA has not approved a State or Tribal
certification plan, the Agency is authorized to implement an EPA plan
for the Federal certification of applicators of restricted use
pesticides pursuant to sections 11 and 23 of FIFRA. 7 U.S.C. 136i,
136u; 40 CFR 171.11.
    EPA has drafted a Plan for those areas of Indian country where no
other EPA-approved or EPA-implemented plan applies. A separate proposal
and public comment period for a Federal certification plan to address
use of restricted use pesticides in Region 8 Indian country was
recently published in the Federal Register on April 20, 2011 (76 FR
22096; FRL-8855-8).

B. What is the statutory authority for this plan?

    The plan will be implemented under the authority of section
11(a)(1) of FIFRA, as amended by the Food Quality Protection Act of
August 3, 1996, and regulations in 40 CFR 171.11. Additional
enforcement authorities are found in sections 8, 9, 13, 14, and 23 of
FIFRA.

C. Summary of the Plan

    1. Applicability. EPA intends to implement this Federal
certification plan in ``Indian country,'' as defined in 18 U.S.C. 1151,
where no other EPA-approved or EPA-implemented plan applies. ``Indian
country'' is defined in 18 U.S.C. 1151 as:

    (a) All land within the limits of any Indian reservation under
the jurisdiction of the United States Government, notwithstanding
the issuance of any patent, and, including rights-of-way running
through the reservation;
    (b) All dependent Indian communities within the borders of the
United States whether within the original or subsequently acquired
territory thereof, and whether within or without the limits of a
State; and
    (c) All Indian allotments, the Indian titles to which have been
extinguished, including rights-of-way running through the same.

Consistent with the statutory definition of Indian country, as well as
Federal case law interpreting this statutory language, EPA treats lands
held by the Federal government in trust for Indian Tribes that exist
outside of formal reservations as informal reservations and, thus, as
Indian country. For a list of Federally recognized Tribes as of October
2010, see the Federal Register (October 1, 2010; 75 FR 60810),
available at: http://www.bia.gov/idc/groups/vxraca/documents/text/idc011463.pdf.
    There are two types of applicators of restricted use pesticides:
Private and commercial. A ``private applicator'' is defined as:

    A certified applicator who uses or supervises the use of any
pesticide which is classified for restricted use for purposes of
producing an agricultural commodity on property owned or rented by
the applicator or the applicator's employer or (if applied

without compensation other than trading of personal services between
producers of agricultural commodities) on the property of another
person. 7 U.S.C. 136(e)(2).

    A ``commercial applicator'' is defined as:

    An applicator (whether or not the applicator is a private
applicator with respect to some uses) who uses or supervises the use
of any pesticide which is classified for restricted use for any
purpose or on any property other than as set forth in the definition
of a private applicator. 7 U.S.C. 136(e)(3).

