[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Pages 16452-16456]
[FR Doc No: 2011-6856]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0013]

TUV Rheinland PTL, LLC; Recognition as an NRTL

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: This notice announces the Agency's final decision to grant
recognition to TUV Rheinland PTL, LLC, as a Nationally Recognized
Testing Laboratory under 29 CFR 1910.7.

DATES: This recognition becomes effective on March 23, 2011 and will be
valid until March 23, 2016, unless terminated or modified prior to that
date in accordance with 29 CFR 1910.7.

FOR FURTHER INFORMATION CONTACT: Office of Technical Programs and
Coordination Activities, NRTL Program, Occupational Safety and Health
Administration, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Room N-3655, Washington, DC 20210, or phone<PHONE_NUMBER>. For
information about the Nationally Recognized Testing Laboratory Program,
go to http://www.osha.gov, and select ``N'' in the site index.

SUPPLEMENTARY INFORMATION:

Notice of Final Decision

    The Occupational Safety and Health Administration (OSHA) hereby
gives notice of its recognition of TUV Rheinland PTL, LLC (TUVPTL) as a
Nationally Recognized Testing Laboratory (NRTL). The scope of this
recognition includes testing and certification of the equipment and
materials, and use of the supplemental program, listed below. OSHA will
detail TUVPTL's scope of recognition on an informational Web page for
the NRTL, as further explained below.
    OSHA recognition of an NRTL signifies that the organization meets
the legal requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
approved by the NRTL to meet OSHA standards that require product
testing and certification.
    The Agency processes applications by an NRTL for initial
recognition, or for an expansion or renewal of this recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding, and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition, or
modifications of that scope. OSHA maintains an informational Web page
for each NRTL that details its scope of recognition. These pages are
available from OSHA's Web site at http://www.osha.gov/dts/otpca/nrtl/index.html. Each NRTL's scope of recognition has three elements: (1)
The type of products the NRTL may test, with each type specified by its
applicable test standard; (2) the recognized site(s) that has/have the
technical capability to perform the product testing and certification
activities for test standards within the NRTL's scope; and (3) the
supplemental program(s) that the NRTL may use, each of which allows the
NRTL to rely on other parties to perform activities necessary for
product testing and certification.
    TUVPTL applied for recognition as an NRTL (See Ex. 2--TUVPTL
application dated 7/29/2008) \1\ pursuant to 29 CFR 1910.7, and OSHA
published the required preliminary notice in the Federal Register on
November 18, 2010 (75 FR 70692) to announce the application. The notice
included a preliminary finding that TUVPTL could meet the requirements
for recognition detailed in 29 CFR 1910.7, and invited public comment
on the application by December 20, 2010. OSHA received no comments in
response to this notice. OSHA now is proceeding with this final notice
to grant TUVPTL's recognition application.
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    \1\ A number of documents, or information within documents,
described in this Federal Register notice are the applicant's
internal, detailed procedures, or contain other confidential
business or trade-secret information. These documents and
information, designated by an ``NA'' at the end of, or within, the
sentence or paragraph describing them, are not available to the
public.
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    All public documents pertaining to the TUVPTL application are
available for review by contacting the Docket Office, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue, NW., Room N-2625, Washington, DC 20210. These
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2010-0013.
    The current address of the laboratory facility (site) that OSHA
recognizes for TUVPTL is: TUV Rheinland PTL, 2210 South Roosevelt
Street, Tempe, Arizona 85282.

General Background on the Application

    According to public information (http://www.tuvptl.com/tuv-ptl-history.html), TUVPTL states that it is a testing and certification
laboratory for photovoltaic products and a leading test organization
for photovoltaic technology. Arizona State University (ASU) established
the organization in 1992 as the Photovoltaic Testing Laboratory (PTL).
The TUVPTL Web site states that the PTL was instrumental in the
development of many major standards concerning photovoltaic products.
It was part of ASU until becoming an affiliate of TUV Rheinland Group.
    TUV Rheinland North America, Inc., (TUVRNA), a currently recognized
NRTL, submitted an application, dated July 29, 2008, to expand its
recognition to include TUVPTL as a recognized site. (See Ex. 2.) In
response to OSHA's request for clarification, TUVRNA amended its
application to provide additional technical details, and then provided
further details in a later update. (See Ex. 3--TUVPTL amended
application dated 5/29/2009.) OSHA's NRTL Program staff performed an
on-site assessment of TUVPTL's facility in January 2010. Based on this
assessment, TUVPTL revised its application to seek recognition as an
NRTL, thus superseding the July 2008 expansion application by TUVRNA.
(See Ex. 4--TUVPTL revised application dated 1/29/2010.) This revised
application incorporated the bulk of the amended application. The OSHA
staff recommended recognition of TUVPTL in their on-site review report
of the assessment. (See Ex. 5--OSHA on-site review report on TUVPTL.)
    Due to its close affiliation with TUVRNA, the applicant will use
many TUVRNA operational and quality-control procedures for operating as
an NRTL. For example, TUVPTL's NRTL quality-control system will follow
that used by TUVRNA: QP100001--Product Certification Quality Manual
(Ex. 3; see document designated QP100001). Through its application
information (see Ex. 2), TUVPTL represents that it maintains the
experience, expertise, personnel, organization, equipment, and
facilities suitable for accreditation as an OSHA NRTL. It also states
that it meets, or will meet, the requirements for recognition defined
in 29 CFR 1910.7.
    This notice discusses the four requirements for recognition (i.e.,
capability, control procedures, independence, and creditable reports

and complaint handling) below, along with examples that illustrate how
TUVPTL meets each of these requirements. The applicant's summary
addressing OSHA's evaluation criteria (see Detailed Application
Information/Evaluation Criteria (DAI/EC) summary documents, Exs. 3 and
4) reference many, but not all, of the documents or processes described
below in this notice.

