prisoners or handicapped or mentally disabled persons, consideration
shall be given to the inclusion of one or more individuals who are
knowledgeable about and experienced in working with these subjects.
    (b) Every nondiscriminatory effort will be made to ensure that no
IRB consists entirely of men or entirely of women, including the
institution's consideration of qualified persons of both sexes, so long
as no selection is made to the IRB on the basis of gender. No IRB may
consist entirely of members of one profession.
    (c) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas.
    (d) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
    (e) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
    (f) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of issues which
require expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.

Sec.  26.1108  IRB functions and operations.

    In order to fulfill the requirements of this subpart each IRB
shall:
    (a) Follow written procedures:
    (1) For conducting its initial and continuing review of research
and for reporting its findings and actions to the investigator and the
institution;
    (2) For determining which projects require review more often than
annually and which projects need verification from sources other than
the investigator that no material changes have occurred since previous
IRB review;
    (3) For ensuring prompt reporting to the IRB of proposed changes in
research activity; and
    (4) For ensuring that changes in approved research, during the
period for which IRB approval has already been given, may not be
initiated without IRB review and approval except where necessary to
eliminate apparent immediate hazards to the human subjects.
    (b) Follow written procedures for ensuring prompt reporting to the
IRB, appropriate institutional officials, and the Environmental
Protection Agency of:
    (1) Any unanticipated problems involving risks to human subjects or
others;
    (2) Any instance of serious or continuing noncompliance with this
subpart of the requirements or determinations of the IRB; or
    (3) Any suspension or termination of IRB approval.
    (c) Except when an expedited review procedure is used (see Sec.
26.1110), review proposed research at convened meetings at which a
majority of the members of the IRB are present, including at least one
member whose primary concerns are in nonscientific areas. In order for
the research to be approved, it shall receive the approval of a
majority of those members present at the meeting.

Sec.  26.1109  IRB review of research.

    (a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this subpart.

    (b) An IRB shall require that information given to subjects as part
of informed consent is in accordance with Sec.  26.1116. The IRB may
require that information, in addition to that specifically mentioned in
Sec.  26.1116 be given to the subjects when, in the IRB's judgment, the
information would meaningfully add to the protection of the rights and
welfare of subjects.
    (c) An IRB shall require documentation of informed consent in
accordance with Sec.  26.1117.
    (d) An IRB shall notify investigators and the institution in
writing of its decision to approve or disapprove the proposed research
activity, or of modifications required to secure IRB approval of the
research activity. If the IRB decides to disapprove a research
activity, it shall include in its written notification a statement of
the reasons for its decision and give the investigator an opportunity
to respond in person or in writing.
    (e) An IRB shall conduct continuing review of research covered by
this subpart at intervals appropriate to the degree of risk, but not
less than once per year, and shall have authority to observe or have a
third party observe the consent process and the research.

Sec.  26.1110  Expedited review procedures for certain kinds of
research involving no more than minimal risk, and for minor changes in
approved research.

    (a) The Secretary, HHS, has established, and published as a Notice
in the Federal Register, a list of categories of research that may be
reviewed by the IRB through an expedited review procedure. The list
will be amended, as appropriate after consultation with other
departments and agencies, through periodic republication by the
Secretary, HHS, in the Federal Register. A copy of the list is
available from the Office for Human Research Protections, HHS, or any
successor office.
    (b)(1) An IRB may use the expedited review procedure to review
either or both of the following:
    (i) Some or all of the research appearing on the list and found by
the reviewer(s) to involve no more than minimal risk,
    (ii) Minor changes in previously approved research during the
period (of 1 year or less) for which approval is authorized.
    (2) Under an expedited review procedure, the review may be carried
out by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson from among members of the IRB. In
reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the non-expedited procedure set forth in Sec.
26.1108(b).
    (c) Each IRB which uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals which have
been approved under the procedure.
    (d) The Administrator may restrict, suspend, or terminate, an
institution's or IRB's use of the expedited review procedure for
research covered by this subpart.

Sec.  26.1111   Criteria for IRB approval of research.

    (a) In order to approve research covered by this subpart the IRB
shall determine that all of the following requirements are satisfied:
    (1) Risks to subjects are minimized:
    (i) By using procedures which are consistent with sound research
design and which do not unnecessarily expose subjects to risk, and
    (ii) Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of the knowledge that
may reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may result
from the research (as distinguished from risks and benefits subjects
would receive even if not participating in the research). The IRB
should not consider possible long-range effects of applying knowledge
gained in the research (for example, the possible effects of the
research on public policy) as among those research risks that fall
within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the research and the
setting in which the research will be conducted and should be
particularly cognizant of the special problems of research involving
vulnerable populations, such as prisoners, mentally disabled persons,
or economically or educationally disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject
or the subject's legally authorized representative, in accordance with,
and to the extent required by Sec.  26.1116.
    (5) Informed consent will be appropriately documented, in
accordance with, and to the extent required by Sec.  26.1117.
    (6) When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as prisoners, mentally disabled
persons, or economically or educationally disadvantaged persons,
additional safeguards have been included in the study to protect the
rights and welfare of these subjects.

Sec.  26.1112  Review by institution.

    Research covered by this subpart that has been approved by an IRB
may be subject to further appropriate review and approval or
disapproval by officials of the institution. However, those officials
may not approve the research if it has not been approved by an IRB.

Sec.  26.1113  Suspension or termination of IRB approval of research.

    An IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious harm
to subjects. Any suspension or termination of approval shall include a
statement of the reasons for the IRB's action and shall be reported
promptly to the investigator, appropriate institutional officials, and
the Administrator of EPA.

Sec.  26.1114  Cooperative research.

    In complying with this subpart, sponsors, investigators, or
institutions involved in multi-institutional studies may use joint
review, reliance upon the review of another qualified IRB, or similar
arrangements aimed at avoidance of duplication of effort.

Sec.  26.1115  IRB records.

