[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48572-48574]
[DOCID:fr23se09-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0440]

Availability of Grant Funds for the Support of Cooperative
Agreement Award to Georgetown University Entitled: Genome Wide
Methylation Arrays for Detecting Markers of Increased Susceptibility to
Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors
(U01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Veterinary
Medicine (CVM), and Office of New Animal Drugs (ONADE) is announcing
the availability of grant funds for the support of a sole source,
cooperative agreement award to Georgetown University, Lombardi Cancer
Research Center and Department of Oncology entitled: ``Genome Wide
Methylation Arrays for Detection Markers of Increased Susceptibility to
Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors
(U01).'' The main purpose of this study is to help gain an
understanding of the extent to which exposures to endocrine disruptors
early in life increase later susceptibility to developing breast cancer
by inducing heritable epigenetic changes in transcription factors,
which are linked to increased breast cancer risk. The study is subject
to the requirements of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 331, et seq.) regulations issued under it and
applicable Department of Health and Human Services statutes and
regulations.

DATES: Important dates are as follows:
    1. The application due date is 30 days from the publication in the
Federal Register.
    2. The anticipated start date is September 2009.

FOR FURTHER INFORMATION CONTACT:
    Peer Review/Administrative Contact: Michelle Fuller, Center for

Veterinary Medicine (HFV-10), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
<EMAIL_ADDRESS>    Scientific Contact: M. Cecilia Aguila, Center for Veterinary
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl.
(rm. E478), Rockville, MD 20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>    For more information on this funding opportunity announcement
(FOA), and to obtain detailed requirements, please refer to the full
FOA located at http://www.fda.gov/cvm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Request for Application: RFA FD09-020
Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    More than 80,000 chemicals are registered for use in commerce in
the United States and an estimated 2,000 new chemicals are introduced
annually. These chemicals are used or present as contaminants in
everyday items such as: Foods, personal care products, prescription
drugs, household cleaners, and lawn care products (National Toxicology
Program, 2002). Scientists are continually learning more about how
these compounds interact with the body and the long-term impact of
these interactions on our health. For example, many synthetic chemicals
have been identified as known or suspected EDCs (endocrine disruptors),
including DES (diethylstilbesterol), BPA (bisphenol A), and GEN
(genistein). The long-term impact of these chemicals on human health is
still largely unknown, particularly when the exposure levels are
relatively low and do not cause any apparent toxic effects. EDCs may
have estrogenic, antiestrogenic, androgenic, and/or anti-androgenic
actions and /or they may disrupt adrenal and/or thyroid functions, too.
    The endocrine system participates in many important functions of an
organism, such as sexual differentiation before birth, sexual
maturation during puberty, reproduction in adulthood, growth,
metabolism, digestion, cardiovascular and immune functions, and
excretion. Hormones are implicated in the etiology of certain cancers
of hormone-dependent tissues, such as those of the breast, uterus, and
prostate gland. Environmentally released man-made chemicals are
suspected of being responsible for numerous adverse effects on the
endocrine function in wildlife species as well as in humans.
    EDCs may be harmful to human health following fetal exposure. This
likely relates to epigenetic changes in gene methylation patterns
occurring during gametogenesis and embryonic development. During these
periods, most of our genes are demethylated, followed by remethylation;
the timing and pattern of remethylation depends on the tissue lineage,
intrauterine environment, and maternal nutrition and other exposures.
Several genes have been identified whose expression is epigenetically
altered in adult tissues in animals that have been exposed in utero to
environmental contaminants with endocrine disrupting activity.
Therefore, we hypothesize that in utero EDC exposures increase
hypomethylation of genes, including those that regulate mammary stem
cell behavior.
    It is increasingly evident that many diseases, including breast
cancer, may originate during fetal life. Experimental findings and
limited human data show that maternal exposures during pregnancy to
synthetic estrogens such as DES or endocrine disruptors present in food
may precipitate mammary gland development and increase breast cancer
risk. To date, traditional toxicity tests such as the 2-year rodent
bioassay have been the bases for most regulatory decisions regarding
the carcinogenic potential of chemicals in the food. The agency
recommends an in utero exposure in these bioassays for direct food and
color additives. Therefore, only a limited number of chemicals have
been studied by this approach. Additionally, these in vivo toxicology
studies are not routinely used to predict the effects of in utero
exposures on later susceptibility to various diseases.

