[Federal Register Volume 77, Number 89 (Tuesday, May 8, 2012)]
[Rules and Regulations]
[Pages 26943-26945]
[FR Doc No: 2012-11057]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0417; Directorate Identifier 2012-NE-11-AD;
Amendment 39-17045; AD 2012-09-10]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Canada Turboprop
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Pratt & Whitney Canada PT6A-38, -41, -42, -42A, -61, -64, -66, -66B, -
110, -112, -114, -114A, -121, -135, and -135A series turboprop engines.
This AD requires removal from service of certain part manufacturer
approval (PMA) replacement Timken Alcor Aerospace Technologies, Inc.
(TAATI) first stage sun gears and planet gears installed in the
reduction gearbox. This AD was prompted by failures of certain first
stage sun gears manufactured by TAATI. We are issuing this AD to
prevent failure of the sun gear and planet gears which will result in
an engine in-flight shut down, possible uncontained engine failure,
aircraft damage, and serious injuries.

DATES: This AD becomes effective May 23, 2012.
    We must receive comments on this AD by June 22, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Department of Transportation, 1200 New Jersey
Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC
20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (phone:<PHONE_NUMBER>) is the same as the
Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Paul Craig, Aerospace Engineer, Los
Angeles Aircraft Certification Office, FAA, 3960 Paramount Blvd., Suite
100, Lakewood, CA 90712; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received two reports of sun gears, part number (P/N) E3028456,
and installed in reduction gearboxes, failing during operation. We also
received one report of a sun gear, P/N E3037304, showing premature wear
and broken gear teeth during inspection. All three gear failures
occurred between 60 and 127 hours of operation time-since-new. These
conditions, if not corrected, could result in failure of the sun gear
and planet gears in the propeller reduction gearbox assembly, which
will result in an engine in-flight shut down, possible uncontained
engine failure, aircraft damage, and serious injuries. We determined
that the affected PMA replacement TAATI first stage sun gears and
planet gears listed in this AD, would have been installed after
December 22, 2008. The affected parts are listed as follows:
    First stage sun gears P/N E3028456, all serial numbers (S/Ns), and
the associated planet gears.

    First stage sun gears P/N E3037304, all S/Ns, and the associated
planet gears.
    Planet gear sets P/N E3101455-02, all S/Ns, and the associated sun
gears.
    Planet gear sets P/N E3101525-02, all S/Ns, and the associated sun
gears.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires removal from service within 40 operating hours
after the effective date of the AD, of the PMA replacement TAATI first
stage sun gears and planet gears, as listed in the Discussion section
above, and installed in the reduction gearbox assemblies of Pratt &
Whitney Canada PT6A-38, -41, -42, -42A, -61, -64, -66, -66B, -110, -
112, -114, -114A, -121, -135, and -135A series turboprop engines.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the short compliance time required in this AD to start the inspections.
Therefore, we determined that notice and opportunity for public comment
before issuing this AD are impracticable and that good cause exists for
making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2012-0417; Directorate
Identifier 2012-NE-11-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
Web site, anyone can find and read the comments in any of our dockets,
including, if provided, the name of the individual who sent the comment
(or signed the comment on behalf of an association, business, labor
union, etc.). You may review the DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78).

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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

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 AD:

2012-09-10 Pratt & Whitney Canada: Amendment 39-17045; Docket No.
FAA-2012-0417; Directorate Identifier 2012-NE-11-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 23,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pratt & Whitney Canada PT6A-38, -41, -42, -
42A, -61, -64, -66, -66B, -110, -112, -114, -114A, -121, -135, and -
135A series turboprop engines:
    (1) That have had maintenance done to the power section module
involving first stage sun gear or planet gear replacement since
December 22, 2008; and
    (2) That have any of the following Timken Alcor Aerospace
Technologies, Inc. (TAATI) part manufacturer approval (PMA)
replacement first stage sun gears or planet gear sets installed:
    (i) First stage sun gears P/N E3028456, all serial numbers (S/
Ns).
    (ii) First stage sun gears P/N E3037304, all S/Ns.
    (iii) Planet gear sets P/N E3101455-02, all S/Ns.
    (iv) Planet gear sets P/N E3101525-02, all S/Ns.

(d) Unsafe Condition

    This AD was prompted by failures of certain first stage sun
gears, manufactured by TAATI. We are issuing this AD to prevent
failure of the sun gear and planet gears in the propeller reduction
gearbox assembly, which will result in an engine in-flight shut
down, possible uncontained engine failure, aircraft damage, and
serious injuries.

(e) Compliance

    (1) Comply with this AD within the compliance times specified,
unless already done.
    (2) Within 40 operating hours after the effective date of this
AD, remove from service the following PMA replacement TAATI first
stage sun gear and the planet gears from the propeller reduction
gearbox assembly:
    (i) First stage sun gears P/N E3028456, all S/Ns, and the
associated planet gears.
    (ii) First stage sun gears P/N E3037304, all S/Ns, and the
associated planet gears.

    (iii) Planet gear sets P/N E3101455-02, all S/Ns, and the
associated sun gears.
    (iv) Planet gear sets P/N E3101525-02, all S/Ns, and the
associated sun gears.

(f) Installation Prohibition

    After the effective date of this AD, do not install on any
airplane, any engine or power section module with a TAATI PMA
replacement first stage sun gear or a planet gear set, as listed in
paragraph (c) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Los Angeles Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19
to make your request.

(h) Special Flight Permits

    Special flight permits are not authorized.

