[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36590-36592]
[FR Doc No: 2023-11899]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4656]

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug
Development Programs for Treatment; Revised Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug
Development Programs for Treatment.'' This draft guidance is intended
to revise and replace the current draft guidance for industry entitled
``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing
Effectiveness of Drugs for Treatment'' issued on December 5, 2019. This
draft guidance provides recommendations for drug development programs
for drugs intended to treat patients with interstitial cystitis/bladder
pain syndrome (IC/BPS).

DATES: Submit either electronic or written comments on the draft
guidance by August 4, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4656 for ``Interstitial Cystitis/Bladder Pain Syndrome:
Establishing Drug Development Programs for Treatment.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-002, 301-
796-3993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Interstitial Cystitis/Bladder Pain Syndrome:
Establishing Drug Development Programs for Treatment.'' IC/BPS is a
complex, poorly understood heterogeneous syndrome of unknown etiology.
This draft guidance provides recommendations to assist applicants in
developing products intended for treatment of IC/BPS. As with the 2019
draft guidance, this draft guidance incorporates advice FDA received at
a December 2017 advisory committee meeting on appropriate patient
selection criteria and trial design features, including enrollment
criteria and acceptable efficacy endpoints for drugs intended to treat
IC/BPS.
    This draft guidance encourages sponsors to assess dosing
strategies, explore multiple efficacy endpoints, and collect safety
information during early drug development to inform design strategy and
selection of clinically meaningful endpoints for later clinical trials.
This draft guidance also provides advice on enrollment criteria,
efficacy endpoints, and other considerations for clinical trials to
support an IC/BPS indication. This draft guidance provides
recommendations based on the Agency's current thinking on the
development of patient-reported outcomes to evaluate patient symptoms
to demonstrate a clinically meaningful change with treatment for this
condition.
    This draft guidance revises and provides updates to the draft
guidance entitled ``Interstitial Cystitis/Bladder Pain Syndrome (IC/
BPS): Establishing Effectiveness of Drugs for Treatment'' issued on
December 5, 2019 (84 FR 66681). FDA considered comments received on the
2019 draft guidance in revising the draft guidance. Changes from the
2019 draft guidance include discussion of early drug development
considerations, selection of patient outcomes for development, and
clarification of evaluation of Hunner's lesions. In addition, editorial
changes made to improve clarity include revised references to current
Agency guidances on patient-reported outcomes and updated clinical
considerations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the current thinking of FDA on
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug
Development Programs for Treatment.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 relating investigational new drug
applications, including clinical trial design and study protocols, have
been approved under OMB control number 0910-0014.

III. Electronic Access

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

guidance-documents, or https://www.regulations.gov.

    Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11899 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)]
[Notices]
[Pages 44096-44098]
[FR Doc No: 2018-18676]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83925; File No. SR-CboeBYX-2018-017]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use on Cboe BYX Exchange, Inc.

August 23, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 9, 2018, Cboe BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the Exchange's fee schedule
applicable to its equities trading platform to: (1) Increase the ADV
requirements to qualify for Add/Remove Volume Tier 6 associated with
fee codes W, BB, and N, and (2) increase the routing fee charged to
orders routed to Investors Exchange LLC using the Destination Specific
routing strategy under fee code IX, and eliminate an outdated reference
to the TRIM and TRIM2 routing strategies in this fee code.
    The text of the proposed rule change is available at the Exchange's
website at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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 parts of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
fee schedule applicable to its equities trading platform (``BYX
Equities'') to: (1) Increase the ADV \5\ requirements to qualify for
Add/Remove Volume Tier 6 associated with fee codes W,\6\ BB,\7\ and
N,\8\ and (2) increase the routing fee charged to orders routed to
Investors Exchange LLC (``IEX'') using the Destination Specific \9\
routing strategy under fee code IX,\10\ and eliminate an outdated
reference to the TRIM and

TRIM2 \11\ routing strategies in this fee code.
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    \5\ ``ADAV'' means average daily added volume calculated as the
number of shares added per day and ``ADV'' means average daily
volume calculated as the number of shares added or removed,
combined, per day. See BYX Fee Schedule, Definitions. ADAV and ADV
are calculated on a monthly basis. The Exchange excludes from its
calculation of ADAV and ADV shares added or removed on any day that
the Exchange's system experiences a disruption that lasts for more
than 60 minutes during regular trading hours (``Exchange System
Disruption''), on any day with a scheduled early market close and on
the last Friday in June (the ``Russell Reconstitution Day''). Routed
shares are not included in ADAV or ADV calculation. With prior
notice to the Exchange, a Member may aggregate ADAV or ADV with
other Members that control, are controlled by, or are under common
control with such Member (as evidenced on such Member's Form BD).
    \6\ W is associated with orders that remove liquidity from BYX
in Tape A securities.
    \7\ BB is associated with orders that remove liquidity from BYX
in Tape B securities.
    \8\ N is associated with orders that remove liquidity from BYX
in Tape C securities.
    \9\ Destination Specific is a routing option under which an
order checks the System for available shares and then is sent to an
away trading center or centers specified by the User. See Rule
11.13(b)(3)(E).
    \10\ IX is associated with orders routed to IEX using the
Destination Specific, TRIM or TRIM2 routing strategies.
    \11\ TRIM and TRIM2 are both routing options under which an
order checks the System for available shares and then is sent to
destinations on the applicable System routing table. See Rule
11.13(b)(3)(G).
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Fee Codes W, BB, and N: Add/Remove Volume Tier 6
    The Exchange provides a standard rebate of $0.00050 for orders that
remove liquidity from BYX in securities priced at or above $1.00.
Members may also qualify for a higher rebate based on the Exchange's
Add/Remove Volume Tiers, which are designed to encourage Members to
bring order flow to BYX by providing higher rebates for removing
liquidity and discounted fees for adding liquidity to firms based on
their activity on the Exchange.\12\ Currently, Members can qualify for
a higher rebate of $0.0015 pursuant to Tier 6 of the Add/Remove Volume
Tiers if the Member has: (1) An ADV that is greater than or equal to
0.05% of TCV,\13\ and (2) an ADAV that is greater than or equal to
500,000 shares. The Exchange proposes to increase the ADV requirement
for Tier 6 so that an ADV that is greater than or equal to 0.08% of TCV
would be required. The current ADAV requirement of greater than or
equal to 500,000 shares would remain unchanged. The proposed change
applies to fee codes W, BB, and N, which relate to orders that remove
liquidity from BYX in Tapes A, B, and C, respectively.
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    \12\ See BYX Fee Schedule, footnote 1, Add/Remove Volume Tiers.
    \13\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply. The Exchange excludes from its calculation of TCV volume
on any day that the Exchange experiences an Exchange System
Disruption, on any day with a scheduled early market close and the
Russell Reconstitution Day.
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Fee Code IX: IEX Routing Fees
    Currently, the fee schedule provides that orders in securities
priced at or above $1.00 routed to IEX using specified routing
strategies--i.e., Destination Specific, TRIM, or TRIM2--are charged a
fee of $0.0010 per share under fee code IX. The Exchange proposes to
increase the routing fee charged to orders routed to IEX to $0.0030 so
that the Exchange can recoup increased costs associated with routing
order flow to that market. Furthermore, in May 2018, the Exchange
removed IEX from the System routing table for its TRIM and TRIM2
routing strategies, which are designed to route to low cost away
markets, due to increased costs associated with routing to IEX. Since
IEX is no longer considered as a potential routing destination for
those strategies, the Exchange proposes to eliminate the reference to
these routing strategies in fee code IX.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\14\ in general, and
furthers the objectives of Section 6(b)(4) and 6(b)(5),\15\ in
particular, as it is designed to provide for the equitable allocation
of reasonable dues, fees and other charges among its members and other
persons using its facilities and is designed to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, 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.
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    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(4) and (5).
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Fee Codes W, BB, and N: Add/Remove Volume Tier 6
    The Exchange believes that the proposed changes to the Add/Remove
Volume Tier 6 are reasonable because the proposed changes are designed
to incentivize Members to bring more order flow to the Exchange. Under
the Exchange's fee schedule members are eligible for a rebate for
liquidity removing orders that may be increased based on meeting
certain additional requirements. With respect to Add/Remove Volume Tier
6, Members that meet specified ADV and ADAV requirements are eligible
for such an increased remove rebate. The Exchange is proposing to
increase the ADV requirements for this rebate tier to encourage Members
to send more order flow to the Exchange in order to qualify for the
rebate. The Exchange believes that the rebates are still competitive
with rebates provided on other equities exchanges, notwithstanding the
higher volume requirements required to meet this tier. The Exchange
also believes that the proposed change is equitable and not unfairly
discriminatory because the proposed ADV requirements (and associated
rebate) would apply equally to all Members. Furthermore, the Exchange
believes that all market participants would benefit from additional
trading opportunities if the Exchange is successful in incentivizing
increased order flow.
Fee Code IX: IEX Routing Fees
    As other exchanges amend the fees charged for accessing liquidity,
the Exchange believes that it is appropriate to amend its own routing
fees so that it can recoup costs associated with routing orders to such
away markets. The Exchange believes that the proposed fees for orders
routed to IEX are reasonable because they reflect the costs associated
with executing orders on IEX and additional operational expenses
incurred by the Exchange. The Exchange is proposing to increase its
routing fees due to an announced change in IEX's fee schedule that
would result in a significant increase in the transaction fees being
charged by IEX to some orders, including orders routed by the
Exchange.\16\ The Exchange believes that it is reasonable to pass these
increased costs to Members that use the Exchange to route orders to
that market. Members that do not wish to pay the proposed fee can send
their routable orders directly to IEX instead of using routing
functionality provided by the Exchange. The Exchange also believes that
this change is equitable and not unfairly discriminatory because the
proposed fees would apply equally to all Members that use the Exchange
to route orders to IEX using the Destination Specific routing strategy.
Routing through the Exchange is voluntary, and the Exchange operates in
a competitive environment where market participants can readily direct
order flow to competing venues or providers of routing services if they
deem fee levels to be excessive.
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    \16\ See SR-IEX-2018-16 (pending publication).
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    The Exchange also believes that the proposed change to eliminate
references to TRIM and TRIM2 is consistent with the public interest and
the protection of investors as this is a non-substantive change being
made because the Exchange no longer routes to IEX using these routing
strategies. The Exchange had previously routed orders to IEX using the
TRIM and TRIM2 order routing strategies, which are designed to route to
low cost venues, but recently stopped doing so due increased routing
costs associated with trading on IEX. As such, the Exchange believes
that updating the fee schedule to reflect that these two routing
strategies are not available for routing to IEX will increase
transparency around the operation of the Exchange to the benefit of
Members and investors. Because this change merely updates a fee code to
remove references to routing strategies that are not in use on the
Exchange, it will have

