[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Rules and Regulations]
[Pages 28833-28835]
[FR Doc No: 2015-12109]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0304]
RIN 1625-AA00

Safety Zones; Apra Outer Harbor and Adjacent Waters, Guam

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a safety zone for underwater
detonation operations in the waters of Apra Outer Harbor, Guam. This
rule is effective from 10 a.m. until 4 p.m. on May 15, 2015 and May 21,
2015 (kilo, Local Time). The enforcement period for this rule is from
10 a.m. to 4 p.m. on May 15, 2015 and May 21, 2015. The Coast Guard
believes this safety zone regulation is necessary to protect all
persons and vessels that would otherwise transit or be within the
affected area from possible safety hazards associated with underwater
detonation operations.

DATES: This rule is effective without actual notice from May 20, 2015
through 4 p.m. May 21, 2015 (kilo, Local Time). For the purposes of
enforcement, actual notice will be used from 10 a.m. on May 15, 2015
until May 20, 2015.

ADDRESSES: Documents indicated in this preamble are part of docket
USCG-2015-0304. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number USCG-2015-03XX in the ``SEARCH'' box and click
``SEARCH''. Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m. (EST), Monday through Friday, except Federal
holidays. You may also visit the Coast Guard Sector Guam, Naval Base
Guam, between 7:30 a.m. and 3:30 p.m. (Kilo, Local Time), Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief, Kristina Gauthier, Sector Guam, U.S. Coast Guard;
(671) 355-4866<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a)of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
Coast Guard received notice of this operation on March 31, 2015, only
46 days before the operation is scheduled. Due to this late notice, the
Coast Guard did not have time to issue a notice of proposed rulemaking.
    Under 5 U.S.C. 553(d)(3), for the same reason mentioned above, the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. Due to the
late notice and inherent danger in underwater detonation exercises,
delaying the effective period of this safety zone would be contrary to
the public interest.

B. Basis and Purpose

    The legal basis for this rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C 1231; 33 CFR 1.05-1, 6.04-6, 160.5; and Department of Homeland
Security Delegation No. 0170.1. A safety zone is a water area, shore
area, or water and shore area, for which access is limited to
authorized person, vehicles, or vessels for safety purposes.
    The purpose of this rulemaking is to protect mariners from the
potential hazards associated with a U.S. Navy training exercise which
include detonation of underwater explosives. Approaching too close to
such exercises could potentially expose the mariner to flying debris or
other hazardous conditions.

C. Discussion of Rule

    In order to protect the public from the hazards of the U.S. Navy
training exercise, the Coast Guard is establishing a temporary safety
zone, effective from 10 a.m. May 15, 2015 through 4 p.m. May 21, 2015
(Kilo, Local Time). The enforcement periods for this rule will be from
10 a.m. to 4 p.m. on May 15, 2015 and May 21, 2015.
    The safety zone is located within the Guam COTP Zone (See 33 CFR
3.70-15), and will cover all waters bounded by a circle with a 700-yard
radius for vessels

persons in the water, centered at: 13[deg]27.700' N. and
144[deg]38.500' E., from the surface of the water to the ocean floor.
    The general regulations governing safety zones contained in 33 CFR
165.23 apply. Entry into, transit through or anchoring within safety
zones is prohibited unless authorized by the COTP or a designated
representative thereof. Any Coast Guard commissioned, warrant, or petty
officer, and any other COTP representative permitted by law, may
enforce the zone. The COTP may waive any of the requirements of this
rule for any person, vessel, or class of vessel upon finding that
application of the safety zone regulation is unnecessary or impractical
for the purpose of maritime safety. Vessels or persons violating this
rule may be subject to the penalties set forth in 33 U.S.C. 1232 and/or
50 U.S.C. 192.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The Coast Guard expects
the economic impact of this rule to be extremely minimal based on the
short duration of the safety zone regulation and the limited geographic
area affected by it.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This safety zone regulation will not have a significant economic
impact on a substantial number of small entities for the following
reasons. This rule would affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to transit through a portion of the zones from 10 a.m. through 4 p.m.
on May 15, 2015 and May 21, 2015. This rule will be enforced for only 6
hours each day and vessel traffic can pass safely around the safety
zone. The safety zone does not encompass the entire harbor and safe
transit is still allowed to pass through, in and out of Apra Harbor.
Further, traffic will be allowed to pass through the zones with the
permission of the Coast Guard Patrol Commander<PHONE_NUMBER>. Before the
effective period, we will issue maritime advisories widely available to
users of outer Apra Harbor.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it would not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This rule is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves a closed area of
Apra Outer Harbor, to vessel traffic, for 6 hours on both May 15, 2015
and May 21, 2015. This rule is categorically excluded from further
review under paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. A preliminary environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. This rule is
categorically excluded, under figure 2-1, paragraph (34)(g), of the
Instruction.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record-
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T14-0304 to read as follows:

Sec.  165.  T14-0304 Safety Zones; Apra Outer Harbor and adjacent
waters, Guam.

    (a) Location. The following area, within the Guam Captain of the
Port (COTP) Zone (See 33 CFR 3.70-15), from the surface of the water to
the ocean floor, is a safety zone: Seven-hundred-yard-radius zone--All
waters bounded by a circle with a 700-yard radius centered at
13[deg]27.700' N. and 144[deg]38.500' E., (NAD 1983).
    (b) Effective period. This section is effective from 10 a.m. on May
15, 2015 to 4 p.m. on May 21, 2015 (Kilo, Local Time).
    (c) Enforcement periods. The safety zones described in paragraph
(a) of this section will be enforced during the U.S. Navy underwater
detonation operation, from 10 a.m. until 4 p.m. on May 15, 2015 and May
21, 2015 (Kilo, Local Time).
    (d) Regulations. The general regulations governing safety zones
contained in 33 CFR 165.23 apply. No vessels may enter or transit the
safety zone unless authorized by the COTP or a designated
representative thereof.
    (e) Enforcement. Any Coast Guard commissioned, warrant, or petty
officer, and any other COTP representative permitted by law, may
enforce these temporary safety zones.
    (f) Waiver. The COTP may waive any of the requirements of this
section for any person, vessel, or class of vessel upon finding that
application of the safety zone is unnecessary or impractical for the
purpose of maritime security.
    (g) Penalties. Vessels or persons violating this rule are subject
to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: April 30, 2015.
James B. Pruett,
Captain, U.S. Coast Guard, Captain of the Port Guam.
[FR Doc. 2015-12109 Filed 5-19-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24130-24131]
[FR Doc No: 2017-10736]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0879; FDA-2013-N-0579; FDA-2016-N-2474; FDA-
2016-D-1853; FDA-2013-N-0764; FDA-2013-N-0825; FDA-2013-N-0797; FDA-
2013-N-0578]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
Street, North Bethesda, MD 20852,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Procedures for the Safe Processing and         0910-0354       2/29/2020
 Importing of Fish and Fishery Products.
Biological Products: Reporting of              0910-0458       2/29/2020
 Biological Product Deviations and Human
 Cells, Tissues, and Cellular and Tissue-
 Based Product Deviations; Form FDA 3486
 and Addendum, 3486A....................
Designation of New Animal Drugs for            0910-0605       2/29/2020
 Minor Use or Minor Species.............
Unique Device Identification System.....       0910-0720       2/29/2020
Animal Feed Regulatory Program Standards       0910-0760       2/29/2020
Premarket Approval of Medical Devices--        0910-0231       3/31/2020
 21 CFR Part 814........................
Human Tissue Intended for                      0910-0302       3/31/2020
 Transplantation........................
General Licensing Provisions: Biological       0910-0338       3/31/2020
 License Application, Changes to an
 Approved Application, Labeling,
 Revocation and Suspension, and Form FDA
 356h...................................
------------------------------------------------------------------------

