[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Notices]
[Page 34345-34347]
[DOCID:fr14jn06-82]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0481; FRL-8071-4]

Notice of Filing of a Pesticide Petition for Establishment of
Regulations for Residues of Fluopicolide in or on Various Food
Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
fluopicolide in or on grapes, raisin, leafy vegetables (except
Brassica) (Group 4), fruiting vegetables (Group 8), cucurbit vegetables
(Group 9), potato, sweet potato roots, and wheat (forage/grain/hay/
straw).

DATES: Comments must be received on or before July 14, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0481 and pesticide petition number (PP)
5F7016, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0481. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either 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
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT:  Janet Whitehurst, 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:
     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 provides
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. What Should I Consider as I Prepare My Comments for EPA?

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

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the home page

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all

documents in the docket for the pesticide including the petition
summary.

New Tolerance

    PP 5F7016. Valent U.S.A. Company, 1600 Riviera Ave., Walnut Creek,
CA 94596-8025, proposes to establish a tolerance for residues of the
fungicide fluopicolide in or on food commodities grape at 2.0 parts per
million (ppm); raisin at 6.0 ppm; vegetable, leafy (except Brassica)
(Group 4) at 20.0 ppm; vegetable, fruiting (Group 8) at 0.8 ppm;
vegetable, cucurbit (Group 9) at 0.4 ppm; potato at 0.02 ppm; sweet
potato, roots at 0.02 ppm; wheat, forage at 0.2 ppm; wheat, grain at
0.02 ppm; and wheat, hay and straw at 0.5 ppm. A practical analytical
method utilizing liquid chromatography and mass spectrometry detection
is available and has been validated for detecting and measuring levels
of fluopicolide in and on various crops. The limit of quantitation is
0.01 ppm.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: May 31, 2006.
 Donald R. Stubbs,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-9189 Filed 6-13-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27898-27904]
[FR Doc No: 2011-11710]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2010-1028; FRL-9305-2]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Prevention of Significant Deterioration; Greenhouse Gas
Permitting Authority and Tailoring Rule Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Virginia Department of Environmental Quality (VADEQ)
on October 27, 2010. This revision pertains to EPA's greenhouse gas
(GHG) Prevention of Significant Deterioration (PSD) permitting
provisions as promulgated on June 3, 2010 in the Tailoring Rule. The
SIP revision modifies Virginia's PSD program to

establish appropriate emission thresholds for determining which new
stationary sources and modifications become subject to Virginia's PSD
permitting requirements for their GHG emissions. EPA is approving
Virginia's SIP revision because the Agency has determined that this SIP
revision is in accordance with the CAA and Federal regulations
regarding PSD permitting for GHGs.

DATES: This final rule is effective on June 13, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2010-1028. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
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 either electronically through http://www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Virginia Department of Environmental Quality, 629 East Main Street,
Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: David Talley,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Throughout this document, whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA. On January 12, 2011 (76 FR 2070), EPA published a
Notice of Proposed Rulemaking (NPR) for the Commonwealth of Virginia.
The NPR proposed approval of a new Chapter 85 of 9 VAC 5. The formal
SIP revision was submitted by the VADEQ on October 27, 2010.

II. Summary of Virginia's SIP Revision

    On October 27, 2010, VADEQ submitted a revision to EPA for approval
into the Virginia SIP. This SIP revision would establish appropriate
emission thresholds for determining which new or modified stationary
sources become subject to Virginia's PSD permitting requirements for
GHG emissions. Final approval of Virginia's October 27, 2010, SIP
revision puts in place the GHG emission thresholds for PSD
applicability set forth in EPA's ``Prevention of Significant
Deterioration and Title V Greenhouse Gas Tailoring Rule--Final Rule''
(the Tailoring Rule, 75 FR 31514, June 3, 2010) ensuring that smaller
GHG sources emitting less than these thresholds will not be subject to
permitting requirements.

III. What is the background for today's proposed action?

    This section briefly summarizes EPA's recent GHG-related actions
that provide the background for today's final action. More detailed
discussions of the background are found in the preambles for those
actions. In particular, the background is contained in what we call the
GHG PSD SIP Narrowing Rule,\1\ and in the preambles to the actions
cited in that rule.
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    \1\ Limitation of Approval of Prevention of Significant
Deterioration Provisions Concerning Greenhouse Gas-Emitting Sources
in State Implementation Plans; Final Rule. 75 FR 82536 (December 30,
2010).
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A. GHG-Related Actions

