[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Rules and Regulations]
[Pages 59178-59180]
[FR Doc No: 2020-20675]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0330; Product Identifier 2020-NM-031-AD; Amendment
39-21236; AD 2020-18-15]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A350-941 and -1041 airplanes. This AD was
prompted by a report indicating that when the number 2 engine thrust
reverser (T/R) was opened, the right-hand T/R hinge nut located at
position 4 was found detached; investigation revealed that certain nuts
could have been installed with noncompliant locking features, or with
locking features that could degrade quicker than anticipated. This AD
requires replacing any existing nut on the T/R hinge with a new nut,
installing a new nut and washer if necessary, and applying a torque
stripe at each T/R hinge location, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective October 26, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 26,
2020.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0330.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0330; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0028, dated February 14, 2020
(``EASA AD 2020-0028'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A350-941 and -1041 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus SAS
Model A350-941 and -1041 airplanes. The NPRM published in the Federal
Register on April 16, 2020 (85 FR 21115). The NPRM was prompted by a
report indicating that when the number 2 engine T/R was opened, the
right-hand T/R hinge nut located at position 4 was found detached;
investigation revealed that certain nuts could have been installed with
noncompliant locking features, or with locking features that could
degrade quicker than anticipated. The NPRM proposed to require
inspecting each T/R hinge for the presence of a nut and washer,
installing a new nut and washer if necessary, and applying a torque
stripe at each T/R hinge location, as specified in an EASA AD.
    The FAA is issuing this AD to address this condition, which, if
occurring on multiple hinge attachments, could lead to in-flight loss
of a T/R, consequent structural damage to the airplane, and possible
injury to persons on the ground. See the MCAI for additional background
information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Support for the NPRM

    The Air Line Pilots Association, International (ALPA), Manikandan
Raja, and an anonymous commenter stated support for the NPRM.

Request To Exempt Operators From Torque Stripe Requirement

    Delta Airlines (DAL) asked that operators be exempt from applying
the torque stripe required by EASA AD 2020-0028 (referenced in the
proposed AD as the appropriate source of service information for
accomplishing the required actions). DAL stated that there are no
mandated requirements in EASA AD 2020-0028 or the service information
referenced in EASA AD 2020-0028 for repetitive inspections of the nut
or verification for the presence of an intact torque stripe to ensure
the nut has not rotated over time. DAL added that the current aircraft
maintenance manual (AMM) instructs operators to apply a torque stripe
at the

intended locations during routine maintenance. DAL noted that the
torque stripe has the potential to degrade over time, which could
create a potential noncompliance risk to operators, despite having
previously accomplished the requirements in the proposed AD.
    The FAA acknowledges that adding the torque stripe is a one-time
task with no repeated check; however, the FAA agrees with the state of
design that adding it is done to bring the aircraft back to type
design. DAL's approved maintenance program should not affect the
requirements of this AD. The FAA has not changed this AD in this
regard.

Explanation of Change to AD

    The Reason section of EASA AD 2020-0028 stated that ``this AD
requires a one-time inspection of the T/R hinge nuts'' as one of the
proposed requirements. In the FAA NPRM, the FAA added an inspection of
the T/R hinge for the presence of nut and washer, in order to more
closely correspond to the instructions in the service information
referenced in EASA AD 2020-0028. EASA has since advised the FAA that
the inspection is unnecessary. The FAA has therefore revised this AD to
remove that inspection and to instead require compliance ``with all
required actions and compliance times specified in, and in accordance
with, EASA AD 2020-0028.'' The FAA further revised the Summary section
to remove the inspection and expand upon the required actions,
including possible replacement.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0028 describes procedures for replacing any existing
nut on the T/R hinge with a new nut, installing a new nut and washer if
neither is installed, and applying a torque stripe at each location.
This material is reasonably available because the interested parties
have access to it through their normal course of business or by the
means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 13 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S.  operators
----------------------------------------------------------------------------------------------------------------
Up to 4 work-hours x $85 per hour = Up              $984  Up to $1,324..............  Up to $17,212.
 to $340.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2020-18-15 Airbus SAS: Amendment 39-21236; Docket No. FAA-2020-0330;
Product Identifier 2020-NM-031-AD.

(a) Effective Date

    This AD is effective October 26, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2020-0028, dated February 14,
2020 (``EASA AD 2020-0028'').

(d) Subject

    Air Transport Association (ATA) of America Code 78, Exhaust.

(e) Reason

    This AD was prompted by a report indicating that when the number
2 engine thrust reverser (T/R) was opened, the right-

hand T/R hinge nut located at position 4 was found detached;
investigation revealed that certain nuts could have been installed
with noncompliant locking features, or with locking features that
could degrade quicker than anticipated. The FAA is issuing this AD
to address this condition, which, if occurring on multiple hinge
attachments, could lead to in-flight loss of a T/R, consequent
structural damage to the airplane, and possible injury to persons on
the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0028.

(h) Exceptions to EASA AD 2020-0028

    (1) Where EASA AD 2020-0028 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0028 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0028
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (k) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0028 that contains RC procedures and
tests: Except as required by paragraph (j)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0028,
dated February 14, 2020.
    (ii) [Reserved]
    (3) For information about EASA 2020-0028, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0330.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 26, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-20675 Filed 9-18-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Rules and Regulations]
[Pages 37958-37960]
[FR Doc No: 2014-15688]

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ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1516 and 1552

[EPA-HQ-OARM-2013-0149; FRL-9913-36-OARM]

EPAAR Clause for Ordering by Designated Ordering Officers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) amends the EPA
Acquisition Regulation (EPAAR) to update policy, procedures, and
contract clauses. The final rule updates the Ordering--By Designated
Ordering Officers clause and a corresponding prescription.

DATES: This final rule is effective on July 3, 2014.

ADDRESSES: Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov, or in hard copy at the Office of Environmental
Information (OEI) Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the EPA Docket Center is (202)
566-1752. This Docket Facility is open from 8:30 a.m. to 4:30 p.m.
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy, Training,
and Oversight Division, Office of Acquisition Management (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The subject clause is currently codified in the EPAAR as the April
1984 basic clause without any alternates. The basic clause only
contemplates order issuance prior to receiving formal input from the
contractor. On December 21, 1989, a class deviation was issued to
prescribe an alternate to the clause that provides for negotiating the
terms and conditions of a task/delivery order prior to order issuance.
There are several benefits to negotiation prior to order issuance: The
Government is not charged directly for the time involved in
negotiations and the associated costs are part of bid and proposal
costs which are indirect charges spread across all Government
contracts; it allows for more accurate pricing for the order, and it
enables the Government to hold the Contractor to negotiated
requirements as soon as the order is issued. As a result, the subject
clause and corresponding prescription are being updated to add the 1989
class deviation. Because the class deviation provides several benefits
that the basic clause does not, it will be designated as the basic form
of the Ordering clause, and the previous basic form is being re-
designated as Alternate

I. In addition, the EPAAR 1516.505(a) subject clause prescription is
being updated accordingly. On April 7, 2014 (79 FR 19039) EPA sought
comments on the proposed rule and received no comments.

