United States
Environment.il Protection
Agency
Office of Pesticides and
Toxic Substances
Washington. D C 2046O
EPA-560/TIIS-83-007
September 1983
Toxic Substances
Federal Activities in
Toxic Substances
Toxic Integration
Information Series
CPSOCEQ*DOL»DOT»DHHS
EPA»FDA«USDA
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Toxics Integration Information Series
FEDERAL ACTIVITIES
/
IN
TOXIC SUBSTANCES
Edited by
Catherine Allin
Wade Richardson
J. David Sandier
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Aqencv
September 1983
U.S. Environmental Protection Agency
Region 5, Library (PL-12J)
77 West Jackson Boulevacd, 12th Floor
Chicago, IL 60604-3590
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CONTENTS
Page
FOREWARD iv
OTHER TOXICS INTEGRATION SERIES PUBLICATIONS vi
FEDERAL AGENCIES 1
Consumer Product Safety Commission (CPSC) 2
Council on Environmental Quality (CEQ) 30
Department of Agriculture (DOA) 37
Food Safety and Inspection Service (FSI) 39
Department of Health and Human Services (DHHS) 56
Food and Drug Administration (FDA—Overview) 59
National Center for Toxicological Research (NCTR) 75
National Institutes of Health (NIH—Overview) 87
National Cancer Institute (NCI) 90
National Institute of Environmental Health
Sciences (NIEHS) 108
National Institute for Occupational Safety
and Health (NIOSH) 123
Center for Environmental Health 142
Department of Labor (DOL) 153
Occupational Safety and Health Administration (OSHA) 155
Mine Safety and Health Administration (MSHA) 171
Department of Transportation (DOT) 180
Materials Transportation Bureau (MTB) 182
United States Coast Guard (USCG) 190
Environmental Protection Agency (EPA) 205
Office of Pesticides and Toxic Substances (OPTS) 212
Office of Toxic Substances (OTS) 216
Office of Pesticide Programs (OPP) 236
Office of Water (OW) 252
Office of Water Regulations and Standards (OWRS) 253
Office of Drinking Water (ODW) 264
Office of Solid Waste and Emergency
Response (OSWER) 276
Office of Solid Waste (OSW) 278
Office of Emergency and Remedial Response (OERR) 297
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Office of Air, Noise, and Radiation (OANR).... 311
Office of Air Quality Planning and Standards
(OAQPS)/Office of Mobile Sources (QMS) 313
PROGRAMS 326
National Toxicology Program (NTP) 327
APPENDIX 341
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FOREWORD
In 1976, one of the most comprehensive pieces of Federal
environmental legislation, the Toxic Substances Control Act
(TSCA), was enacted. TSCA was designed to address both the
overlaps and the gaps in existing health and environmental
legislation. The Act provides broad authority to the
Environmental Protection Agency (EPA) to regulate the thousands
of chemicals in commerce. TSCA directs EPA to take appropriate
regulatory action if any of these chemicals are found to present
an unreasonable risk to human health or the environment. When
signing TSCA into law, the President stated that, "[TSCAl closes
a gap in our current array of laws to protect the health of our
people and the environment." He spoke of the various mandates of
current environmental statutes and concluded that "none of the
existing statutes provide(s) comprehensive protection." This is
what TSCA was designed to do.
Because of the comprehensive authority of TSCA, Congress
recognized that the potential existed for duplicative regulatory
action. For this reason, Section 9 of TSCA directs EPA to
integrate and coordinate the various Federal activities involved
with controlling toxic substances whenever regulatory action is
contemplated or initiated under this Act.
There are nearly two dozen Federal statutes governing toxic
substances as well as a comparable number of Federal agencies
responsible for the research, regulatory, and advisory provisions
of these various acts. Effective integration of toxic substances
activities requires an awareness and comprehension of the many
Federal statutes involved as well as an understanding of the
organizational structure and relevant activities of the agencies
responsible for implementing these statutes.
This document is an outgrowth of the efforts on the part of
EPA's Chemical Coordination Staff to develop the knowledge and
expertise needed to integrate and coordinate Federal toxic
substances regulatory activities. During the process of
familiarizing ourselves with the relevant Federal statutes and
agencies, we concluded that much of the information we had been
gathering was also of interest to others. Therefore, we decided
to publish the material in a readily usable format and make it
available to a wider audience.
In this second edition five new offices have been added for
a total of 22 offices located within 8 Federal agencies or
departments which, in our judgment, have a primary role in the
control of toxic substances. Because this field is quite new and
rapidly expanding, we recognize that much of the material
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presented here may quickly become outdated. Therefore, it is
anticipated that this document will be updated annually, and
future editions will include additional aqencies and statutes.
We welcome any suggestions for improving and/or expanding this
material.
A brief note on the format may be helpful in using this
publication. The information on each office is divided into
several sections. The first section describes the organization
of the office and highlights those divisions, branches, etc.,
which are concerned with toxic substances. The second section
summarizes the statutory authority for the office and briefly
explains those subsections of the statute which pertain to
toxics. The third section (for regulatory agencies only)
highlights the regulatory development process followed by that
agency. The final section briefly describes the various
toxics-related programs and activities.
We have also included an Appendix which provides a graphic
summary of 14 major statutes involved with controlling toxic
substances. The first 3 charts in the Appendix focus on 8
categories of exposure pathways and the fourth chart summarizes
the major information-gathering/producing provisions of the 14
statutes.
This publication would not have been possible without the
cooperation and support of staff members in the various agencies
and offices covered herein. Their assistance and encouragement
were instrumental in guiding the manuscript through several
stages of preparation. We deeply appreciate and gratefully
acknowledge this assistance.
Any comments or suggestions you may have should be directed
to:
Director, Chemical Coordination Staff
Office of Pesticides and Toxic Substances (TS-777)
U.S. Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Telephone (202) 382-3375
Walter W. Kovalick, Jr.
Director
Chemical Coordination Staff
-IV-
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CHEMICAL COORDINATION PUBLICATIONS LIST
OTHER PUBLICATIONS IN THE TOXICS INTEGRATION POLICY SERIES:
State Integrated Toxics Management: Fact and Challenge
(July 1981) EPA-560/TIP-81-001; PB81-242406
Measuring and Comparing the Cost-Effectiveness of EPA
Regulatory Efforts to Control Toxics-Related Health
Risks - Volume 1, Feasibility Study (June 1981)
EPA 560/TIIS-82-007
Chemical Substances Designation (December 1981)
EPA-560/TIIS-82; PB83-130294
OTHER PUBLICATIONS IN THE TOXICS INTEGRATION INFORMATION SERIES:
EPA Chemical Activities Status Report - 1st Edition (June 1979)
EPA-560/13-79-003
EPA Chemical Activities Status Report - 2nd Edition
(December 1980) EPA-560/13-80-040(a), PB81-176414;
EPA-13-80-040(b), PB81-176422
EPA Chemical Activities Status Report - 3rd Edition (June 1982)
EPA-560/TIIS-82-002a, -002b
Chemical Selection Methods: An Annotated Bibliography -
2nd Edition (March 1983) EPA-560/TIIS-83-003
Chemical Substances Designation (December 1981)
EPA-560/TIIS-82-003, PB83-130294; -004, PB83-13032; -005,
PB83-130310; -006; PB83-130328
Directory of Federal Coordinating Groups for Toxic Substances -
1st Edition (June 1979) EPA-560/13-80-008; PB80-137870
Directory of Federal Coordinating Groups for Toxic Substances -
2nd Edition (March 1980) PB80-177314
Directory of Federal and International Coordinating Groups
for Toxic Substances - 3rd Edition (Mav 1983)
EPA-560/TIIS-83-004
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Perspectives on the Top 50 Production Volume Chemicals
(July 1980) EPA-560/13-80-27; PB80-221682
TSCA Status Report for Existing Chemicals Volume 1, Issue 2
(July 1980) EPA-560/13-80-033
TSCA Status Report for Existing Chemicals Volume 2, Issue 2
(July 1981) EPA-560/TIIS-81-004
Chemical Selection Methods: An Annotated Bibliography
(November 1980) EPA-560/THS-80-001 ; PB81-241481
Chemical Information Resources Handbook (January 1981)
EPA-560/TIIS-81-002; PR82-225657 — 2nd edition
(September 1983), EPA 560/TIIS-83-006
Toxic Substances Control Act Grants to states (July 1981)
EPA-560/TIIS-81-003; PB81-232969
TSCA Chemicals in Commerce Inventory: Regional and State
Perspectives (August 1981) EPA-560/TIIS-81-005
State Integrated Toxics Management: 20 Profiles (Reprint
August 1983) EPA-560/TIIS-83-005
Overview of the Industry File Index System (June 1983)
EPA-560/TIIS-83-002
For copies contact:
National Technical Information Service
4285 Port Royal Road
Springfield, VA 22161
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FEDERAL AGENCIES
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CONSUMER PRODUCT SAFETY COMMISSION
Washington, D.C. 20207
Locator: 202-492-6600
Information: 301-492-6957
Organization page 4
Statutory Authorities page 12
Regulatory Development page 15
Toxics-Related Activities page 16
The U.S. Consumer Product Safety Commission (CPSC),
established May 14, 1973 as an independent regulatory agency, is
charged with reducing unreasonable risks of injury associated
with consumer products. The Commission is responsible for
implementing the Consumer Product Safety Act, the Federal
Hazardous Substances Act, the Poison Prevention Packaging Act of
1970, the Flammable Fabrics Act, and the Refrigerator Safety Act.
The Commission issues and enforces mandatory safety
standards, helps industry develop voluntary safety standards, and
bans unsafe products when safety standards are not feasible. It
also monitors recalls of defective products, informs and educates
consumers about product hazards, conducts research and develops
test methods, collects and publishes injury and hazard data, and
promotes uniform product regulations by governmental units.
CPSC is headed by five Commissioners appointed by the
President with the advice and consent of the Senate.
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COMMISSIONER
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ORGANIZATION*
OFFICE OF THE GENERAL COUNSEL
o Provides legal counsel to the Commissioners and staff of
CPSC.
o Furnishes CPSC with relevant scientific and technical
expertise.
o In conjunction with the Department of Justice, conducts
or supervises conduct of litigation in which CPSC is a
party.
o Provides final legal review and recommendations on
safety standards, rules, regulations, petition actions,
procurements, personnel and administrative actions, and
drafts documents for publication in the Federal
Register.
OFFICE OF PROGRAM MANAGEMENT
o Supervises hazard-related programs delineated in the
CPSC operating plan or assigned by the Executive
Director.
o Exercises program review over the progression of
projects.
o Manages, coordinates, and recommends corrective
adjustments to maintain Commission priorities.
o Works in conjunction with Associate Executive Directors
to ensure that legal, technical, environmental,
economic, and social impacts of projects are
comprehensively and objectively presented to the
Commission.
o Provides continual direction to all projects (for
chemicals and environmental hazards activities, see
"Health Sciences.")
*Note: Only those offices which customarily have dealt with
toxics-related issues are described here.
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EPIDEMIOLOGY
o provides professional expertise and analysis of the role
of human interaction with toxic substances. Aids in
developing information on scenarios for use in
establishing product safetv standards for toxic
substances.
o Collects injury data and prepares injury data analysis
to identify hazards, hazard patterns and human factor
analysis.
ECONOMIC ANALYSIS
o Collects data on the chemical ingredients of consumer
products.
o Provides information required for evaluating the
economic effect of various options for reducing the
unreasonable risks of injury associated with some
consumer products.
ENGINEERING
o Develops and evaluates product safety standards and test
methods.
o Furnishes relevant scientific and technical expertise.
HEALTH SCIENCES
o Provides scientific and technical expertise in the
chemical, biological, toxicological, physiological,
medical, and other health-related sciences.
o Collects data and assesses needs for product safety
standards.
o Develops and evaluates performance criteria, quality
control standards, and test methods.
o Conducts compliance testing and provides technical
supervision to CPSC field chemical laboratories.
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Serves as Secretariat for National Poison Prevention
Week.
Provides program management for acute and chronic
chemical and environmental hazards activities.
COMPLIANCE AND ADMINISTRATIVE LITIGATION
o Supervises surveillance and enforcement policy, legal
case quality, productivity, planning input, and review.
o Identifies and acts on any defective consumer product
already in distribution.
o Evaluates industry compliance with existing safety
standards.
o Conducts enforcement litigation.
o Provides legal advice and case guidance to CPSC field
offices.
o Participates in the development of standards prior to
promulgation.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office j?hone Mail Stop
Chairman 202-634-7740 Room 800
1111 18th St. NW.
Washington, D.C. 20207
Executive Director 301-492-6550 Room 436
5401 Westbard Ave.
Bethesda, MD 20207
Directorate For Health 301-492-6957 Room 700
Sciences 5401 Westbard Ave.
Bethesda, MD 20207
Secretary 301-492-6800 Room 336
5401 Westbard Ave.
Bethesda, MD 20207
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Office of General Counsel
301-492-6800
Office of Program Management 301-492-6554
Directorate For Epidemiology 301-492-6440
Directorate For Economic
Analysis
Directorate For Engineering
Sciences
Directorate For Compliance
and Administrative
Litigation
Tnteragency Liaison
301-492-6462
301-492-6504
301-492-6621
301-492-6957
Room 200
5401 Westbard Ave.
Bethesda, MD 20207
Room 426
5401 Westbard Ave.
Bethesda, MD 20207
Room 600
5401 Westbard Ave.
Bethesda, MD 20207
Room 646
5401 Westbard Ave.
Bethesda, MD 20207
Room 738
5401 Westbard Ave.
Bethesda, MD 20207
Room 240
5401 Westbard Ave.
Bethesda, MD 20207
Room 700
5401 Westbard Ave.
Bethesda, MD 20207
REGIONAL AND FIELD OFFICES
MIDWESTERN REGIONAL OFFICE - Victor P. Petralia,
Director&~Press Contact
230 South Dearborn Street, Room 2945
Chicago, IL 60604
(312) 353-8260
FTS 8 353-8260
John H. Mooney
Indianapolis Resident Post
Federal Building U.S. Courthouse
Room 349
46 East Ohio
Indianapolis, IN 46204
(317) 269-7645
FTS 8 331-7645
DuWayne A. Kapelis
Cincinnati Resident Post
Federal Office Building
Room 3031
550 Main Street
Cincinnati, OH 45202
(513) 684-2872
FTS 8 684-2872
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John F. Rabusch
Twin Cities Resident Post
316 N. Robert Street
Room 12 8
Saint Paul, MN 55101
(612) 725-7781
FTS 8-725-7781
Sandra L. Glazier
Milwaukee Resident Post
Federal Building
517 East Wisconsin Avenue
Milwaukee, WI 53202
(414) 291-1468
FTS 8 362-1468
Iowa
Illinois
Indiana
Michigan
Minnesota
Nebraska
Harry Jettke
Cleveland Resident Post
815 Superior Avenue
Room 1512
Cleveland, OH
(216) 522-3886
FTS 8 942-3886
James J. Testasecca
Detroit Resident Post
McNamara Federal Building
Room M-24
477 Michigan Avenue
Detroit, MI 48226
(313) 226-4040
FTS 8 226-4040
North Dakota
Ohio
South Dakota
Wisconsin
SOUTHWESTERN REGIONAL OFFICE - Jeanne Devers-White,
Director & Press Contact
Room 1 C 10, 1100 Commerce Street
Dallas, TX 75242
(214) 767-0841
FTS 8 729-0841
Charles Chancellor
Denver Resident Post
U.S. Customs House
721 Nineteenth Street
Room 579
Denver, CO 80202
(303) 837-2904
FTS 8 327-2904
Harold E. Snyder
Kansas City Resident Post
1009 Cherry Street
Kansas City, MO 64106
(816) 374-2034
FTS 8 758-2034
Sidney Englander
New Orleans Resident Post
4298 Elysian Fields Avenue
New Orleans, LA 70122
(504) 589-3742
FTS 8 682-3742
Earl Strauther
Saint Louis Resident Post
808 North Collins
Saint Louis, MO 63102
(314) 425-6281
FTS 8 279-6281
-8-
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Cecil 0. Smith
Houston Resident Post
1440 North Loop
Room 250
Houston, TX 77009
(713) 229-3519
FTS 8 526-7519
Charles Hill
Tulsa Resident Post
333 West 4th Street
Room 3077
Tulsa, OK 74103
(918) 581-7606
FTS 8 745-7606
Arkansas
Colorado
Kansas
Louisiana
NORTHEASTERN REGIONAL OFFICE
Director and Press Contact
6 World Trade Center
Vesey Street, 6th Floor
New York, NY 10048
(212) 264-1125
FTS 8 264-1125
Jerome Donovan
Boston Resident Office
99 Hiqh Street
Room 1756
Boston, MA 02110
(617) 223-0696
FTS 8 223-0696
William Robinson
Bridgeport Resident Post
915 Lafayette Boulevard
Bridgeport, CT 06604
(203) 579-5915
FTS 8 643-4915
Thomas Giasomo
Buffalo Resident Post
220 Delaware Avenue
Buffalo, NY 14202
(716) 846-4116
FTS 8 437-4116
Missouri
New Mexico
- Otto T. Hall
Oklahoma
Texas
Benedict Fink
Pittsburgh Resident Post
Federal Building
Room 2318
1000 Libertv Avenue
Pittsburgh, PA 15222
(412) 644-6582
FTS 8 722-6582
Edgardo San Miguel
San Juan Resident Post
Federal Building
Room 199
Carlos Chardon Avenue
Hato Rey, PR 00918
(809) 753-4403
Kenneth Thompson
Rockville Resident Post
11820 Coakley Circle
Rockville, MD 20207
(301) 443-3281
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Carl Francis
Philadelphia Resident Post
Custom House Building
2nd & Chestnut Street
Room 600
Philadelphia, PA 19106
(215) 597-9105
FTS 8 597-9105
Connecticut
Delaware
District of
Columbia
Massachusetts
Maryland
Maine
New Jersey
New Hampshire
New York
Pennsylvania
Puerto Rico
Rhode Island
Vermont
Virgin Islands
SOUTHEASTERN REGIONAL OFFICE - Leslie Y. Pounds
Director and Press Contact
800 Peachtree Street, N.W.
Suite 10
Atlanta, Georgia 30308
(404) 881-2231
FTS 8 257-2231
Allan Dobbins
Charlotte Resident Post
Room 355
230 South Tryon Street
Charlotte, NC 28202
(704) 371-6151
FTS 8 672-6151
Paul Phillips
Miami Resident Post
299 E. Broward Boulevard
Room 202F
Fort Lauderdale, FL 33301
(305) 577-7161,63-7266
FTS 8 820-7161
Edward Morganto
Orlando Resident Post
7200 Lake Ellenor Drive
c/o FDA
(305) 420-6261
FTR 8 820-6261
Alabama
Florida
Georgia
Kentucky
Mississippi
North Carolina
South Carolina
Tennessee
West Virginia
Virginia
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WESTERN REGIONAL OFFICE - Lee D. Baxter
Director and Press Contact
555 Battery Street
Room 416
San Francisco, CA 94111
(415) 556-1819
FTS 8 556-1819
Donald K. F. Ching
Honolulu Resident Post
P.O. Box 50052
Honolulu, HI 96850
(808) 546-7523
FTS 8 546-7523
Roger Burrows
Los Angeles Resident Post
3660 Wilshire Boulevard
Room 1100
Los Angeles, CA 90010
(213) 688-7272
FTS 8 798-7272
William Biggs
Phoenix Resident Post
DHHS, IHS, Environmental Health
3738 N. 16th St., Suite A
Phoenix, AR 85016-5981
(602) 241-2397
FTS 8 261-2397
Joseph S. Burchyski
Portland Resident Post
U.S. Courthouse
Room 207
620 S.W. Main Street
Portland, OR 97205
(503) 221-3056
FTS 8 423-3056
Joan Bergy
Seattle Resident Post
6046 Federal Office Building
909 First Avenue
Seattle, WA 98174
(206) 442-5276
FTS 8 399-5276
Alaska
Arizona
California
APRIL 1983
CPSC HOTLINE
Hawaii
Idaho
Montana
Nevada
Oregon
Utah
Washington
Wyoming
800 638-2772 (Continental U.S.A.)
800 638-8333 (Alaska, Hawaii, Virgin Islands only)
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STATUTORY AUTHORITIES
Consumer Product Safety Act
T5 U.S.C. §§2051 et seq.
The Consumer Product Safety Act (CPSA) grew out of a desire
for a less fragmented approach to the regulation of the safety of
consumer products. Prior to 1973, several agencies had authority
over different aspects of consumer product safety. The Consumer
Product Safety Act established the Consumer Product Safety
Commission as an independent regulatory commission and also gave
the Commission responsibility for the Federal Hazardous
Substances Act (FHSA), the Poison Prevention Packaging Act of
1970 (PPPA), the Flammable Fabrics Act (FFA), and the
Refrigerator Safety Act (RSA).
The purposes of the CPSA are to assist consumers in
evaluating the comparative safety of consumer products, to
protect the public against unreasonable risks of injury
associated with consumer products, to develop uniform safety
standards for consumer products, to minimize conflicting State
and local regulations, and to promote research and investigation
into the causes and prevention of product-related deaths,
illnesses, and injuries.
Key Sections of Act--Toxic Focus
sec. 5(a) Requires Commission to maintain an injury information
clearinghouse on hazards associated with consumer
products.
sec. 6 Provides procedures for disclosure of information
obtained by the Commission.
sec. 7 Provides authority to promulgate consumer product
safety standards in order to prevent risks of injury
associated with consumer products. The standard can
consist of performance requirements or requirements
for labeling with clear warnings or instructions.
Voluntary standards must be relied on if they would be
adequate.
sec. 8 Provides authority for banning consumer products that
present an unreasonable risk of injury and for which
no standard is feasible.
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sec. 9 Details administrative procedures for promulgation of
consumer product safety rules.
sec. 12 Empowers the Commission to seek immediate court action
against imminently hazardous consumer products.
sec. 14 Requires manufacturers of consumer products to certify
conformity to CPSC safety standards..
sec. 15 Authorizes the Commission to require manufacturers of
hazardous products to take certain actions
(notification and repair, replacement, or refund).
sec. 26 Provides for the appointment of Chronic Hazard
Advisory Panels.
sec. 30(d) Gives the Commission the authority to regulate risks
of injury under this act rather than FHSA, PPPA, or
FFA, if the Commission finds it by Rule to be in the
public interest.
Regulatory Options Available Under Statute
o Assisting in voluntary standards development
o Issuing mandatory standards
o Ordering, remove or recall of products
o Banning
Federal Hazardous Substances Act
15 U.S.C. §§1261 et seq.
The Federal Hazardous Substances Act (FHSA) was enacted in
1960, as a labeling law. The original law established
definitions for toxic, corrosive, irritant, flammable, and
radioactive substances. Materials that met the definitions were
required to bear cautionary labeling. Subsequently, two
provisions were added that permit the banning of certain
household substances. A hazardous household substance can be
banned by regulation under FHSA if the Commission decides that
the degree or nature of the hazard involved warrants removal of
such substance from interstate commerce because no cautionarv
labeling that could be required under the Act would be adequate
to address the hazard. If the substance is deemed to pose an
imminent hazard to public health, the Commission can prevent its
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distribution in interstate commerce upon publication of a Federal
Register notice of imminent hazard pending the completion of the
rulemaking proceedings.
Key Sections of Act--Toxics Focus
sec. 2 Establishes definitions for hazardous substances and
requires substances which meet the definitions to be
labeled. Authorizes banning of hazardous substances
where the nature and degree of the hazard is such that
no possible labelinq would be adequate to protect the
public health and safety.
sec. 3 Allows the Commission to declare products hazardous
and to require special labelinq.
sec. 4 Outlines illegal acts under the Federal Hazardous
Substances Act.
sec. 5-8 Gives the Commission authority to seek penalties,
seizures, and injunctions.
sec. 10 Gives the Commission authority to promulgate
regulations for efficient enforcement of this act.
sec. 15 Authorizes the repurchase of certain banned hazardous
substances.
sec. 20 Directs the CPSC to establish the Toxicoloqical
Advisory Board to give scientific and technical advice
to the Commission.
Regulatory Options Available Under Statute
o Declaring products to be hazardous substances which must
be labeled in accordance with the Act
o Requiring special labeling for hazardous household
substances
o Banning hazardous household substances
o Requiring the repurchase of banned hazardous substances.
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Poison Prevention Packaging Act of 1970
15 U.S.C. §§1471 et seg.
Administration of the Poison Prevention Packaging Act of
1970 (PPPA) was transferred to the Commission from the Food and
Drug Administration in 1973. Under this Act, the Commission can
establish standards for special packaging of household substances
in order to protect children from handling, using, or ingesting
hazardous substances. Products that can be regulated under PPPA
include products covered by the Federal Hazardous Substances Act
as well as food, drugs, cosmetics, and fuels in portable
containers.
Key Sections of Act—Toxics Focus
sec. 3 Gives the Commission authority to establish special
packaging standards for hazardous household
substances.
sec. 4 Authorizes manufacturers to supply noncomplying
products in a single size especially for use by
elderly or handicapped persons.
sec. 5 Establishes requirements for proceedings to issue,
amend, or repeal a regulation prescribing a standard.
Regulatory Options Available Under Statute
o Establishing special packaging standards
o Establishing exemptions from special packaging standards
for particular substances
REGULATORY DEVELOPMENT
REGULATORY PROCESS
1. Identification of "candidate product" for regulatory
development:
o Internal—data gathering and analysis.
o External—Commission receives petition.
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2. Development of strategy:
o Conduct relevant analyses.
o Satisfy Section 9 (CPSA) requirements
preliminarily—assessment of economic impact of
proposed regulation; must show that regulation will
reduce "unreasonable risk" and that an adequate
voluntary standard does not exist.
o Convene and obtain findings of a Chronic Hazard
Advisory Panel (for chemical chronic hazards only).
3. Preparation of briefing package by Program Manager and
drafting of advance notice of proposed rulemaking by the
Office of General Counsel.
4. Review of briefing package and advance proposed
rulemaking.
5. Revision of briefing package and advance notice of
proposed rulemaking.
6. Approval of advance notice of proposed rulemaking.
Solicitation of public comments.
7. Review of public comments, development of proposed
regulation, solicitation of public comments, development
of final rule approval by Commission, promulgation of
final rule, and commencement of enforcement activities.
EXISTING REGULATIONS
Consumer Product Safety Act 16 CFR 1000-1404
Federal Hazardous Substances Act 16 CFR 1500-1512
Flammable Fabrics Act 16 CFR 1700-1704
Refrigerator Safety Act 16 CFR 1750
TOXICS-RELATED ACTIVITIES
The Consumer Product Safety Commission addresses toxic
substances through its Directorate for Health Sciences. Within
the Directorate, activities fall within two major areas, the
Chemical Hazards Program and Health Sciences Support.
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I. Chemical Hazards Program
The goal of the Chemical Hazards Program is to reduce the
number of deaths, injuries, and illnesses resulting from consumer
exposure to hazardous chemicals in consumer products. To achieve
this goal, the program strives to meet two objectives. First,
the Commission attempts to limit exposure to hazardous chemicals
in consumer products which may have acute effects, such as burns,
poisonings and deaths. In 1980, an estimated 383,000 people,
including 131,000 children under 5 years of age, were treated in
hospital emergency rooms for acute injuries associated with
chemical consumer products. The estimated social costs
attributable to these injuries were in excess of $500 million.
The second objective is to limit exposure to hazardous chemicals
which may cause chronic adverse health effects, such as cancer,
neurotoxic disorders, birth defects, and deaths. A 1981 report
by the Office of Technology Assessment of the Congress estimated
that perhaps as many as 15,000 new cancers and 8,000 cancer
deaths every year may be associated with exposure to carcinogens
in consumer products. The Chemical Hazards Program also strives
to reduce exposure to hazardous chemicals in the indoor air. The
chemicals may be emitted from building materials or furnishings,
from household cleaning and craft products, and from unvented
heating and cooking appliances.
To meet its objectives, the Commission:
o identifies potentially hazardous chemicals used in
consumer products;
o determines the toxicity of the identified chemicals, the
amount of the chemicals present in consumer products,
the extent of consumer exposure through the indoor air
and through foreseeable use or misuse of the products,
and the marketing patterns of those products. This
information allows the Commission to judge the potential
risk posed to consumers by the chemicals;
o develops options for reducing consumer exposure to
hazardous chemicals and indoor air pollutants, and
utilizes efforts of other agencies whenever possible.
The Commission uses hazard assessments prepared by other
government agencies and participates in the National Toxicology
Program to supplement its resources and minimize duplication of
effort in dealing with acute and chronic chemical hazards.
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A. FY 1983 and FY 1984 Activities
o Poison Prevention
PPPA Exemptions. In FY 1983, the Commission
completed action to grant exemptions for oral
contraceptives dispensed in specific types of
packaging. The Commission also made a final
decision to continue the policy of exemptions
for promotional samples of prescription drugs
which are distributed to physicians. In FY
1984, the Commission will complete action on a
petition to exempt hormonal products
containing conjugated estrogens, and will
consider other formal requests from industry
for exemptions under the PPPA.
PPPA Protocol Testing. To comply with the
PPPA, industry often tests packaging to ensure
that it is child-resistant, but not overly
difficult for adults to use properly. The
test procedures which have been used since
enactment of the PPPA are quite costly and
complex. In addition, the test protocol does
not include adults over age 45. Older
consumers often have difficulty using
child-resistant packaging and, consequently,
abuse or misuse the packaging in the home. In
FY 1983, the Commission published, for public
comment, an Advance Notice of Proposed
Rulemaking to revise the PPPA test protocol.
These revisions are meant to reduce the
testing burden in time and cost for industry,
and to provide for the inclusion of older
adults in the test process. In FY 1984,
verification tests will be conducted.
Special Packaging Evaluation. In FY 1983, the
Colnmission proposed a regulation, under the
PPPA, to require child-resistant packaging for
over-the-counter products containing
diphenhydramine. In FY 1984, the Commission
will complete action on diphenhydramine, and
will complete evaluation of injury data to
determine if special packaging is needed for
petroleum distillates, and topical drug
products.
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Pharmacy/Medical Community Awareness. In FY 1983,
the Commission worked witn State Boards of
Pharmacy, and other state orqanizations, to bolster
enforcement of child-resistant packaqinq dispensing
practices, and developed a draft text on poison
orevention packaqinq for pharmacy and medical
students to increase their awareness of inqestion
hazards. In FY 1984, the Commission will pilot
test and complete development of the PPPA test, and
will neqotiate Memoranda of Understanding with
individual states, providinq for state
administration and enforcement of the PPPA
prescription drug regulation.
- Dual Purpose Packaging. It is estimated that
up to 20 percent of child-resistant packaging
by FY 1984 will use dual purpose closures
(that is, closures which can be used in a
child-resistant or non child-resistant
mode). This usage may lead to increased
accidental poisonings of children. In FY
1983, the Commission completed development and
evaluation of proposals for a pilot study to
assess the impact of dual purpose packaging,
and initiated a consumer survey of accidental
ingestion incidents. In FY 1984 the
Commission will complete the consumer survey,
and will consider whether or not further
action is warranted.
Strong Sensitizers. Certain chemicals cause a
severe reaction in susceptible individuals. The
Commission currently requires special labelinq for
only five such substances, which are present in
consumer products. In FY 1983, the commission
conducted in-depth reviews of the literature on
human sensitization to nickel, chromium, colophony
and PTBP-F. It completed action to revise the
definition of "strong sensitizer" under the Federal
Hazardous Substances Act, and initiated steps to
set up an advisory panel to review the
Commissioner's recommendations regarding strong
sensitizers. During the year, the Commission
awarded a contract to obtain data on exposure
levels and thresholds of sensitization reaction in
humans for a variety of chemicals will be
undertaken in FY 1984, and existing labeling
requirements will be modified, if warranted.
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o Potassium Dichrornabe. In FY 1983, the Commission
considered, and took appropriate action on a
petition to ban potassium dichromate for use in
home humidifiers.
o Emerging Chemical Hazards. In FY 1983 the
Commission prepared over 60 preliminary and 20
in-depth economic reports and more than 10
preliminary and in-depth toxicity assessments of
chemicals in the computerized data system for
tracking emerging chemical hazards (STIC). It also
completed preliminary recommendation reports for
over 25 chemicals; these reports combine
preliminary economic and toxicity assessments and
recommend further activity, when appropriate, on
toxic chemicals in consumer products. A conversion
of the data system for tracking chemicals into a
new data processing program was completed in FY
1983. Monitoring major sources of toxicity data
for chronic chemical hazards in consumer products
and up-dating the STIC data base will continue in
FY 1984.
o Dyes and Finishes. In FY 1983 the Commission
completed its study of benzidine congener dyes. It
found the economic importance of these dyes to be
decreasing: the use of these dyes is being
discontinued in consumer dye products and
commercial textile applications. The amount of dye
likely to be inhaled during consumer use was found
to be significantly less than previously believed,
and experiments indicate the dyes do not penetrate
the skin in measurable amounts. The review and
testing of other potentially hazardous dyes and
consumer exposure to them began in FY 1983 and will
continue in FY 1984. More than 20 dyes were
studied in-depth in FY 1983, and in addition, 10 to
15 will be similarly analyzed in FY 1984. In FY
1984, the Commission will evaluate consumer
exposure to the flame retardant chemical,
tris(1,3-dichloroisooroply)phosphate, an animal
carcinogen. Other flame retardant finishes to
which consumers are exposed will be evaluated for
evidence of toxicity.
o Indoor Air Quality. Consumers may be exposed to
potentially hazardous chemicals released from
various household materials under the jurisdiction
of CPSC. The Commission is currently investigating
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exposure to several substances which may have an
adverse effect on indoor air quality.
Combustion Products. The hazard to the
millions of families who use uninvented
fuel-fired appliances results from the toxic
gases produced by the burning flame. The
Commission identified work in this area as a
priority in FY 1983, PY 1984 and FY 1985.
-- Kerosene Heaters. During FY 1983 the
Commission completed its testing and
health hazard analysis of kerosene
heaters and began, in cooperation with
the kerosene heater industry and
Underwriters Laboratory, to develop a
voluntary standard to limit emissions of
nitrogen dioxide and carbon monoxide.
The industry anticipated that the
standard could address units produced for
the 1984-85 heating season. The success
of the voluntary effort will be evaluated
in FY 1985. During FY 1983, the
Commission completed an in-depth
toxicological evaluation of the health
hazards presented by carbon monoxide,
nitrogen dioxide, sulfur dioxide and
other substances emitted into the indoor
air from unvented heaters.
[Invented Gas Space Heaters. During FY
1983, the Commission completed a
preliminary hazard evaluation of
pollutant emissions from unvented gas
space heaters. The analysis concluded
that a potential health hazard might
exist from anticipated patterns of
consumer use. A joint CPSC-industry task
group has been formed to coordinate
laboratory testing, in-home monitoring
studies, consumer use surveys, and
pollutant exposure modeling efforts. The
final hazard analysis and recommendations
will be completed in FY 1984. Voluntary
emissions standards, if warranted, will
be implemented in FY 1985.
Other Fuel-fired Products. During FY
1984 and FY 1985, concurrent with the
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on-goinq investiqation and voluntary
standards development on unvented qas and
kerosene heaters, the Commission will be
evaluatinq new products, e.q., cabinet
heaters and catalytic heaters as well as
evaluating existing products such as coal
and wood burning stoves, and
technological improvements made to qas
stoves and ovens. Hazard analysis for
qas stoves and coal and wood burning
stoves are scheduled for completion in FY
1985.
Asbestos in the Home. Asbestos has been used
in a wide variety of products in the home.
Some of these products may be deteriorating
and releasing asbestos fibers, or the asbestos
may be released during remodelinq or
renovation efforts. In FY 1983, the
Commission distributed over 10,000 copies of
the consumer information booklet, Asbestos in
the Home, to conduct limited monitoring
efforts to determine levels of asbestos fibers
in the air of homes where fibers are believed
to be being emitted.
Organic Pollutants. Organic pollutants such
as toluene and benzaldehyde may be generated
in the home during the normal use of some
consumer products, and may be emitted from
structural materials, furnishings, and
combustion sources. In FY 1983, the
Commission evaluated information from a
monitoring study in 40 homes on the identity
and concentration of organic pollutants in
residential air. An evaluation was completed
in FY 1983 of the toxicoloqical significance
of seventeen of the compounds present during
monitorinq. Additional monitoring efforts to
define highly volatile organic chemicals, that
may be of more toxicological significance will
be completed in FY 1984. Efforts to identify
the sources of the most toxicologically
significant of the orqanic chemicals will be
completed in FY 1984. Hazard evaluation of
orqanic chemicals and recommendations for
remedial strategies will be completed in FY
1985.
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Asbestos in Products. Inhalation of microscopic
fibrous particles of asbestos is recognized as a
cause of lung cancer in humans. The Commission
re-established a testing facility, and during FY
1983 tested products for emission of asbestos
fiber. The Commission established and received the
report of a Chronic Hazard Advisory Panel on
asbestos during FY 1983. In FY 1984 the Commission
will, if warranted, begin rulemaking on certain
products which could expose consumers to hazardous
asbestos fibers.
Children's Chemical Hazards. In FY 1984, the
Commission will continue efforts on children's
chemical hazards—school lab chemicals and
children's exposure to carcinogens—as priority
activities.
- Children's Chemical Hazards. Children
enrolled in some school laboratory classes may
be exposed to toxic chemicals for which the
hazards and unsafe uses may not be known even
by the instructor. For example, formaldehyde,
a carcinogen, is still used in chemistry
classes. The Commission staff developed a
program to inform teachers about chronic
adverse health effects of school laboratory
chemicals, and to advise teachers regarding
less hazardous substitute chemicals and to use
precautions necessary to minimize classroom
exposure. During FY 1982, the Chemical
Hazards Program completed the technical
evaluation and guidance portion of the effort
to inform teachers of the health hazards of
school lab chemicals. During FY 1983, this
information was disseminated by the Council of
State Science Supervisers. During FY 1984,
the classroom teachers' evaluations of the
material will be reviewed to determine if
revisions are necessary.
~ Children's Exposure to Carcinogens. During FY
1984, the Commission will determine the
success of FY 1983 efforts to encourage the
industry to voluntarily reduce/remove two
identified carcinogens from children's
products:
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Nitrosoamines. Testing during FY 1983
demonstrated that these potent
carcinogenic substances can be ingested
by a child sucking on pacifiers made of
latex rubber. The Commission
investigated the exposure to these
substances and the potential risk
involved, and has worked with the
industry to reduce or eliminate
nitrosoamine contamination of children's
products. During FY 1984 the Commission
will decide whether voluntary action has
sufficiently reduced the hazard and will
convene a Chronic Hazard Advisory Panel,
if warranted.
Plasticizers. An estimated 9-22 million
pounds of the plasticizer,
di(2-ethylhexyl)phthalate (DEHP), is used
annually in 130 million children's
products. DEHP has been shown to be
carcinogenic to laboratory animals.
Testing completed in FY 1983 demonstrated
that children are exposed to DEHP through
oral and skin contact with plastic
articles (for example, teething rings)
containing DEHP. Based on the results of
the exposure testing, an in-depth
toxicity assessment and risk assessment
was completed in FY 1983, the Commission
may convene a Chronic Hazard Advisory
Panel (CHAP) in FY 1984 to evaluate the
carcinogenicity of DEHP. Based on the
CHAP report, the Commission will decide
whether to issue an ANP'R.
Interagency Support. The CPSC coordinates with
other Federal agencies to share information,
expertise and facilities as well as to avoid
duplication and to seek consistent Federal
approaches to common problems. In 1983, the
Commission shared information on adverse health
effects and consumer use with EPA for over 70 new
chemicals and for over 50 chemicals already in
production. It shared its expertise with FDA on
nitrosoamines in pacifiers and on tamper proof
packaging (Tylenol) and with the National
Toxicology Program, which tests chemicals which may
be used in consumer products. In 1984, the
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Commission will work with other agencies on three
CPSC 1984 priority projects: chlorocarbons, fire
toxicity and indoor air quality. The Commission is
also involved with other Federal agencies under the
direction of the Office of Science and Technology
Policy to complete development of consistent
principles for the identification and evaluation of
cancer causing substances.
B. Proposed FY 1985 Activities
o Poison Prevention.
Dual Purpose Packaging. In FY 1985, the
Commission staff will evaluate the results of
the consumer survey of ingestion incidents
started in FY 1984. Recommendations for
further study, if necessary, will be
developed.
Special Packaging. In FY 1985, CPSC will
complete action on special packaging
requirements for petroleum distillates and
will develop recommendations for topical
drugs.
- Testing. The Commission will compete
verification tests for revisions to the PPPA
protocol. Appropriate action for specific
revisions to the protocol will be completed.
Exemptions. The Commission will continue to
process industry requests for exemptions from
special packaging regulations.
o Chlorocarbons. Preliminary results of long term
animal tests of dichloromethane (used as a paint
remover and solvent) and perchloroethylene (widelv
used in dry cleaning) indicate that these chemicals
may cause cancer and other adverse health
effects. Both chemicals are widely used by
consumers. Based on test results of FY 1983 and FY
1984, the Commission will conduct toxicity and
exposure assessments to determine the risk posed to
consumers, and may in FY 1984 convene a Chronic
Hazard Advisory Panel to assist in evaluating the
hazard. This project is a Commission priority in
FY 1984 and FY 1985.
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o Emerging Chemical Hazards. In FY 1985, the
Commission will maintain and update its
computerized data system for tracking chemicals
(STIC) by continuing to monitor major sources of
toxicity data for chronic chemical hazards in
consumer products.
o Dyes and Finishes. The Commission will continue to
assess the toxicity and bioavailability of dyes and
flame retardants which may be hazardous to
consumers.
o Indoor Air Quality. The Commission will continue
to emphasize the characterization of pollutant
emissions from combustion appliances and the
development of voluntary standards to reduce
emissions from those which may pose a hazard to
consumers in the home.
Combustion Products. The Commission will
determine the extent of the hazard presented
by exposure to toxic combustion products
emitted from various fuel-fired appliances,
and will work with industry to develop
remedial strategies, as appropriate. The
success of voluntary industry action on
unvented gas space heaters and kerosene
heaters will be assessed in FY 1985. Hazard
analyses for gas stoves, coal and wood stoves
should be completed in FY 1985.
Asbestos. The Commission will prepare a
report on consumer exposure to asbestos from
permanent home fixtures such as furnaces,
boiler cement and duct work. The report will
include information for consumers on the safe
handling of these products.
Organic Pollutants. Major hazardous organic
pollutants and their consumer product sources
will be identified from the 40 home monitoring
study data. Population exposure and risk will
be estimated and cost effective remedial
strategies reviewed. This project effort will
be completed in FY 1985.
o Carcinogens in Children's Products. If it is
recommended that Chronic Hazard Advisory Panel be
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convened, the Panel will complete its review in FY
1984 of phthalate carcinoqenicity, and the
Commission will undertake appropriate remedial
strategies, in FY 1984 and FY 1985 as required. If
voluntary industry action has not reduced the
identifiable hazards from nitrosoamines in rubber
children's products, an advisory panel in FY 1984
will review selected nitrosoamines as a preliminary
step toward possible requlatory action. In FY
1985, regulatory action would be implemented.
o Strong Sensitizers. Based on the hazard assessment
and evaluation to be completed in FY 1984, the
Commission may identify additional chemicals which
are strong sensitizers, and initiate appropriate
action, re: consumer products containing these
chemicals.
o Interagency Support. The Commission is expected to
continue its cooperative activities with the
Federal agencies in research planning, chemical
testing, facilities sharing, coordinated regulatory
development and risk assessments.
II. Health Sciences Support
A. FY 1983 and FY 1984 Activities
o Lab Facilities. The Commission continues to share
laboratory facilities, equipment and expertise with
the Food and Drug Administration.
° Toxicity Support. In FY 1983, Health Sciences
collected and evaluated toxicity data on several
hundred chemicals and chemical classes for a number
of the Commission's hazard programs. Health
Sciences collected poison information from several
data bases and administered the CPSC contract for
pathology services. Toxicity data collection and
evaluation will continue at approximately the same
level for FY 1984, with attention being focused on
volatile organics in indoor air, combustion
products, chlorocarbons, strong sensitizers,
chlorinated hydrocarbons, fire retardants, dyes,
petroleum distillates, topical drugs, and various
chemicals in household products reviewed by the
Toxicological Advisory Board.
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o Short-Term Testing. In FY 1983, the Directorate
for Health Sciences conducted tests of chemicals in
consumer products for mutagenicity and
carcinogenicity. Testing results were used as a
basis for further testing by the National
Toxicology Program. Due to staff constraints, this
project will be substantially reduced in scope in
FY 1984.
0 Exposure/Risk Assessment. In FY 1983, Health
Sciences analyzed human exposure to chemicals such
as dyes, nitrosoamines, phthalates and formaldehyde
from pressed wood products. In addition, by use of
computerized models for risk estimation, the
Commission was able to perform risk assessments for
consumer exposure to chemicals such as
nitrosoamines, formaldehyde, and phthalates. In FY
1984, such assessments are planned for methylene
chloride, perchloroethylene and formaldehyde in
pressed wood products, and for other chemicals as
needed.
o Biological, Medical and Toxicological Support. In
FY 1983, Health Sciences provided extensive support
services to various Commission hazard programs and
compliance activities. In FY 1984, the Directorate
will continue to provide these services.
o Mast Cell Test. In FY 1983, Health Sciences
developed preliminary methodology needed to
evaluate the use of cell cultures for initial
screening for eye irritation testing. Due to staff
constraints, this project will be reduced in scope
in FY 1984.
B. Proposed FY 1985 Activities
o Health Sciences Support. The Directorate for
Health Sciences will continue to provide
biological, medical and toxicological support to
Commission hazard programs and compliance efforts
as requested.
o Exposure/Risk Assessment. Exposure and risk
assessments will continue to be performed for
potentially hazardous chemicals found in consumer
products. Such assessments may involve hazardous
dyes, chlorinated hydrocarbons and various indoor
air pollutants.
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o Toxic 1 t y__Support. Collection and evaluation of
toxicity data on suspected chemical hazards will
continue. An estimated 200 chemicals will be
reviewed.
o Laboratory Equipment. To maintain a
state-of-the-art capability in the Health Sciences
Laboratory, obsolete laboratory equipment will be
replaced or upgraded, thereby enabling in-house
laboratory analyses to be carried out in an
effective, accurate and cost-effective manner.
o Laboratory Facilities. CPSC will continue to share
facilities, equipment and expertise with FDA.
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COUNCIL ON ENVIRONMENTAL QUALITY
72? Jackson Place NW
Washinqton, D.C. 20006
Locator: 202-395-5700
Information: 202-395-5770
Organization page 33
Statutory Authorities paqe 34
Toxics-Related Activities paqe 36
The Council on Environmental Quality (CEO) is the policy
advisory body for environmental matters in the Executive Office
of the President. Created by the National Environmental Policy
Act of 1969 (NEPA), its principal responsibilities are to oversee
the implementation of that Act and to develop and advise the
President on national policies and proqrams affectinq
environmental quality. Additional responsibilities were provided
by the Environmental Ouality Improvement Act of 1970, Executive
Order 11514, as amended by Executive Order 11991, and
reorganization Plan No. 1 of 1977.
The Council on Environmental Quality's general charqe
includes:
o Developinq and recommendinq national policies which
foster and promote improvement of environmental quality,
includinq review and assessment of the effectiveness of
existing and proposed Federal facilities, proqram
policies, and activities which affect environmental
quality; development of the President's environmental
message to Congress; and assisting in development of the
President's environmental legislation programs.
o Assistinq Federal agencies in coordinating programs and
activities which affect, protect, and improve
environmental quality. Tnis includes promulgating and
maintaining regulations implementing the procedural
provisions of NEPA and the referral process under
section 309 of the Clean Air Act, overseeing the NEPA
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process, developing guidelines for eyaluatinq
environmental impacts of Federal actions, and developinq
and promoting means to prevent or reduce adverse effects
of such actions.
o Gathering and analyzing information concerning
conditions and trends in the quality of the environment,
developing special studies and analyses on environmental
quality and health, and assisting the President in the
preparation of the annual environmental qualitv report
to the Congress.
The Council's specific statutory responsibilities include:
o Issuing regulations to implement the procedural
provisions of NEPA, including regulations for the
preparation of environmental impact statements (EIS) for
major Federal actions which significantly affect the
quality of the human environment.
o Resolving conflicts which are referred to the Council by
agencies under Section 102(2) of NEPA and Section 309 of
the Clean Air Act.
o Preparing for transmittal by the President to the
Congress an annual report setting forth conditions and
trends in environmental quality.