    EPA has recently undertaken a series of actions pertaining to the
regulation of GHGs that, although for the most part distinct from one
another, establish the overall framework for today's final action to
approve Virginia's October 27, 2010 SIP revision. Four of these actions
include, as they are commonly called, the Endangerment Finding and
Cause or Contribute Finding, which EPA issued in a single final
action,\2\ the Johnson Memo Reconsideration,\3\ the Light-Duty Vehicle
Rule,\4\ and the Tailoring Rule.\5\ Taken together and in conjunction
with the CAA, these actions established regulatory requirements for
GHGs emitted from new motor vehicles and new motor vehicle engines;
determined that such regulations, when they took effect on January 2,
2011, subjected GHGs emitted from stationary sources to PSD
requirements; and limited the applicability of PSD requirements to GHG
sources on a phased-in basis. EPA took this last action in the
Tailoring Rule, which, more specifically, established appropriate GHG
emission thresholds for determining the applicability of PSD
requirements to GHG-emitting sources.
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    \2\ Endangerment and Cause or Contribute Findings for Greenhouse
Gases Under Section 202(a) of the Clean Air Act. 74 FR 66496
(December 15, 2009).
    \3\ Interpretation of Regulations that Determine Pollutants
Covered by Clean Air Act Permitting Programs. 75 FR 17004 (April 2,
2010).
    \4\ Light-Duty Vehicle Greenhouse Gas Emission Standards and
Corporate Average Fuel Economy Standards; Final Rule. 75 FR 25324
(May 7, 2010).
    \5\ Prevention of Significant Deterioration and Title V
Greenhouse Gas Tailoring Rule; Final Rule. 75 FR 31514 (June 3,
2010).
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    The PSD permitting program is implemented through the SIP, and so
in December 2010, EPA promulgated several rules to implement the new
GHG PSD SIP program. Recognizing that some states had approved SIP PSD
programs that did not apply PSD to GHGs, EPA issued a SIP call and, for
some of these states, a Federal Implementation Plan (FIP).\6\
Recognizing that other states had approved SIP PSD programs that do
apply PSD to GHGs, but that do so for sources that emit as little as
100 or 250 tons per year (tpy) of GHG, and that do not limit PSD
applicability to GHGs to the higher thresholds in the Tailoring Rule,
EPA issued the GHG PSD SIP Narrowing Rule. Under that rule, EPA
withdrew its approval of the affected SIPs to the extent those SIPs
covered GHG-emitting sources below the Tailoring Rule thresholds. EPA
based its action primarily on the ``error correction'' provisions of
CAA section 110(k)(6).
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    \6\ Specifically, by notice dated December 13, 2010, EPA
finalized a SIP Call that would require those states with SIPs that
have approved PSD programs but do not authorize PSD permitting for
GHGs to submit a SIP revision providing such authority. ``Action To
Ensure Authority To Issue Permits Under the Prevention of
Significant Deterioration Program to Sources of Greenhouse Gas
Emissions: Finding of Substantial Inadequacy and SIP Call,'' 75 FR
77698 (Dec. 13, 2010). EPA has begun making findings of failure to
submit that would apply in any state unable to submit the required
SIP revision by its deadline, and finalizing FIPs for such states.
See, e.g. ``Action To Ensure Authority To Issue Permits Under the
Prevention of Significant Deterioration Program to Sources of
Greenhouse Gas Emissions: Finding of Failure To Submit State
Implementation Plan Revisions Required for Greenhouse Gases,'' 75 FR
81874 (December 29, 2010); ``Action To Ensure Authority To Issue
Permits Under the Prevention of Significant Deterioration Program to
Sources of Greenhouse Gas Emissions: Federal Implementation Plan,''
75 FR 82246 (December 30, 2010). Because Virginia's SIP already
authorizes Virginia to regulate GHGs, Virginia is not subject to the
proposed SIP Call or FIP.
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B. Virginia's Actions

    On July 28, 2010, Virginia provided a letter to EPA, in accordance
with an EPA request to all states in the Tailoring Rule, with
confirmation that the Commonwealth of Virginia has the authority to
regulate GHGs in its PSD program. The letter also confirmed that
current Virginia rules require regulating GHGs at the 100/250 tpy
threshold that generally applies to all air pollutants subject to PSD
and that is provided under the CAA PSD provisions, section 169(1),
rather than at the higher thresholds set in the Tailoring Rule. (See
the docket for this rulemaking for a copy of Virginia's letter.)
    In the SIP Narrowing Rule, published on December 30, 2010, EPA
withdrew

its approval of Virginia's SIP--among other SIPs--to the extent that
the SIP applies PSD permitting requirements to GHG emissions from
sources emitting at levels below those set in the Tailoring Rule.\7\ As
a result, Virginia's current federally approved SIP provides the state
with authority to apply PSD to GHG-emitting sources and requires new
and modified sources to receive a PSD permit based on GHG emissions,
but only if those sources emit at or above the Tailoring Rule
thresholds.
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    \7\ ``Limitation of Approval of Prevention of Significant
Deterioration Provisions Concerning Greenhouse-Gas Emitting Sources
in State Implementation Plans; Final Rule.'' 75 FR 82536 (December
30, 2010).
---------------------------------------------------------------------------

    Virginia's October 27, 2010 SIP revision amends its SIP to put in
place the GHG emission thresholds for PSD applicability set forth in
EPA's Tailoring Rule. EPA's approval of Virginia's October 27, 2010
incorporates these adopted by the Commonwealth into the Federally-
approved SIP. Doing so will clarify the applicable thresholds in the
Virginia SIP.
    The basis for this SIP revision is that limiting PSD applicability
to GHG sources which emit at or above the higher thresholds in the
Tailoring Rule is consistent with the SIP provisions that provide
required assurances of adequate resources, and thereby addresses the
flaw in the SIP that led to the SIP Narrowing Rule. Specifically, CAA
section 110(a)(2)(E) includes as a requirement for SIP approval that
States provide ``necessary assurances that the State * * * will have
adequate personnel [and] funding * * * to carry out such [SIP].'' In
the Tailoring Rule, EPA established higher thresholds for PSD
applicability to GHG-emitting sources on grounds that the states
generally did not have adequate resources to apply PSD to GHG-emitting
sources below the Tailoring Rule thresholds,\8\ and no State, including
Virginia, asserted that it did have adequate resources to do so.\9\ In
the SIP Narrowing Rule, EPA found that the affected states, including
Virginia, had a flaw in their SIP at the time they submitted their PSD
programs, which was that the applicability of the PSD programs was
potentially broader than the resources available to them under their
SIP.\10\ Accordingly, for each affected state, including Virginia, EPA
concluded that EPA's action in approving the SIP was in error, under
CAA section 110(k)(6), and EPA rescinded its approval to the extent the
PSD program applies to GHG-emitting sources below the Tailoring Rule
thresholds.\11\ EPA recommended that States adopt a SIP revision to
incorporate the Tailoring Rule thresholds, thereby (i) assuring that
under State law, only sources at or above the Tailoring Rule thresholds
would be subject to PSD; and (ii) avoiding confusion under the
Federally approved SIP by clarifying that the SIP applies to only
sources at or above the Tailoring Rule thresholds.\12\
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    \8\ Tailoring Rule, 75 FR 31517/1.
    \9\ SIP Narrowing Rule, 75 FR 82540/2.
    \10\ Id. at 82542/3.
    \11\ Id. at 82544/1.
    \12\ Id. at 82540/2.
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IV. EPA's Response to Comments Received on the Proposed Action