II. Final Rule

    This final rule updates the EPAAR 1516.505(a) clause prescription,
and amends EPAAR 1552.216-72 to add an alternate version to the
Ordering--By Designated Ordering Officers clause. It also provides
additional information in Section (III)(C) below relating to the
Regulatory Flexibility Act as amended by the Small Business Regulatory
Enforcement Fairness Act of 1996.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO)12866 (58 FR 51735, October 4, 1993) and
therefore, not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
No information is collected under this action.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute; unless the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's final rule on small
entities, ``small entity'' is defined as: (1) A small business that
meets the definition of a small business found in the Small Business
Act and codified at 13 CFR 121.201; (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This action
revises a current EPAAR clause and does not impose requirements
involving capital investment, implementing procedures, or record
keeping. The previous basic form of the clause (which is now Alternate
I) is already codified in the EPAAR, and the form that is being re-
designated as the basic form has already been in wide use as an EPA
clause deviation since 1989. Depending on procurement specifics, EPA
uses the basic form of the clause about twice as often as the alternate
form, because the basic form provides several benefits to negotiation
prior to order issuance, as discussed in the Background section above.
Therefore this rule will not have a significant economic impact on
small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Local, and Tribal
governments and the private sector.
    This rule contains no Federal mandates (under the regulatory
provisions of the Title II of the UMRA) for State, Local, and Tribal
governments or the private sector. The rule imposes no enforceable duty
on any State, Local or Tribal governments or the private sector. Thus,
the rule is not subject to the requirements of Sections 202 and 205 of
the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and Local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This rule does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government as
specified in Executive Order 13132.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications as specified in Executive Order 13175.

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

    Executive Order 13045, entitled ``Protection of Children from
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under Executive Order 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to Executive Order 13045
because it is not an economically significant rule as defined by
Executive Order 12866, and because it does not involve decisions on
environmental health or safety risks.

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

    This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution of Use'' (66 FR 28335 (MAY 22, 2001), because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    Section 12(d) (15 U.S.C 272 note) of NTTA, Public Law 104-113,
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTA directs EPA to provide
Congress, through OMB, explanations when the Agency decides

not to use available and applicable voluntary consensus standards.
    This final rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

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

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This final rulemaking does not involve human health or
environmental effects.

List of Subjects

48 CFR Part 1516

    Government procurement.

48 CFR Part 1522

    Equal employment opportunity, Government procurement, Individuals
with disabilities, Labor, Veterans.

    Dated: June 11, 2014.
John R. Bashista,
Director, Office of Acquisition Management.

    Therefore, 48 CFR Chapter 15 is amended as set forth below:

0
1. The authority citation for 48 CFR parts 1516 and 1552 continues to
read as follows:

    Authority: 5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended,
40 U.S.C. 486(c); and 41 U.S.C. 418b.

PART 1516--TYPES OF CONTRACTS

0
2. Revise 1516.505(a) as follows:

1516.505  Contract clauses.

    (a) The Contracting Officer shall insert the clause in 1552.216-72,
Ordering--By Designated Ordering Officers, or a clause substantially
similar to the subject clause, in indefinite delivery/indefinite
quantity type solicitations and contracts. The Contracting Officer
shall insert Alternate I when formal input from the Contractor will not
be obtained prior to order issuance.
* * * * *

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
3. Revise 1552.216-72 to read as follows:

1552.216-72  Ordering--by designated ordering officers.

    As prescribed in 1516.505(a), insert the subject clause, or a
clause substantially similar to the subject clause, in indefinite
delivery/indefinite quantity type solicitations and contracts.

ORDERING--BY DESIGNATED ORDERING OFFICERS (----2014)

    (a) The Government will order any supplies and services to be
furnished under this contract by issuing task/delivery orders on
Optional Form 347, or an agency prescribed form, from ------ through
------. In addition to the Contracting Officer, the following
individuals are authorized ordering officers.
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-----------------------------------------------------------------------
    (b) A Standard Form 30 will be the method of amending task/
delivery orders.
    (c) The Contractor shall acknowledge receipt of each order by
having an authorized company officer sign either a copy of a
transmittal letter or signature block on page 3 of the task/delivery
order, depending upon which is provided, within ---- calendar days
of receipt.
    (d) Prior to the placement of any task/delivery order, the
Contractor will be provided with a proposed Performance Work
Statement/Statement of Work and will be asked to respond with
detailed technical and cost proposals within ---- calendar days or
less. The technical proposal will delineate the Contractor's
interpretation for the execution of the PWS/SOW, and the pricing
proposal will be the Contractor's best estimate for the hours, labor
categories and all costs associated with the execution. The
proposals are subject to negotiation. The Ordering Officer and the
Contractor shall reach agreement on all the material terms of each
order prior to the order being issued.
    (e) Each task/delivery order issued will incorporate the
Contractor's technical and cost proposals as negotiated with the
Government, and will have a ceiling price which the contractor shall
not exceed. When the Contractor has reason to believe that the labor
payment and support costs for the order which will accrue in the
next thirty (30) days will bring total cost to over 85 percent of
the ceiling price specified in the order, the Contractor shall
notify the Ordering Officer.
    (f) Under no circumstances will the Contractor start work prior
to the issue date of the task/delivery order unless specifically
authorized to do so by the Ordering Officer. Any verbal
authorization will be confirmed in writing by the Ordering Officer
or Contracting Officer within ---- calendar days.

(End of clause)

    Alternate I. As prescribed in 1516.505(a), insert the subject
clause, or a clause substantially similar to the subject clause, in
indefinite delivery/indefinite quantity contracts when formal input
from the Contractor will not be obtained prior to order issuance.
    (a) The Government will order any supplies and services to be
furnished under this contract by issuing task/delivery orders on
Optional Form 347, or any agency prescribed form, from ---- through
----. In addition to the Contracting Officer, the following
individuals are authorized ordering officers:
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    (b) A Standard Form 30 will be the method of amending task/
delivery orders.
    (c) The Contractor shall acknowledge receipt of each order and
shall prepare and forward to the Ordering Officer within ----
calendar days the proposed staffing plan for accomplishing the
assigned task within the period specified.
    (d) If the Contractor considers the estimated labor hours or
specified work completion date to be unreasonable, the Contractor
shall promptly notify the Ordering Officer and Contracting Officer
in writing within ---- calendar days, stating why the estimated
labor hours or specified completion date is considered unreasonable.
    (e) Each task/delivery order will have a ceiling price, which
the Contractor may not exceed. When the Contractor has reason to
believe that the labor payment and support costs for the order,
which will accrue in the next thirty (30) days, will bring total
cost to over 85 percent of the ceiling price specified in the order,
the Contractor shall notify the Ordering Officer.
    (f) Paragraphs (c), (d), and (e) of this clause apply only when
services are being ordered.

(End of clause)

[FR Doc. 2014-15688 Filed 7-2-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 14, 2006 (Volume 71, Number 178)]
[Notices]
[Page 54282]
[DOCID:fr14se06-39]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0384; FRL-8219-7]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the June 27-30, 2006
HSRB Meeting; Correction of EPA Contact Telephone Number

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; correction.

