[Federal Register: November 19, 2007 (Volume 72, Number 222)]
[Notices]
[Page 65126-65127]
[DOCID:fr19no07-117]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Eleventh Meeting: RTCA Special Committee 203/Minimum Performance
Standards for Unmanned Aircraft Systems and Unmanned Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION:  Notice of RTCA Special Committee 203, Minimum Performance
Standards for Unmanned Aircraft Systems and Unmanned Aircraft.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 203, Minimum Performance Standards
for Unmanned Aircraft Systems and Unmanned Aircraft.

DATES: The meeting will be held December 11-13, 2007.
    Times: December 11th from 9 a.m.-5 p.m., December 12th from 9 a.m.-
5 p.m., December 13th from 9 a.m.-3 p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1828 L Street, NW.,
Suite 805, Washington, DC 20036. Point of Contact: Rudy Ruana;
Telephone:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
    Note: Workgroup 1 breakout sessions will take place at SAIC,
located at 400 Virginia Ave., SW., Ste 800 and 525 School Street,
4th Floor, Washington, DC 20024; Metro: L'Enfant Plaza; Dress is
Business Casual; Workgroup meetings on December 13th may go on until
5 p.m.

FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street,
NW., Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 203 meeting. The agenda will
include;
     December 11:
     Opening Plenary Session (Welcome and Introductory Remarks,
Approval of Eleventh Plenary Summary).
     Approval of Eleventh Plenary Summary.
     Presentations to the Plenary.
     Work plan status and review.
     Workgroup 1 status.
     Workgroup 2 status.
     Workgroup 3 status.
     Plenary Adjourns.
     Workgroups 1, 2, and 3 Breakouts.
     December 12:
     Workgroups 1, 2, and 3 Breakouts.
     December 13:
     Workgroups 1, 2, and 3 Breakouts.
     Plenary Reconvenes.
     Closing Plenary Session (Other Business, Date, Place and
Time of Next Plenary, Adjourn).
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FUTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on November 5, 2007.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 07-5721 Filed 11-16-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 73009-73011]
[FR Doc No: 2021-27821]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93818; File No. SR-NYSEArca-2021-91]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change To Amend Rule 6.87-O

December 17, 2021.

I. Introduction

    On October 20, 2021, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Rule 6.87-O (``Nullification and
Adjustment of Options Transactions including Obvious Errors''). The
proposed rule change was published for comment in the Federal Register
on November 4, 2021.\3\ This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 93472 (October 29,
2021), 86 FR 60926 (``Notice''). Comments received on the proposal
are available on the Commission's website at: https://www.sec.gov/comments/sr-nysearca-2021-91/srnysearca202191.htm.
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II. Description of the Proposed Rule Change

A. Background

    Pursuant to Rule 6.87-O, when reviewing an options transaction as
potentially erroneous, the Exchange needs to determine the
``Theoretical Price'' of the option, i.e., the Exchange's estimate of
the correct market price for the option. If the applicable option
series is traded on at least one other options exchange, then the
Theoretical Price of an option series is generally the last national
best bid (``NBB'') just prior to the trade in question with respect to
an erroneous sell transaction or the last national best offer (``NBO'')
just prior to the trade in question with respect to an erroneous buy
transaction.\4\ However, there may be situations where the NBB or NBO
is not available or may not be reliable. Specifically, under Rule 6.87-
O(b)(1)-(3), these situations occur when there are no quotes or no
valid quotes for comparison purposes, when the NBBO is determined to be
too wide to be reliable, and at the open of each trading day. In each
of these circumstances, because the NBB or NBO is not available or is
deemed to be unreliable, the Exchange determines Theoretical Price.\5\
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    \4\ See Rule 6.87-O(b).
    \5\ This includes at times the use of a singular third-party
vendor, known as a TP Provider (currently CBOE Livevol, LLC). See
Notice, supra note 3, at 60926.
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    Under Rule 6.87-O(c), the Exchange determines whether an obvious
error has occurred by comparing the execution price of the transaction
with the Theoretical Price.\6\ If the execution price is determined to
be higher or lower than the Theoretical Price by a minimum amount, as
described in Rule 6.87-O(c)(1), the Exchange will either adjust or bust
the transaction as provided for by Rule 6.87-O(b)(4).
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    \6\ See Rule 6.87-O(c)(1).
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    Following discussions with other exchanges and a cross-section of
industry participants and in coordination with the Listed Options
Market Structure Working Group (``LOMSWG'') (collectively, the
``Industry Working Group''), the Exchange proposes: (1) To amend Rule
6.87-O(b)(3) to permit the Exchange to determine the Theoretical Price
of a customer option transaction in a wide market so long as a narrow
market exists at any point during the 10-second period after an opening
or re-opening; and (2) to amend Rule 6.87-O(c)(4)(B) to adjust, rather
than nullify, customer transactions in obvious error situations,
provided the adjustment does not violate the limit price. According to
the Exchange, other options exchanges will also submit substantively
identical proposals to the Commission following approval of this
proposal.\7\
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    \7\ See Notice, supra note 3, at 60926.
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B. Rule 6.87-O(b)(3)

    Pursuant to Rule 6.87-O(b)(3), the Exchange will determine the
Theoretical Price if the NBBO for the subject series is wide
immediately before execution and a narrow market (as set forth in the
rule) existed during the ten seconds prior to the transaction. Rule
6.87-O(b)(3) further specifies that, should there be no narrow quotes
during the ten seconds prior to the transaction, the Theoretical Price
for the affected series will be the NBBO that existed at the time of
execution (regardless of its width).\8\ The Exchange observes, however,
that in the first seconds of trading, there is no 10-second period
``prior to the transaction.'' \9\ According to the Exchange, the
Industry Working Group has further observed that prices in certain
series can be disjointed at the start of trading.\10\ Accordingly, the

Exchange proposes to amend Rule 6.87-O(b)(3) to address trading in
certain circumstances immediately after the opening before liquidity
has had a chance to enter the market by allowing the Exchange to
determine the Theoretical Price in a wide market so long as a narrow
market exists at any point during the 10-second period after an opening
or re-opening.
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    \8\ See also id. at 60927.
    \9\ See id.
    \10\ See id.
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    The proposed rule change would also better harmonize section (b)(3)
with section (b)(1) of the Rule. Under section (b)(1), the Exchange is
permitted to determine the Theoretical Price for transactions occurring
as part of the opening auction process (as defined in Rule 6.64-O) if
there is no NBB or NBO for the affected series just prior to the
erroneous transaction. In contrast, under the current version of
section (b)(3), the Exchange would not be able to determine the
Theoretical Price for the trade occurring during core trading. Thus, if
an erroneous trade occurs on the Exchange during the 10-second period
immediately following an opening or reopening, and an erroneous trade
occurs on another exchange as a part of its opening auction during the
first 10 seconds of trading, the trade on the other exchange could be
submitted for review under (b)(1) and only that exchange would be able
to determine the Theoretical Price. Under the current version of
section (b)(3), the Exchange would not be able to determine the
Theoretical Price because the erroneous transaction occurred during the
first 10 seconds of core trading and not as a part of the opening
process. Under the proposed rule change, however, both trades would be
entitled to the same review regarding the same Theoretical Price based
upon the same time.\11\
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    \11\ See Notice, supra note 3, at 60928.
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    Pursuant to the proposed rule change, the Exchange would determine
the Theoretical Price if the bid/ask differential of the NBB and NBO
for the affected series just prior to the Customer's erroneous
transaction was equal to or greater than the minimum amount set forth
in proposed Rule 6.87-O(b)(3)(A) \12\ and there was a bid/ask
differential less than the minimum amount during the 10 seconds prior
to the transaction.\13\ If there was no bid/ask differential less than
the minimum amount during the 10 seconds prior to the transaction, then
the Exchange would determine the Theoretical Price if the bid/ask
differential of the NBB and NBO for the affected series just prior to
the Customer's erroneous transaction was equal to or greater than the
minimum amount set forth in proposed Rule 6.87-O(b)(3)(A) and there was
a bid/ask differential less than the minimum amount anytime during the
10 seconds after an opening or re-opening.\14\ If there was no bid/ask
differential less than the minimum amount during the 10 seconds
following an opening or re-opening, then the Theoretical Price of an
option series would be the last NBB or NBO just prior to the customer
transaction in question, as set forth in Rule 6.87-O(b).\15\ Customer
transactions occurring more than 10 seconds after an opening or re-
opening would continue to be subject to proposed Rule 6.87-
O(b)(3)(A).\16\
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    \12\ The Exchange proposes to move the existing text of Rule
6.87-O(b)(3) into a new subparagraph (A).
    \13\ See proposed Rule 6.87-O(b)(3)(B)(i).
    \14\ See proposed Rule 6.87-O(b)(3)(B)(ii).
    \15\ See proposed Rule 6.87-O(b)(3)(B)(iii).
    \16\ See supra note 12. See also Notice, supra note 3, for
additional description and examples of the proposed rule change.
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C. Rule 6.87-O(c)(4)(B)