    EPA received a single set of relevant comments on its January 12,
2011 (76 FR 2070) proposed action to approve revisions to Virginia SIP.
These comments, provided by the Air Permitting Forum (hereinafter
referred to as ``the Commenter''), raised concerns with regard to EPA's
January 12, 2011 proposed action. A full set of these comments is
provided in the docket for today's final action. A summary of the
comments and EPA's responses are provided below.
    Generally, the adverse comments fall into four categories. First,
the Commenter asserts that PSD requirements cannot be triggered by
GHGs. Second, the Commenter expresses concerns regarding ``EPA's
statement that it may narrow its prior SIP approvals'' to ensure that
sources with GHG emissions that are less than the Tailoring Rule's
thresholds will not be obligated under Federal law to obtain PSD
permits prior to a SIP revision incorporating those thresholds. The
Commenter explains that this SIP approval narrowing action would be
``illegal.'' \13\ Third, the Commenter states that EPA has failed to
meet applicable statutory and executive order review requirements.
Lastly, the Commenter states: ``If EPA proceeds with this action, it
must condition approval on the continued validity of its determination
that PSD can be triggered by GHGs.'' EPA's response to these four
categories of comments is provided below.
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    \13\ Although the Commenter discussed only the proposal to
narrow, the final PSD SIP Narrowing Rule had been issued prior to
when the commenter submitted its comments. EPA assumes these
comments are intended to apply to the final PSD SIP Narrowing Rule.
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    Comment 1: The Commenter asserts that PSD requirements cannot be
triggered by GHGs. In its letter, the Commenter states: ``[n]o area in
the Commonwealth of Virginia has been designated attainment or
unclassifiable for greenhouse gases (GHGs), as there is no national
ambient air quality standard (NAAQS) for GHGs. Therefore, GHGs cannot
trigger PSD permitting requirements.'' The Commenter notes that it made
this argument in detail in comments submitted to EPA on the Tailoring
Rule and other related GHG rulemakings. The Commenter attached those
previously submitted comments to its comments on the proposed
rulemaking related to this action. Finally, the Commenter states that
``EPA should immediately provide notice that it is now interpreting the
Act not to require that GHGs trigger PSD and allow Virginia to rescind
that portion of its rules that would allow GHGs to trigger PSD.''
    Response 1: EPA established the requirement that PSD applies to all
pollutants newly subject to regulation, including non-NAAQS pollutants,
in earlier national rulemakings concerning the PSD program, and EPA has
not re-opened that issue in this rulemaking. Accordingly, these
comments are not relevant to this rulemaking. In addition, EPA has
explained in detail, in recent rulemakings concerning GHG PSD
requirements, its reasons for disagreeing with these comments. For
convenience, we briefly summarize these reasons here, although, again,
we have not re-opened this issue in this rulemaking.
    In an August 7, 1980 rulemaking at 45 FR 52676, 45 FR 52710-52712,
and 45 FR 52735, EPA stated that a ``major stationary source'' was one
that emitted ``any air pollutant subject to regulation under the Act''
at or above the specified numerical thresholds; and defined a ``major
modification,'' in general, as a physical or operational change that
increased emissions of ``any pollutant subject to regulation under the
Act'' by more than an amount that EPA variously termed as de minimis or
significant. In addition, in EPA's NSR Reform rule at 67 FR 80186 and
67 FR 80240 (December 31, 2002), EPA added to the PSD regulations the
new definition of ``regulated NSR pollutant'' [currently codified at 40
CFR 52.21(b)(50) and 40 CFR 51.166(a)(49)], noted that EPA added this
term based on a request from a commenter to ``clarify which pollutants
are covered under the PSD program'' and explained that in addition to
criteria pollutants for which a NAAQS has been established, ``[t]he PSD
program applies automatically to newly regulated NSR pollutants, which
would include final promulgation of an NSPS [new source performance
standard] applicable to a previously unregulated pollutant.'' Id. at 67
FR 80240 and 67 FR 80264. Among other things, the definition of
``regulated NSR pollutant'' includes ``[a]ny pollutant that otherwise
is subject to

