[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Page 17559]
[FR Doc No: 2014-06934]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3367-EM; Docket ID FEMA-2014-0003]

Pennsylvania; Amendment No. 1 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the Commonwealth of Pennsylvania (FEMA-3367-EM), dated February 6,
2014, and related determinations.

DATES: Effective Date: February 20, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective February 20, 2014.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-06934 Filed 3-27-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Notices]
[Page 9438-9442]
[DOCID:fr04mr09-92]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28637; 812-13541]

DFA Investment Dimensions Group Inc., et al.; Notice of
Application

February 26, 2009.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 12(d)(1)(J)
of the Investment Company Act of 1940 (the ``Act'') for exemption from
sections 12(d)(1)(A) and (B) of the Act and under sections 6(c) and
17(b) of the Act for an exemption from section 17(a) of the Act.

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Summary of the Application: The order would permit certain management
investment companies and unit investment trusts registered under the
Act to acquire shares of certain open-end management investment
companies or unit investment trusts registered under the Act that are
outside of the same group of investment companies as the acquiring
investment companies.

Applicants: DFA Investment Dimensions Group Inc. (``DFAIDG''),
Dimensional Emerging Markets Value Fund Inc. (``DEM''), Dimensional
Investment Group Inc. (``DIG''), and The DFA Investment Trust Company
(``DFAITC,'' and together with DFAIDG, DEM, and DIG, the ``Trusts'')
and Dimensional Fund Advisors LP (``Advisor'').

Filing Dates: The application was filed on June 11, 2008, and amended
on December 8, 2008. Applicants have agreed to file an amendment during
the notice period, the substance of which is reflected in this notice.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on March 23, 2009, and should be accompanied by proof of service
on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-

1090; Applicants, 2901 Via Fortuna, Terrace V, Floor 2, Austin, TX
78746.

FOR FURTHER INFORMATION CONTACT: Jill Ehrlich, Attorney Adviser, at
(202) 551-6819, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Public Reference Desk, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington DC 20549-0102 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. The Trusts are open-end management investment companies
registered under the Act and are each comprised of separate series
(each, a ``Fund'' and collectively the ``Funds'') that pursue distinct
investment objectives and strategies. Each of DFAIDG, DEM, and DIG is
organized as a Maryland corporation. DFAITC is organized as a Delaware
statutory trust. Certain Funds pursue their investment objectives
through a master-feeder arrangement in reliance on section 12(d)(1)(E)
of the Act.\1\ The Advisor is a Delaware limited partnership and is
registered as an investment adviser under the Investment Advisers Act
of 1940 (``Advisers Act'').\2\ The Advisor serves as investment adviser
to those Funds that invest directly in portfolio securities.
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    \1\ A Fund of Funds (as defined below) may not invest in a Fund
that serves as a feeder Fund unless the feeder Fund is part of the
same group of investment companies as its corresponding master fund.
    \2\ All references to the term ``Advisor'' herein include
successors-in-interest to the Advisor. Successors-in-interest are
limited to any entity resulting from a reorganization of the Advisor
into another jurisdiction or a change in the type of business
organization.
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    2. Applicants request relief to permit registered management
investment companies (``Investing Management Companies'') and
registered unit investment trusts (``Investing Trusts,'' and together
with the Investing Management Companies, ``Funds of Funds'') that are
not part of the same ``group of investment companies,'' within the
meaning of section 12(d)(1)(G)(ii) of the Act, as the Trusts, to
acquire shares of the Funds in excess of the limits in section
12(d)(1)(A) of the Act, and to permit a Fund, any principal underwriter
for a Fund, and any broker or dealer registered under the Securities
Exchange Act of 1934 (``Broker'') to sell shares of a Fund to a Fund of
Funds in excess of the limits of section 12(d)(1)(B) of the Act.
Applicants request that the relief apply to: (1) Each open-end
management investment company or unit investment trust registered under
the Act that currently or subsequently is part of the same ``group of
investment companies,'' within the meaning of section 12(d)(1)(G)(ii)
of the Act, as the Trusts and is advised or sponsored by the Advisor or
any entity controlling, controlled by, or under common control with the
Advisor (such open-end management investment companies are referred to
as ``Open-end Funds;'' such unit investment trusts are referred to as
``UIT Funds;'' and both Open-end Funds and UIT Funds are included in
the term ``Funds''); (2) each Fund of Funds that enters into a
Participation Agreement (as defined below) with a Fund to purchase
shares of the Funds; and (3) any principal underwriter to a Fund or
Broker selling shares of a Fund.\3\
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    \3\ All entities that currently intend to rely on the requested
order are named as applicants. Any other entity that relies on the
order in the future will comply with the terms and conditions of the
application. A Fund of Funds may rely on the requested order only to
invest in the Funds and not in any other registered investment
company.
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    3. Each Investing Management Company will be advised by an
investment adviser within the meaning of section 2(a)(20)(A) of the Act
and registered as an investment advisor under the Advisers Act (``Fund
of Funds Adviser''). A Fund of Funds Adviser may contract with an
investment adviser which meets the definition of section 2(a)(20)(B) of
the Act (a ``Subadviser''). Any Subadviser will be registered as an
investment adviser under the Advisers Act. Each Investing Trust will
have a sponsor (``Sponsor''). Applicants represent that to ensure that
Funds of Funds comply with the terms and conditions of the requested
relief, a Fund of Funds must enter into a participation agreement
between a Trust, on behalf of the relevant Funds, and the Fund of Funds
(``Participation Agreement'') before investing in a Fund beyond the
limits imposed by section 12(d)(1)(A). The Participation Agreement will
require the Fund of Funds to adhere to the terms and conditions of the
requested order. The Participation Agreement will include an
acknowledgment from the Fund of Funds that it may rely on the requested
order only to invest in the Funds and not in any other registered
investment company.
    4. Applicants state that the Funds will offer Funds of Funds simple
and efficient investment vehicles to achieve their asset allocation or
diversification objectives. Applicants state that the Funds also
provide high quality, professional investment program alternatives to
Funds of Funds that do not have sufficient assets to operate comparable
funds.

Applicants' Legal Analysis

A. Section 12(d)(1)

    1. Section 12(d)(1)(A) of the Act, in relevant part, prohibits a
registered investment company from acquiring shares of an investment
company if the securities represent more than 3% of the total
outstanding voting stock of the acquired company, more than 5% of the
total assets of the acquiring company, or, together with the securities
of any other investment companies, more than 10% of the total assets of
the acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, and
any Broker from selling the investment company's shares to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or if the sale
will cause more than 10% of the acquired company's voting stock to be
owned by investment companies generally.
    2. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security, or transaction, or any class or classes of
persons, securities or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Applicants seek an exemption under section
12(d)(1)(J) of the Act to permit Funds of Funds to acquire shares of
the Funds in excess of the limits in section 12(d)(1)(A) of the Act,
and a Fund, any principal underwriter for a Fund and any Broker to sell
shares of a Fund to a Fund of Funds in excess of the limits of section
12(d)(1)(B) of the Act.
    3. Applicants state that the proposed arrangement and conditions
will adequately address the concerns underlying the applicable limits
in sections 12(d)(1)(A) and (B) of the Act, which include concerns
about undue influence by a fund of funds over underlying funds,
excessive layering of fees, and overly complex fund structures.
Accordingly, applicants believe that the requested exemption is
consistent with the public interest and the protection of investors.
    4. Applicants believe that neither a Fund of Funds nor a Fund of
Funds Affiliate would be able to exert undue