B. Research Objectives

    The main purpose of the this study is to help gain an understanding
of the extent to which exposures to endocrine disruptors early in life
increase later susceptibility to developing breast cancer by inducing
heritable epigenetic changes in transcription factors, which are linked
to increased breast cancer risk. This will be accomplished, first, by
exposing pregnant rodents to estrogen and estrogen-like endocrine
disruptors at doses previously found to increase mammary cancer among
offspring. Focus will be on the resulting hypomethylated genes that
express high levels of transcription factors, which regulate
proliferation, apoptosis, and differentiation of mammary epithelial
cells. Second, humans will be exposed to maternal diet containing
plant-derived compounds with hormonal activity during pregnancy to
determine if the diet induces epigenetic changes among daughters in the
same transcription factors identified in rodents. Third, the study will
utilize genetically modified animal models to determine if the
epigenetic changes identified in global methylation arrays are causally
linked to an increased susceptibility to developing mammary cancer in
vivo.
    The data from this study will be used to develop the Prenatal
Endocrine Disruption and Mammary Tumor Susceptibility assay (PEDMATS),
which will provide a novel approach for predicting the safety of
chemicals with endocrine activity. Consequently, the agency will
benefit from the proposed study, which combines mechanism-focused
toxicology studies and modern molecular biology tools, and addresses
the question of the cellular target of breast cancer initiation; i.e.,
mammary stem and progenitor cells. PEDMATS would help the agency to
predict the potential breast cancer risk for chemicals that have been
identified as having, or that may have, endocrine activity, and for
which there are no valid rodent carcinogenicity bioassays. Another
valuable feature of this approach is the potential that the PEDMATS
studies can be integrated into the current reproductive and
developmental toxicity assessment battery used to evaluate the safety
of new drugs.

C. Eligibility Information

    Georgetown University is uniquely qualified to conduct this
research. It has the expertise to study genetic markers in breast
cancer in animal models and humans. Importantly, Georgetown University
has expertise and proven ability in identifying genes affected in
breast cancer. The data analysis is a critical component of the
hybridization array experiments and poses a number of challenges due to
the large amount of data generated even in a single experiment.
Sophisticated, statistically principled data mining tools should be
used. These state-of-the-art clustering pattern analyses use standard
Finite Normal Mixture models and probabilistic component subspaces,
multimodal clusters being automatically identified using Akaide
information criterion and minimal information analysis. Georgetown
University, Lombardi Cancer Center recently developed a simple approach
for the exploration of limited gene expression data sets. To reduce
dimensionality, a simple univariate statistical analysis (t-test) to
compare gene expression data is

used. The reduced dimensional data set is visualized in three
dimensions using these novel algorithms. These visualized algorithms
derive the first three principal components from Fisher's matrix and
project the multidimensional data into three dimensional gene
expression data space. Exploration of the reduced dimensional data set
allows for the identification of discriminant genes that are either
assembled into a predictive neural network, and/ or selected for
functional studies. These approaches have proved useful in recent
studies conducted by Dr. Hilakivi-Clarke (Georgetown University,
Lombardi Cancer Center) in identifying genes affected by timing of
dietary exposures on breast cancer risk and are the preferred
approaches for this study.
    Georgetown University, Lombardi Cancer Research Center Animal Core
Facility has an AAALAC (Association for Assessment and Accreditation of
Laboratory Animal Care) accredited animal facility where the animals
can be housed. Georgetown can provide the software, hardware, and
sophisticated, statistically principled data mining tools. In addition,
Georgetown University is already collaborating in an on-going women
study in Finland measuring hormone and adipokine levels from blood
samples.
    This is a sole source award to Lombardi Comprehensive Cancer Center
and Department of Oncology, Georgetown University, Washington, DC.

II. Award Information/Funds Available

    Awards are made under the authorization of section 301 of the
Public Health Service Act (PHS Act) (42 U.S.C. 241), as amended, and
under Federal regulations at 42 CFR part 52 and 45 CFR parts 74 and 92.

A. Award Amount

    The total amount CVM expects to award is $100,400 in the first year
and $104,400 in the second year for a total award of $204,800; total
award amount includes direct and indirect costs.

B. Length of Support

    The project period will be from September 2009 to August 31, 2011.
The first budget period will be from September 2009 to August 31, 2010.
    The second year award will depend on the availability of funds and
recipient approved performance.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://
www.fda.gpo/cvm. Persons interested in applying for a grant may obtain
application forms and instructions at http://grants.nih.gov/grants/
forms.htm. For all paper application submissions, the following steps
are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration
(CCR)
     Step 3: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 (DUNS Number) and 2 (CCR), in detail, can be found at
http://www07.grants.gov/applicants/organization_registration.jsp. Step
3 (eRA Commons), in detail, can be found at https://
commons.era.nih.gov/commons/registration/registrationInstructions.jsp.
    After you have followed these steps, submit paper applications to
the Grants Management Contact at the following address:
    Gladys M. Bohler, Division of Acquisition Support and Grants (HFA-
500), Food and Drug Administration, 5630 Fishers Lane, rm. 2105,
Rockville, MD 20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
    Dated: September 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22848 Filed 9-22-09; 8:45 am]