Capability

    Section 1910.7(b)(1) states that, for each specified item of
equipment or material requiring listing, labeling, or acceptance by an
NRTL, the NRTL must have the capability (including proper testing
equipment and facilities, trained staff, written testing procedures,
and calibration and quality-control programs) to perform appropriate
testing. The ``Capability'' section of the DAI/EC summary document (NA)
shows that the applicant has security measures and detailed procedures
in place to restrict or control access to its facility, to areas within
its facility, and to confidential information. This section also states
that TUVPTL's facility has equipment for monitoring, controlling, and
recording environmental conditions during tests, and for handling test
samples. It states further that the facility has adequate test areas
and energy sources, and procedures for controlling incompatible
activities. OSHA's on-site review report (Ex. 5, p. 2) confirmed this
information concerning the facility, as well as its adequacy. TUVPTL
provided a detailed list of its testing equipment (NA), and OSHA's on-
site review (Ex. 5, p. 2) confirmed that this equipment is in place and
adequate for the scope of testing requested.
    The ``Capability'' section of the DAI/EC summary documents (NA)
indicates that TUVPTL has detailed procedures addressing the
maintenance and calibration of equipment, as well as the types of
records maintained for, or supporting, many laboratory activities. It
also indicates that TUVPTL has detailed procedures for conducting
testing, review, and evaluation, and for capturing the test data
required by the standard for which it seeks recognition. OSHA's on-site
review report (Ex. 5, p. 2) notes that TUVPTL currently is using these
procedures to test products for other NRTLs. Further, this section
indicates that TUVPTL has detailed procedures for processing
applications and developing new procedures.
    The revised application (Ex. 4) indicates that TUVPTL has the
necessary procedures to adequately address training or qualifying staff
for particular technical tasks (NA). The revised application and OSHA's
on-site review report (Ex. 5, p. 3) indicate that TUVPTL has the
qualified personnel to perform the proposed scope of testing based on
their education, training, technical knowledge, and experience. The
revised application and OSHA's on-site review report (Ex. 5, p. 3) also
provide evidence that TUVPTL has an adequate quality-control system in
place.

Control Procedures

    Section 1910.7(b)(2) requires that the NRTL provide controls and
services, to the extent necessary, for the particular equipment or
material undergoing listing, labeling, or acceptance. These controls
and services include procedures for identifying the listed or labeled
equipment or materials, inspections of production runs at factories to
assure conformance with test standards, and field inspections to
monitor and assure the proper use of identifying marks or labels.
    The ``Control Programs'' section of the DAI/EC summary document
shows that TUVPTL has the quality-control manual and detailed
procedures to address the steps involved in listing and certifying
products. TUVPTL will use the certification mark of its affiliate,
TUVRNA, which is similar to an arrangement granted by OSHA to two other
affiliated NRTLs. (See 67 FR 3737, January 25, 2002.) However, TUVPTL
personnel must perform the final technical review, make the
certification decision, and authorize the use of the mark. OSHA is
imposing this condition as part of TUVPTL's NRTL recognition. In
addition, the ``Control Programs'' section shows that the applicant has
certification procedures (NA), and that these procedures address
authorization of certifications and audits of factory facilities. The
audits apply to both the initial evaluations and the follow-up
inspections of manufacturers' facilities. This section indicates that
procedures also exist for authorizing the use of the certification
mark, and the actions taken when TUVPTL finds that the manufacturer is
deviating from the certification requirements. Factory inspections will
be a new activity for TUVPTL, and OSHA will need to review the
effectiveness of TUVPTL's inspection program when it is in place. As a
result, OSHA is imposing a condition as part of TUVPTL's NRTL
recognition that ensures that TUVPTL conducts inspections properly, and
at the frequency set forth in the applicable NRTL Program policy (see
OSHA Instruction CPL 1-0.3, Appendix C, paragraph III.A).

Independence

    Section 1910.7(b)(3) requires that the NRTL be completely
independent of employers that are subject to the testing requirements,
and of any manufacturers or vendors of equipment or materials tested
under the NRTL Program. OSHA has a policy for the independence of NRTLs
that specifies the criteria used for determining whether an
organization meets the above requirement. (See OSHA Instruction CPL 1-
0.3, Appendix C, paragraph V.) This policy contains a non-exhaustive
list of relationships that would cause an organization to fail to meet
the specified criteria.
    The ``Independence'' section of the DAI/EC, and additional
information submitted by TUVPTL (Ex. 4, section titled, ``Information
For Evaluating Compliance'') shows that it has none of these
relationships, or any other relationship that could subject it to undue
influence when testing for product safety. TUVPTL's major owner is a
subsidiary of the parent company of TUVRNA, the NRTL currently
recognized by OSHA. OSHA found no information about TUVRNA's ownership
that would raise an issue of TUVPTL's non-compliance with the NRTL
Program's independence policy.
    There are two other owners of TUVPTL, each owning less than 10% of
the organization. One owner is an individual, and OSHA found no
information showing any affiliation of this individual with
manufacturers, vendors, or major users of products requiring NRTL
approval. The remaining owner is Arizona Technology Enterprises (AzTE),
which has a Web page (http://www.azte.com/page/about_us/foundation)
that states that it ``was established in 2003 as a limited liability
company whose sole member is the ASU Foundation. The ASU Foundation is
an independent non-profit organization that acts as the principal agent
through which gifts are made to benefit [ASU].'' OSHA found no
information to indicate that a manufacturer, vendor, or major user of
products requiring NRTL approval, or the major owners of these
entities, has an ownership interest in the Foundation or ASU, with ASU
being a nonprofit, state-operated educational institution.
    According to AzTE's Web page (http://www.azte.com/page/for_industry), ``AzTE drives the transfer of discoveries and innovation
from ASU's labs to the marketplace through technology partnering and
the creation of new technology-based ventures.'' AzTE acts as the agent
to license these technologies, and takes an equity stake in the
companies that commercialize the