influence over the Funds.\4\ To limit the control that a Fund of Funds
may have over a Fund, applicants propose a condition prohibiting the
Fund of Funds Adviser or Sponsor, any person controlling, controlled
by, or under common control with the Fund of Funds Adviser or Sponsor,
and any investment company or issuer that would be an investment
company but for section 3(c)(1) or 3(c)(7) of the Act that is advised
or sponsored by the Fund of Funds Adviser or Sponsor, or any person
controlling, controlled by, or under common control with the Fund of
Funds Adviser or Sponsor (``Fund of Funds Advisory Group'') from
controlling (individually or in the aggregate) a Fund within the
meaning of section 2(a)(9) of the Act. The same prohibition would apply
to each Subadviser, any person controlling, controlled by or under
common control with the Subadviser, and any investment company or
issuer that would be an investment company but for section 3(c)(1) or
3(c)(7) of the Act (or portion of such investment company or issuer)
advised or sponsored by the Subadviser or any person controlling,
controlled by or under common control with the Subadviser (``Subadviser
Group''). Applicants propose other conditions to limit the potential
for undue influence over the Funds, including that no Fund of Funds or
Fund of Funds Affiliate (except to the extent it is acting in its
capacity as an investment adviser to an Open-end Fund or sponsor to a
UIT Fund) will cause a Fund to purchase a security in an offering of
securities during the existence of an underwriting or selling syndicate
of which a principal underwriter is an Underwriting Affiliate
(``Affiliated Underwriting''). An ``Underwriting Affiliate'' is a
principal underwriter in any underwriting or selling syndicate that is
an officer, director, member of an advisory board, Fund of Funds
Adviser, Subadviser, Sponsor, or employee of the Fund of Funds, or a
person of which any such officer, director, member of an advisory
board, Fund of Funds Adviser, Subadviser, Sponsor or employee is an
affiliated person; however any person whose relationship to a Fund is
covered by section 10(f) of the Act is not an Underwriting Affiliate.
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    \4\ A ``Fund of Funds Affiliate'' is defined as a Fund of Funds
Adviser, Subadviser, Sponsor, promoter, or a principal underwriter
of a Fund of Funds, and any person controlling, controlled by, or
under common control with any of those entities. A ``Fund
Affiliate'' is defined as an investment adviser, sponsor, promoter,
or principal underwriter of a Fund, and any person controlling,
controlled by, or under common control with any of those entities.
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    5. Applicants do not believe that the proposed arrangement will
involve excessive layering of fees. The board of directors or trustees
of each Investing Management Company, including a majority of the
directors or trustees who are not ``interested persons'' (within the
meaning of section 2(a)(19) of the Act) (``Disinterested Trustees''),
will find that the advisory fees charged under the advisory contract
are based on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Open-end Fund in which the Investing Management Company may invest.
In addition, a Fund of Funds Adviser or trustee or Sponsor of a Fund of
Funds will waive fees otherwise payable to it by the Fund of Funds in
an amount at least equal to any compensation (including fees received
pursuant to any plan adopted by an Open-end Fund under rule 12b-1 under
the Act) received from a Fund by the Fund of Funds Adviser, trustee, or
Sponsor, or an affiliated person of the Fund of Funds Adviser, trustee,
or Sponsor, other than any advisory fees paid to the Fund of Funds
Adviser, trustee, or Sponsor, or its affiliated person by an Open-end
Fund, in connection with the investment by the Fund of Funds in the
Fund. Applicants also state that with respect to registered separate
accounts that invest in a Fund of Funds, no sales load will be charged
at the Fund of Funds level or at the Fund level.\5\ Other sales charges
and service fees, as defined in Rule 2830 of the NASD Conduct Rules
(``Rule 2830''), if any, will only be charged at the Fund of Funds
level or at the Fund level, not both. With respect to other investments
in a Fund of Funds, any sales charges and/or service fees charged with
respect to shares of the Fund of Funds will not exceed the limits
applicable to a fund of funds as set forth in Rule 2830.
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    \5\ Applicants represent that a Fund of Funds will represent in
the Participation Agreement that no insurance company sponsoring a
registered separate account will be permitted to invest in the Fund
of Funds unless the insurance company has certified to the Fund of
Funds that the aggregate of all fees and charges associated with
each contract that invests in the Fund of Funds, including fees and
charges at the separate account, Fund of Funds, and Fund levels,
will be reasonable in relation to the services rendered, the
expenses expected to be incurred, and the risks assumed by the
insurance company.
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    6. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants propose condition 12 to
ensure that the proposed structure will not result in unnecessary
complexity. Applicants also note that a Fund reserves the right to
reject any investment by a Fund of Funds.

B. Section 17(a)

    1. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include any person 5% or
more of whose outstanding voting securities are directly or indirectly
owned, controlled, or held with power to vote by the other person.
Applicants seek relief from section 17(a) to permit a Fund that is an
affiliated person, or an affiliated person of an affiliated person, of
a Fund of Funds to sell its shares to and redeem its shares from a Fund
of Funds.\6\
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    \6\ Applicants acknowledge that receipt of compensation by (a)
an affiliated person of a Fund of Funds, or an affiliated person of
such person, for the purchase by the Fund of Funds of shares of a
Fund or (b) an affiliated person of a Fund, or an affiliated person
of such person, for the sale by the Fund of its shares to a Fund of
Funds may be prohibited by section 17(e)(1) of the Act. The
Participation Agreement also will include this acknowledgment.
---------------------------------------------------------------------------

    2. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
it finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned, (b) the proposed transaction is consistent with the policies
of each registered investment company involved, and (c) the proposed
transaction is consistent with the general purposes of the Act. Section
6(c) of the Act permits the Commission to exempt any person or
transactions from any provision of the Act if such exemption is
necessary or appropriate in the public interest and consistent with the
protection of investors and the purposes fairly intended by the policy
and provisions of the Act. Applicants submit that the proposed
arrangement satisfies the standards for relief under sections 17(b) and
6(c) of the Act.
    3. Applicants believe that any proposed transactions directly
between Funds and a Fund of Funds will be consistent with the policies
of each Fund and such Fund of Funds. The Participation Agreement will
require any Fund of Funds that purchases shares from a Fund to
represent that the purchase of shares from the Fund by a Fund of Funds
will be accomplished in compliance with the investment restrictions of
the Fund of Funds and will be consistent with the investment

policies set forth in the Fund of Fund's registration statement.
    4. Applicants state that the terms of the arrangement are fair and
reasonable and do not involve overreaching. Applicants note that all
shares of the Funds sold and redeemed by the Funds will be sold and
redeemed at net asset value as required by rule 22c-1 under the Act.
Applicants also state that the proposed arrangement is consistent with
the policies and provisions of the Act.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. The members of a Fund of Funds Advisory Group will not control
(individually or in the aggregate) a Fund within the meaning of section
2(a)(9) of the Act. The members of a Subadviser Group will not control
(individually or in the aggregate) a Fund within the meaning of section
2(a)(9) of the Act. If, as a result of a decrease in the outstanding
voting securities of a Fund, the Fund of Funds Advisory Group or the
Subadviser Group, each in the aggregate, becomes a holder of more than
25% of the outstanding voting securities of a Fund, it (except for any
member of the Fund of Funds Advisory Group or Subadviser Group that is
a separate account) will vote its shares of the Fund in the same
proportion as the vote of all other holders of the Fund's shares. This
condition does not apply to the Subadviser Group with respect to a Fund
for which the Subadviser or a person controlling, controlled by, or
under common control with the Subadviser acts as the investment adviser
within the meaning of section 2(a)(20)(A) of the Act (in the case of an
Open-end Fund) or as the sponsor (in the case of a UIT Fund). A
registered separate account will seek voting instructions from its
contract holders and will vote its shares in accordance with the
instructions received and will vote those shares for which no
instructions were received in the same proportion as the shares for
which instructions were received. An unregistered separate account will
either (a) vote its shares of the Fund in the same proportion as the
vote of all other holders of the Fund's shares, or (b) seek voting
instructions from its contract holders and vote its shares in
accordance with the instructions received and vote those shares for
which no instructions were received in the same proportion as the
shares for which instructions were received.
    2. No Fund of Funds or Fund of Funds Affiliate will cause any
existing or potential investment by the Fund of Funds in shares of a
Fund to influence the terms of any services or transactions between the
Funds of Funds or a Fund of Funds Affiliate and the Fund or a Fund
Affiliate.
    3. The board of directors or trustees of an Investing Management
Company, including a majority of the Disinterested Trustees, will adopt
procedures reasonably designed to assure that the Fund of Funds Adviser
and any Subadviser are conducting the investment program of the
Investing Management Company without taking into account any
consideration received by the Investing Management Company or a Fund of
Funds Affiliate from a Fund or a Fund Affiliate in connection with any
services or transactions.
    4. Once an investment by a Fund of Funds in the securities of an
Open-end Fund exceeds the limit in section 12(d)(1)(A)(i) of the Act,
the board of trustees of the Open-end Fund (``Board''), including a
majority of the Disinterested Trustees, will determine that any
consideration paid by the Open-end Fund to a Fund of Funds or a Fund of
Funds Affiliate in connection with any services or transactions (a) Is
fair and reasonable in relation to the nature and quality of the
services and benefits received by the Open-end Fund, (b) is within the
range of consideration that the Open-end Fund would be required to pay
to another unaffiliated entity in connection with the same services or
transactions, and (c) does not involve overreaching on the part of any
person concerned. This condition does not apply with respect to any
services or transactions between an Open-end Fund and its investment
adviser(s), or any person controlling, controlled by, or under common
control with such investment adviser(s).
    5. No Fund of Funds or Fund of Funds Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Open-end Fund or sponsor to a UIT Fund) will cause a Fund to purchase a
security in any Affiliated Underwriting.
    6. The Board of an Open-end Fund, including a majority of the
Disinterested Trustees, will adopt procedures reasonably designed to
monitor any purchases of securities by an Open-end Fund in an
Affiliated Underwriting once an investment by a Fund of Funds in the
securities of the Open-end Fund exceeds the limit in section
12(d)(1)(A)(i) of the Act, including any purchases made directly from
an Underwriting Affiliate. The Board of the Open-end Fund will review
these purchases periodically, but no less frequently than annually, to
determine whether the purchases were influenced by the investment by
the Fund of Funds in the Open-end Fund. The Board of the Open-end Fund
will consider, among other things, (a) whether the purchases were
consistent with the investment objectives and policies of the Open-end
Fund, (b) how the performance of securities purchased in an Affiliated
Underwriting compares to the performance of comparable securities
purchased during a comparable period of time in underwritings other
than Affiliated Underwritings or to a benchmark such as a comparable
market index, and (c) whether the amount of securities purchased by the
Open-end Fund in Affiliated Underwritings and the amount purchased
directly from an Underwriting Affiliate have changed significantly from
prior years. The Board of the Open-end Fund will take any appropriate
actions based on its review, including, if appropriate, the institution
of procedures designed to assure that purchases of securities in
Affiliated Underwritings are in the best interests of shareholders.
    7. Each Open-end Fund will maintain and preserve permanently in an
easily accessible place a written copy of the procedures described in
the preceding condition, and any modifications to such procedures, and
will maintain and preserve for a period of not less than six years from
the end of the fiscal year in which any purchase in an Affiliated
Underwriting occurred, the first two years in an easily accessible
place, a written record of each purchase of securities in Affiliated
Underwritings once an investment by a Fund of Funds in the securities
of an Open-end Fund exceeds the limit in section 12(d)(1)(A)(i) of the
Act, setting forth from whom the securities were acquired, the identity
of the underwriting syndicate's members, the terms of the purchase, and
the information or materials upon which the determinations of the Board
of the Open-end Fund were made.
    8. Before investing in a Fund in excess of the limits in section
12(d)(1)(A), the Fund of Funds and the Fund will execute a
Participation Agreement stating without limitation that their boards of
directors or trustees and their investment advisers, or sponsors and
trustees, as applicable, understand the terms and conditions of the
order and agree to fulfill their responsibilities under the order. At
the time of its investment in shares of an Open-end Fund in excess of
the limit in section 12(d)(1)(A)(i), a Fund of Funds will notify the
Open-end Fund of the investment. At such time, the Fund of Funds will
also transmit to the Open-end Fund a list of the names of each

