[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Rules and Regulations]
[Page 20431-20436]
[DOCID:fr25ap07-7]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 174 and 180

[EPA-HQ-OPP-2005-0116; FRL-7742-2]

Administrative Revisions to Plant-Incorporated Protectant
Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct Final Rule.

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SUMMARY:  EPA is taking direct final action to move existing active and
inert ingredient plant-incorporated protectant tolerance exemptions
from 40 CFR part 180, Tolerances and Exemptions from Tolerances for
Pesticide Chemicals in Food to 40 CFR part 174, Procedures and
Requirements for Plant-Incorporated Protectants, subpart W. EPA is also
making some conforming changes to the text of the individual exemptions
being transferred from part 180 so that they are consistent with part
174, as well as some minor technical corrections to the wording of
certain individual exemptions. This action is administrative in nature
and no substantive changes are made or are intended.

DATES: This Direct Final Rule is effective on July 24, 2007 without
further notice, unless EPA receives adverse comment by June 25, 2007.
If EPA receives such adverse comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.
    If this Direct Final Rule becomes effective on July 24, 2007, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. Objections and requests for
hearings must be received on or before September 24, 2007.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0116. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Mike Mendelsohn, Biopesticides and
Polllution Prevention Division (BPPD) (7511P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http:// www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR parts 174 and 180
through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0116 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before September 24, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0116, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.

II. Background

    In 2001, EPA published a final rule, establishing certain basic
parameters of its regulatory program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for a specific class of

pesticide products--plant-incorporated protectants (66 FR 37772, July
19, 2001). EPA defined these products as pesticidal substances, along
with the genetic material necessary to produce them, when produced and
used in living plants. As part of that rule, EPA changed the name of
this type of pesticide from ``plant-pesticide'' to ``plant-incorporated
protectant.'' EPA also established a new part in title 40 of the Code
of Federal Regulations (CFR) specifically for plant-incorporated
protectants (40 CFR part 174). In the same issue of the Federal
Register, EPA established a blanket tolerance exemption for all
residues of nucleic acids that are part of a plant-incorporated
protectant (PIP) (66 FR 37817, July 19, 2001). See 40 CFR 174.475.

A. What Action is the Agency Taking?

    In this Direct Final Rule, the Agency is making minor technical
changes to conform the wording of certain individual tolerance
exemptions with the above regulations. The specific technical changes
are discussed below.
    The Agency is moving some tolerance exemptions listed under 40 CFR
part 180 to 40 CFR part 174 in order to consolidate all plant-
incorporated protectant-specific regulations in the same part.
    The Agency is also making some conforming changes to the wording of
the exemptions so that they are consistent with the provisions
currently in part 174. These changes consist of revising the term
``plant-pesticides'' in these exemptions to read ``plant-incorporated
protectants'' and changing the term ``vegetative insecticidal protein''
to the more broad term ``plant-incorporated protectant.''
    Further, for these exemptions, as well as those found in newly
redesignated 40 CFR 174.501, 174.502, 174.503, 174.504, 174.505,
174.506, and 174.528 (formerly Sec. Sec.  174.452, 174.453, 174.454,
174.455, 174.456, 174.457, and 174.458, respectively), EPA is also
deleting the references to the phrase ``genetic material necessary for
its production'' and the term ``regulatory regions,'' as well as the
definitions of these terms, from individual tolerance exemptions. As
noted above, EPA established a blanket tolerance exemption for nucleic
acids, which includes the residues of genetic material necessary for
the production of pesticidal substances in living plants, and residues
of the genetic material necessary to produce any inert ingredient (40
CFR 174.475 redesignated as Sec.  174.507). Retaining the references to
the phrase ``genetic material necessary for the production of the
individual substances,'' and to ``regulatory regions'' in the text of
the individual exemptions would be wholly duplicative of redesignated
40 CFR 174.507, and has the potential to cause confusion as to the
intended scope of that provision. Accordingly, the Agency is removing
these references. These deletions will in no way affect the legal
status of such residues, given the provisions at 40 CFR 174.507.
    Similarly, inclusion of the definitions of these terms in the
individual exemptions becomes unnecessary once the exemptions are moved
to part 174, as the terms are defined at Sec.  174.3, which is
generally applicable to all regulations contained in part 174.
Moreover, the wording of the definitions varies slightly between some
of the individual tolerance exemptions. While the Agency does not
believe that there is any substantive difference between the different
formulations, to avoid any confusion, EPA has chosen to delete the
definitions from the individual tolerance exemptions. The deletion of
these definitions from the individual tolerance exemptions will in no
way affect the legal status of the residues exempted.
    Further, for these exemptions and for 40 CFR 174.451, Scope and
Purpose, redesignated as Sec.  174.500, EPA is changing the terms
``plant raw agricultural commodities,'' ``Raw agricultural
commodities,'' ``raw agricultural commodities, in food, and in animal
feeds,'' ``plant racs,'' and ``plant commodities'' to read ``food
commodities.'' While the Agency does not believe that there is any
substantive difference between the different formulations, to avoid any
confusion, EPA has chosen to use the one term ``food commodities.''
This change will in no way affect the legal status of the residues
exempted.
    EPA is changing the term ``delta-endotoxin'' to read ``Cry
protein'' and removing any subspecies designations for Bacillus
thuringiensis PIPs. The terms ``delta-endotoxin'' and ``Cry protein''
are redundant. While the Agency does not believe that there is any
substantive difference between these different formulations, to avoid
any confusion, EPA has chosen to use the one term ``Cry protein''
without a subspecies designation. This change will in no way affect the
legal status of the residues exempted.
    EPA is adding the term ``enzyme'' to descriptions of current PIP
inert ingredients to clarify the function of these proteins and to make
classification easier for the layman. While the Agency does not believe
that there is any substantive difference between these and the current
naming formulations, to clarify the function of these proteins and make
classification easier for the layman, EPA has chosen to add the term
``enzyme.'' This change will in no way affect the legal status of the
residues exempted.
    EPA is updating Bacillus thuringiensis derived plant-incorporated
protectant exemptions to conform to updated nomenclature as determined
by the Bacillus thuringiensis Pesticidal Crystal Proteins Nomenclature
Committee, a non-governmental scientific committee, http://www.biols.susx.ac.uk/home/NeilCrickmore/Bt/.
 EPA is standardizing the

tolerance exemption descriptions to list the ``residues of'' portion of
the exemption first and to list field corn, sweet corn and popcorn as
corn; corn, field; corn, sweet; and corn, pop. These changes will in no
way affect the legal status of the residues exempted.
    EPA is adding language to the exemption at Sec.  174.513
(redesignated from Sec.  180.1183), Potato Leaf Roll Virus Resistance
Gene (also known as orfl/orf2 gene), and the genetic material necessary
for its production to clarify that residues in or on all food
commodities are covered under this regulation. The phrase ``in or on
all raw agricultural commodities'' was inadvertently excluded from the
regulatory text of this exemption. However, the preamble to the rule
clearly stated the Agency's intention to exempt residues of this
product in or on all raw agricultural commodities. See 62 FR 43650,
August 15, 1997. In addition, EPA's findings and supporting analyses
concerning the safety of these residues addressed residues in or on all
raw agricultural commodities. The inclusion of the phrase ``all food
commodities'' in the individual tolerance exemption will in no way
affect the legal status of the residues covered by the regulation.
    Finally, EPA is adding language to the exemption at Sec.  174.523
(redesignated from Sec.  180.1174), CP4 Enolpyruvylshikimate-3-
phosphate (GP4 EPSPS), and the genetic material necessary for its
production in all plants to clarify that this PIP inert ingredient is a
synthase. The word ``synthase'' corresponds to the last ``S'' in ``CP4
EPSPS'' and was inadvertently excluded from the exemption. However, the
Notice of Filing (the pesticide petition) clearly stated ``synthase''
in describing the ingredient. See 60 FR 54689, October 25, 1995 (FRL-
4982-4). The inclusion of the phrase ``synthase'' in the individual
tolerance exemption will in no way affect the legal status of the
residues covered by the regulation.