    (a) An IRB shall prepare and maintain adequate documentation of IRB
activities, including the following:
    (1) Copies of all research proposals reviewed, scientific
evaluations, if any, that accompany the proposals, approved sample
consent documents, progress reports submitted by investigators, and
reports of injuries to subjects.
    (2) Minutes of IRB meetings which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the

 discussion of controverted issues and their resolution.
    (3) Records of continuing review activities.
    (4) Copies of all correspondence between the IRB and the
investigators.
    (5) A list of IRB members identified by name; earned degrees;
representative capacity; indications of experience such as board
certifications, licenses, etc., sufficient to describe each member's
chief anticipated contributions to IRB deliberations; and any
employment or other relationship between each member and the
institution, for example, full-time employee, a member of governing
panel or board, stockholder, paid or unpaid consultant.
    (6) Written procedures for the IRB in the same detail as described
in Sec.  26.1108(a) and Sec.  26.1108(b).
    (7) Statements of significant new findings provided to subjects, as
required by Sec.  26.1116(b)(5).
    (b) The records required by this subpart shall be retained for at
least 3 years, and records relating to research which is conducted
shall be retained for at least 3 years after completion of the
research. All records shall be accessible for inspection and copying by
authorized representatives of EPA at reasonable times and in a
reasonable manner.

Sec.  26.1116  General requirements for informed consent.

    No investigator may involve a human being as a subject in research
covered by this subpart unless the investigator has obtained the
legally effective informed consent of the subject or the subject's
legally authorized representative. An investigator shall seek such
consent only under circumstances that provide the prospective subject
or the representative sufficient opportunity to consider whether or not
to participate and that minimize the possibility of coercion or undue
influence. The information that is given to the subject or the
representative shall be in language understandable to the subject or
the representative. No informed consent, whether oral or written, may
include any exculpatory language through which the subject or the
representative is made to waive or appear to waive any of the subject's
legal rights, or releases or appears to release the investigator, the
sponsor, the institution or its agents from liability for negligence.
    (a) Basic elements of informed consent. In seeking informed consent
the following information shall be provided to each subject:
    (1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental;
    (2) A description of any reasonably foreseeable risks or
discomforts to the subject;
    (3) A description of any benefits to the subject or to others which
may reasonably be expected from the research;
    (4) A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject;
    (5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained;
    (6) For research involving more than minimal risk, an explanation
as to whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained;
    (7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to
contact in the event of a research-related injury to the subject; and
    (8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled.
    (b) Additional elements of informed consent. When appropriate, one
or more of the following elements of information shall also be provided
to each subject:
    (1) A statement that the particular treatment or procedure may
involve risks to the subject (or to the embryo or fetus, if the subject
may become pregnant) which are currently unforeseeable;
    (2) Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to
the subject's consent;
    (3) Any additional costs to the subject that may result from
participation in the research;
    (4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by the
subject;
    (5) A statement that significant new findings developed during the
course of the research which may relate to the subject's willingness to
continue participation will be provided to the subject; and
    (6) The approximate number of subjects involved in the study.
    (c) The informed consent requirements in this subpart are not
intended to preempt any applicable Federal, State, or local laws which
require additional information to be disclosed in order for informed
consent to be legally effective.
    (d) Nothing in this subpart is intended to limit the authority of a
physician to provide emergency medical care, to the extent the
physician is permitted to do so under applicable Federal, State, or
local law.
    (e) If the research involves intentional exposure of subjects to a
pesticide, the subjects of the research must be informed of the
identity of the pesticide and the nature of its pesticidal function.

Sec.  26.1117  Documentation of informed consent.

    (a) Informed consent shall be documented by the use of a written
consent form approved by the IRB and signed by the subject or the
subject's legally authorized representative. A copy shall be given to
the person signing the form.
    (b) The consent form may be either of the following:
    (1) A written consent document that embodies the elements of
informed consent required by Sec.  26.1116. This form may be read to
the subject or the subject's legally authorized representative, but in
any event, the investigator shall give either the subject or the
representative adequate opportunity to read it before it is signed; or
    (2) A short form written consent document stating that the elements
of informed consent required by Sec.  26.1116 have been presented
orally to the subject or the subject's legally authorized
representative. When this method is used, there shall be a witness to
the oral presentation. Also, the IRB shall approve a written summary of
what is to be said to the subject or the representative. Only the short
form itself is to be signed by the subject or the representative.
However, the witness shall sign both the short form and a copy of the
summary, and the person actually obtaining consent shall sign a copy of
the summary. A copy of the summary shall be given to the subject or the
representative, in addition to a copy of the short form.

Sec. Sec.  26.1118 through 26.1122 [Reserved]

Sec.  26.1123   Early termination of research.

    The Administrator may require that any project covered by this
subpart be terminated or suspended when the

Administrator finds that an IRB, investigator, sponsor, or institution
has materially failed to comply with the terms of this subpart.

Sec.  26.1124 [Reserved]

Sec.  26.1125  Prior submission of proposed human research for EPA
review.

    Any person or institution who intends to conduct or sponsor human
research covered by Sec.  26.1101(a) shall, after receiving approval
from all appropriate IRBs, submit to EPA prior to initiating such
research all information relevant to the proposed research specified by
Sec.  26.1115(a), and the following additional information, to the
extent not already included:
    (a) A discussion of:
    (1) The potential risks to human subjects;
    (2) The measures proposed to minimize risks to the human subjects;
    (3) The nature and magnitude of all expected benefits of such
research, and to whom they would accrue;
    (4) Alternative means of obtaining information comparable to what
would be collected through the proposed research; and
    (5) The balance of risks and benefits of the proposed research.
    (b) All information for subjects and written informed consent
agreements as originally provided to the IRB, and as approved by the
IRB.
    (c) Information about how subjects will be recruited, including any
advertisements proposed to be used.
    (d) A description of the circumstances and methods proposed for
presenting information to potential human subjects for the purpose of
obtaining their informed consent.
    (e) All correspondence between the IRB and the investigators or
sponsors.
    (f) Official notification to the sponsor or investigator, in
accordance with the requirements of this subpart, that research
involving human subjects has been reviewed and approved by an IRB.

Subpart L--Prohibition of Third-Party Research for Pesticides
Involving Intentional Exposure of Human Subjects who are Pregnant
Women or Children

Sec.  26.1201  To what does this subpart apply?

