[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Rules and Regulations]
[Pages 43520-43521]
[FR Doc No: 2012-17897]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2011-0577; FRL-9356-1]
RIN 2070-AB27

Significant New Use Rules on a Certain Chemical Substance;
Removal of Significant New Use Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is removing significant new use rules (SNURs) promulgated
under the Toxic Substances Control Act (TSCA) for five chemical
substances which were the subject of premanufacture notices (PMNs). EPA
published these SNURs using direct final rulemaking procedures. EPA
received notice of intent to submit adverse comments on the rules.
Therefore, the Agency is removing these SNURs, as required under the
expedited SNUR rulemaking process. EPA intends to publish in the near
future proposed SNURs for these five chemical substances under separate
notice and comment procedures.

DATES: This final rule is effective on July 25, 2012.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    A list of potentially affected entities is provided in the Federal
Register of April 27, 2012 (77 FR 25236) (FRL-9343-4). If you have
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. What Rule is being removed?

    In the Federal Register of April 27, 2012 (77 FR 25236), EPA issued
several direct final SNURs, including SNURs for five chemical
substances that are the subject of this removal. These direct final
rules were issued pursuant to the procedures in 40 CFR part 721 subpart
D. In accordance with Sec.  721.160(c)(3)(ii), EPA is removing these
rules issued for five chemical substance which were the subject of PMNs
P-01-384, P-01-385, P-01-386, P-01-387, and P-01-388 because the Agency
received notice of intent to submit adverse comments without sufficient
time to respond prior to the effective date of the rule. EPA intends to
publish proposed SNURs for these chemical substances under separate
notice and comment procedures.
    For further information regarding EPA's expedited process for
issuing SNURs, interested parties are directed to 40 CFR part 721,
subpart D, and the Federal Register of July 27, 1989 (54 FR 31314). The
record for the direct final SNUR for these chemical substances that are
being removed was established at EPA-HQ-OPPT-2011-0577. That record
includes information considered by the Agency in developing this rule
and the notice of intent to submit adverse comments.

III. How do I access the docket?

    To access the electronic docket, please go to http://www.regulations.gov and follow the online instructions to access docket
ID number EPA-HQ-OPPT-2011-0577. Additional information about the
Docket Facility is provided under ADDRESSES in the Federal Register of
April 27, 2012 (77 FR 25236). If you have questions, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

IV. Statutory and Executive Order Reviews

    This final rule removes existing regulatory requirements and does
not contain any new or amended requirements. As such, the Agency has
determined that this removal will not have any adverse impacts,
economic or otherwise. The statutory and executive order review
requirements applicable to the direct final rule were discussed in the
Federal Register of April 27, 2012 (77 FR 25236). Those review
requirements do not apply to this action because it is a removal and
does not contain any new or amended requirements.

V. 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
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 the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: July 16, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.

Sec.  [emsp14]9.1  [Amended]

0
2. The table in Sec.  [emsp14]9.1 is amended by removing the following
sections under the undesignated center heading ``Significant New Uses
of Chemical Substances'': Sec. Sec.  721.10308, 721.10309, 721.10310,
721.10311, and 721.10312.

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec. Sec.  [emsp14]721.10308, 721.10309, 721.10310, 721.10311, and
721.10312  [Removed]

0
4. Remove Sec. Sec.  [emsp14]721.10308, 721.10309, 721.10310,
721.10311, and 721.10312.

[FR Doc. 2012-17897 Filed 7-24-12; 8:45 am]
BILLING CODE 6560-50-P


SUPPORTING STATEMENT FOR

AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title of the Information Collection

Title:  Experimental Use Permits (EUPs) for Pesticides

OMB No. 2070-0040				EPA No. 0276.15

1(b)	Short Characterization/Abstract

This Information Collection Request (ICR) is a renewal of an existing
ICR that is currently approved by OMB and is due to expire June 30,
2014.  The information collection provides EPA with the data necessary
to determine whether to issue an experimental use permit (EUP) under
section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (Attachment A, pp. 58-59).  FIFRA requires that before a
pesticide product may be distributed or sold in the U.S., it must be
registered by EPA.  However, FIFRA section 5 authorizes EPA to issue an
EUP to allow pesticide companies to temporarily ship pesticide products
for experimental use for the purpose of gathering data necessary to
support the application for registration of a pesticide product.  In
general, EUPs are issued either for a pesticide not registered with the
Agency or for a new use of a registered pesticide.

The information collected and reported under an EUP is a summary of that
which is routinely submitted in connection with registration.  The EUP
allows for large scale field testing, if necessary, in order to collect
sufficient data to support registration.  An EUP is not required if the
person conducting the tests does not expect to receive benefits in pest
control.

The prospective registrant files EPA Form 8570-17, Application for An
Experimental Use Permit to Ship and Use a Pesticide for Experimental
Purposes Only (see Attachment B) for a permit to generate information or
data necessary to register a pesticide under Section 3 of FIFRA.  This
information from the applicant is necessary in order to grant and
effectively monitor the EUP.  The applicant must also provide the Agency
with a final report on the results of the experimental program which
includes information such as: amount of the product applied; the crops
or sites treated; any observed adverse effects; any adverse weather
conditions which may have inhibited the program; the goals achieved; and
the disposition of containers, unused pesticide material, and affected
food/feed commodities.

If the food/feed treated under the terms of an EUP is to be shipped in
commerce, the applicant must also submit a petition for temporary
tolerance pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 346a) unless a tolerance is already
established.  The information collection activities associated with
tolerances are addressed in a separate ICR (EPA ICR #597), which is
approved by OMB under OMB Control Number 2070-0024.  As such, tolerance
related activities are not described in this ICR.

2.	NEED FOR AND USE OF THE COLLECTION

2(a).  Need/Authority for the Collection

As required by section 5 of FIFRA, and Part 172 of Title 40 of the Code
of Federal Regulations (40 CFR Part 172), the information collected and
reported is necessary to evaluate the potential hazard of the product
and to make certain that the permit was issued for genuine experimental
purposes rather than as a form of temporary registration.  (See
Attachment C for a link to the regulations).  To ensure compliance, the
final report is compared with the objectives of the testing program.
The information also enables EPA to identify whether the treated food or
feed crops will be used in a commercial market.  Such use would require
the existence of a tolerance or the issuance of a temporary tolerance.
If there is no tolerance, the crop must be destroyed because the use was
for research purposes only.  Since it is common for applicants to
request extensions of EUPs, it is imperative that the Agency has reports
in hand in order to judge the need for such extensions.

Exemptions from EUP requirements:

Under the existing EUP regulations, small-scale experimental uses of
pesticides are presumed exempt from the EUP requirements.  EPA will not
require an EUP for a substance or mixture of substances being put
through laboratory or greenhouse tests, or fewer than one surface acre
per pest for terrestrial tests or fewer than ten acres per pest for
aquatic tests, in which the sole purpose under the following small scale
field testing scenarios:

Land-Pesticide testing on plots of land ten acres or less in size:

Test plots may be as large as ten acres per pest if the effect of each
pesticide on several pests is being investigated at a different time for
each pest.  However, if pesticide effects on more than one pest are
being investigated all at the same time, the test plot may not exceed
ten acres in size.  Furthermore, any food or feed crops involved in or
affected by the tests must be destroyed or consumed only by experimental
animals unless a tolerance or exemption from a tolerance has been
established.

Aquatic Uses-Pesticide testing on water bodies one surface acre or less
in size:

Water bodies may be as large as one acre per pest if the effect of each
pesticide on several pests is being investigated at a different time for
each pest.  However, if pesticide effects on more than one pest are
being investigated all at the same time, the water body may not exceed
one acre in size.  Bodies of water involved in or affected by the tests
may not be used for irrigation, drinking water supplies, or body contact
through recreational activities.  In addition, pesticides may not be
tested in waters that contain or which affect any fish, shellfish or
other plants or animals which may be taken for food or feed unless a
tolerance or exemption from tolerance exists for the test product.