    The specific tolerance exemptions that EPA is transferring from
part 180, subpart D to part 174, subpart W are identified in the
codified portion of this document. In addition to redesignating these
sections into part 174, EPA is making non-substantive changes to
terminology and for that reason the revised tolerance language that
will appear in 40 CFR part 174 appears at the end of this document as
regulatory text. While EPA believes that it has accurately transferred
each of the tolerance exemptions included in this rule, the Agency
would appreciate readers notifying EPA of discrepancies, omissions or
technical problems by submitting such comments to the address under FOR
FURTHER INFORMATION CONTACT.
    EPA is publishing this rule without prior proposal because EPA
views this as a non-controversial amendment and anticipates no adverse
comments since the changes are entirely administrative in nature. As
discussed further below, these revisions are being made merely to make
the wording of certain tolerance exemptions consistent with the wording
adopted in subsequent regulations. No changes have been made that
affect in any way the legal status of the residues covered by the
existing tolerance exemptions. All of the substantive issues reflected
in the revisions to the regulatory text previously were the subject of
notice and comments rulemaking; as no substantive changes are
contemplated by this regulation, EPA anticipates no adverse comment on
this notice. However, in the ``Proposed Rules'' section of this Federal
Register, EPA is publishing a separate document that will serve as the
proposal to these administrative revisions to plant-incorporated
protectant tolerance exemptions if adverse comments are filed. This
Direct Final Rule will be effective on July 24, 2007 without further
notice unless the Agency receives adverse comment by June 25, 2007. If
EPA receives adverse comment, EPA will publish a timely withdrawal in
the Federal Register informing the public that this rule will not take
effect. The Agency will address all public comments in a subsequent
final rule based on the proposed rule. The Agency will not institute a
second comment period on this action. Any parties interested in
commenting must do so at this time.

B. What is the Agency's Authority for Taking this Action?

    This action is being finalized under sections 408(e)(1)(B) of the
Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)(1)(B).
    Section 408(e)(1)(B) provides that the Administrator may issue a
regulation modifying an exemption of a pesticide chemical residue from
the requirement of a tolerance, 21 U.S.C. 346a(e)(l)(B). Because EPA is
making no substantive modifications to the tolerance exemptions, the
Agency has not made separate findings regarding the safety of the
individual exemptions. EPA believes that the safety standard is
applicable only where the Agency takes affirmative action to either
substantively modify the tolerance exemption, or has reviewed the
tolerance exemption and determined to leave it in effect. EPA is taking
neither action in this notice, but is merely making technical
modifications to conform the wording of the individual exemptions to
wording that is consistent with the surrounding regulations.

III. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, (58 FR 51735, October 4, 1993) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to 0MB review.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) a small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is a
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule will not impose any requirements on small entities since this
action is administrative in nature and no substantive changes are being
made.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects

40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements, Plant-incorporated protectants.

40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 12, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

0
Therefore, Title 40, chapter I of the Code of Federal Regulations is
amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a, and 371.

0
2. In the following table, the sections in the first column are
transferred to 40 CFR part 174, subpart W and redesignated as the
sections in the second column.

------------------------------------------------------------------------
                                                        Redesignated as
                     Old Section                          New section
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180.1134                                                         174.521
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180.1147                                                         174.509
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180.1151                                                         174.522
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180.1155                                                         174.510
------------------------------------------------------------------------
180.1173                                                         174.511
------------------------------------------------------------------------
180.1174                                                         174.523
------------------------------------------------------------------------
180.1182                                                         174.512
------------------------------------------------------------------------
180.1183                                                         174.513
------------------------------------------------------------------------
180.1184                                                         174.514
------------------------------------------------------------------------
180.1185                                                         174.515
------------------------------------------------------------------------
180.1186                                                         174.516
------------------------------------------------------------------------
180.1190                                                         174.524
------------------------------------------------------------------------
180.1192                                                         174.517
------------------------------------------------------------------------
180.1214                                                         174.518
------------------------------------------------------------------------
180.1215                                                         174.519
------------------------------------------------------------------------
180.1216                                                         174.525
------------------------------------------------------------------------
180.1217                                                         174.520
------------------------------------------------------------------------
180.1249                                                         174.526
------------------------------------------------------------------------
180.1252                                                         174.527
------------------------------------------------------------------------

Sec. Sec.  180.1227 and 180.1242  [Removed]

0
3. Section 180.1227 and 180.1242 are removed.

PART 174--[AMENDED]

0
4. The authority citation for part 174 continues to read as follows:

    Authority:  7 U.S.C. 136 - 136y; 21 U.S.C. 346a and 371.

Sec.  174.21  [Amended]

0
5. Section 174.21 is amended as follows:
0
i. In paragraph (b) by revising the reference ``Sec. Sec.  174.475
through 174.479'' to read ``Sec. Sec.  174.507 through 174.508.''
0
ii. In paragraph (c) by revising the reference ``Sec. Sec.  174.485
through 174.490'' to read ``Sec.  174.705.''

Sec. Sec.  174.475 and 174.479  [Redesignated as Sec. Sec.  174.507 and
174.508]

0
6. Sections 174.475 and 174.479 are redesignated as Sec. Sec.  174.507
and 174.508, respectively.

Sec. Sec.  174.480 and 174.485  [Redesignated as Sec. Sec.  174.700 and
174.705]

0
7. Sections 174.480 and 174.485 are redesignated as Sec.  174.700 and
Sec.  174.705, respectively and remain in subpart X.

0
8. Sections 174.451, 174.452, 174.453, 174.454, 174.455, 174.456, and
174.457 are redesignated as Sec. Sec.  174.500, 174.501, 174,502,
174.503, 174.504, 174.505, and 174.506, respectively, and revised to
read as follows:

Sec.  174.500  Scope and purpose.

    This subpart lists the tolerances and exemptions from the
requirement of a tolerance for residues of plant-incorporated
protectants in or on food commodities.

Sec.  174.501  Bacillus thuringiensis VIP3A protein; temporary
exemption from the requirement of a tolerance.

