[Federal Register: November 27, 2009 (Volume 74, Number 227)]
[Notices]
[Page 62360-62363]
[DOCID:fr27no09-107]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28998; File No. 812-13636]

Pioneer Floating Rate Trust and Pioneer High Income Trust; Notice
of Application

November 20, 2009.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from sections
18(a)(1)(A) and 18(a)(1)(B) of the Act.

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Applicants: Pioneer Floating Rate Trust and Pioneer High Income Trust
(each, an ``Applicant'' and collectively, ``Applicants'').

Summary of Application: Applicants request an order (``Order'')
granting an exemption from sections 18(a)(1)(A) and 18(a)(1)(B) of the
Act for a period from the date of the Order until October 31, 2010. The
Order would permit each Applicant to issue or incur debt that would be
used to redeem all or a portion of the auction market preferred shares
(``AMPS'') that it issued prior to February 1, 2008 and that are
outstanding at the time of such issuance or incurrence of debt (``post-
Order debt''), and to refinance such post-Order debt, subject to the
200% asset coverage requirement ordinarily applicable to a senior
security that is stock. The Order also would permit each Applicant to
declare dividends or any other distributions on, or purchase, capital
stock during the term of the Order, provided that any such post-Order
debt has asset coverage of at least 200% after deducting the amount of
such transaction.

Filing Dates: The application was filed on February 27, 2009, and
amended on August 25, 2009 and November 19, 2009.

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 December 14, 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, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090. Applicants: Dorothy E. Bourassa, Esq.,
Pioneer Investment Management, Inc., 60 State Street, Boston, MA 02109-
1820.

FOR FURTHER INFORMATION CONTACT: Laura J. Riegel, Senior Counsel, at
(202) 551-6873, or Marilyn Mann, 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 via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. Each Applicant is organized as a Delaware statutory trust and is
registered under the Act as a non-diversified closed-end management
investment company. Each Applicant is advised by Pioneer Investment
Management, Inc. and has issued and outstanding a class of common
shares and a class of one or more series of AMPS.
    2. Applicants state that they issued their AMPS for purposes of
investment leverage to augment the amount of investment capital
available for use in the pursuit of their investment objectives.
Applicants state that, through the use of leverage, they seek to
enhance the investment return available to the holders of their common
shares by earning a rate of portfolio return (which includes the return
obtained from securities that are purchased from the proceeds of AMPS
offerings) that exceeds the dividend rate that each Applicant pays to
the AMPS holders. Applicants represent that the AMPS

holders are entitled to receive a stated liquidation preference amount
of $25,000 per share (plus any accumulated but unpaid dividends) in any
liquidation, dissolution, or winding up of the relevant Applicant
before any distribution or payment to holders of the Applicant's common
shares. They state that dividends declared and payable on their AMPS
have a similar priority over dividends declared and payable on their
common shares. In addition, Applicants state that their AMPS are
``perpetual'' securities and that Applicants are not required to redeem
them so long as certain asset coverage tests are met. Further,
Applicants state that their AMPS are redeemable at each Applicant's
option.
    3. Applicants state that prior to February 2008, dividend rates on
the AMPS for each dividend period were set at the market clearing rate
determined through an auction process that brought together bidders,
who sought to buy AMPS, and AMPS holders, who sought to sell AMPS.
Applicants represent that each Applicant's Statement of Preferences
setting forth the terms and conditions of the AMPS (the ``Statement of
Preferences'') provides that if an auction fails to clear (because of
an imbalance of sell orders over bids), the dividend payment rate over
the next dividend period is set at a specified maximum applicable rate
(the ``Maximum Rate'') determined by reference to a short-term market
interest rate (such as LIBOR or a commercial paper rate). Applicants
state that an unsuccessful auction is not a default; the relevant
Applicant continues to pay dividends to all AMPS holders, but at the
specified Maximum Rate rather than a market clearing rate. Applicants
represent that they experienced no unsuccessful auctions prior to
February 2008.
    4. Applicants state that if investors did not purchase all of the
AMPS tendered for sale at an auction prior to the failure of the
auction market, dealers historically would enter into the auction and
purchase any excess shares to prevent the auction from failing.
Applicants represent that this auction mechanism had generally provided
readily available liquidity to holders of AMPS for more than twenty
years. Applicants state that they understand that many investors may
have invested short-term cash balances in AMPS believing they were safe
short-term investments and, in many cases, the equivalent of cash.
Applicants state that in February 2008, the financial institutions that
historically provided ``back stop'' liquidity to AMPS auctions stopped
participating in them and the auctions began to fail. Applicants
further state that, beginning in February 2008, Applicants experienced
auction failures due to an imbalance between buy and sell orders.
Applicants believe that there is no established secondary market that
would provide holders of the Applicants' AMPS with the liquidation
preference of $25,000 per share. Applicants state that neither of the
Applicants would be able to replace its AMPS entirely with new debt
without the Order providing temporary relief from the 300% asset
coverage test. As a result, Applicants state that there is currently no
reliable mechanism for holders of their AMPS to obtain liquidity, and
believe that the current lack of liquidity is causing distress and
creating severe hardship for holders of their AMPS.
    5. Applicants seek relief for a temporary period from the date on
which the Order is granted until October 31, 2010 (``Exemption
Period''). The proposed replacement of AMPS with debt would provide
liquidity for holders of the AMPS, while Applicants continue their
diligent efforts to obtain a more permanent form of financing, such as
a new type of senior security that is equity.\1\ Applicants submit that
the gradual reduction of leverage through the use of proceeds of any
common share issuances or the development of an alternative form of
preferred stock might take several months, if at all, after the Order
has been issued. Applicants state that it is uncertain when, or if, the
securities and capital markets will return to conditions that would
enable the Applicants to achieve compliance with the asset coverage
requirements that would apply in the absence of the Order. Given the
uncertainty and the current and continuing unsettled state of the
securities and capital markets, applicants believe that the Exemption
Period is reasonable and appropriate. Each Applicant's incurrence of
debt to redeem its AMPS would be subject to approval by the Applicant's
board of trustees (``Board'').
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    \1\ See, e.g., Eaton Vance Management, SEC No-Action Letter
(June 13, 2008) (permitting the issuance of ``liquidity protected
preferred shares'' to supplement or replace Eaton Vance funds'
auction rate preferred stock).
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Applicants' Legal Analysis

    1. Section 18(a)(1)(A) of the Act provides that it is unlawful for
any registered closed-end investment company to issue any class of
senior security representing indebtedness, or to sell such security of
which it is the issuer, unless the class of senior security will have
an asset coverage of at least 300% immediately after issuance or sale.
Section 18(a)(2)(A) of the Act provides that it is unlawful for any
registered closed-end investment company to issue any class of senior
security that is a stock, or to sell any such security of which it is
the issuer, unless the class of senior security will have an asset
coverage of at least 200% immediately after such issuance or sale.\2\
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    \2\ Section 18(h) of the Act defines asset coverage of a class
of senior security representing an indebtedness of an issuer as the
ratio which the value of the total assets of the issuer, less all
liabilities and indebtedness not represented by senior securities,
bears to the aggregate amount of senior securities representing
indebtedness of the issuer. The section defines asset coverage of
the preferred stock of an issuer as the ratio which the value of the
total assets of the issuer, less all liabilities and indebtedness
not represented by senior securities, bears to the aggregate amount
of senior securities representing indebtedness of the issuer plus
the aggregate amount the class of senior security would be entitled
to on involuntary liquidation.
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    2. Section 18(a)(1)(B) prohibits a registered closed-end investment
company from declaring a dividend or any other distribution on, or
purchasing, its own capital stock unless its outstanding indebtedness
will have an asset coverage of at least 300% immediately after
deducting the amount of such dividend, distribution or purchase
price.\3\ Section 18(a)(2)(B) prohibits a registered closed-end
investment company from declaring a dividend or other distribution on,
or purchasing, its own common stock unless its outstanding preferred
stock will have an asset coverage of at least 200% immediately after
deducting the amount of such dividend, distribution or purchase price.
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    \3\ An exception is made for the declaration of a dividend on a
class of preferred stock if the senior security representing
indebtedness has an asset coverage of at least 200% at the time of
declaration after deduction of the amount of such dividend. See
section 18(a)(1)(B) of the Act. Further, section 18(g) of the Act
provides, among other things, that ``senior security,'' for purposes
of section 18(a)(1)(B), does not include any promissory note or
other evidence of indebtedness issued in consideration of any loan,
extension or renewal thereof, made by a bank or other person and
privately arranged, and not intended to be publicly distributed.
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    3. Section 6(c) of the Act provides, in relevant part, that the
Commission, by order upon application, may conditionally or
unconditionally exempt any person, security, or transaction from any
provision of the Act if and to the extent 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.
    4. Applicants request that the Commission issue an Order under

