[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Proposed Rules]
[Pages 52419-52420]
[FR Doc No: 2019-21219]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2019-0282; FRL-10000-59-OAR]
RIN 2060-AM75

Reclassification of Major Sources as Area Sources Under Section
112 of the Clean Air Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Reopen comment period.

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SUMMARY: On July 26, 2019, the Environmental Protection Agency (EPA)
proposed a rule titled ``Reclassification of Major Sources as Area
Sources Under Section 112 of the Clean Air Act.'' The EPA is reopening
the comment period on the proposed rule that closed on September 24,
2019. The comment period will remain open until November 1, 2019 to
allow additional time for stakeholders to review and comment on the
proposal.

DATES: The public comment period for the proposed rule published in the
Federal Register on July 26, 2019 (84 FR 36304), is being reopened.
Written comments must be received on or before November 1, 2019.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2019-0282, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-
HQ-OAR-2019-0282 in the subject line of the message.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-OAR-
2019-0282.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2019-0282, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except federal holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. Do not submit information that you consider to be
Confidential Business Information (CBI) or otherwise protected through
https://www.regulations.gov/ or email. This type of information should
be submitted by mail as discussed below.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email 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, the EPA recommends that you include your name and
other contact information in the body of your comment and with any

digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA's Docket Center homepage at https://www.epa.gov/dockets.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and the EPA's electronic public docket without prior
notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 Code of Federal Regulations
part 2. Send or deliver information identified as CBI only to the
following address: OAQPS Document Control Officer (C404-02), OAQPS,
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2019-0282.

FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Ms. Elineth Torres, Sector Policies and Programs
Division (D205-02), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: To allow for additional time for
stakeholders to provide comments, the EPA has decided to reopen the
public comment period until November 1, 2019.

    Dated: September 25, 2019.
Panagiotis Tsirigotis,
Director, Office of Air Quality Planning and Standards.
[FR Doc. 2019-21219 Filed 10-1-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Proposed Rules]
[Page 65594-65595]
[DOCID:fr26oc10-22]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0807; FRL-9209-2]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio; Ohio Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve amendments to the Ohio
Administrative Code (OAC) relating to the consolidation of Ohio's
Ambient Air Quality Standards (AAQS) into Ohio's State Implementation
Plan (SIP) under the Clean Air Act. On April 8, 2009, and August 11,
2009, Ohio EPA adopted amendments to various rules in the

OAC to consolidate the state's AAQS. On September 10, 2009, Ohio EPA
requested from EPA approval of amendments to OAC with the intent to
consolidate Ohio's AAQS into a single rule to provide greater
accessibility for the regulated community and to the citizens of Ohio.
EPA is proposing to approve the request because the revisions clarify
the state's rules and thus better serve the purpose of providing for
meeting these standards.

DATES: Comments must be received on or before November 26, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2009-0807, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Jay Bortzer, Chief, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604.
    5. Hand Delivery: Jay Bortzer, Chief, Air Programs Branch (AR-18J),
U.S. Environmental Protection Agency, 77 West Jackson Boulevard,
Chicago, Illinois 60604. Such deliveries are only accepted during the
Regional Office normal hours of operation, and special arrangements
should be made for deliveries of boxed information. The Regional Office
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Melissa M. Barnhart, Environmental
Scientist, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: September 17, 2010.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2010-26964 Filed 10-25-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 15, 2005 (Volume 70, Number 240)]
[Notices]
[Page 74386-74388]
[DOCID:fr15de05-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52929; File No. SR-BSE-2005-56]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment No. 1 Thereto Relating to the Initial Listing and
Maintenance To List Options on Certain Securities

December 8, 2005.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 30, 2005, the Boston Stock Exchange, Inc. (``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. On December 6, 2005, the Exchange
filed Amendment No. 1 to the proposed rule change.\3\ The Exchange
filed the proposed rule change as a ``non-controversial'' rule change
under Rule 19b-4(f)(6) under the Act,\4\ which rendered the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change, as
amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange made non-substantive
changes to the text of the proposed rule change.
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend section 3 (Criteria for Underlying
Securities) and section 4 (Withdrawal of Approval of Underlying
Securities) of Chapter IV of the Rules of the Boston Options Exchange
(``BOX''). Below is the text of the proposed rule change. Proposed
additions are in italics and proposed deletions are in [brackets].
* * * * *

