O«B«C ®8 Pesssesdes ewS
tettc Swhsswsess
. O.C. 204GO
Federal Activities in
Toxic Substances
Toxic Integration
Information Series
CPSOCEQ»DOL»DOT«DHHS
EPA»FDA»USDA
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Other Publications in the Toxics Integration Information Series:
EPA Chemical Activities Status Report, First Edition—
EPA-560/13-79-003 (June 1979)
Directory of Federal Coordinating Groups for Toxic Substances,
First Edition—EPA-560/13-79-004 (June 1979)
Directory of Federal Coordinating Groups for Toxic Substances,
Second Edition—EPA-560/13-80-008 (March 1980)
Perspectives on the Top 50 Production Volume Chemicals—
EPA-560/13-80-027 (June 1980)
For further information or to order copies contact:
Industry Assistance Office (TS-799)
U.S. Environmental Protection Agency
401 M Street SW.
Washington, DC 20460
Telephone toll-free 800-424-9065
or in Washington, DC, 554-1404
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Toxics Integration Information Series EPA-560/13-80-015
FEDERAL ACTIVITIES
IN
TOXIC SUBSTANCES
Edited by
Judith Colle
With the Assistance of
Elaine Schosman
Kathryn SIike
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
May 1980
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CONTENTS
FOREWORD v
FEDERAL AGENCIES
Consumer Product Safety Commission (CPSC) 3
Council on Environmental Quality (CEQ) 23
Department of Agriculture (DOA) 33
Food Safety and Quality Service (FSQS) 37
Department of Health and Human Services (DHHS) 59
Bureau of Foods/Bureau of Drugs (FDA) 63
National Center for Toxicological Research (NCTR) 85
National Cancer Institute (NCI) 99
National Institute of Environmental Health Sciences (NIEHS) 115
National Institute for Occupational Safety and Health (NIOSH) .... 133
Department of Labor (DOL) 149
Occupational Safety and Health Administration (OSHA) 153
Department of Transportation (DOT) 169
Materials Transportation Bureau (MTB) 171
United States Coast Guard (USCG) 181
Environmental Protection Agency (EPA) '. 195
Office of Pesticides and Toxic Substances (OPTS) 203
Office of Toxic Substances (OTS) 207
Office of Pesticide Programs (OPP) 225
Office of Water and Waste Management (OWWM) 245
Office of Water Planning and Standards (OWPS) 247
Office of Drinking Water (ODW) 257
Office of Solid Waste (OSW) 269
Office of Air, Noise, and Radiation (OANR) 281
Office of Air Quality Planning and Standards (OAQPS)/Office of
Mobile Source Air Pollution Control (OMSAPC) 283
PROGRAMS
National Toxicology Program (NTP) ..... 297
APPENDIX 307
iii
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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,
"[TSCA] 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 the staff of
EPA's Office of Toxics Integration 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.
The scope of this first edition is limited to 17 offices located within 8
Federal agencies or departments which, in our judgment, have a primary role in
the control of toxic substances. Becaus this field is quite new and rapidly
expanding, we recognize that much of the material presented here may quickly
become outdated.* Therefore, it is anticipated that this document will be
updated annually, and future editions will include additional agencies and
statutes. We welcome any suggestions for improving and/or expanding this
material.
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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 12
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
12 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, Toxics Integration Staff
Office of Pesticides and Toxic Substances (TS-793)
U.S. Environmental Protection Agency
401 M Street SW.
Washington, DC 20460
Telephone (202) 755-2778
Walter W. Kovalick, Jr.
Director
Toxics Integration Staff
VI
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Federal Agencies
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CONSUMER PRODUCT SAFETY COMMISSION
1111 18th St. NW.
Washington, DC 20207
Locator: 202-492-6600
Information: 301-492-6731
Organization page 6
Statutory Authorities page 10
Regulatory Development .page 14
Toxics-Related Activities page 15
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.
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CPSC is headed by five Commissioners appointed by the President with the
advice and consent of the Senate.
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CONSUMER PRODUCT SAFETY COMMISSION
ORGANIZATIONAL CHART*
COMMISSIONER
R. DAVID PITTLE
COMMISSIONER
EDITH B. SLOAN
COMMISSIONER
SUSAN KING
CHAIRMAN
COMMISSIONER
STEWART
M. STATLER
ADVISORY COUNCILS
Toxicofogical Advisory Board
National Advisory Committee
for Flammable Fabrics Act
Technical Advisory Committee
POISON PREVENTION ON
PACKAGING
Product Safety Advisory Council
*NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances activities.
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ORGANIZATION
OFFICE OF THE GENERAL COUNSEL
o Provides legal counsel to the Commissioners and staff of CPSC.
o Prepares the CPSC legislative program, and comments on relevant
legislative proposals originated in other Agencies.
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 chronic chemicals and
environmental hazards activities, see "Health Sciences.")
HAZARD IDENTIFICATION AND ANALYSIS
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 safety standards for toxic
substances.
*Note: Only those offices which customarily have dealt with toxics-related
issues are described here.
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o Supervises technical policy, technical quality and productivity,
planning input, and review.
o Collects injury data and prepares injury data analysis to identify
hazards or hazardous patterns, human factor analysis, economic impact
analysis of remedial regulations, environmental assessments, and
environmental impact statements.
o Collects data on the chemical ingredient of consumer products.
ENGINEERING AND SCIENCES
o Develops and evaluates product safety standards and test methods.
o Furnishes CPSC with 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.
o Serves as Secretariat for National Poison Prevention Week.
o Provides program management for chronic chemical and environmental
hazards activities.
COMPLIANCE AND ENFORCEMENT
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 Establishes 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.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone
Chairman
Executive Director
Secretary of CPSC
Office of General
Counsel
Office of Program
Management
202-634-7740
301-492-6550
202-634-7770
202-634-7770
301-492-6557
Hazard Identification
and Analysis 301-492-6567
Engineering and
Sciences
Deputy for Health
Sciences
Compliance and
Enforcement
301-492-6494
301-492-6957
301-492-6621
Interagency Liaison 301-492-6731
Mail Stop
Room 800
1111 18th St. NW.
Washington, D.C. 20207
Room 436
5401 Westbard Ave.
Bethesda, MD 20207
Room 317
1111 18th St. NW.
Washington, D.C. 20207
Room 528
1111 18th St. NW.
Washington, D.C. 20207
Room 426
5401 Westbard Ave.
Bethesda, MD 20207
Room 600-B
5401 Westbard Ave.
Bethesda, MD 20207
Room 735
5401 Westbard Ave.
Bethesda, MD 20207
Room 700
5401 Westbard Ave.
Bethesda, MD 20207
Room 240
5401 Westbard Ave.
Bethesda, MD 20207
Room 304
5401 Westbard Ave.
Bethesda, MD 20207
REGIONAL AND FIELD OFFICES
CPSC Atlanta
Area Office
1330 West Peachtree St., NW.
Atlanta, GA 30309
404-881-2231
FTS: 8-257-2231
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CPSC Boston
Area Office
CPSC Chicago
Area Office
CPSC Cleveland
Area Office
CPSC Dallas
Area Office
Room 1607
100 Summer St.
Boston, MA 02110
Room 2945
230 South Dearborn St,
Chicago, IL 60604
Plaza Nine Bldg.
Room 520
55 Erieview Plaza
Cleveland, OH 44114
Room 1610
11 Commerce St.
Dallas, TX 75242
617-223-5576
FTS: 8-223-5576
312-353-8260
FTS: 8-353-8260
216-522-7160
FTS: 8-293-7160
214-767-0841
FTS: 8-729-0841
CPSC Denver
Area Office
CPSC Kansas City
Area Office
CPSC Los Angeles
Area Office
CPSC New York
Area Office
CPSC Philadelphia
Area Office
CPSC San Francisco
Area Office
CPSC Seattle
Area Office
CPSC Twin Cities
Area Office
Guaranty Bank Bldg.
Suite 938
817 17th St.
Denver, CO 80202
Midland Bldg.
Suite 1000
1221 Baltimore Ave.
Kansas City, MO 64105
Suite 1100
3660 Wilshire Blvd.
Los Angeles, CA 90010
6 World Trade Center
6th Floor
Vesey St.
New York, NY 10048
10th Floor
400 Market St.
Philadelphia, PA
19106
U.S. Customs House
Room 416
555 Battery Street
San Francisco, CA 94111
3240 Federal Bldg.
915 Second Ave.
Seattle, WA 98174
Metro Square
Suite 580
7th & Robert
St. Paul, MN 55101
303-837-4795
FTS: 8-327-4795
816-374-3151
FTS: 8-758-3151
213-688-7272
FTS: 8-798-7272
212-264-2266
FTS: 8-264-1134
215-597-9362
FTS: 8-597-9362
415-556-1819
FTS: 8-556-1819
206-442-5276
FTS: 8-399-5276
612-725-7781
FTS: 8-725-7781
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STATUTORY AUTHORITIES
Consumer Product Safety Act
Public Law 92-573 15 U.S..C. §§ 2051-2063
The Consumer Product Safety Act (CPSA) grew out of the need for a unified
and comprehensive 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
(PPPA), the Flammable Fabrics Act (FFA), and the Refrigerator Safety Act
(RSA).
The purposes of the Act 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—Toxics 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.
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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 requirements as to the
various aspects of a consumer product such as packaging,
composition, design, or requirements for labeling with clear
warnings or instructions.
sec. 8 Provides authority for banning consumer products that present
an unreasonable risk of injury.
sec. 9 Details administrative procedures for promulgation of consumer
product safety rules•
sec. 10 Allows the public to petition the Commission for a consumer product
safety rule.
sec. 12 Empowers the Commission to take immediate action against imminently
hazardous consumer products.
sec. 13 Provides for the promulgation of rules concerning new consumer
products.
sec. 14 Requires manufacturers of consumer products to certify conformity
to CPSC safety standards. Allows CPSC to require the use and
prescribe the form and content of labels.
sec. 15 Authorizes the Comuission to require manufacturers of hazardous
products to take certain actions (notification and repair,
replacement, or refund).
sec. 30(d) Gives the Commission the ability to regulate risks of injury under
this act rather than FHSA, PPPA, or FFA, if the Commission finds it
to be in the public interest.
Regulatory Options Available Under Statute
o Assisting in voluntary standards development
o Enacting mandatory standards
o Removing or recalling of products
o Banning
Federal Hazardous Substances Act
Public Law 86-613 15 U.S.C. §§ 1261-74
The Federal Hazardous Substances Act (FHSA) was enacted in 1960. It began
as a labeling law. The original law established definitions for toxic,
corrosive, irritant, flammable, and radioactive substances. Materials that
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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 cautionary 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 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 labeling would be adequate to protect
the public health and safety.
sec. 3 Allows the Commission to declare products hazardous, to require
special labeling, and to ban imminent hazards.
sec. 4 Outlines illegal acts under the Federal Hazardous Substances Act.
sec. 5-9 Gives the Commission authority to invoke penalties, seize products,
hold hearings, issue injunctions, and subpoena witnesses.
sec. 10 Gives the Commission authority to promulgate regulations for
efficient enforcement of this act.
sec. 15 Requires the repurchase of banned hazardous substances up the chain
of distribution to manufacturers.
sec. 20 Establishes the Toxicological 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 Repurchasing of banned hazardous substances up the chain of
distribution
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Poison Prevention Packaging Act
Public Law 91-601 15 U.S.C. §§ 1471-1476
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.
sec. 6 Establishes the Technical Advisory Committee to assist the Commission
in implementing the Act.
Regulatory Options Available Under Statute
o Establishing special packaging standards
o Establishing exemptions from special packaging standards for
particular substances
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
1. Identification of "candidate product" for regulatory development:
o Internal—data gathering and analysis.
o External—Commission receives petition. Notification of
hazardous product by manufacturer (Section 15, CPSA).
2. Development of strategy:
6.
7.
o
o
Conduct relevant analyses.
Satisfy Section 9 (CPSA) requirements—assessment of economic
impact of proposed regulation; must show that regulation will
reduce "unreasonable risk."
3. Preparation of briefing package by Program Manager and drafting of
proposed regulation by the Office of General Counsel.
4. Review of briefing package and proposed regulation by agency staff.
5. Revision of briefing package and proposed regulation.
Approval of proposal by Commission.
Review of public comments, development of final regulation, approval
by Commission, promulgation of final rule, and commencement of
enforcement activities.
EXISTING REGULATIONS
Consumer Product Safety Act
Federal Hazardous Substances Act
Poison Prevention Packaging Act
16 CFR 1015^1402-
16 CFR 1500-1512
16 CFR 1700-1704
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TOXICS-RELATED ACTIVITIES*
The Consumer Product Safety Commission has two programs which address
toxic substances: The Acute Chemical Hazards program and the Chronic Chemical
Hazards program.
The Acute Chemical Hazards Program is concerned with products that have
immediate injurious effects. Such hazards have long been recognized, and
Congress has given the Commission specific powers to -deal with them. Under
the Poison Prevention Packaging Act (PPPA), the Commission may require child-
resistant packaging for household substances which present serious hazards.
In addition, the Federal Hazardous Substances Act (FHSA) not only sets base-
line labeling requirements for hazardous household products and allows the
Commission to require additional cautionary labeling if necessary, but also
allows the Commission to ban products altogether if labeling is inadequate to
protect the public. Special packaging requirements are now in effect for 14
categories of hazardous substances.
The Chronic Chemical Hazards program is concerned with reducing consumer
exposure to products which cause or contribute to adverse health effects whose
appearance occurs some time after exposure to a substance. The program is
designed to enable the agency to identify the substances and exposures of
concern, evaluate them and their risks, set priorities, and determine the
regulatory and honregulatory methods for reducing or eliminating the risks.
*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-Toxics Integration staff.
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A step-by-step approach has been developed for identifying candidates for
regulation. Usually chemicals are identified as candidates for screening
through test results or toxicity data published by government, industry, the
research community, and others. Typical sources have been the National Cancer
Institute (NCI) and the International Agency for Research in Cancer (IARC).
The screening process, involving a pipeline of increasingly finer screens,
asks whether the chemical has toxic properties (such as an ability to cause
cancer, mutation, or birth defects); whether it is used in consumer products;
whether the uses are within CPSC's jurisdiction; whether the uses may result
in consumer exposure; whether the exposure results in absorption of the
chemical; and whether the exposure is widespread, of long duration, or
intense. This step-by-step process is designed to enable the Commission to
set priorities for action among the thousands of chemicals.in use today.
In addition to looking at suspect chemicals, the Commission looks at
product categories which may result in widespread consumer exposure. The
Commission then asks what the products contain, whether the contents have been
tested for potential toxic effects by any Government agency, whether industry
has tested the contents', and, as appropriate, whether testing needs to be
conducted to measure the safety of an ingredient suspected to be hazardous.
Initially, during Fiscal Year 1979, the program focused on carcinogens;
during Fiscal Year 1980 and beyond, the program will continue to emphasize
carcinogens while paying careful attention to chemicals that cause other
chronic health problems, particularly birth defects and neurological
dysfunctions.
Brief descriptions of the substances currently included in these two
programs are provided below.
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Asbestos
The Consumer Product Safety Commission has banned consumer garments
containing asbestos, tape joint compounds containing asbestos/ and artificial
fireplace embers of asbestos. In May 1978 the Commission initiated actions
against hand-held hairdryers containing asbestos and voluntary corrective
action was undertaken by the industry to refit, exchange, or refund the
purchase price of hairdryers containing asbestos. An Advanced Notice of
Proposed Rulemaking has been published commencing an investigation of asbestos
use in consumer products and seeking comment on CPSC possible regulatory
approaches to asbestos.
CPSC is closely coordinating these regulatory activities with the
Environmental Protection Agency and the other IKLG agencies to ensure maximum
effectiveness and to minimize reporting burdens on industry.
Benzene
The Commission on May 19, 1978, proposed a rule to regulate consumer
products containing benzene as an intentional ingredient or as a contaminant.
The Commission took this action because of information indicating that
exposure to benzene may cause blood disorders, including leukemia, and
chromosomal abnormalities. Due to complex issues raised by the proposed rule,
the Commission has extended to October 13, 1980, the time in which it must
issue a final rule or withdraw the proposed regulation.
The staff has conducted a limited market survey to update information on
the benzene content of consumer products, is assessing the results of animal
teratology studies, and is conducting a study of the air levels of benzene
produced by the use of consumer products containing benzene. The Commission
has published a general order requiring firms that have used benzene as an
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ingredient in their -products since January 1, 1979, to report that use to the
Commission. Regulatory activities with other Federal agencies are being
coordinated through the IRLG Benzene workgroup.
F ormaldehyde
The Commission has received over 1,000 complaints to date dealing
primarily with formaldehyde release in the home from urea-formaldehyde foam
(UFF) insulation. A recent report of the possible carcinogenicity in test
\
animals from formaldehyde vapors in animals has heightened the Commission's
concern. The Commission is currently gathering and evaluating existing data
on formaldehyde toxicity and chemistry. It is also waiting for the results of
studies it has implemented with the Department of Energy (to determine the
factors involved in formaldehyde off-gassing from UFF). The Commission staff
has recommended that the Commission propose a regulation that would require
manufacturers of UFF insulation to provide information to customers concerning
the release of formaldehyde from the product. The Commission intends to
prepare recommendations for regulatory options for UFF insulation by
September 1980. Regulatory activities will be coordinated with other Federal
agencies through the IRLG Formaldehyde Task Group which is chaired by CPSC's
Dr. Andrew Ulsamer.
Benzidine-Based and Benzidine-Derived Dyes
On October 18, 1978, the Commission was petitioned by Artist-Craftsmen of
New York, Inc. et al., to issue a rule under Section 8 of the CPSA banning
benzidine-based and benzidine-derived dyes. The petitioners state that the
dyes present a risk of bladder cancer to humans and can be inhaled, ingested,
and absorbed through the skin during consumer use.
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The staff is evaluating data on the metabolism, epidemiology,
carcinogenicity, mutagenicity, and exposure to these dyes. Retail dye packet
samples are being analyzed for the presence of . benzidine, o-tolidine, and
o-dianisidine and of dyes based upon these compounds. Experimental studies
are being conducted on the skin absorption and metabolic fate of the
benzidine-based dye group. CPSC is coordinating regulatory activities with
other Federal agencies through the IRLG Benzidine Task Group.
Chemical Room Deodorizers
This project was initiated by the staff in early Fiscal Year 1979 to
investigate potential toxic effects from chronic exposure to low levels of
chemical substances in room deodorizers. The staff plans to conduct a study
to identify the chemicals used in these products and will conduct studies of
the reproductive effects of at least one of the most popular formulations.
Carbon Monoxide
In the course of developing a consumer product safety standard to reduce
consumer exposure to toxic gases from unvented gas-fired space heaters, an
additional issue of potential toxic effects from chronic exposure to low
levels of carbon monoxide from a variety of sources was identified. The staff
is conducting a comprehensive search and review of current information. A
study is planned to measure actual levels of carbon monoxide produced by
unvented gas-fired space heaters and other fuel-burning appliances. The
health effects of those levels will be evaluated.
Chlorofluorocarbons
During 1979 the ban on nonessential uses of fully halogenated chloro-
fluorocarbons in propellants in aerosols became fully effective. The Inter-
agency Chlorofluorocarbon Workgroup (CPSC, EPA, FDA et al.) continues its work
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to develop regulatory options for other nonaerosol propellant uses of
chlorofluorocarbons. In addition, the study has opened a broader issue
related to other potentially toxic gases which may be present in the indoor
environment as a result of emissions from consumer products.
Hydrocarbon Propellants
The Commission has directed the staff to gather and evaluate data and
information on potential health effects of hydrocarbon propellants in aerosol
consumer products. The staff is examining the consumer safety implications of
the switchover from .chlorofluorocarbons (CFCs) to hydrocarbon propellants.
Consumer products subject to CPSC's jurisdiction have been identified and
formulation data collected. The Commission staff plans to evaluate toxicity
and exposure data for hydrocarbon propellants.
Labeling of Aerosol Propellant Ingredients
Several years ago, the Commission determined that aerosol consumer
products containing vinyl chloride monomer propellants potentially presented
an unreasonable carcinogenic risk to the public. Subsequently, products
containing these chemicals were banned and the Commission directed the staff
to consider drafting a proposed rule requiring labeling of aerosol products
with the composition of substances used as propellants. The staff and
Commissioners will consider this issue further.
Lead
Lead has been banned from paints at levels in excess of 0.06 percent since
1978. Subsequently, both consumer complaints and reports in the scientific
literature have alerted CPSC to the use of lead in consumer products such as
decorated glassware, gift wrap paper, and wearing apparel. The staff is
assessing the bioavailability of lead from such products and estimating
s~*
potential exposure levels in order to develop regulatory options.
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Hexane
The Commission received a petition in July 1979, to ban marketing,
dissemination, distribution, and sale of products containing n-hexane. While
the petition was formally denied, the Commission has instructed the staff to
evaluate the toxicity of n-hexane, to obtain technical data on levels of
consumer exposure to products containing n-hexane, and to provide an
assessment of potential hazard. The staff is also evaluating the possible
additive effects of chemical agents such as methyl ethyl ketone and methyl
butyl ketone which are frequently associated with n-hexane.
Art Hazards
The major substances to which artisans are exposed are: pigments,
solvents, lead, and other heavy metals. During the past 8 months the
Commission has completed a study to identify 1) firms and industries in the
area of arts and crafts; 2) art and craft products; and, 3) chemicals and
materials used in these products and the potential health effects of these
chemicals. The study provides baseline data should the Commission decide to
take future regulatory action in the area of art products.
21
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22
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COUNCIL ON ENVIRONMENTAL QUALITY
722 Jackson Place NW.
Washington, D.C. 20006
Locator: 202-395-5700
Information: 202-395-5770
Organization page 23
Statutory Authorities page 29
Toxics-Related Activities Page 32
The Council on Environmental Quality (CEQ) 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 programs affecting
environmental quality. Additional responsibilities were provided by the
Environmental Quality Improvement Act of 1970, Executive Order 11514, as
amended by Executive Order 11991, and Reorganization Plan No. 1 of 1977.
CEQ's general charge includes:
o Developing and recommending national policies which foster and pro-
mote improvement of environmental quality, including review and
23
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t
assessment of -the effectiveness of existing and proposed Federal
facilities, program policies, and activities which affect environ-
mental quality, development of the President's environmental message
to Congress, and assisting in development of the President's
environmental legislation programs,
o Assisting Federal agencies in coordinating programs and activities
\
which affect, protect, and improve environmental quality. This
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 process, developing
guidelines for evaluating environmental impacts of Federal actions,
and developing 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, including the development and
maintenance of UPGRADE, developing special studies and analyses on
environmental quality and health, and assisting the President in the
preparation of the annual environmental quality 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,
24
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o Preparing for transmittal by the President to the Congress an annual
report setting forth conditions and trends in environmental quality.
o Developing and maintaining the National Oil and Hazardous Materials
Pollution Contingency Plan under Section 311 of the Clean Water Act.
CEQ 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. CEQ
has a long and active involvement in the toxic substances and environmental
health fields. CEQ 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. CEQ has been involved in the
implementation of TSCA, participating in the development and review of various
program and budget issues. Pursuant to the President's 1977 Environmental
Message charging CEQ with developing recommendations to address gaps and
overlaps in information, research, and regulation of Federal programs dealing
with toxic substances, CEQ chairs the Toxic Substances Strategy Committee,
whose final report to the President will be published in May, 1980. CEQ
chairs the Interagency Task Force on Environmental Data and Monitoring which
is designed to develop effective and systematic toxics data monitoring
capabilities of the Federal Government. CEQ cochairs (with EPA) the
Interagency Toxic Substances Data Committee, a permanent interagency committee
formed pursuant to-Section 'TO(b) dflthe Toxic Substances Control Act and other
legislative and executive mandates. The Data Committee is charged with the
responsibility of developing ;ah integrated data network to support Government
in toxics research and regulation. The Council isj a statutory member of the
Interagency Testing Committee formed pursuant to Section 4 of TSCA and
25
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participates in other interagency committees addressing toxics research and
regulation. In addition to TSCA-related activities, the Council reviews
toxics-related budget, policy, and program issues, including those relating to
pesticides, occupational health, hazardous waste, consumer products, drugs,
pollution, and environmental health research. The Council also has been
active in promoting Federal support for the development and use of 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 has a toxic substances and
environmental health staff to direct this effort. The Council does not issue
"toxics regulations." Therefore, a regulatory development section is not in-
cluded for this agency.
The Council is organized into 11 functional components:
o Executive Office
o Public and Congressional Affairs
o General Counsel
o Administrative Office
o Environmental Data and Monitoring
o Land Use and Wildlife
o Energy and Resource Recovery
o Economics and Pollution Control
o International and Global Affairs
o Environmental Health and Toxic Substances
o Public Lands and Water Resources
26
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The principal staff component involved in toxic substances matters is the
Environmental Health and Toxic Substances staff. Other staff units with addi-
tional responsibility include General Counsel, Environmental Data and Monitor-
ing, International and Global Affairs, and Economics and Pollution Control.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Name Title Phone* Area of focus
Robert Harris Council Member 202-395-5700 Environmental health
and toxic substances
Nicholas Yost General Counsel 202-395-5750 Environmental impact
statements
Robert B. Nicholas Senior Staff 202-395-4980 Environmental health
Member and toxic substances
*A11 mail should be addressed to the Washington, D.C., address.
27
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COUNCIL ON ENVIRONMENTAL QUALITY
ORGANIZATIONAL CHART
EXECUTIVE OFFICE
CHAIRMAN
MEMBERS
EXECUTIVE DIRECTOR
DEPUTY EXECUTIVE DIRECTOR
SPEECHWRITER
ro
CO
J_
PUBLIC AND
CONGRESSIONAL
AFFAIRS
GENERAL
COUNSEL
J.
ENVIRONMENTAL
DATA AND
MONITORING
ENERGY AND
RESOURCE
RECOVERY
J_
ADMINISTRATIVE
OFFICE
ECONOMICS AND
POLLUTION
CONTROL
J_
INTERNATIONAL
AND GLOBAL
AFFAIRS
LAND USE
AND WILDLIFE
PUBLIC LANDS
AND WATER
RESOURCES
ENVIRONMENTAL
HEALTH AND
TOXIC
SUBSTANCES
-------
STATUTORY AUTHORITIES
National Environmental Policy Act
Public Law 91-190 42 U.S.C. §§ 4341-4347
The Council on Environmental Quality was established in 1970 under Section
202 of this Act. NEPA establishes a national policy of using all practicable
means to prevent damage to the environment. It charges Federal agencies with
the duty of analyzing the potential impact of a proposed action and its
alternatives, and to consider these impacts and the goals set forth in NEPA in
the course of their decisionmaking. 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. §§ 4371-4374
The Environmental Quality Improvement Act of 1970 created an Office of
Environmental Quality to provide staff support to CEQ. It brought more fund-
ing 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.
29
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Toxic Substances Control Act
Public Law 94-469 15 U.S.C. § 2601
CEQ is one of eight statutory members of the Interagency Testing
Conmittee. 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.C. § 242
CEQ's responsibilities under this Act include participation in an ongoing
study of the health costs of pollution and 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 5, 1970) as amended by
Executive Order 11991 (May 24, 1977), and
Reorganization Plan No» 1 of 1977
This Order and Plan empowers the Council to recommend to the President and
to Federal agencies priorities in environmental programs. It gives the Coun-
cil responsibility for advising and assisting the President and Federal agen-
cies in achieving international cooperation for dealing with environmental
30
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problems, under the foreign policy guidance of the Secretary of State. It
also authorizes the Council to issue regulations binding on all Federal agen-
cies 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 a facility whose products, emissions, or effluents are
prohibited or regulated because their toxic effects on the environment create
a serious public health risk.
Assignment of Functions Under Section 311 of the
Clean Water Act (Formerly Federal Water
Pollution Control Act), August 7, 1973
. ilk- '
Executive Order 11735
This Order delegates authority to various agencies of the Federal Govern-
ment to deal with actual or threatened discharges of oil or hazardous sub-
stances in waterways, from both onshore and offshore facilities'. The
Environmental Protection Agency and the U.S. Coast Guard are empowered to
exercise'' the authority of the President in enforcing regulations issued
pursuant to this Order. The Council on Environmental Quality is the
designated coordinating agency for the preparation of the "National Oil and
Hazardous Materials Pollution Contingency Plan" (see 40 CFR 150 and 44 FR
28196).