no impact on the transaction fees actually assessed to Members.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposed changes to the Add/Remove Tiers are designed to incentivize
Members to bring more order flow to BYX as the Exchange competes for
order flow with other equities markets. Furthermore, the proposed
changes to the IEX routing fees are meant to recoup costs associated
with executing orders on that market, and to increase transparency by
properly reflecting the routing strategies available for IEX, and are
therefore not designed to have any significant impact on competition.
The Exchange operates in a highly competitive market in which market
participants can readily direct their order flow to competing venues.
In such an environment, the Exchange must continually review, and
consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \17\ and paragraph (f) of Rule 19b-4
thereunder.\18\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
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 furtherance of the purposes of the Act.
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 email to [email protected]. Please include
File Number SR-CboeBYX-2018-017 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeBYX-2018-017. This
file number should be included on the subject line if email 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing will also be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBYX-2018-017 and should be submitted
on or before September 19, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-18676 Filed 8-28-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Proposed Rules]
[Pages 20062-20070]
[FR Doc No: 2019-09335]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2019-0038; FRL-9992-67]

TSCA Section 21 Petition To Initiate a Reporting Rule Under TSCA
Section 8(a) for Asbestos; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition for rulemaking; denial.

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SUMMARY: This document provides the reasons for EPA's response to a
January 31, 2019, petition it received under section 21 of the Toxic
Substances Control Act (TSCA) from the Attorneys General of
Massachusetts, California, Connecticut, Hawaii, Maine, Maryland,
Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island,
Vermont, Washington, and the District of Columbia (``petitioners'').
Generally, the petitioners requested that EPA initiate a rulemaking
proceeding under TSCA section 8(a) for the reporting of the manufacture
(including import) and processing of asbestos. After careful
consideration, EPA denied the petition for the reasons discussed in
this document.

DATES: EPA's response to this TSCA section 21 petition was signed April
30, 2019.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Tyler Lloyd, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to those persons who manufacture
(which includes import) or process or may manufacture or process the
chemical asbestos (general CAS No. 1332-21-4). Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action.

B. How can I access information about this petition?

    The docket for this TSCA section 21 petition, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0038, is available at
https://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21, (15 U.S.C. 2620), any person can petition
EPA to initiate a rulemaking proceeding for the issuance, amendment, or
repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth
the facts which it is claimed establish that it is necessary to
initiate the action requested. EPA is required to grant or deny the
petition within 90 days of its filing. If EPA grants the petition, the
Agency must promptly commence an appropriate proceeding. If EPA denies
the petition, the Agency must publish its reasons for the denial in the
Federal Register. A petitioner may commence a civil action in a U.S.
district court to compel initiation of the requested rulemaking
proceeding either within 60 days of either a denial or, if EPA does not
issue a decision, within 60 days of the expiration of the 90-day
period.

B. What criteria apply to a decision on a TSCA section 21 petition?

    TSCA section 21(b)(1) requires that the petition ``set forth the
facts which it is claimed establish that it is necessary to issue,
amend or repeal a rule.'' 15 U.S.C. 2620(b)(1). TSCA section 8(a)(1),
the section under which petitioners request the EPA to act here,
authorizes the EPA Administrator to promulgate rules under which
manufacturers (including importers) and processors of chemical
substances must maintain such records and submit such information as
the EPA Administrator may reasonably require (15 U.S.C. 2607). TSCA
section 8(a)(2) outlines the information that the EPA Administrator may
require under TSCA section 8(a)(1), insofar as it is known to the
person making the report or insofar as reasonably ascertainable. Under
TSCA section 8(a), EPA has promulgated several data collection rules,
such as the Chemical Data Reporting (CDR) rule at 40 CFR part 711,
which covers asbestos.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On January 31, 2019, the Attorneys General of Massachusetts,
California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New
Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont,
Washington, and the District of Columbia (petitioners) petitioned EPA
to initiate a rulemaking proceeding under TSCA section 8(a) for the
reporting of the manufacture, import, and processing of asbestos (Ref.
1).
    The petitioners requested specific TSCA section 8(a) reporting
requirements for asbestos in order to collect information for the
ongoing asbestos risk evaluation being conducted under TSCA section
6(b), which is to be completed by December 22, 2019 (15 U.S.C.
2605(b)(4)(G)(i)) and no later than June 22, 2020 if EPA exercises a
six-month extension (15 U.S.C. 2605(b)(4)(G)(ii)), and, if necessary,
for any subsequent risk management decisions under TSCA section 6(a).
The petitioners specifically requested that EPA:
     Eliminate any applicability of the ``naturally occurring
substance'' (NOCS) exemption in the CDR for asbestos reporting;
     Apply the CDR reporting requirements to processors of
asbestos, as well as manufacturers (including importers) of the
chemical substance;
     Eliminate any applicability of the impurities exemption in
the CDR for asbestos reporting; and
     Eliminate any applicability of the articles exemption in
the CDR with respect to imported articles that contain asbestos.