(i) Related Information

    For more information about this AD, contact Paul Craig,
Aerospace Engineer, Los Angeles Aircraft Certification Office, FAA,
3960 Paramount Blvd., Suite 100, Lakewood, CA 90712; phone: 562-627-
5252; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on May 3, 2012.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2012-11057 Filed 5-7-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Notices]
[Page 54887-54888]
[DOCID:fr09se10-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0414]

Determination of Regulatory Review Period for Purposes of Patent
Extension; REPEL-CV

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for REPEL-CV and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that medical device.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA recently approved for marketing the medical device, REPEL-CV.
REPEL-CV, a bioresorbable adhesion barrier, is indicated for reducing
the severity of post-operative cardiac adhesions in pediatric patients
who are likely to require reoperation via sternotomy. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for REPEL-CV (U.S. Patent No. 5,711,958) from
SyntheMed, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated February 17, 2010, FDA advised the
Patent and Trademark Office that this medical device had undergone a
regulatory review period and that the approval of REPEL-CV represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that the FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
REPEL-CV is 4,023 days. Of this time, 3,256 days occurred during the
testing phase of the regulatory review period, while 767 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: March 3, 1998. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the act for human tests to begin
became effective March 3, 1998.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): January 30, 2007. FDA has verified the
applicant's claim that the premarket approval application (PMA) for
REPEL-CV (PMA P070005) was initially submitted January 30, 2007.
    3. The date the application was approved: March 6, 2009. FDA has
verified the applicant's claim that PMA P070005 was approved on March
6, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,742 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by November 8, 2010. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by March 8, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see

ADDRESSES) electronic or written comments and written petitions. It is
only necessary to send one set of comments. It is no longer necessary
to send three copies of mailed comments. However, if you submit a
written petition, you must submit three copies of the petition.
Identify comments with the docket number found in brackets in the
heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22496 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-S


RECIPROCATING SEPARATE ENGINES MODEL TYPE #

OF POWER CYLINDERS CYLINDER ARRANGEMENT POWER CYLINDER BORE POWER CYLINDER ST ROKE RATED RPM RATED HP BMEP COMPRESSION RATIO CYCLE YEARS MANUFACTURED USER CODE/ NUMBER UNITS ARROW C 66 0 0 0 0 0 0 0 2 0 0 N. 02/ 5 BRIGGS STRATTON 252411 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 BUDA 8PC 2505 0 0 0 0 0 0 0 2 0 0 T. 01/ 2 CATERPILLAR 3306ST 0 0 0 0 145 0 0 4 0 0 E. 03/ 1 3512 12 V 6.7 7.5 1200 742 0 0 4 0 0 E. 03/ 1 3512TA 0 0 0 0 730 0 0 4 0 0 E. 03/ 1 3516 TC 0 0 0 0 1002 0 0 4 0 0 E. 03/ 1 3516TA TC 0 0 0 0 761 0 0 4 0 0 B. 06/ 14, E. 03/ 1 379 TA 8 V 6.25 8 1000 368 148.4 7 4 1965 0 A. 05/ 6, A. 06/ 1, C. 06/ 1, W. 06/ 1 379TA TC 0 0 0 0 0 0 0 4 0 0 L. 01/ 1 398 NA, TA 12 V 6.25 8 1000 555 149.2 7 4 1965 0 A. 05/ 110, B. 01/ 1, E. 06/ 1, U. 03/ 2, W. 06/ 1 398NA 0 0 0 0 0 0 0 4 0 0 L. 01/ 1, P. 02/ 1 398TA TC 0 0 0 0 0 0 0 4 0 0 L. 01/ 3 399 NA, TS 16 V 6.25 8 1200 830 139.5 7 4 1965 0 C. 06/ 1, E. 06/ 1 399NAHCR 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 399TA 0 0 0 0 0 0 0 4 0 0 C. 14/ 1, P. 02/ 2 G3306NA 6 V 4.75 2.75 1200 110 113.8 10.5 4 0 0 T. 04/ 1 G333 NA 6 0 0 1670 110 0 0 4 0 0 C. 02/ 1 G342 0 0 0 0 0 0 0 4 0 0 N. 02/ 2, P. 06/ 3, W. 10/ 1 G342NA 0 0 0 0 0 0 0 4 0 0 N. 02/ 1, P. 02/ 5 G342NAHCR 0 0 0 0 0 0 0 4 0 0 N. 02/ 2 G343 0 0 0 0 0 0 0 4 0 0 T. 01/ 4 G353 TA 0 0 0 0 275 0 0 0 0 T. 05/ 2 G379 NA, TA 8 V 6.25 8 1200 465 155 0 4 0 0 B. 06/ 2, C. 19/ 3, Q. 01/ 2 G379NA 8 V 6.25 8 1200 330 110.9 10 4 0 0 T. 04/ 1 G398 0 0 0 0 415 0 0 4 0 0 M. 07/ 1 G398AS TC 12 V 6.25 8 1000 490 0 7.1 4 0 0 N. 14/ 2 G398NA 0 0 0 0 300 0 0 4 0 0 C. 07/ 1, P. 02/ 4 G398TA 0 0 0 0 0 0 0 4 0 0 P. 02/ 2 G398TAS1 0 0 0 0 0 0 0 0 0 P. 02/ 1 G399 NA 16 V 6.25 8 0 0 0 0 4 0 0 C. 02/ 1 G399NA 0 0 0 0 0 0 0 4 0 0 P. 02/ 2 G399TA 0 V 0 0 0 700 0 0 4 0 0 P. 02/ 27 G399TALC 0 0 0 0 0 0 0 4 0 0 P. 02/ 2 G399TALCR TPA 12 V 6.25 8 1200 730 0 0 4 0 0 P. 02/ 6 CBC RCB12 EL 0 0 0 0 2950 0 0 0 0 T. 05/ 4 SUP 16GTL TA 16 V 10 10.5 900 2200 146.9 0 4 0 0 T. 05/ 2 CLIMAX K 67 0 0 0 0 208 0 0 2 0 0 E. 03/ 2 K 75 0 0 0 0 0 0 0 2 0 0 Q. 01/ 1 R 165 0 0 0 0 145 0 0 2 0 0 E. 03/ 2 R 6I 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 V 125 0 0 0 0 350 0 0 2 0 0 C. 07/ 1, T. 04/ 2, W. 03/ 1 V 125 HC 0 0 0 0 298 0 0 2 0 0 W. 03/ 1 V 85 8 V 7.5 7 1200 318 0 0 2 0 0 E. 03/ 2 CONTINENTAL MOTORS B427 6 IL 0 0 0 0 0 0 4 1952 0 W. 01/ 1 F124 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 COOPER ENERGY SERVICES ( COOPER/ COOPER BESSEMER)

