restrictions on transfers or to impose any charges on transfers until
at least 30 days after each proposed Substitution. The Insurance
Companies will also send each Contract owner a current prospectus for
each of the relevant Replacement Portfolios to the extent they have not
previously received a current version. Each Insurance Company also is
seeking approval of the proposed Substitutions from any state insurance
regulators whose approval may be necessary or appropriate.
    29. The proposed Substitutions will take place at relative net
asset value determined on the date of the Substitutions pursuant to
Section 22 of the 1940 Act and Rule 22c-1 thereunder, with no change in
the amount of any Contract owner's Contract value, cash value, or death
benefit or in the dollar value of his or her investment in the Separate
Accounts. Each Substitution will be effected by redeeming shares of the
Removed Portfolio in cash and/or in-kind on the Substitution Date at
their net asset value and using the proceeds of those redemptions to
purchase shares of the Replacement Portfolio at their net asset value
on the same date. All in-kind redemptions from a Removed Portfolio of
which any of the Applicants is an affiliated person will be effected in
accordance with the conditions set forth in the no-action letter issued
by the staff of the Commission to Signature Financial Group, Inc. (Dec.
28, 1999).
    30. Contract owners will not incur any fees or charges as a result
of the proposed Substitutions, nor will their rights or insurance
benefits or the Insurance Companies' obligations under the Contracts be
altered in any way. All expenses incurred in connection with the
proposed Substitutions, including any brokerage, legal, accounting, and
other fees and expenses, will be paid by the Insurance Companies. In
addition, the proposed Substitutions will not impose any tax liability
on Contract owners. The proposed Substitutions will not cause the
Contract fees and charges currently being paid by Contract owners to be
greater after the proposed Substitutions than before the proposed
Substitutions. All Contract-level fees will remain the same after the
proposed Substitutions. No fees will be charged on the transfers made
at the time of the proposed Substitutions because each proposed
Substitution will not be treated as a transfer for purposes of
assessing transfer charges or computing

the number of permissible transfers under the Contracts.
    31. With respect to those who were Contract owners on the date of
the proposed Substitutions, the Insurance Companies will reimburse, on
the last business day of each fiscal period (not to exceed a fiscal
quarter) during the two years following the date of the proposed
Substitutions, the subaccounts investing in the Replacement Portfolios
such that the sum of each Replacements Portfolio's net operating
expense ratio (taking into account any expense waivers or
reimbursements) and subaccount expense ratio (asset-based fees and
charges deducted on a daily basis from subaccount assets and reflected
in the calculations of subaccount unit value) for such period will not
exceed, on an annualized basis, the sum of the corresponding Removed
Portfolio's net operating expense ratio (taking into account any
expense waivers or reimbursements) and subaccount expense ratio for
fiscal year 2005, except for the Substitutions involving the Lord
Abbett Series Fund--Growth and Income Portfolio, PIMCO Variable
Insurance Trust--Real Return Portfolio and Lord Abbett Series Fund--
Bond-Debenture Portfolio. With respect to the Lord Abbett Series Fund--
Growth and Income Portfolio, PIMCO Variable Insurance Trust--Real
Return Portfolio and Lord Abbett Series Fund--Bond-Debenture Portfolio,
the Insurance Companies will reimburse, on the last business day of
each fiscal period (not to exceed a fiscal quarter) for the life of
each Contract outstanding on the date of the proposed Substitutions,
the subaccounts investing in the Replacement Portfolios such that the
sum of each Replacement Portfolio's net operating expense ratio (taking
into account any expense waivers or reimbursements) and subaccount
expense ratio (asset-based fees and charges deducted on a daily basis
from subaccount assets and reflected in the calculations of subaccount
unit value) for such period will not exceed, on an annualized basis,
the sum of the corresponding Removed Portfolio's net operating expense
ratio (taking into account any expense waivers or reimbursements) and
subaccount expense ratio for fiscal year 2005.
    32. For a period of two years from the date of each proposed
Substitution, except the Substitutions involving the Lord Abbett Series
Fund--Growth and Income Portfolio, PIMCO Variable Insurance Trust--Real
Return Portfolio and Lord Abbett Series Fund--Bond-Debenture Portfolio,
the Insurance Companies will not increase total Separate Account
charges (net of any waivers or reimbursements) for any existing owner
of the Contracts on the date of the proposed Substitutions. With
respect to the Lord Abbett Series Fund--Growth and Income Portfolio,
PIMCO Variable Insurance Trust--Real Return Portfolio and Lord Abbett
Series Fund--Bond-Debenture Portfolio, at no time after the date of the
proposed Substitutions will the Insurance Companies increase the total
Separate Account charges (net of any waiver or reimbursements) of each
Contract outstanding on the date of the proposed Substitutions.