technology. AzTE's Web page (http://www.azte.com/page/portfolio) shows
that the vast majority of the technologies licensed in this manner do
not involve the types of products for which OSHA requires NRTL
approval. Companies may use materials and items developed from a few of
these technologies (such as a sensor, electrode, or wafer) in
manufacturing these types of products, but OSHA found only one product
that AzTE licenses that requires NRTL approval. The entity to which
AzTE licensed this product, a bacterial detection system, was Biosense
International (Biosense). At the time OSHA published its preliminary
notice to announce TUVPTL's application (75 FR 70692), the State of
Arizona Corporate Commission, which registered Biosense as a
corporation, administratively dissolved Biosense as of June 14, 2010.
At the time OSHA prepared this final notice, Biosense is in good
standing according to the Commission's Web site. However, OSHA has no
information that AzTE's ownership of BioSense would pose any conflicts
with OSHA's independence requirement. The remainder of AzTE's equity
stakes are minor, thus mitigating the undue influence that such
companies could exert on TUVPTL should these companies sell or use
products tested by TUVPTL.
    To address future business ventures by AzTE, OSHA is imposing
conditions on TUVPTL to avoid any situation that could conflict with
OSHA's NRTL independence requirement; OSHA will actively monitor
TUVPTL's compliance with these conditions.
    In summary, the information related to independence demonstrates
that TUVPTL meets the independence requirement. Additionally, OSHA is
imposing conditions on TUVPTL that will enable OSHA to monitor TUVPTL's
compliance with the NRTL independence requirements in the future.

Creditable Reports and Complaint Handling

    Section 1910.7(b)(4) specifies that an NRTL must maintain effective
procedures for producing credible findings and reports that are
objective and free of bias, and for handling complaints and disputes
under a fair and reasonable system. The ``Report and Complaint
Procedures'' section of the DAI/EC summary document (NA) shows that the
applicant has detailed procedures describing the content of the test
reports, and other detailed procedures describing the preparation and
approval of these reports. This section also shows that the applicant
has procedures for recording, analyzing, and processing complaints from
users, manufacturers, and other parties in a fair manner.

Supplemental Programs

    OSHA is approving TUVPTL to use the following supplemental program
for which it applied:
Program 9: Acceptance of Services Other Than Testing or Evaluation
Performed by Subcontractors or Agents (Calibration Services Only)
    OSHA is approving TUVPTL to use Program 9 only for calibration
services, and added this limitation to the program's description above.
The application notice for TUVPTL indicated this limitation, and OSHA
is adding it here for clarity. As noted in an earlier Federal Register
notice of NRTL recognition (75 FR 222), OSHA will approve a new NRTL to
use Program 9 for other services or other supplemental programs only
after OSHA determines that the new NRTL tests, evaluates, and performs
inspections adequately using its own staff located at its recognized
site(s).

Additional Conditions

    As noted above, a minor owner of TUVPTL, AzTE, may have an equity
stake in companies that use technologies licensed by AzTE. In its
present review, OSHA found that AzTE's ownership interest in these
companies does not currently result in a conflict with OSHA's NRTL
independence requirement; however, the possibility exists that AzTE
could, in the future, acquire sufficient ownership in one of these
companies to establish such a conflict or potential conflict should any
of these companies sell, or become a major user of, the types of
products that require NRTL approval. Thus, OSHA is imposing conditions
to avoid conflicts or possible conflicts. These conditions are numbered
1 and 2 under the ``Conditions'' section below.
    Additionally, as described above, while TUVPTL has testing, review,
and evaluation procedures, OSHA could not review how TUVPTL fully
implemented them because TUVPTL was not using them fully for testing
and certifying products under the NRTL Program. In addition, as also
described above, while TUVPTL has factory-inspection procedures, it
currently does not conduct regular factory inspections. In this regard,
TUVPTL only recently developed some components of these factory-
inspection procedures. Therefore, OSHA will, having granted NRTL
recognition to TUVPTL, review the effectiveness of TUVPTL's factory-
inspection program, and do so within a reasonable period. Consequently,
OSHA is recognizing TUVPTL conditionally for these procedures, i.e.,
subject to a later determination of the effectiveness with which TUVPTL
implements these procedures. In addition, because TUVPTL will use the
mark of its affiliate, TUV Rheinland of North America, Inc., OSHA is
imposing a condition to ensure that TUVPTL personnel perform the
critical steps involved in certification. These conditions are numbered
3 and 4 under the ``Conditions'' section below.
    These conditions apply solely to TUVPTL's operations as an NRTL,
and only to those products that it certifies for purposes of enabling
employers to meet OSHA product-approval requirements. These conditions
are in addition to all other conditions that OSHA normally imposes in
its recognition of an organization as an NRTL.
    Imposing these conditions is consistent with OSHA's past
recognition of several organizations as NRTLs that met the basic
recognition requirements, but needed to further refine or implement
their procedures (for example, see 63 FR 68306, 12/10/1998, and 65 FR
26637, 05/08/2000). Based on TUVPTL's current activities in testing and
certification, OSHA is confident that TUVPTL will conform to the
requirements for recognition noted above.