section 6(c) of the Act to exempt each Applicant from the 300% asset
coverage requirements set forth in sections 18(a)(1)(A) and (B) of the
Act. Specifically, Applicants seek relief to permit each Applicant, for
the Exemption Period, to issue or incur post-Order debt for the purpose
of redeeming all or a portion of its AMPS that were issued prior to
February 1, 2008 and that are outstanding at the time of such issuance
or incurrence, as well as any refinancing of such debt until the
expiration of the Exemption Period, subject to asset coverage of 200%
ordinarily applicable to a senior security that is stock, rather than
the asset coverage of 300% ordinarily applicable to a senior security
constituting indebtedness. Applicants also seek relief to permit each
Applicant to declare dividends or any other distributions on, or
purchase, capital stock during the Exemption Period, provided that any
such post-Order debt has asset coverage of at least 200% after
deducting the amount of such transaction. Applicants state that, except
as permitted under the Order, the Applicants would meet all of the
asset coverage requirements of section 18(a) of the Act. In addition,
Applicants state that within the Exemption Period each Applicant that
borrows in reliance on the Order will either pay down or refinance the
post-Order debt so that the Applicant would, upon expiration of the
Exemption Period and thereafter, have asset coverage of at least 300%
for each class of senior security representing indebtedness to the
extent required by the Act.
    5. Applicants state that section 18 reflects congressional concerns
regarding preferential treatment for certain classes of shareholders,
complex capital structures, and the use of excessive leverage.
Applicants submit that another concern was that senior securities gave
the misleading impression of safety from risk. Applicants believe that
the request for temporary relief is necessary, appropriate and in the
public interest and that such relief is consistent with the protection
of investors and the purposes intended by the policy and provisions of
the Act.
    6. Applicants note that the illiquidity of AMPS is a unique,
exigent situation that is posing severe hardships on AMPS holders.
Applicants represent that the proposed replacement of their AMPS with
debt would provide liquidity for the Applicants' AMPS holders while the
Applicants continue their efforts to obtain a more permanent form of
financing (such as through the issuance of preferred equity-based
instruments) that fully complies with the asset coverage requirements
of section 18.\4\
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    \4\ See supra note 1.
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    7. Applicants represent that the Order would help avoid the
potential harm to common shareholders that could result if the
Applicants were to deleverage their portfolios in the current difficult
market environment \5\ or that could result if a reduction in
investment return reduced the market price of common shares. Applicants
also state that the Order would permit Applicants to continue to
provide their common shareholders with the enhanced returns that
leverage may provide.
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    \5\ Applicants state that each Applicant invests a portion of
its assets in either senior securities loans or preferred
securities. Applicants believe that it is difficult to sell such
securities in the current market because the liquidity of that
market has been reduced in substantial part as a result of the
market makers' own impaired capital positions. Applicants thus
believe that it would be disadvantageous to sell these portfolio
securities in the current market.
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    8. Applicants believe that the interests of both classes of the
Applicants' current investors would be well served by the requested
order--the AMPS holders because they would achieve the liquidity that
the market currently cannot provide (as well as full recovery of the
liquidation value of their shares), and the common shareholders because
the adverse consequences of forced deleveraging would be avoided and
each Applicant's investment return would be enhanced to the extent that
the cost of the new form of leverage is lower than the cost of
continuing to pay the Maximum Rate on their outstanding AMPS.
    9. Applicants represent that the proposed borrowing would be
obtained from banks, insurance companies or qualified institutional
buyers (as defined in rule 144A(a)(1) under the Securities Act of 1933)
who would be capable of assessing the risk associated with the
transaction. Applicants also state that, to the extent the Act's asset
coverage requirements were aimed at limiting leverage because of its
potential to magnify losses as well as gains, they believe that the
proposal would not unduly increase the speculative nature of the
Applicants' common shares because the relief is temporary and the
Applicants would be no more highly leveraged if they replace the
existing AMPS with borrowing.\6\ Applicants also state that the
proposed liquidity solution would not make Applicants' capital
structure more complex, opaque, or hard to understand or result in
pyramiding or inequitable distribution of control.
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    \6\ Applicants acknowledge that managing any portfolio that
relies on borrowing for leverage entails the risk that, when the
borrowing matures and must be repaid or refinanced, an economically
attractive form of replacement leverage may not be available in the
capital markets. For that reason, any portfolio that relies on
borrowing for leverage is subject to the risk that it may have to
deleverage, which could be disadvantageous to the portfolio's common
shareholders.
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    10. Applicants state that the current state of the credit markets,
which has affected their AMPS, is an historic event of unusual
severity, which requires a creative and flexible response on the part
of both the public and private sectors. Applicants believe that these
issues have created an urgent need for limited, quick, thoughtful and
responsive solutions. Applicants believe that the request meets the
standards for exemption under section 6(c) of the Act.

Applicants' Conditions

    Applicants agree that any order of the Commission granting the
requested relief shall be subject to the following conditions:
    1. Each Applicant that borrows subject to 200% asset coverage under
the Order will do so only if such Applicant's Board, including a
majority of the trustees who are not ``interested persons'' as defined
in section 2(a)(19) of the Act (``Independent Trustees''), shall have
determined that such borrowing is in the best interests of such
Applicant, its common shareholders, and its AMPS shareholders. Each
Applicant shall make and preserve for a period of not less than six
years from the date of such determination, the first two years in an
easily accessible place, minutes specifically describing the
deliberations by the Board and the information and documents supporting
those deliberations, the factors considered by the Board in connection
with such determination, and the basis of such determination.
    2. Upon expiration of the Exemption Period, each Applicant will
have asset coverage of at least 300% for each class of senior security
representing indebtedness.
    3. The Board of an Applicant that has borrowed in reliance on the
Order shall receive and review, no less frequently than quarterly
during the Exemption Period, detailed progress reports prepared by
management (or other parties selected by the Independent Trustees)
regarding and assessing the efforts that the Applicant has undertaken,
and the progress that the Applicant has made, towards achieving
compliance with the appropriate asset coverage requirements under
section 18 by the expiration of the Exemption Period. The Board,
including a majority of the Independent Trustees, will make such
adjustments as it deems necessary or appropriate to ensure that the

Applicant comes into compliance with section 18 of the Act within a
reasonable period of time, not to exceed the expiration of the
Exemption Period. Each Applicant will make and preserve minutes
describing these reports and the Board's review, including copies of
such reports and all other information provided to or relied upon by
the Board, for a period of not less than six years, the first two years
in an easily accessible place.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-28352 Filed 11-25-09; 8:45 am]

BILLING CODE 8011-01-P


           PRESENTATION TO SACC PREPARATORY VIRTUAL MEETING ON DCM
                               NOVEMBER 12, 2019

      Thank you for the opportunity to address the scope and clarity of the draft charge questions for the peer review of the draft TSCA Risk Evaluation of Methylene Chloride (Dichloromethane, or DCM).  I speak on behalf of the Halogenated Solvents Industry Alliance, or HSIA, which represents producers and users of DCM. These comments specifically address the charge questions and focus on how in the short term the Committee could assist EPA in addressing shortcomings of both the exposure and hazard elements of the draft Evaluation.

