[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52472-52477]
[FR Doc No: 2018-22567]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3516]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Disease Awareness and Prescription Drug Promotion on
Television

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Disease Awareness and
Prescription Drug Promotion on Television.''

DATES: Submit either electronic or written comments on the collection
of information by December 17, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 17, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

that if you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3516 for ``Disease Awareness and Prescription Drug Promotion
on Television.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00
p.m., 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected]. For copies of the questionnaire contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Disease Awareness and Prescription Drug Promotion on Television (OMB
Control Number 0910--NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The FDA's Center for Drug Evaluation and Research (CDER), Office of
Prescription Drug Promotion (OPDP) is responsible for ensuring that
prescription drug promotional materials are truthful, balanced, and
accurately communicated. This project is being proposed as part of the
research program of OPDP. OPDP's research program supports this mission
by providing scientific evidence to help ensure that our policies
related to prescription drug promotion will have the greatest benefit
to public health. Toward that end, we have consistently conducted
research to evaluate the aspects of prescription drug promotion that we
believe are most central to our mission, focusing in particular on
three main topic areas: Advertising features, including content and
format; target populations; and research quality. Through the
evaluation of advertising features we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits; focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience; and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study falls under the topic of both target populations and advertising
features.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our

policies as well as our research program. Our research is documented on
our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm.
The website includes links to the latest Federal Register notices and
peer-reviewed publications produced by our office. The website
maintains information on studies we have conducted, dating back to a
DTC survey conducted in 1999.
    The present research concerns disease awareness and prescription
drug promotion communications on television. When pharmaceutical
companies market a new drug, they often also release disease awareness
communications about the medical condition the new drug is intended to
treat (Ref. 1; Ref. 2). FDA is interested in whether and to what extent
this practice may result in consumers confusing or otherwise
misinterpreting the different information and claims presented in
disease awareness communications and prescription drug promotion. Prior
research has documented that in both print (Ref. 3) and online (Ref. 4)
contexts, consumers tend to conflate the information presented in
prescription drug promotional materials with information presented in
disease awareness communications. Specifically, the results of these
studies suggest consumers incorrectly ascribe benefits to a
prescription drug as a result of being exposed to information in a
disease awareness communication that broadly describes the symptoms and
negative consequences of the disease. There are ways in which this
effect can be attenuated. For example, prior research has indicated
that greater visual distinctiveness between the two ad types can
ameliorate such confusion (Ref. 3). The present research seeks to
extend previous studies of print and online promotion to the context of
television promotion, and broadly examine how perceptual similarity
between the two communication types, as well as their temporal
proximity and exposure frequency, may impact the nature and extent of
viewer confusion.
    Fors Marsh Group (FMG) is conducting this research under the
guidance and supervision of FDA to determine how the similarity,
temporal positioning, and frequency of exposure to disease awareness
communications and prescription drug television promotion impact
consumer perception and understanding of the benefits and risks of a
prescription drug product. These objectives will be achieved using two
experimental studies. The first study will explore the impact on
consumer perception and comprehension of different levels of temporal
separation between the disease awareness communication and prescription
drug promotion within a single period of television programming, as
well as the level of similarity versus distinctiveness between these
communication types. Temporal separation is defined as the spacing or
proximity between the disease awareness communication and prescription
drug promotion in the hour-long programming, for example, if they are
shown back-to-back or if they are separated by other ads or television
programming. Similarity/distinctiveness is defined by variations
between the disease awareness communication and prescription drug
promotion, including visual and presentation elements such as the
setting, actors, and colors. The second study will experimentally
examine the impact of disease awareness communication temporal
separation and exposure frequency on consumer perception and
comprehension. Temporal separation in this second study again refers to
the spacing or proximity between the disease awareness communication
and prescription drug promotion but is operationally defined as either
one day or one week. Exposure frequency is defined as the number of
times that participants will view the disease awareness communication,
either one, three, or six times. The results of this latter study will
examine the practice of ``seeding the market,'' in which pharmaceutical
companies release disease awareness communications before releasing
product promotion communications. Similarity versus distinctiveness
will also be examined in this study.
    We propose the following hypotheses for this research:
    Study 1:
    H1: Increased perceptual similarity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
    H2: Increased temporal proximity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
    Study 2:
    H1: Increased frequency of exposure to a disease awareness
communication before exposure to a prescription drug promotion will
result in significantly more conflation of the information presented in
both pieces.
    H2: Increased temporal proximity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
    H3: Increased perceptual similarity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
    In each instance, conflation is operationalized as the extent to
which an individual remembers and attributes benefits to a product that
is based on information presented in a disease awareness communication
and not in the drug promotion.
    To address these hypotheses, Study 1 will employ a 3x4 factorial
design in which participants are randomly assigned to one disease
awareness communication condition, plus one control condition where
participants will not view a disease awareness communication. The
extent to which the disease awareness communication is perceptually
similar to the product promotion communication will vary, as will the
temporal separation of the disease awareness communication and product
promotion communication. Table 1 depicts our design visually.

                                                          Table 1--Study 1 Experimental Design
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                                                                                Disease awareness and product ad temporal separation
                                      Perceptual similarity --------------------------------------------------------------------------------------------
        Disease awareness ad              to product ad                                   Within same           In neighboring       In non-neighboring
                                                                  Back to back         commercial pod \1\      commercial pods        commercial pods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Yes................................  Similar...............
                                     Semi-similar..........
                                     Distinct..............