31
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TOXICS-RELATED ACTIVITIES
Program Description
The Council's toxics program is policy oriented. CEQ conducts studies on
an ad hoc basis/ develops programs for interagency coordination and makes
recommendations for executive action. Among the current studies being
conducted by the Council are the following: cancer incidence and mortality
trends, human reproductive hazards from environmental pollution, and ground
water contamination from hazardous waste disposal.
32
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DEPARTMENT OF AGRICULTURE
14th Street and Independence Avenue SW.
Washington, D.C. 20250
*
Locator: 202-447-5781
Information: 202-447-2791
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.
The act of Congress, approved May 15, 1862, created the Department of
Agriculture, which was administered by a Commissioner of Agriculture until
1889. By act of 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.
33
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This publication focuses on the responsibilities and activities of the
Food Safety and Quality Service (FSQS) located within the Department's Food
and Consumer Services Office.
34
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DEPARTMENT OF AGRICULTURE
ORGANIZATIONAL CHART*
OFFICE OF THE
GENERAL COUNSEL
SECRETARY
OEPUTV SECRETARV
JUDICIAL OFFICER
ASSISTANT SECRETARY
ADMINISTRATION
U)
Ul
BOARD OF CONTRACT
APPEALS'
MANAGEMENT STAFF
OFFICE OF
ADMINISTRATIVE LAW
JUDGES
OFFICE OF EQUAL
OPPORTUNITY
OFFICE OF OPERATIONS
AND FINANCE
OFFICE OF PERSONNEL
OFFICE OF SAFETY AND
HEALTH MANAGEMENT
DIRECTOR
ECONOMICS. POLICY
ANALYSIS, AND BUDGET
ECONOMICS,
STATISTICS, AND
COOPERATIVES SERVICE
OFFICE OF BUDGET,
PLANNING, AND
EVALUATION ,
ASSISTANT SECRETARV
RURAL DEVELOPMENT
FARMERS HOME
ADMINISTRATION
RURAL ELECTRIFICATION
ADMINISTRATION
WORLD FOOD AND
AGRICULTURAL OUTLOOK
AND SITUATION BOARD
RURAL TELEPHONE BANK
OFFICE OF GOVERNMENTAL
AND PUBLIC AFFAIRS
OFFICE OF ENERGY
OFFICE OF THE
INSPECTOR GENERAL
ASSISTANT SECRETARY
FOOD AND CONSUMER
SERVICES
FOOD AND NUTRITION
SERVICE
ASSISTANT SECRETARV
MARKETING AND
TRANSPORTATION
SERVICES
AGRICULTURAL
MARKETING
SERVICE
ANIMAL AND PLANT
HEALTH
INSPECTION SERVICE
FEDERAL GRAIN
INSPECTION SERVICE
OFFICE OF
TRANSPORTATION
UNDER SECRETARV
INTERNATIONAL AFFAIRS
AND COMMODITY
PROGRAMS
AGRICULTURAL
STABILIZATION AND
CONSERVATION SERVICE
COMMODITY CREDIT
CORPORATION
FEDERAL CROP INSURANCE
CORPORATION
FOREIGN AGRICULTURAL
SERVICE
OFFICE OF THE GENERAL
SALES MANAGER
OFFICE OF INTERNATIONAL
COOPERATION AND
DEVELOPMENT
ASSISTANT SECRETARY
CONSERVATION.
RESEARCH,
AND EDUCATION
FOREST SERVICE
SCIENCE AND EDUCATION
ADMINISTRATION
SOIL CONSERVATION
SERVICE
•NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic
substances activities.
-------
36
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THE FOOD SAFETY AND QUALITY SER VICE
U.S. Department of Agriculture
14th and Independence Avenue SW.
Washington, D.C. 20250
Locator: 202-447-6617
Information: 202-447-7943
Organization page 40
Statutory Authorities page 46
Regulatory Development page 50
Toxics-Related Activities page 55
The Pood Safety and Quality Service (FSQS) was organized by the Secretary
of Agriculture in March 1977 to bring together the Department of Agriculture's
consumer programs related to food safety, quality, and procurement. The
purpose of this organizational change was to develop and provide better
services to consumers by assuring that foods are safe,, wholesome, and
nutritious, that they are of good quality, and that they are uniformly and
honestly labeled.
FSQS administers the Federal Meat Inspection Act and the Poultry Products
Inspection Act, which provide for uniform Federal-State inspection of all meat
• v
and poultry products. Inspection regulations require prior approval of the
construction and equipment of plants operating in interstate commerce;
37
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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 FSQS 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, FSQS participates in the regulation of toxics under two
separate statutory authorities. First, FSQS 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 poultry
food supplies. Second, under the Federal Food, Drug, and Cosmetic Act
(FFDCA), the Food and Drug Administration (FDA) regulates toxic substances
which may be found in foods, drugs, or cosmetic products.
38
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U.S. DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND QUALITY SERVICE
ORGANIZATIONAL CHART*
ASSURANCE
DIVISION
FRUIT AND
VEGETABLE
QUALITY
DIVISION
COMMODITY
SERVICES
-ITV
CE
M
D
LE
V
•
•
•
•
MEA1
D
POU
„?
DIVISION
DAIRY
QUALITY
DIVISION
•NOTE: A partial organizational chart is shown to highlight (in gray) those
components ordinarily involved with toxic substances activities.
-------
ORGANIZATION*
OFFICE OF THE ADMINISTRATOR
o Maintains management control over the following activities delegated to
FSQS by the Secretary of Agriculture:
Inspection and grading programs for dairy products, fruits and
vegetables, meat and poultry, and other foods;
Inspection of the quality of egg products and regulation of the
disposition of eggs containing harmful bacteria;
Processing and distribution of various food products; and
Transportation and sale of foods determined unsafe.
o Administers a Government-wide program to ensure the quality of food
obtained by Federal agencies*
SCIENCE PROGRAM (SCI)
o Works in conjunction with the Office of the Administrator to formulate
FSQS scientific and laboratory policies and to coordinate research
proj ects.
o Operates the FSQS 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 foods and the regulation of
direct and indirect additives in meat and poultry.
Chemistry Division (SCI)
o Develops analytical methods and approves those that are suitable for
supporting a regulatory program.
o Conducts special studies for FSQS where necessary and performs
comparison studies with Federal and commercial laboratories.
o Maintains a quality assurance program to ensure the validity of
experimental results.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
40
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Microbiology Division (SCI)
o Conducts a general microbiology program to identify pathogens and
toxins in support of 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
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 food.
Food Ingredient Assessment Division (SCI)
o Coordinates the establishment of FSQS 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 Performs chemistry, microbiology, and pathology studies in analyzing
food and nutrition products.
o Supervises State laboratories under contract to FSQS to analyze food
for chemical economic adulteration analysis.
41
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COMPLIANCE PROGRAM (CP)
o Supervises FSQS monitoring and enforcement programs.
o Works with other FSQS branches to formulate new policies and programs.
o Coordinates the development of FSQS 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 Develops the agency1s labeling policy and standards for meat and
poultry.
o Initiates actions to withdraw services and conduct debarment
proceedings.
Regulations and Coordination Division (CP)
o Publishes FSQS regulations, instructions, and notices.
o Reviews regulations for adequacy, clarity, and compliance with agency
requirements.
MEAT AND POULTRY INSPECTION (MPI)
o Ensures the wholesome quality 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, approves new construction of plants and
equipment, develops sanitary requirements, and reviews the inspection
systems of countries exporting food to the United States.
o Monitors and evaluates State meat and poultry inspection programs.
Technical Services (MPI)
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 the establishment of regulatory
criteria concerning the disposition of carcasses.
42
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o Develops requirements for facilities, equipment, and sanitation and
'"' approves new construction and equipment for meat and poultry plants.
o Prepares environmental considerations for the Meat and Poultry
Inspection Program.
Field Operations (MPI)
o Inspects meat and poultry products during processing.
o Checks the accuracy of label information and monitors plants, other
facilities, and individuals for compliance with legal orders.
o Inspects meat and poultry entering or leaving the United States.
Regional Offices (MPI)
o Plans and coordinates Field 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.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL*
Division/Office Phone Mail Stop
Office of the Administrator 202-447-7025 332-E
Science Program • 202-447-2326 402-A
Chemistry Division 202-447-7623 403-A
Microbiology Division 202-447-4212 602-A
Pathology and Epidemiology
Division ' 301-344-2640 101 318-C
Beltsville, MD
Residue Evaluation and
Surveillance Division 202-447-8096 404-A
Field Service Laboratories
Division 202-447-4198 404-A
*FTS numbers are the same.
43
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Division/Office
Compliance Program
Regulations Coordination
Division
Meat and Poultry Inspection
Technical Services
Field Operations
Food Ingredient Assessment
Phone
202-447-8803
202-447-3317
202-447-3473
202-447-3521
202-447-3679
202-447-7680
Mail Stop
344-E
2940-S
341-E
4911-S
4869-S
2148-S
REGIONAL AND FIELD OFFICES
Area Supervisor
Region I
Meat and Poultry
Inspection Program
New Hampshire Area Office
Federal Building and
U.S. Post Office
Boom 433
Concord, NH 03301
603-834-4747
Area Supervisor
Regional Director
Regional Director
Main Station Supervisor
Region II
Meat and Poultry
Inspection Program
26 Federal Plaza
Room 1737
New York, NY 10007
Region III
Meat and Poultry
Inspection Program
1421 Cherry Street
Seventh Floor
Philadelphia, PA 19102
Region IV
Meat and Poultry
Inspection Program
1718 Peachtree Street, NW.
Room 216
Atlanta, GA 30309
Region V
Meat Quality Division
4101 South Halsted Street
Room 217
Chicago, IL 60609
212-264-1390
215-597-4219
404-257-3911
312-353-5751
44
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Regional Director Region VI 214-729-9116
Meat and Poultry
Inspection Program
1100 Commerce Street
Room 5F41
Dallas, TX 75242
Fed-State Supervisor Region VIII 303-839-2825
Poultry and Dairy
Quality Division
c/o Colorado Department
of Agriculture
2331 West 31st Avenue
Room 113
Denver, CO 80211
Regional Director Region IX 415-536-7402
Meat and Poultry
Inspection Program
620 Central Avenue, Building 2C
Alameda, CA 94501
Area Supervisor Region X 206-434-9497
Washington Area Office
Meat and Poultry
Inspection Program
711 South Capital Way
Evergreen Plaza Building
5th Floor
P.O. Box 2167 ,,,
Olympia, WA 98507
45
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STATUTORY AUTHORITIES
Federal Meat Inspection Act
Public Law 90-201 21 U.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 purposes 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) Prohibits the use of any food additive determined
(2)(c) 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.
46
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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 Drug
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, tag, or label
o Notify the Governor of the State
o Refuse to provide or withdraw inspection service
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."
"Adulteration11 applies to any poultry carcass or poultry product
that is found to contain added poisonous or deleterious
substances, including 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.
47
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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 conditions 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
o Determine fine or imprisonment or both
o Prescribe conditions for storage and handling
o Destroy and prescribe terms and conditions for destruction
o Detain
o Proceed against, seize, and condemn
o Issue inj unctions
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. FSQS
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.
48
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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
o Establish standards or conditions
o Require registration or certification
49
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
Regulatory development at FSQS is a three-part process which begins with
the placement of a regulatory initiative on the FSQS Work Plan. The
initiative then follows through the Decision Log Movement, the Impact Analysis
Movement, and the Docket Clock. (This is explained in greater detail in the
steps below, and the diagrams which follow.) Both the Office of Primary
Interest and the Regulations Coordination Division play a central role in this
process. Also, the Meat and Poultry Inspection and Residue Monitoring
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 FSQS) begins the regulatory process by entering an initiative
onto the FSQS Work Plan. Once on the Work Plan, the initiative may
be published in the Federal Register. Placement on the Work Plan
also triggers the Decision Log Movement within FSQS. (Diagram 1)
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 Residue Monitoring Programs.
3. When the decision is found to be significant or not significant an
Impact Analysis Movement is prepared. (Diagram 2)
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 (Docket Clock). 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 Development and Program Planning for
the development of a public participation plan as appropriate.
(Diagram 3)
5. The approved Docket, along with a proposed public participation plan
and comments, are presented to the Administrator for final approval.
50
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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 Cosmetic Act 21 CFR 1-1702
51
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Diagram 1. DECISION LOG MOVEMENT
OPI
(Docket included
on work plan)
REGULATIONS
COORDINATION DIVISION
(Prepares Decision
Log)
Decision Log to:
DEPUTY
ADMINISTRATOR
COMPLIANCE
ui
to
REGULATIONS
COORDINATION
DIVISION
(Proceed with clearance
on docket)
Decision Log to:
ADMINISTRATOR
FOOD SAFETY
QUALITY SERVICE
I
OFFICE OF BUDGET,
PLANNING AND
EVALUATION
1
ASSISTANT SECRETARY
FOOD AND
CONSUMER SERVICES
(For designation of
significant or not significant) I
RCD — Regulations Coordination Division
OPI - Office of Primary Interest
PD and PP — Policy Development and Program Planning
D/A - Deputy Administrator
OGC — Office of General Counsel
ADM, Assistant SEC — Administrator, Assistant Secretary
FR - Federal Register
-------
Diagram 2. IMPACT ANALYSIS MOVEMENT
OPI IMPACT
ANALYSIS
in
W
PD and PP
OPI DEPUTY
ADMINISTRATOR
(Signature)
DIRECTOR,
PD and PP
(Signature)
If "Not Significant'
_
RCD
Proceed with final clearance on docket.
(Impact goes ahead of docket.)
ASSISTANT SECRETARY
FOOD AND
CONSUMER SERVICES
(Signature)
I
ADMINISTRATOR
FOOD SAFETY AND
QUALITY SERVICE
(Signature)
If "Significant"
Departmental Approval
(DIRECTOR, ECONOMICS,
POLICY ANALYSIS AND
BUDGET)
RCD — Regulations Coordination Division
OPI - Office of Primary Interest
PD and PP — Policy Development and Program Planning
D/A - Deputy Administrator
OGC - Office of General Counsel
ADM, Assistant SEC - Administrator, Assistant Secretary
FR - Federal Register
-------
Diagram 3. DOCKET CLOCK
/Adm \
^Record/
ROD - Regulations Coordination Division
OPI — Office of Primary Interest
PD and PP — Policy Development and Program Planning
D/A — Deputy Administrator
OGC - Office of General Counsel
ADM, Assistant SEC - Administrator, Assistant Secretary
FR - Federal Register
54
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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
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.
^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.
55
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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 ante mortem and post mortem 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.
The Meat and Poultry Inspection (MPI) Program 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 product. 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 catastrophy if all product was
held until analyses were completed for all possible residues. Least of all,
the need for holding facilities to prevent loss of product in itself would
eliminate a "fresh" product from the market.
56
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The time required for collecting, shipping, and analyzing tissues is not
complementary to the speed of kill and movement of fresh product to market.
However, it does permit a followup action on any further product identified
from the same origin.
This leads to the surveillance phase, which consists of analysis plus
control when a particular residue, if present, would make the meat unfit for
food. All the followup sampling falls in this category whenever the
monitoring program finds a residue violation or information is obtained that a
residue problem may exist. This phase is always biased by knowledge of a
specific problem and designed to answer specific questions. The various
approaches used in this phase are:
1. Single Premise Residue Confirmation Program —
testing of animals from a premise which was found to contain
residues near or above violative levels on previous laboratory
analyses .
2. Integrated Production Systems Residue Program —
to determine whether a residue violation involves single premise
or the entire operation under an integrated management system.
3. Inspector Initiated Samples —
tissues analyzed for cause; suspicion of violative residues.
4. Investigation of Residue "Breaks" —
to establish the existence of a break and formulate the necessary
controls .
5. "Named" Residue Surveillance —
to develop residue data on a compound in one or more species,
evaluate a change in practice and determine that the National
Residue Monitoring is representative of a smaller geographic area.
6. Method Development Residue Program —
to collect samples for the. final development of an analytical
method.
As indicated by the descriptive titles,, .these .programs are designed to
answer specific questions and are terminated as soon as the answer is
obtained.
57
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Most often it is at the producers' facilities where—by accident -or lack
of concern—drugs and chemicals are misused. The law does not permit
jurisdiction on their facilities, only at the slaughter plant. However,
authority on the farm is governed by other Federal and State agencies.
58
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DEPARTMENT OF
HEAL TH AND HUMAN SER VICES
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.
59
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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.
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.
60
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
ORGANIZATIONAL CHART
EXECUTIVE ASSISTANT I I
TO THE SECRETARY/ •••
EXECUTIVE SECRETARY'
SECRETARY
OFFICE OF
ASSISTANT
SECRETARY
FOR
MANAGEMENT
AND BUDGET
UNDER SECRETARY
Deputy Under Secretaries
(2)
OFFICE OF
ASSISTANT
SECRETARY
FOR
LEGISLATION
OFFICE OF
ASSISTANT
SECRETARY
FOR
PERSONNEL
ADMIN-
ISTRATION
OFFICE OF
ASSISTANT
SECRETARY
FOR PUBLIC
AFFAIRS
OFFICE OF
GENERAL
COUNSEL
OFFICE OF
ASSISTANT
SECRETARY
FOR PLANNING
AND
EVALUATION
OFFICE FOR
CIVIL
RIGHTS
OFFICE OF
INSPECTOR
GENERAL
I
OFFICE OF HUMAN
DEVELOPMENT SERVICES
ADMINISTRATION ON AGING
ADMINISTRATION FOR CHILDREN,
YOUTH, AND FAMILIES
ADMINISTRATION FOR
NATIVE AMERICANS
ADMINISTRATION FOR PUBLIC
SERVICES
1
,
PUBLIC HEALTH SERVICE
CENTER FOR DISEASE CONTROL
FOOD AND DRUG
ADMINISTRATION
HEALTH RESOURCES
ADMINISTRATION
HEALTH SERVICES
ADMINISTRATION
NATIONAL INSTITUTES
OF HEALTH
ALCOHOL, DRUG ABUSE,
AND MENTAL HEALTH
ADMINISTRATION
1
HEALTH CARE
FINANCING ADMINISTRATION
HEALTH STANDARDS AND
QUALITY BUREAU
BUREAU OF QUALITY CONTROL
BUREAU OF PROGRAM
OPERATIONS
BUREAU OF PROGRAM POLICY
BUREAU OF SUPPORT SERVICES
PRINCIPAL
REGIONAL
OFFICIALS
1
SOCIAL SECURITY
ADMINISTRATION
OFFICE OF SYSTEMS
OFFICE OF GOVERNMENTAL
AFFAIRS
OFFICE OF FAMILY
ASSISTANCE
OFFICE OF HEARINGS
AND APPEALS
OFFICE OF OPERATIONAL
POLICY AND PROCEDURE
OFFICE OF ASSESSMENT
OFFICE OF
CHILD SUPPORT
ENFORCEMENT
-------
62
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BUREA U OF FOODS7BUREA U OF DR UGS
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Secretary's Office
Locator: 301-443-1544
Information: 301-443-1544
Organization page 66
Statutory Authority( ies) page 70
Regulatory Development page 74
Toxics-Related Activities page 75
The Food and Drug Administration (FDA) is a scientific regulatory agency
&
responsible for the safety of the Nation's foods, cosmetics, human and
veterinary drugs, medical devices, biologies, and electronic radiological
products.
The manufacturer has the prime responsibility for ensuring the safety of
its products. FDA's role is to monitor the industry and to provide the
consumer the best assurances possible that industry is meeting its
responsibility. Given the magnitude of the job and the scarcity of resources,
sf.
FDA's strategy is to maximize the impact of its regulatory efforts.
63
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This strategy is implemented by: (1) working with manufacturers to
identify critical control points and develop good manufacturing practices; (2)
statistically sampling establishments and products to identify problem areas
and to measure the effectiveness of manufacturers' quality control efforts;
and (3) conducting a safety review of all food and drug components to
determine if they pose any hazard in light of ever new scientific evidence and
techniques.
This section covers the activities of the Bureau of Foods and the Bureau
of Drugs. The functions and responsibilites of the National Center for
Toxicological Research are covered in a separate section.
64
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FOOD AND DRUG ADMINISTRATION
ORGANIZATIONAL CHART*
OFFICE OF THE
COMMISSIONER
COMMISSIONER
DEPUTY
COMMISSIONER
Ji
J\
L
OFFICE OF
HEALTH AFFAIRS
ASSOCIATE
COMMISSIONER FOR
HEALTH AFFAIRS
OFFICE OF POLICY
COORDINATION
ASSOCIATE
COMMISSIONER FOR
POLICY
COORDINATION
OFFICE OF
MANAGEMENT
AND OPERATIONS
ASSOCIATE
COMMISSIONER FOR
MANAGEMENT AND
OPERATIONS
1
BUREAU OF
VETERINARY
MEDICINE
DIRECTOR
BUREAU OF
MEDICAL DEVICES
DIRECTOR
I
OFFICE OF
LEGISLATIVE
AFFAIRS
ASSOCIATE
COMMISSIONER FOR
LEGISLATIVE
AFFAIRS
L
OFFICE OF
PUBLIC AFFAIRS
ASSOCIATE
COMMISSIONER FOR
PUBLIC AFFAIRS
BUREAU OF
RADIOLOGICAL
HEALTH
DIRECTOR
BUREAU OF
BIOLOGICS
DIRECTOR
1
NATIONAL CENTER
FOR
TOXICOLOGICAL
RESEARCH **
DIRECTOR
1
EXECUTIVE
DIRECTOR OF
REGIONAL
OPERATIONS
•NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances activities.
••NOTE: Although NCTR falls under the organizational structure of FDA, the
Center's operating authority is derived from an Interagency agree-
ment between DHHS and EPA. Because of the complexity of its
organizational ties and the extent of its toxics-related activities,
NCTR is developed separately in this Overview.
-------
ORGANIZATION*
OFFICE OF REGULATORY AFFAIRS
o Assists Commissioner and other officials on regulations and compliance
issues that have an impact on policy development, execution, and
long-range program goals.
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 legal actions to ascertain compliance with
regulatory policy and enforcement objectives.
o Coordinates development of new or novel Agencywide compliance programs,
such as bio-research monitoring activities.
o Monitors compliance activities to ensure uniform application of FDA
policy.
OFFICE OF PLANNING AND EVALUATION
o Develops program and planning strategy through analysis and evaluation
of issues affecting policies and program performance.
o Initiates and monitors the Agencywide 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.
o Recommends new programs, changes in existent programs, and program
priorities.
o Develops systems to evaluate FDA program accomplishments.
*NOTE: Only those offices that deal with toxics or toxics-related issues are
developed in this section.
66
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o Evaluates impact of FDA programs on consumer protection.
o Manages the FDA Evaluation Review Board.
BUREAU OF FOODS
o Develops FDA policy involving safety, composition, quality, and
labeling of foods, food additives, colors, and cosmetics.
o Conducts research and develops standards regarding these products.
o Conducts research designed to improve the detection, prevention, and
control of contamination responsible for illness or injury from these
products.
o Develops and promulgates good manufacturing practices for food
processing industries.
o Plans FDA surveillance, compliance, and regulatory activities relating
to foods, food additives, colors, and cosmetics.
o Reviews industry petitions and recommends regulations for food
standards and for the safe use of color and food additives.
o Collects and interprets data on nutrition, food additives, and
environmental factors affecting the total chemical result posed by
direct and indirect food additives.
o Maintains a nutrition data bank.
BUREAU OF DRUGS
o Develops FDA policy with regard to the safety, effectiveness, and
labeling of all drugs for human use.
o Reviews and evaluates new drug applications and notices of claimed
investigational exemptions for new drugs.
o Develops and implements standards for the safety and effectiveness of
all over-the-counter drugs.
o Monitors the quality of marketed drugs through product testing,
surveillance and compliance programs.
o Develops and promulgates regulations and guidelines for current good
manufacturing practices.
o Develops and disseminates information and educational materials about
drugs to the medical community.
o Conducts research and develops scientific standards on the composition,
quality, safety, and efficacy of human drugs.
67
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o Collects and evaluates information on the effects and use trends of
marketed drugs.
o Monitors prescription drug advertising and promotional labeling to
ensure accuracy and integrity.
o Analyzes data on accidental poisonings and disseminates toxicity and
treatment information on household products and medicines.
o Evaluates applications for methadone treatment centers and other
activities using methadone or similar drugs.
o Directs the FDA antibiotic and insulin certification program.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Office of Regulatory
Affairs
Phone*
301-443-1594
Mail Stop
HFC-1
Office of Planning and
Evaluation
301-443-4230
HFP-1
Bureau of Foods
Bureau of Drugs
202-245-1057
301-443-2894
HFF-1
HFD-1
REGIONAL AND FIELD OFFICES
Division/Office
Regional Food and Drug
Director
Regional Food and Drug
Director
Regional Food and Drug
Director
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 Streets
Room 900
Philadelphia, PA 19106
*FTS numbers are the same.
68
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Division/Office
Phone
Mail Stops
Regional Food and Drug
Director
404-881-4266
FTS: 8-257-4266
Regional Food and Drug
Director
312-353-1047
FTS: 8-353-1047
Regional Food and Drug
Director
Regional Food and Drug
Director
Regional Food and Drug
Director
214-749-2735
FTS: 8-729-0317
816-374-5646
FTS: 8-758-5646
303-837-4915
FTS: 8-327-4915
Regional Food and Drug
Director
415-556-2062
FTS: 8-556-2062
Regional Food and Drug
Director
206-442-5304
FTS: 8-399-5304
Region IV
HFR-41
880 West Peachtree
Street, N.W.
Atlanta, GA 30309
Region V
HFR-51
175 West Jackson
Boulevard
Room A-1945
Chicago, IL 60604
Region VI
HFR-61
3032 Bryan Street
Dallas, TX 75204
Region VII
HFR-71
1009 Cherry Street
Kansas City, MO 64106
Region VIII
HFR-81
U.S. Customhouse
721 19th Street
Room 500
Denver, CO 80202
Region IX
HFR-91
U.N. Plaza Federal Office
Building
Room 526
San Francisco, CA 94102
Region X
HFR-01
909 1st Avenue
Room 5003
Seattle, WA 98174
69
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STATUTORY AUTHORITIES
The Federal Food, Drug/ and Cosmetic Act (FFDCA)
Public Law 717 21 U.S.C. $$ 301-392
The Federal Food, Drug, and Cosmetic Act was passed in 1938 to expand the
Food and Drugs 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 approval of new drugs. The 1938 Act required predistribution
clearance for safety of new drugs and brought cosmetics and devices 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; that drugs for human and animal use are not adulterated or misbranded
and are safe and effective for their intended use, including 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
70
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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 (only proof of safety was required under the 1938 statute). The
1962 Amendments also gave FDA authority to regulate prescription drug
advertising. The responsibility for regulating the advertising of drugs sold
over the counter is assigned to the Federal Trade Commission.
Key Sections of Act—Toxics Focus
sec. 301 Details prohibitions under the Act.
sec. 302, Injunctions, penalties, seizures.
303, 304
sec. 401 Authorizes FDA to promulgate regulations fixing definitions and
standards of identity quality, and fill for foods.
sec. 402(a)(1).A food shall be deemed to be adulterated if it bears or
contains any poisonous or deleterious substance which may
render it injurious to health, or;
sec. 402(a)(2) if it contains any added poisonous or deleterious substance.
sec. 403 Details reasons for deeming foods misbranded.
sec. 406 Authorizes FDA to set tolerances for poisonous or deleterious
substances in food which cannot be avoided by good
manufacturing practice.
sec. 409(a) A food additive shall be deemed unsafe unless it is exempted
from sec. 402(a) or its safe use is otherwise regulated.
sec. 409(b) Allows public to petition FDA to regulate food additives.
sec. 409(c)(1) Requires FDA to establish regulations detailing conditions for
safe use of particular food additives, or deny sec. 409(b)
petitions.
sec. 409(c)(3) No additive shall be deemed safe if it is found to induce
cancer when ingested by man or animal.
sec. 409(c)(5) Other relevant factors such as probable quantity of consumption
of additive, cumulative effects and safety factors shall be
consid.ered.
sec. 409(d) Empowers FDA to take initiative at any time to propose
regulations prescribing conditions of safe use of food
additives.