B. What support do the petitioners offer?

    The petitioners request that EPA initiate a rulemaking proceeding
under TSCA section 8(a) ``to address infirmities in asbestos
reporting'' under EPA's CDR rule at 40 CFR 711. In support of their
request, the petitioners state that ``[r]obust reporting of the
importation and use of asbestos in the U.S. is necessary for EPA to
satisfy its statutory mandate under TSCA section 6(a) to establish
requirements to ensure that asbestos does not present an unreasonable
risk of injury to health or the environment and for states and the
public to have access to data necessary to themselves evaluate such
risks'' (Ref. 1).
    The petitioners present their views as to EPA's need for
``comprehensive data with respect to the manufacture (including import)
and use of asbestos in the U.S.'' when conducting the asbestos risk
evaluation and undertaking any potential subsequent risk management
actions. The petitioners conclude that such data are not being
collected under the current CDR rule. Several times in their request,
the petitioners cite EPA's response to a previous petition filed under
TSCA section 21 by the Asbestos Disease Awareness Organization (ADAO)
and five other non-governmental organizations. In that petition, which
EPA received on September 27, 2018, ADAO and others requested that EPA
initiate rulemaking proceedings under TSCA section 8(a) to amend the
CDR rule to increase reporting of asbestos to CDR (Ref. 2). EPA denied
the petition on December 21, 2018, on the grounds that the petitioners
did not demonstrate that it is necessary to amend the CDR rule (84 FR
3396, February 12, 2019) (FRL-9988-56). The petition from ADAO et al.
and EPA's response are in Docket ID

No. EPA-HQ-OPPT-2018-0682 at https://www.regulations.gov.
    The CDR rule, which is one of several reporting rules promulgated
under TSCA section 8(a), requires manufacturers (including importers)
to provide EPA with information on the production and use of chemicals
in commerce, generally 25,000 pounds or more of a chemical substance at
any single site, with a reduced reporting threshold (2,500 pounds)
applying to chemical substances subject to certain TSCA actions,
including, as applicable here, actions taken under TSCA section 6.
    While asbestos is already required to be reported under the CDR
rule by manufacturers (including importers) meeting certain criteria,
the petitioners point out that CDR exempts from reporting chemicals,
like asbestos, that are naturally occuring chemical substances, present
as an impurity, or incorporated into an article. Additionally, the
petitioners note that CDR does not require reporting from processors of
chemical substances.
    The petitioners assert that ``[a]ny TSCA risk evaluation that EPA
conducts without access to accurate and complete asbestos data cannot
satisfy TSCA's risk evaluation criteria, including TSCA's requirement
that EPA use the `best available science' in carrying out TSCA's
mandate to eliminate unreasonable risk of injury to health or the
environment presented by the manufacture (including importation),
processing, distribution in commerce, use, or disposal of a toxic
chemical substance'' (Ref. 1).
    Petitioners contend that the requested action under TSCA section
8(a) ``would enable EPA to present and rely on a complete set of
domestic data about the amount, and uses, of asbestos, is consistent
with those goals and with the statute's requirements'' (Ref. 1).
    In their request, the petitioners state that ``[a]sbestos is a
known human carcinogen and there is no safe level of exposure to this
highly toxic material ubiquitous in our built environment'' (Ref. 1).
The petitioners cite research finding dangers from asbestos and provide
a review of asbestos assessments and regulations under federal and
state law.
    In their petition, they state that in 1989, EPA concluded that
``asbestos is a highly potent carcinogen regardless of the type of
asbestos or the size of the fiber'' and assert that ``EPA has long
possessed an abundance of information that supports aggressive
regulatory actions to protect the public from asbestos disease risks''
(Ref. 1).
    The petitioners restate their belief that EPA has ``chos[en] to put
on blinders and ignore some of the most meaningful data with respect to
risks of exposure to the chemical substance'' (Ref. 1), a view which
many of the petitioning Attorneys General first expressed in comments
on EPA's Problem Formulation of the Risk Evaluation for Asbestos (83 FR
26998, June 11, 2018) (FRL-9978-40). Moreover, the petitioners cite
language in the Problem Formulation that states that ``import volumes
of products containing asbestos is [sic] unknown'' (Ref 1). The
petitioners assert that EPA's response to the ADAO Petition directly
contradicts what EPA stated in the Problem Formulation.

IV. Background Considerations: Review of EPA Actions, Activities, and
Regulations

    To understand EPA's reasons for denying the petitioners' requests,
it is important to first review the details of EPA's ongoing risk
evaluation of asbestos, existing TSCA section 8(a) rules including the
CDR rule, general exemptions for TSCA section 8(a) rules, and past
reporting of asbestos under TSCA section 8(a). These details are
explained in the following units.

A. Risk Evaluation of Asbestos

    On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the
21st Century Act (Pub. L. 114-182) amended TSCA (15 U.S.C. 2601 et
seq.). The new law includes statutory requirements mandating that EPA
conduct risk evaluations for existing chemicals. On December 19, 2016
(81 FR 91927) (FRL-9956-47), EPA designated asbestos as one of the
first 10 chemical substances subject to the Agency's initial chemical
risk evaluations pursuant to TSCA section 6(b)(2)(A) (15 U.S.C.
2605(b)(2)(A)), which required EPA to identify the first 10 chemicals
to be evaluated no later than 180 days after the date of enactment of
the Act.
    EPA is currently evaluating the risks of asbestos under its
conditions of use, pursuant to TSCA section 6(b)(4)(A). Through scoping
and subsequent research for the asbestos risk evaluation, EPA
identified the conditions of use of asbestos, including imported raw
bulk chrysotile asbestos for the fabrication of diaphragms for use in
chlorine and sodium hydroxide production; several imported chrysotile
asbestos-containing materials, including sheet gaskets in chemical
manufacturing where extremely high temperatures are needed; brake
blocks for oil drilling; aftermarket automotive brakes/linings; other
vehicle friction products; and other gaskets (Ref. 3). In identifying
the conditions of use for asbestos and the rest of the first 10
chemicals undergoing risk evaluation under amended TSCA, EPA included
use information reported under the CDR rule. In addition to using CDR
data to identify the current conditions of use of asbestos, EPA
conducted extensive research and outreach. This included EPA's review
of published literature and online databases including Safety Data
Sheets (SDSs), the United States Geological Survey's Mineral
Commodities Summary and Minerals Yearbook, the U.S. International Trade
Commission's Dataweb, and government and commercial trade databases.
(See Docket ID No. EPA-HQ-OPPT-2016-0736). EPA's review of these data
sources served as the basis for the conditions of use of asbestos.
Additionally, EPA worked with its Federal partners, such as Customs and
Border Protection, to enhance its understanding of import information
on asbestos-containing products in support of the risk evaluation.
    EPA also reviewed company websites of potential manufacturers,
importers, distributors, retailers, or other users of asbestos and
received public comments (1) during the February 2017 public meeting on
the scoping efforts for the risk evaluations for the first ten
chemicals, (2) when EPA published the Scope of the Risk Evaluation for
Asbestos in June 2017, and (3) when EPA published the Problem
Formulation of the Risk Evaluation for Asbestos in June 2018, all of
which were used to identify the conditions of use. (See Docket ID No.
EPA-HQ-OPPT-2016-0736). In addition, to inform EPA's understanding of
the universe of conditions of use for asbestos for the scope document
published in June 2017, EPA convened meetings with companies, industry
groups, chemical users, and other stakeholders (Ref. 3). Lastly, on
June 11, 2018 (83 FR 26922; FRL-9978-76), EPA proposed a significant
new use rule (SNUR) under TSCA section 5, in an administrative proposal
separate and apart from the ongoing risk evaluation process under TSCA
section 6, for certain uses of asbestos (including asbestos-containing
products) and specifically asked for public comment or information on
ongoing uses of asbestos. In the public comments submitted on the SNUR,
EPA received no new information on any ongoing uses. (See Docket ID No.
EPA-HQ-OPPT-2018-0159).
    In the Asbestos Problem Formulation document, based on the
aforementioned outreach and research, EPA did not identify any
conditions of use of