No.................................  N/A...................
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                     [GRAPHIC] [TIFF OMITTED] TN17OC18.023

    Study 2 will employ a 2x2x3 factorial design in which participants
are randomly assigned to one disease awareness communication condition.
The varying factors in Study 2 are the temporal separation between the
disease awareness and product promotion communication, the number of
exposures to the disease awareness communication, and the perceptual
similarity of the disease awareness communication to the product
promotion communication. Table 3 visually depicts our design. Of note,
to reduce the overall number of experimental conditions for Study 2, no
semi-similar experimental condition is used.
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    \1\ A commercial pod refers to a group of ads into which the
test ad is inserted, designed to simulate an advertising break
during a television program. As depicted in Table 2, by neighboring
commercial pods, we mean commercial pods separated only by
television programming and no other commercial pods. By non-
neighboring commercial pods, we mean commercial pods separated by
both television programming and one or more (one, as studied here)
other commercial pods.

                                      Table 3--Study 2 Experimental Design
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                                                                   Exposures to disease awareness ad
   Time delay until product ad        Perceptual     -----------------------------------------------------------
 exposure (temporal separation)    similarity of ads     One exposure       Three exposures      Six exposures
----------------------------------------------------------------------------------------------------------------
One Day.........................  Similar...........
                                  Distinct..........
One Week........................  Similar...........
                                  Distinct..........
----------------------------------------------------------------------------------------------------------------

                                  [GRAPHIC] [TIFF OMITTED] TN17OC18.024

    Study 1 and 2 Sample. The targeted voluntary sample for both
studies will comprise adults who self-report a current asthma
diagnosis, a lifetime incidence of asthma, or experience a large number
of asthma symptoms. These groups are believed to be very likely to be
targeted by disease awareness and product promotion

communications for asthma. The combined incidence rate of these groups
is 22.2% (Ref. 5; Ref. 6). In addition, several exclusion criteria are
specified. These include: (1) Training or employment as a healthcare
professional, (2) employment with a pharmaceutical company, an
advertising agency, a market research company, or the Department of
Health and Human Services (HHS), and (3) participation in market
research within the past three months on the topic of prescription
drugs. Pretest participants will also be ineligible for the main study.
    Pretesting. Pretesting will take place before the main studies to
evaluate the procedures used in the main studies. Each of the two
pretests will have the same design as its respective main study
(pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both
pretests will be to: (1) Ensure that the mock stimuli are
understandable, viewable, and delivering intended messages; (2)
identify and eliminate any challenges to embedding the mock stimuli
within the online survey; (3) ensure that survey questions are
appropriate and meet the analytical goals of the research; and (4)
pilot test the methods, including examining response rates and timing
of survey. The two pretests will be conducted simultaneously.\2\ Based
on pretest findings, we will refine the mock stimuli, survey questions,
and data collection process, as necessary, to optimize the full-scale
study conditions.
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    \2\ Pretesting will be preceded by cognitive interviewing, not
described here. Cognitive interviews are used to probe a small
sample of participants on how and why they responded to various
questions as they did, resulting in strong measurement instruments.
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    Measurement. Our planned analyses are designed to address the key
hypotheses. For both Study 1 and Study 2, we anticipate that the
primary analysis will be analysis of variance (ANOVA) to compare the
main and interaction effects of the experimental factors.
    The focal dependent variable will be conflation--a measure of
memory and perceptions regarding the promoted drug relative to the
information presented in the disease awareness communication.
Conflation will be measured by using the number of benefits that are
incorrectly attributed to the prescription drug product based on
responses to a number of both open-ended and closed-ended items.
    Other key dependent variables will reflect perceptions and
attitudes toward the product ad. These include measures of:
    1. Perception of product promotion effectiveness;
    2. Behavioral intentions toward the drug;
    3. Perceived efficacy of the drug; and
    4. Perceived risks of the drug.
    In addition to the primary variables of interest, we have also
identified potential covariates that will be included in the analyses:
    1. Knowledge about asthma;
    2. Health literacy; and
    3. Perceived ad effectiveness.
    We expect that knowledge about asthma and increased health literacy
may moderate any conflation that results from ad similarity, temporal
proximity, and frequency of exposure. Perceptions of promotion
effectiveness, on the other hand, can be examined both as an outcome/
dependent variable but also as a covariate that examines involvement
with the product promotion. Greater involvement may attenuate
conflation in that it directs more in-depth processing of both the
disease awareness communication and product promotion, and therefore
more correct understanding of the claims in each (Ref. 7; Ref. 8; Ref.
9).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 5--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Study 1 Pretest screener........             385               1             385  0.08 (~5 min.)              31
Study 2 Pretest screener........             329               1             329  0.08 (~5 min.)              26
Study 1 screener................           3,007               1           3,007  0.08 (~5 min.)             241
Study 2 screener................           2,643               1           2,643  0.08 (~5 min.)             211
Study 1 Pretest.................             270               1             270  1.33 (~1 hr 20             360
                                                                                min.)
Study 2 Pretest.................             158               1             158       0.53 (~32              84
                                                                                min.)
Study 1.........................           2,105               1           2,105  1.33 (~1 hr 20           2,800
                                                                                min.)
Study 2.........................           1,269               1           1,269  0.53 (32 min.)             673
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. https://www.fiercepharma.com/marketing/unbranded-pharma-ad-what-are-they-good-for-actually-quite-a-bit-marketer-panelists-say?mkt_tok=eyJpIjoiWkRnelpUSmlORFpoWkdNMSIsInQiOiJPaENIUERpT0tnUmt6Y1BPMk9LTnpreUI3bUtPOVRzRnh1RzNuWUtYQmp0cWJhcW05UFhlcllwTzI3V0RJSndjVkZLR3NGUHBLamJOZmJSK2FZeWtIVXczeFRFcmtEV0NFaVdCSjArUmx4dUlRVHZpUzFFOWlVY0dNb1RzOU9XayJ9&mrkid=20932234.
2. https://www.fiercepharma.com/marketing/avanir-launches-nuedexta-brand-campaign-retires-danny-glover-pba-disease-awareness-ad.
3. Aikin, K. J., Sullivan, H. W., & Betts, K. R. (2016). Disease
information in direct-to-consumer prescription drug print ads.
Journal of Health Communication, 21, 228-239.
4. Sullivan, H. W., O'Donoghue, A. C., Rupert, D. J., Willoughby, J.
F., Amoozegar, J. B., & Aikin, K. J. (2016). Are disease awareness
links on prescription drug websites misleading?