regulation under the Act.'' See 40 CFR 52.21(b)(50)(d)(iv); see also 40
CFR 51.166(a)(49)(iv).
    In any event, EPA disagrees with the Commenter's underlying premise
that PSD requirements were not triggered for GHGs when GHGs became
subject to regulation as of January 2, 2011. As just noted, this has
been well-established and discussed in connection with prior EPA
actions, including, most recently, the Johnson Memo Reconsideration and
the Tailoring Rule. In addition, EPA's January 12, 2011 proposed
rulemaking notice provides the general basis for the Agency's rationale
that GHGs, while not a NAAQS pollutant, can trigger PSD permitting
requirements. The January 12, 2011 notice also refers the reader to the
preamble to the Tailoring Rule for further information on this
rationale. In that rulemaking, EPA addressed at length the comment that
PSD can be triggered only by pollutants subject to the NAAQS and
concluded that such an interpretation of the Act would contravene
Congress's unambiguous intent. See 75 FR 31560-31562. Further
discussion of EPA's rationale for concluding that PSD requirements are
triggered by non-NAAQS pollutants such as GHGs appears in the Tailoring
Rule Response to Comments document (``Prevention of Significant
Deterioration and Title V GHG Tailoring Rule: EPA's Response to Public
Comments''), pp. 34-41; and in EPA's response to motions for a stay
filed in the litigation concerning those rules [``EPA's Response to
Motions for Stay,'' Coalition for Responsible Regulation v. EPA, D.C.
Cir. No. 09-1322 (and consolidated cases)], at pp. 47-59, and are
incorporated by reference here. These documents have been placed in the
docket for today's action.
    Comment 2: The Commenter expresses concerns regarding the legality
of narrowing prior SIP approvals if states cannot interpret their
regulations to include the Tailoring Rule thresholds within the phrase
``subject to regulation.''
    Response 2: While EPA does not agree with the Commenter's assertion
that the narrowing approach that EPA proposed in the Tailoring Rule and
finalized in the PSD SIP Narrowing Rule is illegal, the validity of the
narrowing approach is irrelevant to the action that EPA is today taking
for Virginia's October 27, 2010 SIP revision. EPA did not propose to
narrow its approval of Virginia's SIP as part of its January 12, 2011
proposed action, and in today's final action, EPA is acting to approve
a SIP revision submitted by Virginia and is not otherwise narrowing its
approval of prior submitted and approved provisions in the Virginia
SIP. Accordingly, the legality of the narrowing approach is not at
issue in this rulemaking.
    Comment 3: The Commenter states that EPA has failed to meet
applicable statutory and executive order review requirements.
Specifically, the Commenter refers to the statutory requirements and
executive orders for the Paperwork Reduction Act, the Regulatory
Flexibility Act (RFA), the Unfunded Mandates Reform Act, and Executive
Order 13132 (Federalism). Additionally, the Commenter mentions that EPA
has never analyzed the costs and benefits associated with triggering
PSD for stationary sources in Virginia, much less nationwide.
    Response 3: EPA disagrees with the Commenter's statement that EPA
has failed to meet applicable statutory and executive order review
requirements. As stated in EPA's proposed approval of Virginia's
October 27, 2010 SIP revision, this action merely approves state law as
meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. Accordingly, EPA's
approval, in and of itself, does not impose any new information
collection burden, as defined in 5 CFR 1320.3(b) and (c), that would
require additional review under the Paperwork Reduction Act. In
addition, this SIP approval will not have a significant economic impact
on a substantial number of small entities, beyond that which would be
required by the state law requirements, so a regulatory flexibility
analysis is not required under the RFA. Accordingly, this rule is
appropriately certified under section 605(b) of the RFA. Moreover, as
this action approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandates or significantly
or uniquely affect small governments, such that it would be subject to
the Unfunded Mandates Reform Act. Furthermore, this action does not
have Federalism implications that would make Executive Order 13132
applicable, because it merely approves a state rule implementing a
Federal standard and does not alter the relationship or the
distribution of power and responsibilities established in the CAA.
Finally, regarding the Commenter's assertion that EPA has ``never
analyzed the costs and benefits of triggering PSD for stationary
sources in Virginia, much less nationwide'', this comment is not
relevant to the current action because this action is not triggering
GHG PSD requirements.
    Today's rule is a routine approval of a SIP revision, which
approves state law, and does not impose any requirements beyond those
imposed by state law. To the extent these comments are directed more
generally to the application of the statutory and executive order
reviews to the required regulation of GHGs under PSD programs, these
comments are irrelevant to the approval of state law in today's action.
However, EPA provided an extensive response to similar comments in
promulgating the Tailoring Rule. EPA refers the Commenter to the
sections in the Tailoring Rule entitled ``VII. Comments on Statutory
and Executive Order Reviews,'' 75 FR 31601-31603, and ``VI. What are
the economic impacts of the final rule?,'' 75 FR 31595-31601. EPA also
notes that today's action does not in-and-of itself trigger the
regulation of GHGs. To the contrary, GHGs are already being regulated
nationally, and PSD permitting for GHG emissions by Virginia is already
authorized under the existing SIP. Today's action simply puts in place
the GHG emission thresholds for PSD applicability set forth in EPA's
Tailoring Rule, thereby ensuring that smaller GHG sources emitting less
than these thresholds will not be subject to permitting requirements.
    Comment 4: The Commenter states that ``[i]f EPA proceeds with this
action, it must condition approval on the continued validity of its
determination that PSD can be triggered by GHGs.'' Further, the
Commenter remarks on the ongoing litigation in the U.S. Court of
Appeals for the D.C. Circuit. Specifically, regarding EPA's
determination that PSD can be triggered by GHGs or is applicable to
GHGs, the Commenter mentions that ``EPA should explicitly state in any
final rule that the continued enforceability of these provisions in the
Virginia SIP is limited to the extent to which the Federal requirements
remain enforceable.''
    Response 4: EPA believes that it is most appropriate to take
actions that are consistent with the Federal regulations that are in
place at the time the action is being taken. To the extent that any
changes to Federal regulations related to today's action result from
pending legal challenges or other actions, EPA will process appropriate
SIP revisions in accordance with the procedures provided in the Act and
EPA's regulations. EPA notes that in an order dated December 10, 2010,
the United States Court of Appeals for the D.C. Circuit denied motions
to stay EPA's regulatory actions related to GHGs. Coalition for
Responsible Regulation, Inc. v. EPA, Nos. 09-1322, 10-1073, 10-1092
(and consolidated cases), Slip Op.

at 3 (D.C. Cir. December 10, 2010) (order denying stay motions).

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) that are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. * * *'' The opinion
concludes that ``[r]egarding Sec. 10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
PSD program consistent with the Federal requirements. In any event,
because EPA has also determined that a state audit privilege and
immunity law can affect only state enforcement and cannot have any
impact on Federal enforcement authorities. EPA may at any time invoke
its authority under the CAA, including, for example, sections 113, 167,
205, 211 or 213, to enforce the requirements or prohibitions of the
state plan, independently of any state enforcement effort. In addition,
citizen enforcement under section 304 of the CAA is likewise unaffected
by this, or any, state audit privilege or immunity law.

VI. Final Action

    EPA is approving 9 VAC5 Chapter 85 as a revision to the Virginia
SIP. EPA has determined that this SIP submittal is approvable because
it is in accordance with the CAA and EPA regulations regarding PSD
permitting for GHGs.
    As discussed above, in the PSD SIP Narrowing Rule, EPA both
narrowed its prior approval of a number of SIPs and asked that each
affected state withdraw from EPA consideration the part of its SIP that
is no longer approved, and stated that approval of a SIP revision
incorporating the Tailoring Rule thresholds into a SIP would count as
removing these no-longer-approved provisions. Today's SIP revision
approval accomplishes exactly this. Because EPA is approving Virginia's
changes to its air quality regulations to incorporate appropriate
thresholds for GHG permitting applicability into Virginia's SIP, then
paragraph (t) in Sec.  52.2423 of 40 CFR part 52, as included in EPA's
PSD SIP Narrowing Rule--which codifies EPA's limiting its approval of
Virginia's PSD SIP to not cover the applicability of PSD to GHG-
emitting sources below the Tailoring Rule thresholds--is no longer
necessary. In today's action, EPA is also amending Section 52.2423 of
40 CFR part 52 to remove this unnecessary regulatory language; the
removal of this now-extraneous language is ministerial in nature.

VII. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human

health or environmental effects, using practicable and legally
permissible methods, under Executive Order 12898 (59 FR 7629, February
16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the Virginia SIP is not approved to apply in Indian country
located in the Commonwealth, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 12, 2011. Filing a petition for
reconsideration by the Administrator of this final rule to approve
Virginia's October 27, 2010 SIP revision does not affect the finality
of this action for the purposes of judicial review nor does it extend
the time within which a petition for judicial review may be filed, and
shall not postpone the effectiveness of such rule or action. This
action pertaining to greenhouse gas permitting in Virginia may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, and Reporting and recordkeeping
requirements.