Applicants' Legal Analysis

    1. Section 26(c) of the 1940 Act prohibits the depositor of a
registered unit investment trust that invests in the securities of a
single issuer from substituting the securities of another issuer
without Commission approval. Section 26(c) provides that ``[t]he
Commission shall issue an order approving such substitution if the
evidence establishes that it is consistent with the protection of
investors and the purposes fairly intended by the policy and provisions
of this title.'' Section 26(c) protects the expectation of investors
that the unit investment trust will accumulate shares of a particular
issuer and is intended to ensure that unnecessary or burdensome sales
loads, additional reinvestment costs and other charges will not be
incurred due to unapproved substitutions of securities.
    2. The proposed Substitutions involve a substitution of securities
within the meaning of Section 26(c) of the 1940 Act. The Section 26
Applicants, therefore, request an order from the Commission pursuant to
Section 26(c) approving the proposed Substitutions.
    3. The Section 26 Applicants have reserved the right under the
Contracts to substitute shares of another eligible investment fund for
one of the current investment funds offered as a funding option under
the Contracts. The prospectuses for the Contracts and the Separate
Accounts contain appropriate disclosure of this right. The Section 26
Applicants have reserved this right of substitution both to protect
themselves and their Contract owners in situations where either might
be harmed or disadvantaged by events affecting the issuer of the
securities held by a Separate Account and to preserve the opportunity
to replace such shares in situations where a substitution could benefit
the Insurance Companies and their respective Contract owners.
    4. Applicants assert that each Replacement Portfolio and its
corresponding Removed Portfolio have similar, and in some cases
substantially similar or identical, investment objectives, policies and
risks. In addition, the proposed Substitutions retain for Contract
owners the investment flexibility that is a central feature of the
Contracts. According to the Applicants, any impact on the investment
programs of affected Contract owners, including the appropriateness of
the available investment options, should therefore be negligible.
    5. Applicants maintain that the ultimate effect of each
Substitution would be to remove overlapping and duplicative investment
options and that each Substitution will permit each Insurance Company
to present information to its Contract owners in a simpler and more
concise manner. Applicants anticipate that after each proposed
Substitution, Contract owners will be provided with disclosure
documents that contain a simpler presentation of the available
investment options under their Contracts.
    6. Applicants also state that, as a result of each proposed
Substitution, Contract owners with subaccount balances invested in each
Replacement Portfolio will have lower net operating expenses. Each
Insurance Company has agreed to impose a two year expense limit, except
with respect to the proposed Substitutions involving the Lord Abbett
Series Fund--Growth and Income Portfolio, PIMCO Variable Insurance
Trust--Real Return Portfolio and Lord Abbett Series Fund--Bond-
Debenture Portfolio for which each Insurance Company has agreed to
impose an expense limit for the life of each Contract, so that the sum
of each Replacement Portfolio's net operating expense ratio (taking
into account any expense waivers and reimbursements) and subaccount
expense ratio (asset-based charges deducted on a daily basis from
subaccount assets and reflected in the calculation of subaccount unit
values) for each fiscal period (not to exceed a fiscal quarter) will
not exceed, on an annualized basis, the sum of the corresponding
Removed Portfolio's net operating expense ratio and subaccount expense
ratio for fiscal year 2005.
    7. Applicants contend that, therefore, each Substitution protects
the Contract owners who have allocated Contract value to each Removed
Portfolio by: (i) Providing an underlying investment option for
subaccounts invested in the Removed Portfolio that is similar to the
Removed Portfolio; (ii) providing such Contract owners with simpler
disclosure documents; and (iii) providing such Contract owners with an
investment option that would have net operating