asbestos as an impurity. In EPA's Asbestos Problem Formulation for the
Risk Evaluation (Ref. 3), the Agency identified the conditions of use
as imported raw bulk chrysotile asbestos for the fabrication of
diaphragms for use in chlorine and sodium hydroxide production; and
several imported chrysotile asbestos-containing materials, including
sheet gaskets; brake blocks for oil drilling, aftermarket automotive
brakes, linings, and other vehicle friction products; and other
gaskets.
    The purpose of EPA's risk evaluation is to determine whether a
chemical substance presents an unreasonable risk to health or the
environment, under the conditions of use, including an unreasonable
risk to a relevant potentially exposed or susceptible subpopulation (15
U.S.C. 2605(b)(4)(A)). As part of this process, EPA must evaluate both
hazard and exposure, excluding consideration of costs or other non-risk
factors, use scientific information and approaches in a manner that is
consistent with the requirements in TSCA section 26 for the best
available science, and ensure decisions are based on the weight of
scientific evidence. EPA intends to finalize the risk evaluation for
asbestos by December 2019, the deadline that Congress set in TSCA. EPA
acknowledges the statute provides that EPA may extend the deadline to
complete a risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)).
As discussed in Unit V.A., even if EPA were to exercise this extension
authority in the case of the ongoing asbestos risk evaluation, that
would not affect the Agency's reasons for denying this petition.

B. TSCA Section 5(a) SNUR and Asbestos

    On April 17, 2019, EPA signed the SNUR for asbestos and asbestos-
containing products (84 FR 17345, April 25, 2019; FRL-9991-33). Section
5(a)(2) of TSCA, as amended by the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, authorizes EPA to determine that a use of a
chemical substance is a ``significant new use.'' Once EPA determines
that a use of a chemical substance is a significant new use, TSCA
section 5(a)(1) requires persons to submit a significant new use notice
(SNUN) to EPA at least 90 days before they manufacture (including
import) or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)(i)). TSCA prohibits the manufacturing (including
importing) or processing from commencing until EPA has conducted a
review of the notice, made an appropriate determination on the notice,
and taken such actions as are required in association with that
determination (15 U.S.C. 2604(a)(1)(B)(ii)). Those actions could
include a prohibition on a use of that chemical substance.
    For that SNUR, the significant new use of asbestos is manufacturing
(including importing) or processing for uses that are neither ongoing
nor already prohibited under TSCA. The following uses are subject to
the SNUR: Adhesives, sealants, and roof and non-roof coatings; arc
chutes; beater-add gaskets; cement products; extruded sealant tape and
other tape; filler for acetylene cylinders; friction materials (with
certain exceptions); high-grade electrical paper; millboard; missile
liner; packings; pipeline wrap; reinforced plastics; roofing felt;
separators in fuel cells and batteries; vinyl-asbestos floor tile;
woven products; any other building material; and any other use of
asbestos that is neither ongoing nor already prohibited under TSCA.
    The asbestos SNUR prohibits these discontinued uses of asbestos
from restarting without EPA having an opportunity to evaluate each
intended use (i.e., significant new use) for potential risks to health
and the environment and take any necessary regulatory action, which may
include a prohibition. The SNUR ensures that the conditions of use that
are in the scope of the risk evaluation and not subject to the SNUR are
the only ongoing uses of asbestos and asbestos-containing products in
the United States.

C. TSCA Section 8(a) Rules

    Section 8(a)(1) of TSCA authorizes the EPA Administrator to
promulgate rules under which manufacturers and processors of chemical
substances must maintain such records and submit such information as
the EPA Administrator may ``reasonably require.'' 15 U.S.C. 2607. The
Agency is prohibited by TSCA section 8(a)(5)(A) from requiring
reporting that is ``unnecessary or duplicative'' and must apply the
reporting obligations under TSCA section 8(a) to those persons who are
likely to have the relevant information. 15 U.S.C. 2607(a)(5).
    EPA has promulgated several data reporting rules under TSCA section
8(a); the CDR rule is the largest data collection rule, in terms of the
number of entities subject to reporting under the rule.
    The CDR rule requires U.S. manufacturers (including importers) of
chemicals on the TSCA Chemical Substance Inventory, with some
exceptions, to report to EPA every four years the identity of chemical
substances manufactured (including imported) for all years since the
last principal reporting year (40 CFR 711.8(a)(2)). Generally,
reporting is required for substances with production volumes of 25,000
pounds or more at any single site during any of the calendar years
since the last principal reporting year. However, a lower threshold
(2,500 pounds) applies for chemical substances that are the subject of
certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation
generally exempts several groups of chemical substances from its
reporting requirements, e.g., polymers, microorganisms, naturally
occurring chemical substances, certain forms of natural gas, and water
(see 40 CFR 711.5 and 711. 6). Asbestos is subject to the lower
production volume reporting threshold of 2,500 pounds; thus,
manufacturers and importers of asbestos are required to report asbestos
under the CDR rule unless they qualify for an exemption.

D. Exemptions From Reporting Under the TSCA Section 8(a) Rules

    EPA has specified general reporting and recordkeeping provisions
for TSCA section 8(a) information gathering rules at 40 CFR 704 and has
promulgated general exemptions to reporting at 40 CFR 704.5 using the
Agency's broad discretion in TSCA section 8(a) to fashion reporting
schemes ``as the Administrator may reasonably require.'' (15 U.S.C.
2607(a)(1)(A)). However, also utilizing this discretion, EPA can
revise, remove, or add to these exemptions. The exemptions at 40 CFR
704.5 are for articles, byproducts, impurities, non-isolated
intermediates, research and development, and small manufacturers and
importers.
    If the chemical substance is imported solely as part of an article,
the chemical substance is generally exempt from being reported under
TSCA section 8(a). An article is defined in 40 CFR 704.3 as ``a
manufactured item (1) which is formed to a specific shape or design
during manufacture, (2) which has end-use function(s) dependent in
whole or in part upon its shape or design during end use, and (3) which
has either no change of chemical composition during its end use or only
those changes of composition which have no commercial purpose separate
from that of the article, and that result from a chemical reaction that
occurs upon end use of other chemical substances, mixtures, or
articles; except that fluids and particles are not considered articles
regardless of shape or design.''

    Impurities are also generally exempt from reporting under rules
promulgated pursuant to TSCA section 8(a). An impurity is defined as a
chemical substance unintentionally present with another chemical
substance (40 CFR 704.3). Impurities are not manufactured for
distribution in commerce as chemical substances per se and have no
commercial purpose separate from the substance, mixture, or article of
which they are a part.
    The exemption from reporting naturally occurring chemical
substances under the CDR rule, found at 40 CDR 711.6(b), is one example
of an exemption that has been added to TSCA section 8(a) reporting
requirements under EPA's broad discretion to fashion reporting schemes
``as the Administrator may reasonably require''.
    While TSCA section 8(a) provides EPA with the authority to collect
information from processors, EPA has used its discretion to not require
processors to report under the CDR rule. Processing information is
reported by the manufacturers: If a manufacturer reports a chemical
under the CDR rule, it must also report processing and use information
for the chemical substance unless it is exempted from this reporting by
40 CFR 711.6(b).

E. Recent Asbestos Reporting Under TSCA Section 8(a)

    Two companies, both from the chloro-alkali industry, reported
importing raw asbestos during the 2016 CDR reporting cycle (Ref. 4) and
did not claim the exemption for naturally occurring chemical
substances. Both companies claimed their reports as confidential
business information. Because asbestos has not been mined or otherwise
produced in the United States since 2002 (Ref. 5), all raw asbestos
currently in commerce in the U.S. is imported.

