[Federal Register Volume 64, Number 215 (Monday, November 8, 1999)]
[Notices]
[Pages 60815-60819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29265]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-00281; FRL-6389-5]
Notice of Availability of FY 2000 Grant Funds for Technical
Studies
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of funds availability.
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SUMMARY: EPA is soliciting pre-application grant proposals for
technical studies to minimize lead hazards to occupants from home
improvement projects, repainting projects, renovation projects and
remodeling projects. EPA anticipates that approximately $700,000 will
be available in Fiscal Year 2000, with individual grants/cooperative
agreements awarded in the range of $60,000 to $100,000. Decisions on
awarding of these grant funds will be made based on the evaluation of
pre-application grant proposals. The primary purpose of this grant
program is to fund technical studies to gain knowledge that will lead
to the minimization of lead hazards to occupants from home improvement
projects, repainting projects, renovation projects, and remodeling
projects. EPA will consider awarding these grant funds for technical
studies of the topics listed in Unit V. of this notice. EPA will also
consider awarding these grant funds for technical studies that are not
specifically mentioned in this notice, but are relevant to the
minimization of lead hazards to occupants from home improvement
projects, repainting projects, renovation projects, and remodeling
projects. In such instances, the applicant should describe how the
proposed technical study addresses the primary purpose of this notice.
DATES: All pre-application grant proposals must be post-marked by
January 12, 2000, and must be received by January 19, 2000.
ADDRESSES: Submit pre-application proposals to: John Schwemberger, Mail
Code 7404, Environmental Protection Agency, 401 M St., SW., Room E-
813B, Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: John Schwemberger, Technical Branch,
National Program Chemicals Division (7404), Office of Pollution
Prevention and Toxics, Rm. E-813B, Environmental Protection Agency, 401
M St., SW., Washington, DC, 20460, (202) 260-7195, fax: (202) 260-0001,
e-mail: schwemberger.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Notice Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to those persons or organizations that wish to
obtain funding from the Federal government to conduct or complete a
technical study related to lead hazards from renovation and remodeling
(R&R)1. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under ``FOR FURTHER INFORMATION CONTACT.''
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In the rest of this notice, the terms ``renovation and
remodeling activities,'' ``renovation and remodeling,'' and ``R&R''
will be used to refer to home improvement projects, repainting
projects, renovation projects, and remodeling projects.
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II. Scope and Purpose of this Grant Program
A. Findings from EPA Research on Renovation and Remodeling Activities
Over the past several years, EPA has engaged in a series of data
collection efforts to investigate lead exposure associated with R&R
activities. These studies, collectively referred to as the R&R Study,
have focused on lead exposure associated with a wide variety of work
activities typically conducted during R&R.
Analysis of environmental data from the R&R Study indicates that
substantial quantities of lead can be produced or released during R&R
activities. The cleanup methods commonly employed by R&R workers (broom
or ``shopvac'') are generally not effective in reducing the
environmental lead to levels considered safe by EPA. In addition,
examination of blood lead measurements of child occupants has
demonstrated significant associations between some R&R activities and
elevated blood lead levels.
The results of the EPA R&R Study have been published in a series of
reports available free of charge from the National Lead Information
Center by calling 1-800-424-LEAD. Request the reports ``Lead Exposure
Associated with Renovation and Remodeling Activities: Summary Report''
(EPA Report 747-R-96-005); ``Lead Exposure Associated with Renovation
and Remodeling Activities: Environmental Field Sampling Study, Volume
I: Technical Report'' (EPA Report 747-R-96-007); ``Lead Exposure
Associated with Renovation and Remodeling Activities: Environmental
Field Sampling Study, Volume II: Appendices'' (EPA Report 747-R-96-
008); and ``Lead Exposure Associated with Renovation and Remodeling
Activities: Worker Characterization and Blood Lead Study'' (EPA Report
747-R-96-006).
B. Recent NHANES Study
Data from the Third National Health and Nutrition Examination
Survey (NHANES III) confirm the findings of earlier surveys that
children who live in older housing are more vulnerable to lead
poisoning, and have blood-lead levels that are elevated above the
national average. Older residences tend to contain both lead-based
paint and lead depositions from the fallout of vehicle exhaust that
have accumulated over several decades. In addition, large or extensive
R&R projects are often conducted in older houses. Since older houses
contain more lead, conducting R&R activities in them can create an
exposure hazard to the occupants.