Fund of Funds Affiliate and Underwriting Affiliate. The Fund of Funds
will notify the Open-end Fund of any changes to the list of the names
as soon as reasonably practicable after a change occurs. The Fund and
the Fund of Funds will maintain and preserve a copy of the order, the
Participation Agreement and, in the case of an Open-end Fund, the list
with any updated information for the duration of the investment and for
a period of not less than six years thereafter, the first two years in
an easily accessible place.
    9. Before approving any advisory contract under section 15 of the
Act, the board of directors or trustees of each Investing Management
Company, including a majority of the Disinterested Trustees, will find
that the advisory fees charged under such advisory contract are based
on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Open-end Fund in which the Investing Management Company may invest.
These findings and their basis will be recorded fully in the minute
books of the appropriate Investing Management Company.
    10. A Fund of Funds Adviser, or trustee, or Sponsor of a Fund of
Funds, as applicable, will waive fees otherwise payable to it by the
Fund of Funds in an amount at least equal to any compensation
(including fees received from any plan adopted by an Open-end Fund
under rule 12b-1 under the Act) received from a Fund by the Fund of
Funds Adviser, trustee or Sponsor, or an affiliated person of the Fund
of Funds Adviser, trustee or Sponsor, other than any advisory fees paid
to the Fund of Funds Adviser, trustee or Sponsor, or its affiliated
person, by an Open-end Fund, in connection with the investment by the
Fund of Funds in the Fund. Any Subadviser will waive fees otherwise
payable to the Subadviser, directly or indirectly, by the Investing
Management Company in an amount at least equal to any compensation
received from a Fund by the Subadviser, or an affiliated person of the
Subadviser, other than any advisory fees paid to the Subadviser or its
affiliated person by an Open-end Fund, in connection with the
investment by the Investing Management Company in the Fund made at the
direction of the Subadviser. In the event that the Subadviser waives
fees, the benefit of the waiver will be passed through to the Investing
Management Company.
    11. With respect to registered separate accounts that invest in a
Fund of Funds, no sales load will be charged at the Fund of Funds level
or at the Fund level. Other sales charges and service fees, as defined
in Rule 2830, if any, will only be charged at the Fund of Funds level
or at the Fund level, not both. With respect to other investments in a
Fund of Funds, any sales charges and/or service fees charged with
respect to shares of the Fund of Funds will not exceed the limits
applicable to a fund of funds as set forth in Rule 2830.
    12. No Fund will acquire securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A) of the Act, except to the
extent that the Fund (a) acquires such securities in compliance with
section 12(d)(1)(E) of the Act; (b) receives securities of another
investment company as a dividend or as a result of a plan of
reorganization of a company (other than a plan devised for the purpose
of evading section 12(d)(1) of the Act), or (c) acquires (or is deemed
to have acquired) securities of another investment company pursuant to
exemptive relief from the Commission permitting such Fund to (i)
acquire securities of one or more investment companies for short-term
cash management purposes, or (ii) engage in interfund borrowing and
lending transactions.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-4604 Filed 3-3-09; 8:45 am]

BILLING CODE 8011-01-P


0.58
                                                                       constant
                                                                          -3.62
                                -4.60 to -2.64
                                                                      <0.001
                                                                           1997
                                                                          -0.61
                                 -1.87 to 0.66
                                                                           0.35
                                                                           1998
                                                                          -2.02
                                 -4.14 to 0.10
                                                                           0.06
                                                                           1999
                                                                          -0.64
                                 -1.92 to 0.63
                                                                           0.32
                                                                           2002
                                                                          -2.15
                                -4.28 to -0.02
                                                                           0.05

                       Table 32.   HEJ Exposure and CBD
                                                                       Variable
                                                                    Coefficient
                                                        95% confidence interval
                                                                        P-value
                                                        HEJ Exposure (μg/m[3])
                                                                           0.03
                                 -0.70 to 0.77
                                                                           0.93
                                                                       Constant
                                                                          -3.49
                                -4.45 to -2.53
                                                                      <0.001
                                                                           1997
                                                                          -0.62
                                 -1.88 to 0.65
                                                                           0.34
                                                                           1998
                                                                          -2.05
                                 -4.16 to 0.07
                                                                           0.06
                                                                           1999
                                                                          -0.68
                                 -1.94 to 0.59
                                                                           0.30
                                                                           2002
                                                                          -2.21
                                -4.33 to -0.09
                                                                           0.04

                     Table 33.  Exposure Duration and CBD
                                                                       Variable
                                                                    Coefficient
                                                        95% confidence interval
                                                                        P-value
                                                        Exposure Duration (yrs)
                                                                          0.052
                                                                  -0.01 to 0.11
                                                                           0.10
                                                                       constant
                                                                          -4.18
                                                                 -5.40 to -2.96
                                                                     < 0.001
                                                                           1997
                                                                          -0.53
                                                                  -1.84 to 0.69
                                                                           0.38
                                                                           1998
                                                                          -2.01
                                                                  -4.13 to 0.11
                                                                           0.06
                                                                           1999
                                                                          -0.67
                                                                  -1.94 to 0.60
                                                                           0.30
                                                                           2002
                                                                          -2.22
                                                                 -4.34 to -0.10
                                                                           0.04

	In the models described in Tables 26 to 33, cumulative exposure and exposure duration appeared to be more closely related to relative risk of both sensitization and CBD than LTW average exposure or HEJ exposure.  For CBD, this is not surprising since the disease is believed to respond to the accumulated burden of beryllium retained in the lung over time.  Lung burden would be expected to primarily track number of years exposed, cumulative exposure, and, to a lesser extent, long-term average exposure.  The model results are consistent with this biological expectation.
	On the other hand, beryllium sensitization is an immune hypersensitivity response that is expected to be primarily dependent on beryllium concentration at the target site, rather than accumulated lung burden over an extended period of time.  The more frequently the critical target concentration is achieved, the greater the risk of becoming sensitized.  This biological mode of action is consistent with the sensitization model results that show a stronger statistical association with cumulative and LTW average exposure than with number of years exposed.
	OSHA estimated risk using the models presented in Table 26 and Table 30 (cumulative exposure, data truncated at 2002) for the preceding TWA PEL of 2 μg/m[3], the new TWA PEL of 0.2  μg/m[3], and the other TWA PELs that OSHA considered: 0.5 μg/m[3], 0.2 μg/m[3], and 0.1 μg/m[3].  To estimate risk of sensitization and CBD from a working lifetime of exposure, the Agency assumed 45 years of exposure at each level, for total cumulative exposures of 90, 45, 22.5, 9, and 4.5 μg/m[3]-years (corresponding to 45 years of occupational exposure at 2 μg/m[3], 1 μg/m[3], 0.5 μg/m[3], 0.2 μg/m[3], and 0.1 μg/m[3], respectively).  However, most workers in the data set were exposed to beryllium for shorter time periods.  There is, therefore, more uncertainty associated with risk estimates for a working lifetime of exposure than with risk estimates for shorter exposure durations.  In addition to risk estimates for 45 years of exposure, OSHA estimated risk associated with five, ten, and twenty years of exposure at each level.  The Agency used the models based on cumulative exposure in the data set truncated at 2002 to derive risk estimates because the cumulative exposure metric showed the most consistent association with sensitization and CBD in these models.
	Risk estimates for sensitization and CBD were calculated using the equation:

where pit is the probability that worker i is found to have the health outcome of interest (sensitization or CBD) at time t, β0t is the time-specific intercept, β1 is the exposure coefficient, and Xit is the cumulative exposure for worker i at time t. The time-specific intercept β0t is modeled as a constant plus dummy variables for the non-reference diagnosis year.  Thus, the model provides time-specific estimates of risk for a worker with any given exposure level, varying across the years in which cases were diagnosed.
	Table 34 below presents a range of sensitization risk estimates based on all time-specific intercepts, where the upper end of the range is derived using β0,1995 = -3.48 and the lower end is derived using β0,1998 = -5.08 (the time-specific intercepts for 1995 and 1999, respectively).  Each estimate represents the number of sensitized workers the model predicts in a group of 1,000 workers exposed at the specified level, duration, and time.  Thus, for example, 56 workers would be expected to be sensitized among 1,000 occupationally exposed at 2 μg/m[3] for 10 years from 1985 to 1995.  Similarly, Table 35 presents a range of CBD risk estimates based on all time-specific intercepts, where the upper end of the range is derived using β0,1995 = -3.77 and the lower end is derived using β0,2002 = -5.90 (the time-specific intercepts for 1995 and 2002, respectively).
                                   Table 34
Expected Cases of Sensitization per 1,000 Workers Exposed at Preceding, Final, and Alternate TWA PELs; Cumulative Exposure Metric

                               Exposure Duration

                                    5 years
                                   10 years
                                   20 years
                                   45 years
                           Exposure Level (μg/m[3])
Cumulative (μg/m[3]-yrs)
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                                                            2.0
                                     10.0
                                  8.4 - 41.1
                                     20.0
                                 11.5  -  55.7
                                     40.0
                                21.3  -  101.0
                                     90.0
                                96.3  -  394.4
                                                                            1.0
                                      5.0
                                  7.2 - 35.3
                                     10.0
                                  8.4 - 41.1
                                     20.0
                                 11.5  -  55.7
                                     45.0
                                24.8  -  116.9
                                                                            0.5
                                      2.5
                                  6.7 - 32.7
                                      5.0
                                  7.2 - 35.3
                                     10.0
                                  8.4 - 41.1
                                     22.5
                                  12.4 - 60.0
                                                                            0.2
                                      1.0
                                  6.4 - 31.3
                                      2.0
                                  6.6 - 32.2
                                      4.0
                                  7.0 - 34.3
                                      9.0
                                 8.2  -  39.9
                                                                            0.1
                                      0.5
                                  6.3 - 30.8
                                      1.0
                                  6.4 - 31.3
                                      2.0
                                  6.6 - 32.2
                                      4.5
                                  7.1 - 34.8

                                   Table 35
Expected Cases of CBD per 1,000 Workers Exposed at Preceding, Final, and Alternate TWA PELs;
                           Cumulative Exposure Metric

                               Exposure Duration

                                    5 years
                                   10 years
                                   20 years
                                   45 years
                           Exposure Level (μg/m[3])
Cumulative (μg/m[3]-yrs)
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                 μg/m[3]-yrs
                                  cases/1000
                                                                            2.0
                                     10.0
                                  3.7 - 30.9
                                     20.0
                                 5.1  -  41.9
                                     40.0
                                 9.4  -  76.6
                                     90.0
                                43.6  -  312.9
                                                                            1.0
                                      5.0
                                  3.2 - 26.6
                                     10.0
                                 3.7  -  30.9
                                     20.0
                                  5.1 - 41.9
                                     45.0
                                 11.0  -  88.8
                                                                            0.5
                                      2.5
                                  3.0 - 24.6
                                      5.0
                                 3.2  -  26.6
                                     10.0
                                  3.7 - 30.9
                                     22.5
                                 5.5  -  45.2
                                                                            0.2
                                      1.0
                                  2.8 - 23.5
                                      2.0
                                 2.9  -  24.2
                                      4.0
                                  3.1 - 25.8
                                      9.0
                                 3.6  -  30.0
                                                                            0.1
                                      0.5
                                  2.8 - 23.1
                                      1.0
                                 2.8  -  23.5
                                      2.0
                                  2.9 - 24.2
                                      4.5
                                  3.1 - 26.2

	This preliminary statistical modeling analysis predicted substantial risks of both sensitization and CBD at the preceding PEL of 2 μg/m[3], with particularly high risks predicted for a 45-year working lifetime of exposure.  The predicted risk is much reduced, but still significant, at the final TWA PEL of 0.2 and the action level of 0.1 μg/m[3].

Comments Received on the Preliminary Statistical Analysis
      As discussed in the NPRM, OSHA did not rely on this preliminary statistical analysis for its significance of risk determination or to develop its benefits analysis due to limitations in the analysis, primarily constraints related to the size of the study.  The Agency relied on its analyses of the epidemiological literature and the prevalence analysis of the NJH data for its preliminary significance of risk determination, and on the prevalence analysis for its preliminary estimate of benefits.  Although OSHA did not rely on the results of the preliminary statistical analysis for its findings, the Agency presented the DTPHA in the NPRM in order to inform the public of its results, explain its limitations, and solicit public comment on the Agency's approach.  After considering comments on this preliminary model, OSHA instructed its contractor to change the statistical analysis to address technical concerns and to incorporate suggestions from Crump and Proctor, as well as NIOSH (Document ID 1660; 1725).  The comments OSHA received on the preliminary statistical analysis, OSHA's response to these comments, and the methods and results of the final statistical analysis are presented here.
      Dr. Kenny Crump and Ms. Deborah Proctor submitted comments on OSHA's preliminary risk assessment (Document ID 1660).  Crump and Proctor agreed with OSHA's review of the epidemiological literature and the prevalence analysis presented previously in this section.  They stated that they "agree with OSHA's conclusion that there is a significant risk (> 1/1000 risk of CBD) at the [then] current PEL, and that risk is reduced at the [then] proposed PEL (0.2 μg/m[3]) in combination with stringent measures (ancillary provisions) to reduce worker's exposures. This finding is evident based on the available literature...and the prevalence data presented for the Cullman facility" (Document ID 1660, p. 2).  Crump and Proctor also provided a detailed evaluation of the statistical analysis of the NJH data presented in the NPRM, including a critique of OSHA's modeling approach and interpretation and suggestions for alternate analyses.
      One of the concerns raised by Crump and Proctor was with OSHA's interpretation of the Discrete Time Proportional Hazards Analysis (DTPHA):  "OSHA misinterpreted the output of the DTPHA as a cumulative probability of effect (CBD or BeS [sensitization]), whereas in reality it represents the condition[al] probability of effect at a specific time, given no previous effect" (Document ID 1660, p. 1).  That is, they believed that OSHA interpreted the results of the DTPHA to reflect the total predicted cases of CBD or sensitization, rather than the number of newly identified cases at any given time.
      Crump and Proctor's criticism likely reflects a misunderstanding that arose from the way OSHA described the results of the proportional hazards analysis in the NPRM.  There, OSHA stated:
      [t]he models provide time-specific point estimates of risk for a worker with any given exposure level.... Each estimate represents the number of sensitized workers the model predicts in a group of 1000 workers at risk during the given year with an exposure history at the specified level and duration.  For example, in the exposure scenario where 1000 workers are occupationally exposed to 2 μg/m[3] for 10 years in 1995, the model predicts that about 56 (55.7) workers would be sensitized that year.  The model for CBD predicts that about 42 (41.9) workers would be diagnosed with CBD that year (80 FR 47639 (8/7/15)).