    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislative, and Analysis.
[FR Doc. 2017-10736 Filed 5-24-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Rules and Regulations]
[Pages 52185-52187]
[FR Doc No: 2015-21202]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0900; Directorate Identifier 2015-NE-12-AD;
Amendment 39-18251; AD 2015-17-18]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Turbomeca S.A. Arrius 2F turboshaft engines with a certain part number
oil pump installed. This AD requires inspection, and if necessary,
replacement before further flight of the oil pump driver assembly and/
or the oil pump shaft, or the oil pump itself. This AD was prompted by
cases of deterioration of the gas generator front bearing due to a link
loss between the pump driver and the oil pump shaft. We are issuing
this AD to prevent link loss between the pump driver and the oil pump
shaft, which could lead to an engine in-flight shutdown, forced
landing, and damage to the helicopter.

DATES: This AD becomes effective October 2, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 2,
2015.

ADDRESSES: For service information identified in this AD, contact
Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00;
telex: 570 042; fax: 33 (0)5 59 74 45 15. You may view this service
information at the FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-0900.

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-2015-
0900; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
Document Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Philip Haberlen, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM was published in the Federal Register on May 21, 2015 (80 FR
29224). The NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A risk of an in-flight shutdown (IFSD) has been identified on an
ARRIUS 2F engine, due to deterioration of gas generator front
bearing. This could be the result of lack of lubrication,

due to a link loss between pump driver and oil pump shaft.
    This condition, if not detected and corrected, could lead to
cases of IFSD, possibly resulting in forced landing with consequent
damage to the helicopter and injury to occupants.

Related Service Information Under 1 CFR Part 51

    Turbomeca S.A. has issued Mandatory Service Bulletin (MSB) No. 319
79 4834, Version B, dated October 21, 2014. The MSB describes
procedures for inspecting the oil pump driver assembly on the oil pump
shaft, the pump driver splines, and the oil pump splines. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 29224, May 21,
2015).

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed.

Costs of Compliance

    We estimate that this AD affects about 96 engines installed on
helicopters of U.S. registry. We also estimate that it would take about
two hours per engine to comply with this AD. The average labor rate is
$85 per hour. Required parts would cost about $17,312 per engine. Based
on these figures, we estimate the cost of this AD on U.S. operators to
be $1,678,272.

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.

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 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 to the extent
that it justifies making a regulatory distinction, 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 adding the following new airworthiness
directive (AD):

2015-17-18 Turbomeca S.A.: Amendment 39-18251; Docket No. FAA-2015-
0900; Directorate Identifier 2015-NE-12-AD.

(a) Effective Date

    This AD becomes effective October 2, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Turbomeca S.A. Arrius 2F turboshaft
engines with oil pump, part number (P/N)<PHONE_NUMBER>, installed,
except for:
    (1) Engines, equipped with an oil pump, P/N<PHONE_NUMBER>, that
were overhauled in a Turbomeca repair center after January 1, 2013,
and
    (2) Engines with a serial number of 34776 or higher, provided
that the oil pump was not replaced on that engine since the first
flight of that engine on a helicopter.

(d) Reason

    This AD was prompted by cases of deterioration of the gas
generator front bearing due to a link loss between the pump driver
and the oil pump shaft. We are issuing this AD to prevent link loss
between the pump driver and the oil pump shaft, which could lead to
an engine in-flight shutdown, forced landing, and damage to the
helicopter.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Inspect the pump driver assembly on the oil pump shaft, the
pump driver splines, and the oil pump splines, using paragraph
2.4.2, Operating Instructions, of Turbomeca S.A. Mandatory Service
Bulletin (MSB) No. 319 79 4834, Version B, dated October 21, 2014,
as follows:
    (i) For engines with fewer than 250 engine hours (EH),
accumulated since new, since last overhaul, or since last
installation of an affected oil pump, whichever occurred later,
inspect before exceeding 300 EH, accumulated since new, since last
overhaul, or since last installation of an affected oil pump, as
applicable.
    (ii) For engines with 250 EH or more, but fewer than 300 EH,
accumulated since new, since last overhaul, or since last
installation of an affected oil pump, whichever occurred later,
inspect within 50 EH.
    (iii) For engines with 300 EH or more, but fewer than 800 EH,
accumulated since new, since last overhaul, or since last
installation of an affected oil pump, whichever occurred later,
inspect within 100 EH.
    (iv) For engines with 800 EH or more, accumulated since new,
since last overhaul, or since last installation of an affected oil
pump, whichever occurred later, inspect during the next scheduled
500 EH inspection.
    (2) If any oil pump drive assembly and/or oil pump shaft, or the
oil pump itself, fails the inspection required by this AD, then
before further flight, replace the failed part(s) with part(s)
eligible for installation.
    (3) The instruction to report inspection results and the
instruction to return a compliance certificate to Turbomeca S.A. as
stated in paragraph 2.4.2, Operating Instructions, of Turbomeca S.A.
MSB No. 319 79 4834, Version B, dated October 21, 2014, are not
required by this AD.