expenses that are lower than the current investment option.
    8. Applicants assert that the proposed Substitutions are not of the
type that Section 26(c) was designed to prevent. Unlike traditional
unit investment trusts where a depositor could only substitute
investment securities in a manner which permanently affected all the
investors in the trust, the Contracts provide each Contract owner with
the right to exercise his or her own judgment, and transfer Contract
values and cash values into and among other investment options
available to Contract owners under their Contracts. Additionally, the
Section 26 Applicants claim that the Substitutions will not, in any
manner, reduce the nature or quality of the available investment
options. Moreover, the Section 26 Applicants will offer Contract owners
the opportunity to transfer amounts out of the affected subaccounts
without any cost or other penalty that may otherwise have been imposed
for a period beginning on the date of the supplement notifying Contract
owners of the proposed Substitutions (which supplement will be
delivered to Contract owners at least thirty (30) days before the
Substitutions) and ending no earlier than thirty (30) days after the
Substitution Date. The Substitutions, therefore, will not result in the
type of costly forced redemption that Section 26(c) was designed to
prevent.
    9. Applicants maintain that the proposed Substitutions are also
unlike the type of substitution that Section 26(c) was designed to
prevent in that by purchasing a Contract, Contract owners select much
more than a particular underlying fund in which to invest their
Contract values. They also select the specific type of insurance
coverage offered by the Section 26 Applicants under the applicable
Contract, as well as numerous other rights and privileges set forth in
the Contract. Contract owners also may have considered the Insurance
Company's size, financial condition, and its reputation for service in
selecting their Contract. These factors will not change as a result of
the proposed Substitution.
    10. Section 17(a)(1) of the 1940 Act prohibits any affiliated
person (as defined in Section 2(a)(3) of the 1940 Act) of a registered
investment company, or any affiliated person of such a person, acting
as principal, from knowingly selling any security or other property to
that company. Section 17(a)(2) of the 1940 Act generally prohibits the
same persons, acting as principals, from knowingly purchasing any
security or other property from the registered investment company.
    11. The Section 17 Applicants state that shares held by a separate
account of an insurance company are legally owned by the insurance
company and that, the Insurance Companies and their affiliates
collectively own substantially all of the shares of EQAT. Accordingly,
EQAT and its respective Portfolios are arguably under the control of
the Insurance Companies, notwithstanding the fact that the Contract
owners may be considered the beneficial owners of those shares held in
the Separate Accounts. If EQAT is under the common control of the
Insurance Companies, then each Insurance Company is an affiliated
person or an affiliated person of an affiliated person of EQAT and its
respective Portfolios. If EQAT and its respective Portfolios are under
the control of the Insurance Companies, then EQAT and its respective
affiliates are affiliated persons of the Insurance Companies.
    12. The Section 17 Applicants note that, regardless of whether or
not the Insurance Companies can be considered to control EQAT and its
respective Portfolios, because the Insurance Companies and their
affiliates own of record more than 5% of the shares of each of them and
are under common control with each Replacement Portfolio's investment
adviser, the Insurance Companies are affiliated persons of EQAT and its
respective Portfolios. Likewise, EQAT's respective Portfolios are each
an affiliated person of the Insurance Companies.
    13. In addition to the above, the Insurance Companies, through
their respective Separate Accounts, in the aggregate own more than 5%
of the outstanding shares of certain of the Removed Portfolios,
including the Dreyfus Variable Investment Fund--International Value
Portfolio, Lord Abbett Series Fund--Bond-Debenture Portfolio, T. Rowe
Price Fixed Income Series, Inc.--Prime Reserve Portfolio, Old Mutual
Insurance Series Fund--Mid-Cap Portfolio and PIMCO Variable Insurance
Trust--Real Return Portfolio. Therefore, each Insurance Company is an
affiliated person of those portfolios.
    14. The Section 17 Applicants state that the proposed In-Kind
Transactions could be seen as the indirect purchase of shares of
certain Replacement Portfolios with portfolio securities of certain
Removed Portfolios and the indirect sale of portfolio securities of
certain Removed Portfolios for shares of certain Replacement
Portfolios. Pursuant to this analysis, the proposed In-Kind
Transactions also could be categorized as a purchase of shares of
certain Replacement Portfolios by certain Removed Portfolios, acting as
principal, and a sale of portfolio securities by certain Removed
Portfolios, acting as principal, to certain Replacement Portfolios. In
addition, the proposed In-Kind Transactions could be viewed as a
purchase of securities from certain Removed Portfolios, and a sale of
securities to certain Replacement Portfolios, by MONY or MLOA (or their
Separate Accounts), acting as principal. If categorized in this manner,
the proposed In-Kind Transactions may be deemed to contravene Section
17(a) due to the affiliated status of these participants.
    15. Rule 17a-7 under the 1940 Act exempts from the prohibitions of
Section 17(a), subject to certain enumerated conditions, a purchase or
sale transaction between registered investment companies or separate
series of registered investment companies, which are affiliated
persons, or affiliated persons of affiliated persons, of each other,
between separate series of a registered investment company, or between
a registered investment company or a separate series of a registered
investment company and a person which is an affiliated person of such
registered investment company (or affiliated person of such person)
solely by reason of having a common investment adviser or investment
advisers which are affiliated persons of each other, common directors,
and/or common officers.
     16. MONY, MLOA, their Separate Accounts, certain Removed
Portfolios, and certain Replacement Portfolios, in connection with
their participation in the proposed In-Kind Transactions, must rely on
that portion of Rule 17a-7 that requires that they be affiliated
persons of each other solely by reason of having a common investment
adviser or affiliated investment advisers, common directors, and/or
common officers. That is not the case as detailed above. Moreover, one
of the conditions enumerated in Rule 17a-7 requires that the
transaction be a purchase or sale, for no consideration other than cash
payment against prompt delivery of a security for which market
quotations are readily available. If the proposed In-Kind Transactions
are viewed as purchases and sales of securities, the consideration in
the proposed redemptions of shares of certain Removed Portfolios and
the proposed purchases of shares of certain Replacement Portfolios
would not be cash, but would be the portfolio securities received from
the Removed Portfolio.
    17. Section 17(b) of the 1940 Act provides that the Commission may,
upon application, issue an order