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

SUMMARY: On September 5, 2006, the U.S. Environmental Protection
Agency's (EPA or Agency) Office of the Science Advisor (OSA) announced
a public teleconference of the Human Studies Review Board (HSRB) to be
held September 26, 2006 from 1-4 p.m., eastern time. Please be advised
that the contact telephone number for the DFO was incorrect.

FOR FURTHER INFORMATION CONTACT: Maria Szilagyi, Designated Federal
Officer (DFO), EPA, Office of the Science Advisor, (8105),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460: telephone number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>General information concerning the EPA HSRB can

be obtained from the EPA Web site at http://www.epa.gov/osa/hsrb/.

    Correction: In the Federal Register of September 5, 2006, in FR
Doc. E6-14644, on page 52326 (2nd column), correct the entry for
telephone/voice mail to read telephone/voice mail at<PHONE_NUMBER>.

    Dated: September 8, 2006.
George Gray,
EPA Science Advisor.
 [FR Doc. E6-15255 Filed 9-13-06; 8:45 am]

BILLING CODE 6560-50-P


EPA Reviewer:     Tim McMahon, Ph.D
Signature:

Senior Toxicologist, Antimicrobials Division (7510P)       Date

TXR#:

DATA EVALUATION RECORD

STUDY TYPE:  Skin Sensitization non-guideline (Repeat Open Application
Test)

PC CODEs: 021101
      DP BARCODE:  331024

TEST MATERIAL (PURITY):  CopperShield® wood preservative

SYNONYMS:  none

CITATIONS:	Proctor, Deborah M.; Gujral, Jaspreet; Su, Steave (2006):
Repeated Open Application Test for Allergic Contact Dermatitis due to
Hexavalent Chromium [Cr(VI)] as CopperShield® : Risk Assessment for
Dermal Contact with Cr(VI). Study performed by Dermatology Specialists,
PSC, 444 South First Street, Louisville, KY 40202. Project number FPRL
012506.   Unpublished. MRID 46884001.

		Proctor, Deborah M.; Gujral, Jaspreet; Su, Steave (2006): Repeated
Open Application Test for Allergic Contact Dermatitis due to Hexavalent
Chromium [Cr(VI)] as Potassium Dichromate : Risk Assessment for Dermal
Contact with Cr(VI). Study performed by Dermatology Specialists, PSC,
444 South First Street, Louisville, KY 40202. Project number FPRL
012406.   Unpublished. MRID 46930701.

SPONSOR:   Forest Products Research Laboratory, LLC, 4660 Main Street,
Suite B-320, Springfield, OR 97478.

EXECUTIVE SUMMARY:

A Repeat Open Application Test (ROAT) was performed on 60 human study
subjects who had been confirmed allergic to hexavalent chromium [Cr(VI)]
through closed-patch testing.  The purpose of this study was to develop
a 10% minimum elicitation threshold value (MET10%) for elicitation of
allergic contact dermatitis for hexavalent chromium (as contained within
the CopperShield® wood preservative treatment solution).  The study
design involved the application of five concentrations of hexavalent
chromium (as contained within the CopperShield® wood preservative
treatment solution) to the right forearm of the test subjects and
application of five concentrations of potassium dichromate to the left
forearm of the same subjects.  Ten additional subjects not sensitive to
hexavalent chromium served as controls using the highest concentration
of copper contained within the wood treatment solution.

Test subjects received application of both CopperShield® treatment
solution and potassium dichromate once per day for 10 days.   Duration
of each exposure was 6 hours after which the forearms were washed using
soap provided to them.  Prior to the next application, participants were
evaluated for occurrence of any skin responses, including erythema,
papules, pruruitis, scaling, and vesicles.  Results were evaluated by
Dr. Fowler, who interpreted them as either allergic or irritant in
nature and graded each response.  Seventy-two hours following the last
testing day, participants were evaluated by Dr. Fowler to determine if
an allergic contact dermatitis response had occurred.   Results from the
ROAT phase of the study were modeled using Benchmark Dose Software
(BMDS) to fit the dose-response data and calculate the 10% Minimum
Elicitation Threshold value.

Results of closed-patch testing with potassium dichromate using 12mm
Finn Chambers showed that all participants for the ROAT phase of the
study were confirmed to have sensitivity to hexavalent chromium.
According to the report, the number of participants in the ROAT phase of
the study who exhibited a high grade of ACD response (+3) was
disproportionate to the North American Contact Dermatitis Group database
from 1998-2002  for this grade of reaction. Twenty-six percent (26%) of
the ROAT study participants showed a +3 reaction to the initial patch
test, while the NACDG database of 495 individuals shows a 7.7% response
percentage for a +3 reaction. Thus, to ensure that the dose-response
observed in this study was representative of the hexavalent
chromium-sensitized population in the United States, the dose-response
in the ROAT study was extrapolated to the NACDG population by simulating
the percent response expected to the ROAT if the proportions of +1, +2,
and +3 responders in the current study had been consistent with that of
the general U.S.  hexavalent chromium-sensitized population.

In addition to normalization of the dose-response data, two scenarios
were modeled from the CopperShield® results.  Scenario 1 included only
responses determined to be allergic in nature.  Under this scenario it
was assumed that if a participant reacted to a lower dose, they were
allergic to all higher doses even if they did not actually react to the
higher dose.  Scenario 2 included both irritant and allergic responses
in calculation of a 10% response level. The purpose of this scenario was
to determine the effect on the 10% MET if all of the irritant responses
were allergic in nature.

For Scenarios 1 and 2, the report stated that of all the models run, the
unconstrained log-probit model provided the best fit for the
dose-response data.   For CopperShield®, the 10% MET values for
Scenarios 1 and 2 of the untransformed dose-response data were 270 and
91.8 ng Cr(VI)/cm2 respectively, while 10% MET values for the patch-test
normalized data were 349 and 166 ng Cr(VI)/cm2 respectively.   With the
exception of the Scenario 2 untransformed data, these 10% MET values are
higher than the previously reported value by Nethercott et al. (1994) of
89 ng Cr(VI)/cm2 from closed patch test data.  Such values may be
expected on the basis that the ROAT protocol is an open application test
procedure that more closely resembles real-life exposures than the
closed-patch test technique.

This study is classified acceptable/non-guideline and fulfills the
purpose for which it was conducted. However, determination of a single
10% MET value will require further discussion within the Office of
Pesticide Programs.

COMPLIANCE:   A signed statement of no data confidentiality claims was
submitted.  This study was not conducted according to Good Laboratory
Practice as outlined in 40 CFR Part 160 as this was a human clinical
study and GLP guidelines are not specifically applicable.  A signed
statement by Amy Bradley, Senior Scientist at Exponent, Inc. was
included with the study report.  I. MATERIALS AND METHODS

A. MATERIALS:

1. Test Materials:

 CopperShield®

Description:

Wood preservative formulation

Lot/Batch #:

Not provided

Purity:

 35.46% chromic acid and 14.07% copper oxide [according to label]

CAS # of TGAI:

Concentration verified by laboratory analysis of test solutions

1. Test Materials:

 Potassium dichromate

Description:

Stock solution obtained from Fisher Scientific Co., Houston, Texas

Lot/Batch #:

Not provided

Purity:

  1000 mg Cr(VI)/L

CAS # of TGAI:

Concentration verified by laboratory analysis of test solutions

According to the report (page 66), before the ROAT phase of the study,
the concentration of the CopperShield® test solution preparation was
verified.  The stock solution was diluted to an expected concentration
of 250 mg/L Cr(VI).  However, colorimetric analysis showed Cr(VI)
concentration to be 70 mg/L (table 7a, page 67 of the report).  A repeat
analysis was performed using ion chromatography because copper was
suspected to have interfered with colorimetric analysis of Cr(VI) in the
CopperShield® solution.