CEO addresses a wide variety of environmental policy issues,
including those pertaining to evaluation of the health effects of
exposure to toxic substances, and program and/or regulatory
strategies for their control. CKO has a long and active
involvement in the toxic substances and environmental health
fields. CEO prepared the first Toxic Substances Control Act
(TSCA) legislation proposed to Congress by the President in 1970
and participated in events leading to the passage of TSCA in
1976. CEO has been involved in the implementation of TSCA,
participatinq in the development and review of various proqram
and budget issues. CEO cochairs (with EPA) the Interaqency Toxic
Substances Data Committee, a permanent interaqency committee
formed pursuant to Section 10(b) of the Toxic Substances Control
Act and other legislative and executive mandates. The Data
Committee is charqed with the responsibility of developinq an
integrated data network to support Government in toxics research
and regulation. The Council is a statutory member of the
Interagency Testing Committee formed pursuant to Section 4 of
TSCA and participates in other interagency committees addressing
toxics research and regulation. The Council also has been active
in promoting Federal support for the development and use of
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integrated pest management and in analyzing the economic benefits
of toxic substances regulations.
The Council on Environmental Quality operates on a policy
level to assist Federal agencies in program development and
implementation and to provide environmental advice to the
President. The Council does not issue "toxics regulations."
Therefore, a regulatory development section is not included for
this agency.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Name Title j^hone Area of Focus
W. Ernst Minor Council Member 202-395-4506 Environmental health
and toxic substances
Dinah Bear General Counsel 202-395-5754 Environmental impact
statements
-32-
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STATUTORY AUTHORITIES
National Environmental Policy Act
Public Law 91-190 42 U.S.C. SS..434T^4347
The Council on Environmental Quality was established in 1970
under Section 202 of this Act. NEPA establishes a national
policy of usinq all practicable means to prevent damage to the
environment. It charges Federal agencies with the duties of
analyzing the potential impact of a proposed action and ?ts
alternatives and considering these impacts and the goals set
forth in NEPA in the course of their decision making. The duties
and functions of CEQ are spelled out in Section 204 of the Act.
Among other responsibilities, the Council must review and
appraise the various programs and activities of the Federal
Government to determine their consistency with NEPA's goals.
Environmental Quality Improvement Act of 1970
Public Law 91-224 42 U.S.C. S§4371-4374
The Environmental Quality Improvement Act of 1970 created an
Office of Environmental Qualitv to provide staff support to
CEQ. It brought more funding and responsibilities to CEQ. It
specified that CEQ should appraise Federal programs and policies,
review monitoring, evaluate the effects of technology, and assist
Federal agencies in the development of environmental standards.
Toxic Substances Control Act
Public Law 94-469 15 U.S.C. §2601
CEQ is one of eight statutory members of the Interagency
Testing Committee. This Committee was established under Section
4(e) of the Act to recommend (to the Administrator of EPA)
chemical substances and mixtures for priority consideration when
promulgating regulations under section 4(a). In addition, CEQ
cochairs, with EPA, the Interagency Toxic Substances Data
Committee and has been directed under Section 25(b) to coordinate
a study on the development of a chemical information network.
Health Services Research, Health Statistics, and
Health Care Technology Act
42 U. S. CT"S 2T2"
CEQ's responsibilities under this Act include participation
in an ongoing study of the health costs of pollution and
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assistance in the establishment of guidelines for the collection
of health information and statistics in order to improve
coordination of environmental and health studies.
Executive Order 11514 (March 5f 1970) as amended by
Executive Order 11991 (May~24, 1977)r~ancT
Reorganization Plan No. 1 of 1977
This Order and Plan empowers the Council to recommend to the
President and to Federal aqencies priorities in environmental
programs. It gives the Council responsibility for advising and
assisting the President and Federal agencies in achieving
international cooperation for dealing with environmental
problems, under the foreign policy guidance of the Secretary of
State. It also authorizes the Council to issue regulations
binding on all Federal agencies to implement the procedural
provisions of the National Environmental Policy Act.
Environmental Effects Abroad of Major Federal Actions,
January 5, 1979
Executive Order 12114
This Order requires that environmental review procedures be
established for major international Federal actions, including
those involving the export of a product or involving a facility
whose products, emissions, or effluents are prohibited or
regulated because their toxic effects on the environment create a
serious public health risk.
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TOXICS-RELATED ACTIVITIES
Program Description
The Council's toxics program is policy oriented. CEO
conducts studies on an ad hoc basis, develops programs for
interagency coordination and makes recommendations for executive
action.
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DEPARTMENT OF AGRICULTURE
14th Street and Independence Avenue SW.
Washington, D.C. 20250
Locator: 202-655-4000
Information: 202-447-5247
The Department of Agriculture (USDA) serves all Americans.
It works to improve and maintain farm income and to develop and
expand markets abroad for agricultural products. The Department
helps to curb poverty, hunger, and malnutrition. It works to
enhance the environment and to maintain our production capacity
by helping landowners protect the soil, water, forests, and other
natural resources. Rural development, credit, and conservation
programs are key resources for carrying out national growth
policies. USDA research findings directly or indirectly benefit
all Americans. The Department, through inspection and grading
services, safeguards and assures standards of quality in the
daily food supply.
An act of Congress, approved May 15, 1862, created the
Department of Agriculture, which was administered by a
Commissioner of Agriculture until 1889. On February 9, 1889, the
powers and duties of the Department were enlarged. The
Department was made the eighth executive department in the
Federal Government, and the Commissioner became the Secretary of
Agriculture.
This publication focuses on the responsibilities and
activities of the Food Safety and Inspection Service (FSIS)
located within the Department's Marketing and Inspection Services
Office.
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THE FOOD SAFETY AND INSPECTION SERVICE
U. S. Department of Agriculture
14th and Independence Avenue SW.
Washington, D.C. 20250
Locator: 202-447-6617
Information: 202-447-7943
Organization page 41
Statutory Authorities page 47
Regulatory Development oage 51
Toxics-Related Activities page 53
The Food Safety and Inspection Service (FSIS) is responsible
for inspection of meat and poultry for safety, wholesomeness, and
accurate labeling.
FSIS administers the Federal Meat Inspection Act and the
Poultry Products Inspection Act, which provide for uniform
Federal-State inspection of all meat and poultry products.
Inspection regulations require prior approval of the construction
and equipment of plants operating in interstate commerce;
inspection of birds and animals before, during, and after
slaughter; continuous inspection of all processing operations;
and prior approval of labels for meat and poultry products.
The FSIS inspection program also includes activities to
guard against disease and residues in domestic and imported meat
and poultry products, and monitoring activities in foreign plants
handling these products for import into the United States.
In addition, FSIS participates in the regulation of toxics
under two separate statutory authorities. First, FSIS may issue
its own regulations as provided by both the Meat Inspection and
the Poultry Products Inspection Acts for any toxic substances
which may threaten to contaminate meat and ooultry food
supplies. Second, under the Federal Food, Drug, and Cosmetic Act
(FFDCA), the Food and Drug Administration (FDA) also regulates
toxic substances which may be found in foods (as well as drugs or
cosmetic products).
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ORGANIZATION*
OFFICE OF THE ADMINISTRATOR
Maintains management control over the following
activities delegated to FSIS by the Secretary of
Agriculture:
Inspection programs for meat and poultry;
Processing and distribution of various food
products; and
Transportation and sale of foods determined unsafe.
SCIENCE PROGRAM (SCI)
o Works in conjunction with the Office of the
Administrator to formulate FSIS scientific and
laboratory policies and to coordinate research projects.
o Operates the FSIS regulatory field service laboratories
and maintains liaison with other laboratories around the
world.
o Conducts a program of scientific data collection and
review.
o Conducts the food-borne hazard reporting system for the
detection of human diseases stemming from bacteria in
meat and poultry and the regulation of direct and
indirect additives in those foods.
Chemistry Division (SCI)
o Develops analytical methods and approves those that are
suitable for supporting a regulatory program.
o Conducts special studies for FSIS where necessary and
performs comparison studies with Federal and commercial
laboratories.
*NOTE: Only those offices which deal with toxics or toxics-
related issues are developed in this section.
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Maintains a quality assurance program to ensure the
validity of analytical results.
Microbiology Division (SCI)
o Conducts a qeneral microbiology program to identify
pathogens and toxins in support of meat and poultry
inspection (MPI) field programs.
o Analyzes canned foods and determines the presence of
extraneous material in food products in support of MPI
field programs.
o Develops new methods for detecting antibiotic residues.
o Maintains a quality assurance program to ensure the
validity of results.
Pathology and Epidemiology Division (SCI)
o Assists MPI with the development of criteria used in
ante mortem and post mortem inspections of livestock and
poultry.
o Operates a national diagnostic pathology program and a
food-borne hazard reporting center to investigate
potential risks of unsafe meats and poultry to human
health.
o Studies the application of field tests in pathology and
parasitology.
Residue, Evaluation, and Surveillance Division (SCI)
o Conducts monitoring and surveillance programs to
determine the extent of drug, pesticide, antibiotic, and
environmental residues in food of animal origin.
o Assists in the evaluation of cooperative residue
programs performed by industry.
o Conducts toxicological studies of substances found in
meat and poultry.
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Food Ingredient Assessment Division (SCI)
o Coordinates the establishment of FSIS nutritional
policies and recommends research.
o Approves use of food additives in meat and poultry
products.
o Determines safety of compounds and packages used by
industry.
Field Service Laboratories Division (SCI)
o Analyze meat and poultry and their products to determine
the presence of environmental and druq contaminants,
naturally occurring toxins, poisons, and economic
adulteration using the disciplines of chemistry,
microbiology, and pathology.
o Supervises contract laboratories that analyze meat and
poultry and their products for economic adulteration and
for chlorinated hydrocarbon pesticides.
MEAT AND POULTRY INSPECTION (MPI)
o Ensures the wholesomeness of meat and poultry products
in interstate and foreign commerce by in-plant
inspection of all livestock and poultry as well as the
reinspection of processed meat and poultry products.
o Conducts field tests and inspections of livestock,
poultry, and derived products.
o Controls and disposes of condemned and inedible foods.
o Monitors processing facilities, and reviews the
inspection system of countries exporting food to the
United States.
o Monitors and evaluates State meat and poultry inspection
programs.
Regional Operations (MPI)
o Inspects meat and poultry products during processing.
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Checks the accuracy of label information and monitors
plants, other facilities, and individuals for compliance
with legal orders.
Inspects meat and poultry entering or leaving the United
States.
Regional Offices (MPI)
o Plans and coordinates Regional Operations programs for
inspection, control of condemned products, and a variety
of other activities relating to facilities and
processing.
o Reviews State inspection programs and coordinates
activities between the States and the Federal
Government.
o Grants and suspends inspection privileges under the
Federal Meat Inspection Act and the Poultry Products
Inspection Act.
Compliance Division (MPI)
o Supervises FSIS monitoring and enforcement programs.
o Work with other FSIS programs to formulate new policies
and programs.
o Coordinates the development of FSIS regulations and
takes action to ensure regulatory compliance.
o Administers enforcement activities, advises the
Administrator on matters of regulatory compliance, and
maintains liaison with other enforcement groups.
o Initiates actions to withdraw services and conducts
debarment procedures.
TECHNICAL SERVICES (TS)
o Analyzes agricultural practices and scientific advances
for their effect on food safety and public health.
o Develops procedures for inspecting livestock, poultry,
and their processed products and coordinates tne
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establishment of regulatory criteria concerning the
disposition of carcasses.
o Develops the Agency's labeling policy and standards for
meat and poultry.
o Develops requirements for facilities, equipment, and
sanitation and approves new construction and equipment
for meat and poultry plants.
o Prepares environmental and economic impact statements
for regulations issued by the Agency.
POLICY AND PROGRAM PLANNING (PPP)
Regulations Office (PPP)
o Publishes FSIS regulations, instructions, and notices.
o Reviews regulations for adequacy, clarity, and
compliance with Agency requirements.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL*
Division/Office
Office of the Administrator
Science Program
Chemistry Division
Microbiology Division
Phone
202-447-7025
202-447-2326
202-447-7623
202-447-4212
Pathology and Epidemiology Div. 301-344-2460
Residue Evaluation and
Surveillance Division
Field Service Laboratories Div.
Food Ingredient Assessment Div.
202-447-2807
202-447-4954
202-447-7680
Room
332-E
402-A
404-A
410-A
101-318-C
Beltsville, Md
602-A
412-A
510-A
:FTS numbers are the same.
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Policy and Program Planninq
Regulations Office
Meat and Poultry Inspection
Regional Operations
Technical Services
REGIONAL AND FIELD OFFICES (MPI)
Western Regional Office
Northeastern Regional Office
Southeastern Regional Office
Southwestern Regional Office
Northcentral Regional Office
202-447-6525
202-447-3317
202-447-8803
202-447-3697
202-447-2709
620 Central Ave.
Bldg. 2C
Alameda, CA 94501
1421 Cherry St.
7th Floor
Philadelphia, PA 19102
1718 Peachtree St., NW.
Room 216
Atlanta, GA 30309
1100 Commerce St.
Room 5F41
Dallas, TX 75242
607 E. Second St
Des Moines, IA 50316
327-E
2940-S
344-E
4860-S
350-E
415-273-740,
215-597-421'
404-881-391
214-767-91K
515-284-404;
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STATUTORY AUTHORITIES
Federal Meat Inspection Act
Public TavT 90-201 T\ rj.S.C. $601 et seq.
The Federal Meat Inspection Act is the result of a 1967
congressional revision (the Wholesome Meat Act of 1967) of the
original Meat Inspection Act of 1907. The ourposes of the Act
are to provide safe and wholesome meat and meat products and to
ensure uniform inspection, labeling, and packaging of meats.
Key Sections of Act—Toxics Focus
sec. 1(m) Gives a detailed definition of the word
"adulterated" by including any carcass, meat,
or meat product that is found to include
poisonous or deleterious substances, including
pesticides, chemicals, additives, or colorings
that are found unfit for human food.
sec. 1(m) (2)(c) Prohibits the use of any food additive
determined unsafe under the Food, Drug, and
Cosmetic Act (sec. 409).
sec. 2 Expresses the concern of Congress to assure
that meat and meat products are wholesome,
properly marked, labeled, and packaged.
sec. 3 Requires the Secretary to provide rules and
regulations for animal inspection, and
segregation for diseased animals.
sec. 4 Requires a post mortem inspection of all
animals slaughtered to determine possible
adulteration.
sec. 10 Prohibits any person, firm, or corporation
from selling adulterated or misbranded meat
and meat products. Also, this section
prohibits the handling of meat and meat
products in a way that causes adulteration or
misbranding.
sec. 20 Requires importation of meat only from
countries maintaining inspection systems
equivalent to United States systems. The
section also requires the reinspection of
products at the port of entry.
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sec. 402 Requires the detention and destruction of
adulterated products found moving in commerce.
sec. 409 Requires that tolerances established for
various substances be coordinated with those
established by the Food and Druq
Administration under FFDCA section 408.
Regulatory Options Available Under Statute
o Prescribe and implement terms and conditions for
destruction
o Refuse to inspect and pass or clear
o Refuse to stamp, mark, taq, or label
o Notify the Governor of the State
o Refuse to provide or withdraw inspection services
o Detain
o Proceed against, seize, and condemn
o Determine fine or imprisonment or both
o Issue injunctions
The Poultry Products Inspection Act
Public Law 90-492 21 U.S.C. §451 et seq.
The Poultry Products Inspection Act was first passed in
1957, then amended in 1962 and 1968. The Act provides for the
uniform inspection of poultry and poultry products and for the
regulation of poultry processing and distribution practices. The
principal purpose of the Act is to ensure that poultry and
poultry products are wholesome, properly marked, labeled, and
packaged.
Key Sections of Act-Toxics Focus
sec. 4{g) Gives a detailed definition of the term
"adulterated." "Adulteration" applies to any
poultry carcass or poultry product that is
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found to contain added poisonous or
deleterious substances, includinq pesticides,
chemicals, additives, or colorings that are
found unfit for human food within the meanings
of sections 408 and 409 of the FFDCA.
sec. 1(y) Defines the terms "pesticide chemical", "color
additive", and "raw agricultural commodity" as
having the same meanings as in FFDCA.
sec. 6(a) Requires an ante mortem inspection of all
poultry suspected of adulteration at official
establishments or facilities subject to
inspection under this Act.
sec. 6(b) Requires a post mortem inspection of all birds
processed and a quarantine and segregation if
the birds are found unsafe for human food.
sec. 6(c) Requires the condemnation and destruction of
all adulterated birds.
sec. 9(a)(4) Prohibits the sale, transport, or offer for
sale of any adulterated or misbranded poultry
products.
sec. 14 Regulates the condition under which poultry
products for human food will be stored or
handled to prevent adulteration or
misbranding.
sec. 17 Prohibits the importation of slaughtered
poultry or poultry products unless they are
healthful, wholesome, fit for human food, and
not adulterated. They must contain no dye,
chemical, preservative, or ingredient unfit
for human consumption.
Regulatory Options Available Under Statute
o Condemn and destroy
o Refuse to render, provide, or withdraw inspection
service
o Quarantine, segregate, and reinspect
o Withhold use
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o Determine fine or imprisonment or both
o Prescribe conditions for storage and handlinq
o Destroy and prescribe terms and conditions for
destruction
o Detain
o Proceed against, seize, and condemn
o Issue injunctions.
The Federal Food, Drug, and Cosmetic Act
Public Law 69 21 U.S.C. §§301-392
The purpose of FFDCA is to safeguard public health by
prohibiting the introduction into interstate commerce of any
food, drug, or cosmetic that is adulterated or misbranded and to
regulate additives and toxins in foods. FSIS is given statutory
authority under three sections of the Act.
Key Sections of Act--Toxics Focus
sec. 408 Authorizes the establishment of tolerances for
pesticide chemical residues in food in order to
protect public health.
sec. 409 Deems a food additive unsafe unless it is proven
safe.
sec. 512 Following the Drug Animal Amendments of 1968, a
separate class of substances known as "new animal
drugs" was established with FFDCA. Such substances
are regulated when residues in foods exceed the
tolerance levels established under this section.
Regulatory Options Available Under Statute
o Ban
o Set tolerances
o Deem products to be misbranded
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o Establish standards or conditions
o Require registration or certification
REGULATORY DEVELOPMENT
REGULATORY PROCESS
Regulatory development at FSIS is a three-part process which
begins with the placement of a regulatory initiative on the FSIS
Work Plan. (This is explained in greater detail in the steps
below.) Both the Office of Primary Interest and the Requlations
Coordination Division play a central role in this process. Also,
the Meat and Poultry Inspection and Science Programs provide
special assistance and information regarding decisions to
regulate or rule against harmful adulterants in meat and poultry
products.
1. The Office of Primary Interest (which may include any
Division Office within FSIS) begins the regulatory
process by entering an initiative onto the FSIS Work
Plan. Once on the Work Plan, the initiative mav be
published in the Federal Register.
2. Reviews and studies are conducted on all available
information. Special assistance and information may
also be provided by the Meat and Poultry Inspection and
Science Programs.
3. When the decision is found to be significant or not
significant, an Impact Analysis is prepared.
4. The Office of Primary Interest prepares the rule or
regulation (Docket) and submits it to the Regulations
Coordination Division for movement through the final
review process. This process involves the Office of
Primary Interest, the Deputy Administrators, and the
General Counsel. Also at this time, the Docket is
submitted to Policy and Program Planning for the
development of a public participation plan as
appropriate.
5. The approved Docket, along with a proposed public
participation plan and comments, are presented to the
Administrator for final approval.
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6. The proposed or Final Standard is published in the
Federal Register.
EXISTING REGULATIONS
Federal Meat Inspection Act 9 CFR 301-335
Poultry Products Inspection Act 9 CFR 301-329, 381
Federal Food, Drug, and 21 CFR 1-1702
Cosmetic Act
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TOXICS-RELATED ACTIVITIES*
Meat and Poultry Inspection Program
The basic purpose of the Meat and Poultry Inspection Program
(MPI) is to assure safe meat and poultry products for
consumers. Authority under the meat and poultry inspection acts
to regulate and perform inspections begins when livestock or
poultry arrive at slaughter plants. At this time, inspectors
evaluate animals for exposure to drugs, pesticides, or other
chemical adulterants. Should such adulteration be visibly
detected, it is then retained by MPI and removed from consumer
channels to prevent further marketing of the food. Immediately
upon receipt of a violative result, the MPI region notifies FDA,
State Department of Agriculture, EPA (for pesticides), MPI
inspectors, and the producer, that a violation occurred and
informs them of the followup actions that will be taken by MPI.
Followup actions usually require that additional animals from the
particular farm be retained at slaughter pending testing to
confirm that adequate remedial action has been taken. Also,
agencies regulating drug and pesticide usage have the opportunity
to investigate why regulations were violated. The resulting
investigation reports give FDA and EPA insight into where
potential program changes may be beneficial.
Meat and Poultry Residue Program (MPR)
The Federal Meat Inspection Act and the Poultry Products
Inspection Act authorize the United States Department of
Agriculture (Meat and Poultry Inspection Program) to inspect meat
and poultry prepared for transportation or sale in interstate
commerce. Routine antemortem and postmortem inspection cannot
usually detect the presence or absence of a chemical or drug
residue unless clinical signs are present. This makes laboratory
analysis of tissues vital in obtaining information for
dissemination to the Federal and State Agencies in controlling
potential adulterants of the meat and poultry supply.
*Included here are those activities identified as toxics-related
from the information provided by each agency or office at the
time of publication. It is recognized that some activities may
have inadvertently been omitted. Please bring any such
omissions, as well as new additions, to the attention of the
Office of Pesticides and Toxic Substances, Chemical Coordination
Staff.
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The Meat and Poultry Inspection (MPI) Proqram has developed
a system to determine the existence of toxic residue problems and
provide an active exchange with other government agencies and
producers. There is a twofold effort on the part of MPI to
control residues. In the first part, the monitoring phase is
designed to randomly select and analyze edible tissues from
animals and poultry for residues. This provides the needed
information for incidences, trends, and compliance with
tolerances. It has a 95 percent probability of detecting a
residue when 1 percent or more of the animals or poultry going to
slaughter contain detectable levels. It is not designed to
detect and condemn violative products. However, the program
identifies and reflects on production practices that utilize
drugs and chemicals for the much-needed meat supply.
Marketing practices before and after slaughter emphasize why
monitoring programs cannot do more. Marketing would be a
catastrophe if all products were held until analyses were
completed for all possible residues. Least of all, the need for
holding facilities to prevent loss of a product in itself would
eliminate a "fresh" product from the market.
The Residue Monitoring Program supports FSIS inspection
programs to help assure a wholesome meat and poultry supply. The
Monitoring Program can only help identify problems; it has no
power to correct. Correction is obtained through surveillance,
educational, and regulatory programs. These programs provide
both short-term and more permanent solutions.
Surveillance programs are basically of two types. First,
there is the Contamination Response System, triggered when there
is a finding of a residue which has the potential for widespread
problems with the meat and poultry supply. Under this system,
the agency determines the extent of the contamination by working
with other agencies and using sampling programs when indicated.
In other cases, a routine agency followup program is required,
involving pretesting before release of animals or poultry.
The second type, called the Exploratory Surveillance
Program, is used to determine if a potential problem may exist.
This is specially designed to obtain answers to specific
questions, such as whether the analytical method used gives
reliable results on samples from multiple sources, or whether a
compound used under specific commercial conditions results in a
residue problem.
Based on knowledge gained from tracking residue problems to
their sources, FSIS believes that violative residues can be
prevented. FSIS has joined with the Extension Service, producer
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groups, and regulatory agencies in a new cooperative education
effort called the Residue Avoidance Program, which is designed to
help farmers identify points in their production systems where
chemical and drug contamination can occur and become a problem.
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DEPARTMENT OP
HEALTH AND HUMAN SERVICES
200 Independence Ave SW.
Washington, D.C. 20201
Locator: 202-245-6296
Information: 202-245-6343
On Sunday, May 4, 1980, the Department of Health and Human
Services (DHHS) came into being as a result of the separation of
the Department of Education from the 27-year-old Department of
Health, Education, and Welfare. The new department was created
by the Department of Education Organization Act, signed by
President Carter on October 17, 1979, which provided for
establishment of a separate Department of Education.
DHHS has a proposed fiscal 1981 budget of some $226 billion
and is responsible for almost 300 programs conducted by 140,000
full-time employees working throughout the United States and the
world. DHHS is the Federal Government's principal agency for
furthering the good health of Americans and providing them with
essential human services.
The new Department has four principle components:
o The Public Health Service conducts research, combats
illness and disease, ensures safety of food and drugs,
and supports and develops health care resources.
o The Health Care Financing Administration assists
Americans in obtaining health care.
o The Office of Human Development Services provides
social services to millions of needy Americans through
Federal/State programs.
o The Social Security Administration administers the
Social Security program, the Supplemental Security
Income program, and the Aid to Families of Dependent
Children program.
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In addition to the activities of these four major
components, DHHS administers a refugee assistance program
authorized by the Refugee Assistance Act of 1980.
This publication highlights several agencies within DHHS.
These include the Bureau of Food, the Bureau of Drugs and the
National Center for Toxicological Research located within the
Food and Drug Administration; the National Cancer Institute and
the National Institute of Environmental Health Sciences of the
National Institutes of Health; and the National Institute for
Occupational Safety and Health.
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POOD AND DRUG ADMINISTRATION
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Secretary's Office
Locator: 301-443-1544
Information: 301-443-1544
Organization page 62
Regulatory Authority page 71
The Food and Drug Administration, part of the Public Health
Services, is the Nation's oldest and principal consumer
protection agency. FDA's mission is to ensure that food is safe,
pure and wholesome; that human and animal drugs, biological
products, and therapeutic devices are safe and effective; and
that radiological products and use procedures do not result in
unnecessary exposure to radiation. To carry out this mission,
the FDA administers several laws, including the Federal Food,
Drug and Cosmetic Act, and several specific provisions of the
Public Health Service Act.
FDA employs over 7,000 people and is organized along product
lines within seven primary organizational units: Office of the
Commissioner, Bureau of Foods, Bureau of Veterinary Medicine,
National Center for Drugs and Biologies, the National Center for
Devices and Radiological Health, the National Center for
Toxicological Research, and the field force which reports to the
Associate Commissioner for Regulatory Affairs.
Approximately 60 percent of FDA's employees work at the FDA
headquarters operations in the Washington, D.C., metropolitan
area. Work at headquarters includes the approval of drugs (human
and animal), medical devices, and food and color additives;
research on analytical and regulatory science; and various
compliance activities.
The remainder of FDA's workforce is located in ten regional
offices, 21 district offices, and 124 resident stations. Most
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field employees inspect firms that produce regulated products and
analyze product samples. They work out of district offices and
resident posts, both of which feature field laboratories set up
to perform a variety of analytical tests for measuring compliance
with the law.
For fiscal year 1983, FDA's budget was 362 million dollars,
and the Agency has proposed an FY 84 budget for 385.4 million
dollars.
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OFFICE OF REGULATORY AFFAIRS
o Assists Commissioner and other officials on requlations
and compliance issues that have an impact on policy
development, execution, and lonq-ranqe program qoals.
o Establishes and enforces compliance policy.
o Acts as liaison with other Federal agencies on FDA
compliance matters and coordinates Agencywide voluntary
compliance and industry information activities.
o Directs and coordinates FDA regulatory process.
o Evaluates proposed leqal actions to ascertain compli-
ance with regulatory policy and enforcement objectives.
o Coordinates development of new or novel Agencywide
compliance programs, such as bio-research monitorinq
activities.
o Monitors compliance activities to ensure uniform
application of FDA policy.
OFFICE OF PLANNING AND EVALUATION
o Develops program and planning strateqy throuqh analysis
and evaluation of issues affecting policies and program
performance.
o Initiates and monitors the Aqencywide planning system
including the 5-year plan, strategic plan, and
functional plans.
o Conducts operations research, economic and special
studies as a basis for forecasting trends, needs, and
problems requiring FDA solutions or involvement.
o Evaluates impacts of external factors on FDA programs,
including industry and economics, consumer
expectations, and protective legislation.
*Note:Only those ottices that deal with toxics or toxics-
related issues are developed in this section.
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Recommends new programs, changes in existing programs,
and program priorities.
Develops systems to evaluate FD?\ program accomplish-
ments.
Evaluates impact of FDA programs on consumer
protection.
Manages the FDA Evaluation Review Board.
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NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR)
1. National Center for Toxicological
Research - Overall Functions
2. Authority and Effective Date
1. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH - OVERALL
FUNCTIONS (HFT).
a. Conducts research programs to study the biological
effects of potentially toxic chemical substances found
in man's environment, emphasizing: the determination
of the adverse health effects resulting from long-term,
low-level exposure to chemical toxicants, determination
of the basic biological processes for chemical
toxicants in animal organisms, development of improved
methodologies and test protocols for evaluating the
safety of chemical toxicants, and development of data
to facilitate the extrapolation of toxicological data
from laboratory animals to man.
b. Conducts additional research programs which utilize
facilities and expertise of the Center and contribute
to its overall scientific capability.
c. Develops Center programs as a national resource in
close cooperation with other agencies in the Public
Health Service and the Environmental Protection Agency
(EPA) and under the National Toxicology Program.
d. Operates with the advice of a Policy Board, consisting
of members appointed by the Secretary of Health and
Human Services and by the Administrator, EPA. The NCTR
Policy Board recommends program priorities, reviews
program and research results, reviews budget require-
ments and allotments, recommends management policies,
reviews qualifications of applicants for key positions,
and advises agency heads on matters concerning the
Center.
2. AUTHORITY AND EFFECTIVE DATE. The functional statements for
the Center were approved by the Secretary of Health and
Human Services and published in the Federal Register (44 FR
11273) on February 28, 1979.
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NATIONAL CENTER FOR DRUGS AND BIOLOGICS
1. National Center for Drugs and Bioloqics -
Overall Functions
2. Authority and Effective Date
1. NATIONAL CENTER FOR DRUGS AND BIOLOGICS - OVERALL FUNCTIONS
(HFN).
a. Develops FDA policy with regard to the safety, effect-
iveness, and labeling of all drugs and biologicals for
human use .
b. Plans and conducts research related to the development,
manufacture, testing, and use of both new and old
biological products to develop a scientific base for
establishing standards designed to ensure the continued
safety, purity, potency, and efficacy of biological
products.
c. Inspects manufacturer's facilities for compliance with
standards, tests products submitted for release,
establishes written and physical standards, and
approves licensing of manufacturers to produce
biological products.
d. Reviews and evaluates new drug applications (NDA's) and
notices of claimed investigational exemption for new
drugs (IND's).
e. Develops and implements standards for the safety and
effectiveness of all over-the-counter (OTC) drugs.
f. Monitors the quality of marketed drugs and biologicals
through product testing, surveillance, and compliance
programs.
g. Develops and promulgates guidelines on current Good
Manufacturing Practices for use by the biological and
drug industry.
h. Develops and disseminates information and educational
material dealing with biologicals and drugs to the
medical community and the public, in coordination with
the Office of the Commissioner.
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Conducts research and develops scientific standards on
the composition, quality, safety, and efficacy of human
drugs.
BUREAU OF VETERINARY MEDICINE
1. Bureau of Veterinary Medicine -
Overall Functions
2. Authority and Effective Date
1. BUREAU OF VETERINARY MEDICINE - OVERALL FUNCTIONS (HFV).
a. Develops and recommends the veterinary medical policy
of the Food and Druq Administration with respect to the
safety and efficacy of animal drugs, feed additives,
and devices.
b. Evaluates, for animal safety and efficacy, proposed and
marketed animal drugs and feed additives and marketed
devices for animal use.
c. Coordinates the veterinary medical aspects of the FDA
inspection and investigational programs and provides
veterinary medical opinions in drug hearings and court
cases.
d. Plans, directs, and evaluates FDA's surveillance and
compliance programs relating to animal drugs, animal
feeds, and other veterinary medical matters.
e. In cooperation with other Agency components, provides
FDA policy development and direction on environmental
impact matters.
2. AUTHORITY AND EFFECTIVE DATE. The functional statements for
the Bureau were approved by the Secretary of Health and
Human Services and published in the Federal Register
(47 FR 3608) on January 26, 1982.
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BUREAU OF FOODS
1. Bureau of Foods - Overall Functions
2. Authority and Effective Date
1. BUREAU OF FOODS - OVERALL FUNCTIONS (HFF).
a. Develops FDA policy with respect to the safety,
composition, quality (including nutrition), and
labeling of foods, food additives, colors, and
cosmetics.
b. Conducts research and develops standards on the
composition, quality, and safety of foods, food
additives, colors, and cosmetics.
c. Conducts research designed to improve the detection,
prevention, and control of contamination that may be
responsible for illness or injury conveyed by foods,
food additives, colors, and cosmetics.
d. Develops and promulgates current good manufacturing
practices for the food processing industry and model
ordinances, codes, and model regulations for State and
local government use in assuring food safety and
quality.
e. Plans FDA surveillance and compliance programs and
evaluates progress toward objectives of planned proqram
and regulatory activities relating to foods, food
additives, colors, and cosmetics.
f. Reviews industry petitions and recommends promulgation
of regulations for food standards and for the safe use
of color and food additives.
g. Collects and interprets data on nutrition, food
additives, and environmental factors affecting the
total chemical insult posed by direct and indirect food
additives .
h. Analyzes regulatory samples as necessary to support
Bureau compliance programs.
i. Participates in training of FDA field personnel and
provides guidance to the regulated industries in the
application of the most effective procedures to assure
food safety and quality.
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NATIONAL CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
1. National Center for Devices and Radiological
Health - Overall Functions
2. Authority and Effective Date
1. NATIONAL CENTER FOR DEVICES AND RADIOLOGICAL HEALTH -
OVERALL FUNCTIONS (HFW).
a. Develops and carries out a national program designed to
control unnecessary exposures of humans to, and assure
the safe and efficacious use of, potentially hazardous
ionizing and nonionizing radiation.
b. Develops policy and priorities regarding FDA programs
relating to the safety, effectiveness, and labeling of
medical devices for human use.
c. Conducts an electronic product radiation control
program including the development and administration of
performance standards.
d. Develops, plans, and evaluates surveillance and
compliance programs for medical devices and radiation
exposure.
e. Plans, conducts, and supports research and testing
relating to medical devices and to the health effects
of radiation exposure.
f. Reviews and evaluates medical device premarket approval
applications (PMAA's), product development protocols
(PDP's), and exemption requests for investigational
devices (IDE1s).
g. Develops, promulgates, and enforces performance
standards for appropriate categories of medical devices
and Good Manufacturing Practice (GMP) regulations for
manufacturers.
h. Provides technical and other nonfinancial assistance to
small manufacturers of medical devices.
i. Develops regulations, standards, and criteria and
recommends changes in FDA legislative authority
necessary to protect the public health.
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j. Provides scientific and technical support to other
components within FDA and other agencies on matters
relating to radiological health and medical devices.
k. Maintains appropriate liaison with other Federal,
State, and international agencies, with industry, and
with consumer and professional organizations.
2. AUTHORITY AND EFFECTIVE DATE. The functional statements for
this Center were approved by the Secretary of Health and
Human Services and published in the Federal Register (47 FR
44615) on October 8, 1982.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Phone*
Mail Stop
Office of Regulatory Affairs 301-443-1594 HFC-1
Bureau of Veterinary Medicine 301-443-3450 HFV-1
Bureau of Foods 202-245-1057 HFF-1
National Center for Drugs 301-443-2894 HFN-1
and Biologies
Include All Bureaus and Centers (NCDRH, NCTR, etc.)
REGIONAL AND FIELD OFFICES
Division/Office
Regional Food and Drug
Director
Regional Food and Drug
Director
Regional Food and Drug
Director
*FTS numbers are the same.
Phone
617-223-1278
FTS: 8-223-1278
212-965-5416
FTS: 8-663-5416
215-597-4390
FTS: 8-597-4390
Mail Stops
Region I
HFR-11
585 Commercial Street
Boston, MA 02109
Region II
HFR-21
830 3rd Avenue
Brooklyn, NY 11232
Region III
HFR-31
2nd and Chestnut Stree
Room 900
Philadelphia, PA 191C
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FDA'S REGULATORY AUTHORITY
The Food and Druq Adminstration1s authority is derived from
laws passed by Congress and assigned to the U.S. Department of
Health and Human Services (HHS). As an agency of the Department,
PDA has been delegated the responsibility to implement these
laws. Federal laws define the requirements applicable to
business and industry dealing in interstate commerce, as well as
the authority of the agency that will administer and enforce each
law. The implementing agency must make rules—regulations—
telling the affected industry and the public specifically how the
law is to be applied.
FDA is responsible for enforcinq a number of statutes, but
three are especially important: The Food, Druq, and Cosmetic
Act; the Public Health Service Act; and the Fair Packaqinq and
Labelinq Act.
The Food, Druq and Cosmetic Act (21 U.S.C. 301-392)—often called
the FD&C Act
F.nforcing the FD&C Act accounts for about 90 percent of
FDA's workload. This statute and its amendments provide for the
regulation of foods (includinq food additives), color additives,
human and animal drugs (including medicated animal feeds),
medical devices, and cosmetics. Generally, the Act qives FDA
authority to requlate only those products which are in interstate
commerce. Meat and poultry, however, are principally controlled
by a separate statute enforced by the U.S. Department of
Agriculture.
Imported products are also subject to the provisions of the
FD&C Act. FDA inspectors and investigators inspect imports while
the qoods are still in the custody of the U.S. Customs Service;
violative products may be detained. Their entry into this
country may be permitted if the violation can be corrected (by
reprocessing a food product, for example).
A model for most State food and drug laws, and even for
those of other countries, the Act provides a number of regulatory
controls. These include preventive measures such as premarket
approvals and establishment of quality standards for various
products; authority to monitor the marketplace by means of
factory inspections and other surveillance; and several
mechanisms, administrative and judicial, to correct problems
Violative conditions explicitly prohibited by the Act
generally fall into two categories: adulteration and
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misbranding. In addition, the Act forbids violations of the new
drug provisions and of the emergency permit controls applicable
to certain foods. The FD&C Act provides three major legal
sanctions against violations.
o Seizure of offending products is one such control; whole
lots of a product may be taken into the custody of the
U.S. courts and thereby kept off the market.
o FDA may also recommend criminal prosecution for the
person and/or firm responsible for product violations.
o The third major control provided by the Act is the
injunctions authority, whereby a Federal district court
enjoins, or forbids, shipment of an offending product
through interstate commerce. (The order could apply to
all products prepared in a factory shown to be
unsanitary or otherwise not meeting quality
requirements. Injunctions or restraining orders may be
preliminary, temporary, or permanent.)
The Public Health Service Act (PHS Act - 1944)
Three sections of the Act are enforced by FDA:
o 42 U.S.C. 262-263—The interstate sale of biological
products such as vaccines, serums, and blood is
regulated under this law. The products must be safe,
pure, and potent. Blood banks and manufacturers of
vaccines, serums, and antitoxins must be licensed by
FDA. Among other requirements for licensing, the
products must meet the standards for production and
product testing established by FDA. FDA also tests the
products, usually on a lot-by-lot basis. Biological
products may also be defined as drugs or medical devices
under the FD&C Act, and its sanctions can be applied
(e.g., seizure, criminal prosecution, or injunction).
o 42 U.S.C 264—Under this section of the PHS Act, FDA
ensures the safety of pasteurized milk and shellfish;
the sanitation of food service operations; and the
sanitation of the food, water, and sanitary facilities
for travelers on interstate vessels, trains, planes, and
buses.
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42 U.S.C. 263b - 263n—Radiation Control for Health and
Safety Act (1968 Amendment to the Public Health Sercie
Act)
This section protects the public from unnecessary
exposure to radiation from electronic products such as
color television sets, microwave ovens, and x-ray
machines. FDA sets performance standards for these and
similar products.
Products meeting FDA standards are certified. In the
case of defective products, the law provides that the
manufacturer will repair, replace, or refund the cost of
the products.
In certain circumstances, radiological products are also
medical devices, subject to requirements of the FD&C Act
as well as the Radiation Control Act.
The Fair Packaging and Labeling Act (1966)
The law requires that product labels be honest and informative so
consumers will know what they are buying and how to use it
properly. The label must also state the manufacturer's or
distributor's name and address. The Federal Trade Commission
enforces this act for all products other than foods, drugs,
medical devices, and cosmetics. The labeling for prescription
drugs is controlled by sections of the Food, Drug, and Cosmetic
Act.
Other Laws
FDA enforces several other Federal laws, including the Tea
Importation Act and the Federal Import Milk Act, and a few food
standards that were established by direct act of Congress—e.g.,
standards for butter and for nonfat dry milk. FDA also helps
enforce the Controlled Substances Act by making recommendations
to the Drug Enforcement Agency on the "scheduling" of drugs with
a potential for abuse, placing limits on access to them. The
principal Acts enforced by FDA can be found in the booklet Food
and Drug Administration Acts, available from the Office of
Consumer Affairs, Consumer Communications Staff (HFE-88). It
contains the Federal Food, Drug, and Cosmetic Act; the Public
Health Service Act, Biological Products; the Radiation Control
for Health and Safety Act; and the Fair Packaging and Labeling
Act. For a complete description of the legal requirements of
products under FDA jurisdiction—in layman's terms—see
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Requirements of Laws and Regulations Enforced by the U.S. Food
and Drug Administationf HEW Publication No. (FDA) 79-1042. This
little blue book is affectionately known at FDA as "Pub 2." It
is also available from the Consumer Communications Staff
(HFE-88).
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NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
Jefferson, Arkansas 72079
Locator: 501-541-4611
FTS-542-4611
Information: 501-541-4503
FTS-542-4503
Organization page 79
Statutory Authorities page 86
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR)
On February 1, 1971, President Richard Nixon announced that
a new, major project aimed at investigating the health effects of
a variety of chemicals would be established in the biological
facilities on the Pine Bluff Arsenal. The new activity was to be
known as the National Center for Toxicological Research (NCTR).
The Center was developed as a result of the growing
recognition of two kinds of needs: (1) better approaches to the
understanding of what the data acquired from experimental animals
means for man; and (2) more extensive facilities for the safety
evaluation of the many chemicals in man's surroundings.
The President stated that the Center would initially be
administered by the Food and Drug Administration, but should be
considered as a national resource for all of government,
industry, and the academic community.
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Research activities are directed at four specific goals:
o Determination of adverse effects resulting from
long-term, low-level exposure to various chemical
substances;
o Development of experimental data to facilitate
extrapolation of laboratory results to man;
o Determination of basic biological processes in animals
to provide a more accurate extrapolation of laboratory
results to humans; and
o Development of improved methods and testing protocols
for evaluating the relative safety of chemical
substances.
Regulatory agencies are currently faced with a dilemma of
providing reasonable protection to the population with an
inadequate knowledge base with respect to the actual harm caused
by exposure to toxic and potentially toxic chemicals. The
purpose of the NCTR has been and is to continue to expand that
knowledge base so that rational decisions can be made with
respect to limiting exposure to these chemicals.
There are many who believe that, as a society, the desire to
protect our members has outstripped our knowledge of the actual
harm caused by chemical exposures. Clearly, a balance must be
established between protecting society from harm and improving
the quality of life through product development (and, therefore,
increased risk). If the balance is tipped in favor of assuring
knowledge of human harm prior to restrictive action, one would
have to await years and perhaps generations of human exposure
and, therefore, potential damage to thousands, if not millions,
of people before one could assess actual human health hazards.
If the balance is tipped in the direction of over-protection, one
would restrict the use of chemicals at the first indication of
possible harm. That indication may come from knowledge of
similar compounds or may be as a result of indication of harm to
laboratory animals or microorganisms. Carrying this philosophy
to its logical conclusion, one quickly deprives society of needed
chemicals and restricts its ability to advance for the common
good, compete in international markets, and utilize advancing
technology to improve the quality of life.
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The balancing of these two concerns is difficult because
knowledge is limited at this time. Current technology simply
does not allow for the conduct of laboratory experiments which
result in definitive knowledge about what effects exposure will
have on a human's health.
NCTR's purpose is to expand the knowledge base that can be
of practical benefit to the regulatory agencies such that the
necessary balancing can be accomplished with fewer unknowns. Tf
we can extend knowledge to the point where we can clearly and
accurately describe the harmful effects that will most likely
occur upon exposure to chemicals, society will be in a much
better position to decide if the benefits are more desirable than
the harm caused by exposure. Without an improved knowledge
base,society is simply unable to make rational determinations in
these matters.
NCTR's approach to research is one of problem solving, not
just problem finding. This approach can be categorized as
follows: (1) leadership among the scientific community; (2) new
programs of cooperation and consensus building among all sectors;
and (3) close attention to maximizing its own productivity.
In the area of leadership among the scientific community,
NCTR operates under the principle that in order for government
science to be capable of solving difficult regulatory problems,
it must do a better job of staying current with the rapid
advancements emerging from academia and apply those advances to
the currently existing regulatory problems.
With respect to developing new programs of cooperation, it
is clear that the most significant advances will be accomplished
by recognition of the best and most current scientific knowledge
available. NCTR's approach to this problem is to identify purely
scientific (as opposed to sociologic, economic, or political)
aspects of the problem and identify those areas in which
consensus can be attained across all relevant sectors.
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ORGANIZATION*
DIRECTOR FOR NCTR
o Oversees Center activities and research efforts.
o Maintains liaison with representatives from the
scientific and research communities.
o Coordinates NCTR programs with the activities of the
Environmental Protection Agency, Food and Drug
Administration, National Institutes of Health, National
Toxicology Program, Department of Defense Agencies,
Consumer Product Safety Commission, and Department of
Agriculture.
o Monitors performance of the Center's supporting
contractors.
o Implements Departmental research policies.
o Directs research programs in developing biomarkers at
the molecular level, permitting more rational bases for
extrapolating animal data to human health effects.
Office of Scientific Intelligence
o Provides services to NCTR as a liaison and focal point
on matters pertaining to the National Toxicology Program
(NTP) and the World Health Organization (WHO).
o Participates in compound nominations and selections for
chemical evaluations for the NTP and prepares Executive
Summaries on compound use, population exposure, and
safety evaluations or research performed on selected
compounds.
o Conducts chemical evaluations on selected NTP compounds.
*NOTE: Only those offices which deal with toxics or
toxic-related issues are developed in this section.
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ASSOCIATE DIRECTOR FOR RESEARCH
Division of Carcinogenesis Research
o Conducts research to utilize gene patterns and specific
mutations in developing in vivo toxicological assay
systems.
o Engages in research to determine the metabolic
activation of chemical toxicants.
o Identifies the nature of damage to cellular constituents
by activated chemical toxicants.
o Investigates the effects of cellular repair mechanisms
of the toxic response.
o Determines critical detoxification pathways.
o Elucidates biochemical mechanisms by which chemical
carcinogenesis is initiated and expressed.
o Evaluates compounds of regulatory interest with regard
to mechanisms of action.
Division of Mutagenesis Research
o Estimates the risk to humans from exposure to chemicals
in the environment.
o Develops methods to measure both microlesions (single
gene mutations or small deletions) and macrolesions
(serious chromosomal aberrations) for use in toxicology
and safety evaluations.
o Works to improve short-term, in vivo bioassays for
identifying the effects of toxic substances on genes.
o Focuses research on developing reliable and economical
methods for evaluating the genotoxic potential of
chemicals. Results are then used to identify the
chemical risk to humans.
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Division of Teratogenesis Research
o Develops sound information bases of comparative
pharmacokinetics and metabolism to define valid
mathematical models for extrapolation of animal data to
man.
o Expands knowledge of basic developmental processes which
can be affected by toxicants and defines mechanisms of
teratogenicity.
o Develops and validates improved procedures for detecting
the full range of possible toxic manifestations
throughout the lifespan of the organism.
o Manages the teratology portion of the National
Toxicology Program.
o Currently conducts four major projects: the Behavioral
Teratology Collaborative Study; Reliability of Animal
Models in Teratology; Development and Use of Mathe-
matical Extrapolation Models in Teratogenesis; and
Utility of Fetal Histopathology in Teratology Testing.
Division of Biometry
o Performs statistical analyses to support NCTR
experimental programs.
o Develops statistical hypotheses for researchers and
provides criteria for establishing the validity of
statistical analyses performed at the Center.
o Maintains liaison with Environmental Protection Agency,
Food and Drug Administration, National Institutes of
Health, and other organizations concerned with biometric
applications to toxicology.
Division of Chemistry
o Develops chemical procedures for performing trace
analysis of carcinogens, teratogens, mutagens,
toxicants, and other substances, or their analogs and
metabolites.
o Studies chemical behavior, dosage forms, safe use and
disposal of chemicals.
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o Develops data bases to assist in the compliance with
Good Laboratory Practice (GLP) requirements.
o Develops analytical methods to ensure nutritional
integrity and absence of harmful substances in animal
diets.
o Determines concentrations of chemically dosed products.
Analytical Chemical Techniques Branch
o Develops techniques for improving the accuracy of trace-
level chemical analyses.