exempting any proposed transaction from Section 17(a) if: (i) The terms
of the proposed transactions are reasonable and fair and do not involve
overreaching on the part of any person concerned; (ii) the proposed
transactions are consistent with the policy of each registered
investment company concerned; and (iii) the proposed transactions are
consistent with the general purposes of the 1940 Act.
    18. The Section 17 Applicants request an order pursuant to Section
17(b) of the 1940 Act exempting them from the provisions of Section
17(a) to the extent necessary to permit them to carry out the In-Kind
Transactions in connection with the proposed Substitutions.
    19. The Section 17 Applicants submit that the terms of the proposed
In-Kind Transactions, including the consideration to be paid and
received are reasonable and fair and do not involve overreaching on the
part of any person concerned. The Section 17 Applicants also submit
that the proposed In-Kind Transactions are consistent with the policies
of the relevant Removed Portfolios and the relevant corresponding
Replacement Portfolios, as recited in the current registration
statement and reports of the relevant investment company filed with the
Commission under the federal securities laws. Finally, the Section 17
Applicants submit that the proposed In-Kind Transactions are consistent
with the general purposes of the 1940 Act.
    20. The Section 17 Applicants state that they will assure
themselves that the investment companies will carry out the proposed
In-Kind Transactions in conformity with the conditions of Rule 17a-7
(or, as applicable, a Removed Portfolio's and a Replacement Portfolio's
normal valuation procedures, as set forth in the relevant investment
company's registration statement), except that the consideration paid
for the securities being purchased or sold will not be cash. The In-
Kind Transactions will be effected at the respective net asset values
of each Removed Portfolio and the corresponding Replacement Portfolio,
as determined in accordance with the procedures disclosed in the
Portfolios' registration statements and as required by Rule 22c-1 under
the 1940 Act. The In-Kind Transactions will not change the dollar value
of any Contract owner's investment in any of the Separate Accounts, the
value of any Contract, the accumulation value or other value credited
to any Contract, or the death benefit payable under any Contract. After
the proposed In-Kind Transactions, the value of a Separate Account's
investment in a Replacement Portfolio will equal the value of its
investments in the Removed Portfolio (together with the value of any
pre-existing investments in the Replacement Portfolio) before the In-
Kind Transactions.
    21. When the Commission initially proposed and adopted Rule 17a-7,
it noted that the purpose of the rule was to eliminate the filing and
processing of applications ``in circumstances where there appears to be
no likelihood that the statutory finding for a specific exemption under
Section 17(b) could not be made'' by establishing ``conditions as to
the availability of the exemption to those situations where the
Commission, upon the basis of its experience, considers that there is
no likelihood of overreaching of the investment companies participating
in the transaction.'' When the Commission amended Rule 17a-7 in 1981 to
cover transactions involving non-investment company affiliates, it
indicated that such transactions could be reasonable and fair and not
involve overreaching if appropriate conditions were imposed on the
transaction. In this regard, the Section 17 Applicants state they will
assure themselves that the In-Kind Transactions will be in substantial
compliance with the conditions of Rule 17a-7 under the 1940 Act. The
Section 17 Applicants assert that because the proposed In-Kind
Transactions would comply in substance with the principal conditions of
Rule 17a-7, the Commission should consider the extent to which the In-
Kind Transactions would meet these or other similar conditions and
issue an order if such conditions would provide the substance of the
protections embodied in Rule 17a-7.
    22. The Section 17 Applicants state that the proposed In-Kind
Transactions will be effected based upon the independent current market
price of the portfolio securities as specified in paragraph (b) of Rule
17a-7. The proposed In-Kind Transactions will comply with paragraph (d)
of Rule 17a-7 because no brokerage commission, fee or other
remuneration (except for any customary transfer fees) will be paid to
any party in connection with the proposed In-Kind Transactions.
Furthermore, a written record of the proposed In-Kind Transactions will
be maintained and preserved in accordance with paragraph (g) of Rule
17a-7. With respect to those securities for which market quotations are
not readily available, the Substitutions will be effected in accordance
with the relevant Removed Portfolios' and the relevant corresponding
Replacement Portfolios' normal valuation procedures, as set forth in
the registration statement for the relevant investment company.
    23. Even though the proposed In-Kind Transactions will not comply
with the cash consideration requirement of paragraph (a) of Rule 17a-7,
the Section 17 Applicants state that the terms of the proposed In-Kind
Transactions will offer to each of the relevant Removed Portfolios and
each of the relevant Replacement Portfolios the same degree of
protection from overreaching that Rule 17a-7 generally provides in
connection with the purchase and sale of securities under that Rule in
the ordinary course of business. In particular, the Insurance Companies
and their affiliates cannot effect the proposed In-Kind Transactions at
a price that is disadvantageous to any Replacement Portfolio.
    24. The Section 17 Applicants represent that the proposed
redemption of shares of each of the relevant Removed Portfolios will be
consistent with the investment policies of each Removed Portfolio and
the corresponding Replacement Portfolio, as recited in their respective
current registration statements, provided that the shares are redeemed
at their net asset value in conformity with Rule 22c-1 under the 1940
Act. Likewise, the proposed sale of shares of each of the relevant
Replacement Portfolios for investment securities is consistent with the
investment policies of the relevant Replacement Portfolio, as recited
in the relevant Trust's registration statement, provided that: (i) The
shares are sold at their net asset value; and (ii) the investment
securities are of the type and quality that a Replacement Portfolio
could have acquired with the proceeds from the sale of its shares had
the shares been sold for cash. To assure the second of these conditions
is met, the Manager and relevant Adviser will examine the portfolio
securities being offered to each Replacement Portfolio and accept only
those securities as consideration for shares that it would have
acquired for each such Portfolio in a cash transaction.
    25. Applicants also assert that the proposed In-Kind Transactions
are consistent with the general purposes of the 1940 Act and that the
proposed In-Kind Transactions do not present any conditions or abuses
that the 1940 Act was designed to prevent. In particular, Sections
1(b)(2) and 1(b)(3) of the 1940 Act state, among other things, that the
national public interest and the interest of investors are adversely
affected ``when investment companies are organized, operated, managed,
or their portfolio securities are selected in the