Using ion chromatography, the results of dilution gave values closer to
the expected result (246 mg/L Cr(VI)  identified;  250 mg/L expected).

To verify that all test solutions used during the ROAT study contained
the expected amount of Cr(VI), the CopperShield® solutions and
potassium dichromate solutions were analyzed for total chromium, Cr(VI),
copper, and pH.  Results of theses analyses, presented in Table 7c of
MRID 46884001 and Table 7c of MRID 46930701, showed the measured
concentration of Cr(VI) in the dose solutions to be in good agreement
with the expected concentration.  Tables 7b and 7c are reproduced below
from the reports:

Data copied without alteration from page 68 of MRID 46884001.

Data copied without alteration from page 64 of MRID 46930701.

2. Vehicle and/or positive control:   Deionized water containing 153
mg/L copper chloride (the concentration of copper in the highest dose
tested in the ROAT study) was used as a control solution in this study
as part of the ROAT protocol.

B.  STUDY DESIGN and METHODS:

The objective of the present study was to develop a 10% Minimum
Elicitation Threshold value (MET10) for hexavalent chromium (CrVI) as
contained within the ACC wood treatment solution in previously
sensitized individuals.  The results of this experiment would provide a
value for determining a level of exposure to hexavalent chromium as
contained within the ACC treatment solution considered protective for
elicitation of allergic contact dermatitis. An additional concurrent
experiment was also conducted using potassium dichromate for purposes of
providing data for assessing risk from exposure to hexavalent chromium
in environmental media such as contaminated soil. The ROAT study is
designed to represent more realistic dermal exposures that might occur
to potential dermal sensitizers and potential allergic contact
dermatitis reactions in people (i.e. repeated, non-occluded exposures).

Study Participants

A two-stage strategy was used to identify study participants for this
study according to the report (page 36).  A list of potentially eligible
participants was first compiled from the patient population of Dr.
Joseph Fowler’s private medical practice (Dermatology Specialists,
PSC).   Second, a research assistant who did not work in the clinic
contacted individuals on this list by telephone to determine willingness
to participate in this study and to verify that they met the inclusion
and exclusion criteria described in this report

Inclusion criteria included age over 18 years, English speaking, able
and willing to travel to the dermatology clinic for all visits, and
known chromium sensitization status.  Exclusion criteria included
current exposure to chromium or copper in the workplace or home, active
eczematous allergic contact dermatitis, fissures or lesions of the skin,
serious systemic disease or medical condition, current use of
immunosuppressive drugs, pregnancy or attempting pregnancy, current
breast feeding, illicit drug or alcohol use, and plans to leave the area
for 2 days or more.

A total of 148 individuals who had demonstrated a positive reaction to
Cr(VI) in previous patch tests were contacted by the study research
assistants.

Of these, 88 were found eligible and agreed to come for an initial visit
to the clinic.

In addition to the above, 12 individuals who were not known to be
sensitive to Cr(VI) were identified among the employees, former
employees, and relatives of employees of Dr. Fowler to participate as
part of the non-sensitized population.

 Initial Clinic Visit

For individuals who were determined to be eligible and who were
interested in participating in the study, the research staff scheduled
an initial visit to the research facility at the clinic. If consent was
given to participate in the study at the clinic on the initial visit, a
patch test was performed to confirm sensitivity to CrVI.

The initial visit to the clinic included a brief questionnaire given to
potential participants regarding occupational and medical history
relevant to the conduct of the study. Potential participants were also
examined by Dr. Fowler for presence of any skin disease.  Participants
were asked to refrain from activities during the study period that could
irritate the test sites and also instructed to avoid contact with
anything to which they are known to be allergic.  Participants were
instructed not to use topical steroids or other treatments in the test
areas starting one week before the test, during patch-testing days, and
during the two-week ROAT study period.

IRB Approval and Informed Consent

Informed consent forms were given to study participants and they were
allowed to decide whether to participate in the study.  Consent
procedures were approved by Schulman Associates Institutional Review
Board (SAIRB).

Patch Testing

Patch testing was conducted using 12 mm Finn Chambers to verify that
participants were Cr(VI)-sensitive.    Potassium dichromate (0.25%) was
used in a 12mm Finn Chamber applied to an area of skin on the upper
back.  The loaded chamber was secluded with Scanpor® tape to expose an
area of approximately 1 cm2.   The actual concentration of potassium
dichromate applied to the Finn Chamber was not stated in the report.
Depending on the volume of the solution applied to the test patch, this
dose could vary.  Typically, a 10 or 20 microliter volume is used for
Finn Chamber testing.  If this is the case, then, knowing that a 0.25%
solution was used, the dose could be in the range of 25-50 micrograms
applied to the 1 cm2 area of the skin.

Participants who were thought to be CrVI sensitive on the basis of
previous patch tests but who were negative in the current patch test
procedure were excluded from participation in the ROAT study. Those
thought to be non-sensitized but who showed a positive reaction in the
patch test were asked if they were interested in participating in the
ROAT as a member of the sensitized group.

According to the report (page 61), eighty-eight patch tests were
performed on participants who were thought to be sensitive to CrVI in
the past, and 12 participants who were not known to be allergic to CrVI.
 Of the 88 participants, 62, or 70%, had a positive reaction to the
patch test.  One individual who had a positive reaction did not continue
into the ROAT phase of the study based on the presence of active
dermatitis at the time of the ROAT phase.  Three other participants had
scheduling conflicts and chose not to participate in the ROAT phase.
Thus, in the end, 58 individuals with previous positive patch tests for
CrVI were included in the ROAT phase of the study.  This group consisted
of 25 men and  35 women

Of the 12 tested that were thought to be non-sensitized, ten of these
participants had negative reactions and were included on the control
population for this study.  This population consisted of women only.
The two who tested positive for CrVI sensitivity agreed to participate
in the ROAT study as part of the test group.

Those individuals who consented to participate in the study were patch
tested, as noted above.  This involved three visits to the clinic.  On
the first visit, the patch was applied; on the second visit
(approximately 48 hours after application), the patch was removed; on
the third visit (another 48 hours) the patch test was read.

Dose levels for ROAT exposures

As stated above, 60 participants who were determined to be
CrVI-sensitive and 10 who were not CrVI-sensitive participated in the
ROAT study.

Doses used in the ROAT phase of the study were 0, 90, 250, 750, and 2500
ng/cm2.  According to the report, the lowest non-zero concentration
tested in this study represents the MET10 from the study of Nethercott
et al.  (Occup. Environ. Med 51: 371-380, 1994) and was the
concentration used by EPA in determining the level of concern for dermal
contact with CrVI in articles that may contain CrVI.  The top
concentration used in the present study represents, according to the
report, the concentration of CrVI on CopperShield® treated wood
immediately following treatment and is considered the extreme
upper-bound of possible exposures to CrVI from exposure to
CopperShield® treated wood.