In the NPRM's description, OSHA intended the phrase "the number of sensitized workers" to mean the number of sensitized workers identified in the facility's screening program.  Similarly, OSHA intended "[number] workers would be sensitized that year" to mean the number of workers who would be identified as sensitized in screening that year.  The phrase OSHA used for the CBD model results ("[number] workers would be diagnosed with CBD that year") better conveys OSHA's intended meaning.  In the discussion of modeling results presented here, OSHA is careful to refer to cases of sensitization identified and cases of CBD diagnosed in any given year.  These phrases mean cases of sensitized newly identified and cases of CBD newly diagnosed, which OSHA believes will be evident to readers because this is the usual meaning of "cases identified" or "cases diagnosed" in a given year.  Thus, OSHA's interpretation of the proportional hazards model results is consistent with Crump and Proctor's description of "the condition[al] probability of effect at a specific time, given no previous effect" (Document ID 1660, p. 1), and OSHA has clarified its description of model results accordingly.
      Crump and Proctor also commented that the type of model used by OSHA in the preliminary risk analysis (the DTPHA) is used as a substitute for a different method, the Cox continuous proportional hazard model, "to make computation feasible when analyzing a large data set with a large number of tied times."  Because the NJH data set is small, they argued, it is not necessary to use a DTPHA in place of a Cox proportional hazards model (Document ID 1660, p. 9).  OSHA has reviewed the NJH data set, and agrees with Crump and Proctor that the computations required for the Cox analysis are feasible.  OSHA concluded that the Cox model is a more appropriate model for analyzing this data set than the DTPHA that was used in the preliminary analysis. Thus, Dr. Stone conducted the reanalysis of the NJH data using the Cox proportional hazards model.
      Crump and Proctor further commented that the DTPHA may not be appropriate to analyze the NJH data set, because one of the assumptions of the DTPHA model is that "the health status of all cohort members is fully known at every discrete time applied in the modeling" (that is, the sensitization or CBD status of every worker in the data set is known at each time that some cases of sensitization or CBD are reported) (Document ID 1660, p. 5).  The NJH data set does not report results for every worker at every testing time because, while annual testing was conducted in the facility beginning in 1995, individual workers were only tested every other year.  Crump and Proctor also commented that the DTPHA cannot account for irregularity in the length of time between rounds of testing (Document ID 1660, p. 9).  They are referring to the fact that testing for beryllium sensitization and CBD began in 1995 and was conducted every year thereafter.  However, by 1995, many workers in the data set had been employed at the Cullman facility for years.  The first interval between time points in the model (1969 to 1995) was therefore much longer than subsequent intervals.  Crump and Proctor recommend that OSHA use the screening protocol and date of hire for each worker to determine the most likely years of testing for each worker and use both the last year a subject was known to be free of sensitization (or CBD) and the first year he or she was known to have sensitization (or CBD) in the modeling procedure to calculate his or her contribution to model likelihood (Document ID 1660, p. 10).
      OSHA agrees that the screening protocol can be used to develop reasonable assumptions about the years of testing for each worker in the data set.  For the reanalysis, Dr. Stone used the screening protocol to determine years in which each worker in the data set was scheduled to receive a BeLPT and removed workers who were not scheduled to be tested in a given year from the analysis for that year.  This procedure addresses Crump and Proctor's concern that the sensitization or CBD status of every worker in the data set is not known at each time that some cases of sensitization or CBD are reported (Document ID 1660, p. 5).  However, OSHA does not agree that Crump and Proctor's suggested approach can adequately address the issue they raised regarding the difference between the first interval (prior to medical testing) and subsequent testing intervals. Because workers in the data set had been exposed to beryllium for many years before the first round of medical screening in 1995, the results of medical testing from this year represent the pre-existing (prevalent) cases of sensitization and CBD in a population with long-term exposures.  That is, there is no information on when in the interval before 1995 these cases developed.  In contrast, the results of testing from years following 1995 represent new (incident) cases arising in the population.
      The method suggested by Crump and Proctor cannot adequately address the fact that undetected cases of sensitization and CBD had accrued for up to 26 years between 1969 (the year the Cullman facility opened) and the first screening in 1995.  Due to the length of this interval, Crump and Proctor's suggested statistical method cannot adequately approximate the time that cases of sensitization and CBD arose within this span of time.  For this reason, instead of using Crump and Proctor's proposed method, OSHA has excluded the cases of sensitization and CBD that were found in the 1995 screening from the reanalysis.  This step greatly reduces uncertainty in the timing of case development in the analysis.  After excluding the cases identified in 1995, the remaining cases in the data set were identified within two years of their development, since workers were screened every two years beginning in 1995.
      Crump and Proctor stated that OSHA should have provided the statistical uncertainty around the risk estimates for beryllium sensitization and CBD derived from the DTPHA (Document ID 1660, pp. 1-2).  OSHA notes that Tables VI-18a and VI-18b in Chapter VI of the NPRM (80 FR 47640-41) report ranges of risk based on the 95% confidence interval around the exposure coefficient; however, these intervals did not include statistical uncertainty in the "baseline" risk due to issues in the estimation of baseline risk in OSHA's model.  As pointed out by NIOSH in its comment, the meaning of these ranges was clearly described in the NPRM (Document ID 1725, p. 6).  For the re-analyses that Dr. Stone conducted to address other comments and suggestions raised by Crump and Proctor, the Agency presents 95% confidence intervals consistent with Crump and Proctor's suggestion.  Since the Cox proportional hazard models do not estimate baseline risk, the 95% confidence intervals based on the exposure coefficient uncertainty fully represent the statistical uncertainty in OSHA's risk estimates for beryllium sensitization and CBD.
      Crump and Proctor commented that "OSHA's implementation of the DTPHA estimated yearly background levels of [beryllium] effects that were implausibly variable and implausibly high" (Document ID 1660, p. 2).  In addition, "[t]he estimated ranges of risks from posited [beryllium] exposures include the `background' risks estimated by OSHA's model, and consequently a sizable fraction of OSHA's estimated exposure-related risk is not due to [beryllium] exposure" (Document ID 1660, p. 2).  Crump and Proctor further commented that "a separate background response was estimated for each year included in the analysis... [A] more appropriate way of handling background rates in the DTPHA would be to make them independent of time, and bounded to insure reasonable values that are consistent with the literature," that is, no more than 1 percent, the rate of confirmed sensitization among new employees in Donovan et al. (2007) (Document ID 1660, p. 6).
      In response to Crump and Proctor's comments, NIOSH noted that it is difficult to judge the plausibility of baseline rates based on currently available information, and that the yearly baseline rates estimated in the DTPHA model for sensitization were not much different from Crump and Proctor's suggestion of 1 percent as a fixed baseline (Document ID 1725, p. 6).  NIOSH stated that a near zero baseline rate for sensitization and CBD is expected, and suggested that OSHA could use a fixed low intercept (the statistical model term representing baseline risk) such as 0.5 percent in its statistical model (Document ID 1725, p. 6).
      OSHA agrees with Crump and Proctor that the baseline risks estimated in the DTPHA model were implausibly variable and high.  However, OSHA does not agree with their suggestion to subtract baseline risks from OSHA's risk estimates, because the "baseline" risks in the statistical model do not reflect a "background" (i.e., unrelated to beryllium exposure) level of sensitization or CBD.  As explained in Section V, Health Effects, beryllium sensitization and CBD occur only as a result of exposure to beryllium.  As a result, beryllium sensitization and CBD do not have a "background" rate unrelated to beryllium exposure.  Thus, both the "baseline" rates of beryllium sensitization and CBD estimated by the proportional hazards models and the additional cases predicted at various exposure levels reflect cases acquired from beryllium exposure, and OSHA intentionally reported the combined number of cases in its risk estimates.  Although OSHA understands that subtracting "baseline" from total risk is standard practice when a true baseline risk exists, OSHA does not believe that subtracting the model's "baseline" from the total number of predicted sensitization and CBD cases was necessarily appropriate in reporting the results of the preliminary risk assessment for beryllium.  OSHA therefore disagrees with Crump and Proctor's criticism and their conclusion that the Agency erred in presenting the total number of predicted cases of sensitization and CBD in its preliminary risk assessment.  OSHA does, however, find that the suggestion offered by Crump and Proctor and NIOSH to fix a low intercept is reasonable.  The reanalysis presented later in this section therefore estimates risk using two choices of "background" risk for sensitization, 1 percent and 0.5 percent, and a "background" rate of 0.5 percent for CBD, based on Crump, Proctor, and NIOSH's recommendations.
      Crump and Proctor additionally expressed concern that the results of the fractional polynomial analysis OSHA conducted to check for nonlinearities in the DTPHA models (which did not find evidence of such nonlinearities) might have been affected by the issues of baseline rate estimation in the DTPHA discussed above (Document ID 1660, pp. 7-8).  Crump and Proctor further speculated that, due to genetic susceptibility factors that can influence individuals' risk of sensitization or CBD, workers' risk might increase sharply with increasing exposure at lower exposures and then approach a plateau at higher exposures.  They presented graphs based on the prevalence of sensitization and CBD in the NJH data set that appear to show a sharp increase in risk of both around the level of 5 μg/m[3]-years cumulative exposure (Document ID 1660, pp. 8-9).  To address Crump and Proctor's concern and confirm that a non-linear model is still not appropriate following changes made for the reanalysis, Dr. Stone performed a new fractional polynomial analysis to check for possible nonlinearities in the reanalysis, which incorporates fixed baseline rates as recommended by Crump and Proctor.
      Crump and Proctor also criticized OSHA for excluding three years of data (2003 to 2005) from some models in the DTPHA due to uncertainty in workers' job histories (Document ID 1660, p 11).  They pointed out that workers' exposure estimates from the early years of the Cullman facility's operation are at least as uncertain (due to lack of sampling data) as those from 2003 to 2005; therefore, they said, it does not make sense to include data from the early years but not from 2003 to 2005.  They recommended that OSHA consider including data from the years 2003 to 2005, and also perform an analysis excluding workers hired before 1980 from the data to explore the effects of uncertainty in exposure estimates for the early years of the plant on the model results.  OSHA agrees and has incorporated both of these suggestions into the reanalysis, described below.
	Crump and Proctor further recommended that OSHA develop a statistical model of beryllium sensitization risk using an exposure metric designed to capture beryllium concentration.  In particular, they suggested that OSHA construct an additional exposure metric, such as duration of exposure above a specified air concentration or cumulative exposure above a specified air concentration (Document ID 1660, pp. 11-12).  However, OSHA does not have the data necessary to conduct a meaningful analysis along these lines.  The exposure data in the NJH data set reflect long-term averages (exposure levels averaged over a year or more); they do not show how much time any given worker was exposed above any particular concentration.  Therefore, OSHA was unable to develop an analysis of this type.
      Finally, Crump and Proctor suggested that OSHA should conduct analyses that "assume two subpopulations with differing sensitivities to [beryllium], and posit distinct hazards for each subpopulation" to conduct a "formal test of the hypothesis of a sensitive subpopulation" (Document ID 1660, pp. 10-11).  OSHA does not believe such an analysis would benefit the beryllium risk analysis.  The procedure recommended by Crump and Proctor does not account for the complexity of genetic risk factors related to beryllium exposure (which exist in a variety of forms) or the lack of well-established information about their effects (see Section V, Health Effects, for a discussion of genetic risk factors for beryllium-related health effects).  It is therefore likely to generate misleading results.  The genetic risk factors of individuals in the NJH data set are unknown and the data set is too small to support a model-fitting procedure to effectively test for the presence of multiple sensitive subpopulations.  Furthermore, the relative hazards for each genetic subgroup are not well defined and, in Crump and Proctor's suggested procedure, would have to be assumed by OSHA.  For all of these reasons, OSHA believes that risk estimates resulting from the suggested analysis would be unreliable and potentially misleading.  OSHA therefore chose not to conduct this analysis.