A randomized study. Journal of Health Communication, 21, 1198-1207.
5. Centers for Disease Control and Prevention. (2018a, May 18). 2016
National Health Interview Survey (NHIS) data. Retrieved from https://www.cdc.gov/asthma/nhis/2016/table2-1.htm.
6. Centers for Disease Control and Prevention. (2018b, May 15). Most
recent asthma data. Retrieved from https://www.cdc.gov/asthma/most_recent_data.htm.
7. Petty, R. E., & Cacioppo, J. T. (1979). Issue involvement can
increase or decrease persuasion by enhancing message-relevant
cognitive responses. Journal of Personality and Social Psychology,
37, 1915-1926. doi: 10.1037/0022-35<IP_ADDRESS>5.
8. Petty, R. E., & Cacioppo, J. T. (1986). The elaboration
likelihood model of persuasion. Advances in Experimental Social
Psychology, 19, 123-205. doi: 10.1016/S0065-2601(08)60214-2.
9. Petty, R. E., Cacioppo, J. T., & Goldman, R. (1981). Personal
involvement as a determinant of argument-based persuasion. Journal
of Personality and Social Psychology, 41, 847-855. doi: 10.1037/
0022-35<IP_ADDRESS>7.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22567 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Rules and Regulations]
[Page 51931-51934]
[DOCID:fr24au10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0800; Directorate Identifier 2010-NM-162-AD;
Amendment 39-16416; AD 2010-18-03]
RIN 2120-AA64

Airworthiness Directives; Dassault-Aviation Model FALCON 7X
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Several in service events related to various electrical systems,
have led to the discovery of a common root cause: A leakage failure
mode of Transient Voltage Suppressor (TVS) diodes used on Power
Distribution Control Units (PDCU) cards or Generator Control Unit
(GCU) cards in the Primary Power Distribution Boxes (PPDB). Due to
such TVS diode failure mode, operation of some electrical circuits
is degraded and some control signals are set at unexpected levels.
Further analysis indicated that combination of a TVS diode failure
with other systems failures could significantly reduce flight
safety.
* * * * *
    The unsafe condition is a leakage failure mode of TVS diodes used
on PDCU cards or GCU cards in the PPDB, which in combination with other
system failures could lead to loss of controllability of the airplane.
This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective September 8, 2010.

    We must receive comments on this AD by October 8, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0073, dated April 15, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Several in service events related to various electrical systems,
have led to the discovery of a common root cause: A leakage failure
mode of Transient Voltage Suppressor (TVS) diodes used on Power
Distribution Control Units (PDCU) cards or Generator Control Unit
(GCU) cards in the Primary Power Distribution Boxes (PPDB). Due to
such TVS diode failure mode, operation of some electrical circuits
is degraded and some control signals are set at unexpected levels.
Further analysis indicated that combination of a TVS diode failure
with other systems failures could significantly reduce flight
safety.
    To prevent and correct this condition, some Airplane Flight
Manual (AFM) procedures have been modified to reduce the time of
exposure to further failures whenever a TVS diode failure occurs.
Additionally, a field tester has been developed to test all TVS
diodes installed on the PDCU and GCU cards for the detection of
components beyond acceptable tolerances. The criteria for PDCU or
GCU card replacement in case of detection of faulty components have
been identified.
    This AD requires the accomplishment of the revised AFM
procedures, the testing and, as necessary, the replacement of the
affected PDCU and GCU cards.
    Meanwhile, Dassault Aviation is developing a modification
(M724), to improve PDCU and GCU cards, with TVS diodes having
reduced susceptibility to the leakage failure mode.

    The unsafe condition is a leakage failure mode of TVS diodes used
on PDCU cards or GCU cards in the PPDB, which in combination with other
system failures could lead to loss of controllability of the airplane.
You may obtain further information by examining the MCAI in the AD
docket.

