National Institute for Occupational Safety and Health; Assessment of Respiratory Exposure Hazards in Composting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 738]

National Institute for Occupational Safety and Health; Assessment

of Respiratory Exposure Hazards in Composting

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997

[[Page 31826]]

funds for a cooperative agreement to conduct cross-sectional studies at

composting facilities of respiratory exposures and respiratory health

effects among compost workers.

CDC is committed to achieving the health promotion and disease

prevention objectives of Healthy People 2000, a national activity to

reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Occupational Safety and

Health. (For ordering a copy of Healthy People 2000, see the section

Where to Obtain Additional Information.)

CDC, National Institute for Occupational Safety and Health (NIOSH)

is committed to the program priorities developed by the National

Occupational Research Agenda (NORA). (For ordering a copy of the NORA,

see the section WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

This program is authorized under Sections 20(a) and 22(e)(7) of the

Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a) and

671(e)(7)).

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the nonuse of all tobacco products, and

Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in

certain facilities that receive Federal funds in which education,

library, day care, health care, and early childhood development

services are provided to children.

Eligible Applicants

Applications may be submitted by public and private, non-profit and

for-profit organizations and governments, and their agencies. Thus,

universities, colleges, research institutions, hospitals, other public

and private organizations, State and local health departments or their

bona fide agents, federally recognized Indian tribal governments,

Indian tribes or Indian tribal organizations, and small, minority- and/

or women-owned businesses are eligible to apply.

Note: Public Law 104-65, dated December 19, 1995, prohibits an

organization described in section 501(c)(4) of the IRS Code of 1986,

that engages in lobbying activities to influence the Federal

Government, from receiving Federal funds.

Availability of Funds

Approximately $200,000 will be available in FY 1997 to fund up to

two awards at approximately $100,000 each. It is expected that the

awards will begin on or about September 30, 1997, and will be made for

12-month budget periods within the project period of up to 3 years. The

funding estimate is subject to change.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative bodies. Under the

provisions of 31 U.S.C. Section 1352 (which has been in effect since

December 23, 1989), recipients (and their subtier contractors) are

prohibited from using appropriated Federal funds (other than profits

from a Federal contract) for lobbying Congress or any Federal agency in

connection with the award of a particular contract, grant, cooperative

agreement, or loan. This includes grants/cooperative agreements that,

in whole or in part, involve conferences for which Federal funds cannot

be used directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1997 HHS Appropriations Act, which became

effective October 1, 1996, expressly prohibits the use of 1997

appropriated funds for indirect or ``grass roots'' lobbying efforts

that are designed to support or defeat legislation pending before State

legislatures. This new law, Section 503 of Pub. L. No. 104-208,

provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * * except

in presentation to the Congress or any State legislative body itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract recipient,

or agent acting for such recipient, related to any activity designed to

influence legislation or appropriations pending before the Congress or

any State legislature.

Department of Labor, Health and Human Services, and Education, and

Related Agencies Appropriations Act, 1997, as enacted by the Omnibus

Consolidated Appropriations Act, 1997, Division A, Title I, Section

101(e), Pub. L. No. 104-208 (September 30, 1996).

Background

Composting is the decomposition of organic materials under aerobic

conditions which produces a stable, humus-like material which can be

used as a soil amendment. Materials composted can include yard waste,

food/household waste, food processing waste, agricultural wastes,

biosolids, and animal wastes. The recycling of biosolids and the

organic fractions of municipal solid waste is increasing because of the

benefits that can arise and because the disposal alternatives such as

land filling and incineration are more costly, unpopular, or restricted

by law. The consequence of this is a dramatic increase in the number of

composting operations and the number of workers exposed to organic

dusts at these facilities. The proceedings from a national composting

council workshop indicate that there were approximately 2500 composting

facilities operating in the United States during 1992 with a large

expected growth rate (over 45 percent) in the number of composting

facilities during subsequent years. The rapid growth in this industry,

combined with the potential for worker exposure to organic dusts

containing many toxic and immunogenic constituents, indicates the need

for studies to address potential respiratory health problems among

workers in this industry. Upper respiratory tract irritation, organic

dust toxic syndrome (ODTS), asthma, bronchitis, and hypersensitivity

pneumonitis are among the respiratory health problems described to

occur from organic dust exposures such as those associated with

composting.