Animal Treatment Uses:

Tests may be conducted only in cases where experimental animals will not
be used for food or feed unless a tolerance or exemption from tolerance
exists for the test product.

Other Uses:

In instances where testing operations do not accurately reflect whether
the testing is to be considered small-or large-scale acreage limits, the
Agency will determine on a case-by-case basis whether an exemption from
the requirement from an EUP is appropriate.

The exemptions described above are not definitive, but 40 CFR 172.3
gives EPA discretionary authority to exempt particular testing
operations from the EUP requirements under other conditions.  40 CFR
172.3 also allows EPA discretionary authority to require EUPs for
testing operations even when the exemption conditions of 40 CFR 172.3(b)
and (c) are met.

EUP for Small-scale Field Testing of Microbial Pesticides:

The Agency may require an EUP for small scale field testing of certain
unique microbial pesticides (i.e., genetically-altered and
non-indigenous microbial pest control agents) because of the potential
concern for microorganisms to reproduce and multiply in the environment
and the potential for these microbial pesticides to cause unforeseen
adverse impacts.  Prior to the initiation of any small scale field
testing involving genetically-altered or non-indigenous microbial pest
control agents, the research organization, company, or individual must
submit a notification to the Agency so that a determination can be made
as to whether an EUP is required.  The requirements for a EUP for field
testing of microbial pesticides are found in 40 CFR 172.43-172.59.
These requirements differ significantly from the EUP requirements for
testing other pesticides.

2(b).  Practical Utility/Users of the Data

The information collected and reported under an EUP will enable the
Agency to:

Determine whether a new request for an EUP or a renewal, extension or
amendment of an EUP, if requested, is justified;

allow for adequate monitoring of the EUP program; and

ascertain the cause/effect relationship when a pesticide is registered
and later found to have adverse effects (as in the case of
phytotoxicity); and

allow the Agency to review efficacy data which may contain important
health data.

3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a).  Non duplication

The respondent is not required to submit EUP-related information or data
to any other Federal agency or to any other EPA program offices.  FIFRA
section 7, however, does require annual pesticide production reports
from all persons who produce pesticides (see Attachment A, p. 65).  The
pesticide material produced in conjunction with an EUP would be included
in these annual production reports; however, annual production
information is not required as a condition of the EUP, only total
production in the final report.

3(b).  Public Notice Required Prior to ICR Submission to OMB

Pursuant to 5 CFR 1320.8(d), EPA is publishing a Federal Register (FR)
Notice announcing this proposed information collection activity and
providing a 60-day public comment period.

3(c). Consultations on this Renewal ICR

In the context of an individual EUP, consultation and/or dialogue
between the respondent and EPA occurs on an informal, ongoing "as
needed" basis, primarily during the submission and review of the
application for an EUP.  Historically, when technical, administrative or
other problems arise, the respondent is given ample opportunity to
inform the agency and vice versa. This communication between both
parties may take place either in a telephone conversation or in a
meeting setting, but not necessarily by a prescribed schedule.

In addition, as required under 5 CFR 1320.8(d)(1), EPA staff will
contact several representatives of pesticide registrants by e-mail to
seek feedback on the EUP information reporting requirements and the
regulatory burden estimates expressed by the Agency in this ICR.  EPA
will provide a list of those representatives, the questions posed to
those representatives, and any responses that are received as part of
the final ICR supporting statement.

3(d).  Effects of Less Frequent Collection

There is only one submission required in conjunction with each request
for EPA approval to conduct testing on certain pesticides.  Therefore,
the frequency of the collection cannot be reduced, except to eliminate
the collection altogether.  The Agency then would have no means by which
to evaluate the potential human health risks and environmental hazard
presented by a proposed test.

3(e).  General Guidelines

The only guideline under the Paperwork Reduction Act (PRA) that is
exceeded in this collection is the time period for retaining records.
EPA requirements in 40 CFR 169.2(k) state that records containing
research data relating to registered pesticides be retained as long as
the registration is valid and the manufacturer remains in business.
Pesticide registrations are valid until they are either voluntarily
canceled or withdrawn by the registrant or until EPA has cause to
suspend or cancel the registration.  Since the average period of
marketability of a pesticide ranges from 15 to 30 years, the PRA
guidelines specifying that data other than health, medical, or tax
records not be required to be retained for more than three years will be
exceeded in this program.

3(f).  Confidentiality

When trade secret information or Confidential Business Information (CBI)
is provided to the Agency, such information is protected from disclosure
under FIFRA Section 10, as amended and EPA's confidentiality regulation
in 40 CFR Part 2, Subpart B.  Data submitted to the Agency are handled
strictly in accordance with the FIFRA CBI Security Manual.  This manual
contains instructions relative to all contact with confidential
documents, including responsibility of EPA employees; physical security
measures; CBI materials within EPA, such as CBI typing procedures
(documents typed internally or on contract); and division internal
procedures.  The manual dictates that: (1) all CBI must be marked or
flagged as such, (2) all CBI must be kept in secure, double-locked
areas, and (3) all CBI for destruction must be cleared by a document
control officer and placed in the Office of Chemical Safety and
Pollution Prevention paper shredder.

3(g).  Sensitive Questions

No information of a sensitive or private nature is requested in
conjunction with this information collection activity.  Further, this
information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB Circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a).  Respondents/NAICS Codes

 The North American Industrial Classification System (NAICS) code for
respondents participating in this data collection is 325320 (Pesticide
and other Agricultural Chemical Manufacturing).

4(b).  Information Requested

4(b) (i)	Data Items

Form 8570-17 must be submitted to EPA with each EUP application. The
type of information to be submitted with the application depends on
whether the product is already registered and whether a tolerance is
required for the testing covered under the EUP.  40 CFR 172.4 lists the
information that is required.

An application for an EUP may be submitted by any company or person
wishing to generate the information necessary as required by section 3
of FIFRA in accordance with the regulations found in 40 CFR 172.2(a).
The applicant may be a potential registrant, an independent researcher
or testing laboratory, or any similar agent or consultant of a
manufacturer.  Applications must be submitted to the following address:

Document Processing Desk (EUP)

U.S. Environmental Protection Agency

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave. NW

Washington, D.C. 20460

Information Required in All EUP Applications:

Each EUP application must contain the following information together
with a completed copy of 8570-17:

Applicant’s name and address;

The registration number of the product, if it has been registered
(information requirements for unregistered products are listed below in
a separate section);

Purpose or objectives of the proposed testing;

Detailed description of the proposed testing program including the
following test parameters:

Pest organism(s) involved;

Amount of pesticide proposed to be used;

Crops, fauna, and flora involved;

Sites and modes of pesticide applications;

Pesticide dosage rates;

Location of test site, including States;

Number of acres in test site;

Number of structural sites or number of animals by State to be included
in the testing;

Proposed dates of the testing; and

How the testing will be supervised.

Name, street address, telephone number and qualifications of program
participants, including those not employed by the applicant;

Names and street addresses of cooperators (persons owning or controlling
application sites and granting permission to permittees to use these
sites);

Results of prior testing of product by applicant to determine:

Toxicity and effects in or on target organisms;

Toxicity and effects in or on non-target plants, animals and insects at
or near the application site; and

Adverse effects to the environment from application of this product; and

How the applicant intends to store and dispose of unused pesticide and
containers from the proposed experimental use.

Information Required When the Product to be Tested is Not Already
Registered:

New data required to be submitted for EUP applications for field testing
of both unregistered chemical and plant-incorporated pesticides (PIP) to
show that the pesticide during testing will not cause an unreasonable
adverse effect to man and the environment are substantially greater than
registered pesticides that have already met these requirements of FIFRA
for their labeled uses.

In addition to the information listed immediately above, when the
product to be tested has not been registered, the applicant must provide
the following information:

A complete confidential statement of composition giving the composition
of the formulation to be tested as a tabulation of the names and
percentage by weight of each ingredient, both active and inert;

Chemical and physical properties of each active ingredient of the
formulation being tested including the analytical methods to be used to
determine these;

Available data on the rate of decline of residues on the treated crop or
site together with other information relevant to determining when
workers can safely re-enter treated areas; and

Available toxicity and exposure data, including human epidemiological
data, relevant to assessing the potential of the product to cause injury
to users and other people who may be exposed.

