[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66095-66096]
[FR Doc No: 2018-27563]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0312; Airspace Docket No. 18-AGL-7]
RIN 2120-AA66

Establishment of Class E Airspace; Glen Ullin, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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SUMMARY: This action corrects a final rule published in the Federal
Register of September 26, 2018, that established Class E airspace
extending upward from 700 feet above the surface at Glen Ullin Regional
Airport, Glen Ullin, ND. The state identifier ``WI'' was inadvertently,
included in the header of the legal description instead of ``ND''.

DATES: Effective date 0901 UTC, February 28, 2019. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register for Docket
No. FAA-2018-0312 (83 FR 48530, September 26, 2018), establishing Class
E airspace at Glen Ullin Regional Airport, Glen Ullin, ND. Subsequent
to publication, the FAA identified a clerical error that the state
identifier in the header of the legal description listed the airport as
Glen Ullin Regional Airport, Glen Ullin, WI. This correction changes
the state identifier in the legal description from ``WI'' to ``ND'' and
to read ``Glen Ullin Regional Airport, ND''.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of September 26, 2018 (83 FR 48530) FR Doc. 2018-
20870, Establishment of Class E Airspace; Glen Ullin, WI, is corrected
as follows:

Sec.  71.1   [Amended]

0
On page 48531, column 3, in instruction 2, following the heading ``AGL
ND E5 Glen Ullin, ND [NEW]'',

remove ``Glen Ullin Regional Airport, WI'' and add in its place ``Glen
Ullin Regional Airport, ND''.

    Issued in Fort Worth, Texas, on December 13, 2018.
John Witucki,
Acting Manager, Operations Support Group, Central Service Center.
[FR Doc. 2018-27563 Filed 12-21-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Notices]
[Page 68870-68871]
[DOCID:fr06de07-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2426-197]

California Department of Water Resources and the City of Los
Angeles; Notice Denying Late Intervention

November 28, 2007.
    On June 8, 2005, the Commission issued a public notice of
California Department of Water Resources' (California DWR) and the City
of Los Angeles' application to amend their license for the California
Aqueduct Project No. 2426. On June 11, 2007, Friends of the River filed
a late motion to intervene in the proceeding.
    In determining whether to grant late intervention, the Commission
may consider such factors as whether the movant had good cause for
filing late, whether the movant's interest is adequately represented by
other parties to the proceeding, and whether granting the intervention
might result in disruption to the proceeding or prejudice to other
parties.\1\ Movants for late interventions must, among other things,
demonstrate good cause why the time limit should be waived.\2\
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    \1\ 18 CFR 385.214(d) (2007).
    \2\ 18 CFR 385.214(b)(3) (2007).
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    Friends of the River argues that good cause exists for late
intervention because it had no actual notice of the deadline for
motions to intervene. It states that it only became aware of the
deadline when the Commission issued the Environmental Assessment (EA)
for the proposed license amendment on March 1, 2007. Friends of the
River also argues that even if it had received actual notice of the
deadline, it still would not have known of its actual need to become a
party in the proceeding until the Commission issued its environmental
determinations in the EA.
    Movant's assertions are without merit. The Commission issued public
notice of

the amendment application on June 8, 2005, and published notice in the
Federal Register on June 15, 2005.\3\ Movant therefore was on notice of
licensee's application, but failed to timely respond to it.\4\ Allowing
late intervention at this point in the proceedings would create
prejudice and additional burdens on the Commission and its applicants.
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    \3\ 70 FR 34,750 (2005).
    \4\ See Federal Crop Ins. Corp. v. Merrill, 332 U.S. 380 (1947)
(holding that Federal Register publication provides notice to all
affected parties).
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    The Commission expects parties to intervene in a timely manner
based on the reasonably foreseeable issues arising from the applicant's
filings and the Commission's notice of proceedings.\5\ The Commission
has held that the party bears the responsibility for determining when a
proceeding is relevant to its interests, such that it should file a
motion to intervene. When a party fails to intervene in a timely
fashion, the party assumes the risk that the case will be settled in a
manner that is not to its liking.\6\ The Commission has previously
explained that an entity cannot ``sleep on its rights'' and then seek
untimely intervention.\7\ Therefore, Friends of the River's argument
that it would not have known of its actual need to become a party in
the proceeding until the Commission issued its environmental
determinations in the EA is without merit.
---------------------------------------------------------------------------

    \5\ See California Water Resources Department and the City of
Los Angeles, 120 FERC ] 61,057 at n.9 (2007).
    \6\ Id. at P 13.
    \7\ Id. at P 14.
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    Movant has failed to demonstrate good cause standard for granting
late intervention. The motion for late intervention in these
proceedings filed by movant is therefore denied.
    This notice constitutes final agency action. Requests for rehearing
by the Commission of this rejection must be filed within 30 days of the
date of issuance of this notice, pursuant to 18 CFR 385.713 (2007).

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23622 Filed 12-5-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Rules and Regulations]
[Page 68142-68146]
[DOCID:fr23de09-5]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 736, 738, 740, 742, 743, and 772

[Docket No.<PHONE_NUMBER>-91276-01]
RIN 0694-AE62

Amendments to the Export Administration Regulations (EAR) Based
Upon the Accession of Albania and Croatia to Formal Membership in the
North Atlantic Treaty Organization (NATO)

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) is publishing this
final rule to amend certain requirements in the Export Administration
Regulations (EAR) that apply to Albania and Croatia. These changes are
based upon the accession of Albania and Croatia to formal membership in
the North Atlantic Treaty Organization (NATO) on April 1, 2009.
Consistent with the EAR license requirements and licensing policies
that apply to members of NATO, this final rule amends the EAR to remove
certain crime control (CC), national security (NS), and regional
stability (RS) license requirements for these two countries. A license
continues to be required for exports and reexports to Albania or
Croatia of items on the Commerce Control List (CCL) controlled for
national security or regional stability reasons that are identified as
requiring a license to destinations indicated under NS Column 1 (also
NS Column 2, for Albania) or RS Column 1, respectively, on the Commerce
Country Chart. Certain restraint devices, discharge type arms, and
related technology described on the CCL continue to require a license
for crime control reasons to Albania or Croatia. A license also
continues to be required for specially designed implements of torture
described on the CCL. Furthermore, this rule does not affect any
license requirements that apply to these countries based on other
reasons for control identified in the EAR. This final rule also removes
the EAR prohibition that applied to certain in transit shipments
through Albania, removes Albania from Country Group D, and adds Albania
to Country Group B. Croatia has already been designated in the EAR as a
Country Group B country. In addition, this rule amends the provisions
of License Exception APR (Additional Permissive Reexports) that apply
to reexports of certain thermal

imaging cameras to include Albania and Croatia among the list of
eligible destinations. Finally, this rule amends the definition of
``NATO (North Atlantic Treaty Organization)'' in the EAR to include
Albania and Croatia.

DATES: This rule is effective December 23, 2009. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE62, by any
of the following methods:
     E-mail<EMAIL_ADDRESS>Include ``RIN 0694-
AE62'' in the subject line of the message.
     Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy
Division, by calling<PHONE_NUMBER>, if you are faxing comments.
     Mail or Hand Delivery/Courier: Willard Fisher, U.S.
Department of Commerce, Bureau of Industry and Security, Regulatory
Policy Division, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, Attn: RIN 0694-AE62.
    Send comments regarding this collection of information, including
suggestions for reducing the burden, to Jasmeet Seehra, Office of
Management and Budget (OMB), by e-mail to Jasmeet_K._
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory
Policy Division, Bureau of Industry and Security, Department of
Commerce, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230. Comments on this collection of information should
be submitted separately from comments on the final rule (i.e., RIN
0694-AE62)--all comments on the latter should be submitted by one of
the four methods outlined above.