5. OSHA's Reanalysis of the NJH data set

      As noted above, Dr. Stone reanalyzed the NJH data set in order to address concerns raised by Crump and Proctor (Document ID 1660).  This section summarizes the methods and results of the reanalysis.  Where OSHA's approach in the reanalysis differed from the approach taken in the preliminary statistical analysis, the reasons for OSHA's choices were discussed above and are briefly summarized here.
      OSHA's reanalysis uses a Cox proportional hazards model instead of the DTPHA used in the preliminary statistical analysis.  Like the DTPHA, a Cox proportional hazards model can accommodate time-dependent data; however, the Cox model has the advantage that it does not estimate different "baseline" rates of sensitization and CBD for different years.  The form of the Cox model is:  hZ(t) = h0(t) exp(Zβ), where  h0(t) is the baseline hazard at time t (i.e., Z=0), Z is a vector of possibly time-dependent predictors, and β is a vector of the corresponding coefficients, estimated using partial likelihood.  The exp(Zβ) term represents the HR.  Time-specific risk sets were constructed to accommodate the time-dependent exposures.  P-values were based on likelihood ratio tests (LRTs), with p-values <0.05 considered to be statistically significant.  As in the preliminary statistical analysis, Dr. Stone used fractional polynomials to check for possible nonlinearities in the exposure-response models, and checked the effects of age and smoking habits using the data on birth year and smoking (current, former, never) provided in the NJH data set.
      Data on workers' estimated exposures and health outcomes through 2005 were included in the reanalysis.   The 1995 risk set (i.e., analysis of cases of sensitization and CBD identified in 1995) was excluded from all models in the reanalysis so as not to analyze long-standing (prevalent) cases of sensitization and CBD together with newly arising (incident) cases of sensitization and CBD.  In addition, Dr. Stone performed an analysis excluding workers hired before 1980 to examine the possible effects of uncertainty in exposures prior to the start of exposure sampling in 1980.
      Dr. Stone used the testing protocols provided in the Newman et al. study on the Cullman population to determine years in which each employee was scheduled to be tested, and excluded employees from the analysis for years in which they were not scheduled to be tested (Newman et al., 2001, Document ID 1354).  These models are labeled "Accounting for scheduled testing" in Tables 36 to 39 below.  Dr. Stone also fit models in the reanalysis using the previous approach for comparison.  The previous approach included all employees with no previously recorded sensitization or CBD in all time points of the analysis, without regard to whether they were likely to have been tested in any given year.  These models are labeled "Not accounting for scheduled testing" in Tables 36 to 39.
      Tables 36 to 39 present modeling results of analyses using cumulative exposure and LTW average exposure as predictors.  As shown in these tables, LTW average exposure was more strongly associated with beryllium sensitization and cumulative exposure was more strongly associated with CBD.  OSHA therefore used the final model for LTW average exposure to estimate risk of sensitization at the preceding TWA PEL, the final TWA PEL, and several alternate TWA PELs the Agency considered.  Similarly, OSHA used the final model for cumulative exposure to estimate risk of CBD at the preceding, final, and alternate TWA PELs.  In calculating these risks, OSHA applied a small, fixed estimate of "baseline" risk (i.e., risk of sensitization or CBD among persons with no known exposure to beryllium), using rates suggested by Dr. Crump and Ms. Proctor and NIOSH (1% and 0.5% for sensitization and 0.5% for CBD) (Document ID 1660;1725).
      OSHA's final risk estimates for sensitization and CBD, generated using the Cox proportional hazards models shown in Tables 37 and 38, are presented in Table 40 and Table 41, respectively, along with 95% confidence intervals based on the statistical uncertainty in the exposure coefficient for each model.  Since the Cox models do not estimate baseline risk and other variables were not included in the final models, the 95% confidence intervals based on the exposure coefficient uncertainty fully represent the statistical uncertainty in OSHA's risk estimates for beryllium sensitization and CBD.

Results of the Beryllium Sensitization Analysis
      OSHA's reanalysis for beryllium sensitization is based on 18 cases.  The eight cases of sensitization identified in 1995 were excluded from the reanalysis because there is no information on when in the interval before 1995 these cases developed, as discussed previously.  As shown in Table 37, the HR for sensitization increased significantly with increasing LTW average exposure, without or with accounting for scheduled testing (HR=3.06 and HR = 2.92, respectively; p = 0.001 for both; note that numbers are rounded to the second decimal place).
       As shown in Table 36 below, cumulative exposure was also a statistically significant predictor for beryllium sensitization, although it was not as strongly related to sensitization as LTW average exposure (HR=1.04, 95% CI 1.01  -  1.07 not accounting for testing; HR=1.04, 95% CI 1.00  -  1.07 accounting for testing).   Across most models in the reanalysis, p-values and standard errors were slightly larger when scheduled testing was taken into account, due to the smaller risk sets when employees not scheduled to be tested in a given year were excluded from that year.
Table 36: Cox Proportional Hazards Model:  Cumulative Exposure and Sensitization
                                                                       Variable
                                                                   Hazard Ratio
                                                        95% confidence interval
                                                                        P-value
Not accounting for scheduled testing:

Cumulative Exposure (μg/m[3]-yrs)
                                                                           1.04
                                 1.01  -  1.07
                                                                           0.02
Model fit: LRT 3.94; Wald p=0.048

Accounting for scheduled testing:

                                             Cumulative Exposure (μg/m[3]-yrs)
                                                                           1.04
                                 1.00  -  1.07
                                                                           0.03
Model fit: LRT=3.73; Wald p=0.054

      Table 37: Cox Proportional Hazards Model:  LTW Average Exposure and Sensitization
                                                                       Variable
                                                                   Hazard Ratio
                                                        95% confidence interval
                                                                        P-value
Not accounting for scheduled testing:

                                                LTW Average Exposure (μg/m[3])
                                                                           3.06
                                 1.58  -  5.92
                                                                          0.001
Model fit: LRT= 8.50; Wald p=0.004

Accounting for scheduled testing:

                                               LTW Average Exposure (μg/m[3])
                                                                           2.92
                                 1.51  -  5.66
                                                                          0.001
Model fit: LRT=7.92; Wald p=0.005

      None of the analyses Dr. Stone performed to check for nonlinearities in exposure-response or effects of smoking, age, or hire prior to 1980 substantially impacted the results of the analyses for beryllium sensitization.  In tests for potential nonlinearities, Dr. Stone did not find evidence that a nonlinear exposure-response model would fit the NJH data set for beryllium sensitization better than the linear exposure-response used in the main analyses for either cumulative exposure or LTW average exposure.  Models that included smoking status (current, former, never) or age as a variable yielded HRs and confidence intervals virtually identical to those in models that did not consider smoking status.  For example, in the model that used the LTW average exposure metric and accounted for scheduled testing and age, the average exposure HR was 3.06 (95% CI 1.57 - 6.01).  In the model that used the LTW average exposure metric and accounted for scheduled testing and smoking the average exposure HR was 3.04 (95% CI 1.56 - 5.94).  When workers who were hired before 1980 were removed from the analysis (as suggested by Crump and Proctor in order to examine the possible effects of uncertainty in exposures prior to the start of exposure sampling in 1980), the LTW average exposure HR increased slightly to 3.15 (95% CI 1.39 - 7.21) when scheduled testing was accounted for, and to 3.23 (95% CI 1.41 - 7.45) when scheduled testing was not accounted for.