    Subpart L applies to any person who, after April 7, 2006, conducts
or supports research with a human subject intended:
    (1) For submission to EPA for consideration in connection with any
action that may be performed by EPA under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or
    (2) To be held for later inspection by EPA under the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or
section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
346a).
    (b) For purposes of determining a person's intent under paragraph
(a) of this section, EPA may consider any available information
relevant to determining the intent of a person who conducts or supports
research with human subjects after the effective date of the rule. EPA
shall rebuttably presume such intent existed if:
    (1) The person or the person's agent has submitted or made
available for inspection the results of such research to EPA; or
    (2) The person is a member of a class of people who, or whose
products or activities, are regulated by EPA under FIFRA or the FFDCA
and, at the time the research was initiated, the results of the
research would be relevant to EPA's exercise of its authority under
FIFRA or the FFDCA with respect to that class of people, products, or
activities.

Sec.  26.1202  Definitions.

    The definitions in Sec.  26.1102 shall be applicable to this
subpart as well. In addition, the definitions at 45 CFR 46.202(a)
through (f) and at 45 CFR 46.202(h) are applicable to this subpart. In
addition, a child is a person who has not attained the age of 18 years.

Sec.  Sec.  26.1203  Prohibition of research involving intentional
exposure of any pregnant woman, fetus, or child.

    Notwithstanding any other provision of this part, under no
circumstances shall a person conduct or sponsor research covered by
Sec.  26.1201 that involves intentional exposure of any human subject
who is a pregnant woman (and therefore her fetus) or child.

Subpart M--Requirements for Submission of Information on the
Ethical Conduct of Completed Human Research

Sec.  26.1301  To what does this subpart apply?

    This subpart applies to any person who submits a report containing
the results of any human research if:
    (a) The report is submitted after April 7, 2006, and
    (b) The report is submitted for consideration in connection with
any action that may be performed by EPA under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a).

Sec.  26.1302  Definitions.

    The definitions in Sec.  26.102 shall apply to this subpart as
well.

Sec.  26.1303  Submission of information pertaining to ethical conduct
of completed human research.

    Any person who submits to EPA data derived from human research
covered by this subpart shall provide at the time of submission
information concerning the ethical conduct of such research. To the
extent available to the submitter and not previously provided to EPA,
such information should include:
    (a) Copies of all of the records relevant to the research specified
by Sec.  26.1115(a) to be prepared and maintained by an IRB.
    (b) Copies of all of the records relevant to the information
identified in Sec.  26.1125(a) through (f).
    (c) Copies of sample records used to document informed consent as
specified by Sec.  26.1117, but not identifying any subjects of the
research.
    (d) If any of the information listed in paragraphs (a) through (c)
of this section is not provided, the person shall describe the efforts
made to obtain the information.

Subpart N--[Reserved]

Subpart O--Administrative Actions for Noncompliance

Sec.  26.1501  To what does this subpart apply?

    This subpart applies to any human research subject to subparts A
through L of this part. References to State or local laws in this
subpart are intended to include the laws of federally recognized
American Indian and Alaska Native Tribal Governments.

Sec.  26.1502  Lesser administrative actions.

    (a) If apparent noncompliance with the applicable regulations in
subparts A through L of this part concerning the operation of an IRB is
observed by an officer or employee of EPA or of any State duly
designated by the Administrator during an inspection. EPA may send a
letter describing the noncompliance to the IRB and to the parent
institution. The agency will require that the IRB or the parent
institution respond to this letter within a reasonable time period
specified by EPA and describe the corrective actions that will be taken
by the IRB, the institution, or both to achieve compliance with these
regulations.
    (b) On the basis of the IRB's or the institution's response, EPA
may

schedule a reinspection to confirm the adequacy of corrective actions.
In addition, until the IRB or the parent institution takes appropriate
corrective action, the Agency may:
    (1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
    (2) Direct that no new subjects be added to ongoing studies subject
to this part;
    (3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects; or
    (4) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, notify relevant State and
Federal regulatory agencies and other parties with a direct interest of
the deficiencies in the operation of the IRB.
    (c) The parent institution is presumed to be responsible for the
operation of an IRB, and EPA will ordinarily direct any administrative
action under this subpart against the institution. However, depending
on the evidence of responsibility for deficiencies, determined during
the investigation, EPA may restrict its administrative actions to the
IRB or to a component of the parent institution determined to be
responsible for formal designation of the IRB.

Sec.  26.1503  Disqualification of an IRB or an institution.

    (a) Whenever the IRB or the institution has failed to take adequate
steps to correct the noncompliance stated in the letter sent by the
Agency under Sec.  26.1502(a) and the EPA Administrator determines that
this noncompliance may justify the disqualification of the IRB or of
the parent institution, the Administrator may institute appropriate
proceedings.
    (b) The Administrator may disqualify an IRB or the parent
institution from studies subject to this part if the Administrator
determines that:
    (1) The IRB has refused or repeatedly failed to comply with any of
the regulations set forth in this part, and
    (2) The noncompliance adversely affects the rights or welfare of
the human subjects of research.
    (c) If the Administrator determines that disqualification is
appropriate, the Administrator will issue an order that explains the
basis for the determination and that prescribes any actions to be taken
with regard to ongoing human research, covered by subparts A through L
of this part, conducted under the review of the IRB. EPA will send
notice of the disqualification to the IRB and the parent institution.
Other parties with a direct interest, such as sponsors and
investigators, may also be sent a notice of the disqualification. In
addition, the agency may elect to publish a notice of its action in the
Federal Register.
    (d) EPA may refuse to consider in support of a regulatory decision
the data from human research, covered by subparts A through L of this
part, that was reviewed by an IRB or conducted at an institution during
the period of disqualification, unless the IRB or the parent
institution is reinstated as provided in Sec.  26.1505, or unless such
research is deemed scientifically sound and crucial to the protection
of public health, under the procedure defined in Sec.  26.1706.

Sec.  26.1504  Public disclosure of information regarding revocation.

    A determination that EPA has disqualified an institution from
studies subject to this part and the administrative record regarding
that determination are disclosable to the public under 40 CFR part 2.

Sec.  26.1505  Reinstatement of an IRB or an institution.

    An IRB or an institution may be reinstated to conduct studies
subject to this part if the Administrator determines, upon an
evaluation of a written submission from the IRB or institution that
explains the corrective action that the institution or IRB has taken or
plans to take, that the IRB or institution has provided adequate
assurance that it will operate in compliance with the standards set
forth in this part. Notification of reinstatement shall be provided to
all persons notified under Sec.  26.1502(c).

Sec.  26.1506  Debarment.