(f) Credit for Previous Action

    If you inspected the oil pump driver assembly on the oil pump
shaft, the pump driver splines, and the oil pump splines, and
replaced any part(s) with part(s) eligible for installation before
the effective date of this AD in accordance with Turbomeca S.A. MSB
No. 319 79 4834, Version A, dated November 25, 2013, you met the
requirements of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Philip Haberlen,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2015-0049,
dated March 17, 2015 (Corrected May 7, 2015), for more information.
You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0900-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Turbomeca S.A. MSB No. 319 79 4834, Version B, dated October
21, 2014.
    (ii) Reserved.
    (3) For service information identified in this proposed AD,
contact Turbomeca, S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74
40 00; telex: 570 042; fax: 33 (0)5 59 74 45 15.
    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on August 17, 2015.
Diane S. Romanosky,
Acting Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-21202 Filed 8-27-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Rules and Regulations]
[Pages 62443-62451]
[FR Doc No: 2013-24651]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0268; FRL-9397-1]
RIN 2070-AJ95

Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl
Carboxylate Chemical Substances; Final Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is amending
a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS)
chemical substances to add PFAS chemical substances that have completed
the TSCA new chemical review process, but have not yet commenced
production or import and is designating (for all listed PFAS chemical
substances) processing as a significant new use. EPA is also finalizing
a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical
substances that designates manufacturing (including importing) and
processing for use as part of carpets or for treating carpet (e.g., for
use in the carpet aftercare market) as a significant new use, except
for use of two chemical substances as a surfactant in carpet cleaning
products. For this SNUR, EPA is also making an exemption inapplicable
to persons who import or process the LCPAC chemical substances as part
of an article. Persons subject to these SNURs will be required to
notify EPA at least 90 days before commencing any significant new use.
The required notifications will provide EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit that
activity before it occurs.

DATES: This final rule is effective December 23, 2013.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2012-0268, 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), EPA West 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<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. 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:
Nicholas Nairn-Birch, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3668; 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 potentially affected by this action if you manufacture
(including import) or process any of the chemical substances listed in
Table 4 of the regulatory text in this document or that meet the LCPFAC
chemical category definition as described in this rule.
    Potentially affected entities may include, but are not limited to:
     Manufacturers (including importers) of one or more of
subject chemical substances (North American Industrial Classification
System (NAICS) codes 325 and 324110); e.g., chemical manufacturing and
petroleum refineries.
     Carpet and rug mills (NAICS code 314110).
     Fiber, yarn, and thread mills (NAICS code 31311).
     Home furnishing merchant wholesalers (NAICS code 423220).
     Carpet and upholstery cleaning services (NAICS code
561740).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The NAICS codes have been provided to assist you and others
in determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in 40 CFR
721.5, 40 CFR 721.9582, and 40 CFR 721.10536, which is in the
regulatory text of this document. If you have any questions regarding
the applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the agency taking?

    In the Federal Register of August 15, 2012 (77 FR 48924) (FRL-9358-
7), EPA proposed to amend a SNUR at 40 CFR 721.9582 for PFAS chemical
substances to add PFAS chemical substances that have completed the TSCA
new chemical review process, but have not yet commenced production or
import, and to designate (for all listed PFAS chemical substances)
processing as a significant new use. In addition, the Agency also
proposed a new SNUR for LCPFAC chemical substances that designates
manufacturing (including importing) and processing for use as part of
carpets or for treating carpet (e.g., for use in the carpet aftercare
market) as a significant new use. On December 30, 2009, EPA issued the
``Long-Chain Perfluorinated Chemicals (PFCs) Action Plan'' (Ref. 1).
Today's action is consistent with the purpose of that action plan.
    This final rule requires persons who intend to manufacture
(including import) or process one or more of the PFAS chemical
substances listed in Table 4 of the regulatory text for the uses
identified in 40 CFR 721.9582(a)(2) to submit a Significant New Use
Notice (SNUN) at least 90 days before commencing manufacture (including
import) or processing. Given the structural similarity of these
chemicals to the PFAS chemicals covered under 40 CFR 721.9582 and EPA's
health and environmental concerns associated with them, EPA has
concluded that today's action on these PFAS chemicals is warranted and
any manufacturing (including importing) or processing for any use of
these uncommenced PFAS chemicals would be a significant new use.
    EPA is also finalizing a SNUR for LCPFAC chemical substances that
requires persons to notify the Agency at least 90 days before
commencing manufacture (including import) or processing for use as part
of carpets or for treating carpet (e.g., for use in the carpet
aftercare market) as a significant new use, except for use of two
LCPFAC chemical substances as surfactants in carpet cleaning products.
Comments submitted to the docket after the comment period indicated use
of two LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products as an ongoing use. The use of these two chemical
substances is not included as a significant new use in this final rule.
    For this SNUR, EPA is also making the article exemption at 40 CFR
721.45(f) inapplicable to persons who import LCPFAC chemical substances
as part of carpets. The article exemption at 40 CFR 721.45(f) is based
on an assumption that people and the environment will generally not be
exposed to chemical substances in articles (see 49 FR 35014; September
5, 1984). However, as stated in Unit IV. of the proposed rule (77 FR
48928; August 15, 2012), exposure to LCPFAC chemical substances may
occur both during the carpet manufacture process and during the
lifetime of the finished carpet. Therefore, exposure would increase if
in the future LCPFAC chemical substances are incorporated in carpets
and then imported. The article exemption at 40 CFR 721.45(f) remains in
effect, however, for persons who import LCPFAC chemical substances as
part of other types of articles. The article exemption at 40 CFR
721.45(f) also remains in effect for processing of LCPFAC chemical
substances as part of an article (i.e., carpet) since EPA is aware that
this is an ongoing use. This final action does not affect the exemption
at 40 CFR 721.45(f) for PFAS chemical substances, which remains in
effect for persons who import or process these chemical substances.
    The term PFAS refers to a general category of perfluorinated
sulfonate chemical substances of any chain

