[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Rules and Regulations]
[Pages 44533-44537]
[FR Doc No: 2017-19455]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 770

[EPA-HQ-OPPT-2017-0244; FRL-9966-56]
RIN 2070-AK35

Compliance Date Extension; Formaldehyde Emission Standards for
Composite Wood Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; compliance date extension.

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SUMMARY: EPA is extending the compliance dates for the formaldehyde
emission standards for composite wood products final rule issued
pursuant to the Toxic Substances Control Act (TSCA) Title VI, and
published in the Federal Register on December 12, 2016. EPA is
extending the December 12, 2017, manufactured-by date for emission
standards, recordkeeping, and labeling provisions until December 12,
2018; extending the December 12, 2018 compliance date for import
certification provisions until March 22, 2019; and extending the
December 12, 2023, compliance date for provisions applicable to
producers of laminated products until March 22, 2024. Additionally,
this final rule will extend the transitional period during which the
California Air Resources Board (CARB) Third Party Certifiers (TPC) may
certify composite wood products under TSCA Title VI without an
accreditation issued by an EPA TSCA Title VI Accreditation Body, so
long as the TPC remains approved by CARB, is recognized by EPA, and
complies with all aspects of the December 12, 2016 final rule until
March 22, 2019. EPA believes that extension of these compliance dates
and the transitional period for CARB TPCs adds needed regulatory
flexibility for regulated entities, reduces compliance burdens, and
helps to prevent disruptions to supply chains while still ensuring that
compliant composite wood products enter the supply chain in a timely
manner.

DATES: This final rule is effective on October 25, 2017.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2017-0244, is available at
http://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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Erik Winchester, National
Program Chemicals Division, 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. Does this action apply to me?

    You may be affected by this final rule if you manufacture
(including import), sell, supply, offer for sale, test, or work with
the certification of hardwood plywood, medium-density fiberboard,
particleboard, and/or products containing these composite wood
materials in the United States. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
     Veneer, plywood, and engineered wood product manufacturing
(NAICS code 3212).
     Manufactured home (mobile home) manufacturing (NAICS code
321991).
     Prefabricated wood building manufacturing (NAICS code
321992).
     Furniture and related product manufacturing (NAICS code
337).
     Furniture merchant wholesalers (NAICS code 42321).
     Lumber, plywood, millwork, and wood panel merchant
wholesalers (NAICS code 42331).
     Other construction material merchant wholesalers (NAICS
code 423390), e.g., merchant wholesale distributors of manufactured
homes (i.e., mobile homes) and/or prefabricated buildings.
     Furniture stores (NAICS code 4421).
     Building material and supplies dealers (NAICS code 4441).
     Manufactured (mobile) home dealers (NAICS code 45393).
     Motor home manufacturing (NAICS code 336213).
     Travel trailer and camper manufacturing (NAICS code
336214).
     Recreational vehicle (RV) dealers (NAICS code 441210).
     Recreational vehicle merchant wholesalers (NAICS code
423110).
     Engineering services (NAICS code 541330).
     Testing laboratories (NAICS code 541380).
     Administrative management and general management
consulting services (NAICS code 541611).
     All other professional, scientific, and technical services
(NAICS code 541990).
     All other support services (NAICS code 561990).
     Business associations (NAICS code 813910).
     Professional organizations (NAICS code 813920).
    If you have any questions regarding the applicability of this
action, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. Background

A. What action is the agency taking?

    EPA shares the concerns raised by industry stakeholders regarding
the time needed to comply with provisions of the formaldehyde emission
standards for composite wood products final rule (81 FR 89674, December
12, 2016) (FRL-9949-90), and, therefore, is extending several rule
compliance dates. EPA also believes that CARB TPCs should be allotted
the full two years granted by the December 12, 2016 final rule to
operate under the transitional period as promulgated in Sec.  770.7(d).
    1. Direct Final Rule and Notice of Proposed Rulemaking. Given that
EPA extended the effective date of the TSCA

Title VI final rule from February 10, 2017 until May 22, 2017, the
Agency issued a proposed (82 FR 23735) (FRL-9962-85) and direct final
rule (82 FR 23769) (FRL-9962-86) on May 24, 2017 that regulated
entities should have at least the same amount of time to comply with
the various regulatory timeframes as initially allotted in the final
rule. The two extensions to the final rule effective date (82 FR 8499,
January 26, 2017 (FRL-9958-87) and 82 FR 14324, May 24, 2017 (FRL-9960-
28-OP) resulted in delaying the ability of regulated entities to begin
implementation activities to establish certification programs, certify
composite wood products and distribute those products into supply
chains, such that compliance would be achieved by the required dates.
The Agency solicited public comment on this action by issuing a
companion Notice of Proposed Rulemaking (82 FR 23769) (FRL-9962-85)
with the direct final rule in the event EPA received adverse public
comment. EPA did receive nine (9) comments from the public on this
action, at least one of which the Agency considered to be adverse in
nature with respect to the proposed extension of compliance dates. The
direct final action was withdrawn on July 6, 2017, as published in the
Federal Register (82 FR 31267) (FRL-9963-74).
    EPA considered all of the public comments submitted in response to
the provisions outlined in the direct final rule and companion
proposal. Due to the adverse comments, EPA was compelled to withdraw
the direct final rule (82 FR 31267) (FRL-9963-74). The Agency then
proceeded with the notice of proposed rulemaking (82 FR 23769) (FRL-
9962-85) and is now issuing this final rule and a Response to Comments
document which addresses the comments received.
    2. Stakeholder Feedback Since the December 12, 2016 Final Rule.
Since publication of the December 12, 2016 final rule, the Agency has
engaged the composite wood product industry stakeholders, other related
regulated entities, and the larger public through webinar
presentations, trade group meetings, conference presentations, and
teleconferences to discuss and support implementation of the December
12, 2016 final rule. Through this stakeholder outreach, the Agency
received both formal and informal feedback regarding compliance
challenges faced by regulated entities, including the final rule's
compliance dates. In addition, the Agency received several unsolicited
letters and general correspondence from composite wood product industry
stakeholders requesting that the Agency amend specific provisions of
the December 12, 2016 final rule. Written inquiries and correspondence
from Hooker Furniture, Composite Panel Association, American Home
Furnishings Alliance (AHFA), and a consortium of trade associations
including AHFA, Kitchen Cabinet Manufacturers, International Wood
Products Association, Recreation Vehicle Industry Association, National
Retail Foundation, and Retail Industry Leaders Association are included
in the supporting documents section of the public docket for this
action. Industry concerns included challenges in meeting the compliance
dates due to the complexities of the domestic and imported composite
wood product supply chains, import certification requirements, non-
complying lot notification requirements, prohibition on early labeling,
and laminated product provisions of the final rule.
    Since publication of the direct final action, the Agency has been
contacted by multiple stakeholders, national trade associations, and
other regulated entities who overwhelmingly confirm that regulated
entities will require additional time to comply with the TSCA Title VI
emission standards compliance date due to supply chain, global
business, and factory supply logistics. National groups representing
importers and importers themselves have noted that there will be
significant logistical hurdles with sourcing compliant composite wood
panels for fabrication of finished goods and component parts before the
manufactured-by date that the Agency had not considered in choosing the
proposed March 22, 2018 compliance date in the direct final rule.
Several commenters suggested extending the compliance date for the
emission standards, recordkeeping, and labeling requirements in order
to allow adequate time for the production and integration of TSCA Title
VI certified composite wood products into the domestic and import
supply chains. The supply chain begins with the production of panels,
then fabrication of component parts and finished goods to ultimately
having compliant products available for sale to consumers. Commenters
suggested extensions ranging from a compliance date of December 12,
2018 to July 22, 2019. Commenters also noted that EPA had not fully
understood or considered the logistical hurdles that regulated entities
face to comply with the rule requirements. Commenters noted that
extending the compliance date further than what was proposed on May 24,
2017 (82 FR 23769), will help ensure that an adequate supply of
certified composite wood products enter the supply chain. The earliest
some regulated entities communicated being able to import TSCA Title VI
compliant component parts and finished goods is approximately May 2018.
One commenter also noted that achieving full compliance with all of
their imported products as TSCA Title VI compliant could take until
July 2019, given the anticipated inventory of non-TSCA Title VI
certified panels and finished goods currently in their inventory and
the time needed to obtain compliant panels to fabricate and sell
compliant component parts and finished goods.
    Other commenters did not support any further extension of the
compliance dates as they noted that further delay would be a hindrance
to the health benefits from reduced formaldehyde emissions in the home
environment, and stated that extending the compliance date defeated the
purpose of establishing a compliance date in the final rule. Some
commenters supported the compliance date extension as proposed stating
that it would restore the December 12, 2016, final rule's regulatory
timeframe. A full response to comments received during the public
comment period is included in the Response to Comments document in the
supporting documents section of the public docket for this action.
    After considering the public comments both supportive and non-
supportive of extending the compliance dates, the agency believes that
the December 12, 2018 compliance date for the emission standards
provides a balanced and reasoned timeline for importers, distributors,
and regulated entities to establish compliant supply chains and comply
with the TSCA Title VI final rule. Additionally, the agency believes
extending this compliance date reflects the Congressional intent under
TSCA Title VI that the agency implement provisions to ensure compliance
with the formaldehyde emission standards as soon as possible while
enabling regulated entities to achieve compliance. The Agency does not
believe that the extension provided for the emissions compliance date
would result in any significant increases in health risk, in part
because on July 11, 2017, EPA published a direct final rule that allows
voluntary early labeling of compliant composite wood products after
August 25, 2017, which facilitates TSCA Title VI compliant products
entering commerce sooner than under the original December 12, 2017,
compliance date for the emission standards, recordkeeping, and labeling
requirements. Moreover, CARB