Interim Action

    This AD does not require the inspection of and on-condition
replacement of the PDCU and GCU cards in paragraph (3) of EASA AD 2010-
0073, dated April 15, 2010, and this AD does not provide credit for
accomplishment of certain service bulletins in paragraph (4) of EASA AD
2010-0073, dated April 15, 2010. The planned compliance time for the
inspection of and on-condition replacement of the PDCU and GCU cards in
paragraph (3) of EASA AD 2010-0073, dated April 15, 2010, would allow
enough time to provide notice and opportunity for prior public comment
on the merits of those actions. Therefore, we are considering further
rulemaking to address this issue.

FAA's Determination and Requirements of This AD

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

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

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 a
leakage failure mode of TVS diodes used on PDCU cards or GCU cards in
the PPDB, combined with other possible systems failures, could lead to
loss of control of the airplane. 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-2010-0800; Directorate
Identifier 2010-NM-162-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 we
receive about this AD.

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, Safety.

Adoption of the Amendment

0
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:

2010-18-03 Dassault-Aviation: Amendment 39-16416. Docket No. FAA-
2010-0800; Directorate Identifier 2010-NM-162-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 8, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Dassault-Aviation Model FALCON 7X
airplanes, certificated in any category, all serial numbers except
those on which Dassault-Aviation Modification M724 is embodied.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical Power.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    ``Several in service events related to various electrical
systems, have led to the discovery of a common root cause: a leakage
failure mode of Transient Voltage Suppressor (TVS) diodes used on
Power Distribution Control Units (PDCU) cards or Generator Control
Unit (GCU) cards in the Primary Power Distribution Boxes (PPDB). Due
to such TVS diode failure mode, operation of some electrical
circuits is degraded and some control signals are set at unexpected
levels. Further analysis indicated that combination of a TVS diode
failure with other systems failures could significantly reduce
flight safety.''
* * * * *
The unsafe condition is a leakage failure mode of TVS diodes used on
PDCU cards or GCU cards in the PPDB, which in combination with other
system failures could lead to loss of controllability of the
airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 30 days after the effective date of this AD, revise
the Abnormal Procedures and Limitations sections of the Dassault F7X
Airplane Flight Manual (AFM) to include the following statement.
This may be done by inserting copies of this AD into the AFM
Limitations section and Abnormal Procedures section.

    ``Upon display of ELEC:BUS MISCONFIG TIED in Crew Alerting
System (Abnormal procedure 3-190-20), land at nearest suitable
airport
    Upon display of ELEC:LH ESS PWR LO or ELEC:LH ESS NO PWR
(Abnormal procedure 3-190-40), land at nearest suitable airport
    Upon display of ELEC:RH ESS PWR LO and ELEC:RH ESS NO PWR
(Abnormal procedure 3-190-45), land at nearest suitable airport
    Upon display of HYD:BACKUP PUMP HI TEMP (Abnormal procedure 3-
250-15), set off the pump and if the backup pump is still rotating
(green) in hydraulic synoptic, descend to a safe altitude or below
15,000 ft
    Caution: These temporary amendments take precedence over the
same procedures displayed through the Electronic Check List (ECL) in
the aeroplane.''

    Note 1: When a statement identical to that in paragraph (g) of
this AD has been included in the Limitations section and Abnormal
Procedures section in the general revisions of the AFM, the general
revisions may be inserted into the AFM, and the copy of this AD may
be removed.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows:
    (1) While the European Aviation Safety Agency (EASA) AD 2010-
0073, dated April 15, 2010, has a compliance time of ``after the
effective date of this AD,'' this AD requires that the actions be
done within 30 days after the effective date of this AD.
    (2) This AD does not require the inspection of and on-condition
replacement of the PDCU and GCU cards in paragraph (3) of EASA AD
2010-0073, dated April 15, 2010, and this AD does not provide credit
for accomplishment of certain service bulletins in paragraph (4) of
EASA AD 2010-0073, dated April 15, 2010.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2010-0073, dated April 15, 2010, for related information.

Material Incorporated by Reference

    (j) None.

    Issued in Renton, Washington, on August 11, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-20839 Filed 8-23-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 16, 2008 (Volume 73, Number 137)]
[Notices]
[Page 40907-40908]
[DOCID:fr16jy08-120]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Forty-Fifth Meeting, RTCA Special Committee 186 Automatic
Dependent Surveillance-Broadcast (ADS-B)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 186 Automatic Dependent
Surveillance Broadcast (ADS-B) meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 186 Automatic Dependent Surveillance
Broadcast (ADS-B).

DATES: The meeting will be held August 12-14, 2008, at 9 a.m. (Unless
otherwise noted).

ADDRESSES: The meeting will be held at Crowne Plaza Hotel, 1-5 Spencer
Street, Melbourne, VIC 3005 Australia, +61 3 9648 2777; fax +61 3 9629
5631; Web: http://www.crowneplaza.com.au.

FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat (Hal Moses), 1828
L Street, NW., Suite 805, Washington, DC, 20036,<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (P.L. 92-463, 5 U.S.C., Appendix 2), notice is
hereby given for a Special Committee 186 meeting. The agenda will
include:
     August 12:
     Chairman's Introductory Remarks, Review of Meeting Agenda
     Review/Approval of the Forty-fourth Meeting Summary, RTCA
Paper No. 127-08/SC186-263, Date Place and Time of Next Meeting
     Review proposed TOR's for Working Groups
     Working Group Reports
     WG-1--Operations and Implementation
     WG-2--TIS-B MASPS
     WG-3--1090 MHz MOPS
     WG-4--Application Technical Requirements
     WG-5--UAT MOPS
     RFG--Requirements Focus Group
     ICAO Asia Pacific Focus Group
     Program Status
     ASA
     FAA
     August 13:
     RFG--Requirements Focus Group
     ITP-Status
     VSA/RAD--document review
     Document ``Library'' Review & Joint Planning Session
     Closing Plenary Session (New/Other Business, Review
Actions Items/Work Program, Adjourn)
     August 13:

Melbourne Center & Ground Station Visit

    This ATC Centre is one of two centres that provide ATC services for
a total of 11% of the earth's surface. It includes an ATC automation
system the integrates radar, flight plan processing, ADS-C, ADS-B,
CPDLC, Maestro flow management and will soon support WAM. It supports
enroute, terminal areas and towers. There are no paper strips except in
the control towers. This visit will include a briefing and a visit

to the centre. You can expect to see ADS-B tracks on screen. More info
at http://www.airservicesaustralia.com.
    The ADS-B ground station at Melbourne is not a fielded unit, but
rather an ADS-B ground station that forms part of the Test & Evaluation
system.
     Note:

Registration

    Airservices Australia will be providing lunch as well as morning
and afternoon teas on Day 1 & 2. A dinner is planned on the evening of
Day 2. Airservices will also provide a bus on Day 3 for the centre
visit. For catering purposes could you please register for the meeting
by e-mailing the following information to
<EMAIL_ADDRESS>    Name.
    Organization.
    E-mail.
    Phone.
    Address.
    An indication if you are able to attend a dinner on the evening of
Day 2 and if you have any special dietary needs. In addition, please
provide the following information to enable us to make the security
arrangements for your visit to the ATC centre if you intend to attend
on August 13th.
    Name.
    Date and country of birth.
    Nationality and Passport Number.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on July 3, 2008.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E8-15957 Filed 7-15-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47291-47296]
[FR Doc No: 2012-19399]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0139; FRL-9356-6]

Residues of Didecyl Dimethyl Ammonium Chloride; Exemption From
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Didecyl dimethyl ammonium chloride
(DDAC) in or on broccoli grown from treated seeds when applied by
immersion. Pace Chemicals Ltd. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of DDAC in
or on broccoli seed.

DATES: This regulation is effective August 8, 2012. Objections and
requests for hearings must be received on or before October 9, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0139, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. 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 OPP 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: Tracy Lantz, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-

OPP-2011-0139 in the subject line on the first page of your submission.
All objections and requests for a hearing must be in writing, and must
be received by the Hearing Clerk on or before October 9, 2012.
Addresses for mail and hand delivery of objections and hearing requests
are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0139, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP) 0F7747 by Pace Chemicals Ltd., 8321 Willard Street,
Burnaby, British Columbia, V3N 2X3. The petition requested that 40 CFR
part 180 subpart D be amended by establishing an exemption from the
requirement of a tolerance for residues of Didecyl dimethyl ammonium
chloride on broccoli grown from treated seeds when applied by
immersion. This notice referenced a summary of the petition prepared by
the petitioner Pace Chemicals Ltd which is available in the docket,
http://www.regulations.gov. A comment was received on the notice of
filing. EPA's response to these comments is discussed in Unit VII.C.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by Didecyl
dimethyl ammonium chloride, part of the Aliphatic Alkyl Quaternary
group of compounds, are discussed in this unit.
    The Aliphatic Alkyl Quaternaries are corrosive and highly
irritating to the eye and skin, with moderate acute toxicity by oral,
dermal, and inhalation routes of exposure. These chemicals are
classified as ``not likely'' to be human carcinogens based on negative
carcinogenicity in rat and mouse feeding studies using doses above the
limit dose. There is no evidence of these chemicals being associated
with increased susceptibility of infants and children based on two
developmental toxicity studies and a 2-generation reproductive toxicity
study. Lastly, they are negative for mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects from the toxicity studies can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Toxicology
Disciplinary Chapter for the Reregistration Eligibility Decision (RED)
for Didecyl Dimethyl Ammonium Chloride (DDAC).
    Toxic Endpoints--For hazards that have a threshold below which
there is no appreciable risk, the dose at which no adverse effects are
observed (NOAEL) from the toxicology study identified as appropriate
for the risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in
variations in sensitivity among members of the human population as well
as other unknowns. A detailed discussion of EPA's conclusions regarding
the toxic endpoints for the Aliphatic Alkyl Quaternaries can be found
at 73 FR 37852 (July 2, 2008).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other sources, including drinking
water from ground water or surface water and exposure through pesticide
use in gardens, lawns, or buildings (residential and other non-
occupational exposures).

A. Dietary Exposure

    1. Food. Studies have not been submitted measuring residues of
Didecyl dimethyl ammonium chloride (DDAC) in broccoli resulting from
treatment of broccoli seed. Instead, EPA estimated the DDAC residue
concentration that could theoretically result in broccoli heads from
the proposed seed treatment use. The number of broccoli seed/pound (lb)
is about 144,000 (Oregon State University, Commercial Vegetable
Production Guides. Broccoli. Brassica oleracea (Italica Group). Last
revised August 6, 2004). The proposed treatment rate is 1,200 milligram
(mg) DDAC/100 g seed.