Rules of the Boston Options Exchange Facility

Chapter IV. Securities Traded On The Boston Options Exchange Facility
Sec. 3 Criteria for Underlying Securities
    (a) Underlying securities with respect to which put or call options
contracts are approved for listing and trading on BOX must meet the
following criteria:
    i. The security must be registered with the SEC and be an ``NMS
stock'' as defined in Rule 600 of Regulation NMS under the Exchange Act
    (1) Listed on a national securities exchange; or
    (2) Traded through the facilities of a national securities
association and reported as a ``national market system'' (``NMS'')
security as set forth in Rule 11Aa3-1 under the Exchange Act]; and
    ii. The security shall be characterized by a substantial number of
outstanding shares that are widely held and actively traded.
    Subsections (b) through (j) No Change.
Sec. 4 Withdrawal of Approval of Underlying Securities
    Subsection (a) No Change.
    (b) An underlying security will not be deemed to meet BOXR's
requirements for continued approval whenever any of the following
occur: i. through iv. No Change.
    v. {Reserved{time} [The issuer has failed to make timely reports as
required by applicable requirements of the Exchange Act or Rules
thereunder, and such failure has not been corrected within thirty (30)
days after the date the report was due to be filed.]
    vi. The underlying security ceases to be an ``NMS stock'' as
defined in Rule 600 of Regulation NMS under the Exchange Act. [The
issue, in the case of an underlying security that is principally traded
on a national securities exchange, is delisted from trading on that
exchange and neither meets NMS criteria nor is traded through the
facilities of a national securities association, or the issue, in the
case of an underlying security that is principally traded through the
facilities of a national securities association, is no longer
designated as an NMS security.]
    vii. No Change.
    Subsection (c) through (j) No Change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend a BOX rule pertaining to the
continued approval of securities that underlie options traded on the
Exchange. Specifically, the Exchange proposes to eliminate section
4(b)(v) of Chapter IV of the BOX rules. Section 4(b)(v) of Chapter IV
of the BOX rules sets forth various situations under which an
underlying security previously approved for options trading will in
usual circumstances be deemed to no longer meet Exchange requirements
for the continuance of such approval. In such circumstances, section
4(b)(v) of Chapter IV of the BOX rules provides that the Exchange will
not open for trading any additional series of options in that class and
may also limit any new opening transactions in those options series
that have already be opened.
    Currently, section 4(b)(v) of Chapter IV of the BOX rules provides
that an underlying security will no longer be approved for options
trading on the Exchange when:
    ``(v) The issuer has failed to make timely reports as required by
applicable requirements of the Exchange Act or Rules thereunder, and
such failure has not been corrected within thirty (30) days after the
date the report was due to be filed.''\5\
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    \5\ Phrase ``or Rules thereunder'' added pursuant to telephone
conference between Bill Meehan, Assistant Vice President, Exchange,
and David L. Orlic, Attorney, Division of Market Regulation,
Commission, on December 7, 2005.
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    The Exchange proposes to eliminate this provision because it limits
investors' ability to use options to hedge existing equity positions in
such securities, and it is not necessary in the context of the rest of
section 4(b) of Chapter IV of the BOX rules.
    First, section 4(b)(v) of Chapter IV of the BOX rules can and does
impact investors' interests by preventing them from using new options
series to hedge positions they may hold in the underlying security of
companies that fail to make timely reports required by the Act. The
Exchange states that such a restriction is inconsistent with rules and
regulations in the markets for the underlying securities because no
similar trading restriction is placed upon the trading of the
underlying security itself. Thus, section 4(b)(v) of Chapter IV of the
BOX rules only serves to limit the abilities of shareholders in such
companies who may wish to hedge their positions with new options
series, at a time when the ability to hedge may be particularly
important.
    The Exchange believes that section 4(b)(v) of Chapter IV of the BOX
rules has outlived any usefulness and now serves to unnecessarily
burden and confuse the investing public. This provision was appropriate
when it was first implemented in or around 1976, when the listing and
trading of standardized options was still in its infancy and
information pertaining to public companies was not readily available to
the general investing public. The Exchange believes that today's listed
options market, however, is a mature one with investors who have access
to a significant amount of real-time market information to assist them
in making informed investment decisions, including information as to
whether companies have timely filed reports as required by the Act, and
if not, why not. Therefore, the Exchange states that there is no reason
to limit investors' ability to trade in options classes, including new
series within those classes, simply because a company is not timely in
filing its reports. The Exchange further advises that this restriction
is further misplaced, considering that investors are not similarly
restricted from buying or selling shares of the underlying security in
the equity markets.
    Moreover, the Exchange believes that section 4(b)(v) of Chapter IV
of the BOX rules limits an investors' ability to hedge his underlying
stock positions at a time when he may be in most need to protect his
investment. The failure of a public company to comply with its
reporting requirements under the Act could cause a significant movement
in the price of that company's stock. Restricting the Exchange from
opening new options series may leave investors without means to hedge
their positions with options contracts at strike prices that more
accurately reflect the contemporaneous price trends of the underlying
stock.
    Clearly, new options series on a security should not be permitted
to be opened if the underlying security ceases to be an NMS stock.
Typically, the Exchange becomes aware of issues that may impact the
continued listing of a security well before that security is delisted
from its primary market. Exchange staff routinely monitors daily press
releases and informational releases disseminated by various entities,
such as the primary listing market of a security and private news
services, in an effort to monitor the activities and news items
pertaining to the issuers of securities that underlie options traded on
the Exchange.\6\ In many cases, an issuer is given a substantial amount
of time to cure this deficiency before the primary market actually
delists the issuer's security. Many times, the issuer is able to comply
without its security ever being delisted. During this period, BOX staff
continually monitors the status of the issuer's compliance with its
reporting requirements to determine whether the security may be
delisted. Finally, the primary listing market typically issues a press
release well in advance of delisting an issuer's security to give
investors and other market participants adequate notice.
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    \6\ This is consistent with Section 4(d) of Chapter IV of the
BOX rules.
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    Given the availability of data and information relating to public
issuers of securities in today's markets, and in light of the extensive
amount of additional continued listing standards under section 4(b) of
Chapter IV of the BOX rules, the Exchange believes that waiting until a
security is actually delisted by its primary market is the appropriate
point at which to restrict the issuance of new options series in an
options class. Accordingly, the Exchange hereby proposes to eliminate
section 4(b)(v) of Chapter IV of the BOX rules.
    Additionally, as a matter of ``housekeeping,'' the Exchange also
proposes to clarify section 3(a)(i) and section (4)(b)(vi) of Chapter
IV of the BOX rules, which govern the criteria for the initial and
continued listing of options on a particular security, respectively.
Both of these provisions include as part of their criteria a
requirement that the underlying security must be a national market
system security (``NMS security''). As part of the recently adopted
Regulation NMS, among other things, the Commission revised the
definition of an NMS security.\7\ Specifically, Rule 600(b) under
Regulation NMS defines an NMS security as ``any security or class of
securities for which transaction reports are collected, processed, and
made available pursuant to an effective transaction reporting plan, or
an effective national market system plan for reporting transactions in
listed options.'' As such, each of these Rules will be amended to
reflect these new terms.
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    \7\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with

section 6(b) of the Act \8\ in general, and furthers the objectives of
section 6(b)(5) of the Act \9\ in particular, in that the elimination
of section 4(b)(v) of Chapter IV of the BOX rules will serve to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and is designed to promote just and equitable
principles of trade and to protect investors and the public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) by its terms,
does not become operative for 30 days after the date of filing, or such
shorter time as the Commission may designate, if consistent with the
protection of investors and the public interest, the proposed rule
change has become effective pursuant to section 19(b)(3)(A) of the Act
\10\ and subparagraph (f)(6) of Rule 19b-4 thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
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    The Exchange has requested that the Commission waive the five-day
pre-filing notice requirement and the 30-day operative delay period for
``non-controversial'' proposals and make the proposed rule change
effective and operative upon filing. The Commission believes that
waiver of the five-day pre-filing notice and the 30-day operative delay
is consistent with the protection of investors and the public interest
because this filing does not raise any novel issues. For this reason,
the Commission designates the proposal to be effective and operative
upon filing with the Commission.\12\
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    \12\ For the purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