interest of directors, officers, investment advisers, depositors, or
other affiliated persons thereof, * * * or in the interest of other
investment companies or persons engaged in other lines of business,
rather than in the interest of all classes of such companies' security
holders; * * * when investment companies issue securities containing
inequitable or discriminatory provisions, or fail to protect the
preferences and privileges of holders in their outstanding
securities.'' As explained above, the terms of the proposed In-Kind
Transactions are designed to prevent the abuses described in Sections
1(b)(2) and 1(b)(3) of the 1940 Act.
    26. The Section 17 Applicants submit that, for all the reasons
stated above, the terms of the proposed In-Kind Transactions as set
forth in the Application, including the consideration to be paid and
received, are reasonable and fair to: (i) Each of the relevant
Replacement Portfolios and each of the relevant Removed Portfolios; and
(ii) Contract owners. The Section 17 Applicants also assert that the
proposed In-Kind Transactions do not involve overreaching on the part
of any person concerned. Furthermore, the Section 17 Applicants
represent that the proposed In-Kind Transactions are, or will be,
consistent with all relevant policies of (i) the relevant Replacement
Portfolios and the relevant Removed Portfolios as stated in the
relevant investment company's registration statement and reports filed
under the 1940 Act, and (ii) the general purposes of the 1940 Act.

Conclusion

    For the reasons set forth in the Application, the Section 26
Applicants and the Section 17 Applicants respectively state that the
proposed Substitutions and the related In-Kind Transactions meet the
standards of Section 26(c) of the 1940 Act and of Section 17(b) of the
1940 Act, and request that the Commission issue an order of approval
pursuant to Section 26(c) of the 1940 Act and an order of exemption
pursuant to Section 17(b) of the 1940 Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Lynn Taylor,
Assistant Secretary.

Appendix A

    The charts below compare the average annual total returns of the
Class IA shares of each Replacement Portfolio and relevant class of
shares (as indicated below) of each Removed Portfolio for the one-,
five- and ten-year or since inception periods ended December 31,
2005.
---------------------------------------------------------------------------

    \25\ Replaced November 30, 2005.