compliant composite wood panels, component parts, and finished goods,
which are subject to identical formaldehyde emission standards as TSCA
Title VI, make up the majority of composite wood products already in
the domestic supply chains and that will continue during the additional
time provided to comply with TSCA. The Agency also believes that the
extended compliance dates proposed for import certification, laminated
products, and the CARB TPC transitional period are adequate. EPA
received no adverse comments on these dates, which are being finalized
as proposed. As such, this final rule will extend the December 12,
2018, compliance date for import certification provisions until March
22, 2019; and extend the December 12, 2023, compliance date for
provisions applicable to producers of laminated products until March
22, 2024. Additionally, this final action will extend the transitional
period during which the CARB TPCs may certify composite wood products
under TSCA Title VI without an accreditation issued by an EPA TSCA
Title VI Accreditation Body so long as the TPC remains approved by
CARB, is recognized by EPA, and complies with all aspects of the
December 12, 2016, final rule until March 22, 2019.
    3. Final Rule. EPA is publishing this final rule to provide
regulated entities with the time needed to ensure certified composite
wood products enter the supply chains. EPA is extending the compliance
dates for the December 12, 2016, final rule by: Extending the December
12, 2017, date for emission standards, recordkeeping, and labeling
provisions, until December 12, 2018; extending the December 12, 2018
date for import certification provisions until March 22, 2019; and
extending the December 12, 2023 compliance date for provisions
applicable to producers of laminated products until March 22, 2024.
Additionally, this final rule will extend the CARB TPC transitional
period under Sec.  770.7(d), which is currently set to end December 12,
2018, until March 22, 2019 to be consistent with the regulatory
timeframe of the December 12, 2016 final rule.
    The Agency believes that this final rule balances the further
extended compliance dates commenters noted would be needed, and the
proposed compliance dates in the May 24, 2017 (82 FR 23735), direct
final rule that several trade groups concurred with in their public
comments. EPA has begun recognizing TPCs and Accreditation Bodies to
the TSCA Title VI program since the May 22, 2017, effective date of the
December 12, 2016, final rule and anticipates that panel producers and
TPCs will work together to provide compliant products for further
downstream distribution and fabrication into component parts and
finished goods so that those composite wood products will be compliant
by or before December 12, 2018.
    As previously noted, this final rule establishes a compliance date
of December 12, 2018, for the emission standards, recordkeeping, and
labeling provisions. Beginning this date, all imported panels and
component parts or finished goods subject to the rule must comply with
40 CFR part 770. Existing stock of non-certified panels manufactured in
the United States or imported into the United States before the
manufactured-by date may continue to be distributed in commerce and
integrated further into component parts and finished goods until that
stock is depleted, providing documentation is kept regarding the date
of manufacture or import. Further, existing stock of component parts
and finished goods that contain non-certified panels manufactured
internationally and subsequently imported into the United States before
the manufactured-by date may continue to be distributed into commerce
and integrated into finished goods until that stock is depleted,
providing documentation is kept regarding the date of manufacture or
import.
    EPA notes that it has previously referred to the compliance date
for the emission standards, recordkeeping, and labeling provisions as
the ``manufactured-by date'' for composite wood products. To clarify,
the ``manufactured-by date'' in this context refers to the compliance
date for the emission standards, recordkeeping, and labeling
provisions. Additionally, EPA has also described the compliance date
for the provisions applicable specifically to producers of laminated
products, finalized in this rule to be March 22, 2024, as the
``manufactured-by date'' for laminated products. To clarify, the
``manufactured-by date'' in this context refers to the compliance date
for the provisions applicable specifically to producers of laminated
products.
    In addition, to clarify EPA's original intent regarding the
compliance dates referenced in the December 12, 2016, final rule, and
to better align with the final rule's preamble discussion the Agency
has amended the text preceding the compliance dates from ``after'' to
``beginning,'' as proposed. EPA intends regulated entities to begin
complying with the referenced rule requirements as of the dates listed
in the final rule. EPA did not receive adverse comment on this aspect
of the proposal.
    EPA is also proceeding with amending subparagraph Sec.  770.15(e)
to clarify that TPCs receive recognition after they apply to EPA, not
after the conclusion of the transitional period as the codified text
currently reads. EPA did not receive adverse comment on this aspect of
the proposal. As such, the Agency is finalizing this amendment as
proposed.
    Additionally, EPA is clarifying Sec.  770.2(d) to note that
existing CARB-approved TPCs that enter the TSCA Title VI program under
the reciprocity provisions of the final rule must be EPA-recognized
before they may begin certifying products as TSCA Title VI compliant.
EPA notes that this requirement is already explicitly stated in Sec.
770.7(d), and that this editorial clarification is solely intended to
resolve any ambiguity to be interpreted between the two aforementioned
codified sections of the regulatory text. EPA did not receive adverse
comment on this aspect of the proposal.

B. What is the agency's authority for taking this action?

    These regulations are established under authority of Section 601 of
TSCA, 15 U.S.C. 2697.