FOR FURTHER INFORMATION CONTACT: John Varesi, Sensors and Aviation
Division, Office of National Security and Technology Transfer Controls,
Bureau of Industry and Security, Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    This final rule amends certain requirements in the Export
Administration Regulations (EAR) that apply to Albania and Croatia.
These changes are based upon the accession of Albania and Croatia to
formal membership in the North Atlantic Treaty Organization (NATO) on
April 1, 2009.
    This rule amends the Commerce Country Chart (Supplement No. 1 to
Part 738 of the EAR) by revising certain license requirements that
apply to Albania and Croatia to be consistent with those that apply to
other members of NATO. Specifically, this rule removes certain crime
control (CC), national security (NS) and regional stability (RS)
license requirements for Albania and Croatia. As a result of the
changes made by this rule, Albania and Croatia are no longer designated
as RS Column 2 destinations on the Commerce Country Chart and Croatia
is no longer designated as an NS Column 2 destination. However, a
license continues to be required for exports and reexports to Albania
or Croatia of items on the Commerce Control List (CCL) (Supplement No.
1 to Part 774 of the EAR) that are controlled for national security or
regional stability reasons and are identified as requiring a license to
destinations indicated under NS Column 1 (also NS Column 2, for
Albania) or RS Column 1, respectively, on the Commerce Country Chart. A
license also continues to be required for exports and reexports to
Albania or Croatia of restraint devices, discharge type arms, and
related technology that are controlled for crime control reasons under
Export Control Classification Numbers (ECCNs) 0A982, 0A985, and 0E982,
respectively, on the CCL. Specially designed implements of torture that
are controlled under ECCN 0A983 also continue to require a license for
export and reexport to Albania or Croatia. In addition, this rule does
not affect license requirements that apply to Albania or Croatia based
on other reasons for control identified in the EAR, such as chemical/
biological (CB), missile technology (MT), nuclear proliferation (NP),
and encryption items (EI).
    Consistent with the changes described above, this rule amends the
national security (NS) license requirement provisions in Section
742.4(a) of the EAR by adding Croatia to the list of countries that are
not subject to the NS Column 2 license requirements indicated in
various Export Control Classification Numbers (ECCNs) on the CCL. In
addition, this rule adds Albania and Croatia to the list of countries
identified in Section 742.4(a) of the EAR that are not subject to the
NS Column 2 license requirements that apply to certain ECCN 6A003.b.4.b
cameras described therein. Although this rule does not remove all of
the NS Column 2 license requirements for Albania, as it does for
Croatia, the rule does make Albania eligible for the exemption that
applies to certain ECCN 6A003.b.4.b cameras described in Section
742.4(a) of the EAR--this policy is consistent with the treatment that
is provided for exports of such cameras to Cyprus, Malta, and South
Africa, which also are subject to most NS Column 2 license
requirements.
    Consistent with the changes in the regional stability (RS) license
requirements for Albania and Croatia described above, this rule adds
both countries to the list of countries identified in Section
742.6(a)(4)(ii) of the EAR as not subject to the RS Column 2 license
requirements that apply to certain ECCN 6A003.b.4.b cameras described
therein. This rule also amends the RS Column 1 license requirements
described in Section 742.6(a) of the EAR by adding Albania and Croatia
to the list of countries to which certain exports or reexports of
cameras controlled under ECCN 6A003.b.4.b, as described in Section
742.6(a)(2)(ii) or (a)(2)(iv) of the EAR, may be authorized in
accordance with the requirements of Section 742.6(a)(2)(iii) or
(a)(2)(v), respectively. In addition, this rule adds Albania and
Croatia to the list of countries in Section 742.6(a)(3) of the EAR
whose governments are authorized to reexport without a license
``military commodities'' controlled under ECCN 0A919 as part of a
military deployment.
    This rule also amends Section 743.3(b) of the EAR by adding Albania
and Croatia to the list of countries that are subject to the reporting
requirements described in this section, which apply to exports of ECCN
6A003.b.4.b thermal imaging cameras that have been authorized under the
EAR without a validated license.
    Most of the amendments to Sections 740.16(b)(3), 742.4(a),
742.6(a), and 743.3(b) of the EAR that are described above involve
provisions of the EAR that were affected by a final rule published by
BIS on May 22, 2009 (74 FR 23941), which revised certain license
requirements and license exception eligibility requirements for thermal
imaging cameras controlled by ECCN 6A003.b.4.b on the CCL. This final
rule does not affect the scope of these requirements, except insofar as
they apply to exports of such cameras to Albania and Croatia. For
additional information on the application of these requirements to
Albania and Croatia, please refer to the BIS point of contact
identified in the May 22, 2009, final rule.
    In addition to the national security and regional stability changes
described above, this rule amends Section 736.2(b)(8)(ii) of the EAR
(i.e., General Prohibition Eight) to remove ``Albania'' from the list
of countries that are subject to the prohibition against certain in
transit shipments. This prohibition

applies to intransit shipments through specified countries of items
that generally would require a license for export or reexport to such
countries and that are not authorized under either a license or a
license exception.
    This rule also amends Supplement No. 1 to Part 740 of the EAR
(titled ``Country Groups'') by removing ``Albania'' from ``Country
Group D'' and adding ``Albania'' to ``Country Group B--Countries,''
consistent with the treatment provided to other members of NATO.
``Croatia'' has already been designated in the EAR as a Country Group B
country (see the interim rule titled, ``Simplification of Export
Administration Regulations,'' published at 61 FR 12714, March 25, 1996;
Country Group B, p. 12782). Whether or not a country has been
designated by the EAR as a Country Group B country can affect its
eligibility status with respect to certain license exceptions described
in Part 740 of the EAR (e.g., License Exceptions LVS, GBS, and TSR).
    Consistent with the status of Albania and Croatia as members of
NATO, this rule also amends the License Exception APR (Additional
Permissive Reexports) provisions in Section 740.16(b)(3) of the EAR to
add Albania and Croatia to the list of eligible destinations for
certain thermal imaging cameras controlled under ECCN 6A003.b.4.b on
the CCL.
    Finally, this rule amends Section 772.1 of the EAR to update the
definition of ``NATO (North Atlantic Treaty Organization)'' by adding
``Albania'' and ``Croatia.''
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of August 13,
2009, 74 FR 41325 (August 14, 2009), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
contains collections of information subject to the requirements of the
PRA. These collections have been approved by OMB under Control Number
0694-0088 (Multi-Purpose Application), which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748, and Control
Number 0694-0133, which carries a burden hour estimate of 60 hours
annually for all reports submitted in accordance with Section 743.3 of
the EAR. Send comments regarding these burden estimates or any other
aspect of these collections of information, including suggestions for
reducing the burden, to Jasmeet Seehra, Office of Management and Budget
(OMB), and to the Regulatory Policy Division, Bureau of Industry and
Security, Department of Commerce, as indicated in the ``ADDRESSES''
section of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military and foreign affairs
function of the United States (Sec. 5 U.S.C. 553(a)(1)). Further, no
other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required to be given for this rule under 5 U.S.C. 553 or by any
other law, the analytical requirements of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) are not applicable.
    Therefore, this regulation is issued in final form. Although there
is no formal comment period, public comments on this regulation are
welcome on a continuing basis.

List of Subjects

15 CFR Part 736

    Exports.

15 CFR Part 738

    Administrative practice and procedure, Exports, Foreign trade.

15 CFR Part 740

    Administrative practice and procedure, Exports, Foreign trade,
Reporting and recordkeeping requirements.

15 CFR Part 742

    Exports, Foreign trade.

15 CFR Part 743

    Administrative practice and procedure, Reporting and recordkeeping
requirements.

15 CFR Part 772

    Exports.