71
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sec. 501 Details reasons for deeming drugs and devices to be
adulterated.
sec. 502 Details reasons for deeming drugs and devices to be misbranded.
sec. 503(a) Allows FDA to exempt certain drugs and devices from labeling
and packaging requirements.
sec. 503(b) Describes types of drugs that shall be dispensed by
prescription only, and requirements for labeling a
prescription.
sec. 505 Requires manufacturers to submit new drug applications to FDA
for approval prior to introducing a new drug into
inter state commerc e.
sec. 505(e) Allows the Secretary, DHHS to suspend a new drug application
immediately if the substance presents an imminent hazard to
health.
sec. 505(i) Authorizes FDA to establish regulations permitting the shipment
of investigational new drugs in interstate commerce without an
approved new drug application.
sec. 510 Requires registration and listing by manufacturers of drugs and
devices.
sec. 513 Establishes a classification system for devices.
sec. 514 Establishes rulemaking procedures for issuing device
performance standards.
sec. 515 Requires premarket approval requirements, for Class III devices.
Requires that benefit to the public be shown.
Allows FDA to ban unsafe or ineffective devices.
sec. 516 Allows FDA to ban devices that present substantial deception or
unreasonable and substantial risk of illness or injury.
sec. 701 Authorizes FDA to issue regulations for the efficient
enforcement of the Act.
sec. 702 Authorizes FDA to conduct examinations and inspections, to
execute and serve search warrants, to seize products, and make
arrests.
sec. 703 Requires carriers and recipients of foods, drugs, devices, or
cosmetics in interstate commerce to allow FDA access to their
records.
sec. 704 Allows FDA to conduct inspections.
72
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sec. 706 Details requirements for listing and certification of color
additives for foods, drugs, and cosmetics.
sec. 706(b) A color additive shall be deemed unsafe and shall not be listed
5(B) if it induces cancer when ingested by man or animal.
Regulatory Options Available Under Statute
o Ban
o Set tolerances
o • Deem products to be misbranded
o Establish standards or conditions
o Require registration or certification
o Require premarket approval
o Publicize
o Injunction
o Seizure
o Conduct hearings
o Subpoena
o Recall
o Issue or change regulation
o Inspect
o Sample and test
o Administrative detention
o Labeling review
o Adverse findings letter
73
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
The following flowcharts highlight the regulatory processes followed by
the Bureau of Foods and the Bureau of Drugs. Although the step-by-step
approach to regulatory development differs within the individual Bureaus/
the most important regulatory proposals generated by either Bureau must be
submitted to the Commissioner's Staff Offices for final approval. (Execution
of some routine, repetitive regulatory procedures is delegated by the
Commissioner to FDA Bureau Directors.) The regulatory process within the
Commissioner's Staff follows the same path, regardless of which Bureau submits
the regulatory proposal.
EXISTING REGULATIONS
Federal Food, Drug, and Cosmetic Act 21 CFR 1-1299
74
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BUREAU OF FOODS REGULATORY PROCESS
Appropriate Branch
1 . Receives petition
2. Determines whether
petition is adequate
for filing, contacts
petitioner if not
3. Circulates petition
through technical
review appropriate for
nature and uses of
the substance
4. Drafts regulation
utilizing input from
technical review of
petition
S. Prepares Environmental
and regulatory impact
documentation
6. Circulates regulation
for technical review
-^
/
Technical Review
• Chemistry and Physics
• Toxicology
• Nutrition
• Food Technology
• Microbiology
/
if
Regulations Coordinator
Staff
1. Assigns incoming petitions
to appropriate branch
2. Ensures that appropriate
technical branches have
reviewed package
3. Preliminary legal review
4. Edits and rewrites
as necessary
5. Tracking system
6. Interegency liaison
7. Liaison with office
of General Counsel
/
Associate Director
for
Compliance
Policy and Compliance
Review
^-
Bureau Director
Approval
Regulations Policy Staff
1. Coordinates final
editing with Office
of Federal
Register Writer.
Coordinates with
2
' General Counsel
for final legal
review
3. Conducts policy
Office of
Federal Register Writer
Final editing and
production of
clean draft
Office of
General Counsel
Legal Review
Associate Commissioner
for
Regulatory Affairs
Approval
Commissioner
of
Food and Drugs
Approval
Commissioner's Staff
-------
BUREAU OF DRUGS REGULATORY PROCESS
Appropriate Bureau unit
identifies the need for FR
document.
i
ADRA drafts document
and action memo and coor-
dinates the development of
necessary supporting docu-
mentation
ADRA coordinates intra-
Bureau and intra -Agency
clearance.
Federal Register writer
edits and types final.
Commissioner approves
and signs ?
Based on inputs from various
sources.
Appropriate Bureau unit may
draft basic content of docu-
ment and provide to ADRA as
starter.
"This excludes the following: antibiotic documents,
DESI documents, and other documents relating to
withdrawal or refusal of NDA approval, which are
depicted on other flow charts; OTC monographs,...
documents pertaining to insulin, and documents
establishing a bioequivalent requirement for which
processing procedures have been modified somewhat.
"This includes the development of necessary impact
statements, to which the Office of Planning and
Evaluation contributes.
'"This includes NDE, Compliance, General Counsel,
EDRO, the Regulations and Policy Staff of ACRA,
and others as appropriate.
Acronyms:
ADRA • • Assistant Director for Regulatory Affairs
HFD-1 - - Director. Bureau of Drugs
ACRA - - Associate Commissioner for Regulatory Affairs
GC - - General Counsel
DESI • - Drug Efficacy Study Implementation
NDA - - New Drug Application
OTC - - Over the Counter
NDE - - New Drug Evaluation
EDRO - Executive Director of Regional Operations
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TOXICS-RELATED ACTIVITIES
The Program Management System (PMS) is an Agencywide system consisting of
the vital processes necessary to manage the FDA. It can be viewed as an
umbrella system encompassing planning, budgeting, reporting, and evaluation.
The PMS covers all FDA program activities. Integral to PMS is a framework of
nine programs, such as the Food Safety Program and the Human Drugs Program.
These 9 programs are subdivided into 41 projects; for example, Drug Quality
Assurance and Food Sanitation and Quality Control. These projects are the
basic building blocks for all management activities.
Keeping track of the accomplishments, performance, and impact of an agency
with such diverse responsibilities as FDA is difficult, albeit critical.
Because much authority and responsibility is decentralized in FDA, a system
using the PMS structure has been developed to regularly assess the objectives,
the tactics, and the accomplishments of Agency activities. Under this system,
each of the Agency's PMS projects is periodically evaluated by an independent
team headed by the Office of Planning and Evaluation. These PMS evaluations
focus on key project issues and strategies which assess the project's
direction, problems, and needs. Each evaluation results in a briefing to the
Commissioner by the manager of the project under evaluation.
*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.
77
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The following descriptions highlight projects that typify toxics-related
activities by FDA.
Chemical Contaminants
This project consists of identifying and assessing the health risks posed
by chemical contaminants through surveillance, research/ and regulatory ini-
tiatives. Toxic metals, pesticides, and industrial chemicals are monitored,
as well as imported foods and foods grown near nuclear power plants. There is
ongoing work to establish policies for the use of sewage sludge and effluents
on food, forage, and feed crops.
Food Additives
This project evaluates petitions submitted by manufacturers of additives,
monitors the use of additives in processed foods, reviews the safety of the
GRAS (Generally Recognized As Safe) list and other food additive substances,
and provides scientific support to regulatory responsibilities under the Food
Safety program. In addition, the Food Additive Project is part of the FDA's
bio-research monitoring activities which include Good Laboratory Practices
(GLP) inspections of testing facilities, toxicity studies on food and color
additives and GRAS substances, and the cyclic review of food ingredients.
Mycotoxins and Other Natural Poisons
This project's mission is to identify mold toxins (mycotoxins) which can
contaminate food, and those food plant metabolites which can be toxic, and to
establish the means whereby such toxins in foods can be controlled. The
Agency seeks to encourage self-regulation by educating the affected industries
on the technical aspects of this problem. It develops information on the
78
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conditions necessary to prevent contamination from these toxins. The project
also interacts with the USDA and the Natural Poisons project to provide
support for developing analytical methods and other control procedures which
enable industry to screen out toxin-contaminated products from the food
supply.
Nutrition
New initiatives are being taken in the area of nutrient toxicity and
interactions. These deal with the toxicity of essential nutrients which are
ingested at levels significantly higher than the human requirement, as well as
the changes in requirements modified by the interactions of these essential
nutrients with other nutrients, food additives, dietary supplements and
environmental contaminants. The Nutrition project conducts surveillance
programs designed to evaluate new and traditional products for nutritional
composition, maintains the- Food Composition Data Bank to provide necessary
background data to develop new guidelines and standards, and conducts research
in nutrient toxicity and nutrient interactions. Where false or misleading
nutritional claims are made on or for a food product, action is taken under
the Food Economics Program.
Shellfish Safety
Shellfish, such as oysters, clams, and mussels, become contaminated from
polluted waters because of their ability to concentrate pathogenic micro-
organisms and toxic chemicals from their environments. This project develops
guidelines and regulations promoting sanitation in the control of growing
waters, harvesting procedures, processing facilities, and marketing practices.
Also, as part of the National Shellfish Sanitation Program (NSSP), a
79
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cooperative State/Federal Program, this project develops enforceable standards
of quality for shellfish products.
Cosmetics
The mission of this project is to ensure that cosmetic products are safe,
truthfully and informatively labeled, and truthfully packaged. The major
project activities are: conducting research to determine cosmetics' safety
and identify hazardous ingredients; maintaining registries for the voluntary
filing of cosmetic manufacturers, and cosmetic formulations, and the reporting
of adverse reactions to -cosmetics; maintaining surveillance to ensure com-
pliance with regulations; and supporting regulatory activities.
Biopharmaceutics
FDA has established a Biopharmaceutics Project to address both the
bioavailability and bioequivalence of drugs. The bioavailability of a drug
refers to the amount of active drug substance which becomes systemically
available to achieve its therapeutic action. If too much active drug sub-
stance were unexpectedly .introduced systemically, it could lead to toxic or
adverse reactions, whereas deficient levels could cause inadequate therapeutic
response.
Under this project, FDA develops bioequivalence regulations,
bioavailability guidelines, and reviews and evaluates pharmacokinetic
protocols for possible labeling revision and studies for new chemical entities
and dosage forms.
Also, the project interacts regularly with the activities of various other
projects within the Human Drug Program, including New Drug Evaluation, Drug
Quality Assurance, Prescription Drug Labeling, Antibiotic Insulin .Certifi-
cation, OTC Drug Evaluation and Bioresearch Monitoring.
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Drug Experience and Trend Analysis
The mission of this project is to monitor the short- and long-term effects
and uses of marketed drugs to establish a scientific basis for regulatory
actions, and support new drug review processes. It monitors drug experience
reports submitted to FDA and drug monitoring studies through the application
of epidemiological techniques. The project analyzes, maintains, and dis-
seminates information regarding drug use trends and drug experience data to
help reduce adverse effects. The information gathered by the Drug Experience
and Trend Analysis project also helps to satisfy the information needs of
other FDA projects, including New Drug Evaluation, Drug Abuse Treatment
Monitoring and Poison Control. In addition, the project performs reviews of
the Adverse Reaction Section of labels for the Prescription Drug Labeling
project.
Drug Quality Assurance
Congress has vested in FDA the responsibility to monitor the overall
quality of drugs; maintain drug establishment registration and drug product
listing; and take necessary measures to ensure that the manufacturing,
processing, packing, and holding of drugs, and the facilities and controls
used in these processes, are such that the highest quality products feasible
may be marketed.
Marketed drugs have been found to be deficient in many ways, such as being
subpotent or superpotent, contaminated with other drugs, compounded with the
wrong active ingredient, and contaminated with microorganisms. As a result of
such deficiencies, serious injuries and deaths have occurred. The project
81
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seeks to monitor the quality of all drugs marketed in the U.S. through inspec-
tions and sample analyses. To support this effort, the project conducts
pharmaceutical research on methodology and standards in drug chemistry, drug
bioanalysis, and drug microbiology; and participates in domestic and inter-
national compendial, and other methodology/standard-setting activities. In
addition, it strives to achieve voluntary support from the pharmaceutical
industry whenever possible by informing them of problems with either their
product or their manufacturing process so that correction may be as expe-
ditiously as possible.
Finally, the Drug Quality Insurance project develops and maintains a
listing of all products subject to the provisions of the Drug Listing Act of
1972. It registers and maintains a current listing of all regulated estab-
lishments engaged in the manufacture, preparation, compounding, or propagation
of drug products. These listings provide data for most other Human Drug
Program projects, and other Federal agencies as well. These agencies include
the Drug Enforcement Administration, the Social and Rehabilitation Service,
the Health Care Financing Administration, and the Environmental Protection
Agency.
New Drug Evaluation
The mission of this project is to ensure that new drugs are evaluated and
approved for marketing on the basis of adequate evidence of safety and effec-
tiveness; ensure that new drugs are properly labeled; ensure that once
marketed, experience in use confirms this judgment; and ensure that clinical
investigations of new drugs properly safeguard the rights of human subjects
while developing high quality data on safety and efficacy. To this end,
project activities include evaluating the safety and efficacy of new drugs,
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conducting research which supports new drug evaluations, and developing new
guidelines, regulations, and labeling. The project also responds to requests
for information, works to improve the management of the new drug evaluation
process, and evaluates the abuse potential of investigational drugs, new drugs
and marketed drugs. Because its activities extend into other drug-related
areas, New Drug Evaluation works in close conjunction with most other Human
Drug Program projects.
Poison Control
The National Clearinghouse for Poison Control was established in 1957 and
now services a network of over 580 Centers. It provides toxicity and treat-
ment information about household products and medicines to the network of
Poison Control Centers, maintains surveillance of the problem by compiling an
information base of poisoning reports in a computer system, conducts research
on poisoning prevention and improved treatment procedures, and conducts educa-
tional programs about poisoning prevention.
The project assists the Poison Prevention Week Council in national poison
prevention activities, including educational programs and information for
National Poison Prevention Week. It supplies data and information about in-
juries from the ingestion of household products to the Commissioners of the
Consumer Product Safety Commission for establishing regulatory priorities
under the Poison Prevention Packaging Act. In addition, the project makes
case report data available to the EPA for determining the prevalence and
hazards of misusing products covered under the Federal Insecticide, Fungicide,
and Rodenticide Act. • The Poison Control project also supplies information and
data to other FDA Human Drug Program projects, including Drug Quality
Assurance, OTC Drug Evaluation, Drug Experience and Trend Analysis and
Prescription Drug Labeling.
83
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84
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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 88
Statutory Authorities page 93
Toxics-Related Activities page 94
The National Center for Toxicological Research (NCTR) was established in
early 1971 and became operational in mid-1972 as a joint venture of the
Federal Food and Drug Administration and the Environmental Protection Agency.
The Center was created to help provide a better understanding of the
relationships of the chemicals in the environment and the possible adverse
effects of these chemicals. NCTR has since developed an advanced scientific
program of toxicological experimentation which is supported by its own
research laboratories and other related facilities. Research activities are
directed toward four specific goals:
o Determination of adverse effects resulting from long-term, low level
exposure to various chemical substances.
v
o Development of experimental data to facilitate extrapolation of
laboratory results to man. ,
85
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o Determination of basic biological processes in animals to provide a
more accurate extrapolation of laboratory results to humans.
o Development of improved methods and testing protocols for evaluating
the relative' safety of chemical substances.
To this end, the Food and Drug Administration is responsible for
administering the Center in such a way that it is responsive to the needs of
the signatory agencies (EPA and HHS) when their programs require research and
development suitable to the Center's capabilities. In addition, other agen-
cies, universities, and industry may also participate to the extent that their
expertise is required.
Guidelines for the Center are developed by an Interagency Policy Board,
with voting members from HHS and EPA and nonvoting members from The Council on
Environmental Quality (CEQ). The Policy Board provides interagency reviews of
research programs conducted by the Center to ensure that programs are oriented
toward the needs of the agencies. Specifically, the Policy Board recommends
program policies to the Director, reviews budgetary requirements, evaluates
research results, recommends appropriate management policy, approves key
appointments, and advises agency heads on matters concerning the Center.
86
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
NATIONAL CENTER FOR
TOXICOLOGICAL RESEARCH
ORGANIZATIONAL CHART*
•NOTE:
A PARTIAL ORGANIZATIONAL
CHART IS SHOWN TO HIGHLIGHT
THOSE COMPONENTS ORDINARILY
INVOLVED WITH TOXIC
SUBSTANCES ACTIVITIES.
-------
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 Environmental
Protection Agency, Food and Drug Administration, National Institutes
of Health, and National Toxicology Program.
o Monitors performance of the Center's supporting contractors.
o Implements Departmental research policies.
ASSOCIATE DIRECTOR FOR CHEMICAL EVALUATION
Division of Chemical Toxicology
o Conducts research and evaluation efforts under the guidance of the
National Chemical lexicological Testing Program.
o Develops improved methods for toxicological evaluations.
o Performs research on chronic and subchronic toxicological conditions
with particular emphasis on dose-response relationships.
o Studies the connection between nutrition and toxicity and advises
other NCTR offices on nutritional matters.
Nutrition Branch,
f
o Conducts chronic and subchronic 1-aboratory studies to determine
carcinogenic and other harmful effects of toxic chemicals.
o Performs research on how diet affects biological and biochemical
processes that may alter carcinogenic and toxicological responses.
*NOTE: Only those offices which deal with toxics or toxic-related issues are
developed in this section*
88
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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
classifications.
o Provides scientific guidance to other NCTR programs concerning
pathology.
ASSOCIATE DIRECTOR FOR RESEARCH
Division of Carcinogenesis Research
o Conducts long-term studies for evaluating the effects of carcinogenic
substances on laboratory animals.
o Conducts experiments to determine dose-time response relationships of
chemical toxicants in laboratory animals.
o Develops information on toxic responses and designs new methods for
applying toxicity assessments.
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 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 Works to develop improved methods for evaluating adverse health
effects of chemicals.
o Studies the application of laboratory findings to humans in
determining the effects of chemical agents on the fetus.
o Manages the teratology section of the National Toxicological Program.
89
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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 Petal 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.
o Studies chemical behavior, dosage forms, safe use and disposal of
chemicals.
o Develops data bases to assist in the compliance with good laboratory
practice (6LP) requirements.
Diet Analysis Branch
o Develops analytical methods to ensure nutritional integrity and
absence of harmful substances in animal diets.
o Provides radioimmunoassay services.
Analytical Methods Branch
o Develops techniques for improving the accuracy of trace-level chemical
analyses.
Division of Microbiology and Immunology
Microbiology Branch ?
o Develops improved procedures for using microorganisms to assess
chemical toxicity.
o Provides microbiological services to support NCTR's toxicological
operations.
90
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Immune-toxicology 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 toxically damaged tissues.
o Develops techniques for early diagnosis of carcinogenic growths.
o Examines biological changes resulting from exposure to toxic chemical
compounds•
ASSOCIATE DIRECTOR FOR MANAGEMENT
Division of Toxic Data Management Systems
o Operates the Toxic Data Management System (TDMS) in conjunction with
National Cancer Institute and National Institutes of Health.
o Assists EPA Office of Testing and Evaluation in developing an
automated data system, in accordance with TSCA guidelines.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Division of
Carcinogenes is
Research
Division of
Mutagenesis Research
Division of Tera-
togenesis Research
Division of
Biometry
Division of
Chemistry
Diet Analysis
Branch
Spectroscopic
Techniques Branch
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
501-541-4446
FTS: 8-542-4446
501-541-4368
FTS: 8-542-4368
Mail Stop
HFT-110
HFT-120
HFT-130
HFT-140
HFT-150
HFT-152
HFT-154
91
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Division/Office
Division of
Microbiology and
Immunology
Microbiology
Branch
Innnunotc>xicology
Branch
Cell Biology
Branch
Division of Chemical
Toxicology; Nutrition
Chemical and Evalua-
tion Branch
Diet Preparation
Branch
Division of
Pathology
Phone
501-541-4449
FTS: 8-542-4449
501-541-4450
FTS: 8-542-4450
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: 8-542-4385
501-541-4185
FTS: 8-542-4185
Mail Stop
HFT-160
HFT-162
HFT-163
HFT-164
HFT-210
HFT-213
HFT-230
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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 Health and Human Services)
and the Environmental Protection Agency signed on April 1, 1971. The
Interagency Agreement establishes the Center's mission, functions, structure,
and research responsibilities. Statutory authority enabling the Department of
Health, Education, and Welfare and the Environmental Protection Agency to
direct the Center's activities resides in the Presidential letter and in the
general legislative requirements assigning to the Agencies toxics-related
research responsibilities. 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.
93
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TOXICS-RELATED ACTIVITIES'
Research Experiments
As a research facility, a principal activity of NCTR is the performance
of experiments in toxics-related areas, including carcinogenesis, mutagenesis,
and teratogenesis research. Experiments in other toxic fields are also
conducted by the respective Divisions within NCTR: Biometry, Chemistry,
Microbiology and Immunology, Chemical Toxicology and Pathology. For a listing
of specific experiments, contact the Planning and Evaluation Staff at NCTR
(501) 541-4503 or FTS-542-4503.
Toxic Data Management Systems
In a joint effort with the National Cancer Institute (NCI) and the
National Institutes of Health (NIH), NCTR developed the Toxic Data Management
Systems (TDMS) in 1977 to address data processing and reporting problems of
agencies involved in toxicological research. This Division provides a number
of different support services: documentation of chemical compounds; analysis
*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, Toxics Integration staff.
94
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NATIONAL INSTITUTES OF HEALTH
Public Health Service
Department of Health and Human Services
Bethesda, MD 20014
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), works to improve human health by acquiring new scientific knowledge.
Specifically, NIH
o conducts biomedical research in its own laboratories;
o provides grants to nonprofit organizations and institutions for
research and for medical education, including improvement or
construction of library facilities, buildings, equipment and other
resources;
o provides grants for the training of research investigators; and
o promotes effective ways to communicate biomedical information to
scientists, health practitioners, and the public.
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
95
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exchange and which 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.
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.
96
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
PUBLIC HEALTH SERVICE
ORGANIZATIONAL CHART
ASSOCIATE DIRECTOR FOR
EXT. RES. AND TRAINING
ASSOCIATE DIRECTOR FOR
MED. APPLICATIONS OF RES.
ASSOCIATE DIRECTOR FOR
CLINICAL CARE
ASSISTANT DIRECTOR FOR
INTRAMURAL AFFAIRS
DIRECTOR
DEPUTY DIRECTOR
DEPUTY DIRECTOR
(Science)
10
NATIONAL
CANCER
INSTITUTE
NATIONAL INSTITUTE ON
AGING
NATIONAL INSTITUTE OF
CHILD HEALTH AND
HUMAN DEVELOPMENT
NATIONAL INSTITUTE OF
GENERAL MEDICAL
SCIENCES
NATIONAL
HEART, LUNG, AND BLOOD
INSTITUTE
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES
NATIONAL INSTITUTE OF
DENTAL RESEARCH
NATIONAL INSTITUTE OF
NEUROLOGICAL AND
COMMUNICATIVE DISORDERS
AND STROKE
ASSOCIATE DIRECTOR FOR
PROGRAM PLAN. AND EVAL.
ASSOCIATE DIRECTOR FOR
ADMINISTRATION
ASSOCIATE DIRECTOR FOR
COMMUNICATIONS
NATIONAL
LIBRARY OF
MEDICINE
NATIONAL INSTITUTE OF
ARTHRITIS, METABOLISM,
AND DIGESTIVE DISEASES
NATIONAL INSTITUTE OF
ENVIRONMENTAL
HEALTH SCIENCES
NATIONAL
EYE INSTITUTE
CLINICAL CENTER
DIVISION OF
COMPUTER RESEARCH
AND TECHNOLOGY
DIVISION OF
RESEARCH GRANTS
DIVISION OF
RESEARCH RESOURCES
DIVISION OF
RESEARCH SERVICES
FOGARTY
INTERNATIONAL
CENTER
-------
98
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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
Organization .page 103
Statutory Authorities page 106
Toxics-Related Activities page 109
The essential and continuing goal of the National Cancer Institute (NCI)
is the same today as it was when the Institute was created by an Act: of
Congress 40 years ago: 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 support.
The first two components encompass the scientific and technical
activities, while the support component includes those activities needed to
99
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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, and that the National Cancer Program would invest 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. 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. In 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 agency.
More specifically, NCI 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
100
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studies on environmental carcinogens, including pesticides, aromatic amines
(components of dyestuffs, hair dyes, and polymers), and halogenated aliphatic
compounds (used in pesticides, solvents, and drycleaning agents). In other
programs, the synergistic effects of physical environmental agents are under
investigation, and food additives are being studied in terms of inhibiting
environmental carcinogens. In addition, NCI acts as an information
clearinghouse on cancer and has developed a data bank on international cancer
research.
101
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL CANCER INSTITUTE
ORGANIZATIONAL CHART*
PRESIDENT'S
CANCER
PANEL
DIRECTOR
DEPUTY DIRECTOR
ASSISTANT
DIRECTORS
NATIONAL CANCER
ADVISORV BOARD
O
ro
OFFICE OF
RESEARCH
SAFETY
OFFICE OF
PROGRAM PLANNING
AND ANALYSIS
OFFICE OF
CANCER
COMMUNICATIONS
DIVISION OF
CANCER BIOLOGY
AND DIAGNOSIS
NCI EXECUTIVE
COMMITTEE
OFFICE OF
INTERNATIONAL
AFFAIRS
OFFICE OF
ADMINISTRATIVE
MANAGEMENT
DIVISION OF
CANCER
TREATMENT
DIVISION OF
CANCER RESEARCH
RESOURCES AND
CENTERS
*NOTE: A partial organizational chart is shown to highlight (in gray) those
components ordinarily involved with toxic substances activities.
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ORGANIZATION
NOTE: NCI is currently undergoing reorganization. The materials presented
here may be subject to change.
DIVISION OF CANCER CAUSE AND PREVENTION
o Plans and directs a program of laboratory, field, and demographic re-
search on the cause and natural history of cancer and the means for
preventing cancer through in-house and contract research.
o Evaluates mechanisms of cancer induction by viruses and by
environmental carcinogenic hazards.
o Serves as the focal point for the Federal Government on the synthesis
of clinical , epidemiological , and experimental data relating to the
cause of cancer.
o Advises the Director of NCI in evaluation of program activities
relating to cancer control and on grants and grant applications as they
relate to cancer cause and prevention .
Carcinogenesis Research Program
o Plans , directs , and conducts a basic and applied research program on
the role of chemical and physical causative factors and the prevention
of carcinogenesis .
o Develops and conducts programs in the areas of carcinogenesis and
related toxicology, metabolism, chemistry, cell biology, and
experimental tumor pathology.
Office of the Scientific Coordinator for Environmental Cancer
o Serves as a focal point for environmental cancer information and data
through contract resources .
o Maintains the primary monitoring and collaborative function for coor-
dinating 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 .
*NOTE: Only those offices which deal with toxics or toxics- related issues are
developed in this section.
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Conducts liaison activities for the National Cancer Program as it
relates to the national effort on environmental and occupational
cancer.
DIVISION OF CANCER CONTROL AND REHABILITATION
o Plans, directs, and coordinates an integrated program of cancer
control and rehabilitation activities with the goal of identifying,
testing, evaluating, demonstrating, communicating, and promoting the
widespread application of available and new methods for reducing the
incidence, morbidity, and mortality of cancer.
o Serves as the focal point of a coordinated national effort to control
cancer, involving all appropriate elements of the Department of
Health, Education, and Welfare, other Federal agencies, State and
local health departments, voluntary health agencies, and other
elements of the private health community.
o In collaboration with the research divisions of the National Cancer
Institute, identifies candidate control techniques and methods for
inclusion in the field test and demonstration activities of the
Division.
o Serves as the focal point of the National Cancer Institute for
research in cancer rehabilitation.
o Participates in evaluation of and advises the Institute Director on
program-related aspects of grants and contracts as they relate to
cancer control and rehabilitation.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone* Mail Stop
Director 301-496-5615 Building 31
Room 11A-52
Bethesda, MD 20205
Division of Cancer 301-496-6618 Building 31
Cause and Prevention Room 11A-03
Bethesda, MD 20205
Carcinogenesis Research 301-496-1882 7910 Woodmont
Program 301^496-5946 Landow Building
Room 8A-18
Bethesda, MD 20205
*FTS numbers are the same
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Division/Office
Scientific Coordinator for
Environmental Cancer
Division of Cancer
Control and Rehabilitation
Phone*
301-496-1625
301-427-8640
Mail Stop
7910 Woodmont
Landow Building
Room 36-37
Bethesda, MD 20205
Blair Building
Room 732
8300 Colesville Road
Silver Spring, MD 20910
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STATUTORY AUTHORITIES
The National Cancer Institute Act
Public Law 75-244
This Act, passed by Congress and signed 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 cancer
(a,b) 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 research
(a,b,c) projects, to make information regarding these projects available
to the public, and to review all applications for grants-in-aid.