Exposure (Charge Questions 4.1  -  4.6)
      EPA acknowledges that most of the exposure studies on which it relies were conducted in the 1980s, while recognizing that in 1997 the Occupational Safety and Health Administration (OSHA) adopted a standard under § 6(b)(5) of the Occupational Safety and Health Act lowering the permissible exposure limit (PEL) for DCM from 500 ppm to 25 ppm, and setting a short-term exposure limit, or STEL, of 125 ppm.  Employers generally keep concentrations of airborne DCM below a 12-1/2 ppm (8-hour TWA) action level to avoid triggering the standard's ancillary provisions.  How can EPA produce an assessment in 2019 that assumes workplace exposures are still at 1990s levels, when the current action level is only 2.5% of the earlier permissible exposure limit?  The 25 ppm PEL has been in effect for over 20 years.
      In addition, EPA has adopted national emission standards, or NESHAPs, for most DCM applications, for which it relied on exposure assessments showing workplace concentrations below 25 ppm.  Indeed, some of these NESHAPs, such as the one for commercial paint stripping, require these operations to:
 Evaluate each application to ensure there is a need for paint stripping;
 Evaluate each application where a paint stripper containing DCM is used to ensure that there is no alternative paint stripping technology that can be used;
 Reduce exposure of all paint strippers containing DCM to the air;
 Optimize application conditions to reduce DCM evaporation; and
 Practice proper storage and disposal of paint strippers containing DCM (e.g., store stripper in closed, airtight containers).

Larger operations must:

       Develop and implement a written DCM minimization plan to minimize the use and emissions of DCM; and
       Maintain copies of annual usage of paint strippers containing DCM on site at all times.
      Most significantly for present purposes, covered businesses must maintain records of paint strippers containing DCM used for paint stripping operations sufficient to verify annual usage of paint strippers containing DCM. These records, and those maintained under other NESHAPs, are accessible to EPA.  At a minimum, the Committee should recommend that EPA review its own records for NESHAP-regulated sources to assess exposures in the post-§ 6(b)(5), post-NESHAPs era.

Hazard (Charge Questions 5.9 and 5.10 Chronic)
	Regarding potential cancer risk, HSIA applauds EPA's recognition that the highest quality data available  -  well-conducted worker cohort studies  -  show no overall increased cancer risk.  It is regrettable that the epidemiology is then ignored in favor of linear extrapolation from high-dose bioassays in mice.  It is most important that the Committee address the following charge questions:
 5.9.  Please comment on the appropriateness of using a linear low-dose extrapolation versus a non-linear or threshold approach, recognizing that methylene chloride is predominantly metabolized by cytochrome P450 2E1 to carbon monoxide at low concentrations (a high affinity, low capacity pathway) and by glutathione S-transferase T1-1 to two reactive intermediates (i.e., S-(chloromethyl)glutathione) and formaldehyde) at high concentrations (a low affinity, high capacity pathway).

 5.10. Please comment on the appropriateness of applying the PBPK model and assumptions within the model, specifically using the internal dose metric of daily mass of methylene chloride metabolized via the GST pathway as the basis for performing a linear low-dose extrapolation for quantifying potential cancer risks from chronic exposures to methylene chloride.

      We plan to provide comments in due course showing that mouse liver and lung tumors from methylene chloride exposure do not occur from events expected for genotoxic carcinogens, but from a non-genotoxic MOA that involves hypoxia from increased levels of carboxyhemoglobin and tissue carbon monoxide.  These data were published by Mel Andersen in 2017 using reactome ontologies and bioinformatic tools to evaluate and visualize the pattern of genomic responses in the liver and lung of female B6C3F1 mice following inhalation exposure to methylene chloride vapor from 100 to 4,000 ppm methylene chloride for 13 weeks (6 hours/day, 5 days/week).  A physiologically-based pharmacokinetic (PBPK) mouse model for methylene chloride, which includes both the conjugation and oxidation pathways, was modified to simulate the rates of methylene chloride oxidation to carbon monoxide (CO) in lung and liver and the time course of carboxyhemoglobin (HbCO) in blood.  The findings from Andersen et al. suggest that a non-linear or threshold approach should be considered to estimate cancer risk for methylene chloride.


[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Rules and Regulations]
[Pages 18906-18915]
[FR Doc No: 2011-7461]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0307; FRL-8864-1]

Mancozeb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
mancozeb in or on almonds, cabbage, lettuce, peppers, and broccoli. Dow
AgroSciences LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 6, 2011. Objections and
requests for hearings must be received on or before June 6, 2011, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0307. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How 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-2005-0307 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
June 6, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2005-0307, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 30, 2005 (70 FR 71836) (FRL-
7747-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
3E6536 for mandarin oranges/mandarins; PP 4F4324 for almond nuts and
almond hulls; PP 4F4333 for broccoli, cabbage, lettuce, and peppers) by
Dow AgroSceinces LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The
petitions requested that 40 CFR 180.176 be amended by establishing
tolerances for residues of the fungicide mancozeb, zinc manganese
ethylenebis dithiocarbamate, in or on mandarin