V. Petition Response

A. What was EPA's response?

    After careful consideration, EPA has denied the petition. A copy of
the Agency's response, which consists of a letter to the signatory
petitioner from the State of California (Ref. 6), is available in the
docket for this TSCA section 21 petition. In accordance with TSCA
section 21, the reasons for the denial are set forth in this Federal
Register document.
    EPA agrees that knowledge of which entities are importing and using
asbestos and asbestos-containing products, where and how these
activities occur, and the quantities of asbestos involved is important
for identifying exposed populations, and characterizing pathways of
exposure. EPA already has this information, which it has obtained
through reporting, voluntary submission, and modeling. EPA has used
information currently reported under the CDR rule and other sources of
data to identify and characterize the conditions of use for asbestos,
and is using this information as part of the ongoing risk evaluation
for asbestos under TSCA section 6(b).
    EPA does not believe that petitioners have demonstrated that it is
necessary to initiate a rulemaking proceeding under TSCA section 8(a)
to obtain additional information in order to conduct its risk
evaluation on asbestos and any potential subsequent risk management.
While the petitioners assert that EPA's response to the ADAO Petition
directly contradicts what EPA stated in the Problem Formulation
regarding EPA's acknowledgement of a lack of certain data, EPA
disagrees. EPA believes that the Agency is aware of all ongoing uses of
asbestos and already has the essential information that EPA would
receive if EPA were to grant the petition. Since asbestos was announced
in December 2016 as one of the first ten chemicals for evaluation under
TSCA, the Agency has conducted market research, public outreach,
voluntary data collection, collaborative work with other Federal and
State agencies, and stakeholder engagement. Given EPA's understanding
of asbestos and reporting under TSCA section 8(a), as a result of
implementation of the CDR rule and other TSCA section 8(a) rules, EPA
does not believe that the requested reporting requirements would
collect the data the petitioners believe the Agency lacks. Where EPA
lacks information, the Agency has relied on models. This use of modeled
data is in line with EPA's final Risk Evaluation Rule (Ref. 7) and
EPA's risk assessment guidelines. Furthermore, EPA will provide
opportunity for peer and public review of the draft Asbestos Risk
Evaluation, which EPA will use to refine the risk evaluation of
asbestos.
    Further, even if EPA believed that the requested reporting
requirements would collect new and useful information, EPA would not
complete the rulemaking proceeding in time to collect data to inform
the ongoing risk evaluation. The petitioners' request does not factor
in the necessary timeframes for any rulemaking proceeding that would be
required to propose and then finalize such amendments. To allow for the
notice and comment period for the public and regulated community
required under the Administrative Procedure Act (5 U.S.C. 553) and for
appropriate internal deliberation prior to proposal and after the close
of the comment period, EPA typically needs at least 18 months to
finalize the promulgation, amendment, or repeal of a rule. EPA would
then need to provide time for implementation, data collection, and data
review prior to making use of the reported information. EPA intends to
finalize the risk evaluation for asbestos in December 2019, but EPA
notes that it has statutory authority to extend that deadline by up to
six months. If EPA finds unreasonable risk for a condition of use, risk
management must promptly be initiated with a proposed rule issued one
year after EPA makes such a determination.
    While it is possible that the requested rulemaking proceeding
itself could be completed prior to any potential subsequent risk
management decision(s) being finalized, EPA does not believe that the
requested section 8(a) reporting requirements on asbestos would collect
information useful for any necessary risk management, for the reasons
explained in Unit V.B. Given the statutorily required timing for
finalizing the asbestos risk evaluation and initiating risk management,
if unreasonable risk exists for a condition of use, the requested TSCA
section 8(a) reporting requirements on asbestos would not provide
timely or useful information to inform either the ongoing asbestos risk
evaluation or any potential subsequent risk management action. EPA
believes that this would still be the case even were it to exercise its
statutory authority to extend the deadline to complete the asbestos
risk evaluation for six months, because the requested section 8(a)
reporting requirements would likely not collect that would further
inform the risk evaluation beyond the information EPA already has, as
explained in Unit V.B.

B. What are the details of the petitioners' requests and EPA's decision
to deny each of the requests?

    This unit provides the reasons for EPA's decision to deny the
petition asking EPA to initiate rulemaking proceedings under TSCA
section 8(a) for the reporting of the manufacture, import, and
processing of asbestos.
1. Eliminate Exemption for Naturally Occurring Chemical Substances for
Asbestos
    a. Petitioners' request. The petitioners ask that the requested
TSCA section 8(a) reporting requirements for asbestos remove any
exemption for naturally occurring chemical substances. The petitioners
state that the import of raw asbestos represents ``pathways of

exposure that present risks to health and the environment that EPA must
consider in conducting its risk evaluation and regulating asbestos''
(Ref. 1). In support of this request, the petitioners question EPA's
prior assertion that the Agency has sufficient information about
asbestos use and exposure, as obtained through CDR and other
``voluntary disclosures'' (Ref. 1). The petitioners believe that EPA
contradicted itself in that in the response to the earlier ADAO
petition the Agency stated it has sufficient information for the risk
evaluation, while in the Problem Formulation EPA said ``[i]t is
important to note that the import volumes of products containing
asbestos is [sic] unknown'' (Ref. 1).
    b. Agency response. Raw asbestos is the only type of asbestos to
which the naturally occurring substance exemption could apply. As
defined by the CDR-specific rules in 40 CFR 711.6(a)(3), a naturally
occurring chemical substance is:

    Any naturally occurring chemical substance, as described in 40
CFR 710.4(b). The applicability of this exclusion is determined in
each case by the specific activities of the person who manufactures
the chemical substance in question. Some chemical substances can be
manufactured both as described in 40 CFR 710.4(b) and by means other
than those described in 40 CFR 710.4(b). If a person described in
Sec.  711.8 manufactures a chemical substance by means other than
those described in 40 CFR 710.4(b), the person must report
regardless of whether the chemical substance also could have been
produced as described in 40 CFR 710.4(b). Any chemical substance
that is produced from such a naturally occurring chemical substance
described in 40 CFR 710.4(b) is reportable unless otherwise
excluded.