8 V 250 TC 0 0 0 0 2700 0 0 2 0 0 C. 07/ 3 8 V 275 C2 PUR 8 V 18 20 275 3200 112 0 2 0 0 C. 07/ 3, S. 01/ 1 8 W 330 TC 0 0 0 0 4000 0 0 2 0 0 C. 07/ 1 8Q155HC2 PUR 8 V 15.5 14 475 3000 118 0 2 0 0 S. 01/ 2 JS 5 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 JS 6 SG 6 INLN 13 16 450 950 135 0 2 0 0 B. 05/ 1 JS 8 8 0 0 0 600 0 0 2 0 0 E. 03/ 3 JS 8 G 8 IL 13 16 450 615 63.7 0 2 0 0 E. 03/ 5 LS SUP 0 IL 15.5 22 330 0 144.4 0 4 1960 0

E. 06/ 20, P. 02/ 3 LS 8 G SC 8 0 0 0 960 0 0 4 1960 1960 E. 03/ 1 LSV SUP 22 V 15.5 0 330 0 144.6 0 4 1960 0 E. 06/ 16, N. 02/ 3, P. 02/ 33, T. 01/ 5 LSV 12 SC, TC 12 V 15.5 22 327 3300 0 0 4 0 0 C. 07/ 5, P. 02/ 12, T. 01/ 5, U. 03/ 4 LSV 12 SG SC 0 0 0 0 0 0 0 4 1960 1960 P. 02/ 20 LSV 16 SC 0 0 0 0 0 0 0 4 1960 1960 C. 07/ 1, C. 08/ 20, P. 02/ 3 LSV 16 SG SC 0 0 0 0 0 0 0 4 1960 1960 P. 02/ 2 COOPER ENERGY SERVICES ( DELAVAL)

HA 6 TS 6 IL 14 15 630 2000 185 8.25 4 1969 1983 P. 02/ 1 HA 6 C4 TS 0 0 0 0 0 0 0 4 0 0 P. 02/ 4, T. 04/ 2 HV 12C TPU 12 V 13 15 630 3450 165 10.5 4 1969 1987 C. 13/ 2 HV 12C 4 TC 0 0 0 0 0 0 0 4 0 0 L. 01/ 1 MODEL TYPE #

OF POWER CYLINDERS CYLINDER ARRANGEMENT POWER CYLINDER BORE POWER CYLINDER STROKE RATED RPM RATED HP BMEP COMPRESSION RATIO CYC LE YEARS MANUFACTURED USER CODE/ NUMBER UNITS COOPER ENERGY SERVICES ( DELAVAL)

HV 16C TC, TPU 16 V 13 15 600 4000 165 10.5 4 1969 1987 C. 06/ 1, C. 13/ 3 HV 8 C4 TA 8 V 13 15 600 1930 165 0 4 0 0 N. 11/ 1 HVA 12 TC 12 V 14 15 630 4000 185 8.25 4 1969 1983 C. 06/ 1 HVA 16 C6 TC 16 V 14 15 630 4830 185 0 4 0 0 S. 03/ 5 HVA 8 TC 8 V 14 15 630 2750 185 8.25 4 1969 1983 N. 01/ 1 COOPER ENERGY SERVICES ( ENTERPRISE)

HV 12 TC, TPU 0 0 0 0 3000 0 0 4 0 0 C. 07/ 1, N. 10/ 3 HV 12C TC 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 HV 16 TPU 16 VEE 13 15 600 4000 0 0 4 0 0 N. 10/ 3 HV 16C TP 0 0 0 0 0 0 0 4 0 0 N. 02/ 4 HV 8 TE, TPU 8 V 13 15 600 2000 0 0 4 0 0 N. 10/ 2 HVA 8 C2 TC, TS 8 V 14 15 630 3250 217.8 0 4 0 0 N. 02/ 2 HVA 16 C6 TC 16 V 14 15 630 4830 185 0 4 0 0 M. 02/ 2 COOPER ENERGY SERVICES ( SUPERIOR)

12G825 NA 12 V 10 10.5 900 1200 107 0 4 1960 0 C. 06/ 3, Q. 01/ 1, U. 03/ 2 12SGT TC 12 V 10 10.5 900 2000 177 0 4 1975 0 U. 03/ 3 16G825 NA 16 V 10 10.5 900 1600 107 0 4 1960 0 C. 06/ 16, Q. 01/ 1 16GTB 16 10 10.5 900 2650 176.7 0 4 1989 0 A. 07/ 1 16GTL TC 16 V 10 10.5 900 2200 147 0 4 1978 0 N. 16/ 2 16SGT TC 11 V 10 0 900 2650 177 0 4 1975 0 E. 06/ 1 16SGTB TC 0 0 0 0 2650 0 0 2 0 0 A. 07/ 1, L. 01/ 1, M. 07/ 2, T. 04/ 3, W. 03/ 4 6G510 NA 6 IL 8.5 9 1000 400 103 0 4 1950 0 C. 06/ 5, E. 06/ 3, I. 01/ 1, M. 08/ 8, W. 06/ 1 6G825 NA 6 IL 10 10.5 1000 650 107 0 4 1955 0 B. 01/ 1, C. 01/ 1, E. 06/ 10, I. 01/ 2, M. 08/ 8, Q. 01/ 1 6GTL TC 6 IL 10 10.5 900 825 147 0 4 1978 0 A. 05/ 2, M. 08/ 1, W. 03/ 2 8G825 NA 8 IL 10 10.5 900 800 107 0 4 1960 0 A. 05/ 4, C. 01/ 1, C. 06/ 45, E. 06/ 11, L. 01/ 10, M. 08/ 1, N. 16/ 2, Q. 01/ 3 8GT825 TC 8 IL 10 10.5 900 1100 147 0 4 0 0 C. 01/ 2, I. 02/ 2 8GTL TC, TS 8 IL 10 10.5 900 1100 147 0 4 1978 0 A. 05/ 8, B. 06/ 3, C. 06/ 50, C. 11/ 1, E. 06/ 18, I. 01/ 1, M. 08/ 1, W. 03/ 2 8GTLA TC 11 IL 10 0 900 1100 147 0 4 1982 0 B. 06/ 3, C. 06/ 3 8GTLA825 TC 8 IL 10 10.5 900 1100 0 0 4 0 0 M. 02/ 1 8GTLB TC 8 IL 10 10.5 900 1100 147 0 4 1986 0 B. 06/ 3, I. 02/ 1, M. 07/ 1, M. 08/ 1, M. 09/ 1, S. 03/ 3 8SGTB TC 8 INLI 10 10.5 900 1350 180 8.1 4 0 0 N. 14/ 2, W. 03/ 2 125GTA 12 V 10 10.5 900 2000 0 0 4 0 0 M. 02/ 2 COOPER ENERGY SERVICES ( WHITE)