C. Benefits of the Evaluation Program for Renovation and Remodeling
Every year thousands of residential R&R activities are conducted
across the United States in homes which contain lead-based paint. In
many of these cases, exposure to hazardous levels of lead
[[Page 60816]]
may be a serious problem. The efforts supported by this grant will
involve the investigation of approaches, methods, and technologies
which can minimize the potential for lead hazards to occupants from R&R
activities. This grant effort applies to R&R activities conducted by
either home owners or home improvement contractors. Findings generated
by grantees are intended to be published in scientific publications,
and the data (other than confidential information such as names and
addresses) made available to the scientific community at the time of
publication.
III. EPA Quality Assurance Requirements
EPA has quality assurance requirements that must be addressed once
a grant has been awarded. After a grant is awarded, the grantee must
submit a Quality Assurance Project Plan (QAPjP) to EPA for approval
before the generation of any new data or the evaluation of any existing
data can occur.
Quality assurance project plan requirements are stated in the
document ``EPA Requirements for Quality Assurance Plans'' (EPA QA/R5).
Guidance for the development of QAPjPs can be found in the EPA document
entitled, ``Guidance for Quality Assurance Project Plans'' (EPA QA/G-
5). QAPjPs for studies which generate new data must develop data
quality objectives (DQOs) for the study. Guidance for developing DQOs
can be found in the EPA publication, ``Guidance for the Data Quality
Objective Process, EPA QA/G4'' (EPA/600/R-96/055). Grantees who use
existing data must state the data acceptance criteria as a part of the
required QAPjP. Guidance for performing data quality assessments (DQA)
can be found in the EPA publication entitled, ``Guidance for Data
Quality Assessment-Practical Methods for Data Analysis, EPA QA/G9''
(EPA/600/R-96-084). Copies of all of the quality assurance related
documents noted above can be downloaded from the EPA Quality Assurance
Division web site at http://es.epa.gov/ncerqa/qa/index.html.
EPA intends to establish an assistance program for grantees to help
them develop quality assurance plans for the awarded study. However,
the responsibility for completing the quality assurance requirements
remains with the applicants. If for some reason EPA cannot carry out
the assistance program, the applicants will be required to meet the
quality assurance requirements or risk losing funding.
IV. Human Subjects Approval and Data Confidentiality
Research supported by EPA that uses human subjects must comply with
40 CFR part 26, Protection of Human Subjects (referred to as ``the
Common Rule''). If there are child research subjects, the research must
also comply with 45 CFR part 46, subpart D.
If a study involves humans, including just asking them questions,
human subjects approval by EPA may be required before the study can be
funded. If the study is exempt from human subjects approval (40 CFR
26.101(b) lists the exemptions), the exempt finding must be confirmed
by EPA. One important exemption is for studies which involve the
analysis of existing data sets, documents, or specimens where either
these data sets, documents, or specimens are publicly available or
recorded in such a manner that the subjects cannot be identified.
For non-exempt studies, the approval process typically involves:
(1) Documenting that the applicant holds a multiple project assurance
(MPA) which is approved and on file with the Department of Health and
Human Services (DHHS) (If the applicant does not hold an DHHS MPA, EPA
may issue a single project assurance (SPA) provided the applicant meets
the requirements of the Common Rule.); (2) documenting approval from
the applicant's Institutional Review Board; (3) submitting a copy of
the study proposal and protocols for data collection; and (4)
submitting a copy of the consent form and a description of procedures
for obtaining informed consent.
Formal human subjects approval or a finding of an exemption from
human subjects approval will be made by EPA's Review Official as part
of the formal grant application process for those applicants who are
selected for funding. For purposes of the pre-application process,
applicants should be sure to address the mandatory requirements
described in Unit VIII. regarding human subjects approval, data
confidentiality, and study restrictions.
V. Activities
This NOFA covers whose goal is minimizing lead hazards to occupants
from R&R activities. Several studies on R&R will be funded up to the
amount of funding available, and the exact number of studies will
depend upon the mix of dollar values of the most highly rated
proposals.
The list below is only provided to describe examples of possible
topics for study in this area, and the ordering below should not be
construed as in any particular order. Other ideas related to R&R are
openly encouraged. The best proposals will be selected regardless of
category. More than one organization might possibly be funded in the
same topic area.