    Dated: April 25, 2011.
James W. Newsom,
Acting Regional Administrator, Region III.
    40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by adding
entries for Chapter 85, Sections 5-85-10, 5-85-40, 5-85-50; 5-85-60,
and 5-85-70 after existing section 5-80-2240 to read as follows:

Sec.   52.2420 Identification of plan.

* * * * *
    (c) * * *

                                 EPA-Approved Virginia Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                                                Explanation
         State citation               Title/subject            State        EPA approval date     [former SIP
                                                          effective  date                          citation]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
             9 VAC 5, Chapter 85 Permits for Stationary Sources of Pollutants Subject to Regulation
----------------------------------------------------------------------------------------------------------------
                                              Part I Applicability
----------------------------------------------------------------------------------------------------------------
5-85-10........................  Applicability..........  1/2/11           5/13/11 [Insert     .................
                                                                            page number where
                                                                            the document
                                                                            begins].
----------------------------------------------------------------------------------------------------------------
                         Part III Prevention of Significant Deterioration Permit Actions
----------------------------------------------------------------------------------------------------------------
5-85-40........................  Prevention of            1/2/11           5/13/11 [Insert     .................
                                  Significant                               page number where
                                  Deterioration Area                        the document
                                  Permit Actions.                           begins].
5-85-50........................  Definitions............  1/2/11           5/13/11 [Insert     .................
                                                                            page number where
                                                                            the document
                                                                            begins].
----------------------------------------------------------------------------------------------------------------
                                     Part IV State Operating Permit Actions
----------------------------------------------------------------------------------------------------------------
5-85-60........................  State Operating Permit   1/2/11           5/13/11 [Insert     .................
                                  Actions.                                  page number where
                                                                            the document
                                                                            begins].
5-85-70........................  Definitions............  1/2/11           5/13/11 [Insert     .................
                                                                            page number where
                                                                            the document
                                                                            begins].

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

* * * * *

0
3. In Sec.  52.2423, paragraph (t) is removed.

[FR Doc. 2011-11710 Filed 5-12-11; 8:45 am]
BILLING CODE 6560-50-P


	EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

	Petition Numbers (PP#) 8E7425, 8E7426

EPA has received pesticide petitions (PP #) 8E7425 and 8E7426 from IR-4,
500 College Road East, Suite 201W, Princeton, NJ 08540,  proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(d), to amend 40 CFR 180.598 by establishing a tolerance
for residues of novaluron
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino
]carbonyl]-2,6-difluorobenzamide in or on Stone Fruit (Crop Group 12) at
8 parts per million (ppm) (PP# 8E7426), Bushberries (Subgroup 13-07B) at
7 ppm (PP# 8E7425), Leafy Brassica (Subgroup 5B) at 25 ppm (PP# 8E7426),
Turnip Greens at 25 ppm (PP# 8E7426), and by increasing a tolerance for
residues of novaluron on egg from 0.05 to 0.07 parts per million (ppm)
(PP# 8E7426). Makhteshim-Agan of North America, Inc., 4515 Falls of
Neuse Road, Raleigh, NC 27609, is the manufacturer and basic registrant
of novaluron. Makhteshim-Agan of North America, Inc., prepared and
summarized the following information in support of the subject pesticide
petition for novaluron. EPA has determined that the petition contains
data or information regarding the elements set forth in section
408(d)(2) of the FFDCA. However, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A.	Residue Chemistry

     	1.   	Plant Metabolism

	The qualitative nature of the residue of novaluron in plants is
adequately understood based on acceptable plant metabolism studies
reflecting its uses on apples, cabbage, cotton, and potatoes. These
plant metabolism studies have demonstrated that novaluron does not
metabolize and is non-systemic (does not translocate within the plant).
The results observed in the plant and livestock metabolism studies show
similar metabolic pathways. The residue of concern, which should be
regulated, is the parent compound, novaluron, only.

2.	Analytical Method

	An adequate analytical method, gas chromatography/electron capture
detector (GC/ECD), as published in the Federal Register of April 5, 2006
(Volume 71, Number 65; FRL-7756-8), is available for enforcing
tolerances of novaluron residues in or on stone fruit, bushberries,
leafy brassica and turnip greens. The method verification trial supports
a limit of quantitation (LOQ) of 0.05 ppm, and the limit of detection
(LOD) is 0.005 ppm for the different matrices. The limit of quantitation
(LOQ = 0.05 ppm) was taken as the lowest level validated by this method.

		3. 	Magnitude of Residues

i.     Stone Fruit:  A total of 32 residue trials were conducted in
cherries, peaches and plums during the 2005 and 2006 season covering the
major growing areas in the NAFTA Regions. The supported use pattern on
all stone fruit crops is a maximum of three foliar applications at a
maximum rate of  50 fl. oz product/A, or 0.32 lb ai/A, for a total
seasonal application of approximately 0.96 lb ai/A , and a pre-harvest
interval (PHI) of 7 days.  The proposed tolerance for the stone fruit
crop group (#12) is 8 ppm.  Additional crop-specific details are as
follows:

Cherries:  Seven field trials were conducted at the supported use
pattern covering NAFTA Regions I (1 trial), V (3 trials), X (1 trial),
and XII (1 trial).  Measured novaluron residues range from 0.74 ppm to
4.08 ppm, with an average residue of 2.17 ppm.  The estimated tolerance
for cherries only is 8 ppm using the MRL calculator.

Peaches:  Fifteen field trials were conducted at the supported use
pattern covering NAFTA Regions I (1 trial), II (5 trials), V (4 trials),
VI (1 trial), X (4 trials), and XI (1 trial). Measured novaluron
residues range from 0.18 ppm to 2.10 ppm, with an average residue of
0.61 ppm.  The estimated tolerance for peaches only is 1.8 ppm using the
MRL calculator.

Plums:  Ten field trials were conducted at the supported use pattern
covering NAFTA Regions I (1 trial), V (3 trials), X (5 trials), XI (1
trial), and XII (1 trial).  Measured novaluron residues range from 0.08
ppm to 0.80 ppm, with an average residue of 0.40 ppm.  The estimated
tolerance for plums only is 1.9 ppm using the MRL calculator.  Dried
plums from one trial in California had an estimated, maximum
concentration factor for novaluron residues of 3.39.