    Current Rule 6.87-O(c)(4) provides that obvious error transactions
involving non-customers would be adjusted, while transactions involving
customers are nullified, unless a certain specified condition
applies.\17\ Under this proposed rule change, Rule 6.87-O(c)(4)(B)
would be amended to provide that even obvious error transactions
involving a customer will be adjusted, instead of nullified, as long as
the adjustment does not violate the customer's limit price.
Specifically, pursuant to proposed Rule 6.87-O(c)(4)(B), where at least
one party to an erroneous transaction is a customer, the execution
price of the transaction would be adjusted pursuant to the adjustment
criteria in Rule 6.87-O(c)(4)(A), which provides for the adjustment of
prices a specified amount away from the Theoretical Price. Any customer
obvious error exceeding 50 contracts would be subject to the size
adjustment modifier defined in Rule 6.87-O(a)(4).\18\ However, if such
adjustment(s) would result in an execution price higher (for buy
transactions) or lower (for sell transactions) than the customer's
limit price, the trade would be nullified.\19\
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    \17\ Specifically, current Rule 6.87-O(c)(4)(C) provides that if
an OTP Holder has 200 or more customer transactions under review
concurrently and the orders resulting in such transactions were
submitted during the course of two minutes or less, where at least
one party to the obvious error is a non-customer, then the Exchange
will apply the non-customer adjustment criteria found in Rule 6.87-
O(c)(4)(A).
    \18\ See proposed Rule 6.87-O(c)(4)(B).
    \19\ See id.
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D. Implementation Date

    The Exchange represents that it will announce the effective date of
the proposed rule change in a Trader Update distributed to all OTP
Holders and OTP Firms, which will be no sooner than six months from the
approval of this proposal.\20\
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    \20\ See Notice, supra note 3, at 60928.
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III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\21\ In
particular, the Commission finds that the proposed rule change is
consistent with the requirements of Section 6(b) of the Act \22\ and
with Section 6(b)(5) of the Act,\23\ which requires, among other
things, that the Exchange's rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. Further, the
Commission believes that proposed modifications to Rule 6.87-O will
foster cooperation and coordination with persons engaged in regulating
and facilitating transactions.
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    \21\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \22\ 15 U.S.C. 78f(b).
    \23\ 15 U.S.C. 78f(b)(5).
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    One commenter, a LOMSWG member, expressed broad support for the
proposal, stating that the proposal is designed to protect retail
customers.\24\ Specifically, the commenter argues that the proposed
change to Rule 6.87-O(b)(3) would provide a more uniform treatment of
customer erroneous transactions occurring during the 10-second period
immediately following an opening or re-opening.\25\ The commenter also
argues that the proposed change to Rule 6.87-O(c)(4)(B) would provide
for uniform treatment of customer and non-customer erroneous
transactions, stating that the proposal reflects changes in the
dynamics of options market customers by extending hedging protections
previously available to non-customers.\26\
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    \24\ See Letter from Ellen Greene, Managing Director, Equities &
Options Market Structure, Securities Industry and Financial Markets
Association, to Vanessa Countryman, Secretary, Commission, dated
November 23, 2021, at 2 (``SIFMA Letter'').
    \25\ See id. See also text accompanying note 11.
    \26\ See SIFMA Letter, supra note 25, at 2.
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    The Commission believes that the proposal to amend Rule 6.87-
O(b)(3)(B)

is designed to achieve more consistent results for participants across
U.S. options exchanges than under the current harmonized rules, while
maintaining a fair and orderly market, protecting investors, and
protecting the public interest. Specifically, the proposed change to
Rule 6.87-O(b)(3) is designed to increase the consistency and
transparency in the handling of erroneous options transactions in
situations immediately after an opening or re-opening where there is no
10-second period prior to the transaction by allowing for the
calculation of a Theoretical Price during the 10-second period
immediately following an opening and reopening.\27\
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    \27\ See Notice, supra note 3, at 60928.
---------------------------------------------------------------------------

    The Commission also believes that the Exchange's proposed change to
Rule 6.87-O(c)(4) is consistent with the Act and would further the goal
of providing increased transparency and uniformity in the handling of
erroneous options transactions involving customers and non-customers.
As the Exchange observes, the proposed rule change would better
harmonize the treatment of non-customer transactions and customer
transactions under the Rule and provide greater certainty of execution
for all participants to options transactions, while still respecting a
customer's limit price.\28\
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    \28\ See id. at 60928-29.
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    The proposed rule change will become operative no sooner than six
months following its approval, on a date to be announced in a Trader
Update made available by the Exchange to its OTP Holders and OTP Firms.
This delayed implementation is designed to allow other options
exchanges time to adopt rules consistent with this proposal and for all
options exchanges to coordinate the date of implementation of such
harmonized rules.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\29\ that the proposed rule change (SR-NYSEArca-2021-91) be, and
hereby is, approved.
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    \29\ 15 U.S.C. 78s(b)(2).
    \30\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-27821 Filed 12-22-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72043-72047]
[DOCID:fr26no08-71]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2008-0820; FRL-8746-4]

Proposed Approval of the Central Characterization Project's
Remote-Handled Transuranic Waste Characterization Program at Oak Ridge
National Laboratory

AGENCY: Environment Protection Agency.

ACTION: Notice of availability; opening of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA or we) is announcing
the availability of, and soliciting public comments for 45 days on, the
proposed approval of the radioactive, remote-handled (RH), transuranic
(TRU) waste characterization program implemented by the Central
Characterization Project (CCP) at Oak Ridge National Laboratory (ORNL)
in Oak Ridge, Tennessee. This waste is intended for disposal at the
Waste Isolation Pilot Plant (WIPP) in New Mexico.
    In accordance with the WIPP Compliance Criteria, EPA evaluated the
characterization of RH TRU debris waste from ORNL-CCP during an
inspection conducted on June 30--July 2, 2008. Using the systems and
processes developed as part of the U.S. Department of Energy's (DOE's)
Carlsbad Field Office (CBFO) program, EPA verified whether DOE could
adequately characterize RH TRU waste consistent with the Compliance
Criteria. The results of EPA's evaluation of ORNL-CCP's RH program and
its proposed approval are described in the Agency's inspection report,
which is available for review in the public dockets listed in
ADDRESSES. We will consider public comments received on or before the
due date mentioned in DATES.
    This notice summarizes the waste characterization processes
evaluated by EPA and EPA's proposed approval. As required by the 40 CFR
194.8, at the end of a 45-day comment period EPA will evaluate public
comments received, and if appropriate, finalize the reports responding
to the relevant public comments, and issue a final report and approval
letter to DOE.