III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action has been determined to be a significant regulatory
action under Executive Order 12866 (58 FR 51735, October 4, 1993) and
was submitted to the Office of Management and Budget (OMB) for review
under Executive Orders and 13563 (76 FR 3821, January 21, 2011) and any
changes made in response to OMB review have been reflected in the
docket for this action.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is considered an Executive Order 13771 (82 FR 9339,
February 3, 2017) deregulatory action. This action provides regulatory
relief by extending the compliance date for certain provisions of the
formaldehyde emission standards for composite wood products final rule.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA because it does not create any new reporting or
recordkeeping obligations. OMB has previously approved the information
collection activities contained in the existing regulations and has
assigned OMB control number 2070-0185 (EPA ICR Number 2446.02).

D. Regulatory Flexibility Act (RFA)

    The Agency certifies that this action will not have a significant
economic impact on a substantial number of small entities under the
RFA, 5 U.S.C. 601 et seq. In making this determination, the impact of
concern is any significant adverse economic impact on small entities.
An agency may certify that a rule will not have a significant economic
impact on a substantial number of small entities if the rule relieves
regulatory burden, has no net burden or otherwise has a positive
economic effect on the small entities subject to the rule. This rule
extends, in response to two delays of the rule effective date and
public comment, the compliance dates and transitional period for CARB
TPCs to provide the time needed to achieve compliance post-effective
date. This will reduce the burden on TPCs, panel producers,
fabricators, importers, distributors, and retailers, because shortening
of the compliance period by even a few months makes it more difficult
for some of them to establish business relationships, certify product,
and distribute certified product into commerce to downstream entities
before the original compliance date. EPA therefore concludes that this
action will relieve or have no net regulatory burden for directly
regulated small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This final rule
will not impose substantial direct compliance costs on Indian tribal
governments.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
Executive Order 13045 has the potential to influence the regulation. As
addressed in Unit II.A., this action would not materially alter the
final rule as published, and will allow regulated entities additional
time to establish their supply-chain and certification programs under
the final rule, post effective date.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

    This final rule does not involve technical standards. As such,
NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA has determined that the human health or environmental risk
addressed by this action will not have potential disproportionately
high and adverse human health or environmental effects on minority,
low-income or indigenous populations, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994). As addressed in Unit II.A., this
action would not materially alter the final rule as published, and will
allow regulated entities additional time to establish their supply-
chain and certification programs under the final rule, post effective
date.

IV. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 770

    Environmental protection, Formaldehyde, Incorporation by reference,
Reporting and recordkeeping requirements, Third-party certification,
Toxic substances, Wood.

    Dated: August 31, 2017.
Wendy Cleland-Hamnett,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, 40 CFR chapter I, subchapter R, is amended as follows:

PART 770--FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD PRODUCTS

0
1. The authority citation for part 770 continues to read as follows:

    Authority: 15 U.S.C. 2697.

0
2. Revise Sec.  770.2 to read as follows:

Sec.  770.2  Applicability and compliance dates.

    (a) [Reserved].
    (b) Laboratory and Product ABs that wish to accredit TPCs for TSCA
Title VI purposes may apply to EPA beginning May 22, 2017, to become
recognized. Laboratory and Product ABs must be recognized by EPA before
they begin to provide and at all times while providing TSCA Title VI
accreditation services.
    (c) TPCs that are not approved by the California Air Resources
Board (CARB) that wish to provide TSCA Title VI certification services
may apply to EPA beginning May 22, 2017, to become recognized. TPCs
must be recognized by EPA and comply with all of the applicable
requirements of this part before they begin to provide and at all times
while providing TSCA Title VI certification services.
    (d) Notwithstanding any other provision of this part, TPCs that are
approved by CARB to certify composite wood products have until March
22, 2019, to become accredited by an EPA TSCA Title VI AB(s) pursuant
to the requirements of this part. During this two-year transition
period, existing CARB-approved TPCs that are recognized by EPA and CARB
TPCs approved during this transition period may carry out certification
activities under TSCA Title VI, provided that they remain approved by
CARB and comply with all aspects of this part other than the
requirements of Sec.  [thinsp]770.7(c)(1)(i) and (ii) and (c)(2)(iii)
and (iv). After the two-

year transition period, CARB-approved TPCs may continue to certify
composite wood products under TSCA Title VI provided the TPC maintains
its CARB approval, follows the requirements under this part, submits to
EPA documentation from CARB supporting their eligibility for
reciprocity and has received EPA recognition as an EPA TSCA Title VI
TPC. All TPCs that are certifying products as compliant with TSCA Title
VI, both during and after the transition period, are subject to
enforcement actions for any violations of TSCA Title VI or these
regulations.
    (e) Beginning December 12, 2018, all manufacturers (including
importers), fabricators, suppliers, distributors, and retailers of
composite wood products, and component parts or finished goods
containing these materials, must comply with this part, subject to the
following:
    (1) Beginning December 12, 2018, laminated product producers must
comply with the requirements of this part that are applicable to
fabricators.
    (2) Beginning March 22, 2024, producers of laminated products must
comply with the requirements of this part that are applicable to
hardwood plywood panel producers (in addition to the requirements of
this part that are applicable to fabricators) except as provided at
Sec.  [thinsp]770.4.
    (3) Beginning March 22, 2024, producers of laminated products that,
as provided at Sec.  [thinsp]770.4, are exempt from the definition of
``hardwood plywood'' must comply with the recordkeeping requirements in
Sec.  [thinsp]770.40(c) and (d) (in addition to the requirements of
this part that are applicable to fabricators).
    (4) Composite wood products manufactured (including imported)
before December 12, 2018 may be sold, supplied, offered for sale, or
used to fabricate component parts or finished goods at any time.

0
3. In Sec.  770.3 the term ``laminated product producer'' is revised to
read as follows:

Sec.  770.3  Definitions.

* * * * *
    Laminated product producer means a manufacturing plant or other
facility that manufactures (excluding facilities that solely import
products) laminated products on the premises. Laminated product
producers are fabricators and, beginning March 22, 2024, laminated
product producers are also hardwood plywood panel producers except as
provided at Sec.  [thinsp]770.4.
* * * * *

0
4. In Sec.  770.7, paragraph (d)(1) introductory text is revised to
read as follows:

Sec.  770.7  Third-party certification.

* * * * *
    (d) * * *
    (1) During transitional period. The transitional period is defined
as the period beginning on December 12, 2016 and ending on March 22,
2019. TPCs already approved by CARB and TPCs subsequently approved by
CARB during the transitional period must apply for EPA recognition in
accordance with Sec.  770.8 before they can certify any products under
this part. Once recognized by EPA, CARB-approved TPCs become EPA TSCA
Title VI TPCs and may certify composite wood products under TSCA Title
VI until March 22, 2019, as long as they:
* * * * *

0
5. In Sec.  770.10, paragraph (a) is revised to read as follows:

Sec.  770.10  Formaldehyde emission standards.

    (a) Except as otherwise provided in this part, the emission
standards in this section apply to composite wood products sold,
supplied, offered for sale, or manufactured (including imported) on or
after December 12, 2018 in the United States. These emission standards
apply regardless of whether the composite wood product is in the form
of a panel, a component part, or incorporated into a finished good.
* * * * *

0
6. In Sec.  770.12, paragraph (a) is revised to read as follows:

Sec.  770.12  Stockpiling.