0
Accordingly, parts 736, 738, 740, 742, 743, and 772 of the Export
Administration Regulations (15 CFR Parts 730-774) are amended as
follows:

PART 736--[AMENDED]

0
1. The authority citation for 15 CFR part 736 is revised to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp. p. 219; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, May 13, 2004;
Notice of August 13, 2009, 74 FR 41325 (August 14, 2009); Notice of
November 6, 2009, 74 FR 58187 (November 10, 2009).

Sec.  736.2  [Amended]

0
2. In Section 736.2(b)(8)(ii), remove the country, ``Albania,''.

PART 738--[AMENDED]

0
3. The authority citation for 15 CFR part 738 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; Notice of August 13, 2009, 74 FR 41325 (August 14, 2009).

0
4. Supplement No. 1 to part 738 is amended in the entries for
``Albania'' and ``Croatia,'' by adding a reference to footnote number 2
in the entry for ``Albania,'' and by adding a reference to footnote
number 3 in the entries for ``Albania'' and ``Croatia'' to read as
follows:

                                                                      Supplement No. 1 to Part 738--Commerce Country Chart
                                                                                [Reason for control]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                  Countries                   Chemical &  biological       Nuclear       National  Security    Missile   Regional  Stability   Firearms        Crime control      Anti-terrorism
---------------------------------------------         weapons         nonproliferation ----------------------   Tech   ---------------------- convention ------------------------
                                             ------------------------------------------                      ----------                      ------------                        ---------------
                                                CB      CB      CB       NP       NP      NS         NS          MT       RS         RS           FC        CC      CC      CC      AT      AT
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  1       2       3        1        2       1             2        1        1             2         1         1       2       3       1       2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                * * * * * * *
Albania \2 3\...............................      X   ......  ......       X   .......      X   ............       X        X   ............  ..........  ......  ......  ......  ......  ......

                                                                                * * * * * * *
Croatia \3\.................................      X   ......  ......       X   .......      X   ............       X        X   ............  ..........  ......  ......  ......  ......  ......

                                                                                * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\2\See Sec.  742.4(a) for special provisions that apply to exports and reexports to these countries of certain thermal imaging cameras.
\3\See Sec.  742.6(a)(3) for special provisions that apply to military commodities that are subject to ECCN OA919.

PART 740--[AMENDED]

0
5. The authority citation for 15 CFR part 740 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 13, 2009, 74 FR 41325 (August 14, 2009).

Sec.  740.16  [Amended]

0
6. Section 740.16(b)(3) introductory text is amended by removing the
phrase ``Australia, Austria, Belgium, Bulgaria, Canada,'' and adding in
its place the phrase, ``Albania, Australia, Austria, Belgium, Bulgaria,
Canada, Croatia,''.

Supplement No. 1 to Part 740 [Amended]

0
7. In Supplement No. 1 to part 740, Country Groups, the table titled
``Country Group B--Countries'' is amended by adding, in alphabetical
order, the country ``Albania''.

0
8. In Supplement No. 1 to part 740, Country Groups, the table titled
``Country Group D'' is amended by removing the entry for ``Albania''.

PART 742--[AMENDED]

0
9. The authority citation for 15 CFR part 742 is revised to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec 1503, Public Law 108-11, 117 Stat. 559; E.O. 12058,
43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3
CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential
Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003;
Notice of August 13, 2009, 74 FR 41325 (August 14, 2009); Notice of
November 6, 2009, 74 FR 58187 (November 10, 2009).

Sec.  742.4  [Amended]

0
10. Section 742.4(a) is amended:
0
a. By removing the word ``Bulgaria,'' immediately following the
parenthetical phrase in the third sentence and adding in its place the
phrase, ``Bulgaria, Croatia,''; and
0
b. By removing the phrase ``except Australia, Austria, Belgium,
Bulgaria, Canada,'' in the fourth sentence and adding in its place the
phrase, ``except Albania, Australia, Austria, Belgium, Bulgaria,
Canada, Croatia,''.

0
11. Section 742.6 is amended:
0
a. By revising the first sentence in paragraph (a)(2)(iii);
0
b. By revising the first sentence in paragraph (a)(2)(v);
0
c. By revising paragraph (a)(3); and
0
d. By revising paragraph (a)(4)(ii).
    The revisions read as follows:

Sec.  742.6   Regional stability.

    (a) * * *
    (2) * * *
    (iii) BIS may issue licenses for cameras subject to the license
requirement of paragraph (a)(2)(ii) of this section that are fully-
packaged for use as consumer-ready civil products that, in addition to
the specific transactions authorized by such license, authorize exports
and reexports of such cameras without a license to any civil end-user
to whom such exports or reexport are not otherwise prohibited by U.S.
law in Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg,
Malta, the Netherlands, New Zealand, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden,
Switzerland, Turkey, and the United Kingdom. * * *
* * * * *
    (v) BIS may also issue licenses for the cameras described in
paragraph (a)(2)(iv) that, in addition to the specific transactions
authorized by such license, authorize exports and reexports to
authorized companies described in the license for the purpose of
embedding such cameras into a completed product that will be
distributed only in Albania, Australia, Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, New Zealand, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, South
Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. * *
*
    (3) Special RS Column 1 license requirement applicable to military
commodities. A license is required for reexports to all destinations
except Canada for items classified under ECCN 0A919 except when such
items are being reexported as part of a military deployment by a unit
of the government of Albania, Australia, Austria, Belgium, Bulgaria,
Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, New Zealand,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa,
South Korea, Spain, Sweden, Switzerland, Turkey,

the United Kingdom or the United States.
    (4) * * *
    (ii) Special RS Column 2 license requirements applicable only to
certain cameras. As indicated by the CCL, and RS column 2 and footnote
number 4 to the Commerce Country Chart, a license is required to any
destination except Albania, Australia, Austria, Belgium, Bulgaria,
Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, New Zealand,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa,
South Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
for fully-packaged thermal imaging cameras for use as consumer-ready
civil products controlled by 6A003.b.4.b when incorporating ``focal
plane arrays'' that have not more than 111,000 elements and a frame
rate of 60Hz or less and that are not being exported or reexported to
be embedded in a civil product.
* * * * *

PART 743--[AMENDED]

0
12. The authority citation for 15 CFR part 743 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq; Public Law 106-508; 50
U.S.C. 1701 et seq; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 13, 2009, 74 FR 41325 (August 14, 2009).

Sec.  743.3  [Amended]

0
13. Section 743.3(b) is amended by removing the phrase ``to Australia,
Austria, Belgium, Bulgaria,'' and adding in its place the phrase ``to
Albania, Australia, Austria, Belgium, Bulgaria, Croatia,''.

PART 772--[AMENDED]

0
14. The authority citation for 15 CFR part 772 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
13, 2009, 74 FR 41325 (August 14, 2009).

0
15. In Section 772.1, the definition of ``NATO (North Atlantic Treaty
Organization)'' is revised to read as follows:

Sec.  772.1  Definitions of terms as used in the Export Administration
Regulations (EAR).