length. The PFAS chemical substances for which EPA is modifying an
existing SNUR are currently listed in 40 CFR 721.9582 in paragraph
(a)(1). The PFAS chemical substances that EPA is adding to an existing
SNUR are being inserted into this list. All of these chemical
substances are collectively referred to in this rule as perfluoroalkyl
sulfonates, or PFAS chemical substances.
    The term LCPFAC refers to the long-chain category of perfluorinated
carboxylate chemical substances with perfluorinated carbon chain
lengths equal to or greater than seven carbons and less than or equal
to 20 carbons. Based on comments filed on the proposed SNUR and all
information available to EPA, the category definition of LCPFAC
chemical substances differs in this final rule from the definition
described in the proposed SNUR. The upper limit of the perfluorinated
carbon chain length is now 20 carbons. In the proposed SNUR, there was
no upper limit. Also, the LCPFAC chemical subgroup described in 40 CFR
721.10536(b)(1)(vi) of the proposed rule is removed from the definition
in this final SNUR.
    LCPFAC chemical substances are synthetic chemicals that do not
occur naturally in the environment. The LCPFAC chemical substances
subject to this SNUR are identified as follows, where 5 < n < 21 or 6 <
m < 21:
    a. CF3(CF2)n-COO-M
where M = H\+\ or any other group where a formal dissociation can be
made;
    b. CF3(CF2)n-CH=CH2;
    c. CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
    d. CF3(CF2)m-CH2-X
where X is any chemical moiety, and
    e. CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
    The category of LCPFAC chemical substances, based on the chemical
structures delineated in 40 CFR 721.10536 (b)(1)(i) through (b)(1)(v)
of this final rule, also includes the salts and precursors of these
perfluorinated carboxylates. LCPFAC precursors may be simple
derivatives of perfluorooctanoic acid (PFOA) and higher homologues or
certain polymers that may degrade to PFOA or higher homologues. These
precursors include all fluorotelomers.
    It is important to note that any LCPFAC chemical substance
identified by paragraphs (b)(1)(i) through (b)(1)(v) of this final rule
that is intentionally used during fluoropolymer formulation, such as an
emulsion stabilizer in aqueous dispersions, is subject to reporting for
the significant new uses described in 40 CFR 721.10536(b)(2). For
example, ammonium perfluorooctanoate (APFO)--when used as an aqueous
dispersion agent in fluoropolymer production--is subject to this SNUR
if the final fluoropolymer product is used as part of carpets or to
treat carpets.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a 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)). As
described in Unit II.C., the general SNUR provisions are found at 40
CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. However, EPA is making the exemption at 40 CFR 721.45(f)
inapplicable to persons who import LCPFAC chemical substances as part
of carpets under this SNUR. As a result, persons subject to the
provisions of this rule would not be exempt from significant new use
reporting if they import LCPFAC chemical substances as part of carpets.
However, the articles exemption will remain in effect for persons who
process chemical substances as part of an article because existing
stocks of carpets may still contain LCPFAC substances.
    Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of premanufacture notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.

III. Rationale and Objectives for This Final Rule

A. Rationale

    As discussed in Units III. and IV. of the proposed rule (77 FR
48924; August 15, 2012), PFAS and LCPFAC chemical substances are found
world-wide in the environment, wildlife, and humans. They are
bioaccumulative in wildlife and humans, and are persistent in the
environment. They are toxic to laboratory animals, producing
reproductive, developmental, and systemic effects in laboratory tests.
The exact sources and pathways by which these chemicals move into and
through the environment and allow humans and wildlife to become exposed
are not fully understood, but are likely to include releases from
manufacturing of the chemicals, processing of these chemicals into
products like carpets and textiles, and aging and wear of products
containing them.
    Since the manufacture (including import) and processing of PFAS and
LCPFAC chemical substances for these uses have been discontinued in the
United States, EPA expects their presence in humans and the environment
to decline over time as has been observed in the past when production
and use of other persistent chemicals has ceased. EPA is concerned that
the manufacturing (including import) or processing of these chemical
substances, as well as importing these chemicals as part of articles,
for the new uses identified in this rule could be reinitiated in the
future. If reinitiated, EPA believes that such use would increase the
magnitude and duration of human and environmental exposure to

these chemical substances, constituting a significant new use.
    EPA is adding processing of PFAS chemical substances (for any use
in the United States, other than the uses listed under 40 CFR 721.9582
(a)(3), (a)(4), and (a)(5)) to the significant new uses of those
chemical substances. EPA is concerned about the potential for PFAS
chemical substances manufactured (including imported) for an ongoing
use to be redirected to other uses without prior notice to the Agency.
For example, a chemical substance could be initially manufactured for
uses listed under 40 CFR 721.9582 (a)(3), (a)(4), or (a)(5), and then
redirected for another use after its initial manufacture or import. For
similar reasons, EPA is designating processing of LCPFAC chemical
substances or use as part of carpets or to treat carpet as a
significant new use, except for one specifically identified ongoing use
of two LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products. As such, persons who process PFAS or LCPFAC chemical
substances for a significant new use will be required to first notify
EPA, even if they are not themselves manufacturers of the chemical
substance. Note, the exemption at 40 CFR 721.45(f) is not applicable
for persons who import these LCPFAC chemical substances as part of an
article, but is applicable for persons who process these LCPFAC
chemicals substances as part of an article. Pursuant to 40 CFR
721.45(f), processing of PFAS and LCPFAC chemical substances as part of
articles remains exempt from notice requirements.
    Accordingly, EPA will have the opportunity to evaluate and control,
where appropriate, activities associated with those uses, if such
manufacturing (including importing) or processing were to start or
resume. The required notification provided by a SNUN will provide EPA
with the opportunity to evaluate activities associated with a
significant new use and an opportunity to protect against unreasonable
risks, if any, from exposure to PFAS and LCPFAC chemical substances.
    Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to promulgate a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows the
Agency to evaluate the use according to the specific parameters and
circumstances surrounding that intended use.
    With this action, the Agency is designating as significant new uses
of LCPFAC chemical substances use as part of carpet or to treat carpet.
The Agency believes the 2010/2015 PFOA Stewardship Program, in which
companies committed to work toward eliminating facility emissions and
product content of PFOA--a LCPFAC chemical substance--by 2015, will
eliminate many other ongoing uses of LCPFAC chemical substances. As
those uses are phased out in the United States, EPA anticipates taking
additional regulatory actions to prevent resumption of the uses without
prior notice to EPA.

B. Objectives

    Based on the considerations in Unit III.A. of this rule, EPA will
achieve the following objectives with regard to the significant new
use(s) that are designated in this rule:
    1. EPA will receive notice of any person's intent to manufacture
(including import) or process PFAS or LCPFAC chemical substances for
the described significant new use before that activity begins.
    2. EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing
(including importing) or processing PFAS or LCPFAC chemical substances
for the described significant new use.
    3. EPA will be able to regulate prospective manufacturers
(including importers) or processors of PFAS or LCPFAC chemical
substances before the described significant new use of the chemical
substance occurs, provided that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6 or 7.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of the
PFAS and LCPFAC chemical substances subject to this rule, as discussed
herein, EPA considered relevant information about the toxicity of these
substances, likely human exposures and environmental releases
associated with possible uses, and the four factors listed in TSCA
section 5(a)(2).
    Except for the ongoing uses specified in 40 CFR 721.9582 (a)(3)
through (a)(5), the Agency believes the manufacture (including import)
and processing of any of the PFAS chemical substances subject to this
rule has been discontinued. Any new use of these chemicals, including
processing, could change the type and form of exposure and/or the
magnitude and duration of exposure to humans and the environment
relative to what currently exists. Based on these considerations of the
statutory factors discussed in this unit, EPA has determined that the
manufacture (including import) or processing of any of the PFAS
chemical substances subject to this rule, for any use except ongoing
uses specified in 40 CFR 721.9582 (a)(3) through (a)(5), is a
significant new use.
    Exposure to LCPFAC chemical substances may occur both during the
carpet manufacture process and during the lifetime of the finished
carpet via inhalation and ingestion of dust generated from the abrasion
of carpets. This is of particular concern for children since they
engage in a variety of activities on carpets for longer periods of time
and have a greater degree of hand-to-mouth activity in their earliest
years. This will change both the magnitude of exposure and the duration
of exposure. Except for one ongoing use specified in 40 CFR
721.10536(b)(3), the Agency believes the manufacture (including import)
and processing of LCPFAC chemical substances as part of carpet or to
treat carpet has been discontinued. EPA also believes LCPFAC chemicals
substances are no longer imported as part of carpet. If reinitiated,
EPA believes these uses of LCPFAC chemical substances would
significantly increase the magnitude and duration of exposure to humans
and the