    (a) The sale of stockpiled inventory of composite wood products,
whether in the form of panels or incorporated into component parts or
finished goods, is prohibited after December 12, 2018.
* * * * *

0
7. In Sec.  770.15, paragraph (a) and (e) are revised to read as
follows:

Sec.  770.15  Composite wood product certification.

    (a) Beginning December 12, 2018, only certified composite wood
products, whether in the form of panels or incorporated into component
parts or finished goods, are permitted to be sold, supplied, offered
for sale, or manufactured (including imported) in the United States,
unless the product is specifically exempted by this part.
* * * * *
    (e) If a product is certified by a CARB-approved TPC that is also
recognized by EPA, the product will also be considered certified under
TSCA Title VI until March 22, 2019 after which the TPC needs to comply
with all the requirements of this part as an EPA TSCA Title VI TPC
under Section 770.7(d) in order for the product to remain certified.
* * * * *

0
8. In Sec.  770.30, paragraphs (b) introductory text, (c), and (d) are
revised to read as follows:

Sec.  770.30  Importers, fabricators, distributors, and retailers.

* * * * *
    (b) Importers must demonstrate that they have taken reasonable
precautions by maintaining, for three years, bills of lading, invoices,
or comparable documents that include a written statement from the
supplier that the composite wood products, component parts, or finished
goods are TSCA Title VI compliant or were produced before December 12,
2018 and by ensuring the following records are made available to EPA
within 30 calendar days of request:
* * * * *
    (c) Fabricators, distributors, and retailers must demonstrate that
they have taken reasonable precautions by obtaining bills of lading,
invoices, or comparable documents that include a written statement from
the supplier that the composite wood products, component parts, or
finished goods are TSCA Title VI compliant or that the composite wood
products were produced before December 12, 2018.
    (d) Beginning March 22, 2019, importers of articles that are
regulated composite wood products, or articles that contain regulated
composite wood products, must comply with the import certification
regulations for ``Chemical Substances in Bulk and As Part of Mixtures
and Articles,'' as found at 19 CFR 12.118 through 12.127.
* * * * *

[FR Doc. 2017-19455 Filed 9-22-17; 8:45 am]
BILLING CODE 6560-50-P


Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Data Requirement: : EPA DP Barcode None EPA MRID Not Assigned EPA Guideline Open Literature Test material: Purity: n o t reported Common name Atrazine chemical name: IUPAC CAS name 6 chloro N ethyl N'( 1 methylethyl) 1,3,5 triazine 2,4 diamine CAS No. 1912 24 9 synonyms EPA PC Code: 80803 Primary Reviewer: Thomas M. Steeger, Ph. D., Senior Biologist Dat e : May 1, 2003 Environmental Fate and Effects Division, ERB 4, U. S. Environmental Protection Agency Secondary Reviewer( s): Joseph E. Tietge, Research Aquatic Biologist Date: Mid Continent Ecology Division, National Health and Environmental Effects Research Laboratory ( Duluth), U. S. Environmental Protection Agency Stephanie Irene, Ph. D., Senior Advisor Date: 05/ 01/ 03 Environmental Fate and Effects Division, ERB 3, U. S. Environmental Protection Agency Mary J. Frankenberry, Senior Statistician Date: Environmental Fate and Effects Division, ERB 3, U. S. Environmental Protection Agency EPA PC Code 080803 Date Evaluation Completed: 05/ 01/ 2003 CITATION: Reeder, A. L., G. L. Foley, D. K. Nichols, L. G. Hansen, B. Wikoff, S. Faeh, J. Eisold, M. B. Wheeler, R. Warner, J. E. Murphy, and V. R. Beasley 1998. Forms and prevalence of intersexuality and effects of environmental contaminants on sexuality in cricket frogs ( Acris crepitans). Environmental Health Perspectives 106 ( 5): Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 2 of 10 EXECUTIVE SUMMARY:

In an effort to assess the prevalence of gonadal intersexuality in adult and juvenile cricket frogs ( Acris crepitans) and to determine whether sexuality is altered in response to exposure to environmental contaminants, cricket frogs were collected over a three year period ( 1993  1995) in various locations throughout the state of Illinois. Additionally, water/ sediment samples were collected at sampling sites in 1994 and 1995 to determine whether the prevalence of intersex could be related to chemical residues. In a separate study, cricket frogs were also collected at a site known to be contaminated with PCBs and PCDFs and the prevalence of intersex was determined relative to control sites.

Of the 55 adult and juvenile male and female frogs collected in 1993, 2 ( 3.6%) had both an ovary and testis. In the testis of one, spermatogenesis was normal; in the other, an immature ovary was present as well as a testis with no active spermatogenesis. Of the 243 frogs examined in 1994, 6 ( 2.5%) contained both ovary and testis; five of the affected animals had areas of normal spermatogenesis in the testis interspersed with oocytes. One animal had a mature ovary and mature testis with normal spermatogenesis. Of the 43 frogs examined in 1995, only one ( 2.3%) had an ovotestis. Across all three sampling years the prevalence of intersex was 2.8%. In specimens with an ovary on one side and an testis on the other, ovarian size ranged form well developed mature female to extremely small with a few oocytes present.

Of the five sites where intersex was found, four had detectable atrazine. Of the four sites where no intersex was observed, only one contained detectable levels of atrazine. According to the authors the relationship between detection of atrazine and prevalence of intersex " approached significance" ( P = 0.07). At one site treated with copper sulfate in 1994, 1 frog of 33 collected had an ovotestis. In 1995, no relationship between the detection of atrazine and the prevalence of intersex. No intersex was identified in frogs collected from a pond treated with endothall in 1995. Lead residues measured in 1994 and 1995 were not associated with the prevalence of intersex.

Of the frogs collected from PCB and control sites, only 1 frog with an ovotestis was identified from the control. Sex ratios differed significantly ( probability not given) between contaminated and control sites. In 13 juveniles from control and 13 from contaminated sites, gonadal tissue was immature and could not be identified for histological preparation. According to the authors, the association between sex ratios of PCB/ PCDF contaminated and control groups revealed a significant difference ( p = 0.0007).

While a wide range of chemical residue analyses were conducted, no data are provided on the results of these analyses. It is not clear why the study focuses primarily on atrazine; however, the authors suggest that there may be a trend between atrazine residues and the proportion of animals exhibiting intersex. The only statistically significant relationship though was between sex ratios in PCB/ PCDF contaminated sites relative to controls; however, the sample size for making this determination was low ( n= 4).

In this paper, Reeder et al. ( 1998) discussed the range of chemical residues in the field collection sites and how these chemicals, combined with environmental conditions, could impact gonadal development. These factors contributed to the limited utility of this study because the investigation did not demonstrate a significant effect of chemical residues on the prevalence of intersex in cricket frogs. This study underscored the need to have focused study designs with sufficient power in terms of sample size to discriminate effects if they exist. Also, the report acknowledged that little is known about natural intersex rates in cricket frogs. Without a better Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 3 of 10 understanding of the biology of the cricket frog and the toxicological phenomenon being examined, it is difficult to interpret the significance of the reported observations.

I. MATERIALS AND METHODS GUIDELINE FOLLOWED: Nonguideline Study COMPLIANCE: Not conducted under full Good Laboratory Practices A. MATERIALS:

1. Test Material Atrazine Description:

Lot No./ Batch No. : Not reported Purity: Stability of Compound Under Test Conditions: Not reported Storage conditions of test chemicals: Not reported 2. Test organism:

Species: Cricket frogs ( Acris crepitans) .