* * * * *
    NATO (North Atlantic Treaty Organization). A strategic defensive
organization that consists of the following member nations: Albania,
Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia,
France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania,
Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Turkey, the United Kingdom, and the United
States.
* * * * *

    Dated: December 14, 2009.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. E9-30484 Filed 12-22-09; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register Volume 82, Number 62 (Monday, April 3, 2017)]
[Notices]
[Page 16185]
[FR Doc No: 2017-06468]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2195-148]

Portland General Electric Company; Notice of Application Accepted
for Filing, Soliciting Comments, Protests, and Motions To Intervene

    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission and is available
for public inspection:
    a. Type of Application: Non-project use of project lands and water.
    b. Project No: 2195-148.
    c. Date Filed: November 7, 2016 and supplemented on March 22, 2017.
    d. Applicant: Portland General Electric Company (licensee).
    e. Name of Project: Clackamas River Hydroelectric Project.
    f. Location: River Mill Development (Estacada Lake) of the
Clackamas River Hydroelectric Project located in Clackamas County,
Oregon.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Thomas Nilan, Manager, Portland General
Electric Company, 121 SW. Salmon Street, 3 WTC-BR05, Portland, Oregon
97204; phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Ballantine at<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, or motions to intervene
is 30 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file comments,
protests, or motions to intervene using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2195-148.
    k. Description of Request: Portland General Electric Company
requests Commission approval to grant the Oregon Department of Fish and
Wildlife (Oregon DFW) an easement to use project lands and water within
the River Mill development of the Clackamas River Hydroelectric
Project, for the construction and operation of a gravity fed intake
system. The intake would provide water to the Oregon DFW owned
Clackamas Hatchery located outside of the project boundary on Dog
Creek, a tributary of the Clackamas River. The intake would provide a
continuous gravity fed 50 cubic feet per second (approximately 32
million gallons per day) from Estacada Lake, to the fish hatchery. The
intake system would be located within the project boundary
approximately 250 feet upstream of the River Mill Dam on the south side
of the forebay and consist of a dual-cylindrical intake screen, track
system for deploying the intake screens into the reservoir, control
building, and conveyance pipes. Project water routed to the hatchery
would be returned to the Clackamas River via Dog Creek, downstream of
the project.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call<PHONE_NUMBER> or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all comments or protests filed, but only those who file a
motion to intervene in accordance with the Commission's Rules may
become a party to the proceeding. Any comments, protests, or motions to
intervene must be received on or before the specified date for the
particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENT''; ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person commenting, protesting or motioning to intervene;
and (4) otherwise comply with the requirements of 18 CFR 385.2001
through 385.2005. All comments, protests, or motions to intervene must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. If an intervener
files comments or documents with the Commission relating to the merits
of an issue that may affect the responsibilities of a particular
resource agency, they must also serve a copy of the document on that
resource agency. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: March 28, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06468 Filed 3-31-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52782-52784]
[FR Doc No: 2022-18546]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Review Transparency
and Communication for New Molecular Entity New Drug Applications and
Original Biologics License Applications in Prescription Drug User Fee
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 28, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0746. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Review Transparency and Communication for New Molecular Entity New Drug
Applications (NME NDA) and Original Biologics License Applications
(BLAs) in Prescription Drug User Fee Submissions

OMB Control Number 0910-0746--Revision

    This information collection supports the evaluation of certain
performance goals and procedures set forth in what is known as FDA's
``goals letter'' or ``commitment letter'' under the seventh
authorization of the Prescription Drug User Fee Act (PDUFA VII). The
goals letter is the result of Agency, industry, and public input, as
Congressionally mandated under the applicable statutes. The document
entitled ``PDUFA Reauthorization Performance Goals and Procedures
Fiscal Years 2023 Through 2027'' (PDUFA VII Commitment Letter)
represents current performance goals agreed to by FDA in support of
these respective programs. The document is available at: https://www.fda.gov/media/151712/download.
    To implement certain performance goals, we established a review
program (the Program) to promote greater transparency and increased
communication between the FDA review team and the applicant on the most
innovative products that we review. The Program goals are intended to
increase the efficiency and effectiveness of the first review cycle
process and decrease the number of review cycles necessary for approval
so that patients have timely access to safe, effective, and high-
quality new drugs and biologics. A key aspect of the extension of the
Program is to conduct an interim and final assessment that will
evaluate how well the parameters of the Program have achieved the
intended goals.
    Based on sponsors' responses and other data, on December 2, 2020,
we published an interim report that is available on FDA's website at
https://www.fda.gov/media/144130/download. We learned that review teams
have been effective in enhancing transparency and communication, with
milestone meetings also enhancing the predictability of the review
process. We have also adapted certain good practices, including
providing pre-submission advice and templates; allocating time for
applicant-identified discussion topics in late-cycle meetings where
feasible; and recommending request response times of greater than 2
days for applicants with a global presence.
    We are revising the information collection to continue the Program
and these assessments under the ``PDUFA VII Commitment Letter''. The
goals letter includes the procedures, and commitments that apply to
aspects of the human drug review program that are important for
facilitating timely access to safe, effective, and innovative new
medicines for patients. Several of these commitments aim to continue to
enhance communication between FDA and sponsors during application
review. FDA and sponsors interact in a variety of ways throughout
application review. One such way is via a communication, called an
information request (IR), sent to an applicant as the discipline review
occurs. FDA uses IRs to request further information or clarification
that is needed or would be helpful to allow completion of the
discipline review. IRs may be in the form of letters, emails, or Faxes.
    FDA uses product quality IRs to request further information or
clarification needed for FDA's assessment of identity, strength,
quality, purity, sterility/microbial controls, or potency of drug
substances or drug products. Ensuring that patients can have confidence
in the safety and effectiveness of their medications is a longstanding
priority for FDA. The Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER) have worked
to address this priority, in part, by performing Chemistry,
Manufacturing, and Controls (CMC) and Current Good Manufacturing
Practice (CGMP) reviews for CDER- and CBER-regulated products. It is
during these reviews that CDER or CBER may issue a product quality, or
CMC, IR. IRs from both CDER and CBER are expected to follow Four-Part
Harmony in which reviewers are expected to communicate: (1) what was
provided, (2) what is the issue or deficiency, (3) what is needed, and
(4) why it is needed. The PDUFA VII Commitment Letter includes
commitments for FDA to update and conduct training on existing policies
and procedures (Manual of Policies and Procedures and Standard
Operating Procedures and Policies) based on the four essential
components.
    FDA is committed to assessing current practices of CDER, CBER, and
sponsors in communicating through product quality IRs during
application review and effectiveness of Four-Part Harmony. We will
contract with an independent third party to conduct assessments
intended to identify best practices and areas of improvement in
communications between FDA review staff and sponsors through product
quality IRs. To accomplish these goals, the contractor will separately
engage both FDA staff and sponsors through contractor-led interviews.
Given the volume of IRs and IR amendments, these interviews will focus
on a sample of applications and their associated IRs. The contractor
may also choose to leverage web-based surveys, in addition to
interviews, to accomplish the goals of the assessment. The contractor
will anonymize and aggregate sponsor and FDA responses before including
them in an assessment report, which is required by the PDUFA VII
Commitment Letter. FDA will publish the report on FDA's website and in
the Federal Register, for public comment.
    This assessment, utilizing information collected through surveys
and interviews with FDA and original NDA and BLA sponsors, will be of
great interest to FDA's stakeholders, including the regulated industry.
Equally important, the assessment will be critical in helping FDA
understand sponsor perspectives on what is working well, ongoing
challenges and pain points, lessons learned, and opportunities for
improvement.
    Per the commitment letter, FDA will select a contractor to design a
sampling method, in accordance with the requirements in the statement
of work, for identifying applications to be included in the assessment.
The contractor will also prepare a protocol and script for scheduling
and conducting interviews with sponsors associated with the sample
applications. If the contractor determines a survey to be necessary,
they will develop a web-based survey to deploy. The protocol will
ensure that the contractor schedules and conducts interviews and
deploys any survey in a timely, consistent manner using good interview
and survey practices. The interview script will include open-ended
questions aimed at obtaining a thorough understanding of applicants'
experiences and insights relevant to product quality IRs associated
with their application under the Program. If deployed, the survey would
include closed and/or open-ended questions with the same purpose.
    The contractor will analyze interview (and survey, if deployed)
responses to identify challenges with Four-Part Harmony and best
practices for