Final Decision and Order

    The NRTL Program staff examined TUVPTL's application, the
additional submissions, the on-site review report, and other pertinent
information. Based on this examination and the analysis, OSHA finds
that TUVPTL meets the requirements of 29 CFR 1910.7 for recognition as
a Nationally Recognized Testing Laboratory subject to the limitations
and conditions listed below. The recognition applies to the site listed
above, and the test standard listed below. Pursuant to the authority
granted by 29 CFR 1910.7, OSHA hereby grants the recognition of TUVPTL,
subject to this limitation and these conditions.

Limitation

    OSHA limits the recognition of TUVPTL to testing and certification
of products for demonstration of conformance to the following test
standard,\2\ which OSHA determines is an appropriate test standard
within the meaning of 29 CFR 1910.7(c):
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    \2\ The designation and title of this test standard was current
at the time OSHA prepared this notice.

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UL 1703 Flat-Plate Photovoltaic Modules and Panels
    OSHA limits recognition of any NRTL for a particular test standard
to equipment or materials (i.e., products) for which OSHA standards
require third-party testing and certification before use in the
workplace. Consequently, if a test standard also covers any product for
which OSHA does not require such testing and certification, an NRTL's
scope of recognition does not include that product.
    The American National Standards Institute (ANSI) may approve the
test standard listed above as an American National Standard. However,
for convenience, we may use the designation of the standards-developing
organization for the standard instead of the ANSI designation. Under
the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C,
paragraph XIV), any NRTL recognized for a particular test standard may
use either the proprietary version of the test standard or the ANSI
version of that standard. Contact ANSI to determine whether a test
standard is currently ANSI-approved.

Conditions

    TUVPTL also must abide by the following conditions of its NRTL
recognition, in addition to those conditions already required by 29 CFR
1910.7:
    1. AzTE must comply with the following conditions during the period
it has an ownership interest in TUVPTL, or in any company that may
subsequently purchase or replace TUVPTL, and understands that failure
to comply with these conditions may result in OSHA revoking or imposing
limits on TUVPTL's NRTL recognition:
    a. Identify the total number of companies in which it has an
ownership interest and, of this total, the number in which AzTE's
interest in the total ownership of a company is 2% or less, and the
number in which this interest in a company exceeds 2%.
    b. Provide OSHA, annually and as requested, (i) an updated list of
companies in which AzTE's ownership interests in a company exceed 2% of
the total ownership of the company, and (ii) for each of these
companies, a description of each company's business purpose. AzTE also
must state whether any of these companies manufactures, distributes, or
sells a type of product shown on OSHA's Web page titled, ``Type of
Products Requiring NRTL Approval.''
    c. Provide OSHA access (e.g., when auditing TUVPTL) to the
record(s) or document(s) filed with the applicable legal authority
(e.g., the Secretary of State or other state authority) describing
AzTE's ownership interest in those companies in which OSHA determines
AzTE has an ownership interest exceeding 2% of the total ownership of
the company.
    d. Provide OSHA, annually and as requested, the names and
affiliations of any of its directors who are not directors of the
Arizona State University Foundation.
    2. TUVPTL must comply with the following conditions while AzTE, or
any other entity that manufactures, distributes, or sells a product
tested by TUVPTL, or is affiliated with such an entity,\3\ has an
ownership interest in TUVPTL:
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    \3\ Any condition that applies to AzTE also would apply to such
an entity.
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    a. Not test or certify any product under the NRTL Program made,
distributed, or sold by a company owned in excess of 2% by AzTE. In
addition, before testing or certifying any product for an NRTL client
applicant, TUVPTL will follow detailed procedures, reviewed and found
acceptable by OSHA, to determine that such a company did not make,
distribute, or sell the product.
    b. Cease certifications related to the NRTL Program if the
following criteria are met: (i) AzTE has more than a 10% ownership
interest in a company; (ii) OSHA determines that such a company or one
of its subsidiaries, affiliates, or significant owners, makes,
distributes, or sells a type of product for which OSHA requires NRTL
approval (i.e., one currently shown in OSHA's Web page titled, ``Type
of Products Requiring NRTL Approval''); and (iii) OSHA determines that
the risk of actual or potential undue influence resulting from this
ownership is not minor (see Condition 2.c, below). If these criteria
are met, and AzTE does not, within 60 days of OSHA's request, take
steps to reduce such ownership interests below 10%, OSHA will initiate
the process to revoke TUVPTL's NRTL recognition.
    c. For purposes of Condition 2.b, above, TUVPTL must provide or
make available, at OSHA's request, information required by OSHA to
determine whether a risk of actual or potential undue influence is not
minor. This information may include, but is not limited to, a financial
statement(s) or the annual report of the company owned by AzTE, and, if
not included in the document(s) provided, a list of the types of
products sold or made by the company, and the overall percentage of the
company's total revenue derived from selling these products. If TUVPTL
cannot or does not provide or make available this information at OSHA's
request, OSHA will be unable to determine whether the risk is minor,
and, thus, will commence the process to revoke TUVPTL's NRTL
recognition.
    d. To provide OSHA, annually and as requested, TUVPTL's overall
client list, noting those clients that are NRTL clients and, for each
such client, whether it is a company in which AzTE has more than a 10%
ownership interest. Each list shall be in an electronic format, and
shall include the information specified by OSHA. For example, this
information may include the client's name and address; the product
name(s) and model number(s); the fees paid during the last calendar
year by the client for testing and certifying its product(s); and the
percentage of TUVPTL's total revenue derived during the last calendar
year from testing and certifying this/these product(s).
    3. Within 30 days of certifying its first products under the NRTL
Program, TUVPTL will notify the OSHA NRTL Program Director of this
activity so that OSHA may schedule its first audit of TUVPTL. At this
first audit of TUVPTL, TUVPTL must demonstrate that it properly
conducted testing, review, evaluation, and factory inspections; TUVPTL
must conduct factory inspections at the frequency set forth in the
applicable NRTL Program policy.
    4. Only TUVPTL personnel may perform the final technical review,
make the final certification decision, and authorize use of the TUV
Rheinland of North America, Inc., mark for those products TUVPTL
certifies under the NRTL Program;
    5. TUVPTL will allow OSHA access to TUVPTL's facilities and records
to ascertain continuing compliance with the terms of its NRTL
recognition, and to perform such investigations as OSHA deems
necessary;
    6. If TUVPTL has reason to doubt the efficacy of any test standard
it is using under its NRTL recognition, it will promptly inform the
test standard-developing organization of this concern, and provide that
organization with the appropriate relevant information on which it
bases its concern;
    7. TUVPTL will not engage in, or permit others to engage in, any
misrepresentation of the scope or conditions of its NRTL recognition.
As part of this condition, TUVPTL agrees that it will allow no
representation that it is either a recognized or an accredited NRTL
without clearly indicating the specific equipment or material to which
this recognition applies, and also clearly