Age at test initiation: Weight at study initiation: ( mean and range) not reported Length at study initiation: ( mean and range) not reported Source: Field collected along pond banks in sites distributed across Illinois B. STUDY DESIGN:

Objective: to assess the prevalence of gonadal intersexuality in adult and juvenile cricket frogs ( Acris crepitans) and to determine whether sexuality is altered in response to exposure to environmental contaminants Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 4 of 10 1. Experimental Conditions a) Range finding Study: In 1993, a pilot study focused on pond site identification and preliminary assessment of histologic lesions in Illinois cricket frogs, 20 sites selected.

b) Definitive Study In 1994 and 1995 frogs were collected from specific sites based on suitable habitat and presence of cricket frogs; ponds were of comparable size and were distributed across the state of Illinois. Table 1 . Experimental Parameters Parameter Details Acclimation: period: conditions: ( same as test or not) Feeding: Health: ( any mortality observed) NA Duration of the test NA Test condition static/ flow through Type of dilution system for flow through method.

Renewal rate for static renewal NA Aeration, if any NA Test vessel Material: ( glass/ stainless steel) Size:

Fill volume: NA Source of dilution water Quality: NA Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Parameter Details Page 5 of 10 Water parameters: Hardness pH Dissolved oxygen Total Organic carbon Particulate Matter Ammonia Nitrite Metals Pesticides Chlorine Temperature Salinity Intervals of water quality measurement NA Number of replicates/ groups: negative control: 0.004% ethanol treated ones: NA Number of organisms per replicate / groups: In 1993, gonads of 50 intact cricket frogs from 18 sites. In 1994, gonads of 242 frogs examined from 8 sites ( 24  39 frogs from the various sites). In 1995, gonads of 40 frogs examined from 7 sites ( 4  7 frogs per site).

Biomass loading rate NA Test concentrations: nominal: NA Solvent ( type, percentage, if used) NA Lighting NA Feeding NA Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Parameter Details Page 6 of 10 Recovery of chemical Level of Quantitation Level of Detection NA Positive control { if used, indicate the chemical and concentrations} NA Other parameters, if any NA 2. Observations: Table 2: Observations Criteria Details Parameters measured including the sublethal effects/ toxicity symptoms prevalence of gonadal abnormalities in terms of testicular oocytes.

Observation intervals NA Were raw data included? No Other observations, if any Study A In 1994, eight sites with similar size studied ( 5 in south, 2 in central and 1 in northeast Illinois). In 1995, seven of the ponds studied in 1994 and one pond in the agricultural area of east central Illinois, studied.

In 1993, gonads of 50 intact cricket frogs from 18 sites in east central and southern Illinois examined for gross morphology. In 1994, gonads of 242 frogs examined from 8 sites ( 24  39 frogs from the various sites). In 1995, gonads of 40 frogs examined from 7 sites ( 4  7 frogs per site).

Animals from 1993 subject to whole body histologic sections while samples from 1994 and 1995 were subject to gonad histology.

Composite water and sediment samples collected in acetone rinsed containers from multiple locations in each pond studied in 1994 and 1995. Samples collected at the end of May and again in late Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 7 of 10 July/ early August in 1994 and at the end of May in 1995. Additional water samples were collected at sites 11 and 12 in June 1998 following an aquatic plant kill. Water analyzed ( State of Illinois Animal Disease Laboratory, Centralia, IL) for herbicides, fungicides, insecticides, PCBs and metals ( Table 1; source: Reeder et al. 1998).

Study B In mid July 1995, 16 juvenile cricket frogs collected from three sites in Crab Orchard National Wildlife Refuge in southern Illinois where point contamination with PCBs, PCDFs, and PCDDs had previously occurred. On the same sampling days, 16 juvenile frogs also collected from each of three control sites located outside the area of PCB and PCDF contamination but within a 16 km radius of the Crab Orchard site.

Fisher's Exact Test used to compare prevalence of intersex gonads and detection of atrazine at those sites. Fisher's Exact test also used to compare sex ratios among control and PCB/ PCDF sites using SigmaStat software.

II. RESULTS and DISCUSSION:

Study A Although cricket frog testicular tissue is typically heavily pigmented, about 20% of males had testes with reduced or absent pigmentation particularly on the right side; however, normal spermatogenesis was observed in both pigmented and nonpigmented testes. Mature females contained large egg mass with bipolar eggs ( tan/ black coloring).

Of the 55 adult and juvenile male and female frogs collected in 1993, 2 ( 3.6%) had both an ovary and testis. In the testis of one, spermatogenesis was normal; in the other, an immature ovary was present as well as a testis with no active spermatogenesis. Of the 243 frogs examined in 1994, 6 ( 2.5%) contained both ovary and testis; five of the affected animals had areas of normal spermatogenesis in the testis interspersed with oocytes. One animal had a mature ovary and mature Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 8 of 10 testis with normal spermatogenesis. Of the 43 frogs examined in 1995, only one ( 2.3%) had an ovotestis. Across all three sampling years, the prevalence of intersex was 2.8% ( report claims 2.6%). In specimens with an ovary on one side and an testis on the other, ovarian size ranged form welldeveloped mature female to extremely small with a few oocytes present.

Of the five sites where intersex was found, four had detectable atrazine. Of the four sites where no intersex was observed, only one contained detectable levels of atrazine. According to the authors the relationship between detection of atrazine and prevalence of intersex " approached significance" ( P = 0.07). At one site treated with copper sulfate in 1994, 1 frog of 33 collected had an ovotestis. In 1995, no relationship between the detection of atrazine and the prevalence of intersex. No intersex was identified in frogs collected from a pond treated with endothall in 1995. Concentrations of lead from both years not associated with intersex either.

Study B Of the frogs collected from PCB and control sites, only 1 frog with an ovotestis was identified from the control. Sex ratios differed significantly ( probability not given) between contaminated and control sites. In 13 juveniles from control and 13 from contaminated sites, gonadal tissue was immature and could not be identified for histological preparation. According to the authors, the association between sex ratios of PCB/ PCDF contaminated and control groups revealed a significant difference ( p = 0.0007). .

F. REVIEWER'S COMMENTS:

It is not clear what was driving the sampling design used in this study. Sample size varied considerably between years: 1993 ( 55 frogs), 1994 ( 243 frogs) and 1995 ( 43 frogs).

There are several discrepancies between the tables and the text. In discussing the prevalence of intersex relative to atrazine, the authors refer to 5 sites with residues and 4 sites without residues in the 1994 sampling; however, according to the methods section only 8 sites ( not 9) were sampled in 1994.

In study A, a wide range of chemicals were analyzed in both water and sediment at each of the collection sites in 1994 and 1995; however, the results section does not discuss the outcome of these analyses but rather focuses primarily on atrazine thus implying that it was either the only chemical were residues were detected or that it was the only chemical residues where the researchers could Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 9 of 10 identify a significant relationship. Since no data are provided on residue levels, it isn't possible for the Agency to verify whether a correlation existed between atrazine residues and the prevalence of intersex; however, the results section suggests that if a relationship did exist in 1994, it was transient since no relationship existed in 1995. Further, it isn't clear whether the lack of a " relationship" between atrazine residues in 1995 and atrazine residues was a result of only one intersex animal being found in spite of atrazine residues or whether there were no detectable atrazine residues. The article implies that the authors attempted to correlate atrazine residues only to cases where intersex was determined. If this is the case then the analysis is somewhat biased since zero prevalence would not be captured. Atrazine residues at each sites should have been compared to the rate of intersex at each site; however, it doesn't appear that the study was designed to anticipate such an analysis. The utility of calculating an overall prevalence of abnormalities seems unsound, as it unnecessarily combines data from sites identified as contaminated or control.