This Plan applies to both commercial and private applicators.
    2. Provisions of Plan.--i. Why is EPA developing a Plan? The Plan
will allow the certification of applicators and legal use of RUPs in
those parts of Indian country where there are currently no mechanisms
in place for such certification and use. RUPs cannot be legally used in
Indian country unless EPA has explicitly approved a mechanism of
certification for such an area. To date, EPA has not approved any state
plan for the certification of applicators of restricted use pesticides
in any area of Indian country. There are very few areas of Indian
country for which there are approved non-Federal plans and only one
area that is currently covered under a Federal plan.
    ii. To whom will the Plan apply? The Plan will only apply to
persons who intend to apply RUPs in Indian country excluding the areas
of Indian country that are currently covered by another EPA-approved or
EPA-implemented plan. Tribes may continue to pursue options available
under 40 CFR 171.10 for their areas of Indian country, including
seeking EPA approval of Tribal plans for such areas under 40 CFR
171.10(a)(2) or utilizing a state's certification program under 40 CFR
171.10(a)(1). An option implemented under 40 CFR 171.10 would replace
this Federal plan for the relevant area of Indian country. For a list
of Federally recognized Tribes as of October 2010, see the Federal
Register available at: http://www.bia.gov/idc/groups/xraca/documents/text/idc011463.pdf. In the event that the Federal applicator
certification regulations at 40 CFR 171.11 are revised, EPA will
revisit the Plan to determine if modification of this Plan is
necessary.
    iii. Certification procedures. To become certified to use RUPs in
Indian country, applicators must submit an application form to the EPA
Regional Office that covers the Indian country where they wish to apply
RUPs as well as proof of the valid Federal, state, or Tribal
certification upon which their Federal certification will be based. The
Form is available at http://www.regulations.gov under docket
identification number EPA-HQ-OPP-2010-0723.
    EPA is proposing that the certification on which the Federal
certificate will be based must be from a state or Tribe with a
contiguous boundary to the area of Indian country. EPA believes that
this provision provides greater assurance that the applicator has the
competency to apply RUPs on the contiguous area of Indian country. An
exception will be included that the EPA Region has discretion to allow
Federal certification under the plan based on a valid certification
from another nearby state or Tribe.
    Under 40 CFR 171.11(e), a Federal certificate expires 2 years after
the date of issuance for commercial applicators and 3 years for private
applicators, or until the expiration date of the original Federal,
state, or Tribal certificate, whichever occurs first. A proposed rule
is currently under development that will allow a Federal certification
based on a valid Federal, state or Tribal certification, to expire when
the original certificate expires, unless the certificate is suspended
or revoked. If this amendment is finalized, the Agency will utilize the
expiration date of the original valid certification.
    Where EPA, as opposed to a Tribe or a state, implements a
certification program, both FIFRA and the regulations require that EPA
offer private applicators an option to be certified without taking an
examination. See 7 U.S.C. 136i(a)(1), 40 CFR 171.11(d)(1). Therefore,
in lieu of submitting proof of a valid Federal, state, or Tribal
certification, private applicators also have the option of showing
documentation that they have physically attended and completed an
approved training course and self-study evaluation. Federal
certification under this option is valid for four years from the date
of issuance, unless suspended or revoked.
    iv. Commercial applicator categories. EPA proposes to recognize the
categories authorized in the original certificate, and commercial
applicators will be authorized to apply RUPs in Indian country for uses
covered in their underlying Federal, state or Tribal certificate. EPA
is considering language that would generally exclude categories for
sodium cyanide capsules used with ejector devices for livestock
predator control and for sodium fluoroacetate used in livestock
protection collars. Under this Plan, a Federal certificate would only
include the sodium cyanide capsules and sodium fluoroacetate livestock
protection collars categories if the relevant Indian Tribe for the area
of Indian country at issue obtains its own registration for this
product and conducts its own monitoring and supervision.
    v. Implementation. EPA will administer routine maintenance
activities associated with implementation of this Plan and will conduct
inspections and take enforcement actions as appropriate. States,
Tribes, and other Federal agencies that issued a certification upon
which the Federal certification is based are not approved or authorized
by EPA to assure compliance in Indian country with the Federal
certification provided by this Plan. As with all cases where a non-
Federal official uses Federal credentials to conduct inspections, when
a Tribal inspector conducts an inspection under Federal credentials
under a cooperative agreement with EPA, violations would be referred to
EPA for enforcement action, as appropriate.
    EPA may, if appropriate, deny, modify, suspend, or revoke the
Federal certificate under this Plan. The applicant or Federal
certificate holder has the right to request a hearing if EPA decides to
modify, suspend, or revoke the Federal certificate. If EPA decides to
deny, revoke, suspend or modify a Federal certificate, EPA will notify
the agency that issued the original certificate upon which the Federal
certificate was based.
    If the Federal, state, or Tribal certificate upon which the Federal
certificate is based is suspended, modified, or revoked, EPA will begin
procedures to suspend, modify or revoke the Federal certification.
    EPA will allow, during the 6 month period after publication of the
final Plan, applicators to apply RUPs under the Plan in Indian country
only for the categories for which they already have a valid state,
Tribal or Federal certificate \1\ if they submit a complete application
to the appropriate EPA Region showing proof of a valid state, Tribal,
or Federal certification.\2\
---------------------------------------------------------------------------

    \1\ Please see Section IX of the Plan and Unit III.C.2.d of this
notice for commercial applicator categories recognized under the
Plan, as there are proposed exceptions for sodium cyanide capsules
used with ejector devices and sodium fluoroacetate used in livestock
protection collars.
    \2\ Although predicated in part on the applicator's existing
valid certification, any use permitted under this Plan is allowed
and will be enforced only under Federal authority.
---------------------------------------------------------------------------

    Beginning 6 months after publication of the final Plan, applicators
who are covered under this Plan and have not received a written Federal
certification from the appropriate EPA Region are

prohibited from applying RUPs in the Indian country of that Region.