indicating that OSHA limits its NRTL recognition to specific products;
    8. TUVPTL will inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
changes in its operations as an NRTL, including details of these
changes;
    9. TUVPTL will meet all of the terms of its NRTL recognition, and
will always comply with all OSHA policies pertaining to this
recognition; and
    10. TUVPTL will continue to meet the requirements for NRTL
recognition in all areas covered by the scope of this recognition.

Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue, NW.,
Washington, DC 20210, directed the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to Sections
6(b) and 8(g) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 655 and 657), Secretary of Labor's Order No. 4-2010 (75 FR
55355), and 29 CFR part 1911.

    Signed at Washington, DC, on March 18, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-6856 Filed 3-22-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: August 8, 2008 (Volume 73, Number 154)]
[Notices]
[Page 46263-46268]
[DOCID:fr08au08-55]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0598; FRL-8377-2]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Inventory) to
notify EPA and comply with the statutory provisions pertaining to the
manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of
TSCA, EPA is required to publish a notice of receipt of a
premanufacture notice (PMN) or an application for a test marketing
exemption (TME), and to publish periodic status reports on the
chemicals under review and the receipt of notices of commencement to
manufacture those chemicals. This status report, which covers the
period from June 23, 2008 through July 18, 2008, consists of the PMNs
and TMEs, both pending or expired, and the notices of commencement to
manufacture a new chemical that the Agency has received under TSCA
section 5 during this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before September 8, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0598, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
      Mail: Document Control Office (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2008-0598. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0598. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form

of encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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 electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics (7408M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the premanufacture notices
addressed in the action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Why is EPA Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical (i.e., a chemical
not on the TSCA Inventory to notify EPA and comply with the statutory
provisions pertaining to the manufacture of new chemicals. Under
sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a
notice of receipt of a PMN or an application for a TME and to publish
periodic status reports on the chemicals under review and the receipt
of notices of commencement to manufacture those chemicals. This status
report, which covers the period from June 23, 2008 through July 18,
2008, consists of the PMNs and TMEs, both pending or expired, and the
notices of commencement to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs

    This status report identifies the PMNs and TMEs, both pending or
expired, and the notices of commencement to manufacture a new chemical
that the Agency has received under TSCA section 5 during this time
period. If you are interested in information that is not included in
the following tables, you may contact EPA as described in Unit II. to
access additional non-CBI information that may be available.
    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: the EPA case number assigned to the
PMN; the date the PMN was received by EPA; the projected end date for
EPA's review of the PMN; the submitting manufacturer; the potential
uses identified by the manufacturer in the PMN; and the chemical
identity.