DATES: Comments must be received on or before January 12, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0820, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail: to<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    Instructions: Direct your comments to Attn: Docket ID No. EPA-HQ-
OAR-2008-0820. The Agency's policy is that all comments received will
be included in the public docket without change and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at www.regulations.gov. As provided in EPA's regulations at 40 CFR part
2, and in accordance with normal EPA docket procedures, if copies of
any docket materials are requested, a reasonable fee may be charged for
photocopying.

FOR FURTHER INFORMATION CONTACT: Rajani Joglekar or Ed Feltcorn,
Radiation

Protection Division, Center for Waste Management and Regulation, Mail
Code 6608J, U.S. Environmental Protection Agency, 1200 Pennsylvania
Avenue, Washington, DC, 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What Should I Consider as I Prepare My Comments for EPA?

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

II. Background

    DOE is developing the WIPP, near Carlsbad in southeastern New
Mexico, as a deep geologic repository for disposal of TRU radioactive
waste. As defined by the WIPP Land Withdrawal Act (LWA) of 1992 (Pub.
L. 102-579), as amended (Pub. L. 104-201), TRU waste consists of
materials that have atomic numbers greater than 92 (with half-lives
greater than twenty years), in concentrations greater than 100
nanocuries of alpha-emitting TRU isotopes per gram of waste. Much of
the existing TRU waste consists of items contaminated during the
production of nuclear weapons, such as rags, equipment, tools, and
sludges.
    TRU waste is itself divided into two categories, based on its level
of radioactivity. Contact-handled (CH) TRU waste accounts for about 97
percent of the volume of TRU waste currently destined for the WIPP. It
is packaged in 55-gallon metal drums or in metal boxes and can be
handled under controlled conditions without any shielding beyond the
container itself. The maximum radiation dose at the surface of a CH TRU
waste container is 200 millirems per hour. CH waste primarily emits
alpha particles that are easily shielded by a sheet of paper or the
outer layer of a person's skin.
    Remote-handled (RH) TRU waste emits more radiation than CH TRU
waste and must therefore be both handled and transported in shielded
casks. Surface radiation levels of unshielded containers of remote-
handled transuranic waste exceed 200 millirems per hour. RH waste
primarily emits gamma radiation, which is very penetrating and requires
concrete, lead, or steel to block it.
    On May 13, 1998, EPA issued a final certification of compliance for
the WIPP facility. The final rule was published in the Federal Register
on May 18, 1998 (63 FR 27354). EPA officially recertified WIPP on March
29, 2006 (71 FR 18015). Both the certification and recertification
determined that WIPP complies with the Agency's radioactive waste
disposal regulations at 40 CFR part 191, subparts B and C, and is
therefore safe to contain TRU waste.
    The final WIPP certification decision includes conditions that (1)
prohibit shipment of TRU waste for disposal at WIPP from any site other
than the Los Alamos National Laboratories (LANL) until the EPA
determines that the site has established and executed a quality
assurance program, in accordance with Sec. Sec.  194.22(a)(2)(i),
194.24(c)(3), and 194.24(c)(5) for waste characterization activities
and assumptions (Condition 2 of Appendix A to 40 CFR part 194); and (2)
(with the exception of specific, limited waste streams and equipment at
LANL) prohibit shipment of TRU waste for disposal at WIPP (from LANL or
any other site) until EPA has approved the procedures developed to
comply with the waste characterization requirements of Sec.
194.22(c)(4) (Condition 3 of Appendix A to 40 CFR part 194). The EPA's
approval process for waste generator sites is described in Sec.  194.8
(revised July 2004).
    Condition 3 of the WIPP Certification Decision requires EPA to
conduct independent inspections at DOE's waste generator/storage sites
of their TRU waste characterization capabilities before approving their
program and the waste for disposal at the WIPP. EPA's inspection and
approval process gives EPA (a) discretion in establishing technical
priorities, (b) the ability to accommodate variation in the site's
waste characterization capabilities, and (c) flexibility in scheduling
site waste characterization inspections.
    As described in Section 194.8(b), EPA's baseline inspections
evaluate each waste characterization process component (equipment,
procedures, and personnel training/experience) for its adequacy and
appropriateness in characterizing TRU waste destined for disposal at
WIPP. During an inspection, the site demonstrates its capabilities to
characterize TRU waste(s) and its ability to comply with the regulatory
limits and tracking requirements under (194.24. A baseline inspection
may describe any limitations on approved waste streams or waste
characterization processes [Sec.  194.8(b)(2)(iii)]. In addition, a
baseline inspection approval must specify what subsequent waste
characterization program changes or expansion should be reported to EPA
[Sec.  194.8(b)(4)]. The Agency is required to assign Tier 1 (T1) and
Tier 2 (T2) designations to the reportable changes depending on their
potential impact on data quality. A T1 designation requires that the
site must notify EPA of proposed changes to the approved components of
an individual waste characterization process (such as radioassay
equipment or personnel), and EPA must also approve the change before it
can be implemented. A waste characterization element with a T2
designation allows the site to implement changes to the approved
components of individual waste characterization processes (such as
visual examination procedures) but requires EPA notification. The
Agency may choose to inspect the site to evaluate technical adequacy
before approval. EPA inspections conducted to evaluate T1 or T2 changes
are follow-up inspections under the authority of Sec.  194.24(h). In
addition to the follow-up inspections, if warranted, EPA may opt to
conduct

continued compliance inspections at TRU waste sites with a baseline
approval under the authority of Sec.  194.24(h).
    The site inspection and approval process outlined in Sec.  194.8
requires EPA to issue a Federal Register notice proposing the baseline
compliance decision, docket the inspection report for public review,
and seek public comment on the proposed decision for a period of 45
days. The report must describe the waste characterization processes EPA
inspected at the site, as well as their compliance with Sec.  194.24
requirements.

III. Proposed Baseline Compliance Decision

    EPA has performed a baseline inspection of RH TRU waste
characterization activities at ORNL-CCP (EPA Inspection No. EPA-ORNL-
CCP-RH-4.08-8). The purpose of EPA's inspection was to verify that the
waste characterization program implemented at ORNL-CCP for
characterizing RH TRU, retrievably-stored, debris waste is technically
adequate and meets the regulatory requirements at 40 CFR 194.24.
    The RH waste that DOE is proposing for WIPP disposal is generated
from operation of the Radiochemical Engineering Development Center
(REDC) hot cell laboratory at ORNL. The REDC was used primarily to
recover and purify curium for fabrication into targets. The same
facility and apparatus were used to separate, purify and store
transcurium \1\ radionuclides produced by irradiation of curium targets
in the ORNL High Flux Isotope Reactor (HFIR) from 1991 until February
2007 for a variety of commercial and federal applications. The REDC
also processed Mark-42 target assemblies to recover plutonium,
americium and curium isotopes that were shipped to the Los Alamos
National Laboratory (LANL). A target is a material that was placed
within the HFIR primarily for defense programs (see attached inspection
report for more information on this topic).
---------------------------------------------------------------------------