Spectroscopic Techniques Branch
o Advances state-of-the-art technology and methodologies
for trace-level analysis and detection of compounds at
parts per billion levels employing mass and nuclear
magnetic resonance (NMR) spectroscopy.
o Provides analytical services to Federal, state, and
local qovernment agencies in detection of trace levels
of deleterious compounds (i.e., Dioxin).
Division of Molecular Biology
Immunotoxicology Branch
o Conducts research on immunotoxicants that suppress
reactions to harmful organisms.
o Assesses the impact of chemical agents on natural
defense and repair mechanisms.
Cell Biology Branch
o Analyzes cells from toxicologically damaged tissues.
o Develops techniques for early diagnosis of carcinogenic
growths.
o Examines biological changes resulting from exposure to
toxic chemical compounds.
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ASSOCIATE DIRECTOR FOR CHEMICAL EVALUATION
Division of Chemical Toxicology
o Conducts research and evaluation efforts under the
guidance of the National Chemical Toxicological Testing
Program.
o Develops improved methods for toxicological evaluations.
o Performs research on chronic and subchronic toxicologi-
cal effects with particular emphasis on dose-response
relationships.
o Studies the correlations between nutrition and toxicity,
and advises other NCTR offices on nutritional matters.
Nutrition Chemical and Evaluation Branch
o Conducts chronic and subchronic laboratory studies to
determine carcinogenic and other harmful effects toxic
chemicals.
o Performs research on how diet affects biological and
biochemical processes that may alter carcinogenic and
toxicological responses.
Diet Preparation Branch
o Mixes chemical compounds into animal feed for use in
experimental diet studies.
Division of Pathology
o Studies laboratory animal responses to toxic and
carcinogenic agents.
o Develops improved pathology techniques, methodologies,
and morphologic classification.
o Provides scientific guidance to other NCTR programs
concerning pathological evaluation of laboratory animal
tissues/sera.
Division of Microbiological Services
o Develops improved procedures for using microorganisms to
enhance chemical biodegradation.
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Provides microbiological services to support NCTR's
toxicological operations.
ASSOCIATE DIRECTOR FOR MANAGEMENT
Division of Toxicology Data Management Systems
o Conceptualizes, develops, implements, and operates the
Toxicology Data Management System (TDMS) for the
National Toxicology Program (NTP) and at NCTR.
o Assists EPA Office of Testing and Evaluation in
developing an automated data system, in accordance with
TSCA guidelines.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Division of Carcinoqenesis
Research
Division of Mutaqenesis
Research
Division of Teratoqenesis
Research
Division of Biometry
Division of Chemistry
Spectroscopic Techniques
Branch
Division of Molecular
Bioloqy
Immunotoxicoloqy Branch
Cell Bioloqy Branch
Division of Chemical
Toxicoloqy; Nutrition
Chemical and Evaluation
Branch
Diet Preparation Branch
Division of Patholoqy
Division of Microbioloqical
Services
Phone
501-541-4204
FTS: 8-542-4204
501-541-4496
FTS: 8-542-4496
501-541-4304
FTS: 8-542-4304
501-541-4519
FTS: 8-542-4519
501-541-4556
FTS: 8-542-4556
501-541-4368
FTS: 8-542-4368
501-541-4449
FTS: 8-542-4449
501-541-4491
FTS: 8-542-4491
501-541-4574
FTS: 8-542-4574
501-541-4551
FTS: 8-542-4551
501-541-4385
FTS: 8-542-4185
501-541-4185
FTS: 8-542-4185
501-541-4449
FTS: 8-542-4449
Mail Stop
HPT-110
HFT-120
HFT-130
HFT-140
HFT-150
HFT-154
HFT-160
HFT-163
HFT-164
HFT-210
HFT-213
HFT-230
HFT-250
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STATUTORY AUTHORITIES
NCTR received its authority through President Nixon's
announcement on January 27, 1971, establishing the research
center at Pine Bluff, Arkansas. Its implementing authority
originates in an Interagency Agreement between the Department of
Health, Education, and Welfare (now The Department of Health and
Human .Services, DHHS) and the Environmental Protection Agency
(EPA) signed on April 1, 1971. The Interagency Agreement
establishes the Center's mission, functions, structure, and
research responsibilities. Statutory authority enabling the DHHS
and the EPA to direct the Center's activities resides in the
Presidential letter and in the general legislative requirements
assigning to the Agencies toxics-related research responsibili-
ties. These Acts include the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. §§348, 355; the Federal Insecticide, Fungicide,
and Rodenticide Act, 7 U.S.C. §135; the Clean Air Act, 42 U.S.C.
§1857; the Solid Waste Disposal Act, 42 U.S.C. §3251; and the
Federal Water Pollution Control Act, 33 U.S.C. §1151.
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NATIONAL INSTITUTES OP HEALTH
Public Health Service
Department of Health and Human Services
Bethesda, MD 20205
Locator: 301-496-2351
Information: 301-496-2535
The National Institutes of Health (NIH), an agency of the
Department of Health and Human Services (formerly the Department
of Health, Education, and Welfare), provides leadership and
direction to programs designed to improve human health through
the following activities:
o Conducts and supports research in the causes, diagnosis,
prevention, and cure of diseases of man, in the
processes of human growth and development, in the
biological effects of environmental contaminants, and in
related sciences.
o Supports the training of research personnel, the
construction of research facilities, and the development
of other research resources.
o Directs programs for the collection, dissemination, and
exchange of information in medicine and health,
including the development and support of medical
libraries and the training of medical librarians and
other health specialists.
To carry out these functions, NIH is organized into 11
research Institutes, 4 Divisions, and the National Library of
Medicine. The organization also includes a research hospital
called the Clinical Center, and the Fogarty International Center,
which fosters international biomedical exchange and provides
facilities for foreign scholars in residence. NIH is
headquartered in Bethesda, Maryland. However, one of its
Institutes—the National Institute of Environmental Health
Sciences—is at Research Triangle Park, North Carolina.
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This publication will focus on the responsibilities and
activities of two of the NIH Institutes—the National Cancer
Institute and the National Institute of Environmental Health
Sciences.
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NATIONAL CANCER INSTITUTE
Department of Health and
Human Services
Public Health Service
National Institutes of Health
Bethesda, Maryland 20205
Locator: 301-496-4000
Information: 301-496-6641
Orqanization paqe 93
Statutory Authorities paqe 97
Toxics-Related Activities paqe 101
The essential and continuinq qoal of the National Cancer
Institute (NCI) is the same today as it was when the Institute
was created by an Act of Congress in 1937: To develop the means
for reducing the incidence, morbidity, and mortality of cancer.
The NCI continues to be the lead Federal agency in cancer,
responsible and accountable for the investment of progress toward
that goal. The Institute coordinates the National Cancer Program
(NCP), which encompasses a variety of programs sponsored by NCI,
other branches of NIH, and Federal and non-Federal agencies. The
Program has three major components: research, control and
resource development.
The first two components encompass the scientific and
technical activities, while the resource development includes
those activities needed to carry out the research and control
efforts effectively (e.g., construction and manpower development
activities). The addition of cancer control responsibilities to
NCI's research responsibilities, and the specific emphasis placed
on the expansion of comprehensive cancer centers as focal points
for research, teaching, and demonstration, served to further
emphasize the axiom that the ultimate purpose of disease research
is to produce results that can be translated into improved
methods for prevention and treatment of disease in people. The
National Cancer Program has invested significant effort and
resources in this area.
One important characteristic of the NCP since its inception
has been the extensive and continuous participation of the
biomedical community in the major planning efforts of the NCI.
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Beginning with the development of the first edition of the
National Cancer Program Plan in 1972, periodic planning sessions
have been held for the purpose of revising and updating the major
recommendations for research and control activities. The general
character of the Program has also become increasingly a product
of more extensive and frequent interaction among Congress, the
public, the biomedical community, and Federal agencies. Tn
particular, the consistent and active roles of the President's
Cancer Panel and the National Cancer Advisory Board have
established a model for effective and productive relationships
between national advisory committees and the Federal agencies.
More specifically, NCT conducts and monitors research into
the cause, prevention, diagnosis, and treatment of cancer and
provides grants-in-aid to educational, public, or nonprofit
institutions to perform cancer research. NCI also supports the
professional education of cancer researchers through fellowships
and project grants. Currently, the Institute is conducting, or
funding through grants and contracts, laboratory and epidemiolo-
gical studies on environmental carcinogens, including pesticides,
motor exhausts, low-level radiation exposures, asbestos and other
fibers, halogenated hydrocarbons found in drinking water, and
other pollutants. In other programs, intra- and inter-species
variability is under investigation in order to elucidate the
causes of species-dependent response to carcinogen exposure;
these efforts involve studies on carcinogen metabolism, pharmaco-
kinetics, carcinogen-DNA adduct formation and DNA repair. In
addition, food additives and natural components of foods are
being evaluated for their ability to inhibit environmental
carcinogens. NCI also acts as an information center on cancer
and has developed a data bank on international cancer research.
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ORGANIZATION*
Note: NCI is currently undergoing reorganization. The
materials presented here may be subject to change.
DIVISION OF CANCER AND PREVENTION (DCCP)
o Plans and directs a national program of basic research
including laboratory, epidemiologic and biometric
research on the cause and natural history of cancer and
the means for preventing cancer through intramural
research grants, cooperative agreements, and contracts.
o Evaluates the potential relationship between oncogenes
and environmental carcinogenic agents in relation to the
risk of cancer in humans.
o Serves as the focal point for the Federal Government on
the synthesis of clinical, epidemiological, and
experimental data relating to cancer causation.
o Advises the Director of NCI in evaluation of program
activities relating to cancer causation and on grants
and grant applications as they relate to cancer causes
and prevention.
Carcinogenesis Intramural Program
o Plans, directs, and conducts a basic and applied
research program on the occurrance and inhibition of
cancer caused or promoted by chemical or physical agents
separately or together, or in combination with
biological agents.
o Develops and conducts programs in the areas of
carcinogenesis and related toxicology, metabolism,
chemistry, cell biology, and experimental tumor
pathology.
*Note: Only those offices which deal with toxics or toxics-
related issues are developed in this section.
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Field Studies and .Statistics Program
o Plans, directs, and manages a program of epidemiologic,
demographic, statistical and mathematical research on
the distribution and occurrence of human cancer, and the
identification of its characteristics and causes.
o Studies mortality and morbidity statistics, and makes
correlations with demographic and environmental
variables to formulate clues to cancer etiology.
o Performs field studies in an effort to detect the
specific environmental and host determinants of cancer.
Office of the Director, DCCP
o Serves as a focal point for environmental/occupational
cancer information and data through cooperative
agreements and contracts.
o Maintains the primary monitoring and collaborative
function for coordinating the NCI/EPA Collaborative
Program on Environmental Cancer and the NCI/NIOSH
Collaborative Program on Occupational Carcinogenesis.
o Compiles and distributes publications on carcinogens in
drinking water, carcinogens in air pollutants,
carcinogens in food, diet, drugs, and cosmetics.
o Conducts liaison activities for the National Cancer
Program as it relates to the national effort on
environmental and occupational cancer.
DIVISION OF RESOURCES, CENTERS AND COMMUNITY ACTIVITIES (DRCCA)
o Plans and conducts research, evaluation, demonstration,
technology transfer, education and information
dissemination programs to expedite the use of new
information relevant to the prevention, detection, and
diagnosis of cancer, and the pretreatment evaluation,
treatment, rehabilitation, and the continuing care of
cancer patients in the community and in cancer centers.
o Plans, directs, and coordinates the support of cancer
research at cancer centers and through organ site
programs.
o Supports professional and paraprofessional clinical
education, research training, and continuing education.
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o Administers project grant programs for the construction,
alteration, renovation, and equipping of basic and
clinical research facilities.
o Coordinates program activities with related activities
in the other Divisions of NCI, the National Toxicology
Program, other NIH Institutes, and other Federal and
State agencies, and establishes liaison with
professional and voluntary health agencies, labor
organizations, and trade associations.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Director, NCI
Division of Cancer
Cause and Prevention, NCI
Division of Resources,
Centers and Community
Activities, NCI
Division of Cancer Treatment,
NCI
Division of Cancer Biology
and Diagnosis, NCI
Division of Extramural
Activities, NCI
Phone*
301-496-5615
301-496-6618
301-496-6616
301-496-4291
301-496-4345
301-496-5147
Mail Stop
Building 31
Room 11A-52
Bethesda, MD
20205
Building 31
Room 11A-03
Bethesda, MD
20205
Building 31
Room 4A-32
Bethesda, MD
20205
Building 31
Room 3A-52
Bethesda, MD
20205
Building 31
Room 3A-03
Bethesda, MD
20205
Building 31
Room 10A-03
Bethesda, MD
20205
*FTS numbers are the same
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STATUTORY AUTHORITIES
The National Cancer Institute Act
Public Law 75-244
This Act, passed by Congress and siqned by President
Roosevelt in 1937, established the National Cancer Institute.
The purpose of the Act was "to provide for, foster, and aid in
coordinating research relating to cancer." The Act also
established the precedent for providing grants-in-aid to non-
Federal scientists engaged in cancer research and created the
National Cancer Advisory Council. This Act has been superseded
by the National Cancer Act of 1971, which is dealt with below.
Key Sections of Act--Toxics Focus
sec. 1 Established NCI as a part of the Public Health Service.
sec. 2 Authorizes the Surgeon General to conduct and coordinate
(a,b) cancer research with other agencies, organizations, and
individuals.
sec. 3 Created the National Cancer Advisory Council, a six-
member council composed of "leading medical or
scientific authorities."
sec. 4 Authorizes the Council to evaluate cancer-related
(a,b,c) research projects, to make information regarding these
projects available to the public, and to review all
applications for grants-in-aid.
The Public Health Services Act of 1944
Public Law 78-410 42 U.S.C. § 281
Enacted on July 1, 1944, the Public Health Services Act
established the National Cancer Institute as a division of the
National Institutes of Health and gave the Surgeon General broad
powers to foster research relating to health and disease. The
act also consolidated many NCI revisions into this single law.
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Key Sections of Act—Toxics Focus
sec. 401 "The NCI shall be a division of the National
Institutes of Health."
sec. 402 Foster and coordinate cancer research.
sec. 403 Transfers statutory authority for the
administration of NCI from the National Cancer
Institute Act of 1937 to the Public Health Services
Act of 1944.
sec. 404 Transfers statutory authority for the National
Cancer Advisory Council from the National Cancer
Institute Act of 1937 to the Public Health Services
Act of 1944.
The National Cancer Act of 1971
Public Law 92-218 42 U.S.C. 35 281-286
This Act broadened the responsibilities and authorities of
the NCI Director and initiated the National Cancer Program. The
Act also created the international cancer research data bank and
established a three-member President's Cancer Panel and the
National Cancer Advisory Board.
Key Sections of Act--Toxics Focus
sec. 3(a) Amends Part A of Title IV of the Public Health
Services Act by adding after section 406 the
following section regardinq the "National Cancer
Program."
sec. 407(a) Authorizes the Director of NCI to coordinate all
NIH activities related to cancer.
sec. 407(b)(1) Initiates an expanded, intensified, and
coordinated cancer research program.
sec. 407(b)(4) Establishes "an international cancer research
data bank to collect, catalog, store, and
disseminate information regarding the results of
cancer research undertaken in any country for
the use of any person involved in cancer
research in any country."
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sec. 407(c)(1) Establishes the President's Cancer Panel, a
three-member panel appointed by the president to
appraise the National Cancer Proqram.
sec. 408 Provides the establishment of new cancer
research and demonstration centers.
The National Cancer Act Amendments of 1974
Public Law 93-352 42 U.S.C. §§ 281-286
In addition to authorizing appropriations for Fiscal Years
1975-77, these amendments brought about improvements and chanqes
in the National Cancer Proqram. Also, they established guide-
lines for the dissemination and interpretation of information on
cancer research, directed the NCP to explore the role of
nutrition in the treatment, rehabilitation, and causation of
cancer, and removed the limits on the number of comprehensive
cancer centers that could be initiated by the NCI.
Key Sections of Act—Toxics Focus
sec. 103 Directs NCI to include in the data bank information
reqardinq "nutrition proqrams for cancer patients
and the relationship between nutrition and cancer."
sec. 108 Authorizes NCI to contract for a specific program
"to disseminate and interpret, on a current basis,
for professionals and other health officials,
scientists, and the qeneral public," information on
the cause, prevention, diagnosis, and treatment of
cancer.
The National Cancer Act Amendments of 1977
Public Law 95-622 42 U.S.C. §§ 281-286
The National Cancer Institute mandate was extended for one
year when the President signed the Health Planning and Health
Services Research and Statistics Extension Act. The number of
expert appointments was increased from 100 to 151 through this
legislation.
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The National Cancer Act Amendments of 1978
Public Law 95-622 42 U.S.C. §§ 281-286
Through the Community Mental Health Centers Act the National
Cancer act was amended to emphasize education and demonstration
programs in cancer treatment and prevention; the act stipulated
that the Institute devote more resources to prevention, focusing
particularly on environmental, dietary, and occupational cancer
causes.
Key Sections of Act—Toxics Focus
sec. 402 Authorized the NCI to expand and intensify its
research program for the prevention of cancer
caused by occupational or environmental exposure
to carcinogens.
sec. 407(a)(1) The membership of the National Cancer Advisory
Board was expanded from 23 to 29. Not more than
five of the appointed members shall be
individuals knowledgeable in environmental
carcinogenesis (including carcinogenesis
involving occupational and dietary factors).
The National Cancer Act Amendments of 1980
Public Law 96-538 42 U.S.C. S§ 281-286
The Health Programs Extension Act of 1980 extended the
National Cancer Institute authorization for three years.
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TOXICS-RELATED ACTIVITIES*
The broad goals of NCI's toxics programs are to identify
environmental carcinogens, to establish and measure the relation
between carcinogens and the incidence of cancer, and to prevent
cancer through educational and other programs. NCI is a major
source of information on cancer incidence and mortality for
researchers studying environmental carcinogens. Through its
programs, the NCI seeks to develop knowledge on the causes of
cancer from epidemiological studies correlating exposure amounts
with the incidence of cancer; from animal-human correlations
developed by comparing results of studies in experimental animals
with epidemiological studies; from comparative studies in various
species on carcinogen metabolism, pharmacokinetics, carcinogen-
DNA adduct formation and DNA repair; and from studies of host
factors leading to increased or decreased susceptibility to
environmental carcinogens.
The Institute's programs touch on a broad range of cancer-
related areas of study: the susceptibility of fetuses and
children to environmental agents; cancer mapping, or the relation
of cancer incidence to potential environmental causes;
correlation studies linking localized mortality rates with
corresponding environmental data; the connection of cancer
incidence to occupation; and special studies to determine the
factors at work in communities with particularly high or
particularly low rates of cancer. In addition, the NCI conducts
programs studying the relationships between synthetic estrogens
and breast cancer, artificial sweeteners and bladder cancer,
halogenated hydrocarbons in drinking water and increased rates of
cancer, and occupational hazards and cancer.
In addition, the NCI provides advice and staff expertise on
environmental carcinogenesis to other government agencies. It
provides advice in an informal way to agencies by keeping their
staffs apprised of new information and developments in the area
of carcinogenesis research. The NCI also provides input to NIOSH
on occupational and environmental carcinogenesis through members
of the Environmental Epidemiology Branch of the Field Studies and
Statistics Program. Other NCI staff members serve on panels and
*Included are those activities identified as toxics-related from
the information provided by each agency at the time of
publication. It is recognized that some activities may have
inadvertently been omitted. Please bring any such omission to
the attention of the Office of Pesticides and Toxic Substances,
Chemical Coordination Staff.
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committees organized by regulatory and other agencies. For
example, NCI staff are members of the Interaqency Testing
Committee organized to evaluate chemicals covered by the Toxic
Substances Control Act. Staff from the NCI also serve as members
of the Task Force on Environmental Cancer and Heart and Lunq
Disease and on the DHHS Committee to Coordinate Environmental and
Related Programs. The latter committee was established by the
Assistant Secretary for Health as a multi-agency group to
exchange information on environmental health, toxicology and
related programs. In addition to representatives from each
agency in HHS which supports or conducts these types of programs,
there are liaison representatives from CPSC, EPA, OSHA, CEQ,
Library of Congress, Department of Energy, National Oceanographic
and Atmospheric Administration, Department of Defense and the
NSF. The Interagency Collaborative Group on Environmental
Carcinogenesis is an informational committee, chaired by a
representative from NCI, which serves as a forum for exchanging
information among its member organizations: NCI, NIEHS, FDA,
USDA, and CEO, NOAA, NASA, the Department of Transportation, NSF
and others involved in environmental carcinogenesis research.
The NCI is also involved in developing collaborative activities
related to environmental carcinogenesis. The cooperative
projects on environmental/occupational carcinoqenesis are with
other Federal agencies (NIEHS, EPA, NIOSH, and OSHA), State
agencies and other institutions. The NCI/EPA and CNI/NIOSH
collaborative programs on environmental and occupational
carcinogenesis are managed jointly by co-project officers from
NCI and the EPA or NIOSH.
In 1981, the carcinogenesis testing program was transferred
to the National Institute of Environmental Health Sciences
(NIEHS) from NCI, and action which provides for direct management
by the National Toxicology Program of the NIH components of the
program. Nevertheless, the NCI maintains a significant level of
involvement in the carcinogenesis testing program by nominating
chemicals for testing in the bioassay program and by membership
on the NTP Executive Committee, which selects the chemicals to be
tested.
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The Cancer Control Program
The Cancer Control Program, established in 1972, has
numerous activities aimed at controlling the occurrence and
impact of the major causes of cancer. Educational programs have
been developed for health professions, the medical community, and
the general public. The Cancer Control Program conducts
conferences for analyzing and determining the scientific basis of
recommendations for cancer screening programs and provides
research grants to individuals or institutions studying methods
of cancer control. Under the Cancer Control Program, an
information network on the diagnosis and treatment of specific
types of cancer is being developed. This network will link
hospitals and physicians at the community level with selected
primary hospitals.
Cancer control research, defined as the reduction of cancer
incidence, morbidity and mortality through an orderly sequence
from research on interventions and their impact in defined
populations to their broad, systematic application, is the
mission of DRCCA. Cancer control research activities and
interventions are designed to promote the application of
knowledge gained through basic research and technological
advances to the problems of cancer prevention and control. DRCCA
facilitates and supports research to reduce the incidence of
cancer from all risk factors (occupational/environmental,
behavioral/lifestyle, heredity/genetic) in populations determined
to be high-risk or high-need and in the public-at-large.
Interdisciplinary efforts, drawing on the fields of occupational
health and medicine, education, behavioral-social sciences, and
communication/information sciences interact to develop, implement
and evaluate programs aimed at modifying the risk for cancer in
populations.
Selected examples from the Program areas of DRCCA:
1. Smoking, Tobacco and Cancer Program
The National Cancer Institute's (NCI) Smoking, Tobacco, and
Cancer Program (STCP) serves as the focal point for NCI's
research, disease prevention, and health promotion activities
related to smoking and cancer. Although responsibility for
programmatic research and control activities rests with several
of NCI's divisions and offices, central coordination of the STCP
is provided by the Office of the Director, DRCCA, where the
broader emphasis on cancer control research is administered. The
STCP's overall goals are to identify cancer risks associated with
smoking and tobacco use and to develop strategies for prevention
and cessation of tobacco-use behavior. Current activities
include community and school-based intervention and education
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programs aimed at deterrinq risk of smokinq behavior in children
and adolescents, the development of cessation programs targeted
toward high risk subgroups, studies aimed at understanding the
bio-behavioral dependence on smoking and tobacco use,
epidemiological studies to assess health effects due to changing
smoking and tobacco habits, toxicological studies to determine
promoting and carcinogenic effects of constituents in both the
particulate and gaseous phases of cigarettes, and biological and
epidemiological studies to identify individuals and groups at
unusually high risk for the development of cancer.
Some current areas of research of particular relevance to risk
assessment and reduction include:
o Studies to develop, implement, and evaluate smoking
prevention programs for youth and adolescents.
o Studies to develop, implement, and evaluate formal and
informal self-help approaches for smokinq cessation.
o Studies focused on the prevention implications of
understanding the psychosocial and situational variables
that influence smoking and non-smoking behavior among
youth.
o Studies to develop effective methods for modifying
smoking behavior among special at-risk populations.
o Studies to determine stimulation and stress levels which
might predispose individuals to smoke.
Future risk-related research to be supported through the
STCP will focus primarily upon risk reduction activities. As a
result of a number of consensus meetings held at NCI during the
winter and spring of 1983, several RFAs have been developed, and
others planned, which will: (1) continue and expand the NCI
STCP's interest in longitudinal school-based smoking prevention
studies and development of self-help strategies for the
prevention and cessation of smoking; (2) initiate studies focused
on longitudinal evaluation of physician and dentist
interventions, evaluation of smoking prevention and cessation
activities using the mass media; and (3) conduct smoking
prevention and cessation research among Hispanic and Black
populations.
2. Cancer Prevention Program
A. The Occupational Cancer Branch:
All projects in occupational cancer control involve the
assessment of risk factors in occupationally defined
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populations and the evaluation of approaches to the
modification of such risk factors. At present, studies
are underway to reduce risks in the following areas:
Population Target Site of Cancer Grant No.
Painters Multiple 34919
Coke Oven Lung 34916
Rubber Bladder; Multiple 34912
Auto Assembly Multiple 34914
Chemical Workers Multiple 34917
Insulation Production Lung; Mesothelioma; Colon 27582
(Asbestos)
Pattern Makers Colo-rectal 27582
Dye Workers Bladder 27582
Additionally, program planning is underway to inventory
existing information on workers at high risk of cancer, to
develop criteria for establishing future program priorities
and to propose priorities for future program activities.
Each of the activities involves risk assessment.
B. The Cancer Detection Branch supports the:
(1) Human Radiation Carcinogenesis Study of the three well-
defined irradiated populations and their controls. These
individuals have been studied longitudinally over 15 years
for reported morbidity and mortality. The effects of
irradiation earlier in life on subsequent health remain
evident in this population. The prolect aims to continue
longitudinal surveillance, quantify the cancer risks and
screen these high-risk populations for cancer; and
(2) Study of Predictive Value of the Wolfe Classification
in Breast Cancer Detection Demonstration Projects
(BCDDPs). The focus of the study is the relationship of the
Wolfe classification of mammographic parenchymal patterns to
the risk of developing breast cancer and the relation of the
patterns to other risk factors for breast cancer. Conducted
in the case-control mode, this long term study aims to
provide scientific evidence for the predictability of the
Wolfe classification scheme.
3. The Cancer Control Science Program
The Health Promotion Sciences Branch supports research
relative to health promotion/disease prevention efforts,
utilizing behavioral, social, educational or communication
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interventions to alter lifestyle practices so as to prevent the
carcinogenic effects of known risk factors. Examples of peer
review grant supported projects include:
Behavioral Aspects of Cancer Incidence and Mortality (34457)
examines overall relationships between cancer ana demographic
characteristics, relating risk factors and mortality or incidence
and multivariate multiple logistic regression. This prospective,
descriptive study in a defined population, Alameda County,
California, has the potential for generating hypotheses to be
tested regarding the relationship of behavioral factors, personal
health habits, and psychosocial functioning on the occurrence of
cancers of all types and on total cancer deaths.
Psychosocial Stress and Cancer Risk; A Prospective .Study
(34618) examines relationships between cancer and stressors in a
population of workers with 30 years' exposure to asbestos. The
project capitalizes on a unique opportunity to test hypotheses
about the relationship between psychological factors, including
life stressors, and cancer in a population at high risk of
developing cancer and other diseases within the next five years.
Primary Prevention of Cancer in Childhood (25521) is a
controlled clinical trial of 1200 students, initially ages nine
and ten, to identify major cancer and other disease risk factors,
to reduce elevated risk status through planned interventions and
to reinforce and maintain reduced risk status. This ongoing
program is expected to make significant contributions to
nutrition, cancer education and the modification of behaviors
which increase risk factors.
The Diet, Nutrition, and Cancer Program
The Diet, Nutrition and Cancer Program (DNCP), established
in 1974, coordinates efforts within the NCI to develoo and
disseminate information about the role of diet and nutrition in
the etiology and prevention of cancer and in the treatment, long
term management, and rehabilitation of the cancer patient, and to
coordinate NCI nutrition activities with those of other
organizations. Studies of dietary manipulation aimed at reducing
cancer incidence have been supported in animals and are being
initiated in humans.
In 1981, the DNCP was placed organizationally in the
Division of Resources, Centers, and Community Activities of the
NCI, where efforts continue toward developing an integrated and
coordinated nutrition program within the Institute. However,
each division retains responsibility for funding and day-to-day
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management of specific nutrition projects. For example, DCCP is
placing considerable emphasis on studies in the area of diet,
nutrition and cancer, focusing on inhibitors of carcinogenesis
which are present as normal constituents of foodstuffs.
The Cancer Centers Program
The Cancer Centers Program was founded in 1961 for the
development and dissemination of information on the most
effective methods of cancer prevention, diagnosis, treatment, and
rehabilitation. The emphasis of the program is on providing
financial support to institutions engaged in multidisciplinary
research. The Program seeks to attract physicans and scientists
of diverse background in order to develop a broad base of
information cancer control activities.
Supporting Programs
The major objectives of the Carcinogenesis Intramural
Program (DCCP) are to conduct and support research to identify
the determinants of cancer in man, to understand their mechanisms
of action and to develop and evaluate measures that will arrest,
reverse, or otherwise interfere with the initiation or
progression of the cancer process. These objectives include the
development of optimum procedures for culturing epithelial cells
from various animal and human tissues and the evaluation of the
effects of environmental carcinogens and co-carcinogens on those
cells; the development of sensitive procedures to detect the
covalent binding of chemical carcinogens to DNA of individuals
potentially exposed to such substances; to correlate individual
differences in metabolism of environmental carcinogens with
susceptibility to tumor induction; and identification, isolation
and characterization of new tumor inhibitory substances and the
synthesis and evaluation of analogs of known inhibitors.
The programs at the Frederick Cancer Research Facility
pursue a wide variety of fundamental studies in biological and
chemical carcinogenesis with the objective of providing
information applicable to the understanding and control of cancer
in man. Studies are being performed on the interaction between
chemical structure and carcinogenic activity, and on the
biochemical and molecular mechanisms of action of chemical
carcinogens.
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NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Department of Health and
Human Services
Public Health Service
National Institutes of Health
P.O. Box 12233
Research Triangle Park, N.C. 27709
Information: 919-541-3345
FTS: 629-3345
Organization page 111
Statutory Authorities page 122
The National Institute of Environmental Health Sciences
(NIEHS) has the broadest responsibility among Federal agencies
for the support of biomedical research and the training of
research manpower relating to the effects of chemical, physical,
and biological environmental agents on human health. The goal of
NIEHS is to provide the scientific information base, advanced
scientific methodology, and trained scientific manpower to reach
an understanding of the total impact of environmental factors on
human health, so that the health of the American people can be
protected and environmentally-induced disease can be prevented.
NIEHS pursues its mission by supporting research training in
environmental toxicology, environmental pathology, environmental
mutagenenis, and environmental epidemiology, and by funding basic
and applied research on the consequences of the exposure of
humans and other biological systems to potentially toxic or
harmful agents in the environment. In its research, NIEHS
attempts to learn: (1) how and where potentially harmful
environmental agents are released into the environment; (2) how
they affect humans and other biological systems in the
environment; (3) the extent of exposure of various population
groups (particularly sensitive populations) to these agents; (4)
the effects these agents cause, both separately and in
combination with other environmental agents; (5) what happens in
biological systems after exposure to hazardous agents; and (6)
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what diseases are caused or aggravated. In addition to these
activities, NIEHS carries out efforts to identify hazardous
environmental agents before they are released into the
environment. These efforts include the development, testing, and
validation of biological test systems that can be used to predict
the toxicity in human populations that would occur from exposure
to environmental factors.
Thus, NIEHS is a research organization whose goal is to
provide knowledge about the impact of environmental factors on
human health in order to protect the public health and to prevent
environmentally-related diseases. Once this information is
developed, NIEHS transmits it to regulatory agencies, other
Government agencies, the medical community, industry, and the
general public for appropriate action. Accordingly, results of
NIEHS research, testing, and methods development form the basis
for prevention programs for environmentally-induced diseases and
for action by regulatory and other agencies.
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ORGANIZATION*
OFFICE OF HEALTH HAZARD ASSESSMENT
o Plans, develops, and directs the Institute's health hazard
assessment activities.
o Identifies environmental and technological developments
having the potential for adversely affecting human health.
o Evaluates the health significance of these developments.
o Recommends Institute policy and program action based upon
these assessments.
o Serves as the Institute focal point for functions of this
kind, including managing its functions as a World Health
Organization Collaborating Center.
EXTRAMURAL PROGRAM
o Plans, directs, and evaluates the Institute's grant
program, which supports research and research training in
environmental health.
o Develops program priorities and recommends funding levels
to assure maximum use of available resources in attainment
of Institute objectives.
o Prepares reports for and provides advice to the Institute
Director, staff, and advisory groups to assist them in
carrying out their responsibilities.
o Represents the Institute Director in the development and
implementation of grant policy.
*NOTE: Only those offices which deal with toxics or toxics-
related issues are developed in this section.
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INTRAMURAL RESEARCH PROGRAM
o Plans and conducts the Institute's basic laboratory
research program to ensure maximum utilizaton of available
resources in the attainment of Institute objectives.
o Evaluates research efforts and establishes proqram
priorities.
p Integrates ongoing and new research activities into the
program structure.
o Collaborates with other Institute and NIH programs and
maintains awareness of national research efforts in
program areas.
o Provides advice to the Institute Director and staff on
matters of scientific interest.
Laboratory of Genetics
o Studies the structure, function, and regulation of genes
of prokaryotic and eukaryotic organisms with emphasis on
understanding the impact mutational events have on the
fitness of organisms.
o Conducts studies in prokaryotic and eukaryotic systems
intended to improve the basic understanding of mutation
mechanisms, mutation repair, and mutation avoidance
processes.
o Develops and validates in vitro and in vivo mutation
induction systems and models to detect and quantitate
mutagenic activity of environmental agents.
o Studies amounts and types of genetic variation in natural
populations and develops systems and models to facilitate
extrapolation from experimental systems to humans.
o Advises the staff of NIEHS and other entities on issues
pertaining to genetics.
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Laboratory of Pharmacology
o Plans and conducts studies on the biological effects of
environmental factors.
o Studies species differences in metabolism of, and dose-
and time-response relations for, the actions of selected
environmental hazards.
o Studies accumulation, distribution, and disposition of
environmental chemicals in a variety of animal species.
o Studies the interactions between toxic chemicals and
between these and other normal body constituents or drugs
to elucidate those interactions which may be adversely
synergistic.
o Conducts selected studies in marine biology research, and
coordinates and advises Institute staff and personnel of
other organizations on marine biology research applicable
to effects of environmental pollutants on human health.
Laboratory of Molecular Biophysics
o Plans and conducts studies to develop, improve, and
utilize spectroscopic methods (nuclear magnetic resonance,
electron spin resonance, and mass spectrometry) to
characterize and measure the molecular interactions that
occur between environmental agents and biological systems.
o Plans and conducts physical organic and bioorganic
chemical studies of environmental agents, biological
materials, and their conversion products with emphasis on
elucidation of chemical mechanisms in biological damage.
o Develops, improves, and utilizes analytical methodology
for specified agents and problems in collaborative
research with other NIEHS laboratory and research
programs.
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Comparative Medicine Branch
o Manages a program for environmental animal procurement,
housing, and utilization within the Institute.
o Develops, refines, and advises Institute scientists and
programs of appropriate animal models for use in Institute
research programs.
o Maintains collaborative laboratories in microbiology,
experimental surgery, laboratory animal medicine, and
mammalian reproduction.
o Plans and conducts research appropriate to these
laboratory functions.
Laboratory of Reproductive and Developmental Toxicology
o Conducts research directed toward the understanding of
mechanisms of reproductive, endocrinologic, and
developmental toxicity produced by exposure to
environmental agents.
o Determines mechanisms of teratogenesis by using in vivo
and in vitro techniques to develop more rapid and
economical laboratory methods to predict teratogenesis.
o Assesses environmental agents for their teratogenic
potential.
o Determines the molecular mechanisms underlying cellular
differentiation.
o Studies the molecular basis and determines the effects of
environmental agents on the endocrine function of the
reproductive system.
o Analyzes the effects of prenatal exposure to hormonally
active environmental agents on the development of
reproductive tract function.
o Determines the possible gestational origin of subtle toxic
effects which do not become apparent until later in life.
o Defines the effects of environmental agents on oogenesis
and spermatogenesis.
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Develops preclinical indicators of reproductive,
endocrinologic, and developmental toxicity using in vitro
cells and tissues, lower animals, and biochemical test
systems.
Laboratory of Behavioral and Neurological Toxicology
o Plans, conducts, and coordinates studies on behavioral and
neurological effects of environmental chemicals and
stressors to develop better tests for these effects, as
well as to use behavioral and neurological indices as
early warning systems for environmentally-induced
diseases.
o Evaluates behavioral and neurologic toxicity of selected
chemicals, including the effects of chronic microwave
exposure in developing animals.
o Studies neurophysiological effects of chemicals and high
noise levels on cellular mechanisms of electrical impulse
propagation and processing.
o Collaborates with other Institute programs to develop
broad interdisciplinary programs for evaluating subtle
effects of chemicals on the central and peripheral nervous
systems.
o Serves as a national focus for activities in this research
area, maintaining liaison and collaboration with other
laboratories investigating the effects of chemicals on
behavior.
Laboratory of Pulmonary Function and Toxicology
o Develops a central focus at NIEHS for research on effects
of environmental chemicals and stressors on the lung.
o Conducts studies to develop new methods for assessing and
detecting adverse effects of chemicals on the lung.
o Plans and conducts studies to elucidate the mechanisms by
which chemicals and other stressors cause adverse effects
on the lung.
o Investigates the nature of adverse effects of selected
chemicals and mixtures of chemicals on the lung, and
attempts to understand species differences in lung damage
by selected chemicals.
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BIOMETRY AND RISK ASSESSMENT PROGRAM
o Plans and conducts basic and applied environmental health
oriented research in the areas of risk assessment,
statistics, biomathematics, and epidemiology.
o Collaborates with scientists involved in the Toxicology
Research and Testing Program, assuming responsibility for
data management and statistical analysis.
o Provides statistical, mathematical, data processing, and
computer engineering support to other program areas within
the Institute.
o Assists the Office of the Director in addressing specific
health issues that bear on the welfare of the general
public.
Statistics and Biomathematics Branch
o Conducts a broad research effort ranging from statistical
analysis to biomathematical modeling aimed at developing
new or improved methods for qualitative and quantitative
risk estimation, particularly in the areas of
carcinogenesis, mutagenesis, teratogenesis, and
reproduction.
o Maintains an active research program in statistical
methodology development relevant to design and analysis
issues arising in laboratory experimentation, with special
emphasis on toxicological screening studies.
o Provides a comprehensive consulting service for the
Epidemiology Branch, the Toxicology Research and Testing
Program, and the Intramural Research Program.
Epidemiology Branch
o Initiates field studies of human diseases, particularly
those of a chronic nature, that are suspected of having an
environmental component in their etiologies.
o Investigates the effects of environmental toxins on fetal
and child development.
o Conducts basic and applied research on the development and
use of laboratory methods to monitor human populations for
environmental exposures and their effects.
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Computer Technology Branch
o Operates and maintains the Institute's computer systems
and the network of terminals connected to the various
computers at NIH/DCRT.
o Provides programming consultation services, including
software systems development, to Institute personnel.
o Maintains an active computer engineering group which
provides continuing support to laboratory research
activities in various branches.
o Provides systems analysis and project managment support to
both Institute and NTP system development projects.
TOXICOLOGY RESEARCH AND TESTING PROGRAM
o Plans and conducts research to develop, validate, and
evaluate methods for characterizing the toxicology of
chemical compounds and other environmental agents.
o Plans and conducts a program of research and testing,
including short term screening and long term animal
toxicology and carcinogenesis studies, to establish the
toxicity of chemical compounds and other environmental
agents.
o Collaborates with chemical toxicology test development and
testing programs of other Government agencies.
o Disseminates results of tests, test development, and test
validation efforts to interested members of the scientific
community and to Federal regulatory agencies.
Carcinogenesis and Toxicology Evaluation Branch
o Conducts research intended to develop and validate
improved toxicity testing methodologies, establish short
term and screening test systems, and improve
interpretation of long term toxicology and carcinogenesis
results.
o Collaborates as toxicology experts with other scientific
staff in the program involved in test development and
validation and test protocol preparation.
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o Monitors testing program to assure the quality and
validity of the toxicology components of the tests.
Systemic Toxicology Branch
o Conducts research to improve test protocols, to develop
new tests, and to improve interpretation of test results
related to the toxicity of chemicals on a variety of
organs, tissues, and cells.
o Collaborates as specific experts in fields such as
toxicology, immunology, pharmacokinetics, and physiology
with other scientific staff of the program involved in
test development and validation and test protocol
preparation.
Cellular and Genetic Toxicology Branch
o Plans, develops, and implements a combined intramural and
collaborative research program.
o Studies the genetic and related effects which result from
exposure to environmental agents.
o Develops, standardizes, and applies short terra in vitro
test systems in which large numbers of chemicals can be
screened for cellular and genetic toxicity.
o Develops and standardizes in vitro and in vivo test
systems as models for carcinogenesis and mutagenesis that
provide for extrapolation to humans.
o Develops and utilizes computer data files for storage,
retrieval, and analysis of genetic toxicity test data.
Chemical Pathology Branch
o Conducts research using pathologic methodology into the
induction of morphologic changes induced by toxic
environmental agents.
o Studies and interprets the results of tests using
pathologic methodology.
o Collaborates as pathology experts with other scientific
staff in the program involved in test development and
validation and test protocol preparation.
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o Monitors testing program to assure the quality and
validity of pathology components of the test.
Program Operations Branch
o Maintains continual planning, oversight, coordination, and
surveillance of toxicology testing activities.
o Undertakes scientific and technical monitoring of test
laboratories.
o Assembles, maintains, and utilizes scientific, management,
and financial data bases related to the testing activities
of the program.
o Maintains an interface between research staff and
contracts management staff to ensure proper conduct of
tests and reporting of bioassay and related toxicology
results.
Program Resources Branch
o Provides a range of special support resources for
toxicology and carcinogenesis testing and test development
activities.
o Assures acquisition and quality control of test animals.
o Provides for acquisition, quality control, and
standardization of test chemicals.
o Monitors laboratory safety, chemistry, and animal care
practices.
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STATUTORY AUTHORITY
Public Health Service Act
Public Law 78-410 42 U.S.C. § 201
The authority under which the NIEHS supports and conducts
its research in Section 301 of the Public Health Service Act,
which gives the Secretary of HHS broad powers to conduct and
support research relating to the causes, diagnosis, treatment,
control, and prevention of physical and mental diseases and
impairments of man.
Key Sections of Act—Toxics Focus
sec. 301(a) Authorizes Surgeon General to conduct and
"promote the coordination of research
investigations, experiments, demonstrations, and
studies relating to the causes, diagnosis,
treatment, control, and prevention of physical
and mental diseases and impairments of man,
including water purification, sewage treatment,
and pollution of lakes and streams."
sec. 301 (b) Authorizes the Surgeon General to make available
any research facilities, public authorities,
health officials, or scientists engaged in
related fields of study.
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NATIONAL INSTITUTE
FOR OCCUPATIONAL SAFETY AND HEALTH
Department of Health and Human Services
Public Health Services
Centers for Disease Control
HEADQUARTERS
1600 Clifton Road, N.E.
Atlanta, Georgia 30333
Laboratories
Robert A. Taft Laboratories
4676 Columbia Parkway
Cincinnati, Ohio 45226
55 Ridge Avenue
Cincinnati, Ohio 45213
Appalachian Laboratory for
Occupational Safety and Health
944 Chestnut Ridqe Road
Morgantown, West Virginia 26505
Organization Page 126
Statutory Authorities Page 135
Toxics-Related Activities Page 138
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Introduction
The National Institute for Occupational Safety and Health
(NIOSH), created by the Occupational Safety and Health Act of
1970, is the principal Federal agency involved in research to
eliminate on-the-job hazards to the health and safety of the
Nation's workforce.
Before 1970, investigators could enter workplaces only at
the request of employees or State and local health departments.
The 1970 Act gave the Institute this access, as well as specific
responsibility for research, for recommending standards to the
Occupational Safety and Health Administration, and for training
professionals in the field of occupational safety and health.
The Federal Mine Safety and Health Amendments Act of 1977 confers
responsibility to conduct Health Hazard Evaluations in mines,
research related to miner health, and to approve dust samplers
and respirators. This legislation also gives NIOSH the authority
to recommend standards for health in mines.
Since 1973, NIOSH has been administered by the Centers for
Disease Control and is headquartered in Atlanta, Georgia. Major
NIOSH laboratory facilities are located in Cincinnati, Ohio, and
Morgantown, West Virginia. In addition, personnel are stationed
in the ten DHHS regional offices.
At the Institute's main laboratories in Cincinnati, studies
include the effects of exposure to hazardous substances in the
workplace, as well as the psychological, motivational, and
behavioral factors involved in occupational safety and health.
Staff in Cincinnati are also responsible for the preparation and
update of the Criteria documents and other information
documents. These documents, which utilize research performed in
NIOSH laboratories or under contract, serve as the basis for
standards to be promulgated by the Occupational Safety and Health
Administration or by the Mine Safety and Health Administration
and for assessment of hazards and recommendations for worker
protection.
At its second laboratory, in Morgantown, West Virginia,
NIOSH conducts studies in respiratory disease and mining
health. In addition, the Institute's safety research and
respirator certification programs are located there.
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NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
DECEMBER 1982
OFFICE OF THE DIRECTOR
COM: (404) 329-3771
FTS: 236 3771
_L
OFFICE OF ADMINISTRATIVE
ft MANAGEMENT SERVICES
COM: (404) 329-3691
FTS: 236-3691
OFFICE OF PROGRAM
PLANNING ft EVALUATION
COM: (404) 329-3794
FTS: 236-3794
DIVISION OF
SAFETY RESEARCH
COM: (304)291-4595
FTS: 923-4595
DIVISION OF RESPIRATORY
DISEASE STUDIES
COM: (304) 291-4474
FTS: 923-4474
DIVISION OF BIOMEDICAL
& BEHAVIORAL SCIENCE
(513) 684-8465
OFFICE OF EXTRAMURAL
COORDINATION ft
SPECIAL PROJECTS
DIVISION OF STANDARDS
DEVELOPMENT &
TECHNOLOGY TRANSFER
(513)684-8302
DIVISION OF SURVEILLANCE
HAZARD EVALUATIONS ft
FIELD STUDIES
(513) 684-4428
DIVISION OF PHYSICAL
SCIENCES ft ENGINEERING
(513) 684-4321
DIVISION OFTRAINING &
MANPOWER DEVELOPMENT
(513) 684-8221
REG I
REG II
REG III
REG IV
REGV
REG VI
REG VII
REG VIM
REG IX
REGX
ATLANTA FACILITY
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY
AND HEALTH
1600 CLIFTON ROAD, NE
ATLANTA, GEORGIA 30333
CINCINNATI FACILITY
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY
AND HEALTH
4676 COLUMBIA PARKWAY
CINCINNATI, OHIO 45226
MORGANTOWN FACILITY
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY
AND HEALTH
944 CHESTNUT RIDGE ROAD
MORGANTOWN, WEST VIRGINIA 26505
NIOSH REGIONAL OFFICES
DHHS, REGION I
GOVT. CENTER (JFK FED. BLDG.I, ROOM 1401
BOSTON, MASSACHUSETTS 02203
TEL.: 617/223-3848
FTS: 223-3848
DHHS, REGION II
26 FEDERAL PLAZA, ROOM 3337
NEW YORK, NEW YORK 10278
TEL.: 212/264-2485/8
FTS: 264-2485
DHHS, REGION III
P.O. BOX 13716
PHILADELPHIA, PENNSYLVANIA 19101
TEL.: 215/596-6716
FTS: 596-6716
DHHS, REGION IV
101 MARIETTA TOWERS, SUITE 1007
ATLANTA, GEORGIA 30323
TEL.: 404/221-2396
FTS: 242-2396
DHHS, REGION V
300 SOUTH WACKER DRIVE, 26TH FLOOR
CHICAGO, ILLINOIS 60606
TEL.: 312/886-3651
FTS: 886-3651
DHHS, REGION VI
1200 MAIN TOWER BUILDING, ROOM 1835
DALLAS, TEXAS 75202
TEL.: 214/767-3916
FTS: 729-3916
DHHS, REGION VII
601 EAST 12TH, FOB, 5TH FLOOR WEST
KANSAS CITY, MISSOURI 64106
TEL.: 816/374-3491
FTS: 758-3491
DHHS, REGION VIII
1961 STOUT, FOB, ROOM 1185
DENVER, COLORADO 60294
TEL.: 303/837-6382
FTS: 327-6382
DHHS, REGION IX
50 UNITED NATIONS PLAZA, ROOM 303
SAN FRANCISCO. CALIFORNIA 94102
TEL.: 415/556-3781
FTS: 556-3781
DHHS, REGION X
2901 THIRD AVENUE, MS/402
SEATTLE, WASHINGTON 98121
TEL.: 206/442-0530
FTS: 399 0530
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ORGANIZATION*
NIOSH HEADQUARTERS
Office of the Director
o Provides management leadership for NIOSH; leads the
mission to conduct research, training, technical
assistance, and related activities to ensure safe and
healthful conditions for workers.