0 0 0 0 0 0 0 0 0 M. 02/ 1, N. 10/ 1 12 GT 825 TE 12 VEE 10 10.5 900 1500 0 0 4 0 0 N. 10/ 2 12 GTLA TC 0 0 0 0 1650 0 0 4 0 0 C. 07/ 1 16 SGTV TA 16 V 10 10.5 900 2650 178 8.2 4 0 0 C. 02/ 1 12 VGT 825 TC 12 V 10 10.5 900 1500 0 0 4 0 0 M. 02/ 5 6 G 510 NA 6 IL 8.5 9 900 388 103 0 4 0 0 C. 07/ 5, N. 10/ 1, P. 02/ 3, T. 04/ 2, W. 03/ 2 6 G 825 NA 6 IL 10 10.5 1000 600 107 0 4 0 0 M. 02/ 2 6 GTL 0 0 0 0 800 0 0 4 0 0 M. 07/ 3 6 GTLB 0 0 0 0 650 0 0 0 0 C. 07/ 4 8 GT 825 TC, TE, NA 8 IL 10 10.5 900 1000 147 0 4 0 0 C. 07/ 1, I. 02/ 2, M. 02/ 4, N. 02/ 2, N. 10/ 1, P. 02/ 5 8 G 825 NA, PS 8 IL 10 10.5 900 600 107 0 4 0 0 C. 05/ 1, C. 07/ 3, I. 01/ 1, L. 01/ 3, M. 02/ 6, M. 07/ 7, P. 02/ 70, W. 03/ 8 8 GTL 825 0 0 0 0 900 0 0 4 0 0 C. 07/ 1 8 G 852 0 0 0 0 800 0 0 4 0 0 C. 07/ 2 8 GTL 0 0 0 0 1100 0 0 4 0 0 M. 07/ 3 8 GTLA 0 0 0 0 1100 0 0 4 0 0 C. 07/ 2 8 GTLB 0 0 0 0 890 0 0 0 0 C. 07/ 3 G 1600 0 0 0 0 0 0 0 4 0 0 K. 02/ 1 G 3400 6 V 3.75 4.5 1600 62 90.74 10 4 0 0 T. 04/ 1 CUMMINS G855 0 0 0 1800 210 0 0 4 0 0 S. 09/ 1 GTA 1710 GS 0 0 0 0 585 0 0 4 0 0 E. 03/ 1 GTA 855 0 0 0 0 0 0 0 4 0 0 P. 06/ 1 DRESSER RAND ( DRESSER/ CLARK)

HMB 6 NA 6 IL 8.63 8.88 600 330 70 0 2 0 0 C. 01/ 4 FAIRBANKS MORSE MEP 8G 8 8.13 10 0 0 0 0 0 0 N. 02/ 1 FORD 240 GF7 NA 0 0 0 0 69 0 0 2 0 0 C. 07/ 1 300 C. I. NA 0 0 0 0 0 0 0 2 0 0 E. 03/ 1 5C276AA NA 6 IL 0 0 0 0 0 0 4 0 0

W. 01/ 1 C5PG NA 0 0 0 0 0 0 0 2 0 0 T. 01/ 1 ENGINE NA 0 0 0 0 0 0 0 2 0 0 E. 03/ 1 HERCULES 6G825 NA 6 IL 10 10.5 1000 650 107 0 4 0 0 A. 05/ 1 G2300 0 0 0 0 0 0 0 4 0 0 P. 06/ 1, W. 01/ 1 G339H 0 0 0 0 0 0 0 4 0 0 T. 01/ 3 G3400 0 0 0 0 0 0 0 4 0 0 E. 10/ 1, P. 06/ 1 HXE 0 0 0 0 130 0 0 4 0 0 E. 03/ 1 MODEL TYPE #

OF POWER CYLINDERS CYLINDER ARRANGEMENT POWER CYLINDER BORE POWER CYLINDER STROKE RATED RPM RATED HP BMEP COMPRESSION RATIO CYCLE YEARS MANUFACTURED USER CODE/ NUMBER UNITS INTNL HARVESTER T CU 50 0 0 0 0 0 0 0 2 0 0 W. 10/ 2 UV 401 0 0 0 0 0 0 0 2 0 0 M. 15/ 2 UV 549 8 V 0 0 0 0 0 0 4 0 0 W. 01/ 1 KOHLER 4RM22 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 LE ROI F 1500 0 0 0 0 130 0 0 0 0 C. 07/ 2 H 540 0 0 0 0 138 0 0 2 0 0 E. 03/ 1 L 3000 0 0 0 0 0 0 0 2 0 0 P. 02/ 2 M. E. P.