environment relative to what currently exists. Based on these
considerations of the statutory factors discussed in this unit, EPA has
determined that the manufacture (including import) or processing of any
of the LCPFAC chemical substances subject to this rule for use as part
of carpet or to treat carpets, except ongoing uses specified in 40 CFR
721.10536(b)(3), is a significant new use. EPA has further determined
that importing any of the LCPFAC chemical substances subject to this
rule as part of carpet constitutes a significant new use and warrants
making inapplicable the article exemption at 40 CFR 721.45(f).

V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
may have begun commercial manufacture (including import) or processing
of the chemical substance(s) subject to this rule for a significant new
use after the proposal was published on August 15, 2012 (77 FR 48924),
must cease such activity before the effective date of this final rule.
To resume their activities, these persons will have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. Uses arising after the
publication of the proposed rule are distinguished from uses that exist
at publication of the proposed rule. The former would be new uses, the
latter ongoing uses. To the extent that additional ongoing uses were
found in the course of rulemaking, EPA has excluded these uses from the
final SNUR. EPA promulgated provisions to allow persons to comply with
this SNUR before the effective date. If a person were to meet the
conditions of advance compliance under 40 CFR 721.45(h), that person
would be considered to have met the requirements of the final SNUR for
those activities.

VI. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require
developing any particular test data before submission of a SNUN. There
are two exceptions: (1) Development of test data is required where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)(1)); and (2) development of
test data may be necessary where the chemical substance has been listed
under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence
of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing
covering the chemical substance, persons are required only to submit
test data in their possession or control and to describe any other data
known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR
721.25; and 40 CFR 720.50). However, as a general matter, EPA
recommends that SNUN submitters include data that would permit a
reasoned evaluation of risks posed by the chemical substance during its
manufacture (including import), processing, use, distribution in
commerce, or disposal. EPA encourages persons to consult with the
Agency before submitting a SNUN. As part of this optional pre-notice
consultation, EPA would discuss specific data it believes may be useful
in evaluating a significant new use. SNUNs submitted for significant
new uses without any test data may increase the likelihood that EPA
will take action under TSCA section 5(e) to prohibit or limit
activities associated with this chemical.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
    1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
    2. Potential benefits of the chemical substance.
    3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.

VII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No.
7710-25, generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR
720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

VIII. Discussion of the Final Significant New Use Rule and Response to
Comments

    This action finalizes the SNUR proposed in the Federal Register on
August 15, 2012 (77 FR 48924). This final rule requires persons who
intend to manufacture (including import) or process one or more of the
chemical substances listed in Table 4 of the regulatory text for the
uses identified in 40 CFR 721.9582(a)(2) to submit a SNUN at least 90
days before commencing manufacture (including import) or processing.
This rule also requires persons who intend to manufacture (including
import) or process one or more LCPFAC chemical substances, as defined
in 40 CFR 721.10536(b)(1), for use as part of carpets or for treating
carpets (except for one specifically identified ongoing use of two
LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products) to submit a SNUN at least 90 days before commencing
manufacture (including import) or processing.
    It should be noted that the LCPFAC chemical substances category
definition now delineates a perfluorinated carbon chain length upper
limit of 20 carbons. The definition in the proposed rule contained no
upper limit. Also, the LCPFAC chemical subgroup that was described in
40 CFR 721.10536(b)(1)(vi) of the proposal is removed from the
definition in this final SNUR. The rationale for these changes is
explained in greater detail in the response to comments below.
    The Agency reviewed and considered all comments received related to
the proposed rule. Copies of all non-CBI comments are available at
http://www.regulations.gov in the public docket for this action, EPA-
OPPT-2012-0268. A discussion of the comments germane to the rulemaking
and the Agency's responses follow.
    1. Comment summary. In defining the chemicals subject to this SNUR
in the proposed rule, no upper limit was given for carbon chain length.
Submitters suggested an upper limit of 20 carbons, which would exclude
from the LCPFAC