When Testing May Result in Pesticide Residue on Food:

	When the product to be tested is to be used in such a manner to leave
residue on food or feed, the applicant has three options for determining
that treated crops are not used for food or feed use without a
tolerance:

The applicant may submit evidence that a tolerance or a tolerance
requirement exemption has been established under Section 408 of the
FFDCA;

The applicant may submit a petition for a new tolerance or for an
exemption from the requirement for a tolerance established under Section
408 of the FFDCA (Chapter 7 of this document, Tolerance Petitions,
describes this process in detail); and

The applicant may certify that the food or feed derived from the
experimental program will be destroyed or will be fed only to
experimental animals which will be destroyed. Alternatively, the
applicant may certify that the food or feed derived from the
experimental program will be disposed of in another manner which does
not endanger man or the environment; the permit application shall
specify the means of such disposal.

EUP applications should be submitted to EPA as far in advance as
possible of the first shipping date, at least six months in advance.
FIFRA section 5(a) requires EPA to complete EUP reviews within 120 days,
and failure to provide the appropriate information or data may delay
processing of the EUP beyond this date.

Labeling Requirements:

All pesticides shipped or used under an EUP must be labeled with
directions and conditions for use including the following:

The prominent statement “For Experimental Use Only”;

The Experimental Use Permit Number;

The statement “Not for sale to any person other than a participant or
cooperator of the EPA-approved Experimental Use Program”;

The name, brand or trademark;

The name and address of the permittee, producer, or registrant;

The net contents;

An ingredient statement;

Warning or caution statements;

Any limitations on entry of persons into treated areas;

The establishment registration number, except in those cases where
application of the pesticide is made solely by the producer; and

The directions for trial use.

Extensions or renewal of EUPs:

EUPs and associated temporary tolerances are usually issued for a period
of one or two years. The permit and any associated temporary tolerances,
may be extended, renewed, or amended upon written request to the Agency,
if circumstances warrant.

Fee Requirements:

If an application for an EUP is accompanied by a petition for a
tolerance, temporary tolerance, an exemption from the requirement of a
tolerance, or a temporary tolerance exemption, the petition is subject
to fee requirements.  An extension or renewal request for a temporary
tolerance is also subject to a fee requirement.  In October 2012, the
Pesticide Registration Improvement Act (PRIA) of 2012 became effective.
The goal of this Act is to create a more predictable evaluation process
for affected pesticide decisions, and couple the collection of
individual fees with specific decision review periods. The legislation
also promotes shorter decision review periods for applications including
reduced-risk.  Certain submitted EUP actions are included under PRIA and
the burden hours and costs associated with these activities are
estimated in the Pesticide Registration Fees Program ICR, (OMB Control
No.: 2070-0179, EPA ICR No.: 2330), and are not duplicated in this ICR.

Use of an EUP Product on Food or Feed Crops:

A product may only be used on food or feed crops if the Agency has
issued tolerances or exemptions from requirements for tolerances for all
inert ingredients, metabolites, and degradation products, as well as
active ingredients. If the proposed labeling bears instructions for use
of the product on food or feed crops, or if the intended use of the
product results or may be expected to result, directly or indirectly, in
pesticide residues in or on food or feed, applicants must submit a
statement indicating whether a tolerance or an exemption from the
requirement of a tolerance has been issued by the Agency under section
408 of the FFDCA.

If a tolerance, exemption from the requirement of a tolerance has not
been issued for such residues, applicants must include with the
application a petition for establishment of appropriate tolerances,
exemptions from the requirement of a tolerance, or food additive
regulation in accordance with 40 CFR 180. Alternatively, applicants may
certify that the food or feed derived from the experimental program will
be destroyed or fed only to experimental animals for testing purposes,
or otherwise disposed of in a manner which will not endanger man or the
environment.

Suggested Format for an EUP Application:

The following format is an example of an acceptable EUP application. Not
all of the items are necessary in every case. Depending on whether the
product being tested is already registered with EPA, and whether a
tolerance is necessary because treated crops will be used as food or
feed, several of these entries may not be necessary.

Section A - This section should include a data sheet detailing the
chemical and physical properties of the test chemical along with a
complete statement of the names and percentages by weight of each active
and inert ingredient in the formulation to be shipped.

Section B - This section should include a copy of the proposed
experimental label. The minimum labeling requirements are set forth in
40 CFR 172.6.

Section C - This section should include toxicity data, including LD
ADVANCE \d3 50 ADVANCE \u3  values, eye and skin irritation data for the
formulated product, and subacute, teratology (one species),
mutagenicity, and possibly chronic and reproduction data on the active
ingredient. Data on the product’s toxicity to fish and wildlife may
also be included in Section C as appropriate.

Section D - This section should include residue data, including when
appropriate, data on: (1) food or feed commodities; (2) non-food crops
such as tobacco; or (3) foliage or other sites where the product may be
used and on which remaining residues of the product may pose a risk to
man or the environment. Section D also includes a description of the
analytical methods used, a summary of the residue data acquired, and
when appropriate, environmental fate data.

Section E - This section should include product performance information
demonstrating that the product is useful for the purposes proposed.
Because EPA has waived the requirement for submitting efficacy data for
all products except those with public health uses, Section E need not
contain actual efficacy data, but should include a summary of the
results of all efficacy testing performed on the product.

Section F - This section should include a statement explaining whether a
tolerance exists or is being requested, especially if the product is to
be tested in a manner that may result in residues in food or feed. If a
tolerance is being requested, the temporary tolerance petition must be
provided with the EUP application.  Given the occurrence whenever all
food or feed derived from the experimental program is to be destroyed or
fed to experimental animals, a statement of explanation must be
included.

Section G - The section should include details concerning the proposed
experimental program, including:

qualifications, names, addresses and telephone numbers of all EUP
participants, including cooperators, i.e., persons who grant permission
for an experimental use pesticide to be used on application sites which
they own or control;

names of states in which the product will be used, along with the amount
of active ingredient and acreage (or other appropriate measures) to be
used in each state, and the names of states in which the pesticide may
be shipped for further distribution;

details of the proposed EUP program, including types of pests or
organisms targeted; the crops, animals, surface, or sites to be treated;
the geographical areas where the material is to be used; the use
patterns, intended plot sizes, number of plots, number of replicates,
and other test parameters to be used;

information on prior testing, including a description and the specific
results of any appropriate prior testing of the product conducted by the
applicant to determine, toxicity and effects in or on any target
organisms at the site of application; phytotoxicity and other forms of
toxicity or effects on nontarget plants, animals and insects, at or near
the site of application ; or any adverse effects on the environment;

objectives of the EUP program, including a statement specifying the type
of data to be collected and the intended gain from conducting the
program;

justification for the quantity (volume) of active ingredient proposed to
be used under the EUP, including a statement specifying the various
parameters used to determine the quantity of active ingredient;

a statement proposing a suitable duration for the EUP commensurate with
the program objectives; and

details concerning the method of disposing of unused materials at the
conclusion of the testing program.

Program Surveillance and Data Reporting Requirements for an EUP:

Once the permit is issued and the pesticide testing is underway, the
applicant is required to track the results at each test site and submit
a final report to EPA which shall include (40 CFR 172.8):

All data gathered during the testing program. Although field notes need
not be included in this report, they must be kept available for EPA
review upon request.

A report of how pesticide containers and unused pesticides were disposed
of, including the quantity disposed of, disposal sites and disposal
methods.

In the case where meat-producing animals or birds are treated by or
exposed to an experimental use pesticide, the applicant must report the
name and location where the animals will be processed to the U.S.
Department of Agriculture, Animal and Plant Health Inspection Service,
Washington, DC, 20250.

The applicant must also report any adverse effects from use of or from
exposure to the pesticide being tested.