IV. Specific Comments Are Sought

    EPA is seeking comment on the entire Plan but would specifically
like comments on the following issues:
    1. Notification to Tribes. The Tribal Pesticide Program Council
(TPPC) has requested that a notification provision be included in the
Plan. This provision would require that applicators of RUPs notify the
relevant Tribe before each RUP application that is made in Indian
country. The Agency has questions as to whether this approach can be
practically implemented without causing undue burden to applicators,
the Tribes and the Agency.
    We are interested in obtaining comment regarding the relative value
of this approach as an actual requirement. On the one hand, requiring
notification to Tribes prior to application could provide Tribes some
benefit in knowing where and when RUP applications occur. EPA is
concerned, however, that requiring notifications may impose resource
burdens on Tribes to receive and review such notifications. The TPPC
suggested a possibility that EPA could receive these notifications and
post them publically for Tribes to access. However, EPA is not likely
to have the capacity or resources to receive these notifications. EPA
also notes that Tribes wishing to receive prior notification may wish
to consider including relevant notification requirements under Tribal
law. The Plan notes that applicators certified under the Plan are
responsible for complying with any applicable Tribal requirements.
    One alternative approach being considered is that EPA could post a
list of Federal certifications issued under this Plan. As a matter of
convenience, EPA could arrange the list geographically by state or by
EPA Region such that certifications issued for all Indian country
located in a particular state or EPA Region would be grouped together.
This approach would provide EPA and Tribes easy access to the list of
applicators who may legally apply RUPs within Indian country. EPA would
like to know if this option would be useful to Tribes.
    Another approach being considered is to have the Tribes provide a
contact person to a website so that applicators would know who to
contact to learn of any applicable Tribal requirements for a particular
Tribe. Would this option be useful for Tribes? Would it be burdensome?
    2. Private applicator certification. Under FIFRA section 11(a)(1),
for Federal certification plans, EPA must offer a no-test option for
private applicators. For more background, see Unit III.C. 2. (c) of
this document. EPA proposes that private applicators who wish to obtain
Federal certification under the no-test provision submit documentation
of physical attendance and completion of an EPA-approved training and
self-study evaluation. Are there any other suggestions to assure
private applicator competence in the absence of passing a certification
exam?
    3. Option to not participate in the Plan. Some Tribes have
indicated that they would prefer that the plan include an option for
Tribes to not participate in the Plan (e.g., an ``opt-out provision'').
EPA has not proposed an opt-out provision in the Plan for several
reasons. First, EPA believes that Tribes not wanting to participate in
this Plan may still develop their own Tribal certification plan or
pursue other available mechanisms under 40 CFR 171.10. Further, Tribes
concerned about the application of RUPs in their Indian country may
have the option of adopting additional restrictions on such
applications through Tribal codes, laws, regulation or other applicable
Tribal requirements. Additionally, EPA has not generally provided opt-
out provisions for other actions under FIFRA. Other reasons EPA did not
include an opt-out provision include:
     An opt-out approach does not allow EPA to adequately
address the equity, safety and enforcement issues that occur in the
absence of this Plan.
     There are resource and implementation burdens on Tribes,
applicators and EPA that such a provision would impose.
     An opt-out provision presents communication difficulties
to the regulated community, and thus makes compliance more difficult.

Please share your thoughts on this issue.

V. Consultation With Tribal Governments

    In the absence of an EPA-approved certification program in areas of
Indian county, EPA, consistent with its statutory authorities and the
Federal government's trust responsibility to Federally-recognized
Tribes, has worked with the Tribes, on a government-to-government
basis, to appropriately develop a certification program that will help
ensure the protection of human health and the environment in Indian
country. EPA consulted with the Tribes on November 29 and December 13,
2010 to ensure development of a Federal plan that effectively meets
their needs and those of restricted use pesticide applicators in Indian
country.
    During the consultations, several issues were discussed, such as
the desire for notification to Tribes prior to RUP use, assuring the
competency of private applicators, and the possibility of an opt-out
provision in the Plan. EPA is specifically seeking comment on these
issues as described in the previous section. Additional concerns were
raised that we respect Tribal sovereignty, not require unfunded
mandates, and provide adequate enforcement to assure RUPs are used
legally and safely. EPA believes that the proposed Plan addresses all
of these concerns.
    In addition to the consultations dedicated specifically to this
Plan, EPA has also worked closely with the Tribal Pesticide Program
Council while developing this Plan.
    EPA drafted the Federal plan in consultation with the Tribes
consistent with, among other things, the following policies, orders and
guidance: EPA Policy for the Administration of Environmental Programs
on Indian Reservations, November 8, 1984; Guidance on the Enforcement
Principles Outlined in the 1984 Indian Policy, January 17, 2001;
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, November 6, 2000 which was reaffirmed by Presidential
memorandum, Tribal Consultation, November 5, 2009; and the Proposed EPA
Policy on Consultation and Coordination with Indian Tribes, June 9,
2010.\3\
---------------------------------------------------------------------------

    \3\ The draft policy was published in the Federal Register for
comment on December 15, 2010.
---------------------------------------------------------------------------

VI. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C.3501 et
seq.), the information collection activities described in this document
and the revised Information Collection Request (ICR), OMB Control No.
2070-0029, are currently going through the renewal/amendment process
and will be reviewed by the Office of Management and Budget. As part of
this process, EPA is proposing to implement a revised form designed
specifically for pesticide applicators who wish to be certified in
Indian country. EPA estimates the paperwork burden associated with
completing this form to be 10 minutes per response. Under the PRA,
``burden'' means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, disclose or provide
information to or for a Federal Agency. For this collection it includes
the time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes

of collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. The information collection activities and the form are
included in a separate public docket. See http://www.regulations.gov,
docket identification number EPA-HQ-OPP-2010-0723.

List of Subjects

    Environmental protection, Education, Pests and pesticides.

    Dated: May 11, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-12226 Filed 5-17-11; 8:45 am]
BILLING CODE 6560-50-P


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal)

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS), were proposed on July 18, 2000 ( 65 FR 44616), and promulgated on June 10, 2002 ( 67 FR 39812), and amended on March 17, 2003 ( 68 FR 12592). Respondents are owners or operators of each new, reconstructed, or existing affected source. These standards apply to each facility that is a major source of hazardous air pollutant ( HAP), at which a coil coating line is operated. The coil coating line is a process and the collection of equipment used to apply an organic coating to the surface of a metal coil that is less than 0.15 millimeters ( 0.006 inches) thick, and the coating line is controlled by a common control device that also receives organic HAP emissions from a coil coating line that is subject to the requirements of this subpart.