                                            I. 71 Premanufacture Notices Received From: 06/23/08 to 07/18/08
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-08-0486                            06/20/08                09/17/08                CBI                    (G) Lamination         (G) Polymer with
                                                                                adhesive               .alpha.-hydro-
                                                                                .omega.-
                                                                                hydroxypoly[oxy(meth
                                                                                yl-1,2-ethanediyl)],
                                                                                3-hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methylpropanoic acid
                                                                                and
                                                                                alkyldiisocyanate,
                                                                                ammonium salt
P-08-0487                            06/23/08                09/20/08                CBI                    (G) Dispersion         (G) Triazine
                                                                                additive for           derivative
                                                                                printing ink
P-08-0488                            06/23/08                09/20/08                CBI                    (G) Dispersion         (G) Triazine
                                                                                additive for           derivative
                                                                                printing ink
P-08-0489                            06/23/08                09/20/08                CBI                    (G) Open,              (G) Azo substituted
                                                                                nondispersive use;     benzoic acid
                                                                                polymer precursor
P-08-0490                            06/24/08                09/21/08                Wacker Polymers LP     (S) Binder for         (S) Tert-decanoic
                                                                                building materials,    acid, ethenyl ester,
                                                                                sealants, paints,      polymer with ethene,
                                                                                adhesives, plasters;   ethenyl acetate and
                                                                                methyl 2-methyl-2-
                                                                                propenoate
P-08-0491                            06/25/08                09/22/08                Huntsman               (S) Exhaust dyeing of  (G) Reaction product
                                                                                International, LLC     cotton                 of substituted
                                                                                naphthalenesulfonic
                                                                                acid triazin amino
                                                                                compound and
                                                                                substituted
                                                                                naphthalenesulfonic
                                                                                acid substitued
                                                                                triazin phenyl alkyl
                                                                                sulfonyl compound
P-08-0492                            06/23/08                09/20/08                CBI                    (G) for printing ink   (G) Aluminum diazo
                                                                                naphthalene
                                                                                derivative
P-08-0493                            06/23/08                09/20/08                CBI                    (G) for printing ink   (G) Aluminum diazo
                                                                                naphthalene
                                                                                derivative
P-08-0494                            06/23/08                09/20/08                CBI                    (G) Dispersion         (G) Benzene sulfonic
                                                                                additive for           acid alkyl amine
                                                                                printing ink
P-08-0495                            06/23/08                09/20/08                CBI                    (G) Dispersion         (G) Benzene sulfonic
                                                                                additive for           acid alkyl amine
                                                                                printing ink
P-08-0496                            06/24/08                09/21/08                CBI                    (G) Coatings for       (G) Alkene-carboxylic
                                                                                various materials      acid copolymer
                                                                                alkanolamine salt
P-08-0497                            06/24/08                09/21/08                CBI                    (G) Coatings for       (G) Alkene-carboxylic
                                                                                various materials      acid copolymer salt
P-08-0498                            06/25/08                09/22/08                CBI                    (G) Enhanced oil       (G) Sodium sulfonate
                                                                                recovery               surfactant
                                                                                applications
P-08-0499                            06/25/08                09/22/08                Genencor, a danisco    (S) In-situ            (S) Arylesterase -
                                                                                division               peroxyacetic acid      the CAS Registy
                                                                                generation for         number (9032-73-9)
                                                                                bleaching textile      was determined by
                                                                                products               using the enzyme
                                                                                classification
                                                                                number for this
                                                                                enzyme.arylesterase
                                                                                (ec
                                                                                <IP_ADDRESS>) is
                                                                                referenced in the
                                                                                Brenda Comprehensive
                                                                                Enzyme Information
                                                                                System and in the
                                                                                expasy enzyme
                                                                                database. synonyms
                                                                                are paraoxonase and
                                                                                alpha-esterase. The
                                                                                systematic name is
                                                                                aryl-ester
                                                                                hydrolase.
                                                                                Arylesterases act on
                                                                                many phenolic
                                                                                esters. It is likely
                                                                                that the three forms
                                                                                of human paraoxonase
                                                                                are lactonases
                                                                                rather than aromatic
                                                                                esterases [7,8]. The
                                                                                natural substrates
                                                                                of the paraoxonases
                                                                                are lactones, with
                                                                                ()-5-hydroxy-
                                                                                6E,8Z,11Z,4Z-
                                                                                eicostetraenoic-acid
                                                                                1,5-lactone being
                                                                                the best substrate.
P-08-0500                            06/25/08                09/22/08                The Dow Chemical       (G) Consumer goods     (S) Benzene, ethenyl-
                                                                                Company                and adhesives          , polymer with 1,3-
                                                                                butadiene and 2-
                                                                                methyl-1,3-butadiene
P-08-0501                            06/27/08                09/24/08                CBI                    (G) Contained use in   (G) Polyacrylate salt
                                                                                energy production
P-08-0502                            06/27/08                09/24/08                CBI                    (G) Component of an    (G) Cyclic guanidine
                                                                                industrial coating
P-08-0503                            06/30/08                09/27/08                CBI                    (G) Adhesive           (G) Epoxy resin
                                                                                component composite
                                                                                resin component
P-08-0504                            06/30/08                09/27/08                CBI                    (G) Laminate resin     (G) Formaldehyde,
                                                                                polymer with amine
                                                                                and A phenol
P-08-0505                            06/30/08                09/27/08                CBI                    (G) Oil-field          (G) Copolymer of
                                                                                chemical               substituted
                                                                                propanesulfonic
                                                                                acid, maleate of
                                                                                ethylene oxide-
                                                                                propylene oxide
P-08-0506                            06/30/08                09/27/08                CBI                    (G) Intermediate       (G) Maleate of
                                                                                ethylene oxide-
                                                                                propylene oxide
                                                                                copolymer