    Residue of Bacillus thuringiensis VIP3A protein are temporarily
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in cotton seed, cotton oil, cotton meal, cotton
hay, cotton hulls, cotton forage, and cotton gin byproducts. This
temporary exemption from the requirement of a tolerance expires May 1,
2007.

Sec.  174.502  Bacillus thuringiensis Cry1A.105 protein in corn;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1A.105 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant in the food and feed commodities of corn; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of a tolerance will permit the use of the food commodities
in this paragraph when treated in accordance with the provisions of the
experimental use permit 524-EUP-97 which is being issued under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
(7 U.S.C. 136). This temporary exemption from the requirement of a
tolerance expires and is revoked June 30, 2009; however, if the
experimental use permit is revoked, or if any experience with or
scientific data on this pesticide indicate that the tolerance is not
safe, this temporary exemption from the requirement of a tolerance may
be revoked at any time.

Sec.  174.503  Bacillus thuringiensis Cry2Ab2 protein in corn;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant in the food and feed commodities of corn; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of a tolerance will permit the use of the food commodities
in this paragraph when treated in accordance with the provisions of the
experimental use permit 524-EUP-97 which is being issued under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
(7 U.S.C. 136). This temporary exemption from the requirement of a
tolerance expires and is revoked June 30, 2009; however, if the
experimental use permit is revoked, or if any experience with or
scientific data on this pesticide indicate that the tolerance is not
safe, this temporary exemption from the requirement of a tolerance may
be revoked at any time.

Sec.  174.504  Bacillus thuringiensis Cry1F protein in cotton;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in cotton are
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in food and feed commodities of cotton.

Sec.  174.505  Bacillus thuringiensis modified Cry3A protein (mCry3A)
in corn; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry3A protein (mCry3A)
in corn are exempt from the requirement of a tolerance when used as
plant-incorporated protectant in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.

Sec.  174.506  Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in
corn; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins
in corn are exempted from the requirement of a tolerance when used as
plant-incorporated protectants in the food and feed commodities of
corn; corn, field; corn, sweet; and corn, pop.

0
9. Newly redesignated Sec. Sec.  174.509 through 174.527 are revised to
read as follows:

Sec.  174.509  Bacillus thuringiensis Cry3A protein; exemption from the
requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3A protein are exempted from
the requirement of a tolerance when used as a plant-incorporated
protectant in potatoes.

Sec.  174.510  Bacillus thuringiensis Cry1Ac protein in all plants;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ac protein in all plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

Sec.  174.511  Bacillus thuringiensis Cry1Ab protein in all plants;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ab protein in all plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

Sec.  174.512  Coat Protein of Potato Virus Y; exemption from the
requirement of a tolerance.

    Residues of Coat Protein of Potato Virus Y are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant
in or on all food commodities.

Sec.  174.513  Potato Leaf Roll Virus Resistance Gene (also known as
orf1/orf2 gene); exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the plant-incorporated protectant Potato Leaf Roll Virus
Resistance Gene (also known as orf1/orf2 gene) in or on all food
commodities.

Sec.  174.514  Coat Protein of Watermelon Mosaic Virus-2 and Zucchini
Yellow Mosaic Virus; exemption from the requirement for a tolerance.

    Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini
Yellow Mosaic Virus are exempt from the requirement of a tolerance when
used as a plant-incorporated protectant in or on all food commodities.

Sec.  174.515  Coat Protein of Papaya Ringspot Virus; exemption from
the requirement of a tolerance.

    Residues of Coat Protein of Papaya Ringspot Virus are exempt from
the requirement of a tolerance when used as a plant-incorporated
protectant in or on all food commodities.

Sec.  174.516  Coat protein of cucumber mosaic virus; exemption from
the requirement of a tolerance.

    Residues of Coat Protein of Cucumber Mosaic Virus are exempt from
the requirement of a tolerance when used as a plant-incorporated
protectant in or on all food commodities.

Sec.  174.517  Bacillus thuringiensis Cry9C protein in corn; exemption
from the requirement of a tolerance.

    The plant-incorporated protectant Bacillus thuringiensis Cry9C
protein in corn is exempted from the requirement of a tolerance for
residues, only in corn used for feed; as well as in meat, poultry,
milk, or eggs resulting from animals fed such feed.

Sec.  174.518  Bacillus thuringiensis Cry3Bb1 protein in corn;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3Bb1 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.

Sec.  174.519  Bacillus thuringiensis Cry2Ab2 protein in cotton;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in cotton is
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in the food and feed commodities, cotton seed,
cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and
cotton gin byproducts.

Sec.  174.520  Bacillus thuringiensis Cry1F protein in corn; exemption
from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in corn are exempt
from the requirement of a tolerance when used as plant-incorporated
protectants in the food and feed commodities of corn; corn, field;
corn, sweet; and corn, pop.

Sec.  174.521  Neomycin phosphotransferase II; exemption from the
requirement of a tolerance.

    Residues of the neomycin phosphotransferase II (NPTII) enzyme are
exempted from the requirement of a tolerance in all food commodities
when used as a plant-incorporated protectant inert ingredient.

Sec.  174.522  Phosphinothricin Acetyltransferase (PAT); exemption from
the requirement of a tolerance.

    Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.

Sec.  174.523  CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS)
synthase in all plants; exemption from the requirement of a tolerance.

    Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS)
synthase enzyme in all plants are exempt from the requirement of a
tolerance when used as plant-incorporated protectant inert ingredients
in all food commodities.

Sec.  174.524  Glyphosate Oxidoreductase GOX or GOXv247 in all plants;
exemption from the requirement of a tolerance.

    Residues of the Glyphosate Oxidoreductase GOX or GOXv247 enzyme in
all plants are exempt from the requirement of a tolerance when used as
plant-incorporated protectant inert ingredients in all food
commodities.

Sec.  174.525  E. coli B-D-glucuronidase enzyme as a plant-incorporated
protectant inert ingredient; exemption from the requirement of a
tolerance.

    Residues of E. coli B-D-glucuronidase enzyme are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant
inert ingredient in all food commodities.

Sec.  174.526  Hygromycin B phosphotransferase (APH4) marker protein in
all plants; exemption from the requirement of a tolerance.

    Residues of the Hygromycin B phosphotransferase (APH4) enzyme in
all plants are exempt from the requirement of a tolerance when used as
a plant-incorporated protectant inert ingredient in cotton.

Sec.  174.527  Phosphomannose isomerase in all plants; exemption from
the requirement of a tolerance.

    Residues of the phosphomannose isomerase (PMI) enzyme in plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.

0
10. Section 174.458 is redesignated as 174.528 and revised to read as
follows:

Sec.  174.528  Bacillus thuringiensis Vip3Aa20 protein; temporary
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa20 protein in corn are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities of corn;
corn, field; corn, sweet; corn, pop. This temporary exemption from the

requirement of tolerance will permit the use of the food commodities in
this paragraph when treated in accordance with the provisions of the
experimental use permit 67979-EUP-6, which is being issued in
accordance with the provisions of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary
exemption from the requirement of a tolerance expires and is revoked
March 31, 2008; however, if the experimental use permit is revoked, or
if any experience with or scientific data on this pesticide indicate
that the temporary tolerance exemption is not safe, this temporary
exemption from the requirement of a tolerance may be revoked at any
time.