Office of Program Planning and Evaluation
o Plans and coordinates Institute strategy regarding
mission and objectives; conducts policy analyses,
program planning and evaluation; and implements control
functions to ensure compliance toward program
objectives.
DIVISION OF STANDARDS DEVELOPMENT AND TECHNOLOGY TRANSFER
Document Development Branch
o Provides the scientific effort necessary to develop
criteria for occupational health standards.
o Coordinates the development and final approval of
occupational health criteria and standards documents in
cooperation with the U.S. Department of Labor.
Priorities Research Analysis Branch
o Analyzes information on the exposure of workers to
safety and health hazards.
o Prepares and periodically revises a priority list of
substances and industries for which activity is
warranted, either for future research or for new
recommendations.
o Prepares and annually revises the legislatively mandated
Registry of Toxic Effects of Chemical Substances
(RTECS).
*NOTE: Only those offices which deal with toxics effects or toxics-related
issues are developed in this section.
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o Conducts Special Occupational Hazards Reviews of
potential workplace hazards when new evidence of a
particular hazard is received, and prepares recommended
emergency temporary standards as appropriate.
o Assists the Mine Safety and Health Administration,
Department of Labor, in the development of draft
regulations.
Technical Information Branch
o Receives, stores, develops and disseminates technical
information on occupational safety and health hazards.
o Develops publications promoting safe and healthful
working conditions.
DIVISION OF TRAINING AND MANPOWER DEVELOPMENT
o Conducts short-term training programs in occupational
safety and health, including programs in toxicology and
hazardous waste.
DIVISION OF SURVEILLANCE, HAZARD EVALUATIONS, AND FIELD STUDIES
Hazard Evaluation and Technical Assistance Branch
o Conducts the legislatively mandated Health Hazard
Evaluation program.
o Provides medical, technical, and consultative assistance
to Federal, State, and local agencies, labor, industry,
and others to control occupational health hazards and to
prevent related trauma and diseases.
Industry-wide Studies Branch
o Conducts epidemiological industry-wide field studies to
determine the incidence and prevalence of acute and
chronic disease in the working population and their
offspring.
Surveillance Branch
o Develops and maintains a national surveillance system
for the early detection and continuous assessment of the
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magnitude and extent of occupational illness and of
exposures to hazardous aqents.
DIVISION OF BIOMEDICAL AND BEHAVIORAL SCIENCE
o Conducts laboratory research for the development of
criteria for standards in the areas of toxicology,
behavioral science, physiology, ergonomics, and the
effects of physical agents.
Experimental Toxicology Branch
o Performs laboratory research to develop critical
toxicity data on materials found in the occupational
environment.
o Investigates the mechanisms of occupational disease.
o Contributes to the development of occupational health
criteria for the recommendation of standards.
DIVISION OF PHYSICAL SCIENCES AND ENGINEERING
Engineering Control Technology Branch
o Plans and conducts laboratory and worksite research to
assess and develop engineering control techniques to
prevent worker exposure to toxic substances and harmful
physical agents.
Methods Research Branch
o Conducts research to develop new sampling and analytical
methods for use in measuring potential contaminants in
the workplace.
Measurements Research Support Branch
o Provides sampling consultation and analytical support
for Health Hazard Evaluations, engineering control
systems, and other NIOSH field research.
DIVISION OF RESPIRATORY DISEASE STUDIES
o Conducts clinical and epidemiological research on
occupational respiratory disease.
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Provides legislatively mandated medical and autopsy
services under the Federal Mine Safety and Health Act of
1977.
Conducts medical research to fulfill the Institute's
responsibilities under the Federal Mine Safety and
Health Act of 1977.
Conducts Health Hazard Evaluations for mines.
DIVISION OF SAFETY RESEARCH
Testing and Certification Branch
o Tests and certifies respirators; tests other personal
protective devices and occupational hazard measuring
devices.
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NIOSH REGIONAL OFFICES
DHHS, Reqion I
Govt. Center (JFK Fed. Bldg.), Room 1401
Boston, Massachusetts 02203
Tel: 617/223-3848
FTS: 223-3848
DHHS, Region II
26 Federal Plaza, Room 3337
New York, New York 10278
Tel: 212/264-2485/8
FTS: 264/2485
DHHS, Region III
P.O. Box 13716
Philadelphia, Pennsylvania 19101
Tel: 215/596-6716
FTS: 596-6716
DHHS, Region IV
101 Marietta Towers, Suite 1007
Atlanta, Georgia 30323
Tel: 404/221-2396
FTS: 242-2396
DHHS, Region V
300 South Wacker Drive, 26th Floor
Chicago, Illinois 60606
Tel: 312/886-3651
FTS: 886-3651
DHHS, Region VI
1200 Main Tower Building, Room 1835
Dallas, Texas 75202
Tel: 214/767-3916
FTS: 729-3916
DHHS, Region VII
601 East 12th, FOB, 5th Floor West
Kansas City, Missouri 64106
Tel: 816/374-3491
FTS: 758-3491
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DHHS, Region VIII
1961 Stout, FOB, Room 1185
Denver, Colorado 80294
Tel: 303/837-6382
FTS: 327-6382
DHHS, Region IX
50 United Nations Plaza, Room 303
San Francisco, California 94102
Tel: 415/556-3781
FTS: 556-3781
DHHS, Region X
2901 Third Avenue, MS/402
Seattle, Washington 98121
Tel: 206/442-0530
FTS: 399-0530
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DIRECTORY FOR NIOSH OFFICES/DIVISIONS AND INFORMATION SERVICES
Division/Office
Office of the Director
FTS: 236-3771
Office of Administrative
and Management Services
Office of Program Planning
and Evaluation
Office of Extramural
Coordination and Special
Projects
Division of Standards
Development and Technology
Transfer
Division of Training and
Manpower Development
Division of Surveillance,
Hazard Evaluations,
and Field Studies
Division of Biomedical and
Behavioral Science
Division of Physical
Sciences and Engineering
Division of Respiratory
Disease Studies
Division of Safety Research
FTS: 923-4595
Public Information Officer
FTS: 236-3061
Legislative Officer
FTS: 236-3061
Clearinghouse for
Occupational Safety and
Health Information
(Technical Information
Branch)
Phone
Com: (404) 329-3771
Com: (404) 329-3691
FTS: 236-3691
Com: (404) 329-3794
FTS: 236-3794
Com: (301) 496-6723
FTS: 496-6723
Com: (513) 684-8302
FTS: 684-8302
Com: (513) 684-8221
FTS: 684-8221
Com: (513) 684-4428
FTS: 684-8221
Com: (513) 684-8465
FTS: 684-8465
Com: (513) 684-4321
FTS: 684-4321
Com: (304) 291-4474
FTS: 923-4474
Mail Stop
Atlanta, Ga.
Atlanta, Ga.
Atlanta, GA.
Bethesda, MD
Cincinnati, Ohio
Cincinnati, Ohio
Cincinnati, Ohio
Cincinnati, Ohio
Cincinnati, Ohio
Morgantown, WV
Com: (304) 291-4595 Morgantown, WV
Com: (404) 329-3061 Atlanta, Ga.
Com: (404) 329-3061 Atlanta, Ga.
Com: (513) 684-8326
FTS: 684-8326
Cincinnati, Ohio
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REGIONAL OFFICES
Name
NIOSH
DHHS, Region I
NIOSH
DHHS, Region II
NIOSH
DDHS, Region III
NIOSH
DHHS, Region IV
NIOSH
DHHS, Region V
NIOSH
DHHS, Region VI
NIOSH
DHHS, Region VII
NIOSH
DHHS, Region VIII
NIOSH
DHHS, Region XI
NIOSH
DHHS, Region X
Address
Government Center
JFK Fed. Bldg. Room 1401
Boston, MA 02203
Federal Bldg.
26 Federal Plaza, Room 3337
New York, NY 10278
P.O. Box 13716
Philadelphia, PA 19101
101 Marietta Tower
Suite 1007
Atlanta, Ga. 30323
300 South Wacker Drive
26th Floor
Chicago, IL 60606
1200 Main Tower Bldg.
Room 1835
Dallas, TX 75202
601 East 12th Street
FOB, 5th Floor West
Kansas City, MO 64106
1861 Stout, FOB, Room
Denver, CO 80294
50 United Nations Plaza,
Room 303
San Francisco, CA 94102
2901 Third Avenue, MS/402
Seattle, WA 98121
Phone
(617) 223-3848
FTS: 223-3848
(212) 264-2485/8
FTS: 264-2485
(215) 596-6716
FTS: 596-6716
(404) 221-2396
FTS: 242-2313
(312) 886-3651
FTS: 886-3651
(214) 767-3916
FTS: 729-3916
(816) 374-3491
FTS: 758-3491
(303) 873-6382
FTS: 327-6382
(415) 556-3781
FTS: 399-0530
(206) 442-0530
FTS: 399-0530
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Current NIOSH Working Groups
Working Group on the Control of
Occupational Lung Disease
MEMBERS
John Hankinson (Chairperson)
Tom Hodous
Frank Hearl
Frank Green
Bob Mullan
Jim Melius
Bill Moorman
Lawrence Doemeny
John Gamble
Martin Sepulveda
MAIL STOP
ALOSH - 256
ALOSH - 240
ALOSH - 120
ALOSH - 240
TAFT - F-2
RIDGE - R-9
TAFT - C-23
RIDGE - R-1
ALOSH - 224
ALOSH - 240
Working Group on the Control of
Musculoskeletal Injuries
Vern Putz-Anderson
(Chairperson)
Roger Jensen
Roger Nelson
Lee Sanderson
Shiro Tanaka
Donald Badger
TAFT - C-24
ALOSH - 124
ALOSH - C-14
ALOSH - S-105
Cincinnati - F-6
TAFT - C-24
Working Group on the Control of
Occupational Cancers
TELEPHONE
923-4755
923-4223
923-4221
923-4581
684-3269
684-4328
684-4275
684-4322
923-4476
923-4223
684-8383
923-7454
496-7807
923-7576
684-2352
684-8286
William Halperin
(Chairperson)
Richard Niemeier
David Groth
Todd Frazier
Paul Caplan
James Jones
Francis H. Green
RIDGE - F-8
TAFT - C-23
TAFT - C-26
Cincinnati - F-2
RIDGE - R-5
RIDGE - R-5
ALOSH - 204
684-2694
684-8394
684-8361
684-2641
684-4224
684-4295
923-7581
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STATUTORY AUTHORITIES
Occupational Safety and Health Act of 1970
Public Law 91-596
For a brief history of this Act, please refer to the
introductory section on the Occupational -Safety and Health
Administration.
Key Sections of Act—Toxics Focus
sec. 20(a)(2) Authorizes the Secretary of Health, Education,
and Welfare (HEW) (as of May 4, 1980—
Department of Health and Human Services
(DHHS)) to undertake various types of research
relating to toxic substances in the work
environment in order to meet his
responsibility for the formulation of health
and safety standards under this Act.
sec. 20(a)(5) Allows the Secretary of HEW (now DHHS) to
develop regulations requiring employers to
measure, record, and make reports on the
exposure of employees to substances or
physical agents which may endanger the health
or safety of employees.
sec. 20(a)(6) Directs the Secretary of HEW (now DHHS) to
provide annually a "list of all known toxic
substances by generic family or other useful
grouping, and the concentrations at which such
toxicity is known to occur."
sec. 20(a)(e) Delegates the functions of the Secretary of
HEW (now DHHS) under this Act of the Director
of NIOSH.
sec. 21 Directs the Secretary of HEW (now DHHS) to
conduct education and training programs to
ensure an adequate supply of personnel to
carry out this Act.
sec. 22(c) Authorizes NIOSH to develop and recommend
occupational safety and health standards and
to perform all functions of the Secretary of
HEW (now DHHS) under section 20 and 21 of this
Act.
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sec. 22(a) Establishes NIOSH within HEW (now DHHS) to
perform the Secretary of HEW's functions under
sections 20 and 21 of this Act.
Federal Mine Safety and Health Amendments Act of 1977
Public Law 95-164
The Federal Mine Safety and Health Amendments Act of 1977
was signed by President Carter on November 9, 1977.
The law is the first to bring all mines in the U. S.--more
than 20,000 underground and surface, coal and non-coal
facilities—under a single safety and health program. It is also
the first safety and health program to cover all of the Nation's
400,000 miners.
The Act repeals the Federal Metal and Nonmetallic Mine
Safety Act of 1966 and embodies many aspects of the Coal Mine
Health and Safety Act of 1969, strengthening its provisions and
expanding its scope to cover all mines.
On March 9, 1978, (120 days after enactment) responsibility
for enforcing and administering mine safety and health was
transferred from the U. S. Department of the Interior to the
U. S. Department of Labor. The act created a new Mine Safety and
Health Administration headed by an assistant secretary of labor.
The law also established an independent, five-member Federal
Mine Safety and Health Review Commission to decide on appeals of
enforcement of actions by mine operators or representatives of
miners.
Key Sections of Act—Toxics Focus
sec. 101(a)(6)(b) Stipulated that for each toxic material or
harmful agent found in a mine, NIOSH must
determine potential toxicity at concentrations
used or found in the mine.
sec. 103(a) Authorizes NIOSH to make inspections in mines
to obtain information on health and safety
conditions and mandatory standards.
sec. 501(a) Authorizes NIOSH to engage in research
activities relating to mine safetv and health.
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Toxic Substances Control Act
Public Law 94-469
The Toxic Substances Control Act was signed on October 11,
1976. This law establishes a committee to recommend for priority
rulemaking a list of chemical substances and mixtures known to
cause or contribute to cancer, gene mutations, or birth defects.
Key Sections of Act—Toxics Focus
sec. 4 Provides for consultation on toxicological
tests and epidemiology and service on the
Toxic Substances Selection Committee.
Comprehensive Environmental Response, Compensation, and
Liability Act of 1980
Public Law 96-510
This law, enacted December 11, 1980, creates within the
Public Health Service an agency to be known as the Agency for
Toxic Substances and Disease Registry. Established within the
Centers for Disease Control, this agency is to (1) maintain a
national registry of persons exposed to toxic substances; (2)
maintain a listing of areas closed or restricted in use because
of toxic substances contamination; (3) provide appropriate
medical care and testing to exposed individuals in case of public
health emergencies related to exposure to toxic substances; and
(4) to conduct periodic survey and screening programs to
determine relationships between exposure to toxic substances and
illness.
Key Sections of Act—Toxics Focus
sec. 104 Stipulates cooperation in implementing
hazardous waste cleanup.
sec. 111 Protects workers at hazardous waste cleanup.
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TOXICS-RELATED ACTIVITIES*
Current programs within NIOSH are divided into four major
areas: research, criteria documentation and standards
development, technical assistance, and manpower development.
Summaries of the first three areas are included in this section,
Research
The largest effort within NIOSH, both in terms of dollars
and personnel, is directed toward applied occupational safety and
health research. Most of the research is concerned with
developing new or modifying existing criteria for recommended
occupational safety and health standards. Primary areas of
research are toxicology, physical and chemical agents, physiology
and ergonomics, engineering, behavioral and motivational factors,
and epidemiological industry-wide studies. Several of these
areas are highlighted below.
A major objective of the toxicology research is to determine
acute, subchronic, and chronic toxicities of new or existing
industrial chemicals in the workplace. These data, besides being
used for the development of criteria documents, are also utilized
to calculate a relative hazard index for each material tested and
to identify the most dangerous routes of exposure.
NIOSH*s Industry-wide Studies Program develops basic
information to be included in the development of the recommended
standards. The objectives of this program are: to determine the
health experience of current or former workers? to evaluate the
industrial environment in terms of stressful agents present,
degree of exposure, sources of contaminants, and present
controls; to develop, to the extent possible, an exposure-
response relationship between each agent or combination of agents
and incidence of specific diseases; to devise medical examination
procedures which will detect in employees the effects of
exposures to harmful agents; and to formulate sampling methods
and environmental survey strategies.
*Included are those activities identified as toxics-related from the
information provided at the time of publication. It is recognized that some
activities may have been inadvertently omitted. Please bring any such
omissions or new additions to the attention of the Office of Pesticides and
Toxic Substances, Chemical Coordination Staff.
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These research efforts are undertaken at the NIOSH research
labs (located in Cincinnati, Ohio, and Morgantown, West Virginia)
and under contract with universities and private research
institutes.
Criteria Documentation and Standards Development
Criteria Documents. NIOSH provides recommended safety and
health standards in the form of criteria documents to the
Secretary of Labor for promulgation and enforcement. Criteria
documents are publications on specific occupational safety and
health problems. The development of criteria documents includes
not only the recommendation of the environmental limit where
information is available to support it, but also the
recommendation of work practice controls, medical evaluation,
information for the workers to recognize and avoid the hazard,
and identification of specific research gaps identified during
the development of the criteria document.
Subjects may include individual chemicals or physical
agents, classes or groups of chemicals or agents, industries,
occupations, or specific processes within an industry. The order
of hazards selected for criteria development is determined by a
NIOSH priority system based on the number of workers exposed;
severity of the toxic response, including carcinogenicity; amount
of material being used, produced, or handled; and new information
regarding occupational health hazards.
The criteria documents are prepared by the Division of
Standards Development and Technology Transfer located in
Cincinnati, Ohio.
Special Hazard Reviews. The complex and time-consuming
criteria documentation process is not always appropriate for
particularly hazardous substances, including some carcinogens.
For these hazards, NIOSH developed a Special Hazard Review which
contains information on the hazard's known health effects,
recommended good work practices and exposure levels, suggested
monitoring and recordkeeping requirements, and sampling methods.
Emergency Temporary Standards. Where NIOSH determines that
worker health protection requires immediate action, a recommended
emergency temporary standard is developed and sent to OSHA. The
preparation of an emergency temporary standard may be intitiated
as a result of OSHA's compliance experience or because of a
report of adverse health reports from industry, research groups,
or other interested parties. Information obtained as a result of
NIOSH field studies or a health hazard evaluation report can also
result in the development of emergency temporary standards.
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Technical Services
NIOSH provides a number of technical services to employees,
employers, and organizations in the occupational safety and
health field. These include:
o Health Hazard Evaluations. A Health Hazard Evaluation
is a an on-site investigation of health hazards in a
specific workplace. The evaluations may be recruested by
an authorized representative of employees or by an
employer. If a NIOSH investigator finds any employees
in imminent danger, the employers and the Department of
Labor are notified immediately. In cases where there is
no imminent danger, NIOSH will mail a copy of the
findings to the employer or employee who requested the
evaluation. NIOSH was also given authority to perform
evaluation in mines under the Federal Mine Safety and
Health Act of 1977.
Contact: Division of Surveillance, Hazard Evaluations,
and Field Studies.
o Current Intelligence Bulletins. The Bulletins serve as
a means to promptly notify occupational health
professionals of health and safety hazards that
previously may not have been recognized. The Bulletin
is based on the evaluation of new information on a
particular hazard in light of other known epidemiology,
production, and use data. Since accuracy and speed are
of the utmost importance, the review and evaluation
process preceding issuance takes only 3 to 4 weeks.
Contact: Division of Standards Development and
Technology Transfer.
o Registry of Toxic Effects of Chemical Substances.
Annual publication of the registry is mandated by the
OSH Act. The registry itself is a compendium of
unevaluated toxicity data abstracted from scientific
literature. The format permits searches by groupings of
chemicals or by chemical structure. The current edition
(1981-82) lists over 59,000 different substances.
Contact: Division of Standards Development and
Technology Transfer.
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Respirator Program. In cooperation with industry,
labor, universities and respirator manufacturers, NIOSH
tests and certifies respirators, performs field
investigations, and conducts research.
Contact: Division of Safety Research.
j'rade Name Ingredients File. This data base includes
ingredient information from the manufacturers of the
nearly 100,000 trade name products. Represented are
chemical and physical agents found to be used in a
sample of about 4,000 worksites.
Contact: Division of Surveillance, Hazard Evaluations,
and Field Studies.
Training Program. NIOSH offers a full schedule of short
courses in industrial hygiene, occupational safety,
industrial toxicology, occupational health nursing, and
occupational medicine.
Contact: Division of Training and Manpower Development.
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CENTER FOR ENVIRONMENTAL HEALTH
Department of Health and Human Services
Public Health Service
Centers for Disease Control
HEADQUARTERS
Centers for Disease Control
Atlanta, Georgia 30333
Organization page 147
Statutory Authorities oage 1 49
Toxics-Related Activities page 151
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The Centers for Disease Control (CDC), under the Authority
of Section 301 of the Public Health Service Act, carries out the
overall mission to lead public health efforts to prevent disease,
disability and death and to enhance the health of the American
people.
In the first major organizational change since 1973, CDC was
reorganized in 1980 to enhance the fulfillment of its mission for
the improvement of disease prevention and health promotion
activities.
The CDC, as reorganized, will carry out its functions
through six operational bureau-level Centers.
The goal of the Center for Environmental Health (CEH), the
CDC component responsible for environmental public health,
including toxic substances activities, is to prevent or control
environmentally-related health problems occurring outside the
workplace. To accomplish this, CEH conducts programs designed to
assist the public health community in the surveillance, investi-
gation, analysis, prevention and control of environmentally
induced health problems such as cancer, birth defects, injuries,
environmental hazards and related chronic diseases. As the focus
within the Department of Health and Human Services (DHHS) for
environmental public health program services and emergency
response, the Center has been authorized to act on behalf of the
Department for the health activities to be conducted under the
Comprehensive Environmental Response, Compensation and Liability
Act of 1980 (Superfund)*. The Center also serves as the
coordinating point in the Public Health Service (PHS) for the
review of Environmental Impact Statements (in accordance with the
National Environmental Policy Act) and for radiation emergencv
planning to better respond to accidents such as the Three Mile
Island nuclear reactor leak.
Located at the Chamblee, Georgia facility of the CDC
complex, the Center's 300 person staff provides for the
administrative, programmatic and laboratory support of a variety
of environmental health programs.
*0n April 25, 1983, the Secretary of Health and Human Services
established within the Public Health Service a new Agency for
Toxic Substances and Disease Registries (ATSDR) which will carry
out the health-related authorities and programs of Superfund.
The new agency will be located in the CDC facility in Atlanta,
Georgia. The Assistant Administrator and other agency staff can
be reached at (404) 452-4111 or FTS-236-4111.
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The Center also provides technical advice and assistance
through a staff of eight Public Health Advisors assigned to the
Environmental Protection Agency (EPA) regional offices to assist
EPA and the State and local public health officials in their
efforts to address toxic chemical spills and waste dump hazards
under the Superfund program.
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GEORGE E. HARDY, JR
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DONALD A. BERRETH
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CENTER FOR
ENVIRONMENTAL
HEALTH
DIRECTOR
VERNONN. HOOK
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ORGANIZATION*
Office of the Director, Superfund Implementation Group
o Coordinates activities of CEH staff members to provide
on-scene medical, technical and epidemiological
assistance to Environmental Protection Agency (EPA),
other Federal agencies, and State and local health
officials in evaluating site contamination and
protection of public health and worker safety.
o Maintains and makes available at the field response
level, current information on the human health risks of
toxic substances.
o As the focal point within DHHS for Superfund activities,
provides coordination of the available scientific
expertise present in a wide variety of PHS programs
including: CDC's National Institute for Occupational
Safety and Health, the National Institute of Health's
(NIH) National Library of Medicine, the DHHS's National
Toxicology Program, and the Food and Drug
Administration.
Chronic Disease Division
o Conducts epidemiological investigations of risk factors
to human health environmental contamination problems.
o Provides technical input into Superfund site assessment
activities.
o Provides consultation to Federal, State and local health
officials on a variety of environmental health problems.
o Carries out genetic research to determine the effect of
toxic chemical exposure on genetic diseases trends.
*NOTE: Only those offices which deal with toxic effects or
toxic-related issues are developed in this section.
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Clinical Chemistry Division
o Provides laboratory support to toxic substances
activities within the Center.
o Provides assistance to State public health laboratories
through the development of analytical methods and
materials for toxicological research.
o Provides support to proficiency testing programs
relating to toxic substances testing.
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Section 301
STATUTORY AUTHORITIES
Public Health Service Act
Provides assistance to conduct and promote
research, investigations, experiments,
demonstrations and studies relating to the causes,
diagnosis, treatment and control and prevention of
physical and mental diseases and impairments in
man.
Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (Superfund)
Executive Order 12316 - delegates authorities for these
sections to the Secretary of HHS.
Sections:
o 104(b) authorizes the President to undertake
investigations, monitoring surveys, testing and other
information gathering to determine the extent of danger
to the public health or welfare....
o 104 (i) establish an agency, to be known as the Agency
for Toxic Substances and Disease Registry. The
Administrator of such Agency shall:
(1) "...establish and maintain a national registry of
serious diseases and illnesses and a national registry
of persons exposed to toxic substances."
(2) "establish and maintain inventory of literature,
research, and studies on the health effects of toxic
substances."
(3) "...establish and maintain a complete listing of areas
closed to the public or otherwise restricted in use
because of toxic substance contamination."
(4) "in case of public health emergencies caused or believed
to be caused by exposure to toxic substances, provide
medical care and testing of exposed individuals...."
(5) "...conduct periodic survey and screening programs to
determine relationships between exposure to toxic
substances and illness. In cases of public health
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emergencies, exposed persons shall be eliqible for
admission to hospitals and other facilities and services
operated by the Public Health Service."
301 (f) "...shall study and, not later than two years
after the enactment of this Act, shall modify the
National Contingency Plan to provide for the protection
of the health and safety of employees involved in
response actions."
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TOXICS-RELATED ACTIVITIES
Birth Defects Monitoring Program. This program was
implemented in" 1974. It maintains current, national surveillance
of birth defects among about 25 percent of U. S. births. Some
150 separate birth defect categories are monitored for incidence
trends. This program will allow the Center to determine the
effect of environmental agents on birth defects occurrence and
will indicate progress or lack of progress in reducing birth
defect occurrence.
Veterans Birth Defects Study (Agent Orange). Agent Orange,
a defolient used in Vietnam, has been suspected of causing birth
defects in children of U. S. Armed Forces exposed to Agent
Orange. This study, a major epidemiologic analytical study, will
assess the possible relationship of birth defects in the
offspring of veterans of service in Vietnam. The study will draw
on the Metropolitan Atlanta Congenital Defects Program (MACnp)
and a data base source for defect cases. The MACDP maintains a
registry of all babies born with birth defects detected near
birth in the five-county metropolitan Atlanta area and provides
an excellent base for studies of this type.
Genetics. The health effects of environmental exposure are
influenced by the unique genetic makeup of each individual.
Environmental factors can induce genetic damages in both somatic
and germ cells. The genetic changes in somatic cells may lead to
cancer, and gene damage in germ cells can result in pollution of
the human gene pool causing increases of genetic diseases in
future generations. The Genetics Laboratory of the Center is
concerned with the quantification of cellular and genetic damage
(chromosome breakage, sister chromatid exchange, chromosomal
fragile sites, cell metabolic assays) resulting from exposure to
environmental agents. Research methods are being applied to a
study of human cells in order to refine, improve and establish
assay systems which will allow detection of human susceptibility
to environmental toxins.
Detection and Measurement of Toxic or Hazardous
Substances?As more toxic chemicals are used by industry and
agriculture, the threat of human exposure becomes greater. The
Center is concerned with this threat and through the Clinical
Chemistry and Toxicology Laboratories is attempting to address
the problem. Low level exposure to chemical agents and the
resultant impact upon human health must be assessed in order to
provide appropriate protection to the community. The mass
spectrometer, recently installed and calibrated at CDC, allows
the Clinical Chemistry Division to detect and measure chemical
substances such as polybrominated biphenyls (PBBs),
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polychlorinated biphenyls (PCB's), dioxins, metals and other
elements at trace levels in biologic samples. Definitive
identification and quantification of trace organic compounds such
as these is the first step in evaluating the impact of toxic
chemical exposure on the human system.
Superfund. Congress, recognizing the need to help States
and local communities address the growing problem of dealing with
toxic chemical spills and waste dump hazards, established the
Comprehensive Environmental Response, Compensation and Liability
Act of 1980. The Act established a fund, through a system of
tariffs on the manufacture of toxic substances, for addressing
these hazardous situations. Under the authority of the Act, DHHS
is responsible for the health aspects of the program, the lead
for which has been delegated administratively to CDC. Within
CDC, CEH, through the Superfund Implementation Group, developed
and is implementing a comprehensive program to address the
environmental hazards posed by these dumps and toxic chemical
spills, utilizing expertise from various PHS agencies. These
activities are being carried out in cooperation with EPA and
other Federal, State and local agencies.
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DEPARTMENT OF LABOR
200 Constitution Avenue NW.
Washington, D.C. 20210
Locator: 202-523-6666
Information: 202-523-7304
The purpose of the Department of Labor is to foster,
promote, and develop the welfare of the wage earners of the
United States, to improve their working conditions, and to
advance their opportunities for profitable employment. In
carrying out this mission, the Department administers: more than
130 Federal labor laws guaranteeing workers' rights to safe and
healthful working conditions; a minimum hourly wage and overtime
pay; freedom from employment discrimination; unemployment
insurance; and workers' compensation. The Department also
protects workers' pension rights; sponsors job training programs;
helps workers find jobs; works to strengthen free collective
bargaining; and keeps track of changes in employment, prices, and
other national economic measurements. As the Department seeks to
assist all Americans who need and want to work, special efforts
are made to meet the unique job market problems of older workers,
youths, minority group members, women, the handicaoped, and other
groups.
A Bureau of Labor was first created by Congress in 1884
under the Interior Department. The Bureau of Labor later become
independent as a Department of Labor without executive rank. It
again returned to bureau status in the Department of Commerce and
Labor, which was created by act of February 14, 1903.
The Department of Labor, ninth executive department, was
created by act approved March 4, 1913.
This publication focuses on the duties and activities of the
Occupational Safety and Health Administration, which is headed by
an Assistant Secretary of Labor for Occupational Safety and
Health.
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ADMINISTRATIVE LAW JUDGES
NAHUNLIII
BENEFITS REVIEW BOARD
ROBERT L.RAMSEY
SECRETARY OF LABOR
RAYMOND J. DONOVAN
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EXECUT
EMPLOYEES COMPENSATION
APPEALS BOARD
E. GERALD LAMBOLEY
UNDER SECRETARY OF LABOR
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Y REAGAN,
KEVOLPE
MARK COWAN, CATH
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EXECUTIVE SECRETARIAL
RUTH MORGENSTERN
DIRECTOR
INFORMATION AND
PUBLIC AFFAIRS
VERNON LOUVIERE
SOLICITOR
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POLICY
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\NJ SECRETARY FOR
NISTRATIONAND
UANAGMENT
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DIRECTOR
WOMEN'S BUREAU
LENORA COLE-ALEXANDER
INSPECTOR GENERAL
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DEPUTY UNDER SECRETARY FOR
EMPLOYMENT STANDARD
ROBERT COLLYER
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DEPUTY UNDER SECRETARY
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LEGISLATION
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COMMISSION
LABOR STATI
JANET NORW
ASSISTANT SECRETARY
VETERAN'S
EMPLOYMENT
AND TRAINING SERVICES
WILLIAM PLOWDEN, JR.
3TANT SECRETARY
NE SAFETY AND
HEALTH
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ASSISTANT SECRETARY
LABOR-MANAGEMENT
RELATIONS
— V —
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OCCDPATIONAL SAFETY AND
HEALTH ADMINISTRATION
Department of Labor
200 Constitution Avenue NW,
Washington, D.C. 20210
Locator: 202-523-6666
Information: 202-523-8151
Organization page 1 58
Statutory Authority page 161
Regulatory Development page 166
Toxics-Related Activities page 168
The Occupational Safety and Health Administration (OSHA) is
the Agency within the U.S. Department of Labor responsible for
administering and enforcing the Occupational Safety and Health
Act of 1970. Under the provisions of the Act, OSHA is to develop
and enforce mandatory job safety and health standards to
"...assure as far as possible [that] every working man and woman
in the Nation [has] safe and healthful working conditions..." and
to:
o Encourage employers and employees to reduce hazards in
the workplace and to implement new or improve existing
safety and health programs.
o Establish "separate but dependent responsibilities and
rights" for employers and employees for the achievement
of better safety and health conditions.
o Establish reporting and recordkeeping procedures to
monitor job-related injuries and illnesses.
o Encourage the development of "fully effective" job
safety and health programs by the States. These
programs' standards must be at least as effective as
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those of the Federal program. (As of June 1983, 24
states or jurisdictions had established their own OSH
programs.)
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DIRECTORATE OF POLICY LEGISLATION, AND REGULATORY ANALYSIS
o Develops and evaluates agency policy in coordination
with other OSHA Directorates.
o Analyzes proposed legislation and Executive Orders to
determine effect upon OSHA programs and prepares
testimony for OSHA witnesses before congressional
committees.
o Advises the assistant Secretary as to proqram options
and alternatives available.
o Coordinates OSHA policies and plans with other Federal
agencies with related programs and coordinates OSHA's
international programs.
o Develops regulatory and economic analyses to support the
standard-setting process and assures compliance with
applicable executive orders, court decisions and other
requirements of law.
DIRECTORATE OF HEALTH STANDARDS PROGRAMS
o Provides workplace standards and regulations to assure
healthful working conditions for the Nation's workers.
o Coordinates, with the Directorate of Technical Support,
the need for studies to evaluate the various
consequences of proposed occupational health standards.
o Maintains liaison with appropriate agencies regarding
research and experiments related to occupational health
standards.
o Provides information about health standards and
rulemaking activities.
*Note: Only those directorates which deal with toxics or
toxics-related issues are discussed in this section,
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DIRECTORATE OF TECHNICAL SUPPORT
o Serves as a source of Agency expertise on scientific,
environmental, and engineering issues involved in the
overall occupational safety and health field.
o Provides medical and epidemiological expertise and
support for other OSHA offices.
o Processes variances from the OSHA standards.
o Provides chemical analyses and instrument calibrations
to the OSHA compliance officers.
o Operates a clearinghouse of occupational safety and
health data (the Technical Data Center).
o Provides rapid response to occupational health related
emergencies at the workplace (Health Response Team).
o Maintains public records containing information
pertinent to OSHA rulemaking actions (Docket Office).
o Provides chemical analyses and instrument calibration to
the OSHA compliance officers.
o Operates a clearinghouse of occupational safety and
health data (the Technical Data center).
o Provides rapid response to occupational health related
emergencies at the workplace (Health Response Team).
o Maintains public record containing information pertinent
to OSHA rulemaking actions (Docket Office).
DIRECTORATE OP FEDERAL COMPLIANCE AND STATE PROGRAMS
o Provides directives on all standards, explaining
compliance with standards.
DIRECTORATE OF FIELD COORDINATION
o Responsible for toxics and toxics-related issues when
questions of enforcement arise.
o Disseminates information about toxic substances to OSHA
field offices.
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FOR FURTHER INFORMATION:
Federal and State Agencies:
Industry and General Public:
Chief, Division of Interagency
^rograms
II. S. Department of Labor--OSHA
200 Constitution Avenue NW.
Room N3628
Washington, D.C. 20210
Phone: 202-523-9296, FTS: 523-9296
Chief, Division of News Media
Service
U.S. Department o>f Labor--OSHA
200 Constitution Avenue NW.
Room N3637
Washington, D.C. 20210
Phone: 202-523-8151
FTS: 523-8151
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STATUTORY AUTHORITIES
The Occupational Safety and Health Act of 1970
Public Law 91-596 29 U.5.C. S 6*51 et seq.
The Occupational Safety and Health Act of 1970 was the
result of a concerted effort by Congress to pass nationwide job
safety legislation. Prior to 1970, Federal authority for
occupational safety and health was confined to a few acts of
limited scope (such as the Walsh-Healy Public Contracts Act,
which covered workers employed on certain Federal contracts, the
McNamara O'Hara Services Contract Act, the Maritime Safety Act,
and the Construction Safety Act). Although a number of States
had modern laws or sufficient resources to administer and enforce
safety and health regulations, some had no plans at all. Before
OSHA, the quality and scope of the regulations as well as the
effort directed toward enforcement a.nd compliance varied widely,
and many States feared that strict adherence to standards would
give them a competitive and economic disadvantage.
The Occupational Safety and Health Act is the first
comprehensive Federal legislation in the field of occupational
safety and health. In general, the Act covers all employers and
their employees in the 50 States, the District of Columbia,
Puerto Rico, the Canal Zone, and all other territories under
Federal Government jurisdiction.
As defined by the Act, an employer is any "person engaged in
a business affecting commerce who has employees, but does not
include the United States or any State or political subdivision
of a State."
Section 19 of the Act specifically delegates responsibility
for Federal employee occupational safety and health to the head
of each Federal agency. This responsibility is comparable to
that of employers in the private sector. If an agency is found
to be neglecting any area of occupational safety and health for
its workers, OSHA may provide advice and assistance in resolving
problems through its Office of Federal Agency Programs.
At this time, 24 States or jurisdictions operate
occupational safety and health plans that cover both State and
local government employees. State and local government employees
of States without such plan.s are excluded from the coverage of
the Act.
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Three new agencies were established by the Act to carry out
the functions of the statute:
o The Occupational Safety and Health Administration within
the Department of Labor, which is responsible for
carrying out most of the Secretary's responsibilities
under the Act.
o The National Institute for Occupational Safety and
Health (NIOSH) within the Department of Health and Human
Services (HHS), which is responsible for conducting
research in occupational safety and health areas for use
by OSHA in the development of health and safety
standards.
o An independent Occupational Safety and Health Review
Commission to adjudicate enforcement cases, review
citations and proposed penalties, establish abatement
dates, etc.
In addition to these agencies, the Act established a 12-
member National Advisory Committee on Occupational Safety and
Health (NACOSH) which meets at least twice a year to advise,
consult with, and make recommendations to the Secretarv on
matters relating to the administration of the Act.
SCOPE OF OSHA ACTIVITIES IN TOXIC SUBSTANCES AREAS
At this time, there are numerous ways in which OSHA
activities affect the issue of toxic substances in the
workplace. These include:
Existing standards; As of June 1983, OSHA had established
standards for many toxic substances found in the workplace.
The object of these standards is to eliminate or reduce
worker exposure to toxic substances, and thereby reduce the
risks of chronic or acute injury in the exposed worker
population. OSHA toxics related standards can be found at 29
CFR 1910.1000, et seq. The standards found at 1910.1000 list
approximately 400 chemicals and classes of substances for
which a permissible exposure limit (PEL) has been
established. Standards that follow 1910.1000 are
individualized standards for specific chemicals, including
some for carcinogens. For example, 1910.1007 is the OSHA
standard for 3,3'-Dichlorobenzidine and its salts. Standards
such as the one at 1910.1007 include exposure limits, but
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also have requirements for engineering controls, maintenance
and decontamination activities, informational signs, worker
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harm to (the) employees." This section may be used
to cite hazards for which there is no current OSHA
standard. A hazard is "recognized" if the
employer's industry recognizes the condition to be
a hazard (shown, for example, by trade magazine
articles about the hazard) or if the employer has
actual knowledge of the hazard (for example, if the
employer has bought respirators specifically
designed to mitigate against exposure to one
substance). The actual presence of the hazard in
the workplace must also have been reasonably
foreseeable. Thus, for example, excess concentra-
tions of a toxic substance in the air would be a
recognized hazard if the presence of the substance
is known or should have been known to the employer
(or is commonly known to the industry as a whole)
and if the actual concentration could have been
detected through the use of sampling devices.
sec. 6(b) Authorizes the Secretary to promulgate occupational
(1-4) safety or health standards with provisions for
public participation in the rulemaking process.
sec. 6(b)(5) Details the development of standards for toxic
materials or harmful physical agents.
sec. 6(b){7) Requires that standards prescribe the use of
appropriate forms of warning, suitable protective
or control equipment, the monitoring of employee
exposure, and medical examinations or tests as mav
be necessary.
sec. 6(c)(1) Directs the Secretary to provide for an immediate,
emergency temporary standard covering employees
exposed to grave danger from exposure to toxic
substances, physically harmful agents, or new
hazards.
sec. 8 Gives OSHA compliance officers (inspectors) the
authority to enter any work area for inspection and
investigation (subject to interpretation of
Marshall vs. Barlows, Inc., Supreme Court
decision).
sec. 9 Authorizes the issuance of a citation to employers
who have violated any rule or standard.
sec. 12 Establishes the Occupational Safety and Health
Review Commission which affirms, codifies, or
vacates citations or proposed penalties.
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sec. 13 Authorizes the Secretary to petition the courts to
restrain imminent danqer situations.
sec. 16 Allows the issuance of variances, tolerances, and
exemptions to the Act.
sec. 17 Sets the conditions for penalties.
sec. 20 Directs the Secretary of Health and Human Services
(a)(2) (HHS) to develop specific plans for research,
demonstrations, and experiments to produce criteria
identifying toxic substances.
sec. 20 Directs the Secretary of HHS to develop criteria
(a)(3) that describe safe exposure levels for toxic
materials and hazardous physical aqents.
sec. 20 Allows the Secretary of HHS to develop requlations
(a)(5) requiring employers to measure, record, and make
reports on employee exposure to substances or
physical aqents which may endanger employee health
or safety.
sec. 20 Directs the Secretary of HHS to provide annually a
(a)(6) "list of all known toxic substances bv generic
family or other useful grouping, and the
concentrations at which such toxicity is known to
occur (Registry of Toxic Effects of Chemical
Substances (RTECS)).
sec. 22 Establishes the National Institute for Occupational
Safety and Health to do research and establish
recommended standards.
Regulatory Options Available Under Statute
o Promulgate occupational safety and health standards,
including emergency temporary standards
o Inspect and investigate hazardous conditions
o Issue citations and proposed penalties
o Petition the courts to restrain imminent danger
situations
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o Approve or reject State plans for administering and
enforcing health/safety programs under the Act
REGULATORY DEVELOPMENT
The development of OSHA health standards is a complex
process. It reauires internal consideration by the agency,
coordination with affected parties, as well as review by the
Department of Labor and the Office of Management and Budget.
While the process itself is complicated, the general policy for
standards development is clearly explained by OSHA's directive on
the Regulation Management System (OSHA Instruction RUL. 1 CH-1,
November 1, 1982). The policy statement for general standards
development activities is quoted below:
The following policies govern standards activities. They are
based on the Occupational Safety and Health Act, as
interpreted by the courts, and on good administrative
practice. They must be adhered to explicitly, except in
those extraordinary circumstances when the Assistant
Secretary personally approves an exception.
A. Each standard must address a demonstrable significant
risk of material health impairment or injury?
B. Alternative approaches, including non-regulatory means,
must be explored to mitigate the adverse effects of the
risk;
C. Each standard must be reasonably necessary and
appropriate to substantially reduce employee risk;
D. Each standard must be shown to be both technically and
economically feasible on an industry-by-industry basis
to the extent practicable;
E. The cost-effectiveness of alternative approaches must be
considered;
F. The most cost-effective approaches which ensure
protection from the risk must be chosen;
G. Facts to support the standard must be developed, with
special attention given to the documentation of the risk
and the technological and economic feasibility of the
standard;
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H. The public must have an early and meaningful opportunity
to participate in the development of each standard.
Affected parties, including States, must be requested to
provide relevant information concerning risk,
feasibility and cost-effectiveness, and all information
obtained must be considered fully when developing each
standard.
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TOXICS-RELATED ACTIVITIES
The following list is adapted from the Unified Agenda
published in the Federal Register on April 25, 1983 (48 FR 18184,
et seq.). Since rulemaking procedures are sometimes slow and
difficult and because timetables are constantly changing,
information about proposed completion dates has not been
included.
ACCESS TO EMPLOYEE EXPOSURE AND MEDICAL RECORDS
The regulation, promulgated in May 1980 [45 PR 35212],
requires employers to preserve and maintain exposure and medical
records pertinent to an employee's occupational exposure to toxic
substances, and to assure access to these records by employees,
designated employee representatives, and OSHA. OSHA has reviewed
the regulation and on July 13, 1982 [47 FR 30420] proposed
certain modifications, including revisions of the definitions of
"toxic substance" and "exposure records," changes in the scope
and application of the regulation and additional trade secret
protection provisions.
ASBESTOS
OSHA is revising this rule because NTOSH and other sources
have provided data to OSHA indicating that the present OSHA
permissible exposure limit (PEL) may not adequately protect
workers from asbestos-related diseases. The revision will
include a change in the PEL and modification of other
requirements to assure that industry compliance is achieved in
the most cost-effective way.
CARCINOGEN POLICY
The Carcinogen Policy describes the criteria and procedures
OSHA will use to identify, classify, and then regulate
carcinogens. The Policy also establishes a process for screening
chemicals and for setting priorities for potential rulemaking
activities. The validity of the scientific criteria set forth in
the Policy and the cost effectiveness of the rule are being
reexamined. The original standard was issued in 1980 before the
Supreme Court "benzene" decision on significant risk.
Thereafter, a final rule deleting provisions of the Carcinogen
Policy that were inconsistent with the benzene decision was
published on 1/19/81 [46 FR 4889]. A" proposal was published on
1/23/81 [46 FR 7402] to permit consideration of alternatives to
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the risk analysis section of the Carcinogen Policy. The proposal
was withdrawn on 3/27/81 [46 FR 19000]. A new advance notice of
proposed rulemakinq was published on 1/5/82 [47 PR 1871 with
comments due by 4/5/82. That document also proposed to stay the
publication of the candidate and priority lists of carcinogenic
substances. The end of the comment period on the proposed stay
of the candidate and priority lists was 2/19/82. A final
decision to stay the lists was published 1/4/83 [48 FR 241],
ETHYLENE DIBROMIDE (EDB)
Since 1970, several independent scientific studies have
concluded that ethylene dibromide (EDB) can cause cancer in
laboratory animals. Tn addition, EDB has been shown to be
mutagenic in several test systems. This evidence raises serious
concern about the adequacy of the current permissible exposure
limits for EDB, which were adopted by OSHA in 1971. OSHA
published an advance notice of proposed ruleraaking for this
chemical on December 18, 1981 [46 FR 61671].
ETHYLENE OXIDE (EtO)
OSHA has announced its intention to conduct rulemaking on
whether to revise the current standard for ethylene oxide (EtO)
because NIOSH and other sources have provided data indicating
that the current permissible exposure limit may not be adequate
to protect worker health. A proposed rule (NPRM) was published
on 4/21/83 [48 FR 1783] .
HAZARD COMMUNICATION
The proposed standard would require chemical manufacturers
to assess the hazards of chemicals which they produce and to
provide information to their employees about these hazards by
means of hazards communication programs, including labels,
material safety data sheets, and training. The original
proposal, published 1/16/81 [46 FR 4412], was withdrawn 2/12/81
[46 FR 12020] to permit further analysis of regulatory
alternatives. A new proposal was published 3/19/82 [47 FR
12092]. Public hearings were held in various locations during
June and July 1982.
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HEALTH HAZARDS OF CHEMICALS IN LABORATORIES
Existing OSHA standards are designed to protect employees
who are engaged in work involving exposure to only a few toxic
chemicals during relatively standardized, continuous, or
repetitive processes. In contrast, laboratory workers are
exposed to a multitude of toxic substances under frequently
changing or unpredictable conditions. OSHA will examine whether
prudent work practices and protective equipment, chosen for the
specific facilities and task, are more effective, feasible and
economical for laboratory work than adhering to OSHA's current
substance-specific exposure standards.
INORGANIC ARSENIC
In 1978, OSHA issued a new regulation reducing the
permissible limit for employee exposure to inorganic arsenic.
Because of the Supreme Court's decision in Industrial Union
Department v. American Petroleum Institute (the "benzene"
decision 448 U.S. 6TT7(iy«U) ) , tne Ninth circuit Court of Appeals
remanded the standard to the Agency to make findings about
whether exposure to inorganic arsenic in the workplace posed a
significant risk. On 4/9/82 [47 FR 15358], OSHA published a
notice reopening the inorganic arsenic rulemaking record for the
purpose of receiving evidence and making findings on the degree
of risk from occupational exposure to arsenic and the
significance of that risk. Public hearings were held 7/13/ -
7/16/82. On 1/14/83 [48 FR 1864], OSHA published a Supplemental
Statement of Reasons for the Final Rule and forwarded its
findings regarding risk to the Ninth Circuit Court. OSHA is
awaiting the Court's decision on this matter.