EPA may require advance notice from the applicant of the intended test
dates, sites and times. The applicant must also allow EPA access to the
testing site to determine whether the testing complies with the terms
and conditions of the permit.

	4(b) (ii)	 Respondent Activities

	The following are the activities to be conducted by a respondent
(applicant) in order to comply with the provisions of EPA Form 8570-17.

Activity	Explanation

read FIFRA Section 5

and 40 CFR 172.8(b) 	become familiar with the legislation and
regulations and determine the requirements as they pertain to a
proposed experimental use of a pesticide

plan activities	plan the actions necessary to comply with the
legislation and regulations

create information	develop information required for notification

gather information	gather information required for the notification or
containment records

process, compile, and  review information 	check information for
accuracy and completeness

complete paperwork	prepare notification document or containment record

record, disclose, and display information	submit notification to OPP

store, maintain, and file information	retain copies of all submissions

5.	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a).  Agency Activities

	The following are activities necessary to evaluate a submitted request
for an EUP:

Activity	Explanation

review submitted application package 	review application form and
package for completeness and appropriateness

record submission	record submission in tracking system

analyze submission	conduct scientific reviews of data

file submission 	store and maintain submission information in Agency’s
file system

5(b).  Collection Methodology and Management

A submitted EUP package usually includes three parts: an EPA Application
Form 8570-17, the product label, and, in most cases, supporting data.
The application form and the product label are pin-punched by date by
the Front-End Application Processing Unit for initial screening.  If
everything is found to be complete, the proposed EUP is given a file
symbol, entered into the appropriate tracking system, and a registration
jacket is created identifying the document by the appropriate Product
Manager (PM) for the chemical being employed.  The accompanying data is
identified and processed for review.

The three-part EUP package is sent to the designated PM who is
responsible for managing the registration action.  The testing program
and labeling program are reviewed by the PM while the data portion is
routed for scientific review to the appropriate discipline.  On
completion of the scientific review, the PM receives a written analysis
of the data.  If the data is found to be acceptable, an EUP is issued.
If not, the EUP request is rejected and the PM then notifies the
applicant in writing of the deficiencies before the EUP request can be
resubmitted.  The file is then updated in the tracking system to reflect
the latest status and the registration jacket is stored in the file
room.

5(c).  Small Entity Flexibility

The Agency recognizes that many small businesses are involved in
research and development activities with pesticides.  In setting forth
the notification requirements, EPA has sought to minimize the regulatory
burden on research and development activities.  Toward this end, the
Agency has identified the minimum amount of data to be submitted to
permit a scientific assessment of the proposed research.  Much of this
information already would be available to the respondent as part of the
normal information developed during the research and development stage.
These data requirements are flexible and may be adjusted as appropriate
to the specific product under review.  As an alternative to submitting a
Notification, an applicant may apply for, and obtain an EUP before
conducting a field test with a pesticide.  Because the notification
requirements have been designed from the outset to minimize the burden
on respondents, as a result, there are no special measures taken for
small businesses since the burden is considered to be at a minimal
level.

5(d).  Collection Schedule

Not applicable.  This activity is conducted only when an EUP request is
made.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a).   Estimating the Respondent Burden

The burden associated with this collection of information is described
in detail in the following sections.  In calculating the respondent
burden, EPA will provide burden estimates for those who apply for
chemical pesticide EUPs and for those who apply for plant-incorporated
protectants (PIPs) EUPs.  Consultations during the previous renewal
cycle (EPA No. 0276.14) and a review of the Agency process for EUP data
submissions indicated the need for the creation of a second response
type specifically for PIPs because the requirements for field testing of
PIPs tend to be more intensive than for chemical pesticides and because
of the time needed to assemble and format the data to fulfill PR Notice
2011-3 requirements (Attachment F).

Based on the number of EUP applications received in fiscal years 2010,
2011 and 2012, the estimated annual number of responses for chemical
pesticides is 8 and the estimated number of EUP applications for PIPs is
2 for each year of the three year renewal cycle.  Total respondent
burden hours are estimated at 32.8 hours per response for chemical
pesticides at a cost of $1,970.52 per response, and 147 hours per
response for PIPs at a cost of $9,054.07 per response. The total annual
respondent burden of the EUP program is estimated to be 556 hours and
$33,872.

6(b)   Estimating Respondent Costs

	Respondent cost is based on the burden as described above and
summarized below, and wages, benefits, and overhead for all labor
categories for affected industries, state government, and EPA employees.
 This approach uses a transparent and consistent methodology employing
publicly-available data to provide more accurate estimates and allow
easy replication of the calculations.

Methodology: The methodology uses data on each sector and labor type for
an Unloaded wage rate (hourly wage rate), and calculates the loaded wage
rate (unloaded wage rate + benefits), and the fully loaded wage rate
(loaded wage rate + overhead).  Costs are indexed to 2012 dollars.

Wage Rates: Wages are estimated for occupations (management, technical,
and clerical) within applicable sectors.  The Agency uses average
unloaded wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at  HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .  For loaded wage rates,
benefits represent 44% of unloaded wage rates, based on benefits for all
civilian non-farm workers, from  HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .  Fully loaded wage rates
include an additional 50% on top of the loaded wage rate to capture
overhead costs (EPA guidelines 20-70%).  The data and calculations for
wage rates used in this document are presented in Attachments G and H.

	Sectors: The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table.  Within each sector, the wage data are provided by
Standard Occupational Classification (SOC).  The SOC system is used by
Federal statistical agencies to classify workers into occupational
categories for the purpose of collecting, calculating, or disseminating
data (see   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm"
http://www.bls.gov/oes/current/oes_stru.htm  ).

To determine respondent costs, the Agency used the BLS estimates of
labor rates for the NAICS code for Pesticide Registrants (NAICS 325300).
 The managerial labor rate is based on the SOC for management
occupations; the technical labor rate is based on the SOC for life,
physical and social science occupations; and the clerical labor rate is
based on the SOC for office and administrative support occupations.  The
labor rates are fully loaded and indexed to May 2012 dollars (See
Attachment G).  The fully loaded hourly mean wage rate estimate for
managerial occupations is $117.73 per hour.  For technical occupations,
the fully loaded mean wage rate is $62.57 per hour, and for occupations
the fully loaded mean wage rate is $37.33 per hour. (See Worksheet for
Pesticide Registrants, NAICS: 325300).

Using the Agency’s burden estimate and the fully-loaded labor rates,
the Agency estimates the applicant labor costs to be approximately
$1,970.52 per chemical pesticide EUP response, and $9,054.07 per PIPs
EUP response. The total labor cost associated with the paperwork burden
of the EUP program is estimated to be $33,872 (15,764 + 18,108).

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR CHEMICAL
PESTICIDES

COLLECTION ACTIVITIES	BURDEN HOURS (PER YEAR	TOTAL

	Management

$117.73/hr.	Technical

$62.57/hr.	Clerical $37.33/hr.	Hours	Costs

Read regulations	 1.3 	 1.3 	 -   	 2.5 	$225.38

Plan activities	 -   	 2.5 	 -   	 2.5 	$156.43

Create information	 -   	 3.0 	 2.0 	 5.0 	$262.38

Gather information	 -   	 4.3 	 4.0 	 8.3 	$415.25

Compile and review	 2.0 	 6.0 	 2.0 	10.0 	$685.56

Complete paperwork	 0.3 	 0.8 	 2.0 	 3.1 	$156.91

Store/maintain data	 -   	 0.5 	 1.0 	 1.5 	$68.62

TOTAL BURDEN	 3.6 	 18.3 	 11.0 	32.8 	$1,970.52

ANNUAL BURDEN: 32.8 Hours per Response x 8 Responses per Year = 262
Hours

ANNUAL COSTS

	(a) Management:  3.6 hours x $117.73 x 8 respondents 	 	 $3,344

	(b) Technical:   18.3 hours x $62.57 x 8 Respondents 		 $9,135

	(c) Clerical:    11.0 hours x $37.33 x 8 respondents		 $3,285

							 Total		 $15,764*

*Cost estimates affected by rounding in calculation.