10 T NA 0 0 0 0 0 0 0 2 0 0 P. 02/ 2 10 TC NA 10 IL 8.5 0 900 2250 95.5 9.7 0 0 E. 06/ 3 12 SG BS 10 IL 8.13 0 900 2600 92 9.75 2 0 0 E. 06/ 2 6 0 0 0 0 0 0 0 2 0 0 L. 01/ 1 6 SG BS 6 IL 8.13 10 900 1350 95.5 9.75 2 0 0 A. 05/ 6 6 TC NA 10 IL 8.5 0 900 1300 95.5 9.7 0 0 E. 06/ 3 8 G 0 0 0 0 0 0 0 0 0 N. 02/ 2, P. 02/ 2 8 SG BS 10 IL 8.13 0 900 1800 95.5 9.75 2 0 0 E. 06/ 3 MAZDA 13 GN 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 UA 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 ONAN 100CKB 3CR/ 3195 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 15JC 4R/ 1K 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 15JC4R79025 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 2196 1 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 5.0 CCK3RV 12F 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 50KU6R813E 0 0 0 0 0 0 0 2 0 0 T. 01/ 1 5CCK3RV 12F 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 75JB18R 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 F1 226 0 0 0 0 0 0 0 2 0 0 T. 01/ 1 L5.0 JC 0 0 0 0 0 0 0 2 0 0 K. 02/ 1 ROH LINE 3230 0 0 0 0 0 0 0 2 0 0 C. 14/ 2 F 1500 0 0 0 0 125 0 0 2 0 0 H884 0 0 0 0 265 0 0 2 0 0 E. 03/ 2 L 3230 0 0 0 0 250 0 0 2 0 0 C. 07/ 4 WAUKESHA 0 0 0 0 170 0 0 4 0 0 E. 03/ 2 1197 0 0 0 0 0 0 0 4 0 0 K. 02/ 1 12V AT25GL TC 12 V 9.84 11.81 1000 2587 190.1 9 4 0 0 N. 02/ 1 3711( 3712) 12 V 7.5 7 1200 525 93 10 4 0 0 M. 06/ 1 3711 GU 0 0 0 0 320 0 0 4 0 0 C. 07/ 1 5108 GI 0 0 0 0 842 0 0 4 0 0 W. 03/ 1 5108 GL 0 0 0 0 842 0 0 4 0 0 W. 03/ 1 5108 GSI TC 0 0 0 0 0 0 0 4 0 0 L. 01/ 1 5108 GU 0 0 0 0 500 0 0 4 0 0 C. 07/ 4 6 LR0 F2894GR NA 6 IL 8.5 8.5 1200 406 93 10 4 1955 1967 A. 05/ 4 6 LRO F2894GR NA 9 IL 8.5 0 1200 406 93 10 4 1955 1967 E. 06/ 1 6 LRORB 0 0 0 0 0 0 0 4 0 0 P. 02/ 5 6 LROU 0 0 0 0 0 0 0 4 0 0 P. 02/ 2 6 WAK 0 0 0 0 0 0 0 4 0 0 P. 02/ 1 6 WAK 133 P 0 6.25 6.5 1180 0 0 0 4 0 0 S. 09/ 1 6 WAKB 0 0 0 0 140 0 0 4 0 0 C. 07/ 4 6 WAKU 0 0 0 0 0 0 0 4 0 0 P. 02/ 1 7040 NA 0 0 0 0 0 0 0 4 0 0 L. 01/ 1 7042 NA 0 0 0 0 0 0 0 4 0 0 L. 01/ 13 7042 GL 0 0 0 0 1102 0 0 4 0 0 Q. 01/ 2, W. 03/ 4 7042 GSI TC 0 0 0 0 0 0 0 4 0 0 L. 01/ 2 7042 GSIU 0 0 0 0 1143 0 0 4 0 0 W. 03/ 2 7042 GU 0 0 0 0 625 0 0 4 0 0 C. 07/ 2 817 GU 6 I. L. 5.38 6 1600 141 85.29 9 4 0 0 M. 06/ 1 F 11 GSI 6 I. L. 5 5.71 1800 225 93 10 4 0 0 M. 06/ 1 F 1197 0 0 0 0 0 0 0 4 0 0 C. 14/ 1 F 1197 G 0 0 0 0 0 0 0 4 0 0 B. 06/ 1, K. 02/ 2, N. 02/ 8 F 1197 GU 0 0 0 1400 186 0 0 4 0 0 C. 07/ 1, K. 02/ 1, M. 02/ 2, M. 07/ 1, M. 15/ 4, N. 02/ 1, P. 02/ 6, S. 03/ 3, S. 09/ 2, T. 04/ 2, T. 01/ 5 F 18 G 6 I. L. 5.98 6.5 1800 238 95 11 4 0 0 M. 06/ 1 F 1905 6 I. L. 7 8.25 1200 239 82.8 10 4 0 0 M. 06/ 1 F 1905 G 0 0 0 0 0 0 0 4 0 0 Q. 01/ 1 F 1905 GR 6 IN L 7 8.25 1000 180 0 10.1 4 0 0 N. 02/ 2, W. 10/ 2 F 1905 GRU 0 0 0 0 206 0 0 0 0 C. 02/ 1, C. 07/ 1, P. 02/ 1 F 2475 F 0 0 0 0 0 0 0 4 0 0 Q. 01/ 1 F 2895 G NA 6 IL 8.5 8.5 1000 369 101 10 4 1967 0 N. 02/ 19, Q. 01/ 2, T. 01/ 1, W. 06/ 3 F 2895 GL 6 IL 8.5 8.5 1000 506 138.5 10 4 0 0 M. 04/ 1, T. 04/ 2 F 2895 GSI TC, TI( B) 6 IL 8.5 8.5 1000 506 138 8.2 4 1967 0 E. 03/ 1, N. 16/ 1 MODEL TYPE #

OF POWER CYLINDERS CYLINDER ARRANGEMENT POWER CYLINDER BORE POWER CYLINDER STROKE RATED RPM RATED HP BMEP COMPRESSION RATIO CYC LE YEARS MANUFACTURED USER CODE/ NUMBER UNITS WAUKESHA F 2895 GSIU 0 0 0 0 446 0 0 4 0 0 E. 03/ 1 F 2895 GU NA 0 0 0 0 0 0 0 4 0 0 K. 02/ 1, M. 07/ 1, P. 02/ 4 F 3520 GU NA 6 V 9.38 8.5 1200 330 61.9 0 4 0 0 N. 02/ 1 F 3521 C 0 0 0 0 0 0 0 4 0 0 Q. 01/ 1 F 3521 G 6 IL 9.37 8.5 1200 512 96 10 4 0 0 A. 05/ 2, N. 02/ 1, Q. 01/ 1 F 3521 GS1 TI( B) 6 IL 9.38 8.5 1000 615 138 8 4 1971 0 A. 06/ 1 F 3521 GSIU TC 6 9.38 8.5 1200 550 0 0 4 0 0 C. 02/ 1 F 3521 GU NA 6 IL 9.38 8.5 900 373 101 0 4 0 0 K. 02/ 2, N. 02/ 1, P. 02/ 2 F 544 G 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 F 55 RGU 0 0 0 0 93 0 0 4 0 0 C. 07/ 1 F 554 GU 0 0 0 0 0 0 0 4 0 0 N. 02/ 1, T. 01/ 1 F 5554 G 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 F 817 0 0 0 0 0 0 0 4 0 0 C. 14/ 2 F 817 G NA 6 5.38 6 1200 250 0 0 4 0 0 N. 02/ 18, S. 03/ 1, T. 04/ 1 F 817 GU 0 0 0 0 95 0 0 4 0 0