communication via product quality IRs. The contractor will also use the
interview (and survey, if deployed) data to consider trends across IRs,
compare IRs before and after implementation of Four-Part Harmony, and
add context to the contractor's review of the sample IRs, as well as
any other data collected. The contractor will synthesize and interpret
the results to develop a set of findings and recommendations for the
Program to be included in a final assessment report. In turn, FDA will
use the independent assessment findings and recommendations to:
     determine the success of Four-Part Harmony in improving
communications via product quality IRs;
     determine whether and how to refine implementation of
Four-Part Harmony during the remainder of PDUFA VII;
     demonstrate compliance with the commitment to conduct the
independent assessments
     and publish them for public comment; and
     share information about the Program with the regulated
community, the public health community, Congress, and the general
public.
    In the Federal Register of March 21, 2022 (87 FR 16006), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received; however, we have
slightly increased the estimate from our 60-day notice to fully align
with planned program goals.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
           Activity                Number of      responses per   Total annual    Average burden    Total hours
                                  respondents      respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
Surveys......................  120 (one to                    1             120  0.25 (15                     30
                                three per                                         minutes).
                                application).
Interviews...................  120 (one to                    1             120  1.5............             180
                                three per
                                application).
                                                ----------------------------------------------------------------
    Total....................  ................  ..............  ..............  ...............             210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We plan interviews with up to three sponsor representatives per
each application in each interview under the Program. Sponsors will
participate in interviews via teleconference. In addition, if the
contractor decides to conduct a survey, sponsors will respond to
surveys (one survey response per individual) by completing a fillable
form online. We estimate that 120 applicant representatives will expend
approximately 15 minutes to complete a survey, for a total of 30 annual
burden hours. We further estimate that up to 120 applicant
representatives (up to three sponsor representatives for each of up to
40 applications) will participate in the interviews each year and that
each interview will last approximately 90 minutes, for a total of 180
burden hours. There will be no recordkeeping or third-party disclosure
burdens for this information collection.

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18546 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P


 Page 1 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 APR 13, 2006 MEMORANDUM: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES SUBJECT: Initial Ethical Review of MITC Human Odor Threshold and Eye Irritation Studies FROM: John M. Carley TO: Anna Lowit, HED REF: MRID 44400401 Russell, M., Rush, T. ( 1996) Methyl Isothiocyanate: Determination of Human Olfactory Threshold and Human No Observable Effect Level for Eye Irritation. Unpublished study performed by Sensory Testing Laboratory, School of Medicine, Univ. of California, Davis, and Zeneca Ag Products Western Research Center, Richmond CA. Project numbers MITC UCD 1A 1993 and MITC UCD 1B 1994; Report no. RR 96 049B. 136 p.

MRID 46546601 AMVAC ( 2005) Raw Data for Methyl Isothiocyanate: Determination of Human Olfactory Detection Threshold and Human No Observable Effect Level for Eye Irritation: Supplement to MRID 44400401. Unpublished document. 43 p.

MRID 46558201 Metam Sodium Task Force ( 2005) Raw Data for Methyl Isothiocyanate: Determination of Human Olfactory Detection Threshold and Human No Observable Effect Level for Eye Irritation: Second Supplement to MRID 44400401. Unpublished document. 13 p.

MRID 46584901 University of California, Davis, Human Subjects Review Committee Records of HS Protocol 89 488, 90 605R, 91 665R, 94 601R, 95 553R, 96 547R, and 97 324R. Unpublished documents. 39 p.

The original report ( MRID 44400401) combines two independent studies  one to establish an odor threshold, and one to measure eye irritation  in a single report. Because the two studies were conducted separately and raise different concerns, this review deals with each of them in turn. The first supplemental report ( MRID 46546601) provides additional information about the ethical conduct of the eye irritation study. The second and third supplements ( MRIDs 46558201 and 46584901) address the ethical conduct of the odor threshold study. Page 2 of 16 I have performed an initial review of available information concerning the referenced documents. This review characterizes the ethical conduct of the research in terms of both current ethical standards and ethical standards prevailing when the studies were conducted. Each review applies the " Summary Framework for Ethical Assessment Using Seven Criteria of Emanuel et al." developed by the EPA Science Policy Committee's Human Studies Work Group. The completed " framework" is attached. This framework was derived from the work of Emanuel, et al. ( 2000), which summarizes seven general principles for ethical treatment of human subjects in clinical research. The Emanuel article was primarily directed at those who consider proposals for new medical research and decide which are worthy of funding or approval. These are very different decisions from those we in EPA must make when we determine whether we can ethically consider already completed human studies.

The Emanuel article reflects current standards for ethical research prevailing in the U. S. This research was conducted in the U. S. in 1992 95 in an institution  the University of California at Davis  holding a " multi project assurance" from HHS/ OPRR promising compliance with the Common Rule. It asserts compliance with both the Common Rule and the Declaration of Helsinki. I have considered both standards to have prevailed when the research was conducted.

I. Ethics Review of the Odor Threshold Study A. Summary Assessment of Ethical Conduct of the Research Here is a summary of my observations about the odor threshold study under the seven headings used in the Emanuel framework. Supporting details are in the first attachment.

1. Value of the Research to Society: The study has never been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. The study may, however, provide some information that could help inform EPA's assessment of human health risks of MITC. Its stated purpose was " to determine the human olfactory threshold for MITC."

2. Scientific Validity of the Research: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

3. Subject Selection: Methods of recruitment are not described. Subjects were 33 healthy males and females aging from 18 to 34, drawn from the university community surrounding the testing institution. There is no evidence suggesting bias in their selection or that any subjects were from an especially vulnerable population.

4. Risk Benefit Ratio: The research was characterized by the investigator in correspondence with the IRB at different times as of both " no risk" and " minimal risk." The investigator did not change this characterization when MITC was Page 3 of 16 added to the list of odorants he was already testing. There is no documentation of how risks were characterized to subjects. Benefits to society are not reported. There is no documentation of how risks and benefits were weighed by the investigators or the overseeing IRB. Participants were compensated $ 25 for participating in the study.

5. Independent Ethical Review: MRID 46584901 documents IRB approval by the University of California, Davis Human Subjects Review Committee, initially in 1989 and in annual renewals for several years thereafter, excluding, however, 1992 and 1993, when the MITC odor threshold study was actually conducted. The description of the study submitted to the IRB is much broader than the MITC study reported here, and it is not clear what the IRB approved. Neither a protocol nor any informed consent material concerning the MITC testing using the olfactometer is available. The IRB did not waive written informed consent, or respond to the investigator's request for a waiver of written informed consent, until three years after the MITC work was completed.

6. Informed Consent: Orally informed oral consent is asserted ( MRID 46558201) There is no documentation or description of what candidates were told to inform their consent, or of the process by which consent was sought. The investigator requested from the IRB a waiver from the standard requirement of the Common Rule for written consent; the IRB did not respond to this request until after this research was completed.

7. Respect for Potential and Enrolled Subjects: The privacy of subjects was not compromised in the report. The freedom of subjects to withdraw from the research was not addressed.

B. Compliance with Ethical Standard Prevailing when the Research Was Conducted Numerous ethical deficiencies are apparent when this study is reviewed against the principles of the Declaration of Helsinki ( 1989), with which the author asserts compliance, and the Common Rule, which the IRB was obliged to apply under the terms of the Multi Project Assurance they held from HSS/ OPRR at the time of the research:

  Declaration of Helsinki Basic Principle # 2: " The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor . . . ."

The protocol for this research  especially the work with MITC and the olfactometer  was not clearly formulated. Based on the records of the IRB, this " project" began with mailing 11 million " scratch and sniff" odor surveys by the National Geographic Society, and later changed into testing some 100 150 people a year in the university community. Page 4 of 16 The MITC work was an aspect of this later phase, and MITC was one of several chemicals used in testing for olfactory threshold.

  Declaration of Helsinki Basic Principle # 5: " Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. . . ."

If a careful assessment of risks and benefits was conducted, it was not reported.

  Declaration of Helsinki Basic Principle # 9: " In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing.

The primary report is entirely silent about consent, and the information provided by the investigator to the IRB about consent was irrelevant to the research with MITC. The IRB failed to notice or respond to the investigator's inappropriate request for waiver of the customary requirement for written informed consent.