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

File Number SR-BSE-2005-56 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-BSE-2005-56. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BSE-2005-56 and should be
submitted on or before January 5, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Jonathan G. Katz,
Secretary.
[FR Doc. E5-7369 Filed 12-14-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39035-39038]
[FR Doc No: 2021-15653]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0387]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recommended Content
of Medical Product Communications That Are Consistent With the Food and
Drug Administration-Required Labeling and Recommendations for Drug and
Device Manufacturer Communications With Payors, Formulary Committees,
and Similar Entities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 23, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control numbers for
the collections of information are 0910-0856 and 0910-0857. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

I. Medical Product Communications That Are Consistent With the FDA-
Required Labeling--Questions and Answers

OMB Control Number 0910-0856--Extension

    This information collection supports the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and FDA's implementing regulations that govern
drug and device labeling and prescription drug and restricted device
advertising. Section 502(a) of the FD&C Act (21 U.S.C. 352(a))
specifies that a drug or device shall be deemed to be misbranded if its
labeling is false or

misleading in any particular, and that labeling may be considered
misleading if it fails to reveal material facts about the product being
promoted, including facts that are material in light of the
representations made in a promotional piece (section 201(n) of the FD&C
Act (21 U.S.C. 321(n))). Similarly, under sections 201(n) and 502(n) of
the FD&C Act and FDA's implementing regulations (21 CFR 202.1(e)(5)(i)
and (iii)), an advertisement for a prescription drug must not be false
or misleading with respect to side effects, contraindications, or
effectiveness, or fail to reveal material facts about the product being
advertised, including facts that are material in light of the
representations made in a promotional piece. The FD&C Act also
specifies that restricted device advertisements must not be false or
misleading (section 502(q)(1)) and must reveal facts that are material
about the product being advertised (section 201(n)).
    To assist respondents with drug and device labeling requirements
and prescription drug and restricted device advertising, we developed
the guidance for industry entitled ``Medical Product Communications
That Are Consistent With the FDA-Required Labeling--Questions and
Answers'' (June 2018) (medical product communications guidance),
available at https://www.fda.gov/media/133619/download. This medical
product communications guidance includes recommendations that firms
consider when developing ``consistent with the FDA-required labeling
(CFL)'' presentations in their labeling and advertising materials to
help ensure the presentations are not false or misleading in violation
of the FD&C Act and FDA's implementing regulations. The guidance also
describes FDA's thinking when examining the consistency of a firm's
product communications with that product's own FDA-required labeling.
    As explained in the guidance, if a firm communicates information
that is not contained in its product's FDA-required labeling but that
is determined to be consistent with the FDA-required labeling, FDA does
not intend to rely on that communication to establish a new intended
use that is different from the use or uses for which the product is
legally marketed. Establishing a product's intended uses is an element
in establishing certain violations under the FD&C Act and Public Health
Service Act. Firms' communications about their products that are
consistent with the products' FDA-required labeling but that are false
or misleading may subject a firm to enforcement action under the FD&C
Act. Thus, the guidance not only describes FDA's thinking on
communications that are consistent with the FDA-required labeling, but
also provides general recommendations intended to help firms comply
with requirements in the FD&C Act and FDA's implementing regulations
for conveying information that is consistent with the FDA-required
labeling in a truthful and non-misleading way. The medical product
communications guidance recommends that firms accurately represent in
the communications any study results or other data and information that
are relied upon to support a firm's CFL promotional communication.
Other recommendations include the clear and prominent disclosure of
aspects of study design and methodology that are material for audiences
to accurately interpret the information being presented (e.g., type of
study, study objectives, product dosage and use regimens, control or
controls used, patient population studied), as well as material
limitations related to the study design, methodology, and results.
Also, the guidance recommends that firms accurately characterize and
contextualize the relevant information about the product, including by
disclosing unfavorable or inconsistent findings. In addition, the
guidance recommends that firms disclose material contextual information
from the FDA-required labeling in these communications, such as data
and information from studies in the FDA-required labeling that are
relevant to the data or information presented in the CFL promotional
communication.
    The recommendations will help ensure that health care professional
and consumer audiences receive truthful information about the benefits
and risks of drugs and devices in firms' CFL promotional communications
and that material contextual information is included in these
communications so that audiences are not misled. Accurate information
helps these audiences know whether drugs or devices may be appropriate
for them or their patients and know what they can expect to experience
when prescribing or using these products.
    In the Federal Register of May 10, 2021 (86 FR 24868), we published
a 60-day notice requesting public comment on the proposed collection of
information. Two comments were received; one appearing to question the
effectiveness of the information collection and the other offering its
support. Neither comment suggested FDA revise its estimate of the
attendant information collection.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                  Information collection activity                       Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324               30            9,720                4           38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since our last request for OMB approval, we have made no
adjustments to the currently approved burden estimate.