oranges/mandarins at 5.0 parts per million (ppm) (PP 3E6536), almond
nuts at 0.1 ppm and almond hulls at 10.0 ppm (PP 4F4324); and broccoli
at 13.0 ppm, cabbage at 10.0 ppm, lettuce at 10.0 ppm, and peppers at
7.0 ppm (PP 4F4333). That notice referenced a summary of the petition
prepared by Dow AgroSciences LLC, the registrant, which is available in
the docket, http://www.regulations.gov. One comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA is
setting the tolerances at levels different than originally requested in
the petitions, with the exception of almond. The reason for these
changes is explained in Unit IV.D. The request for mandarin oranges has
been withdrawn.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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 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 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. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for mancozeb including
exposure resulting from the tolerances established by this action.
    Mancozeb is a member of the ethylene bisdithiocarbamate (EBDC)
group of fungicides that also includes the related active ingredients
maneb and metiram. Mancozeb, maneb and metiram, are all metabolized to
ethylenethiourea (ETU) in the body and all degrade to ETU in the
environment. Therefore, EPA has considered the aggregate or combined
risks from food, water and non-occupational exposure resulting from
mancozeb alone and ETU from all sources (i.e., the other EBDC
fungicides) for this action.
    In response to the petitions submitted to establish tolerances for
residues of mancozeb on almond, cabbage, leaf lettuce, peppers, and
broccoli, EPA completed two risk assessments in 2007:
     A mancozeb risk assessment which considered all existing
and proposed uses for mancozeb, and
     An ETU risk assessment that considered exposure to ETU
from all sources (mancozeb, metiram, and maneb) for all existing and
proposed uses.
    Although the 2007 mancozeb review showed risks that were
acceptable, the 2007 ETU review demonstrated unacceptable cancer risks,
therefore preventing the Agency from acting on the petitions for
almond, cabbage, leaf lettuce, peppers, and broccoli. The Agency worked
to refine the cancer risk assessment for ETU. A refined cancer risk
assessment for ETU from all sources has been completed and the Agency
is now prepared to act on the proposed tolerances for almond, cabbage,
leaf lettuce, peppers, and broccoli. Because the 2010 ETU review dealt
strictly with refining the cancer risk, the Agency will be relying on
three risk assessments to support this tolerance document. These
assessments are as follows:
     A 2007 risk assessment for mancozeb for acute, short-term,
intermediate-term, chronic, and cancer risk (refer to risk assessment
in the Docket EPA-HQ-OPP-2005-0307 titled ``Mancozeb: Human Health Risk
Assessment to Support Proposed New Uses on Broccoli, Cabbage, Lettuce,
Peppers and Almonds''),
     A 2007 risk assessment for ETU for acute, short-term,
intermediate-term and chronic risk (refer to risk assessment in the
Docket EPA-HQ-OPP-2005-0307 titled ``Ethylenethiourea (ETU) from EBDCs:
Health Effects Division (HED) Human Health Risk Assessment of the
Common Metabolite/Degradate ETU''),
     A 2010 addendum to the 2007 ETU assessment for cancer risk
(refer to risk assessment in the Docket EPA-HQ-OPP-2005-0307 titled
``Addendum to the Aggregate Human Health Risk Assessment of the Common
Metabolite/Degradate Ethylene Thiourea (ETU) to Support New Tolerances
on Imported Grapes and Bananas for Metiram and for New Tolerances for
Mancozeb on Almonds, Broccoli, Cabbage, Lettuce, and Peppers.'').
    In the Federal Register of April 16, 2010, (75 FR 19967) (FRL-8822-
2) the voluntary cancellation of the last product containing maneb
registered for use in the United States was announced by the Agency.
Therefore, it is important to note that since all products for maneb
have been cancelled and there are limited existing stocks for maneb
still in the channels of trade, the risk assessments for ETU likely
overestimates the exposures to this common metabolite. EPA's assessment
of exposures and risks associated with mancozeb and ETU follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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 addition to evaluating mancozeb, EPA also evaluated the
risks of ETU, a contaminant, metabolite and degradation product of
mancozeb and the other EBDC group of fungicides, which includes the
related active ingredients metiram and maneb.
    1. Mancozeb. Mancozeb is not acutely toxic via the oral, dermal or
inhalation routes of exposure. Further, mancozeb is not a skin irritant
nor is it a skin sensitizer, although it does cause mild eye
irritation. The findings in multiple studies demonstrate that the
thyroid is a target organ for mancozeb. Thyroid toxicity was manifested
as alternations in thyroid hormones, increased thyroid weight, and
microscopic thyroid lesions (mainly thyroid follicular cell
hyperplasia). These effects are due to the ETU metabolite. In a
subchronic study in the rat, neuropathology was seen (injury to
peripheral nerves) microscopically with associated clinical signs
(abnormal gait and limited use of rear legs) and loss of muscle mass.
An acute neurotoxicity study with mancozeb has been completed and
reviewed since the 2007 risk assessment; neuropathology was not
observed, and minimal effects upon motor activity were observed at high
doses. The Agency conducted a preliminary dietary assessment using a
point-of-departure from this study and found no risk concerns. Other
toxicity included increases in bilateral retinopathy in the chronic rat
study. Elevated cholesterol and a mild, regenerative, anemia occurred
in subchronic and chronic dog studies.
    Mancozeb is rapidly absorbed and eliminated in the urine. In oral
rat metabolism studies with radiolabelled

mancozeb and other EBDCs, an average 7.5% in vivo metabolic conversion
of EBDC to ETU occurred, on a weight-to-weight basis. Metabolism data
indicate mancozeb does not bio-accumulate. Mancozeb has been tested in
a series of in vitro and in vivo genotoxicity assays, which have shown
that it exhibits weak genotoxic potential.
    Thyroid follicular cell adenomas and carcinomas were increased in
high-dose males and females in the combined rat toxicity/
carcinogenicity study with mancozeb. Doses in a mouse study were too
low to assess carcinogenicity, and there were no treatment-related
changes in tumor rates. Historically, mancozeb's potential for
carcinogenicity has been based on its metabolite ETU, which is
classified as a probable human carcinogen. However, since ETU is known
to be the chemical causing the thyroid tumors observed, the cancer
assessment has been done only for ETU rather than the parent compound.
    Developmental defects in the rat developmental toxicity study
included hydrocephaly, skeletal system defects, and other gross defects
which occurred at a dose causing maternal mortality and did not
indicate increased susceptibility of offspring. Abortions occurred in
the rabbit developmental toxicity study at the high dose which also
caused maternal mortality, and there was no indication of enhanced
susceptibility of offspring in the rabbit. There was no evidence of
reproductive toxicity in the 2-generation reproduction study in rats.
    2. ETU. The thyroid is a target organ for ETU; thyroid toxicity in
subchronic and chronic rat, mouse, and dog studies included decreased
levels of T4, increases or decreases in T3,
compensatory increases in levels of TSH, increased thyroid weight, and
microscopic thyroid changes, chiefly hyperplasia. Overt liver toxicity
was observed in one chronic dog study. ETU is classified as a probable
human carcinogen based on liver tumors in female mice.
    Developmental defects in the rat developmental study were similar
to those seen with mancozeb, and included hydrocephaly and related
lesions, skeletal system defects, and other gross defects. These
defects showed increased susceptibility to fetuses because they
occurred at a dose which only caused decreased maternal food
consumption and body weight gain.
    Specific information on the studies received and the nature of the
adverse effects caused by mancozeb as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Mancozeb: Human Health
Risk Assessment to Support Proposed New Uses on Broccoli, Cabbage,
Lettuce, Peppers and Almonds'' on pages 13-15 in docket ID number EPA-
HQ-OPP-2005-0307.
    Additionally, specific information on the studies received and the
nature of the toxic effects caused by ETU as well as the NOAEL and the
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document titled ``Ethylenethiourea (ETU) from
EBDCs: Health Effects Division (HED) Human Health Risk Assessment of
the Common Metabolite/Degradate ETU'' on pages 16-17 in docket ID
number EPA-HQ-OPP-2005-0307.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mancozeb and ETU used
for human risk assessment is discussed in Unit IV.B. of the final rule
published in the Federal Register of August 18, 2010 (75 FR 50902)
(FRL-8841-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mancozeb, EPA considered exposure under the petitioned-for
tolerances as well as all existing mancozeb tolerances in 40 CFR
180.176. In evaluating dietary exposure to ETU, EPA considered exposure
under the petitioned-for tolerances discussed in this document as well
as all existing uses of the EBDC group of fungicides (maneb, metiram,
mancozeb) including the uses for which there are maneb tolerances even
though all maneb registrations have been canceled. EPA assessed dietary
exposures from mancozeb and ETU in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for mancozeb and ETU. In estimating acute dietary exposure, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII).
    a. Mancozeb. The following assumptions were made for the acute
exposure assessments: The Agency conducted a highly refined,
probabilistic acute dietary assessment incorporating maximum percent
crop treated information for new and existing uses, field trial or
monitoring data, and processing and cooking factors.
    b. ETU. The following assumptions were made for the acute exposure
assessments: The Agency conducted a highly refined, probabilistic acute
dietary assessment incorporating maximum percent crop treated
information for new and existing EBDC uses, field trial or monitoring
data for existing EBDC uses, and processing and cooking factors. It was
assumed that commodities would not be treated with more than one EBDC
in a season, as there are label restrictions regarding treatment with
multiple EBDCs. Percent crop treated was estimated by summing the
percent crop treated for the individual EBDCs. For residue values, EPA
used either market basket survey data or field trial data. For a few
commodities, mancozeb-derived ETU from mancozeb field trial data were
used for both mancozeb and maneb because maneb field trial data were
not available and application rates were sufficiently similar to
estimate maneb-derived ETU values.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII.