A schematic of the application sites and chemicals applied was shown on
page 51 of the study report.  A flexible transparent plastic template
(consisting of five 1 cm2 cut outs arranged linearly and spaced 2 cm
apart) was used as a guide to administering the test substances on the
forearms.   Study participants were blinded to the control and test
solutions being applied.  Ten microliters of each test solution was
applied with a micropipette in the 1 cm2 square areas marked on the
forearms.  The two highest doses were tested at opposite ends of the
template to reduce the possibility of “excited skin syndrome.”  The
vehicle/control solution was applied in the middle of the template.
After application, the test solutions on the forearms were dried using a
hair blow-dryer.  According to the report, this procedure had no effect
on the applied dose based on the statement that CrVI is non-volatile.

Exposure time for each application in the ROAT study was six hours to
both the CopperShield® solutions and to the potassium dichromate
solutions. After the six hour exposure, participants washed their
forearms using soap provided to them.  This was apparently not done at
the clinic, based on the statement in the report that “Each day when
they came in for testing, they were reminded to wash off the test
solutions.  At the subsequent study visit, each participant was asked to
recall the time when they washed their forearms and this was recorded in
their study file.”  (page 51 of MRID 46884001).

Participants received a total of 10 applications of all test solutions
(five times per week, Monday through Friday, for two weeks).
Participants were divided into three groups, or ‘rounds’ according
to the report (page 52). Round one consisted of 25 participants (22
Cr-sensitive and 3 controls). Round two consisted of 31 participants (26
Cr-sensitive and 5 controls). Round three consisted of 14 participants
(12 Cr-sensitized and 2 controls).  The three rounds were stated to be
identical in terms of procedures conducted and methods used, with the
exception of the soap used to wash the test sites in Round 1 vs. Rounds
2 and 3.

RESULTS

Interpretation of allergic and irritant responses

On each day of testing, prior to application of the test solution for
that day, skin responses were evaluated.  Evaluation was made for
presence of allergic contact dermatitis as well as irritant responses.

If the response was determined to be allergic, the challenge to that
dose was discontinued.  If the response was considered irritant or
uncertain, dosing was continued to aid in the interpretation. Dosing was
discontinued only for the dose to which an individual experienced an
allergic response.

Seventy-two hours after the last testing day, participants were
evaluated by Dr. Fowler to determine the presence of an ACD response.
All skin responses were graded for erythema, vesicle formation, papule,
scaling, and prurutis,  The grading of each of these was performed using
the following criteria (Table 3 of the report, page 54 of MRID
46884001):

Data copied without alteration from page 54 of MRID 46884001.

Results of Patch Testing

A summary of the responses to patch testing for determination of
Cr-sensitivity and individual responses to the ROAT study is shown in
the following table (Table 8, from pages 70-72 of MRID 46884001).

addiI

In addition to these data, the study authors were interested in
determining whether the 10% MET from the study population in this report
were representative of the Cr(VI)-sensitized population in the United
States.  To determine this, the number of participants with a +1, +2, or
+3 patch-test reaction were compared to the proportions of individuals
with these same patch test grades in the NACDG database of patch-test
grades for all individuals patch tested by NACDG physicians from 1998
through 2002.

The number of participants in each patch-test grade and dose group was
extrapolated (scaled up or down) depending on the relative proportion of
the total number of people in each of the three patch-test grades. The
data from the patch-test normalized population were the used for
estimating the 10% MET values that are representative of the general
Cr(VI)-sensitized population in the United States.

A corollary to this determination was finding out if the results of
prior patch-testing on the study population, which was performed using
8-mm Finn chambers, was comparable to the 12-mm chambers that were used
to make the current determination of sensitivity to Cr(VI) in the same
study population.  As discussed in Nethercott et al. (1994), it has been
suggested that a sub-MET concentration could induce a sensitization
response based on an increase in surface area of the patch due to
greater systemic uptake of the chemical.  Although shown not to be the
case from experimentation done in the Nethercott et al. study, the
current investigation also looked into this possibility.  These data are
summarized in Table 6 of the report, pages 64-65 of MRID 46884001 and
are shown below:

The table shows (and as discussed in the report), that 41 of the 58 test
subjects, or 71%, had the same patch test grade with the 8-mm and 12-mm
patch.  Fourteen subjects had a higher test grade with the 12-mm patch
than the 8-mm patch, and 3 subjects had a lower patch test grade with
the 12-mm patch than the 8-mm patch.  The report also stated (page 59)
that there were 26 participants who tested positive with the 8-mm patch
but did not have a positive response with the 12-mm patch in this study.
 It is assumed from examining the data in Table 6 that these were
subjects who eventually did not participate in the ROAT phase of the
study as shown in Table 8.

 Results of ROAT

Summary dose-response data for the ROAT phase of the study were
presented in Table 12, page 95 of MRID 46884001 for the CopperShield®
treatment solution and on page 89 of MRID 46930701 for potassium
dichromate.  Individual reactions were presented in Tables 10 and 11,
pages 90-94 of MRID 46884001 and Tables 10 and 11, pages 85-88 of MRID
46930701.  It is to be noted that the statement was made in MRID
46884001 (page 69) that “participants who had a higher grade of
reaction (2+ and 3+) on the initial patch test were far more likely to
develop an allergic response during the ROAT.”   It would not be known
what the initial induction dose of CR(VI) was for the study participants
nor what elicitation doses these participants would have received over
the years.  Thus, the relationship between the patch test data and the
results of the ROAT could not be examined further. It is known from
previous experimental work in animals (Scott et al., 2002) that doses
required for both induction and elicitation are dose-responsive in
nature, that is, elicitation doses can be affected by the induction dose
and vice-versa.

The summary table notes responses interpreted under two scenarios.
Scenario 1 included responses determined only to be allergic in nature,
while Scenario 2 included both allergic and irritant responses combined.

Data reproduced unaltered from page 95 of MRID 46884001 for the
CopperShield® treatment solution.

Data copied unaltered from MRID 46930701 for potassium dichromate.

Dose-Response Modeling and Calculation of 10% Minimum Elicitation
Threshold

Two scenarios were modeled with respect to calculation of the 10% MET in
both studies.  Dose-response modeling in both cases was done following
the USEPA benchmark dose approach and using the Benchmark Dose Software
distributed by EPA.

In the first scenario, the statistical analysis included all allergic
responses. While in the second scenario, the statistical analysis
included both allergic and irritant responses; that is, the assumption
in the second scenario was that all visible irritant responses were
allergic in nature.  The equations used for patch–test normalization
for both Scenario 1 and 2 are given in Appendix F, pages 322-324 of the
report.

The summary data on page 95 of MRID 46884001 show the dose-response for
the various concentrations of CopperShield® applied to the skin in the
ROAT phase of the study.  For Scenario 1, the point closest to the 10%
response level was the 250 ng/cm2 concentration of Cr(VI), [response of
12%], while modeling of this result predicted a 9.6% response.  From the
best fitting model for Scenario 1 (allergic responses only), a value of
270 ng/cm2 concentration of Cr(VI) is determined.