 1.--The Dreyfus Socially Responsible Growth Fund, Inc. (Initial Class Shares) (``Removed Portfolio'') Replaced
           by EQ/Calvert Socially Responsible Portfolio (Class IA Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                Since
              Portfolio  Periods Ended 12/31/2005                   1 year          5 years         inception*
                                                                   (percent)       (percent)        (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio.........................................            8.92           (2.00)           (0.87)
Russell 1000 Growth Index.....................................            5.26           (3.58)           (3.74)
Russell 3000 Index\25\........................................            6.12            1.58             1.86
Removed Portfolio.............................................            3.62           (5.27)            5.93
S&P 500.......................................................            4.91            0.54             9.07
----------------------------------------------------------------------------------------------------------------
* The Replacement Portfolio commenced operations on September 1, 1999. The Removed Portfolio commenced
  operations on December 31, 2000.

      2.--Dreyfus Variable Investment Fund--International Value Portfolio (Initial Class Shares) (``Removed
 Portfolio'') Replaced by EQ/Mercury International Value Portfolio (Class IA Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                Since
               Portfolio  periods ended 12/31/2005                    1 year          5 years       inception*
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................           11.07            2.46            8.80
MSCI EAFE Index.................................................           13.54            4.55            6.17
Removed Portfolio...............................................           11.89            6.88            7.97
MSCI EAFE Index.................................................           13.54            4.55            5.42
----------------------------------------------------------------------------------------------------------------
* The Replacement Portfolio commenced operations on March 25, 2002. The Removed Portfolio commenced operations
  on May 1, 1996.

 3.--Lord Abbett Series Fund--Growth and Income Portfolio (Class VC Shares) (``Removed Portfolio'') Replaced by
           EQ/Lord Abbett Growth and Income Portfolio (Class IA Shares) (``Replacement Portfolio'')**
----------------------------------------------------------------------------------------------------------------
                                                                      1 year          5 years        10 years*
               Portfolio periods ended 12/31/2005                    (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Removed Portfolio...............................................            3.25            3.10           10.22

S&P 500.........................................................            4.91            0.54            9.07
----------------------------------------------------------------------------------------------------------------
* The Removed Portfolio commenced operations on December 11, 1989.
** The inception date for the Replacement Portfolio is April 29, 2005 and, therefore, the Portfolio does not
  have performance information for a full fiscal year.

4.--T. Rowe Price Fixed Income Series, Inc.--Limited-Term Bond Portfolio (``Removed Portfolio'') Replaced by EQ/
                   Short Duration Bond Portfolio (Class IA Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                10 years or
                                                                      1 year          5 years          since
               Portfolio periods ended 12/31/2005                    (percent)       (percent)      inception*
                                                                                (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................            1.38             N/A            1.58
Lehman 1-3 Year Government Credit Index.........................            1.77             N/A            1.72
Removed Portfolio...............................................            1.74            4.17            4.80
Merrill Lynch 1-5 Year U.S. Corporate and Government Index......            1.44            4.63            5.35
----------------------------------------------------------------------------------------------------------------
* The predecessor of the Replacement Portfolio, the Enterprise Short Duration Portfolio, commenced operations on
  May 1, 2003. The assets of the Enterprise Short Duration Portfolio were transferred to the Replacement
  Portfolio on July 9, 2004. The Removed Portfolio commenced operations on May 13, 1994.

  5.--T. Rowe Price Fixed Income Series, Inc.--Prime Reserve Portfolio (``Removed Portfolio'') Replaced by EQ/
                      Money Market Portfolio (Class IA shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                10 years or
                                                                      1 year          5 years          since
               Portfolio  periods ended 12/31/2005                   (percent)       (percent)      inception*
                                                                                (percent
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................            2.85            2.00            3.72
3-Month Treasury Bill...........................................            3.07            2.34            3.85
Removed Portfolio...............................................            2.79            1.96            3.48
Lipper Variable Annuity Underlying Money Market Funds Average...            2.69            1.85            3.38
----------------------------------------------------------------------------------------------------------------
*The predecessor of the Replacement Portfolio, the HRT/Alliance Money Market Portfolio, commenced operations on
  July 13, 1981. The assets of the HRT/Alliance Money Market Portfolio were transferred to the Replacement
  Portfolio on October 18, 1999. The Removed Portfolio commenced operations on December 31, 1996.

 6.--T. Rowe Price International Series, Inc.--International Stock Portfolio (``Removed Portfolio'') Replaced by
                EQ/Alliance International Portfolio (Class IA shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                      1 year          5 years        10 years*
               Portfolio  periods ended 12/31/2005                   (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................           15.61            5.20            4.87
MSCI EAFE Index.................................................           13.54            4.55            5.84
Removed Portfolio...............................................           16.03            1.84            5.09
MSCI EAFE Index.................................................           14.02            4.94            6.18
----------------------------------------------------------------------------------------------------------------
*The predecessor of the Replacement Portfolio, the HRT/Alliance International Portfolio, commenced operations on
  April 3, 1995. The assets of the HRT/Alliance International Portfolio were transferred to the Replacement
  Portfolio on October 18, 1999. The Removed Portfolio commenced operations on March 31, 1994.