[FR Doc. E7-7768 Filed 4-24-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30229-30230]
[FR Doc No: 2022-10702]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]

Assessing User Fees Under the Generic Drug User Fee Amendments of
2017; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Assessing
User Fees Under the Generic Drug User Fee Amendments of 2017.'' This
guidance provides stakeholders information regarding the implementation
of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies
and procedures surrounding its application. This guidance is finalizing
FDA's draft guidance for industry ``Assessing User Fees Under the
Generic Drug User Fee Amendments of 2017,'' published in November 2019.

DATES: The announcement of the guidance is published in the Federal
Register on May 18, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-D-0880 for ``Assessing User Fees Under the Generic Drug User
Fee Amendments of 2017.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Keith F. Verrett Jr., Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 2179, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Assessing User Fees Under the Generic Drug User Fee
Amendments of 2017.'' GDUFA II (Pub. L. 115-52, Title III), was signed
into law on August 18, 2017. GDUFA II extends FDA's authority to assess
and collect generic drug user fees from fiscal year (FY) 2018 through
FY 2022. The extension of this user fee authority under GDUFA II
continues FDA's and industry's ability to meet the goals of improving
public access to safe and effective generic drugs and enhancing the
predictability of the review process.
    The guidance announced in this notice replaces the draft guidance
for industry on ``Assessing User Fees Under the Generic Drug User Fee
Amendments of 2017,'' dated October 2019 and published in November
2019. This guidance addresses changes in user fee assessments from
GDUFA I, user fees incurred by industry under GDUFA II, payment
procedures, reconsideration and appeals, and other additional
information to assist industry in complying with GDUFA II. This
guidance also describes how FDA determines affiliation for purposes of
assessing generic drug user fees.
    FDA has reviewed the comments submitted to the docket and
determined that the comments do not require substantive changes from
the draft guidance. Clarifying language was, however, added to this
final guidance largely based on the public comments and to update the
Agency's treatment of sponsor requests for ``transfer'' of certain user
fee payments eligible for refund toward applicable user fee
liabilities.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Assessing User Fees Under the Generic Drug
User Fee Amendments of 2017.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in Form FDA 3913 (User Fee Payment Refund Request) have
been approved under OMB control number 0910-0805 and the collections of
information in Form FDA 3914 (User Fee Payment Transfer Request) have
been approved under OMB control number 0910-0805.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10702 Filed 5-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Page 88059]
[FR Doc No: 2023-27881]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2628-000]

Alabama Power Company; Notice of Authorization for Continued
Project Operation

    The license for the R.L. Harris Hydroelectric Project No. 2628 was
issued for a period ending November 30, 2023.
    Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the
Commission, at the expiration of a license term, to issue from year-to-
year an annual license to the then licensee(s) under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2628 is issued to
Alabama Power Company for a period effective December 1, 2023, through
November 30, 2024, or until the issuance of a new license for the
project or other disposition under the FPA, whichever comes first. If
issuance of a new license (or other disposition) does not take place on
or before November 30, 2024, notice is hereby given that, pursuant to
18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that Alabama Power Company is authorized to continue
operation of the R.L. Harris Hydroelectric Project under the terms and
conditions of the prior license until the issuance of a subsequent
license for the project or other disposition under the FPA, whichever
comes first.

    Dated: December 13, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-27881 Filed 12-19-23; 8:45 am]
BILLING CODE 6717-01-P


From: "Lorenzen, Thomas (ENRD)"<EMAIL_ADDRESS>Howard
Hoffman/DC/USEPA/US@EPACc: Elliott Zenick/DC/USEPA/US@EPA, "Miller,
Wendy (ENRD)"<EMAIL_ADDRESS>02/03/2012 12:00 PMSubject:
RE: Tom, can we speak to you at 2:00 today?Howard,Got your voicemail.  I
don't think I can talk with you about transitional sources outside the
inter-agency process at this point, absent some clearance which you'd
probably have to seek.  I'd probably also have to include Wendy Miller
from LPS on any such call, assuming clearance is
obtained.Tom-----Original Message-----From: Howard Hoffman
<EMAIL_ADDRESS>Sent: Friday, February 03, 2012
8:18 AMTo: Lorenzen, Thomas (ENRD)Cc: Elliott ZenickSubject: Tom, can we
speak to you at 2:00 today?Elliott and me, and possibly Patricia.Howard
J. Hoffman EPA-OGC-ARLO(202) 564-5582 (v); -5603 (fax);<PHONE_NUMBER>
(cell)The contents of this e-mail and any attachments to itmay be
attorney-client or deliberative-process privileged.From: "Lorenzen,
Thomas (ENRD)"<EMAIL_ADDRESS>Howard
Hoffman/DC/USEPA/US@EPA, "Rosen, Perry (ENRD)"
<EMAIL_ADDRESS>01/18/2012 10:28 AMSubject: Re: Quick
question:  Could the DC Circuit issue a partial           stay of a
rule, that is, stay just a particular issue in a           rule, or does
the DC Circuit either stay the entire rule or           dismis the stay
petition?  Thx.  nmI've not seen them do that, but it would seem to be
within theirequitable power to fashion relief that is as narrow as
possible,assuming they find the rule can be severed in that way.Sent
Using U.S. DOJ/ENRD BES 5 ServerFrom: Howard Hoffman
<EMAIL_ADDRESS>Wednesday, January 18, 2012
10:13 AMTo: Lorenzen, Thomas (ENRD); Rosen, Perry (ENRD)Subject: Quick
question: Could the DC Circuit issue a partial stay of arule, that is,
stay just a particular issue in a rule, or does the DCCircuit either
stay the entire rule or dismis the stay petition? Thx. nmHoward J.
Hoffman EPA-OGC-ARLO(202) 564-5582 (v); -5603 (fax);<PHONE_NUMBER>
(cell)The contents of this e-mail and any attachments to itmay be
attorney-client or deliberative-process privileged.


Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
EXECUTIVE SUMMARY
 Identification of the Information Collection  -  Title and Numbers
	Title: Notification of Chemical Exports - TSCA Section 12(b)
	EPA ICR No.: 0795.17
	OMB Control No.: 2070-0030
	Docket ID No.: EPA-HQ-OPPT-2015-0435
 Abstract
Section 12(b) of the Toxic Substances Control Act (TSCA) states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which submission of information is required under TSCA section 4 or 5(b), or for which a rule, action or order has been proposed or promulgated under TSCA section 5, 6, or 7, shall notify the EPA Administrator of such export or intent to export. The Administrator in turn will notify the government of the importing country of the notice and of EPA's regulatory action with respect to the substance.
In several regulations implementing section 12(b), EPA described the notification requirements applicable to persons exporting chemicals, including frequency of notification, covered chemicals, and content of the notification. (45 FR 82844, December 16, 1980; 58 FR 40242, July 27, 1993; 71 FR 66234, Nov. 14, 2006). These rules are codified at 40 CFR Part 707, Subpart D.
This information request is therefore considered mandatory when TSCA section 12(b) export notification requirements are prompted. The export notice must include five easily ascertainable items: the name and address of the exporter, the name of the chemical, the country of import, the date of export or intended export, and the section of TSCA under which EPA has taken action (section 4, 5, 6 or 7). There are currently over 1,000 substances or categories of substances that have been regulated or proposed to be regulated under the applicable sections of TSCA.
In an effort to reduce the information collection burden for TSCA section 12(b) export notification, EPA's Office of Pollution Prevention and Toxics (OPPT) makes available to the public on its website a list of chemical substances subject to TSCA section 12(b) export notification requirements (see "Chemicals Subject to TSCA Section 12(b) Export Notification Requirements" at: http://www.epa.gov/tsca-import-export-requirements). In addition, OPPT also makes available a comprehensive listing of the "sunset" dates for chemicals subject to TSCA section 4 actions (i.e., the dates on which the TSCA section 4 testing, reimbursement, and reporting requirements and/or TSCA section 4-triggered TSCA section 12(b) export notification requirements have terminated ("sunset") or have been calculated to sunset) (see "Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions" at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/sunset-dates-chemicals-subject-final-tsca-section-4-test). Also, to improve chemical safety and provide more streamlined access to information on chemicals, EPA continues to expand its internet accessible database, ChemView, which greatly improves access to health and safety data on chemicals regulated under TSCA. Among other things, ChemView includes the list of chemicals subject to TSCA section 12(b) export notification requirements. The 12(b) list in ChemView is routinely updated as new actions require additions to the list and as chemicals are removed from the list when the regulatory action that triggered the section 12(b) requirement expires (sunsets).
EPA believes that the 12(b) list and sunset table serve as useful tools to assist industry in complying with TSCA and have resulted in an overall reduction of the information collection burden.
 Summary Total Burden and Costs
Estimate for
Burden
(hours)
Costs
(Dollars)
Respondent:

Per response burden and costs:
0.62
$38.57
Total estimated number of potential respondents:
266
n/a
Total estimated average number of responses for each respondent:
18
n/a
Total estimated annual number of responses:
4,788
n/a
Total estimated annual burden & costs:
2,968
$184,690[(a)]
Agency:

Total estimated annual burden and costs:
937
$106,760
[(a) Includes estimated cost for capital investment or maintenance and operational costs.]
This ICR renewal's estimate reflects a slight increase in respondent burden of 34 hours from that which is currently approved (i.e., 2,934 to 2,968 hours). This is a net increase in burden caused by assuming 100% electronic submissions despite a small increase in burden due to a larger number of respondents compared to the previous ICR.

Supporting Statement
   Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.
 This information collection is necessary to implement statutory requirements of export notification pursuant to section 12(b) of TSCA and is consistent with the requirements of 5 CFR 1320.6.
TSCA section 12(b) requires exporters to submit a notice to EPA for each country to which a chemical subject to TSCA section 12(b) requirements is exported. Specifically, TSCA section 12(b) states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which submission of information is required under TSCA section 4 or 5(b), or for which a rule, action or order has been proposed or promulgated under TSCA section 5, 6, or 7, shall notify the EPA Administrator of such export or intent to export. The Administrator in turn will notify the government of the importing country of the notice and of EPA's regulatory action with respect to the substance. See Attachment 1 for 15 U.S.C. 2611(b).
Regulations implementing the statutory mandate in TSCA section 12(b) appear in 40 CFR Part 707, Subpart D, and include the following additional provisions:
 No notice of export will be required for articles, except polychlorinated biphenyl (PCB) articles, unless the Agency so requires in the context of individual TSCA section 5, 6, or 7 actions.
 Any person who exports or intends to export PCBs or PCB articles, for any purpose other than disposal, shall notify EPA of such intent or exportation under TSCA section 12(b). PCBs and PCB articles are defined at 40 CFR 761.3.
 Any person who would be prohibited by a TSCA section 5 or 6 regulation from exporting a chemical substance or mixture, but who is granted an exemption by EPA to export that chemical substance or mixture, shall notify EPA under TSCA section 12(b) of such intent to export or exportation.
 An exporter will be subject to possible enforcement action (including penalties) for not complying with the applicable provisions of TSCA section 12(b).

 The full text of 40 CFR part 707 is provided in Attachment 2.
   Indicate how, by whom, and for what purpose the information is to be used.  Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection
As required by TSCA section 12(b), the Administrator will use the information collected under this ICR to furnish the required notice to the government of the importing country. The importing country typically uses the information provided to ensure that chemicals imported into their country comply with their applicable laws and regulations.
   Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
 TSCA section 12(b) export notifications are received by EPA's Program Management Operations Division (PMOD) within Office of Pollution Prevention and Toxics (OPPT). PMOD notifies appropriate foreign governments of the export of the specific TSCA-regulated chemicals to their country in accordance with the requirement in TSCA section 12(b) and the regulations at 40 CFR part 707, Subpart D.
12(b) export notification must be submitted to the Agency's in electronic information reporting system designed to be a user-friendly interface for parties engaged in reporting under TSCA section 12(b). The modernization of the TSCA section 12(b) export notification process enables electronic reporting for TSCA section 12(b), which greatly reduces the burden on industry to submit the paper section 12(b) notifications and on OPPT in the processing of paper submissions per the recently finalized Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (June 7, 2023 88 FR 37155 (FRL-8223-02-OCSPP)).
To file electronically, submitters must use the EPA provided application. To access the application, users must register with EPA's Central Data Exchange (CDX). CDX is the Agency's portal for submitting information to EPA in a secure manner. When registering, a user will need to ensure they are registering for the Chemical Safety and Pesticide Programs (CSPP) data flow which will provide them access to the Chemical Information Submission System (CISS) where the TSCA section 12(b) can be accessed. (Note: Users who have previously registered with CDX are able to add "Submission for Chemical Safety and Pesticide Program (CSPP)" to their current registration.) This reporting tool is compatible with Windows, Mac, Linux, and UNIX based computers, and uses "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet.
   Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.
 The exporter submits one notice to EPA. There is no duplication of this mandate or collection activity, and there are no viable alternate sources for the Agency to obtain the information necessary to satisfy the statutory mandate.