    A chemical substance qualifies as naturally occurring only if it
is: (1)(i) Unprocessed or (ii) processed only by manual, mechanical, or
gravitational means; by dissolution in water; by flotation; or by
heating solely to remove water; or (2) extracted from air by any means
(40 CFR 710.4(b)). Articles containing asbestos would not be considered
a naturally occurring chemical substance, given the processing required
to create the article.
    EPA does not believe that the requested elimination of the
exemption for naturally occurring chemical substances would result in
the reporting of any information that is not already known to EPA, for
several reasons. EPA's understanding is that the chloro-alkali industry
is the only importer of raw bulk asbestos, and the Agency has
sufficient volume, import, use, and hazard data from that industry to
conduct the risk evaluation. EPA has no reason to believe there are
other importers of raw asbestos. Raw asbestos generally refers to
asbestos as a naturally occuring chemical substance. Implementing TSCA
section 8(a) asbestos reporting requirements for manufacturers
(including importers) of asbestos as a naturally occuring chemical
substance, therefore, would not provide any additional useful or timely
information to EPA on the use of raw asbestos.
    Because the purpose of domestic manufacturing or importing of raw
asbestos is to make asbestos diaphragms, for which EPA already has use
and exposure information, the request to require reporting on naturally
occurring substances for asbestos would not provide any additional data
to EPA. EPA already has this information obtained through extensive
outreach and research (as described in Unit IV.A.), and the Agency is
prohibited by TSCA section 8(a)(5)(A) from requiring reporting that is
unnecessary or duplicative.
    EPA disagrees that there is a contradiction between what EPA stated
in the Asbestos Problem Formulation and what EPA stated in the petition
response to ADAO. While EPA did state in the problem formulation that
the imported volumes of products containing asbestos are unknown, the
requested reporting of naturally occurring substances would not provide
imported volumes of products containing asbestos, given that articles
are not considered naturally occurring substances. As used in the
asbestos Problem Formulation, the term ``products containing asbestos''
refers to asbestos articles. For more information on the data
availability and evaluation of asbestos in articles, see Unit V.B.iii.
for EPA's response to the request for reporting of imported asbestos
articles.
    EPA finds that petitioners have failed to set forth sufficient
facts to establish that it is necessary for the Agency to use its
discretion to no longer exempt naturally occurring asbestos from
reporting requirements under TSCA section 8(a).
2. Apply the CDR Reporting Requirements to Processors of Asbestos
    a. Petitioners' request. The petitioners note that EPA has the
authority to require that processors report under TSCA section 8(a),
but EPA does not require processors to report to CDR. The petitioners
believe a rulemaking proceeding to subject CDR reporting requirements
on the processing of asbestos is needed in order ``to enable EPA to
carry out its responsibility to impose requirements on processors to
eliminate unreasonable risks of injury to health or the environment
arising from exposures to asbestos'' (Ref. 1). In support of their
request, the petitioners cite the U.S. Geological Survey (USGS)
Minerals Yearbook for 2016 (Ref. 5) and state that ``U.S. firms
exported and reexported $35.4 million of manufactured asbestos products
in 2016, including asbestos based friction products like brake linings,
clutch linings, and disk pads, and gaskets, packing, and seals, in the
amount of 2,710 metric tons'' (Ref.1).
    b. Agency response. EPA knows of two ongoing uses of asbestos that
constitute processing: (1) The processing of raw asbestos into
diaphragms and (2) the fabrication of gaskets from imported asbestos-
containing sheets. Information on these uses is well understood by EPA
as a result of direct communication with these processors (see Problem
Formulation of the Risk Evaluation for Asbestos (Ref. 3, pg. 25)).
    To support a claim that there is ongoing processing of articles
that EPA is unaware of, the petitioners cite the export and reexport of
articles described in the USGS Minerals Yearbook for 2016 (Ref. 5). The
petitioners, however, neglect to note that the same report states that
these shipments were likely misclassified and that ``[s]hipments
reported under these categories may have been reexports and (or)
exports of products that were similar but did not contain asbestos.''
In identifying the conditions of use for asbestos during the TSCA risk
evaluation process, EPA reviewed the U.S. International Trade
Commission's Dataweb and other government and commercial trade
databases. EPA was unable to confirm any processing of asbestos beyond
processing of raw asbestos into diaphragms and the fabrication of
gaskets from imported asbestos-containing sheets.
    Since asbestos is not mined in the United States, raw asbestos is
imported solely by the chlor-alkali industry; because sheet gaskets are
the only imported asbestos-containing products that may involve
processing, EPA does not believe there are additional, unknown
processors of asbestos in the United States. Accordingly, EPA does not
believe that requiring reporting from processors of asbestos under TSCA
section 8(a) will provide useful information not already in the
Agency's possession. The petitioners have failed to indicate what
additional information EPA would collect by requiring asbestos
processors to report under section 8(a) and the Agency is prohibited by
TSCA section 8(a)(5)(A) from requiring

reporting that is unnecessary or duplicative. Therefore, EPA finds that
petitioners have failed to set forth sufficient facts to establish that
it is necessary for the Agency to use its discretion to require TSCA
section 8(a) reporting for processors of asbestos.
3. Eliminate Exemption for Reporting of Imported Articles Containing
Asbestos
    a. Petitioners' request. In support of their request to eliminate
the reporting exemption for imported articles containing asbestos, the
petitioners state that ``the Asbestos Problem Formulation provides
virtually no information about the amount of asbestos in any of these
products, the quantities in which they may be imported, and where they
may be used, let alone any information about the extent to which the
public may be exposed to these asbestos-containing products'' (Ref. 1).
Furthermore, the petitioners state that ``EPA simply throws up its
hands, stating that `[c]onsumer exposures will be difficult to evaluate
since the quantities of these products that still might be imported
into the United States is not known' '' (Ref. 1).
    b. Agency response. EPA has relied on extensive outreach and
research to determine the conditions of use of asbestos (as described
in Unit IV.A.). The Agency does not believe that requiring TSCA section
8(a) reporting on imported articles for asbestos would be helpful in
collecting additional import information on asbestos-containing
articles because the Agency has identified the articles that are
imported into the United States and promulgated a significant new use
rule under TSCA section 5 to require notification to the Agency of any
new uses, including different or new articles. The Agency is prohibited
by TSCA section 8(a)(5)(A) from requiring reporting that is unnecessary
or duplicative. Even if EPA were to require reporting on imported
articles for asbestos, EPA does not believe that potentially useful
information for EPA's ongoing asbestos risk evaluation would be
``reasonably ascertainable'' by importers and thus EPA could not
require this information to be reported under TSCA section 8(a). Nor
would EPA be able to collect new data in time to inform the risk
evaluation, which EPA intends to complete in December 2019. EPA,
however, acknowledges the statute provides that EPA may extend the
deadline to complete a risk evaluation by six months (15 U.S.C.
2605(b)(4)(G)(ii)). As discussed in Unit V.A., even if EPA were to
exercise this extension authority in the case of the ongoing asbestos
risk evaluation, that would not affect the Agency's reasons for denying
this petition. If EPA finds unreasonable risk for a condition of use,
risk management must promptly be initiated with a proposed rule issued
one year after EPA makes such a determination.
    EPA has sufficient information on imported articles containing
asbestos to conduct the risk evaluation and inform any potential risk
management decisions based on the risk determination. The only
asbestos-containing articles that EPA has identified that are currently
imported into the United States are asbestos-containing sheet gaskets,
other gaskets, aftermarket automotive brakes/linings, other vehicle
friction products, and brake blocks. Furthermore, the final Asbestos
SNUR, published on April 25, 2019, ensures that no significant new uses
of asbestos, including as an article, can begin without EPA first
evaluating the significant new use and then, if necessary, taking
action to prohibit or limit the activity.
    The petitioners state that EPA lacks information on the quantity of
asbestos contained in articles and assert that the Agency ``lack[s]
this information despite'' communication with Chemours, a company that
uses asbestos-containing gaskets, and Branham Corporation, the gasket
supplier to Chemours (Ref. 1). Yet, as stated in the Asbestos Problem
Formulation, Chemours notified EPA of their current use of imported
gaskets from China (Comment identified by Document ID No. EPA-HQ-OPPT-
2016-0736-0067). Chemours stated that these sheet gaskets are composed
of 80% (minimum) chrysotile asbestos, encapsulated in Styrene Butadiene
Rubber, and used to create tight chemical containment seals during the
production of titanium dioxide. Furthermore, as stated in the Asbestos
Problem Formulation, on October 30, 2017, EPA met with Chemours and
Branham Corporation, who provided EPA with additional information on
the fabrication and use of the gaskets (Ref. 3).
    Similarly, the petitioners stated that EPA lacks information on
asbestos-containing brake blocks, even though a domestic brake block
manufacturer confirmed the continued import of these products (Ref. 1).
However, EPA believes that it is able to conduct scientifically
rigorous risk evaluations even without the information to which
petitioners refer. For the asbestos risk evaluation, in instances where
the specific use information on asbestos is unknown, EPA has made use
of best available science. EPA's assumptions, uncertainty factors, and
models or screening methodologies used when assessing risks associated
with the conditions of use of asbestos-containing articles will be peer
and publicly reviewed. It is standard practice for EPA to make
conservative assumptions in the absence of complete information.
Considering the extensive outreach and research conducted since
December 2016, EPA has no reason to believe there are ongoing imports
of articles containing asbestos that are unknown to EPA.
    Additionally, information reported under TSCA section 8(a) is
limited to that which is ``known to or reasonably ascertainable'' by
the reporter. Thus, even if EPA were to require the reporting of
asbestos-containing articles under TSCA section 8(a), importers would
rely on information readily available to them, such as Safety Data
Sheets or other documentation provided by their foreign supplier. As a
result, EPA does not believe that the requested reporting requirement
would result in importers reporting articles that are not already known
to EPA because the Agency has conducted its own research to analyze
Safety Data Sheets and other evidence in order to determine the
conditions of use of asbestos for the risk evaluation. Requiring
importers of asbestos-containing articles to report under TSCA section
8(a), therefore, would not provide any new use information that would
inform the ongoing risk evaluation or any subsequent risk management
decisions, if needed, and the Agency is prohibited by TSCA section
8(a)(5)(A) from requiring reporting that is unnecessary or duplicative.
    For these reasons, EPA believes that the petitioners have failed to
set forth sufficient facts to establish that it is necessary for the
Agency to use its discretion to require reporting from importers of
asbestos-containing articles under section 8(a).
4. Eliminate Impurities Exemption for Asbestos.
    a. Petitioners' request. In support of their request eliminate the
impurities exemption for asbestos, the petitioners state that
``contamination of talc with asbestos is well-known, having been
discovered as impurities in cosmetics, baby powder, and crayons'' (Ref.
1). As such, the petitioners assert that the ``presence of asbestos in
such consumer products, whether unintentional ``impurities'' or as an
unintended ingredient in the article, dictates that these exemptions
cannot apply with respect to the reporting requirements for asbestos in
commerce'' (Ref. 1).