category definition polymers weighing greater than 1,000 daltons.
    Response. EPA agrees with commenters that there should be an upper
limit to the chain length in the definition. PFAC chemicals with
greater than 20 perfluorinated carbons can be considered polymers
within the polymer exemption under 40 CFR 723.250 (e.g., exceed a
molecular weight of 1,000 daltons and contain at least three monomer
units). As it is not the Agency's intent to regulate fluoropolymers in
this rule, the LCPFAC category definition in this final rule includes a
perfluorinated carbon chain length upper limit of 20.
    2. Comment summary. Commenters requested clarification as to
whether or not fluoropolymers are included in the LCPFAC definition.
Commenters also requested a definition of fluoropolymers that clearly
distinguished them from fluorotelomer-based chemicals.
    Response. It is not the Agency's intent to regulate fluoropolymers.
The category definition is changed in this final rule to include a
perfluorinated carbon chain length upper limit of 20. With this change,
fluoropolymers no longer meet the LCFPAC chemical substances
definition.
    Since fluoropolymers are not subject to this SNUR, EPA will not
include a definition of fluoropolymers. However, the Agency notes that
it has distinguished fluoropolymer and fluorotelomer-based chemicals in
two corresponding enforceable consent agreement test rules published on
July 8, 2005 (70 FR 39630 and 70 FR 39623).
    3. Comment summary. Several commenters argued that the proposed 40
CFR 721.10536(b)(1)(vi) [``structurally similar degradation products of
any of the compounds in (i) through (v) of this paragraph''] is
prohibitively broad and unnecessary and therefore unenforceable. They
argued that it should be either removed or replaced with a definition
that explicitly delineates LCPFAC precursors.
    Response. The Agency agrees that the chemical subgroup definition
described in 40 CFR 721.10536(b)(1)(vi) is unnecessary and it is
removed from the LCFPAC category definition in this final rule. The
Agency believes that 40 CFR 721.10536 (b)(1)(i)-(b)(1)(v) do not
exclude any LCPFAC chemical substances defined in 40 CFR
721.10536(b)(1)(vi), and thus sufficiently define the LCPFAC category
of chemicals.
    4. Comment summary. A submitter claimed that the LCPFAC chemical
category definition is not adequate to verify which chemicals are in
use by suppliers. Instead, a thorough list of CAS numbers is needed.
    Response. EPA believes the most precise way to identify the
chemicals subject to this SNUR is through the chemical structure
definition. Downstream customers should have sufficient information
from suppliers (i.e., CAS number and unique chemical identity) to
generate the specific structure for any potentially reportable
substance, which they can compare to the LCPFAC category definition.
    As a convenience to the regulated community, EPA has made available
in the public docket an illustrative list of chemical substances
subject to the rule. As part of that list, EPA has provided specific
examples of chemicals that meet the various components of the LCPFAC
category definition.
    5. Comment summary. A submitter suggested that 40 CFR
721.10536(b)(1)(ii) of the regulatory text should state
``CF3(CF2)mCH=CH2, where m > 6''
rather than
``CF3(CF2)nCH=CH2, where n
> 5'' to be consistent with PFOA precursors identified in the PFOA
Stewardship Program.
    Response. EPA disagrees with this comment. The specific structural
formula was chosen to accommodate the possibility of oxidation cleavage
of the olefin to produce PFOA directly. Applied to the representative
structure suggested by the submitter, this mechanism would produce
perfluorononanoic acid (PFNA), which is one carbon longer than PFOA,
the smallest of the LCPFAC chemical substances.
    6. Comments summary. A commenter expressed concern that the article
exemption was not made inapplicable to PFAS as part of carpets.
    Response. The Agency recognizes this concern and is addressing it
in the upcoming proposed SNUR for long-chain perfluoroalkyl carboxylate
chemical substances. Doing so in the upcoming proposed SNUR will allow
EPA to solicit and respond to any public comments.
    7. Comment summary. Submitters requested clarification on the
applicability of the articles exemption to export notifications.
    Response. This SNUR does not require notice of export for articles
as part of the section 5 action. In accordance with 40 CFR 707.60(b),
persons who export LCFPAC chemical substances contained in articles
remain exempt from notices of export under TSCA 12(b).
    8. Comment summary. One commenter asserted that the following
statement in the proposed rule's preamble is incorrect: ``These
precursors include certain fluoropolymers and all fluorotelomers.'' In
support of this assertion, the submitter notes that many new short-
chain fluorotelomer products cannot break down to PFOA.
    Response. The LCPFAC category definition does not include short-
chain fluorotelomers. The quote refers only to precursors of the long-
chain perfluorinated chemicals defined in 40 CFR 721.10536(b)(1), which
excludes short-chain fluorotelomers. Fluoropolymers are also no longer
included in the LCPFAC definition.
    9. Comment summary. A commenter noted that even fluoropolymers not
made with PFOA can have detectable levels of PFOA in them due to
environmental cross-contamination, which creates an enforcement and
compliance problem. The uncertainty this issue creates suggests that
fluoropolymers should be excluded from the LCPFAC definition. The
commenter also requested clarification of the term `contamination' used
in the preamble.
    Response. Fluoropolymers are not subject to this SNUR. In the
preamble of the proposed rule, the Agency referred to a `contaminated'
chemical as one that does not meet the LCPFAC definition itself, but
that contains a LCPFAC chemical substance due to its intentional use
during chemical formulation. In such a case, this LCPFAC chemical
substance would be subject to this SNUR for the significant new uses
described in 40 CFR 721.10536(b)(2). For example, APFO used as an
emulsifier in the production of fluoropolymers would be subject to this
SNUR for the significant new uses described in 40 CFR 721.10536(b)(2).

IX. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substance included in this
rule (Ref. 2). In the event that a SNUN is submitted, costs are
estimated at $8,589 per SNUN submission for large business submitters
and $6,189 for small business submitters. These estimates include the
cost to prepare and submit the SNUN, and the payment of a user fee.
Businesses that submit a SNUN would be subject to either a $2,500 user
fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small
business with annual sales of less than $40 million when combined with
those of the parent company (if any), a reduced user fee of $100 (40
CFR 700.45(b)(1)). The costs of

submission of SNUNs will not be incurred by any company unless a
company decides to pursue a significant new use as defined in this
SNUR. EPA's complete economic analysis is available in the public
docket for this rule (Ref. 2).
    The final SNUR will require importers of LCPFAC chemical substances
as part of carpets to notify EPA at least 90 days before importing any
such articles containing chemicals subject to the final rule. The final
rule may also affect firms that do not currently import carpet
containing the chemicals, but who may be interested in importing these
articles in the future. Typically, firms have an understanding of the
contents of the articles they import. However, EPA acknowledges that
importers of articles may have varying levels of knowledge about the
chemical content of the articles that they import.
    While not required by the SNUR, these parties may incur costs to
take additional steps to determine whether the articles they plan to
import are covered by this SNUR. This determination may involve
gathering information from suppliers along the supply chain, and/or
testing samples of the article itself. EPA believes that the LCPFAC
chemical substances included in this final rule are no longer being
manufactured (including imported) for use as part of carpet or for
treating carpet (e.g., for use in the carpet aftercare market) in the
United States, except for use of two chemical substances in carpet
cleaning solution, and that LCPFAC chemical substances are not being
imported as part of carpets. Therefore, EPA believes that these costs
would be minimal.

B. Export Notification

    Under TSCA section 12(b) and the implementing regulations at 40 CFR
part 707, subpart D, exporters must notify EPA if they export or intend
to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under section 5. For
persons exporting a substance the subject of a SNUR, a one-time notice
must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). EPA is unable
to make any estimate of the likely number of export notifications for
the chemical covered in this SNUR.

X. References

    As indicated under ADDRESSES, a docket has been established for
this rule under docket ID number EPA-HQ-OPPT-2012-0268. The following
is a listing of the documents cited in this document. The docket
includes information considered by EPA in developing this rule,
including the documents listed in this unit, which are physically
located in the docket. In addition, interested parties should consult
documents that are referenced in the documents that EPA has placed in
the docket, regardless of whether these referenced documents are
physically located in the docket. For assistance in locating documents
that are referenced in documents that EPA has placed in the docket, but
that are not physically located in the docket, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT. The
docket is available for review as specified under ADDRESSES.