 The Agency carefully considered alternatives to imposing a notification requirement on the chemical exporters, but no viable alternate sources were identified that would accomplish what the statute requires or provide the required information as specified in the statute. Prior to promulgating the TSCA section 12(b) rule, EPA considered the possibility of using export data gathered by the U.S. Census Bureau in lieu of imposing notification requirements in a TSCA section 12(b) rule. However, several problems with the Census export data continue to make such an approach impractical. These problems include, among others, the fact that Census data are often not chemical-specific; Census exempts certain shipments and exporters that are not exempt from TSCA section 12(b) notifications; and Census data would not be available for up to eight weeks following export, a delay that would prevent EPA from providing an importing government the timely notice required by TSCA section 12(b).
 In addition, the Agency's activities are not duplicative of any other agency's actions. Importing countries do not receive such notifications from any other sources.
   If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.
TSCA section 12(b) does not exempt small businesses. However, most reporting has been by large companies which do most of the exporting. All reporting is assumed to be electronic. The burden on any exporter is relatively minimal, estimated at 12 hours with an associated cost of approximately $817 per firm.
   Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
 In general, there are basically two collection schedules related to the TSCA section 12(b) export notification requirements, i.e., a one-time collection and an annual collection. On an annual basis, excluding TSCA section 4 chemicals, and certain TSCA section 5 chemicals, an exporter must submit only one TSCA section 12(b) notice for each country to which a chemical subject to TSCA section 12(b) is exported. For TSCA section 4 chemicals, and certain TSCA section 5 chemicals, an exporter must only submit one TSCA section 12(b) notice for the first export or intended export of a subject chemical to a particular country.
 The collection methodology is event-based, i.e., the exporter's decision to export a chemical subject to TSCA section 12(b). With the exception of TSCA section 4 chemicals, and certain TSCA section 5 chemicals, an exporter must submit, on an annual basis, one TSCA section 12(b) notice for each country to which a chemical subject to TSCA section 12(b) is exported. For TSCA section 4 chemicals, and certain TSCA section 5 chemicals, an exporter must only submit a TSCA section 12(b) notice for the first export or intended export to a particular country. The TSCA section 12(b) notice may be submitted to EPA within seven days after the exporter accepts a definite contractual obligation or no later than the date of export.
 If the collection of information was conducted less frequently, the statutory requirements would not be met.
   Explain any special circumstances that require the collection to be conducted in a manner:
requiring respondents to report information to the agency more often than quarterly;
requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
requiring respondents to submit more than an original and two copies of any document;
requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
Not applicable.
   Not applicable. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.
    Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
    Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.
Pursuant to 5 CFR 1320.8(d), EPA will publish a notice in the Federal Register, announcing the planned renewal of this information collection activity, soliciting public comment on specific aspects of the ICR and providing a 60-day public comment period.
In addition to the public notice that EPA will publish in the Federal Register concerning the renewal of this ICR, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR. A summary of the full consultation will be provided in Attachment 3.

   Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
Not applicable.
   Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.
 The exporter may claim all or part of a TSCA section 12(b) export notice confidential. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended section 14 of TSCA and requires the exporter to substantiate and certify claims of confidentiality unless the information claimed confidential is exempt from the substantiation requirements under TSCA section 14(c) through CDX see Attachment 4
 EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA and 40 CFR part 703. Information submitted under specific reporting requirements of TSCA, or in support of TSCA, is subject to the provisions of section 14 of TSCA and to EPA's Regulations on the Confidentiality of Business Information (see 40 CFR 703). Failure to follow these procedures fully at the time of document submission to EPA is interpreted by the Agency as a waiver of confidentiality claims. Submitters may claim confidentiality for proprietary information. However, notwithstanding any claim of confidentiality, the foreign government of the importing country will be notified of the export of the substance(s) in question.
   Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108.
   Provide estimates of the hour burden of the collection of information. The statement should:
 Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under `Annual Cost to Federal Government'.
 Respondents to this collection are exporters of chemical substances, which are mostly chemical companies classified under the North American Industrial Classification System (NAICS) codes 325 and 324. Exporters are required to include the following information in their export notification:
 the name and address of the exporter;
 the name of the chemical;
 the country of import;
 the date of export or intended export; and
 the TSCA section 4, 5, 6 or 7 action that triggers the notice.

 In providing the required TSCA section 12(b) export notification, the respondent (exporter) is likely to engage in the following activities:
 Compile and maintain a list of chemical products manufactured by the company that are also subject to a TSCA section 4, 5, 6 or 7 action (e.g., compare the list of their chemicals to be exported with EPA's list of TSCA section 12(b) chemicals subject to export notification);
 Check this list against outgoing orders to determine if a product/chemical on the list is expected to be exported to a customer outside of the U.S.;
 If it is, identify whether a TSCA section 12(b) notice is required (e.g., is it the first shipment to that country this year); and
 If product/chemical is on the list and a TSCA section 12(b) notice is required to be completed the required export notice be sent via EPA's CDX system within the required time period.
The burden to exporters of this information collection activity comprises the time required to perform the steps outlined in this section of this document. The burden to respondents of this information collection activity comprises the time required to perform the steps outlined above.

A notice is a package received by the EPA from one firm. A firm may submit more than one notice per year. Each notice may contain several chemicals and/or importing countries. A notice subsequently becomes a letter of notification that EPA issues to the government of the importing country.

Ever since a change in reporting requirements published on November 14, 2006, there has been a one-time notification requirement for exporters of chemical substances or mixtures. In addition, the change required the Agency to notify foreign governments after it receives the first export notification from an exporter. The shift to one-time-only export notification in the amendments affected almost all notifications received under TSCA section 5 (EPA, 2006). Note that EPA also promulgated de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required.

For the purposes of this ICR, based on best available information, EPA assumes that the level of reporting will be consistent with that of the last ICR period. The only important change in the current ICR period compared to the last ICR period is a change in mode of reporting - all reporting during this ICR period is assumed to be electronic.  Table 1 presents the level of reporting over the current ICR period. Based on the reporting over the current ICR period, EPA estimates that 226 firms will respond per year. Table 2 presents the unit burden by activity. The activities involved and calculation details are listed below. EPA estimates the total annual burden at 2,694 hours.

Compile List. Since this information collection activity has been in place for 20 years, most respondents will have already developed a list of their products subject to TSCA section 12(b) reporting.  Respondents need only check for new regulations promulgated and any new products exported by the firm.  EPA estimates that respondents will carry out this activity only once per year. Updating the list is estimated to take an average of one hour of technical time (which may also include some proportion of legal time).  This could vary depending on the number of products from two hours per year up to two hours per month of technical time (which may also include some proportion of legal time).  This variation is dependent on the number of products exported by the firm and the number of their products subject to TSCA section 12(b). EPA estimates unit burden for compiling the list estimated at an average of 9.3 hours of technical time per firm per year.

 Write or Revise Letter.  Firms that export chemicals subject to TSCA section 12(b) reporting must prepare an export notice to send to EPA.  EPA estimates that respondents will carry out this activity once per year. EPA expects that the time needed for initial preparation of the export notice probably varies depending on whether the firm has prior experience with this program, but this step is estimated to take an average of one hour of technical time (which may also include some proportion of legal time) per year for each firm subject to TSCA section 12(b) reporting.
 CBI Substantiation. Firms are required to provide CBI substantiation for any claims of data confidentiality. When estimating this burden, EPA accounts for the burden associated with the substantiation of ChemID and non-ChemID claims. CBI substantiation for ChemID elements involves providing answers to questions concerning reasons that CBI status of chemical substance is to be maintained. CBI substantiation for ChemID claim is estimated to take 1.15 hours per report, including both technical and managerial time (EPA, 2017; EPA, 2019). A firm will claim CBI for ChemID elements when submitting a chemical that is not included in the 12(b) list. Approximately two percent of submissions include chemicals that are not listed, and as a result, include ChemID claims. Therefore, when estimating the burden per firm associated with ChemID claims, the burden of 1.15 hours is scaled by two percent. Firms are required to provide CBI substantiation for non-ChemID data elements, which is estimated to take 0.96 hours per report, including both technical and managerial time (EPA, 2017). Based on the previous ICR period, approximately seven percent of submissions claimed CBI for non-ChemID elements. Therefore, when estimating the burden per firm associated with non-ChemID claims, the burden of 0.96 hours is scaled by seven percent. Assuming each firm submits 18 reports per year, the total burden associated with CBI substantiation is estimated to be 1.62 hours per year per firm.
Check Orders and Send Notices.  The firms that export chemicals subject to TSCA section 12(b) reporting must check outgoing shipments against the list of their products described above.  A form letter notifying EPA is electronically prepared detailing the importing country for the shipment of a TSCA section 12(b) chemical if it is the first shipment of the year to the importing country. This whole process is assumed to have no time burden as it is absorbed in the efficiencies of e-reporting overall. EPA estimates each firm will submit approximately 18 reports per year. Therefore, the agency expects to receive a total of 4,034 notices per year.