Seed are to be soaked for 10 minutes and then dried.
    The highest seeding rate for broccoli is 1.5 pound per acre (lb/A)
(680 g/acre). The lower end of yield in a major broccoli-producing
state is 13,000 lb/A in AZ (USDA/NASS; 2003-08). If 680 g seed are
treated with 1,200 mg DDAC/100 g, a total of 8.2 g DDAC would be
applied to the seed. If all the DDAC is retained by the seed and the
680 g of seed/acre are planted, the equivalent application rate would
be 0.0181 lb DDAC/acre. If all the DDAC were absorbed and translocated
to the 13,000 lb of harvested broccoli, the maximum theoretical residue
level in broccoli would be 1.4 parts per million (ppm).
    The intent of the proposed DDAC seed treatment, however, is to
control pathogens on the surface of the broccoli seed which is the
major way a number of serious diseases of crucifers are spread and not
to control pathogens in soil. Therefore, draining and triple rinsing
are conducted to reduce DDAC residues on the seed and there is no
intended adsorption (binding) of the DDAC to the seed because the
registrant is not claiming residual protection of seed from pathogens
in the soil. However, while not intended, it is likely that traces of
DDAC would have adsorbed to the seed coat during the 10-minute soaking
time.
    Taking the draining and rinsing of seed into account, EPA has made
a conservative estimate of how much of the theoretical estimate of 1.4
ppm of DDAC on broccoli could actually be present. After seed are
soaked in the DDAC solution for 10 min, the solution is drained. EPA
estimates that at least 90% of the solution volume will drain off,
leaving 10%. This would reduce the theoretical value of 1.4 ppm DDAC in
harvested broccoli to 0.14 ppm. This is considered to be reasonable
because the treatment solution volume is typically 2 liter (L) for each
100 g of seed and most of the DDAC will be eliminated by draining
because of DDAC's solubility in water. Virtually no absorption of
solution into the seeds is expected within the 10-minute soaking time.
Also, if more than traces of solution were absorbed by seed, this would
be detrimental to the seed treatment process because metabolic
processes would be activated which would reduce seed viability and
increase rotting. Another 90% of the DDAC from the drained seed is
expected to be removed by the three water rinses which would reduce the
calculated value of 0.14 ppm to 0.014 ppm. This is reasonable because
most of the DDAC is in solution in the film of water between the
drained seed and, due to its water solubility; the three rinses are
expected to remove any free DDAC remaining.
    Although there is no known plant uptake and metabolism studies
available for Aliphatic Alkyl Quaternaries similar to DDAC, there are
data indicating that DDAC is stable to hydrolysis and will bind tightly
to soil. Thus, EPA expects traces of DDAC to be adsorbed (bound) to
both the seed coat and the soil surrounding each seed. Considering its
immobility, there is little likelihood that DDAC would be absorbed
through the seed coat, translocated through the seed and developing
shoot, and ultimately concentrated in the harvested broccoli head. This
issue was addressed in an earlier EPA decision (K. Leifer, P. Wagner,
OPP, RD, 8/1/06 http://www.epa.gov/opprd001/inerts/dialkyl.pdf)
reassessing the safety of three tolerance exemptions for DDAC when used
as an inert ingredient (preservative) in pesticide formulations
applied: To growing crops (40 CFR 180.920), postharvest to crops (40
CFR 180.910), or to livestock (40 CFR 180.930). In that decision, EPA
concluded that soil application of DDAC to growing crops under 40 CFR
180.920 would not result in systemic uptake by plants because the DDAC
would be bound to soil and, therefore, unavailable for plant uptake.
Due to the strong binding of DDAC to the seed coat, cellulose, lignin,
organic matter, and clay particles, EPA believes that the calculated
concentration of 0.014 ppm DDAC in harvested broccoli heads/side shoots
is a great overestimate. Given that the calculated concentration for
DDAC in broccoli is both very small (0.014 ppm) and considered to be a
large overestimate, dietary exposures to DDAC from use in treatment of
broccoli seed are expected to be negligible.
    2. Drinking water exposure. Contamination of drinking water with
Didecyl dimethyl ammonium chloride residues is expected to be
negligible as the treatment rate is very low (8.2 g/acre or 0.0181 lb/
acre) and the use is expected to be minor. Crucifer seed production is
carried out in only a few small areas of the country. In addition,
based on data indicating that DDAC is stable to hydrolysis and binds
tightly to soil, these residues are expected to be immobilized by
components of the soil and sediments. DDAC is classified as a
surfactant possessing a charged moiety (N\+\) and components that are
nonpolar/lipophilic (the two 10-carbon alkyl groups). These components
provide DDAC with properties allowing it to adsorb both to clay
particles (via cation exchange) and organic matter (via hydrophobic
attraction of the two alkyl groups). It adsorbs rapidly to soil and
sediments but is not readily desorbed. It also binds to cellulose and
lignin (organic matter) thus permitting its use as a wood preservative.
    The only other Aliphatic Alkyl Quaternaries outdoor uses in
addition to growing crops are as algaecides in decorative/swimming
pools, antisapstain wood preservative treatment, once-through cooling
tower treatment, and oil field uses. The pond and oil field uses are
considered to be contained. The other uses are not expected to
significantly contaminate drinking water sources. Therefore, the
Aliphatic Alkyl Quaternaries contributions to drinking water exposure
are considered to be negligible and are not quantified.
    It should be noted that the Agency estimated water concentrations
resulting from the antisapstain and cooling tower uses to which aquatic
animals may be exposed. These levels were not considered appropriate
for use in the drinking water assessment due to the very conservative
nature of the models used, that the model estimates runoff/point source
concentrations and not water body concentrations, and the fact that the
models do not account for dilution.
    Specific information on the dietary and drinking water exposure
assessments for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Dietary Risk
Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC) & Didecyl Dimethyl Ammonium
Chloride (DDAC).