    \1\ Transcurium isotopes are elements with atomic numbers (No.)
greater than that of Curium (Cm), 96, i.e., berkelium (Bk), atomic
No. 97; californium (Cf), atomic No. 98; einsteinium (Es), atomic
No. 99; fermium (Fm), atomic No. 100; and mendelevium (Md), atomic
No. 101. By definition, these are potentially TRU, depending on
their radioactive emission (alpha, beta, or gamma) and half-life,
even though they may contain small or immeasurable concentrations of
plutonium and/or americium isotopes normally associated with TRU
wastes.
---------------------------------------------------------------------------

    ORNL-CCP stores RH waste from the REDC in concrete casks, boxes,
and drums at ORNL. These wastes are transferred to the TRU Waste
Processing Center (TWPC) hot cells for repackaging into 55-gallon (208-
liter) drums for characterization. ORNL-CCP was expecting EPA to
evaluate for approval RH debris waste from three time periods (April
1972-November 1978, December 1978-October 1991, and November 1991-
February 2007). Early in the inspection, EPA inspectors concluded that
ORNL--CCP had done limited characterization work for the first two time
periods and the available information for the earlier periods was not
complete. As a result, EPA inspectors informed the Carlsbad Area Field
Office (CBFO) and ORNL-CCP that the scope of the inspection would only
cover debris waste generated from November 1991-February 2007. Today's
proposed baseline approval, therefore, is limited to retrievably-stored
RH TRU debris wastes that were generated during this specific time
frame.
    ORNL initially stored these wastes in 32 concrete casks. ORNL-CCP
presented preliminary information regarding RH TRU debris wastes that
had been generated in two other time periods; the Pre-Solvent
Extraction Test Facility (SETF) period from April 1972-November 1978
and the SETF period from December 1978-October 1991. At the time of
this inspection, characterization of the Pre-SETF and SETF wastes had
not begun and there was insufficient objective evidence to support
their approval. ORNL-CCP has stated that they will present these wastes
for EPA approval in the future and EPA will evaluate each of these as
Tier 1 (T1) changes in accordance with the tiering described in the
accompanying inspection report.
    The EPA inspection team identified four concerns related to waste
characterization processes ORNL-CCP had implemented to characterize
retrievably-stored RH debris waste (see Attachment B of the
accompanying inspection report). ORNL-CCP revised specific documents to
address the concerns and submitted them for EPA review following the
initial onsite inspection. The EPA inspection team completed their
review of the revised documents and determined that the revised
documents adequately addressed all aspects of the four EPA concerns.
    EPA has determined that the ORNL-CCP RH waste characterization
program was technically adequate and that all concerns have been
resolved. Therefore, EPA is proposing to approve the ORNL-CCP RH waste
characterization program for ORNL RH Waste Stream OR-REDC-RH-HET that
was evaluated during this baseline inspection, as described and
documented in the accompanying inspection report. The proposed approval
includes the following:
    (1) The AK process for the RH retrievably-stored TRU debris waste
stream designated as Waste Stream OR-REDC-RH-HET that was generated
from REDC activities conducted between November 1991 and February 2007
that is currently stored at ORNL and will be repackaged into 55-gallon
drums.
    (2) The radiological characterization process using DTC and scaling
factors for assigning radionuclide values to Waste Stream OR-REDC-RH-
HET that is documented in CCP-AK-ORNL-501, Revisions 0 and 1, and
detailed in this report.
    (3) The VE process to identify waste material parameters and the
physical form of the waste.
    (4) The WWIS to submit data for both characterization and
certification for RH TRU waste.
    (5) The attainment of pertinent data quality objectives (DQOs).
    ORNL-CCP must report and receive EPA approval of any Tier 1 (T1)
changes to the ORNL-CCP waste characterization activities from the date
of the baseline inspection, and ORNL-CCP must notify EPA regarding Tier
2 (T2) changes according to Table 1, below. Table 1 in this report
closely follows the format used in recent CH and RH baseline approval
reports.

 Table 1--Tiering of RH TRU Waste Characterization Processes Implemented
     by ORNL-CCP, Based on June 30-July 2, 2008 Baseline Inspection
------------------------------------------------------------------------
                                                         ORNL--CCP RH WC
    RH WC Process elements          ORNL-CCP RH WC         Process--T2
                                  Process--T1 Changes      Changes \a\
------------------------------------------------------------------------
Acceptable Knowledge (AK).....  Addition of any new     Notification to
                                 waste streams not       EPA when
                                 approved under this     updates are
                                 baseline (AK-1).        made to the
                                                         documents
                                                         included in AK-
                                                         1, AK-2, AK-3,
                                                         AK-4, AK-6, AK-
                                                         9, AK-13, AK-14
                                                         and AK-15,
                                                         outside of the
                                                         specific T1
                                                         changes listed
                                                         in the previous
                                                         column.
                                Modification of the     Notification to
                                 approved population     EPA of
                                 of the OR-REDC-RH-HET   availability of
                                 wastes to include any   and/or
                                 containers not          revisions to
                                 included in the CCP-    Add Container
                                 AK-ORNL-501, Revision   Memoranda (AK-
                                 1 analysis (AK-1).      3).
                                Modification(s)         Notification to
                                 resulting from          EPA of
                                 incorporation of new    availability of
                                 information specific    documentation
                                 to the approved RH      of RH sample
                                 debris waste (OR-REDC-  reclassified as
                                 RH-HET) population to   CH and subject
                                 the following           to confirmatory
                                 documents: CSSF (AK-1   analyses via
                                 and AK-2); CCP-AK-      NDA (AK-9).
                                 ORNL-501 (AK-1); CCP-
                                 AK-ORNL-500 (AK-2 and
                                 AK-9); AKSR (AK-6);
                                 CTP (AK-9); AK
                                 Accuracy Reports (AK-
                                 1 and AK-15); and the
                                 WSPF (AK-14).
                                Implementation of load  Notification to
                                 management (AK-16).     EPA of
                                                         availability of
                                                         DRF(s) or data
                                                         limitation
                                                         information
                                                         pertaining to
                                                         CCP's
                                                         assessment of
                                                         ORNL's original
                                                         radiological
                                                         characterizatio
                                                         n of wastes
                                                         generated post-
                                                         1999 (AK-13).
Radiological Characterization,  Application of new      Revisions of CCP-
 Dose-to-Curie (DTC) and the     scaling factors for     AK-ORNL-501 or
 application of radionuclide-    isotopic                CCP-TP-504 that
 specific scaling factors.       determination other     require CBFO
                                 than those documented   approval (RC-
                                 in CCP-AK-ORNL-501      3), (RC-4), (RC-
                                 (RC-3).                 8).
                                Use of any alternate    Results from the
                                 radiological            any RH TRU
                                 characterization        container(s)
                                 procedure other than    that qualify as
                                 DTC, with established   CH and are
                                 scaling factors as      subject to NDA
                                 documented in CCP-TP-   (RC-8).
                                 504, Revision 6, or
                                 substantive
                                 modification of the
                                 DTC procedure \b\ (RC-
                                 4).
                                Any new waste stream    ................
                                 not approved under
                                 this baseline or
                                 addition of
                                 containers to Waste
                                 Stream OR-REDC-RH-HET
                                 that requires
                                 changing the
                                 documented
                                 radionuclide scaling
                                 factors in CCP-AK-
                                 ORNL-501 (RC-4).
Visual Examination (VE).......  Implementation of VE    Changes to VE
                                 by any system other     procedure(s)
                                 than two operators      that require
                                 performing VE \c\ (VE-  CBFO approval
                                 2).                     (VE-1).
                                                        Addition of new
                                                         Sample Category
                                                         Groups to the
                                                         VE process that
                                                         is subject to
                                                         this proposed
                                                         approval (VE-
                                                         2).
WIPP Waste Information System   None at this time.....  Changes to WWIS
 (WWIS).                                                 procedure(s)
                                                         that require
                                                         CBFO approval
                                                         (WWIS-1).
                                                        Changes to the
                                                         Excel
                                                         spreadsheet
                                                         titled WWIS
                                                         Data Entry
                                                         Summary
                                                         Characterizatio
                                                         n and
                                                         Certification
                                                         (WWIS-2).
------------------------------------------------------------------------
\a\ Upon receiving EPA approval, ORNL-CCP will report all T2 changes to
  EPA at the end of each fiscal quarter.
\b\ ``Substantive changes'' means changes with the potential to impact
  the site's waste characterization activities or documentation thereof,
  excluding changes that are solely related to ES&H, nuclear safety, or
  RCRA, or that are editorial in nature.
\c\ Modifications to approved equipment include all changes with the
  potential to affect NDA data relative to waste isolation and exclude
  minor changes, such as the addition of safety-related equipment.