BILLING CODE 4160-01-S


SUPPORTING STATEMENT FOR AN

INFORMATION COLLECTION REQUEST

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)  Title of the Information Collection

TITLE:  Requirements for Certified Applicators Using 1080 Collars for
Livestock Protection

OMB NO. 2070-0074			EPA No. 1249.09

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 on November
30, 2010.  This information collection activity enables the
Environmental Protection Agency (EPA) to obtain the information needed
to track the use of registered 1080 collars and the record keeping
requirements imposed by an administrative judge in October 1982 and
confirmed by the Agency in 1983.  This ICR affects Certified
Applicators, four States (Montana, New Mexico, South Dakota, and
Wyoming) that monitor the program, and one registrant.  Applicators who
are certified to apply livestock protection collars are required to keep
records of:  a) the number of collars attached on livestock; b)
pasture(s) where collared livestock were placed; c) the dates of each
attachment, inspection, and removal; d) the number and locations of
livestock found with ruptured or punctured collars and the apparent
cause of the damage; e) the number, dates, and approximate location of
all collars lost; and f) the species, locations, and dates of all
suspected poisonings of humans, domestic animals or non-target wild
animals resulting from collar use.

EPA receives annual monitoring reports from registrants, certified
applicators, and State lead agencies. Applicators maintain records, and
the registrants/state agencies do monitoring studies and submit the
reports.  These records are monitored by either a) State lead agencies,
or b) registrants. This ICR also covers monitoring activities associated
with collar use and to the preparation and submission of an annual
monitoring report to EPA that are over and above requirements that are
either conditions of registration or obligations associated with the
handling and regulation of any restricted use pesticide product.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)  Need/Authority for the Collection

EPA banned all predator uses of Sodium Monofluoroacetate (Compound 1080)
in 1972.  In 1981 and 1982, EPA received applications to register 1080
in several delivery mechanisms, one of which was the toxic collar.
Following extensive public hearings in 1982, EPA's Administrative Law
Judge Nissen declared, on October 22, 1982, that the Agency could
register the collar, with certain specific use restrictions, after going
through the normal registration process.  The Administrative Law Judge
included restrictions and recordkeeping requirements in Attachment C of
his initial decision (see Attachment A).  On October 31, 1983, then EPA
Assistant Administrator Lee M. Thomas affirmed Judge Nissen's initial
decision, including the use restrictions and recordkeeping requirements.

Prior to 1972, 1080 was used for predator control in a number of ways,
some of which were subject to the 1982 proceedings, which either did not
receive a favorable ruling from the Administrative Law Judge or were not
subsequently registered for other reasons. As there have been occasional
reports of predator control use and other uses of 1080 by illegal
methods subsequent to 1972, EPA believes that it is extremely important
to account for the 1080 that is supplied for legal use so as to maintain
surveillance on the toxic collar program and to deter diversion of 1080
in the program from legal to illegal predator control use.  As 1080 is a
highly soluble material of potent but delayed oral toxicity, there are
additional concerns about transfer of this material to persons who might
use or threaten to use it as a weapon of terrorism.

2(b)  Practical Utility/Users of the Data

As a condition of the 1080 livestock protection collar registration, EPA
has required submission of annual reports monitoring use of all
livestock protection collar products.  Depending upon the product, the
registrant or the State lead agency for pesticide regulation is
designated as being responsible for submitting an annual monitoring
report.  The requirement to submit reports is imposed for at least the
first four years of the collars' use under the registration.  Factors
affecting the extension of requirements to submit annual reports
include:  1) quality of reports submitted previously; 2) amount of use
reported; 3) results of collar use (in terms of numbers punctured by
coyotes, numbers punctured by other causes, numbers lost, nontarget
poisonings, etc.); 4) frequency and nature of violations reported; and
5) arrangements made between EPA and registrants regarding annual
reports of collar use to meet other requirements for reporting
information.  EPA reviews the annual reports to assess compliance with
the 1982 Administrative Law decision and the requirements of product
labeling.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)  Nonduplication

The processes for recordkeeping, reporting nontarget exposure incidents,
and submitting monitoring reports are not duplicative of any other known
information collection requirement.  This information would not be
compiled or reported but for these special requirements for livestock
protection collars.  While certain information on collar production may
be required by agencies that prepare monitoring reports, this
information would not, in the main, be duplicative of the confidential
production reports that all pesticide registrants must file.  The
reports are limited to one specific, heavily regulated product and
represent the most efficient means for others to generate and EPA to
receive this information.  This information may not, in all cases, be
available to the State lead agencies but for the specific reporting
requirements that they impose upon registrants of 1080 livestock
protection collars.