TABLE 1: REPORTING IN PREVIOUS ICR PERIOD BY YEAR

Year
Number of Firms
Reports
Report per Firm
Number of Reports Claiming CBI
Percent of Reports Claiming CBI
2020
219
4,423
20.20
368
8.32%
2021
251
4,114
16.39
239
5.81%
2022
209
3,565
17.06
272
7.63%
Average
226
4,034
17.85
293
7.25%

TABLE 2: UNIT BURDEN PER ACTIVITY

Activity
Electronic Reporting (hours)

Technical
Managerial
Clerical
Compile list
9.3
0
0
Write letter
1
0
0
Check order and send notice
0
0
0

Table 2 provides the estimated unit burden per reporting activity.  Firms are required to provide CBI substantiation for any claims of data confidentiality. The burden associated with CBI substantiation is compromised of the time required to substantiate ChemID and non-ChemID claims. This estimate takes into account the expectation that each firm will submit 18 reports per year. It also accounts for the expectation that approximately two percent of reports will include ChemID claims and approximately seven percent of reports submitted will include non-ChemID claims. Therefore, the annual burden per firm associated with CBI substantiation is estimated by:
		                	    Number             ChemID                  Non-ChemID
			               of Reports	     Element	       	   Element
CBI Substantiation Burden=       18       x      0.02  x  1.15    +   0.07  x  0.96=1.62 hours.
         (per firm)
Given a 100 percent e-reporting rate, the annual burden per firm is estimated by:
                                                                                Check order                   CBI
	                   Compile list     Write letter           and send notice      Substantiation
Annual burden=     9.3      +                    1         +              0                               1.62          =11.92 hours.
Therefore, the annual aggregate burden across all 226 firms is estimated by:
  Annual Aggregate  Burden=  226           x          11.92= 2,694 hours.
The annual burden per firm is estimated to be 11.92 hours and the annual aggregate burden is estimated to be approximately 2,694 hours.
The costs to respondents are based on the time needed to complete the tasks listed in section 3 (hours estimated in section 6(a)), the hourly cost of labor at appropriate levels (labor rates), the number of firms affected, and/or the number of notices generated.

EPA estimates annual cost for e-reporting in Table 4. Based on an expected e-reporting rate of 100 percent, the annual aggregate cost is estimated to be approximately $184,690.

TABLE 3: INDUSTRY WAGE RATES (2022$)

                                Labor Category
                                 Data Series 1
                                     Wage
                                Fringe Benefit
                               Fringes as % Wage
                             Over-head % wage [2]
                         Fringe + Overhead Factor [3]
                            Hourly Loaded Wages [4]

                                      (a)
                                      (b)
                                 (c) =(b)/(a)
                                      (d)
                                 (e)=(c)+(d)+1
                                 (f)=(a)x(e)
Managerial
BLS ECEC, Private Manufacturing industries, "Mgt, Business, and Financial"
                                    $53.46
                                    $23.97
                                      45%
                                      17%
                                     1.62
                                    $86.61
Professional / Technical
BLS ECEC, Private Manufacturing industries, "Professional and related"
                                    $42.04
                                    $18.41
                                      44%
                                      17%
                                     1.61
                                    $67.68
Clerical
BLS ECEC, Private Manufacturing industries, "Office and Administrative Support"
                                    $20.97
                                    $9.13
                                      44%
                                      17%
                                     1.61
                                    $33.76
[1] Source: Employer Costs for Employee Compensation Supplementary Tables. (U.S. BLS, 2022).
[2] An overhead rate of 17% is used based on assumptions in Wage Rates for Economic Analysis of the Toxics Release Inventory Program( Rice,2002),and the Revised Economic Analysis for the Amended Inventory Update Rule:Final Report (U.S.EPA, 2002).
[3] The inflation factor of "1" in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation
[4] Wage data are rounded to the closest cent in this analysis.

TABLE 4: ANNUAL COST PER FIRM FOR ELECTRONIC REPORTING (2022$)

Activity
Number of Hours
Percentage of Submissions
Cost
Compile list
9.3 (technical)
100%
$629.42
Write letter
1 (technical)
100%
$67.68
Check order and send notice (e-reporting)
0
100%
$0
CBI Substantiation
(ChemID) 1
0.77 (technical)

+
0.38 (managerial)
2%
$30.61
CBI Substantiation
(non-ChemID)[2]
0.64 (technical)

+
0.32 (managerial)
7%
$89.50
Total Annual Cost Per firm
$817.21
Values may not sum due to rounding.
[1]The estimated burden associated with CBI substantiation for ChemID claims consists of 0.77 hours of technical time and 0.38 hours of managerial time. Burden estimates are based on the expectation that each firm will submit 18 reports per year and that 2% of reports will claim CBI for a ChemID element.
[2]The estimated burden associated with CBI substantiation for non-ChemID claims consists of 0.64 hours of technical time and 0.32 hours of managerial time. Burden estimates are based on the expectation that each firm will submit 18 reports per year and that 7% of reports will claim CBI for non-ChemID elements.

Given a 100 percent e-reporting rate, the annual cost per firm is estimated to be $817.21. Therefore, the annual aggregate cost across all 226 firms is estimated by
        Annual Aggregate Cost=      226      x     $ 817.21  =$184,690.

   Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
There are no O&M costs associated with the collection.
   Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.
Agency unit costs are based on past TSCA section 12(b) analyses, including the previous ICR, and information provided by . The Agency cost can be divided into four parts: (1) receiving and processing incoming notices, (2) preparing and mailing notifications to importing countries, (3) responding to requests for information and clarification from firms and importing countries, and (4) reviewing CBI claim substantiation. The allocation of burden hours and costs among these four parts is not exact, but the analysis below is reasonably accurate in terms of the overall burden estimate and the approximate allocation of that burden among these tasks. EPA presents activity descriptions followed by a summary of Agency costs in Table 8. The total annual Agency cost estimated at $106,760.