IV. Availability of the Baseline Inspection Report for Public Comment

    EPA has placed the report discussing the results of the Agency's
inspection of the ORNL-CCP Site in the public docket as described in
ADDRESSES. In accordance with 40 CFR 194.8, EPA is providing the public
45 days to comment on these documents. The Agency requests comments on
the proposed approval decision, as described in the inspection report.
EPA will accept public comment on this notice and supplemental
information as described in Section 1.B. above. EPA will not make a
determination of compliance before the 45-day comment period ends. At
the end of the public comment period, EPA will evaluate all relevant
public comments and revise the inspection report as necessary. If
appropriate, the Agency will then issue a final approval letter and
inspection report, both of which will be posted on the WIPP Web site.
    Information on the certification decision is filed in the official
EPA Air Docket, Docket No. A-93-02 and is available for review in
Washington, DC, and at the three EPA WIPP informational docket
locations in Albuquerque, Carlsbad, and Santa Fe, New Mexico. The
dockets in New Mexico contain only major items from the official Air
Docket in Washington, DC, plus those documents added to the

official Air Docket since the October 1992 enactment of the WIPP LWA.

    Dated: November 18, 2008.
Elizabeth Cotsworth,
Director, Office of Radiation and Indoor Air.
 [FR Doc. E8-28124 Filed 11-25-08; 8:45 am]

BILLING CODE 6560-50-P


a Source: U.S. Office of Personnel Management. (2018). Salary Table 2018-DCB. Retrieved March 26, 2018 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/DCB_h.aspx.
[b] The 60 percent fringes-and-overhead rate is from an EPA guide, Instructions for Preparing ICRs (EPA, 2009).
[c] Wage data are rounded to the closest cent in this analysis.

References and Attachments to the Supporting Statement
Bureau of Labor Statistics (BLS). (2014, July). Employment Cost Index Historical Listing - Volume V. Series: All Private Workers Total Compensation (not seasonally adjusted).
Bureau of Labor Statistics (BLS). (2019, June 18). Employer Costs for Employee Compensation Historical Supplementary Tables: December 2006 - March 2019. Retrieved August 5, 2019, from http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf
Environmental Protection Agency (EPA). (2002). Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0011
EPA. (2009). ICR Handbook: EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Retrieved from https://www.pdffiller.com/10247637--ICR-Handbook---Environmental-Protection-Agency-
EPA. (2013a). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.reginfo.gov/public/do/DownloadDocument?objectID=31908502
EPA. (2013b, September 1). Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Filename: Standard Nano Test Costs 9-01-2013.xls.
EPA. (2016, June 30). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Enforceable Consent Agreements (ECAs), Voluntary Testing Agreements (VTAs), Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2015-0436-0007
EPA. (2017a). Burden and Cost Report for the Final Rule: TSCA Inventory Notification Requirements. Docket Number EPA-HQ-OPPT-2016-0426 (August 11, 2017).
EPA. (2017b, February 22). General Substantiation Questions to Support CBI Claims. Retrieved September 16, 2019, from https://www.epa.gov/tsca-cbi/general-substantiation-questions-support-cbi-claims
EPA. (2018a). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Enforceable Consent Agreements (ECAs), Voluntary Testing Agreements (VTAs), Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.reginfo.gov/public/do/DownloadDocument?objectID=80611002
EPA. (2018b, February 26). Technical Background Document TSCA User Fees NPRM.
EPA. (2018c, September 25). Economic Analysis of the Final Rule for Fees for the Administration of the Toxic Substances Control Act, EPA-HQ-OPPT-2017-0401; RIN 2070-AK27.
EPA. (2019a). Economic Analysis for the Proposed Rule: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.
EPA. (2019b, August 14). The Frank R. Lautenberg Chemical Safety for the 21st Century Act (EPA website). Retrieved from https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act
FedEx. (2019). Postage based on 0.4 lb package shipped 3-day business rate from Kansas City MO to Washington DC. Retrieved September 5, 2019, from https://www.fedex.com/ratefinder/home?cc=US&language=en&locId=express
Fees for the Administration of the Toxic Substances Control Act. , 40 CFR § 700, 720, 723, 725, 790, and 791 (2018).
Frank R. Lautenberg Chemical Safety for the 21st Century. , 40 CFR § 790-799 (2016).
Nielsen, L., & Day, S. (2018, March). Smart Math Saves Time and Improves Communication.
Office of Personnel Management (OPM). (2018). Pay & Leave: Salaries & Wages: Salary Table 2018-DCB. Retrieved from www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/DCB_h.aspx
Piccirillo, V. (2004, September 20). Vincent Piccirillo, personal communication.
Rice, C. (2002). Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0005
Staples. (2019). Staples 8.5" x 11" Copy Paper. Retrieved September 5, 2019, from https://www.staples.com/Staples-Copy-Paper-8-1-2-x-11-Case/product_135848

Attachments:
Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2015-0436. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the following listing.
Attachment 1:
Toxic Substances Control Act (TSCA) Section 4 - 15 USC 2603
Attachment 2:
Procedures Governing Testing Consent Agreements and Test Rules, 40 CFR 790
Attachment 3
TSCA Section 4 e-Reporting Screenshots
Attachment 4
TSCA Section 4 User Guide  -  Primary Support v1.0p
Attachment 5
TSCA Section 4 User Guide  -  Primary Authorized Official_v1.0p
 Appendix A: Specific Legacy Assumptions Converted to Standardized Assumptions
Table A-1 depicts a detailed table of tests that has been historically part of ICR renewal methodology. In this revision, the assumption is simplified to a generic set of ten tests, with total costs at $1.6 million (Bureau of Labor Statistics (BLS), 2014; EPA, 2013b; Piccirillo, 2004). Of the ten tests in Table A-1, three tests are of long duration and seven are of short duration
In this ICR revision, the assumption is simplified to a generic set of seven screening-level tests, including five physiochemical tests, one environmental fate and degradation test, and one aquatic toxicity test, with a total cost of $58,177. These tests are listed in Table A-2 and the costs were estimated using test costs developed for OPPT's New Chemical Program, and are meant to serve as seven generic tests that may be performed at any point during the three-year period. Future ICR renewals can take into account the actual duration of tests and build a new generic frequency distribution accordingly.
Table A-1 Legacy TSCA Section 4 "Standard" Testing Battery Laboratory Costs (2014$), Per Chemical
                              Test Protocol Name
                                Protocol Number
                               Date of Estimate
                         Mean Cost Estimate (2014$)[a]
                           Validation Costs (2014$)
Algal Acute Toxicity
797.105
                                                                       8/3/1990
                                                                    $12,132.58
                                                                     $4,398.95
Daphnid Acute Toxicity
797.13
                                                                      4/25/1996
                                                                    $11,965.05
                                                                     $4,398.95
Fish Acute Toxicity
797.14
                                                                      4/25/1996
                                                                    $18,285.73
                                                                     $4,398.95
Gene Mutations in Somatic Cells
798.53
                                                                      8/16/1994
                                                                    $25,366.24
                                                                     $4,398.95
Subchronic Oral Toxicity
870.31
                                                                       9/3/2005
                                                                   $167,921.14
                                                                     $4,398.95
Prenatal Developmental Tox. (2 species)[b]
870.37
                                                                       1/1/2010
                                                                   $152,450.48
                                                                    $10,683.16
Reproduction/Fertility Effects[b]
870.38
                                                                       1/1/2010
                                                                   $422,689.97
                                                                    $10,683.16
Salmonella Reverse Mutation Assay
870.5265
                                                                      9/16/1996
                                                                     $9,792.46
                                                                     $4,398.95
In vivo Bone Marrow Cytogenetics
870.5395
                                                                      2/27/2005
                                                                    $24,968.83
                                                                     $4,398.95
Developmental Neurotoxicity[b]
870.63
                                                                       1/1/2010
                                                                   $754,982.00
                                                                    $10,683.16
Subtotal
                                                                 $1,600,554.48
                                                                    $62,842.13
Total
                                  $1,663,397
Footnotes:
[a] Where multiple versions of a test have been assessed by EPA (e.g., covering different species or routes of exposure), the mean cost estimate is used. All testing costs are updated to 2014 dollars.
b Designated as "long duration" studies.