II. Recommendations for Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities

OMB Control Number 0910-0857--Extension

    This information collection also supports implementation of section
502(a) of the FD&C Act and applicable Agency regulations. Section
502(a)(1) of the FD&C Act provides that a drug or device is deemed to
be misbranded ``[i]f its labeling is false or misleading in any
particular.'' Under longstanding FDA practice and FDA's statute and
regulations, and under case law,

labeling encompasses more than merely the label of the drug, but
extends to other written, printed, or graphic matter ``accompanying
such article'' (section 201(m) of the FD&C Act; see also 21 CFR
1.3(a)). Section 502(a) of the FD&C Act also includes a provision about
communication of health care economic information (HCEI) to payors
through labeling or advertising. To assist respondents in this regard,
we developed the guidance for industry and review staff entitled ``Drug
and Device Manufacturer Communications With Payors, Formulary
Committees, and Similar Entities--Questions and Answers'' (June 2018)
(drug and device communications guidance), available at https://www.fda.gov/media/133620/download.
    This drug and device communications guidance includes
recommendations regarding information firms should include in HCEI for
prescription drugs if they choose to disseminate such materials (HCEI
materials) to payors, in accordance with section 502(a) of the FD&C
Act. Specifically, if a manufacturer communicates HCEI for approved
prescription drugs (including biological products that also meet the
definition of drug under the FD&C Act and approved or cleared medical
devices (collectively referred to as medical products)) to payors, FDA
recommends that firms include in HCEI materials disseminated to payors
information about: (1) Various aspects of study design and methodology
of an economic analysis (i.e., type of analysis, modeling technique,
patient population, perspective or viewpoint, treatment comparator,
time horizon, outcome measures, cost estimates, and assumptions); (2)
factors that limit generalizability of an economic analysis;
limitations to an economic analysis; and (3) sensitivity analyses, if
applicable, to allow for informed decision making by payors.
    Furthermore, FDA recommends that firms include other information
when disseminating HCEI materials, as applicable, to provide a balanced
and complete presentation. Such information includes a statement of the
FDA-approved indication of the drug and a copy of the most current FDA-
approved labeling. Under section 502(a) of the FD&C Act, firms must
also include a conspicuous and prominent statement to describe any
material differences between the HCEI and the FDA-approved labeling.
HCEI materials should also disclose whether certain studies or data
sources were omitted from an economic analysis and how the omission of
those studies or data sources may alter the conclusions presented in
the analysis. Moreover, FDA recommends that HCEI materials disclose
important risk information associated with the approved use of the
drug, and pursuant to section 502(a) of the FD&C Act, HCEI materials
must disclose any additional risk information related to assumptions
that vary from the approved labeling. In addition, HCEI materials
should disclose potential financial or affiliation biases to the extent
reasonably known by firms at the time of dissemination.
    The drug and device communications guidance provides similar
recommendations for HCEI materials disseminated to payors about
approved or cleared devices.
    If firms choose to make communications to payors about unapproved
products or unapproved uses of approved or cleared products, FDA
recommends that firms include a clear statement with their
communications that the product or use is not approved or cleared and
that the safety or effectiveness of the product or use has not been
established.
    In the Federal Register of May 10, 2021, we published a 60-day
notice requesting public comment on the proposed collection of
information. Two comments were received; one appearing to question the
effectiveness of the information collection and the other offering its
support. Neither comment suggested FDA revise its estimate of the
attendant information collection.
    We estimate the burden of this collection of information as
follows:

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
       Information collection activity            Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when               430          10.465           4,500  20.......................................          90,000
 firms choose to disseminate HCEI materials
 to payors about approved prescription drugs.
Recommended information to be included when               236              10           2,360  20.......................................          47,200
 firms choose to disseminate HCEI materials
 to payors about approved or cleared devices.
Recommended information to be included when               717               2           1,434  0.5 (30 minutes).........................             717
 firms choose to disseminate information
 about unapproved products or unapproved uses
 of approved or cleared products.
Followup information to payors regarding                  359               2             718  2........................................           1,436
 previously communicated information about
 unapproved products or unapproved uses of
 approved or cleared products.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............           9,012  .........................................         139,353
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have adjusted the estimate of burden we associate with the
information collection recommendations in the guidance to reflect an
increase of 2,000 hours and 100 responses annually.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15653 Filed 7-22-21; 8:45 am]
BILLING CODE 4161-01-P


TSCA Nanoscale Materials Inventory Paper: Public Comments with EPA
Responses

12/20/07

1) EPA-HQ-OPPT-2004-0122-0065.1 (David Rejeski, Director, Project on
Emerging Nanotechnologies)

“EPA is far too focused on the legal definition of a chemical
substances under TSCA....As J. Clarence Davies pointed out in his August
2 testimony, when TSCA was drafted in the early 1970s, no one had heard
of nanotechnology.  The TSCA paper fails to even acknowledge that the
legal constraint imposed by the definition of ‘chemical
substance’---developed nearly 40 years ago, well before the advent of
this wave of nano-engineered chemicals—is a problem.”

EPA response:

	As the commenter acknowledges, the definition of “chemical
substance” is a legal definition, one that EPA is not free to ignore
for policy reasons.  The federal government's current understanding is
that existing statutory authorities are adequate to address oversight of
nanotechnology and its applications.  As with any developing area, as
new information becomes available the federal government will adapt or
develop additional oversight approaches, as necessary, to address the
area of nanotechnology.  Congress has given EPA multiple tools in the
statute to assess and address existing chemical risks.   Several
provisions of TSCA are available as effective tools for assessing and
managing potential risks of nanoscale materials, for example:

Manage chemical substances which present “unreasonable risks” under
§6

Define through rulemaking “significant new uses” of chemical
substances and

	require notification to the Agency prior to such “significant new
uses” under    	5(a)(1)(B)

Receive statutorily required notifications of “substantial risk”
information from chemical manufacturers, processors, and distributors
under §8(e)

Require manufacturers and processors of chemical substances to submit
lists or copies of reasonably ascertainable health and safety studies
under §8(d)

Require manufacturers and processors to develop new test data on
chemicals under §4

Require manufacturers and processors to report information on chemical
use and exposures and other information under §8(a)

.