For Scenario 2 [allergic and irritant responses combined], the data
point closest to the 10% response level was the 90 ng/cm2 concentration
of Cr(VI) from the study (7% response). The modeled 10% response would
be 91.8 ng/cm2 concentration of Cr(VI)

Summary data on page 89 of MRID 46930701 for potassium dichromate and
modeling results on page 92 of this same report show that for Scenario
1, the point closest to the 10% response level was  the 90 ng/cm2
concentration of potassium dichromate [response of 8%], while modeling
predicted an 8.7% response.  From the best fitting model for Scenario 1,
a value of 118 ng/cm2 was determined as the 10% MET.

For Scenario 2 in MRID 46930701, which included both irritant and
allergic responses, page 89 of the report showed the 90 ng/cm2
concentration as the 10% response level.  The model predicted a 10.2%
response at this concentration.  From the bet fitting model, the 10% MET
value for Scenario 2 was determined to be 86.6 ng/cm2 for potassium
dichromate.

Extrapolation of Study Results to NACDG Cr(VI)–Sensitized Population

Details of the process used to extrapolate results from the present
study to the NACDG clinical population were discussed on page 101 of the
study report.  Table 15 reproduced below from the report shows
comparison of the patch-test grades in this study with the NACDG (North
American Contact Dermatitis Group) database.  As compared to the NACDG
database, there appeared to be a higher proportion of subjects in the
present study with a +3 reaction to patch testing (26.7%) as compared to
the NACDG clinical database (7.7%), and a lower percentage of responses
at the +1 and +2 reaction levels.

Data copied unaltered from page 101 of MRID 46884001.

From the data presented in this table, it is observed that the
proportion of participants showing a +3 reaction in the patch test was
considerably higher than the proportion of participants showing a +3
reaction from the NACDG database.  To ensure that the dose-response
observed in this study was representative of the chromium-sensitized
population in the United States, results from the present ROAT study
were extrapolated to the NACDG database as described on page 96 of MRID
46930701 and page 102 of MRID 46884001.

Calculated values for the 10% MET for both the original data and the
normalized data are shown in the following table from page 108 of MRID
46884001 and page 103 of MRID 46930701.

Data copied unaltered from page 108 of MRID 46884001.

When normalized to the U.S. population (on the basis of the NACDG
database of 495 individuals from 1998-2002), the resulting 10% MET
values of 349 ng/cm2   and 166 ng/cm2  for Scenario 1 and 2 respectively
are higher than the 10% MET values of 270 ng/cm2 and 91.8 ng/cm2 that
were derived from the dose-response data set prior to normalization of
the data.

Data copied unaltered from page 103 of MRID 46930701.

Calculated 10% MET values for scenarios 1 and 2 using the original
dose-response data show values of 118 and 86.6 ng/cm2  for potassium
dichromate.  When normalized to the U.S. population (on the basis of the
NACDG database of 495 individuals from 1998-2002), the resulting 10% MET
values are 364 ng/cm2  and 269 ng/cm2  for Scenario 1 and 2
respectively.

It is of interest that the 10% MET value obtained from the
non-normalized dose-response data in the study with potassium dichromate
(118 ng Cr(VI)/cm2) is approximately 30% higher than the 10% MET value
derived from the Nethercott et al. (1994) study (89 ng Cr(VI)/cm2).  The
closeness of these two values from different studies suggests that for
potent dermal sensitizers, results from open or closed tests may not
differ significantly, and also suggests that for both the Nethercott et
al. study and the present study, the test population may have been
composed of persons more sensitive to Cr(VI) than the general
Cr-sensitive population.

E. REVIEWER’S CONCLUSIONS:

The current submitted study was designed to obtain a 10% Minimum
Elicitation Threshold value (or 10% MET) from subjects known to be
sensitive to Cr(VI) employing the Repeat Open Application Test protocol.
 From the FIFRA Science Advisory Panel review of this issue in May of
2004, it was suggested that such a test would provide a more realistic
basis for conducting a risk assessment of dermal sensitization risk from
contact with treated wood containing Cr(VI).  Previously, the Agency
relied upon the study of Nethercott et al, (1994) in which a
‘sensitization reference dose’ of 9 ng/cm2 was derived from a 10%
MET value of 89 ng Cr(VI)/cm2.  An uncertainty factor of 10 was applied
to the 10% MET from the Nethercott et al. study to account for lack of
data on human variability in the dermal sensitization response to
Cr(VI), especially from repeated dermal contact.  It is known that
repeated contact with dermal sensitizers can lower the concentration
subsequently needed to cause an elicitation of allergic contact
dermatitis, and the Nethercott study was based on a single dermal
exposure.

The present study utilized a study population of 60 human subjects who
were exposed to various concentrations of Cr(VI) once a day over a
period of 10 days using the ROAT protocol.  Exposure was to Cr(VI) both
as contained within the CopperShield® wood preservative treatment
solution and as potassium dichromate.  Values from these two experiments
are intended for different applications.  The 10% MET value obtained
from study of the CopperShield® wood treatment solution is for
determination of a ‘safe’ area dose for protection against
elicitation of allergic contact dermatitis that could occur from contact
with the treated wood.  The 10% MET value obtained from study of
potassium dichromate is for application to environmental cleanup, for
example, soil contaminated with Cr(VI).  It is noted that both test
materials were examined concurrently on the same subjects.

The study participants were first confirmed to be Cr(VI) sensitive
through patch testing using 12mm Finn Chambers.  The participants also
had a previous history of testing for Cr(VI) sensitivity and the results
of these previous tests were compared to the current patch testing.
Comparison of the results of the previous patch testing with the current
patch test showed that 41 of the 58 test subjects, or 71%, had the same
patch test grade with the 8-mm and 12-mm patch.  Fourteen subjects had a
higher test grade with the 12-mm patch than the 8-mm patch, and 3
subjects had a lower patch test grade with the 12-mm patch than the 8-mm
patch.  The results of the ROAT test showed that participants who had an
initial patch test grade that was 2+ or 3+ also appeared more likely to
show allergic contact dermatitis reactions in the ROAT phase and at
lower concentrations (Table 8 of MRID 46884001).

The patch test results also showed what appeared to be a
disproportionate percentage of participants who had a 3+ reaction grade
to the patch test when compared to a population whose patch test
reactions were obtained from the North American Contact Dermatitis Group
(NACDG) database of 1998-2002.  This database consisted of 495
individuals. The history of these individuals is not known. It was
desired that the dose-response observed in this study be representative
of the Cr(VI) sensitized population in the United States.  To accomplish
this, the following procedure, from page 102 of MRID 46884001, was
followed, as reproduced from the report (below):

On the basis of the normalized results, benchmark dose modeling was
conducted on the dose-response data.  Modeling was conducted on both the
original data and the normalized data.  Results for the calculation of
10% minimum elicitation thresholds were derived and presented on page
108 of the report in summary form.