  Declaration of Helsinki Basic Principle # 12: " The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with."

No such statement appears in the protocol.

  Common Rule § 111( a)( 2): [ In order to approve research covered by this policy the IRB shall determine that] " 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."

IRB records do not evidence any discussion of either risks or benefits of the research.

  Common Rule § 111( a)( 4): [ In order to approve research covered by this policy the IRB shall determine that] " Informed consent will be sought from each prospective subject . . ."

IRB records do not evidence any discussion of informed consent.

  Common Rule § 111( a)( 5): [ In order to approve research covered by this policy the IRB shall determine that] " Informed consent will be appropriately documented, in accordance with, and to the extent required by Sec. 26.117."

IRB records do not provide evidence that the board noticed or discussed the investigator's request for waiver of written informed consent.

  Common Rule § 115: IRB Records Page 5 of 16 IRB records of this research fall well short of the requirements of the Common Rule.

  Common Rule § 116: General requirements for informed consent The content of the oral informed consent process is not documented. It cannot be determined whether it was consistent with these requirements of the Common Rule.

  Common Rule § 117: Documentation of informed consent.

( a) Except as provided in paragraph ( c) of this section, 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. ( c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: ( 1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or ( 2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Informed consent is not documented for this research. The failure either to document consent or to waive the Common Rule requirement to document consent is a serious shortcoming in the conduct of this odor threshold study. Given the investigator's assertion, however, that informed oral consent was obtained, this lapse does not in my judgment amount to clear and convincing evidence that this study was fundamentally unethical.

Available documentation suggests that the IRB noticed neither the lack of any consent materials nor the investigator's request for waiver of written consent during the first several years they reviewed this research. After the MITC work had been completed they waived written consent based on an argument from the investigator that applied only to the mail out survey work completed years earlier.

C. Standards for Judging Ethical Acceptability On February 6, 2006, EPA published a final rule, " Protections for Subjects in Human Research," effective on April 7, 2006. Section 26.1704 of that regulation provides in pertinent part:

EPA shall not rely on data from any research initiated before [ April 7, 2006, the effective date of the final rule] if there is clear and convincing evidence that the Page 6 of 16 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.

In addition, section 26.1703 of the final rule provides in pertinent part:

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.

I have applied the standards in sections 26.1704 and 26.1703 in arriving at the conclusions below.

D. Conclusions All subjects were at least 18 years old. Female subjects said they were not pregnant; this was a requirement to participate in the research. Section 26.1703 does not prohibit reliance on this study.

Although there are serious gaps in the documentation of the ethical conduct of this study, there is no clear evidence that the research was intended to harm participants, or that it was fundamentally unethical in other ways. Deficient documentation does not itself constitute evidence that the ethical conduct of this study was deficient relative to standards prevailing when it was conducted.

From the documentation available I have identified many deficiencies relative to the standards of the 1989 Declaration of Helsinki and the Common Rule, with both of which the study asserts compliance. These ethical deficiencies do not, in my judgment, amount to " clear and convincing evidence" that this study was " fundamentally unethical." This review, however, does not take a position on either the persuasiveness of the evidence or the overall significance of the identified deficiencies relative to the prevailing ethical standards. This decision is deferred pending review of the research by the Human Studies Review Board as required by EPA regulation before EPA takes an action relying on this study.

II. Ethics Review of the Eye Irritation Study A. Summary Assessment of Ethical Conduct of the Research Here is a summary of my observations about the eye irritation study under the seven headings used in the Emanuel framework. Supporting details are in the second attachment.

1. Value of the Research to Society: The study has never been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. The study Page 7 of 16 may, however, provide some information that could help inform EPA's assessment of human health risks of MITC.

Its purpose was stated in the study report as " to determine the concentrations of MITC vapor that, after various periods of exposure, would produce no observable irritation responses in the eyes of normal, human volunteer test subjects." In the informed consent materials the purpose was stated as "[ t] he State of California wants to establish eye irritation levels for . . . MITC as a potential warning signal to exposed workers. . . . [ T] his study is designed to provide these data."

2. Scientific Validity of the Research: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

3. Subject Selection: Subjects were healthy males and females aged 18 to 67, drawn from the community of the testing institution. It is impossible to be sure how many subjects actually participated, since it is reported that many of them took part in more than one phase of this four phase study under different identifiers. It appears likely that subjects included at least some students of the investigators, and perhaps also colleagues or employees of the investigators. This could lead to either or both undue influence in recruiting or bias in reporting subjective effects. I found no other indication that subjects were members of particularly vulnerable populations.

4. Risk Benefit Ratio: Risks to subjects were characterized as transient eye irritation and tearing. The study report does not address steps taken to minimize risks to subjects, or possible alternative methods to obtain similar information. Expected societal benefits are not discussed in the report, or in the documentation of the ethics committee's review. There is no discussion of how societal benefits were balanced against the risks to individual subjects. Participants were compensated for participating in each phase of the study, $ 60 250 depending on its duration.

5. Independent Ethical Review: Initial approval and annual renewals with protocol revisions were provided by a registered IRB and are documented. There is no documentation of IRB discussion. Documentation of risk minimization and of risk/ benefit balancing is weak, and recruiting of students or employees as subjects could have involved undue influence.

6. Informed Consent: Consent materials are brief but clear, and include all elements required by the Common Rule.

7. Respect for Potential and Enrolled Subjects: The privacy of subjects was not compromised. They were free to withdraw at any time, although compensation would have been reduced for early withdrawal.

B. Compliance with Ethical Standard Prevailing when the Research Was Page 8 of 16 Conducted Some minor deficiencies are apparent when this study is reviewed against the principles of the Declaration of Helsinki ( 1989), with which it asserts compliance, and the Common Rule, which the IRB was obliged to apply under the terms of the Multi Project Assurance from HHS/ OPRR held by UC Davis at the time of this research.

Although documentation of risk reduction and societal benefits is weak, and there is some possibility of undue influence in the recruitment as subjects of students of the investigators, there is no clear evidence that the conduct of this research fell short of Common Rule standards.

C. Standards for Judging Ethical Acceptability On February 6, 2006, EPA published a final rule, " Protections for Subjects in Human Research," effective on April 7, 2006. Section 26.1704 of that regulation provides in pertinent part:

EPA shall not rely on data from any research initiated before [ April 7, 2006, the effective date of the final rule] 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.

In addition, section 26.1703 of the final rule provides in pertinent part:

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.

I have applied the standards in sections 26.1704 and 26.1703 in arriving at the conclusions below.

D. Conclusions All subjects were at least 18 years old. Female subjects said they were not pregnant; this was a requirement to participate in the research. Section 26.1703 does not prohibit reliance on this study.

Although there are some minor gaps in the documentation of the ethical conduct of this study, there is no clear evidence that the research was intended to harm participants, or that it was fundamentally unethical in other ways. Deficient documentation does not itself constitute evidence that the ethical conduct of this study was deficient relative to standards prevailing when it was conducted. Page 9 of 16 From the documentation available I have identified only minor deficiencies relative to the standards of the 1989 Declaration of Helsinki, with which the study asserts compliance, and the Common Rule. These deficiencies do not, in my judgment, amount to " clear and convincing evidence" that this study was " fundamentally unethical." This review, however, does not take a position on either the persuasiveness of the evidence or the overall significance of the identified deficiencies relative to the prevailing ethical standards. This decision is deferred pending review of the research by the Human Studies Review Board as required by EPA regulation before EPA takes an action relying on this study.

Attachments Cited reference:

Emanuel, E.; Wender, D.; Grady, C. ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711. Page 10 of 16 Attachment 1: Odor Threshold Framework for Ethical Assessment Using Seven Criteria of Emanuel et al. 1 April 13, 2006 MRID 44400401 Russell, M., Rush, T. ( 1996) Methyl Isothiocyanate: Determination of Human Olfactory Threshold and Human No Observable Effect Level for Eye Irritation. Unpublished study performed by Sensory Testing Laboratory, School of Medicine, Univ. of California, Davis, and Zeneca Ag Products Western Research Center, Richmond CA. Project numbers MITC UCD 1A 1993 and MITC UCD 1B 1994; Report no. RR 96 049B. 136 p.