    If EPA determines that an institution or investigator repeatedly
has not complied with or has committed an egregious violation of the
applicable regulations in subparts A through L of this part, EPA may
recommend that institution or investigator be declared ineligible to
participate in EPA-supported research (debarment). Debarment will be
initiated in accordance with procedures specified at 40 CFR part 32.

Sec.  26.1507  Actions alternative or additional to disqualification.

    Disqualification of an IRB or of an institution is independent of,
and neither in lieu of nor a precondition to, other statutorily
authorized proceedings or actions. EPA may, at any time, on its own
initiative or through the Department of Justice, institute any
appropriate judicial proceedings (civil or criminal) and any other
appropriate regulatory action, in addition to or in lieu of, and
before, at the time of, or after, disqualification. The Agency may also
refer pertinent matters to another Federal, State, or local government
agency for any action that that agency determines to be appropriate.

Subpart P--Review of Proposed and Completed Human Research

Sec.  26.1601  EPA review of proposed human research.

    (a) EPA shall review all protocols submitted under Sec.  26.1125 in
a timely manner. With respect to any research or any class of research,
the Administrator may recommend additional conditions which, in the
judgment of the Administrator, are necessary for the protection of
human subjects.
    (b) In reviewing proposals covered by this subpart, the
Administrator may take into account factors such as whether the
applicant has been subject to a termination or suspension under Sec.
26.123(a) or Sec.  26.1123 and whether the applicant or the person or
persons who would direct or has/have directed the scientific and
technical aspects of an activity has/have, in the judgment of the
Administrator, materially failed to discharge responsibility for the
protection of the rights and welfare of human subjects (whether or not
the research was subject to Federal regulation).
    (c) When research covered by subpart K takes place in foreign
countries, procedures normally followed in the foreign countries to
protect human subjects may differ from those set forth in subpart K.
(An example is a foreign institution which complies with guidelines
consistent with the World Medical Assembly Declaration of Helsinki,
issued either by sovereign states or by an organization whose function
for the protection of human research subjects is internationally
recognized.) In these circumstances, if the Administrator determines
that the procedures prescribed by the institution afford protections
that are at least equivalent to those provided in subpart K, the
Administrator may approve the substitution of the foreign procedures in
lieu of the procedural requirements provided in subpart K.
    (d) Following initial evaluation of the protocol by Agency staff,
EPA shall submit the protocol and all supporting materials, together
with the staff evaluation, to the Human Studies Review Board.
    (e) EPA shall notify the submitter of the proposal of the results
of the EPA and Human Studies Review Board reviews.

Sec.  26.1602  EPA review of completed human research.

    (a) When considering data under FIFRA or FFDCA from research
involving intentional exposure of humans, EPA shall review the material
submitted under Sec.  26.1303 and other available, relevant information
and document its conclusions regarding the scientific and ethical
conduct of the research.
    (b) EPA shall submit its review of data from human research covered
by subpart Q, together with the available supporting materials, to the
Human Studies Review Board if EPA decides to rely on the data and:
    (1) The data are derived from research initiated after April 7,
2006, or
    (2) The data are derived from research initiated before April 7,
2006, and the research was conducted for the purpose of identifying or
measuring a toxic effect.
    (c) In its discretion, EPA may submit data from research not
covered by paragraph (b) of this section to the Human Studies Review
Board for their review.
    (d) EPA shall notify the submitter of the research of the results
of the EPA and Human Studies Review Board reviews.

Sec.  26.1603  Operation of the Human Studies Review Board.

    EPA shall establish and operate a Human Studies Review Board as
follows:
    (a) Membership. The Human Studies Review Board shall consist of
members who are not employed by EPA, who meet the ethics and other
requirements for special government employees, and who have expertise
in fields appropriate for the scientific and ethical review of human
research, including research ethics, biostatistics, and human
toxicology.
    (b) Responsibilities. The Human Studies Review Board shall comment
on the scientific and ethical aspects of research proposals and reports
of completed research with human subjects submitted by EPA for its
review and, on request, advise EPA on ways to strengthen its programs
for protection of human subjects of research.

Subpart Q--Ethical Standards for Assessing Whether to Rely on the
Results of Human Research in EPA Actions

Sec.  26.1701  To what does this subpart apply?

    This subpart applies to EPA's decisions whether to rely in its
actions taken under the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 346a) on scientifically valid and relevant
data from research involving intentional exposure of human subjects.

Sec.  26.1702  Definitions.

    The definitions in Sec.  26.1102 and Sec.  26.1202 shall apply to
this subpart as well.

Sec.  26.1703  Prohibition of reliance on research involving
intentional exposure of human subjects who are pregnant women (and
therefore their fetuses) or children.

    Except as provided in Sec.  26.1706, in actions within the scope of
Sec.  26.1701, EPA shall not rely on data from any research involving
intentional exposure of any human subject who is a pregnant woman (and
therefore her fetus) or child.

Sec.  26.1704  Prohibition of reliance on unethical human research with
non-pregnant adults conducted before April 7, 2006.

    Except as provided in Sec.  26.1706, in actions within the scope of
Sec.  26.1701, EPA shall not rely on data from any research initiated
before April 7, 2006, if there is clear and convincing evidence that
the conduct of the research was fundamentally unethical (e.g., the
research was intended to seriously harm participants or failed to
obtain informed consent), or was significantly deficient relative to
the ethical standards prevailing at the time the research was
conducted. This prohibition is in addition to the prohibition in Sec.
26.1703.

Sec.  26.1705  Prohibition of reliance on unethical human research with
non-pregnant adults conducted after April 7, 2006.

    Except as provided in Sec.  26.1706, in actions within the scope of
Sec.  26.1701, EPA shall not rely on data from any research initiated
after April 7, 2006, unless EPA has adequate information to determine
that the research was conducted in substantial compliance with subparts
A through L of this part, or if conducted in a foreign country, under
procedures at least as protective as those in subparts A through L of
this part. This prohibition is in addition to the prohibition in Sec.
26.1703.

Sec.  26.1706  Criteria and procedure for decisions to protect public
health by relying on otherwise unacceptable research.