Composting is an emerging technology area. Under the NIOSH National

Occupational Research Agenda (NORA), emerging technologies represent a

priority area for research efforts to (1) Assess their potential to

cause harm to workers, (2) evaluate specific worksites, (3) develop

effective control strategies where occupational hazards exist, (4)

identify superior new technologies that diminish risk, and (5) share

information for the benefit of all persons at risk and those

responsible for managing the risk.

This project addresses many of these emerging technology criteria

described in NORA.

Purpose

The purpose of this project is to conduct research to identify

potential exposure hazards and respiratory health problems among

workers in the composting industry. This information

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will be used to promote respiratory health for this workforce and

direct prevention efforts as appropriate.

The specific objectives for this cooperative agreement program

include the following: develop a research protocol(s) for a cross-

sectional study of respiratory exposures and respiratory health effects

among workers employed at composting facilities; conduct in-depth

environmental investigations of respiratory exposure hazards at

selected composting facilities; conduct in-depth clinical

investigations on the respiratory health status of workers at selected

composting facilities; and describe the composting processes used at

each survey site including the control procedures used to reduce worker

exposures.

Note: Protocols should exclude sampling sites in Department of

Health and Human Services (DHHS) Region VII from the sample (DHHS

Region VII includes the following States: Iowa, Kansas, Missouri,

and Nebraska). This exclusion is to avoid duplication with ongoing

composting research efforts completed through the NIOSH funded

Centers for Agriculture Research, Education and Disease Injury and

Prevention in DHHS Region VII.

Program Requirements

In conducting activities to achieve the purpose of this agreement,

the recipient will be responsible for conducting activities under A.

(Recipient Activities) below, and CDC/NIOSH will be responsible for

conducting activities under B. (CDC/NIOSH Activities) below:

A. Recipient Activities

1. Develop a research protocol(s) for a cross-sectional study of

respiratory exposures and respiratory effects among workers employed at

composting facilities. Obtain scientific peer review of the

protocol(s), revise, and finalize the protocol(s).

2. Conduct a comprehensive environmental investigation of

respiratory exposure hazards at selected composting facilities.

Personal and area environmental sampling data collected from each of

these facilities should include, at a minimum, particulate not

otherwise regulated (formerly known as ``total dust''), metals,

endotoxins, viable microorganisms, and ammonia.

3. Conduct in-depth clinical investigations on the respiratory

health status of workers at selected composting facilities. Study

design should take into account sources of bias in particular the

problems encountered when limiting the study to current employees.

Clinical investigations should include, at a minimum:

a. The development and administration of a questionnaire designed

to gather information on work and exposure history and respiratory

health effects. The questionnaire should be administered to all members

of this study population.

b. The development and implementation of a pulmonary function

testing program appropriate to the investigation of respiratory health

effects among compost workers at selected facilities.

4. Clarify the composting processes used at each survey site

including the control procedures used to reduce worker exposures.

5. Collaborate with CDC/NIOSH scientists on study research efforts.

6. Report and disseminate, if desired, research results and

relevant health and safety education and training information to

appropriate health care providers, the scientific community,

agricultural workers and their families, management and union or other

worker representatives, and Federal, State, and local agencies.

Emphasis should be placed on the rapid dissemination of significant

public health findings and the translation of research findings into

prevention efforts.

B. CDC/NIOSH Activities

1. Provide technical assistance in the areas of program development

and study research efforts, implementation, maintenance.

2. Provide technical assistance, if needed, related to the

development and implementation of the pulmonary function testing

program.

3. Provide technical assistance, if needed, related to the

collection, review and/or analysis of data.

4. Collaborate in the reporting and dissemination of research

results and relevant health and safety education and training

information.

Technical Reporting Requirements

An original and two copies of semi-annual progress reports are

required. Timelines for the semi-annual reports will be established at

the time of award. Final financial status and performance reports are

required no later than 90 days after the end of the project period. All

reports are submitted to the Grants Management Branch, Procurement and

Grants Office, CDC.

Semi-annual progress report should include:

A. A brief program description.

B. A listing of program goals and objectives accompanied by a

comparison of the actual accomplishments related to the goals and

objectives established for the period.

C. If established goals and objectives to be accomplished were

delayed, describe both the reason for the deviation and anticipated

corrective action or deletion of the activity from the project.