Results of the CBD Analysis
      OSHA's reanalysis for CBD is based on 13 cases, six fewer than the number of cases in the analysis performed for the NPRM.  Six CBD cases had been diagnosed in 1995 and were excluded in the reanalysis.  As shown in Table 38, the HR for CBD increased significantly with increasing cumulative exposure, without or with accounting for scheduled testing (HR=1.04 for both; p=0.02 for both).
      LTW average exposure was not as strong a predictor for CBD as cumulative exposure.  The HR for CBD increased somewhat with increasing LTW average exposure, with or without accounting for the scheduled testing, although this increase was not statistically significant at the 0.05 level (HR=2.34 not accounting for testing; HR=2.25 accounting for testing).
    Table 38: Cox Proportional Hazards Model:  Cumulative Exposure and CBD
                                                                       Variable
                                                                   Hazard Ratio
                                                        95% confidence interval
                                                                        P-value
Not accounting for scheduled testing:

Cumulative Exposure (μg/m[3]-yrs)
                                                                           1.04
                                  1.01 - 1.08
                                                                           0.02
Model fit: LRT 3.97; Wald p=0.046

Accounting for scheduled testing:

Cumulative Exposure (μg/m[3]-yrs)
                                                                           1.04
                                  1.01 - 1.08
                                                                           0.02
Model fit: LRT=3.89; Wald p=0.049

    Table 39: Cox Proportional Hazards Model:  LTW Average Exposure and CBD
                                                                       Variable
                                                                   Hazard Ratio
                                                        95% confidence interval
                                                                        P-value
Not accounting for scheduled testing:

LTW Average Exposure (μg/m[3])
                                                                           2.34
                                  0.98 - 5.57
                                                                           0.06
Model fit: LRT= 2.94; Wald p=0.09

Accounting for scheduled testing:

                       LTW Average Exposure (μg/m[3])
                                                                           2.25
                                  0.94 - 5.35
                                                                           0.07
Model fit: LRT=2.71; Wald p=0.10

      In tests for potential nonlinearities, Dr. Stone did not find evidence that a nonlinear exposure-response model would fit the NJH data set for CBD better than the linear exposure-response used in the main analyses for either cumulative exposure or LTW average exposure.  Models that included smoking status (current, former, never) or age as a variable yielded HRs and confidence intervals virtually identical to those in models that did not consider smoking status or age.  For example, in the model that used the cumulative exposure metric and accounted for scheduled testing and smoking, the cumulative exposure HR was 1.04 (95% CI 1.01 - 1.08), which was identical to the results achieved when not accounting for smoking status or age.  In the model that used the cumulative exposure metric and accounted for scheduled testing and age, the cumulative exposure HR was 1.05 (95% CI 1.01 - 1.08).
	When workers who were hired before 1980 were removed from the analysis, eight cases of CBD remained in the data set.  The cumulative exposure HR dropped to slightly below one and was not statistically significant (HR 0.96, 95% CI 0.81 - 1.13, p = 0.6).  This result may partially reflect the latency required for CBD to develop.  As discussed in Section V, Health Effects, CBD can develop quickly (e.g., within a few years) or slowly (e.g., over decades); thus, excluding workers hired before 1980 means that some members of the study population would not have had sufficient time to develop CBD from their exposure.
      The reduced time for CBD to develop, in combination with genetic risk factors, may explain the lack of significant exposure-response observed in this analysis.  It has been theorized that certain genetic traits may greatly increase both risk of CBD from low beryllium exposures and speed of progression from sensitization to CBD (see Section V, Health Effects).  If this is the case, some workers in the NJH data set would be expected to follow an exposure-response pattern of gradually increasing risk with gradually increasing exposure, and some would be expected to develop CBD from virtually any exposure.  OSHA finds some support for this explanation in the patterns of exposure and onset of disease among the eight cases of CBD diagnosed in workers hired after 1980.  Three had both rapid onset of CBD (1 year after hire) and very low cumulative exposures (0.115 to 0.138 μg/m[3]-years), suggesting membership in a genetically sensitive subpopulation.  Four cases of CBD developed in workers hired between 1981 and 1986 who were diagnosed with CBD between 16 and 19 years after hire, suggesting they were not members of a genetically sensitive subgroup.  These four had much higher cumulative exposures (1.5 to 8.7 μg/m[3]-years).
      The higher the proportion of such a sensitive subpopulation among cases, the more difficult it is for a statistical model to detect an exposure-response relationship in the population as a whole.  By excluding workers hired before 1980, the analysis specifically excludes several workers with CBD that took many years to develop.  In contrast, using the pre-1980 hire cutoff does not exclude any cases of rapidly developed CBD.  The shortened development time for CBD in the models that exclude workers hired prior to 1980 thus may selectively increase the proportion of cases that occurred in genetically sensitive individuals, which could explain why a statistically significant exposure-response was observed in the main models but not in this analysis.

Risk Estimates for Beryllium Sensitization and CBD Based on OSHA's Reanalysis

	 OSHA used the Cox proportional hazards models, accounting for scheduled testing, to derive quantitative risk estimates for sensitization and CBD.  The LTW average exposure metric was used to derive estimates for sensitization because it showed the strongest association with sensitization in the reanalysis.  The cumulative exposure metric showed the strongest association with CBD in the reanalysis, and was therefore used to derive estimates for CBD.
      As discussed previously, OSHA chose to use low fixed rates of "background" sensitization and CBD in its derivation of risk estimates from the Cox proportional hazards models using the Cullman data.  Table 40 summarizes the risk estimates for sensitization and the corresponding 95% confidence intervals using two different fixed "background" rates of sensitization, 1 percent and 0.5 percent.  Table 41 summarizes the risk estimates for CBD and the corresponding 95% confidence intervals using a fixed "background" rate of CBD of 0.5 percent.   The corresponding interval is based on the uncertainty in the exposure coefficient (i.e., the predicted values based on the 95% confidence limits for the exposure coefficient).  Since the Cox proportional hazards model does not estimate a baseline risk, this 95% interval fully represents statistical uncertainty in the risk estimates.

Table 40:  Predicted Cases of Sensitization per 1,000 Workers Exposed at Preceding, New, and Alternative PELs Based on Cox Proportional Hazards Model, LTW Average Exposure Metric, with Corresponding Interval based on the Uncertainty in the Exposure Coefficient. 1% and 0.5% baselines.

                           Exposure Level (μg/m[3])
                      Estimated cases/1000, .5% baseline
                                    95% CI
                       Estimated cases/1000, 1% baseline
                                    95% CI
                                                                            2.0

                                     42.75

                                11.4  -  160.34

                                     85.49

                               22.79  -  320.69

                                                                            1.0

                                     14.62

                                7.55  -  28.31

                                     29.24

                                15.10  -  56.63

                                                                            0.5

                                     8.55

                                6.14  -  11.90

                                     17.10

                                12.29  -  23.80

                                                                            0.2

                                     6.20

                                 5.43  -  7.07

                                     12.39

                                10.86  -  14.15

                                                                            0.1

                                     5.57

                                 5.21  -  5.95

                                     11.13

                                10.42  -  11.89

Table 41:  Predicted Cases of CBD per 1,000 Workers Exposed at Preceding, New, and Alternative PELs Based on Cox Proportional Hazards Model, Cumulative Exposure Metric, with Corresponding Interval based on the Uncertainty in the Exposure Coefficient. 0.5% baseline.

                               Exposure Duration

                                    5 years
                                   10 years
                                   20 years
                                   45 years
                           Exposure Level (μg/m[3])
Cumulative (μg/m[3]-yrs)
                             Estimated cases/1000
                                    95% CI
                                 μg/m[3]-yrs
                             Estimated cases/1000
                                    95% CI
                                 μg/m[3]-yrs
                             Estimated cases/1000
                                    95% CI
                                 μg/m[3]-yrs
                             Estimated cases/1000
                                    95% CI
                                                                            2.0
                                     10.0
                                     7.55
                                  5.34-10.67
                                     20.0
                                     11.39
                                  5.70-22.78
                                     40.0
                                     25.97
                                  6.5-103.76
                                     90.0
                                    203.60
                                 9.02-4595.67
                                                                            1.0
                                      5.0
                                     6.14
                                   5.17-7.30
                                     10.0
                                     7.55
                                  5.34-10.67
                                     20.0
                                     11.39
                                  5.70-22.78
                                     45.0
                                     31.91
                                  6.72-151.59
                                                                            0.5
                                      2.5
                                     5.54
                                   5.08-6.04
                                      5.0
                                     6.14
                                   5.17-7.30
                                     10.0
                                     7.55
                                  5.34-10.67
                                     22.5
                                     12.63
                                  5.79-27.53
                                                                            0.2
                                      1.0
                                     5.21
                                   5.03-5.39
                                      2.0
                                     5.43
                                  5.07 - 5.82
                                      4.0
                                      5.9
                                   5.13-6.77
                                      9.0
                                     7.24
                                   5.30-9.89
                                                                            0.1
                                      0.5
                                      5.1
                                   5.02-5.19
                                      1.0
                                     5.21
                                   5.03-5.39
                                      2.0
                                     5.43
                                  5.07 - 5.82
                                      4.5
                                     6.02
                                   5.15-7.03