In general, all owners or operators subject to NESHAP are required to submit one time notifications and one time reports on compliance status and performance test results. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Semiannual reports are required for periods of operation during which the emission limitation is exceeded, or reports certifying that no exceedances have occurred, are required as well.

Any owner or operator subject to the provisions of this subpart will maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) regional office.

Based on our consultations with industry representatives, there is an average of 1.75 affected facilities at each plant site and each plant site has only one respondent ( i. e., the owner/ operator of the plant site).

Approximately 89 respondents are subject to the regulation, and it is estimated that no 2 additional respondents per year will become subject to the regulation in the next three years. The Office of Management and Budget ( OMB) approved the current Information Collection Request ( ICR) without any " Terms of Clearance."

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction. In addition, section 114( a) states that the Administrator may require any owner/ operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from metal coil surface coating plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NESHAP were promulgated for this source category at 40 CFR part 63, subpart SSSS.

2( b) Practical Utility/ Users of the Data The recordkeeping and reporting requirements in the standard ensure compliance with the applicable regulations which were promulgated in accordance with the Clean Air Act. The collected information is also used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected facility's initial capability to comply with the emission standard. Continuous emission monitors are used to ensure compliance with the standard at all times. During the performance test a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a continuous emission monitor. 3 The notifications required in the standard are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and leaks are being detected and repaired and the standards are being met. The performance test may also be observed.

The required semiannual reports are used to determine periods of excess emissions, identify problems at the facility, verify operation/ maintenance procedures and for compliance determinations.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR part 63, subpart SSSS.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register ( 69 FR 69909) on December 1, 2004. No comments were received on the burden published in the Federal Register.

3( c) Consultations For this information collection, we referenced the most recent ICR, consulted with the preparer of the active ICR, and used several different resources to obtain the most recent data available for metal coil surface coating plants. We accessed the most recent data available on the Air Facility System ( AFS) databases as maintained by the Office of Compliance. We reviewed information available from the United States Census Bureau, and other websites covering metal coil surface coating plants. We consulted with the EPA's Office of Air Quality Planning and Standards, Information Transfer, the Program Integration Division, and Prior Coated Metal, Mr. Greg Gemgnani, ( 610) 797 5200.

3( d) Effects of Less Frequent Collection 4 Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records, including reports and notifications, for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent with the part 70 permit program and the five year statute of limitations on which the permit program is based. Also, the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

3( f) Confidentiality Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are metal coil surface coating plants. The United States Standard Industrial Classification ( SIC) codes for the respondents affected by the standards, which correspond to the North American Industry Classification System ( NAICS) codes, are listed below for source category description. 5 Standard ( 40 CFR, part 63, subpart SSSS) SIC Codes NAICS Codes Metal Coating, Engraving ( except Jewelry and Silverware), and Allied Services to Manufacturers 3479 332812 Gasket, Packing, and Sealing Device Manufacturing 3053 339991 Electrometallurgical Ferroalloy Product Manufacturing 3313 331112 Steel Works, Blast Furnaces ( Including Coke Ovens), and Rolling Mills ( hot rolling purchased steel) 3312 331221 Cold Rolled Steel Sheet, Strip, and Bars 3316 331221 Iron and Steel Pipe and Tube Manufacturing from Purchased Steel 3317 331210 Primary Aluminum Production 3334 331312 Secondary Smelting and Alloying of Aluminum 3341 331314 Aluminum Sheet, Plate, and Foil Manufacturing 3353 331315 Fabricated Structural metal Manufacturing 3441 332312 Sheet Metal Work Manufacturing 3444 332322 Prefabricated Metal Building and Component Manufacturing 3448 332311 Motor Vehicle Metal Stamping 3465 336370 Electroplating, Plating, Polishing, Anodizing and Coloring 3471 332813 All other Miscellaneous Fabricated Metal Product Manufacturing 3499 332999 Printing Machinery and Equipment Manufacturing 3555 333293 All other Motor Vehicle Parts Manufacturing 3714 336399 Photographic Film, Paper, Plate, and Chemical Manufacturing 3861 325992 This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. To determine whether your metal coil surface coating facility is regulated by this action, you should examine the applicability criteria in section 63.5090 of the NESHAP.

4( b) Information Requested None of these reporting or recordkeeping requirements violate any of the regulations 6 established by OMB at 5 CFR part 1320, section 1320.5.

( i) Data Items All data in this ICR that are recorded and/ or reported are required by NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS).