3(b)  Public Notice Required Prior to ICR submission to OMB

In proposing to renew this ICR, EPA published a Federal Register Notice
that provides a 60-day public notice and comment period.  EPA received
no comments.

3(c)  Consultations

In addition to the public notice described in section 3(b) of this ICR
as required under 5 CFR 1320.8(d)(1), EPA staff contacted three relevant
stakeholders and asked them for their assessment of the regulatory
burden estimates expressed by the Agency in the draft ICR.  See
Attachment B for the questionnaire that was used.  EPA consulted with
the following individuals:

Ann Nasr

USDA/APHIS

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
301-734-5170

Kent Drake

Wyoming Department of Agriculture

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
307-777-6781

Bonnie Rabe

New Mexico Department of Agriculture

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

575-646-2133

The Agency received one response from APHIS via email and another from
the Wyoming Department of Agriculture, both of which have been included
in Attachment C.  While responses generally indicated that the burden
and labor cost estimates as stated in the ICR were reasonable and
accurate, one respondent also commented on the need to add Cost of
Living costs (2-3 percent/year) to each year since the last report on
this information.

The Agency uses wage and benefit statistics from the Bureau of Labor
Statistics which are updated periodically to reflect inflation and cost
of living adjustments.  As such, the Agency believes that the burden
estimates in this ICR do not need to be adjusted further.  Please see
Attachments F, G, and H for the methodology used to estimate the wages
of personnel associated with the reporting of this ICR.

	3(d)  Effects of Less Frequent Collection

Annual monitoring reports are the only items pertaining to collars for
which EPA requires scheduled submissions.  Longer intervals between
submissions would make the information received and EPA's responses to
the reports less timely.  Longer intervals also would likely increase
the amount of time that would be needed to prepare each individual
report, increasing the burden on submitters.

	3(e)  General Guidelines

Requiring monitoring reports to be submitted once a year does not
conflict with the general guidelines for data requesters.  The required
reporting of nontarget incidents, in practice, has not generated any
rate of submissions that could be construed as being in violation of
these general guidelines.  The need for such incidents to be reported
rapidly is clear, however.  As discussed below in Section 5(c) of this
ICR, the reporting requirements for small entities have been limited as
much as is legally and responsibly possible.

3(f)  Confidentiality

Under FIFRA, health and safety data submitted by registrants are
considered by EPA to contain no confidential business information (CBI).
 If registrants submit data that relates to trade secrets or commercial
or financial information, such information is protected from disclosure
under Section 10 of FIFRA. Confidential data submitted by registrants to
EPA in response to this particular information collection activity will
be handled strictly in accordance with provisions of the FIFRA
Confidential Business Information Security Manual (Attachment D).  This
manual contains instructions relative to all in contact with
confidential documents, including:  responsibilities of the EPA
employees; physical security measures; CBI copying and destruction
procedures; transfer of CBI materials within the EPA to contractors or
other government offices; computer security; CBI typing procedures; and
procedures internal to EPA.  The manual dictates that all CBI must be
marked or flagged as such, all CBI must be kept in secure
(double-locked) areas, and all CBI intended to be destroyed must be
cleared by a Document Control Officer and shredded.

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.  The names and addresses of
both certified livestock protection collar applicators and any other
person who owns property on which livestock protection collars have been
or will be applied by a certified applicator are considered personal
information that will not be disclosed if ever in the possession of EPA.
In accordance with 7 USC 136i-1(b), unsolicited information of a
sensitive or private nature included in monitoring reports already
received, or submitted in the future, will be protected from public
release.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)  Respondents/NAICS Codes

This information collection activity applies to all certified pesticide
applicators that apply 1080 collars, to the pesticide manufacturer’s
whose products include 1080 collars, and to the government agencies
responsible for implementing and administering a 1080 collar monitoring
program.  Information available to EPA indicates that most, if not all,
of the certified applicators subject to this ICR are employees of the
Animal and Plant Health Inspection Service (APHIS) within the US
Department of Agriculture (USDA), although a small number of other
certified applicators may also apply 1080 collars.  The North American
Industrial Classification System codes assigned to the businesses and
other institutions participating in this program are 325300 (Pesticide,
Fertilizer, and Other Agricultural Chemical Manufacturing), 926140
(Regulation of Agricultural Marketing and Commodities), and 999200
(State Government).