Application Content

The entire application, including appendices, should not exceed 40

pages and the Proposal Narrative section contained therein should not

exceed 25 pages. Pages should be clearly numbered and a complete index

to the application and any appendices included. The original and each

copy of the application must be submitted unstapled and unbound. All

materials must be typewritten, double-spaced, with unreduced type (font

size 12 point) on 8\1/2\'' by 11'' paper, with at least 1'' margins,

headers, and footers, and printed on one side only. Do not include any

spiral or bound materials or pamphlets.

The applicant should provide a detailed budget, with accompanying

justification of all operating expenses, that is consistent with the

stated objectives and planned activities of the project. CDC may not

approve or fund all proposed activities. Applicants should be precise

about the program purpose of each budget item. For contracts described

within the application budget, applicants should name the contractor,

if known; described the services to be performed and provide an

itemized breakdown and justification for the estimated cost of the

contract; the kinds of organizations or parties to be selected; the

period of performance; and the method of selection. Place budget

narrative pages showing, in detail, how funds in each object class will

be spent, directly behind form 424A. Do not put these pages in the body

of the application.

The applicant should provide a detailed description of first-year

activities and briefly describe future-years objectives and activities.

A. Title Page

The heading should include the title of grant program, project

title, organization, name and address, project director's name address

and telephone number.

B. Abstract

A one page, singled-spaced, typed abstract must be submitted with

the application. The heading should include the title of grant program,

project title, organization, name and address, project director and

telephone number. This abstract should include a work plan identifying

activities to be developed, specific activities to be

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completed, and a time-line for completion these activities.

C. Proposal Narrative

The narrative of each application must:

1. Briefly state the applicant's understanding of the need or

problem to be addressed and the purpose of this cooperative agreement.

This should include a draft protocol for the study. The protocol(s)

should include:

(a) A sampling strategy to insure that a representative sample of

composting operations and technologies are included in the study, and

(b) The sampling strategy should maximize the number of study sites

and include a representative sample based on geographic considerations.

2. (a) Describe clearly the objectives of this project, the steps

to be taken in planning and implementing this project, and the

respective responsibilities of the applicant for carrying out those

steps.

(b) Provide a proposed schedule for accomplishing each of the

activities to be carried out in this project and a method of evaluating

the accomplishments.

3. Provide documentation of access to potential study sites with

the sample characteristics specified, and provide documentation of

management and labor representatives to participate in the intervention

study.

4. Document the applicant's expertise in the area of exposure and

health assessment as they pertain to occupational safety and health.

5. Provide the name, qualifications, and proposed time allocation

of the Project Director who will be responsible for administering the

project. Describe staff, experience, facilities, equipment available

for performance of this project, and other resources that define the

applicant's capacity or potential to accomplish the requirements stated

above. List the names (if known), qualifications, and time allocations

of the existing professional staff to be assigned to (or recruited for)

this project, the support staff available for performance of this

project, and the available facilities including space.

6. Human Subjects: State whether or not Humans are subjects in this

proposal. (See Human Subjects in the Evaluation Criteria and Other

Requirements sections.)

7. Inclusion of women, ethnic, and racial groups:

Describe how the CDC policy requirements will be met regarding the

inclusion of women, ethnic, and racial groups in the proposed research.

(See Women, Racial and Ethnic Minorities in the Evaluation Criteria and

Other Requirements sections.)

8. Provide a detailed budget which indicates: (a) anticipated costs

for personnel, travel, communications, postage, equipment, supplies,

etc., and (b) all sources of funds to meet those needs.

Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria:

A. Background and Need (20%)

Responsiveness to the purpose of this project, including the

applicant's understanding of the objectives of the proposed cooperative

agreement and the relevance of the proposal to the objectives.

B. Goals, Objectives and Methods (25%)

1. The extent to which the proposed goals and objectives are

clearly stated, time-phased, and measurable. The extent to which the

methods are sufficiently detailed to allow assessment of whether the

objectives can be achieved for the budget period. The extent to which a

qualified plan is proposed that will help achieve the goals stated in

the proposal.

2. The degree to which the applicant has met the CDC policy

requirements regarding the inclusion of women, ethnic, and racial

groups in the proposed project. This includes: (a) The proposed plan

for the inclusion of both sexes and racial and ethnic minority

populations for appropriate representation; (b) The proposed

justification when representation is limited or absent; (c) A statement

as to whether the design of the study is adequate to measure

differences when warranted; and (d) A statement as to whether the plan

for recruitment and outreach for study participants include the process

of establishing partnerships with community(ies) and recognition of

mutual benefits.