    b. Agency response. Even if EPA were to eliminate the impurities
exemption for asbestos, it is unlikely that requiring this reporting
would yield any new information because rules under TSCA section 8(a)
do not require submitters to perform chemical analyses of products
containing the chemicals they manufacture. Instead, the standard for
all information required to be reported under TSCA section 8(a)(2) is
that it be ``known or reasonably ascertainable.'' EPA is aware that
testing by a small number of importers of talc or products such as
crayons has shown that some of these products are contaminated with
asbestos as an impurity. However, EPA cannot compel importers who have
not tested their imports to conduct this kind of testing under TSCA
section 8(a). EPA can only compel reporting of testing information that
is known or reasonably ascertainable to the reporter. While the
petitioners ``believe that it is reasonable to expect that importers of
talc [. . . will . . .] test it for asbestos and that the results of
such testing constitute `reasonably ascertainable' information for
reporting purposes'' (Ref. 1), the petitioners provide no support for
the belief that importers are testing for asbestos. EPA is not aware of
routine testing of imports for impurities of asbestos. Thus, it is
unlikely that EPA would receive new information that would change its
understanding of the conditions of use for asbestos that can be
addressed under TSCA.
    EPA does not believe that issuing the requested TSCA section 8(a)
reporting requirements would result in reporting of asbestos as an
impurity, to the extent that the presence of asbestos as an impurity in
these articles generally is not known or reasonably ascertainable to
the importer. EPA finds that the petitioners have failed to set forth
sufficient facts to establish that it is necessary for the Agency to
use its discretion to require manufacturers (including importers) of
asbestos as an impurity to report under section 8(a).
5. Enable EPA To Satisfy Requirements for Best Available Science
    a. Petitioners' request. As overall support for their petition, the
petitioners state that EPA must grant their request to satisfy its
statutory obligation under TSCA section 26 to consider the information
``reasonably available'' to it. Additionally, since the petitioners
believe that if EPA were to require reporting on asbestos as a
naturally occurring chemical substance, asbestos-containing articles,
asbestos as an impurity, and from asbestos processors, that this data
is ``reasonably available to the agency'' and thus ``needed for EPA to
be able to make informed technically complex decisions regarding the
regulation of asbestos'' (Ref. 1).
    b. Agency response. TSCA section 26 requires that, to the extent
that EPA makes a decision based on science under TSCA sections 4, 5, or
6, EPA must use scientific standards and base those decisions on the
best available science and on the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i). In the final Risk Evaluation Rule (Ref. 7), EPA
defined ``best available science'' as science that is reliable and
unbiased. This involves the use of supporting studies conducted in
accordance with sound and objective science practices, including, when
available, peer reviewed science and supporting studies and data
collected by accepted methods or best available methods (if the
reliability of the method and the nature of the decision justifies use
of the data).
    Additionally, in the final Risk Evaluation Rule, EPA defined weight
of scientific evidence as a systematic review method, applied in a
manner suited to the nature of the evidence or decision, that uses a
pre-established protocol to comprehensively, objectively,
transparently, and consistently, identify and evaluate each stream of
evidence, including strengths, limitations, and relevance of each study
and to integrate evidence as necessary and appropriate based upon
strengths, limitations, and relevance (Ref. 7 at pg. 33733). EPA sees
weight of the scientific evidence approach as an interrelated part of
systematic review, and further believes that integrating systematic
review into the TSCA risk evaluations is critical to meet the statutory
requirements of TSCA.
    TSCA section 26(k) (15 U.S.C. 2625(k)) states that in carrying out
risk evaluations, EPA shall consider information that is ``reasonably
available,'' but the statute does not further define this phrase. In
the final Risk Evaluation Rule (Ref. 7), EPA defined ``reasonably
available information'' to mean information that EPA possesses, or can
reasonably obtain and synthesize for use in risk evaluations,
considering the deadlines for completing the evaluation. While EPA
prefers high quality data, where available, EPA recognized in the Risk
Evaluation Rule that data is not always necessary to reach a
scientifically grounded conclusion on the potential risks of a chemical
substance, within the timeframes dictated by the statute (Ref. 7 at pg.
33739).
    As outlined in the previous units, EPA does not believe that the
requested asbestos reporting requirements would collect information
that is either new or useful in informing the ongoing asbestos risk
evaluation. EPA believes that it already has sufficient information to
conduct the risk evaluation. Moreover, even if EPA were to initiate the
requested action, EPA would not collect information in a timely manner
to inform the ongoing risk evaluation nor any potentially subsequent
risk management activities, if unreasonable risk for the asbestos uses
being evaluated is determined. EPA intends to finalize the risk
evaluation for asbestos no later than December 2019, EPA acknowledges
the statute provides that EPA may extend the deadline to complete a
risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)). As
discussed in Unit V.A., even if EPA were to exercise this extension
authority in the case of the ongoing asbestos risk evaluation, that
would not affect the Agency's reasons for denying this petition. If EPA
finds unreasonable risk for a condition of use, risk management must
promptly be initiated with a proposed rule issued one year after EPA
makes such a determination.
    Thus, EPA finds that the petitioners have failed to set forth
sufficient facts to establish that it is necessary to grant their
request in order to meet its obligations under TSCA section 26 to make
its decision under TSCA section 6 based on the weight of the scientific
evidence, using reasonably available information, and using the best
available science.

VI. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. The Attorneys General of Massachusetts, California, Connecticut,
Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon,
Pennsylvania, Rhode Island, Vermont, Washington, and the District of
Columbia to Andrew Wheeler, Acting Administrator, U.S. Environmental
Protection Agency. Re: Petition of the Commonwealths of
Massachusetts and Pennsylvania, the States of California,
Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New
York, Oregon, Rhode Island, Vermont, and Washington, and the
District of Columbia under Section 21(a) of TSCA, 15 U.S.C. 2620(a),
for EPA to

Issue an Asbestos Reporting Rule to Require Reporting under TSCA
Section 8(a), 15 U.S.C. 2607(a), of Information Necessary for EPA to
Administer TSCA as to the Manufacture (including Importation),
Processing, Distribution in Commerce, Use, and Disposal of Asbestos.
Received January 31, 2019.
2. Asbestos Disease Awareness Organization, American Public Health
Association, Center for Environmental Health, Environmental Working
Group, Environmental Health Strategy Center, and Safer Chemicals
Healthy Families to Andrew Wheeler, Acting Administrator,
Environmental Protection Agency. Re: Petition under TSCA Section 21
to Require Reporting on Asbestos Manufacture, Importation and Use
under TSCA Section 8(a). Received September 27, 2018.
3. EPA. Problem Formulation of the Risk Evaluation for Asbestos. May
2018. Washington, DC: US Environmental Protection Agency, Office of
Pollution Prevention and Toxics. https://www.epa.gov/sites/production/files/2018-06/documents/asbestos_problem_formulation_05-31-18.pdf.
4. EPA. Public database 2016 chemical data reporting (May 2017
release). Washington, DC: US Environmental Protection Agency, Office
of Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting.
5. Flanagan, DM. (2016). 2015 Minerals Yearbook. Asbestos [advance
release]. In US Geological Survey 2015 Minerals Yearbook. Reston,
VA: U.S. Geological Survey. https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/myb1-2015-asbes.pdf.
6. EPA. Response to Petition to Initiate Rulemaking Under Section
8(a) of TSCA for the Reporting of the Manufacture, Import, and
Processing of Asbestos. Letter. 2019.
7. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register. 82 FR
33726, July 20, 2017 (FRL-9963-38).