When considering only allergic reactions, the original calculated 10%
MET of 270 ng/cm2 is approximately 3-fold higher than the 10% MET value
derived from the study of Nethercott et al. (88 ng/cm2).  The normalized
value of 349 ng/cm2 is even higher.  Reasons that the calculated 10% MET
in this study are higher than previously reported by Nethercott et al.
include normalization of the test results in this study, use of a wood
treatment solution containing Cr(VI) compared to use of potassium
dichromate, and use of an open application test compared to use of
occluded conditions. Occluded conditions might be expected to result in
lower threshold values compared to open application tests.  The present
ROAT study included experimentation on the same test subjects using
potassium dichromate, a form of hexavalent chromium that is typically
used for examination of dermal sensitization to hexavalent chromium.
Results of that study showed original 10% MET value of 118 ng/cm2 for
non–normalized data involving only allergic responses, and a 10% MET
of 86.6 ng/cm2 when allergic and irritant responses were combined.  The
patch test normalized values for potassium dichromate were 364 and 269
ng/cm2 for allergic responses and allergic plus irritant responses,
respectively.  Of interest is the comparison of the MET values for both
the CopperShield® treatment solution and the potassium dichromate
solution.  The original, non-normalized dose-response data show a
difference in the 10% MET values between the wood treatment solution and
potassium dichromate.  That is, the potassium dichromate 10% MET value
is lower (118 ng/cm2 ) compared to the wood treatment solution 10% MET
(270 ng/cm2 ).  However, when the dose-response data was normalized on
the basis of patch test data from the NACDG database, the 10% MET values
are almost the same between the two forms of Cr(VI) tested (349 and 364
ng/cm2 for the wood treatment solution and potassium dichromate,
respectively).  A similar result can be seen using the dose-response
data that combined allergic and irritant responses.

Classification

This study is classified acceptable/non-guideline and fulfills the
purpose for which it was conducted. However, determination of a single
10% MET value will require further discussion within the Office of
Pesticide Programs.

	Skin Sensitization Study (ROAT)  (2006) / Page 	-   PAGE  1  -

[CopperShield® Wood Preservative containing Cr(VI)]	Non-guideline


[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Proposed Rules]
[Pages 15981-15985]
[FR Doc No: 2012-6493]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0066]
RIN 1625-AA08

Special Local Regulations; OPSAIL 2012 Connecticut, Niantic Bay,
Long Island Sound, Thames River and New London Harbor, New London, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish temporary special local
regulations on the navigable waters of Niantic Bay, Long Island Sound,
the Thames River and New London Harbor, New London, Connecticut for
OPSAIL 2012 Connecticut (CT) activities. This action is necessary to
provide for the safety of life on navigable waters during OPSAIL 2012
CT. This action would restrict vessel traffic in portions of Niantic
Bay, Long Island Sound, the Thames River, and New London Harbor unless
authorized by the Captain of the Port (COTP) Sector Long Island Sound
(SLIS).

DATES: Comments and related material must be received by the Coast
Guard on or before May 18, 2012.
    Requests for public meetings must be received by the Coast Guard on
or before April 9, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0066 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Petty Officer Joseph Graun, Prevention Department,
U.S. Coast Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking USCG-2012-0066, indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2012-0066) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2012-0066) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before April 9, 2012 using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

Basis and Purpose

    The legal basis for this rule is 33 U.S.C. 1233, which authorizes
the Coast Guard to define Special Local Regulations.
    This temporary special local regulation is necessary to ensure the
safety of vessels and spectators from hazards associated with OPSAIL
2012 CT.

Discussion of Proposed Rule

    From Friday July 6 through Saturday July 7, 2012 Operation Sail,
Inc. is sponsoring the ``Parade of Sail'' a tall ship marine parade
into New London Harbor. Tall ships and other participating vessels will
be staged in Niantic Bay on July 6, 2012. On July 7, 2012, the tall
ships and participating vessels will commence the ``Parade of Sail''
transiting from Niantic Bay to New London Harbor via Long Island Sound
and the Thames River Federal Channel. The Coast Guard expects a minimum
of 5,000 spectator craft for this event. Once in New London Harbor, the
vessels will be moored or anchored and available for public viewing
until July 8, 2012.
    The COTP SLIS has determined the combination of increased numbers
of recreation vessels, a marine parade and congested waterways has the
potential to result in serious injuries or fatalities. This special
local regulation temporarily establishes regulated areas to restrict
vessel movement around the location of the marine parade to reduce the
risk associated with congested waterways. For these reasons The Coast
Guard proposes five temporary regulated areas on Niantic Bay, Long
Island Sound, the Thames River and New London Harbor from July 6, 2012
through July 7, 2012. Exact coordinates for each area can be found in
the regulation text.
    Area 1; All navigable waters of Niantic Bay extending south into
Long

Island Sound. This proposed area would be used as a staging area for
vessels participating in the ``Parade of Sail''. All vessels would be
authorized to transit Area 1 at no wake speed or at speeds not to
exceed 6 knots, whichever is less to maintain steerage way. In addition
vessels transiting must not maneuver within 100 yards of a tall ship or
other vessel participating in OPSAIL 2012 CT. This regulated area would
be enforced from 6 a.m. July 6, 2012 until 5 p.m. July 7, 2012.
    Area 2; All navigable waters of the Thames River and Long Island
Sound from the Thames River Rail Road Bridge to the mouth of the river
then south west to Bartlett Reef. This area would be for the exclusive
use of vessels participating in the ``Parade of Sail'' and would be
enforced from 10 a.m. until 5 p.m. on July 7, 2012.
    Area 3; All navigable waters at the mouth of the Thames River west
of the federal navigation channel. This area would be used as a
spectator area limited to vessels exceeding 50 feet in length, carrying
passengers for the viewing of the ``Parade of Sail''. Area 3 would be
enforced from 7:30 a.m. until 5 p.m. on July 7, 2012.
    Area 4; All navigable waters at the mouth of the Thames River east
of the federal navigation channel. This area would be used as a
spectator area limited to vessels exceeding 50 feet in length, carrying
passengers for the viewing of the ``Parade of Sail''. Area 4 would be
enforced from 7:30 a.m. until 5 p.m. on July 7, 2012.
    Area 5; All navigable waters of the Thames River west of the
federal navigation channel between Fort Trumbull and the Thames River
Rail Road Bridge. This area will be used as a turning and mooring area
for vessels participating in the ``Parade of Sail'' and would be
enforced from 10 a.m. until 5 p.m. on July 7, 2012.
    The geographic locations of regulated areas, and specific
requirements of this rule are contained in the regulatory text.
    Notice of this special local regulation, would be provided prior to
the event through the Local Notice to Mariners and Broadcast Notice to
Mariners. In addition, the sponsoring organization, Operation Sail,
Inc., is planning to publish information of the event in local
newspapers, pamphlets, Internet sites, television and radio broadcasts.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    Although this regulation prevents traffic from transiting a portion
of Long Island Sound, the Thames River and New London Harbor during
OPSAIL 2012 CT, the effect of this regulation will not be significant
for the following reasons: The limited duration that the regulated
areas will be in effect, mariners would be able to transit around some
areas, persons and vessels would still be able to enter, transit
through, anchor in, or remain within the regulated areas if authorized
by the COTP SLIS or designated representative. The extensive advance
notifications that will be made to the maritime community through the
Local Notice to Mariners, marine information broadcasts and New London
area media; Mariners will be able to adjust their plans accordingly
based on the extensive advance information. In addition, the sponsoring
organization, Operation Sail, Inc., is planning to publish information
of the event in local newspapers, Internet sites, pamphlets, television
and radio broadcasts.
    These regulated areas have been narrowly tailored to impose the
least impact on maritime interests yet provide the level of safety
deemed necessary.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This temporary rule will affect the following entities, some
of which might be small entities: The owners or operators of vessels
intending to transit through Niantic Bay, portions of Long Island
Sound, the Thames River and New London Harbor during various times from
July 6-7, 2012. Although these regulations apply to a substantial
portion of Niantic Bay and New London Harbor, designated areas for
viewing the ``Parade of Sail'' have been established to allow for
maximum use of the waterways by commercial tour boats that usually
operate in the affected areas. Vessels, including commercial traffic,
will be able to transit around some designated areas, persons and
vessels would still be able to enter, transit through, anchor in, or
remain within the regulated areas if authorized by the COTP SLIS or
designated representative. Before the effective period, the Coast Guard
will make notifications to the public through the Local Notice to
Mariners and Broadcast Notice to Mariners. In addition, the sponsoring
organization, Operation Sail, Inc., is planning to publish information
of the event in local newspapers, Internet sites pamphlets, television
and radio broadcasts.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed under FOR
FURTHER INFORMATION CONTACT. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of