    This section establishes the exclusive criteria and procedure by
which EPA may decide to rely on data from research that is not
acceptable under the standards in Sec. Sec.  26.1703 through 26.1705.
EPA may rely on such data only if all the conditions in paragraphs (a)
through (d) of this section are satisfied:
    (a) EPA has obtained the views of the Human Studies Review Board
concerning the proposal to rely on the otherwise unacceptable data,
    (b) EPA has provided an opportunity for public comment on the
proposal to rely on the otherwise unacceptable data,
    (c) EPA has determined that relying on the data is crucial to a
decision that would impose a more stringent regulatory restriction that
would improve protection of public health, such as a limitation on the
use of a pesticide, than could be justified without relying on the
data, and
    (d) EPA publishes a full explanation of its decision to rely on the
otherwise unacceptable data, including a thorough discussion of the
ethical deficiencies of the underlying research and the full rationale
for finding that the standard in paragraph (c) of this section was met.

[FR Doc. 06-1045 Filed 2-3-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25344-25345]
[FR Doc No: 2013-10067]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0038]

Petition for a Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated February 24, 2013, the Naugatuck Railroad (NAUG) has petitioned
the Federal Railroad Administration (FRA) for a waiver of compliance
from certain provisions of the Federal railroad safety regulations
contained at 49 CFR part 240, Qualification and Certification of
Locomotive Engineers. FRA assigned the petition Docket Number FRA-2013-
0038.
    Specifically, NAUG seeks a waiver of compliance from 49 CFR
240.201(d), which provides that only certified persons may operate a
locomotive in any class of locomotive or train service, in order to
operate an ``engineer-for-an-hour'' (EFH) program. NAUG is a wholly
owned subsidiary of the Railroad Museum of New England, Inc. (Museum),
and the EFH program is in support of funding the educational mission of
the Museum. NAUG is a Class III shortline railroad that operates and
controls the Torrington Secondary line, which is owned by the State of
Connecticut, and leased to the railroad. The line extends approximately
20 miles between Waterbury, Connecticut; and Torrington, Connecticut.
    In its petition, NAUG proposes to conduct the EFH program between
Milepost (MP) 4.5 in Watertown, Connecticut; and MP 17.5 in Torrington,
Connecticut. There are no public highway-rail grade crossings between
these two locations. NAUG proposes to operate the EFH program under the
following conditions and controls: (1) NAUG will use a positive
blocking system (pursuant to the Northeast Operating Rules Advisory
Committee Form D Control System rules) to ensure only EFH operations
can be operated over a given segment of track, during daylight hours
only; (2) NAUG will verify that each participant in the EFH program is
in possession of a valid State-issued motor vehicle license; (3) NAUG
will evaluate each participant in the EFH program for his or her visual
fitness to operate the locomotive with respect to obvious signs of
alcohol or drug use; and (4) NAUG will ensure that a certified
locomotive engineer is in the locomotive cab at all times.
    NAUG also states in its petition that a qualified and certified
locomotive engineer will conduct a job briefing with each participant
in the EFH program to ensure that all parties know and understand the
movement that will be made and each individual's responsibilities in
the proposed movements. NAUG proposes to limit the EFH train size to
one locomotive and not more than three cars. No revenue passengers or
members of the public will be on board during EFH rail operations. NAUG
asserts that if FRA were to grant this waiver, it will enable NAUG to
generate funds for the Museum to support its goals of refurbishing
antique railroad equipment and educating the public about railroad
history and operations. NAUG does not believe that the EFH operations
will

pose any safety concerns to the public at large.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
holidays.
    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 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 May 30, 2013 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.
    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 document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on April 24, 2013.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-10067 Filed 4-29-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Proposed Rules]
[Pages 40053-40055]
[FR Doc No: 2013-15958]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0554; Directorate Identifier 2012-SW-009-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (Eurocopter) Model EC135 P1, EC135 P2,
EC135 P2+, EC135 T1, EC135 T2, and EC135 T2+ helicopters. This proposed
AD would require analyzing the main gearbox (MGB) oil for indications
of metal chips or pieces, reviewing the MGB log or equivalent record,
and inspecting certain teeth in the MGB after two chip indications.
This proposed AD is prompted by a partial tooth rupture found in an MGB
that was returned to the manufacturer for repairs. The proposed actions
are intended to detect wear in the MGB that could lead to a gear tooth
rupture, failure of the MGB, loss of power to the main rotor, and
subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by September 3,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address 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 proposed AD, the economic
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 service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review a copy of the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

FOR FURTHER INFORMATION CONTACT: Chinh Vuong, Aerospace Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2009-0106R1, dated November 3, 2011, to correct an unsafe condition
for the Eurocopter Model 635 military helicopter and Model EC135 P1,
EC135 P2, EC135 P2+, EC135 T1, EC135 T2, and EC135 T2+ helicopters.
EASA advises that an MGB was returned to the manufacturer for repair
after ``several chip indications.'' According to EASA, a partial tooth
rupture was detected after disassembly of the gearbox and removal of a
drive pinion. EASA states the tooth rupture was determined to have been
caused by wear.
    EASA AD No. 2009-0106R1 revises EASA Emergency AD 2009-0106-E,
dated April 30, 2009, which superseded Emergency AD 2008-0116-E dated
June 17, 2008. The most recent EASA AD includes requirements and
timetables for oil sampling and analysis; checking the gearbox log card
for chip indications; and corrective measures for chip indications. It
also states that a prescribed modification to the MGB would be
terminating action for the AD.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of these same type designs.

Related Service Information

    Eurocopter issued Alert Service Bulletin (ASB) EC135-63A-012 on
August 8, 2007, which was followed by five revisions, the most recent
of which was issued September 6, 2011. The ASBs prescribe procedures to
monitor and detect wear in time to prevent MGB tooth ruptures in main
transmissions for EC135 and EC635 model helicopters. Revision 5 of the
ASB prescribes procedures for taking and analyzing scheduled oil
samples, identifying and addressing chip indications, and inspecting
certain teeth in gearboxes.