   7.--The Universal Institutional Funds, Inc.--Emerging Markets Equity Portfolio (Class I Shares) (``Removed
    Portfolio'') Replaced by EQ/Van Kampen Emerging Markets Equity Portfolio (Class IA Shares) (``Replacement
                                                  Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                Since
               Portfolio periods ended 12/31/2005                     1 year          5 years       inception*
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................           33.04           17.97            5.48
MSCI EMF Gross Dividend Index...................................           34.54           19.44            7.13
Removed Portfolio...............................................           33.85           16.01            6.95
MSCI Emerging Markets Free Net Index............................           34.00           19.09            6.62
----------------------------------------------------------------------------------------------------------------
* The Replacement Portfolio commenced operations on August 20, 1997. The Removed Portfolio commenced operations
  on October 1, 1996.

    8.--Old Mutual Insurance Series Fund--Mid-Cap Portfolio (``Removed Portfolio'') Replaced by EQ/FI Mid Cap
                             Portfolio (Class IA Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                Since
               Portfolio  periods ended 12/31/2005                    1 year          5 years       inception*
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................            6.63            4.58            4.38
S&P MidCap 400 Index............................................           12.56            8.60            6.91
Removed Portfolio...............................................            5.71            8.18           14.78
S&P MidCap 400 Index............................................           10.26            6.52           11.35
----------------------------------------------------------------------------------------------------------------
* The Replacement Portfolio commenced operations on September 1, 2000. The Removed Portfolio commenced
  operations on November 30, 1998.

 9.--Lord Abbett Series Fund--Mid-Cap Value Portfolio (Class VC Shares) (``Removed Portfolio'') Replaced by EQ/
               Lord Abbett Mid Cap Value Portfolio (Class IA Shares) (``Replacement Portfolio'')**
----------------------------------------------------------------------------------------------------------------
                                                                                Since
               Portfolio  periods ended 12/31/2005                    1 year          5 years       inception*
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Removed Portfolio...............................................            8.22           10.30           15.34
Russell MidCap Value Index......................................           12.65           12.21           12.50
----------------------------------------------------------------------------------------------------------------
* The Removed Portfolio commenced operations on September 15, 1999.
** The inception date for the Replacement Portfolio is April 29, 2005 and, therefore, the Portfolio does not
  have performance information for a full fiscal year.

10.--PIMCO Variable Insurance Trust--Real Return Portfolio (Administrative Class Shares) (``Removed Portfolio'')
            Replaced by EQ/JPMorgan Core Bond Portfolio (Class IA Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                Since
               Portfolio  periods ended 12/31/2005                    1 year          5 years       inception*
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................            2.50            5.41            5.69
Lehman Brothers Aggregate Bond Index............................            2.43            5.87            6.06
Removed Portfolio...............................................            2.09            9.34            9.68
Lehman Brothers U.S. TIPS Index.................................            2.84            8.74            9.07
----------------------------------------------------------------------------------------------------------------
* The Replacement Portfolio commenced operations on January 1, 1998. The Removed Portfolio commenced operations
  on September 30, 1999.

11.--Lord Abbett Series Fund--Bond-Debenture Portfolio (Class VC Shares) (``Removed Portfolio'') Replaced by AXA
                  Premier VIP High Yield Portfolio (Class A Shares) (``Replacement Portfolio'')
----------------------------------------------------------------------------------------------------------------
                                                                                10 years or
                                                                      1 year          5 years          since
               Portfolio  periods ended 12/31/2005                   (percent)       (percent)      inception*
                                                                                (percent)
----------------------------------------------------------------------------------------------------------------
Replacement Portfolio...........................................            3.26            6.32            5.17
Merrill Lynch High Yield Master Cash Pay Only Index.............            2.83            8.76            6.80
Credit Suisse First Boston Global High Yield Index\26\..........            2.25            9.82            7.13
Removed Portfolio...............................................            1.31             N/A            8.53
Lehman Brothers Aggregate Bond Index............................            2.43             N/A            4.97
CSFB High Yield Bond Index......................................            2.26             N/A           10.64
----------------------------------------------------------------------------------------------------------------
* The predecessor of the Replacement Portfolio, the EQ/High Yield Portfolio, merged with the AXA Premier VIP
  High Yield Portfolio on August 15, 2003. The assets of the HRT Alliance High Yield Portfolio were transferred
  to the EQ/High Yield Portfolio on October 19, 1999. The HRT Alliance High Yield Portfolio commenced operations
  on January 2, 1987. The Removed Portfolio commenced operations on December 3, 2001.