4(b)  Information Requested

4(b)(i)  Data Items

	The data that certified livestock protection collar applicators are
required to record and maintain were outlined in the Initial Decision of
the Administrative Law Judge in the 1080 Predacide Hearings.  These
requirements are stipulated in "Use Restriction 5" in the technical
bulletin that is part of the labeling for all livestock protection
collar products registered as pesticides in the United States.  Use
Restriction numbers and content vary somewhat from product to product
due to additional restrictions or considerations either proposed by the
registrants or required by State lead agencies. The complete list of Use
Restrictions can be found in Section V.B.2 of EPA’s 1995
Re-registration Eligibility Decision concerning sodium fluoroacetate
(Attachment E).

Registrants of livestock protection collars are required, by Use
Restriction 4 of the same typical technical bulletin, to:

". . . keep records of all collars sold or transferred at their address
of record.  Records shall include the name, address, state where
livestock protection collar certification was issued, certification
number of each recipient, and dates and numbers of collars sold or
transferred."

Use Restriction 5, from a typical technical bulletin, reads as follows:

"Each applicator shall keep records dealing with the use of livestock
protection collars and the results of such use.  Records shall be
maintained in accordance with appropriate State or Federal regulations
but for not less than two years following disposal or loss of collars.
Such records shall include, but need not be limited to:

The number of collars attached on livestock.

The pasture(s) where collared livestock were placed.

The dates of each attachment, inspection, and removal.

The number and locations of livestock found with ruptured or punctured
collars and the apparent cause of the damage.

The number, dates, and approximate location of all collars lost.

The species, locations, and dates of all suspected poisonings of humans,
domestic animals or non-target wild animals resulting from collar use."

Use Restriction 6, from the same typical technical bulletin, requires
that "suspected" poisonings of "threatened or endangered species,…
humans, domestic animals or nontarget wild animals" be reported, within
three days of the incident, to a designated government agency (EPA
and/or the appropriate State lead agency for regulation of pesticides).
EPA requires that certified applicators of livestock protection collars
keep and report only those records prescribed by Use Restrictions 5 and
6.

4(b)(ii)  Respondent Activities

Certified livestock protection collar applicators are required by
product labeling to prepare and maintain records of various activities
associated with use and fate of livestock protection collars that they
purchase or obtain for use.  Preparing these records consists of writing
down what is done in normal use and handling of collars.

The use of livestock protection collars is a labor-intensive process.
For a typical sheep operation, collar use involves the following
activities:

corralling sheep;

isolating target flocks;

capturing appropriate livestock and equipping them with collars;

redeploying target and main flocks in ways that are expected to direct
coyotes' attacks toward target flocks and away from the remainder of the
producer's sheep;

inspecting target flocks weekly (or more frequently) to account for
livestock alive, dead, or missing; to search for lost sheep or lost
collars; to capture livestock that require adjustments to collar
position or other hands-on attention; and to properly handle and dispose
of irreparably damaged collars; and, when collar use is to be
terminated; corralling target flocks, capturing collared livestock,
removing and inspecting collars, disposing of damaged collars, and
returning intact collars to proper secure storage.

The recordkeeping requirements add the need to record significant data
associated with collar use such as how many collars were used, where and
when they were used, how many were damaged, likely causes of such
damage, where collars went after use, and the occurrence of possible
nontarget exposure incidents.  The time and other costs associated with
preparation and maintenance of sale records are conditions of collar use
which are required by the product’s labeling.  Such requirements are
not part of the subject ICR.  Burdens related to the ICR begin with the
compilation of applicator’s records and with activities associated
with assembling data for inclusion in monitoring reports.

Registrants and/or State lead agencies have developed their own
instruments that facilitate appropriate recordkeeping by certified
applicators.  State lead agencies typically require certified livestock
protection collar applicators to file periodic reports summarizing
collar use.  Data from these reports are included in annual monitoring
reports submitted to EPA by registrants or state lead agencies.  Other
data that appear in monitoring reports include summaries of numbers of
collars sold or otherwise legally circulated in the State and the number
and nature of violations detected with regard to use or handling of
livestock protection collars.

	As with other registrants of pesticide products, livestock protection
collar registrants are required to file annual (confidential) production
reports.  These reports are required of all establishments that produce
pesticides or pesticide devices in the United States, pursuant to
Section 7 of FIFRA.  Since production does not equate with use, the ICR
is not duplicative of the requirement to submit annual production
reports, which is covered by a different ICR.

5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)  Agency Activities

Reports of non-target species poisonings and other incidents included in
the annual monitoring reports filed with EPA by State lead agencies are
reviewed by the Insecticide-Rodenticide Branch, which initiates whatever
regulatory steps are warranted by the incident and places a copy of the
incident report in the registration file for the product involved in the
incident.  To date, no nontarget poisoning incidents have been reported
to EPA by State lead agencies.  Reasons for this appear to be the
limited extent to which collars are used, and the relatively low
potential for occurrence and detection of nontarget incidents.  However,
EPA has noted instances of violations and inaccuracies in inventory in
its reviews of monitoring reports.