A source must make the following reports:

Notification Reports Standard Citation by Section Notification and application of construction or reconstruction 63.5180( b)( 1) and 63.9( b)( 1)( 3)

Notification of anticipated date of initial startup. 63.5180( b)( 2) and 63.9( b)( 4)

Notification to commence construction 63.5180( b)( 2) and 63.9( b)( 4)

Notification of actual startup. 63.5180( b)( 2) and 63.9( b)( 4)

Notification of intent to construct/ reconstruct 63.5180( b)( 2) and 63.9( b)( 4)( 5)

Notification of performance tests. 63.5180( c) and 63.9( e) ( g)

Notification of compliance status 63.5180( d) and 63.9( h)

Reports Report of initial performance test 63.5180( e) and 63.10( d)( 2)

Reports of startup, shutdown, and malfunction plan 63.5180( f), 63.6( e)( 3) and 63.9( d)( 5)

Semiannual compliance report of no deviations 63.5180( g) and 63.10( e)( 5)

Semiannual compliance report of deviation 63.5180( h)( i) and 63.10( e)( 5) 7 A source must keep the following records:

Recordkeeping Maintain records of all reports 63.5190( a)( 1)( a)( 3) and 63.10( b)( 2)

Maintain records of startup, shutdown, or malfunction plan 63.5180( f) and 63.10( b)( 2)

Maintain documentation of corrective action procedures 63.5180( f) and 63.10( b)( 2)

Electronic Reporting At present, respondents are using monitoring equipment that automatically records parameter data, e. g., chart recorder, data logger, temperature indicator, etc. Although personnel at the affected facility must evaluate the data, this internal automation has significantly reduced the burden associated with monitoring and recordkeeping at the plant site.

Also, regulatory agencies, in cooperation with the respondents, continue to create reporting systems to transmit data electronically. However, electronic reporting systems are still not widely used. At this time, it is estimated that approximately 35 percent of the respondents use electronic reporting.

( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate a coil coating line at their metal coil surface coating plants.

Perform initial performance test, Reference Method 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 25, 25A tests, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports, developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information. 8 Respondent Activities Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System ( AFS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard, and the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS which is operated and maintained by EPA's Office of Compliance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government owned facilities. EPA uses the AFS for tracking air pollution compliance and 9 enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner/ operator for five years.

5( c) Small Entity Flexibility A majority of the respondents are large entities ( e. g., large businesses). However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden for NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal).

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 19,901 ( Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs 10 ( i) Estimating Labor Costs This ICR uses the following labor rates:

Managerial $ 96.41 ($ 45.91 + 110%) Technical $ 82.74 ($ 39.40 + 110%) Clerical $ 42.25 ($ 20.12 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, September 2004, " Table 2. Civilian Workers, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The type of industry costs associated with the information collection activities in the subject standard are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring. The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Capital/ Startu p Cost for One Respondent ( C) Number of New Respondents ( D) Total Capital/ Startu p Cost ( B X C) ( E) Annual O& M Costs for One Respondent ( F) Number of Respondents with O& M 1 ( G) Total O& M, ( E X F)

Continuous Monitoring System N/ A N/ A $ 0 $ 48 76 $ 3,648 $ 3,648 1 There is an average of eighty nine sources. Thirteen of these sources are considered synthetic minors and are not subject to the emission limits in the standard.

The total capital/ startup costs for this ICR are $ 0. This is the total of column D in the above table. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR is $ 3,648. This is the total of column G. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M). 11 The total respondent costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 4,000 ( rounded). This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 19,842.

This cost is based on the average hourly labor rate as follows:

Managerial $ 56.02 ( GS 13, Step 5, $ 35.01 x 1.6) Technical $ 41.57 ( GS 12, Step 1, $ 25.98 x 1.6) Clerical $ 22.50 ( GS 6, Step 3, $ 14.06 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2: Average Annual EPA Burden  NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal), attached.

6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, approximately 89 existing respondents are subject to the standard ( averaged over three years). It is estimated that no additional sources per year will become subject to the standard in the next three years. It is also noted that thirteen of these facilities are considered synthetic minors and thus, are not subject to the emission limits in the standard. The overall average number of respondent is, therefore, 89 respondents per year ( see table below).

Number of respondents is calculated using the following table which addresses the three years covered by this ICR. 12 Number of Respondents Respondents That Submit Reports Respondents That Do Not Submit Any Reports Year ( A) Number of New Respondents 1 ( B) Number of Existing Respondents ( C) Number of Existing Respondents That Keep Records but Do Not Submit Reports ( D) Number of Existing Respondents That Are Also New Respondents ( E) Number of Respondents ( E= A+ B+ C D)

1 0 89 0 0 89 2 0 89 0 0 89 3 0 89 0 0 89 Average 0 89 0 0 89 To avoid double counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 89. This number appears on the OMB 83 I form in block 13( a), Number of respondents.

Number of respondents is calculated using the following table which addresses each of the three years covered by this ICR.

The total number of annual responses per year is calculated using the following table:

Total Annual Responses ( A) Information Collection Activity ( B) Number of Respondents ( C) Number of Responses ( D) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( BxC)+ D Initial notification 0 1 0 0 Notification of construction/ reconstruction 0 1 0 0 Notification of anticipated startup 0 1 0 0 Notification of actual startup 0 1 0 0 Notification of compliance status 0 1 0 0 Performance test notification 0 0.11 0 0 Performance test report 0 0.11 0 0 13 Total Annual Responses Semiannual report of exceedances 7.6 2 0 15.2 Semiannual report of no exceedances 68.4 2 0 136.8 Startup, shutdown, malfunction report 7.6 2 0 15.2 Total 167 The number of Total Annual Responses is 167. This number is shown on the OMB 83 I form in block 13( b), Total annual responses.