B. Other Non-Occupational Exposure

    No residential exposure to DDAC residues is expected from this
proposed seed treatment use.
    In general, residential exposure assessment considers all potential
non-occupational pesticide exposure, other than exposure due to
residues in food or in drinking water. Exposures may occur during and
after application as a hard surfaces disinfectant (e.g., walls, floors,
tables, fixtures), to textiles (e.g., clothing, diapers) to swimming
pools and to carpets. Each route of exposure (oral, dermal, inhalation)
is assessed, where appropriate, and risk is expressed as a Margin of
Exposure (MOE), which is the ratio of estimated exposure to an
appropriate NOAEL.
    Residential exposure may occur during the application of Aliphatic
Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping,
trigger pump sprays), carpets, swimming pools, wood as a preservative,
textiles (e.g.,

diaper treated during washing and clothes treated with fabric spray),
and humidifiers. The residential handler scenarios were assessed to
determine dermal and inhalation exposures. Surrogate dermal and
inhalation unit exposure values were estimated using Pesticide Handler
Exposure Database (PHED) data and the Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (USEPA, 1999), and
the SWIMODEL 3.0 was utilized to conduct exposure assessments of
pesticides found in swimming pools and spas (Versar, 2003). Note that
for this assessment, EPA assumed that residential users complete all
elements of an application (mix/load/apply) without the use of personal
protective equipment.
    The duration for most residential exposures is believed to be best
represented by the short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and postapplication scenarios are assumed to be performed on an
episodic, not daily basis.
    Based on toxicological criteria and the potential for exposure, the
Agency has conducted dermal and inhalation exposure assessments for
Aliphatic Alkyl Quaternaries residential use. Specific information on
the residential exposure assessment for Aliphatic Alkyl Quaternaries
can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-
OPP-2006-0338 Didecyl Dimethyl Ammonium Chloride (DDAC) Occupational
and Residential Exposure Assessment.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act safety factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X when reliable data do not
support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional FQPA SF value based on the
use of traditional uncertainty/safety factors and/or special FQPA SFs,
as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence that
Aliphatic Alkyl Quaternaries result in increased susceptibility in in
utero rats or rabbits in the prenatal developmental studies or in young
rats in the 2-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA SF to 1X
except for assessments addressing inhalation exposure. For inhalation
exposure assessments the 10X FQPA SF is retained. Those decisions are
based on the following findings:
    i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete except for a 90-day inhalation toxicity study in the rat which
was requested in the Aliphatic Alkyl Quaternary Reregistration
Eligibility Document. Due to the absence of the 90-day inhalation
toxicity study, a FQPA SF of 10x has been applied to the oral endpoint
to calculate inhalation risks in order to be protective of any
uncertainties associated with route-to-route extrapolation.
    ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
    iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the two-generation
reproductive toxicity study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment was performed based on
10% transfer rate and tolerance-level residues. Similarly conservative
Residential SOPs were used to assess post-application exposure to
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
Aliphatic Alkyl Quaternaries.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    The Aliphatic Alkyl Quaternaries are a group (Group I cluster from
PR Notice 88-2) of structurally similar quaternary ammonium compounds
that are characterized by having a positively charged nitrogen
covalently bonded to two alkyl group substituent's (at least one
C8 or longer) and two methyl substituent's. In finished
form, these quaternary ammonium compounds are salts with the positively
charged nitrogen (cation) balanced by a negatively charged ion (anion).
The anion for the quaternary ammonium compounds in this cluster is
chloride or bromide. Dimethyl Didecyl ammonium chloride, or DDAC, was
chosen as the representative chemical for the Group I Cluster in PR
notice 88-2. On that basis, the toxicology database for DDAC is
accepted as representative of the hazard for this class of quaternary
ammonium compounds.
    EPA's risk assessment for the Group I Cluster is based on an
assessment of the exposure to all aliphatic alkyl quaternary compounds.
Although grouped in 1988 based on structural similarity, a formal
determination of common mechanism has not been conducted. The
individual exposure scenarios in the DDAC assessments (as well as the
aggregate assessment in the RED) were developed by assuming that a DDAC
compound was used on 100 percent of the food contact surfaces
authorized on the label that could result in human exposure. Thus, the
risk assessment for DDAC accounts for exposures to all of the Aliphatic
Alkyl Quaternary compounds. The Agency has not identified any other
substances as sharing a common mechanism of toxicity with Didecyl
dimethyl ammonium chloride.
    Didecyl dimethyl ammonium chloride does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that DDAC does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    Conservative estimates indicate that there is no reasonable
expectation that anything greater than negligible residues of DDAC will
be present in broccoli as a result of the proposed seed treatment use.
EPA has previously. http://www.regulations.gov, Docket ID Number EPA-
HQ-OPP-2006-0572 determined that risks from aggregate exposure are
safe, 72 FR 51180 (September 6, 2007); 73 FR 37852 (July 2, 2008) this
proposed