[ ]
Sources:
1. U.S. Bureau of Labor Statistics. July 2014, Employment Cost Index Historical Listing - Volume V. Series: All Private Workers Total Compensation (not seasonally adjusted).
2. U.S. EPA. 2013. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Filename: Standard Nano Test Costs 9-01-2013.xls.
3. Piccirillo 2004. Vincent Piccirillo, personal communication. September 20, 2004.

Table A-2 Updated TSCA Section 4 "Standard" Testing Battery Laboratory Costs (2018$), Per Chemical
                                   Test Type
                    Corresponding EPA Guideline or Test ID
                               Test Cost (2018$)
Physicochemical Screening Tests
Melting Point
                                                                       830.7200
                                                                         $1,600
Boiling Point
                                                                       830.7550
                                                                         $1,012
Vapor Pressure
                                                                       796.1220
                                                                         $3,065
log Kow
                                                                       796.1950
                                                                         $8,500
Water Solubility
                                                                       830.7840
                                                                        $11,800
Environmental Fate and Pathways
Ready Biodegradation
                                                                       835.3110
                                                                         $9,900
Aquatic Toxicity
Acute Toxicity to Daphnia
                                                                       850.1010
                                                                        $22,300
Total
                                                                        $58,177

 Appendix B: Overlap Model
In previous ICRs, estimates assumed that new actions occurred chronologically without consideration of overlap as shown in Figure 1. As a method to model such effects, EPA considers a scenario in which activities are run in sequence, compared to a scenario in which activities running with overlap. In conjunction with the change to the input value of "number of actions initiated each year" instead of a lumped input variable that contains overlap as well, the overlap model is developed as a factor to apply to the new input value which is the ratio of the overlap burden to the sequential burden (see the top panel of Figure 1). The purpose of the overlap factor is to account for burden from actions proceeding asynchronously and in parallel. Additionally, burden from actions with activities from previous ICR periods (carry-over activities) are captured. This appendix provides the details of developing the standardized overlap factor to apply in ICR burden estimation. Future ICR renewals can take into account the actual overlap and revise the model accordingly.
The overlap factor incorporated into this revised model is the ratio of burden that incorporates overlap considerations to the burden of that considers sequential implementation of the actions (see the bottom panel of Figure 1). The factor's numerator and denominator are modeled considering that certain activities for the action fall in certain years over the time span of the action, depending on the assumptions. For example, for three rules occurring in sequence, there is one study plan in years one, three, and six. But for the model considering overlap, there is one study plan in years one, two, and three. An overlap factor greater than one accounts for the fact that the actions are proceeding asynchronously with activities for each contributing action overlapping, even though action initiations are staggered.
Previous ICR estimates model did not account for this overlap as a separate factor, and the model presented in Figure 1 provides a standardized method to be used with a simplified load variable for "number of actions initiated each year." This generic model is based on assumptions of 1 rule with 1 chemical and 1 sponsor. After accounting for the burden associated with each type of activity under the nominal framework described in Section 5, the overlap factor (burden with overlap accounting divided by burden without overlap) is equal to 2.8.
For each chemical, the unit burden and cost estimates from the previous ICR remain the same under the revised model. These estimates are then adjusted by the overlap factor, as well as any other additional factors to consider such as the number of chemicals per action (see Table C-1 for assumptions) to estimate total burden and costs. In sum, the overlap model facilitates scaling up or down any of the unit-level burden and cost estimates based on changes to program inputs for "number of actions initiated per year."
Figure 1. Overlap Factor Model to Account for Asynchronous, Parallel Activities under Separate Actions

 Appendix C: Derivation of Program Input Information
The Fees for the Administration of the Toxic Substances Control Act rule (2018) basis for "number of expected actions under full implementation" for TSCA section 4 are derived using data from TSCA High Production Volume (HPV) TSCA section 4 actions (EPA, 2018b, 2018c). The metrics of ICR renewals are not as specific as the metrics of the Fees rule, as they reflect prospective generic assumptions to be used in ICR renewals every three years. Updating the standardized assumptions of the ICR revision based on experience, and mapping results to the conditions of the Fees rule produces the results in Table C-1. The structure of the assumptions in the ICR differ from those of the Fees rule, but on balance provide overstated burden estimates. The assumption that the testing is conducted over three years (instead of two years for rules and ECAs, or one year for test orders) understates the burden. However, other assumptions more than compensate, leaving the estimates overstated:
 One sponsor per chemical (instead of four)
 10 tests per chemical (instead of seven)
 Overlap Factor of 2.8 (derived based on three years with each new action staggered by one year)
Table C-1: Translating Fees Rule information to ICR Bases
                                Type of Action
                                   Fees Rule
                                      ICR

              Number of Actions Initiated Per Year (New Actions)
                       Associated Number of Chemicals[1]
                    Number of Sponsors per Chemical Tested
           Notes on Overlap, Action Duration, and Tests Per Chemical
                             New Actions per Year
                        Associated Number of Chemicals
                          Duration; Overlap Factor[2]
        Simplifying Assumptions
(Standardized for all types of actions)
Test Rule
                                      0.5
                                       7
                                       4
One new action every other year and 2 year durations per action; 7 tests per chemical
                                      0.5
                                       7
                          3 years
2.8 overlap factor
                            1 sponsor per chemical
                          7 tests per chemical tested
Test Order
                                      10
                                       7
                                       4
No overlap, as duration is one year or less; 7 tests per chemical
                                      10
                                       7
                          3 years
2.8 overlap factor

Enforceable Consent Agreement
                                      0.5
                                       7
                                       4
One new action every other year and 2-year durations per action; 7 tests per chemical
                                      0.5
                                       7
                          3 years
2.8 overlap factor

Footnotes:
1 The assumption of 7 chemicals per action is used in several calculations in the Fees Rule EA, including the section 4 industry opportunity costs (Section 5.1.2) and the number of small businesses (Section 3.4.2.A). However, the justification for the program cost estimates states that each TSCA section 4 action covers one to five chemicals (Section 3.2.2).
[2] See Figure 1 for a visual rendering.