TABLE 6: AGENCY WAGE RATE (2023$)

                                Labor Category
                       Data Source for Wage Information
                                 Wage ($/hour)
                                Fringe Benefit
                               Fringes as % wage
                              Overhead as % wage
                           Fringe + Overhead Factor
                              Loaded Wage ($/hr)

                                      (a)
                                      (b)
                                (c) = (b) / (a)
                                      (d)
                              (e) = (c) + (d) + 1
                                (f) = (a) * (e)
EPA staff
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates [1]
                                    $60.83
Included in 60% overhead
                                      N/A
                                    60% [2]
                                      1.6
                                    $97.33

[1] Source: U.S. Office of Personnel Management. (2023). Salary Table 2023-DCB. Retrieved March 6, 2023 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salarytables/23Tables/html/DCB_h.aspx.
[2]The 60 percent fringes-and-overhead rate is from an EPA guide, Instructions for Preparing ICRs (U.S. EPA, 2009).

Task 1: Receiving and processing incoming notices. In the first task, notices are received from firms that intend to export a product covered by this rule, the forms are checked for completeness, and the submissions are logged into a document control system.  Based on conversations with the workers responsible for this task, about 10 notices can be processed per hour.  EPA projects that an average of 4,034 notices (as estimated in section 6(a)) will be received per year over the period covered by this ICR, requiring 403.4 hours of support per year.
Task 2: Preparing and mailing notifications to importing countries.  In the second task, workers prepare letters of notification which are subsequently reviewed and sent out to importing countries.  Not all notifications submitted require that a notice be sent out.  This work averages approximately 0.19 hours per notice.  Based on information provided by PMOD, EPA estimates an average of 1,618 notification letters mailed each year.  This yields a burden of 307.42 hours per year.
 Task 3: Responding to requests for information and clarification from firms and importing countries.  The burden described above covers the routine tasks of handling both incoming notices and outgoing notifications.  Some notices sent to importing countries require a follow-up response. Based on information provided by PMOD, the work of responding to non-routine requests for information and clarification from industry and importing countries, and handling other tasks associated with the TSCA section 12(b) program can be expected to require about 54 hours per year.
 Task 4: Review of CBI Claim Substantiation. In the fourth task, any submissions that claim CBI must be reviewed. Electronic submissions are completed by filling out a form. Review of the form for a non-ChemID claim requires 0.25 hours per report. It is expected to take 1.25 hours per report to review CBI claim substantiation that includes a ChemID claim. The estimated Agency burden to review CBI claim substantiation takes into account the expectation that each firm will submit 18 reports per year and that approximately two percent of submissions will include ChemID claims and approximately seven percent of reports submitted will include non-ChemID claims.
TABLE 7: AGENCY CBI SUBSTANTIATION REVIEW BURDEN PER REPORT

Type of Claim
Agency Burden per Report

Electronic Reporting (hours)
ChemID
1.25
Non-ChemID
0.25

 Table 7 displays the Agency burden associated with reviewing ChemID and non-ChemID claims for e-reporting, which are used to calculate the average burden per report.
The Agency burden associated with reviewing CBI claim substantiation for an electronically submitted report is estimated by:

					       	        ChemID	        Non-ChemID
						         Element		Element
Review ofCBI Substantiation Burden =0.02  x  1.25 + 0.07  x 0.25=0.043 hours.
            per electronically submitted report

 Therefore, given an expected 4,034 reports per year and a e-reporting rate of 100 percent, the total Agency burden associated with reviewing CBI claim substantiation is estimated to be 173 hours per year.
TABLE 8: AGENCY ACTIVITIES, ANNUAL BURDEN AND COST (2023$)

                                Agency Activity
                                  Unit Burden
                                     Count
                                 Burden Hours
                                     Cost

                                     Labor
                                   Non-labor
Receiving and Processing Incoming Notices
                      0.1 hour per notice processing rate
                                     4,034
                                      403
                                    $39,263
                                       -
Mailing Notifications to Importing Countries
                          0.19 hour per letter mailed
                                     1,618
                                      307
                                    $29,921
                                       -

                            $26  per certified mail
                              $0.54 per USPS mail
                                 572 certified
                                  1,047 USPS
                                      N/A
                                       -
                                    $15,437
Responding to Requests for Information and Clarification from Firms
                                      N/A
                        54 hours of staff time per year
                                      54
                                    $5,256
                                       -
Review of CBI Claim Substantiation
                     0.043 hour per notice reviewing rate
                                     4,034
                                      173
                                    $16,883
                                       -
Total Burden and Cost
                                   937 hours
                                   $106,760
Values may not sum due to rounding.

   Explain the reasons for any program changes or adjustments reported in hour or cost burden.
This ICR renewal's estimate reflects a slight increase of 34 hours from 2,934 to 2,968 hours in respondent burden. This is a net increase in burden caused by assuming 100% electronic submissions despite a small increase in burden due to a larger number of respondents compared to the previous ICR.
This ICR renewal's estimate reflects an increase of 94 hours in agency burden from 843 hours to 937 hours. This increase is due to the difference in information related to agency burden provided by OPPT PMOD for the current ICR period compared to the information provided by Information Technology and Resources Management Division (ITRMD) within EPA's Office of Program Support (OPS) for the previous ICR period. PMOD started processing the export notifications for TSCA 12(b) rule instead of OPS IMD after a reorganization in 2019.
   For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
Not applicable.
   If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.
Not applicable.
   Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act Submissions."
EPA does not request an exception to the certification of this information collection.
Supplemental Information
 This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0030). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR Part(s) 707. An 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. The public reporting and recordkeeping burden for this collection of information is estimated to be 0.62 hour(s) per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address."
 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 EPA-HQ-OPPT-2015-0435, which is available for online viewing at www.regulations.gov.
List of Attachments
The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2015-0435.
Ref.
Title
1.
15 U.S.C. 2611
2.
40 CFR 707, Subpart D
3.
PRA Consultation Document [Placeholder]
4.
CBI Substantiation EPA Form 9600-031

References
Rice, C. (2002). Wage Rates for Economic Analysis of the Toxic Release Inventory
      Program. Washington, D.C.: U.S. EPA, Office of Pollution Prevention and Toxics, Economics and Policy Analysis Branch.

U.S. Bureau of Labor Statistics (2019). Employer Costs for Employee Compensation (ECEC) Supplemental Tables: December 2006 to March 2019, US Bureau of Labor Statistics, September 17, 2019.

U.S EPA. (2006). Final Economic Analysis of the Amendments to TSCA Section 12(b)
      Export Notification Requirements. Washington, D.C.: Office of Pollution Prevention and Toxics, Economics and Policy Analysis Branch.

U.S. EPA, (2009). ICR Handbook EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Revised 10/2009 Washington, D.C.: U.S. EPA, Office of Environmental Information.

U.S. EPA. (2017). Burden and Cost Report for the Final Rule: TSCA Inventory
      Notification Requirements. Docket Number EPA-HQ-OPPT-2016-0426 (August 11, 2017).

U.S. EPA. (2023). Economic Analysis for the Final Rule: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (April 2, 2023).

U.S. Office of Personnel Management. (2018). Salary Table 2018- DCB, Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Retrieved September 18, 2019 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/DCB.pdf.

U.S. Postal Service (2018). Price List. Notice 123. Retrieved September 17, 2019	from:https://pe.usps.com/Archive/PDF/DMMArchive20181105/Notice123.pdf.