Proposed AD Requirements

    Within 100 hours time-in-service (TIS), and thereafter at intervals
not to exceed 100 hours or 12 months, whichever occurs first, this
proposed AD would require taking an oil sample. The oil sample would
need to be analyzed within 25 hours TIS.
    If the analysis indicates Stage II as defined by the ASB, within 25
hours TIS, this proposed AD would require removing and inspecting the
oil filter element for a chip. If the analysis indicates Stage III as
defined by the ASB, this proposed AD would require removing and
inspecting the oil filter element for a chip within 10 hours TIS.
    If there are no chips, we propose cleaning the oil filter element
and chip detector, inspecting the drive stage toothing, performing a
ground run, and inspecting for leaking oil. If there is a chip, this
proposed AD would require replacing the MGB with an airworthy MGB
before further flight.
    Before the MGB has accumulated 300 hours TIS, this proposed AD
would require determining whether two or more chip indications have
occurred. If two or more chip indications have occurred, this proposed
AD would require inspecting the drive stage toothing, performing a
ground run, and inspecting for leaking oil. At any time if there is a
chip indication, we would require removing and inspecting the chip
detector for deposits (fine particles or metallic fuzz) or a chip, and
removing and inspecting the oil filter element for a chip.
    If there are no chips and a minimal amount of particles or metallic
fuzz, this proposed AD would require cleaning the chip detector and the
oil filter element and entering the chip indication on the MGB log card
before further flight. If there are no chips and some particles or
metallic fuzz, this proposed AD would require cleaning the chip
detector and the oil filter element and entering the chip indication on
the MGB log card before further flight. The proposed AD also would
require inspecting the drive stage toothing, performing a ground run,
and within 10 hours TIS inspecting for leaking oil. The proposed AD
would then require performing a ground run for 15 minutes at the
flight-idle power setting, and then re-inspecting the chip detector for
a chip, particles and metallic fuzz. If there is a chip, this proposed
AD would require replacing the MGB with an airworthy MGB.

Differences Between This Proposed AD and the EASA AD

    The EASA AD applies to military EC635 helicopters. This AD does not
apply to EC635 helicopters because they are not type certificated in
the United States.

Costs of Compliance

    We estimate that this proposed AD would affect 242 helicopters of
U.S. Registry and that labor costs would average $85 per work-hour.
Based on these estimates, we expect the following the costs:
     Taking oil samples would take 1 work-hour. Assuming 2
samples per aircraft per year, we estimate a total cost of $170. No
parts would be needed, so the total cost for the U.S. fleet would be
$41,140.
     A laboratory analysis of 2 oil samples would cost $200 per
helicopter for labor and equipment, for a total fleet cost of $48,400.
     Inspecting the oil filter element for a chip would require
about a half-hour of labor for a cost per helicopter of about $43. No
parts would be needed.
     Inspecting certain teeth in the gearbox, performing a
ground run, and inspecting for leaking oil would take 8 work-hours for
a labor cost of $680. Parts would cost $196, for a total cost per
helicopter of $876.
     If the oil sample analysis indicates metal chips,
recording the results on the aircraft log card would take a half-hour
for a labor cost of about $43 per helicopter.
     Examining the log card for any previously recorded chip
indications would be minimal.
     Inspecting the chip detector for deposits would require
about 5 minutes of labor for a labor cost of about $7.
     Replacing the MGB with an airworthy MGB would require 8
work-hours for a labor cost of $680. Parts would cost $145,000 for
total cost per helicopter of $145,680.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Eurocopter Deutschland GmbH (Eurocopter): Docket No. FAA-2013-0554;
Directorate Identifier 2012-SW-009-AD.

(a) Applicability

    This AD applies to Model EC135 P1, EC135 P2, EC135 P2+, EC135
T1, EC135 T2, and EC135 T2+ helicopters with a main gearbox (MGB),
part number (P/N) 4649 010 003, 4649 010 005, 4649 010 006, 4649 010
006X, 4649 010 008, 4649 010 008X, 4649 001 007, 4649 010 010, or
4649 010 013 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a tooth rupture in the
MGB. This condition could result in failure of the MGB, loss of
power to the main rotor, and subsequent loss of control of the
helicopter.

(c) Comments Due Date

    We must receive comments by September 3, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 100 hours time-in-service (TIS), and thereafter at
intervals not to exceed 100 hours or 12 months, whichever occurs
first, take an oil sample in accordance with the Accomplishment
Instructions, Part 1, of Eurocopter Alert Service Bulletin EC 135-
63A-012, Revision 5, dated September 6, 2011 (ASB EC135-63A-012).
    (2) Within 25 hours TIS after taking the oil sample in paragraph
(e)(1), analyze the oil sample in accordance with the Accomplishment
Instructions, Part 2.A. through Part 2.C. of ASB EC135-63A-012,
except that you are not required to contact Eurocopter.
    (i) If the analysis indicates Stage II as specified by the
Accomplishment Instructions, Part 2.B., of ASB EC135-63A-012, within
25 hours TIS, remove and inspect the oil filter element for a chip,
defined as any solid piece of metal but not metallic fuzz or fine
particles.
    (A) If there are no chips, clean the oil filter element and chip
detector, inspect the drive stage toothing, perform a ground run,
and inspect for leaking oil in accordance with the Accomplishment
Instructions, Part 4.A through 4.G, of ASB EC135-63A-012. Change the
oil.
    (B) If there is a chip, replace the MGB with an airworthy MGB
before further flight.
    (ii) If the analysis indicates Stage III as specified by the
Accomplishment Instructions, Part 2.B., of ASB EC135-63A-012 and if
the water content is between 0.1 and 0.5 percent, within 10 hours
TIS, remove and inspect the oil filter element for a chip.
    (A) If there are no chips, clean the oil filer element and chip
detector, inspect the drive stage toothing, perform a ground run,
and inspect for leaking oil in accordance with the Accomplishment
Instructions, Part 4.A through 4.G, of ASB EC135-65A-012. Change the
oil.
    (B) If there is a chip, replace the MGB with an airworthy MGB
before further flight.
    (3) Before the MGB has accumulated 300 hours TIS, determine
whether two or more chip indications have occurred. If two or more
chip indications have occurred, inspect the drive stage toothing,
perform a ground run, and inspect for leaking oil in accordance with
the Accomplishment Instructions, Part 4.A through 4.G, of ASB EC135-
65A-012.
    (4) Any time there is a chip indication, remove and inspect the
chip detector for deposits (fine particles or metallic fuzz) or
chips, and remove and inspect the oil filter element for a chip.
    (i) If there are no chips and a minimal amount of particles or
metallic fuzz, corresponding to Figure 5, Stage A of ASB EC135-65A-
012, clean the chip detector and the oil filter element and enter
the chip indication on the MGB log card before further flight.
    (ii) If there are no chips and some particles or metallic fuzz,
corresponding to Figure 5, Stage B of ASB EC135-65A-012, clean the
chip detector and the oil filter element and enter the chip
indication on the MGB log card before further flight, and within 10
hours TIS inspect the drive stage toothing, perform a ground run,
and inspect for leaking oil in accordance with the Accomplishment
Instructions, Part 4.A through 4.G, of ASB EC135-65A-012. Perform a
ground run for 15 minutes at the flight-idle power setting, and then
re-inspect the chip detector for a chip, particles, and metallic
fuzz.
    (iii) If there is a chip, replace the MGB with an airworthy MGB.