    a. Mancozeb. The chronic dietary exposure and risk assessment for
mancozeb (non-cancer and cancer) incorporated average values based
either on field trial data or monitoring data and average percent crop
treated data for new and existing uses, as well as processing and
cooking factors.
    b. ETU. Chronic anticipated residues were calculated from field
trial data on EBDCs or monitoring data for ETU. Averages of the field
trial and market basket survey residues were used. EPA also used PCT
data.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight-of-the-evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Mancozeb degrades and/or metabolizes to ETU which causes
thyroid tumors; therefore, EPA has historically attributed mancozeb's
carcinogenicity to the formation of ETU, which is classified as a
probable human carcinogen. The Agency has used the cancer potency
factor (Q1*) of 0.0601 (mg/kg/day) -1
for ETU (based on liver tumors in female mice) for risk assessment.
Therefore, cancer risk from exposure to mancozeb has been calculated by
estimating exposure to mancozeb-derived ETU and using Q1*
for ETU. The same approach has been taken for the other EBDCs. EPA's
estimated exposure to mancozeb-derived ETU and ETU from other EBDCs
included ETU residues found in food as well as ETU formed by metabolic
conversion on parent mancozeb in the body (conversion rate of 0.075).
EPA relied on the same estimates used for the chronic exposure
assessment in assessing cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    In the 2007 acute risk assessment for mancozeb, the Agency
estimated the PCT for existing uses as follows:
    Apple, 41%; asparagus, 34%; barley, 0.9%, beet, sugar, 2.9%;
cantaloupe, 10%; carrot, 13%; casaba, 10%; corn, field, 1%; corn,
sweet, 22%; cottonseed, oil, 0.8%; cucumber, 32%; grape, 14%; honeydew
melon, 13%; oat, 1%; onion, dry bulb, 77%; peanut, 2.3%; pear, 51%;
potato, 50%; pumpkin, 10%; rice, 1%; rye grain, 1%; squash, summer,
86%; squash, winter, 10%; tomato, 80%; watermelon, 30%; wheat, grain,
2.3%.
    In the 2007 chronic risk assessment for mancozeb, the Agency
estimated the PCT for existing uses as follows:
    Apple, 26%; asparagus, 16%; barley, 0.2%, beet, sugar, 1.3%;
carrot, 9%; casaba, 8%; corn, field, 1%; corn, sweet, 12%; cottonseed,
oil, 0.2%; cucumber, 18%; grape, 9%; honeydew melon, 8%; oat, 1%;
onion, dry bulb, 38%; peanut, 0.9%; pear, 32%; potato, 36%; pumpkin,
8%; rice, 1%; rye grain, 1%; squash, summer, 41%; squash, winter, 8%;
tomato, 49%; watermelon, 28%; wheat, grain, 0.9%.
    In the 2007 acute risk assessment for ETU the Agency estimated the
PCT for existing uses as follows:
    Apple, 65%; asparagus, 30%; barley, 2%; bean, dried, 2.5%; beets,
sugar, 15%; Brussels sprouts, 32%; cantaloupe, 12.5%; carrot, 2.5%;
casaba, 12.5%; cauliflower, 15%; celery, 12%; chickpea, 2.5%; Chinese
waxgourd, 15%; chive, 20%; collards, 10%; corn, field, 2.5%; corn,
sweet, 17.5%; cottonseed, oil, 3.5%; cranberry, 31%; cucumber, 40%;
eggplant, 65%; fennel, Florence, 12%; fig, 1%; garlic, 25%; grape,
81.5%; grape, wine, 81.5%; guar, seed, 1%; honeydew melon, 12.5%; kale,
5%; leek, 25%; mustard greens, 5%; oat, 2%; onion, dry bulb, 85%;
peanut, 3.5%; pear, 55%; potato, 85%; pumpkin, 15%; rice, 2.5%; rye
grain, 2%; squash, summer, 35%; squash, winter, 0%; tomato, fresh, 80%;
tomato, processed, 25%; turnip tops, 86%; walnut, 37.5%; watermelon,
55%; wheat, grain, 3.5%.
    In the 2007 chronic risk assessment for ETU the Agency estimated
the PCT for existing uses as follows:
    Apple, 42%; asparagus, 21%; barley, 2%; bean, dried, 1%; beets,
sugar, 6%; Brussels sprouts, 21%; cantaloupe, 6%; carrot, 8%; casaba,
6%; cauliflower, 5%; celery, 12%; chickpea, 1%; Chinese waxgourd, 5%;
chive, 10%; collards, 10%; corn, field, 1%; corn, sweet, 11%;
cottonseed, oil, 2%; cranberry, 31%; cucumber, 20%; eggplant, 45%;
fennel, Florence, 12%; fig, 1%; garlic, 25%; grape, 60%; grape, wine,
60%; guar, seed, 1%; honeydew melon, 6%; kale, 6%; kohlrabi, 1%; leek,
10%; mustard greens, 5%; oat, 2%; onion, dry bulb, 60%; peanut, 2%;
pear, 40%; potato, 63%; pumpkin, 6%; rice, 1%; rye grain, 2%; squash,
summer, 25%; squash, winter, 25%; tomato, fresh, 54%; tomato,
processed, 54%; walnut, 31%; watermelon, 10%; wheat, grain, 2%.
    For the 2010 ETU cancer risk assessment the Agency estimated the
PCT for existing uses as follows:
    Apple, 51%; asparagus, 15%; barley, 1%; bean, dried, 1%; beets,
sugar, 3.5%; Brussels sprouts, 15%; cantaloupe, 7.5%, carrot, 5%;
cauliflower, 10%; chickpea, 1%; collards, 31%; corn, field, 1%; corn,
sweet, 6%; cottonseed, oil, 11%; cranberry, 45%; cucumber, 30%;
eggplant, 30%; fig, 5%; flaxseed, 11%; garlic, 25%; grape, 6%; grape,
wine, 26%; guar, seed, 1%; kale, 73%; leek, 15%; mustard greens, 22%;
oat, 11%; onion, dry bulb, 75%; peanut, 2%; pear, 35%; potato, 67.5%;
pumpkin, 20.5%; rice, 1%; rye grain, 11%; safflower, oil, 11%; squash,
summer, 57%; squash, winter, 26%; tomato, fresh, 30%; tomato,
processed, 30%; turnip tops, 36%; walnut, 36%; watermelon, 45%; wheat,
grain, 11%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most

recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk
analysis. The average PCT figure for each existing use is derived by
combining available public and private market survey data for that use,
averaging across all observations, and rounding to the nearest 5%,
except for those situations in which the average PCT is less than 1. In
those cases, 1% is used as the average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis.
The maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    In the 2007 acute risk assessment for mancozeb, the Agency
estimated the PCT for new uses as follows:
    Almond, 35%; broccoli, 9%; cabbage, 47%; cabbage, Chinese, 47%;
head lettuce 66%; leaf lettuce 61%; pepper, bell, 48%; pepper, non-
bell, 48%.
    In the 2007 chronic risk assessment for mancozeb, the Agency
estimated the PCT for new uses as follows:
    Almond, 35%; broccoli, 7%; cabbage, 42%; cabbage, Chinese, 42%;
head lettuce 58%; leaf lettuce 59%; pepper, bell, 43%; pepper, non-
bell, 43%.
    For the 2007 ETU acute assessment, the Agency estimated the PCT for
new uses as follows:
    Almond, 50%; broccoli, 22%; cabbage, 82%; cabbage, Chinese, 82%;
pepper, bell, 88%; pepper, non-bell, 88%.
    For the 2007 ETU chronic assessment, the Agency estimated the PCT
for new uses as follows:
    Almond, 45%; broccoli, 17%; cabbage, 57%; cabbage, Chinese, 57%;
pepper, bell, 73%; pepper, non-bell, 73%.
    For the 2010 ETU cancer assessment, the Agency estimated the PCT
for new uses as follows:
    Almond, 28%; broccoli, 15%; cabbage, 62%; cabbage, Chinese, 62%;
pepper, bell, 74%; pepper, non-bell, 74%.
    EPA estimates the percent crop treated for new uses (PCTn) of a
pesticide represent the upper bound of use expected during the
pesticide's initial 5 years of registration. The PCTn recommended for
use in the chronic dietary assessment is calculated as the average PCT
of the pesticide or pesticides that are the market leader or leaders,
(i.e., the pesticides with the greatest PCT) on that site over the
three most recent years of available survey data. The PCTn recommended
for use in the acute dietary assessment is the maximum observed PCT
over the same period. Comparisons are only made among pesticides of the
same pesticide types (e.g., the market leader for fungicides on the use
site is selected for comparison with a new fungicide). The market
leader included in the estimation may not be the same for each year
since different pesticides may dominate at different times.
    Typically, EPA uses USDA/NASS as the source data because it is
publicly available and directly reports values for PCT. When a specific
use site is not reported by USDA/NASS, EPA uses proprietary data and
calculates the PCT given reported data on acres treated and acres
grown. If no data are available, EPA may extrapolate PCTn from other
crops, if the production area and pest spectrum are substantially
similar.
    EPA refines PCTn estimates based on approaches other than the
market leader approach if the previous PCTn estimates based on the
market leader indicate that the chemical exposure potentially poses a
risk of concern. EPA considers the pest or pest spectrum targeted by
the chemical for the new uses and identifies other pesticides already
registered on that crop that target the same pest or pest spectrum. The
PCTn is calculated based on the data from the three most recently
available pesticide usage surveys. If multiple chemicals are identified
that target the same pest spectrum, then the one with the highest PCT
is selected from each year/crop combination. Consideration is also
given to the potential for the development of resistance for each
chemical using data available from the Resistance Action Committees.
    EPA has considered all available relevant information and concludes
that it is unlikely that the PCTn values will be exceeded during the
next 5 years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which mancozeb may be applied in a particular area.
    2. Dietary exposure from drinking water--i. Mancozeb. The Agency
has determined that mancozeb is very short-lived in soil and water, and
would not reach water used for human consumption whether from surface
water or ground water.
    ii. ETU. ETU is highly water soluble, and may reach both surface
and ground water under some conditions. The ETU surface water Estimated
Drinking Water Concentrations (EDWCs) were generated using a combined
monitoring/modeling approach. Results of a surface water monitoring
study conducted by the ETU Task Force were used to refine the outputs
of the Pesticide Root Zone Model/Exposure Analysis Modeling System
(PRZM-EXAMS) models; the site/scenario modeled was application of an
EBDC fungicide on peppers in Florida, and was chosen to produce the
highest EDWC acute values. The ground water EDWC was detected in a
Florida community water system intake in a targeted ground water
monitoring study conducted by the EBDC task force from 1999 to 2003.
Both these surface and ground water values represent upper-bound
conservative estimates of the total ETU residual concentrations that
might be found in surface water and ground water due to the use of the
EBDC fungicides.
    Based on the PRZM/EXAMS and monitoring studies, the EDWCs of ETU
acute and chronic exposures are estimated to be 25.2 parts per billion
(ppb), and 0.1 ppb, respectively for surface water. The EDWC for
chronic exposure is estimated to be ppb for ground water 0.21.
    Estimates of drinking water concentrations were directly entered
into the dietary exposure model. For acute dietary risk assessment, the
water concentration value of 25.2 ppb was used to assess the
contribution to drinking water. For chronic dietary risk assessment of
ETU, the water concentration of value 0.21 ppb was used to assess the
contribution to drinking water. For cancer dietary risk assessment of
ETU, the water concentration of value 0.21 ppb was used to assess the
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-

occupational, non-dietary exposure (e.g., for lawn and garden pest
control, indoor pest control, termiticides, and flea and tick control
on pets).
    i. Mancozeb. Mancozeb is currently registered for use on the
following residential sites: Home gardens, golf courses, and sod farms
(potential exposure to mancozeb is from residues remaining on
transplanted turf). The Agency has determined that it is appropriate to
aggregate chronic exposure through food with short- and intermediate-
term residential exposures to mancozeb. Since residues of mancozeb are
not expected in drinking water, only mancozeb food residues are
considered.
    The two scenarios that were evaluated for mancozeb are the ``short/
intermediate-term home garden aggregate (adult)'' which considers
residential handler exposures (inhalation) to adult applicators
combined with average food exposures and the ``short/intermediate-term
treated turf aggregate (toddler)'' which considers residential
incidental oral exposures to toddlers combined with average food
exposures. The only postapplication scenario for adults in contact with
treated turf (golf courses) is via the dermal route of exposure. Since
no dermal endpoints were selected for mancozeb, a quantitative risk
assessment for this scenario is not required.
    ii. ETU. ETU non-dietary exposure is expected as a result of the
registered uses of mancozeb and the other EBDCs on home gardens, golf
courses and sod farms. For ETU, aggregate exposure sources include
food, drinking water, home gardening activities and golfing. The Agency
has determined that it is appropriate to aggregate chronic exposure
through food with short- and intermediate-term residential exposures to
mancozeb.
    The three scenarios that were evaluated for ETU are as follows: The
first is the ``short/intermediate-term home garden aggregate'' which
combines handler exposures (inhalation and dermal) and postapplication
garden exposures (dermal) plus average daily food and drinking water
exposure for adults and postapplication garden exposures (dermal) plus
average daily food and drinking water exposure for youth. The second is
the ``short-term treated turf aggregate (toddlers)'' which combines
treated turf post application exposures (incidental oral and dermal)
plus average daily food and drinking water exposure for toddlers. And
the last is the ``short/intermediate-term treated turf aggregate''
which considers short-term residential exposures (dermal) plus average
daily food and drinking water exposure for adults such as golfing on
treated turf. This assessment is protective of adult and youth golfers.
Although exposure to children golfing could be almost twice that of the
adult golfer because of increased surface area/body weight (SA/BW)
ratios, younger golfers are not expected to use the golf course for the
same length of time as adolescents and adults. The shorter duration on
the golf course for younger golfers offsets the higher SA/BW;
therefore, risks from short-term post-application exposures to young
golfers are likely to be similar to risks for adult golfers.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. 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.''
    As previously mentioned, the risk estimates summarized in this
document are those that result only from the use of mancozeb, and ETU
derived from mancozeb and the other EBDC chemicals, which are all
dithiocarbamates. For the purposes of this action, EPA has concluded
that mancozeb does not share a common mechanism of toxicity with other
substances. The Agency reached this conclusion after a thorough
internal review and external peer review of the data on a potential
common mechanism of toxicity.
    EPA concluded that the available evidence does not support grouping
the dithiocarbamates based on a common toxic effect (neuropathology)
occurring by a common mechanism of toxicity (related to metabolism to
carbon disulfide). After a thorough internal and external peer review
of the existing data bearing on a common mechanism of toxicity, EPA
concluded that the available evidence shows that neuropathology can not
be linked with carbon disulfide formation. For more information, please
see the December 19, 2001 memo, ``The Determination of Whether
Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity'' on
the internet at http://www.epa.gov/oppsrrd1/cumulative/dithiocarb.pdf.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity--i. Mancozeb. In the rat
developmental study, developmental effects were observed in the
presence of severe maternal effects, including maternal mortality and
clinical signs. In the rabbit developmental study, developmental
effects (spontaneous abortions) were observed at the same dose (80 mg/
kg/day) at which maternal effects included mortality and clinical
signs. In the rat reproduction study, no effects were observed in
offspring, while thyroid effects and body weight gain decrements
occurred in adults.
    ii. ETU. There was evidence of increased susceptibility of fetuses
to ETU in the rat developmental studies because hydrocephaly occurred
at doses below that causing maternal toxicity. Acceptable reproductive
and rabbit developmental toxicity studies were not available for ETU.
As a result, the Agency evaluated the level of concern for the effects
observed when considered in the context of all available toxicity data.
In addition, the Agency evaluated the database to determine if there
were residual uncertainties after establishing toxicity endpoints and
traditional uncertainty factors to be used in the ETU risk assessment.
    3. Conclusion--i. Mancozeb. In the 2007 assessment, EPA retained
the presumptive 10X FQPA safety factor for the protection of children
due to the absence of a required developmental neurotoxicity study.
That study has recently been received. Neurotoxicity was not observed
in the study, and the young animals did not show susceptibility, as
compared to the adults, for the slight toxicity that was observed
(reduced body weight gain). Additionally, since the completion of the
2007 assessment, EPA has imposed a new data requirement for
immunotoxicity data and such data has