The Public Healjjj..ces 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
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health and disease. The Act also consolidated many NCI revisions into this
single law.
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. §§ 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 regarding 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
Program.
sec. 408 Provides for 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 changes in the National Cancer
Program. Also, they established guidelines 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 into the data bank information regarding
"nutrition programs for cancer patients and the relationship
between nutrition and cancer."
sec. 108 Authorizes NCI to contract for a specific program "to
(b)(1) disseminate and interpret, on a current basis, for professionals
and other health officials, scientists, and the general public,"
information on the cause, prevention, diagnosis, and treatment
of cancer.
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TOXICS-RELATED ACTIVITIES1
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 bioassays of animals and in vitro systems; from animal-human
correlations developed by comparing bioassays and epidemiological studies; and
from studying pharmacological metabolic relations in various species.
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 correspond-
ing environmental data; the connection of cancer incidence to occupation; and
special studies to determine the factors at work in communities with high
rates of cancer. In addition, the NCI conducts programs studying the rela-
tionships between reserpine and breast cancer, fluorides and generalized
cancer, chlorinated water and increased rates of cancer, and industrial
*Included are those activities identified as toxics-related from the infor-
mation 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, Toxics Integration staff.
109
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hazards and cancer. NCI is also investigating a number of environmental
contaminants, such as asbestos, TRIS, and vinyl chloride.
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 professionals, the medical
community, and the general public. The Cancer Control Program conducts con-
ferences 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.
Through an agreement with the Occupational Safety and Health Administra-
tion (OSHA), NCI has instituted an occupational cancer information and alert
program. Among other studies, this program has examined the carcinogenic
effects of diethylstilbestrol (DBS) and other synthetic estrogens used by
women during pregnancy.
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.
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
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multidisciplinary research. The Program seeks to attract physicians and
scientists of diverse backgrounds in order to develop a broad base of
information on cancer control activities.
The Diet/ Nutrition/ and Cancer Program
The Diet, Nutrition/ and Cancer Program was formed in 1974 to conduct
research and disseminate information on nutrition for cancer patients and on
the relation between nutrition and cancer.
Supporting Programs
The major objectives of the Carcinogenesis Research Program 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 improved methods for removing hazardous chemicals from the environment; to
devise better means for hosts to detoxify environmental agents; to analyze
synergistic actions among animals, viruses, and physical carcinogens; and to
develop rapid and sensitive bioassays.
Under the Carcinogenesis Testing Program, chemicals are studied for their
cancer-causing potential. The program develops bioassays for the in vivo and
in vitro testing of chemical and physical agents in the environment and for
carcinogenic and cocarcinogenic effects. Also, research is conducted on the
development and evaluation of standardized methods, designs, and models for in
vivo and in vitro Carcinogenesis testing, related toxicology, and tumor
pathology.
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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 physicians and
scientists of diverse backgrounds in order to develop a broad base of
information on cancer control activities.
The Diet, Nutrition, and Cancer Program
The Diet, Nutrition, and Cancer Program was formed in 1974 to conduct
research and disseminate information on nutrition for cancer patients and on
the relation between nutrition and cancer.
Supporting Programs
The major objectives of the Carcinogenesis Research Program 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 improved methods for removing hazardous chemicals from the environment; to
devise better means for hosts to detoxify environmental agents; to analyze
synergistic actions among animals, viruses, and physical carcinogens; and to
develop rapid and sensitive bioassays.
Under the Carcinogenesis Testing Program, chemicals are studied for their
cancer-causing potential. The program develops bioassays for the in vivo and
in vitro testing of chemical and physical agents in the environment and for
carcinogenic and cocarcinogenic effects. Also, research is conducted on the
development and evaluation of standardized methods, designs, and models for in
vivo and in vitro Carcinogenesis testing, related toxicology, and tumor
pathology.
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The Frederick Cancer Research Center tests the cancer-causing potential of
chemicals and viruses in laboratory animals. Research on chemicals involves
bioassay for carcinogenicity and some mechanism studies.
The Division of Cancer Treatment studies tumor therapy and the induction
of tumors in primates by antitumor agents and other materials.
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114
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NATIONAL INSTITUTE OF ENVIRONMENTAL
HEAL TH 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: 919-541-3 345
FTS: 629-3345
Organization page 118
Statutory Authorities page 126
Toxics-Related Activities....page 127
The National Institute of Environmental Health Sciences (NIEHS) has the
broadest responsibility among Federal agencies for the support of research,
and the training of research manpower, in the area of effects of chemical and
physical 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. The output of NIEHS programs is
intended to aid those agencies and organizations, both public and private,
-x
with responsibilities for developing and instituting pollution control
regulations or therapeutic measures.
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NIEHS pursues its mission by supporting training in the areas of
environmental toxicology, environmental pathology, environmental mutagenesis,
C
and environmental epidemiology, and by funding "basic and applied research on
the consequences of the exposure of man 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 these agents move, and
possibly change as they move, through the environment; (3) how they affect man
and other biological systems in the environment; (4) the extent of exposure of
various population groups, especially sensitive populations, to these agents;
(5) the effects these agents, by themselves and in combination with other
agents cause in the environment; (6) what happens in biological systems after
exposure to hazardous agents; and (7) what diseases are caused or aggravated.
Supplementary to these activities, NIEHS supports 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 man 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 aid
those agencies charged with developing and instituting control or therapeutic
measures. Once this information base is developed, it is transmitted to
regulatory agencies, other Government agencies, the medical community,
industry, and the general public for subsequent action. After information on
a disease endpoint is generated, it is supplied to the appropriate institutes.
Accordingly, results of NIEHS research form the basis for preventive programs
for environmentally related diseases and for action by regulatory agencies.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
.PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES
ORGANIZATIONAL CHART*
*NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances
research.
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ORGANIZATION*
OFFICE OF HEALTH HAZARD ASSESSMENT
o Plans, develops, and directs the Institute * 8 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
obj ectives.
o Maintains an awareness of national research efforts and assesses the
need for research and research training in environmental health.
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,
which encompasses six major areas (pharmacology, environmental
toxicology, biometry, environmental mutagenesis, environmental
biophysics, and environmental chemistry) to ensure maximum utilization
of available resources in the attainment of Institute objectives.
o Evaluates research efforts and establishes program priorities.
o 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 Institute Director and staff on matters of
scientific interest.
Laboratory of Pharmacology
o Examines the role of enzyme systems and toxication-detoxication of
chemicals and explains organ, sex, strain, and species differences in
toxic response to chemicals.
o Studies species differences in mechanism of and dose- and time-response
relations for the actions of selected environmental hazards. Analyzes
accumulation, distribution, and disposition of environmental chemicals
in a variety of animal species.
o Analyzes 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 man.
Laboratory of Pharmacokinetics
o Plans and develops a focus at NIEHS for pharmacokinetics studies and
collaborative efforts applying pharmacokinetic principles to understand
where and why chemicals accumulate in living organisms and how these
uptake, storage, and release processes are regulated or can be
affected.
o Conducts studies to develop pharmacokinetic models for specific classes
of chemicals in various species, and to develop strategies for
extrapolating chemical behavior and toxicity from one species to
another.
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o Develops and conducts studies on use of pharmacokineti.es data to design
better treatments for toxicities due to persistent chemicals, to
evaluate body burdens of environmental chemicals, and to assess effects
of different rates of exposure to environmental chemicals on
toxicological outcomes.
o Evaluates the role of metabolism in chemical accumulations among
various species.
o Establishes and maintains liaison with various groups in and out of
Government using pharmacokinetic approaches in toxicological
evaluations, preclinical drug testing, and clinical evaluation of
drugs.
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 effect of environmental agents on oogenesis and
spermatogenesis.
o Develops preclinical indicators of reproductive, endocrinologic, and
developmental toxicity using in vitro cells and tissues, lower animals,
and biochemical test systems.
Laboratory of Organ Function and Toxicology
o Studies the effects of environmental agents on renal, gastrointestinal,
and hepatic functions.
o Analyzes the mechanisms by which environmental agents alter the normal
functions of these organ systems, including the roles of metabolism,
endocrine factors, and toxicant-receptor interactions.
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o Identifies sensitive factors of organ-specific toxicity useful in the
early detection of toxicity or prediction of toxicity in experimental
animals or humans.
o Develops methods for extrapolating data from experimental animal models
to the estimation human risks from exposure to environmental agents.
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 and
mixtures.
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.
Biometry Branch
o Provides statistical assistance in the design of Institute laboratory
experiments and in the analysis of data from such experiments.
o Develops improved statistical techniques for estimating and determining
the effects of environmental agents in laboratory test systems.
o Formulates mathematical and probability descriptions of dynamic
processes in biology.
o Plans and conducts epidemiological studies for evaluating the role of
environmental agents in human mortality and morbidity.
o Provides computational data processing services to Institute staff.
Laboratory of Environmental Biophysics
o Conducts studies of biological effects on humans of physical factors in
the environment such as ionizing and nonionizing radiation, noise,
heat, humidity, and vibration.
o Advises and collaborates with other Institute staff on studies
involving the interaction of such physical stressors with other agents
of concern.
o Uses sophisticated spectroscopic techniques to examine the biophysical
mechanisms of chemical interactions with biological micromolecules,
such as nucleic acid and proteins.
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Laboratory of Animal Genetics
o Plans and conducts studies in somatic cell and higher eukaryotic
systems to improve basic understanding of the mutation process at the
cellular level with special reference to environmental mutagenesis.
o Develops and validates in vitro and in vivo test systems and models to
facilitate extrapolation from experimental systems to humans.
o Develops improved models and measurements for monitoring populations
for genetic change and damage.
o Evaluates approaches to the study of genetic damage in exposed human
populations.
o Advises the staff of NIEHS and other entities on matters pertaining to
cellular, eukaryotic, and population genetics and on the screening of
environmental agents for mutagenicity.
Laboratory of Biochemical Genetics
o Investigates discrete and continuously variable characteristics as
indicators of gene-controlled variation at the cell and organism level.
o Studies and evaluates potential indicators for suitability in detecting
newly induced gene variation in whole animals and single cells.
o Conducts studies of enzymes demonstrable by electrophoresis, and
explores their potential for indicating specific structural gene
mutations.
o Explores gross characteristics, variations in which may signal
particular gene mutations.
o Investigates experimentally genetic variation and mutation rate changes
with respect to environmental health concerns.
o Provides consideration of health risks associated with mutagens in the
environment.
o Advises NIEHS staff and staff of other organizations on matters
relating to biochemical genetics.
Laboratory of Molecular Genetic^
o Conducts studies in molecular, microbial, and somatic cell systems
intended to improve understanding at the molecular level of the
processes which either generate or protect against mutations following
exposure to environmental agents.
o Develops and validates in vitro and in vivo test systems and models to
detect mutagenic activity of environmental agents.
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o Advises the staff of NIEHS and other entities on matters pertaining to
molecular, microbial, and cellular genetics, and to the screening of
environmental agents for mutagenicity.
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.
Laboratory of Environmental Chemistry
o Develops analytical, biochemical, immunochemical, physical-organic,
bioorganic, and bioinorganic chemical studies of environmental agents,
biological materials, and their conversion products with emphasis on
biomechanisms.
o Conducts collaborative research with other NIEHS laboratories and
research programs in the chemistry of suspect agents.
o Develops, improves, and utilizes analytical methodology for specified
agents as required by NIEHS laboratory and research programs.
o Synthesizes and characterizes both labeled and unlabeled suspect
environmental agents and their conversion products to support diverse
biological and nonbiological studies.
Comparative Medicine Branch
o Manages a program for environmental animal procurement, housing, and
utilization and for sterile glassware and media preparation 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.
Environmental Biology Branch
o Assists and collaborates with NIEHS laboratories and research programs
in the fields of inhalation toxicology, pathology, electron microscopy,
and histology.
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o Plans, conducts, and collaborates in basic and applied studies in these
fields.
o Coordinates toxicologic bioassays on selected environmental chemicals*
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone
Office of Health
Hazard Assessment
Extramural Program
919-541-3471
FTS: 629-3471
919-755-4015
FTS: 672-4015
Mail Stop
P.O. Box 12233
Research
Triangle Park,
NC 27709
Intramural Research
Program
Laboratory of
Pharmacology
Laboratory of
Pharmacokinetics
Laboratory of
Reproductive and
Developmental
Toxicology
Laboratory of Organ
Function and
Toxicology
Laboratory of
Behavioral and
Neurological Toxicology
Biometry Branch
Laboratory of
Environmental
Biophysics
Laboratory of Animal
Genetics
Laboratory of
Biochemical Genetics
919-541-3205
FTS: 629-3205
919-541-3332
FTS: 629-3332
919-541-3205
FTS: 629-3205
919-541-3333
FTS: 629-3333
919-541-3376
FTS: 629-3376
919-541-3200
FTS: 629-3200
919-541-3441
FTS: 629-3441
919-541-3196
FTS: 629-3196
919-541-4690
FTS: 629-4690
919-541-3378
FTS: 629-3378
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Division/Office
Laboratory of
Molecular Genetics
Laboratory of
Pulmonary Function
and Toxicology
Laboratory of
Environmental
Chemistry
Phone
919-541-2871
FTS: 629-2871
919-541-3450
FTS: 629-3450
919-541-3253
FTS: 629-3253
Mail Stop
P.O. Box 12233
Research
Triangle Park,
NC 27709
Comparative Medicine
Branch
919-541-4473
FTS: 629-4473
Environmental Biology
Branch
919-541-3267
FTS: 629-3267
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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 is
• s-
Section 301 of the Public Health Service Act, which gives the Secretary of HEW
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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TOXICS-RELATED ACTIVITIES
Toxicity Testing Systems
Development of testing systems and testing compounds for potential harmful
effects currently involves many test procedures which are cumbersome and lack
sensitivity. NIEHS is developing simple rapid processes and toxicity tests
for detecting the ability of environmental agents to cause health effects such
as cancer, genetic damage, birth defects, and organ damage. Studies on
developing better test systems for detection of a variety of toxic endpoints
are integral to the NIEHS component of the National Toxicology Program (NTP).
Genetic Toxicology
NIEHS scientists are working to develop new mammalian test systems in an
attempt to extrapolate from these experimental test systems to humans the
mutagenic effects of chemicals. Underlying test development are basic
research efforts on mutagenic mechanisms. Since mutagenic effects cannot be
economically measured in man at the present time/ experimental organisms
ranging from microbes to mammals are currently used in test systems. The
mutagenesis testing program is sequential, incorporating:
o Rapid screening in simple, highly sensitive microbial systems.
o In vitro mammalian cell systems and insect systems.
*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 to the attention of the Office of Pesticides and
Toxic Substances, Toxics Integration staff.
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o Development and validation of whole animal systems.
At full capacity, up to 1000 chemicals per year will be tested in microbial
systems on contract, in direct support of the testing objectives of the
National Toxicology Program.
Reproductive and Developmental Toxicology and Teratology
Little is known about how the mother's pre- or postnatal exposure to drugs
and common chemicals affects the development of offspring. NIEHS scientists
are seeking to develop experimental models to study the mechanisms of such
health effects and to predict damage for humans. Research emphasis includes:
(1) development of model systems for man such as the mouse model for
predicting and understanding toxic effects on the reproductive tract of DBS
and related hormonally active chemicals, (2) development of an interspecies in
vitro fertilization assay for assessing human male fertility, (3) development
and validation of an embryo culture system for predicting chemical
teratogenesis, and (4) identification of biochemical markers, such as enzymes,
which can indicate toxicity.
Risk Assessment
The program in risk assessment is concerned with quantitative estimation
of human health effects from exposure to environmental agents based upon
laboratory, demographic, and epidemiological studies. Emphasis has been on
carcinogenesis, but other toxic endpoints will be explored. Of principal
concern is the problem of extrapolating animal dose-response relations from
the high dose range to the lower dose levels corresponding to environmental
exposures.
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Pharmacokinetics
This program is concerned primarily with developing better ways to study
the rates and mechanisms of uptake, storage, persistence, metabolism, and
excretion of environmental agents. Results in one species may be extrapolated
to another; this program should be valuable as a predictive tool. Efforts in
this program have been concentrated on developing pharmacokinetic models for
the polychlorinated and polybrominated biphenyls that can be used for
species-to-species extrapolation.
Chronic Organ Toxicity
A major goal of this program is to identify early biochemical or
physiological changes in organ function occurring during chronic exposure to
toxic environmental agents. Identifying these changes will provide a better
understanding of mechanisms of toxicity, as well as help predict early
toxicity of environmental agents in humans. Emphasis has been on the renal,
hepatic, and gastrointestinal organ systems.
Pulmonary Toxicology
NIEHS seeks to obtain, through animal studies, information to provide a
scientific basis for prevention of environmentally caused respiratory
diseases. This program studies the structure and function of the normal
respiratory tract, investigates mechanisms of injury and repair in respiratory
tract tissues exposed to environmental toxins (e.g., air pollutants, asbestos,
carcinogens), and studies the pathogenesis of specific disorders of pulmonary
tissues (e.g., pulmonary fibrosis, emphysema).
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Epidemiology
A major goal of the NIEHS epidemiology program is to increase the
effectiveness of human epidemiological studies by integrating them with many
of the NIEHS internal biological research programs. Major emphasis is on an
understanding of the origins of chronic diseases in humans, and their
interactions with environmental factors/ with particular emphasis in the areas
of reproduction, genetics and disease susceptibility, and environmental
carcinogenesis.
Biochemical and Marine Pharmacology
Many chemicals are made toxic by biotransformation processes; furthermore,
organ, strain, and species differences in toxicity often are related to
quantitative differences in metabolism. These programs are concerned
primarily with studying the role of chemical metabolism in mediation of
toxicity. Emphasis is on characterizing the enzymes in liver, skin,
intestine, and lung that make chemicals either more or less toxic, and
defining how various factors such as age, sex, heredity, or other chemicals
can alter the balance between the two types of enzyme systems. As an
extension of these primarily manmalian investigations, studies are conducted
on the uptake, distribution, metabolism, and excretion of pollutants by
various marine species, and on the role of metabolism in the storage, chemical
form, and toxicity of accumulated toxins in these species.
Environmental Chemistry
This program combines environmental detection and analysis of chemicals
with environmental toxicology. Particular emphasis is, and has been, devoted
to various classes of halogenated aromatic chemicals. NIEHS scientists have
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defined in detail the physicochemical properties of the PCBs, PBBs, dioxins,
furans, and chlorinated phenols; examined the relationship between chemical
structure and biological fate and activity; synthesized major and proposed
metabolites; and developed sensitive and specific analytical methodology for
metabolite measurement.
Molecular Biophysics
The objective of this program is to define toxicity by studying how
chemicals interact at the molecular level (nucleic acids, proteins, membrane
components). This research mandates use of sophisticated spectroscopic
techniques such as electron spin resonance. Emphasis also is being placed on
studying the synergistic effects of chemicals with physical factors.
Biophysical approaches to toxicology are few in number, yet where applied,
they have been most instructive.
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132
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NATIONAL INSTITUTE
FOR OCCUPATIONAL SAFETY AND HEALTH
Department of Health and Human Services
Public Health Service
Center for Disease Control
HEADQUARTERS
Parklawn Building
5600 Fishers Lane
Rockville, Md 20857
Laboratories
Robert A. Taft Laboratories
4676 Columbia Parkway
Cincinnati, Ohio 45226
Appalachian laboratory for
Occupational Safety and Health
944 Chestnut Ridge Road
Morgantown, West Virginia 26505
Locator: 202-245-6296
Information: 301-443-2140
Organization page 137
Statutory Authorities page 142
Toxics-Related Activities page 145
The National Institute for Occupational Safety and Health (NIOSH) is the
principal Federal agency involved in research to eliminate on-the-job hazards
to the health and safety of the Nation's work force. Under the provisions of
the Occupational Safety and Health Act (OSHA) of 1970 (Public Law 91-596),
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NIOSH was established within the Department of Health, Education, and Welfare
(as of May 4, 1980—The Department of Health and Human Services (DHHS)) under
the Center for Disease Control of the Public Health Service.
The major responsibility of NIOSH is to provide research and
standards-setting support and recommendation for worker protection to the
Department of Labor, Occupational Safety and Health Administration (OSHA)
under the OSH Act of 1970 and the Mine Safety and Health Act of 1977, as
amended. The Institute also has responsibility for the training of
occupational health manpower.
Under the OSH Act, NIOSH conducts the research for occupational safety and
health standards. These reconmended standards are then sent to the Department
of Labor, Occupational Safety and Health Administration, which is responsible
for the final development, promulgation, and enforcement of the standards.
By authority of the Federal Coal Mine Health and Safety Act, NIOSH sets
mandatory health standards which are then promulgated and enforced by the
Department of the Interior.
NIOSH is located in three separate facilities. The headquarters is in
Rockville, Maryland, where in addition to the major administrative and
planning functions, the staff is also responsible for the preparation and
update of the Criteria Documents and other information documents. These
documents, which utilize research performed in NIOSH labs or under contract,
serve as the basis for standards to be promulgated by OSHA, and for assessment
of hazards and recommendations for worker protection.
The Institute's main labs are in Cincinnati, Ohio, where 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.
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At the NIOSH laboratory in Morgantown, West Virginia, studies in
respiratory disease, agricultural, and noncoal mining health are carried out.
In addition, the Institute's safety research effort is located there.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
CENTER FOR DISEASE CONTROL
NATIONAL INSTITUTE FOR OCCUPATIONAL
SAFETY AND HEALTH
ORGANIZATIONAL CHART*
MOHGANTOWN. WEST VIRGINIA I
*NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances activities.
-------
ORGANIZATION
OFFICE OF PROGRAM PLANNING AND EVALUATION
o Plans and evaluates program.
o Plans and coordinates development of Institute strategy.
OFFICE OF EXTRAMURAL COORDINATION AND SPECIAL PROJECTS
o Advises the Institute of matters relating to the development and
progress of Institute-supported grant research.
o Provides technical advice to the Director and other Institute offices.
Technical Evaluation and Review Branch
o Conducts or coordinates special short-term technical studies including
evaluation of technical information transmitted to the Institute.
o Prepares background information on potentially hazardous substances in
the occupational environment.
o Alerts the entire occupational health community to new information on
potential occupational health hazards.
DIVISION OF CRITERIA DOCUMENTATION AND STANDARDS DEVELOPMENT
Criteria Development Branch
o Provides the scientific effort necessary to develop occupational health
criteria.
o Coordinates the development and final approval of occupational health
criteria and standards documents in cooperation with the U.S.
Department of Labor.
Priorities and Research Analysis Branch
o Analyzes information on the exposure of workers to safety and health
hazards.
*NOTE: Only those offices which deal with toxics effects or toxics-related
issues are developed in this section.
137
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o Reviews the availability and adequacy of current literature to provide
the basic information needed to prepare or update criteria and
standards documents.
o Prepares and periodically revises a priority list of substances and
industries for which various documents should be developed or revised.
o Conducts Special Occupational Hazard Reviews of potential workplace
hazards where new evidence of a particular hazard is received, and
prepares recommended emergency temporary standards as appropriate.
Mine Health Standards Branch
o Compiles and analyzes the results of research, studies, and
investigations pertaining to selected mine health hazards for
preparing criteria and recommended standards.
o Prepares criteria for reconmended health standards.
o Assists the Mine Safety and Health Administration, Department of
Labor, in the development of draft regulations.
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.
Industrywide Studies Branch
o Conducts epidemiological industrywide 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 magnitude and extent of
occupational illness, and exposures to hazardous agents.
DIVISION OF TECHNICAL SERVICES
Clearinghouse for Occupational Safety and Health Information
o Receives, stores, retrieves, and disseminates technical information on
occupational safety and health hazards.
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Technical Information Development Branch
o Prepares and annually revises the legislatively mandated Registry of
Toxic Effects of Chemical Substances.
o Develops publications promoting safe and healthful working conditions.
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
recommmendation of standards.
DIVISION OF PHYSICAL SCIENCES AND ENGINEERING
«
Control Technology Research Branch
o Plans and conducts laboratory and worksite research to assess and
develop engineering control techniques and personal protective
equipment to prevent worker exposure to toxic substances and harmful
physical agents.
DIVISION OF RESPIRATORY' DISEASE STUDIES
o Conducts clinical and epidemiological research on occupational
respiratory disease.
o Provides legislatively mandated medical and autopsy services under the
Federal Mine Safety and Health Act of 1977.
o Conducts medical research to fulfill the Institute's responsibilities
under the Federal Mine Safety and Health Act of 1977.
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office
Office of the Director
Office of Administrative
and Management Services
Office of Program Planning
and Evaluation
Office of Extramural
Coordination and Special
Proj ects
Division of Criteria
Documentation and
Standards Development
Division of Surveillance,
Hazard Evaluations,
and Field Studies
Division of Technical
Services
Division of Biomedical and
Behavioral Science
Division of Physical
Sciences and Engineering
Division of Respiratory
Disease Studies
Public Information Officer
Legislative Officer
Clearinghouse for
Occupational Safety and
Health Information
REGIONAL AND FIELD OFFICES
Phone*
301-443-1530
301-443-1697
301-443-4364
301-443-6437
301-443-3680
513-684-8302
513-684-8465
513-684-4321
304-599-7474
301-443-2140
301-443-2140
513-684-8326
Mail Stop**
Rockville, MD
Rockville, MD
Rockville, MD
Rockville, MD
Rockville, MD
513-684-2427 Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Morgantown, WV
Rockville, MD
Rockville, MD
Cincinnati, OH
Name
NIOSH
DHEW, Region I
Address
Government Center
(JFK Fed. Bldg.)
Boston, MA 02203
Phone
617-223-6668
FTS: 223-6668
*FTS numbers are the same.
**For the complete address see the first page of this section.
140
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Name
Address
Phone
NIOSH
DHEW, Region II
NIOSH
DHEW, Region III
NIOSH
DHEW, Region IV
NIOSH
DHEW, Region V
NIOSH
DHEW, Region VI
NIOSH
DHEW, Region VII
NIOSH
DHEW, Region VIII
NIOSH
DHEW, Region IX
NIOSH
DHEW, Region X
Federal Bldg.
26 Federal Plaza
New York, NY 10007
P.O. Box 13716
Philadelphia, PA 19101
101 Marietta Tower
Suite 502
Atlanta, GA 30303
300 South Wacker Drive
33rd Floor
Chicago, IL 60606
1200 Main Tower Bldg.
Room 1700-A
Dallas, TX 75202
601 East 12th Street
Kansas City, MO 64106
11037 Federal Building
Denver, CO 80294
50 United Nations Plaza
San Francisco, CA 94102
1321 Second Avenue
(Arcade Bldg.)
Seattle, WA 98101
212-264-2485
FTS: 264-2485
215-596-6716
FTS: 596-6716
404-221-2396
FTS: 242-2313
312-886-3881
FTS: 353-3881
214-767-3916
FTS: 729-3916
816-374-5332
FTS: 758-5332
303-837-3979
FTS: 327-3979
415-556-3781
FTS: 556-3781
206-442-0530
FTS: 399-0530
141
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STATUTORY AUTHORITIES
Occupational Safety and Health Act of 1970
Public Law 91-596 29 U.S.C. § 651
For a brief history of this Act, please refer to the section on the
Occupational Safety and Health Administration, page .
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."
Authorizes the Secretary to perform workplace evaluations with
regard to the toxic effect of concentrations found there.
(Health Hazard Evaluations)
sec. 20(a)(e) Delegates the functions of the Secretary of HEW (now DHHS)
under this Act to 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(a) Establishes NIOSH within HEW (now DHHS) to perform the
Secretary of HEW's functions under sections 20 and 21 of this
Act.
142
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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 sections 20 and 21 of this
Act.
Federal Mine Safety and Health Amendments Act of 1977
Public Law 95-164 30 U.S.C. § 802
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 noncoal 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,
adding strengthening 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.