(f) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Chinh Vuong, Aerospace Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in the European Aviation
Safety Agency (EASA) AD No. 2009-0106R1, dated November 3, 2011. You
may view the EASA AD at http://www.regulations.gov in Docket No.
FAA-2013-0554.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6320, Main Rotor
Gearbox.

    Issued in Fort Worth, Texas, on June 18, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-15958 Filed 7-2-13; 8:45 am]
BILLING CODE 4910-13-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Issued by the Department of Transportation on June 25, 2004

NOTICE OF ACTION TAKEN -- DOCKETS OST-2004-18042

________________________________________________________________________
_____________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   American Eagle Airlines, Inc.  filed  6/8/04   for:

XX  Exemption under 49 U.S.C. §40109 to provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between Dallas/Ft. Worth, Texas, and Chihuahua, Mexico.

Applicant rep:  Carl B. Nelson, Jr.<PHONE_NUMBER>  DOT Analyst: Sylvia
Moore<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:   June 25, 2004, through
June 25, 2006

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX   The exemption authority granted is consistent with the aviation
agreement between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  	XX  Holder’s
certificates of public convenience and necessity

		XX  Standard exemption conditions (attached)

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our policy, the dormancy notice
period will begin on October 1, 2004, American Eagle’s proposed
start-up date for the Dallas/Ft. Worth-Chihuahua services.

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

2

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy

Policy and Conservation Act of 1975.  To the extent not granted, we
denied all requests in the referenced Docket.  We may amend, modify, or
revoke the authority granted in this Notice at any time without hearing
at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this order is available on the World Wide Web
at:

  HYPERLINK "http://dms.dot.gov//reports/reports_ aviation.asp"
http://dms.dot.gov//reports/reports_ aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004


[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Rules and Regulations]
[Pages 23118-23119]
[FR Doc No: 2012-9361]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0249]

Annual Marine Events in the Eighth Coast Guard District, Blessing
of the Fleet; Bayou La Batre; Bayou La Batre, AL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce Special Local Regulations for the
Blessing of the Fleet in Bayou La Batre, AL from 2 p.m. until 4 p.m. on
May 6, 2012. This action is necessary for the safety of participants
and spectators, including all crews, vessels, and persons on navigable
waters during the Blessing of the Fleet, Bayou La Batre. During the
enforcement period, entry into, transiting or anchoring in the
regulated area is prohibited to all vessels not registered with the
sponsor as participants or official patrol vessels, unless specifically
authorized by the Captain of the Port (COTP) Mobile or the designated
Coast Guard Patrol Commander.

DATES: The regulations in 33 CFR 100.801 will be enforced from 2 p.m.
until 4 p.m. on May 6, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email LT Lenell J. Carson, Coast Guard Sector
Mobile, Waterways Division; telephone<PHONE_NUMBER> or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Special
Local Regulations for the annual Blessing of the Fleet, Bayou La Batre
event listed in 33 CFR 100.801 (Table 1, VII. Sector Mobile,
158) on May 6, 2012 from 2 p.m. until 4 p.m.
    Under the provisions of 33 CFR 100.801, all persons and vessels not
registered with the sponsor as participants or official patrol vessels
are considered spectators. The ``official patrol vessels'' consist of
any Coast Guard, state or local law enforcement and sponsor provided
vessels assigned or approved by the Commander, Eighth Coast Guard
District, to patrol the event. Spectator vessels desiring to transit
the regulated area may do so only with prior approval of the Patrol
Commander and when so directed by that officer and will be operated at
slowest safe speed in a manner which will not endanger participants in
the event or any other craft. No spectator shall anchor, block, loiter,
or impede the through transit of participants or official patrol
vessels in the regulated area during the effective dates and times,
unless cleared for entry by or through an official patrol vessel. The
Patrol Commander may forbid and control the movement of all vessels in
the regulated area. When hailed or signaled by an official patrol
vessel, a vessel shall come to an immediate stop and comply with the
directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both. Any spectator vessel may
anchor outside the regulated area, but may not anchor in, block, or
loiter in a navigable channel. The Patrol Commander may terminate the
event or the operation of any vessel at any time it is deemed necessary
for the protection of life or property. The Patrol Commander will
terminate enforcement of the special regulations at the conclusion of
the event.
    This notice is issued under authority of 33 CFR 100.35, 33 U.S.C.
1233, and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of this enforcement period via Local Notice to
Mariners and Marine Information Broadcasts.
    If the Captain of the Port Mobile or Patrol Commander determines
that the regulated area need not be enforced for the full duration
stated in this notice of enforcement, he or she may use a Broadcast
Notice to Mariners to grant general permission to enter the regulated
area.

    Dated: March 27, 2012.
D.J. Rose,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2012-9361 Filed 4-17-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54423-54425]
[FR Doc No: 2017-24935]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82063; File No. SR-ICEEU-2017-011]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change, Security Based Swap Submission, or
Advance Notice Relating to Amendments to the ICE Clear Europe
Collateral and Haircut Policy

November 13, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 2, 2017, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II, and III below, which
Items have been primarily prepared by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The principal purpose of the changes is to modify the ICE Clear
Europe