EPA replies directly, in writing, to the originator of the report,
indicating whether the report is acceptable, whether additional details
are needed for the current report or future reports, and whether any
specific corrective steps are needed based upon items discussed in the
monitoring report.

	5(b)  Collection Methodology and Management

As the number of registered livestock protection collar products is very
small (6 at present) and very few reports are expected to be received,
no special provisions for data collection and management are needed.
The reports submitted are handled and processed through mechanisms that
have been developed for handling a wide variety of submissions that
pertain to registered pesticide products.  These include routing the
submission through the routine review process, responding to the
submission in writing, and filing the submission and the response in the
relevant product's registration file.  These submissions are tracked by
EPA's Pesticide Registration Information System (PRISM).

5(c)  Small Entity Flexibility

Most users, including the private company that is a livestock protection
collar registrant, would qualify as small entities.  The degree of
imposition that these recordkeeping and reporting requirements impose on
such individuals is minimal, considering the limited degree of latitude
permitted by the Administrative Law Judge and the Administrator of the
EPA, the extreme toxicity of Compound 1080, and the great potential for
abuse of livestock protection collars should collars or their contents
get into the hands of irresponsible persons.  The main purpose of the
recordkeeping requirements is to promote responsible use and handling.
The main purpose for requiring monitoring reports is to establish a
process through which it is mandatory to inform EPA of the results of
collar use.  EPA then can use the data from reports as bases for future
regulatory decisions.

The mandatory submission of periodic reports from applicators to State
lead agencies based on data that they are already required to collect
adds only a minimal amount of burden.  In the State where the livestock
protection collar product registered to a private firm is used, the lead
agency requires the registrant to submit sales and distribution
documents to the State.

5(d)  Collection Schedule

Livestock protection collar annual monitoring reports are due on a date
prescribed as a condition of registration, usually February 15, for each
year after the first year in which collars may be used legally.

As nontarget exposure incidents must be reported within three days of
their occurrence there is no set schedule for collection of this
information.  Such reporting is required by product labeling and,
therefore, is not part of this ICR.  However, nontarget incidents also
would be reported and discussed in monitoring reports for the year in
which they occurred, with follow-up information regarding dispositions
of cases being indicated.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)  Estimating Respondent Burden

EPA has revised the estimated burden associated with the 1080 livestock
protection collar annual monitoring reports over its 2007 estimates
based on the reports most recently submitted to EPA.  For the next 3
years, EPA expects that 40 certified applicators (30 for New Mexico and
10 for APHIS) will use and/or possess collars annually and,
consequently, contribute information to be used in monitoring reports.
EPA does not expect the burden per applicator, which is currently 40
hours, to decrease over the next 3 years and remains unchanged over our
2007 estimate.  EPA points out that this estimate was developed under
the assumption that, while perhaps unlikely, one non-target species
poisoning incident will occur per year and require 10 hours of burden
(which is included in the 40 hour estimate).  In all, EPA estimates the
total annual burden for certified applicators of 1080 livestock
protection collars to be 1600 hours (40 applicators x 40 hours).

EPA anticipates that 4 registrants and/or State lead agencies will file
annual monitoring reports based upon information obtained from those
certified applicators.  Note that, except in the case of the pesticide
producer, the registrant is the State.  The estimated annual respondent
burden for this activity is 77 hours over the next 3 years, and has not
changed over the 2007 estimates.  The annual burden of the States and
registrants is based on the annual monitoring report alone and not other
requirements related to use, administration, and regulation of 1080
livestock protection collars.  There are currently two States that have
been reporting annually on livestock protection collar use, with two
other States possibly becoming involved in that activity in the future.
EPA estimates the total annual burden for agencies submitting annual
monitoring reports to be 308 hours (4 submitters x 77 hours).

As with other registrants of pesticide products, livestock protection
collar registrants (i.e., the producer(s), not the State agencies) are
required to file annual (confidential) production reports.  There are
four producers.  The estimated annual per respondent burden for this
activity is 9 hours, with a total of 36 hours per year over the next 3
years (4 producers x 9 hours).  The annual respondent burden is less
than in the previous ICR because of a correction in the calculation.  As
in the current ICR, the previous estimate for the number of registrants
was 4, with a burden of 9 hours per respondent.  However, the total
annual respondent burden was calculated as 45 hours per registrant
instead of 36.