C. 07/ 3, M. 15/ 6, P. 02/ 1, T. 04/ 1, T. 01/ 1, W. 03/ 1 GK 140 6 V 4.5 5.25 1000 75 118.6 8 4 0 0 T. 04/ 2 GKU 195 6 IL 0 0 0 0 0 0 4 0 0 W. 01/ 1 GZU 135 0 0 0 0 74 0 0 4 0 0 C. 07/ 1, P. 06/ 1, T. 01/ 1 GZU 140 0 0 0 0 0 0 0 4 0 0 T. 01/ 1 GZU 145 NA 6 IL 0 0 0 0 0 0 4 0 0 K. 05/ 1, W. 01/ 1 H 1077 GSI 8 V 0 0 2000 345 0 0 4 0 0 W. 01/ 1 H 2475 NA 0 0 0 0 250 0 0 4 0 0 A. 04/ 1, C. 07/ 3, I. 01/ 2, T. 01/ 1, W. 03/ 3 H 2475 G 0 0 0 0 0 0 0 4 0 0 P. 02/ 1 H 2475 GU NA 0 0 0 0 273 0 0 4 0 0 C. 07/ 2, P. 02/ 6, W. 01/ 1 H 2476 GU 0 0 0 0 275 0 0 4 0 0 M. 07/ 1, T. 01/ 1 K 5790 GU 12 V 8.5 8.5 1000 600 0 10.1 4 0 0 W. 10/ 2 L 1616 0 0 0 0 0 0 0 4 0 0 K. 02/ 1, K. 05/ 1 L 3711 12 V 7.5 7 900 380 0 0 4 0 0 C. 14/ 1 L 3711 G NA 0 0 0 0 375 0 0 4 0 0 C. 02/ 1, C. 07/ 2, E. 06/ 7, K. 05/ 1, N. 02/ 1, Q. 01/ 3, T. 04/ 1, W. 01/ 1 L 3711 GU 0 0 0 0 317 0 0 4 0 0 C. 07/ 2 L 5100 G 0 0 0 0 0 0 0 4 0 0 P. 02/ 2 L 5108 NA 12 V 8.5 7.5 900 583 91 0 4 0 0 C. 14/ 1 L 5108 G NA 12 V 8.5 7.5 1000 610 95 10 4 1966 0 A. 05/ 6, C. 05/ 1, E. 06/ 5, N. 02/ 18, Q. 01/ 1, T. 01/ 1, W. 06/ 1 L 5108 GL 0 0 0 0 650 0 0 0 0 C. 07/ 1 L 5108 GU NA 12 V 8.5 7.5 900 547 91 0 4 0 0 C. 02/ 1, P. 02/ 11 L 5788 G NA 12 V 8.5 8.5 1000 729 100 10 4 1955 1967 Q. 01/ 2 L 5788 GR NA 9 V 8.5 0 1000 729 100 10 4 1955 1967 A. 05/ 2, E. 06/ 2 L 5788 GRJ 12 V 8.5 8.5 1000 570 0 9.2 4 0 0 W. 10/ 2 L 5788 GRU NA 12 V12 8.5 8.5 1000 900 0 9.21 4 0 0 T. 01/ 1, W. 02/ 1 L 5790 G NA 9 V 8.5 0 1000 738 101 10 4 1966 0 E. 06/ 2, N. 02/ 15, N. 04/ 2, P. 02/ 2 L 5790 GL 0 0 0 0 0 0 0 4 0 0 Q. 01/ 2 L 5790 GSI 0 0 0 0 979 0 0 4 0 0 W. 03/ 3 L 5790 GU NA 0 0 0 0 650 0 0 0 0 C. 07/ 1, M. 07/ 1, P. 02/ 20 L 7040 G NA 9 V 9.38 0 1200 949 89 10 4 1963 1966 E. 06/ 3, N. 02/ 1 L 7040 GU 12 V 9.37 8.5 1000 1200 0 0 4 0 0 P. 02/ 5 L 7042 0 0 0 0 800 0 0 0 0 C. 07/ 1, E. 03/ 3, T. 01/ 2 L 7042 G NA 0 0 0 0 745 0 0 2 0 0 A. 05/ 4, C. 06/ 4, C. 07/ 1, E. 06/ 21, L. 01/ 1, N. 01/ 3, N. 02/ 10, P. 02/ 3, Q. 01/ 2, T. 01/ 2, U. 03/