 Appendix D: IC Organizations, According to TSCA Section 4 Actions and Component Activities
Table D-1: IC Organization Used in Previous ICRs (Legacy ICs)

                    TSCA Section 4 Action or Other Testing
           IC Description
 (List of Activities Included as Bullets)
                                  Test Rules
                        Enforceable Consent Agreements
                           Voluntary Data Submission
1. Testing Agreements*
 Letter of Intent/Study Plan
 Progress Reports
 Study Final Report
 Laboratory Review
 Corporate Review
 Recordkeeping
 Robust Summary (voluntary)

                                     *

2. Test Rules and Test Orders
 Letter of Intent/Study Plan
 Progress Reports
 Study Final Report
 Laboratory Review
 Corporate Review
 Recordkeeping
 Robust Summary (voluntary)
                                      

3. Voluntary Testing Submission
 Final Reports
 Recordkeeping

                                      
4. Testing Exemption Applications
 Prepare Exemption Application
 Corporate Review
 Recordkeeping
                                      

5. Laboratory Costs
 Testing Costs
 Testing Administrative Costs
                                      
                                      

6. CDX Registration
 CDX Registration
 CDX Electronic Signature
                                      
                                      
                                      

Table D-2: ICs Parsed to Separate Voluntary Activities
      IC Number and Description
(List of Activities Included as Bullets)
                    TSCA Section 4 Action or Other Testing

                                  Test Rules
                                  Test Orders
                        Enforceable Consent Agreements
                                Voluntary Data
                                  Submissions
1. CDX Registration
 CDX Registration
 CDX Electronic Signature
                                      
                                      
                                      

2. Initial Response, Test Rules
 Letter of Intent
OR
 Prepare Exemption Application (includes corporate review and recordkeeping)
                                      

3. Study Plan, Test Rules
                                      

4. Test Results, Test Rules
 Study Final Report
 Laboratory Review
 Corporate Review
 Recordkeeping (includes recordkeeping for Study Plan)
                                      

5. Initial Response, Test Orders
 Letter of Intent
OR
 Prepare Exemption Application (includes corporate review and recordkeeping)

                                      

6. Study Plan, Test Orders

                                      

7. Test Results, Test Orders
 Study Final Report
 Laboratory Review
 Corporate Review
 Recordkeeping (includes recordkeeping for Study Plan)

                                      

8. Voluntary Initial Contact, ECAs
 Request to Negotiate a Consent Agreement (as a response to an EPA-initiated FR Notice)

                                      

9. Study Plan, ECAs

                                      

10. Test Results, ECAs
 Study Final Report
 Laboratory Review
 Corporate Review
 Recordkeeping (includes recordkeeping for Study Plan)

                                      

11. Robust Summaries (Voluntary) for Test Rules, Test Orders, ECAs, and Voluntary Data Submissions
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12. Voluntary Data Submission
 Final Reports
 Recordkeeping

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13. Testing Costs (Non-Labor Costs)
 Laboratory Costs
 Testing Administrative Costs
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Notes:
A. Shaded areas indicate the degree to which ICs align with Program Type of Action. Note that the alignments permit use of a standardized unit burden for core activities and reporting out totals according to Program Types of Actions.
B. For ICs 2-13, the unit for a response under these ICs is "per chemical tested." As shown, a number of activities are bundled and weighted according to incidence of the activity within a standardized time period. As a result, standardized unit burdens are employed for purposes of preventing eased QC, improved communication, and preventing errors at the time of IC entries in ROCIS.

 Appendix E: Additional Information on Methodology
Note that it is particularly challenging to design the burden estimate calculations for TSCA section 4 ICR revisions. Any given action contains its own unique set of testing specifications. There may be one or more chemicals -- or even a family of chemicals involved. The tests are specific to the chemical(s) and action, with highly varied counts of tests, test durations, and cost per test.
New issues addressed in this ICR revision are workflow effects and updates in ICR renewals to reflect regulatory conditions. EPA reviewed workflow during an ICR period and considered the nature of the workflow effects on burden for TSCA section 4 actions. Workflow effects include:
        The nature of burden incidence for respondents to TSCA section 4 actions is intermittent and irregular.
        Activities do not occur on a set calendar schedule, but rather on an incidental basis, depending on the details of the particular action.
        Once an action is initiated, a number of activities of differing frequencies follow.
        The timeline for a single action's related activities can stretch out over multiple years, as tests can be conducted over an extended period of time.
The overall magnitude of the burden for the ICR is determined by the sum effect of all actions' requirements with associated activities. However, for purposes of this methodology discussion, only one type of action is considered  -  test rules.  Figure 2 presents the nature of burden incidence in real time (top section) compared to levels of burden estimated in ICR renewals (bottom section). Note that at the times that a larger than anticipated burden is incurred, EPA program staff must prepare and submit a worksheet correction to OMB, as depicted for two incidents in  between Years 3 and 6. Although worksheet corrections are a standard procedure for updating the OMB inventory, to the extent that known effects for TSCA section 4 actions can be anticipated in the ICR revision, EPA believes such effects should be included in the ICR revision's burden and cost estimates.
Figure 2. Comparison of Actual Burden to ICR Estimates for One Type of TSCA Section 4 Action (Test Rules)