The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 1,588,365. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1. Annual Respondent Burden and Cost, NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal), attached.

6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively, and summarized below.

( i) Respondent Tally The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 1,588,365. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1. Annual Respondent Burden and Cost, NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal), attached. Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 119 hours per response.

The total annual capital/ startup and O& M costs to the regulated entity are $ 4,000. This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The cost calculations are detailed in Section 6( b)( iii), Capital/ Startup vs. Operation and Maintenance ( O& M) Costs.

( ii) The Agency Tally The average annual Agency burden and cost over the next three years is estimated to be 489 labor hours at a cost of $ 19,842. See Table 2. Annual Agency Burden and Cost, NESHAP for Metal Coil Surface Coating Plants ( 40 CFR part 63, subpart SSSS) ( Renewal).

6( f) Reasons for Change in Burden 14 There is a decrease of 5,147 hours as compared to the active ICR. The reason for this decrease in labor hours is that there are no new or reconstructed sources in this renewal that would require reporting requirements associated with this standard.

The previous ICR had both capital/ startup costs and O& M costs. Because there are no new sources with reporting requirements, no capital/ startup costs are incurred here. The only cost that is incurred is for the operation and maintenance ( O& M) of the monitors, which reduces the overall costs significantly.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 119 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number OECA 2004 0033, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OECA 2004 0033 and OMB Control Number 2060 0487 in any correspondence. 15 Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 16 Table 1: Annual Respondent Burden and Cost  NESHAP for Metal Coil Surface Coating Plants ( CFR part 63, subpart SSSS)

( Renewal) Burden item ( A) Technical Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C) Technical Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost per year a 1. Applications N/ A 2. Survey and Studies N/ A 3. Acquisition, installation and utilization of technology and systems 80 0.11 8.8 0 0 0 0 $ 0 4. Reporting requirements A. Read Instructions 4 1 4 0 0 0 0 $ 0 B. Required Activities Initial oxidizer performance test 280 0.11c 30.8 0 0 0 0 $ 0 Repeat oxidizer performance test 280 0.11c 30.8 0 0 0 0 $ 0 Initial capture performance test 215 0.11c 23.65 0 0 0 0 $ 0 Repeat capture performance test 215 0.11c 23.65 0 0 0 0 $ 0 Emission rate limit compliance determination 16 12 192 0 0 0 0 $ 0 Startup, shutdown, malfunction plan 32 1 32 0 0 0 0 $ 0 C. Create information Included in 4B D. Gather existing information Included in 4B E. Write report 17 Burden item ( A) Technical Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C) Technical Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost per year a Initial notification 2 1 2 0 0 0 0 $ 0 Notification of construction/

reconstruction 2 1 2 0 0 0 0 $ 0 Notification of anticipated startup 2 1 2 0 0 0 0 $ 0 Notification of actual startup 2 1 2 0 0 0 0 $ 0 Notification of compliance status 4 1 4 0 0 0 0 $ 0 Performance test notification 2 0.11c 0.22 0 0 0 0 $ 0 Performance test report 40 0.11c 4.4 0 0 0 0 $ 0 Semiannual report of exceedances 16 2d 32 7.6e 243.2 12.16 24.32 $ 22,322.24 Semiannual report of no exceedances 8 2f 16 68.4g 1,094.4 54.72 109.44 $ 100,450.06 Startup, shutdown, malfunction report e 8 2 16 7.6h 121.60 6.08 12.16 $ 11,161.11 5. Recordkeeping Requirements A. Read instructions Included in 4B B. Plan activities N/ A C. Implement activities N/ A D. Develop record system N/ A E. Time to enter information Records of all information required by standards 4 52 i 208 76b 15,808 790.4 1580.8 $ 1,450,945.10 18 Burden item ( A) Technical Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C) Technical Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost per year a F. Time to train personnel N/ A G. Time to adjust existing ways to comply with previously applicable requirements N/ A H. Time to transmit or disclose information 0.25j 2 0.5 76 b 38 1.9 3.8 $ 3,486.85 I. Time for audits N/ A Subtotal Labor Burden 17,305.2 865.26 1,730.52 $ 1,588,365.30 TOTAL LABOR BURDEN AND COST 19,901 $ 1,588,365 Assumptions:

a This ICR uses the following labor rates: $ 96.41 per hour for Executive, Administrative, and Managerial labor; $ 82.74 per hour for Technical labor, and $ 42.25 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2004, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

b We have assumed that there are eighty nine respondents, and that no additional new or reconstructed sources will become subject to the rule over the next three years.