In study B, the methods section suggests that they collected 16 frogs from control and from contaminated sites. The results section states that the gonads of 13 frogs from each location were too immature to determine sex. This implies that over 80% of the animals were too immature to determine sex. Therefore, the effective sample size for determining sex ratio differences was low with three animals in each group.

Presentation of the analytical chemistry data is not clear... are blank entries indicative of no analyses or no measurable quantities? The authors note the variety of chemical residues measured in the field studies and how varying levels of response to the wide range of chemicals might influence the frog's sensitivity to the chemicals. Classifying a site categorically as atrazine contaminated based on the sampling plan is misleading. The real question is: what were the atrazine concentrations during the developmental stage of interest? Given this lack of information, it is difficult to accept the correlational association of gonadal abnormalities and atrazine presence, as it has no basis in the biology nor toxicology. Additionally the authors note how environmental factors such as temperature may impact gonadal development. Given the number of potentially confounding effects, it is difficult to place much weight on the statistical relationships developed in what amounts to a reconnaissance survey. These factors contribute to the limited utility of this study since the study does not demonstrate a significant affect of chemical residues on the prevalence of intersex in cricket frogs. The study underscores to need to have focused study designs with sufficient power in terms of sample size to discriminate effects should they exist. Data Evaluation Report on Forms and Prevalence of Intersexuality and Effects of Environmental Contaminants on Sexuality in Cricket Frogs ( Acris crepitans) EPA MRID Number: None Page 10 of 10 The report admits in the introduction that virtually nothing is known about intersex conditions in cricket frogs. Perhaps cricket frogs exhibit ovotestes normally at some low level and the presence and absence of this condition at any one site is a function of small sample sizes. In general, this study is another one that puts the " cart ahead of the horse." That is, they conducted a field study, replete with complications and uncertainties without having a firm understanding of either the biology of the organism that they were studying or the toxicological phenomenon that they attempted to study. It clearly does not contribute to the understanding of whether or not atrazine poses any reproductive risk to anurans.


[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51453-51455]
[FR Doc No: 2017-24050]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81991; File No. SR-ISE-2017-96]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rule 1614

October 31, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 27, 2017, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been prepared

by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Rule 1614, entitled ``Imposition of
Fines for Minor Rule Violations,'' to make a non-substantive,
clarifying change to the rule. [sic]
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.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 aspects of such
statements.

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

1. Purpose
    The Exchange is proposing to amend Rule 1614, entitled ``Imposition
of Fines for Minor Rule Violations,'' to make a non-substantive,
clarifying change to the rule.\3\ [sic] Rule 1614(d)(2) currently sets
forth the fine schedule for the failure to file annual Financial and
Operational Combined Uniform Single (``FOCUS'') Reports on Form X-17A-5
in accordance with Rule 17a-10 \4\ under the Act. The existing schedule
in the Rule does not clearly reflect how a FOCUS Report that is
received on the ninetieth day would be handled for purposes of
assessing a fine. The Exchange therefore proposes to clarify in Rule
1614(d)(2) that FOCUS Reports received by the Exchange over ninety
calendar days late will subject the member to formal disciplinary
action. As such, the Exchange is proposing to change the reference to
``90 or more'' days in the sanction schedule to ``over 90'' days.
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    \3\ The Exchange notes that Chapter 16 of the ISE Rulebook,
including Rule 1614, is incorporated by reference into the rulebooks
of Nasdaq GEMX (``GEMX'') and Nasdaq MRX (``MRX''). As such, the
amendment to ISE Rule 1614 as proposed herein will also impact GEMX
and MRX Rules 1614.
    \4\ 17 CFR 240.17a-10.
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2. Statutory Basis
    The Exchange is proposing to amend Rule 1614, entitled ``Imposition
of Fines for Minor Rule Violations,'' to make a non-substantive,
clarifying change to the rule.\5\ [sic] Rule 1614(d)(2) currently sets
forth the fine schedule for the failure to file annual Financial and
Operational Combined Uniform Single (``FOCUS'') Reports on Form X-17A-5
in accordance with Rule 17a-10 \6\ under the Act. The existing schedule
in the Rule does not clearly reflect how a FOCUS Report that is
received on the ninetieth day would be handled for purposes of
assessing a fine. The Exchange therefore proposes to clarify in Rule
1614(d)(2) that FOCUS Reports received by the Exchange over ninety
calendar days late will subject the member to formal disciplinary
action. As such, the Exchange is proposing to change the reference to
``90 or more'' days in the sanction schedule to ``over 90'' days.
---------------------------------------------------------------------------

    \5\ The Exchange notes that Chapter 16 of the ISE Rulebook,
including Rule 1614, is incorporated by reference into the rulebooks
of Nasdaq GEMX (``GEMX'') and Nasdaq MRX (``MRX''). As such, the
amendment to ISE Rule 1614 as proposed herein will also impact GEMX
and MRX Rules 1614.
    \6\ 17 CFR 240.17a-10.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. As discussed above, the
Exchange's proposal is a non-substantive, technical amendment to Rule
1614(d)(2), and is merely intended to add further clarification to the
Exchange's rules and alleviate potential confusion.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative before 30 days from the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\9\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest.
Clarification of how a FOCUS Report will be handled for purposes of
assessing a fine that is 90 calendar days late will reduce confusion
caused by the ambiguity of the Rule as written before the Exchange
filed this proposed rule change. The Commission believes no purpose is
served in delaying such clarification. Therefore, the Commission hereby
waives the 30-day operative delay and designates the proposed rule
change to be operative upon filing with the Commission.\10\
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    \10\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change 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-ISE-2017-96 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-ISE-2017-96. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site 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 the filing also will 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-ISE-2017-96, and should be
submitted on or before November 27, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24050 Filed 11-3-17; 8:45 am]
BILLING CODE 8011-01-P


the purposes of this section, automatically limiting engine performance
to induce an operator to perform emission-related maintenance--such as
refilling a DEF tank--is considered an emission control. AECDs approved
under this section are not defeat devices, and their proper use during
a qualified emergency situation is not prohibited under Clean Air Act
section 203 (42 U.S.C. 7522). Manufacturers may apply for AECD approval
at any time; however, we encourage manufacturers to obtain preliminary
approval before submitting an application for certification. We may
allow manufacturers to apply an approved AECD to engines and equipment
that have already been placed into service.
    (b) AECD approval criteria. We will approve an AECD where we
determine that the following criteria have been met:
    (1) The AECD's design must be consistent with good engineering
judgment and the manufacturer must show that the AECD deactivates
emission controls only to the extent necessary to address the expected
emergency situation.
    (2) Manufacturers must discourage improper activation of the AECD
by displaying information where it is clearly visible to the equipment
operator when the operator is in a position to activate the AECD.
Unless we approve alternate language, state the following: ``EMERGENCY
USE ONLY. SEE OWNERS MANUAL. PENALTIES APPLY FOR MISUSE.''
    (3) Manufacturers may design and produce their engines with the
AECD initially armed to allow operators to activate the AECD one time
per engine