EPA also reviewed the issue of updating burden estimates to reflect anticipated regulatory conditions for the upcoming ICR renewal period. Historically, EPA has taken a "placeholder" approach in which a set of generic assumptions are used for calculations, with the understanding that actual conditions can appreciably differ. Periodically -- typically during ICR Renewals -- updates to counts for number of actions and number of chemicals tested per action (or simply "number of chemicals tested within a type of action") are applied to estimates to reflect the intensity of the regulatory conditions. For purposes of this methodology discussion, these updates are referred to as "load projections," which differ from methodology changes to standardized estimates and generic assumptions.
In this stage of the methodology evolution, EPA makes changes to methodology to address the two of overlap estimation and load projections. EPA implements a new standardized estimate for overlap, the overlap model. The model constitutes a new standardized estimate designed to capture the activity patterns shown in Figure 1, as applicable to the requirements of TSCA section 4 actions. EPA is also revising the definition for load projection updates to the number of chemicals undergoing testing in new actions initiated annually. Further details are provided below.
As an overview of methodology components, the standardized estimates and generic assumptions of ICR estimates (defined to meet Objective 1 -- reflect the nature of the information collection) must be highly inclusive of the considerations in Figure 1, including the complexity of multiple activities of varying frequencies associated with activities per single chemical tested, as well as the complexity of multiple actions (of the same type) in effect asynchronously. To better address Objective 2 -- provide ease in future updates, the dynamics of carry-over and overlap on total burden are separated from load projection for the ICR period and handled in a standardized overlap model. The new definition for load projection as number of new rules initiated per year with an average of number of chemicals undergoing testing or more simply, chemicals newly tested in TSCA section 4 actions. This change in methodology replaces the complex load projection that requires EPA program staff to consider both factors (load projection and overlap) lumped together. The next section provides a comprehensive summary of methodology features by objective.
Objective 1 -- reflect the nature of the information collection -- is met by extending work from previous ICR renewals to improve upon the standardized estimate. The key estimate is a standardized unit burden that is generic for test rules, test orders, and ECAs. The unit burden contains activities bundled according to a chemical undergoing testing in a TSCA section 4 action. The unit of analysis for this unit burden chemical tested is a TSCA section 4 action pertaining to the overall submission from a sponsor for the rule, order, or ECA. Prior to this ICR revision (EPA, 2016, 2018a), key features include:
 Define response unit as "per chemical tested within an action (e.g., test rules, test orders, ECAs)." Bundling activities to a basis of "per chemical" combines activities of irregular occurrence and differing frequencies to a single metric. This feature shifts the analytical focus away from individual activities and considers a sponsor's overall submission as a bundle of activities, providing a roll-up for the submission. The bundled approach has several advantages. In bundling activities, the irregular frequencies are appropriately weighted across the whole submission. Analysts do not have to repeatedly revisit calculations activity-by-activity. The method minimizes sources of error and document production costs. Additionally, the resultant unit burden estimates are useful for communication purposes, as shown, for example in Table 2's total burden estimate.
 Apply the standardized unit burdens per submission for use in multiple types of actions (rules, orders, ECAs).
 Simplify with the standardized unit burden with generic assumptions:
 One sponsor per chemical, and
 Battery of seven tests per chemical with an associated cost at $58,177 (see details in Appendix A)
As a new enhancement in this ICR revision, EPA employs a model for overlap to account for carry-over burden from previous ICR periods plus the additive effect of concurrent actions' burden effects on the total burden (see illustration in ). EPA is using a standardized estimate for overlap derived based on three years' duration per action with each new action staggered by one year, which leads to an overlap factor of 2.8 (see details in Appendix B). When the factor is applied, for example, the number of chemicals tested in a TSCA section 4 action is multiplied by 2.8 to account for the effect of staggered intermittent burden as portrayed in Figure 2. Use of this new model adds to the list of key features above:
 Account for carry-over and overlap effects separately from new action initiations/load projections.
Objective 2 -- provide ease in future updates -- is related to the new model for overlap described above. Historically, load projections for the ICR required the program staff to consider overlap dynamics as part of the specification set for "number of actions (i.e., rules) per year" and "number of chemicals per action." The input is rather subjective, requiring a knowledge of specific rules in progress at the same time as considering potential future rules and probability of implementation. In this ICR revision, the input metric is simplified, for example, to "number of rules initiated each year" and "average number of chemicals per (new) rule" without need to consider carry-over and overlap which is handled via a standard overlap model.
Objective 3 -- enable minimal changes during the ICR period -- is accomplished by making the estimate comprehensive and sufficiently inclusive of all known considerations for the three-year ICR renewal period. The continued implementation of key principles employed in previous ICR renewals, plus accounting for overlap specifically (as described for Objective 1), the use of concise metrics for updating load projections work in concert to assure that Objective 3 is met.
The revised methodology of this ICR revision reflects a continued shift to standardized estimates and generic assumptions in recognition that the estimates are being used to provide a placeholder function in the OMB burden inventory pending possible further revision based on data from TSCA section 4 actions. In future ICR renewals, when loads projections are updated, the standardized estimates and generic assumptions can be revised (i.e., calibrated) to better reflect the actual conditions and EPA experience (e.g. number of tests per chemical undergoing testing, test durations, and test costs). In this plan for continued methodology revisions with updates to standardized estimates and generic assumptions, EPA provides accurate burden estimates, but avoids conveying a false sense of precision in ICR estimates themselves.
Beyond methodology enhancements, this ICR revision contains analyses for purposes specific to changes anticipated in the upcoming ICR period:
    Analysis of the conditions used for the Fees for the Administration of the Toxic Substances Control Act rule (2018) and translation to load projections for this ICR (provided in Appendix C)
    Incorporation of new activities related to the Lautenberg Act requirements
       Respondent substantiation of confidentiality claims
       Agency reviews of confidentiality claims
For reference, the respondent burden estimates are organized in this section according to the ICs as follows:
    IC #1: CDX Registration for e-Reporting
    IC# 2: Initial Response, Test Rules
    IC #3: Study Plan, Test Rules
    IC #4: Test Results, Test Rules
    IC #5: Initial Response, Test Orders
    IC #6: Study Plan, Test Orders
    IC #7: Test Results, Test Orders
    IC #8: Voluntary Initial Contact, ECAs
    IC #9: Study Plan, ECAs
    IC #10: Test Results, ECAs
    IC #11: Voluntary Robust Summaries for Test Rules, Test Orders
    IC #12: Voluntary Data Submissions
    IC #13 Testing Costs (Non-Labor Costs)
 Appendix F: Specific Data Items Requested
EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical. Regarding testing pursuant to TSCA section 4(a)(1), EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or 4(a)(1)(A)(ii) findings, as long as EPA finds that there is insufficient information and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop the information. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4(a)(1)(B) in the Federal Register of May 14, 1993 (58 FR 28736, 28738-39; FRL-4059-9). Note that the TSCA sections that were previously enumerated as 4(a)(1)(A) and (B) are now enumerated as 4(a)(1)(A)(i) and 4(a)(1)(A)(ii), respectively.
In addition to submitting the specified information to EPA, respondents may also need to submit a letter of intent, study plans and progress reports, or an exemption application. Respondents must also maintain certain records related to the testing.
The specific requirements and procedures governing testing ECAs, test rules, and exemption from test rules are found in 40 CFR part 790. The requirements regarding Good Laboratory Practice standards (GLPs) are found in 40 CFR part 792, the various test guidelines that are incorporated into the individual test rules are in 40 CFR parts 795 through 799, and the chemical specific testing requirements are in 40 CFR part 799.
The following is an overview of the specific requirements for each type of activity:
Test Rules  -  EPA may promulgate a rule describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing under test rules. As such, test rules generally require testing of only a single representative chemical and all chemicals subject to the test rule are assumed to be equivalent to it.
Test Orders  -  EPA may promulgate an order describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test orders generally require testing of only a single representative chemical and all chemicals subject to the test order are assumed to be equivalent to it.
Enforceable Consent Agreements (ECAs) -  EPA may negotiate an ECA under which manufacturers agree to conduct specific testing and submit the information to EPA. The ECA describes what type of testing is to be performed on the chemical and which test guidelines need to be followed to generate the information sought.
As with test rules, the test guidelines have either been published by EPA or another organization (e.g., OECD), or involve alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test rules and ECAs generally require testing of only a single representative chemical and all chemicals subject to the ECA are assumed to be equivalent to it.
Testing Exemption Applications  -  TSCA section 4 allows an entity subject to a test rule or test order to apply for an exemption from the testing requirement if that testing will be, or has been, conducted by another party. Any manufacturer or processor subject to a test rule or order may submit an application to EPA for an exemption from performing any or all of the tests required under the test rule or order. The exemption application process and requirements for test rules are set out in 40 CFR Part 790, Subpart E. The exemption application, which generally must be filed within thirty days after the effective date of the test rule, must identify the test rule, the chemical, and the Chemical Abstract Service Registration Number (CASRN) of the test substance on which the application is based, and the specific testing requirement(s) from which an exemption is sought, along with the basis for the exemption request. An exemption application will generally be approved if a letter of intent to conduct the testing has been received from another party; if a study plan submitted by another party has been approved; or if the data needs identified in the test rule have been satisfied by another party. A procedure is provided for the appeal and hearing of the denial of an exemption application. Exemptions are also only relevant for testing requirements in test rules.
Voluntary Data Submissions  -  Unrelated to any test rule or other testing requirement or agreement, chemical manufacturers may voluntarily submit data to EPA at any time. Historically, voluntary data submissions have been provided as paper submissions. However, these submissions may be provided electronically through CDX, and it is anticipated that such submissions would be provided electronically in the future when applicable. Should submitters decide to do so, EPA simply asks that submitters follow the same procedures for preparing their package and completing their submission as test rule respondents. Since such data submissions are entirely voluntary and based on decisions in which EPA is not a participant, EPA can only provide a general estimate of potential burden and costs associated with such submissions, guided generally by past such submissions, which have been rare. In doing so, EPA believes that the potential costs and burdens for such voluntary submissions are captured in this information collection request.