143
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Key Sections of Act—Toxics Focus
sec. 101(a)(6)(b) Stipulates 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 safety and health.
144
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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 will
be included in this section.
•
Research
The largest effort within NIOSH, both in terms of dollars and personnel,
is directed toward applied occupational health and safety research. Most of
the research is concerned with developing new or modifying existing criteria
for recommended occupational health and safety standards. Primary areas of
research are toxicology, physical and chemical agents, physiology and
ergonomics, engineering, behavioral and motivational factors, and
epidemiological industrywide 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.
*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.
145
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NlOSH's Industrywide Studies Program develops basic information to be
! i
included in the development of 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.
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
^ r ,. .
t .- •*.= f
Criteria Documents. NIOSH provides recommended health and safety
standards in the form of criteria documents to the Secretary of Labor for
promulgation and enforcement. Criteria documents are publications on specific
occupational health and safety 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 recomnendation 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.
146
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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 Criteria
Documentation and Standards Development located at NIOSH headquarters in
Rockville, Maryland.
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 initiated 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.
147
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Technical Services
NIOSH provides a number of technical services to employees and employers
and organizations in the occupational safety and health field. These include:
o Health Hazard Evaluations. A Health Hazard Evaluation is an on-site
investigation of health hazards in a specific workplace. The
evaluations may be requested by an authorized representative of
employees or by an employer. If a NIOSH investigator finds any
employee in imminent danger, his employer 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 evaluations in mines under the Federal Mine
Safety and Health Act of 1977.
o Current Intelligence Bulletins. The Bulletins serve as a means to
promptly notify persons in the occupational field of health and
safety hazards that may not have been previously 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.
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, (1978) lists over 33,000
different substances, as well as 90,000 synonyms for those
substances.
o National Occupational Hazard Survey. This 4-year effort was designed
to find out how many workers are exposed to specific hazards, which
industries they work in, and the jobs they hold. After visits and
contacts with over 5,000 workplaces, NIOSH investigators accumulated
data on 4,500 potential hazards in 66 types of industries and 456
occupational groups.
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DEPAR TMENT 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 handicapped, and other groups.
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The Department of Labor, ninth executive department, was created by act
approved March 4, 1913. A Bureau of Labor was first created by Congress in
1884 under the Interior Department. The Bureau of Labor later became
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.
This publication focuses on the duties and activities of the Occupational
Safety and Health Administration, which is located under the Assistant
Secretary for Occupational Safety and Health.
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DEPARTMENT OF LABOR
ORGANIZATIONAL CHART'
EXECUTIVE AND
SPECIAL ASSISTANTS
EXECUTIVE SECRETARIAT
SECRETARY OF LABOR
UNDER SECRETARY
OF LABOR
DEPUTY UNDER SECRETARY FOR
LEGISLATION AND
INTERGOVERNMENTAL RELATIONS
DEPUTY UNDER SECRETARY FOR
INTERNATIONAL AFFAIRS
LTI
INSPECTOR GENERAL
ASSISTANT SECRETARY
ADMINISTRATION AND
MANAGEMENT
ASSISTANT SECRETARY
POLICY, EVALUATION
AND RESEARCH
DIRECTOR
WOMEN'S BUREAU
ADMINISTRATIVE
LAW JUDGES
BENEFITS REVIEW
BOARD
EMPLOYEES' COMPENSATION
APPEALS BOARD
SOLICITOR
DIRECTOR
INFORMATION.
PUBLICATIONS. AND
REPORTS
ASSISTANT SECRETARY
EMPLOYMENT AND
TRAINING
ASSISTANT SECRETARY
LABOR-MANAGEMENT
RELATIONS
ASSISTANT SECRETARY
EMPLOYMENT
STANDARDS
ASSISTANT SECRETARY
MINE SAFETY AND HEALTH
COMMISSIONER
OF LABOR
STATISTICS
* NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances
activities.
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152
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OCCUPATIONAL SAFETY AND
HEALTH ADMINISTRA TION
Department of Labor
200 Constitution Avenue NW.
Washington, D.C. 20210
Locator: 202-523-6666
Information: 202-523-8151
Organization Page 156
Statutory Authority Page 00
Regulatory Development Page 162
Toxics-Related Activities....... Page 164
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 in order 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.
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Establish reporting and recordkeeping procedures to monitor job-
related injuries and illnesses.
Encourage the development of "fully effective" job safety and
health programs by the States. These programs' standards must be
at least as effective as those of the Federal program.
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DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)
ORGANIZATIONAL CHART*
OFPICE OF
FIELD COORDI-
NATION- AND .
EXPERIMENTAL
PROGRAMS :
•MM
ASSISTANT SECRETARY
AND
DEPUTY
OFFICE OF
INFORMATION
AND CONSUMER
AFFAIRS
U1
Ul
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ORGANIZATION1
DIRECTORATE OF POLICY, LEGISLATION, AND INTERAGENCY PROGRAMS
o Develops OSHA agency policy in coordination with other OSHA
Directorates and Offices.
o Analyzes proposed and related legislation affecting OSHA
programs.
o Advises the Assistant Secretary as to program options and
alternatives available.
o Coordinates OSHA policies and plans with other Federal agencies
with related programs.
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.
DIRECTORATE OF TECHNICAL SUPPORT
o Serves as a source of Agency expertise on scientific, economic,
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.
*Note: Only those Directorates which deal with toxics or toxics-related
issues are developed in this section.
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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
standard for field personnel.
o Explains, interprets, and answers all questions from the public
related to application of standards.
FOR FURTHER INFORMATION:
Federal and State Agencies:
Industry and General Public:
Chief, Division of Interagency Programs
U.S. Department of Labor—OSHA
200 Constitution Avenue NW.
Room N3628
Washington, D.C. 20210
Phone: 202-553-9296
Chief, Division of News Media Service
U.S. Department of Labor—OSHA
200 Constitution Avenue NW.
Room N3637
Washington, D.C. 20210
Phone: 202-523-8151
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STATUTORY AUTHORITIES
The Occupational Safety and Health Act of 1970
Public Law 91-596 29 U.S.C. § 651 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
few acts quite limited in 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). Only a few 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 and compliance varied widely, with many
States fearing that strict adherence to standards would be 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."
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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 plans are excluded from the
coverage of the Act.
«
Three new agencies were established by the Act to carry out the main
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, Education, and Welfare (HEW), 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
Secretary on matters relating to the administration of the Act.
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Key Sections of Act—Toxics Focus
sec. 3 Defines terms of importance of the Act.
sec. 5 States the duties of each employer or employee.
sec. 5(a)(1) Requires the employer to maintain a workplace that is "free from
recognized hazards that are causing or are likely to cause death
or serious physical 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 it is a condition that is
"...(a) of a common knowledge or general recognition in the
particular industry in which it occurs, and (b) detectable (1)
by means of the senses (sight, smell, touch, and hearing), or
(2) is of such wide, general recognition as a hazard in the
industry that even if it is not detectable by means of the
senses, there are generally known and accepted tests for its
existence which should make its presence known to the employer.
For example, excessive concentrations of a toxic substance in
the air would be a recognized hazard if they could be detected
through the use of measuring devices."
sec. 6(b) Authorizes the Secretary to promulgate occupational safety or
(1-4) 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 the use of appropriate forms of warning, suitable
protective or control equipment, the monitoring of employees'
exposure, and medical examinations or tests as may 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 the Administration the authority to enter any work area
for inspection and investigation (subject to interpretation of
Marshall vs. Barlows/ Inc./ Supreme Court decision).
sec. 8(c)(3) Requires each employer to keep records of exposure to toxic
materials and make them available upon request.
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.
sec. 13 Authorizes the Secretary to petition the courts to restrain
inminent danger situations.
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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, Education, and Welfare (HEW) to
(a) (2) develop specific plans for research, demonstrations, and
experiments to produce criteria identifying toxic substances.
sec. 20 Directs the Secretary of HEW to develop criteria to describe
(a)(3) safe exposure levels for toxic materials and hazardous physical
agents.
sec. 20 Allows the Secretary of HEW to develop regulations requiring
(a)(5) 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 Directs the Secretary of HEW to provide annually a "list of all
(a) (6) known toxic substances by generic family or other useful
grouping, and the concentrations at which such toxicity is known
to occur.
sec. 22 Establishes the National Institute for Occupational Safety and
Health to develop and recommend standards.
Regulatory Options Available Under Statute
o Promulgate occupational safety and health standards
o Authorize inspections and investigations
o Issue citations and proposed penalties
o Petition the courts to restrain imminent danger situations
o Approve or reject State plans for administering and enforcing
health/safety programs under the Act
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
1. Decision to initiate health standards development project based on
NIOSH recommendations, new research findings, petitions, or court
order. An. Advisory Committee / permanent or ad hoc, may be convened
either to review current data and make recommendations or to review
OSHA-generated drafts of proposals (arising from Activity No. 3
below). Advanced Notices of Proposed Rulemaking (ANPRM) may be
published in the Federal Register to inform the public of new
initiatives.
2. Decision to regulate triggers concurrent analyses, by Project Officer
in Health Standards Programs (HSP) and counterparts in Technical
Support. The Project Officer reviews all available scientific
literature on the hazard as well as relevant enforcement data and
existing standards. The Project Officer shares data with Technical
Support staff who make initial regulatory analysis, and begin
appropriate studies of economic/technological feasibility.
3. Project Officer prepares draft technical standard and preamble. Upon
consultation with Technical Support, HSP submits action plan to
Secretary of Labor outlining proposed action, need for action, need
for regulatory analysis, standard development schedule, etc.
4. Upon approval by the Secretary of Labor, the proposed rule is put
into Federal Register format, and a draft environmental impact
statement, if required, and draft regulatory analysis, if required,
are prepared for publication. Also, if applicable, any studies of
economic or technological feasibility are prepared for release to the
public.
5. The proposed standard is published in the Federal Register along with
information concerning any public hearing(s) to be held on the
subject. Other pertinent documents, i.e., draft regulatory analysis,
draft environmental impact statement, and any other studies of
economic/technological feasibility, are released to the public. A
minimum of 60 days is given for receipt of written comments from the
public.
6. An informal public hearing is held, if requested by the affected
parties, to allow further public comment, questioning of witnesses,
and submission of additional data.
7. Project staff (composed of staff from Health Standards, Technical
Support, and Solicitor of Labor) analyzes entire rulemaking record to
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identify major issues and prepare, if necessary, final environmental
impact statement and final regulatory analysis. Major decision
points/issues are presented to OSHA management. Review and clearance
is obtained from the Assistant Secretary and Secretary.
8. The final standard is published in the Federal Register to become
effective in 60-90 days. (Compliance with all parts of a standard
may not be required immediately. For example, installation of
engineering controls might be given a "phase-in" period of months or
even years). If required, the final regulatory analysis and final
environmental impact statement are released to the public.
9. If a petition is filed challenging the validity of the final
standard, it may be subject to judicial review.
EXISTING REGULATIONS
Occupational Safety and Health Act 29 CFR 1900-1999
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TOXICS-RELATED ACTIVITIES'
Identification/ Classification/ and Regulation of
Toxic Substances Posing a Potential Carcinogenic Risk
Directorate of Health Standards
OSHA has published a statement of policy and procedure for the regulation
of potential carcinogens found in the occupational environment (January 22,
1980; 45 FR 5002). This action does not in itself impose any requirements on
employers but rather establishes a framework for regulatory action by the
Agency. The Agency is responding to a need to develop a more expeditious
means of evaluating data on potentially carcinogenic materials and for
developing regulations to provide adequate employee protection from exposure
to these substances.
Health Standards Development
New and revised mandatory standards are proposed and promulgated to
protect the safety and health of workers. Priority needs for safety and
health standards are determined for particular occupations, industries, and
work environments, or standards development projects are initiated as a result
of petitions, research findings, and criteria documents. Public comment is
invited on proposed standards. Informal hearings on proposed standards
*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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provide for public testimony and submission of additional data. The record of
rulemaking is evaluated, and final standards are issued on the basis of
4
substantial evidence in this record. Summaries of some current toxics-related
rules under development follow.
OCCUPATIONAL EXPOSURE TO BERYLLIUM
OFFICE OF CARCINOGEN STANDARDS
OSHA is developing a standard for occupational exposure to beryllium. The
standard would include permissible exposure limits and provisions for medical
surveillance, exposure monitoring, methods of compliance, employee training,
recordkeeping, etc.
The Agency is responding to a need to provide more effective protection of
employees from the health hazards of beryllium exposure. The potential
hazards include berylliosis (a disease of the lungs and other organs) and
cancer.
STANDARDS COMPLETION PROJECT
OFFICE OF SPECIAL STANDARDS PROGRAMS
The purpose of the project is to establish a general standard on
environmental monitoring of worker exposure to toxic chemicals, medical
surveillance of exposed employees, employee training, and recordkeeping. In
addition, supplementary, substance-specific guidelines would be prepared for
employer and employee use. The project covers the current list of chemicals
for which OSHA has only permissible exposure limits (29 CFR 1910.1000, Tables
Z-1, Z-2, and Z-3). The Occupational Safety and Health Act of 1970 describes
the above provisions as important elements of a comprehensive and effective
program of industrial hygiene. Conclusion of this project is important to
assuring that the intent of the act is fulfilled.
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OCCUPATIONAL EXPOSURE STANDARDS FOR ASBESTOS, 29 CFR 1910.94(a)
DIRECTORATE OF HEALTH STANDARDS
P
OSHA is considering revisions to its current asbestos standard. Revisions
might include changes to the current permissible exposure limit and provisions
for medical surveillance/ monitoring, etc. Research on the health hazards of
asbestos and concern for the adequacy of the current standard prompted this
review. Asbestos has been linked to a large number of cases of occupationally
related cancer.
OCCUPATIONAL EXPOSURE TO CADMIUM
OFFICE OF CARCINOGEN STANDARDS
OSHA is considering revisions to amend its current permissible exposure
limit for cadmium and to add provisions for medical surveillance, exposure
monitoring, etc. Research on the health effects of cadmium indicates that the
current standard may not be adequately protective. Exposure to cadmium may
cause kidney, liver, adrenal, and other systemic damage as well as several
types of cancer.
OCCUPATIONAL EXPOSURE TO NICKEL
OFFICE OF CARCINOGEN STANDARDS
OSHA is considering revisions to amend its current permissible exposure
limit for nickel and to add provisions for medical surveillance, environmental
monitoring, etc. The National Institute for Occupational Safety and Health
has published a summary of the toxic effects of nickel and recommendations for
controlling occupational exposure to this substance. The NIOSH report, called
a Criteria Document, indicated that OSHA's current standard for nickel may not
be sufficiently protective. Exposure to nickel may increase the risk of lung
and nasal cancer and also causes nasal septum perforation and dermatitis.
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OCCUPATIONAL EXPOSURE TO MBOCA
OFFICE OF CARCINOGEN STANDARDS
OSHA is developing a standard for occupational exposure to MBOCA (4,4
methylene bis (2-chloroaniline)) which may include a permissible exposure
limit and provisions for medical surveillance, environmental monitoring,
methods of compliance, employee training, etc. An earlier standard for MBOCA
was vacated for a procedural reason through judicial action. MBOCA has been
shown to be a carcinogen in three mammalian species•
CHEMICAL HAZARD IDENTIFICATION
OFFICE OF SPECIAL STANDARDS PROGRAMS
OSHA is developing a proposal to require employers to inform employees of
the identities and hazards of chemicals in the workplace, by means of labels,
placards, lists, and substance data sheets. Employees' awareness of the
chemical hazards to which they are exposed provides the knowledge necessary
for individuals to participate actively in the reduction or elimination of
exposure to these harmful agents.
OCCUPATIONAL EXPOSURE TO HEXAVALENT CHROMIUM
OFFICE OF CARCINOGEN STANDARDS
OSHA is developing a standard for occupations exposure to hexavalent
chromium. The standard would include permissible exposure limits and
provisions for medical surveillance, exposure monitoring, methods of
compliance, employee training, etc. The Agency is responding to a need to
provide more effective protection of employees from the health hazards of
hexavalent chromium exposure. The potential hazards include skin ulceration,
nasal septum perforation, and cancer.
OCCUPATIONAL EXPOSURE TO PESTICIDES
OFFICE OF SPECIAL STANDARDS PROGRAMS
OSHA is developing a generic standard to control occupational exposure to
pesticides during the manufacturing and formulating processes. OSHA has
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determined that employees in the pesticide industry have an increased risk of
n
illness due to their exposure to pesticides/ and the Agency has developed
several alternative standards designed to reduce this risk. The standards
include provisions relating to work practices, medical surveillance, employee
training/ and respiratory protection.
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DEPAR TMENT OF TRANSPOR TA TION
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 hazardous materials. The lead agency is the
Materials Transportation Bureau (MTB) of DOT's Research and Special Programs
Administration. The MTB 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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I
DEPARTMENT OF TRANSPORTATION
ORGANIZATIONAL CHART*
SECRETARY
DEPUTY SECRETARY
ADMINISTRATIVE
OFFICES
-J
O
ASSISTANT
SECRETARIES
US. COAST GUARD
FEDERAL AVIATION
ADMINISTRATION
FEDERAL HIGHWAY
ADMINISTRATION
FEDERAL RAILROAD
ADMINISTRATION
NATIONAL HIGHWAY
TRAFFIC SAFETY
ADMINISTRATION
URBAN MASS
TRANSPORTATION
ADMINISTRATION
ST. LAWRENCE SEAWAY
DEVELOPMENT
CORPORATION
RESEARCH ANDSPECIAL
PROGRAMS
ADMINISTRATION
I
•• MATERIALS
TRANSPORTATION
•" ''BUREAU
•NOTE: Only a partial organizational chart is shown to highlight (in gray) the two
administrations within the Department which are involved in toxics-related activities.
-------
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 174
Statutory Authority page 177
Regulatory Development page 179
Toxics-Related Activities page 180
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,
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discussed in the next section, is responsible for all regulations and
activities relating to bulk transportation by water.) To ensure
Departmentwide coordination under the new structure, the Director of MTB must
consult with the other modal administrators within DOT (Federal Highway
Administration [FHA], Federal Aviation Administration [FAA], Federal Railroad
Administration [FRA]) before issuing regulations on matters affecting them*
In addition, with the responsibility for enforcement of regulations other
than those applicable to an individual mode of transportation, the MTB places
primary emphasis on compliance and enforcement authority over container
manufacturers and multimodal reconditioners and shippers of hazardous
materials. The other operating administrators retain jurisdictional
responsibility for enforcement and compliance actions relating to unimodal
transportation of hazardous materials.
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U.S. DEPARTMENT OF TRANSPORTATION
RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION
MATERIALS TRANSPORTATION BUREAU
ORGANIZATIONAL CHART*
RESEARCH AND SPECIAL
PROGRAMS
ADMINISTRATION
MATERIALS
TRANSPORTATION
BUREAU
OFFICE OF PIPELINE
SAFETY
REGULATION
PIPELINE SAFETY
ENFORCEMENT
DIVISION
PROGRAM
DEVELOPMENT
DIVISION
R 8, D
MANAGEMENT
DIVISION
*NOTE: Only a partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances activities.
-------
ORGANIZATION*
OFFICE OF OPERATIONS AND ENFORCEMENT
o Plans and performs inspections, testing, registration, and enforcement
functions necessary to assume compliance with MTB hazardous materials
transportation and pipeline safety regulations.
Operations Division
o Conducts operational studies to help assure enforcement of hazardous
materials transportation safety regulations.
o Develops enforcement action plans.
o Reviews National Transportation Safety Board (NTSB) reports and safety
recommendations and determines DOT response.
Hazardous Materials Enforcement Division
o Conducts inspections and investigations to ensure enforcement of
hazardous materials transportation regulations.
o Reviews and responds to requests for inconsistency rulings and
nonpreemption determinations (in conjunction with the Office of Chief
Counsel).
o Processes hazardous material compliance actions.
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 Rulemaking (NPRM), exemptions, and
interpretations.
Standards Division
o Prepares hazardous materials transportation regulations for issuance or
revision.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
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o Evaluates applications for exemptions.
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.
OFFICE OF PROGRAM SUPPORT
o Provides administrative and research and development support for MTB
hazardous materials and pipeline safety regulatory, compliance, and
enforcement programs.
Information Services Division
o Develops and conducts training and public programs for dissemination of
safety information and Federal standards requirements.
o Establishes and maintains an MTB docket and information service for all
hazardous materials and pipeline safety official matters.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone* Mail Stop
Office of the Director 202-755-9260 DMT-1
Office of Operations
and Enforcement 202-755-9247 DMT-10
Operations Division
Hazardous Materials
Enforcement Division 202-755-5894 DMT-12
*FTS numbers are the same
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Division/Office Phone Mail Stop
Office of Hazardous Materials
Regulation 202-426-0656 DMT-20
Standards Division 202-426-2075 EMT-21
Technical Division 202-755-4906 DMT-22
Office of Program Support 202-472-0656 EMT-40
Information Services
Division 202-472-2784 DMT-43
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STATUTORY AUTHORITIES
Hazardous Materials Transportation 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."
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sec. 112 Preempts State and local requirements that are inconsistent
with the Act or any regulation issued underjthe Act.
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
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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 (FHA), Federal Aviation Administration (FAA), Federal
Railroad Administration (FRA).
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 Rulemaking is 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 General 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 obj ectives:
(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, FHA, FRA, U.S. 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. In 1978 the MTB completed and made available to the public a
comprehensive emergency response training program for the safe handling of
hazardous materials.
^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, Toxics Integration 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 183
Statutory Authority page 188
Regulatory Development .page 190
Toxics-Related Activities page 191
The United States Coast Guard (USC6) 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 cargos to various inspection, licensing, and
operating requirements; and the Magnuson Act of 1950, which gave the Coast
Guard broad authority regarding the supervision of cargo loading and storing,
inspection of vessels, and control of ship movements.
The pollution prevention role of the 1936 Tanker Act 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.
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U.S. DEPARTMENT OF TRANSPORTATION
UNITED STATES COAST GUARD
ORGANIZATIONAL CHART*
(NO INTEftN*IIOMA
03
to
•NOTE: A partial organizational chart is shown here to highlight (in gray)
those components ordinarily involved with toxic substances activities.
-------
ORGANIZATION
MARINE SAFETY COUNCIL (G-CMC)
o Manages and monitors the Coast Guard1 s program for the development and
implementation of regulations affecting the public including those
related to toxic substances.
o Is composed of seven members—The Chief Counsel, and the Chiefs of the
Offices of Merchant Marine Safety, Operations, Engineering, Boating
Safety, Marine Environment and Systems, and Public and International
Affairs.
OFFICE OF RESEARCH AND DEVELOPMENT (G-D)
o 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.
o Conducts a program to develop equipment and methods for responding to
discharges of hazardous chemicals into waters of the United States.
o Develops and maintains the Chemical Hazards Response Information
System.
OFFICE OF CHIEF COUNSEL (G-L)
o Renders advisory services, opinions, and decisions on all matters of a
legal nature.
o Serves as Chairman of the Marine Safety Counsel.
Regulations and Administrative Law Division (G-LRA)
o 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.
183
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o Reviews rules-and regulations for their application to the Coast Guard.
OFFICE OF MERCHANT MARINE SAFETY (G-M)
o Oversees the program for prevention of marine casualties.
o Responsible for the inspection of merchant vessels for compliance to
safety standards.
Cargo and Hazardous Materials Division (G-MHM)
o Initiates or reviews regulations relating to hazardous cargo
containment and handling.
o Studies data on toxicity and other hazards to determine the safety
precautions necessary when handling dangerous cargo.
o Identifies and monitors research projects in hazardous material safety.
o Maintains liaison with other Federal agencies and represents the Coast
Guard on advisory committees involved in regulating hazardous material
and dangerous cargo.
o Administers a program for certification of foreign chemical and gas
tanker vessels.
Technical Advisory Staff (G-MHM)
o Initiates and provides technical management for research and
development projects on hazardous materials.
o Directs activities of the NAS-USCG Advisory Committee on Hazardous
Materials.
o Acts as a liaison with the Natural Research Council Advisory Center on
Toxicology.
Hazard Evaluation Branch (G-MHM-3)
o Conducts the hazard analysis of chemicals prior to authorization for
shipment.
o Initiates research to assign toxicity, fire, and reactivity hazards to
chemicals being or likely to be carried by water.
o Reviews toxicological data from a variety of sources for possible
incorporation into Coast Guard regulations.
Merchant Vessel Inspection Division (G-MUI)
o Develops and enforces safety standards for vessels.
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o Issues standards for the protection of merchant seamen from exposure to
chemicals.
Merchant Vessel Personnel Division (G-MVP)
o Establishes standards for licensing of U.S. merchant seamen and levels
of staffing for U.S. vessels.
o Is currently upgrading the qualifications for tankerman endorsement to
more fully address transfer operations of hazardous materials.
OFFICE OF MARINE ENVIRONMENT AND SYSTEMS (G-W)
o Administers a coordinated Coast Guard environmental program.
o Manages a comprehensive ports and waterways system encompassing all
aspects of marine transportation except vessel safety.
Marine Environmental Protection Division (G-WEP)
o Plans, coordinates, implements, and monitors a program to prevent,
detect, and control pollution of the marine environment in accordance
with statutory requirements and the policies of the Department of
Transportation.
Environmental Coordination Branch (G-WEP-2)
o Establishes and maintains liaison with appropriate Headquarters and
Departmental Offices to ensure coordination of Coast Guard's
environmental program.
o Represents the Coast Guard at meetings involving governmental agencies,
the public and private sectors, and international organizations
regarding general environmental matters.
Pollution Prevention and Enforcement Branch (G-WEP-3)
o Directs the Coast Guard's program to prevent and investigate pollution
discharges into the marine environment.
Pollution Response Branch (G-WEP-4)
o Plans, develops, and implements the Coast Guard Program for pollution
removal from the marine environment.
o Manages and coordinates the National Strike Force.
o Provides Department of Transportation membership in the National
Response Team.
Surveillance and Monitoring Branch (G-WEP-5)
o Plans, develops, and implements Coast Guard programs to detect
pollution in the marine environment.
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National Response Center Staff (G-WEP-6)
o Manages and operates the National Response Center to support the
National Response Team in accordance with the National Oil and
Hazardous Substances Pollution Contingency Plan.
Environmental Impact Branch (G-WEP-7)
o Plans, directs, and monitors a Coast Guard program to comply with the
National Environmental Policy Act of 1969 (NEPA) and related
legislation.
o 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).
Port Safety and Law Enforcement Division (G-WLE)
o Manages the Coast Guard Port Safety/Security Program for ports and
navigable waterways of the United States.
Port Safety Branch (G-WLE-1)
o Develops, manages, and monitors functions administered by the Captains
of the Port and Port Safety stations including the administration of
dangerous cargo regulations.
DIRECTORY FOR TOXICS-RELATED OFFICES AND
Division/Office
U.S.C.G./EPA Liaison Officer
Marine Safety Council
Office of Research
and Development
Office of Chief Counsel
Regulations and Administrative
Law Division
Office of Merchant Marine Safety
Cargo and Hazardous Materials
Division
Technical Advisory Staff
Hazard Evaluation Branch
*FTS numbers are the same
PERSONNEL
Phone*
202-755-077Q
202-426-1616
202-426-1040
202-426-1616
202-426-1534
202-426-2200
202-426-2297
202-426-2306
202-426-2559
Mail Stop
(G-CMC)
(G-D)
(G-L)
(G-LRA)
(G-M)
(G-MHM)
(G-MHM)
(G-MHM-3)
186
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Division/Office
Merchant Vessel Inspection
Division
Merchant Vessel Personnel
Division
Office of Marine Environment
and Systems
Marine Environmental Protection
Division
Environmental Coordination
Branch
Pollution Prevention and
Enforcement Branch
Pollution Response
Branch
Surveillance and
Monitoring Branch
National Response
Center Staff
Environmental Impact
Branch
Port Safety and law Enforcement
Division
Port Safety Branch
Phone
202^426-2178
202-426-1500
202-426-2007
202-426-2010
202-426-9573
202-426-9578
202-426-9568
202-755-7938
202-426-3300
202-426-3300
202-426-1934
202-426-1927
Mail Stop
(G-MVT)
(G-MVP)
(G-WEP)
(G-WEP-2 )
(G-WEP-3 )
(G-WEP-4 )
(G-WEP-5 )
(G-WEP-6 )
(G-WEP-7 )
(G-WLE)
(G-WLE-1 )
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STATUTORY AUTHORITIES
Ports and Waterways Safety Act
Public Law 92-340 46 U.S.C. § 391a (vessels) 33 U.S.C. § 1221 (ports)
The Ports and Waterways Safety Act is designed to provide adequate
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
sec. 101 Authorizes Secretary to establish regulations and procedures for
the safe storage and transportation of toxic substances on vessels
in navigable U.S. waters.
sec. 103 Permits Secretary to investigate accidents causing damage to the
environmental quality of ports/ harbors/ or other coastal areas.
sec. 104 Allows Secretary to establish regulations and other standards to
enforce the Act.
sec.201(2) Defines and sets standards for the transport of liquid cargo in
bulk.
sec.201(3) Permits Secretary to establish rules governing vessel design and
maintenance.
sec.201(4) Provides for consultation with other Federal agencies involved in
marine environmental protection.