power and responsibilities among the various levels of government. We
have analyzed this proposed rule under that Order and determined that
this rule does not have implications for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. It appears
that this proposed rule will qualify for Coast Guard categorical
exclusion (34)(h), as described in figure 2-1 of the Instruction. This
proposed rule establishes temporary special local regulations. We seek
any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

    1. The authority citation for part 100 continues to read as
follows:

    Authority: 33 U.S.C. 1233.

    2. Add Sec.  100.T01-0066 to read as follows:

Sec.  100.T01-0066  Special Local Regulations; OPSAIL 2012 Connecticut,
Niantic Bay, Long Island Sound, Thames River and New London Harbor, New
London, Connecticut.

    (a) Regulated Areas.
    (1) Area 1: All navigable waters of Niantic Bay and Long Island
Sound within the following boundaries: Beginning at position
41[deg]18'53'' N, 072[deg]11'48'' W then to 41[deg]18'53'' N,
072[deg]10'38'' W then to 41[deg]16'40'' N, 072[deg]10'38'' W then to
41[deg]16'40'' N, 072[deg]11'48'' W then to point of origin
41[deg]18'53'' N, 072[deg]11'48'' W (NAD 83).
    (2) Area 2: All navigable waters of the Thames River south of the
railroad bridge and Long Island Sound within the following boundaries:
Beginning on the east side of the federal channel at the Thames River
Rail Road Bridge in the Port of New London 41[deg]21'46'' N,
072[deg]05'14'' W then southward along the east side of the Federal
Channel to 41[deg]17'38'' N, 072[deg]04'40'' W (New London Harbor
Channel Lighted Buoy ``2'' (LLNR 21790)) then south west to
41[deg]15'38'' N, 072[deg]08'22'' W (Bartlett Reef Lighted Bell Buoy
``4'' (LLNR 21065)) then north to 41[deg]16'28'' N, 072[deg]07'54'' W
(Bartlett Reef Lighted Buoy ``1'' (LLNR 21065)) then east to
41[deg]17'07'' N, 072[deg]06'09'' W then continuing east to
41[deg]18'04'' N, 072[deg]04'50'' W which meets the west side of the
federal channel, then north along the west side of the federal channel
to 41[deg]21'46'' N, 072[deg]05'17'' W (Thames River Railroad Bridge in
the Port of New London), then east to the point of origin. (NAD 83).
    (3) Area 3: All navigable water of the Thames River within the
following boundaries. Beginning at 41[deg]18'21'' N, 072[deg]05'36'' W
then to 41[deg]18'21'' N, 072[deg]05'1.5'' W then to 41[deg]18'57'' N,
072[deg]05'6'' W then to point of origin. (NAD 83).
    (4) Area 4: All waters of the Thames River within the following
boundaries. Beginning at 41[deg]19'03'' N, 072[deg]04'48'' W then to
41[deg]19'04'' N, 072[deg]04'33'' W then

to 41[deg]18'42'' N, 072[deg]04'30'' W then to 41[deg]18'40''
N,072[deg]04'45'' W then to point of origin. (NAD 83).
    (5) Area 5: All waters of the Thames River and New London Harbor
within the following boundaries. Beginning at a point located on the
west shoreline of the Thames River 25 yards below the Thames River
Railroad Bridge, 41[deg]21'46'' N, 072[deg]05'23'' W then east to
41[deg]21'46'' N, 072[deg]05'17'' W then south along the western limit
of the federal navigation channel to 41[deg]20'37'' N, 072[deg]05'8.7''
W then west to 41[deg]20'37'' N, 072[deg]05'31'' W then following the
shoreline north to the point of origin. (NAD 83).
    (b) Special local regulations.
    (1) In accordance with the general regulations in section 100.35 of
this part, entering into, transiting through, anchoring or remaining
within the regulated areas is prohibited unless authorized by the
Captain of the Port (COTP) Sector Long Island Sound (SLIS), or
designated representative.
    (2) All persons and vessels are authorized by the COTP SLIS or
designated representative to enter areas of this special local
regulation in accordance with the following restrictions:
    (i) Area 1; all vessels may transit at a slow no wake speed or a
speed not to exceed 6 knots, whichever is less to maintain steerage
way. Vessels transiting must not maneuver within 100 yards of a tall
ship or an OPSAIL 2012 CT participating vessel.
    (ii) Areas 3 & 4; access is limited to vessels greater than 50 feet
in length.
    (iii) Areas 2 & 5; access is limited to vessels participating in
the ``Parade of Sail''.
    (3) All persons and vessels shall comply with the instructions of
the COTP SLIS or designated representative. These designated
representatives are comprised of commissioned, warrant, and petty
officers of the Coast Guard. Upon being hailed by a U.S. Coast Guard
vessel by siren, radio, flashing lights, or other means the operator of
a vessel shall proceed as directed.
    (4) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated areas must contact the COTP SLIS by
telephone at<PHONE_NUMBER>, or designated representative via VHF radio
on channel 16, to request authorization. If authorization to enter,
transit through, anchor in, or remain within the regulated areas is
granted by the COTP SLIS or designated representative, all persons and
vessels receiving such authorization must comply with the instructions
of the COTP SLIS or designated representative.
    (5) The Coast Guard will provide notice of the regulated areas,
prior to the event through the Local Notice to Mariners and Broadcast
Notice to Mariners. Notice will also be provided by on-scene designated
representatives.
    (c) Enforcement Period: This section will be enforced during the
following times:
    (1) Area 1, from 6 a.m. July 6, until 5 p.m. on July 7, 2012.
    (2) Areas 3 and 4, from 7:30 a.m. until 5 p.m. on July 7, 2012.
    (3) Areas 2 and 5, from 10 a.m. until 5 p.m. on July 7, 2012.

    Dated: March 6, 2012.
J.M. Vojvodich,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2012-6493 Filed 3-16-12; 8:45 am]
BILLING CODE 9110-04-P