Examples of possible topics for a study are as follows:
1. Efficacy of cleaning techniques: For example, an evaluation of
vacuuming technology to reduce dust lead loading on carpeted and/or
smooth surfaces after R&R. This could include but not be limited to a
comparison of high efficiency particulate air (HEPA) vacuums, shop
vacuums, other special purpose vacuums or vacuum bags, and regular
vacuums. Also of interest are effective cleaning techniques for
cleaning lead-contaminated carpets and other irregular surfaces.
2. Portable field testing: This could include an evaluation of
portable field testing units to analyze dust, paint, and/or soil before
or after R&R. Dust sampling and analysis could be useful in verifying
that dust cleanup has been properly done after R&R, paint sampling and
analysis could be useful for determining whether paint contains lead
and would need special precautions to prevent lead contamination due to
R&R, and soil sampling and analysis could determine whether lead
contamination was generated from external scraping, for example.
Examples could include but are not limited to the following: portable
XRF, for dust, soil or paint analysis, or alternative field testing
technologies, such as colorimetric devices, anodic stripping voltametry
or laser technology.
3. Field kit: including testing instructions and a mailer to send
samples to a laboratory. A major cost in sampling and analysis before
undertaking R&R activities is the cost of sending a professional to the
home. If a reliable program could be developed for a homeowner to take
samples and mail them to an EPA-recognized laboratory, this could
greatly reduce testing costs and potentially result in much greater
testing to prevent lead poisoning due to R&R activities.
4. Build upon previously conducted studies by EPA or other
organizations to further advance the state of knowledge of the control
of lead hazards created by R&R activities.
5. Clearance testing after R&R: examine the performance of various
methods on different surfaces for clearance after R&R.
6. Studying the effects of R&R on outdoor dust lead levels.
7. Studying the safe use of heat guns for paint removal.
[[Page 60817]]
VI. Grant Term
The applicant's proposed project period should start on October 1,
2000, and may last for up to 2 years. Successful applicants may be
granted time extensions of 6 months beyond the 2-year period, but those
decisions will be made on a case-by-case basis, if and when they become
necessary. Awards of additional funds beyond the initial funding award
are very unlikely.
VII. Eligibility
Eligible recipients include, but are not limited to, non-profit
organizations, institutions of higher learning, state and local
associations, states, federally-recognized Indian Tribes and tribal
organizations, for-profit organizations, trade and professional
associations, labor unions and joint labor/management trust funds.
However, as a result of the Lobbying Disclosure Act of 1995, EPA (and
other Federal agencies) may not award grants to non-profit, section
501(c)(4) organizations that engage in lobbying activities. This
restriction applies to any lobbying activities of a section 501(c)(4)
organization without distinguishing between lobbying funded by Federal
money and lobbying funded by other sources.
In addition, the following conditions apply:
1. There are no requirements for matching funding under this grant
program.
2. No applicant can receive two grants from this NOFA for the same
project at one time. Applicants may submit more than one application so
long as the applications are for separate and distinct projects.
3. If applicants will use funding from other sources (private or
public) in carrying-out their proposed projects, the applicants must
disclose those sources of funding and any restrictions due to funding
from other sources in the pre-application. Evidence of other funding,
if applicable, is required in the pre-application.
4. The grants under this program will be awarded as cooperative
agreements to allow for the substantial involvement anticipated between
EPA and the recipients during the post-award period for these projects.
VIII. Criteria For Selection
Mandatory Requirements and Evaluation Factors
Pre-application proposals will be rated based on the following
mandatory requirements and evaluation factors. There are three
mandatory requirements. The maximum points for each evaluation factor
are provided below. The maximum number of points from all evaluation
factors is 100. Applicants will be required to submit a Study Plan with
an Appendix to be considered. The Study Plan will be divided into
Sections A through J, as indicated in Unit IX. If more than 10 pages
are submitted for either the Study Plan or the Appendix, only the first
10 pages of each will be rated.
Mandatory Requirements
1. If the study will include human subjects, the applicant must
demonstrate that the study will be done in compliance with 40 CFR part
26, that the study will also be done in compliance with 45 CFR part 46,
subpart D if there are child research subjects, and that the applicant
will be able to complete EPA human subjects approval or have an exempt
finding confirmed by EPA.
2. The applicant must demonstrate the study will maintain the
confidentiality of personal information, such as preventing linkage
between names/addresses and data.
3. Restrictions on the study and on the release of non-confidential
data must be judged reasonable and appropriate for a study funded by
EPA.