Bushberries:  A total of nine field trials were conducted with
blueberries covering NAFTA Growing Regions I (1 trial), II (4 trials), V
(3 trials), and XII (1 trial) during the 2005 season. The supported use
pattern consists of three applications, at a maximum rate of  30 fl. oz
product/A, or 0.194 lb ai/A, for a total seasonal rate of 0.58 lb ai/A,
and a PHI of 7 days.  Measured novaluron residues range from 0.61 ppm to
3.81 ppm, with an average residue of 1.97 ppm. The proposed tolerance
for the bushberry crop group (#13B) is 7 ppm.

Leafy Brassica and Turnip Greens:  A total of eleven field trials were
conducted with mustard greens in support of the proposed tolerance for
the leafy brassica crop group (5B) and turnip greens. The field trials
were conducted during the 2005 season covering NAFTA Regions II (3
trials), III (1 trial), IV (1 trial), V (2 trials), VI (1 trial), X (2
trial) , XII (1 trial) at the supported use pattern of three foliar
applications at a maximum rate of  12 fl. oz product/A, or  0.078 lb
ai/A, for a total seasonal rate of 0.23 lb ai/A, and a PHI of 3 days.
Measured novaluron residues range from 1.39 ppm to 18.54 ppm, with an
average residue of 5.41 ppm. The proposed tolerance for the leafy
brassica crop group (5B) and turnip greens is 25 ppm.

B.	 Toxicological Profile

	1.   	Acute Toxicity

In an acute oral toxicity study in rats, novaluron had an LD50 >5,000
mg/kg.  A dermal toxicity study in rats resulted in an LD50 greater than
2,000 mg/kg.  The LC50 for acute inhalation in rats was greater than
5.15 mg/l.  In rabbits, novaluron is not a skin irritant, but it is a
mild eye irritant.  Novaluron is not a sensitizer in guinea pigs.

		2.	  Genotoxicity

The mutagenic potential of Novaluron was investigated in several in vivo
and in vitro studies.  Results in two Ames assays, an in vivo mouse
micronucleus assay, an in vitro unscheduled DNA synthesis (UDS) assay,
an in vitro cell mutation assay, and an in vitro human lymphocyte
clastogenicity test were negative.  Novaluron is therefore considered to
have no potential to induce mutagenicity.

		3.     Reproductive and Developmental Toxicity

	i.   A two generation rat reproduction study was conducted with dose
levels of 1,000, 4,000, and 12,000 ppm (74.2, 297.5, 894.9 mg/kg/day,
and 84, 336.7, 1,009.8 mg/kg/day for males and females, respectively).
Maternal and offspring toxicity was evidenced by increased absolute and
relative spleen weights, whereas reproductive toxicity was observed only
in males at 297.5 mg/kg/day (LOAEL) based on decreased epididymal sperm
counts and increased age at preputial separation in the F1 generation.
The no observed adverse effect level (NOAEL) in males was 1,000 ppm
(74.2 mg/kg/day) and in females it was $12,000 ppm (1,009.8 mg/kg/day).

	ii.    Teratology studies were conducted in the rat and rabbit.  No
treatment-related mortalities were observed in either study.  No effect
on survival, development or growth of fetuses was noted in either
species in either study.  No maternal or developmental toxicity was
observed up to and including the limit dose of 1,000 mg/kg/day (NOAEL).
These two studies demonstrate that novaluron was not teratogenic in
either rats or rabbits.

		4.	Subchronic Toxicity

Rats, mice and dogs all show the same toxicologic response.  Generally,
 novaluron induces small increases in methemoglobin; red cells are
sequestered; and, compensatory hematopoiesis occurs.  The severity of
these changes is well within the physiological capacity of the animals
and is judged   not adverse.

Rats treated topically with novaluron in a 28-day study at 0, 75, 400
and 1,000 mg/kg/day did not show signs of systemic toxicity.  Small
treatment-related increases in methemoglobin were seen in both sexes at
1,000 mg/kg/day and in females at 400 mg/kg/day.  The highest
methemoglobin value seen in females was 1.28% compared with 0.86% in
controls.  Organ weights, macroscopic and microscopic examination of
organs and tissues did not reveal any treatment-related changes.

Two 13-week rat studies were conducted.  In one study, doses were
administered at 50, 100, 200, 400 ppm (3.52, 6.93, 13.83, 27.77
mg/kg/day and 4.38, 8.64, 17.54 and 34.39 mg/kg/day for males and
females, respectively). The LOAELs from the combined results were 27.77
mg/kg/day in males based on increased occurrence of extramedullary
hematopoiesis and hemosiderosis in spleen; and 8.64 mg/kg/day in females
based on reduction in hemoglobin, hematocrit and RBC count; increased
occurrence of extramedullary hematopoiesis and hemosiderosis in spleen
and liver.  The NOAEL was determined to be 4.38 mg/kg/day.

A 13-week mouse study was conducted with dose levels of 30, 100, 1,000,
10,000 ppm (4.2, 12.8, 135.9, 1,391.9 and 4.7, 15.2, 135.6, 1,493.1
mg/kg/day, for males and females, respectively).  The NOAEL was
determined to be 100 ppm (12.8 and 15.2 mg/kg/day, male and females,
respectively).  The LOAEL was 1,000 ppm (135.9 and 135.6 mg/kg/day,
males and females, respectively) based on increased body weight gain,
low erythrocyte counts, and secondary splenic changes.  There were no
clinical treatment-related signs noted.

Two 13-week dog studies were conducted.   One study resulted in an NOAEL
of 100 mg/kg/day and a LOAEL of 300 mg/kg/day based on low erythrocyte
counts and secondary splenic and liver changes.  No clinical
treatment-related signs were noted.  Another study, was conducted using
only one dose level of 10 mg/kg/day.  There were no clinical or
histopathological treatment-related signs and the NOEL was determined to
be 10 mg/kg/day.