LEAD
The current standard for occupational exposure to lead was
promulgated in 1978. It sets a PEL of 50 micro>grams of lead per
cubic meter of air [50 ug/m3], and requires the use of feasible
engineering or work practice controls. There are serious
questions concerning significant risk, feasibility, and cost
effectiveness of the standard in certain industries. Therefore,
OSHA has announced its intention to review and reconsider the
regulation. The advance notice of proposed rulemaking [46 FR
22764] asked for comments on such issues as economic and
technological feasibility and cost effectiveness.
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MINE SAFETY AND HEALTH ADMINISTRATION
Department of Labor
4015 Wilson Boulevard
Arlington, VA 22203
Locator: 703-235-1470
Information: 703-235-1565
Organization Page 173
Statutory Authority Page 1 76
The Mine Safety and Health Administration (MSHA) is the
agency within the U. S. Department of Labor responsible for
directing and administering the provisions of the Federal Mine
Safety and Health Act of 1977 (P.L. 95-164) as a means to
eliminate fatalities, reduce the frequency and severity of
accidents, and minimize health hazards in the mining industry; to
ensure compliance with mandatory Federal safety and health
standards; and to promote and improve safety and health
conditions in the Nation's mines through effective education and
training and technical assistance programs. Among the provisions
of the Act, the Secretary of Labor and the Secretary of Health
and Human Services are directed to develop and promulgate
improved mandatory safety and health standards.
-171-
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ORGANIZATION*
Coal Mine Safety and Health
o Serves as the principal advisor to and consults with the
Assistant Secretary on matters and policies pertaining
to the inspection of the Nation's coal mines, mine
conditions and practices, and accident and injury
prevention.
o Provides direction and leadership in the administration
of nationwide coal mine safety and health inspection and
assistance programs through a system of District,
Subdistrict, and Field Offices located in coal-producinq
States.
o Formulates and coordinates basic policies, programs, and
regulations concerning safety and health in the coal
industry.
o Cooperates in the development of coal mine health
criteria and standards in furtherance of Department of
Health and Human Services responsibilities under the
Act.
o Develops new or revised mine safety and health standards
for application to coal mines.
o Develops criteria and methods for ensuring compliance
with coal mine safety and health standards.
o Provides expertise in analyzing existing and potential
safety and health problems in the coal industry.
o Analyzes records and statistics to determine unsafe or
unhealthful conditions and events in coal mines
demanding immediate attention.
Metal and Nonmetal Mine Safety and^ Health
Serves as the principal advisor to and consults with the
Assistant Secretary on matters and policies pertaining
* NOTE: Only those offices which deal with toxics or toxics-
related issues are developed in this section.
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to the inspection of the Nation's metal and nonmetal
mines, mine conditions and practices, and accident and
injury prevention.
o Provides direction and leadership in the administration
of nationwide metal and nonmetal mine safety and health
inspection and assistance programs throuqh a system of
District, Subdistrict, and Field Offices located
throughout the United States and its territories.
»»
o Formulates and coordinates basic policies, programs, and
regulations concerning safety and health in the metal
and nonmetal industries.
o Cooperates in the development of metal and nonmetal mine
health criteria and standards in furtherance of
Department of Health and Human Services responsibilities
under the Act.
o Develops new or revised safety and health standards for
application to metal and nonmetal mines and mills.
o Develops criteria and methods for ensuring compliance
with metal and nonmetal mine safety and health
standards.
o Provides expertise in analyzing existing and potential
safety and health problems in the metal and nonmetal
industries.
o Analyzes records and statistics to determine unsafe or
unhealthful conditions and events in metal and nonmetal
mines demanding immediate attention.
Technical Support
Administers nationwide technical assistance program to
MSHA officials and the mining industry in furtherance of
safety and health in the Nation's mines.
Formulates and coordinates basic policies, programs,
regulations, and standards to ensure the use of safe
equipment and materials in mines and the presence of
healthful conditions in mines and mills.
Conducts engineering studies and surveys on problems in
the mining industry critical to mine safety and health,
and recommends solutions.
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o Gathers, analyzes, and publishes accident, injury and
occupational illness data to improve MSHA's enforcement
proqrams and to stimulate the continuous improvement of
saEety and health in the mininq industry.
o Conducts indepth studies usinq mine information to
define true cause of accidents, injuries, or
occupational illnesses; determines trends and impact;
recommends improvements to the mininq industry.
o Maintains liaison with the Bureau of Mines (BOM),
Department of the Interior, and the National Institute
for Occupational Safety and Health (NIOSH), Department
of Health and Human Services, for the purpose of
planninq, developinq, and monitorinq mine safety and
health research and in disseminatinq and utilizing
research results in MSHA and the mininq industry.
Standards, Regulations and Variances
o Advises the Assistant Secretary, appropriate DOL/MSHA
officials and others on policy and other matters related
to the promulqation of rules, requlations and standards
and the qrantinq of variances.
o Promulqates and publishes rules, requlations and
standards necessary to implement the Federal Mine Safety
and Health Act of 1977.
o Establishes MSHA policies and criteria for draftinq of
requlations and standards and ensures that requlations/
standards are needed.
o Arranges, announces and conducts public hearings and
consultation meetinqs on proposed standards/regulations
and evaluates the comments/findinqs obtained.
o Prepares or coordinates the preparation of environmental
and regulatory impact statements.
o Assists in the development of legislative proposals on
behalf of the Assistant Secretary.
o Coordinates regulatory/standards matters with other
interested Federal, state and local government agencies.
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STATUTORY AUTHORITIES
THE FEDERAL MINE SAFETY AND HEALTH ACT OF 1977
PUBLIC LAW 95-164
KEY SECTIONS OF ACT — TOXICS FOCUS
Section 101(a)(1) Whenever the Secretary, upon the basis of
information submitted to him in writing by an interested person,
a representative of any organization of employers or employees, a
nationally recognized standards-producing organization, the
Secretary of Health and Human Services, the National Institute
for Occupational Safety and Health, or a State or political
subdivision, or on the basis of information developed by the
Secretary or otherwise available to him, determines that a rule
should be promulgated in order to serve the objectives of this
Act, the Secretary may request the recommendation of an advisory
committee appointed under section 102(c). The Secretary shall
provide such an advisory committee with any proposals of his own
or of the Secretary of Health and Human Services, together with
all pertinent factual information developed by the Secretary or
the Secretary of Health and Human Services or otherwise
available, including the results of research, demonstrations, and
experiments. An advisory committee shall submit to the Secretary
its recommendations regarding the rule to be promulgated within
60 days from the date of its appointment or within such longer or
shorter period as may be prescribed by the Secretary, but in no
event for a period which is longer than 180 days. When the
Secretary receives a recommendation, accompanied by appropriate
criteria, from the National Institute for Occupational Safetv and
Health that a rule be promulgated, modified, or revoked, the
Secretary must, within 60 days after receipt thereof, refer such
recommendation to an advisory committee pursuant to this
paragraph, or publish such as a proposed rule pursuant to
paragraph (2), or publish in the Federal Register his
determination not to do so, and his reasons therefor. The
Secretary shall be required to reauest the recommendations of an
advisory committee appointed under section 102(c) if the rule to
be promulgated is, in the discretion of the Secretary, which
shall be final, new in effect or application and has significant
economic impact.
(2) The Secretary shall publish a proposed rule promulgating,
modifying, or revoking a mandatory health or safety standard in
the Federal Register. If the Secretary determines that a rule
should be proposed and in connection therewith has appointed an
advisory committee as provided by paragraph (1), the Secretary
shall publish a proposed rule, or the reasons for his
determination not to publish said rule,- within 60 days following
the submission of the advisory committee's recommendation or the
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expiration of the period of time prescribed by the Secretary in
such submission. In either event, the Secretary shall afford
interested persons a period of 30 days after any such publication
to submit written data or comments on the proposed rule. Such
comment period may be extended by the Secretary upon a finding of
good cause, which the Secretary shall publish in the Federal
Register. Publication shall include the text of such rules
proposed in their entirety, a comparative text of the proposed
changes in existing rules, and shall include a comprehensive
index to the rules, cross-referenced by subject matter.
Section 101(a)(6)(A) The Secretary, in promulgating mandatory
standards dealing with toxic materials or harmful physical agents
under this subsection, shall set standards which most adequately
assure on the basis of the best available evidence that no miner
will suffer material impairment of health or functional capacity
even if such miner has regular exposure to the hazards dealt with
by such standards for the period of his working life.
Development of mandatory standards under this subsection shall be
based upon research, demonstrations, experiments, and such other
information as may be appropriate. In addition to the attainment
of the highest degree of health and safety protection for the
miner, other considerations shall be the latest available
scientific data in the field, the feasibility of the standards,
and experience gained under this and other health and safety
laws. Whenever practicable, the mandatory health or safety
standard promulgated shall be expressed in terms of objective
criteria and of the performance desired.
(B) The Secretary of Health and Human Services, as soon as
possible after the date of enactment of the Federal Mine Safety
and Health Amendments Act of 1977 but in no event later than 18
months after such date and on a continuing basis thereafter,
shall, for each toxic material or harmful physical agent which is
used or found in a mine, determine whether such material or agent
is potentially toxic at the concentrations in which it is used or
found in a mine. The Secretary of Health and Human Services
shall submit such determinations with respect to such toxic
substances or harmful physical agents to the Secretary.
Thereafter, the Secretary of Health and Human Services shall
submit to the Secretary all pertinent criteria regarding any such
substances determined to be toxic or any such harmful agents as
such criteria are developed. Within 60 days after receiving any
criteria in accordance with the preceding sentence relating to a
toxic material or harmful physical agent which is not adequately
covered by a mandatory health or safety standard promulgated
under this section, the Secretary shall either appoint an
advisory committee to make recommendations with respect to a
mandatory health or safety standard covering such material or
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agent in accordance with paragraph (1), or publish a proposed
rule promulgating such a mandatory health or safety standard in
accordance with paragraph (2), or shall publish his determination
not to do so.
Section 101(a)(7) Any mandatory health or safety standard
promulgated under this subsection shall prescribe the use of
labels or other appropriate forms of warning as are necessary to
ensure that miners are apprised of all hazards to which they are
exposed, relevant symptoms and appropriate emergency treatment,
and proper conditions and precautions of safe use or exposure.
Where appropriate, such mandatory standard shall also prescribe
suitable protective equipment and control or technological
procedures to be used in connection with such hazards, and shall
provide for monitoring or measuring miner exposure at such
locations and intervals, in such manner so as to assure the
maximum protection of miners. In addition, where appropriate,
any such mandatory standard shall prescribe the type and
frequency of medical examinations or other tests which shall be
made available, by the operator and at his cost, to miners
exposed to such hazards in order to most effectively determine
whether the health of such miners is adversely affected by such
exposure. Where appropriate, the mandatory standard shall
provide that where a determination is made that a miner may
suffer material impairment of health or functional capacity by
reason of exposure to the hazard covered by such mandatory
standard, that miner shall be removed from such exposure and
reassigned. Any miner transferred as a result of such exoosure
shall continue to receive compensation for such work at no less
than the regular rate of pay for miners in the classification
such miner held immediately prior to his transfer. In the event
of the transfer of a miner pursuant to the preceding sentence,
increases in wages of the transferred miner shall be based upon
the new work classification. In the event such medical
examinations are in the nature of research, as determined by the
Secretary of Health and Human Services, such examinations may be
furnished at the expense of the Secretary of Health and Human
Services. The results of examinations or tests made pursuant to
the preceding sentence shall be furnished only to the Secretary
or the Secretary of Health and Human Services, and, at the
request of the miner, to his designated physician.
Section 101(a)(9) No mandatory health or safety standard
promulgated under this title shall reduce the protection afforded
miners by an existing mandatory health or safety standard.
Section 101(b)(1) The Secretary shall provide, without regard to
the requirements of chapter 5, title 5, United States Code, for
an emergency temporary mandatory health or safety standard to
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take immediate effect upon publication of the Federal Register if
he determines (A) that miners are exposed to qrave danger from
exposure to substances or agents determined to be toxic or
physically harmful, or to other hazards, and (B) that such
emergency standard is necessary to protect miners from such
danger.
(2) A temporary mandatory health or safety standard shall be
effective until superseded by a mandatory standard oromulqated in
accordance with the procedures prescribed in paragraph (3) of
this subsection.
(3) Upon publication of such standard in the Federal Register,
the Secretary shall commence a proceeding in accordance with
section 101(a), and the standards as published shall also serve
as a proposed rule for the proceeding. The Secretary shall
promulgate a mandatory health and safety standard under this
paragraph no later than nine months after publication of the
emergency temporary standards, as provided in paragraph (2).
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DEPARTMENT OF TRANSPORTATION
400 7th Street SW.
Washington, D.C. 20590
Locator: 202-426-4000
Information: 202-426-4000
The Department of Transportation (DOT) is responsible for
issuing and enforcing regulations ensuring the safe
transportation of hazardous materials by all modes of
transport. Hazardous materials include, but are not limited to,
articles used in industry and general commerce such as
explosives, flammable gases and liquids, poisons, corrosives and
radioactive materials, as well as other toxic substances.
There are two administrations within the Department which
have responsibility for the development of regulations and other
activities relating to transportation of hazard materials. The
lead agency is the Materials Transportation Bureau (MTB) of DOT's
Research and Special Programs Administration. The MTR is
responsible for regulations governing all modes of transportation
except bulk shipments by water. Regulations for bulk shipments
by water are the responsibility of the United States Coast
Guard. For the purposes of this publication, the two
administrations—the Materials Transportation Bureau and the
United States Coast Guard--will be covered in separate sections.
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MATERIALS TRANSPORTATION BUREAU
Research and Special Programs Administration
Department of Transportation
400 7th Street SW.
Washington, D.C. 20590
Locator: 202-426-4000
Information: 202-426-2301
Organization page 1 84
Statutory Authority page 187
Regulatory Development page 188
Toxics-Related Activities page 189
In 1974, Congress enacted the Hazardous Materials
Transportation Act which delegated broad authority to the
Secretary of Transportation in all matters concerning the
transportation of hazardous materials. In July 1975, the
Secretary began to make the administrative changes that Congress
authorized in the Act. By secretarial order, he created the
Materials Transportation Bureau (MTB) and made it the lead agency
in the Department of Transportation's (DOT) hazardous materials
transportation safety program.
In the order creating the Bureau, the Secretary delegated to
the Director of MTB the authority to issue all hazardous
materials safety regulations except those relating to bulk
transportation by water. (The U.S. Coast Guard, discussed in the
next section, is responsible for all regulations and activities
relating to bulk transportation by water.) To ensure Department-
wide coordination under the new structure, the Director of MTB
must consult with the other modal administrators within DOT
(Federal Highway Administration [FHWA], Federal Aviation
Administration [FAA], Federal Railroad Administration [FRA] and
the U.S. Coast Guard) before issuing regulations on matters
affecting them.
-182-
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ORGANIZATION*
OFFICE OF OPERATIONS AND ENFORCEMENT
o Plans and performs inspections, testing, reqistration,
and enforcement functions necessary to assume compliance
with MTB hazardous materials transportation and pipeline
safety regulations.
o Develops analyses of impacts of proposed or existinq
regulatory activities.
Information Services Division
o Develops and conducts training and public programs for
dissemination of safety information and standards
requirements.
Hazardous Materials Enforcement Division
o Conducts inspections and investigations to ensure
enforcement of hazardous materials transportation
regulations.
o Processes hazardous material compliance cictions.
OFFICE OF HAZARDOUS MATERIALS REGULATION
o Plans, recommends and develops a national regulatory
program to protect against the risks to life and
property inherent in the transportation of hazardous
materials (other than bulk transport by water).
o Issues Notices of Proposed Rulemakinq (NPRM),
exemptions, and interpretations.
o Reviews and responds to requests for inconsistency
rulings and nonpreemption determinations (in conjunction
with the Office of Chief Counsel).
*NOTE: Only those offices which deal with toxics or toxics-
related issues are developed in this section.
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Standards Division
o Prepares hazardous materials transportation requlations
for issuance or revision.
o Issues interpretations of standards.
o Maintains liaison with other Federal agencies and other
organizations concerning hazardous materials standards.
Technical Division
o Provides technical evaluations of petitions for
rulemaking and exemptions.
o Prepares technical reports on specific aspects related
to the development of hazardous materials transportation
regulations.
Exemptions and Approvals Division
o Evaluates applications for exemptions.
o Operates approvals and registration functions under the
Hazardous Materials Regulations.
OFFICE OF REGULATORY PLANNING AND ANALYSIS
o Provides integrated planning evaluation of requlatory
programs for MTB.
o Defines requirements for and manages the Hazardous
Materials Information System.
o Establishes and maintains an MTB docket and information
service for all hazardous materials and pipeline safety
official matters.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Phone*
Mail Stop
Office of the Director
Office of Operations
and Enforcement
Hazardous Materials
Enforcement Division
Information Services
Division
Office of Hazardous Materials
Regulation
Standards Division
Technical Division
Exemptions and Approvals
Divisions
Office of Regulatory Planning
and Analysis
202-755-9260
202-755-9247
202-755-5894
202-426-2301
202-426-0656
202-426-2075
202-755-4906
202-755-4962
202-472-2648
DMT-1
DMT-10
DMT-12
DMT-11
DMT-20
DMT-21
DMT-22
DMT-23
DMT-60
*FTS numbers are the same
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STATUTORY AUTHORITIES
Hazardous Materials Transpprtation Act
~Public Law 93-633 49 U.S.C. § 1801
The Hazardous Materials Transportation Act (HMTA) was
developed because of the many problems that had been encountered
in the administration of other statutes concerning the
transportation of hazardous materials (Dangerous Cargo Act,
Transportation of Explosives Act, Federal Aviation Act, Federal
Railroad Safety Act).
The goal of HMTA is to "improve the regulatory and
enforcement authority of the Secretary of Transportation to
protect the Nation adequately against the risks to life and
property which are inherent in the transportation of hazardous
materials in commerce."
Key Sections of Act—Toxics Focus
sec. 103 Defines "hazardous materials."
sec. 104 Authorizes the Secretary to designate materials as
hazardous when the transportation of a particular
quantity and form of a material may pose an
"unreasonable risk" to health, safety, or property.
sec. 105 Requires the Secretary to develop regulations that
govern any safety aspect of the transportation of
hazardous materials.
sec. 106 Authorizes the Secretary to establish criteria for
handling hazardous materials.
sec. 107 Provides for exemptions and exclusions from the
Act.
sec. 111 Allows the Secretary to petition the courts for the
suspension or restriction of the transportation of
a hazardous material which poses an "imminent
hazard."
sec. 112 Preempts State and local requirements that are
inconsistent with the Act or any regulation issued
under the Act.
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Regulatory Options Available Under Statute
o Can require special packaging, handling, labeling,
placarding, routing, or other actions necessary to
ensure the safe transportation of hazardous materials,
o Can petition the courts to suspend or restrict the
transportation of hazardous material which poses an
imminent hazard.
REGULATORY DEVELOPMENT
REGULATORY PROCESS
1. A petition to issue, amend, or repeal a regulation is
received or is proposed as a result of internal action.
2. All activity regarding the proposed rule must be
coordinated with the modal administration affected by
the rule (Federal Highway Administration (FHWA), Federal
Aviation Administration (FAA), Federal Railroad
Administration (FRA), U.S. Coast Guard (USCG)).
3. Depending on the complexity of the rule, the Bureau may
publish an Advance Notice of Proposed Rulemaking (ANPRM)
in the Federal Register. Otherwise, a Notice of Proposed
Rulemakingis published and comments are solicited.
4. All comments received as well as the recommendations of
any technical advisory group established for the purpose
of reviewing the rule are considered.
5. The Director may initiate any further rulemaking
proceedings that he deems necessary.
6. The final rule is prepared, reviewed by the Chief
Counsel (Research and Special Programs Administration)
and then submitted to the Director for his
consideration.
7. If the Director adopts the regulation, it is published
in the Federal Register.
EXISTING REGULATIONS
Hazardous Materials Transportation Act
Hazardous Materials Regulations 49 CFR 171-179
(Subchapter C)
Procedural Regulations 49 CFR 106-107
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TOXICS-RELATED ACTIVITIES*
Compliance Enforcement Program
The Department's Compliance Enforcement Program has two main
objectives: (1) to reduce the number of transportation
incidents, and (2) to minimize the risk of catastrophic
occurrences resulting from the violation of hazardous materials
regulations. Each modal administration (FAA, FHWA, FRA, U.R.
Coast Guard) retains inspection and enforcement authority over
its modal carriers, while the MTB provides guidance and technical
support to ensure uniformity in the interpretation and
application of the regulation.
Research and Development Program
The Department utilizes the services of a number of Federal
and private research organizations to supply the technical data
needed to support the development, modification, compliance, and
enforcement of hazardous materials regulations.
*Included are those activities identified as toxics-related from the information
provided by each agency at the time of publication. It is recognized that some
activities may have inadvertently been omitted. Please bring any such omissions or
new additions to the attention of the Office of Pesticides and Toxic Substances,
Chemical Coordination Staff.
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UNITED STATES COAST GUARD
2100 Second Street SW
Washington, D.C. 20593
Locator: 202-426-4000
Information: 202-426-2158
Organization Page 192
Statutory Authority Page 198
Regulatory Development Page 200
Toxics-Related Activities Page 201
The United States Coast Guard (USCG) has been involved with
the transportation of hazardous materials since 1852 when the
Steamship Inspection Act was passed. This Act specified that
hazardous materials were to be stowed away from boilers on
passenger vessels. The ensuing years saw the passage of a number
of other Acts such as the Tank Vessel Act of 1936, which
subjected tank vessels carrying bulk cargoes to various
inspection, licensing, and operating requirements; and the
Magnuson Act of 1950, which gave the Coast Guard authority
regarding the supervision of cargo loading and storing,
inspection of vessels, and control of ship movements under
specified conditions.
The pollution prevention role of the Coast Guard was
expanded with the passage of the Ports and Waterways Safety Act
of 1972 as amended by the Port and Tanker Safety Act of 1978.
This Act was designed to promote the safety of ports, harbors,
waterfront areas, and navigable waters of the United States.
There is also authority for enforcement of port safety under the
Espionage Act (1917).
Currently, the Coast Guard has hazardous materials
transportation and safety-related responsibilities under the
Federal Water Pollution Control Act, 1972, as amended (the Clean
Water Act amendments), the Outer Continental Shelf Lands Act, as
amended 1978, the Deepwater Port Act (1974) and the Comprehensive
Environmental Response, Compensation and Liability Act, 1980
(CERCLA).
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UNITED STATES COAST GUARD
STRATEGIC PLANNING
COUNCILIG CS)
CHIEF ADMINISTRATIVE
LAW JUDGE (G CJ)
CONGRESSIONAL AFFAIRS
STAFF IG-CC)
MARINE SAFETY COUNCIL (G-CMC)
FOREIGN POLICY ADVISOR (G-CP)
(INTERNATIONAL AFFAIRS STAFF [G CPU)
MEDICAL ADVISOR IG-KI
MASTER CHIEF PETTY OFFICER
OF THE COAST GUARD IG CMCPO)
ADMINISTRATIVE SERVICES
DIVISION IG-CAS)
MANAGEMENT ANALYSIS
DIVISION IG CMA)
BUDGET DIVISION IG-CBU)
OFFICE OF BOATING, PUBLIC. AND
CONSUMER AFFAIRS IG Bl
CONSUMER AFFAIRS AND
ADMINISTRATIVE STAFF (G-BA)
POLICY PLANNING AND
EVALUATION STAFF (G-BP)
AUXILIARY DIVISION (G BAU)
BOATING TECHNICAL DIVISION JG-BBT)
BOATING EDUCATION AND
LIAISON DIVISION IG-BEL)
PUBLIC AFFAIRS DIVISION (G-BPA)
GOVERNMENTAL AFFAIRS
DIVISION IG-BGA)
OFFICE OF HEALTH SERVICES IG-K)
-
1
4
PLANNING STAFF IG K II
MEDICAL ADMINISTRATION
DIVISION IG-KMA)
OPERATIONAL MEDICINE
DIVISION (G KOMI
PHYSICAL DISABILITY
EVALUATION DIVISION (G-KDE)
OFFICE OF OPERATIONS (G D)
-
1
1— 1 PLANS & PROGRAM STAFFIG OP)
INTELLIGENCE & SECURITY
DIVISION IG-OIS)
MILITARY READINESS
DIVISION IGOMR]
OPERATIONAL LAW
ENFORCEMENT DIVISION IG-OLE)
SEARCH & RESCUE DIVISION IG-OSR]
ICE OPERATIONS DIVISION (G 0101
THE COMMANDANT IG Cl
VICE COMMANDANT IG CV1
DEPARTMENT OF TRANSPORTATION
U S COASTGUARD
HEADQUARTERS ORGANIZATION
JUNE 1382
OFFICE OF CIVIL RIGHTS (G H)
CHIEF OF STAFFIG CCS)
OFFICE OF RESEARCH &
DEVELOPMENT (G-D)
CHIEF SCIENTIST IGDS)
PLANS & EVALUATION
STAFF (G-DP)
SYSTEMS
TECHNOLOGY DIVISION (G-DST)
MARINE SAFETY
TECHNOLOGY DIVISION (G DMT)
OFFICEOF CHIEFCOUNSELIG L)
COURT OF MILITARY REVIEW fG-L-3)
CLAIMS & LITIGATION
DIVISION IG-LCL)
GENERAL LAW DIVISION (G-LGL)
LEGAL ADMINISTRATION
DIVISION IG-LLA)
LEGISLATION DIVISION (G LLXI
MARITIME & INTERNATIONAL
LAW DIVISION (G-LMI)
MILITARY JUSTICE DIVISION (G-LMJ)
PROCUREMENT LAW DIVISION (G-LPL)
REGULATIONS & ADMINISTRATIVE
LAW DIVISION (G LRA)
OFFICE OF PERSONNEL [G-P}
PLANNING AND
EVALUATION STAFF IG-P-II
CIVILIAN PERSONNEL DIVISION IG PCI
ENLISTED PERSONNEL DIVISION (G-PE)
OFFICER PERSONNEL DIVISION IG POI
PERSONNEL SERVICES DIVISION IG-PS1
RECRUITING DIVISION (G-PMRI
TRAINING 0 EDUCATION
DIVISION IG PTE)
OFFICE OF ENGINEERING IG E]
-
AERONAUTICAL ENGINEERING
DIVISION IG-EAE]
CIVIL ENGINEERING DIVISION IG ECVI
NAVAL ENGINEERING DIVISION IG-ENE)
OCEAN ENGINEERING DIVISION {G-EOEI
OFFICE OF MERCHANT
MARINE SAFETY (G Ml
INFO & ANALYSIS STAFF IG MA]
PLANNING STAFF IG-MPI
TRAVELING INSPECTOR AND
TRAINING STAFF IG-MT)
MARINE TECHNICAL AND HAZARDOUS
MATERIALS DIVISION IG-MTH]
MARINE INVESTIGATION
DIVISION IG MMII
MERCHANT VESSEL DOCUMENTATION
DIVISION IG MVDI
MERCHANT VESSEL INSPECTION
DIVISION IG-MVII
MERCHANT VESSEL PERSONNEL
DIVISION IG MVP)
OFFICE OF RESERVE IG-R)
-
RESERVE ADMINISTRATION
DIVISION (G RAt
RESERVE PROGRAMS DIVISION IG-RP)
RESERVE TRAINING DIVISION IQ-RT)
OFFICE OF COMMAND, CONTROL
AND COMMUNICATIONS 1G-T)
-
1-
TECHNICAL ADVISOR IG-TTI
GENERAL SUPPORT STAFF |G TAI
HO COMMAND CENTER IG-TQCI
DATA SYSTEMS DIVISION [G-TDSI
ELECTRONIC SYSTEMS DIVISION IG-TESI
PLANS AND POLICY DIVISION IG-TPP)
CIVILIAN EQUAL OPPORTUNITY
DIVISION IG HCEI
MILITARY EQUAL OPPORTUNITY
DIVISION [G-HMEI
PROGRAMS DIVISION IG CPAI
PLANS EVALUATION
DIVISION (G CPE)
SAFETY PROGRAMS
DIVISION IG CSP]
OFFICE OF COMPTROLLER IG f\
1
1 1 PLANNING AND
^^ EVALUATION STAFF IGFP)
— ACCOUNTING DIVISION (GFAC1
— PROCUREMENT DIVISION IG FCP)
NAFA MANAGEMENT
"" DIVISION (G FNM)
LOGISTICS & PROPERTY
" DIVISION IG FLP)
— PERSONAL SUPPORT DIVISION IGFPS)
— QUALITY ASSURANCE DIVISION IGFQAI
OFFICE OF NAVIGATION IG N)
-
1
1 I NAVIGATION LIAISON AND
™ COORDINATION STAFFIG NP)
BRIDGE ADMINISTRATION
DIVISION (G NBR)
RADIONAVIGATION DIVISION IG-NRN)
SHORT RANGE AID TO NAVIGATION
DIVISION 1G-NSR)
OFFICEOF MARINE
ENVIRONMENT & SYSTEMS IG-W)
-
1
LJ PLANNING, COORDINATION, AND
| ANALYSIS STAFF (G WP)
PREVENTION AND ENFORCEMENT
DIVISION IG WPE)
ENVIRONMENTAL RESPONSE
DIVISION IG WER)
WATERWAYS MANAGEMENT
DIVISION (G-WWMJ
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ORGANIZATION*
MARINE SAFETY COUNCIL (G-CMC)
Manages and monitors the Coast Guard's program for the
development and implementation of regulations affecting
the public including those related to toxic substances.
Is composed of seven members-The Chief Counsel, and the
Chiefs of the Offices of Merchant Marine Safety,
Operations, Engineering, Navigation, Boating, Public and
Consumer Affairs, and Marine Environment and Systems.
OFFICE OF RESEARCH AND DEVELOPMENT (G-D)
Plans, directs, and coordinates a program of research,
development, testing, and evaluation for the Coast Guard
aimed at improving or devising new techniques, methods,
equipment, etc.
Conducts a program to develop equipment and methods for
responding to discharges of hazardous chemicals into
waters of the United States.
0 Develops and maintains the Chemical Hazards Response
Information System.
OFFICE OF CHIEF COUNSEL (G-L)
0 Renders advisory services, opinions, and decisions on
all matters of a legal nature.
0 Serves as Chairman of the Marine Safety Council.
Regulation and Administrative Law Division (G-LRA)
0 is responsible (under the direction of the Chief
Counsel) for the legal sufficiency of the Coast Guard's
public rules and other regulatory matters.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
-192-
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Reviews rules and regulations for their application to
the Coast Guard.
Maritime and International Law Division
0 Is responsible (under the direction of the Chief
Counsel) for advisory services, opinions and decisions
on all toxic and toxic-related matters of a leqal
nature.
OFFICE OF MERCHANT MARINE SAFETY (G-M)
0 Oversees the program for prevention of marine
casualties.
0 Responsible for the inspection of merchant vessels for
compliance with safety standards.
Marine Technical and Hazardous Materials Division (G-MTH)
0 Initiates or reviews regulations relating to hazardous
cargo containment, handling and storage.
0 Studies data on toxicity and other hazards to determine
the safety precautions necessary when handling dangerous
cargo.
0 Identifies and monitors research projects in hazardous
material safety.
0 Maintains liaison with other Federal agencies and
represents the Coast Guard on advisory committees
involved in requlating hazardous material and dangerous
cargo.
0 Administers a program for certification of foreign
chemical and gas tanker vessels.
Cargo and Hazards Branch (G-MTH-3)
0 Conducts the hazard analysis of chemicals prior to
authorization for shipment in bulk.
-193-
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Initiates research to assiqn toxicity, flammability and
reactivity hazards to chemicals being or likely to be
carried by water, and to minimize crew exposure to
hazardous materials during transport and transfer
operations.
0 Reviews toxicological data from a variety of sources for
possible incorporation into Coast Guard regulations.
Merchant Vessel Inspection Division (G-MVI)
Develops and enforces safety standards for vessels.
0 Issues standards for the protection of merchant seamen
from exposure to chemicals.
Merchant Vessel Personnel Division (G-MVP)
0 Establishes standards for licensing of U.S. merchant
seamen and levels of staffing for U.S. vessels.
0 Is currently upgrading the qualifications for tankerman
endorsement to more fully address operations of
hazardous materials.
OFFICE OF MARINE ENVIRONMENT AND SYSTEMS (G-W)
8 Administers a coordinated Coast Guard environmental
program.
0 Manages a comprehensive ports and waterways system
encompassing all aspects of marine transportation except
vessel safety.
Environmental Response Division (G-WER)
0 Provides Department of Transportation membership on the
National Response Team.
0 Plans, coordinates, implements, and monitors a program
to control pollution of the marine environment in
accordance with statutory requirements and the policies
of the Department of Transportation.
-194-
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Pollution Response Branch (G-WER-2)
0 Plans, develops, and implements the Coast Guard Proqram
for pollution removal from the marine environment.
0 Manages and coordinates the National Strike Force.
Environmental Coordination Branch (G-WER-3)
0 Establishes and maintains liaison with appropriate
Headquarters and Departmental offices to ensure
coordination of Coast Guard's environmental program.
0 Represents the Coast Guard at meetings involvinq
governmental agencies, the public and private sectors,
and international organizations regarding general
environmental matters.
Port and Environmental Safety Division (G-WPE)
0 Manages the Coast Guard Port Safety/Security Program for
ports and navigable waterways of the United States.
Port and Environmental Safety Enforcement Branch (G-WPE-1)
0 Develops, manages, and monitors functions administered
by the Captains of the Port and Port Safety stations
including the administration of dangerous cargo
regulations.
0 Directs the Coast Guard's program to prevent and
investigate pollution discharges into the marine
environment.
0 Plans, develops, and implements Coast Guard programs to
detect pollution in the marine environment.
Environmental Impact Branch (G-WP-4)
0 Plans, directs, and monitors a Coast Guard program to
comply with the National Environmental Policy Act of
1969 (NEPA) and related legislation.
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Plans, directs, and monitors a Coast Guard program
concerned with the abatement of pollution from Coast
Guard facilities (vessels, vehicles, aircraft,
structures, and shore stations).
National Response Center Staff (G-TGC-2)
0 Manages and operates the National Response Center to
support the National Resoonse Team in accordance with
the National Oil and Hazardous Substances Pollution
Contingency Plan.
Division/Office
Phone*
Mail Stop
U.S.C.G./EPA Liaison Officer
Marine Safety Council
Office of Research and Development
Office of Chief Counsel
Regulations and Administrative
Law Division
Maritime & International Law
Division
Office of Merchant Marine Safety
Marine Technical and Hazardous
Materials Division
Cargo and Hazards Branch
Merchant Vessel Inspection
Division
Merchant Vessel Personnel
Division
Office of Marine Environment
and Systems
Environmental Response Division
202-755-0770
202-426-1477
202-426-1040
202-426-1616
202-426-1534
202-426-1527
202-426-2200
202-426-2167
202-426-1577
202-426-2178
202-426-1500
202-426-2007
202-426-2010
(G-CMC)
(G-D)
(G-L)
(G-LRA)
(G-LMI)
(G-M)
(G-MTH)
(G-MTH-3)
(G-MVI)
(G-MVP)
(G-W)
(G-WER)
-196-
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Pollution Response Branch 202-426-9568 (G-WER-2)
Environmental Coordination Branch 202-426-
9573 (G-WER-3)
Information Analysis Branch 202-426-9571 (G-WER-4)
National Response Center Staff 202-426-2675 (G-TGC-2)
Environmental Impact Branch 202-426-3300 (G-WP-4)
Port and Environmental Safety 202-426-1934 (G-WPE)
Division
Port and Environmental Safetv 202-755-7917 (G-WPE-1)
Enforcement Branch
*FTS numbers are the same
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STATUTORY AUTHORITIES
Port and Tanker Safety Act
Public Law~9"5~-474; 46 U.S .C . §39 1 a (vessels)
33 U.S.C.S1221 (ports)
The Port and Tanker Safety Act is designed to provide
adeauate protection of the Nation's coastal areas and marine
environment. It allows the Secretary of the Department in which
the Coast Guard is operating (currently the Department of
Transportation) to set standards of vessel design and safety and
to establish measures for the safe transportation of potentially
dangerous cargoes, including toxic substances. The Secretary is
authorized to investigate any incidents involving damage to
marine areas or ecosystems, and to ensure compliance with the
provisions of the Act.
Key Sections of Act - Toxics Focus
33 U.S.C.1223, 1225 Authorizes Secretary to establish
regulations and procedures for
the safe storage and
transportation of toxic
substances on vessels in
navigable U.S. waters.
33 U.S.C.1227 Permits Secretary to investigate
accidents causing damage to the
environmental quality of ports,
harbors, or other coastal areas.
33 U.S.C.1231 Allows Secretary to establish
regulations and other standards
to enforce the Act.
46 U.S.C.391a Defines and sets standards for
the transport of liquid cargo in
bulk.
46 U.S.C.391a(6) Permits Secretary to establish
rules governing vessel design and
maintenance.
46 U.S.C.391a(6) Provides for consultation with
other Federal agencies involved
in marine environmental
protection.
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Regulatory Options Available Under Statute
0 Control vessel traffic and operation
0 Establish vessel safety requirements
0 Set standards for transport of danqerous cargoes
0 Limit vessel activity in defined waterfront safety zones
0 Restrict the transportation of hazardous materials (in
bulk cargo from navigable waters)
0 Ban the transportation of hazardous materials in bulk
cargo from navigable waters
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
1. All regulations projects are proposed by the appropriate
program office. The proposal is forwarded to the Marine
Safety Council for its approval.
2. All rulemakinq is conducted pursuant to the informal
rulemaking procedures of the Administrative Procedure Act [5
U.S.C.551-553]. The advance notice of proposed rulemaking,
notice of proposed rulemaking, and supplemental notice of
proposed rulemaking are utilized. Public hearings are held
only for the more important rulemakings.
3. The majority of final rules are cleared through the program
office. For significant rulemaking, clearance by the
Commandant and Secretary of the Department of Transportation
is required.
4. All rules dealing with toxic substances are subject to the
clearance provisions of Executive Order 12291 of February 17,
1981.
EXISTING REGULATIONS
Port and Tanker Safety Act
(ports) 33 U.S.C.JH221 33 CFR 126, 160-165
(vessels) 46 U.S.C.§391a 33 CFR 157, 164; 46 CFR
30-40, 150-154
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TOXICS-RELATED ACTIVITIES*
Marine Transport of Hazardous Cargoes - General
Statute: 33 U.S.C.S1321; 46 U.S.C.S391 a,
49 U.S.C.S1803
Regulations: 46 CFR 146 thru 154 (Subchapter "N" and "O")
Responsible Office: G-MTH (Marine Technical and Hazardous
Materials Division)
Description:
4J5 CFR SURCHAPTER N - DANGEROUS CARGOES
a. 46 CFR 147 Regulations governing use of dangerous
articles as ships stores and supplies on
board vessels.
b. 46 CFR 147A Interim regulations for shipboard
fumigation.
c. 46 CFR 148 Carriage of solid hazardous materials in
bulk.
46 CFR SUBCHAPTER 0 - CERTAIN BULK DANGEROUS CARGOES
a. 46 CFR 150 Compatibility of cargoes and operational
requirements for bulk liquid hazardous
waste cargoes.
b. 46 CFR 151 Regulates the carriage of bulk liquid
hazardous cargoes by barge.
c. 46 CFR 153 Regulates the carriage of hazardous liquids
by tank vessel.
d. 49 CFR 154 Regulates carriage of liquified gases by
tank vessels.
Transfer Operations Involving Bulk Liquid Hazardous Substances
Statute 33 U.S.C.S1321
Regulations: 33 CFR 126, 154, 155, 156; 40 CFR 117
Responsible Office: G-WER (Marine Environmental Protection
Division),
G-WPE (Port Safety and Law Enforcement
Division)
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Description: 40 CFR 117 designates the hazardous substances
regulated under this program (not all listed permitted to be
shipped in bulk).
New Items: Streamlining, consolidation, and addition of
hazardous substances to the present regulations (which speak
only to oil) are in progress. Development of a comprehensive
regulatory packaae to address transfer operations of
hazardous substances.
Arrival and Departure of Vessels
Carrying Certain Dangerous Cargoes
Statute: 33 U.S.C.§§1223, 1228; 46 U.S.C.S391a
Regulations: 33 CFR 161
Responsible Office: G-WPE (Port Safety and Law Enforcement
Division)
Description: 33 CFR 161; requires advance notice of the arrival
or departure of vessels carrying "cargoes of particular
hazard" and defines cargoes of particular hazard.
New Items:
a. To permit advance contingency planning by persons
responsible for safety of ports, prior to port entry,
vessels will be required to report conditions which may
adversely affect the operation of the vessel.
b. IMO is studying additional requirements for vessels in
international waters to report marine casualties to the
nearest country. Regulations implementing the IMO
Convention will be added to 33 CFR 151 upon
ratification.
c. These regulations are being shifted to Subpart C, 33 CFR
160. The cargoes covered are being reviewed for
deletions or additions.
Ocean Dumping Surveillance
Statute: 16 U.S.C.§1431; 33 U.S.C.SS1401, 1417, 1418
Regulations: 33 CFR 158; 40 CFR 220 thru 229
Responsible Office: G-WER (Environmental Response Division)
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Description:
a. 40 CFR 220 thru 229 describe the permit system
established by EPA to regulate ocean dumping of all
materials except dredged material.
b. 33 CFR 323-325 describes the permit system established
by the Army Corps of Engineer (ACOE) to regulate ocean
dumpinq of dredged material.
New Items: Dumping surveillance regulations were proposed during
December 1979.
Inspection of Foreign Flag Tank Ships
Statute: 33 U.S.C.S1321; 46 U.S.C.§391a; 49 U.S.C.§1803
Regulation: 46 CFR 2
Responsible Office: G-MVI (Merchant Vessel Documentation
Division)
Description: The series of tank explosions which occurred in the
winter of 1976-77 prompted an immediate and singularly
successful unilateral inspection program of cargo-handling
systems on foreign flag tank ships entering U.S. ports.
Response to Spills of Oil or Hazardous Substances
Statute: 33 U.S.C.S1321 (FWPCA); 42 U.S.C.S9615 (CERCLA)
Regulations: 33 U.S.C. 153; 40 CFR 110, 116, 117, 300 See 37 F.R. 31180,
July 16, 1982
Responsible Office: G-WER (Environmental Response Division)
Description:
a. 40 CFR 110 defines oil or "harmful ouantity".
b. 40 CFR 116 designates hazardous substances.
c. 40 CFR 117 defines reportable quantities of hazardous
substances.
d. 40 CFR 300 is the Revised National Contingency Plan.
e. 33 CFR 153 is the USCG implementation of the Clean Water
Act in regard to response activity under the National
Contingency Plan, and management of the pollution
revolving fund.
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New Items:
1 .
2.
3.
The National Contingency Plan was revised on March 19,
1980, to conform to the Clean Water Act (as amended in
1977). See 45 FR 17832.
The National Contingency Plan was revised on July 16,
1982 (37 F.R. 31180) pursuant to section 105 of CERCLA
and became effective on December 10, 1982.
E.G. 11735 was amended
The amendment concerns
respond to substantial
on May 10,
delegation
threats.
1983 by E.G. 12418.
of the authority to
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ENVIRONMENTAL PROTECTION AGENCY
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-4361
EPA was created throuqh an executive reorganization plan
designed to consolidate certain Federal Government environmental
activities into a single agency. The plan (Reorganization Plan
No. 3 of 1970) was sent by the President to Congress on July 9,
1970, and EPA was established as an Independent Agency in the
Executive Branch on December 2, 1970.
EPA was formed by combining 15 components from 5 departments
and independent agencies. Water quality responsibilities were
transferred from the Interior Department (the Federal Water
Quality Administration) and the (former) Department of Health,
Education, and Welfare* (the Bureau of Water Hygiene). Other
activities transferred from HEW included the National Air
Pollution Control Administration and the Bureau of Solid Waste
Management.
In addition, EPA acquired the Department of Agriculture's
authority to register pesticides and to regulate their use; the
Food and Drug Administration's authority to set tolerance levels
for pesticides which occur in or on food and to monitor
compliance with those limits; and a portion of the Department of
Interior's pesticides research program.
Finally, EPA assumed some of the authorities of the former
Atomic Energy Commission and HEW for setting environmental
radiation protection standards. The Agency also absorbed the
duties of the Federal Radiation Council.
*As of May" 4, 1980, HEW was divided into two new departments—the
Department of Health and Human Services and the Department of
Education.
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Organizationally, EPA is headed by an Administrator, who is
supported by a Deputy Administrator and six Assistant
Administrators (see chart). Three of the Assistant
Administrators are responsible for "functionalized" activities,
i.e., activities which cut across all media programs. These
activities are planning and management, enforcement, and research
and development. The remaining program activities have been
grouped under three other Assistant Administrators on a media or
pollutant basis, e.g., water pollution, air pollution, solid
waste, toxic substances, etc. The activities carried out by
these Offices are primarily policy development, preparation and
promulgation of regulations, and support and evaluation of
regional activities.
Eight Offices within EPA are highlighted in this
publication. They are the Office of Pesticide Programs and the
Office of Toxic Substances which are located within the Office of
Pesticides and Toxic Substances; the Office of Water Regulations
and Standards and the Office of Drinking Water, located within
the Office of Water; the Office of Emergency and Remedial
Response and the Office of Solid Waste located within the Office
of Solid Waste and Emergency Response; and the Offices of Air
Quality Planning and Standards and Mobile Sources* which are part
of the Office of Air, Noise, and Radiation.
Included in this introductory section on EPA is a
description of the regulatory development process within the
Agency. Since this process is used by all of the EPA Offices, it
was decided to place the description here and refer to it in the
Regulatory Development Section of each Office.
*NOTE: These two Offices are treated in one section, whereas the other Offices are
developed in separate sections.
-206-
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REGULATORY DEVELOPMENT
At the onset of the regulatory development process, all new
EPA regulations are classified as "Major," "Significant," or
"Minor." (See Figure 1). This classification is done by the
Office of Policy and Resource Management (OPRM) in consultation
with the lead office. Over half of the current regulations are
labeled "Significant" and follow the uniform development process
outlined below. Regulations classified as "Major" follow that
same process. Both classes of regulations include provisions for
public review and comment.
Chart 1
Definitions of Terms Used in the EPA Regulatory Development
Process.
Significant Regulations
All regulations are presumed to be Significant if there are
important economic consequences for the public, important
public health issues, inter-media issues, effects on the
administration or operation of other offices or broad
geographic effects.
Major Regulations
A regulation will be classified as Major if it is likely to
meet the definition in Section One of Executive Order
12291. Major regulations require an economic impact
analysis and will receive extra attention from senior Agency
management.
Minor Regulations
These are regulations which are not subject to formal
regulatory development procedures. They include:
regulations that are administrative or procedural in nature
and do not affect certain aspects of EPA programs; minor
amendments to existing regulations; regulatory actions
resulting from detailed Congressional mandates; regulations
which the lead office Assistant Administrator designated as
not sufficiently important to require formal development
procedures; EPA actions on regulations developed by State
and local governments; and certain pesticide-related
actions.
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Lead Office
The Assistant Administrator for the relevant proqrara (the
Office of Air, Noise, and Radiation, the Office of
Pesticides and Toxic Substances, the Office of Water, and
the Office of Solid Waste and Emergency Response) has the
lead responsibility for initiating and writing most new
regulations.
Senior Management
This group includes the Administrator, Deputy Administrator,
and Assistant Administrators.
Work Groups
This is a group of specialists drawn from various offices
within EPA to advise and assist the lead office in preparing
each regulation and its support documents.
Steering Committee
This is a continuing group representing the six Assistant
Administrators. It oversees the mechanics of the process
and conducts the first internal review of materials prepared
by the lead office.
Red Border Review
This is an internal review by the offices of two Assistant
Administrators (Office of Policy and Resource Management and
Office of Legal and Enforcement Counsel). Any program or
Regional Office may be included if they express concern
about a particular review.
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Figure 1. Priority Classification for EPA Regulations
ALL EPA REGULATIONS
SIGNIFICANT
REGULATIONS
Major
Regulations
I Minor
j Regulations
I
Regulations are produced in a multistage process: (1)
approval stage, in which the lead office submits a start action
request to OPRM, (2) preparation of a development plan, (3)
preparation of a decision-package, which also includes writing
the preamble and regulation, and (4) conducting a three-part
internal review. Each regulation goes through Steering Committee
and Red Border reviews twice, first as a proposal and again as a
final. The regulatory development process within EPA is
summarized in Figure 2.
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Figure 2. Stages in the Development of Significant EPA Regulations
(1) Start work.