RESPONSE BURDEN AND COST ESTIMATES PER EUP APPLICATION FOR
PLANT-INCORPORATED PROTECTANTS

COLLECTION ACTIVITIES	BURDEN HOURS (PER YEAR	TOTAL

	Management

$117.73/hr.	Technical

$62.57/hr.	Clerical $37.33/hr.	Hours	Costs

Read regulations	 2.0 	 4.0 	0.0	 6.0 	$485.75

Plan activities	0.0	 20.0 	0.0	 20.0 	$1,251,43

Create information	0.0	 40.0 	 4.0 	 44.0 	$2,652,18

Gather information	0.0	 6.0 	 8.0 	 14.0 	$674.07

Compile and review	 4.0 	 40.0 	 4.0 	 48.0 	$3,123.11

Complete paperwork	 1.0 	 8.0 	 4.0 	 13.0 	$767.63

Store/maintain data	0.0	 1.0 	 1.0 	 2.0 	$99.90

TOTAL BURDEN	7.0	119.0	21.0	147.0	$9,054.07

ANNUAL BURDEN:  147.0 Hours per Response x 2 Responses per Year = 294
Hours

ANNUAL COSTS

	(a) Management:  7.0 hours x $117.73 x 2 Respondents 	 	  $1,648

	(b) Technical:   119.0 hours x $62.57 x 2 Respondents 		$14,892

	(c) Clerical:    21.0 hours x $37.33 x 2 respondents		 $ 1,568

							 Total		$18,108*

*Cost estimates affected by rounding in calculation.

	6(c)   Estimating Agency Burden and Costs

For this ICR renewal, the Agency is using data on internal OPP Divisions
that provide significant support and analysis for the EUP ICR program.
This data is taken from the Time and Attendance Information System
(TAIS), which archives the Agency’s Full Time Equivalents (FTEs) for
most OPP program activities.  The Agency believes that using data from
the TAIS reflects the changes to the internal operations for
implementing and administering EUP activities.  The major impetus for
internal program realignment was to implement the requirements of the
Food Quality Protection Act of 1996 and the Pesticide Registration
Improvement Act of 2012 (PRIA) as reauthorized.

Using this new source of data the estimated number of Agency FTE’s
dedicated to EUP activities is 0.12 managerial FTE, 1.09 technical FTEs,
and 0.07 clerical FTE.  Greater detail is given in the below tables.
The aggregated Agency estimated FTEs dedicated to EUP activities is 1.28
and, based on 2,080 hours per FTE, the burden hours are 2,654.

Distribution of Agency Managerial FTEs Supporting EUP Activities

AD	BPPD	EFED	HED	RD

0.00	0.05	0.03	0.03	0.01

Agency total 	0.12

Distribution of Agency Technical FTEs Supporting EUP Activities

AD	BPPD	EFED	HED	RD

0.03	0.52	0.27	0.23	0.05

Agency total 	1.09

Distribution of Agency Clerical FTEs Supporting FIFRA EUP Activities

AD	BPPD	EFED	HED	RD

0.00	0.03	0.02	0.01	0.00

Agency total 	0.07

To determine Agency costs, the Agency used the Bureau of Labor
Statistics estimates of labor rates for the North American Industry
Classification System (NAICS) code for the Federal Executive Branch
(NAICS 999100).  The managerial labor rate is based on the Standard
Occupational Code (SOC) for management occupations; the technical labor
rate is based on the SOC for life, physical and social science
occupations; and the clerical labor rate is based on the SOC for office
and administrative support occupations.  The labor rates are fully
loaded and indexed to May 2012 dollars (See Attachment H).  The fully
loaded hourly mean wage rate estimate for managerial occupations is
$120.60 per hour.  For technical occupations, the fully loaded mean wage
rate is $78.24 per hour, and for occupations the fully loaded mean wage
rate is $44.61 per hour. (See Attachment H, Worksheet for NAICS 999100
EPA or Federal Government)

To calculate the Agency’s estimated annual cost of EUP activities, the
number of FTEs allocated to EUP activities is multiplied by the cost per
FTE.  This represents the Agency’s estimate of its cost that will
result from EUP activities for each of the next three years.

ANNUAL BURDEN:  1.28 FTE x 2,080 hours per FTE = 2,654 Hours

ANNUAL COSTS

	(a) Management:  241 hours (0.12 FTE) x $120.60 =	$ 29,006

	(b) Technical:   2,270 hours (1.09 FTE) x $78.24 =		$177,617

	(c) Clerical:    143 hours (0.07 FTE) x $44.61 =		$    6,377

						Total			$213,000*

*Cost estimates affected by rounding in calculation

6(d)   Bottom Line Hours and Costs / Master Table

	MASTER TABLE

TOTAL

Hours

Costs

Respondent Burden/Cost Estimates: 	556

          $33,872

Agency Burden/Cost Estimates:

2,654

          $213,000

6(e)   Reasons For Changes in Burden

	Annual respondent burden is estimated in this renewal to be 556 hours.
This is a decrease from the estimate in the previous ICR of 1,351 hours
(1907 – 556 =1,351).  This decrease is an adjustment as a result of
reduced experimental use permit (EUP) submissions by program
participants, as well as a decrease in the portion of EUP applications
that are for plant-incorporated protectants (PIPs).  Estimated
respondent costs have also decreased from $114,566 to $33,872.

Estimated Agency burden and total costs has also been adjusted downwards
from 4,271 hours to 2,654 hours and from $325,325 to $213,000.  This is
a result of a decrease in the number of responses used to calculate
Agency burden.

6(f)   Burden Statement

The total annual “respondent” (applicant) burden for the renewal ICR
entitled Experimental Use Permit (EUP) for Pesticides is estimated to be
556 hours with an average potential per response burden of between 32.8
hours for chemical pesticides and 147 hours for plant-incorporated
protectants.  “Burden” is defined in 5 CFR 1320.3(b).  The agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.  OMB control numbers for certain EPA regulations in
title 40, after initial display in the final rule, are listed in 40 CFR
part 9 and appear on the information collection instrument as
applicable, i.e., form or instructions, and in the Federal Register.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2013-0617, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Docket in the EPA Docket Center, EPA West, Rm.
3334, 1200 Pennsylvania Ave, NW, Washington, DC 20460-0001. This docket
facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The docket telephone number is (703)
305-5805.

You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques. Comments may be submitted to EPA
electronically through http://www.regulations.gov or by mail addressed
to OPP Regulatory Public Docket (7502P), Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460–0001.  You can also send comments to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for
EPA.  Include docket ID No. EPA-HQ-OPP-2013-0617 and OMB control number
2070-0040 in any correspondence, but do not submit EUP applications and
any related information (e.g., forms, reports, etc.) to these addresses.
 The information described in this ICR is to be submitted to the address
identified in section 4(b) of this supporting statement.

7.	ATTACHMENTS to this SUPPORTING STATEMENT

	All of the attachments listed below can be found in the docket for this
ICR, identified as Docket ID Number, EPA-HQ-OPP-2013-0617, which is
accessible electronically through   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  On the main page,
select Advanced Search from the menu bar at the top and select Docket
Search.  Enter the Docket ID Number in the Docket ID field.  Click on
the Submit button.  From the results page, you will be able to link to
the docket view or directly open select documents found in the docket.

Attachment A:	Federal Insecticide Fungicide Rodenticide Act (FIFRA), 7
U.S.C. 136 et seq.