		5.	Chronic Toxicity

	i.    Chronic toxicity and oncogenicity was evaluated in the rat, mouse
and dog.  The rat chronic toxicity and oncogenicity was conducted with
dose levels of 25, 700, 20,000 ppm (1.1, 30.6, 884.2 and 1.4, 39.5,
1,113.5 mg/kg/day for males and females, respectively).  The LOAEL in
male and female rats was 30.6 and 39.5 mg/kg/day, respectively, based on
evidence of erythrocyte damage and turnover resulting in a regenerative
anemia in both sexes. The corresponding NOAEL was 25 ppm (1.1 and 1.4
mg/kg/day for male and female rats, respectively). There was no evidence
of carcinogenicity in this study.  A mouse chronic toxicity study was
conducted with dose levels of 30, 450, 7,000 ppm (3.6, 53.4, 800.0 and
4.3, 63.3, 913.4 mg/kg/day for males and females, respectively).  The
LOAEL in male and female mice was 53.4 and 63.3 mg/kg/day, respectively,
based on erythrocyte turnover due to hemoglobin oxidation and resulting
in a compensated anemia. The corresponding NOAEL was 30 ppm (3.6 and 4.3
mg/kg/day for male and female mice, respectively). There was also no
evidence of carcinogenicity in this study.  Chronic toxicity was
investigated in dogs using dose levels of 10, 100, 1,000 mg/kg/day.  The
NOAEL of 100 mg/kg/day was based on methemoglobin.

		ii.  	The chronic reference dose (cRfD) of 0.011 mg/kg/day has been
established on the basis of the chronic carcinogenicity study in rats.
An uncertainty factor (UF) of 100 was applied to the NOAEL of 1.1
mg/kg/day for male rats deriving to the cRfD.

 		iii. 	 In accordance with the EPA Draft Guidelines for Carcinogen
Risk Assessment (July 1999), novaluron is classified as not likely to be
carcinogenic to humans due to results of oncogenicity studies that show
no evidence of carcinogenicity in rats and mice.

		6.	Animal Metabolism

Metabolism studies in rats and goats were conducted with the parent
material labeled in both the difluorophenyl and chlorophenyl moieties.
Rats absorb little novaluron when it is administered orally.  More than
90% of the dietary administered [chlorophenyl 14C(U)] novaluron is
recovered in the feces.  When the diflurophenyl ring of the molecule is
labeled, the recovered 14C activity in the feces is lower but still
above 75%.  The difference is thought to reflect intestinal metabolism
by microbial flora and the higher absorption of the diflurophenyl
metabolites.

The parent molecule as well as its degradates are absorbed from the
gastrointestinal tract.  All parent material is metabolized either upon
initial entry into the systemic circulation or, if sequestered to the
fat, upon its depuration back to the systemic circulation.  There is no
intact novaluron found in the urine. Novaluron=s high octanol-water
partition coefficient is responsible for its preferential movement to
fat.  The half-life in fat calculated from the rat metabolism study is
approximately 55 hours.

Two groups of metabolites are formed after oral administration of
novaluron.  One group is typified by the aniline metabolite
3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy) aniline, referred
to as 3-TFA.  The other group of metabolites is typified by
2,6-difluorobenzoic acid is from the diflurophenyl moiety of the
molecule.  Nearly all the metabolites are formed at a level of 1% or
less of the applied dose.  They are rapidly excreted.

The metabolism in goats and hens mimics that seen in rats.

	7.     Metabolite Toxicology

Makhteshim-Agan of North America Inc., has determined that there are no
metabolites of toxicological concern and therefore, no metabolites need
to be included in the tolerance expression and require regulation. For
drinking water assessment the soil degradates, chlorophenyl urea and
chloroaniline will be included besides the parent, novaluron.

8.      Endocrine Disruption

No special studies investigating potential estrogenic or other endocrine
effects of novaluron have been conducted.  However, inspection of
in-life data from toxicology studies does not indicate that novaluron is
an endocrine disruptor.  Specifically, endocrine organ weights (e.g.,
thyroid, testes, ovaries, pituitary from the two-generation study) were
not adversely affected by novaluron.  Milestones of sexual development
were not affected by novaluron; and, reproduction was not adversely
affected.  Based on these observations, there is no evidence to suggest
that novaluron has an adverse effect on the endocrine system.

C.   Aggregate Exposure

	1.	Dietary Exposure

Tolerances have been established (40 CFR 180.598) for the residues of
novaluron, in or on the following raw agricultural commodities: Apple,
wet pomace at 8.0; cattle, fat at 11 ppm; cattle, kidney at 1.0 ppm;
cattle, liver at 1.0 ppm; cattle, meat at 0.60 ppm; cattle, meat
byproducts, except liver and kidney at 0.60 ppm; cotton, gin byproducts
at 30 ppm; cotton, undelinted seed at 0.60 ppm; eggs at 0.05 ppm; fruit,
pome, group 11 at 2.0 ppm; goat, fat at 11 ppm; goat, kidney at 1.0 ppm;
goat, liver at 1.0 ppm; goat, meat at 0.60 ppm; goat, meat byproducts
except liver and kidney at 0.60 ppm; hog, fat at 0.05 ppm; hog, meat at
0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, fat at 11 ppm; horse,
kidney at 1.0 ppm; horse, liver at 1.0 ppm; horse, meat at 0.60 ppm;
horse, meat byproducts, except liver and kidney at 0.60 ppm; milk at 1.0
ppm; milk, fat at 20 ppm; poultry, fat at 0.40 ppm; poultry, meat at
0.03 ppm; poultry, meat byproducts at 0.04 ppm; sheep, fat at 11 ppm;
sheep, kidney at 1.0 ppm; sheep, liver at 1.0 ppm; sheep, meat at 0.60
ppm; sheep, meat byproducts, except liver and kidney at 0.60 ppm, and
vegetables, tuberous and corn, subgroup 1C at 0.05 ppm, as published in
the Federal Register of April 5, 2006 (Volume 71, Number 65;
FRL-7756-8).

EPA is presently reviewing the petition PP#7E7199 concerning the pending
tolerances of novaluron on sugarcane and tomatoes.  The average residues
in sugarcane are 0.125 ppm, and in molasses 0.24 ppm.  Residues in
refined sugar are below the LOD (0.005 ppm).  Assuming residues present
at the LOD, the average processing factor for refined sugar is 0.15.  As
for the pending use on tomatoes, EPA has calculated processing factors
of <0.7 for tomato puree, and 1.1 for tomato paste.  The information
from the EPA petition for sugarcane and tomatoes was incorporated into
this dietary assessment.