1. USEPA. ``Long-Chain Perfluorinated Chemicals Action Plan.'' December
30, 2009.
2. USEPA. ``Economic Analysis of the Significant New Use Rule for
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate
Chemical Substances.'' Prepared by Timothy Lehman and Abt Associates
Inc. May 7, 2013.

XI. Statutory and Executive Order Reviews

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

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Office of Management and Budget (OMB) has determined that this SNUR is
not a ``significant regulatory action,'' because it does not meet the
criteria in section 3(f) of the executive order. Accordingly, this
action was not reviewed by OMB under Executive Orders 12866 and 13563
(76 FR 3821; January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in Title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument, or
form, if applicable. The information collection requirements related to
this action have already been approved by OMB pursuant to the PRA under
OMB control number 2070-0038 (EPA ICR No. 1188). This action does not
impose any burden requiring additional OMB approval. If an entity were
to submit a SNUN to the Agency, the annual burden is estimated to
average 92 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this SNUR would not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows. A SNUR applies
to any person (including small or large entities) who intends to engage
in any activity described in the rule as a ``significant new use.'' By
definition of the word ``new'' and based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activity. Since this SNUR will require a person who
intends to engage in such activity in the future to first notify EPA by
submitting a SNUN, no economic impact will occur unless someone files a
SNUN to pursue a significant new use in the future or forgoes profits
by avoiding or delaying the significant new use. Although some small
entities may decide to conduct such activities in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemical substances, the Agency receives only
a handful of notices per year. For example, the number of SNUNs was
four in Federal fiscal year (FY) 2005, eight in FY 2006, six in FY
2007, eight in FY 2008, and seven in FY 2009. During this 5-year
period, three small entities submitted a SNUN. Therefore, EPA believes
that the potential economic impact of complying with this SNUR is not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published as a final rule on August 8,
1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general
determination that proposed and final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538.

E. Executive Order 13132: Federalism

    This action would not have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).

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

    This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly or uniquely affect the communities of Indian
Tribal governments, nor involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
(65 FR 67249, November 9, 2000) do not apply to this rule.

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

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001), because this action is not expected to affect energy supply,
distribution, or use.

I. National Technology Transfer Advancement Act (NTTAA)

    Since this action does not involve any technical standards; section
12(d) of the NTTAA, 15 U.S.C. 272 note, does not apply to this action.

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

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

XII. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: September 30, 2013.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following section in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------

                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
721.10536............................................          2070-0038

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. In Sec.  721.9582:
0
a. Revise paragraph (a)(1) introductory text.
0
b. Add Table 4 to paragraph (a)(1).
0
c. Revise paragraphs (a)(2) through (5).
    The revisions and addition read as follows:

Sec.  721.9582  Certain perfluoroalkyl sulfonates.

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances listed in Table 1, Table 2,
Table 3, and Table 4 of this section are subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
* * * * *

       Table 4--Fourth Set of PFAS Chemicals Subject to Reporting
------------------------------------------------------------------------
    Premanufacture Notice Case No.            Generic chemical name
------------------------------------------------------------------------
P-83-0126.............................  Modified fluoroaliphatic adduct
P-90-0110.............................  Fluorochemical epoxide
P-94-1508.............................  Fluorinated polysiloxane
P-94-1509B............................  Fluorinated polysiloxane
P-98-0809.............................  Fluorochemical esters
P-99-0296.............................  Fluoroalkyl derivative
P-01-0035.............................  Perfluorooctane sulfonate
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Manufacturing (including importing) or processing of any
chemical substance listed in Table 1 of paragraph (a)(1) of this
section for any use.
    (ii) Manufacturing (including importing) or processing of any
chemical substance listed in Table 2 of paragraph (a)(1) of this
section for any

use, except as noted in paragraph (a)(3) of this section.
    (iii) Manufacturing (including importing) or processing of any
chemical substance listed in Table 3 of paragraph (a)(1) of this
section for any use, except as noted in paragraphs (a)(3) through (5)
of this section.
    (iv) Manufacturing (including importing) or processing of any
chemical substance listed in Table 4 of paragraph (a)(1) of this
section for any use.
    (3) Manufacturing (including importing) or processing of any
chemical substance listed in Table 2 and Table 3 of paragraph (a)(1) of
this section for the following specific uses shall not be considered as
a significant new use subject to reporting under this section:
    (i) Use as an anti-erosion additive in fire-resistant phosphate
ester aviation hydraulic fluids.
    (ii) Use as a component of a photoresist substance, including a
photo acid generator or surfactant, or as a component of an anti-
reflective coating, used in a photomicrolithography process to produce
semiconductors or similar components of electronic or other
miniaturized devices.
    (iii) Use in coating for surface tension, static discharge, and
adhesion control for analog and digital imaging films, papers, and
printing plates, or as a surfactant in mixtures used to process imaging
films.
    (iv) Use as an intermediate only to produce other chemical
substances to be used solely for the uses listed in paragraph
(a)(3)(i), (ii), or (iii) of this section.
    (4) Manufacturing (including importing) or processing of
tetraethylammonium perfluorooctanesulfonate (CAS No. 56773-42-3) for
use as a fume/mist suppressant in metal finishing and plating baths
shall not be considered as a significant new use subject to reporting
under this section. Examples of such metal finishing and plating baths
include: Hard chrome plating; decorative chromium plating; chromic acid
anodizing; nickel, cadmium, or lead plating; metal plating on plastics;
and alkaline zinc plating.
    (5) Manufacturing (including importing) or processing of: 1-
Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, potassium
salt (CAS No. 3872-25-1); Glycine, N-ethyl-N-
[(tridecafluorohexyl)sulfonyl]-, potassium salt (CAS No. 67584-53-6);
Glycine, N-ethyl-N-[(pentadecafluoroheptyl)sulfonyl]-, potassium salt
(CAS No. 67584-62-7); 1-Heptanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, ammonium salt (CAS No.
68259-07-4); 1-Heptanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro- (CAS No. 68957-62-0);
Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-methoxy-
(CAS No. 68958-60-1); or 1-Hexanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1) (CAS No. 70225-16-0) for use as a component of
an etchant, including a surfactant or fume suppressant, used in the
plating process to produce electronic devices shall not be considered a
significant new use subject to reporting under this section.
* * * * *

0
5. Add Sec.  721.10536 to subpart E to read as follows:

Sec.  721.10536  Long-chain perfluoroalkyl carboxylate chemical
substances.