C. Strength of Programs (20%)

Strength of the applicant's environmental and clinical research

programs including a demonstrated ability in the conduct of

occupational health studies involving organic dusts, gases, and

respiratory health assessment.

D. Project Management and Staffing Plan (20%)

Training and experience, qualifications, and time commitment of the

project director, staff, and organization. This includes a Project

director who is a distinguished scientist and technical expert and

staff with the necessary training and experience sufficient to

accomplish proposed project.

E. Experience/Expertise (10%)

Applicant's knowledge/understanding and experience in the

composting industry.

F. Facilities and Resources (5%)

Efficiency of resources and novelty of program. This includes the

efficient use of existing and proposed personnel with assurances of a

major time commitment of the Project Director to the program and the

novelty of program approach.

G. Human Subjects (Not Scored)

Whether or not exempt from the DHHS regulations, are procedures

adequate for protection of human subjects? Recommendations on the

adequacy of protections include: (1) Protections appear adequate, and

there are no comments to make or concerns to raise, (2) protections

appear adequate, but there are comments regarding the protocol, (3)

protections appear inadequate and the Objective Review Group has

concerns related to human subjects, or (4) disapproval of the

application is recommended because the research risks are sufficiently

serious and protection against the risks are inadequate as to make the

entire application unacceptable.

H. Budget Justification (Not Scored)

The budget will be evaluated to the extent that it is reasonable,

clearly justified, and consistent with the intended use of funds.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants (other than federally recognized

Indian tribal governments) should contact their State Single Point of

Contact (SPOC) as early as possible to alert them to the prospective

applications and receive any necessary instructions on the State

process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit.

If SPOCs have any State process recommendations on applications

submitted to CDC, they should be sent to Victoria Sepe, Grants

Management Specialist, Grants Management Branch, Procurement and Grants

Office, Centers

[[Page 31829]]

for Disease Control and Prevention (CDC), 255 East Paces Ferry Road,

NE., Room 321, Atlanta, GA 30305, no later than September 1, 1997. The

Program Announcement Number 738 and Program Title should be referenced

on the document. The granting agency does not guarantee to

``accommodate or explain'' State process recommendations it receives

after that date.

Indian tribes are strongly encouraged to request tribal government

review of the proposed application. If tribal governments have any

tribal process recommendations on applications submitted to CDC, they

should forward them to: Victoria Sepe, Grants Management Specialist,

Grants Management Branch, Centers for Disease Control and Prevention,

255 East Paces Ferry Road, NE., Room 321, Mailstop E-13, Atlanta, GA

30305. This should be done no later than September 1, 1997. The

granting agency does not guarantee to ``accommodate or explain'' for

tribal process recommendations it receives after that date.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance Number for this program

is 93.262.

Other Requirements

Paperwork Reduction Act

Projects funded through the cooperative agreement mechanism of this

program involving the collection of information from 10 or more

individuals will be subject to review and approval by the Office of

Management and Budget (OMB) under the Paperwork Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the DHHS Regulations, 45 CFR Part 46,

regarding the protection of human subjects. Assurance must be provided

to demonstrate the project will be subject to initial and continuing

review by an appropriate institutional review committee. The applicant

will be responsible for providing assurance in accordance with the

appropriate guidelines and form provided in the application kit.

In addition to other applicable committees, Indian Health Service

(IHS) institutional review committees also must review the project if

any component of IHS will be involved or will support the research. If

any American Indian community is involved, its tribal government must

also approve that portion of the project applicable to it.

Women and Minority Inclusion Policy

It is the policy of the Centers of Disease Control and Prevention

(CDC) to ensure that women and racial and ethnic groups will be

included in CDC supported research projects involving human subjects,

whenever feasible and appropriate. Racial and ethnic groups are those

defined in OMB Directive No. 15 and include American Indian, Alaskan

Native, Asian, Pacific Islander, Black and Hispanic. Applicants shall

ensure that women, racial and ethnic minority population are

appropriately represented for research involving human subjects. Where

clear and compelling rationale exist that inclusion is inappropriate or

not feasible, this situation must be explained as part of the

application. In conducting the review of applications for scientific

merit, review groups will evaluate proposed plans for inclusion of

minorities and both sexes as part of the scientific assessment and

assigned score. This policy does not apply to research studies when the

investigator cannot control the race, ethnicity and/or sex of subjects.