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Regulatory Options Available Under Statute
o Control vessel traffic and operation
o Establish vessel safety requirements
o Set standards for transport of dangerous cargoes
o Limit vessel activity in defined waterfront safety zones
o Restrict the transportation of hazardous materials (in bulk cargo
from navigable waters)
o Ban the transportation of hazardous materials in bulk cargo from
navigable waters
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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. Depending on the complexity and/or urgency, an Advance Notice of Proposed
Rulemaking (ANPRM) may be published in the Federal Register. Otherwise, a
Notice of Proposed Rulemaking (NPRM) is published, comments are solicited,
and public hearings are held.
3. The final rule is cleared through the Marine Safety Council, the
Commandant, the Secretary of Transportation, and the Department Regulation
Council.
4. The rule is delivered and published in the Federal Register.
EXISTING REGULATIONS
Ports and Waterways Safety Act
(ports) 33 U.S.C. § 1221 33 CFR 160-165
(vessels) 46 U.S.C. § 391a 33 CFR 1, 3, 151, 157, 164
46 CFR 2-197
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TOXICS-RELATED ACTIVITIES'
Carriage of Bulk Liquid Hazardous Cargoes—General
Statutes: 33 U.S.C. § 1321; 46 U.S.C. §§ 325, 391a, 416, 1655; 49 U.S.C.
§ 1803
Regulations: 46 CFR 150, 151, 153, 154 (Subchapter "0")
Responsible Office: G-MHM (Cargo and Hazardous Materials Division)
Description:
a. 46 CFR 151 regulates the carriage of bulk liquid hazardous cargoes by
barge.
b. 46 CFR 153 regulates the carriage of hazardous liquids by tank vessel,
c. 46 CFR 154 regulates carriage of liquified gases by tank vessels.
Certification of Personnel Involved with
Transporting Bulk Liquid Hazardous Cargoes by Barge
Statutes: 46 U.S.C. §§ 375, 391a, 416
Regulations: 33 CFR 155, 46 CFR 12, 30, 31, 35, 70, 90, 98, 105, 151, 157
Responsible Office: G-MVP (Merchant Vessel Personnel Division)
Description:
a. 46 CFR 157 states the general manning requirements for commercial
vessels.
b. Licensed officers or "tankermen" are required to oversee cargo transfer
operations.
New Items: Regulations to streamline and state new licensing qualifications
are in progress.
*Included are those activities identified as toxics-related from the informa-
tion provided by each agency. 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, Toxic
Integration staff.
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Transfer Operations Involving Bulk Liquid Hazardous Substances
Statutes: 33 U.S.C. § 1321
Regulations: 33 CFR 124, 126, 154, 155, 156; 40 CFR 117
Responsible Office: G-WKP (Marine Environmental Protection Division), G-WLE
(Port Safety and Law Enforcement Division)
Description: 33 CFR 124 and 40 CFR 117 designate the hazardous substances
regulated under this program (not all listed are permitted to be
shipped in bulk).
Mew 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 package to
address transfer operations of hazardous substances.
Notification to the Captain of the Port, USCG, of the
Existence of Hazardous Conditions Aboard a Vessel
and/or Marine Casualties
Statutes: 33 U.S.C. §§ 1223, 1228; 46 U.S.C. § 391a
Regulations: 33 CFR 124, 161
Responsible Office: G-WLE (Port Safety and Law Enforcement Division)
Description: 33 CFR 124 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. The regulations are to be consolidated and streamlined in 33 CFR 161.
Interim final regulations were published in November 1979.
c. IMCO is studying additional requirements for vessels in international
waters to report marine casualties to the nearest country. Regulations
implementing the IMCO convention will be added to 33 CFR 161 upon
ratification.
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Ocean Dumpjng Surveillance
Statute: 16 U.S.C. § 1431; 33 U.S.C. §§ 1401, 1417, 1418
Regulations: 33 CFR 158 (Vacant); 40 CFR 220 thru 229
Responsible Office: G-WEP (Marine Environmental Protection Division)
Description:
a. 40 CFR 220 through 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 Engineers (ACOE) to regulate ocean dumping of dredged
material.
c. 33 CFR 158 will contain the regulations covering electronic surveil-
lance equipment required to assist the USCG in surveillance of ocean
dumps which are made in accordance with the terms of permits issued by
EPA and ACOE, and by authorizations issued by ACOE for ocean dumping of
dredged materials.
New Items: Dumping surveillance regulations were proposed during December
1979.
Inspection of Foreign Flag Tank Ships
Statute: 33 U.S.C. § 1321; 46 U.S.C. § 391a; 49 U.S.C. § 1803
Regulation: None
Responsible Office: G-MVI (Marine Investigation Division)
Description: The series of tank ship 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. § 1321
Regulations: 33 CFR 153; 40 CFR 110, 117, 1510
Responsible Office: G-WEP (Marine Environmental Protection Division)
Description:
a. 40 CFR 110 defines oil.
b. 40 CFR 116 designations of hazardous substances.
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c. 40 CFR 117 defines reportable quantities of hazardous substances.
d. 40 CFR 1510 is the 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.
New Items: The National Contingency Plan was revised on March 19, 1980, to
conform to the Clean Water Act (as amended 1977). See 45 FR
17832.
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ENVIRONMENTAL PROTECTION AGENCY
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
EPA was created through 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.
*As of May 4, 1980, HEW was divided into two new departments—the Department
of Health and Human Services and the Department of Education.
195
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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.
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.
Six 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 Planning and Standards, the Office of Solid Waste, and the Office of
Drinking Water, which are located within the Office of Water and Waste
Management; and the Offices of Air Quality Planning and Standards and Mobile
196
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Source Air Pollution Control* 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.
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U. S. ENVIRONMENTAL PROTECTION AGENCY
Organizational Chart
OFFICE OF INSPECTOR GENERAL
OFFICE OF ADMINISTRATIVE JUDGES
OFFICE OF CIVIL RIGHTS
OFFICE OF ENVIRONMENTAL REVIEW
OFFICE OF GENERAL COUNSEL
OFFICE OF INTERNATIONAL ACTIVITIES
OFFICE OF LEGISLATION
OFFICE OF PUBLIC AWARENESS
OFFICE OF PRESS SERVICES
OFFICE OF REGIONAL LIAISON
OFFICE OF INTERGOVERNMENTAL RELATIONS
EXECUTIVE COMMUNICATIONS
SCIENCE ADVISORY BOARD
ADMINISTRATOR
DEPUTY
ADMINISTRATOR
ASST. ADMINISTRATOR
FOR PLANNING
AND MANAGEMENT
VO
00
ASST. ADMINISTRATOR
FOR
ENFORCEMENT
OFFICE OF
MANAGEMENT AND
AGENCY SERVICES
OFFICE OF
PLANNING AND
EVALUATION
OFFICE OF
RESOURCES
MANAGEMENT
ASST. ADMINISTRATOR
FOR RESEARCH
AND DEVELOPMENT
OFFICE OF
GENERAL
ENFORCEMENT
OFFICE OF
WATER
ENFORCEMENT
OFFICE OF
MOBILE SOURCE AND
NOISE ENFORCEMENT
OFFICE OF
MONITOR ING AND
TECHNICAL SUPPORT
OFFICE OF
ENVIRONMENTAL
ENGINEERING AND
TECHNOLOGY
OFFICE OF
ENVIRONMENTAL
PROCESSES AND
EFFECTS RESEARCH
OFFICE OF
HEALTH RESEARCH
REGIONAL OFFICES
ASST. ADMINISTRATOR
FOR AIR. NOISE.
AND RADIATION
OFFICE OF
AIR QUALITY
PLANNING AND
STANDARDS
OFFICE OF
MOBILE SOURCE
AIR POLLUTION
CONTROL
OFFICE OF
NOISE ABATEMENT
AND CONTROL
OFFICE OF
RADIATION
PROGRAMS
ASST. ADMINISTRATOR
FOR WATER AND
WASTE MANAGEMENT
ASST. ADMINISTRATOR
FOR PESTICIDES AND
TOXIC SUBSTANCES
OFFICE OF
WATER PLANNING
AND STANDARDS
OFFICE OF
WATER PROGRAMS
OPERATIONS
OFFICE OF
PESTICIDE
PROGRAMS
OFFICE OF
TOXIC
SUBSTANCES
OFFICE OF
DRINKING WATER
OFFICE OF
SOLID WASTE
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REGULATORY DEVELOPMENT
At the onset of the regulatory development process, all new EPA
regulations are classified as either "Significant" or "Specialized." (See
figure 1) This classification is done by the lead office with the concurrence
of the Office of Planning and Management. Approximately half of the current
regulations are labeled "Significant" and follow the uniform development
process outlined below. All other regulations are referred to as
"Specialized" and follow separate specialized procedures. 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 new regulations are presumed to be Significant unless they fall into one
of the exclusion categories listed under Specialized Regulations. Significant
Regulations follow the formal regulatory development procedures.
Specialized Regulations
Regulations which are not subject to formal regulatory development procedures.
These 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 designates
as not sufficiently important to require formal development procedures; EPA
actions on regulations developed by State and local government; and certain
pesticide-related actions.
Lead Office
The Assistant Administrator for the 'relevant program (the Office of Air,
Noise, and Radiation, the Office of Enforcement, the Office of Pesticides and
Toxic Substances, or the Office of Water and Waste Management) has the lead
responsibility for initiating and writing most new regulations.
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Senior Management
This group includes the Administrator, Deputy Administrator, Assistant
Administrators, Regional Administrators, General Counsel, and appropriate
Staff Office Directors.
Major Regulations
A regulation will be classified as Major if it is likely to: address a major
health or ecological problem; result in a major health, ecological, or
economic impact; cause substantial urban impact; initiate a substantial
regulatory program or change in policy; cause a substantial impact on another
EPA program or another Federal agency program; cause a substantial change in
the scope of State-administered environmental programs; cause a
disproportionate impact on a particular region of the United States; and/or
implement a regulatory program central to the basic purpose of the statute
under which it is adopted. Major regulations will receive extra attention
from senior Agency management.
Routine Regulations
All regulations not classified as Major regulations.
Work Groups
This is a group of specialists drawn from various offices within EPA to advise
and assist the lead office in preparing each significant regulation and its
support materials.
Steering Committee
This is a continuing group representing the six Assistant Administrators,
General Counsel, and appropriate Office Directors on the Administrator's
staff. 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 all Assistant Administrators, General Counsel
and chief Staff Office Directors. The heads of EPA's ten regional offices
(Regional Administrators) also have an opportunity to submit comments. A full
review takes 3 weeks.
200
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Figure 1. Priority Classifications for EPA Regulations
ALL EPA REGULATIONS
SIGNIFICANT ! SPECIALIZED
REGULATIONS ' REGULATIONS
MAJOR j ROUTINE
REGULATIONSt REGULATIONS
i
Significant regulations are produced in a multistage process: (1)
notification stage, in which the lead office notifies senior management that
work is starting on a new regulation, (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 the third and fourth stages twice, first as a
proposal and again in final form.
For internal management purposes, EPA further divides all Significant
regulations into two classes, Major and Routine. Both types follow the
uniform~ regulation development process. However, Major regulations will
receive extra attention from senior Agency management.
The regulatory development process (i.e., Significant Regulations) within
EPA is summarized in figure 2. A more detailed description of this process
can be found in "Improving Environmental Regulations," 44 FR 30988.
201
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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 package:
• 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 by
Administrator
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OFFICE OF PESTICIDES AND
TOXIC SUBSTANCES
Environmental Protection Agency
401 M Street SW.
Washington, D.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 (TSCA).
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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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
ORGANIZATIONAL CHART
ASSOCIATE ASSISTANT
ADMINISTRATOR FOR
' TOXICS INTEGRATION
OFFICE OF
TOXICS INTEGRATION*
ASSISTANT ADMINISTRATOR
FOR PESTICIDES AND
TOXIC SUBSTANCES
ASSOCIATE ASSISTANT
ADMINISTRATOR FOR
PESTICIDES AND
TOXIC SUBSTANCES
.
OFFICE OF
POLICY ANALYSIS
AND MANAGEMENT*
M
O
1
DEPUTY ASSISTANT
ADMINISTRATOR
FOR PESTICIDE
PROGRAMS
DEPUTY ASSISTANT
ADMINISTRATOR
FOR TOXIC
SUBSTANCES
•NOTE: The functions of these two offices are given on the following page.
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ORGANIZATION
OFFICE OF TOXICS INTEGRATION
o Establishes policies, priorities and procedures for the integration and
coordination of Agency and Federal Activities concerning toxic
substances.
o Conducts studies and analyses of Agency and other Federal
priority-setting mechanisms for chemicals and recommends regulatory and
nonregulatory approaches for chemical control.
o Oversees evaluation of OPTS and Agencywide decisionmaking criteria for
ordering and ranking toxic chemicals for risk assessment and
regulation.
o Evaluates TSCA and other EPA statutes in terms of policy consistency
and efficacy of implementation with regard to integrated approaches for
chemical information collection and dissemination and chemical
regulatory control mechanisms.
o Provides staff and operating support to the Toxic Substances Priorities
Committee (TSPC) to assist the TSPC in developing and monitoring
policies and procedures to coordinate and integrate toxic substances
activities.
o Oversees the development of the Chemical Substances Information Network
(CSIN).
o Works with the Interagency Regulatory Liaison Group (IRLG) Agencies to
integrate Federal toxic substances information development, assessment
and control activities.
o Develops policies and procedures to articulate State and Regional
relationships to TSCA implementation.
o Implements OPTS public participation programs.
o Develops and disseminates educational and other mateials designed to
increase awareness of the objectives and mechanisms provided under
TSCA, FIFRA, and other EPA statutes for toxic substances control.
o Coordinates all international aspects of TSCA and FIFRA.
OFFICE OF POLICY ANALYSIS AND MANAGEMENT
o Advises the Assistant Administrator of OPTS on matters of policy,
program evaluation, management, resource allocation, and
administration.
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o Serves as the focal point for all OPTS documents published in the
Federal Register.
206
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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 209
Statutory Authority page 212
Regulatory Development page 218
Toxics-Related Activities page 219
This Office is responsible for the toxic substances activities of the
Agency as mandated by the Toxic Substances Control Act (TSCA). As such, the
Office develops and operates Agency programs and policies for assessment and
control of toxic substances; develops recommendations for Agency priorities
for research monitoring, regulatory, and information-gathering activities
related to toxic substances; develops scientific, technical, economic, and
social data bases for the conduct of hazard assessments and evaluations in
support of toxic substances activities; provides toxic substances guidance to
EPA Regional Offices and coordinates communication with the industrial
community on matters relating to implementation of TSCA.
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
OFFICE OF TOXIC SUBSTANCES
ORGANIZATIONAL CHART
DEPUTY ASSISTANT ADMINISTRATOR
FOR TOXIC SUBSTANCES
M
O
00
REGULATORY
IMPACTS
BRANCH
POLICY BRANCH
MANAGEMENT
OPERATIONS
BRANCH
SYSTEMS
DEVELOPMENT
BRANCH
SYSTEMS
OPERATIONS
BRANCH
INFORMATION
CONTROL
BRANCH
INFORMATION
SUPPORT
SERVICES
BRANCH
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ORGANIZATION
INDUSTRY ASSISTANCE OFFICE
o Informs industry of EPA policy and regulatory positions under TSCA.
o Identifies industry needs and problems in meeting EPA's toxic
substances requirements and promotes discussion between industry and
EPA on toxic substances.
o Advises the Deputy Assistant Administrator on industry activities.
o Assists Regional Offices in responding to inquiries from industry.
ASSESSMENT DIVISION
o Identifies and manages the scientific evaluation of chemical risks to
human health and the environment.
o Performs preliminary evaluations of the types of hazards and degree of
risks reflected in the data submitted under TSCA sections 4, 5, and 8.
o Develops and implements reporting and recordkeeping rules and
guidelines under TSCA section 8.
o Manages (in support of the Chemical Control Division) the scientific
evaluation of chemical problems being considered for regulatory or
nonregulatory action.
o Develops and implements procedures for the selection of specific
chemicals or categories for testing under section 4.
HEALTH AND ENVIRONMENTAL REVIEW DIVISION
o Responsible for detailed assessment of harmful effects of chemicals on
human health and on the. environment in support of OTS regulatory
activities.
o Reviews/ validates/ and evaluates test data submitted by industry as
well as other available information relevant to harmful effects of
chemicals on human health and the environment in support of the risk
assessment activities of the Assessment Division.
209
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Performs scientific assessments of toxicity and other chemical hazards
to human health 'and the environment.
Identifies and develops new methods and techniques for laboratory
testing, epidemiological study, and evaluation of chemical hazards to
human health and the environment through studies that are planned
within the Agency's Research Committee System.
EXPOSURE EVALUATION DIVISION
o Supports OTS detailed risk assessment activities through an integrated
assessment of chemical exposure to humans and the environment.
o Develops standards, guidance, and rule development support to the
Chemical Control Division and the Assessment Division for chemical,
physical, and persistence properties testing, analytical methods, field
sampling, and other exposure-related data and studies, under TSCA
sections 4, 5, and 8.
o Reviews, evaluates, and validates data submitted by industry and other
available information relevant to chemical exposure to humans and the
environment.
o Performs scientific assessments of chemical exposure to humans and the
environment in support of the risk assessment activities of the
Assessment Division.
ECONOMICS AND TECHNOLOGY DIVISION
o Provides economic, engineering, and industrial chemistry support to the
Chemical Control Division for TSCA sections 5, 6, and 7 rulemaking, and
to the Assessment Division for TSCA sections 4 and 8 rulemaking.
o Participates in the development of regulations within OTS ensuring that
economic and technical feasibility issues are fully considered.
o Conducts assessments of the overall economic, engineering, and
industrial chemistry impacts of TSCA regulatory actions and OTS
nonregulatory actions.
CHEMICAL CONTROL DIVISION
o Selects and implements appropriate regulatory and nonregulatory
controls for existing and new chemicals or chemical uses found to
present or to have the potential for presenting unreasonable risks to
human health or the environment.
o Manages the regulatory evaluation and decisionmaking process for
chemicals subject to manufacturing or processing notices under section
5, subject to citizens' petitions under section 21, seeking action
under sections 4, 5, or 6, or identified as candidates for control
action through the efforts of the Assessment Division.
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o Develops generic and chemical-specific rules under sections 5, 6, or 7
of TSCA.
o Evaluates the need for and develops chemical-specific orders and
notices pursuant to sections 5(e), 5(f), 6(b), and 9 and, in
cooperation with the Office of General Counsel, support for court
actions under sections 5(e), 5(f), and 7.
MANAGEMENT SUPPORT DIVISION
o Supports OTS in Officewide policy analysis, program evaluations,
operational policy, management information systems, budget,
administration, and information support functions.
o Supports other OTS divisions in management information systems, program
evaluation, and information support functions.
o Designs and operates a Chemicals in Commerce Information System to
handle data collected in complying with TSCA.
o Develops and maintains an inventory of chemical substances and mixtures
manufactured or processed in the United States.
o Develops policies and procedures for State grants program and for
handling State requests for exemptions from Federal preemption.
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STATUTORY AUTHORITY
The Toxic Substances Control Act
Public Law 94-469 15 U.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.
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,
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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 significant 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.
sec. 5(b) Describes the instances in which a person subject to the
notification requirement 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 good 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 when there is insufficient
information to evaluate the health and environmental effects of
the substance.
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sec. 5(f) Requires the Administrator to take immediate action to prohibit
or limit human or environmental exposure tp 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).
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 (PCBs). 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).
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.
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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.
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 Administrator.
sec. 9(d) Requires that the Administrator consult and coordinate with
other Federal agencies 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 interagency 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.
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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, 5f 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.
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 Data
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).
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sec. 21(b) Details the procedures to be followed.
Regulatory Options Available Under Statute
o 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.
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory development process within EPA, see
page 199 of this publication.
EXISTING REGULATIONS
Toxic Substances Control Act 40 CFR 710-762
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TOXICS-RELATED ACTIVITIES
Within the Office of Toxic Substances, toxics-related activities 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 summaries of these
activities are included here. More detailed information can be obtained from
the Third Annual Report (1979) on the Administration of the Toxic Substances
Control Act which is available from the Industry 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) which lists over 44,000 commercial
chemical substances manufactured or imported in the U.S. On October 31, a
supplement was issued, adding 3,000 more chemicals to this list. Processors
and distributors of chemical substances had until December 31, 1979, to review
the list for completeness and add any chemicals not listed which have been
processed for a commercial purpose since January 1, 1975. A revised chemical
substances inventory will be published in 1980.
In the process of preparing this inventory, the Agency also collected
information on where these chemicals are manufactured and in what quantities.
This information will be useful to EPA when it begins to select chemical
substances for attention and action under TSCA.
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Data Collection/ Dissemination, and Utilization
Under the provisions of section 10(b), EPA is proceeding to develop
computer-based data systems which will enable the Agency to make effective use
of the data submitted under TSCA. The Chemicals in Commerce Information
System (CICIS) will allow the Agency to process and analyze data submitted in
support of the Inventory, health and safety studies, premanufacture
notification, and specific chemical regulations. Portions of CICIS became
operational in late 1979. There will be full public access to all
nonconfidential information on file in this system. A comprehensive Chemical
Substances Information Network (CSIN) currently under development in
cooperation with other Federal agencies will link various toxic substances
data systems, including CICIS, to further facilitate the exchange of
information. The Agency is taking steps to assure that all confidential
business information on file in these systems will be strictly protected.
Section 8—Reporting and Retention of Information
Section 8 of TSCA empowers EPA to obtain various kinds of information from
chemical manufacturers, processors, and distributors. Under this section, the
Agency is currently developing a set of recordkeeping and reporting
regulations and expects to publish a number of proposed rules in 1980. These
include a set of reporting rules under section 8(a) to support the Agency's
comprehensive risk assessment of chemicals in commerce as well as to obtain
data needed by other EPA programs or other Federal agencies. Another section
rS
8(a) rule to be proposed in early 1980 will require reports on the composition
of selected chemical trade name products.
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Under section 8(c) the Agency published a proposed rule (June 1980)
requiring manufacturers, processors, and distributors to maintain and submit
information on adverse health and environmental effects of certain chemicals.
Section 8(d) empowers the Agency to require the submission of health and
safety studies. Final rules promulgated under this section in July 1978 (43
FR 30984) were revoked in January 1979 (44 FR 6099). A new proposed rule
exercising essentially the same authority a the revoked rule will be published
in early 1980.
Under section 8(e), chemical manufacturers, processors, and distributors
are required to report information documenting that a chemical substance or
mixture presents a substantial risk or injury to health or the environment.
To date, the Agency has received over 300 such notices, many of which
contained information already well known or not significant. Several notices,
however, have prompted further investigation by EPA or referral to other
Federal agencies.
Testing
Under section 4 of TSCA, EPA is developing rules requiring manufacturers,
processors, and distributors of chemical substances to perform tests to
determine the chemical's effect on human health and the environment. The Act
requires that these test rules include standards specifying the procedures to
be used in conducting required tests. Testing standards will be directed at
specific characteristics and health effects, as well as environmental fate,
persistence, and ecological effects.
On May 9, 1979/ (44 FR 2733) the Agency proposed test standards for
oncogenic (tumor forming), non-oncogenic chronic, and combined oncogenic and
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non-oncogenic chronic health effects. In addition, on July 26, 1979, (44 FR
n
44054) test standards were proposed for mutagenic effects, teratogenic and
reproductive effects, general metabolism testing, and a variety of acute and
subchronic toxicity studies. Good laboratory practices for each of these
health effects testing standards were also proposed.
The work on test standards for a number of environmental toxicity and
chemical fate characteristics, along with good laboratory practices for each,
is proceeding rapidly. These standards will be proposed in 1980.
Chemical Control
Under TSCA, the Administrator of EPA may prohibit or limit the
manufacturing, processing, distribution in commerce, use, or disposal of a
chemical substance or mixture if he finds that these activities or any
combination of them presents or will present an unreasonable risk of injury to
health or the environment. A number of chemical control actions have been
initiated to date.
Polychlorinated Biphenyls (PCBs)
On May 31, 1979, the final ban rule for polychlorinated biphenyls (PCBs)
was issued. This rule, with a few specified exceptions, banned the
manufacture, processing, distribution, and non-totally enclosed use of PCBs
after July 1 of this year. The May 1979 rule also reduced the minimum PCB
concentration of materials covered by the ban, and the 1978 marking and
disposal rules, from 500 ppm' to 50 ppm.
: r • •#-
Due to the mounting evidence that exposure to asbestos fibers can cause
lung damage and several types of cancer, EPA initiated a nationwide voluntary
program in March 1979 to help States and school districts identify schools
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where deteriorating asbestos-containing material should be removed or sealed.
Subsequently, it was decided to develop regulations to protect against this
risk and an advanced notice of proposed rulemaking (ANPRM) was issued on
September 20, 1979, (44 FR 54676).
Chlorofluorocarbons (CFCs)
In March 1978 the Agency, along with the Food and Drug Administration and
the Consumer Product Safety Commission, banned the use of Chlorofluorocarbons
(CFCs) in aerosol products (43 FR 11301). During 1979, EPA continued to
investigate the feasibility of controlling nonaerosol applications of CFCs
and, in addition, has encouraged other nations to take actions to control CFC
emissions.
Premanufacture Notification
Under section 5 of the Act, any person who intends to manufacture or
import a new chemical substance for commercial purposes in the United States
must submit a notice to EPA at least 90 days prior to its manufacture or
importation. A "new chemical substance" is one not included on the Inventory
of existing substances published under section 8(b) on June 1, 1979. The
requirements of section 5 became effective July 1, 1979.
On January 10, 1979, EPA proposed rules and notice forms for the
premanufacture notification (PMN) program in the Federal Register.
Subsequently, due to the number and nature of comments received on these
proposed rules, the Agency decided to repropose portions of the January 10
notice. The Agency published this reproposal in the Federal Register on
October 16, 1979, (44 FR 59764), allowed a 45-day comment period, and held
public meetings with representatives of the chemical industry, public interest
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groups, organized labor, and others upon request. After EPA reviews the
public record, the Agency expects to promulgate the rules and forms during
mid-1980.
Over the coming months EPA will undertake a major rulemaking effort to
develop significant new use rules both for selected new substances after their
production begins as well as for certain existing substances.
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OFFICE OF PESTICIDE PROGRAMS
Environmental Protection Agency
401 M St. SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization. page 228
Statutory Authorities page 230
Regulatory Development page 235
Toxic-Related Activities....page 236
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
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training activities iri 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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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
OFFICE OF PESTICIDE PROGRAMS
ORGANIZATIONAL CHART
I EXTERNAL AFFAIRS STAFF
L
SPECIAL PROJECTS STAFF
I SCIENCE ADVISORY PANEL
INSECTICIDE/
RODENTICIDE
BRANCH
FUNGICIDE/
HERBICIDE
BRANCH
DISINFECTANTS
BRANCH
PROCESS
COORDINATION
BRANCH
REGULATORY
ANALYSIS AND
LAB AUDITS
BRANCH
CHEMICAL
REVIEW
BRANCH I
CHEMICAL
REVIEW
BRANCH II
CHEMICAL
REVIEW
BRANCH III
CHEMICAL
REVIEW
BRANCH IV
CHEMICAL
REVIEW
BRANCH V
TOXICOLOGY
BRANCH
ENVIRONMENTAL
FATE BRANCH
RESIDUE
CHEMISTRY
BRANCH
ECOLOGICAL
EFFECTS
BRANCH
HEALTH
EFFECTS
BRANCH
•
•
•
•
CHEMICAL AN
BIOLOGICAL
INVESTIGATE
BRANCH
ECONOMIC
ANALYSIS
BRANCH
PLANT
SCIENCES
BRANCH
ANIMAL SCIEN
AND INDEX
BRANCH
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ORGANIZATION
PROGRAM SUPPORT DIVISION (PSD)
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 renewal 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.