    (a) Definitions. The definitions in Sec.  721.3 apply to this
section. In addition, the following definition applies: Carpet means a
finished fabric or similar product intended to be used as a floor
covering. This definition excludes resilient floor coverings such as
linoleum and vinyl tile.
    (b) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified below, where 5 < n <
21 or 6 < m < 21, are subject to reporting under this section for the
significant new uses described in paragraph (b)(2) of this section.
    (i) CF3(CF2)n-COO-M where M = H\+\
or any other group where a formal dissociation can be made;
    (ii) CF3(CF2)n-CH =
CH2;
    (iii) CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
    (iv) CF3(CF2)m-CH2-X
where X is any chemical moiety; and
    (v) CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
    (2) The significant new use for chemical substances identified in
paragraph (b)(1) of this section are: Manufacture (including import) or
processing for use as part of carpets or to treat carpets (e.g., for
use in the carpet aftercare market), except as noted in paragraph
(b)(3) of this section.
    (3) Manufacture (including import) or processing of the following
two long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances
for use as a surfactant in aftermarket carpet cleaning products shall
not be considered a significant new use subject to reporting under this
section:
    (i) Phosphonic acid, perfluoro-C6-12-alkyl derivs. (CAS No. 68412-
68-0) and
    (ii) Phosphinic acid, bis(perfluoro-C6-C12-alkyl) derivs. (CAS No.
68412-69-1).
    (c) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (c).
    (1) Revocation of certain notification exemptions. With respect to
imports of carpets, the provisions of Sec.  721.45(f) do not apply to
this section. A person who imports a chemical substance identified in
this section as part of a carpet is not exempt from submitting a
significant new use notice. The other provision of Sec.  721.45(f),
respecting processing a chemical substance as part of an article,
remains applicable.
    (2) [Reserved]

[FR Doc. 2013-24651 Filed 10-21-13; 8:45 am]
BILLING CODE 6560-50-P


Julie,

Here are some suggestions we made in the proposed rule about ways to
reduce risk to workers (68 FR 33308):

(	All users of nPB should wear appropriate personal protective
equipment, including chemical goggles, flexible laminate protective
gloves and chemical-resistant clothing.  Special care should be taken to
avoid contact with the skin since nPB, like many halogenated solvents,
can be absorbed through the skin.

(	Follow guidelines in the National Emission Standard for Hazardous Air
Pollutants (NESHAP) for halogenated solvents cleaning if you are using
nPB for non-aerosol solvent cleaning.  The equipment and procedural
changes described in the halogenated solvents NESHAP can reduce
emissions, reduce solvent losses and lower the cost of cleaning with
organic solvents.  For more information on the halogenated solvents
NESHAP, visit http://www.epa.gov/ttn/atw/eparules.html and
http://www.epa.gov/ttn/atw/degrea/halopg.html.

(	Use the employee exposure monitoring programs and product stewardship
programs where offered by manufacturers and formulators of nPB-based
solvents and adhesives.

(	Follow all recommended safety precautions specified in the
manufacturer’s Material Safety Data Sheets (MSDSs).

(	Use sufficient ventilation and emissions controls to meet the 25 ppm
AEL in adhesives or aerosol applications (or, once developed, the
applicable OSHA PEL).  Examples of ventilation equipment for aerosol
uses include ventilation hoods and fans.  Adhesive appliers can use
spray booths, ventilation hoods or ducts, and fans to reduce exposure.

(	Request a confidential consultation from your State government.  You
can contact the appropriate state agency that participates in OSHA’s
consultation program.  These contacts are on OSHA’s web site at
http://www.osha.gov/oshdir/consult.html . For further information on
OSHA’s confidential consultancy program, visit OSHA’s web page at
http://www.osha.gov/html/consultation.html.

(	If the manufacturer or formulator of your nPB-based product does not
have an exposure monitoring program, we recommend that you start your
own exposure monitoring program, and/or request a confidential
consultation from your State government.

(	A medical monitoring program should be established for the early
detection and prevention of acute and chronic effects of exposure to
nPB.  The workers' physician(s) should be given information about the
adverse health effects of exposure to nPB and the workers' potential for
exposure.

(	Workers should receive safety training and education that includes
potential health effects of exposure to nPB, covering information
included on the appropriate material data safety sheets, as required by
OSHA's Hazard Communication Standard (29 CFR 1910.1200).

We note that these steps are useful for reducing exposure to any
industrial solvent, and not just nPB.

If you are using nPB for cleaning, you are most likely to control
emissions using a vapor degreaser designed to meet the halogenated
solvents cleaning NESHAP.  The kind of equipment that keeps down
emissions will typically have at least two sets of cooling coils, a
roll-top cover, and a relatively long freeboard, all of which keep
vapors inside the machine.  In addition, it helps to take pieces out of
the vapor degreaser slowly.  Attached are some useful tips that one
cleaning company provides to its customers.

I would not recommend hand wiping using nPB because of the likely high
exposures.

I hope this is helpful.  If you have further questions or you would like
to talk about this, please call me at<PHONE_NUMBER>.

Margaret Sheppard

USEPA/Global Programs Division

SNAP Program

Tel.<PHONE_NUMBER>

Fax<PHONE_NUMBER>

email<EMAIL_ADDRESS>

"Kaiser, Julie A. (JCH)"<EMAIL_ADDRESS>
11/04/03 08:09 AM

To:	Margaret Sheppard/DC/USEPA/US@EPA

cc:

Subject:	SNAP Proposed Rulemaking

Margaret,

The EPA webpage lists you as the contact for questions regarding the

proposed rule.  Other than the MSDS, is there guidance on what
constitutes

"controlled workplace exposure to nPB" to lower health risks to workers?

Please advise.

Thanks,

Julie Kaiser

Sr. Environmental Coordinator

Johnson Controls-HILL

SUMMARY: The Environmental Protection Agency (EPA) published in the
Federal

Register of June 3, 2003, a Notice of Proposed Rulemaking related to the

Significant New Alternatives Policy (SNAP) program's review of n-propyl

bromide. During the public comment period, members of the public
requested

clarification or correction of a number of statements in the preamble to
the

proposed rule. This document identifies, corrects, and clarifies these

portions of the preamble.

SUPPLEMENTARY INFORMATION: The Environmental Protection Agency published
in

the Federal Register of June 3, 2003 (68 FR 33284

<http://www.epa.gov/fedrgstr/EPA-AIR/2003/June/Day-03/a13254.htm>), a
Notice

of Proposed Rulemaking related to the Significant New Alternatives
Policy

(SNAP) program's review of n-propyl bromide. During the public comment

period, members of the public requested clarification or correction of

certain