  HYPERLINK "http://www.epa.gov/opprd001/registrationmanual/FIFRA.pdf"
http://www.epa.gov/opprd001/registrationmanual/FIFRA.pdf

Attachment B:	EPA Form 8570-17 - Application for an Experimental Use
Permit to Ship and Use a Pesticide for Experimental Purposes Only

  HYPERLINK "http://www.epa.gov/opprd001/forms/8570-17.pdf"
http://www.epa.gov/opprd001/forms/8570-17.pdf

Attachment C:	40 CFR Part 172 - Experimental Use Permits

(e-CFR:    HYPERLINK
"http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=7fd873207444a629c7cb2c2
079717f48&rgn=div5&view=text&node=40:<IP_ADDRESS>.21&idno=40"
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=7fd873207444a629c7cb2c20
79717f48&rgn=div5&view=text&node=40:<IP_ADDRESS>.21&idno=40 )

Attachment D:	PLACEHOLDER - Renewal Consultations (List of
Representatives and Questions Posed)

Attachment E:	PLACEHOLDER - Consultations Responses

Attachment F:	Pesticide Registration (PR) Notice 2011-3: Standard Format
for Data Submitted Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA)

  HYPERLINK "http://www.epa.gov/pesticides/PR_Notices/pr2011-3.pdf"
http://www.epa.gov/pesticides/PR_Notices/pr2011-3.pdf

Attachment G:	Work Sheet used to Calculate Registrant Labor Costs

Attachment H:	Work Sheet used to Calculate EPA Labor Costs

August 26, 2013

Page   PAGE  16  of   NUMPAGES  18


[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Rules and Regulations]
[Pages 41426-41427]
[FR Doc No: 2014-16608]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0575]

Drawbridge Operation Regulation; Old River, Between Victoria
Island and Byron Tract, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Route 4 Highway Drawbridge across
Old River, mile 14.8, between Victoria Island and Byron Tract, CA. The
deviation is necessary to allow the bridge owner to paint mechanical
components of the bridge. This deviation allows the bridge to remain in
the closed-to-navigation position during the deviation period.

DATES: This deviation is effective without actual notice from July 16,
2014 until 6 a.m. on July 20, 2014. For the purposes of enforcement,
actual notice will be used from 10 p.m. on July 13, 2014, until July
16, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0575], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: The California Department of Transportation
has requested a temporary change to the operation of the Route 4
Highway Drawbridge, mile 14.8, over Old River, between Victoria Island
and Byron Tract, CA. The drawbridge navigation span provides 12 feet
vertical clearance above Mean High Water in the closed-to-navigation
position. Pursuant 33 CFR 117.183, the draw opens on signal from May 1
through October 31 from 6 a.m. to 10 p.m. and from November 1 through
April 30 from 9 a.m. to 5 p.m. and at other times, opening the draw on
signal if at least four hours advance notice is given to the drawtender
at the Rio Vista drawbridge across the Sacramento River, mile 12.8.
Navigation on the waterway is commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 10 p.m. to 6 a.m. from July 13, 2014 to July 20, 2014 to allow
Caltrans to paint several mechanical components of the bridge. This
temporary deviation has been coordinated with the waterway users. No
objections to the proposed temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies
between 10 p.m. and 6 a.m. during the deviation period. An alternative
route around Victoria Island may be used for vessels unable to pass
through the bridge in the closed position. The Coast Guard will also
inform the users of the waterways through our Local and Broadcast
Notices to Mariners of the change in operating schedule for the bridge
so that vessels can arrange their transits to

minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: July 2, 2014.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2014-16608 Filed 7-15-14; 8:45 am]
BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  3/31/2008

SUBJECT:	Ingredient:  Uniconazole-P

		Title:  Acute, Chronic and Cancer Aggregate Dietary (Food and Drinking Water) Exposure Analyses for the Section 3 Registration Action

PC Code:  128976  	DP Barcode:  D348937

MRID No.:  None	Registration No.:  59639-37

Petition No.:  7E7268	Regulatory Action:  Section 3

Assessment Type:  Single Chemical/Aggregate	Reregistration Case No.:  None

TXR No.:  None	CAS No.:  83657-17-4

FROM:	Douglas Dotson, Ph.D., Chemist

RAB2/Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist

David Hrdy, Senior Scientist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Richard Loranger, Ph.D., Branch Senior Scientist

RAB2/Health Effects Division (7509P)

TO:		Edward Scollon, Ph.D, Toxicologist

		RAB2/Health Effects Division (7509P)

and

Shaja Brothers/Barbara Madden, PM Team 5

RIMUERB/Registration Division (7505P)

Executive Summary

Acute and chronic aggregate dietary exposure analyses were performed for uniconazole-P using the Dietary Exposure Evaluation Model, DEEM-FCID™, Version 2.03.  This Model uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support a Section 3 request for the proposed use on Crop Group 8, Fruiting Vegetables (Except Cucurbits).

Acute Dietary Exposure Results and Characterization

An acute dietary exposure analysis was performed for the population subgroup Females 13-49 only.  This population subgroup is the only one for which an acute dietary endpoint was selected.  The acute analysis was unrefined.  In tolerance petition number 7E7268, the registrant requested a tolerance for only one crop group:  fruiting vegetables, Crop Group 8.  As a result, the analysis included fruiting vegetables and drinking water only.  The recommended fruiting vegetable tolerance (0.01 ppm) was used for fruiting vegetables.  A conservative value was also used for drinking water.  The model-estimated surface water value of 0.0031 ppm was greater than the model-estimated groundwater value of 0.000076 ppm.  As a result, the surface water concentration was used.  A percent crop treated value of 100% was assumed for all fruiting vegetables.  The acute dietary risk estimate for Females 13-49 at the 95th percentile of exposure is 0.4% of the aPAD (on both a per capita basis as well as a per user basis).  Therefore, the dietary risk estimate for this population subgroup is below HED’s level of concern.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary exposure analysis was also unrefined.  The recommended tolerance of 0.01 ppm was used for fruiting vegetables.  A conservative value was also used for drinking water.  The model-estimated surface water value of 0.0015 ppm was greater than the model-estimated groundwater value of 0.000076 ppm.  As a result, the surface water concentration was used.  A percent crop treated value of 100% was assumed for all fruiting vegetables.  The chronic dietary risk estimates for the general U.S. population and all population subgroups are below HED’s level of concern.  The general U.S. population and all subgroups utilize <1% of the cPAD.  The most highly exposed population subgroup is All Infants (<1 year), which utilizes 0.6% of the cPAD.  The general U.S. population utilizes 0.2% of the cPAD.

Cancer Dietary Exposure Results and Characterization

Uniconazole was classified by the HED Carcinogenicity Peer Review Committee (CPRC) as a Group C, possible human carcinogen.  The CPRC recommended the reference dose (RfD) approach for risk assessment, and concluded that the chronic RfD would be protective of all chronic effects including carcinogenicity.  As a result, the chronic dietary exposure analysis is adequate to assess cancer risk.  The general U.S. population utilizes <1% of the cPAD.  Therefore, cancer risk is not of concern to HED.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the point of departure (e.g., NOAEL, LOAEL) divided by the required uncertainty or safety factors.

For uniconazole, HED is concerned when estimated dietary risk exceeds 100% of the PAD for acute, chronic, and cancer exposure scenarios.  References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides website:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/1999).

The proposed use of uniconazole-P on fruiting vegetables is the first food use for the chemical.  As a result, this dietary exposure analysis is the first analysis to be performed for it.