The Agency recognizes that the time needed to prepare reports is
affected primarily by the extent of use and the number of applicator's
to be covered by the report during any given year.  Tables 1, 2, and 3
provide a breakdown of the collection activities per respondent and a
general overview of how the estimates were derived.  The total annual
response burden imposed upon certified applicators, State agencies, and
registrants associated with the use of 1080 livestock protection collars
is estimated to be 1,944 hours (1600 + 308 + 36).

6(b)  Estimating Respondent Costs

As in the previous version of this ICR, the Agency estimates wages,
benefits, and overhead for all labor categories for the pesticide
industry, state government and Agency employees.  The Agency estimates
are based on currently available information on labor rates from the
U.S. Department of Labor and other benefits from publicly available
websites.  A copy of the methodology used to re-estimate the labor rates
and formulas used to derive the fully loaded rates and overhead costs
that are used in this ICR are listed in Attachments F, G, and H.

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above.  The registrant respondent costs for
managerial, technical and clerical rates are estimated at $109.82,
$60.39, and $35.89 per hour, respectively.  These labor rates are fully
loaded and include benefits and overhead costs.

The state government respondent costs for managerial, technical and
clerical rates are estimated at $79.61, $55.72, and $37.31 per hour,
respectively.  These labor rates are fully loaded and include benefits
and overhead costs.

	Based on EPA’s methodology for estimating pesticide-related
information collection request wage rates for industry, state, and EPA -
and based on EPA’s familiarity with the 1080 livestock protection
collars program and experiences with USDA - EPA estimates the
fully-loaded labor rate of a certified applicator of 1080 livestock
protection collars to be approximately equal to the state government
clerical labor rate of $37.31/hr (includes the base wage rate, benefits,
and overhead).

The total annual cost for all respondents associated with this
information collection activity is estimated to be approximately
$77,044.  In summary:

Certified applicators:  $59,696

States:  $15,468

Registrants:  $1,880

The annual cost for a single respondent is:

Certified applicator:  $1,492

State:  $3,867

Registrant:  $470

Tables 1 through 3 present information for estimating costs based on the
burden hours/costs per respondent.

Table 1. Annual Certified Applicator Burden/Cost Estimates

Collection Activities

Burden Hours

Total Costa

1.

Read/hear rule or any collection instrument	3	$111.93

2.

Receive training b	--	--

3.

Plan activities	3	$111.93

4.

Create information	3	$111.93

5.

Gather information	18	$671.58

6.

Process and review information for accuracy	5	$186.55

7.

Record, disclose, or display the information	5	$186.55

8.

Store, file or maintain the information	3	$111.93

TOTAL	40	$1,492.40

(a) Certified Applicator ($37.31/hr)

(b)The burden associated with the training of certified applicators is
accounted for under the ICR for the Agency Certification and Training
Program (EPA ICR# 0155; OMB Control No. 2070-0029).

ANNUAL BURDEN:  	Hour Total (40) x Number of Respondents (40) = 1,600

ANNUAL COST:  		Cost Total ($1,492) x Number of Respondents (40) =
$$59,696

Table 2. Annual State Agency Burden/Cost Estimates

Collection Activities

Burden Hours (per year)

Total Cost

Management

($79.61/hr)

Tech.

($55.72/hr)

Clerical

($37.31/hr)

1.

Read/hear rule or any collection instrument

0

2

0	$111.44

2.

Plan activities

0

10

0	$557.20

3.

Create information

0

15

0	$835.80

4.

Gather information

0

14

0	$780.08

5.

Process, compile, and review information for accuracy and
appropriateness

0

13

0	$724.36

6.

Record, disclose, display or report the information

0

0

20	$746.20

7.

Store, file or maintain the information

0

0

3	$111.93

TOTAL

0

54

23	$3,867.01

ANNUAL BURDEN:  	Hour Total (77) x Number of Respondents (4) = 308

ANNUAL COST:  		Cost Total ($3,867) x Number of Respondents (4) =
$$15,468

Table 3. Annual Registrant Burden/Cost Estimates**

Collection Activities

Burden Hours (per year)

Total Cost

Management

($109.82/hr)

Tech.

($60.39/hr)

Clerical

($35.89/hr)

1.

Read/hear rule or any collection instrument

0

2

0	$120.78

2.

Plan activities

0

1

0	$60.39

3.

Create information

0

0

0	$0.00

4.

Gather information

0

2

0	$120.78

5.

Process, compile, and review information for accuracy and
appropriateness

0

1

0	$60.39

6.

Record, disclose, display or report the information

0

0

2	$71.78

7.