2 L 7042 GSI TC, TI( A), TI( B) 12 V 9.38 8.5 1000 1232 138 8 4 1967 0 A. 05/ 2, C. 02/ 1, E. 06/ 19, K. 02/ 6, Q. 01/ 2, T. 04/ 2, U. 03/ 3 L 7042 GSIU NA, TI( A), TC 12 V 9.38 8.5 900 878 101 0 4 0 0 C. 02/ 2, K. 02/ 1, M. 02/ 3, M. 07/ 1, N. 02/ 1, S. 08/ 5 L 7042 GU NA 12 V 9.57 8.5 900 720 0 0 4 0 0 C. 07/ 2, K. 02/ 3, M. 02/ 1, P. 02/ 36, T. 04/ 2, W. 03/ 5 L 7402 GSI 0 0 0 0 0 0 0 4 0 0 N. 02/ 3 L 75790 GSI TI( A) 9 V 8.5 0 1200 1272 145 8.2 4 1967 0 E. 06/ 1 LRO RB 0 0 0 0 0 0 0 4 0 0 K. 02/ 1 M 2475 0 0 0 0 0 0 0 4 0 0 T. 01/ 1 P 9390 G NA 16 V 9.38 8.5 1000 1194 100 8 4 1969 0 U. 03/ 3 P 9390 OGU 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 V 85U 8 V 0 0 1200 309 0 0 4 0 0 W. 01/ 1 VIK 63 L 0 0 0 0 0 0 0 4 0 0 C. 14/ 1 VRG 220 0 0 0 0 0 0 0 4 0 0 A. 04/ 1, C. 14/ 1, N. 02/ 1, Q. 01/ 1 VRG 232 0 0 0 0 0 0 0 4 0 0 N. 02/ 2 VRG 232 U 0 0 0 0 0 0 0 4 0 0 N. 02/ 4 VRG 310 NA 0 0 0 0 0 0 0 4 0 0 K. 02/ 1, N. 02/ 1 VRG 310 U NA 6 V 3.88 4.38 1000 0 0 0 4 0 0 P. 02/ 1 VRG 330 NA 6 IL 3.88 4.67 2200 60 0 0 4 0 0

C. 02/ 1, N. 02/ 2 VRN 155 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 VRN 310 0 0 0 0 0 0 0 4 0 0 N. 02/ 4 VRN 310 U 6 V 3.88 4.38 1800 50 89.5 8 4 0 0 N. 02/ 1, T. 04/ 1 WAK/ XL 0 0 0 0 0 0 0 4 0 0 N. 02/ 1 WAKC HC 2 6.25 6.5 1000 125 0 0 4 0 0 C. 11/ 2


Page 1 of 3 January 11, 2005 MEMORANDUM Subject: Product Chemistry Science Chapter for Didecyl Dimethyl Ammonium Chloride ( DDAC)

To: A . Najm Shamim, Risk Assessor for DDAC Regulatory Management Branch II Antimicrobials Division ( 7510C)

And Tracy Lantz, CRM for DDAC RED Regulatory Management Branch I Antimicrobials Division ( 7510C)

From: Chris Jiang, Chemist Product Science Branch Antimicrobials Division ( 7510C)

Thru: Karen P. Hicks, CTT Team Leader Product Science Branch Antimicrobials Division ( 7510C)

Michele Wingfield, Branch Chief Product Science Branch Antimicrobials Division ( 7510C)

DP Barcode: D323311 Chemical Code: 069149 EPA Reg. No.: 3377 42 MRID #= s: 44520301 44520302 44520303 Enclosed is the Science Chapter for Didecyl Dimethyl Ammonium Chloride Reregistration Eligibility Decision ( RED). Page 2 of 3 Science Chapter on for Didecyl Dimethyl Ammonium Chloride ( MRID #= s: 44520301, 44520302, 44520303) Product Chemistry Case Overview Chemical Overview The main ingredient covered for this Science Chapter is: Didecyl Dimethyl Ammonium Chloride Chemical Name: Didecyl dimethyl ammonium chloride Common/ Trade Names: Di n decyl dimethyl ammonium chloride, DDAC Chemical Family: Quaternary amines CAS Registry Number: 7173 51 5 OPP Chemical Code: 069149 Molecular Formula: R2C2H6NCl ( R = n decyl)

Molecular Weight: 362.08 SCIENCE ASSESSMENT The Agency thoroughly reviewed the registrants =

submissions ( in house literature) for the purpose of determining the reregistration eligibility of didecyl dimethyl ammonium chloride for use in wood preservatives, in agricultural premises and equipment, in industrial processes and water systems, and in commercial, institutional, and residential premises.

Product Chemistry Assessment The physical and chemical characteristics of didecyl dimethyl ammonium chloride are described below.

Technical Grade Active Ingredient ( TGAI):

Chemical Name: Didecyl dimethyl ammonium chloride Molecular Wt. 362.08 Color: 100 APHA units Physical State: Liquid Odor: Ethanolic * Melting Point: 228.81 oC Boiling Point: Please provide boiling point data Could not be established because test article is a multi component system with each component boiling at a different temperature? Density: 0.9216 g/ cm3 at 25 oC Water Solubility: Completely soluble * Vapor Pressure: 2.33 x 10 11 mm Hg Dissociation Constant: Not applicable * log Kow: 4.6581 Page 3 of 3 pH: 6.31 Stability: Stable with respect to metal, nonmetal, temperature, and light Oxidizing/ Reducing Potential: Not applicable as product does not contain oxidizers or reducers Flash Point: 38.0 o C Explodability: Not applicable for liquids which are not potentially explosive Viscosity: 28.35 cSt at 25 oC Miscibility: Not applicable as product is not to be mixed with petroleum solvents Corrosion Characteristics Corrosive to stainless steel and no corrosion to HDPE Dielectric breakdown voltage: Not applicable as product is not to be used near electrical equipment * Values obtained from EpiSuite Didecyl Dimethyl ammonium chloride PRODUCT CHEMISTRY BIBLIOGRAPHY US EPA =

s MRID #: 44520301, Albemarle DAQ 1010 5 Biocide  Product Chemistry, ( 1998) Albemarle Corp., Lab Project Number 8382 139 Quat 10, Albemarle Corporation.

US EPA =

s MRID #: 44520302, Tolbert, A., Product Chemistry Chemical Characterization for Determining Identity and Purity of 50% Di N Decyl Dimethyl Ammonium Chloride, ( 1998), Lab Project Number Quat 10B, Albemarle Corporation.

US EPA =

s MRID #: 44520303, Tolbert, A., Product Chemistry Chemical Characterization for Determining the Physical and Chemical Properties, and Accelerated Storage Stability of 50% Di N Decyl Dimethyl Ammonium Chloride, ( 1998), Lab Project Number Quat 10A, Albemarle Corporation.

EPISuite Property Assessment Program Appendix I: Impurities evolved during the manufacture of Didecyl dimethyl ammonium chloride Chemical name Methyl chloride Di n decylmethyl amine Di n decylmethyl amine hydrochloride Methanol No percentages of these impurities are given.