without any further input or permission from the manufacturer. The AECD
may be subsequently reset as specified in paragraph (b)(8) of this
section.
    (4) Except as allowed by paragraph (b)(3) of this section, AECD
activation must require either input of a temporary code,
reconfiguration of the engine's electronic control module by a
qualified service technician, or an equivalent security feature that is
unique to each engine.
    (5) The engine controls must be configured to record the total
number of AECD activations in that engine's nonvolatile electronic
memory.
    (6) The engine controls must include an operator-activated switch
or other element of design to allow the operator to manually deactivate
the AECD once a qualified emergency situation has ended. This manual
control may include a ``confirm-delete'' function, as needed, to
prevent unintentionally deactivating the AECD. This control may allow
for manual reactivation of the AECD provided that the AECD's automatic
deactivation limits in paragraph (b)(7) of this section have not yet
been reached, but such reactivation by operators would be allowed only
under emergency situations. This manual deactivation control must not
deactivate operator inducements required by paragraph (b)(9) of this
section.
    (7) The AECD must automatically deactivate within a cumulative
engine run time of 120 hours after the AECD was initially activated
(excluding any time the AECD was deactivated). The AECD may be
subsequently reset as specified in paragraph (b)(8) of this section.
For emission controls that involve a sequence of increasingly severe
engine performance limits to induce operators to perform emission-
related maintenance, the emission controls may be reset to the initial
point of that sequence when the AECD is deactivated.
    (8) The manufacturer must ensure that resetting the AECD cannot
occur without the manufacturer's specific permission, and that
resetting the AECD requires either input of a temporary code,
reconfiguration of the engine's electronic control module by a
qualified service technician, or an equivalent security feature that is
unique to each engine. AECD resets may not occur unless either the
manufacturer has evidence that the emergency situation is continuing or
the operator provides the information required in paragraph (e) of this
section, in writing or by any other means.
    (9) The manufacturer must take appropriate additional steps to
induce operators to report AECD activation and request resetting the
AECD. We recommend including one or more persistent visible and/or
audible alarms that are active from the point when the AECD is
activated to the point when it is reset.
    (c) Required information. Manufacturers producing engines equipped
with an AECD approved under this section must communicate at least the
following information in writing to the operator:
    (1) Instructions for activating, deactivating, and reactivating the
AECD; reporting AECD use; and requesting AECD resets.
    (2) A warning that federal regulations prohibit activating the
emergency AECD for something other than a qualified emergency
situation, failing to disable the emergency AECD after a qualified
emergency situation ends, and failing to notify the manufacturer and
send reports as required under paragraph (e) of this section. The
warning must also identify the maximum civil penalty for such
violations as described in 40 CFR 1068.101.
    (3) Notification that the manufacturer will send the information
from the operator's report under paragraph (e) of this section to EPA
and that federal regulation separately prohibits submitting false
information.
    (d) Resetting AECDs. The operator (or other person responsible for
the engine/equipment) may request resetting the AECD at any time. The
manufacturer may reset the AECD only if the manufacturer has evidence
that the emergency situation is continuing, or after the operator
provides the information required in paragraph (e) of this section, in
writing or by any other means.
    (e) Operator reporting of AECD use. The operator (or other person
responsible for the engine/equipment) must send a written report to the
manufacturer within 60 calendar days after activating an AECD approved
under this section. The report must include the following:
    (1) Contact name, mail and email addresses, and telephone number
for the responsible company or entity.
    (2) A description of the emergency situation, the location of the
engine during the emergency, and the contact information for an
official who can verify the emergency situation (such as a county
sheriff, fire marshal, or hospital administrator).
    (3) The reason for AECD activation during the emergency situation,
such as the lack of DEF, or the failure of an emission-related sensor
when the engine was needed to respond to an emergency situation.
    (4) The engine's serial number (or equivalent).
    (5) A description of the extent and duration of the engine
operation while the AECD was active, including a statement describing
whether or not the AECD was manually deactivated after the emergency
situation ended.
    (f) Operator failure to report. If the operator fails to submit the
report required by paragraph (e) of this section to the manufacturer
within 60 days of activating an AECD approved under this section, the
manufacturer, to the extent it has been made aware of the AECD
activation, must send written notification to the operator that failure
to meet the submission requirements may subject the operator to
penalties under 40 CFR 1068.101.
    (g) Prohibited acts. The following actions by the operator are
improper use of the AECD and are prohibited under Clean Air Act section
203 (42 U.S.C. 7522):
    (1) Activating the emergency AECD for any use other than a
qualified emergency situation where the emission control strategy would
curtail engine performance.
    (2) Failing to disable the emergency AECD after a qualified
emergency situation has ended.
    (3) Failing to disable the emergency AECD after the problem causing
the emission control strategy to interfere with engine performance has
been or can reasonably be fixed.
    (4) Failing to provide the information required under paragraph (e)
of this section within 60 days of AECD activation.
    (h) Manufacturer reporting to EPA. Within 90 days after each
calendar year, the manufacturer must send an annual report to the
Designated Compliance Officer describing the use of AECDs approved
under this section. A manufacturer may request an extension if it is
impractical to meet this deadline as the result of an emergency
situation occurring late in a given calendar year. The annual report
must include a description of each emergency situation leading to each
AECD activation and copies of the reports submitted by operators (or
statements that an operator did not submit a report, to the extent of
the manufacturer's knowledge).
    (i) Submissions to EPA. Notifications and reports submitted to
comply with this section are deemed to be submissions to EPA.
    (j) Recordkeeping. The manufacturer must keep records to document
the use of AECDs approved under this section until the end of the
calendar year five

years after the onset of the relevant emergency situation. We may
approve alternate recordkeeping and reporting requirements.
    (k) Anti-circumvention. We may set other reasonable conditions to
ensure that the provisions in this section are not used to circumvent
the emission standards of this part.

0
13. Section 1039.670 is amended by revising paragraphs (b) and
(c)(3)(ii) to read as follows:

Sec.  1039.670  Approval of an emergency equipment field modification
(EEFM).

* * * * *
    (b) Include in your notification a full description of the EEFM and
any documentation to support your determination that the EEFM is
necessary to prevent the equipment from losing speed, torque, or power
due to abnormal conditions of its emission control system during
operation related to emergency response, or to prevent such abnormal
conditions from occurring during operation related to emergency
response. Examples of such abnormal conditions may include excessive
exhaust backpressure from an overloaded particulate trap, or running
out of diesel exhaust fluid (DEF) for engines that rely on urea-based
selective catalytic reduction. Your determination must be based on an
engineering evaluation or testing or both.
    (c) * * *
    (3) * * *
    (ii) We will deny your request if we determine that the EEFM is not
necessary to prevent the equipment from losing speed, torque, or power
due to abnormal conditions of the emission control system during
operation related to emergency response, or to prevent such abnormal
conditions from occurring during operation related to emergency
response.
* * * * *

Subpart I--Definitions and Other Reference Information

0
14. Section 1039.801 is amended by revising the definitions for
``Diesel exhaust fluid (DEF)'' and ``Emergency equipment'' to read as
follows:

Sec.  1039.801  What definitions apply to this part?