• Send
notification
form
• Invite work
group members
• Schedule a
development
plan
^^
(2) Prepare a
development
plan
• Classify
regulations
as Major
or Routine
• Identify purpose,
issues, major
alternatives
• Plan external
participation
measures
• Describe
analyses including
Regulatory
Analysis when
required
• Establish
development
and publication
schedules
• Notify interested
and affected parties
of development plan
^
(3) Prepare a
decision pacKagc
• Involve public,
State/local
officials
• Analyze effects.
-Environmental
-Economic
-Urban
— Resource
-Paperwork
• Write rule,
preamble
• Recommend
action to
Administrator
»-
(4} Conduct
internal reviews
• Conduct Steering
Committee review
• Conduct "Red
border" review
by senior
management
• Conduct final
review b>
Administrator
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OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
Environmental Protection Agency
401 M Street SW.
Washington, B.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
The Office of Pesticides and Toxic Substances (OPTS) advises
the Administrator of EPA on all matters regarding the assessment,
regulation, and control of pesticides and toxic substances and
manages the Agency's pesticides and toxic substances program
under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Toxic Substances Control Act (TfiCA).
The activities of OPTS will be treated in two separate
sections of this directory. One section will focus on the Office
of Pesticide Programs which handles all Agency activities under
FIFRA. The other section will concentrate on the Office of Toxic
Substances which is responsible for EPA activities under TSCA.
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ORGANIZATION
Chemical Coordination Staff
o Establishes policies and procedures for the coordination
and integration of Agency and Federal activities
concerning toxic substances.
o Creates and analyses chemical and industry information
data bases for integration of Agency chemical
activities.
o Manages the Chemical Substances Information Network
(CSIN).
Chemical Activities Coordination Group
o Identifies and investigates toxic substances activities
within EPA needing integration and coordinates
regulatory and other activities with appropriate groups.
o Conducts studies and analyses of Agency and other
Federal agencies'.criteria and plans for ordering and
ranking toxic chemicals for assessment, technical
evaluation, and regulation.
o Recommends chemical priorities for action, as well as
policies and procedures to integrate Agency toxic
substances activities to the Assistant Administrator.
o Evaluates EPA statutes in terms of policy consistency
and efficacy of implementation with regard to integrated
approaches for chemical information collection and
dissemination.
o Develops procedures for implementation of section 9 of
TSCA for identifying, determining and making
recommendations for use of the most appropriate Federal
authority for regulating toxic substances.
o Analyzes issues regarding chemicals of concern to the
Assistant Administrator and conducts special cross-
agency projects regarding chemicals of concern to the
Deputy Administrator, Associate and Assistant
Administrators.
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o Participates in the development of Agency legislative
packages to enhance toxic substances integration.
o Provides technical support to Regional Offices to ensure
consistent approaches to chemical problems; monitors
section 28 State grants program; and provides technical
assistance to states regarding available information and
analyses of toxic chemicals as well as concepts for
integrated approaches for chemicals management across
agencies at the State level.
Chemical Information Analysis Group
o Screens and evaluates EPA and other Federal activities
and toxic-related data bases to prepare technical
analyses, guidance documents, and other toxics
integration mechanisms.
o
o
Develops toxics integration data bases where there are
critical needs for management information on cross-
agency activities on chemicals.
Maintains and updates such data bases to allow real-time
assessment of technical, scientific and regulatory
activities across the Agency.
Routinely recommends opportunities for further Agency
coordination based upon analyses of such data bases.
Chemical Substances Information Network Group
o Co-chairs and provides staff support to the Interagency
Toxic Substances Data Committee established under TSCA
section 10(b).
o Manages the development and implementation of the
Chemical Substances information Network (CSIN) to
collect, disseminate, and ensure more cost-effective use
of toxicological and other scientific data.
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OFFICE OF TOXIC SUBSTANCES
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization . .page 217
Regulatory Development page 221
Statutory Authority .page 222
Toxics-Related Activities page 229
The Office of Toxic Substances (OTS), as mandated by the
Toxic Substances Control Act (TSCA), is responsible for
developing and operating Agency programs and policies for new and
existing chemicals. In each of these areas, the Office Director
is responsible for information collection, data development,
health, environmental and economic assessment, and negotiated or
regulatory control actions. The Office Director is also
responsible for coordinating communication with the industrial
community, environmental groups, and other parties on matters
relating to the implementation of TSCA; providing technical
support to international activities coordinated by the Office of
International Activities; and managing the ioirit planning of the
toxics research and development under the auspices of the
Chemical Testing and Assessment Research Committee (CTARC).
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ORGANIZATION
TSCA ASSISTANCE OFFICE
o Advises and assists industry, environmental groups,
trade associations, public interest groups, states,
regions, and other counties on OTS plicy and regulatory
prositions relating to TSCA.
o Provides technical assistance to the chemical industry
including the small business community by conducting
periodic surveys of industyr activities, reporting on
EPA actions which may impede or enhance technological
innovation and recommending alternative approaches to
achieving control of chemical risks.
o Assists Regional Offices in responding to external
inquiries to ensure policy consistency.
OFFICE OF PROGRAM MANAGEMENT AND EVALUATION
o Staff office to the Office Director responsible for
budgeting, program planning, resource managment,
adminisrative operations, and program evaluation.
o Coordinates planning activities necessary to develop
recommendations on OTS programs, including the
identification of alternative program goals, priorities,
objectives and plans.
o Provides input to the Agency's Management Accountability
and Reporting System, and develops and implements OTS-
wide systems or processes necessary to provide program
evaluation.
CHEMICAL CONTROL DIVISION
o Selects and implements appropriate regulatory and non-
regulatory controls measures for new chemicals or new
uses of such chemicals found to present or potentially
present unreasonable risks to human health and/or the
environment.
o Responsible for oversight and management of the
regulatory evaluation and decision-making processes for
new chemicals subject ot premanufacturing notice
requirements under section 5.
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Evaluates alternative remedial control measures under
TSCA and makes recommendations concerning the existance
of unreasonable risk, appropriate regulatory control
measures and the priority for action in implementing
such control measures.
Develops generic and chemical-specific rules for new
chemicals under section 5 and for new and existing
chemicals under section 6 and 7 of TSCA; holds public
hearings on such rules as required, and manages any
necessary post-promulgation programs such as review of
exemption application.
EXISTING CHEMICAL ASSESSMENT DIVISION
o Provides program management for TSCA testing and
existing chemicals program. Identifies and manages the
evaluation of, and implements non-regulatory remeidal
control actions for risks posed by existing chemicals to
human health and the environment.
o Identifies specific sources of exposure and potential
effects on human health or the environment for whcih
testing or control regulations may be warranted and
evaluates the types of hazards and degrees of risk
reflected in the data and petitions submitted to the
Agency under TSCA sections 4, 8, and 21.
o Develops and implements recordkeeping and reporting
rules under section 8 of TSCA, to obtain industry data
needed to identify and evaluate possible unreasonable
risks posed by commercial chemicals.
o Develops and implements procedures for systematically
screening available information on existing chemicals
and uses of chemicals to identify priority chemicals or
categories of chemicals for further evaluation.
o Develops and implements procedures for the selection of
specific chemicals or categories for testing under
section 4 to include conducting or coordinating the
review of relevant data on candidate substances,
negotiating industry testing without rulemaking,
preparing test rules and conducting public hearings,
responding to priority disignations of the TSCA
Interagency Testing Committee (ITC), and evaluating
requests for exemptions from testing.
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Manages all activities under sections 12 and 13 relating
to exports and imports.
HEALTH AND ENVIRONMENTAL REVIEW DIVISION
o Responsible for initial review and detailed assessment
of harmful effects of new chemicals on human health and
on the environment under TSCA section 5.
o Develops and updates testing guidelines in support of
section 4 implementation; reviews, validates, and
evaluates test data submitted by industry and other
available information relevant to harmful effects of
chemicals on human health and the environment; performs
scientific assessments of toxicity and other chemical
hazards to human health and the environment.
o Provides technical support to the Existing Chemical
Assessment Division in implementing TSCA testing and
existing chemicals programs and to the Chemical Control
Division in rule development for existing chemicals
under section 6.
o Identifies and develops new methods and techniques for
laboratory testing and evaluation of chemical hazards to
human health and the environment through intramural
efforrts, extramural studies, and collaboration with the
Office of Research and Development and acadeum and
international organizations.
EXPOSURE EVALUATION DIVISION
o Responsible for the integrated assessment of human and
environmental exposure to substances in support of OTS
risk assessment activities.
o Provides standards, guidance, and rule development
support to the Chemical Control Division and the
Existing Chemical Assessment Division for chemical,
physical, and persistence properties testing, analytic
methods, field sampling, and other exposue-related data
and studies, under section 4, 5, and 6 of TSCA.
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o Reviews, evaluates, and validates data submitted by
industry and other available information relevant to
chemical exposure to humans and the environment, and
evaluates human epidemioligcal data and develops
guidelines for epidemiological studies.
o Performs scientific assessments of human and
environmental exposure to chemical substances.
o Identifies and develops new methods and techniques for
laboratory testing, field study, and integrated
evaluation of human and environmental exposure.
o Responsible for developing and implementing regulations
or polychlorinated biphenyls under section 6(e) of TSCA,
ECONOMICS AND TECHNOLOGY DIVISION
o Responsible for economic, industrial chemistry, and
engineering analyses in support of the OTS program
activities including rulemaking under section 4, 5, 6,
7, and 8.
o Provides technological input into manor risks
assessments conducted by OTS.
INFORMATION MANAGEMENT DIVISION
o Responsible for all information and security services in
support of TSCA and is the focal point of toxic chemical
information in EPA Headquarters.
o Maintains the TSCA chemical inventory and provides
search support for all OTS programs.
o Operates the chemical information library which serves
as the primary chemical collection for the entire
Agency, interacts with the international chemcial
information community to exchange data.
o Serves as focal point for receipt and control of all
documents received as a result of TSCA rulemaking
activity, including the security of these documents.
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory development orocess
within EPA, see page 233 of this publication.
EXISTING REGULATIONS
Toxic Substances Control Act 40 CFR 700-762
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STATUTORY AUTHORITY
The Toxic Substances Control Act
Public Law 94-469 1jj_ fT.S.C. § 2601
In 1971, the President's Council on Environmental Quality
developed a legislative proposal for coping with the increasing
problems of toxic substances. Over the next 5 years, Congress
held many hearings, debated and amended the provisions in
committee, failed to resolve the differences between the House
and Senate bills in the 92nd and 93rd Congresses, and finally
passed the present legislation in the fall of 1976. The law
grants the U.S. Environmental Protection Agency (EPA) significant
new authority to anticipate and address chemical risks.
The Toxic Substances Control Act authorizes EPA to obtain
information from industry on the production, use, health effects,
and other matters concerning chemical substances and mixtures.
If warranted after considering the costs, risks, and benefits of
a substance, EPA may regulate its manufacture, processing,
distribution in commerce, use, and disposal. Pesticides,
tobacco, nuclear material, firearms and ammunition, food, food
additives, drugs, and cosmetics are exempted from the Act; these
products are currently handled under other laws.
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Key Sections of Act—Toxics FOCUS
Section 4—Testing of Chemical Substances and
Mixtures
sec. 4(a) The Administrator shall require by rule the testing
of any chemical substance or mixture whose
manufacture, distribution, processing, use, or
disposal is suspected of presenting an unreasonable
risk of injury to health or environment, and about
which insufficient data exist to adjudge that risk.
sec. 4(b) States the requirements for and effects for which
testing rules can be developed under subsection
4(a).
sec. 4(c) Provides for exemptions to the testing rules
developed under subsection 4(a).
sec. 4(e) Provides for the establishment, by committee, of a
priority list of chemical substances or mixtures
(not to exceed 50) for consideration in the
promulgation of rules under subsection 4(a).
(Note: This function is performed by the TSCA
Interagency Testing Committee [ITC] which was
formed in February 1977 and includes
representatives from eight Federal agencies.)
sec. 4(f) Upon receipt of any test data submitted under this
Act, or any other available information which
indicates that a chemical substance or mixture
presents or will present a significiant risk of
serious or widespread harm to humans from cancer,
gene mutations, or birth defects, the Administrator
shall initiate appropriate action under section 5,
6, or 7 to prevent or reduce to a sufficient extent
such risk.
sec. 4(g) A manufacturer or processor may petition for test
standards to be set by the Administrator.
Section 5—Manufacturing and Processing Notices
(Premanufacturing Notification)
sec. 5(a) Section 5 requires a manufacturer or processor to
notify EPA 90 days before producing either a new
chemical substance, i:e., not on the TSCA Inventory
of existing chemicals, or an existing chemical
intended to be used in a "significantly" new way.
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sec. 5(b) Describes the instances in which a person subject
to the notification rectuirement under subsection
5(a) must submit test data to the Administrator
before the manufacture or processing of the
substance can begin.
sec. 5(c) Allows the Administrator, for qood cause, to extend
the notice review period prescribed by subsections
5(a) and 5(b) for a period not to exceed, in the
aggregate, 90 days.
sec. 5(d) Requires the Administrator to publish in the
Federal Register all notices received under
subsection 5(a) together with data describing
health and environmental effects.
sec. 5(e) Sets out the procedures under which the
Administrator can prohibit or limit the
manufacture, processing, distribution in commerce,
use, or disposal of a new substance, or significant
new use of an existing substance v/hen there is
insufficient information to evaluate the health and
environmental effects of the substance.
sec. 5(f) Requires the Administrator to take immediate action
to prohibit or limit human or environmental
exposure to a new chemical substance, or
significant new use of an existing chemical
substance, if he finds a reasonable basis to
conclude that the substance poses an unreasonable
risk.
sec. 5(g) If the Administrator does not prohibit or limit the
manufacturing, processing, etc., of certain new
chemicals or new uses of existing chemicals
(substances that are listed under subsection 5(b)),
then the Administrator must publish his reasons for
not initiating the action.
sec. 5(h) Provides for exemptions to subsections 5(a) and
5(b).
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Section 6—Regulation of Hazardous Chemical Substances and
Mixtures
sec. 6(a) The Administrator may prohibit or limit the
manufacture, processing, distribution, use, or
disposal of a chemical substance or mixture that
presents an unreasonable risk of injury to health
or the environment.
sec. 6(b) Allows the Administrator to require the revision of
inadequate quality control procedures utilized in
the manufacture or processing of chemical
substances or mixtures.
sec. 6(c) Details the procedures for promulgating rules under
subsection 6(a).
sec. 6(d) Allows the Administrator to make a proposed rule
immediately effective upon its publication in the
Federal Register.
sec. 6(e) Requires the Administrator to prescribe regulations
for the labeling and disposal of polychlorinated
biphenyls (PCBsj. Bans the manufacture,
processing, distribution, and use of PCBs in other
than a totally enclosed manner by July 1979.
Section 7 —Imminent Hazards
sec. 7(a) Authorizes the Administrator to bring suit in a
U.S. district court for seizure, relief, or both,
of any imminently hazardous substance or mixture or
article containing it.
sec. 7(b) The district courts will have jurisdiction to grant
temporary or permanent relief for actions brought
under subsection 7(a).
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sec. 7(d) Concurrent with or as soon as possible after the
filing of an action under subsection 7(a) and,
where appropriate, the Administrator shall initiate
rulemaking under subsection 6(a).
sec. 7(f) Defines an imminently hazardous chemical substance
or mixture as that which presents an unreasonable
risk of serious or widespread injury to health or
the environment that is likely to occur before a
section 6 action can protect against the risk.
Section 8—Reporting and Retention of Information
sec. 8(a) Allows the Administrator to promulgate rules for
industry (excludes small manufacturers and
processors) reporting and retention of information
on the manufacture, processing, use, and disposal
of chemical substances, byproducts produced, and
estimates of the number of people exposed in the
workplace.
sec. 8(b) Requires the publication of an inventory of
chemical substances manufactured or processed in
the United States.
sec. 8(c) Requires manufacturers, processors, and
distributors to keep records of and submit
information on allegations of significant adverse
reactions to health and the environment caused by
chemicals.
sec. 8(d) Requires manufacturers, processors, and
distributors to submit, upon request, health and
safety studies to EPA.
sec. 8(e) Requires manufacturers, processors, and
distributors to immediately notify the
Administrator if they have information that
reasonably supports the conclusion that a substance
or mixture poses a substantial risk to health or
the environment.
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Section 9—Relationship to Other Federal Laws
sec. 9(a) Establishes the relationship between the Act and
Federal laws not administered by the Administrator.
sec. 9(a)(2) Authorizes the publication of a report if the
Administrator determines that risk may be prevented
or significantly reduced by another law.
sec. 9(b) Establishes the relationship between this Act and
other laws administered in whole or in part by the
Adminstrator.
sec. 9(c) Requires that the Administrator consult and
coordinate with other Federal aqencies to avoid
duplication and overlap.
Section 10--Research, Development, Collection. Dissemination,
and Utilization of Data"
sec. 10(a) Requires the Administrator to conduct such
research, development, and monitoring as is
necessary to carry out the purposes of this Act.
sec. 10(b) Authorizes the establishment of an interaqency
committee whose primary responsibility shall be to
design an efficient system for the collection,
dissemination, and use of data submitted to the
Administrator under this Act.
Section 12—Exports
sec. 12(a) Chemical substances or mixtures manufactured or
processed solely for export from the United States
are exempt from the Act (except for the reporting
requirements under section 8) if proper labeling
shows they are intended for export use only.
sec. 12(b) Requires exporters to notify EPA when exporting
chemicals for which certain section 4, 5, 6 or 7
actions have been taken. The Agency must in turn
notify the country of import of the EPA regulatory
action and of the availability of test data.
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Section 13—Imports
sec. 13(a) Authorizes the Secretary of the Treasury to refuse
entry of any chemical substance, mixture, or
article containing same if it fails to comply with
any rule promulgated under this Act, or, if it is
in violation of section 5 or 6, a rule or order
under section 5 or 6, or an order or civil action
brought under section 5 or 7.
Section 14--Disclosure of Pata_
sec. 14(a) Any information obtained under TSCA which qualifies
as a trade secret or as commercial or financial
information must be kept confidential by EPA. An
exception may be made where necessary to protect
health or the environment.
sec. 14(b) An exception to confidentiality requirements may
also be made for studies which are submitted
concerning health and safety effects of certain
chemicals.
sec. 14(c) Any person who submits information to EPA under
TSCA may claim that it should be given confidential
treatment, and is entitled to receive advance
notice if EPA decides not to honor the claim.
sec. 14(d) Federal employees who knowingly disclose
confidential information to persons who are not
authorized to receive it are guilty of a
misdemeanor and may be subject to a $5,000 fine
and/or imprisonment for 1 year.
sec. 14(e) All information obtained under TSCA must be made
available to committees of Congress, regardless of
any claim of confidentiality.
Section 21—Citizen's Petitions
sec. 21(a) States that any person may petition the
Administrator to initiate a proceeding for the
issuance, amendment, or repeal of a rule under
section 4, 6, or 8 or an order under subsection
5(e) or 6(b)(2).
sec. 21(b) Details the procedures to be followed.
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Regulatory Options Available Under Statute
EPA may prohibit or limit the manufacture,
processing, distribution in commerce, use, or
disposal of a chemical. Such action can range
from a labeling requirement to a complete ban.
REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory development process
within EPA, see page 233 of this publication.
EXISTING REGULATIONS
Toxic Substances Control Act 40 CPR 710-762
TOXICS-RELATED ACTIVITIES
Within the Office of Toxic Substances, toxics-related
activites center on implementing the major provisions of TSCA.
Specifically, these include those activities dealing with
information gathering and dissemination, testing, premanufacture
notification, and chemical control. Brief summraries of these
activities are included here. These summaries are intended to
familiarize the public with the provisions of the law, not to
constitute an authoritative legal statement of it. More detailed
information can be obtained from the TSCA Report to Congress for
Fiscal Year 1982 (dated January 1983), which is available from
the TSCA Assistance Office (in Washington, D.C., 554-1404; or,
tollfree 800-424-9065).
Information Gathering and Dissemination
Chemical Substances Inventory
On June 1, 1979, the Agency published the initial Chemical
Substances Inventory (under section 8(b) of TSCA) based on
information reported to EPA by chemical manufacturers, importers,
and processors. The inventory—to which new chemicals are added
when they go into production—shows now that nearly 58,000
commercial chemical substances are, or have been, manufactured or
imported into the United States since January 1, 1975.
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It is important to note that the chemical inventory is not a
ist of toxic or hazardous chemicals. Rather, it lists existinq
chemicals by their specific chemical name (e.g., acetonitrile,
bromobenzene, chlormethane, etc.), givinq for the first time an
overall picture of the chemicals used for commercial purposes in
the United States. In addition to beinq unprecedented, this list
is of major importance because chemicals nt on the inventory must
be reviewed by EPA. under the premanufacture noti f icationproqram
before they are allowed into U.S. commerce.
Section 8 - Reporting and Retention of Information
(Recordkeepinq and Reporting)
In addition to compiling the inventory, EPA has used its
TSCA reporting authority to obtain production, use, release, and
exposure data on a number of chemicals--includiriq asbestos and
chemicals recommended by the Interaqency Testing Committee for
test rule consideration.
TSCA, under section 8(c), also requires any person who
manufactures, processes, or distributes in commerce any chemical
substance or mixture to keep records of significant adverse
reactions to health or the environment that alleqedlv were caused
by the chemical under section 8(d). Records concerning health
effects on employees must be kept for 30 years; other records
must be retained for 5 years.
The Agency may require the submission of health and safety
studies which are known or available to those who manufacture,
process, or distribute specified chemicals in commerce under
section 8(d).
In addition, under section 8(e), if the chemical industry
has information which indicates that a chemical presents a
substantial risk of injury to health or the environment, EPA must
be notified.
Research, Monitoring and Data Systems
In addition to establishing a data system within the EPA for
information submitted under TSCA, the Agency, under the
provisions of section 10(b), is responsible for designing and
establishing a system for toxicological and other scientific data
accessible to all Federal agencies.
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EPA has developed the Chemicals-in-Commerce Information
System (CICIS) to store and retrieve TSCA data. This system
contains TSCA confidential business information and
state-of-the-art computer security techniques. The computerized
TSCA Inventory became operational in late 1979, and several
information services have been derived from it, including
subsystems for Freedom of Information Act requests, inventory
profiles for EPA Regional Offices, support for the TSCA
premanufacture review provess, and health and safety study
submissions.
The Interagency Toxic Substances Data Committee (ITSDC),
formed in February 1978 by EPA and the Council on Environmental
Quality, is continuing its work to construct a comprehensive
Chemical Substances Information Network (CSIN).
CSIN enables toxic substances information users to have
access to a number of independent and autonomous data banks in
the public and private sectors. Users can make use of one
computer to manage the logging-in, accessing, and processing of
their queries for relevant records in and among many data and
information systems—one simple access point to a "library of
systems."
III. TESTING OF CHEMICALS
TSCA gives EPA authority to require manufacturers or
processors of certain existing chemicals (i.e., those already
being distributed in commerce) to test their health and
environmental effects. EPA exercises this authoritv only when it
can make certain statutory findings about the substance involved
and when industry fails to develop the needed data on its onw.
These required findings are: (1) that there are insufficient
data already available with which to perform a reasonable risk
assessment; (2) that testing is necessary to provide such data;
(3) that a chemical may present an unreasonable risk of injury to
human health or the environment; or (4) that the chemical is
produced to substantial quantities resulting in significant human
exposure or environmental release.
Testing requirements are imposed only after a rulemaking
proceeding which includes opportunities for both public comments
negotiated rules and an oral presentation at a hearing.
An Interagency Testing Committee of government experts on
chemical substances advises EPA on those that should be tested;
however, actions are not limited to tho-se recommended by the
Committee. The eight Committee members represent the Departments
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of Labor, Commerce, Health and Human Services (including the
National Cancer Institute, the National Institute for
Occupational Safety and Health, and the National Institute of
Environmental Health Sciences), the National Science Foundataion,
the Council on Environmental Duality, and EPA. The Committee
cannot designate more that 50 priority chemicals for testing at
any given time. Within 12 months of designation, F,PA must either
initiate a rulemaking proceeding to imoose testinq requirements
for those designated chemicals or publish in the Federal Register
the resaons for not requiring testing.
PREMANUFACTDRE NOTIFICATION
(PREMANUFACTURE AND SIGNIFICANT NEW USE NOTIFICATIONS)
The authors of TSCA recognized that health and environmental
considerations are more easily addressed before rather than after
a chemical is produced and introduced into commerce. Thus, under
section 5 of TSCA, manufacturers or importers of new chemicals
must give EPA a 90-day advance notification of their intent to
manufacture or import a new chemical. Any chemical which is not
listed on the inventory of existing chemicals (discussed
previously), published by the Agency, is considered "new" for
purposes of this premanufacture notice requirement.
In addition, EPA may designate a use of a chemical as a
significant new use, based on consideration of several factors,
including the anticipated extend and type of exposure to human
beings or the environment. Anyone who intends to manufacture,
import, or process a chemical for such a significant new (even if
the chemical is on the inventory/or went through premanufacture
notification review) must notify EPA 90 days before
manufacturing, importing or processing the chemical for that use.
The 90-day review period for new chemicals and significant
new uses can be extended by EPA for an additional 90 days for a
good cause. Notices submitted for new chemicals, or significant
new uses of chemicals, are to include: the identity of the
chemical, its molecular structure, prooosed categories of use, an
estimate of the amount to be manufactured, imported or processed,
the by-products resulting from the manufacture, processing, use,
and disposal of the chemical, estimates of exposure and any test
data related to the health and environmental effects of the
chemical. In addition, if a rule requiring testing of the
chemical or its chemical class has been issued, the notice must
include test data developed from that testing alona with the
other information.
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Chemicals produced in small quantities solely for
experimental or research and development purposes are
automatically exempt from the premanufacture and significant new
use notification requirements. In addition, any person may apply
for an exemption for chemicals used solely for test marketing
pruposes or those determined by EPA not to present an
unreasonable risk of injury to human health or the environment.
If EPA determines that insufficient information is in a
notification to evaluate potential risk, the Aqency may order
that the manufacture or importation of the chemical be prohibited
until adequate data are developed. The company is under no time
limit to submit the information, but until it does, EPA's ban
remains in effect. After reviewing a premanufacture notification
containing sufficient data, if EPA determines that the new
chemical presents or will present an unreasonable risk of injury
to health or the environment, the Agency can, during the review
period, prohibit the manufacturing, processing, or distribution
in commerce of that chemical.
CHEMICAL CONTROL
REGULATION OF HAZARDOUS CHEMICALS
Under section 6 of TSCA, EPA has the authority to prohibit
or limit the manufacture, import, processing, distribution in
commerce, use, or disposal* of a chemical when these activities
are found to pose an unreasonable risk of injury to human health
or the environment. A number of possible control options are
available, ranging from total prohibition to labeling.
A manufacturer or processor may be required to make and keep
records of the processes used in manufacturing a chemical and to
conduct tests to assure compliance with any regulatory
requirements. Further, the Agency may require a manuacturer or
processor to give notice of any unreasonable risk of injury
presented by his chemical to those who purchase or may be exposed
to that substance. A manufacturer or processor may also be
* Distinction Between Disposal Authority of TSCA & RCRA: TSCA
has the authority to regulate the disposal stage of a chemical's
life cycle on a chemical-by-chemical basis, that is once a
particular chemical s determined to be an unreasonable risk to
human health and the environment (e.g., PCBs). The Resource
Conservation and Recovery Act (RCRA) has the authority to
establish regulations and programs to ensure safe waste treatment
and disposal of any number of chemicals.
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required to recall a substance which presents an unreasonable
risk.
In proposing regulatory actions, EPA must provide an
opportunity for comments by all interested parties.
A rule limiting, but not banning, a chemical may be made
immediately effective when initially proposed in the Federal
Register if the Agency determines that the chemical is likely to
present an unreasonable risk of serious or widespread injury to
health or the environment before normal rulemaking procedures
could be completed. In the case of a rule prohibiting the
manufactuer of the chemical, EPA must first obtain a court
injunction before the rule can be made immediately effective.
For those chemicals that present an imminent and
unreasonable risk of serious or widespread injury to health or
the environment, EPA may ask a court to require whatever action
may be necessary to protect against such risk.
Polychlorinated Biphenyls (PCBs)
In TSCA, Congress singled out Polychlorinated biphenyls
(PCBs) for both immediate regulation and phased withdrawal from
the market. EPA may authorize certain uses of PCBs and may
exempt, pursuant to certain TSCA criteria, specific activities
involving the manufacturing, processing, or distribution in
commerce of PCBs.
Exports and Imports
If a person intends to export a chemical which is subject to
certain testing or regulatory control requirements under TSCA, he
must notify EPA. The AGency is responsible for notifying the
importing country's government of the export and of EPA's
regulatory action or the availability of information.
With respect to imports, no chemical substance, mixture, or
article containing a chemical substance or mixture will be alowed
into the customs territory of the United States if it fails to
comply with any TSCA rule or otherwise violates TSCA.
Chemicals produced solely for export are generally not
subject to TSCA. However, in the case of a chemical produced for
export that presents an unreasonable risk of injury to health or
the environment in the United States, EPA may regulate the
chemical. Testing may also be required for any exported chemical
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if it is necessary to determine whether there is such a risk to
the United States.
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OFFICE OF PESTICIDE PROGRAMS
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-557-7090
Organization Page 238
Statutory Authorities Page 241
Regulatory Development Page 246
Toxic-Related Activities Page 247
The Office of Pesticide Programs is responsible for
implementing the Federal Insecticide, Fungicide,, and Rodenticide
Act (FIFRA), and certain provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA). As such, the Office coordinates all
Agency programs concerning pesticide management and regulation,
including the establishment of tolerance levels for pesticide
residues which occur in or on food; the registration and
reregistration of pesticides; the monitoring of pesticide levels
in food, humans, and nontarget fish and wildlife; and the
preparation of guidelines and standards for products in the
development of more effective pesticide control programs. In
addition, the Office provides policy direction to technical and
manpower training activities in the pesticide area; develops
research needs and monitoring requirements for the pesticide
program; reviews impact statements dealing with pesticides; and
carries out assigned international activities.
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OFFICE OF PESTICIDE PROGRAMS
OFFICE OF PESTICIDE PROGRAMS
OFFICE DIRECTOR
DEPUTY OFFICE DIRECTOR
POLICY & SPECIAL PROJECTS
STAFF
STAFF CHIEF
PROGRAM MANAGEMENT
& SUPPORT DIVISION
DIRECTOR
DEPUTY DIRECTOR
ADMINISTRATION
BRANCH
BRANCH CHIEF
RESOURCE MGMT. &
EVALUATION BRANCH
BRANCH CHIEF
2 SECTIONS
INFORMATION
SERVICES BRANCH
BRANCH CHIEF
3 SECTIONS
SYSTEMS BRANCH
BRANCH CHIEF
2 SECTIONS
BENEFITS & USE
DIVISION
DIRECTOR
DEPUTY DIRECTOR
IPM & PROGRAM
COORDINATION STAFF
STAFF CHIEF
NATIONAL LAB. AUDIT
PROGRAM
STAFF CHIEF
CHEMICAL
OPERATIONS BRANCH
BRANCH CHIEF
2 SECTIONS
SCIENCE SUPPORT
BRANCH
BRANCH CHIEF
3 SECTIONS
ECONOMIC ANALYSIS
BRANCH
BRANCH CHIEF
2 SECTIONS
HAZARD EVALUATION
DIVISION
DIRECTOR
DEPUTY DIRECTOR
SCIENCE INTEGRATION
STAFF
STAFF CHIEF
MANAGEMENT SUPPORT
STAFF
ADMINISTRATIVE
STAFF
TOXICOLOGY BRANCH
BRANCH CHIEF
DEP. BRANCH CHIEF
5 SECTIONS
EXPOSURE ASSESSMENT
BRANCH
BRANCH CHIEF
DEP. BRANCH CHIEF
5 SECTIONS
ECOLOGICAL EFFECTS
BRANCH
BRANCH CHIEF
DEP. BRANCH CHIEF
4 SECTIONS
RESIDUE CHEMISTRY
BRANCH
BRANCH CHIEF
DEP. BRANCH CHIEF
3 SECTIONS
REGISTRATION
DIVISION
DIRECTOR
DEPUTY DIRECTOR
PROGRAM
COORDINATION STAFF
STAFF CHIEF
INSECTICIDE-
RODENTICIDE BRANCH
BRANCH CHIEF
4 PROD. MGMT. TEAMS
1 SECTION
HERBICIDE-
FUNGICIDE BRANCH
BRANCH CHIEF
3 PROD. MGMT. TEAMS
1 SECTION
DISINFECTANT BRANCH
BRANCH CHIEF
2 PROD. MGMT. TEAMS
1 SECTION
REGISTRATION SUP-
PORTS EMERGENCY
RESPONSE BRANCH
BRANCH CHIEF
2 SECTIONS
SPECIAL REVIEW
BRANCH
BRANCH CHIEF
2SECTIONS
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ORGANIZATION
PROGRAM MANAGEMENT AND SUPPORT DIVISION
o Assists in OPP program development and evaluation.
o Prepares various OPP budget proposals.
o Coordinates development and evaluation of OPP research
needs.
o Provides and manages central files and correspondence
control and technical information services.
o Provides centralized support services for computerized
statistical analyses, systems analyses, and design and
operation of ADP systems.
REGISTRATION DIVISION
o Evaluates and coordinates the registration and
reregistrations of: pesticides under Section 3 of FIFRA.
o Establishes tolerances for pesticide residues under the
Food, Drug, and Cosmetic Act.
o Issues experimental use permits under section 5 of
FIFRA.
o Oversees State experimental use and special local needs
registration activities under sections 5 and 24(c) of
FIFRA.
o Issues emergency exemptions under section 18 of FIFRA.
o Carries out special risk/benefit analyses of chemicals
suspected of causing unreasonable risks.
HAZARD EVALUATION DIVISION
o Reviews, evaluates, and validates all data submitted on
the toxicological and adverse effects on humans,
domestic animals, fish and wildlife, and other
biological species resulting from the use of pesticides,
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Performs risk assessments on proposed and existing
pesticide uses.
Provides scientific expertise on adverse effects of
pesticides to other Agency proqrams and other Federal
Agencies.
BENEFITS AND USE DIVISION
Retrieves, validates, and interprets scientific and
technical data relative to benefits derived from the use
of pesticides.
Conducts economic analyses on the impacts of
cancellations/suspensions and on special or emergency
pesticide use applications.
Develops scientific data on the magnitude and effects of
exposure to pesticides on the population by determining
residues and metabolites through analytical methods
development.
Provides data on the amount of environmental exposure
from pesticides of particular regulatory concern to the
agency.
Maintains pesticide laboratory capability to detect
pesticide traces in environmental media and to
characterize components of complex chemical
formulations.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/office Phone Mail
Office of Pesticide Program 703-557-7090 TS-766
Policy and Special Projects Office 703-557-7102 TS-766
(general program information)
Program Management and Support 703-557-2440 TS-757
Division
Registration Division 703-557-7760 TS-767
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Hazard Evaluation Division 703-557-7351 TS-769
Benefits and Use Division 703-557-0500 TS-768
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STATUTORY AUTHORITIES
The Federal Insecticidef Fungicide, and Rodenticide Act (FIFRA)
"Public Law 92-516 7 U.S.C. § 136
Agricultural chemicals have been regulated by the Federal
Government since the turn of the century. The present law, the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), was
passed in 1947 and significantly amended several times since then,
most recently in 1978. It was administered by the Department of
Agriculture until 1970 when jurisdiction was transferred to the
Environmental Protection Agency. The purpose of the Act is to
control the use of pesticides to safeguard the health of the public
and to prevent adverse effects on the environment.
Key Sections of Act—Toxics Focus
sec. 2 Defines terms related to pesticides production and
use.
sec. 3 Requires registration, reregistration, and
classification of pesticides; authorizes conditional
registration pending full data development in certain
circumstances.
sec. 3(g) Requires that pesticides leaving postharvest residues
on food or field crops be given priority in the
reregistration process.
sec. 4 Authorizes EPA to prescribe standards for the
certification of pesticide applicators and use of
restricted use pesticides.
sec. 4(c) Encourages distribution of instructional materials
on integrated pest management (IPM).
sec. 5 Provides for issuance of experimental use permits
for new pesticides so that data required for
registration may be gathered.
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sec. 6{a) Requires cancellation of registration after 5
years unless a request for continuance is submitted
and approved.
sec. 6(b) Authorizes EPA to cancel pesticides that cause
unreasonable adverse effects on the environment.
sec. 6(c) Authorizes EPA to suspend the registration of a
pesticide immediately to prevent an "imminent hazard."
sec. 7 Requires registration of pesticide production
facilities.
sec. 8(a) Authorizes EPA to require that producers maintain
books and records.
sec. 8(b) Authorizes EPA to conduct in-plant inspections of
books and records.
sec. 9 Authorizes EPA to make in-lant inspections and
obtain samples of pesticides, devices, packages, and
labels for purposes of enforcement.
sec. 9(b) Authorizes EPA to obtain and execute warrants.
sec. 9(c) Requires certification of facts to the Attorney
General by EPA for enforcement purposes.
sec. 10 Provides for protection of trade secrets.
sec. 11 Exempts private pesticide applicators from
recordkeeping.
sec. 12 Defines unlawful acts.
sec. 13 Authorizes the Adminstrator to issue a "stop sale,
use, or removal" order for pesticides or devices which
are in violation of any provisions of this Act.
sec. 14 Details the civil and criminal penalties for
violation of the provisions of this Act.
sec. 15 Authorizes the Administrator to issue an indemnity
payment under certain conditions.
sec. 16(b) Allows persons to obtain judicial review on EPA
actions against pesticides.
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sec. 17(a) Permits export of pesticides if in compliance with
various labelinq requirements of the Act. Requires a
purchaser acknowledgment statement prior to export of
an unregistered pesticide.
sec. 17(b) Requires EPA to furnish notices of registration,
cancellation, or suspension to foreign governments.
sec. 17(c) Details procedures to follow regarding the import
of pesticides.
sec. 18 Authorizes emergency exemptions from provisions of
the Act to Federal agencies and States to meet pest
control emergencies, and requires consultation with
affected Governor(s).
sec. 19 Authorizes EPA to establish procedures and
regulations for the safe disposal and/or storage of
pesticides and pesticide containers and to accept for
disposal, upon request of the owner, any cancelled
pesticides.
sec. 20 Authorizes research and monitorinq activities.
sec. 23 Authorizes cooperative agreements with States and
Indian tribes for enforcement and training of
certified applicators.
sec. 24 Authorizes State registration of pesticides,
consistent with section 3, for use within the State to
meet special local needs.
sec. 26 Gives States primary responsibility for
enforcement of the Act.
sec. 28 Requires EPA to cooperate with the Department of
Agriculture to identify pests and develop controls.
Regulatory Options Available Under Statute
o Require registration of pesticides
o Prescribe standards for certification of applicators
o Classification for general or restricted use
o Cancel registration
o Suspension of registration in imminent hazard circumstances
and cancellation upon final determination by the
Administrator
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o Regulate storaqe and disposal of pesticides and pesticide
containers (see also, Resource Conservation and Recovery
Act) '
o Seizure of unregistered, etc., pesticides.
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The Federal Food, Drug, and Cosmetic Act (FFDCA)*
Public Law 69 21 U.S.C. §§ 301-392
The Federal Food, Drug, and Cosmetic Act was passed in 1938 to
replace the earlier Food and Druq Act of 1906. National legislation
in this area became necessary as competition between food
manufacturers for sales profits led to the debasement and/or the
mislabeling of foods and other products. However, weaknesses in the
1906 Act were pointed out when 107 deaths resulted from "Elixir of
Sulfanilamide." This incident called attention to the need for
premarket testing of new drugs. The 1938 Act addressed these needs
and brought cosmetics under FDA regulation as well.
The purposes of the Food, Drug, and Cosmetic Act are to assure
consumers that foods are pure and wholesome, safe to eat, and
produced under sanitary conditions; that medical devices are safe and
effective for their intended uses, includinq drugs used in medicated
feeds for animals; that cosmetics are safe and properly labeled; and
that packaging and labeling of these products is truthful and
informative.
Since 1938, the Act has been amended several times. Among the
more prominent amendments have been the Food Additives Amendment of
1958, which prohibits the introduction of new food additives until
the manufacturer can prove their safety; the Color Additive
Amendments of 1960 which gave FDA authority to control the conditions
for safe use of a color additive, including the amount of color used
in a product; and the Drug Amendments of 1962, which required, among
other things, that all drugs be proven effective as well as safe.
EPA has the authority, under sections 406, 408, and 409 of this
Act, to establish tolerance levels for pesticide residues in food. A
tolerance is the legal maximum residue of a pesticide chemical
allowed to remain in or on a food. Under the FFDCA, if the residue
exceeds the tolerance level then the food is "adulterated" and is
subject to seizure by the Food and Drug Administration (FDA). The
tolerance requirements of the FFDCA are also applicable to imported
food, whether or not the pesticide is registered for use in the
United States.
*Note: The Food and Drug Administration (FDA) is responsible for implementing most
of the provisions of this statute and for enforcing tolerance levels set by EPA.
FDA is covered in another section of this publication.
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Key Sections of Act--^Tgxics Focus
sec. 406 Permits the establishment of tolerances for
poisonous or deleterious substances includinq
pesticides which (1) are required in the production of
food or (2) otherwise cannot be avoided by qood
manufacturinq practices.
sec. 408 Authorizes the establishment of tolerances for
pesticides used in or on food or feed.
sec. 409 Authorizes the establishment of tolerances for
pesticides which are food additives. (A pesticide is
a food additive when (1) it is carried over from use
of a raw aqricultural commodity and after processinq
remains in the processed food at a concentration
hiqher than oriqinally found in the raw aqricultural
commodity, or (2) it is added to a processed food.)
Regulatory Options Available Under Statute
o Set tolerances/revoke tolerances
o Deem products to be misbranded
o Establish standards or conditions
o Require reqistration or certification
REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the requlatory process within EPA, see paqe
232 of this publication.
EXISTING REGULATIONS
Federal Insecticide, Funqicide, and 40 CFR 160-180
Rodenticide Act
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TOXICS-RELATED ACTIVITIES
Registration of jesticides^
Registration or pre-market clearance of pesticides involves a
comprehensive review of human and environmental risks and a limited
review of benefits data submitted by industry. Risk is often
quantified in terms of the number or probability of certain health
and environment effects, while benefits are usually expressed in
dollar values of such effects as increased crop yields, lower food
costs, reduced chance of disease, or the cost savinqs with respect to
the use of alternative control measures.
The Federal Pesticide Act of 1978, which amended FIFRA,
authorized a program for EPA to qrant conditional reqistrations.
Under this proqram, EPA is able to process applications of new
products which are similar to ones already registered and new uses of
old chemicals if sufficient information is available to evaluate the
unique hazards posed by new uses. New chemicals are also eliqible
for conditional registration if EPA determines that the public
interest would be served by registration, and if unreasonable risks
will not be incurred durinq the period required to complete and
submit additional studies.
Central to the conditional reqistration proqram is incremental
risk assessment. The amended FIFRA requires the Agency to focus its
attention only on the increased risks or incremental risks resulting
from the registration of old pesticides and new uses of old
pesticides. Specifically, conditional registration of both identical
and substantially similar products and uses and new uses is
authorized only if the new use or product will not significantly
increase the risk of unreasonable adverse effects on the environment.
In Fiscal Year 1982 the registration program continued to give
top priority to environmentally safe and innovative compounds and
technologies, such as biorational compounds and other alternative
means of pest management. During Fiscal Year 1982, the Reqistration
Program received 232 new active ingredients, 11,020 previously
registered active ingredients, and 23,309 amendments and supplemental
reqistration applications.
Pesticide Tolerances
Under the Federal Food, Druq, and Cosmetic Act, as amended
(FFDCA), the Agency is required to establish tolerance levels and
exemptions from the requirements for .a tolerance. These tolerance
levels protect the public health while giving appropriate
consideration to the production of an adequate, wholesome, and
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economical food supply. Determination of tolerances involves careful
review and evaluation of residue chemistry and toxicology safety data
to ensure that maximum residue levels likely to be found in food or
feed are safe for human consumption. Included in this consideration
is the cumulative effect of the respective pesticide and related
substances with the same physiological activity.
Registration (Generic) Standards
The Registration Standards System, a new approach to
reregistration sanctioned by the 1978 amendments, will streamline the
reregistration process. Instead of reregistering each of the
approximately 50,000 products on a case-by-case basis, the Agency is
developing comprehensive registration standards for each active
ingredient common to numerous pesticide products. Out of the 50,000
registered pesticide products, EPA is concentrating its effort on the
review of approximately 600 chemicals (active ingredients)
representing the major pesticide chemicals produced. The
registration standards program is an on-going, long-term project and
by the end of fiscal year 1982, 43 standards had been issued.
The development of a registration standard is divided into five
phases: (1) Phase I--Data gathering and preparation, (2) Phase II—
Scientific review, (3) Phase III—Identification and analysis of
regulatory options, (4) Phase IV—Regulatory standard drafting and
publication, and (5) Phase V--Integration of comments and preparation
of the revised standard.
For every pesticide chemical and its formulations, safety
criteria are set, to which registrants must adhere, in order to
register and reregister products. An intensive risk/benefit review
will be conducted only for those chemicals which meet the
"unreasonable adverse effects" criteria. All other chemicals require
a risk analysis only. In addition, standards for registration state
tolerable levels of exposure for food consumers, field workers,
applicators, and other persons and organisms unintentionally exposed
to pesticides, and facilitate reassessments of tolerances to minimize
pesticide exposure of workers, applicators, and others.
Special Review
The Special Review (formerly known as Rebuttable Presumption
Against Registration, RPAR) process is an intensive risk/benefit
review of pesticide chemicals suspected of causing unreasonable
adverse health or environmental impact. The process involves
development of recommendations for a regulatory position with regard
to the registration, suspension, cancellation, restriction on uses,
or removal of pesticides containing the chemical under review.
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The Special Review process beqins when a suspected pesticide
chemical is referred to the Special Review Branch for
consideration. Before this chemical can be accepted as an Special
Review candidate, data supporting the statement of risk must be
scientifically validated. The first part of the Special Review
process focuses on the development of a risk assessment, followed by
a publication of the Agency's position on the chemical in the Federal
Register. During the comment period, the public, manufacturers, and
users are given an opportunity to offer evidence in rebuttal or in
support of the presumption against registration.
If the rebuttal comments are unsuccessful, the Agency develops a
risk/benefit analysis for each significant use and each regulatory
option of the special review. Representing the proposed Agency
decision, the second Position Document is published in the Federal
Register followed by a second public comment period. The tentative
Agency decision and supporting data are reviewed by USDA and the EPA
Scientific Advisory Panel (SAP). Their recommendations and
appropriate public comments are incorporated into the final
regulatory document and forwarded to the Assistant Administrator,
Office of Pesticides and Toxic Substances, for approval. After this
comprehensive review and sign-off process is completed, EPA publishes
the final decision in the Federal Register. The Agency may decide to
register or reregister or restrict aTl or some of the uses of the
pesticide. During 1982, the Agency placed increased emphasis on
negotiations with Special Review Chemical Registrants to reach
environmentally sound decisions more quickly.
In 1982, OPP completed Special Reviews for 15 chemicals. Some
of the more important Special Review decisions included the following
chemicals: Toxaphene, Benomyl, Paraquat and the EBDC Fungicides. By
the end of 1982, the Agency has reached proposed or final decisions
on approximately 90% of the original list of suspect chemicals in the
mid-1970's. In the future, risk benefit evaluating will be initiated
as a result of reviews or new data developed through the registration
standards process.
Laboratory Audit Program
The Office of Pesticide Programs established a Laboratory Audit
Program because of indications that there were defects in basic
studies used to support pesticide registrations. The data validation
process is critical to all the basic regulatory programs in OPP,
including removal or restriction of hazardous pesticides and
development of registration standards.
In cooperation with the Federal Drug Administration and EPA's
Office of Enforcement, OPP personnel have been managing systematic
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audits of independent testing laboratories which generate toxicology
data in support of the registration of pesticides. After conducting
laboratory audits, OPP audit personnel recommend appropriate
regulatory and/or judicial action.
During Fiscal Year 1982, OPP personnel, in collaboration with
FDA, conducted 21 on-site data audits involving validation reviews of
possibly faulty lab data.
Special Registration of Pesticides
The Special Registration Program was established to respond
promptly and effectively to unexpected and temporary health and
agricultural exigencies and to support State and local governments in
registering pesticides for local or State use. Under the Special
Registration Program, OPP issues emergency exemptions under section
18 of the FIFRA, Experimental Use Permits (EUPs) under section 5, and
temporary tolerances to establish safe levels of pesticide residues
in food and feed from pesticide use for experimental purposes.* OPP
also monitors section 24(c) registrations by States, and minor use
registrations or minor use/specialty crop petitions for tolerance
submitted by public interest user-orinented groups, such as the
Inter-Regional Research Project No. 4 (IR-4) based at Rutgers
University.