SPECIAL PESTICIDE REVIEW DIVISION
o Assures that chemicals identified as possible cases for the Rebuttable
Presumption Against Registration (RPAR) process are properly evaluated
and processed.
o Develops a comprehensive standard for each pesticide chemical/use-
pattern category. These standards serve as a basis for future
registration and reregistration decisions.
o Prepares and presents technical information to support administrative
and/or court hearings.
o Determines and coordinates, in conjunction with other OPP Divisions
(HED, BFSD, PSD), the need for special reviews or studies of specific
suspect chemicals. ,
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HAZARD EVALUATION DIVISION (RED)
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.
o Performs risk assessments on proposed and existing pesticide uses.
o Provides scientific expertise on adverse effects of pesticides to other
Agency programs and other Federal Agencies.
BENEFITS AND FIELD STUDIES DIVISION (BFSD)
o Retrieves, validates, and interprets scientific and technical data
relative to benefits derived from the use of pesticides.
o Conducts economic analyses on the impacts of cancellations/suspensions
and on special or emergency pesticide use applications.
o Develops scientific data on the magnitude and effects of exposure to
pesticides on the population by determining residues and metabolites
through analytical methods development.
o Conducts field studies to associate actual exposure and risk factors
with identified health effects of uses by the hazard assessment and
regulatory programs.
DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone Mail Stop
Office of Pesticide Programs 202-755-8033 TS-766
External Affairs Staff 202-755-8020 TS-766
(general program information)
Program Support Division 202-426-9033 TS-757
Registration Division 202-426-2451 TS-767
Special Pesticide Review Division 703-557-7438 TS-791
Hazard Evaluation Division 703-557-7351 TS-769
Benefits and Field Studies Division 202-472-9300 TS-768
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STATUTORY AUTHORITIES
The Federal Insecticide/ 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 pesticide 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.
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.'
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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-plant 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 Administrator to issue a 'stop sale, use, or
removal1 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.
sec. 17(a) Permits export of pesticides if in compliance with various
labeling 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).
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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 monitoring 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
o Regulate storage and disposal of pesticides and pesticide containers
(see also, Resource Conservation and Recovery Act)
o Seizure of unregistered, etc., pesticides
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 Drug 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,
*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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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, including 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 refiain 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.
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Key Sections of Act—Toxics Focus
sec. 406 Permits the establishment of tolerances for poisonous or
deleterious substances including pesticides which ( 1) are
required in the production of food or (2) otherwise cannot be
avoided by good manufacturing 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 on a raw agricultural commodity and
after processing remains in the processed food at a
concentration higher than originally found in the raw
agricultural 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 registration or certification
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within EPA, see page 199 of
this publication.
EXISTING REGULATIONS
Federal Insecticide, Fungicide, and 40 CFR 160-180
Rodenticide Act
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TOXICS-RELATED ACTIVITIES
Registration of Pesticides
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 of or probability of certain health and environmental effects, while
benefits are usually expressed in dollar valuations of such effects as
increased crop yields, lower food costs, reduced chance of disease, or the
cost savings with respect to the use of alternative control measures.
The Federal Pesticide Act of 1978, which amended FIFRA, authorized a
program for EPA to grant conditional registrations. Wider this program, 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 eligible for conditional registration if EPA determines that the public
interest would be served by registration, and if unreasonable risks will not
be incurred during the period required to complete and submit additional
studies.
Central to the conditional registration program 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
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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 1979 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 1979, the Registration Program received 59 new active
ingredients, 1,772 previously registered active ingredients, and 26,671
amendments and supplemental registration applications. Out of the 59 new
chemical registration submissions received, 23 were approved. This represents
a 180 percent increase in the approval of new chemical registrations compared
to Fiscal Year 1978. The approval rate for old chemicals, amendments, and
supplemental registrations remained approximately the same for Fiscal Year
1979.
Pesticide Tolerances
Under the Federal Food, Drug, 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 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.
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Pesticide Use Management
The Regional or Use Management Program has been established to assist
States in handling special pesticide incidents (kills, fires, etc.) and
registration needs and to certify applicators to purchase and use restricted
use pesticides. OPP's Use Management Program provides technical assistance,
guidance, and policy to the Regions, States, and local governments concerning
pesticide issues and Agency programs and decisions*
As part of the Public Outreach Program, the Use Management staff in Fiscal
Year 1979 responded to more than 10,000 external requests for
pesticide-related information, such as training materials, certified
applicator standards, registration, and use of pesticide information. In
addition they issued 52 Weekly OPP Operational Reports to the Regions, States,
and other external groups, developed 3 certification and training manuals, and
planned and coordinated the second National Certification and Training Meeting
held in Fiscal Year 1979 in Dallas, Texas.
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 41,000 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 41,000
registered pesticide products, EPA will be concentrating its effort on the
review of approximately 500 chemicals (active ingredients) representing the
major pesticide chemicals produced.
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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 will be
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 will require a risk analysis only. In addition, standards for
registration will state tolerable levels of exposure for food consumers, field
workers, applicators, and other persons and organisms unintentionally exposed
to pesticides, and will facilitate reassessments of tolerances to minimize
pesticide exposure of workers, applicators, and others.
Rebuttable Presumption Against Registration (RPAR)
The RPAR process is an intensive risk/benefit review of pesticide
chemicals suspected of causing unreasonable adverse health or environmental
impact. OPP employees, with the support of other EPA offices and Federal
agencies, develop recommendations for a regulatory position with regard to the
registration, suspension, cancellation, restriction on uses, or removal of
pesticides containing the chemical under review.
The RPAR process begins when a suspected pesticide chemical is referred to
the Special Pesticide Review Division for consideration. Before this chemical
can be accepted as an RPAR candidate, data supporting the statement of risk
must be scientifically validated. After acceptance as an RPAR candidate, a
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project team is named and a comprehensive literature search is initiated for
the pre-RPAR chemical. The first part of the RPAR process focuses on the
development of a risk assessment, followed by a publication of the Agency's
position on the pre-RPAR 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 project team develops a
risk/benefit analysis for each significant use and each regulatory option of
the RPAR chemical. 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 all or some of the uses of the pesticide.
In 1979, OPP completed proposed decisions for nine RPAR chemicals and
proceedings for five chemicals. Some of the more important RPAR decisions
included the following chemicals: Chlorobenzilate, Edrin, DBCP, Trifuralin,
Dimilin, Pronamide, BAAM (Amitraz), 2,4,5-T and Silvex.
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
240
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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 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 1979, OPP personnel conducted 33 on-site data audits
and 190 reviews of registrant validations of possibly faulty lab data. The
lab audit process identified several new suspect chemicals and four labs which
had significant problems.
In Fiscal Year 1979, OPP also developed a prototype standard for the
chemical metolachlor which was designed to give industry and the public an
example of a standard and to solicit their comments concerning the standard.
It should be noted that this prototype standard is not the Agency's final
regulatory position on metolachlor but rather a model that will enable OPP to
improve future standards development.
Other major accomplishments included the completion of an Advanced Notice
of Proposed Rulemaking (ANPRM), establishing the Agency's preferred method for
conducting analyses for registration standards development as well as a number
of miscellaneous changes to the existing registration regulations. The ANPRM
addresses the organization, preparation, content, and maintenance of a
standard as well as the issue of its legal status and the order of development
of standards.
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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 drop petitions for tolerance
7 > i
submitted by public interest user-oriented groups, such as the Inter-Regional
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
*Temporary tolerances submitted in support of EUPs allow for continuing
pesticide research on agricultural crops used for feed or food.
242
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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 of pesticides on
crops for which no tolerances have been established (approximately 95 percent
fall into this category) and, in some cases, pesticides which have been
canceled 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 witchweed and citrus
black 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
i
States registrations of pesticides that are distributed and used only within a
243
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particular registering State. In conjunction with the State registration
overview authority, OPP monitors the issuance of experimental use permits that
are needed to support subsequent State registrations.
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OFFICE OF WATER AND WASTE MANAGEMENT
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
This Office is responsible for EPA activities pertaining to the
management of water and waste programs. These responsibilities include
program policy development and evaluation, standards development and program
policy guidance, overview, and technical support.
There are four major offices within the Office of Water and Waste
Management. Three of those offices are highlighted in this publication. They
include the Office of Water Planning 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 Solid Waste which is
responsible for implementing the Resource Recovery and Conservation Act of
1976.
245
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I
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF WATER AND WASTE MANAGEMENT
ORGANIZATIONAL CHART*
ASSISTA
FOR V
n
NT ADMINISTRATOR
VATER AND WASTE
MANAGEMENT
1
1 1
V'f ':'^PEPWTY' ,ASSl$TAlil]rvf '*' ^ DEPUTY ASSISTANT
;> , ;VAbMiNisTRA^bR"!^ Cj; ADMINISTRATOR
FOR" WATER PLANNING % FOR WATER PROGRAM
;.; , AND STANDARDS ; ^ , OPERATIONS
1 \
X;,'iV-:;'DE,PUTY, ASSISTANT. . /I* .Slp.UTY-ASSISJANj'' "' ''•':
s ';<:•'.' .ADMINISTRATOR' * " ,'„ ^DMINIST*R ATpR* .-,«,-''%
FQR DRINKING WATER "'•» FOR SOOD WASTE
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- .A",. • . -,t ; '.« » • - . -= -.-••,
•NOTE: A partial organizational chart is shown to highlight (in gray) those
components of the Office of Water and Waste Management ordinarily
involved in toxic substances activities.
-------
OFFICE OF WATER PLANNING AND STANDARDS
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization page 249
Statutory Authority page 252
Regulatory Development page 254
Toxics-Belated Activities page 255
The Office of Water Planning and Standards is responsible for developing
an overall program strategy for the achievement of water pollution abatement.
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 guidelines and water quality standards, and other
pollutant standards, regulations, and guidelines. It exercises ' overall
responsibility for the development of effective State and regional water
quality planning and control agencies.
247
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF WATER AND WASTE MANAGEMENT
OFFICE OF WATER PLANNING AND STANDARDS
ORGANIZATIONAL CHART*
Office ot '
AN A LYSIS AND
EVAI^U.
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'NOTE: A partial organizational chart is shown to highlight (in gray)
those components of the Office of Water Planning and Standards
which are ordinarily engaged in toxic substances activities.
-------
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 prepares inflationary impact statements
to support regulations developed by the Office of Water Planning and
Standards for the abatement and control of point and nonpoint sources
of pollution, and for monitoring, planning activities/ and other
regulatory programs of that Office.
o Provides statistical support and expert review of all regulations
developed by the Office of Water Planning and Standards, and those of
other offices upon request. Also provides statistical and operations
research assistance to the monitoring activity and the criteria
development process.
o Integrates the health, economic, and technical studies prepared to
implement EPA's toxics control program for water discharges into a
coherent framework for decisions by top management on the level of
control and the regulatory mechanism for control.
o Conducts national level coordination with other Federal agencies to
secure their participation, support, and agreement with strategy and
regulations, and presents results of analyses to high-level
representatives of industry, the Federal Government, State and local
governments, and public interest groups.
EFFLUENT GUIDELINES DIVISION
o Develops industrial point source effluent limitations and pretreatment
standards for controlling the discharge of toxic compounds and
traditional pollutants into the Nation's waterways.
o Provides engineering and analytical technical expertise in defining
the most appropriate technologies for pollution control arid developing
methods to sample and determine the presence and concentration of
toxic materials in wastewater media and sludges.
o Assists in refining sludge disposal regulations under the Resource
Conservation and Recovery Act.
249
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o Conducts indtepth technical studies relating to innovative 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.
CRITERIA AND STANDARDS DIVISION
o Develops and revises water quality criteria, toxic effluent standards,
and hazardous substance designations and regulations.
o Serves as an authoritative source of technical and scientific
information on water quality criteria and standards, and on the
effects of water pollutants on health and welfare.
o Develops and coordinates programs to correct water pollution problems
in freshwater lakes and estuarine areas.
o Develops standards and guidelines for correction of water pollution
problems resulting from such sources as dredge spoils, in-place
toxicants, discharge from vessels, and aquaculture.
MONITORING AND DATA SUPPORT DIVISION
o Develops strategies for toxic pollutant management on a pollutant-by-
pollutant basis, a source-by-source basis, and an area-by-area basis.
This involves collection, development, and analysis of toxic pollutant
information including sources, uses, losses, ultimate fate,
populations exposed, and risks associated with pollutants. It also
involves collection, development, and analysis of data on industrial,
municipal, and nonpoint source contributions of toxic pollutants to
waters as well as data on their environmental and health implications.
o Manages EPA Regional and State water monitoring programs to identify
and control toxic problems in areas where toxic controls greater than
Best Available Technology (BAT) are required; reviews wasteload
allocations conducted by the Regions and States for technical
adequacy; reviews the water quality impacts of major advanced
treatment (AWT) grant requests and provides final OWPS approval
clearance for same.
o Serves as the Agency focal point for coordinating all ambient water
monitoring activities conducted by EPA headquarters and Regional
Offices.
o Provides all EPA program offices with reports assessing current trends
in water quality, preparing the annual report on fish kill incidents
resulting from both toxic and conventional pollutants and preparing
public information documents detailing specific areas where pollution
250
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control efforts have resulted in significant environmental and/or
public health.
o Obtains/ reviews/ stores/ and analyzes ambient chemical/ biological/
ecological/ and other data relating to toxic substances*
DIRECTORY FOR TOXICS-RELATED OFFICES/PERSONNEL
Division/Office
Office of Water Planning
and Standards
Office of Analysis and
Evaluation
Effluent Guidelines Division
Criteria and Standards
Division
Monitoring and Data Support
Phone*
202-755-0402
202-755-6885
202-426-2576
202-755-0100
202-426-7764
Mail Stop
WH-551
WH-586
WH-552
WH-585
WH-553
*FTS numbers are the same*
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STATUTORY AUTHORITIES
Clean Water Act
Public Law 95-217 33 U.S.C. § 466
The Clean Water Act was passed in 1972 as the Federal Water Pollution
Control Act. It represented a major reorientation of Federal efforts to
achieve and maintain acceptable levels of water quality. The Act established
a national goal of eliminating pollutant discharges into the Nation's
waterways by 1985. In 1977, 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 quality 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.
252
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sec. 307
sec. 306
sec.
sec
308
310
sec. 311
sec. 401
sec. 402
sec. 404(a)
sec. 404(b)
sec. 405(a)
sec. 405 (b)
sec. 504
(f) Information identifying and evaluating nonpoint sources
of pollution.
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
Technology (BAT) if health and ecological impacts are not
mitigated.
Requires EPA to publish regulations establishing standards of
performance for best available technologies to control discharge
of pollutants.
Sets forth conditions for inspections/ monitoring, and entry.
Enables EPA to act in conjunction with the Department of State
and foreign governments to abate water pollution
internationally.
Authorizes EPA to regulate and act to mitigate the discharge of
oil or hazardous substances into-navigable waters.
Requires facilities which discharge pollutants into water to be
certified.
Establishes conditions for issuance of permits to discharge into
navigable waters.
Authorizes the Army Corps of Engineers to issue permits for the
discharge of dredged or fill material into waterways at
specified disposal sites.
Authorizes EPA to prohibit the specification of any area as a
disposal site if the discharge of the dredged or fill material
will have an adverse effect on people or the environment.
Prohibits disposal of sludge without a permit.
Allows regulations to be issued setting out guidelines for
acceptable methods for disposal of sewage sludge.
Authorizes EPA to act to stop or mitigate environmental
discharges which present an imminent hazard.
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 of hazardous dredged or fill material
o Regulate disposal of sludge
253
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within the Environmental
Protection Agency see page 199 of this publication*
EXISTING REGULATIONS
Clean Water Act 40 CFR 400
254
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TOXICS-RELATED ACTIVITIES
The Office of Water Planning and Standards (OWPS) 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 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, and has been 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 one has been proposed.
Effluent Limitations
The major Clean Water Act mechanism to control toxic chemical discharges
is nationally uniform effluent limitations for industry categories. These are
technology- and economic-based limitations on the discharge of specific
process wastewater constituents.* OWPS is developing toxic effluent
limitations for 129 consent decree toxic substances for 21 major industry
categories. The first of these limitations was proposed in late 1979.
*These limitations are implemented via the National Pollutions Discharge
Elimination System (NPDES), which is managed by the Office of Water
Enforcement. Under the NPDES program a permit incorporating any promulgated
effluent limitation is written for every direct discharger to navigable
waters.
255
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Water Quality Criteria
Water Quality Criteria have been proposed for each of the original 65
consent decree toxic substances; promulgation is expected in the fall of 1980.
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 economic-based
limitations.
Monitoring
The Office of Water Planning and Standards is responsible for developing
monitoring strategies for the 129 priority toxic substances, both end-of-pipe
and in-stream. This monitoring will identify water basins where controls more
stringent than the technology-based limitations are required. This monitoring
will also help determine the relative industrial, municipal and nonpoint
source contributions of toxic pollutants to the Nation's waters.
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OFFICE OF DRINKING WA TER
Environmental Protection Agency
401 M Street SW.
Washington, O.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization page 00
Statutory Authority page 00
Regulatory Development page 00
Toxics-Related Activities page 00
The Office of Drinking Water is responsible for the implementation and
coordination of the program established by the Safe Drinking Water Act (as
amended 1977). As such, it establishes standards, develops regulations,
policies, and guidelines for drinking water quality and treatment requisite to
protect the public health and welfare and to protect existing and future
ground water sources of drinking water.
257
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF WATER AND WASTE MANAGEMENT
OFFICE OF DRINKING WATER
ORGANIZATIONAL CHART*
ro
Ui
00
CRITERIA AND
STANDARDS
DIVISION
HEALTH EFFECTS
BRANCH
PROGRAM
DEVELOPMENT AND
EVACUATION
STATE PROGRAMS
DIVISION
DRINKING WATER
BRANCH
GROUND WATER.
BRANCH
TECHNICAL
SUPPORT DIVISION
'NOTE: A partial organization chart is shown here to highlight (in gray) those components
of the Office of Drinking Water which are ordinarily involved in toxic substances
activities.
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ORGANIZATION
CRITERIA AND STANDARDS DIVISION
o 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 Drinking 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 research and health-effects needs.
o Maintains liaison with the Office of Research and Development of the
EPA, and Federal and other agencies having health responsibilities.
o Provides toxicology opinions in emergency situations where a water
supply might be affected.
o Reviews and provides informal advice with respect to direct and
indirect additives to water and their potential health effects.
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
regulations and guidelines.
o Develops appropriate standards and criteria for potable wastewater
reuse.
o Initiates and monitors contracts and special studies in areas of the
science and technology of water supply.
o Provides guidance and technical assistance to other government
agencies with respect to water resources research and emergency water
supply planning.
259
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STATE PROGRAMS DIVISION
o Develops and revises regulations and guidelines for State water
supply programs and Underground Injection Control programs.
o Monitors regional 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 monitoring 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.
o Maintains a group of experienced personnel for technical support in
emergency situations.
/
i
o Plans and prepares studies of the nature and extent of contaminants
in public water supplies and ground water sources.
260
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone*
Office of Drinking Water 202-426-8847
Criteria and Standards Division 202-472-5016
Health Effects Branch 202-472-6820
Science and Technology Branch
State Programs Division
Drinking Water Branch
Ground Water Protection Branch
Technical Support Division
202-472-5030
202-426-8290
202-472-4152
202-426-3934
513-684-4374
Mail Stop
WH-550
WH-550
WH-550
WH-550
WH-550
WH-550
WH-550
555 Ridge Road
Cincinnati, Ohio
45268
*FTS numbers are the same
261
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STATUTORY AUTHORITIES
The Safe Drinking Water Act
Public Law 95-110 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 and amended
in 1977, was designed to protect the 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 apply for primary enforcement status
(primacy) which requires that States have regulations at least as stringent as
262
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Federal standards. To date, 45 States have received primary enforcement
status. EPA has enforcement responsibility only within those States not
granted primacy.
The following States have assumed primacy on the indicated dates:
1 . Oklahoma
2. Connecticut
3. Louisiana
4. Mississippi
5. Nebraska
6. Alabama
7. Arkansas
8. Georgia
9. New York
10. Virginia
11. Iowa
12. Minnesota
13. Tennessee
14. South Carolina
15. Maine
16. Hawaii
17. Kentucky
18. Massachusetts
19. Texas
20. Michigan
2 1 . Maryland
22. North Dakota
The following States
1. Utah
2 . Vermont
3. Puerto Rico
4. North Carolina
5. Northern Mariana
6 . American Samoa
The following States
1 . Indiana
2 . Pennsylvania
3. Oregon
4. South Dakota
5 . Wyoming
04-30-77
05-07-77
05-16-77
06-20-77
06-23-77
07-10-77
07-10-77
08-07-77
09-10-77
09-10-77
09-13-77
09-26-77
09-30-77
09-30-77
10-07-77
10-20-77
10-20-77
12-01-77
01-30-78
02-01-78
02-13-78
02-18-78
are expected to
Islands
are expected to
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
Florida
Wisconsin
Nevada
Kansas
Montana
Idaho
Washington
New Mexico
Delaware
West Virginia
Colorado
California
New Hampshire
Trust Terr.
Guam
Alaska
Arizona
Rhode Island
Ohio
Missouri
Virgin Islands
Illinois
New Jersey
get primacy during Fiscal
get primacy after Fiscal
02-18-78
03-02-78
03-30-78
03-30-78
03-30-78
03-30-78
03-30-78
04-02-78
04-02-78
04-02-78
05-07-78
06-02-78
08-18-78
09-09-78
09-09-78
09-22-78
09-24-78
11-22-78
03-15-79
09-23-79
09-23-79
09-29-79
12-30-79
Year 1980
Year 1980.
263
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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 judgment of the
Administrator, may 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, thereby 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 substance or
matter in water.
Maximum 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.
sec. 1415 Lists the conditions under which a variance may be granted.
sec. 1416 Provides for exemptions to the Act.
264
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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.
Part D—Emergency 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 a contaminant entering a
public water system may pose an imminent or substantial
hazard.
265
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within the Environmental
Protection Agency, see page 199 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
266
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TOXICS-RELATED ACTIVITIES*
The Underground Injection Control Program
Part C of the Safe Drinking Water Act (SDWA) instructs the EPA to
establish a national program to prevent vmderground 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 drinking water, but also ground water that could
potentially serve as a source of drinking water in the future.
In keeping with these requirements EPA published on April 20, 1979, (44 FR
23738) its proposed regulations covering the State underground injection
control programs. The final regulations are expected in 1980.
Additives in Drinking Water
i
The Food and Drug Administration (FDA) and the Environmental Protection
Agency (EPA) have executed a memorandum of understanding (HOU) with regard to
I
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 drinking water
additives. The agreement became effective on June 22, 1979.
*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.
267
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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.
268
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OFFICE OF SOLID WASTE
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization page 271
Statutory Authority .page 274
Regulatory Development page 276
Toxics-Related Activities page 277
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.
269
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF WATER AND WASTE MANAGEMENT
OFFICE OF SOLID WASTE
ORGANIZATIONAL CHART*
DEPUTY ASSISTANT
ADMINISTRATOR
FOR SOLID
WASTE
MANAGEMENT
AND
INFORMATION
STAFF
STATE PROGRAMS
AND RESOURCE
RECOVERY
DIVISION
LAND
DISPOSAL
DIVISION
HAZARDOUS
WASTE
IMPLEMENTATION
BRANCH
STATE
PROGRAMS
BRANCH
HAZARDOUS AND
INDUSTRIAL
WASTE DIVISION
ASSESSMENT
BRANCH
DISPOSAL
BRANCH
RESOURCE
RECOVERY
BRANCH
WASTE
CHARACTERIZATION
BRANCH
INDUSTRY
TECHNOLOGY
BRANCH
ECONOMIC
ANALYSIS
BRANCH
*NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved in toxic substances
activities.
-------
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.
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.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
271
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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.
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.
272
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DIRECTORY FOR TOXICS-RELATED OFFICES AND PERSONNEL
Division/Office Phone*
Office of Solid Waste 202-755-9170
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
202-755-9130
202-755-9116
202-755-9120
202-755-9170
202-755-9185
202-755-9187
202-755-9200
202-755-9190
Mail Stop
WH-562
WH-564
WH-564
WH-564
WH-563
WH-565
WH-565
WH-565
WH-565
*FTS numbers are the same
273
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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. The 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.
Key Sections of Act—Toxics Focus
sec. 1008 Directs the Administrator to develop and publish criteria for
solid waste management.
sec. 3001 Authorizes the development of criteria for identifying
hazardous wastes.
sec. 3002 Authorizes the development of standards regulating the
generators of hazardous wastes.
sec. 3003 Authorizes the development of standards governing the
transportation of hazardous wastes.
sec. 3004 Authorizes the development of standards for the treatment,
storage, and disposal of hazardous wastes.
274
-------
sec. 3005
sec. 3006(a)
sec. 3006(b)
sec. 3007
sec. 4004
sec. 4005(b)
sec. 4005(c)
sec. 7003
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 danger to
public health or the environment.
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 closing or upgrading
of open dumps and directs States to include these programs within
their Solid Waste Management plan.
275
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REGULATORY DEVELOPMENT PROCESS
REGULATORY PROCESS
For a discussion of the regulatory process within EPA, see page 199 of this
publication.
EXISTING REGULATIONS
Resource Conservation and Recovery Act 40 CFR 240-255
276
-------
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 are
scheduled for issuance in 1980.
Hazardous Waste Criteria—Identification and Listing—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.
"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.
277
-------
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 Facilities—RCRA.
3004. Hazardous waste management facilities will be required 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 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 implement
these programs.
278
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Solid Waste Management—RCRA Subtitle D
Wastes not classified as hazardous or exempt from Subtitle C because of
low generation rates (under Section 3001) will be 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 or upgrading 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.
279
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OFFICE OF AIR, NOISE, AND RADIA TION
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
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; arid 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.
281
-------
I
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF AIR, NOISE, AND RADIATION
OFFICE OF
PROGRAM
MANAGEMENT
OPERATIONS
ASSISTANT
ADMINISTRATOR
FOR AIR, NOISE,
AND RADIATION
N)
00
DEPUTY
ASSISTANT
ADMINISTRATOR
FOR AIR
QUALITY
PLANNING AND
STANDARDS
1
MTROL
GRAMS
.OPMENT
riSION
1
; EMISS
STAND
AN
ENGINE
DIVIJ
I
DEPUTY
ASSISTANT
ADMINISTRATOR
FOR MOBILE
SOURCE AIR
POLLUTION
CONTROL
CERTIFICATION
DIVISION
MONITORING
AND
DATA ANALYSIS
DIVISION
1
STRATEGIES
AND AIR
STANDARDS
DIVISION
I
—|
OFFICE OF
POLICY
ANALYSIS
OFFICE OF
[TRANSPORTATION
AND LAND USE
POLICY
DEPUTY
ASSISTANT
ADMINISTRATOR
FOR RADIATION
PROGRAMS
EMISSION
CONTROL
TECHNOLOGY
DIVISION
CRITERIA AND
STANDARDS
DIVISION
PROGRAM
MANAGEMENT
DIVISION
SURVEILLANCE
AND
EMERGENCY
PREPAREDNESS
DIVISION
1
DEPUTY ASSISTANT
ADMINISTRATOR
FOR NOISE
ABATEMENT AND
CONTROL
STATISTICS
AND APPLIED
MATHEMATICS
DIVISION
TECHNOLOGY
AND FEDERAL
PROGRAMS
DIVISION
OFFICE OF
RADIATION
PROGRAMS-
LAS VEGAS
STANDARDS
AND
REGULATIONS
DIVISION
1
STATE AND
LOCAL
PROGRAMS
DIVISION
EASTERN
ENVIRON-
MENTAL
RADIATION
FACILITY
-------
OFFICE OF AIR QUALITY PLANNING
AND STANDARDS
U.S. EPA (MD-11)
Research Triangle Park, NC 27711
Locator: 919-541-5411
8-629-5411
Information: 919-541-5411
8-629-5411
OFFICE OF MOBILE SOURCE AIR
POLLUTION CONTROL
Environmental Protection Agency
401 M Street SW.
Washington, D.C. 20460
Locator: 202-755-2673
Information: 202-755-0720
Organization page 286
Statutory Authority page 289
Regulatory Development page 292
Toxics-Related Activities page 293
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
*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.