MRID 46558201 Metam Sodium Task Force ( 2005) Raw Data for Methyl Isothiocyanate: Determination of Human Olfactory Detection Threshold And Human No Observable Effect Level for Eye Irritation: Second Supplement to MRID 44400401. Unpublished document. 13 p.

MRID 46584901 University of California, Davis. Human Subjects Review Committee records of HS Protocols 89 488, 90 605R, 91 665R, 94 601R, 95 553R, 96,547R, and 97 324R. Unpublished documents. 39 p.

1. Value: The study has never been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. The study may, however, provide some information that could help inform EPA's assessment of human health risks of MITC. Its stated purpose was " to determine the human olfactory threshold for MITC."

a. What was the stated purpose of the research? " to determine the human olfactory detection threshold for MITC" ( 44400401 p. 12)

b. Does it evaluate a diagnostic or therapeutic intervention that could lead to improvements in health or well being? No.

c. Does it test a hypothesis that can generate important knowledge about structure or function of human biological systems, with or without immediate practical application? No.

d. Will society benefit from the knowledge gained from this research? Will its results be disseminated? It has not been published.

e. What government, organization, company and/ or institution( s) funded the research? Metam Sodium Task Force 2. Scientific Validity: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

a. Did the research have a clear scientific objective? See 1( a) above.

b. Was the research designed using accepted principles, methods, and reliable practices? I defer to the science reviewer. The equipment is reported to have been " specifically designed and constructed for this project." ( 44400401, p. 13) Page 11 of 16 c. In what way were human subjects intentionally dosed in this research, and what were the endpoints identified or quantified? Subjects were exposed to an airstream capable of delivering any of five odorants at any of nine concentrations. Upon each exposure they reported whether they could detect the odorant. No other endpoints were identified or quantified.

d. Did the research design have sufficient power to definitively test the objective? I defer to the science reviewer e. To what purpose is the study used, or proposed for use, in the Agency? To inform the weight of evidence assessment of MITC for reregistration/ tolerance reassessment 3. Fair Subject Selection: Methods of recruitment are not described. Subjects were 33 healthy males and females aging from 18 to 34, drawn from the university community surrounding the testing institution. There is no evidence suggesting bias in their selection or that any subjects were from an especially vulnerable population.

a. Were the groups and individuals recruited and enrolled determined solely on the basis of the scientific goals of the study? " Thirty eight human volunteers applied to be test subjects. . . . Applicants were excluded if they scored [ significantly] below the mean on the Smell Identification Test, indicated a significant history of smell dysfunction, evinced current symptoms of cold or allergy, indicated pregnancy, or failed to complete an initial training exercise as an olfactometer subject." ( 44400401 p. 12)

b. Were any susceptible groups used in the study, such as children, prisoners, infirm, or impoverished? Did the burden of participation fall disproportionately on a particular group? All subjects were adults; females said they were not pregnant. There is no indication that members of vulnerable groups were recruited, but recruitment methods are not reported.

4. Favorable Risk Benefit Ratio: The research was characterized by the investigator in correspondence with the IRB at different times as of both " no risk" and " minimal risk" ( MRID 46584901) The investigator did not change this characterization when MITC was added to the list of odorants he was already testing. There is no documentation of how risks were characterized to subjects. Benefits to society are not reported. There is no documentation of how risks and benefits were weighed by the investigators or the overseeing IRB. Participants were compensated $ 25 for participating in the study.

a. Were the risks to individual subjects minimized? Risks to subjects are not identified. The original protocol sent to the IRB characterized the research as of " no risk"; in subsequent renewal applications it was characterized as " minimal risk." Under the Common Rule definition, " minimal risk" is equivalent to the risks of everyday life.

b. If the research presents no health related benefits to individual subjects, what are the societal benefits in terms of knowledge from the study, and do these justify the excess risk to individual subjects? There is no discussion of benefits to society or others, and no record of how the IRB weighed expected societal benefits against the incremental risks to subjects.

c. What compensation was paid to the participants in the study? $ 25. Page 12 of 16 5. Independent Review: MRID 46584901 documents IRB approval by the University of California, Davis Human Subjects Review Committee, initially in 1989 and in annual renewals for several years thereafter, excluding, however, 1992 and 1993, when the MITC odor threshold study was actually conducted. The description of the study submitted to the IRB is much broader than the MITC study reported here, and it is not clear what the IRB approved. Neither a protocol nor any informed consent material concerning the MITC testing using the olfactometer is available. The IRB did not waive written informed consent, or respond to the investigator's request for a waiver of written informed consent, until three years after the MITC work was completed.

a. Was the research asserted to have been overseen by an ethics review body ( ERB)? What ERB? The research was overseen by the University of California, Davis Human Subjects Review Committee.

b. Was the research subject to independent review by individuals unaffiliated with the clinical research? Yes c. Was the research conducted in compliance with the Common Rule? The research was initially asserted to be " no risk", and in subsequent renewal requests as " minimal risk". The investigator requested a waiver of signed consent, but this was not acknowledged or approved by the IRB. A note to the file dated Dec 23, 1996, and included in MRID 46558201, asserts that the consent process was entirely oral. In the absence of a waiver by the IRB of the requirement for written consent, this is non compliant with the Common Rule.

d. Does/ did the research institution ( or any institution participating in the research) hold a Federal Wide Assurance or, previously, Multi Project Assurance during the period of the study? UC Davis held a Multi Project Assurance from the DHHS/ OHRP at the time of this research, under which they had committed to comply with the Common Rule in all research with human subjects conducted at their institution, without regard to whether it was supported by the federal government.

e. Was the research conducted in compliance with another standard? What standard? " All aspects of this research were performed in accordance with the Helsinki Declaration for Testing and Protection of Human Subjects and the Human Subject's Bill of Rights." ( 44400401 p. 13) This assertion is not supported by documentary evidence.

6. Informed Consent: Subjects did not provide written consent. Orally informed oral consent is asserted. There is no documentation of the information provided to candidates to inform their consent or of the process by which consent was sought.

a. Does the research assert that informed consent was obtained from participants? "[ T] est subjects gave consent verbally, rather than by signing a document. . . . all of the test subjects were informed verbally of the risks they were taking, and gave consent after being informed of the risks. They were not exposed to any odorants until they had given informed consent" ( Supplement p. 5)

b. How and under what circumstances was informed consent obtained? Methods and circumstances are not reported, nor is there any documentation of the information provided to candidates to inform their consent.

7. Respect for Potential and Enrolled Subjects: The privacy of subjects was not compromised. The freedom of subjects to withdraw from the research was not addressed.

a. Was information about individual subjects managed so as to ensure their privacy? Yes.

b. Were subjects free to withdraw from the research without penalty? Not reported. Page 13 of 16 1 Emanuel, E; Wender, D; Grady, C ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711. Page 14 of 16 Attachment 2: Eye Irritation Framework for Ethical Assessment Using Seven Criteria of Emanuel et al. 1 April 13, 2006 MRID 44400401 Russell, M., Rush, T. ( 1996) Methyl Isothiocyanate: Determination of Human Olfactory Threshold and Human No Observable Effect Level for Eye Irritation. Unpublished study performed by Sensory Testing Laboratory, School of Medicine, Univ. of California, Davis, and Zeneca Ag Products Western Research Center, Richmond CA. Project numbers MITC UCD 1A 1993 and MITC UCD 1B 1994; Report no. RR 96 049B. 136 p.