2) EPA-HQ-OPPT-2004-0122-0013 (Greenpeace)

“Engineered nanomaterials are sufficiently different from existing
materials that they are being patented, supporting their classification
as “new” materials under TSCA. The PCAST report (May, 2005) reported
that by searching a list of nanotechnology-related keywords, the US
Patent and Trademark Office has issued over 8,600 nanotechnology-related
patents in 2003.  This represents an increase of about 50% over the
number issued in 2000. Not only the U.S. is considering these materials
to be sufficiently innovative as to be patentable; according to the
PCAST report, nanotechnology-related patents in 2003 were also issued in
Japan (926), Germany (684), Canada (244), France (183), and other
countries to a lesser degree.”

EPA response:

The criterion for determining whether chemical substances are different
for TSCA Inventory purposes is based on the TSCA definition of chemical
substance in TSCA §3(2)(A): “the term ‘chemical substance’ means
any organic or inorganic substance of a particular molecular identity,
including (i) any combination of such substances occurring in whole or
in part as a result of a chemical reaction or occurring in nature….”

Determining whether chemical substances are different for TSCA Inventory
listing purposes therefore is based on differences in molecular
identity.  EPA does not believe that novelty under U.S. patent law 35
U.S.C. §102, as a factor in patentable differences between engineered
nanoscale materials and their corresponding existing macroscale
materials, necessarily supports their classification as “new”
substances under TSCA since 35 U.S.C. §102 novelty does not incorporate
the concept of molecular identity in TSCA §3(2)(A).

“We recommend that EPA develop an inventory for all engineered
nanomaterials. EPA maintains under TSCA Section 8(b) an information
Inventory that enables EPA to identify chemicals in commerce. It is
important that all engineered nanomaterials be included on an inventory
as distinct nano-scale materials, with distinct properties. The
inventory should be made publicly available in a transparent database or
repository that is accessible to both the US and International
community.”

EPA response:

The TSCA §8(b) Inventory is a list of chemical substances in commerce;
it is not an inventory of regulated materials or of materials with
specific concerns or properties.  Because EPA does not consider a
nanoscale version of a chemical to be a different chemical substance
from the macroscale version, the nanoscale version would not be listed
separately on the Inventory.  Furthermore, EPA keeps internal databases
with hazard and exposure data.  Since much of these databases include
confidential business information, they are not publicly available.  EPA
is aware of other organizations that are compiling hazard and/or
exposure databases on nanoscale substances and is interested in sharing
non-confidential data with these organizations and making such data
available to the public.

3)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0059.1_"  EPA-HQ-OPPT-2004-0122-0059.1

(J. Clarence Davies, Senior Advisor, Project on Emerging
Nanotechnologies)

“The policy enunciated in the paper flies in the face of the vast
majority of scientific evidence showing that size makes a difference.
The whole field of nanotechnology is based on this fact—materials are
engineered at the nanoscale in order to capitalize on the change in
properties at this small scale.”

“However, the proposed TSCA inventory policy says that EPA will ignore
this difference (“referred to particle size”), noting: “the
nanoscale and non-nanoscale forms are considered the same chemical
substance because they have the same molecular identity.”  Ironically,
there is a significant disconnect between the TSCA inventory policy and
EPA’s NMSP concept paper.  The latter states that size does matter
(even providing examples of size-dependent, novel, or enhanced
properties”) and that nanomaterials present new challenges that need
to be addressed.”

‘The proposed inventory policy undermines the use of TSCA to deal with
nanomaterials.  Under the policy, the Agency is not even able to
identify which new substances are nanomaterials, much less consider the
potential adverse effects from these materials since manufacturers
submitting notices are not required to reveal that a chemical is
nano-sized.  It is a policy that removes any real hope of using TSCA to
provide adequate oversight with respect to nanotechnology.  It is a
policy that takes an already weak statue and makes it a dead letter with
respect to nanotechnology.”

EPA response:

The TSCA Inventory is a list of chemical substances in commerce; it is
not  the mechanism by which EPA addresses concerns regarding specific
substances.  EPA therefore does not agree that there is a
“disconnect” between the Inventory and the NMSP concept papers.

	When reviewing chemical substances for potential risk to human health
and the environment under new and existing chemical sections of TSCA,
EPA does consider physical-chemical and fate properties, human health
and eco data, and exposure information.   EPA’s 28 years of experience
reviewing new chemicals has enabled the Agency to develop considerable
expertise in characterizing new chemical substances.  When reviewing
information on the chemical identity, physical properties, and the
manufacturing process for a new chemical substance, EPA generally has
adequate information or can make inquiries to the new chemical submitter
to determine if the new chemicals substance is produced in nanoscale
form. For review of nanoscale materials and as addressed in the NMSP
concept paper, EPA is interested in other relevant data including
particle size and properties.

EPA believes that its interpretation of TSCA is not only consistent with
the statute, but also one that makes considerable sense for
administration of the TSCA Inventory for the following reasons.  If EPA
were to determine that a difference in physical properties associated
with a form of a chemical substance could alone make it a new chemical
substance, it would create significant administrative and interpretive
difficulties under TSCA:

Although products of nanotechnology may exhibit properties or effects
that differ from non-nano counterparts, the differences are not always
dramatic.  Moreover, the same chemical substance can exhibit
dramatically different properties or effects in different forms in the
non-nano size range.  For example, for a number of substances (e.g.,
particulates, asbestos) important respiratory effects emerge at scales
above the nano range.. Thus, the same principles that are alleged to
make nanoscale materials eligible for new chemical treatment could apply
generally to physical forms of non-nanoscale chemicals, a concept at
odds with the structure of TSCA, and with the potential to greatly
expand both the size of the TSCA Inventory and the burdens for both
regulated entities and EPA.

The potential range of forms and physical properties associated with the
approximately 83,000 chemical substances on the TSCA Inventory is
extraordinarily large, and adoption of a policy under which such forms
and properties might render a chemical substance “new” would result
in significant uncertainty as to the Inventory status of industrial
chemicals.