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

    \26\ Replaced December 31, 2005.
---------------------------------------------------------------------------

 [FR Doc. E6-17236 Filed 10-16-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62486-62489]
[FR Doc No: 2018-26347]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0290; FRL-9985-99]

1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-,
homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer; Tolerance
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No.
55141-01-0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. No. 35641-59-9);
when used as inert ingredients in a pesticide chemical formulation.
BASF Corporation submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of 1-propanesulfonic
acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium
salt) and 1-propanesulfonic acid, 2-methyl-2[(1oxo-2propen-1-y1)amino]-
, sodium salt (1:1), homopolymer on food or feed commodities.

DATES: This regulation is effective December 4, 2018. Objections and
requests for hearings must be received on or before February 4, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0290, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0290 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 4, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0290, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of June 14, 2018 (83 FR 27743) (FRL-9978-
41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11148)
filed by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC<PHONE_NUMBER>. The petition requested that 40 CFR
180.960 be amended by establishing an exemption from the requirement of
a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-
2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01-
0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. Reg. No. 35641-59-
9). That document included a summary of the petition prepared by the
petitioner and solicited comments on the petitioner's request.
    There were no comments received in response to the notice of
filling.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will

result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . . '' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 1-Propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium
salt (1:1), homopolymer both conform to the definition of a polymer
given in 40 CFR 723.250(b) and meet the following criteria that are
used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40
CFR 723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's number average MW of 14,000 is greater than or
equal to 10,000 daltons. The polymer contains less than 2% oligomeric
material below MW 500 and less than 5% oligomeric material below MW
1,000.
    Thus, 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer
meet the criteria for a polymer to be considered low risk under 40 CFR
723.250. Based on their conformance to the criteria in this unit, no
mammalian toxicity is anticipated from dietary, inhalation, or dermal
exposure to 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 1-propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium
salt (1:1), homopolymer could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational
non-dietary exposure was possible. The number average MW of 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-,
homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-
oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer are greater
than 14,000 daltons. Generally, polymers of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer
conform to the criteria that identify a low-risk polymer, there are no
concerns for risks associated with any potential exposure scenarios
that are reasonably foreseeable. The Agency has determined that a
tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic
acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1),
homopolymer to share a common mechanism of toxicity with any other
substances, and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer
do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-
y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer
do not have a common mechanism of toxicity with

other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of 1-propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and
1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-,
sodium salt (1:1), homopolymer, EPA has not used a safety factor
analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 1-propanesulfonic acid, 2-methyl-2-
[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium
salt (1:1), homopolymer.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt or 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium
salt (1:1), homopolymer.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 1-propanesulfonic
acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium
salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-
y1)amino]-, sodium salt (1:1), homopolymer from the requirement of a
tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 14, 2018.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, alphabetically add the polymers in the table to
read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-          55141-01-0
 y1)amino]-, homopolymer, sodium salt, minimum number
 average molecular weight (in amu) 14,000...............

                              * * * * * * *
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-        35641-59-9
 y1)amino]-, sodium salt (1:1), homopolymer, minimum
 number average molecular weight (in amu) 14,000........

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-26347 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52878-52879]
[FR Doc No: 2016-19021]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-1721; FDA-2012-N-0248; FDA-2011-N-0449; FDA-
2012-N-0748; FDA-2012-N-0961; FDA-2012-N-0921; FDA-2014-N-0189; FDA-
2004-N-0258]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Investigational New Drug Regulations....       0910-0014       2/28/2019

Guidance for Industry on Formal Dispute        0910-0430       2/28/2019
 Resolutions; Appeals Above the Division
 Level..................................
SPF Labeling and Testing Requirements          0910-0717       2/28/2019
 for OTC Sunscreen Products.............
Generic Drug User Fee Cover Sheet--Form        0910-0727       2/28/2019
 FDA 3794...............................
Environmental Impact Considerations.....       0910-0322       4/30/2019
FDA Adverse Event Reports; Electronic          0910-0645       5/31/2019
 Submissions............................
Importer's Entry Notice.................       0910-0046       6/30/2019
Exports: Notification and Recordkeeping        0910-0482       6/30/2019
 Requirements...........................
Focused Mitigation Strategies to Protect       0910-0812       6/30/2019
 Food Against Intentional Adulteration..
------------------------------------------------------------------------

    Dated: August 5, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19021 Filed 8-9-16; 8:45 am]
 BILLING CODE 4164-01-P