The applicant's response to Section E of the Study Plan will be
used to rate the applicant on these mandatory requirements.
Evaluation Factors
1. Does the proposed study address the goals of this NOFA and
provide needed and important information to the scientific community?
(25 points)
The applicant's response to Sections A, B, C, and H of the Study
Plan will be used to rate the applicant on this factor.
2. Is the study sound from scientific and practical perspectives?
(35 points)
The applicant's response to Sections D, F, and G of the Study Plan
will be used to rate the applicant on this factor.
3. Does the applicant have the resources and organization to carry
out and complete the study as proposed? (20 points)
The applicant's response to Section I of the Study Plan and to the
Appendix will be used to rate the applicant on this factor.
4. Are the time line and budget realistic and developed
sufficiently? (20 points)
The applicant's response to Section J of the Study Plan will be
used to rate the applicant on this factor.
If two or more pre-applications receive the same score, and it is
necessary to break ties, the following procedure will be used
successively as necessary to resolve tie scores:
(1) Pre-application with highest score in factor 1.
(2) Pre-application with the highest score in factor 2.
(3) Pre-application with the highest score in factor 3.
(4) Pre-application with the highest score in factor 4.
IX. Pre-Application Procedure
A. Overall Requirements for Submission
Applicants must submit a proposal for the pre-application
procedure. The Agency will use applicants' submissions to select
projects to be funded under this grant program. After EPA conducts a
review of all submitted pre-applications, successful applicants will be
contacted and requested to submit other documents (such as the
``Application for Federal Assistance'' form (Standard Form 424 or
SF424), and the ``Budget Information: Non-Construction Programs'' form
(SF424A)), human subjects approval materials where applicable, and
other required forms to complete the application process. However, for
the purposes of the pre-application process, applicants must submit
only what is described below.
Applicants must submit one original and two copies of the pre-
application (double-sided copies are encouraged). Pre-applications must
be reproducible (for example, stapled in the upper left- hand corner,
on white paper, and with page numbers). The pre-application consists of
the following two parts.
1. Study Plan. A study plan describes the applicant's proposed
project. A Table of Contents with page numbers should be included.
Study plans must be no more than 10 pages total. One page is one side
of a single-spaced typed page. The pages must be letter size (8\1/2\''
x 11''), with normal type size (10 or 12 cpi) and must have margins
that are at least 1 inch. The study plan must respond to the format
described below in Section B of this unit.
2. Appendix. The only items that EPA will accept in the Appendix
are resumes of key personnel and the title, description, and reference
name with phone number for work on previous or current grants or
contracts with the Federal government within the last 5 years. The
appendix must be no more than 10 pages total. One page is one side of a
single-spaced typed page. The pages must be letter size (8\1/2\'' x
11''), with normal type size (10 or 12 cpi) and must have margins that
are at least 1 inch.
B. Format for the Study Plan
Applicants must submit a Study Plan in the following format, with,
as stated
[[Page 60818]]
above, a maximum of 10 pages in total for the Study Plan:
A. Title, synopsis, and table of contents. Pre-applications should
include a title, a synopsis of the proposal, and a table of contents.
The title and the synopsis should accurately and concisely describe the
proposed study to the point that a person not familiar with the study
could describe it to someone else who is not familiar with the study.
B. Need for study and relationship of study to other activities.
The applicant should explain why the proposed study should be done and
how it will improve the understanding of ways to minimize lead exposure
to occupants from R&R activities. In addition, the applicant should
indicate why the proposed study is likely to produce useful
information. Finally, the relationship, if any, between the proposed
study and the applicant's ongoing or previous data collection/research
activities should be described.
C. Study objectives. The study objectives should be stated clearly.
Examples of study objectives would be to compare two methods, to
compare a method to a clearance standard, to obtain information on the
characteristics of a method, or to take a survey of certain practices
such as cleanup methods. Any variables used in the description of the
study objectives should be clearly defined.
D. Study design and data specifics. The study design describes how
the study will be executed, what data will be collected, and what
characteristics the data will have. This element covers the design or
plan for the proposal. The study design is critical to the success of
any project since it addresses how well the proposal will answer the
question being examined. The proposal should clearly describe:
How the study design will achieve the objectives of the
study.
``Real-world'' applicability of the design. For example,
if variability is carefully controlled, but the conditions are so
strained as to make the applicability of the results for further use
less straightforward to generalize to other settings, the proposal will
receive a lower score than if the design is more generalizable.