II.	Residue Information

As the proposed use on fruiting vegetables is the first food use for uniconazole-P, there are no tolerances listed for it in the 40CFR.  The residue of concern for risk assessment is parent uniconazole-P, its R-enantiomer, and the Z-isomer.  The analytical method for uniconazole-P does not distinguish between the parent enantiomers and the Z-isomer.  As a result, the field trial values and, therefore, the recommended tolerance account for the Z-isomer.  Uniconazole contains a triazole ring and can potentially be metabolized to 1,2,4 triazole, triazole alanine, and triazole acetic acid.  These compounds result from the metabolism of other triazole pesticides as well, however.  Separate dietary exposure analyses were prepared for these metabolites (D347252 and D347253, W. Cutchin, 12/19/07).  The dietary exposure analyses for the triazole metabolites are adequate to cover the use of uniconazole-P on fruiting vegetable bedding plants for several reasons.  First, the triazole fungicide myclobutanil may be used on tomatoes at a rate of 0.50 lb ai/acre and on peppers and other members of Crop Group 8 at a rate of 0.125 lb ai/acre.  The molecular weights of myclobutanil and uniconazole are very comparable (myclobutanil MW=289 g/mole and uniconazole MW=291).  The equivalent application rates of uniconazole would be 0.50 and 0.126 lb ai/acre on tomatoes and peppers, respectively.  However, the proposed application rate of uniconazole to fruiting vegetables is only 0.018 lb ai/acre.  The myclobutanil application rates are therefore 28x and 7x the uniconazole-P application rates to tomatoes and peppers, respectively.  Second, the proposed use of uniconazole is an early season application to bedding plants prior to fruit being present.  Finally, uniconazole is proposed for greenhouse use on bedding plants that are primarily intended for homeowner use.  Although plants treated with uniconazole-P may be used for commercial fruiting vegetable production, that is not the intended use.  For these reasons, residues of the triazole metabolites will be much lower from the greenhouse use of uniconazole than they are from the field application of myclobutanil and, as stated above, the dietary exposure analyses for the triazole metabolites are adequate to cover the use of uniconazole-P on fruiting vegetable bedding plants.

In the tomato and pepper field trials, the residue values were all below the limit of detection of 0.005 ppm.  HED is recommending in favor of establishing the tolerance at the LOQ of 0.01 ppm.  Therefore, a value of 0.01 ppm was entered for all fruiting vegetable commodities.  Although a tolerance is not requested for okra, that crop was included in this analysis because DEEM has it as a member of the fruiting vegetable crop group.  No processing studies were submitted for tomatoes.  As a result, the following DEEM Version 7.81 default processing factors were used for the specified commodities:  tomato juice (1.5), tomato paste (5.4), tomato puree (3.3), and dried tomatoes (14.3).

 Drinking Water Data

The estimated drinking water concentration (EDWC) used in the dietary risk assessment was provided by the Environmental Fate and Effects Division (EFED, D346559, M. Corbin, 2/12/2008).  The EDWC was incorporated directly into this dietary assessment in the food categories “water, direct, all sources” and “water, indirect, all sources.”  The EDWCs for uniconazole were generated with the FIRST Model for surface water and the SCI-GROW Model for groundwater.  EDWCs reflect exposure to parent only.  The peak surface water value was 0.0031 ppm and the annual average surface water value was 0.0015 ppm.  The groundwater value was 0.000076 ppm.  As the surface water values were greater than the groundwater value, the surface water values were used in both the acute and chronic assessments.

In drinking water, the residues of concern for risk assessment are parent uniconazole and 1,2,4-triazole.  The drinking water concentrations of the triazole metabolites are not being included in these dietary exposure analyses.  They were included in the dietary exposure analyses that were prepared for the metabolites (D347252 and D347253, W. Cutchin, 12/19/07).  The EDWCs used in the dietary exposure analyses were based on myclobutanil application to golf courses (Memo, D320682, I. Maher, 2/28/2006).  The application rate is considerably higher than the proposed application rate of uniconazole to fruiting vegetable bedding plants (10.4 lb ai/A as opposed to 0.0018 lb ai/A).

IV.	DEEM-FCID™ Program and Consumption Information

Acute and chronic dietary exposure assessments for uniconazole were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

V.	Toxicological Information

The HED risk assessment team selected endpoints for dietary exposure assessment.  The endpoints that were selected are summarized in Table 1 below.  The FQPA Safety Factor for uniconazole was reduced to 1x.

Table 1.  Summary of Toxicological Doses and Endpoints for Uniconazole for Use in Dietary Human Health Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)	NOAEL = 5 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x

	Acute RfD = 0.05 mg/kg/day

aPAD = 0.05 mg/kg/day	Prenatal Developmental Toxicity - rat

LOAEL = 25 mg/kg/day based on increased incidence of 14th rib

Chronic Dietary (All Populations)	NOAEL= 2 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.02

mg/kg/day

cPAD = 0.02 mg/kg/day	Chronic Oral (Capsule) Toxicity - dog

LOAEL = 20 mg/kg/day based on the increased absolute and relative liver weight changes in males supported by histological and enzyme changes in the liver

Cancer (oral, dermal, inhalation)	Uniconazole was classified by the HED Carcinogenicity Peer Review Committee as a Group C, possible human carcinogen.  The CPRC recommended the reference dose (RfD) approach for risk assessment, and concluded that the chronic RfD would be protective of all chronic effects including carcinogenicity.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results of the acute analysis reported in Table 2 are for the population subgroup Females 13-49.  The results of the chronic analysis reported in Table 3 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  Cancer risk is determined for the general U.S. population only.  In this case, the chronic dietary risk estimate is protective of cancer effects.

Results of Acute Dietary Exposure Analysis

The results of the acute dietary exposure analysis for Females 13-49 are reported in Table 2.  The dietary risk estimate for this population subgroup, 0.4% aPAD at the 95th percentile of exposure, is below HED’s level of concern.  The %aPAD value is 0.4 on both a per capita basis as well as a per user basis.

Table 2.  Results of Acute Dietary Exposure Analysis

Population Subgroup

aPAD (mkd)*

95th Percentile

99th Percentile

99.9th Percentile

Exposure (mkd)

% aPAD

Exposure (mkd)

% aPAD

Exposure (mkd)

% aPAD

Females 13-49 years old

0.05

0.000182

<1

0.000272

<1

0.000486

<1

*mkd: milligram per kilogram per day

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analysis are reported in Table 3.  The chronic dietary risk estimates for the general U.S. population and all population subgroups are below HED’s level of concern.  The general U.S. population and all subgroups utilize <1% of the cPAD.  The most highly exposed population subgroup is All Infants (<1 year), which utilizes 0.6% of the cPAD.  The general U.S. population utilizes 0.2% of the cPAD.

Results of Cancer Dietary Exposure Analysis

Uniconazole was classified by the HED Carcinogenicity Peer Review Committee as a Group C, possible human carcinogen.  The CPRC recommended the RfD approach for risk assessment and concluded that the chronic RfD would be protective of all chronic effects including carcinogenicity.  As a result, the chronic dietary exposure analysis is adequate to assess cancer risk.  The general U.S. population utilizes <1% of the cPAD.  Therefore, cancer risk is not of concern to HED.

Table 3.  Summary of Dietary Exposure and Risk for Uniconazole

Population Subgroup*

Acute Dietary

(95th Percentile)

Chronic Dietary

Cancer

Dietary Exposure (mg/kg/day)

% aPAD

Dietary Exposure

(mg/kg/day)

% cPAD

Dietary Exposure

(mg/kg/day)

Risk

General U.S. Population	N/A

	N/A

0.000050	<1

Chronic RfD is protective of cancer effects

Chronic RfD is protective of cancer effects

All Infants (< 1 year old)

0.000114	<1

Children 1-2 years old

0.000091	<1

Children 3-5 years old

0.000084	<1

Children 6-12 years old

0.000057	<1

Youth 13-19 years old

0.000042	<1

Adults 20-49 years old

0.000045	<1

Adults 50+ years old

0.000044	<1

Females 13-49 years old	0.000182	<1	0.000044	<1

VII.	Characterization of Inputs/Outputs

Conservative values were used for food residue levels, percent crop treated estimates, and drinking water concentrations.  Further refinements could be made to the analysis, but they are not necessary at the present time.

Conclusions

Acute and chronic dietary risk assessments were performed for uniconazole based on conservative assumptions.  The acute dietary risk estimate for the population subgroup Females 13-49 is below HED’s level of concern.  The chronic dietary risk estimates for the general U.S. population and all population subgroups are also below HED’s level of concern.  The chronic dietary exposure analysis is protective of cancer effects.  The cancer risk to the general U.S. population is below HED’s level of concern.  Previous risk assessments performed for the triazole metabolites are protective of any dietary risk that might result from exposure to these compounds through the greenhouse use of uniconazole on fruiting vegetables.