not been submitted for mancozeb. The absence of an immunotoxicity study
does not raise significant uncertainty. In the absence of that study,
the available toxicity data for mancozeb have been thoroughly examined
for any information which suggests a potential for immunotoxicity. The
analysis did not reveal such information and the Agency does not
believe that conducting the immunotoxicity study will result in a point
of departure (POD) less than the currently selected PODs for risk
assessment.
    Because EPA is relying on the 2007 assessment in evaluating acute
and chronic risks, EPA is retaining the children's safety factor
determination in that assessment (retain the additional 10X factor).
EPA expects that once that determination is revisited, the children's
safety factor will be lowered or removed entirely due to the submission
of the DNT study and the fact that immunotoxicity is not a concern with
mancozeb. These changed circumstances certainly do not support an
additional safety factor higher than 10X. Further, as discussed below,
EPA believes that the 2007 risk assessment does not underestimate
exposure to mancozeb. Accordingly, EPA concludes that the 2007
determination on the children's safety factor protects the safety of
infants and children.
    ii. ETU. The toxicity database for ETU is not complete. EPA lacks
the following studies: A DNT study; a developmental study in rabbits; a
2-generation reproduction study; and a comparative thyroid study in
adults and offspring. Given these multiple data gaps for studies that
directly assess the risk to the young, EPA does not have reliable data
to remove or modify the presumptive 10X FQPA safety factor.
    No further safety factor to protect is needed for the following
reasons. First, the Agency determined that the degree of concern for
the susceptibility seen in ETU developmental studies was low. The
reasons for this conclusion are:
     The teratogenic effects of ETU have been well-
characterized in numerous studies in the published literature, as well
as in a guideline study submitted by the registrant. In addition, since
metabolism studies have shown that approximately 7.5% of mancozeb
converts to ETU in mammalian systems, the extensive toxicity database
with mancozeb on developmental effects provide extensive information
about pre- and post-natal toxicity of ETU;
     There is a clear NOAEL for these effects and the dose-
response relationship, although steep, is well characterized in the
numerous developmental studies in rats.
     The developmental endpoint with the lowest NOAEL was
selected for deriving the acute RfD.
     The target organ (thyroid) was selected for deriving the
chronic RfD as well as endpoints for non-dietary exposures (incidental
oral, dermal, and inhalation). Since the ETU doses selected for overall
risk assessments will address the concern for developmental and thyroid
toxicity, there are no residual uncertainties with regard to prenatal
and/or postnatal toxicity.
    Second, the information on ETU gleaned from the extensive mancozeb
database on effects other than development effects also reduces, to a
degree, the uncertainty arising from the significant datagaps for ETU.
    Third, EPA has concluded that the exposure assessment, although
refined, is unlikely to under-estimate potential exposures especially
considering exposure to maneb was included even though all maneb
products have been canceled. In making this judgment, EPA has taken
into account that it is relying on three separate reviews in this
Notice:
     A 2007 risk assessment for mancozeb for acute, short-term,
intermediate-term, chronic, and cancer risk,
     A 2007 risk assessment for ETU for acute, short-term,
intermediate-term and chronic risk, and
     A 2010 addendum to the 2007 ETU assessment for cancer
risk--and that the percent crop treated estimates differ slightly
between reviews.
    In comparing the percent crop treated information from 2007 and
2010, there are some increases in usage for some crops, and there are
decreases in usage for other crops. These differences appear to largely
offset each other. Further, most of the increases are attributable to
estimated increases in maneb usage but, as noted, maneb was canceled in
2010 and it is unlikely that existing stocks are sufficient to sustain
prior usage levels much less any increased usage. An EPA sensitivity
analysis of the main contributors to ETU exposure showed no significant
increase in exposure from the changed percent crop treated estimated.
The percent crop treated values used in these risk assessments are
detailed in the memo titled ``Mancozeb. Discussion on Percent Crop
Treated Values Used in Aggregate and Chronic Assessments'' in docket
number EPA-HQ-OPP-2005-0307.
    In any event, there are two other aspects of the exposure
assessment that are likely to significantly overstate exposure to
mancozeb and ETU. First, exposure estimates for some crops, including
bananas, a high-consumption food, include the assumption that
everything consumed in the United States has been treated. Second, the
residue data used in the assessment for the proposed commodities and
many other crops are based on crop field trials. Monitoring studies
conducted for several crops have shown that residues on foods close to
the point of consumption are much lower than the residues found in crop
field trials.
    For all of these reasons, EPA concludes that it has not
underestimated exposure to mancozeb and ETU.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk (Mancozeb). The mancozeb acute aggregate assessment
considers acute exposure to mancozeb only and not ETU. Further, this
assessment is based on residues of mancozeb in food only since residues
of mancozeb are not expected in drinking water. Using the exposure
assumptions discussed in this unit for acute exposure, the acute
dietary exposure from food and water to mancozeb will occupy 6.9% of
the aPAD for females 13-49 years of age, the only population group of
concern.
    2. Acute risk (ETU). Using the exposure assumptions discussed in
this unit for acute exposure, the acute dietary exposure from food and
water to ETU will occupy 87% of the aPAD for females 13-49 years of
age, the only population group of concern.
    3. Chronic risk (Mancozeb). There are no long-term residential
exposure scenarios for mancozeb and there is not likely to be residues
of mancozeb in drinking water. Therefore, the long-term or chronic
(non-cancer) aggregate risk for mancozeb includes contribution from
food alone. Using the exposure assumptions described in this unit for
chronic exposure, EPA has concluded that chronic exposure to mancozeb
from food will utilize 3.3% of the cPAD for children 1-2 years of age,
the population group receiving the greatest exposure.
    4. Chronic Risk (ETU). The aggregate chronic risks were calculated
using food