Store, file or maintain the information

0

0

1	$35.89

TOTAL

0

6

3	$470.01

** In all but one case, the registrant is the State and, therefore,
covered under State burdens (Table 2).

ANNUAL BURDEN:  	Hour Total (9) x Number of Respondents (4) = 36

ANNUAL COST:  		Cost Total ($470) x Number of Respondents (4) = $1,880

	6(c)  Estimating Agency Burden and Cost

The Agency's total annual burden associated with the 1080 livestock
program has changed based upon more accurate estimates of the resources
required to complete tasks specifically associated with annual
monitoring reports.

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above.  The EPA labor rates for this renewal for
technical and clerical rates are estimated at $71.58, and $41.21 per
hour, respectively.  These labor rates are fully loaded and include
benefits and overhead costs.  For this ICR, we estimate the annual
Agency burden to be 104 hours and the total annual Agency cost to be
$7,444.  The annual Agency burden is less than in the previous ICR
because of a correction in the calculation as indicated in Section 6(a)
of this ICR.

Table 4.  Annual Agency Burden/Cost Estimates

Collection Activities

Burden Hours (annual)

Total Cost

Tech.

($71.58/hr)

Clerical

($41.21/hr)

1.

Develop any correspondence needed

8

0	$572.64

2.

Answer respondents’ questions

2

0	$143.16

3.

Review data submissions

10

0	$715.80

4.

Analyze data submissions

4

0	$286.32

5.

Store data

2

0	$143.16

TOTAL

26

0	$1,861.08

ANNUAL BURDEN:  	Hour Total (26) x Number of Respondents (4) = 104

ANNUAL COST: 		Cost Total ($1,861) x Number of Respondents (4) = $7,444

6(d)  Bottom Line Burden Hours and Costs

Table 5.  Bottom Line Burden Hours and Costs/Master Table

Total Burden Hours

Total

Cost ($)

Certified Applicator (Table 1)	1,600	$59,696

State (Table 2)	308	$15,468

Registrant (Table 3)	36	$1,880

Bottom Line Respondent Total	1,944	$77,044

Agency Total	104	$7,444

	6(e)  Reasons for Change in Burden

The total annual respondent burden hours reflects a change from the
previous ICR by 9 hours, from 1,953 to 1,944.  This change is due to a
correction to the 2007 cost estimate tables for registrants from 45 to
36 hours, as indicated in Section 6(a) of this ICR.

	6(f)  Burden Statement

The annual respondent burden for the 1080 livestock collar program is
estimated to average 40 hours per certified applicator response, 77
hours per State agency response, and 9 hours per registrant
participating in the program.  Under the Paperwork Reduction Act,
“burden” means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  For this collection, it
is the time reading the regulations, planning the necessary data
collection activities, conducting tests, analyzing data, generating
reports and completing other required paperwork, and storing, filing,
and maintaining the data.  An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number.  The OMB control
number for this information collection appears at the beginning and the
end of this document.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2009-884 to
(1) EPA online using www.regulations.gov (our preferred method), or by
mail to: Public Information and Records Integrity Branch (PIRIB), Mail
Code: 7502P, Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and
(2) OMB by mail to: Office of Information and Regulatory Affairs, Office
of Management and Budget (OMB), Attention: Desk Officer for EPA, 725
17th Street, NW, Washington, DC 20503.

Use EPA’s electronic docket and comment system at www.regulations.gov,
to submit or view public comments, access the index listing of the
contents of the docket, and to access those documents in the docket that
are available electronically.  Once in the system, select “docket
search,” then key in the docket ID number identified above.   Please
note that EPA’s policy is that public comments, whether submitted
electronically or in paper, will be made available for public viewing at
www.regulations.gov as EPA receives them and without change, unless the
comment contains copyrighted material, CBI, or other information whose
public disclosure is restricted by statute.  For further information
about the electronic docket, go to   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .

Attachments to the Supporting Statement

	All of the attachments listed below can be found in the docket for this
ICR (unless otherwise noted); 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, EPA-HQ-OPP-2009-0884
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:	EPA’s Administrative Law Judge’s 1982 Decision on
Restrictions and Recordkeeping Requirements (pp. 217-219, “Attachment
C, Use Restrictions”)

Attachment B:	Sample Consultation Questionnaire

Attachment C:	Consultations Responses

Attachment D:  	Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Confidential Business Security Manual

Attachment E:	EPA’s 1995 Re-registration Eligibility Decision
Concerning Sodium Fluoroacetate

Attachment F:	Methodology for Estimating OPP ICR Wage Rates for States
and Applicators

Attachment G:	Methodology for Estimating OPP ICR Wage Rates for
Registrants

Attachment H:	Methodology for Estimating OPP ICR Wage Rates for EPA

August 31, 2010

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