seed treatment use adds essentially zero additional exposure so the
prior aggregate risk conclusion remains applicable. The only change in
this assessment is the retention of the FQPA 10X safety factor for
inhalation risks which makes the level of concern MOEs of 1000 or
below. The MOEs for residential handler inhalation risks were all
>=3400 and thus are not of concern. Adult and child inhalation risks
were found to be of concern in the Reregistration Eligibility Document
as a result of breathing mist from treated humidifier water; this was
the only child's inhalation scenario. To eliminate this risk, Didecyl
dimethyl ammonium chloride has been restricted to use in evaporative
humidifiers. Evaporative humidifiers, unlike other types of
humidifiers, do not generate and expel treated droplets or mist. The
Didecyl dimethyl ammonium chloride will volatilize in, at most,
negligible amounts from treated water in evaporative humidifiers.
Aliphatic Alkyl Quaternaries are salts that are very soluble in water
and have a negligible vapor pressure; as a result, they have a very low
Henry's Law Constant which means they have a negligible tendency to
volatilize from an aqueous solution such as that in treated humidifier
water.
    Accordingly, in reliance on the previous safety finding, and the
determinations made in that rulemaking document and this document, EPA
finds that there is a reasonable certainty that no harm will result to
the general population or to infants and children from aggregate
exposure to Didecyl dimethyl ammonium chloride residues. Further, EPA
concludes that the proposed use will not pose a risk under reasonable
foreseeable circumstances. Therefore, EPA finds that exempting DDAC
from the requirement of a tolerance when used as a broccoli seed
treatment will be safe.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Didecyl dimethyl ammonium
chloride in broccoli.

C. Response to Comments

    The Agency received one comment in response to the notice of filing
for this petition. The commenter stated that they did not approve of
the toxic chemical ``dimethyl (mercury) ammnia chloride'' being
approved by the Agency.
    In response to this comment, the Agency notes that mercury is not a
component or degradate of Didecyl dimethyl ammonium chloride. EPA
comprehensively evaluated the safety of DDAC in the http://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2006-0572. The
commenter has provided no basis for EPA to vary from its prior
evaluation of the risk posed by DDAC.

VIII. Conclusion

    Therefore, an exemption from the requirements of a tolerance is
established for residues of Didecyl dimethyl ammonium chloride in or on
broccoli grown from treated seeds when applied by immersion.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the

Federal Register. This final rule is not a ``major rule'' as defined by
5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 23, 2012.
Joan Harrigan Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1317 is added to subpart D to read as follows:

Sec.  [emsp14]180.1317  Pesticide chemicals; exemption from the
requirements of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Didecyl dimethyl ammonium chloride in or on broccoli
resulting from the use of Didecyl dimethyl ammonium chloride as a seed
treatment at a treatment concentration of 1200 ppm prior to planting by
immersion.

[FR Doc. 2012-19399 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]
[Page 45097]
[DOCID:fr01au08-127]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Norfolk Southern Corporation

[Docket Number FRA-2008-0077]

    The Norfolk Southern Corporation (NS) seeks a waiver of compliance
from certain provisions of 49 CFR Part 232, Brake System Safety
Standards for Freight and Other Non-Passenger Trains and Equipment.
Specifically, NS is requesting a waiver to increase the 4-hour off-air
requirement, as prescribed in 49 CFR 232.205(a)(3), to 24 hours at
certain locations on NS's Pocahontas Division in West Virginia.
    NS has approximately 12 locations where they will park a train of
approximately 100 cars that have received a Class I brake test. The
locomotives will cut away from the cars and leave them in the siding
without any means to maintain air. These cars will remain in the siding
until another train arrives and attaches to the cars that have been
left in the siding. Because these cars have been off-air for more than
4 hours (sometimes as much as 24 hours) Sec.  205(a)(3) requires that
they be given another Class I brake test, although they have only
travelled a distance of approximately 150 miles. NS feels that these
tests are unnecessary and subject their employees to performing these
tests in less than desirable walking conditions. NS has tried to leave
a locomotive attached to the cars in the siding to maintain air
pressure. However, NS states that this is not cost effective, since the
locomotive may be required to idle for 24 hours at a cost of $57 an
hour, in addition to the system average of $750 per day for the
locomotive out of service cost. The addition of yard air sources has
been considered, but due to the geographic location and lack of
available electrical power, the installation cost is estimated at
$707,397.
    NS does not feel that safety will be compromised as a Class III
brake test would be performed on the blocks left in the siding when
added to trains. To date, NS states that there is no evidence of
vandalism at any of the locations where they would invoke this waiver.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2008-0077) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on July 29, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E8-17707 Filed 7-31-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61802-61803]
[DOCID:fr26oc05-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-34-000]

Wyoming Interstate Company, Ltd.; Notice of Proposed Changes in
FERC Gas Tariff

October 20, 2005.
    Take notice that on October 17, 2005, Wyoming Interstate Company,
Ltd. (WIC) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 2, the following tariff sheets to become effective
November 17, 2005:

Eighth Revised Sheet No. 64
Seventh Revised Sheet No. 64C
Sixth Revised Sheet No. 64G
Fifth Revised Sheet No. 64H
Third Revised Sheet No. 64I

    WIC states that the tariff sheets extend the nomination deadline by
fifteen minutes.
    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 and 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 in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not 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 email
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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5933 Filed 10-25-05; 8:45 am]

BILLING CODE 6717-01-P