Further guidance on this policy is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-47951.

Application Submission and Deadline

A. Preapplication Letter of Intent

Although not a prerequisite of application, a non-binding letter of

intent-to-apply is requested from potential applicants. The letter

should be submitted to Victoria Sepe, Grants Management Specialist,

Grants Management Branch, Procurement and Grants Office, CDC at the

address listed in this section. It should be postmarked no later than

July 1, 1997. The letter should identify Program Announcement 738 and

name of the principal investigator. The letter of intent does not

influence review or funding decisions, but it will enable CDC to plan

the review more efficiently and will ensure that each applicant

receives timely and relevant information prior to application

submission.

B. Application

The original and two copies of the application PHS Form 5161-1

(Revised 7/92, OMB Number 0937-0189) must be submitted to Victoria

Sepe, Grants Management Specialist, Grants Management Branch,

Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., Room 321, Atlanta, GA

30305, on or before July 18, 1997.

1. Deadline: Applications will be considered as meeting the

deadline if they are either:

(a) Received on or before the deadline date, or

(b) Sent on or before the deadline date and received in time for

submission to the objective review group. (The applicants must request

a legibly dated U.S. Postal Service postmark or obtain a receipt from a

commercial carrier or the U.S. Postal Service. Private metered

postmarks will not be acceptable as proof of timely mailing.)

2. Late Applicants: Applications that do not meet the criteria in

1.(a) or 1.(b) above are considered late applications. Late

applications will not be considered and will be returned to the

applicants.

Where to Obtain Additional Information

To receive additional written information call (404) 332-4561. You

will be asked to leave your name, address, and telephone number and

will need to refer to NIOSH Announcement 738. You will receive a

complete program description, information on application procedures,

and application forms. CDC will not send application kits by facsimile

or express mail. Please refer to NIOSH Announcement Number 738 when

requesting information and submitting an application.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Victoria Sepe, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), Mailstop E-13, Room 321, 255 East Paces Ferry Road,

NE., Atlanta, GA 30305, telephone (404) 842-6804, Internet:

[email protected].

Programmatic technical assistance may be obtained from Patrick

Hintz, M.S., Division of Respiratory Disease Studies, National

Institute for Occupational Safety and Health, Centers for Disease

Control and Prevention (CDC), Mailstop P04/111, 1095 Willowdale Road,

Morgantown, WV 26505-2888, telephone (304) 285-5744, Internet:

[email protected].

This and other CDC announcements are available through the CDC

homepage

[[Page 31830]]

on the Internet. The address for the CDC homepage is: http://

www.cdc.gov.

Potential applicants may obtain a copy of Healthy People 2000 (Full

Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary

Report, Stock No. 017-001-00473-1) referenced in the Introduction

section through the Superintendent of Documents, Government Printing

Office, Washington, DC 20402-9325, telephone (202) 512-1800.

The National Occupational Research Agenda: copies of this

publication may be obtained from the National Institute for

Occupational Safety and Health, Publications Office, 4676 Columbia

Parkway, Cincinnati, OH 45226-1998 or telephone 1-800-356-4674, and is

available through the NIOSH Home Page; http://www.cdc.gov/niosh/

nora.html.

NORA Priority Research Areas

Disease and Injury

Allergic and Irritant Dermatitis

Asthma and Chronic Obstructive Pulmonary Disease

Fertility and Pregnancy Abnormalities

Hearing Loss

Infectious Diseases

Low Back Disorders

Musculoskeletal Disorders of the Upper Extremities

Traumatic Injuries

Work Environment and Workforce

Emerging Technologies

Indoor Environment

Mixed Exposures

Organization of Work

Special Populations at Risk

Research Tools and Approaches

Cancer Research Methods

Control Technology and Personal Protective Equipment

Exposure Assessment Methods

Health Services Research

Intervention Effectiveness Research

Risk Assessment Methods

Social and Economic Consequences of Workplace Illness and Injury

Surveillance Research Methods

Dated: June 4, 1997.

Diane D. Porter,

Acting Director, National Institute for Occupational Safety and Health,

Centers for Disease Control and Prevention (CDC).

[FR Doc. 97-15180 Filed 6-10-97; 8:45 am]

BILLING CODE 4163-19-P