MRID 46546601 AMVAC ( 2005) Raw Data for Methyl Isothiocyanate: Determination of Human Olfactory Detection Threshold And Human No Observable Effect Level for Eye Irritation: Supplement to MRID 44400401. Unpublished document. 43 p.

1. Value: The study has not been published, suggesting that its purpose was not mainly to obtain generalizable knowledge. The study may, however, provide some information that could help inform EPA's assessment of human health risks of MITC.

a. What was the stated purpose of the research? "[ T] o determine the concentrations of MITC vapor that, after various periods of exposure, would produce no observable irritation responses in the eyes of normal, human volunteer test subjects." ( MRID 44400401, p. 26). In the informed consent materials the purpose was stated as "[ t] he State of California wants to establish eye irritation levels for . . . MITC as a potential warning signal to exposed workers. . . this study is designed to provide these data." ( MRID 46546601, p. 11)

b. Does it evaluate a diagnostic or therapeutic intervention that could lead to improvements in health or well being? No.

c. Does it test a hypothesis that can generate important knowledge about structure or function of human biological systems, with or without immediate practical application? No.

d. Will society benefit from the knowledge gained from this research? Will its results be disseminated? It has not been published.

e. What government, organization, company and/ or institution( s) funded the research? Metam Sodium Task Force 2. Scientific Validity: I defer to others for a full review of the scientific validity of this study. If it were determined not to have scientific validity, it would also not be ethically acceptable.

a. Did the research have a clear scientific objective? See 1( a) above.

b. Was the research designed using accepted principles, methods, and reliable practices? I defer to the science reviewer.

c. In what way were human subjects intentionally dosed in this research, and what were the endpoints identified or quantified? Subjects wore goggles into which air with measured concentrations of MITC was routed, and exposure continued for durations from a few minutes to 8 hours. Endpoints measured were subjective judgments of irritation, blink rate, tearing, and visual acuity. Page 15 of 16 d. Did the research design have sufficient power to definitively test the objective? I defer to the science reviewer e. To what purpose is the study used, or proposed for use, in the Agency? To inform the weight of evidence assessment of MITC for reregistration/ tolerance reassessment 3. Fair Subject Selection: It is impossible to tell how many subjects actually participated, since it is acknowledged that many of them took part in more than one phase of this four phase study under different identifiers. It appears likely that subjects included at least some students of the investigators, and perhaps also colleagues or employees of the investigators. This could lead to either or both undue influence in recruiting or bias in reporting subjective effects. There is no other indication that subjects came from particularly vulnerable populations. All were over 18 and said they were not pregnant.

a. Were the groups and individuals recruited and enrolled determined solely on the basis of the scientific goals of the study? The supplement indicates that subjects were to include students and " normal adult volunteers", who would be contacted " in person: home or work"; " in person: public place"; and through " in class announcement." ( MRID 46546601, p. 25) " Applicants were excluded if they reported any abnormal eye irritability, wearing contact lenses, frequent headaches, recent asthma attacks, or pregnancy." ( 44400401p. 27)

b. Were any susceptible groups used in the study, such as children, prisoners, infirm, or impoverished? Did the burden of participation fall disproportionately on a particular group? " Volunteers from the Sacramento Metropolitan area applied to be test subjects. . . . Applicants were excluded if they reported any abnormal eye irritability, wearing contact lenses, frequent headaches, recent asthma attacks, or pregnancy. These screening procedures resulted in a subject population of 70 individuals . . . who ranged in age from 18 to 67 years. . . Participants in the previous odor threshold study were invited to participate in this study as well, and they were used when possible. . . . Many of the subjects participated in the study on several occasions in the successive trial series and when different exposure levels were offered, taking new subject identification numbers on every occasion." Recruiting in person at subjects' homes or workplaces, and through in class announcements, could involve undue influence, especially if subjects were students or employees of the investigators, and could introduce possible bias in subjective reporting of effects.

4. Favorable Risk Benefit Ratio: The study report does not address steps taken to minimize risks to subjects, or possible alternative methods to obtain similar information. Expected societal benefits are not discussed in the report, or in the documentation of the ethics committee's review. Participants were compensated $ 60 250, depending on the duration of each phase of the study.

a. Were the risks to individual subjects minimized? Risk minimization is not directly discussed. Materials submitted to the IRB emphasized that doses were low compared to animal NOAELs. ( MRID 46546601) The informed consent materials told potential subjects "[ t] here is no known long term risk though you may experience irritation and tearing of the eyes that quickly goes away at the end of exposure. The maximum exposure level is well below any known health risk." ( MRID 46546601 p. 11)

b. If the research presents no health related benefits to individual subjects, what are the societal benefits in terms of knowledge from the study, and do these justify the excess risk to subjects? Indirect reference is made to the potential for this study to establish threshold levels for eye irritation that would help regulatory authorities to determine safe exposures for workers. It is acknowledged there is no direct benefit to the subjects. There is no direct discussion of benefits to society or others, and there is no record of how the IRB weighed expected societal benefits against the incremental risks to subjects. Page 16 of 16 c. What compensation was paid to the participants in the study? $ 60 for a single, acute exposure; $ 75 for one hour exposure; $ 150 for four hour exposure; $ 250 for eight hour exposure; all prorated in case of early withdrawal.

5. Independent Review: Initial approval and annual renewals with protocol revisions were provided by a registered IRB and are documented. There is no documentation of IRB discussion.

a. Was the research asserted to have been overseen by an ethics review body ( ERB)? What ERB? The research was reviewed and approved by the University of California, Davis Human Subjects Review Committee. The IRB required annual renewal of approval, and received progress reports and protocol revisions.

b. Was the research subject to independent review by individuals unaffiliated with the clinical research? Yes c. Was the research conducted in compliance with the Common Rule? UC Davis held a Multi Project Assurance from HHS/ OPRR at this time of this research, under which they committed to comply with the Common Rule in all research they conducted with human subjects. The study report does not assert compliance with the Common Rule.

d. Does/ did the research institution ( or any institution participating in the research) hold a Federal Wide Assurance or, previously, Multi Project Assurance during the period of the study? UC Davis held a Multi Project Assurance from the DHHS/ OHRP at the time of this research e. Was the research conducted in compliance with another standard? What standard? "[ T] his study was conducted in accordance with the Helsinki Declaration . . . and the Human Subject's Bill of Rights." ( p. 27)

6. Informed Consent: Consent materials are brief, but clear, and include all elements required by the Common Rule.

a. Does the research assert that informed consent was obtained from participants? " Each subject was informed as to the nature of the study and gave written consent to participate." ( MRID 44400401, p. 27). Informed consent materials were included in the supplemental report ( MRID 46546601.)

b. How and under what circumstances was informed consent obtained? Methods and circumstances are not reported. The IC materials are clear that the subject can expect no benefit from participation, and is free to withdraw at any time.

7. Respect for Potential and Enrolled Subjects: The privacy of subjects was not compromised. They were free to withdraw at any time, although compensation would have been reduced for early withdrawal.

a. Was information about individual subjects managed so as to ensure their privacy? Yes.

b. Were subjects free to withdraw from the research without penalty? Yes, although compensation would have been reduced for early withdrawal. No early withdrawals were reported.

1 Emanuel, E; Wender, D; Grady, C ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711.


MEMORANDUM

DATE:                  12/1/14

FROM:                 Ken Mitchell/EPA Region 4

TO:                       Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

SUBJECT:             Discussion of the Clean Power Plan with the Mississippi Bar  -  Summer Session

SUMMARY:
REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAn to a group of Mississippi attorneys and consultants at the Mississippi Bar Summer Session Panel in Destin, FL, on June 23, 2014. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.
ATTENDEES:

EPA
Heather McTeer Toney/EPA R4
Allison Wise/EPA R4

External Stakeholders
James I. Palmer, Jr/Attorney  -  Butler Snow LLP
Jennifer G. Hall/Attorney
Mississippi Department of Environmental Quality
Approximately 100 audience participants