Under the Special Registration Program, emergency exemptions may
be granted to State or Federal agencies, authorizing pesticides to be
used for purposes not included on registered labeling. Emergency
situations which are deemed to justify granting of an emergency
exemption must meet the following requirements: (1) A pest outbreak
has occurred or is about to occur and no pesticide registered for the
particular use, or alternative method of control, is available to
eradicate or control the pest, (2) significant economic or health
problems will occur without the use of the pesticide, and (3) the
time available from discovery or prediction of the pest outbreak is
insufficient for a pesticide to be registered for the particular
use. In determining whether an emergency condition exists, OPP
scientists and product managers carefully evaluate the benefits as
well as the human and environmental risks associated with the use of
such pesticides.
Because of the extremely broad authority provided under section
18 of FIFRA regarding emergencies, these exemptions may include use
*Temporary tolerances submitted in support of EUPs allow for continuing pesticide
research on agricultural crops used for feed or food.
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of pesticides on crops for which no tolerances have been established
(approximately 95 percent fall into this category) and, in rare
cases, pesticides which have been cancelled for the proposed use.
Granting of emergency exemptions results in reduced annual crop
losses amounting to millions of dollars each year. The exemptions
have spared growers catastrophic economic losses and have prevented
the loss of millions of pounds of valuable food commodities.
Emergency exemptions also have been granted for various public health
emergencies, such as rabies and plague; quarantine situations, such
as Mediterranean Fruit Fly; and for protection of endangered species.
Experimental Use Permits (EUPs) allow registrants to perform
large-scale experimentation needed for the development of data for
new pesticides or new uses of currently registered pesticides. Data
generated from the issuance of EUPs are used to evaluate the
potential hazards to man and the environment from the use of these
pesticides. In cases where crops will not be destroyed after the
experimental program is ended, a temporary tolerance for a safe
residue level on the food or feed commodity must be established by
the Agency before the EUP is issued. The Office of Pesticide
Programs issues EUPs and establishes temporary tolerances based upon
a case-by-case scientific determination of the human and
environmental risks and benefits associated with the use of a
particular pesticide.
The Special Registration Program also includes approval or
disapproval of State registrations of pesticides that are distributed
and used only within a particular registering State. Tn conjunction
with the State registration overview authority, opp monitors the
issuance of experimental use permits that are needed to support
subsequent State registrations.
251
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OFFICE OF WATER
Environmental Protection Aqency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-5700
This Office is responsible for EPA activities pertaining to
the management of water programs. These responsibilities include
program policy development and evaluation, standards development,
overview, and technical support.
There are four major offices within the Office of Water.
Three of those offices are highlighted in this publication. They
include the Office of Water Regulations and Standards, which has
major responsibilities under the Clean Water Act (as amended
1977); the Office of Drinking Water, which is responsible for
Agency activities under the Safe Drinking Water Act (as amended
1977); and the Office of Water Enforcement arid Permits, which
develops policies for compliance monitoring and enforcement
actions and for management of the National Pollutant Discharge
Elimination System (NPDES) under the Clean Water Act as amended.
-252-
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Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-5400
Organization paqe 255
Statutory Authority page 258
Regulatory Development page 261
Toxics-Related Activities page 262
The Office of Water Regulations and Standards is responsible
for developing an overall program strategy for the achievement of
water pollution abatement and control. As such, it assures the
coordination of all national water-related activities within this
water program strategy, and monitors national progress toward the
achievement of water quality goals. The Office is responsible
for the development of effluent standards for industrial sources,
water quality monitoring and ocean dumpinq regulations.
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ORGANIZATION
OFFICE OF ANALYSIS AND EVALUATION
o Develops a national water pollution abatement and
prevention plan which sets forth the framework for
implementing Agency water-related activities in an
integrated, coordinated and timely manner.
o Performs economic analyses and inflationary impact
statements to support regulations developed by the
Office of Water Regulations and Standards for the
abatement and control of point and nonpoint sources of
pollution and for monitoring, planning activities and
other regulatory programs of the Office of Water
Regulations and Standards.
o Provides statistical support and expert review of all
regulations developed by the Office of Water Regulations
and Standards and those of other offices upon request.
Also provides statistical and operations research
assistance to the monitorinq activity and the water
quality standards process.
o Performs in-depth analyses and evaluations on the
effectiveness of programs operating within the Office of
Water Regulations and Standards.
EFFLUENT GUIDELINES DIVISION
o Develops industrial point source effluent limitations
and pretreatment standards for controlling the discharge
of toxic, nonconventional and conventional pollutants
into the Nation's waterways.
o Provides engineering and analytical technical expertise
in defining the most appropriate technologies for
pollution control.
o Conducts in-depth technical studies relating to
annovative and alternative treatment technologies and
recycling and reuse of wastewater to minimize the
overall discharge of all toxics into the environment.
o Conducts engineering analyses and data acquisition to
evaluate the occurrence and impact of toxic pollutants
in the raw waste and treated wastewaters and sludge
streams discharged by industry.
-255-
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Provides assistance to State and Regional Permit Writers
in resolvinq engineering, economic and scientific
problems arising from permitting activities based upon
effluent guidelines.
CRITERIA AND STANDARDS DIVISION
o Develops and revises water quality criteria.
o Develops water quality standards, which when adopted by
the States, will provide water quality for the
protection and propagation of fish, shellfish and
wildlife and for recreation in and on the water.
o Assists the States in implementing water quality based
standards programs which when used in combination with
the technology based approach will provide the most
equitable approach to improving the water quality of the
Nation's waters.
o Serves as an authoritative source of technical and
scientific information on water quality criteria and
standards and the effects of water pollutants on health
and welfare.
o Develops regulations regulating ocean disposal under the
Marine Protection Research and Sanctuaries Act
(MPRSA). Designates sites and issues permits for
disposal pursuant to MPRSA.
MONITORING AND DATA SUPPORT DIVISON
o Develops water quality monitoring strategies, systems
and procedures to identify the biological and chemical
measures of environmental quality.
o Develops procedures to assist the States in using water
quality data in technical analyses.
o Provides national guidance and technical assistance for
State efforts to analyze and report on their water
quality and to identify priority problem areas and
needed State action to implement required controls.
o Assists States in conducting WLAs and TMDLs and in
coordinating local cooperative monitoring programs.
-256-
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Obtains, reviews, stores and analyzes ambient chemical,
bioloqical, ecoloqical and other data relating to toxic
substances.
DIRECTORY FOR TOXICS-RELATED OFFICES/PERSONNEL
DIVISION/OFFICE
Office of Water Regulations
and Standards
Office of Analysis and
Evaluation
Effluent Guideline Division
Criteria and Standards
Division
Monitoring and Data Support
Division
Phone*
202-382-5400
202-382-5389
202-382-7120
202-755-0100
202-382-7040
Mail Stop
WH-551
WH-586
WH-552
WH-585
WH-553
*FTS number are the same.
-257-
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STATUTORY AUTHORITIES
Clean Water Act
Public Law 95-217 33 U.S.C. I? 466
The Clean Water Act was passed in 1972 as the Federal Water
Pollution Control Act. Tt represented a manor reorientation of
Federal efforts to achieve and maintain acceptable levels of
water quality. The Act established a national qoal of
eliminating pollutant discharges into the Nation's waterways by
1985. In 1977f amendments to the Act helped shift attention to
the control of toxic pollutants.
The purpose of the Act is to restore and maintain the
chemical, physical, and biological integrity of the Nation's
waters.
Key Sections of Act—Toxics Focus
sec. 301 Requires application of best available technology
economically achievable to prevent discharge of
toxic and nonconventional pollutants from point
sources.
sec. 302 Authorizes EPA to establish effluent limitations
to attain or maintain water quality.
sec. 303 Requires States to issue water qualitv standards
and implementation plans.
sec. 304 Requires EPA to publish:
(a) Water quality criteria information.
(b) Regulations providing guidelines for
effluent limitations.
(c) Information on processes which eliminate or
reduce the
discharge of pollutants.,
(d) Information on the degree of effluent
reduction attainable
through the application of secondary
treatment.
(e) Regulations supplementing the effluent
limitations in order
to regulate toxic or hazardous pollutants.
(f) Information identifying and evaluating
nonpoint sources of pollution.
-258-
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sec. 307 Requires EPA to publish a list of toxic pollutants
or combinations of pollutants and to set effluent
standards, pretreatment standards, and
prohibitions for these. Gives EPA authority to
set standards more stringent than Best Available
Technoloqy (BAT) if health and ecoloqical impacts
are not mitigated.
sec. 306 Requires EPA to publish regulations establishing
standards of performance for best available
technologies to control discharge of pollutants.
sec. 308 Sets forth conditions for inspections, monitoring,
and entry.
sec. 310 Enables EPA to act in conjunction with the
Department of State and foreign governments to
abate water pollution internationally.
sec. 311 Authorizes EPA to regulate and act to mitigate the
discharge of oil or hazardous substances into
navigable waters.
sec. 401 Requires facilities which discharge pollutants
into water to be certified.
sec. 402 Establishes conditions for issuance of permits to
discharge into navigable waters.
sec. 404(a) Authorizes the Army Corps of Engineers to issue
permits for the discharge of dredged or fill
material into waterways at specified disposal
sites.
sec. 404(b) Authorizes EPA to prohibit the specification of
any area as a disposal site if the discharqe of
the dredged or fill material will have an adverse
effect on people or the environment.
sec. 405(a) Prohibits disposal of sludge without a permit.
sec. 405(b) Allows regulations to be issued setting out
guidelines for acceptable methods for disposal of
sewage sludge.
sec. 504 Authorizes EPA to act to stop or mitigate
environmental discharges which present an imminent
hazard.
-259-
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Regulatory Options Available Under Statute
o Set guidelines and standards of performance for effluent
limitations
o Require application of best available technology to
control discharges
o Regulate discharges of hazardous substances
o Issue permits for discharge of dredged or fill material
o Prohibit discharge or hazardous dredged or fill material
o Regulation disposal of sludge
-260-
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For discussion of the regulatory process within the
Environmental Protection Aqency, see paqe 233 of this
publication.
EXISTING REGULATIONS
Clean Water Act 40 CFR 400
-261-
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TOXICS-RELATED ACTIVITIES
The Office of Water Regulations and Standards (OWRS) has
three major toxics-related programs: developing nationally
uniform industrial point source effluent limitations and
pretreatment standards; developing water quality criteria; and
managing ambient and end-of-pipe monitoring programs. These
programs address a priority list of toxic chemicals established
by a 1976 consent decree with the Natural Resources Defense
Council and codified in the 1977 Clean Water Act amendments.
This list of 65 toxic substances includes some categories and
families of substances, which was refined by EPA to an initial
list of 129 specific pollutants. EPA may add to or delete from
this list by a rulemaking; to date, three have been deleted.
Effluent Limitations
The major Clean Water Act mechanism to control toxic
chemical discharges is nationally uniform effluent limitations
for industry categories. These are technology-based,
economically achievable and economically-based limitations on the
discharge of specific process wastewater constituents.*OWRS is
developing toxic effluent limitations for 129 consent decree
toxic substances for 21 major industry categories. As of the
beginning of May 1983, regulations for 13 industries have been
promulgated and regulations for 15 industries have been proposed.
Water Quality Criteria
Water Quality Criteria have been promulgated for 64 of the
65 toxic substances named in the consent decree. These Water
Quality Criteria set ambient concentrations acceptable for
aquatic organisms and human contact. These criteria are used, in
conjunction with use designations, to establish State Water
Quality Standards. Violations of Water Quality Standards may
result in a requirement for water quality-based effluent controls
more stringent than the existing technology- and economically-
based limitations.
*These limitations are implemented via the National Pollutions
Discharge Elimination System (NPDES), which is managed by the
Office of Water Enforcement and Permits. Under the NPDES
program, a permit incorporating any promulgated effluent
limitation is written for every direct discharger to navigable
waters.
-262-
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Monitoring
The Office of Water Regulations and Standards is responsible
for developing monitoring strategies for the 129 priority toxic
substances, both end-of-pipe and in-stream. Water quality
monitoring identifies water bodies where controls more stringent
than the technology-based limitations are required, evaluates the
progress achieved to date in water quality cleanup efforts and
helps to determine the relative industrial, municipal and
nonpoint source contributions of toxic pollutants to the Nation's
waters.
-263-
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OFFICE OF DRINKING WATER
Environmental Protection Aqency
401 M Street SW.
Washinqton, D.C. 20460
Locator: 202-382-2090
Information: 202-382-5508
Organization page 266
Statutory Authority page 270
Regulatory Development page 274
Toxics-Related Activities page 275
The Office of Drinking Water (ODW) is responsible for the
implementation and coordination of the programs established by
the Safe Drinking Water Act. As such, it establishes standards,
develops regulations, policies, and guidelines for drinking water
quality and treatment requisite to protect the public health and
welfare. It also establishes and implements a program to protect
underground sources of drinking water from endanqerment by the
subsurface emplacement of fluids through wells. ODW also has a
mission to coordinate Agency programs from the perspective of
their impact on ground water.
-264-
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ORGANIZATION
CRITERIA AND STANDARDS DIVISION
Establishes and revises regulations and guidelines
relating to primary and secondary drinking water
standards.
Health Effects Branch
o Develops health effects criteria for and manages
development of the Primary Drinkinq Water
Regulations.
o Proposes research and development work necessary to
the establishment of Maximum Contaminant Levels
(MCLs) as well as treatment requirements and
criteria for health-related contaminants in
drinking water.
o Defines health-effects research needs.
o Maintains liaison with the Office; of Research and
Development of the EPA, and Federal and other
agencies having health responsibilities.
o Provides health advisories in emergency situations
where a water supply might be affected.
Science and Technology Branch
o Develops the technical and scientific rationale for
treatment regulations and maximum contaminant
levels.
o Establishes and revises Secondary Drinking Water
Regulations.
o Develops site selection, surveillance, and
operation and maintenance quidelines.
o Evaluates appropriate standards and criteria for
potable wastewater reuse.
o Initiates and monitors contracts and special
studies in areas of the science and technoloqy of
water supply.
-266-
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Reviews and provides informal advice with respect
to direct and indirect additives to water.
STATE PROGRAMS DIVISION
o Develops and revises requlation and guidelines for
State water supply programs and Underground
Injection Control programs.
o Monitors regional and state implementation of State
program aspects of the Safe Drinking Water Act.
Drinking Water Branch
o Develops and revises regulations, guidelines, and
criteria for State public water supply programs
and State grants.
o Provides guidance to, and follows the progress of,
Regions and States in the monitorinq and
administration of progress in Primacy and Non-
Primacy States.
o Coordinates the Interstate Carrier water supply
program on a Regional/State/local level.
Ground Water Protection Branch
o Develops and revises regulations and guidelines for
Underground Injection Control programs.
o Provides guidance to the Regions and States in the
development and implementation of Underground
Injection Control programs.
TECHNICAL SUPPORT DIVISION
o Provides technical assistance to the Regions and
States in the areas of operation and maintenance,
monitoring and surveillance, treatment technology,
and manpower development programs.
o Provides technical support for the use of available
treatment techniques.
-267-
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o Maintains a group of experienced personnel for
technical support in emergency situations.
o Plans and prepares studies of the nature and extent
of contaminants in public water supplies and ground
water sources.
-268-
-------
DIRECTORY FOR TOXICS-RELATED OFFICER AND PERSONNEL
Division/Office Phone^ Mail Stop
Office of Drinking Wat'er 202-382-5508 WH-550
Criteria and Standards Division 202-382-7575 WH-550
Health Effects Branch 202-382-7571 WH-550
Science and Technology Branch 202-382-3034 WH-550
State Programs Division 202-382-5522 WH-550
Drinking Water Branch 202-382-5526 WH-550
Ground Water Protection Branch 202-382-5530 WH-550
Technical Support Division 513-684-4374 26 W. St. Clair St,
Cincinnati, Ohio
45268
*FTS numbers are the same
-269-
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STATUTORY AUTHORITIES
The Safe Drinking Water Act
Public Law 95 42 U.S.C.§300
Under the authority of the U.S. Public Health Service, standards
for potable water were first issued in 1912 in an effort to
prevent the spread of communicable diseases. Over the years,
these standards were modified and expanded many times. The
standards set limits for chemical and biological impurities
affecting human health and also recommended limits for impurities
that affected appearance, taste, or odor. Although the standards
applied only to water systems on interstate carriers such as
trains, planes, and buses they were widely used as guidelines by
most States and large cities. With the establishment of the
Environmental Protection Agency in 1970, the authority to set and
enforce interstate drinking water standards was transferred to
EPA from the Public Health Service.
The Safe Drinking Water Act (SDWA), passed by Congress in
1974, was designed to protect public drinking water supplies by
assuring that minimum national standards for the protection of
human health were met. The Act, which was designated as section
XIV of the Public Health Service Act, gives EPA the authority to
set minimum drinking water standards for all public water systems
in the Nation serving at least 25 people or having at least 15
connections. Implementation of the regulations rests primarily
with the States. A State must applv for primary enforcement
status (primacy) which requires that States have regulations at
least as stringent as Federal standards. To date, 51 States have
received primary enforcement status. EPA has enforcement
responsibility only within those States not granted primacy.
-270-
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The following list indicates which states have assumed primacy,
and the dates of assumption.
1. Oklahoma 04-29-77 27.
2. Connecticut 05-06-77 28.
3. Louisiana 05-07-77 29.
4. Mississippi 06-19-77 30.
5. Nebraska 06-22-77 31.
6. Alabama 07-10-77 32.
7. Arkansas 07-10-77 33.
8. Georgia 08-06-77 34.
9. New York 09-09-77 35.
10. Virginia 09-09-77 36.
11. Iowa 09-11-77 37.
08-01-82 38.
12. Minnesota 09-26-77 39.
13. Tennessee 09-30-77 40.
14. South Carolina 09-30-77 41.
15. Maine 10-07-77 42.
16. Hawaii 10-20-77 43.
17. Kentucky 10-27-77 44.
18. Massachusetts 12-01-77 45.
19. Texas 01-29-78 46.
20. Michigan 02-01-78 47.
21. Maryland 02-12-78 48.
22. North Dakota 02-17-78 49.
23. Florida 02-17-78 50.
24. Wisconsin 03-14-78 51.
25. Nevada 03-29-78
26. Kansas 03-29-78
The following do not have primacy:
District of Columbia
Indiana
Oregon
OTHER
Montana
Idaho
Washington
New Mexico
Delaware
West Virginia
Colorado
California
New Hampshire
Trust Territory
Guam
Alaska
Arizona
Rhode Island
Ohio
Missouri
Virgin Islands
Illinois
New Jersey
Utah
Puerto Rico
North Carolina
Vermont
American Samoa
Northern Mariana
Islands
Pennsylvania
South Dakota
Wyoming
03-29-78
03-29-78
03-29-78
04-01-78
04-01-78
04-01-78
05-06-78
06-02-78
08-18-78
09-09-78
09-09-78
09-22-78
09-24-78
11-22-78
03-15-79
09-22-79
09-22-79
09-28-79
12-30-79
02-28-79
02-29-79
03-14-80
04-25-80
09-30-80
12-04-82
1. Iowa assumed primacy on 09-11-77 and returned primacy on
07-01-81. Redelegation occurred on 08-01-82.
-271-
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Key Sections of Act—Toxics Focus
The Act is divided into four basic parts, which are further
divided into subsections.
Part A--Definitions
Part A defines some basic terms relevant to the Act.
Several of the more important terms include:
Primary Drinking Water Regulation. A regulation which applies to
public water systems, specifying contaminants which, in the
judgement of the Administrator, mav have any adverse effect
on human health, and specifying for each contaminant either
a maximum contaminant level (MCL) or if an MCL is not
economically or technologically feasible, then a treatment
technique which sufficiently reduces the contaminant level.
Secondary Drinking Water Regulation. Applies to public water
systems, and specifies the recommended levels for any
contaminant which may affect the odor or appearance of
water, therebv causing the public to discontinue using it.
Public Water System. A system which provides piped water for
human consumption, and has at least 15 service connections
or serves at least 25 people.
Contaminant. Any physical, chemical, biological, or radiological
substances or matter in water.
jyiaximum Contaminant Level. The maximum permissible level of a
contaminant in water which is delivered to any user of a
public water system.
Part B—Public Water Systems
sec. 1412(a)(1) Requires the Administrator to set primary
drinking water regulations.
sec. 1412(c) Requires the Administrator to promulgate
secondary drinking water regulations.
sec. 1413 Gives primary enforcement responsibility
to the States allowing for Federal
enforcement only in those cases where a
State is unwilling or unable to enforce.
-272-
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sec. 1415 Lists the conditions under which a
variance may be granted.
sec. 1416 Provides for exemotions to the Act.
Part C--Protection of Underground Sources of
Drinking Water
sec. 1421 Requires the Administrator to publish
regulations to control underground
injection of fluids which may endanger
drinking water sources for public water
systems.
sec. 1422 Requires the Administrator to list in the
Federal Register each State for which a
control program is necessary and directs
each listed State to adopt and implement
the regulations developed under section
1421 .
sec.1425 Provides optional demonstration by States
relating to oil and gas injection
programs.
Part D--Emergencv Powers
sec. 1431 Directs the Administrator, in the absence
of action by State authorities, to issue
orders or commence civil actions to
protect public health in the event that a
contaminant entering a public water
system may pose an imminent or
substantial hazard.
-273-
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within the
Environmental Protection Agency, see paqe 233 of this
publication.
EXISTING REGULATIONS
Safe Drinking Water Act
Interim Primary Drinking Water Regulations 40 CFR 141
Secondary Recommended Maximum Contaminant Levels 40 CFR 143
Underground Injection Control 40 CFR 124,
144, 145,
146
-274-
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TOXICS-RELATED ACTIVITIES*
The Underground Injection Control Program
Part C of the Safe Drinkinq Water Act (SDWA) instructs the EPA
to establish a national program to prevent underground injections
of fluids which endanger drinking water sources. Congress intended
the Underground Injection Control Program (UIC) to protect not only
the ground water which already serves as a source of drinkinq
water, but also ground water that could potentially serve as a
source of drinking water in the future.
In keeping with the reauirements, final regulations were
promulgated in 1980 and amended in 1982 and 1983. Six complete and
seven partial state programs have been approved. EPA is also about
to propose direct implementation programs in 22 states.
Additives in Drinking Water
The Food and Drug Administration (FDA) and the Environmental
Protection Agency (EPA) have executed a memorandum of understanding
(MOU) with regard to the control of direct and indirect additives
to and substances in drinking water. The purpose of the MOU is to
avoid the possibility of overlapping jurisdiction between EPA and
FDA with respect to control of drinkinq water additives. The
agreement became effective on June 22, 1979.
The two agencies agreed that the Safe Drinking Water Act's
passage in 1974 implicitly repealed FDA's jurisdiction over
drinking water as a 'food' under the Federal Food, Drug, and
Cosmetic Act (FFDCA). Under the agreement, EPA now retains
exclusive jurisdiction over drinking water served by public water
supplies, including any additives in such water. FDA retains
jurisdiction over bottled drinking water and over water (and
substances in water) used in food or food processing once it enters
the food processing establishment.
*Note: Included here are those activities identified as toxics-
related from the information provided by each agency or
office at the time of publication. It is recognized that
some activities may have inadvertently been omitted.
Please bring any such omissions, as well as new
additions, to the attention of the Office of Pesticides
and Toxic Substances, Toxics Integration staff.
-275-
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OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-4610
The Office of the Assistant Administrator for Solid Waste and
Emergency Response provides Agencywide policy, guidance, and direction
for the Agency's solid waste and emergency response programs. In
addition to managing those programs, the Assistant Administrator
serves as principal adviser to the Administrator in matters pertaining
to them. The Assistant Administrator's responsibilities include: (a)
Program policy development and evaluation; (b) Development of
appropriate hazardous waste standards and regulation; (c) Ensuring
compliance with applicable laws and regulations; (d) Program policy
guidance and overview, technical support, and evaluation of Regional
solid waste and emergency response activities; (e) Development of
programs for technical; programmatic, and compliance assistance to
States and local governments; (f) Development of guidelines and
standards for the land disposal of hazardous wastes; (g) Analyses on
the recovery of useful energy from solid waste; and (h) Development
and implementation of a program to respond to uncontrolled hazardous
waste sites and spills (including oil spills).
Two offices within the Office of Solid Waste and Emergency
Response will be highlighted in this publication. They are the Office
of Solid Waste and the Office of Emergency and Remedial Response.
-276-
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OFFICE OF SOLID WASTE
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-4627
Organization Page 288
Statutory Authority Page 291
Regulatory Development Page 294
Toxics-Related Activities Page 295
The Office of Solid Waste is responsible for implementing the
Resource Conservation and Recovery Act of 1976 (RCRA). As such, the
Office has lead responsibility for the development of all regulations
and guidelines under RCRA as well as the establishment of basic
policies for technical and financial assistance, public participation,
and a number of other programs.
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OFFICE OF SOLID WASTE
CURRENT ORGANIZATION
PROPOSED ORGANIZATION
OFFICE OF SOLID
WASTE
OFFICE OF MGMT.
INFO. SYSTEM
OFFICE OF SOLID
WASTE
OFFICE OF
PROGRAM MGMT.
AND SUPPORT
HAZ. & INDUST.
WASTE DIVISION
WASTE MGMT. AND
ECONOMICS DIV.
TECHNOLOGY BR.
ECONOMIC
ANALYSIS BRANCH
WASTE CHARAC-
TERIZATION
BRANCH
LAND DISPOSAL
BRANCH
ECONOMIC
POLICY AND
ANALYSIS BR.
WASTE TREATMENT
BRANCH
LAND DISPOSAL
DIVISION
PERMITS & STATE
PROGRAMS DIVISION
ASSESSMENT
BRANCH
PERMITS
BRANCH
DISPOSAL
BRANCH
IMPLEMENTATION
BRANCH
STATE PROGRAM &
RESOURCES REC.
DIVISION
STATE PROGRAMS
BRANCH
RESOURCE
RECOVERY BR.
CHARACTERIZATION
& ASSESSMENT
DIVISION
STATE PROGRAM
BRANCH
WASTE IDENT.
BRANCH
HAZ. WASTE
IMP. BRANCH
STUDIES AND
METHODS BRANCH
FINANCIAL RES-
PONSIBILITY AND
ASSESSMENT
BRANCH
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PROPOSED FUNCTIONAL STATEMENT
Office of Program Management and Support
The Office of Program Management and Support under the
supervision of a Director, serves as a point of liaison with OSWER,
OPRM and the Office of Administration in securing and providing
administrative services, budget planning and control, financial
management, and support for the Office of Solid Waste. The Office is
responsible for developing all budget material (OMB and Congressional)
for the Hazardous Waste Media and develops workload analyses in
conjunction with the Regional Offices. The Office handles all budget
execution functions including contracts and grants management for all
OSW divisions, and develops operating plans and guidance for OSW
planning and management, then monitors progress to meet the guidance
given. The Office develops all responses to information requests,
including those filed under FOTA, and is responsible for developing
and maintaining the docket to support all solid and hazardous waste
regulatory activities. Plans and conducts management activities.
Provides administrative support and personnel service for OSW.
WASTE MANAGEMENT AND ECONOMICS DIVISION
The Waste Management and Economics Division, under the
supervision of a Director, i-s responsible for a national program of
hazardous and solid waste regulation under RCRA. The Division has
overall responsibility for section 3004 of RCRA and develops
regulations, guidelines and guidance documents related to the storage,
treatment, and disposal of hazardous wastes, as well as selected
administrative operations at hazardous waste management facilities.
This requires assessment of appropriate technologies for storage,
treatment, and land disposal of hazardous and other industrial
wastes. The Division also develops Office policy on groundwater
protection issues relative to waste disposal. The Division maintains
the primary responsibility for promulgation of waste oil regulations,
and for procurement of recycled materials under RCRA section 6002.
The Division also prepares regulatory impact analyses and
regulatory strategies under Subtitles C and D of RCRA, and integrates
economic impact data with other Agency programs to assess overall
regulatory impact. The Division is the focal point for dealing with
OPRM and OMB on cost/benefit methodologies and cost/risk
assessments.
The Division integrates its activities with other related
programs of the Agency, including those administered under the Clean
Water Act and Toxic Substances Control Act. In cooperation with the
Office of Research and Development, the Division establishes the
research needs of the RCRA waste management regulatory proqram.
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Waste Treatment Branch
The Waste Treatment Branch has primary responsibility for the
assessment of technologies and promulgation of reoulations,
guidelines, and guidances, for the storage, treatment, incineration,
and recovery of hazardous wastes.
Specifically, the Branch has responsibility for development and
amendments to the regulatory program under section 3004 of RCRA except
for land disposal. This includes developing overall administrative
requirements and integrating technical and financial information
developed within the Branch and elsewhere in OSW into regulations for
storage, treatment, and incineration facilities for hazardous waste.
Also included is the development of appropriate operating and design
manuals, monitoring manuals, training manuals, and other industry
specific guidance and guidelines to accompany the regulations.
The Waste Treatment Branch assesses the performance,
availability, and costs of technologies for storage, treatment,
incineration, and recovery of hazardous or industrial wastes in order
to develop recovery, processing and treatment options for
incorporation into regulations or guidelines. The Branch is also
responsible for special waste studies mandated by Congress (e.g.
mining and utility wastes).
The Branch has responsibility for assessment of technologies and
development of a program for waste oil pursuant to the Solid Waste
Disposal Act Amendments of 1980 and the Used Oil Recycling Act of
1980.
The Branch has responsibility for procurement guidelines under
section 6002 of RCRA, for Federal Agencies to revise purchase
specifications to include recovered materials in products.
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Land Disposal Branch
The Land Disposal Branch is responsible for the development of
land disposal regulations under RCRA section 3004, as well as criteria
and guidelines to control the land disposal of non-hazardous waste
authorized by Subtitle D of RCRA. The Branch prepares regulations and
technical guidance related to issues of land disposal facility
location, design, operations, and closure. In conjunction with the
Office of Research and Development, the Branch assesses appropriate
technologies, including performance availability and costs, for land
disposal facilities. Units of concern are landfills, land treatment
units, waste piles, and surface impoundments. The Branch develops
groundwater quality criteria, standards and monitoring requirements
for incorportation in RCRA rules and guidance documents and ensures
that these are compatible with the aroundwater protection policies of
the Agency. The Branch also develops regulations and guidances for
other environmental and health concerns, including air emissions
control and surface water, soils, and food-chain crops protection.
Econ om ic Analysis Branch
The Economic Analysis Branch is responsible for preparinq
regulatory impact analyses and strategies for regulating hazardous
wastes that consider the trade-offs between cost and risk. The Branch
coordinates and prepares regulatory impact analyses required by
Executive Order 12291 and regulatory flexibility analyses as mandated
by the Regulatory Flexibility Act (RFA). These analyses involve
detailed assessments of the costs and benefits of regulatory and non-
regulatory strategies, as well as complex analyses of the impacts of
each alternative strategy on industry and the society as a whole. The
Branch plans, develops and prepares these analyses using analytical
frameworks, economic, financial, mathematical, and risk modeling
techniques, data and information developed in the Branch, elsewhere in
the Office, by Branch contractors and in the academic community. The
Branch is also the focal point for dealing with OPRM, OMB, other
Agencies and institutions on cost/benefit methodologies and cost/risk
assessments.
PERMITS AND STATE PROGRAMS DIVISION
The Permits and State Programs Division, under the supervision of
a Director, is responsible for the nationwide implementation of a
program to control hazardous wastes, including the permitting of
facilities and the authorization of States to operate their proqrams
in lieu of a federal program. As such the Division is the
Headquarters focal point for interaction "with State and local
governments in cooperation with the EPA Regional Offices. The
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Division provides oversight, guidance and support for Regions and
States implementing programs in solid and hazardous waste under
Subtitles C and n of the Resource Conservation and Recovery Act
(RCRA). It develops regulations for what constitutes an eauivalenb
State program under the Act for the purposes of delegating the
hazardous waste program; develops transporter and aenerator
recordkeeping and reporting regulations in cooperation with DOT; and
provides guidance on solid and hazardous waste requirements relative
to State/EPA agreements. The Division assists the Regional Offices in
the implementation of the solid and hazardous waste Programs, through
the State Planning Guidelines and the open dump inventory for Subtitle
D; the manifest, or cradle-to-grave tracking system, and automated
data processing system covering hazardous waste facilities and
handlers affected by RCRA. The Division has overall responsibility
for the development, administration and implementation of the
hazardous waste permit program. This responsibility includes the
development of permit processing regulations, establishment and
interpretation of procedures for RCRA permit issuance, the provision
of Regional guidance for technical content, review, and evaluation of
RCRA permits; and the provision and coordination of technical
assistance to the Regions on permitting actions. The Division is
responsible for the development and management of data tracking and
reporting systems (including ADP systems) needed for Regional and
Headquarters implementation of the hazardous waste requlatory
system. The Division is responsible for implementina the Agency's
municipal, industrial, and hazardous waste resource recovery
program. The Division has the primary responsibility for reaulations,
guidelines and guidance documents related to sections 2003, 4002,
4003, 4005, 4006, 4007, 4008, 4009, 3002, 3003, 3005, 3006, 3010, and
3011, of RCRA.
State Programs Branch
The State Programs Branch is responsible for the nationwide
implementation, through State programs, of solid waste policies and
procedures. The Branch provides the Office's oversight, guidance, and
support to State and local governments, in cooperation with the EPA
Regional Offices, for implementation of State programs responsive to
RCRA Subtitles C and D. The Branch has primary responsibility for
regulations, guidelines, and guidance documents related to sections
4002, 4003, 4005, 4007, 4008, 4009, 3006, and 3011 of RCRA.
The Branch develops and oversees the implementation of
regulations for States' preparation and carrying out of solid waste
management plans. State activities in this area requiring monitoring
and evaluation by the Branch include technical and institutional
aspects of State plans and procedures to identify, upgrade, and close
open dumps; development of regulatory powers; planning, permitting,
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and inspection of facilities, including those for resource recovery
and coordination of regional planning and implementation. The Branch
develops and manages the implementation of regulations defining
"equivalent" programs under RCRA for purposes of State delegation of
the hazardous waste program. The Branch assesses technical and
institutional aspects of State programs to control hazardous wastes
from cradle-to-grave, including permitting, manifest, and planning
programs. The Branch provides guidance on solid and hazardous waste
requirements relative to State-EPA agreements and receipt of federal
financial assistance.
Permits Branch
The Permits Branch is responsible for the development and
implementation of the Hazardous Waste Permit program. This
responsibility includes development of the regulations necessary to
support the RCRA permitting program, and the establishment and
interpretation of procedures used by the Regions and in State programs
in permitting hazardous waste treatment, storage and disposal
facilities. The Branch develops national oermitting strategies,
provides guidance for technical content, review and evaluation of RCRA
permits and evaluates achievement of permit targets. The Branch
coordinates technical assistance to the Regions on permitting actions
and is responsible for the conduct and overall management of Permit
Assistance Teams (PATs). Using in-house expertise and contractual
support, the Branch provides a variety of technical support and policy
guidance necessary for the Regional Offices to implement the
permitting program. A national contract to provide Regions with
technical services for hazardous waste facility permitting is managed
by this Branch. The Branch is also responsible for implementinq the
Agency's municipal, industrial, and hazardous waste resource recovery
program.
Implementation Branch
The Implementation Branch provides support and guidance for the
implementation of Subtitle C of RCRA. This includes responsibility
for the development and management of data tracking and reporting
systems (including ADP systems) needed for Regional Office and
Headquarter's implementation of the hazardous waste regulatory
program. It also includes responsibility for the development and
management of systems which will assist the office to evaluate the
implementation of RCRA and regulations; and responsibility for
coordinating the development of the hazardous waste data management
system with other Agency ADP systems. The Branch is responsible for
the management of the hazardous waste industry assistance program; and
development and implementation of the Agency's industrial waste
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exchange program. The Branch also is responsible for the development
of regulations as well as guidance and assistance in the
implementation of the generator and transporter regulations Parts 262
and 263. The program is responsible for coordinating RCRA
transportation regulatory development and implementation with the
Department of Transportation. The Branch also develops and implements
regulations and procedures for hazardous waste notification under
section 3010 of RCRA.
CHARACTERIZATION AND ASSESSMENT DIVISION
The Characterization and Assessment Division, under the
supervision of a Director, is responsible for developing regulations
under section 3001 of RCRA to determine which wastes are hazardous,
and managing programs to sample and characterize wastes, establish
waste testing protocols, and to list or delist wastes as hazardous.
The Division also has responsibility for developing the financial
responsibility regulations required by section 3004, establishing the
regulatory and other requirements for the CERCLA post-closure
liability fund, as well as other financing and liability options
associated with new legislative proposals. The Division coordinates
all data and assessment activities, supervises the conduct of all
surveys of the regulated community, manages the preparation of
clearance packages and prepares the Office Information Collection
Budget for OMB.
The Division also develops regulations for special classes of
generators of hazardous waste, and manages a complex program for
studying the waste streams and management practices of selected
industries.
The Division integrates its activities with related other
programs of the Agency, includina those administered under the Clean
Water Act and Toxic Substances Control Act. Tn cooperation with the
Office of Research and Development, the Division establishes research
needs related to waste characterization and listing.
Waste Identification Branch
The Waste Identification Branch develops regulations under RCRA
section 3001 which defines hazardous waste. The Branch is responsible
for amendments and revisions to the regulations in response to
petitions, Congressional mandate, or as a function of internal review
and analysis; examples include small quantity generator regulatory
changes, identification of waste to be restricted from land disposal,
amended definition of solid waste and regulation of recycled materials
(from hazardous waste). As required, these changes will be
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coordinated with other OSW organizational units. The Branch responds
to petitions to exclude from regulation particular wastes from
specific facilities. The Branch develops and makes technical
determinations as to hazardous waste characteristics and hazardous
waste lists, and evaluations for wastes to be removed from such
lists. The Branch manages the technical studies necessary for the
section 3001 program and also prepares technical support for Agency
use in legal defense of the regulations.
The Branch cooperates with the Offices of Toxic Substances,
Water, and Research and Development to assure that the section 3001
program is consistent with their chemical regulation programs.
Studies and Methods Branch
The Studies and Methods Branch has the responsibility for studies
related to the waste generation, recovery, and overall management
practices of various industries.
The Branch investigates and validates hazardous waste sampling
methods, develops test protocols and evaluates chemical and biological
tests for applicability to regulatory needs. Through contracts,
cooperation with technical organizations and laboratories, and liaison
with industry, the Branch develops the technical Information base on
industrial waste streams needed to define criteria for and
characteristics of hazardous waste.
The Branch cooperates with the Office of Research and Development
to assure that the RCRA methods development program is consistent with
ORD's test methodology program. The Branch serves as the focal point
for coordination with ORD for divisional research needs and
implementation.
The Studies and Methods Branch has responsibility for the quality
assurance oversight program for the Office of Solid Waste.
Financial Responsibility and Assessment Branch
The Branch develops state-of-the-art reports and policy position
papers on waste management issues such as Federal and State strategies
for hazardous waste facility development and siting. The Branch
provides liaison and information on legislative and policy analysis
aspects of solid, industrial and hazardous waste management to Agency
and Interagency groups to State and local governments, to OMB and the
Congress. It evaluates the impact, effectiveness and efficiency of
the hazardous waste program for internal management, as well as for
the Office of Management and Budget and" the Congress. The Branch
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develops and implements a post-closure liability proqram as required
under the Comprehensive Environmental Response, Compensation and
Liability Act of 1980. It coordinates data assessment activities for
the Office of Solid Waste to meet regulatory needs as well as the
requirement of the Paperwork Reduction Act, and develops the Office
Information Collection Budget. The Branch evaluates proposed
legislation, and develops legislative initiatives for the Office on
solid and hazardous waste management topics.
The Branch is also the focal point for development of financial
responsibility requirements of RCRA section 3004 regulations and of
financing and liability options associated with new legislative
proposals. Alternatives for funding solid waste management programs
and for implementation and administrative systems are analysed by the
Branch.
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ORGANIZATION*
STATE PROGRAMS AND RESOURCE RECOVERY DIVISION
o Responsible for the nationwide implementation of a program to
control hazardous wastes, control the land disposal of all
solid wastes, and conserve resources through the recovery of
solid and hazardous wastes.
Hazardous Waste Implementation Branch
o Provides guidance and support for the implementation of
Subtitle C of RCRA.
o Develops standards and guidance for hazardous waste
generators and transporters.
o Responsible for the hazardous waste permit and notification
programs.
LAND DISPOSAL DIVISION
o Responsible for a national program to control and regulate
the land disposal of all solid and hazardous waste.
Assessment Branch
o Establishes ground water quality criteria and sets up
policies for protecting ground water supplies against the
adverse effects of land disposal.
Disposal Branch
o Develops criteria, guidelines, and regulations for
controlling the land disposal of solid and hazardous wastes,
including sewage sludge.
o Assesses the technologies available for land disposal and
application of wastes.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
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o Develops, in cooperation with the Office of Research and
Development (EPA) and the Technology Branch of the OSW,
technical performance standards for land disposal
alternatives.
HAZARDOUS AND INDUSTRIAL WASTE DIVISION
o Develops regulations for the characterization and control of
hazardous waste.
o Coordinates a national program of technology and
environmental analysis and economic assessment for hazardous
and solid wastes.
o Maintains liaison with the industrial community and the
Office of Pesticides and Toxic Substances (EPA).
Waste Characterization Branch
o Manages technical studies, provides technical support in
regulatory matters, and makes determinations on hazardous
waste characteristics and lists.
o Responsible for developing and validating hazardous waste
sampling methods, designing test protocols, and evaluating
chemical and biological tests for their application to the
listing and characterization process.
o Develops information on waste streams used in defining
criteria for hazardous waste.
Industry Technology Branch
o Promulgates regulations and guidelines for the storage,
treatment, incineration, and recovery of hazardous wastes.
In developing the regulations, the Branch studies the
performance, availability, and costs of various technological
methods.
o Assesses industrial solid waste management practices.
o Develops Federal guidelines for procurement of products
containing recycled materials.
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Economic and Policy Analysis Branch
o Prepares economic assessments and environmental impact
statements.
o Economic analyses focus on the economic impact of hazardous
and solid waste regulatory programs and include both
industrial and public facilities.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Office of Solid Waste
Land Disposal Division
Assessment Branch
Disposal Branch
State Programs and Resource
Recovery Division
Hazardous and Industrial
Waste Division
Waste Characterization Branch
Industry Technology Branch
Economic Analysis Branch
Phone*
202-382-4627
202-382-4658
202-382-4658
202-382-4658
202-382-4756
202-382-4746
202-382-4770
202-382-4761
202-382-4646
Maj.1 Stop
WH-562
WH-564
WH-564
WH-564
WH-563
WH-565
WH-565
WH-565
WH-565
*FTS numbers are the same
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STATUTORY AUTHORITIES
The Resource Conservation and Recovery Act of|1976
Public Law 94-580 48 U.S.C. § 6901
Passage of the Resource Conservation and Recovery Act of 1976
(RCRA) updated and amended the Solid Waste Disposal Act of 1965.
principal goal of RCRA is to protect public health and the environment
by controlling the disposal of solid waste and regulating the
management and handling of hazardous waste materials. In addition,
the Act is designed to promote the conservation of natural resources
through the recovery of usable energy and materials. RCRA authorizes
the Environmental Protection Agency to regulate hazardous wastes from
their generation to disposal; to foster establishment of regulatory
programs in the States for controlling the disposal of solid wastes on
land and prohibiting the use of open dumps; and to assist in
developing national conservation and recovery policies.
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Key Section of Act—Toxics Focus
sec. 1008
sec. 3001
sec. 3002
sec. 3003
sec. 3004
sec. 3005
sec. 3006(a)
sec. 3006(b)
sec. 3007
sec. 4004
sec. 4005(b)
sec. 4005(c)
sec. 7003
Directs the Administrator to develop and publish
criteria for solid waste management.
Authorizes the development of criteria for identifying
hazardous wastes.
Authorizes the development of standards regulatinq the
generators of hazardous wastes.
Authorizes the development of standards governing the
transportation of hazardous wastes.
Authorizes the development of standards for the
treatment, storage, and disposal of hazardous wastes.
Authorizes the issuance of permits for facilities for
treatment, storage, and disposal of hazardous waste.
Directs the Administrator to promulgate guidelines to
assist the States in developing their own hazardous
waste programs.
Authorizes the States to administer their approved
programs.
Grants the Administrator authority to inspect hazardous
waste facilities.
Authorizes development of criteria for classification
of sanitary landfills.
Requires an inventory of all "open dump" disposal sites
in the United States.
Requires the closing or upgrading of those sites which
do not meet the sanitary landfill criteria.
Directs the Administrator to bring suit or take other
legal action when solid or hazardous wastes present a
danager to public health or the environment.
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Regulatory Options Available Under Statute
o Authorizes the Environmental Protection Agency to develop,
and the States to enforce, EPA standards governing the
generation, transportation, treatment, storage, and disposal
of hazardous wastes.
o Authorizes States to establish programs for the closinq or
upgrading of open dumps and directs states to include these
programs within their Solid ixjaste Management Plan.
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REGULATORY DEVELOPMENT PROCESS
REGULATORY PROCESS
For a discussion of the requlatory process within EPA, see page
233 of this publication.
EXISTING REGULATIONS
Resource Conservation and Recovery Act 40
40 CFR 240-267
permitting 40 CFR 271-272
40 CFR 124
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TOXICS-RELATED ACTIVITIES*
Hazardous Waste Management Program_
Under Subtitle C (Hazardous waste Management) the -main effort to
date has focused on the development of regulations for hazardous
wastes from the point of generation through their ultimate disposal.
The following regulations were issued in 1980.Hazardous Waste
Criteria--indentification and Lasting--RCRA 3001 . These regulations
define wastes that will be controlled under the nationwide Hazardous
Waste Management Program. Criteria are provided to identify
characteristics of hazardous wastes, based on ignitability,
corrosiveness, reactivity, and toxicity. Also included are testing
procedures to determine whether a waste meets the described
characteristics. The regulation also lists certain hazardous wastes
and processes which are presumed to generate hazardous wastes. Means
are also provided for demonstration of noninclusion in the Subtitle C
system.
Standards for Generators of Hazardous Wastes—RCRA 3002. This
regulation establishes national standards for generators of hazardous
wastes, covering such items as recordkeeping, containerization and
labeling, waste identification, and reporting. This regulation also
contains provisions for a hazardous waste manifest system.
Standards for Transporters of Hazardous Wastes--RCRA 3003. These
national standards require transporters of hazardous waste to ship
only properly labeled containers and only to permitted facilities.
Standards for Hazardous Waste Treatment Storage and Disposal
FacijLities-RCRA 300~4. Hazardous waste management facilities will be
re'quired to meet certain standards of administration, financial
responsibility, and technical performance regarding operating
procedures, location, and design. These standards contain provisions
to protect surface water, ground water, and air quality.
Permit Regulations for Hazardous Waste Treatment, Storage, and
Disposal Facilities—RCRA 3005 and Guidelines for State Hazardous
Waste Programs—RCRA 3006. As part of EPA's Consolidated Permit
*Included are those activities identified as toxics-related from the information
provided by each agency at the time of publication. It is recognized that some
activities may have inadvertently been omitted. If you are aware of any such
omissions or new additions, please bring them to the attention of the Office of
Pesticides and Toxic Substances, Toxics Integration staff.
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Regulations, these regulations establish a permit program to assure
uniform State (or EPA) control of hazardous waste management
facilities and assist States in developing their own hazardous waste
regulatory programs. The guidelines also specify minimum requirements
States must meet in order to be authorized by EPA to imolement these
programs.
Solid Waste Management—RCRA Subtitle D. Wastes not classified as
hazardous or exempt from Subtitle C because of low generation rates
(under section 3001) are disposed of in sites regulated under
Subtitle D (State or Regional Solid Waste Plans) of RCRA. While not
considered hazardous under the definition of the Act, many of the
wastes disposed of in these facilities nonetheless have the potential
for creating hazardous environmental conditions. To ensure the safe
disposal of these wastes, the Act requires the closure of upgradinq of
all open dumps under section 4005 and requires EPA to issue Criteria
for the Identification of Sanitary Landfills under section 4004.
Section 4005 also requires that all disposal facilities be inventoried
and a determination made as to whether they meet the Landfill
Criteria. Those facilities not meeting the criteria are classified as
open dumps and therefore must be closed or upgraded. The Landfill
Criteria became effective September 13, 1979.
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OFFICE OF EMERGENCY AND REMEDIAL RESPONSE
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-2180
Organization page 301
Statutory Authority page 306
Toxics-Related Activities page 310
The Office of Emergency and Remedial Response ("Superfund")
is responsible for implementing the Comprehensive Environmental
Response, Compensation, and Liability Act of 1980 (CECLA). As
such, the Office has lead responsibility to protect the general
public and the environment from accidental release of hazardous
substances and for the evaluation and prioritization of all known
hazardous waste sites.