In addition to the existing tolerances, this Notice of Filing includes
exposure assessments for potential residues of novaluron in or on
tomatoes, sugarcane, stone fruit, bushberries, leafy brassica and turnip
greens. Average residues from field trials were assumed in the dietary
exposure assessment (see previous section).  An empirical processing
factor of 3.39 was calculated using data from a processing trial for
dried plums.  Otherwise, all DEEM default processing factors were used
for juices, dried fruit, etc. among stone fruit and bushberries.

		i. 	Food

		a.   Acute Dietary Exposure. No toxicological endpoint attributable to
a single exposure was identified in the available toxicology studies,
including the rat and rabbit developmental studies.  Therefore, the
acute aggregate risk is negligible.

b.     Chronic Dietary Exposure.  A chronic dietary risk assessment was
conducted using the Dietary Exposure Evaluation Model (DEEM) software
with the Food Commodity Intake Database (DEEM-FCIDTM Version 2.16),
which incorporates consumption data derived from the 1994 - 1998 USDA
Continuing Surveys of Food Intake by Individuals (CSFII). The assessment
included all uses (existing, pending and proposed), assuming provided
percent crop treated estimates at market maturity [apples (30%), pears
(50%), head and stem brassica (30%), tuberous and corm vegetables (18%),
cotton (12%), tomatoes (15%), sugarcane (28%), stone fruit (20%),
bushberries (15%), leafy brassica (20%), turnip greens (15%)] average
field residues, anticipated residues for meat and milk products with the
exception for cotton seed commodities and poultry, for which
tolerance-level residues were assumed. An empirical processing factor of
3.39 was calculated using data from a processing trial for dried plums.
Otherwise, all DEEM default processing factors were used for juices,
dried fruit, etc. among stone fruit and bushberries.

The appropriate cRfD value for novaluron is 0.011 mg/kg/day, based upon
the NOAEL of 1.1 mg/kg/day from the chronic carcinogenicity study in
rats, and an UF of 100. The chronic dietary exposures account for 7.0%
to 24.4% of the cPAD. The most highly exposed subpopulation, children
aged 1-2 years, has an estimated total novaluron exposure of 0.00268
mg/kg/day), equal to 24.4% of the cPAD. The estimated novaluron exposure
for the general U.S. population (0.000766 mg/kg/day) is equivalent to
7.0% of the cPAD.

c.     Novaluron was classified as “not likely to be carcinogenic to
humans.''. Therefore, a quantitative cancer risk assessment was not
conducted.

ii.     Drinking Water

		a. 	Acute Exposure. Since no acute dietary endpoint was determined,
Makhteshim-Agan of North America, Inc., concludes there is reasonable
certainty of no harm from acute drinking water exposure.

b.    Chronic Exposure.

There are no monitoring data for novaluron to complete a comprehensive
risk assessment for novaluron in drinking water. Therefore, the
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS,
Tier 2 model) was used for the concentration of novaluron (parent) in
surface water, the Food Quality Protection Act (FQPA) Index Reservoir
Screening Tool (FIRST, Tier I model) was used to estimate surface water
concentrations of the chlorophenyl urea and chloroaniline degradates.
For “Screening Concentrations In Ground Water” the SCI-GROW model
was used, assuming that novaluron may reach the surface or the ground
water via the parent compound or via the its degradates. The modeling
represents upper-bound estimates based on the environmental
characteristics and associated modeling parameters, which are designed
to provide conservative, health protective, high-end estimates of water
concentrations, which will not likely be exceeded. Chronic estimates for
the terminal degradate, chloroaniline, represent the worst case,
assuming 100% conversion of the parent compound. Based on the use of
novaluron on apples (highest application rate among all uses), the
calculated EECs of novaluron derived from these models are 2.61 parts
per billion (ppb) for surface water and 0.009 ppb for ground water. The
chronic dietary exposure assessment includes as the worst case the
annual average concentration of 2.61 ppb in surface water.

		2.	Non-Dietary Exposure

	Presently and in the future, novaluron is not considered for
residential uses. Novaluron is not registered for use on any sites that
would result in residential exposure. The term “residential exposure''
refers 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). Therefore, there is no non-dietary exposure
(acute, short-term, intermediate-term or chronic).

D.	Cumulative Effects

To Makhteshim-Agan of North America’s Inc., knowledge, there are
currently no available data or other reliable information indicating
that any toxic effects produced by novaluron would be cumulative with
those of other chemical compounds; thus only the potential risks of
novaluron have been considered in this assessment of its aggregate
exposure.

E.	 Safety Determination

   	1.     U.S. Population

No acute aggregate risk assessment was conducted because there is no
toxicological endpoint attributable to a single exposure.  Short- and
intermediate-term aggregate risk assessments were not performed because
of no current or future residential uses. No cancer aggregate risk
assessment was conducted because novaluron has not been shown to be
carcinogenic.  Therefore, only a chronic aggregate risk assessment was
performed based on potential exposure from food and drinking water,
considering all existing and proposed uses.  The chronic exposure of the
U.S. population utilizes 7% of the cRfD, and the most sensitive
population subgroup (children 1 to 2 years old) utilizes 24.4% of the
cRfD.  In view of these assessments, Makhteshim-Agan of North America
Inc., concludes that there is reasonable certainty that no harm will
result from the proposed uses of novaluron.

		2.	 Infants and Children

Section 408 of FFDCA provides that EPA may apply an additional safety
factor for infants and children to account for prenatal and postnatal
toxicity and the completeness of the database. The toxicology database
for novaluron is complete including acceptable data from rat and rabbit
developmental toxicity studies and a two generation rat reproduction
study that have been used to assess the potential for increased
sensitivity of infants and children. The data provided no quantitative
or qualitative evidence of increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure to novaluron. In addition there is
no concern for developmental neurotoxicity resulting from exposure to
novaluron, and a developmental neurotoxicity study is not required.
Therefore, the Agency determined in its recent review to reduce the FQPA
Safety Factor to 1X (Federal Register of June 2, 2004; 69 FR 31013;
FRL-7359-2). Thus, the chronic population adjusted dose (cPAD) is
considered 0.011 mg/kg/day. The DEEM analysis regarding the aggregate
chronic exposure calculations utilizes less than 24.4% of the cPAD for
the most sensitive subgroup, children 1 to 2 years old. Therefore,
Makhteshim-Agan of North America Inc., concludes that there is
reasonable certainty that no harm will result to infants and children
from aggregate exposure to novaluron residues.

F.	International Residue Limits

At present, there are no Canadian, Mexican, or Codex maximum residue
limits (MRLs) established for novaluron on tomato, tomato paste, and
sugarcane. Therefore, international harmonization is not an issue at
this time.