List of Subjects in 40 CFR Chapter I

    Environmental protection, Asbestos, Flame retardants, Chemicals,
Hazardous substances, Reporting and recordkeeping requirements.

    Dated: April 30, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2019-09335 Filed 5-7-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Rules and Regulations]
[Pages 2899-2902]
[FR Doc No: 2018-00950]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0022; Product Identifier 2015-NM-044-AD; Amendment
39-19162; AD 2018-02-09]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2008-06-20 R1,
which applied to all Fokker Services B.V. Model F28 Mark 0070 and 0100
airplanes, and certain Model F28 Mark 1000, 2000, 3000, and 4000
airplanes. AD 2008-06-20 R1 required revising the Airworthiness
Limitations Section (ALS) of the Instructions for Continued
Airworthiness for certain airplanes, and the maintenance or inspection
program, as applicable, for certain other airplanes, to incorporate new
limitations for fuel tank systems. AD 2008-06-20 R1 also clarified the
intended effect on spare and on-airplane fuel tank system components,
regarding the use of maintenance manuals and instructions for continued
airworthiness. This new AD was prompted by revised fuel airworthiness
limitation items (ALI) tasks, and critical design configuration control
limitations (CDCCL) items, and associated

thresholds, intervals, and instructions. This AD requires contacting
the FAA to obtain instructions for addressing the unsafe condition on
these products, and doing the actions specified in those instructions.
We are issuing this AD to address the unsafe condition on these
products.

DATES: This AD becomes effective February 6, 2018.
    We must receive comments on this AD by March 8, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0022; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
(telephone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriquez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 1601 Lind
Avenue SW, Renton, WA 98057-3356; telephone:<PHONE_NUMBER>; fax: 425-
227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued AD 2008-06-20 R1, Amendment 39-16089 (74 FR 61018,
November 23, 2009) (``AD 2008-06-20 R1''), which applied to all Fokker
Services B.V. Model F28 Mark 0070 and 0100 airplanes, and certain Model
F28 Mark 1000, 2000, 3000, and 4000 airplanes. AD 2008-06-20 R1 was
prompted by revised fuel ALI tasks, and CDCCL items, and associated
thresholds, intervals and instructions. AD 2008-06-20 R1 required
revising the ALS of the Instructions for Continued Airworthiness for
certain airplanes, and the FAA-approved maintenance or inspection
program, as applicable, for certain other airplanes, to incorporate new
limitations for fuel tank systems. AD 2008-06-20 R1 also clarified the
AD's intended effect on spare and on-airplane fuel tank system
components, regarding the use of maintenance manuals and instructions
for continued airworthiness. We issued AD 2008-06-20 R1 to reduce the
potential of ignition sources inside fuel tanks, which, in combination
with flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.
    Since we issued AD 2008-06-20 R1, we have determined that revised
Fuel ALI tasks, and CDCCL items, and associated thresholds, intervals
and instructions need to be implemented.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2015-0030, dated February 24, 2015 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Fokker Services B.V. Model F28 Mark
1000, 2000, 3000, and 4000 airplanes. The MCAI states:

    [Subsequent to accidents involving Fuel Tank System explosions
in flight and on ground] * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88, and the Joint Aviation Authorities
(JAA) published Interim Policy INT/POL/25/12. The review conducted
by Fokker Services on the Fokker F28 design in response to these
regulations identified a number of Fuel Airworthiness Limitation
items (ALI) and Critical Design Configuration Control Limitations
(CDCCL) items to prevent the development of unsafe conditions within
the fuel system.
    To introduce these Fuel ALI and CDCCL items, Fokker Services
published Service Bulletin (SB) F28/28-050 and EASA issued AD 2006-
0208, requiring the implementation of these Fuel ALI and CDCCL
items. That [EASA] AD was later revised to make reference to SBF28-
28-050R1 and to specify that the use of later revisions was
acceptable.
    In 2014, Fokker Services issued Revision 2 of SBF28-28-050 to
update the ALI and CDCCL items and to consolidate Fuel ALI and CDCCL
items contained in a number of other SBs. Consequently, EASA issued
AD 2014-0110, superseding [EASA] AD 2006-0208R1 [which corresponds
to FAA AD 2008-06-20 R1] and requiring the implementation of the
updated Fuel ALI and CDCCL items.
    Since that [EASA] AD was issued, Fokker Services issued Revision
3 of SBF28-28-050, primarily to introduce 5 additional CDCCL items.

    You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0022.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI. We are
issuing this AD because we evaluated all pertinent information and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product, we
find good cause that notice and opportunity for prior public comment
are unnecessary. In addition, for the reason(s) stated above, we find
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2018-0022; Product
Identifier 2015-NM-044-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. This AD
requires contacting the FAA to obtain instructions for addressing the
unsafe condition, and doing the actions specified in those
instructions. Based on the actions specified in the MCAI AD,

we are providing the following cost estimates for an affected airplane
that is placed on the U.S. Register in the future:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Revise the maintenance or inspection         1 work-hour x $85 per hour = $85...              $0             $85
 program.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2008-06-20 R1, Amendment 39-16089 (74 FR 61018, November 23, 2009), and
adding the following new AD:

2018-02-09 Fokker Services B.V.: Amendment 39-19162; Docket No. FAA-
2018-0022; Product Identifier 2015-NM-044-AD.

(a) Effective Date

    This AD becomes effective February 6, 2018.

(b) Affected ADs

    This AD replaces AD 2008-06-20 R1, Amendment 39-16089 (74 FR
61018, November 23, 2009) (``AD 2008-06-20 R1'').

(c) Applicability

    This AD applies to Fokker Services B.V. Model F28 Mark 1000,
2000, 3000, and 4000 airplanes, certificated in any category, all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by the issuance of revised fuel
airworthiness limitation items (ALI) tasks, critical design
configuration control limitations (CDCCL) items and associated
thresholds, intervals and instructions. We are issuing this AD to
reduce the potential of ignition sources inside fuel tanks, which,
in combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Action(s)

    Within 30 days after the effective date of this AD, request
instructions from the Manager, International Section, Transport
Standards Branch, FAA, to address the unsafe condition specified in
paragraph (e) of this AD; and accomplish the action(s) at the times
specified in, and in accordance with, those instructions. Guidance
can be found in Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency (EASA) AD 2015-0030, dated
February 24, 2015.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, International Section, Transport Standards Branch,
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the International Section, send it to the
attention of the person identified in paragraph (i)(2) of this AD.
Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.

(i) Related Information

    (1) Refer to MCAI EASA 2015-0030, dated February 24, 2015, for
related information. You may examine the MCAI on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2018-0022.
    (2) For more information about this AD, contact Tom Rodriquez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone:
425-227-1137; fax:<PHONE_NUMBER>.

(j) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on January 9, 2018.
John P. Piccola, Jr.,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-00950 Filed 1-19-18; 8:45 am]
 BILLING CODE 4910-13-P