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OFFICE OP EMERGENCY AND REMEDIAL RESPONSE
REMEDIAL PROGRAM
The Remedial Proqram is charged with conductinq a
comprehensive effort to evaluate all known hazardous waste sites,
to establish priorities for remedial response, and to undertake
the appropriate remedy at as many sites as possible.
Throuqh the 103(c) notification process mandated by CERCLA
and other efforts by the Reqional Offices, EPA has obtained
information on over 15,000 uncontrolled hazardous waste sites.
This site data is contained in an automated data system known as
ERRIS, Emergency and Remedial Response Information System. The
Regions are now in the process of screening and assessing these
sites in ERRIS to determine the nature and severity of the
problems they present. To date, the Regions have conducted
preliminary assessments at over 5,000 sites and on-site
inspections at over 2,000 sites. Of these,, 2,400 sites have been
determined to require no further action.
EPA is undertaking more extensive site investigations
includinq sampling, lab analysis, and expert technical assess-
ments, at the most serious of these sites. The data from these
sites investigations are then used in the Hazard Rankinq System
to evaluate the relative threats to the public and environment.
The sites with the highest hazard-rankinq scores have been
published as the proposed National Priorities List of 419
specified by CERCLA §105 and are eliqible for fund-financed
cleanup, as well as enforcement actions under CERCLA.
In order to get the proqram underway as quickly as possible,
EPA used available information and a prototype hazard-rankinq
system to publish an Interim Priority List of 115 sites in
October, 1981, ten months after enactment of Superfund. In July,
1983, EPA added another 45 sites to the Interim List.
The National Priorities List was proposed in December, 1982,
after the Agency and the States had investigated over 1100 sites
and scored 709 sites. The comment period closed February 28,
after EPA had received over 250 comments, totaling approximately
8,000 pages. The National Priorities List is scheduled to be
made final in June. The list is to be updated every three or
four months as cleanup actions are completed and additional sites
are scored.
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Being on the National Priorities List does not mean that a
site will automatically receive fund-financed clean-up. Current
agency policy requires that an attempt be made to secure clean-up
by the private party before fund-financed clean-up is
initiated. If negotiations with the responsible party are
unsuccessful, EPA must enter into an agreement with the State
which specifies the roles EPA and the States will have in
implementing the cleanup. If the State is willing to take the
lead in managing the project, a cooperative agreement is
signed. If the State is not willing to take the lead, it becomes
a Federal lead project and a State Contract is siqned. In either
case, the State must provide assurances of its reauired cost
share of 10% (or at least 50% if the site is publicly owned).
After a cooperative agreement or contract is signed,
remedial site work can begin. Remedial investiqations and
feasiblity studies are conducted for each site to characterize
the problem and to evaluate the relative merits of various
proposed remedies. This work is followed by design and
implementation of the remedy that is selected as the most cost-
effective. The entire process is usually subdivided into several
"operable units" and may take from 36-44 months.
While the work at sites is conducted by contractors, the
Army Corps of Engineers has been selected to manage work at
Federal-lead sites. The Corps may also provide technical
assistance during the remedial investigation and feasibility
study.
EPA estimates that Trust Fund monies are sufficient to fund
remedial actions at about 170 sites. This is based on the
following estimate of average site costs:
Remedial Investigations/ $ 800,000
Feasibility Study
Design $ 340,000
Implementation $4,600,000
Initial Remedial Measures $ 260,000
(Shorter term remedial actions
to stabilize site conditions)
TOTAL $6,000,000
-299-
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EMERGENCY RESPONSE PROGRAM
The goal of this program is to protect the general public
and the environment from the hazards associated with accidental
release of oil and hazardous substances. A Federal capability is
maintained to receive notifications of releases, and to direct
response at incidents where the responsible party was
unidentifiable, refused to clean up, or was incapable of adequate
removal, and the State/local authorities lacked the necessary
expertise, equipment, or funding.
A 24-hour capability is maintained to receive and screen
notifications of over 7,000 oil spills and 3,000 releases of
hazardous substances per year. Each notification is assessed for
potential threat to public health and the environment, and a
determination is made as to whether response is appropriate by
EPA, State/local authorities, or the USCG. The EPA is
responsible for inland releases and the USCG responds to releases
in coastal waters.
The Regions maintain a capability for responding on-scene to
120 major oil spill incidents which reauire expenditure of CWA
311(k) funds, and 65 major hazardous release incidents requiring
CERCLA expenditures. At these incidents, an EPA On-Scene
Coordinator (OSC) assesse-s the situation, develops a mitigative
action plan, arranges for cleanup contractor support, and
oversees the response. The average cost of these removal actions
is about $250,000.
The Regions also respond on-scene to 400 oil spills and 400
hazardous release incidents, where cleanup is directed by
State/local authorities or the responsible party, and expenditure
of Federal Funds is not needed. State/local expertise and
cooperation is most effectively gained by their joint
participation in removal operations. These joint operations
improve State/local response capabilities, provide incentive for
State/local authorities to take more removal responsibilities,
and improve State/Federal cooperation. By assisting on-scene,
Regional OSCs transfer response technology in areas such as
safety procedures, mitigative techniques, and appropriate
disposal technology. A Federal presence on-scene is also the
major incentive for adequate cleanup by the responsible party,
and the responsible party frequently relies on technical advice
from the OSCs in selecting and implementing appropriate response
technology.
-300-
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STATUTORY AUTHORITIES
The Comprehensive Environmenta1 Response, Compensation,
and Liability Act of 1980
Public Law 96-510 42~U.S.C. § 9601
The Comprehensive Environmental Response, Compensation and
Liability Act of 1980 (CERCLA), Public Law 96-510, authorizes the
Federal government to respond directly to releases or threatened
releases of hazardous substances, pollutants or contaminants that
may endanger the public welfare. Until this law was passed, the
Federal government lacked the general authority to clean up
hazardous wastes sites or respond to spills of hazardous
substances onto land or into the air or non-navigable waters.
While the Congress had addressed hazardous wastes problems before
(RCRA), Federal responsibilities were mostly regulatory.
Sections of Act --Toxics Focus
sec. 101(14), Covers "hazardous substances" releases
102, 104 into the "environment." Oil is
specifically
excluded.
"Hazardous substances" defined as those
substances designated or regulated under
specified sections of other statutes,
including the Toxic Substances Control
Act, the Clear Air Act, the Clean Water
Act and the Resource Conservation and
Recovery Act (RCRA), and substances
designated under section 102 of CRRCLA.
sec. 102, 103 Administrator is required to designate
spectific amounts of hazardous substances
to be "reportable quantities" — that
amount of a substance which, when
released, "may present substantial danger"
to public health or welfare or the
environment. Due to this requirement,
close coordination must be maintained
between CERCLA, CWA, CAA and TSCA.
Certain persons in charge of vessels or
facilities are required to report to the
National Response Center the release of a
reportable quantity of a hazardous
substance.
-306-
-------
sec. 101 (23), & Authorizes two kinds of direct government
(24), 104 response to releases of hazardous
substances or certain pollutants or
contaminants into the environment:
- Removal Action is taken to mitiqate an
immediate danger and ordinarily is limited
to six months in duration and $1 million
in cost.
- Remedial Action is taken when more
permanent remedy is necessary. States
must make certain assurances including
sharing at least 10 percent of response
costs or at least 50 percent if the
facility from which release occurs was
owned by state or local government.
sec. 104(i) Requires establishment of the Agency for
Toxic Substances and Disease Registry in
HHS. Requires this Agency to effect the
health-related provisions of the Act,
includinq, among others, establishing a
registry of persons exposed to hazardous
substances and medical testing and
evaluation of exposed individuals.
sec. 105 NCP establishes procedures for carrying
out removal and remedial actions and
encourages coordinated federal, state and
local involvement.
NCP also includes a list of national
priorities for remedial action. List must
include at least 400 sites drawn from
candidates submitted by the States.
sec. 106 Authorizes abatement action and issuance
of orders to compel private cleanup or
other measures when public health or
environment is endangered.
Establishes substantial fines for non-
compliance.
-307-
-------
sec. 107 Imposes liability for response costs
incurred by federal government, state, or
other persons and for damages or loss to
natural resources.
Potentially liable parties include
owners/operators of vessels and
facilities, owners/operators of disposal
facilities, and generators and
transporters of hazardous substances.
Establishes narrow defenses to liability
(an act of God, an act of war, or an act
of omission by an unrelated third
party).Creates limits to liability.
sec. 111 Authorizes use of Superfund monies for
payment of response costs and certain
claims under the Clean Water Act and claims
for natural resource damage.
sec. 112 Establishes procedures for paying claims
authorized under section 111. Authorizes
President to assist in settlement and
requires the establishment of a Board of
Arbitrators to decide claims.
Title II Establishes the Hazardous Substance
Response Trust Fund which is financed
primarily by a five-year tax on crude
oiland certain petroleum products and on
the sale of certain chemicals by
manufacturers, producers, or importers.
Creates the Post-Closure Liability Trust
Fund, financed by a tax on the receipt of
hazardous wastes at disposal facilities, to
cover liability for property closed
facilities.
sec. 301 Requires the President to submit to
Congress comprehensive reports on CERCLA's
implementation.
Reports concern the effectiveness of CERCLA
for responding to hazardous substance
releases, a summary of disbursements from
the Fund a record of state participation,
and the impact of taxes imposed by Title II
on the nation's trade balance.
-308-
-------
The Clean Water Act
Public Law 95-676 33 U.S.C. S 1321
The Clean Water Act and its predecessor, the Federal Water
Pollution Control Act, enabled the Federal Government to take
action when oil or desiqnated hazardous substances are discharged
into navigable waters. This statute did not permit the
Government to act when hazardous substances were released
elsewhere into the environment. EPA's Superfund program, in
close coordination with the U.S. Coast Guard, administers
programs under section 311 of the Clean Water Act.
sec. 311 Jurisdiction; Oil and hazadous substance
discharges "into the navigable waters of
the United States, adjoining shorelines,
or ... the water of the contiguous zone."
Removal authorities; President
authorizedto remove oil or hazardous
substances discharged into navigable
waters.
Liability; Imposed for removal costs and
restoration/replacement of natural
resources. Defenses and limits to
liability are established.
Enforcement; Civil penalties for
violation of the Act; injunctive relief
authorized (section 504(a)).
Fund; $35 million revolving fund
established to finance removals and
implementation of other section 311
authorities.
Existing Regulations and Policy Statements Mandated by the
Comprehensive Environmental Response, Compenstation and Liability
Act of 1980 or Section 311 of the Clean Water Act
The National Oil and Hazardous Substance
Contingency Plan 40 CFR Part 300
Oil and Hazardous Substance Emergencies 40 CFR Parts 100-117
-309-
-------
TOXICS RELATED ACTIVITIES
The following regulations are under development pursuant to
CERCLA and section 311 of the Clean Water Act.
Designation of Hazardous Substances -- 40 CFR 302
Section 102 of CERCLA requires EPA to designate hazardous
substances which may present substantial danger to the public
health or welfare or the environment if released into the
environment. EPA is developing this regulation to supplement the
lists of hazardous substances already developed under CWA 307,
311, RCRA 3001, CAA 112, and TSCA 7.
Notification of Release of Hazardous Substances and Determination
c>f Reportable Quantities — 40 CFR 303
EPA is developing reportable quantities for hazardous
substances under section 102 of CERCLA that will trigger the
requirements in section 103 of CERCLA. The reportabie quantity
listed with each designated hazardous substance under CERCLA
section 102 will be the reportable quantity for that substance
under CWA section 117.3.
Notification of Continuous Release of Hazardous Substances —
40 CFR 304
Section 103(a) of CERCLA requires that persons notify the
National Response Center of releases of hazardous substances.
Section 103(f) provides an exemption to these reporting
requirements. EPA is developing regulations that will clarify
Agency policy regarding notification of continuous releases of
designated hazardous substances.
-310-
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OFFICE OF AIR, NOISE, AND RADIATION
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-7400
This Office is responsible for the activities of the Agency
dealing with air, noise, and radiation. The air activities of
the Agency include development of national programs, technical
policies, and regulations for air pollution control; development
of national standards for air quality, emission standards for new
stationary sources, and emission standards for hazardous
pollutants; technical direction, support, and evaluation of
regional air activities; and provision of training in the field
of air pollution control. Related activities include study,
identification, and regulation of noise sources and control
methods; technical assistance to States and agencies having
radiation protection programs; and a national surveillance and
inspection program for measuring radiation levels in the
environment.
Two offices within the Office of Air, Noise, and Radiation
will be highlighted in this publication. They are the Office of
Air Quality Planning and Standards and the Office of Mobile
Source Air Pollution Control.
-311-
-------
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OFFICE OF AIR QUALITY PLANNING AND STANDARDS
U.S. EPA (ANR-443)
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-5575
U.S. EPA (MD-11)
Research Triangle Park, NC 27711
Locator: 919-541-5615
8-629-5615
Information: 919-541-5615
8-629-5615
OFFICE OF MOBILE SOURCES
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-382-2090
Information: 202-382-7645
Organization page 316
Statutory Authority page 320
Regulatory Development page 323
Toxics-Related Activities page 324
The Office of Air Quality Planning and Standards is
responsible for the air quality planning and standards functions
of the Agency. As such, this Office develops national standards
for air quality, emission standards for new stationary sources,
and emission standards for hazardous pollutants. In addition,
*NOTE: Since both of these Offices are responsible for
implementing activities under The Clean Air Act, they are covered
in the same section of this publication. This represents a
slight change in format.
-313-
-------
the Office develops national programs, technical policies,
regulations, guidelines, and criteria for air pollution control;
assesses the national air pollution control program; provides
assistance to States and the Regional Offices, develops emission
factors and monitoring strategies for toxic air pollutants and
monitors compliance with stationary sources emissions limitations
under the Clean Air Act.
The Office of Mobile Sources, under the supervision of a
Director, is responsible for the mobile source air pollution
control functions of the Office of Air, Noise and Radiation. The
Office is responsible for characterizing emissions from mobile
sources and related fuels; developing programs for their control,
including assessment of the status of control technology and in
use vehicle emissions; for carrying out, in coordination as
appropriate with the Office of Legal and Enforcement Counsel,
regulatory compliance programs to ensure adherence of mobile
sources to standards; and for fostering the development of State
motor vehicles.
-314-
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ORGANIZATION*
OFFICE OF AIR QUALITY PLANNING AND STANDARDS
o Develops national ambient air quality standards and
performance standards for new stationary sources and
emission standards for hazardous pollutants.
o Establishes guidelines, criteria, and technical policies
for assessing the effectiveness of air pollution
controls.
o Provides training and technical information to States,
EPA Regional Offices, industry, and other organizations.
o Evaluates regional programs and State implementation
plans.
o Monitors source compliance with standards.
Emission Standards and Engineering Division
o Develops reviews, and revises national emission
standards for hazardous pollutants and performance
standards for new stationary sources. Provides guidance
for delegation o'f standards.
o Studies stationary source categories and analyzes
control methods and economic information.
o Provides technical expertise in emission control
technologies.
o Evaluates development alternatives for their technical
soundness and for their compatibility to emissions
regulations.
Strategies and Air Standards Division
o Identifies and evaluates the need to regulate potential
pollutants and recommends appropriate control
strategies.
o Develops, reviews, and revises national ambient air
quality standards.
*NOTE: Only those offices which deal with toxics or
toxics-related issues are developed in this section.
-316-
-------
o Prepares cost, economic, and benefit analysis in support
of regulatory actions.
Monitoring and Data Analysis Division
o Develops emission factors for toxic air pollutants.
o Develops strategy for monitoring toxic air pollutants.
OFFICE OF MOBILE SOURCES
o Characterizes emissions from mobile sources and develops
control programs.
o Recommends emission standards and any related test
procedures for mobile sources.
o Conducts regulatory compliance programs to ensure that
mobile sources adhere to the standards developed.
Emission Control Technology Division
o The Emission Control Technology Division, under the
supervision of a Director, is responsible for assessing
emissions from all mobile sources and developing new
emission standards in cases where the new standards are
effective to implement. To support the goal of
standards development, the Division must consider test
procedure development, technology assessments,
characterization of regulated and unregulated pollutants
from currently regulated and nonregulated sources, cost
effectiveness analyses, fuel economy test procedures and
the relationships between fuel economy and emissions,
in-use vehicle performance assessments and the
feasibility of implementing in-use vehicle control
strategies.
Engineering Operations Division
o The Engineering Operations Division (EOD), under the
supervision of a Director, is responsible for the
complete range of tasks required to provide the
necessary facilities and equipment in support of all
emission and fuel economy testing programs at the Ann
Arbor facility; provides emission testing services in
support of the Automobile Emission Certification Testing
Program and the Fuel Economy Testing Program and other
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compliance programs; conducts correlation activities
with other governmental and industry emission tes^
facilities on a nationwide and international basis in
the form of evaluation and diagnostic testing and
technical consultation; conducts audits of
manufacturers' test facilities to determine the
acceptability of their procedures (and, ultimately,
their data) for purposes of certification program and
fuel economy program implementation; conducts testing
for other EPA and QMS organizations of a specialized
nature in support of emerging issue assessments,
emerging problem areas, or specialized compliance
activities.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone
* Office of Air Quality
Planning and Standards
Emission Standards and
Engineering Division
Strategies and Air
Standards Division
Monitoring and Data
Analysis Division
Stationary Source
Compliance Division
Office of Mobile Sources
Emission Control Technology
Division
Engineering Operations
Division
202-382-5575
and
919-541-5615
8-629-5615
919-541-5571
8-629-5571
919-541-5504
8-629-5204
919-541-5536
8-629-5536
202-382-2807
8-382-2807
202-382-7645
8-382-7645
313-668-8404
8-374-8404
313-668-8243
8-374-8243
Mail Stop
ANR-443
401 M Street SW.
Washington, D.C.
20460
MD-1 1
Research Triangle
Park, NC 27711
MD-13
Research Triangle
Park, NC 27711
MD-1 2
Research Triangle
Park, NC 27711
MD-1 4
Research Triangle
Park, NC 27711
EN 341
401 M Street SW.
Washington, D.C.
20460
ANR-455
401 M Street SW.
Washington, D.C.
20460
2565 Plymouth Road
Ann Arbor, MI 48105
2565 Plymouth Road
Ann Arbor, MI 48105
*Note that the Director, OAQPS and the Stationary Source
Compliance Division are located in Washington, D.C. The other
divisions are at the RTP address.
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STATUTORY AUTHORITY
Clean Air Act
Public Law 95-11 42 U.S.C. § 7401 et seq.
The Federal mandates for reducing air pollution and
improving air quality are embodied in legislation originally
passed in 1955 and strengthened in 1963, 1965, and 1967.
Comprehensive national control legislation came with the 1970 and
1977 amendments to the Clean Air Act.
1970 Amendments
Before 1970, the Act provided for national control of motor
vehicle emissions studies as well as nationwide planning of
possible control methods, and empowered States to set pollution
control goals.
The 1970 amendments required the Federal Government to set
standards for ambient air quality. These standards were to
define the principal types of pollution and the levels of each
that should not be exceeded for the protection of public health
and welfare. EPA formally adopted the first ambient air quality
standards in 1971. These amendments also specified emission
standards for automobiles.
1977 Amendments
In the late 1960s, study and planning efforts had been based
on individual air quality regions on the presumption that air
pollution problems (and their solutions) would vary from place to
place throughout the country. An air quality region was defined
as an area with definite pollution problems, common pollution
sources, and characteristic weather. Though the geographical
boundaries were seldom exact, the air quality regions were useful
units for management and control; each region had individual
problems and individual characteristics.
The regional concept is still in use in the planning and
control measures being carried out by EPA and the various states,
and the 1977 amendments require the States to rate each region
for its attainment of each air quality standard.
In addition, Congress strengthened efforts to maintain air
quality in regions where the air is already clean. There cannot
be any "significant deterioration" of air quality in such
regions. The law specifies how sulfur oxides and particulates
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will first be regulated in "clean-air regions," and anticipates
later regulation of other pollutants.
Three kinds of "clean-air regions" are defined. Class I
must include all national parks and wilderness areas and may
include further areas named by the States to remain unsullied.
Class II areas can have some industrial development, up to
specified levels. Class III areas can have greater pollution
from additional new sources, sometimes up to the minimum Federal
Ambient Standards.
Any significant pollution source—factory, power plant, or
other—that is proposed must first obtain a permit and meet a
number of conditions, which include using the best available
control methods for the new source.
Industrial development is also permitted in polluted regions
as long as offsetting reductions are made in that region's
existing sources. A new tire factory, for instance, although it
meets the new source performance standards for the rubber
industry, would still add more pollution to the region. Under
the new amendments, the factory can be built if existing sources
reduce their emissions more than enough to compensate for the new
plant.
Key Sections of Act—Toxics Focus
sec. 108 Authorizes EPA to establish air quality criteria
and control techniques for air pollutants from both
stationary and mobile sources.
sec. 109 Gives EPA authority to prescribe national ambient
air quality standards.
sec. 110 Establishes State implementation plans for
attainment of air quality standards.
sec. 111 Authorizes the establishment of standards for
performance of new stationary sources of air
pollutants; requires State plans for implementing
control of existing plants in source categories
covered by NSPS.
sec. 112 Defines hazardous air pollutants and authorizes the
establishment of emission standards for such
pollutants; authorizes EPA to impose alternative
controls when emission standards are not feasible.
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sec. 202 Authorizes motor vehicle emission standards and in
some cases, sets the standards.
sec. 211 Requires registration of fuel and fuel additives.
Authorizes control or prohibition of fuels and fuel
additives. Prohibits marketing of new fuels or
additives without a waiver.
sec. 303 Gives EPA emergency powers to act. to stop air
pollution emissions if necessary to protect against
imminent dangers to health.
Regulatory Options Available Under Statute
o Designation of criteria pollutants and establishment of
ambient air quality standards
o Imposition of new source performance standards and
subsequent state standards on a category of emitter—can
entail numerical limit or engineering control
o Listing as a hazardous air pollutant on health grounds
and imposition of controls on significant emitters—as a
numerical standard or engineering control
o Use of emergency powers in case of imminent hazard—
litigation for RO/TRO.
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within EPA, see
page 233 of this publication.
EXISTING REGULATIONS
CLEAN AIR ACT 40 CFR 50-87
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TOXICS-RELATED ACTIVITIES*
New Source Performance Standards
New Source Performance Standards are specific limits
applicable to individual industries. They set the maximum
amounts of each kind of pollutant, such as sulfur dioxide or
particulates that can be emitted from new plant smokestacks for
each unit of the plant's production. Standards of performance
are proposed following a detailed investigation of air pollution
control methods available to the industry and the impact of their
cost to the industry. The investigations are conducted to ensure
that standards: (1) realistically reflect best demonstrated
control practices; (2) adequately consider the cost, nonair
quality health and environmental impacts, and energy requirements
of such control; (3) are applicable to existing sources that are
modified or reconstructed as well as new installations; and (4)
meet these conditions for all variations of operating conditions
being considered anywhere in the country. Nationwide standards
for new sources are intended to discourage new industrial plants
from locating in States with less stringent regulations. Under
the Federal standards, the industry would have to build a new
plant in compliance with the new source performance standards.
For pollutants not covered by a national ambient standard or a
hazardous emission standard, the NSPS provisions of the Act
require states to adopt standards for control of emissions of
that pollutant from existing plants.
National Emission Standards for Hazardous Pollutants
Under the authority of section 112(b){1) of the Clean Air
Act, EPA may propose national emission standards for specific air
pollutants that are particularly hazardous to health. Standards
are set, at a minimum, to require the best available technology
for both new and existing sources of the pollutant and to limit
the amounts which owners and operators of plants emitting the
pollutant may discharge into the atmosphere. To arrive at the
proposed limits, EPA considers economic, environmental, and
energy impacts associated with both the proposed standard, and
its alternatives.
*Included are those activities identified as toxics-related from
the information provided by each agency at the time of
publication. It is recognized that some activities may have been
inadvertently omitted. Please bring any such omissions or new
additions to the attention of the Office of Pesticides and Toxic
Substances, Toxics Integration staff.
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Motor Vehicle Emission Laboratory
The Motor Vehicle Emission Laboratory (MVEL) is staffed by
three Divisions and numerous support groups. They are
responsible for characterizing motor vehicle emissions, assessing
new technology, developing test procedures, developing
regulations and helping establish emission inspection and
maintenance programs.
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PROGRAMS
-------
NATIONAL TOXICOLOGY PROGRAM
Department of Health and
Human Services
Public Health Service
P.O. Box 12233
Research Triangle Park, N.C. 27709
Information: 919-541-3991
Organization page 331
Statutory Authorities page 340
The National Toxicology Program (NTP), established in
November 1978 as a Department of Health and Human Services (DHHS)
cooperative effort, coordinates and manages the Department's
activities in toxicology testing and test development and
validation. The four DHHS agencies whose relevant toxicology
programs comprise the NTP are the National Cancer Institute*,
National Institutes of Health (NCI/NIH); National Institute of
Environmental Health Sciences (NIEHS/NIH); National Center for
Toxicological Research, Food and Drug Administration (NCTR/FDA);
and National Institute for Occupational Safety and Health,
Centers for Disease Control.
NTP's goal is to develop the scientific information
necessary to strengthen the science base in toxicology and to
protect the health of the American public from exposure to toxic
chemicals. Under the broad objective of identifying those
chemicals potentially toxic to humans and developing and
validating new and better integrated test methods, the NTP
emphasizes four specific goals:
*NOTE: On July 14, 1981, the DHHS Secretary approved the
transfer of the NCI carcinogenesis bioassay program to the NIEHS
in order to integrate the NIH components of the NTP. NIEHS is
responsible for all NIH/NTP activities; but the NCI continues to
be involved in the NTP through the Executive Committee, the Board
of Scientific Counselors, and the operational components.
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o To expand the spectrum of toxicologic information on
chemicals being tested.
o To increase the numbers of chemicals tested in various
short-term assays within funding limits.
o To develop and validate a series of test protocols more
appropriate for regulatory needs.
o To establish a coordinated communications network to
collect, evaluate, and disseminate toxicological
information generated by the program.
The NTP's predominant long-term objective is the
development, validation, and application of better, less
expensive, more specific test methodologies. However, chemical
testing for toxicology continues to be a central concern and to
use the greatest amount of resources. By broadening the
protocols to more fully characterize the overall toxicological
profile of chemicals, the NTP has implemented a comprehensive
approach to testing, one which examines the carcinogenicity,
genetic toxicity, chemical disposition (absorption, distribution,
metabolism, and excretion), fertility and reproductive effects,
and major organ toxicity of chemicals.
To ensure that the NTP toxicology research, chemical testing
priorities, and test development efforts are responsive to public
health concerns and to regulatory needs, the NTP Executive
Committee provides coordination between DHHS research and
regulatory agencies. This committee, made up of the heads of the
Federal research and regulatory agencies, serves as NTP's major
advisory body and provides primary oversight for the program.
This interagency group also serves as a forum for discussion of
science policy issues and provides for timely information
exchange among the various agencies as well as with industry and
other interested groups.
Another responsibility of the Executive Committee has been
the development of chemical nomination and sel€»ction procedures
to determine which chemicals to examine toxicologically under the
NTP activity. To ensure that its chemical selection takes into
account both public and private concerns, the NTP urges all
persons interested in proposing chemicals for testing to do so as
well as recommend the type tests to be considered. Testing
recommendations or questions should be directed to Dr. Dorothy
Canter, NIH/NTP, Room 2B55, Bldg. 31, National Institutes of
Health, Bethesda, MD 20205, (301) 496-3511 or FTS 629-3511.
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In selecting chemicals for test, the NTP Executive Committee
operates under the principle that industry will test chemicals
for health and environmental effects as intended and mandated by
the Congress under legislative authorities. Therefore, the NTP,
acting under its chemical selection principles, will test:
1. Chemicals found in the environment that are not closely
associated with commercial activities.
2. Desirable substitutes for existing chemicals,
particularly therapeutic agents, that might not be
developed or tested without Federal involvement.
3. Chemicals that should be tested to improve scientific
understanding of structure-activity relationships and
thereby assist in defining groups of commercial
chemicals that should be tested by industry.
4. Certain chemicals tested by industry, or by others, the
additional testing of which by the Federal Government is
justified to verify the results.
5. Previously tested chemicals for which other testing is
desirable to cross-compare testing methods.
6. "Old chemicals" with the potential for significant human
exposure which are of social importance but which
generate too little revenue to support an adequate
testing program (some of these may be "grandfathered"
under FDA laws).
7. Two or more chemicals together, when combined human
exposure occurs (such testing probably cannot be
required of industry if the products of different
companies are involved).
8. In special situations, as determined by the Executive
Committee, marketed chemicals which have potential for
large-scale and/or intense human exposure, even if it
may be possible to require industry to perform the
testing.
The NTP Board of Scientific Counselors provides scientific
oversight of the NTP, advises the Director and Executive
Committee on scientific content and policy, and evaluates the
quality of the research and testi-ng conducted by the NTP
components. When projects are completed and technical reports on
the results are prepared, the Technical Reports Review
Subcommittee of the Board, supplemented by an ad hoc panel of
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expert reviewers, evaluates the reports for technical and
scientific merit. Through this extensive review, the NTP is
assured that its program efforts are of high quality and
relevance.
To disseminate the information developed by the program, the
NTP publishes a number of documents.*
o NTP Annual Plan - contains current information on plans
for research, testing, and validation efforts and
results from completed research.
o NTP Review of Current DHHS, DOE, and EPA. Research
Related to Toxicology - contains information on
toxicological research and test methods development
activities, as well as personnel and resources committed
to those activities, at 17 DHHS agencies, DOE, and EPA.
o NTP Technical Bulletin - provides timely and frequent
announcements of the NTP research activities and
specific actions.
o Annual Report on Carcinogens - contains a listing of
substances either "known" or "reasonably anticipated" to
be carcinogens, as well as available information on the
production and use of these substances, human exposures,
and regulations designed to protect the public health.
o Technical Reports - provides results of NTP's long-term
carcinogenesis studies. Reports for chemicals now being
started on test will contain results related to target
organ effects, chemical disposition, fertility and
reproductive effects, urinalysis, clinical chemistry,
hematology, and other endpoints as appropriate.
Through this testing and information dissemination, the NTP
attempts to identify and provide information on hazardous
chemicals so that preventive and protective measures can be taken
to protect the health of the American public.
*NOTE:To receive copies of or to be placed on the mailing list
for any of the NTP publications, please write to: NTP Public
Information Officer, P.O. Box 12233 (M.D. B2-04), Research
Triangle Park, N.C. 27709, (919) 541-3991 or FTS 629-3991.
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ORGANIZATION*
NIEHS/TOXICOLOGY RESEARCH AND TESTING PROGRAMS
o Plans and conducts research to develop, validate, and
evaluate methods for characterizing the toxicology of
chemical compounds and other environmental agents.
o Plans and conducts a program of research and testing,
including short-term screening and long-term animal
toxicology and carcinogenesis studies, to establish the
toxicity of chemical compounds and other environmental
agents.
o Collaborates with chemical toxicology test development
and test programs of other government agencies.
o Disseminates results of tests, test development, and
test validation efforts to interested members of the
scientific community and to Federal regulatory agencies,
Carcinogenesis and Toxicology Evaluation Branch
o Designs, conducts, and interprets carcinogenesis and
related studies on chemicals.
o Work closely with other branches to develop data that
elucidate general mechanisms that may be involved in
toxic effects.
*The majority of NTP's budget and other resources are
administered by the NTP Director, Deputy Director, and staff
located within the NIEHS. The NIOSH and NCTR components are not
under direct NTP management, but each plays a specific role in
the program's operations, contributes on the basis of annual
aggrements, .and actively participates in the chemical selection
process and on the Steering Committee. In these organizational
sections, only those offices that are assigned specific
responsibility for NTP activities and that deal with toxics or
toxics-related issues are developed. However, other offices
within these agencies may collaborate on NTP projects and carry
out NTP-related activities.
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o Conducts research intended to develop and validate
improved toxicity testing methodologies, establish
short-term and screening test systems, and improve
interpretation of long-term toxicology and
carcinogenesis results.
o Monitors testing program to assure the quality and
validity of the toxicology components of the tests.
Systemic Toxicology Branch
o Develops methods for assessing toxic effects involving
immune, renal, pulmonary, reproductive, and other bodily
functions.
o Performs studies to develop basic knowledge of chemical
absorption, distribution, metabolism, and excretion.
o Conducts research to improve test protocols, to develop
new tests, and to improve interpretation of test results
related to the toxicity of chemicals on a variety of
organs, tissues, and cells.
o Collaborates as specific experts in fields such as
toxicology, -immunology, pharmacokinetics, and physiology
with other scientific staff of the program involved in
test development and validation and with test protocol
preparation.
Cellular and Genetic Toxicology Branch
o Develops and validates a variety of in vivo and in vitro
methods to detect and define effects of chemicals on
genetic components.
o Develops and standardizes in vivo test systems as models
for carcinogenesis and mutagenesis that provide for
extrapolation to humans.
o Investigates somatic as well as heritable gene damage
that results from exposure to environmental agents.
o Studies effects of chemicals on experimental organisms
and on human populations.
o Develops and utilizes computer data files for storage,
retrieval, and analysis of genetic toxicity test data.
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Chemical Pathology Branch
o Provides pathology support to all segments of the NTP,
and especially to carcinogenesis studies.
o Develops standards for tumor and non-tumor pathology
diagnoses and nomenclature.
o Develops clinical chemistry parameters for assessing
cellular and organ function.
o Monitors the testing program to assure the quality and
validity of pathology components of the tests.
Program Operations Branch
o Maintains continual planning, oversight, coordination,
and surveillance of toxicology testing activities.
o Undertakes scientific and technical monitoring of test
laboratories.
o Provides logistical support for coordinating and
scheduling the contract testing functions.
o Monitors quality assurance and good laboratory practices
at the testing laboratories.
Program Resources Branch
o Provides a range of special support resources for
toxicology and carcinogenesis testing and test
development activities.
o Assures acquisition and quality control of test animals
and provides for acquisition, quality control, and
standardization of tests.
o Monitors laboratory safety, chemistry, and animal care
practices.
NIOSH
Protects U.S. workers from work-related hazards through
a comprehensive research program designed to coordinate
laboratory investigations, field surveys, and
epidemiologic studies so the appropriate standards and
controls can be developed.
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o Concentrates research efforts to reduce unnecessary
morbidity and mortality related to the ten leading work-
related diseases and injuries:
Occupational lung diseases: asbestosis, byssinosis,
silicosis, coal workers' pneumonconiosis, lung
cancer, occupational asthma.
Musculoskeletal injuries: disorders of the back,
trunk, upper extremity, neck, lower extremity;
traumatically-induced Raynaud's phenomenon.
Occupational cancers (other than lung): leukemia;
mesothelioma; cancers of the bladder, nose, and
liver.
Amputations, fractures, eye loss, lacerations, and
traumatic deaths.
- Cardiovascular diseases: hypertension, coronary
artery disease, acute myocardial infarction.
Disorders of reproduction: infertility, spontaneous
abortion, teratogenesis.
Neurotoxic disorders: peripheral neuropathy, toxic
encephalitis, psychosis, extreme personality changes
(exposure-related).
- Noise-induced loss of hearing.
- Dermatologic conditions: dermatoses, burns
(scalding), chemical burns, contusions (abrasions).
Psychologic disorders: neuroses, personality
disorders, alcoholism, drug dependency.
o Develops criteria from research and evaluation studies
for use by the Occupational Safety and Health Adminis-
tration as the basis for its standards development
process.
Division of Biomedical and Behaviorial Sciences
o Acts as lead division for NTP research.
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NCTR
Conducts research in support of NTP on work-related
diseases and injuries:
Occupational lung diseases: studies the etiology,
dose-response, and interactive factors in
occupationally-induced asthma.
Occupational cancers: performs bioassay screeninq of
single chemicals; assesses carcinogenic potential of
complex mixtures and the modification of carcinoqenic
action by promoters and cocarcinogens; studies the
etiology of the carcinogenic process in various
workplace environments; examines the influence of
personal and occupational factors and substituted
materials on the mechanisms of the diseases; studies
the importance of the route of exposure.
Cardiovascular diseases: performs chronic inhalation
studies to assess the potential toxic myocardial
effects of selected aliphatic amines of industrial
importance.
Disorders of reproduction: identifies and assesses
chemicals that prevent or inhibit reproduction
through effects on adults of either sex, interfere
with normal development and produce effects either in
utero or postnatally, and cause genetic disease
and/or cancer through transplacental transfer.
- Neurotoxic disorders: identifies and characterizes
chemical hazards, reevaluates and develops
recommended limits, and recommends substitute
chemicals or improved work practices to reduce
exposure.
- Dermatologic conditions: develops and evaluates
quantitative in vivo techniques for studyinq the
extent and rate of percutaneous absorption of
chemicals. These studies provide support for NTP
skin carcinogenesis assays, such as with glutural-
dehyde.
Determines adverse effects resulting from long-term,
low-level exposure to various chemical substances.
Develops experimental data to facilitate extrapolation
of laboratory results to humans.
-335-
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o Determines basic biological processes in animals to
provide a more accurate extrapolation of laboratory
results to humans.
o Develops improved methods and testing protocols for
evaluating the relative safety of chemical substances.
Office of Scientific Intelligence
o Provides services to NCTR as a liaison and focal point
on matters pertaining to the National Toxicology Program
and the World Health Organization.
o Participates in compound nominations and selections for
chemical evaluations for the NTP and prepares Executive
Summaries on compound use, population exposure, and
safety evaluations or research performed on selected
compounds.
o Conducts chemical evaluations on selected NTP compounds.
Division of Mutagenesis Research
o Estimates the risk to humans from exposure to chemicals
in the environment.
o Develops methods to measure both microlesions (single
gene mutations or small deletions) and macrolesions
(serious chromosomal aberrations) for use in toxicology
and safety evaluations.
o Works to improve short-term, in vivo bioassays for
identifying the effects of toxic substances on genes.
o Focuses research on developing reliable and economical
methods for evaluating the genotoxic potential of
chemicals. Results are then used to identify the
chemical risk to humans.
Division of Teratogenesis Research
o Manages the teratology portion of the National
Toxicology Program.
o Develops sound information bases of comparative pharma-
cokinetics and metabolism to define valid mathematical
models for extrapolation of animal data to humans.
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o Expands knowledge of basic developmental processes which
can be affected by toxicants and defines mechanisms of
teratogenicity.
o Develops and validates improved procedures for detecting
the full range of possible toxic manifestations
throughout the lifespan of the organism.
o Currently conducts four major projects: the Behavioral
Teratology Collaborative Study, Reliability of Animal
Models in Teratology, Development and Use of
Mathematical Extrapolation Models in Teratogenesis, and
Utility of Fetal Histopathology in Teratology Testing.
Division of Toxicology Data Management Systems
o Conceptualizes, develops, implements, and operates the
Toxicology Data Management System (TDMS) at NCTR for the
National Toxicology Program.
o Assists EPA Office of Testing and Evaluation in
developing an automated data system, in accordance with
TSCA guidelines.
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NATIONAL TOXICOLOGY PROGRAM ORGANIZATIONAL AREAS AND LEADERS
-338-
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NATIONAL TOXICOLOGY PROGRAM ORGANIZATIONAL AREAS AND LEADERS
(con't.)
-339-
-------
NTP ADVISORY BODIES
Executive Committee
Commissioner, FDA (Chairperson): Dr. Arthur H. Hayes, Jr.
Chairman, Consumer Product Safety
Commission: Nancy Steorts
Assistant Secretary for Health, DHHS
(non-voting): Dr. Edward N. Brandt, Jr.
Administrator, Environmental
Protection Agency: William D. Ruckelshaus
Director, NCI: Dr. Vincent deVita
Director, NIOSH: Dr. J. Donald Millar
Director, NIEHS (and NTP Director): Dr. David P. Rail
Director, NIH: Dr. James B. Wyngaarden
Assistant Secretary of Labor,
Occupational Safety and Health
Administration: Thorne Auchter
Board of Scientific Counselors
Professor, Department of Biostatistics,
University of Washington: Norman Breslow, Ph.D.
Professor, Wistar Institute: Leila Diamond, Ph.D.
Associate Professor of Pharmacology,
University of North Carolina
School of Medicine Curtis Harper, Ph.D
Professor and Director, Center for
Environmental Toxicology, Michigan
State University Jerry B. Hook, Ph.D
Associate Professor, Department of
Obstetrics and Gynecology,
University of Cincinnati Jean Manson, Ph.D
Director, Biomedical Sciences
Division
Lawrence Livermore Laboratory
University of CaliforniaMortimer L. Mendelsohn, M.D. ,
(Chairperson)Ph.D.
Director, McArdle Laboratory,
University of Wisconsin Henry Pitot, Ph.D.
Chief, Pathology Department, Chemical
Industry Institute of Toxicology: James A. Swenberg, D.V.M., Ph.D,
-340-
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STATUTORY AUTHORITY
Public Health Service Act
Public Law 78-410 42 U.S.cTs 201
The authority under which the NTP supports and conducts its
activities in section 301 of the Public Health Service Act, which
the Secretary of HHS broad powers to conduct and support research
relating to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and impairments of
man.
Key Sections of Act—Toxics Focus
sec. 301(a) Authorizes Surgeon General to conduct and "promote
the coordination of research investigations,
experiments, demonstrations, and studies relating
to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and
impairments of man, including water purification,
sewage treatment, and pollution of lakes and
streams."
sec. 301(b) Authorizes the Surgeon General to make available
any research facilities, public authorities, health
officials, or scientists engaged in related fields
of study.
Public Law 95-622 42 U.S.C. § 241
Effective October 1, 1978, section 301 of the Public Health
Services Act was amended to authorize the Secretary to conduct
and support studies and testing of substances for
carcinogenicity, teratogenicity, mutagenicity, and other harmful
biological effects. This authority is in addition to that
granted by the above sections.
Key Section of Act—Toxics Focus
sec. 301(b)(1) Authorizes Secretary to conduct and support
through grants and contracts studies and
testing of substances for carcinogenicity,
teratogenicity, mutagenicity, and other harmful
biological effects.
-341-
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APPENDIX
-------
STATUTORY AUTHORITIES TO CONTROL TOXIC SUBSTANCES
IN TWELVE MAJOR ACTS
Prepared by
Hollis Call
The following charts are intended to provide a summary
representation of the statutory authorities to control toxic
substances and the major information gathering/producing
authorities contained in 12 selected acts.
Limitations
These charts are designed to serve three essential
purposes: one, to allow a quick reference of the statutory
authorities contained in these 12 acts; two, to provide an
overall picture of control authorities relevant to the lifecycle
of a toxic substance; and three, to give an idea of some of the
gaps, overlaps, and perhaps some of the legislative deficiencies
present in the statutory framework for controlling toxic
substances.
For each statute depicted in these charts, an appropriate
Office or Agency administering that statute reviewed the material
in an effort to make these charts as accurate as possible.
However, for several reasons, there are some limitations on the
use of this material.
First, this area of analysis is often very complex and
further complicated by the fact that some of the statutory
authorities shown in the charts have not yet been fully
implemented or tested. Gernally, a complete interpretation of
the statutes' authorities can be accomplished only by reviewing
the respective statutes, the Code of Federal Regulations, and any
administrative or judicial judgments affecting the way in which
these authorities are interpreted and used.
Another limitation that should be pointed out arises as a
consequence of attempting to subsume what are often broadly
stated authorities into discrete categories. Thus, the fact that
several sections of different statutes may be listed in one box
does not necessarily indicate that these secitons can be
equated. In most cases, they cannot. The additional analysis
required to allow for direct comparison of these authorities is
beyond the scope of this overview. However, a footnote is
provided where the differences are particularly egregious. For
convenience, only Chart 1 is footnoted; these footnotes apply as
well to Charts 2 and 3.
-343-
-------
Observations
There are several preliminary observations that might be
made from a reading of these charts.
One is that although there may be specific instances of a
lack of statutory authority to control a toxic hazard, there do
not appear to be many gaping holes in the statutory framework.
As TSCA becomes fully implemented the comprehensive coverage of
the toxic substance lifecycle will increase.
However, the existence of a full complement of statutory
authorities does not ensure or indicate effective control of
toxic substances. Over 30 pieces of legislation have some
regulatory authority over toxic substances. Each piece in this
statutory framework was added incrementally over the past 2
decades. Each piece of legislation was a response to specific
perceived needs and thus each has as a somewhat different
orientation to toxic substance control, with different regulatory
considerations.
The implications of these characteristics for regulating
toxics, which typically fall under the jurisdiction of more than
one statute, may be signficant. Deficiencies in the regulatory
coverage may arise as a result of conflicts between shared
jurisdictions and a lack of integrated operational relationships
between Agencies rather than simply an absence of statutory
coverage. Whether these relationships present themselves as
obstacles or conversely as opportunities will in part help
determine whether toxic substances are controlled effectively and
efficiently.
On the vertical axis are eight different types of regulatory
action that a statute might authorize to control toxics. These
types, or classes, of control actions are general and are not
intended to be exhaustive of all regulatory or control options
available. In many instances, Agency efforts to control toxic
substances are more subtle and indirect than the types of control
actions listed in these charts. The Federal Insecticide,
Fungicide, and Rodenticide Act's (FIFRA's) "rebuttable
presumption against registration," for example, plays an
important role in the regulatory fabric for regulating toxics, a
role which is difficult to depict in these charts. Nevertheless,
the types of control actions listed represent the predominant
regulatory actions undertaken by Agencies to control toxic
substances.
-344-
-------
It should also be pointed out that there will be cases of
overlap between these types of control actions. For example: a
"guideline" or "standard" could be similar in effect to a
"quantity limitation" or even a "prohibition," depending on how
the standard was written and the response of the affected
party. Distinctions between these authorities are based, in
these charts, on a reading of the language in the statutes
themselves.
The types of control actions listed in this chart should be
self-descriptive. However, additional elaboration of the
distinction between "labeling/packaging" and "notice" refers to
the authority to require a specified party to give notice to
those specifically exposed to a toxic hazard from a chemical
substance or product which is in use, distribution, disposal,
etc. "Labeling" authorities on the other hand, generally refer
to requirements for labeling of products to reduce or eliminate
the risk from a toxic chemical substance or product prior to
potential exposure through distribution, use, transportation, or
disposal.
Chart 1
The horizontal axis of this chart contains eight columns
which represent eight "points" in the life cycle of a toxic
substance. As such these points reflect both potential health or
environmental exposure pathways, and potential points of
regulatory control of a toxic substance.
Although the distinction made in these charts between
manufacturing/processing, commerical distribution,
transportation, use, etc., serves a useful analytical purpose,
there may be overlap among these in some statutory provisions.
Prohibiting or banning manufacturing/processing of a chemical,
for example, would probably also have a similar effect on the end
use of that chemical. On the other hand, a prohibition/ban on
maufacturing of a chemical for a particular use would still allow
manufacturing and use of that chemical for a particular use would
still allow manufacturing and use of that chemical for non-banned
uses. A decision by an Agency to control a toxic substance in
either manufacturing, in use, or in manufacturing for a
particular use, will depend largely upon the authorities
available, the nature of the risk presented, and required
regulatory considerations.
-345-
-------
Charts 2 and 3
These charts contain the same information as Chart 1, but
the information is referenced differently for user convenience.
Chart 2 allows the reader to easily find any particular statute,
control authorities. The lifecycle points to which each cited
section of the statute apply are listed to the right of each
section.
Chart 3 also allows referencing by statute, in this case
according to points of lifecycle of a toxic substance. In this
chart, the symbols representing the relevant control type are
listed to the right of each section cited.
In both Charts 2 and 3, a legend appears at the bottom of
the page referring to either types of control action (Chart 3) or
chemical lifecycle (Chart 2).
Chart 4
Direct control actions taken by Agencies represented in
these charts (Charts 1 thru 3} do not give a complete picture of
the legislative framework to control toxic substances. Another
significant class of authorities which complement control actions
are provisions for gathering/producing information. Chart 4
contains selected information gathering/producing authorities in
these 12 Acts. The information in this chart display was taken
in part from an EPA publication, Chemical Reporting and Record-
Keeping Authorities Under 15 Environmental and~Consumer Acts.
-346-
-------
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CAA
CWA
FIFRA
RCRA
SDWA
TSCA
CPSA
PPPA
FHSA
OSHA
HMTA
FFDCA
PROHIBITIONS/
BANS
211(c) MP
211(c) CD
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6la)(6) D
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14(a) 1
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302 MP
304 MP
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301 EE
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6(8)11) CD
6(a)(2) CD
6(a)(1) T
6(a)(2l T
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111(al EE
112(b)(1) EE
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106(a) T
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REGISTRATION
CERTIFICATION,
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211(a),(b) CD
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204 U
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311 EE
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-------
CHART 3
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FIFRA
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PROCESSING
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GS GUIDELINES, STANDARDS
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RC REGISTRATION, CERTIFICATION
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