List of Attachments:

Attachment 1:  Residue Input File for Acute Analysis

Attachment 2:  Results of Acute Dietary Exposure Analysis

Attachment 3:  Residue Input File for Chronic Analysis

Attachment 4:  Results of Chronic Dietary Exposure Analysis

Attachment 1:  Residue Input File for Acute Analysis

Acute NOAEL:  5 mg/kg/day

Acute PAD:    0.05 mg/kg/day

DEEM-FCID Version 2.03

Filename: C:\Documents and Settings\ddotson\My Documents\DEEMFCID\Uniconazole\UniconAC.R98

Date created/last modified: 02-12-2008/16:49:33/8

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

08001480 8    Eggplant                           0.010000   1.000  1.000

08002340 8    Okra                               0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.010000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.010000   1.000  1.000

08002710 8    Pepper, bell, dried                0.010000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.010000   1.000  1.000

08002720 8    Pepper, nonbell                    0.010000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.010000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.010000   1.000  1.000

08003740 8    Tomatillo                          0.010000   1.000  1.000

08003750 8    Tomato                             0.010000   1.000  1.000

08003751 8    Tomato-babyfood                    0.010000   1.000  1.000

08003760 8    Tomato, paste                      0.010000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.010000   5.400  1.000

08003770 8    Tomato, puree                      0.010000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.010000   3.300  1.000

08003780 8    Tomato, dried                      0.010000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.010000  14.300  1.000

08003790 8    Tomato, juice                      0.010000   1.500  1.000

86010000 O    Water, direct, all sources         0.003100   1.000  1.000

86020000 O    Water, indirect, all sources       0.003100   1.000  1.000

Attachment 2:  Results of Acute Dietary Exposure Analysis

NOAEL:  5 mg/kg/day

aPAD:   0.05 mg/kg/day

DEEM-FCID Version 2.03 (1994-98 data)

Adjustment factor #2 NOT used.

Residue file: UniconAC.R98

Analysis Date: 02-12-2008/16:51:36

Residue file dated: 02-12-2008/16:49:33/8

Daily totals for food and food form consumption used.

======================================================================== =======

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE

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

Females 13-49 yrs:

  0.000182    0.36   27424    0.000272    0.54   18376    0.000486    0.97   10293

Attachment 3:  Residue Input File for Chronic Analysis

Chronic NOAEL:  2 mg/kg/day

Chronic PAD:    0.02 mg/kg/day

DEEM-FCID Version 2.03

Filename: C:\Documents and Settings\ddotson\My Documents\DEEMFCID\Uniconazole\UniconCHR.R98

Chemical: Uniconazole

Date created/last modified: 02-12-2008/16:48:50/8

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

08001480 8    Eggplant                           0.010000   1.000  1.000

08002340 8    Okra                               0.010000   1.000  1.000

08002700 8    Pepper, bell                       0.010000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.010000   1.000  1.000

08002710 8    Pepper, bell, dried                0.010000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.010000   1.000  1.000

08002720 8    Pepper, nonbell                    0.010000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.010000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.010000   1.000  1.000

08003740 8    Tomatillo                          0.010000   1.000  1.000

08003750 8    Tomato                             0.010000   1.000  1.000

08003751 8    Tomato-babyfood                    0.010000   1.000  1.000

08003760 8    Tomato, paste                      0.010000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.010000   5.400  1.000

08003770 8    Tomato, puree                      0.010000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.010000   3.300  1.000

08003780 8    Tomato, dried                      0.010000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.010000  14.300  1.000

08003790 8    Tomato, juice                      0.010000   1.500  1.000

86010000 O    Water, direct, all sources         0.001500   1.000  1.000

86020000 O    Water, indirect, all sources       0.001500   1.000  1.000

Attachment 4:  Results of Chronic Analysis

Chronic NOAEL:  2 mg/kg/day

Chronic PAD:    0.02 mg/kg/day

DEEM-FCID Version 2.03  (1994-98 data)

Adjustment factor #2 NOT used.

Residue file name: C:\Documents and Settings\ddotson\My Documents\DEEMFCID\Uniconazole\UniconCHR.R98

Analysis Date 02-12-2008/16:52:28     Residue file dated: 02-12-2008/16:48:50/8

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000050                 0.2%

U.S. Population (spring season)             0.000049                 0.2%

U.S. Population (summer season)             0.000052                 0.3%

U.S. Population (autumn season)             0.000049                 0.2%

U.S. Population (winter season)             0.000049                 0.2%

Northeast region                            0.000048                 0.2%

Midwest region                              0.000051                 0.3%

Southern region                             0.000047                 0.2%

Western region                              0.000055                 0.3%

Hispanics                                   0.000058                 0.3%

Non-hispanic whites                         0.000049                 0.2%

Non-hispanic blacks                         0.000048                 0.2%

Non-hisp/non-white/non-black                0.000057                 0.3%

All infants (< 1 year)                      0.000114                 0.6%

Nursing infants                             0.000042                 0.2%

Non-nursing infants                         0.000141                 0.7%

Children 1-6  yrs                           0.000085                 0.4%

Children 7-12 yrs                           0.000054                 0.3%

Females 13-19 (not preg or nursing)         0.000041                 0.2%

Females 20+ (not preg or nursing)           0.000045                 0.2%

Females 13-50 yrs                           0.000047                 0.2%

Females 13+ (preg/not nursing)              0.000047                 0.2%

Females 13+ (nursing)                       0.000057                 0.3%

Males 13-19 yrs                             0.000042                 0.2%

Males 20+ yrs                               0.000044                 0.2%

Seniors 55+                                 0.000043                 0.2%

Children 1-2 yrs                            0.000091                 0.5%

Children 3-5 yrs                            0.000084                 0.4%

Children 6-12 yrs                           0.000057                 0.3%

Youth 13-19 yrs                             0.000042                 0.2%

Adults 20-49 yrs                            0.000045                 0.2%

Adults 50+ yrs                              0.000044                 0.2%

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

Uniconazole	Dietary Exposure and Risk Assessment	DP Number: 348937

PC Code:  128976

________________________________________________________________________ ______________

 PAGE

Page   PAGE  9  of   NUMPAGES  12


[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
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DEPARTMENT OF ENERGY

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[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
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their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2011-0158], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
DMF. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
    You may submit your comments and material by electronic means,
mail, fax, or hand delivery to the DMF at the address under ADDRESSES;
but please submit them by only one means. To submit your comment
online, go to http://www.regulations.gov, and type ``USCG-2011-0158''
in the ``Keyword'' box. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\; by
11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Keyword'' box insert ``USCG-2011-0158'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    Title: Drawbridge Operation Regulations.
    OMB Control Number: 1625-0109.
    Summary: The Bridge Program receives approximately 150 requests
from bridge owners or the general public per year to change the
operating schedule of various drawbridges across the navigable waters
of the United States. The information needed for the change to the
operating schedule can only be obtained from the bridge owner and is
generally provided to the Coast Guard in a written format.
    Need: 33 U.S.C. 499 authorizes the Coast Guard to change the
operating schedules of drawbridges that cross over navigable waters of
the United States.
    Forms: None.
    Respondents: Public and private owners of bridges over navigable
waters of the United States.
    Frequency: On occasion.
    Burden Estimate: The estimated burden remains the same at 150 hours
per year.

    Dated: April 29, 2011.
R. E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-11273 Filed 5-9-11; 8:45 am]
BILLING CODE 9110-04-P


 E.O. 12866 Meeting on the Greenhouse Gas New Source

Performance Standard for Electric Generating Units Rule

Tue 02/07/2012 11:00 AM - 11:30 AM

Attendance is  for RobertJ Wayland

Chair:

<EMAIL_ADDRESS>

Location:

202-395-6392; code 3862485

This entry has an alarm. The alarm will go off   before the entry starts.

Required:

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Kevin Culligan/DC/USEPA/US, Peter Tsirigotis/RTP/USEPA/US, RobertJ Wayland/RTP/USEPA/US

 This meeting was requested by David Doniger, NRDC.Call-in number:  202-395-6392; code 3862485.