A related consideration is that there is no clear, agreed on definition
of nanotechnology or of nanoscale materials.  Nanotechnology is not so
much a scientific term with a precise meaning as it is a description of
a range of processes and materials.  EPA sees no basis in the language
of TSCA or EPA’s current regulations to make regulatory distinctions
based on whether a material is deemed a product of nanotechnology.

Even if a focus on properties could somehow be limited to products of
nanotechnology, there can be different forms of some nanoscale
substances: different particle sizes within the nano range, different
agglomeration rates once released, different nanofilament lengths, just
to name a few.  And each may or may not have different properties.  For
example, quantum dots can be engineered at many different sizes
throughout the nanoscale to fluoresce at uniquely different frequencies.
  Under the approach suggested by the commenter, each form or size could
potentially be a different chemical substance.  The commenter suggests
that differences in properties would justify treating two materials as
different chemical substances, but EPA sees no basis in the statute or
regulations, and no basis from a scientific perspective, to delineate
how much novelty in terms of properties or other considerations would be
needed to distinguish a material as a new chemical substance.

Declaring nanosized materials to be per se new chemicals would be
regulation with a blunt instrument.  Some nanoscale materials have been
used for centuries, such as certain pigments in stained glass windows.
As stated above, some nanoscale materials have different properties,
some do not.  TSCA gives EPA more targeted regulatory tools, such as
Significant New Use Rules under §5(a)(2), information collection under
Section 8, or testing under Section 4 that provide for greater
flexibility.  Using these tools, EPA can draw meaningful lines and
address risk and other issues associated with nanotechnology as needed.

	The Agency’s interpretation is also consistent with the Council on
Environmental Quality’s November 8, 2007 Principles for Nanotechnology
Environmental, Health, and Safety Oversight1, which states,
“Regulation should focus where need exists and where scientific
information supports action (e.g. targeted to specific groups and
classes of materials instead of a “one-size-fits-all” approach).”

4)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0064.1_"  EPA-HQ-OPPT-2004-0122-0064.1

(Richard A. Denison, Senior Scientist, Environmental Defense)

“EPA’s approach is not required by precedent. EPA effectively says
it cannot consider particle size (and by implication, any other
nano-specific characteristics) to distinguish among substances on the
Inventory because it has not done so in the past. The first and simplest
response to this argument is that EPA may well not have needed or
recognized that it needed to make such distinctions before nanoscale
materials came along and rendered such distinctions critically
important. The real question is whether it can if it needs to. As we
have documented extensively elsewhere, EPA has ample authority under
TSCA to distinguish among chemical substances based on factors such as
physical properties and production processes. Moreover, we have shown
that it has actually done so where such factors are necessary to clearly
and unambiguously identify and name a substance or distinguish among
substances.  In its paper, EPA maintains that since EPA generally has
not considered units of matter beyond molecules, such as physical
aggregates, to be reportable under the TSCA Inventory, EPA has not used
particle size to distinguish for Inventory purposes two substances that
are known to have the same molecular identity. (page 4, emphasis added).
Putting aside EPA’s erroneous equating of molecular identity. with
chemical structure [here commenter references its May 22, 2006 letter to
EPA stating that the use of both the terms “molecular structure” and
“chemical identity” in TSCA §8(a)(2)(A) indicates that the two
terms must have different meanings],  one of EPA’s own examples cited
in the paper one page earlier (page 3) shows that it can take into
account more than strictly the chemical structure of a single molecule
in distinguishing among substances: EPA indicates that it has identified
different crystal lattice forms, each of which is comprised of the same
molecule (the example cited is the molecule titanium dioxide), as having
distinct molecular identities. It is very hard to understand why EPA was
able and willing to make the distinction in this example between two
super-molecular, aggregate (albeit regularly repeating) forms of the
same molecule, yet says it cannot do so in the case of nanoscale vs.
larger super-molecular aggregates.”

  HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0079.1_"  EPA-HQ-OPPT-2004-0122-0079.1

(George A. Kimbrell, The International Center for Technology Assessment;
Ian Illuminato Friends of the Earth)

“EPA can and has considered particle size or any other nano-specific
characteristics to distinguish nanomaterial substances from existing
chemicals. EPA has the authority under TSCA to distinguish between
chemicals based on physical properties and has done so in the past.
“Molecular identity” is not equivalent to “molecular formula.”
TSCA itself differentiates “molecular identity” from “chemical
structure.”

EPA response:

One commenter points out that “chemical identity” and “molecular
structure” are both used in TSCA § 8(a)(2), and argues that the two
terms must therefore have different meanings, and that “molecular
identity” must be different from “molecular structure.”  EPA
agrees that the terms can have distinct meanings in some circumstances,
but it does not follow that “molecular identity” is best read in a
way that allows two materials composed of the same molecules to be
considered different chemical substances based on particle size or
properties.

Although a nanomaterial with new properties may well be considered to
have a different form than a conventional counterpart (just as liquid
water may have a different form than ice), it does not necessarily
follow that it has a different “molecular identity” (liquid water
and ice are different physical forms of the same molecule, as dictated
by temperature and pressure).  For example, some nanomaterials are
produced simply by milling an existing non-nanomaterial to a small
particle size.  This smaller sized version may have different properties
from the non-nano version, but in no sense can it be said to have a
different molecular identity, or to be a different chemical.

As stated in the Inventory Paper, EPA views molecular identity as being
based on such structural and compositional features as the types and
number of atoms in the molecule, the types and number of chemical bonds,
the connectivity of the atoms in the molecule, and the spatial
arrangement of the atoms within the molecule.  EPA considers chemical
substances that differ in any of these structural and compositional
features to have different molecular identities. In some cases, these
structural and compositional features are relatively straightforward to
convey and this can often be done with either a chemical name or
molecular structure. In other cases, e.g., class 2 substances structural
and compositional features are not straightforward to convey.  In these
cases, chemical name and molecular structure can individually be
insufficient to represent molecular identity and as such are used in
combination, to the extent ascertainable by the PMN submitter, to
provide the best understanding of the molecular identity.