The feasibility and practicality of the project. For
example, can all groups involved follow the plan?
Ways to control unwanted effects and variability, such as
seasonal variation in blood-lead levels.
Sample size/power determinations.
How the samples were/will be selected? Was a randomized
sampling plan followed?
The process used to obtain the data. For example, what
type of chemical analysis was used? Or, if a survey, what questions
were or will be asked?
The presence of a control group where applicable.
E. Human subjects approval, data confidentiality, and study
restrictions. If the study will include human subjects, the applicant
must demonstrate that the study will be done in compliance with 40 CFR
part 26, that the study will also comply with 45 CFR part 46, subpart D
if there are child research subjects, and that the applicant will be
able to complete EPA human subjects approval or have an exempt finding
confirmed by EPA. In addition, the applicant must describe plans to
maintain the confidentiality of personal information.
The applicant must also describe any restrictions on the study and
associated data. This includes, for example, restrictions due to other
sources of funding, rules of the applicant's institution, or guarantees
made to cooperating human subjects.
F. Quality assurance. In order to have confidence in the product of
a study, the quality of the data sets in support of the study should be
determined and demonstrated to be adequate. This demonstration of data
quality assurance applies to both newly generated data and existing
data sets which are to be used as a part of the study. Some of the
areas of data quality assurance which need to be taken under
consideration include evaluations of data bias, precision, and
representativeness.
Pre-applications should include a description of the process to be
used to evaluate the quality of newly generated data and/or existing
data. This description should identify key areas of data quality
assurance which will be taken under consideration in order to have
confidence in the final study product.
G. Statistical analysis plan. The statistical analysis plan should
include the translation of the study objectives to appropriate
statistical terms, such as a test of hypotheses or estimation of
confidence limits around a point estimate. The statistical analysis
plan should also mention the statistical approach used to evaluate the
data. If a hypothesis is to be evaluated, the alternative hypothesis,
the type I error and the statistical tests that will be used should be
described. In the case of descriptive statistics, the procedure for
calculating an appropriate confidence interval, with the level of
confidence, for the point estimates should be described. If a model,
such as a regression model, is to be developed, the description of the
model and the assumptions underlying the model should be stated.
The analysis plan should also include the statistical software that
will be used. Other items to consider are: graphical analyses to be
carried out; data transformations and the reason for these
transformations; consideration of confounding variables; and data
assumptions, such as normality and independence.
H. Products and dissemination. Products from grantees should
include articles on study findings in scientifically peer reviewed
publications. Pre-applications need to state what products will be
produced, and what means of product information dissemination will be
used in order to make study findings and study data available to the
scientific community.
I. Organizational resources. The pre-application must include a
description of the applicant's organizational resources. The applicant
should demonstrate that these resources are sufficient to implement the
proposed activity in a timely manner and within budget while meeting
the proposed study objectives. The applicant should document the
knowledge and experience of the project director and staff, including
the day-to-day program manager(s), staff members, consultants, and
contractors. In particular, the experience of key staff in relevant
areas such as personnel management, administrative support, data
management and statistical analysis, chemical analysis, quality
assurance, and report writing should be documented. Resumes of key
personnel should be included in the Appendix.
If the applicant has received other grants or contracts from the
Federal government in the last 5 years, the applicant must furnish a
title and description of the previous work, and the name and phone
number of a Federal government employee who is familiar with the
applicant's performance on that grant or contract. This information
should be included in the Appendix.
J. Time line, financial plan, and sources of other funding. Pre-
applications should include a time line or schedule for completing the
proposed study, a financial plan which estimates all costs associated
with the proposed study on a yearly basis with totals for the entire
study, and identification of other sources of funding for the proposed
study. The financial plan should include the following categories of
costs: personnel, fringe benefits, travel, equipment, supplies,
contractual, construction, other, total direct charges (sum of
personnel, fringe benefits,
[[Page 60819]]
travel, equipment, supplies, contractual, construction and other),
indirect charges and total (sum of total direct charges and indirect
charges.) A part of the study schedule should include a provision for
verbal and written updates to EPA.
Sources of other funding, either pending or already established,
must be identified. Information sufficient to verify sources of any
other funding already established must be included in this section.
List of Subjects
Environmental protection, Lead.
Dated: November 3, 1999.
William H. Sanders III,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 99-29265 Filed 11-5-99; 8:45 am]
BILLING CODE 6560-50-F