P-08-0507                            06/30/08                09/27/08                CBI                    (S) Laminating         (G) Aromatic
                                                                                adhesive               polyester polyether
                                                                                polyurethane
P-08-0508                            06/30/08                09/27/08                Dupont Company         (G) Intermediate for   (G) Perfluorinated
                                                                                polymerization aid     aliphatic carboxylic
                                                                                acid
P-08-0509                            06/30/08                09/27/08                Dupont Company         (G) Polymerization     (G) Perfluorinated
                                                                                aid                    aliphatic carboxylic
                                                                                acid, ammonium salt
P-08-0510                            07/02/08                09/29/08                CBI                    (G) Co-stabilizer for  (G) Organosulfide
                                                                                plastics
P-08-0511                            07/02/08                09/29/08                Zeon Chemicals L.P.    (S) Automotive seals   (G) Modified
                                                                                and gaskets            acrylonitrile,
                                                                                butadiene polymer,
                                                                                hydrogenated
P-08-0512                            07/02/08                09/29/08                CBI                    (G) Chemical           (G) Alcohol
                                                                                intermediate           propoxylate
P-08-0513                            07/02/08                09/29/08                CBI                    (G) Enhanced oil       (G) Alcohol
                                                                                recovery               propoxylate sulfate
                                                                                applications           salt
P-08-0514                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
P-08-0515                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
P-08-0516                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
P-08-0517                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
P-08-0518                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
P-08-0519                            07/02/08                09/29/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
P-08-0520                            07/02/08                09/29/08                CBI                    (G) Urethane           (G) Aromatic
                                                                                component              isocyanate
P-08-0522                            07/03/08                09/30/08                CBI                    (G) Raw material for   (G) 1-propanone, 2-
                                                                                the manufacturing of   hydroxy-2- methyl-,
                                                                                realese coatings       1-(4-alkylaryl)
                                                                                derivates
P-08-0523                            07/07/08                10/04/08                CBI                    (G) Mechanical         (G) TDI polyester
                                                                                devices                polypropylene
                                                                                ethylene copolymer
P-08-0524                            07/07/08                10/04/08                CBI                    (S) Unsaturated        (G) Unsaturated
                                                                                polyester used in      polyester
                                                                                ultra violet curable
                                                                                inks and coatings.
P-08-0525                            07/08/08                10/05/08                CBI                    (G) Asphalt additive   (G) Fatty acid
                                                                                production of energy   maleated
P-08-0526                            07/08/08                10/05/08                CBI                    (G) Open non-          (G) Aliphatic
                                                                                dispersive (resin)     urethane resin
P-08-0527                            07/08/08                10/05/08                CBI                    (G) Vinyl acrylic      (G) Vinyl acetate -
                                                                                pressure sensitive     acrylic copolymer
                                                                                adhesive
P-08-0528                            07/08/08                10/05/08                CBI                    (G) Additive for       (S) Butanoic acid, 2-
                                                                                consumer use           methyl-, 5-hexen-1-
                                                                                products; dispersive   yl-ester
                                                                                use
P-08-0529                            07/08/08                10/05/08                Nippon Kayaku          (S) Additives for      (G) 1,2,3 -
                                                                                America, Inc.          industrial inkjet      propanetriol,
                                                                                printer.               homopolymer, ether
                                                                                with aliphatic
                                                                                alcohol
P-08-0530                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0531                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0532                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0533                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0534                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0535                            07/09/08                10/06/08                CBI                    (G) Fragrance -        (G) Silicic acid
                                                                                dispersive use.        ester polymer
P-08-0536                            07/08/08                10/05/08                Eastman Chemical       (S) Plasticizer        (S) Hexanoic acid, 2-
                                                                                Company                                       ethyl-, 2,2-dimethyl-
                                                                                1-(1-methylethyl)-
                                                                                1,3-propanediyl
                                                                                ester
P-08-0537                            07/08/08                10/05/08                CBI                    (G) Acid inhibitor     (G) Comple keto-amine
P-08-0538                            07/11/08                10/08/08                CBI                    (G) Pigment            (G) Polyetheramine
                                                                                dispersant             derivative
P-08-0539                            07/09/08                10/06/08                Futurefuel Chemical    (S) Biodiesel fuel     (S) Fatty acids,
                                                                                Company                                       lesquerella, me
                                                                                ethers
P-08-0540                            07/09/08                10/06/08                Futurefuel Chemical    (S) Biodiesel fuel     (S) Fatty acids,
                                                                                Company                                       camelina, me ethers
P-08-0541                            07/09/08                10/06/08                Futurefuel Chemical    (S) Biodiesel fuel     (S) Fatty acids,
                                                                                Company                                       peanut-oil, me
                                                                                esters
P-08-0542                            07/09/08                10/06/08                Futurefuel Chemical    (S) Biodiesel fuel     (S) Fatty acids, palm-
                                                                                Company                                       oil, me esters
P-08-0543                            07/14/08                10/11/08                CBI                    (S) Chemical           (G) Methyl ester of
                                                                                intermediate           hydroxy alkyl acid
P-08-0544                            07/15/08                10/12/08                Strategic Marketing    (G) Aromatic additive  (G)
                                                                                SMF Management                                Methylpropylpyranol
                                                                                Associates
P-08-0545                            07/16/08                10/13/08                CBI                    (G) Open, non-         (G) Surface-active,
                                                                                dispersive use.        blocked isocyanate
                                                                                polymer

P-08-0546                            07/17/08                10/14/08                Oxea Corporation       (G) Industrial         (S) 1,3-butanediol,
                                                                                antifreeze; chemical   manufacture of, by-
                                                                                intermediate           products from
                                                                                distributing
                                                                                residues
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the TMEs
received:

                                       II. 7 Test Marketing Exemption Notices Received From: 06/23/08 to 07/18/08
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-08-0010                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
T-08-0011                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
T-08-0012                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Sited limited      (G)
                                                                                intermediate           Poly(oxyalkylenediyl
                                                                                ), maleate half-
                                                                                ester
T-08-0013                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
T-08-0014                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
T-08-0015                            07/02/08                08/15/08                Cytec Industries Inc.  (G) Emulsifier         (G)
                                                                                Poly(oxyalkylenediyl
                                                                                ), substituted
                                                                                maleate half-ester,
                                                                                metal salts
T-08-0016                            07/07/08                08/20/08                SC Johnson and Son,    (G) non-dispersive     (G) Hydrolyzed
                                                                                Inc.                   use                    cellulosic ether
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table III of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the
Notices of Commencement to manufacture received:

                           III. 27 Notices of Commencement From: 06/23/08 to 07/18/08
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-03-0257                             07/02/08                06/06/03                (G) Polyester polymer
P-05-0727                             06/23/08                05/30/08                (S) Carbamic acid,
                                                                                [(dimethoxymethylsilyl)me
                                                                                thyl]-, methyl ester
P-06-0645                             07/14/08                07/09/08                (S) 3-decen-5-one, 4-
                                                                                methyl-, (3e)-
P-06-0755                             06/23/08                06/09/08                (G) Titanium phosphate,
                                                                                glycolate complex
P-07-0046                             06/24/08                06/12/08                (S) 4H-indeno[4,5-d]-1,3-
                                                                                dioxole, 3a,5,6,7,8,8b-
                                                                                hexahydro- 2,2,6,6,7,8,8-
                                                                                heptamethyl-
P-07-0064                             06/23/08                06/08/08                (G) Modified rosin,
                                                                                hydrocarbon resin
P-07-0068                             07/08/08                06/26/08                (G) Polyester resin
P-07-0079                             07/09/08                06/27/08                (G) Substituted
                                                                                piperidinol, carbonate
P-07-0333                             07/11/08                07/03/08                (G) Aromatic isocyanate
                                                                                prepolymer
P-07-0454                             07/14/08                06/26/08                (G) Alkyl amine
P-07-0455                             07/14/08                06/26/08                (G) Alkyl amidoamine
P-07-0456                             07/14/08                06/26/08                (G) Alkylamine
P-07-0707                             07/07/08                06/20/08                (G) Blocked aromatic
                                                                                polyisocyanate
P-08-0081                             06/30/08                06/18/08                (S) Soybean oil, maleated,
                                                                                ester with polyethylene
                                                                                glycol mono-C12	16-alkyl
                                                                                ethers
P-08-0157                             06/23/08                06/15/08                (G) Quaternary ammonium
                                                                                compounds, dialkyl
                                                                                dimethyl, halides,
                                                                                reaction products with
                                                                                silica
P-08-0164                             06/23/08                06/16/08                (S) 1,2,4,5-benzenetetra
                                                                                carboxylic acid; 1,4-
                                                                                bis(2-((2-methyl-1-oxo-2-
                                                                                propenyl)oxy)ethyl)ester
P-08-0186                             06/23/08                05/28/08                (S) D-glucopyranose,
                                                                                oligomeric, decyl octyl
                                                                                glycosides, 3-
                                                                                (dodecyldimethylammonio)-
                                                                                2-hydroxypropyl ethers,
                                                                                chlorides
P-08-0205                             07/14/08                06/16/08                (G) Acrylic acid polymer
                                                                                with alkyl acrylate,
                                                                                alkenyl benzene and acryl
                                                                                amide, ammonium salt
P-08-0208                             06/20/08                06/12/08                (G) Acrylic styrene
                                                                                polymer
P-08-0218                             06/26/08                06/02/08                (G) Isocyanate terminated
                                                                                polymer with
                                                                                polyoxyalkylene polyols
                                                                                and isocyanate
P-08-0232                             07/09/08                06/15/08                (S) 2H-pyran, 5,6-dihydro-
                                                                                4-methyl-2-[(2,2,3-
                                                                                trimethyl-3-cyclopenten-1-
                                                                                yl)methyl]-
P-08-0235                             07/07/08                07/01/08                (G) Heteropolyclic lactone

P-08-0242                             07/07/08                06/09/08                (S) 1,2,3,4-butanetetrol
                                                                                meso-erythritol
P-08-0243                             07/02/08                06/12/08                (G) Organomodified silanic
                                                                                hydrogen fluid
P-08-0244                             07/02/08                06/13/08                (G) Modified silicone
                                                                                polyether copolymer
P-08-0250                             07/14/08                06/19/08                (S) Poly(oxy-1,4-
                                                                                butanediyl), .alpha.-
                                                                                hydro-.omega.-hydroxy-,
                                                                                polymer with ammonia
P-08-0267                             07/10/08                06/22/08                (G) Modified polyolefin,
                                                                                aminoalkanoic acid and
                                                                                polyether copolymer
P-08-0326                             07/11/08                06/26/08                (G) Isocyanate terminated
                                                                                urethane polymer
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental protection, Chemicals, Premanufacturer notices.

    Dated: July 31, 2008.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. E8-18321 Filed 8-7-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Page 27313]
[FR Doc No: 2014-10933]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Immune Responses to Enzyme Replacement Therapies: Role of Immune
Tolerance Induction; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research, in cosponsorship with the National
Organization for Rare Disorders (NORD), is announcing a 1-day public
workshop entitled ``Immune Responses to Enzyme Replacement Therapies:
Role of Immune Tolerance Induction.'' Partners and stakeholders
planning the workshop also include representatives from academia,
industry, and patients. The purpose of this workshop is to provide a
forum to discuss the role of immune tolerance induction in patients
receiving replacement biological products.

DATES: The public workshop will be held on June 9, 2014, from 8 a.m. to
5 p.m.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Bldg. 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Maureen Dewey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-
796-9905<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA's Center for Drug Evaluation and
Research, in co-sponsorship with NORD, is announcing a 1-day public
workshop entitled ``Immune Responses to Enzyme Replacement Therapies:
Role of Immune Tolerance Induction.'' The cosponsored workshop will
facilitate an ongoing dialogue among relevant parties on issues related
to the role of immune tolerance induction in enzyme replacement
therapies. The workshop will discuss the impact of anti-drug and
neutralizing antibodies on efficacy and safety of enzyme replacement
therapies intended to treat patients with lysosomal storage diseases
and the risks and benefits of implementing prophylactic immune
tolerance regimens to preclude generation of these antibodies.
Stakeholders, including patients and patient organizations, industry
sponsors, academia, and FDA, will discuss challenging issues related to
immune tolerance induction in enzyme replacement therapies.
    Registration: There is no fee to attend the public workshop, but
advanced online registration is requested. Space is limited, and
registration will be on a first-come, first-served basis. To register
online, please visit https://events.rarediseases.org/?page_id=4ⅇ=13.
Onsite registration the day of the workshop will be available, but
advanced registration is preferred.
    If you need special accommodations due to a disability, please
contact Maureen Dewey (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
    Transcripts: Transcripts of the workshop will be available for
review at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
at http://www.regulations.gov approximately 30 days after the workshop.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Send faxed requests to<PHONE_NUMBER>.

    Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10933 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P