This approach is consistent with the statutory text.  EPA views
“chemical identity” as referring typically to a chemical’s formal
name (e.g., the Chemical Abstracts name based on 9th Collective Index
nomenclature rules) or, where needed, other information to identify the
chemical.  In most cases, a chemical’s CAS name conveys its structure.
 However, this will not always be the case.   EPA believes that Congress
included chemical identity in section 8(a)(2) in recognition of the
complexity of identification of commercially produced chemicals, and the
fact that a single, identifiable molecular structure will not always be
available.  In addition, Congress recognized that formal name and common
or trade name are commonly used to identify chemicals and included them
simply as pieces of identifying information.  (The fact that a chemical
is sold under two trade names, for example, would not lead to the
conclusion that each product is a different chemical.)

	Recognition by Congress of the complexities of chemical identification
does not signal that Congress intended EPA to ignore traditional
chemistry concepts in implementing TSCA.  On the contrary, the focus on
“molecular identity” is evidence that Congress intended traditional,
molecule-based approaches to chemical identification.    Congress chose
to subject only new chemical substances to pre-manufacture review.  The
commenters’ approach would treat materials as different chemical
substances even if the molecules of which they are composed are
identical in every respect.

Regarding the comment on super-molecular, chemical substances such as
metal oxides that have the same molecular formula (e.g., TiO2, titanium
dioxide) can have different spatial arrangements of atoms resulting in
different molecular structures in three dimensions.  Therefore they have
different molecular identities.  These different substances are not
different “super-molecular” forms, rather they are different
molecules, (e.g. orthorhombic brookite TiO2 has a different molecular
structure in three dimensions than tetragonal anatase TiO2).  EPA
therefore does not agree that it has distinguished between
“super-molecular” forms of the same molecule.

5)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0076.1_"  EPA-HQ-OPPT-2004-0122-0076.1

(Douglas Fratz, & Jane E. Wishneff, Consumer Specialty Products
Association)

“We are, however, concerned regarding one view taken by EPA in this
paper. EPA notes that it considers chemical substances to have different
molecular identities for the purposes of TSCA when they “have
different isotopes of the same elements.” CSPA has expressed in the
past its disagreement with this interpretation in terms of defining what
chemicals are “new” and therefore subject to Premanufacture
Notification (PMN) and related provisions of Section 5. Chemical
substance is defined by the statute in terms of molecular identity as
follows:

. . . . the term “chemical substance” means any organic or inorganic
substance of a particular molecular identity including — (i) any
combination of such substances occurring in whole or in part as a result
of a chemical reaction or occurring in nature and (ii) any element or
uncombined radical. (Emphasis added).

We believe that any attempt to define “chemical substance” in
sub-atomic terms (rather than purely in terms of molecular identities)
is inconsistent with TSCA, as well as many related existing EPA
regulations, policy statements or guidance documents. This concept was
previously considered and rejected by the Administration Law Judge in an
enforcement action against the Concord Trading Corporation in 1997, a
case in which EPA attempted to treat “depleted zinc oxide” (which
differs in isotopic distribution from normal zinc oxide, but has
identical molecular structure) as a new chemical and therefore subject
to PMN (Docket No. TSCA-94-H-19). We believe that this sixth and final
bullet relating to different isotopes should be eliminated, and chemical
substances considered to have different molecular identities for the
purposes of TSCA only when they meet one or more of the criteria in
bullets one through five.”

EPA-HQ-OPPT-2004-0122-0084.1

(William P. Gulledge, American Chemistry Council Nanotechnology Panel)

	“The sixth example addresses isotopes stating that EPA consider
substances that are identical other than the isotopic composition to
have different molecular identities.  The Panel recognizes that the TSCA
Inventory does include some compounds where the only difference is
isotopic composition (e.g., Hydrogen/Deuterium/Tritium; Water/Deuterium
Oxide).  Nevertheless, the Panel disagrees that isotopic composition
should be considered and urges EPA to withdraw this example from this
guidance document.”

EPA response:

The specific issue raised by the commenters is beyond the scope of the
Inventory paper.  Nonetheless, chemical substances containing different
isotopes of a given element have different molecular weights due to the
different atomic weights of the isotopes.  Substances having definite
differences in molecular weight are considered different chemical
substances for TSCA Inventory listing purposes.  The TSCA Inventory
includes numerous separate listings for certain isotopically distinct
chemical substances (e.g., water (H2O), which has a molecular weight of
18 is distinct from deuterated water (D2O), which has a molecular weight
of 20).  Therefore they have different chemical identities and molecular
structures.

The administrative judge in In the Matter of Concord Trading
Corporation, USEPA Docket. No. TSCA-94-H-19 (July 1997), did not reject
EPA’s interpretation that an isotopic difference can distinguish a new
chemical substance; the decision addressed only whether sufficient
information had been presented by EPA to support a motion for summary
decision in the specific case.

6)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0079.1_"  EPA-HQ-OPPT-2004-0122-0079.1

(George A. Kimbrell, The International Center for Technology Assessment;
Ian Illuminato Friends of the Earth)

“First, and in general, concerning the details of the document, we
strongly disagree with EPA’s proposed approach to determining TSCA
status of nanomaterials. EPA’s proposed approach constitutes an
unnecessarily cramped statutory interpretation that creates bad policy
and ignores the scientific realities of nanomaterials….”

“Thus, “traditional” or “historical” approaches used by EPA
and upon which EPA today unfortunately purports to apply to
nanomaterials will become less, not more applicable to nanomaterials.
Putting off what is needed today for another day exacerbates the risks
to workers, health and environment from these new materials.”

“EPA’s decision to “continue to apply its current Inventory
approaches” is unfortunate and unnecessary policy decision that is
belied by the current scientific understanding of nanotechnologies and
nanomaterials. Again, nanomaterials do not neatly fit under principles
of “traditional chemistry”, Newtonian physics, or bulk material
safety and toxicology testing methods. The adverse effects of
nanomaterials cannot be reliably predicted from the known toxicity of
the bulk material. Some experts recommend that up to sixteen
physicochemical parameters be evaluated -- a “far cry from the two or
three [parameters] usually measured” for bulk materials. Assuming
their safety or categorizing nanomaterials as equivalent to bulk
material counterparts ignores their fundamental differences and
associated hazards and unknowns.”

  HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jsp" \o "EPA-HQ-OPPT-2004-0122-0085"  EPA-HQ-OPPT-
2004-0122-0078.1

(National Institute for Occupational Safety and Health)

“NIOSH is concerned that failing to consider particle size in defining
new chemicals under TSCA does not take into consideration (the basic
principles of nanoscale properties, and (2) the goal of identifying,
assessing, and managing the potential hazard of chemical
substances....Nanoscale particles exhibit enhanced reactivity compared
to their bulk counterparts because of their high-specific surface
area....This size effect on reactivity can be due to many factors (e.g.,
proportion of surface sites at edges or corners, presence of distorted
high-altered surface regions, and quantum effects)....Such factors
appear to be consistent with the types of structural and compositional
features that EPA now considers in its determination of molecular
identity.”

EPA response:

The determination whether chemical substances are different for TSCA
Inventory listing purposes is a separate and distinct issue from EPA’s
information needs for reviewing materials for potential risk to human
health and the environment and deciding whether to take regulatory
action with respect to such materials.  In the latter, EPA does consider
information beyond what is normally relevant for bulk materials, and has
outlined a number of those types of data in the NMSP concept paper and
at the public meeting on Nanoscale Materials Characterization Peer
Consultation held in September 2007.

Further, EPA disagrees with NIOSH’s contention that, by not
considering size in defining new chemicals under TSCA, EPA does not take
into consideration nanoscale properties and the goal of identifying,
assessing, and managing the potential hazard of chemical substances.
When EPA identifies, assesses and manages chemical substances that are
nanoscale materials, for example as new chemical submissions under TSCA
§5 or submissions under the NMSP, the Agency will fully consider
available information on the nanoscale properties of the chemical
substances.  As noted in the paragraph above, the Agency has already
identified a number of types of nanoscale property data that would be
useful to the Agency as it conducts such reviews.  EPA also disagrees
with the assertion that size effects on reactivity are consistent with
the kinds of structural and compositional features that EPA considers in
determining molecular identity.

7)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0079.1_"  EPA-HQ-OPPT-2004-0122-0079.1

(George A. Kimbrell, The International Center for Technology Assessment;
Ian Illuminato Friends of the Earth)

“The paper makes no mention of TSCA §5 significant new use rules
(SNURs) as a possible means of nanomaterial oversight under TSCA. While
there might be problems with any such approach, EPA’s failure to even
acknowledge the statutory pathway or address potential advantages or
deficiencies is further evidence of EPA’s abdication of its statutory
responsibilities to protect health and the environment.”

EPA response:

The Inventory paper is limited to issues regarding when a nanomaterial
may be considered a different chemical substance from one that is
otherwise the same except in macroscale form; the paper is not intended
to comprehensively address EPA’s regulatory authorities with respect
to nanoscale substances.  TSCA §5 (a)(2) SNURs, are addressed in the
NMSP Concept Paper.

8)   HYPERLINK
"http://www.regulations.gov/fdmspublic/custom/jsp/search/searchresult/do
cketDetail.jspHQ-OPPT-2004-0122-0080.1_"  EPA-HQ-OPPT-2004-0122-0080.1

(Mark G. Herwig, The General Electric Company)

“[T]he proposed Inventory status regime stops completely at the
molecular identity phase, and does not include any determinant factor
related to “novel” properties for purposes of Inventory status.
What this translates to is a nanoscale material of a non-nano scale
material, currently Inventory listed or exempt, would not require any
further TSCA Section 5 action.  On the contrary however, where there is
reference to differing spatial arrangements of atoms of a similar
nanoscale substance (i.e. carbon nanotubes [CNT]), would in each case,
be considered a new chemical substance under TSCA, even though its
physical and chemical properties are nearly identical – thereby
requiring TSCA Section 5 action for each form of CNT manufactured or
imported.  GE strongly recommends that the Agency revisit this,
including the wealth of information exchanged during the recent Peer
Consultation on Material Characterization, in determining how nanoscale
materials should be managed under TSCA for Inventory and NMSP reporting
purposes.”

EPA response:

Chemical substances on the TSCA Inventory are not subject to TSCA §5
new chemicals requirements but may be subject to review by EPA under the
existing chemicals provisions of TSCA.

Regarding carbon nanotubes, EPA encourages potential manufacturers to
submit a  bona fide intent to manufacture or import notice with the
required supporting data and EPA will make determinations on specific
cases.  EPA is hoping to better understand this issue based on reporting
as new chemicals under TSCA §5, and augmented with additional
information reported/developed under the NMSP

9)   HYPERLINK
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cketDetail.jsp" \o "EPA-HQ-OPPT-2004-0122-0085"
EPA-HQ-OPPT-2004-0122-0087

(Mark Duvall, The Dow Chemical Company)

“EPA should provide much more detailed guidance on how to classify
nanomaterials as new or existing chemicals, and should clarify whether
carbon nanotubes are different than graphite or carbon for Inventory
purposes.”

EPA response:

The Inventory paper states that carbon nanotubes and fullerenes are
currently considered to be new chemical substances because their
molecular identities are different from the carbon allotropes (e.g.,
carbon and graphite) currently listed on the TSCA Inventory (a carbon
nanotube and a fullerene have yet to be added to the Inventory).   EPA
will provide guidance in the future on determining the TSCA Inventory
status of nanoscale substances and in the interim will provide more
clarity on a case by case basis.

 Council on Environmental Quality’s November 8, 2007 Principles for
Nanotechnology Environmental, Health, and Safety Oversight,
http://www.ostp.gov/html/Nano%20EHS%20Principles%20Memo_OSTP-CEQ_FINAL.p
df

 See 40 CFR §720.25.

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