      The Cox proportional hazards model, used with the fixed "baseline" rates of 0.5 percent and 1 percent, predicted risks of sensitization totaling 43 and 86 cases per 1,000 workers, respectively, or 4.3 and 8.6 percent, at the preceding PEL of 2 μg/m[3].  The predicted risk of CBD is 204 cases per 1,000 workers, or 20.4 percent, at the preceding PEL of 2 μg/m[3], assuming 45 years of exposure (cumulative exposure of 90 μg/m[3]-yr).  OSHA notes that this level of cumulative exposure (90 μg/m[3]-yr) is substantially higher than the highest level of cumulative exposure of any worker in the NJH data set (61.86 μg/m[3]-yr); thus, the risk estimates for lower cumulative exposures may be more reliable (for example, 26 cases of CBD per 1,000 at 40 μg/m[3]-yr, which equals 20 years of exposure at the preceding TWA PEL).  The predicted risks of sensitization at the new PEL of 0.2 μg/m[3] are substantially lower, at 6 and 12 cases per 1,000 for the baselines of 0.5 percent and 1.0 percent, respectively.  The predicted risk of CBD is also substantially lower at the new PEL of 0.2 μg/m[3] (9 μg/m[3]-year), at 7 cases per 1,000 assuming 45 years of exposure.
      Due to limitations in the Cox analysis, including the small size of the data set, relatively limited exposure data from the plant's early years, constraints related to the size of the study, and limited follow-up time on many workers, OSHA must interpret the model-based risk estimates presented in Tables 40 and 41 with caution.  The Cullman study population is a relatively small group and can support only limited statistical analysis.  For example, its size precludes inclusion of multiple covariates in the exposure-response models and a two-stage exposure-response analysis to model both sensitization and the subsequent development of CBD within the subpopulation of sensitized workers cannot be performed.  The limited size of the NJH data set is characteristic of studies on beryllium-exposed workers in modern, low-exposure environments, which are typically small-scale processing plants (up to several hundred workers, with up to 20-30 cases).  However, these more recent studies, including Cullman, also have important strengths: they include workers hired after the institution of stringent exposure controls, and have extensive exposure sampling using full-shift personal lapel samples.  In contrast, older studies of larger populations tend to have higher exposures, less exposure data, and exposure data collected in short-term samples or outside of workers' breathing zones.
      Another limitation of the Cullman data set, which is common to recent low-exposure studies, is the short follow-up time available for many of the workers.  While in some cases CBD has been known to develop in short periods (< 2 years), it more typically develops over a longer time period. Sensitization typically occurs in a shorter time frame, but new cases of sensitization have also been observed in workers exposed to beryllium for many years.  Because the data set is limited to individuals still working at the plant, the NJH data set cannot capture CBD occurring among workers who retire or leave the plant.  OSHA thus presumes that the data set does not fully represent the risk of sensitization and, in particular, CBD among workers exposed to beryllium at this facility. The short follow-up time is likely a significant source of uncertainty in the statistical analysis, which could lead to underestimation of risk in this population.
      Particle size, particle surface area, and beryllium compound solubility are believed to be important factors influencing the risk of sensitization and CBD among beryllium-exposed workers.  The workers at the Cullman machining plant were primarily handling poorly-soluble beryllium compounds, such as beryllium metal and beryllium metal/beryllium oxide composites; however, quantitative information on exposure to poorly-soluble and soluble forms of beryllium was not available.  Particle size distributions from a limited number of airborne beryllium samples collected just after the 1996 installation of engineering controls indicate worker exposure to a substantial proportion of respirable particulates (Kelleher et al., 2001, Document ID 1363).  There was no available particle size data for the 1980 to 1995 period, prior to installation of engineering controls, when total beryllium mass exposure levels were greatest. Particle size data was also lacking from 1998 to 2003 when additional control measures were in place and total beryllium mass exposures were lowest.  For these reasons, OSHA was not able to quantitatively account for the influence of particle size and solubility in developing the risk estimates based on the NJH data set.  However, it is not unreasonable to expect the sensitization and CBD experienced by this cohort to generally reflect the risk from exposure to beryllium that is relatively insoluble and contains a substantial proportion of respirable particles.
      Additional uncertainty is introduced when extrapolating the quantitative estimates presented above to operations that process beryllium compounds with different solubility and particle characteristics than those encountered at the Cullman machining plant.  OSHA does not have sufficient information to quantitatively assess the degree to which the risks of beryllium sensitization and CBD based on the NJH data may be impacted in workplaces where different beryllium forms and processes are used.  However, this uncertainty does not alter OSHA's conclusions, based on the literature review and the prevalence analysis of the NJH data set, that there is significant risk at the preceding TWA PEL, new TWA PEL and the action level of 0.1 μg/m[3] (see the preamble to the final rule at Section VII, Significance of Risk).  The studies reviewed provide clear evidence of sensitization and CBD risk among workers exposed to a number of beryllium forms during different processes, such as beryllium machining, beryllium-copper alloy production, and beryllium ceramics production.  The Agency has determined that all of these forms of beryllium exposure create risks of sensitization and CBD among beryllium-exposed workers.
6. Conclusions
	OSHA investigated the exposure-response relationship for beryllium sensitization and CBD by analyzing a data set that NJH provided on workers at a beryllium machining facility in Cullman, Alabama.  OSHA's analysis of this data set showed positive exposure-response trends using multiple analytical approaches, including examination of beryllium sensitization and CBD prevalence by exposure categories and a Cox proportional hazards modeling approach.
	The prevalence analysis shows that cases of beryllium sensitization and disease occur at average levels of exposure below the preceding TWA PEL and at the final TWA PEL (see Table 7).  The lowest prevalence of beryllium sensitization (2.2%) and CBD (1%) was observed among workers with LTW average exposure levels in the lowest quartile of exposure (< 0.08 μg/m[3]).  In the quartiles of LTW average exposure closest to the preceding PEL of 2 μg/m[3], the prevalence of beryllium sensitization and CBD was high.  Of workers with LTW average exposures between 0.51 μg/m[3] and 2.15 μg/m[3], 15.4 percent were sensitized to beryllium, about two-thirds of whom were diagnosed with CBD (10.3% of workers in the quartile).  High prevalences of beryllium sensitization (> 7.8%) and CBD (> 5.5%) were observed among workers in the second and third quartiles of exposure as well (exposures between 0.08 μg/m3  and 0.51 μg/m[3]).
	OSHA's final statistical analysis of the NJH data set found increasing risk of sensitization with both cumulative exposure and average exposure.  OSHA also found an increasing risk of CBD with cumulative exposure and number of years exposed, but did not find a statistically significant relationship between CBD and average exposure.  OSHA used the LTW average model results to estimate HRs and risk of sensitization at the preceding TWA PEL of 2 μg/m3 and the new TWA PEL of 0.2 μg/m[3] and below and used the cumulative exposure model results to estimate HRs and risk of CBD at the same exposure levels.  For the CBD model, OSHA also estimated risk for various time periods of exposure, from 5 years to a working lifetime of 45 years.
      The Cox proportional hazards model, used with the fixed "baseline" rates of 0.5 percent and 1 percent, predicted risks of sensitization totaling 43 and 86 cases per 1,000 workers, respectively, or 4.3 and 8.6 percent, at the preceding PEL of 2 μg/m[3].  The predicted risks of sensitization at the new PEL of 0.2 μg/m[3] are substantially lower, at 6 and 12 cases per 1,000 for the baselines of 0.5 percent and 1.0 percent, respectively.  The predicted risk of CBD is 204 cases per 1,000 workers, or 20.4 percent, at the preceding PEL of 2 μg/m[3], assuming 45 years of exposure (cumulative exposure of 90 μg/m[3]-yr), and 26 cases per 1,000 workers at the preceding PEL, assuming 20 years of exposure (cumulative exposure of 40 μg/m[3]-yr).  The predicted risk of CBD is also substantially lower at the new PEL of 0.2 μg/m[3] (9 μg/m[3]-year), at 6 cases per 1,000, assuming 45 years of exposure and using a baseline of 0.5 percent.  Because the statistical models used to derive these values were based on a small data set, OSHA believes these risk estimates must be viewed with caution.  Nevertheless, the statistical exposure-response models support the qualitative conclusions of the literature analysis discussed in the preamble to the final rule (Section VII, Significance of Risk) and the prevalence analysis of the NJH data that significant risk of sensitization and CBD exists at the preceding PEL of 2.0 μg/m[3], and that this risk can be lessened by lowering workers' exposure levels.