[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14943-14944]
[FR Doc No: 2022-05515]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0017]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 23 individuals from the
hearing requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. The exemptions enable these hard of hearing and deaf
individuals to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on March 4, 2022. The exemptions
expire on March 4, 2024.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2021-0017, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

II. Background

    On January 19, 2022, FMCSA published a notice announcing receipt of
applications from 23 individuals requesting an exemption from the
hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in
interstate commerce and requested comments from the public (87 FR
2979). The public comment period ended on February 18, 2022, and two
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received two comments in this proceeding. Both comments
received indicated that Gary Sturdevant submitted a hearing exemption
application to FMCSA.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on current medical information and literature, and the 2008
Evidence Report, ``Executive Summary on Hearing, Vestibular Function
and Commercial Motor Driving Safety.'' The evidence report reached two
conclusions regarding the matter of hearing loss and CMV driver safety:
(1) No studies that examined the relationship between hearing loss and
crash risk exclusively among CMV drivers were identified; and (2)
evidence from studies of the private driver's license holder population
does not support the contention that individuals with hearing
impairment are at an increased risk for a crash. In addition, the
Agency reviewed each applicant's driving record found in the Commercial
Driver's License Information System, for commercial driver's license
(CDL) holders, and inspections recorded in the Motor Carrier Management
Information System. For non-CDL holders, the Agency reviewed the
driving records from the State Driver's Licensing Agency. Each
applicant's record demonstrated a safe driving history. Based on an
individual assessment of each applicant that focused on whether an
equal or greater level of safety is likely to be achieved by permitting
each of these drivers to drive in interstate commerce as opposed to
restricting him or her to driving in intrastate commerce, the Agency
believes the drivers granted this exemption have demonstrated that they
do not pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the hearing standard in Sec.  391.41(b)(11) is likely
to achieve a

level of safety equal to that existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must report any crashes or accidents as defined in Sec.
390.5; (2) each driver must report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver is prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 23 exemption applications, FMCSA
exempts the following drivers from the hearing standard, Sec.
391.41(b)(11), subject to the requirements cited above:

 Yunier Alegre (FL)
 Kenneth Alston (NJ)
 Charles Armand (NJ)
 Baldemar Barba (TX)
 Gary Barber (WI)
 Desmond Dantzler (AZ)
 Jeremy Descloux (WA)
 Philip Fatigato (IL)
 William Hoke (NY)
 Edward Larizza (CA)
 Kevin Maddox (GA)
 Bikien McKoy (NC)
 Rage Muse (MN)
 Orlando Padilla (FL)
 Michael Paul (IL)
 Aaron Pitsker (CA)
 Michael Principe (TX)
 William Rivas (CA)
 Kenneth Salts (OH)
 Isaac Soto (IL)
 Gary Sturdevant (TX)
 Richard Taulbee (GA)
 Matthew Taylor (TX)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-05515 Filed 3-15-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: June 25, 2009 (Volume 74, Number 121)]
[Notices]
[Page 30288-30289]
[DOCID:fr25jn09-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-59-000]

Buckeye Power, Inc., on Behalf of Itself and Members; Notice of
Filing

June 18, 2009.
    Take notice that on June 10, 2009, Buckeye Power, Inc. (Buckeye),
on behalf of itself and its member electric distribution cooperatives
(members),\1\

filed a request for waiver of certain Commission regulations concerning
purchases from and sales to qualifying cogeneration and small power
production facilities (QFs). Buckeye also proposes that it assume its
members' obligation to purchase electric energy from QFs, and that its
members assume Buckeye's obligation to sell electric energy to QFs,
under sections 292.303(a) and 292.303(b), respectively, of the
Commission's regulations.
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    \1\ Adams Rural Electric Cooperative, Inc., Buckeye Rural
Electric Cooperative, Inc., Butler Rural Electric Cooperative, Inc.,
Carroll Electric Cooperative, Inc., Consolidated Electric
Cooperative, Inc., Darke Rural Electric Cooperative, Inc., Firelands
Electric Cooperative, Inc., The Frontier Power Company, Ouernsey-
Mnskingum Electric Cooperative, Inc., Hancock-Wood Electric
Cooperative, Inc., Holmes-Wayne Electric Cooperative, Inc., Licking
Rural Electrification, Inc., Logan County Cooperative Power and
Light Association, Inc., Lorain-Medina Rural Electric Cooperative,
Inc., Mid-Ohio Energy Cooperative. Inc., Midwest Electric, Inc.,
North Central Electric Cooperative, Inc., North Western Electric
Cooperative, Inc., Paulding-Putnam Electric Cooperative, Inc.,
Pioneer Rural Electric Cooperative, Inc., South Central Power
Company, Tricounty Rural Electric Cooperative, Inc., Union Rural
Electric Cooperative, Inc., and Washington Electric Cooperative,
Inc.
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link, and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 10, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-14935 Filed 6-24-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Notices]
[Page 60493]
[DOCID:fr30se10-126]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Renewal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Renewal.

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SUMMARY: Pursuant to section 14 (a) (2) (A) of the Federal Advisory
Committee Act, and in accordance with section 102-3.65, title 41 of the
Code of Federal Regulations, the FAA gives notice it has renewed the
Aviation Rulemaking Advisory Committee (ARAC) for a 2-year period
beginning September 17, 2010. The Committee's primary purpose is to
provide the public with an earlier opportunity to participate in the
FAA's rulemaking process. It will continue to operate in accordance
with the rules of the Federal Advisory Committee Act and the Department
of Transportation Order 1120.3B, Committee Management Policy and
Procedures.
    For further information about the ARAC, please contact Ms. Renee
Butner, FAA Office of Rulemaking, 800 Independence Avenue, SW.,
Washington, DC 20591; telephone number:<PHONE_NUMBER>.

    Issued in Washington, DC, on September 24, 2010.
Pamela A. Hamilton-Powell,
Executive Director, Aviation Rulemaking Advisory Committee.
[FR Doc. 2010-24538 Filed 9-29-10; 8:45 am]
BILLING CODE 4910-13-P