and water exposure only because golfing and toddler transplanted turf
exposure scenarios were considered to occur only on a short term basis.
Using the exposure assumptions described in this unit for chronic
exposure, EPA has concluded that chronic exposure to ETU from food and
water will utilize 58% of the cPAD for children (1 to 2 years old), the
population group receiving the greatest exposure.
    5. Short-and intermediate-term risk (Mancozeb). Short- and
intermediate-term aggregate exposure takes into account short- and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Mancozeb is currently registered for uses that could result in
short- and intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food with short- and intermediate-term residential exposures to
mancozeb. The two scenarios that were evaluated for mancozeb are the
following:
    i. Short/intermediate-term home garden aggregate (adult). The
aggregate short/intermediate-term home garden MOEs for adults are
110,000. Because for mancozeb EPA is concerned only with MOEs that are
below 1,000, this MOE does not raise a risk concern.
    ii. Short-term treated turf aggregate (toddler). The mancozeb
short-term aggregate risk (MOE) for toddlers exposed to treated turf is
1,100. Because for mancozeb EPA is concerned only with MOEs that are
below 1,000, this MOE does not raise a risk concern.
    6. Short- and intermediate-term risk (ETU). Short- and
intermediate-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Mancozeb is currently registered for uses that could result in
short- and intermediate-term residential exposure to ETU. The 2007
assessment also included products containing maneb which were expected
to result in short- and intermediate-term exposure. As previously
discussed, these products have since been cancelled. The Agency
determined that it was appropriate to aggregate chronic exposure
through food with short- and intermediate-term residential exposures to
ETU. The three scenarios that were evaluated for ETU are the following.
    i. ETU short/intermediate-term home garden aggregate. The ETU
short/intermediate-term home garden aggregate MOEs for adults is 13,000
and 17,000 for youth, respectively. Because for ETU EPA is concerned
only with MOEs that are below 1,000, this MOE does not raise a risk
concern.
    ii. ETU short-term treated turf aggregate (toddlers). The ETU
short-term treated turf aggregate MOE for toddlers is 1,100. Because
for ETU EPA is concerned only with MOEs that are below 1,000, this MOE
does not raise a risk concern.
    iii. ETU short/intermediate-term treated turf aggregate. The ETU
short-term treated turf aggregate MOE for golfers is 6,100. Because for
ETU EPA is concerned only with MOEs that are below 1,000, this MOE does
not raise a risk concern.
    7. Aggregate cancer risk for U.S. population (mancozeb and ETU). As
noted earlier in this document, mancozeb degrades and/or metabolizes to
ETU which causes the same types of thyroid tumors as those seen when
animals are dosed with mancozeb; therefore, EPA has historically
attributed mancozeb's carcinogenicity to the formation of ETU, which is
classified as a probable human carcinogen (B2).
    The cancer risks were aggregated using the food and drinking water
doses for the general population and the food, water and recreational
doses for golfers, home gardeners and athletes. The average daily dose
was used for food and water exposures and the lifetime average daily
dose was used for the recreational exposures. The aggregate doses were
multiplied times the potency factor for ETU, 0.0601 (mg/kg/
day)-1 to determine the cancer risks. The risk is estimated
to be 3 x 10-6.
    EPA generally considers cancer risks (expressed as the probability
of an increased cancer case) in the range of 1 in 1 million (or 1 x
10-6) or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. Although the ETU exposure
risk assessment is refined, it retains significant conservatism in
that, for leafy greens, field trial data and not market basket data on
similar crops is used in estimating exposure. The leafy greens have
tended to be among the top contributors to the aggregate risk (along
with water and leaf lettuce). For other commodities, market basket data
has shown reductions in residues one to two orders of magnitude lower
than field trial data. Moreover, the only remaining EBDC registration
for leafy greens (maneb) was canceled in 2010 but the exposure
assessment does not take this into account. Additional conservatism is
included in the exposure assessment by the assumption of 100 percent
crop treated for many commodities. Accordingly, EPA has concluded the
aggregate cancer risk for all existing mancozeb and other EBDC uses and
the uses associated with the tolerances established in this action fall
within the range of 1 x 10-6 and are thus negligible.
    8. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to mancozeb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for the enforcement of tolerances
for the plant commodities which are the subject of this request. The
Pesticide Analytical Method (PAM) Vol. II lists Methods I, II, III, IV,
and A for the determination of dithiocarbamate residues in/on plant
commodities. The Keppel colorimetric method (Method III) is the
preferred method for tolerance enforcement. The Keppel method
determines EBDCs as a group by degradation to CS2. The
analytical methodology for ETU is based on the original method
published by Olney and Yip (JAOAC 54:165-169).
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
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 U.N. 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.
    There are no established or proposed Codex MRLs for residues of
mancozeb; however, Codex limits for mancozeb and similar fungicides are
grouped under dithiocarbamates measured as carbon disulfide. There are
Codex MRLs for almonds; almond hulls; cabbages, head; lettuce, head;
cos lettuce; peppers, sweet. Tolerances for the EBDC pesticides are
expressed in terms of carbon disulfide (CS2), which is the
same as the Codex tolerance expression. The level of 0.1 ppm for
almonds is also the same as the Codex MRL for almonds. However, for the
reasons indicated below, the tolerance levels being established for the
other subject crops cannot be harmonized with the associated Codex
MRLs.
     Based on the calculations in the Agency's tolerance
spreadsheet, in accordance with the Agency's ``Guidance for Setting
Pesticide Tolerances Based on Field Trial Data,'' the appropriate
tolerance level for cabbage is 9.0 ppm. The tolerance level cannot be
harmonized with Codex; the highest residue level in the crop field
trials (6.0 ppm in CS2 equivalents) is greater than the
Codex MRL for cabbage (5 ppm).
     The available data indicate that the appropriate tolerance
level for head lettuce is 3.5 ppm. The tolerance level cannot be
harmonized with Codex; the highest residue level in the crop field
trials (2.2 ppm in CS2 equivalents) is considerably less
than the Codex MRL of 10 ppm for head lettuce.
     The available data indicate that the appropriate tolerance
level for leaf lettuce is 18 ppm. The tolerance level cannot be
harmonized with Codex; the highest residue level in the crop field
trials (14 ppm in CS2 equivalents) is greater than the Codex
MRL for Cos lettuce (10 ppm).
     The appropriate tolerance level for pepper is 12 ppm. The
tolerance level cannot be harmonized with Codex as the Codex MRL has
been established for sweet pepper only.
     The appropriate tolerance level for almond hulls is 4 ppm.
This value cannot be harmonized with Codex as it is significantly below
the Codex MRL of 20 ppm.

C. Response to Comments

    The company Cerexagri, Inc. submitted a comment on the initial
notice of filing in 2006. Cerexagri proposed that EPA reject the
petitions for reasons primarily dealing with information included in
the risk assessment provided by Dow AgroSciences in the petitions. The
Agency conducts its own risk assessments and does not rely on those
provided by registrants. For example, Cerexagri did not agree with Dow
AgroSciences proposal to assume that ``mancozeb uses will simply
replace a share of the existing maneb market''. Nor did Cerexagri agree
with Dow AgroSciences use of market basket data to extrapolate expected
residues on the proposed commodities. The EPA did not base PCT
estimates for new commodities based on the assumption that one EBDC
will replace another but instead used its standard market leader
approach to determine appropriate PCT numbers. Further, the EPA relied
on the results of the crop field trial data to estimate exposure to the
proposed commodities and many other crops. Results of the Market Basket
Survey were only used for commodities/chemicals associated with the
survey. Therefore, the objections voiced by Cerexagri are not relevant
to the conclusions reached by the Agency regarding these petitions.
    Finally, Cerexagri requested that the EPA first engage in a public
process that would seek the participation of the grower community,
research community and other interested parties before determining
which new uses of EBDC fungicides should be approved because approval
of the uses requested in this petition may preclude the approval of
other uses. EPA, however, has followed all procedural requirements in
the FFDCA section. Moreover, in the time since this petition was
submitted, no further uses of EBDCs have been requested.

D. Revisions to Petitioned-For Tolerances

    All of the tolerance levels being established in this document,
with the exception of almond, are different than the levels requested
in the original tolerance petitions. EPA revised the tolerance levels
based on analysis of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's ``Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.''

V. Conclusion

    Therefore, tolerances are established for residues of mancozeb,
zinc manganese ethylenebis dithiocarbamate in or on almond at 0.1 ppm;
almond, hulls at 4 ppm; broccoli at 7 ppm; cabbage at 9 ppm; lettuce,
head at 3.5 ppm; lettuce, leaf at 18 ppm; and pepper at 12 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, such as the tolerances 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: March 21, 2011.
Lois Rossi,
 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. Section 180.176 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.176  Mancozeb; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................          0.1
Almond, hulls..............................................          4

                                * * * * *
Broccoli...................................................          7
Cabbage....................................................          9

                                * * * * *
Lettuce, head..............................................          3.5
Lettuce, leaf..............................................         18

                                * * * * *
Pepper.....................................................         12

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

* * * * *
[FR Doc. 2011-7461 Filed 4-5-11; 8:45 am]
BILLING CODE 6560-50-P