Collateral and Haircut Policy to incorporate certain changes to the
calculation of absolute collateral limits for bonds provided as
Permitted Cover by Clearing Members. The changes also make certain
clarifications and updates and add certain general provisions
addressing overall risk appetite and risk limits.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe proposes revising its Collateral and Haircut
Policy (the ``Collateral and Haircut Policy'') to incorporate certain
changes to the calculation of absolute collateral limits for bonds
provided as Permitted Cover by Clearing Members and certain other
revisions as described below. The amendments do not involve any changes
to the ICE Clear Europe Clearing Rules or Procedures.
    The Collateral and Haircut Policy establishes a maximum amount of
bonds from an individual issuer that ICE Clear Europe will accept from
a Member Group (an ``Absolute Limit''). The Absolute Limit is designed
to take into account the trading liquidity of the bond, and accordingly
the ability of ICE Clear Europe to liquidate the collateral when
required. Currently, the underlying data used in the calculation of the
Absolute Limit is based on the bi-annual International Capital Market
Associate repo survey of market participants (the ``ICMA Data''), as a
proxy for secondary market trading activity. Under the revised
Collateral and Haircut Policy, the Absolute Limit will be determined
using actual secondary market trading volume data provided by ICE Data
Services (the ``IDS Data''). The IDS Data is compiled from a wide range
of market data sources for transactions in government and corporate
bonds. In certain circumstances where official trading volume data is
published from a primary source, such as a governmental or central
bank, such data will be used in lieu of the IDS Data. (For example, for
bonds issued by Canada and Japan, ICE Clear Europe will utilize data
provided by the Bank of Canada and the Japan Securities Dealers
Association, respectively, instead of IDS Data.) In either case, the
Absolute Limit for each bond issuer and collateral type will be 10% of
the average daily volume over the past three months, rounded to the
nearest million. ICE Clear Europe believes that the revised approach
will provide a more direct and accurate estimation of liquidity than
under the current approach, which will facilitate calculation of
conservative and appropriate absolute concentration limits.
    The revisions also provide that in order to capture price
volatility information on a conservative basis, the haircut calculation
methodology, which incorporates a historical VaR model, among other
factors, will use a two-sided VaR estimation based on the largest
absolute returns.
    The Collateral and Haircut Policy has also been amended to more
clearly take into account the existence of ICE Clear Europe's
approximately U.S. $1 billion in committed repo facilities. As under
the existing policy, in certain circumstances the Clearing House may
permit a Clearing Member to maintain a collateral bond position in
excess of normal absolute limits, in reliance on the Clearing House's
ability to obtain cash for any excess securities using the committed
repo facility. The amendments clarify that the repo facilities are
available at any time there is an intra-day liquidity need, and are not
limited to use in case of Clearing Member default.
    The amendments also note certain particular scenarios in which the
clearing risk department may, consistent with the current policy,
consider other qualitative and quantitative factors in setting prudent
haircuts. These include the need to clean the bond price input data to
remove spurious effects caused by changes in the different underlying
bonds used to build bond price time-series. In this regard, the time
series of bond price data in some instances may be spliced together
from bonds with the same maturities but certain differences in other
terms. These differences may cause the bonds to trade at different
price levels, which could introduce spurious price spikes into the time
series. To avoid an effect on the calculated haircut levels, ICE Clear
Europe removes such spurious price spikes from the time series. The
policy also notes that the clearing house may also need to consider the
impact of unexpected currency de-pegging events on the calculation of
cross-currency FX haircuts (such as the Swiss franc de-pegging from the
Euro in January 2015, which caused unexpected sharp movements in the
underlying exchange rate), as such events may not be fully captured by
the quantitative approach in the Collateral and Haircut Policy.
    In addition, the Collateral and Haircut Policy has been revised to
add certain general provisions, consistent with the approach taken in
other ICE Clear Europe policies, addressing overall risk appetite and
risk limits in the context of the purposes of the Collateral and
Haircut Policy. Certain references in the policy to internal ICE Clear
Europe personnel, departments and committees have been updated. The
amendments also provide further detail as to the process for annual
independent validation and governance oversight of relevant models used
to support the Collateral and Haircut Policy. The policy owner, with
the support of risk department personnel, will be responsible for the
continuous review and reporting of the risk profile of the policy. The
policy will be reviewed at least annually by the CDS and F&O Risk
Committees and approved by the Board. Any material changes to the
policy must be discussed with the Executive Risk Committee, reviewed by
the CDS and F&O Risk Committees and the Board Risk Committee and
approved by the Board. A ``red-amber-green'' escalation process has
also been implemented to handle identified risks or situations as they
arise.
(b) Statutory Basis
    ICE Clear Europe believes that the changes described herein are
consistent with the requirements of Section 17A of the Act \3\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22,\4\ and in particular are consistent with the prompt and
accurate clearance of and settlement of securities transactions and, to
the extent applicable, derivative agreements, contracts and
transactions, the safeguarding of securities and funds in the custody
or control of ICE Clear Europe or for which it is responsible and the
protection of investors and the public interest, within the meaning of
Section 17A(b)(3)(F) of the Act.\5\ The amendments are intended, among
other matters, to adopt a more robust and direct method for obtaining
relevant bond trading volume data that is used

to determine concentration limits and to clarify certain other matters
relating to calculation of haircuts and limits. The amendments also
enhance the governance process around the Collateral and Haircut
Policy. In ICE Clear Europe's view, the amendments will help ICE Clear
Europe more clearly determine the liquidity of relevant bonds, which in
turn will facilitate establishment of accurate concentration limits. As
a result, ICE Clear Europe believes the amendments are consistent with
the requirements of Section 17A(b)(3)(F) \6\ of the Act. In addition,
for the foregoing reasons, the amendments will facilitate setting and
enforcing appropriately conservative haircuts and concentration limits,
and provide for a review of the sufficiency of such haircuts and limits
not less than annually, within the meaning of Rule 17Ad-22(e)(5).\7\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78q-1.
    \4\ 17 CFR 240.17Ad-22.
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ 17 CFR 240.17Ad-22(e)(5).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed changes to the rules
would have any impact, or impose any burden, on competition not
necessary or appropriate in furtherance of the purpose of the Act. ICE
Clear Europe is adopting the amendments to the Collateral and Haircut
Policy in order to enhance the calculations of concentration limits and
haircuts and make certain other governance and related enhancements to
the Collateral and Haircut Policy. The amendments will apply to all
Clearing Members and products. ICE Clear Europe does not believe the
amendments would materially affect the cost of clearing, adversely
affect access to clearing in these products for Clearing Members or
their customers, or otherwise adversely affect competition in clearing
services. Although the amendments may change the haircuts or
concentration limits for particular bonds, which may affect the costs
and benefits of using those bonds as collateral, ICE Clear Europe
believe that such changes are appropriate in light of the risk
management enhancements provided by the revised policy. As a result,
ICE Clear Europe believes that any impact or burden on competition from
such amendments would be appropriate in furtherance of the purpose of
the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2017-011 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2017-011. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2017-011 and should be
submitted on or before December 8, 2017.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24935 Filed 11-16-17; 8:45 am]
 BILLING CODE 8011-01-P