Within those eighty nine existing sources, only seventy six are subject to the emission limits in the standard. The remaining thirteen respondents are permitted as synthetic minors and therefore, are not subject to the emission limits in the standard.

c This is a one time startup costs associated with initial compliance determination and acquisition, installation, and utilization of technology and systems needed to support recordkeeping and reporting. The one time startup costs are amortized over the 15 year life of control equipment at 7 percent interest. For computational purposes, the number of occurrences per respondent per year is amortized over 15 years.

d It is assumed that report of exceedances are required semiannually.

e We have assumed that 10 percent of respondents will report exceedances.

f It is assumed that reports of no exceedances are required semiannually.

g We have assumed that 90 percent of respondents will report no exceedances.

h We have assumed that 10 percent of respondents will file startup, shutdown, malfunction report semiannually.

i Information is entered on a weekly basis. 19 j It will take 15 minutes to transmit or disclose information twice a year.

Table 2: Average Annual EPA Burden  NESHAP for Metal Coil Surface Coating Plants ( CFR part 63, subpart SSSS) ( Renewal)

Burden item ( A) Technical Person Hours Per Occurrence ( B) Number of Occurrences Per Year ( C) Technical Person Hours Per Plant Per Year ( C= AxB) ( D) Plants Per Year b ( E) Technical Hours Per Year ( E= CxD) ( F) Management Hours Per Year ( F= 0.05xE) ( G) Clerical Hours Per Year ( G= 0.1xE) ( H) Total Cost,

Per Yeara Initial performance test 495 1 495 0 0 0 0 $ 0 Repeat performance test retesting preparation 4 1 4 0 0 0 0 $ 0 Repeat performance retesting 495 1 495 0 0 0 0 $ 0 Excess Emissions Enforcement Activities 120 1 120 0 0 0 0 $ 0 Review reports Notification of applicability 2 1 2 0 0 0 0 $ 0 Notification of construction/ reconstruction 2 1 2 0 0 0 0 $ 0 Notification of anticipated startup 2 1 2 0 0 0 0 $ 0 Notification of actual startup 2 1 2 0 0 0 0 $ 0 Notification of special compliance requirements N/ A Notification of compliance status 2 1 2 0 0 0 0 $ 0 Review of initial performance test report 8 1 8 0 0 0 0 $ 0 Review of repeat performance test report 8 1 8 0 0 0 0 $ 0 Semiannual report of excess emissions d 8 2 16 7.6c 121.6 6.08 12.16 $ 5,669.11 Semiannual report of no excess emissions f 2 2 4 68.4e 273.6 13.68 27.36 $ 12,755.50 Review of NESHAP waiver application N/ A 20 Burden item ( A) Technical Person Hours Per Occurrence ( B) Number of Occurrences Per Year ( C) Technical Person Hours Per Plant Per Year ( C= AxB) ( D) Plants Per Year b ( E) Technical Hours Per Year ( E= CxD) ( F) Management Hours Per Year ( F= 0.05xE) ( G) Clerical Hours Per Year ( G= 0.1xE) ( H) Total Cost,

Per Yeara Review startup, shutdown, malfunction report 2 2 4 7.6g 30.4 1.52 3.04 $ 1,417.28 Subtotals Labor Burden and Cost 425.6 21.28 42.56 $ 19,841.89 TOTAL LABOR BURDEN AND COST ( rounded) 489 $ 19,842 Assumptions:

a This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $ 56.02 for Managerial ( GS

13, Step 5, $ 35.01 x 1.6), $ 41.57 for Technical ( GS 12, Step 1, $ 25.98 x 1.6) and $ 22.50 Clerical ( GS 6, Step 3, $ 14.06 x 1.6). These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule" which excludes locality rates of pay.

b We have assumed that there are eighty nine respondents, and that no additional new or reconstructed sources will become subject to the rule over the next three years.

Within those eighty nine existing sources, only seventy six are subject to the emission limits in the standard. The remaining thirteen respondents are permitted as synthetic minors and therefore, are not subject to the emission limits in the standard.

c We have assumed that 10 percent of respondents will report excess emissions.

d It is assumed that reports of excess emissions are required semiannually.

e We have assumed that 90 percent of respondents will report no excess emissions.

f It is assumed that reports of no excess emissions are required semiannually.

g We have assumed that 10 percent of startup, shutdown, malfunction reports will be reviewed.


currently regulated based on a NOAEL of 1.5 mg/kg/day for chronic
dietary exposure and 9 mg/kg/day for acute dietary exposure.  HED does
not believe that conducting a special series 870.7800 immunotoxicity
study will result in NOAELs less than the NOAELs of 1.5 and 9 mg//kg/day
currently identified for indoxacarb, and an additional uncertainty
factor (UFDB) for database uncertainties does not need to be applied for
the lack of an immunotoxicity study.

8.2.  Chemistry

 tc \l2 "8.2.	Chemistry

860.1200 Directions for Use

	•	The available blueberry and garden beet field trial data did not
provide results supporting the use of an adjuvant in the spray mix.
Therefore, the Section B proposed label directions should be amended to
prohibit the use of adjuvants in applications made to bushberries and
garden beets.

[It is noted that the individual bushberry commodities specified on the
proposed label directions for use did not list lingonberry, a member of
the bushberry crop subgroup 13-07B, under the crops available for
treatment. It is unclear if the omission was intentional. If desired,
lingonberry may be added to the label.]