* * * * *
    Diesel exhaust fluid (DEF) means a liquid reducing agent (other
than the engine fuel) used in conjunction with selective catalytic
reduction to reduce NOX emissions. Diesel exhaust fluid is
generally understood to be an aqueous solution of urea conforming to
the specifications of ISO 22241.
* * * * *
    Emergency equipment means any of the following types of equipment
that is not a motor vehicle:
    (1) Specialized vehicles used to perform aircraft rescue and/or
fire-fighting functions at airports, with particular emphasis on saving
lives and reducing injuries coincident with aircraft fires following
impact, or aircraft ground fires.
    (2) Wildland firefighting equipment designed primarily to support
wildland fire suppression operations. For example, a bulldozer designed
with special features for fighting wildfires would be a piece of
emergency equipment.
    (3) Any other equipment that we have determined will likely be used
in emergency situations where emission control function or malfunction
may cause a significant risk to human life. For example, we would
consider nonroad equipment that is certain to be retrofitted with a
slip-on firefighting module to be emergency equipment, irrespective of
the equipment manufacturer's original design. In making this
determination, we may consider any factor that has an effect on the
totality of the actual risk to human life. For example, we may consider
how frequently the equipment will be used in emergency situations or
how likely it is that the emission controls will cause a significant
risk to human life when the equipment is used in emergency situations.
We will consider to what extent the flexibility provisions of Sec.
1039.665 already address the risk. In the example above, we would not
consider equipment to be emergency equipment if there is merely a
possibility (rather than a certainty) that the equipment will be
retrofitted with a slip-on firefighting module.
* * * * *
[FR Doc. 2014-18738 Filed 8-7-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19231-19232]
[FR Doc No: E9-9641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Neurological Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 14, 2009, from 8
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
    Contact Person: Peter L. Hudson, Center for Devices and
Radiological Health, (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), code<PHONE_NUMBER>. Please call the Information
Line for up-to-date information on this meeting. A

notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice.
Therefore, you should always check the agency's Web site and call
the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss, make recommendations and
vote on a premarket approval application for the DuraSeal Xact\TM\
Sealant System, sponsored by Confluent Surgical Inc. This device is
indicated for use as an adjunct to sutured dural repair to obtain
watertight closure during spinal surgery.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 30, 2009. Oral presentations from the public will be scheduled
for 30 minutes at the beginning of the committee deliberations and
for 30 minutes near the end of the deliberations. Those desiring to
make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 28, 2009. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public
hearing session. The contact person will notify interested persons
regarding their request to speak by April 29, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Ms. AnnMarie
Williams, Conference Management Staff, at<PHONE_NUMBER>, at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9641 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Notices]
[Page 14858-14859]
[DOCID:fr19mr08-116]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57485; File No. SR-Amex-2008-04]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Granting Accelerated Approval of Proposed Rule Change Relating to the
Dissemination of the Index Value for Index-Linked Securities

March 12, 2008.

I. Introduction

    On January 30, 2008, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change relating to the dissemination of the index value
for Index-Linked Securities.\3\ The proposed rule change was published
for comment in the Federal Register on February 20, 2008 for a 15-day
comment period.\4\ The Commission received no comments on the proposal.
This order approves the proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Index-Linked Securities are securities that provide for the
payment at maturity of a cash amount based on the performance of an
underlying index or indexes. See Amex Company Guide Sections 107D.
    \4\ See Securities Exchange Act Release No. 57325 (February 13,
2008), 73 FR 9375.
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II. Description of the Proposal

    The Exchange proposed to amend sections 107D(i) and section
107(d)(h)(3)(ii) of the Amex Company Guide (``Company Guide'') to
conform the index dissemination requirements relating to Index-Linked
Securities to that of Index Fund Shares and Portfolio Depository
Receipts (collectively, exchange-traded funds or ``ETFs'').\5\ Section
107(D)(i)(iii) of the Company Guide provides that the current value of
an index will be widely disseminated at least every 15 seconds. The
proposed amendment provides that the current value of an index or
composite value of more than one index will be widely disseminated at
least: (i) Every 15 seconds with respect to indexes containing only
securities listed on a national securities exchange; or (ii) every 60-
seconds with respect to indexes containing foreign country securities.
If the official index value does not change during some or all of the
period when trading is occurring on the Exchange, then the last
calculated official index value must remain available throughout
Exchange trading hours. In addition, the Exchange proposes to amend the
delisting requirements set forth in section 107D(h)(3)(ii) to
distinguish between indexes consisting solely of securities listed on a
national securities exchange and those including components that are
foreign country securities.
---------------------------------------------------------------------------

    \5\ See Commentary .02(b)(ii) to Rule 1000A--AEMI (Index Fund
Shares) and Commentary .03(b)(ii) to Rule 1000--AEMI (Portfolio
Depository Receipts).
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\6\ In particular, the Commission finds that the proposed rule
change is consistent with section 6(b)(5) of the Act,\7\ which
requires, among other things, that the rules of an exchange be designed
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, protect investors and the
public interest.
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    \6\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission notes that opportunities to invest in derivative
securities products based not only on U.S. securities, but also on an
international or global index of equity securities, provide additional
choices to accommodate particular investment needs and objectives, to
the benefit of investors. With respect to the dissemination of the
value of an index that is comprised, at least in part, of

non-U.S. components, the proposed 60-second standard reflects
limitations, in some instances, on the frequency of intra-day trading
information with respect to foreign country securities and the fact
that in many cases, trading hours for overseas markets overly only in
part, or not at all, with the Exchange's trading hours. In addition, if
an index or portfolio value does not change during some or all of the
period when the derivative securities product trades on the Exchange,
the last official calculated index value will remain available
throughout Exchange trading hours. The Commission believes that such
60-second standard relating to the dissemination of the value of an
index composed, at least in part, of foreign securities should apply to
Index-Linked Securities as well as ETFs and finds that the Exchange's
proposal is consistent with the Act on the same basis that it approved
the other exchange's generic listing standards for ETFs based on
international or global indexes.\8\ In addition, the Commission notes
that it has approved substantively identical dissemination requirements
for Index-Linked Securities listed on another national securities
exchange.\9\
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    \8\ See, e.g., Securities Exchange Act Release Nos. 55269
(February 9, 2007), 72 FR 7490 (February 15, 2007) (SR-NASDAQ-2006-
050); 55113 (January 17, 2007), 72 FR 3179 (January 24, 2007) (SR-
NYSE-2006-101); and 54739 (November 9, 2006), 71 FR 66993 (November
17, 2006) (SR-Amex-2006-78).
    \9\ See Securities Exchange Act Release No. 57389 (February 27,
2008), 73 FR 11973 (March 5, 2008) (SR-NYSEArca-2008-06).
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    The Commission finds good cause for approving the proposed rule
change before the 30th day after the date of publication of notice of
filing thereof in the Federal Register. The Commission notes that the
proposal is substantively identical to a proposed rule change that the
Commission approved for another national securities exchange.\10\ In
addition, the Commission believes that accelerated approval of the
proposed rule change, which clarifies the dissemination of the value of
the index underlying an issue of Index-Linked Securities, should
promote the continued listing and trading of Index-Linked Securities to
the benefit of investors. Therefore, the Commission finds good cause,
consistent with section 19(b)(2) of the Act, to approve the proposed
rule change on an accelerated basis.
---------------------------------------------------------------------------

    \10\ Id.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\11\ that the proposed rule change (SR-Amex-2008-04) is approved on
an accelerated basis.
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    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5429 Filed 3-18-08; 8:45 am]

BILLING CODE 8011-01-P