860.1550 Proposed Tolerances

	•	A revised Section F must be submitted which consistently denotes
the bushberry crop subgroup designation as being 13-07B in their
submission proposing tolerance levels.

	•	While not germane to the petition 8E7324 (bushberry subgroup13-07B
and garden beet), a revised Section F proposing tolerances for residues
of indoxacarb in egg, and poultry meat, fat, and meat byproducts remains
outstanding.

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Appendices

Appendix 1:  Chemical Structures

Appendix 2: Rationale for Toxicology Data Requirements

 tc \l2 "8.3.	Occupational/Residential Exposure

Appendix 1:  Chemical Structures

Common Name

Chemical Name

Structure

Indoxacarb/R-indoxacarb

CAS Name:  (R,S)-Methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]am
ino]-carbonyl]indeno[1,2-e] [1,3,4]-oxadiazine-4a(3H)-carboxylate

IN-JT333

CAS Name:  Methyl
7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)-phenyl]amino]carbonyl]ind
eno-[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate

CAS Inverted Name:  Indeno-[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylic
acid, 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)-
phenyl]amino]carbonyl]-, methyl ester

5-HO-IN-JT333

CAS Name:  Methyl
7-chloro-2,5-dihydro-5-hydroxy-2-[[[4-(trifluoromethoxy)phenyl]-amino]ca
rbonyl]indeno[1,2-e]-[1,3,4]oxadiazine-4a(3H)-carboxylate

Appendix 2:  Rationale for Toxicology Data Requirements  TC \l1
"Appendix II – Rationale for Toxicology Data Requirements

Guideline Number:  870.7800

Study Title:  Immunotoxicity

Rationale for Requiring the Data

The immunotoxicity study is a new data requirement under 40 CFR Part 158
as a part of the data requirements for registration of a pesticide (food
and non-food uses).

The Immunotoxicity Test Guideline (OPPTS 870.7800) prescribes functional
immunotoxicity testing and is designed to evaluate the potential of a
repeated chemical exposure to produce adverse effects (i.e.,
suppression) on the immune system. Immunosuppression is a deficit in the
ability of the immune system to respond to a challenge of bacterial or
viral infections such as tuberculosis (TB), Severe Acquired Respiratory
Syndrome (SARS), or neoplasia.  Because the immune system is highly
complex, studies not specifically conducted to assess immunotoxic
endpoints are inadequate to characterize a pesticide’s potential
immunotoxicity.  While data from hematology, lymphoid organ weights, and
histopathology in routine chronic or subchronic toxicity studies may
offer useful information on potential immunotoxic effects, these
endpoints alone are insufficient to predict immunotoxicity.

Practical Utility of the Data

How will the data be used?

Immunotoxicity studies provide critical scientific information needed to
characterize potential hazard to the human population on the immune
system from pesticide exposure. Since epidemiologic data on the effects
of chemical exposures on immune parameters are limited and are
inadequate to characterize a pesticide’s potential immunotoxicity in
humans, animal studies are used as the most sensitive endpoint for risk
assessment.  These animal studies can be used to select endpoints and
doses for use in risk assessment of all exposure scenarios and are
considered a primary data source for reliable reference dose
calculation. For example, animal studies have demonstrated that
immunotoxicity in rodents is one of the more sensitive manifestations of
TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) among developmental,
reproductive, and endocrinologic toxicities.  Additionally, the EPA has
established an oral reference dose (RfD) for tributyltin oxide (TBTO)
based on observed immunotoxicity in animal studies (IRIS, 1997).

How could the data impact the Agency's future decision-making?

If the immunotoxicity study shows that the test material poses either a
greater or a diminished risk than that given in the interim decision’s
conclusion, the risk assessments for the test material may need to be
revised to reflect the magnitude of potential risk derived from the new
data.

If the Agency does not have these data, a 10X database uncertainty
factor may be applied for conducting a risk assessment from the
available studies.

 Maximum Application Rate = 0.11 lb ai/acre

*application rate used to calculate MOEs has been adjusted by a 4/3
factor to account for 4 parts of toxic indoxacarb for every 3 parts of
active indoxacarb.

 Units Treated taken from Science Advisory Council for Exposure,
Standard Operating Procedure 9.1, Standard Values for Daily Acres
Treated in Agriculture, Rev.  25 SEP 2001.

 Dermal Unit Exposure = mg ai/lb ai handled from the Pesticide Handler
Exposure Database (PHED), Version 1.1, August 1998. (100%)

 Inhalation Unit Exposure = mg ai/lb ai handled from the Pesticide
Handler Exposure Database (PHED), Version 1.1, August 1998. (100%)

 Dermal Dose = Dermal Unit Exposure * Application Rate * Units Treated *
Absorption Factor (dermal 100%)  Body Weight (70 kg).

 Inhalation Dose = Inhalation Unit Exposure * Application Rate * Units
Treated * Absorption Factor (inhalation 100%)  Body Weight (70 kg).

 Dermal Margin Of Exposure (MOE) = NOAEL (mg/kg/day)  ADD
(mg/kg/day); where the NOAEL = 50 mg/kg/day for all durations of  dermal
exposure

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