283
-------
addition, the Office develops national programs, technical policies,
regulations, guidelines, and criteria for air pollution control; assesses the
national air pollution control program; and provides assistance to States and
the Regional Offices.
The Office for Mobile Source Air Pollution Control has the responsibility
for the mobile source air pollution control functions of the Agency. The
Office is responsible for characterizing, emissions from mobile sources and
then developing programs for their control; developing and recommending
emission standards and. related test procedures for mobile sources; and
carrying out a regulatory compliance program to ensure adherence of mobile
sources to standards.
284
-------
ENVIRONMENTAL PROTECTION AGENCY*
OFFICE OF AIR, NOISE, AND RADIATION
OFFICE OF AIR QUALITY PLANNING AND STANDARDS
OFFICE FOR MOBILE SOURCE AIR POLLUTION CONTROL
OFFICE OF
PROGRAM
MANAGEMENT
OPERATIONS
ASSISTANT
ADMINISTRATOR
FOR AIR. NOISE,
AND RADIATION
OFFICE OF
POLICY
ANALYSIS
CONTROL PROGRAMS
DEVELOPMENT
DIVISION
CERTIFICATION
DIVISION
MONITORING AND
DATA ANALYSIS
DIVISION
PROGRAM
MANAGEMENT
OFFICE
OFFICE OF
TRANSPORTATION
AND LAND USE
POLICY
DEPUTY ASSISTANT
ADMINISTRATOR
FOR RADIATION
PROGRAMS
1
DEPUTY ASSISTANT
ADMINISTRATOR
FOR NOISE
ABATEMENT AND
CONTROL
*NOTE: A partial organizational chart is shown to highlight (in gray)
those components ordinarily involved with toxic substances activities.
-------
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.
Emission Standards and Engineering Division
o Develops reviews, and revises national emission standards for hazardous
pollutants and performance standards for new stationary sources.
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 potential pollutants and analyzes new control strategies.
o Develops, reviews, and revises ambient air quality standards.
*NOTE: Only those offices which deal with toxics or toxics-related issues are
developed in this section.
286
-------
o Identifies and analyzes potential effects of identified pollutant
control strategies.
o Develops new or revises former air quality standards, control
techniques, and emission standards, based on economic impact
assessments and land use studies which the Division itself conducts.
o Provides technical expertise in control strategies, energy and fuel
policies, and land use planning to EPA Regional Offices.
OFFICE FOR MOBILE SOURCE AIR POLLUTION CONTROL
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 Characterizes current emissions from mobile sources for potential
future control.
o Evaluates the technical possibility and cost effectiveness of control
strategies.
o Assesses and develops control technologies for existent mobile sources
to establish future standards.
o Develops and disseminates technical and economic data on near-term
control technology for national and regional control strategies.
o Tests and evaluates control techniques.
o Develops and coordinates emissions testing procedures with other public
and industry emissions testing laboratories.
Engineering Operations
o Conducts vehicle testing and supports the test facility operations.
287
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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
Office for Mobile Source
Air Pollution Control
919-541-5411
8-629-5411
919-541-5271
8-629-5271
919-541-5204
8-629-5204
202-426-2464
8-426-2464
Emission Control Technology 313-668-8404
Division 8-374-8404
Engineering Operations
Division
313-668-8243
8-374-8243
Mail Stop
MD-11
Research Triangle
Park, NC 27711
MD-13
Research Triangle
Park, NC 27711
MD-12
Research Triangle
Park, NC 27711
ANR-455
401 M Street SW.
Washington DC 20460
2565 Plymouth Road
Ann Arbor, HI 48105
2565 Plymouth Road
Ann Arbor, MI 48105
288
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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. Strong 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.
1977 Amendments
In the late 1960's 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
289
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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 will first be regulated in "clean-air regions," and
anticipates later regulation of other pollutants.
Three kinds of "clean-air regions" are defined. Class 1 must include all
national parks and wilderness areas any may include further areas named by the
States to remain unsullied. Class 11 areas can have some industrial
development, up to specified levels. Class III areas can have about twice as
much pollution from additional new sources, sometimes up to the minimum
Federal Standards.
Any potential 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
290
-------
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; incorporates State plans for
implementing new source performance standards programs.
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.
sec. 202 Authorizes motor vehicle emission standards and in some cases, sets
the standards.
sec. 211 Requires registration of fuel and fuel additives.
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 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 all emitters—as a numerical standard or engineering
control
o Imposition of land use controls in nonattainment areas
o Use of emergency powers in case of imminent hazard—litigation for
RO/TRO
291
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REGULATORY DEVELOPMENT
REGULATORY PROCESS
For a discussion of the regulatory process within EPA, see page 199 of this
publication.
EXISTING REGULATIONS
CLEAN AIR ACT 40 CFR 50-87
292
-------
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 industrial plants from moving to 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.
*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, Toxics Integration staff.
293
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National Emission Standards for Hazardous Pollutants
Under the authority of Section 112(b)(1) of the Clear Air Act, EPA may
propose national emission standards for specific air pollutants that are
particularly hazardous to health. Proposed standards are based on the best
available control technology (BACT) for both new and existing sources of the
pollutant and 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 beneficial and adverse economic, environmental, and
energy impacts associated with both the proposed standard, and its
alternatives.
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.
294
-------
Programs
-------
296
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NATIONAL TOXICOLOGY PROGRAM
Public Health Service
Department of Health and Human Services
P.O. Box 12233
Research Triangle Park, N.C. 27709
Information: 919-541-3780
8-629-3780
(Ms. Leslie Gardner)
Overview and General Information page 297
NTP Program and Project Leaders. page 301
Chemical Selection Principles page 304
Overview and General Information
The National Toxicology Program (established in November 1978) develops
scientific information about potentially toxic and hazardous chemicals which
can be used for protecting the health of the American people and for the
primary prevention of chemically-induced disease. The National Toxicology
.Program centralizes and strengthens the Department of Health and Human
Services' (DHHS) activities in toxicology testing and test development/
validation efforts and provides toxicological information needed by research
and regulatory agencies. Three specific goals have been identified:
297
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o to expand the toxicological profiles of the chemicals nominated,
selected, and being tested;
o to increase the number and rate of chemicals under test;
o to develop, coordinate, and validate a series of tests/protocols more
appropriate for regulatory needs.
The National Toxicology Program's Charter Agencies. Presently, the four
DHHS agencies whose relevant toxicology programs comprise the NTP are the
National Cancer Institute, National Institutes of Health; National Institute
of Environmental Health Sciences, National Institutes of Health; National
Center for Toxicological Research, Food and Drug Administration; National
Institute for Occupational Safety and Health, Center for Disease Control.
The NTP Executive Committee provides linkage between DHHS research and
regulatory agencies to ensure that the NTP toxicology research, testing, and
test development are responsive to regulatory needs and to the wants of the
public. This unique aspect of the NTP brings together the research and
regulatory agencies doing fundamental biomedical research. The current
members representing those governmental agencies that comprise the NTP
Executive Committee are:
o Dr. Eula Bingham (Chairperson), Assistant Secretary of Labor,
Occupational Safety and Health Administration
o Honorable Douglas M. Costle, Administrator, Environmental Protection
Agency
o Dr. Donald Fredrickson, Director, National Institutes of Health
o Dr. David P. Rail, Director, National Institute of Environmental
Health Sciences
o Dr. Julius B. Richmond (non-voting), Assistant Secretary for Health,
Department of Health and Human Services
o Dr. Vincent deVita, Jr., Acting Director, National Cancer Institute.
298
-------
The NTP Board of Scientific Counselors provides scientific oversight of
the NTP; advises the NTP Director and the NTP Executive Committee on
scientific content, philosophy, and policy; and evaluates the merit and
overall quality of the science conducted in the NTP components. These eight
scientists have been appointed by the Secretary of the Department of Health
and Human Services:
o Joseph C. Dunbar, Ph. D., Associate Professor of Physiology, Wayne
State University School of Medicine (1982)
o Curtis Harper, Ph. D., Associate Professor of Pharmacology, University
of North Carolina School of Medicine (1981)
o Margaret Hitchcock, Ph. D., Assistant Professor of Pharmacology, Yale
University Medical School (1983)
o Marjorie G. Horning, Ph. D., Professor of Biochemistry, Baylor College
of Medicine (1983)
o Mortimer L. Mendelsohn, M.D., Ph. D., Director, Biomedical Sciences
Division, Lawrence Livermore Laboratory, University of California
(1982)
o Norton Nelson, Ph. D., (Chairperson), Professor of Environmental
Medicine, New York University School of Medicine (1983)
o Thomas H. Shepard, M.D., Professor of Pediatrics and Head of Central
Laboratory for Human Embryology, University of Washington School of
Medicine (1981) .
o Alice S. Whittemore, Ph. D., Adjunct Professor of Family, Community,
and Preventive Medicine, Stanford University (1983).
NTP Annual Plans. The development and approval of the NTP Annual Plan
remains central to the effective planning, coordination, and operation of the
National Toxicology Program. As NTP Director, Dr. David P. Rail (also the
Director of the National Institute of Environmental Health Sciences) reports
to the Assistant Secretary for Health.
299
-------
The 1980 NTP Annual Plan contains information on the NTP research,
testing, and validation efforts for the coming fiscal year as well as for the
previous fiscal year. This 117-page report divides into 10 sections:
Introduction and Executive Summary, Background, Participating Agencies,
Oversight and Review, Planning Assumptions and Program Balance, Organization,
Toxicology Research and Testing Overview, Coordinative Management Activities,
Information Generation and Dissemination, Annual Report on Carcinogens.
A companion to the NTP Annual Plan is the 334-page NTP Review of Current
DHHS Research Related to Toxicology. This compilation emphasizes three major
areas: DHHS Agencies' Role in the Support of Toxicology Research, Testing,
and Method Development; Chemical Compounds Currently Being Tested by DHHS
Agencies for Toxicological Properties; Toxicology Methods Currently Being
Developed by DHHS Agencies.
To bridge the .yearly gap between Annual Plans, NTP has started an NTP
Technical Bulletin to keep those persons or groups interested in the NTP
informed about the NTP's most current and proposed activities. The NTP
Technical Bulletins augment the Annual Plans by more timely and frequent
announcements of the NTP research activities and specific actions.
For those wanting more information about the National Toxicology Program
as well as to receive the NTP Annual Plan for Fiscal Year 1980, the NTP Review
of Current DHHS Research Related to Toxicology, or the NTP Technical Bulletin,
please indicate which publications you wish to receive and return this
information to:
Ms. Leslie Gardner
National Toxicology Program
P.O. Box 12233
Research Triangle Park, NC 27709
300
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NTP Programs and Project Leaders
The program segments of the NTP are grouped into two categories—
toxicologic research and testing, and coordinative management activities.
Individual NTP scientists have been appointed as Leaders of major program
segments. Each scientist serves as the center for a particular program
activity and is responsible for developing (in collaboration with other NTP
colleagues) the subprogram activities, the implementation plan, as well as the
coordination and supervision of the program work. Programs and Project
Leaders are listed in the following table.
301
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Area
MAJOR NATIONAL TOXICOLOGY PROGRAM AREAS AND LEADERS
Leader Contributing Agency* Telephone
FTS
Director
Deputy Director
Dr. D. P. Rail
Dr. J. A. Moore
NTP
NTP
919-541-3201
919-541-3267
629-3201
629-3267
w
o
to
Toxicologic Research and Testing
Care inogene sis
Short-Term Test Development
Tumor Pathology
Chemical Disposition
General Toxicology
Toxicopathology
>
Genetic Toxicology
Immunologic Toxicology
Neurobehavioral Toxicology
Pulmonary Toxicology
Reproductive and Developmental
~ Tdxicology
Dr. R. Griesemer
Vacant
Dr. J. Ward
Dr. H. Matthews
Dr. J. Moore
Dr. E. McConnell
Dr. E. Zeiger
Dr. J. Dean
Dr. C. Mitchell
Dr. T. Lewis
Dr. J. Holson
NCI
NCI
NIEHS
NTP
NIEHS
NIEHS
NIEHS
NIEHS
NIOSH
202-496-5591
202-496-6868
919-541-3369
919-541-3267
919-541-3231
919-541-4482
919-541-4659
919-541-3220
513-684-8392
same
same
629-3369
629-3267
629-3231
629-4482
629-4659
629-3220
same
NCTR
501-542-4303
same
-------
Area
MAJOR NATIONAL TOXICOLOGY PROGRAM AREAS AND LEADERS (cont.)
Leader Contributing Agency* Telephone
FTS
Coordinative Management Activities
Bioassay Coordination
Chemical Nomination
Chemical Repository
Data Management and Analysis
Carcinogenesis
•Mutagene si s
: Toxicology
TDMS (Development)
rw
p Information Dissemination
w
Laboratory Animal Quality Control
Laboratory Health and Safety
Technical Information
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Mr.
Dr.
J.
L.
C.
D.
M.
K.
B.
J.
A.
J.
F. Douglas
Fishbein
Jameson
Walters
Hoel**
Chu
Margolin
Moseman
Kbnvicka
E. Huff
NCI
NCTR
NCI
NIEHS
NIEHS
NCI
NIEHS
NIEHS
NCTR
NTP
202-496-5591
501-542-4390
202-496-1152
919-541-3355
919-541-3205
202-496-1152
919-541-3460
919-541-3437
501-542-4534
919-541-3780
same
same
same
629-3355
629-3205
same
629-3460
629-3437
629-4534
629-3780
Vacant
Dr.
Dr.
H.
H.
Maher
Kissman
NCI
NLM
202-496-9526
202-496-3147
same
same
^Addresses: National Cancer Institute, Bethesda, MD 20205; National Institute of Environmental
Health Sciences, Research Triangle Park, NC 27709; National Library of Medicine,
Bethesda, MD 20014; National Toxicology Program, Research Triangle Park, NC 27709;
National Institute for Occupational Safety and Health, Cincinnati, OH 45226; National
Center for Toxicological Research, Jefferson, AR 72079.
**Dr. J. Maseman, Acting Program Leader
-------
NTP Chemical Selection Principles
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); and
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.
Chemical Nomination. NTP urges all those interested in proposing
chemical(s) for testing to do so, and to recommend the type test(s) to be
considered and to supplement each nomination with the following necessary
information, if known:
I. Chemical Identification
a. Chemical Abstracts Service (CAS) preferred name
b. Common or generic name and synonyms
304
-------
c. CAS Registry Number
d. Chemical class and related compounds
e. Physical and chemical properties
i. Physical description
ii. Structural and molecular formula and molecular weight
iii. Melting and boiling points
iv. Solubility
v. Stability and reactivity
vi. Other relevant information
f. Commercial product(s) composition
g. References
II. Production, Use, Occurrence, and Analysis
a. Production
i. Source and synthesis, year and pathway of first
production
ii. Current production and pathway
b. Uses
c. Occurrence in the Environment
i. Naturally occurring
ii. Air, water, and soil
iii. Occupational
d. Analysis
e. References
III. Toxicology
a. Human data, case reports, and epidemiological studies
b. Experimental animal information
c. In vitro and other short-term tests
d. Other relevant information
e. References
IV. Disposition and Structure-Activity-Relations
a. Absorption, distribution, metabolism, and excretion
b. Structure-activity correlations and considerations
c. References
V. Ongoing Toxicological and Environmental Studies in the Government,
Industry, and Academia
VI. Rationale for Recommendation and Suggested Studies
305
-------
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 infor-
mation 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
actsi 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 a 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 compli-
cated by the fact that some of the statutory authorities shown in the charts
have not yet been fully implemented or tested. Generally, a complete inter-
pretation of the statutes' authorities can be accomplished only by reviewing
the respective statutes, the Code of Federal Regulations, and any adminis-
trative or judicial judgments affecting the way in which these authorities are
interpreted and used.
309
-------
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 sections 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 parti-
cularly egregious. For convenience, only Chart 1 is footnoted; these
footnotes apply as well to Charts 2 and 3.
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 statu-
tory 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 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 signi-
310
-------
ficant. 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 con-
versely 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 regu-
latory or control options available. In many instances Agency efforts to
control toxic substances are more subtle and indirect than the types of con-
trol 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.
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" of even a "prohibition,"
depending on how the standard was written and the response of the affected
party. Distinctions between these authorities is 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 speci-
311
-------
fied 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 lifecycle of a toxic substance. As such these points
reflect both potential health or environmental exposure pathways, and poten-
tial points of regulatory control of a toxic substance.
Although the distinction made in these charts between manufacturing/pro-
cessing, commercial distribution, transportation, use, etc., serves a useful
analytical purpose, there may be overlap among these in some statutory pro-
visions. 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 probibition/ban on manufacturing of a 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.
312
-------
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 applies 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 repre-
senting 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 refer-
ring to either types of control action (Chart 3) or chemical lifecycle (Chart
2).
313
-------
Chart 4
Direct control actions taken by Agencies represented in these charts
(Charts 1 thru 3) does not give a complete picture of the legislative frame-
work to control toxic substances. Another signficant 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.
314
-------
w
_-»'
CHART 1
PROHIBITIONS)
BANS
QUANTITY
LIMITATIONS
GUIDELINES,
STANDARDS,
nimrrv
UUftbl 1 I
CRITERIA
,..•.-..
REQUIRED
LABELING)
PACKAGING
PROVISIONS
REGISTRATION
CERTIFICATION
OR PERMITS
RECALL,
REPLACE,
REPURCHASE,
SEIZURE
TO REQUIRE
NOTICE OF
HAZARDS
TO THOSE
EXPOSED
IMMINENT
UATADflC
HAZAHUS
MANUFACTURING/
PROCESSING
TSCA 5(8), (f);1
6(8)
CAA 211(c)
CPSA 19(aND.I2)
TSCA 511);
6(8)121
CPSA 9UH2)
CWA 301; 302; 304;
306
TSCA B(b)(2)
CAA 111(b)(e)
RCRA 3002(21.13)
TSCA Bla)(3)z
CPSA 14(a)
CAA IBSIa); 172(b)
FIFRA 7(a)
FFDCA 510
TSCA 6(a)(7|
CPSA 15(d)
FHSA IS(a)ll)
TSCA 6(8)17)
TSCA 7
COMMERCIAL
DISTRIBUTION
TSCA B(a)ll);
6M(2)
CAA 211(c)
CPSA 8; ISIaHD.
(2)
FIFRA 6; 12(a); 13(a)
FFDCA 301(a), (d)
FHSA 4(a),(f)
TSCA Blaldl;
8(a)(2)
TSCA B(al(3)
CAA211(a),(b);
203(a)(1)
FIFRA 3(a); 8
FFDCA 505; ,5,12
CPSA 15(d),(e)
FHSA 15(8)12)
FIFRA
CPSA 12
TSCA 7
FIFRA B(e)
EMISSIONS,
j EFFLUENTS
CWA 307(8)12)
306
311(b)(DIB)
SDWA 1424(a)
CAA 110(a)|2|IB)3
CWA 301
307(8)12)
CWA 311(b](1);
307(a)(2);
303:304:306
CAA 108;109;111(a);
1 12(b)(1)i
180-169; 202
SDWA 1421; 1412
CWA 301(b)l2);
401; 402
SDWA 1421;
1424(b)
CWA 311 (b)(2)
CWA 504
CAA 303; 311
RCRA 7003
SDWA 1431
TRANS-
PORTATION
TSCA 8(a)l1);*
6|a)|2)
CPSA 8; 19(a)s
HMTA 105(a|
TSCA 6(a)(1l;
6la)|2) „
HMTA 105(a)8
FIFRA 19(b)7
RCRA 3003
HMTA lOBIa)
CWA 311
TSCA 6(8)13)
RCRA 3803(8)12)
HMTA 105|a)
HMTA 10B(b);
IDBIc)
RCRA 3003
TSCA 7
RCRA 7003
HMTA 11 Kb)
CWA 311
IMPORTS
TSCA13(a)lb)
FIFRA 6; 12(a); 13la)
CPSA 17|a)
FHSA 14(a)
FFDCA SOKal
TSCA 6(a)(5)
CPSA 9(d|(2)
TSCA 6(b)|2)
CPSA 17|a)(1)
FFDCA 801(a)
TSCA 13(a)
FIFRA 17(c|
CPSA 17(8)12)
FHSA 14(a)
FFDCA 801 la)
FIFRA 17(c]
CPSA 17(a)(2)
FIFRA 13
~
TSCA 13la)
CPSA 17(8)13)
FHSA 14la)
FIFRA Bid
END USE
(PRODUCTS)
CPSA 6
TSCA 6la)(2)(A);
6(a)l5)
FIFRA 6;12|a);13(a)
FHSA 2(q)(1)(A)(B)
TSCA 6(8)15)
CAA 202(a)|1)
CPSA 7(a)(1);
7(cl
FIFRA 3ld)
FFDCA 401; 406: 408
TSCA 6la)l5)
TSCA 6(8)13)
FIFRA 3|e)(5)(B)
CPSA 7;14(e);27(e)
FHSA 2lp);3|b)
PPPA3
FFDCA 505|d)
502; 403; 602;
FIFRA 3la); 4(a);
5; 6; 18
CPSA 14(a)
FFDCA 505
512
706
CAA 204; 21 Kb)
TSCA 6la)(7l
FIFRA 12; 13
CPSA 15(d),(c)
FHSA 6; 15|a)
FFDCA 304
CPSA 15
TSCA 7(a||1)
FIFRA 6|c)
SDWA 1431(a)
CPSA 12
FHSA 2(q)(2); 3(e)l2l
FFDCA 505 (e);
STORAGE/
DISPOSAL
TSCA 6(a)l6)
RCRA 3804. 3005
CWA 307(a)(5)
FIFRA 19
RCRA 3004, 3005
4004, 1008
TSCA 6(a)(6)
TSCA 6(a)(3)
RCRA 3002(2).|3)
3004
CWA 405
RCRA 3005
TSCA 7(a)
RCRA 7003
WORKPLACE
EXPOSURE
OSHA 13(a)8
OSHA 5|a);6la);
BlbHS);
B(c)ll);
20(a)(2).(3);
22
OSHA 6(b)(7)
OSHA 6|b)(7);
8lc)l3);
13(c);
20la)(b)
OSHA 13
-------
CHART 2
CM
CWA
HfflA
KM
SOW*
TSCA
CPU
PPPA
FHSA
OSHA
NHTA
FFDCA
PROHIBITIONS/
BANS
211k) MP
211*1 CD
307WB) EE
311 EE
311MII EE
MIMUM CD
0.-12WEI3W 1
17kl 1
0:12Wc13W U
3004 D
3005 D
1414W EE
sum HP
BUI HP
(Mil CD
OWO) CO
WiXI) T
OWBI T
tlHM 1
OW» U
6WI5I U
OWOI D
10W HP
1 CD
IOW CD
1 T
IOW T
I7W 1
0 U
4WW CD
I4W 1
2WI1IWJBI U
I3U W
105W T
301WW CD
S01UI
OUANTTTY
UMITATIONS
11011X2) EE
301 HP
302 HP
304 HP
300 HP
301 EE
307W EE
5m HP
CMUI HP
OWItl CD
OWB) CO
tliKII T
own T
OliHSI 1
OWIS1 U
9IM2I HP
OWB) 1
105W T
warn:
cih CUMBKUI nsrawiiM
E£ OnMMIfffUIQni
T: lumnmoi
t •ran
K BBonmocni
DC MrawnMuc
K mmucfonnK
GUIDELINES,
STANDARDS,
QUALITY
CRITERIA
(MANNER OR
METHOD)
111MW HP
IN EE
IN EE
mill EE
112M1I EE
100-1N EE
202 R
2D2WI1I U
303 EE
304 EE
100 EE
307WB) EE
3I1MII EE
311 T
307WR) D
10M T
3W U
11 D
3002 HP
3003 T
1000 D
3004 D
3005 0
4004 D
1412 EE
1421 EE
OfelBI HP
I»H2) 1
OWS) U
twin o
17W 1
7WI1I U
7lel U
t
BW W
OW W
OMB •
OWIII W
20WDI W
22 W
10IM T
IOIW 1
401 U
401 U
400 U
REQUIRED
LABEL! NO/
PACKAGING
I7kl I
3(eKS U
3003WBI T
3M2I2U3) 0
3004 D
BWBI HP
ttaat CD
OWOI T
13W 1
011)131 U
OWI3I D
17WGD 1
14W U
7 U
27k) U
3 II
14W 1
3H U
2PI U
owm w
0»X7I "
105W T
001W 1
403 U
502 U
505W U
SI2HXII II
002 U
REGISTRATION
CERTIFICATION,
OR PERMITS
105W HP
17200 HP
211WA) CD
203MII CO
204 II
211M U
30INCD EE
411 U
402 EE
405 D
7W HP
3W41 CD
17W 1
3M U
4M5 U
HI U
U
3003 T
3005 D
1421 EE
1424M EE
14W HP
17WOI 1
14W U
lOOdHO T
610 HP
605 CD
612 CD
505 U
512 U
700 U
RECALL,
REPLACE
REPURCHASE,
SEIZURE
12 CO
13WA1 CD
12:13 U
13 1
OWI7I HP
owm u
15IA HP
16HUc) CD
IHftlcl U
15UI1) HP
15WCD CD
0 1)
16W U
304 U
TO REQUIRE
NOTICE TO
THOSE EXPOSED
311M2) EE
OWI7) HP
MK7I W
HCH3) W
13lcl W
20WM W
IMMINENT
HAZARDS
3D3 EE
311 EE
504 EE
311 T
Ok) CD
Ok) I
Ok) U
7003 EE
7003 D
1431 EE
7 HP
7 CD
7 T
13W 1
7 U
7 D
14W 1
3kX2l U
2kX2l U
13 W
HIM T
50SM U
SllkXtl U
Ji ..
'Is!
-••. r..\*--&B&^-:?-'-:
ft
316
-------
CHARTS
MA
CWA
FtfRA
RCRA
SOW*
TSCA
CPIA
PPPA
fHt»
DIM*
HMTH
,, FFOCA
\.
MANUFACTURING/
PROCESSING
21 lie) P
11IM.lt) GS
IBStal RC
I72M1) GS
307(1X2) GS
303:304 GS
301 GS
30t»X2| RC
401:402 RC
3110)1(2) 1
504 IH
7003 m
1424M P
1412 GS
1421 GS
1421 RC
1424k) RC
1431 IH
TRANSPORTATION
311 GS
I9t>) GS
3003 GS
3003W LP
3003 RC
7003 IH
SMI1) P
0*iX2l P
ItaNtl OL
l|lX2l OL
XlX3) LP
7 n
I P
life) P
losw at
10IW GS
105UI LP
lOHb) RC
10Wcl RC
111*1 W
IMPORTS
17lcl P
17W IP
17le) RC
12W P
13W P
1 P
13 n
Mel IH
13MM P
ftoXH 01
MlX2l GS
13M LP
131.1 IH
171.1 P
17(1X11 GS
HO 01
17llK2) IP
17UHI RC
17UX3I IH
14W P
1*1.1 LP
14ta) M
OOlll) P
I01M GS
001(1) LP
END USE
(PRODUCTS)
202UX1I GS
204 RC
21HbN2l RC
1 P
12lil P
131.1 P
3U GS
3(eXi) LP
3d) RC
4ta) RC
5*11 RC
12:13 RR
Mel IH
14311.) IH
OliX2) P
ItoXS) P
M.XSI 01
OliKBl GS
OI.K3) LP
11.101 RR
7 IH
1 P
7I.X1I GS
7lcl GS
14lcl LP
14W RC
15M.fc) m
IS R
12 m
3 LP
3 LP
2wniwum p
3tt2b> LP
1 RR
ISM RR
3M M
401 GS
401 GS
401 OS
401 IP
802 IP
SOW LP
HIM) LP
102 LP
Bit RC
512 RC
701 RC
304 RR
HIM M
5I2WII IH
STORAGE/
DISPOSAL
3071.1 GS
405 RC
11 GS
3004 P
3005 P
3002(21(31 IP
3004 IP
3004 GS
3005 GS
4004 GS
1000 GS
3005 RC
7003 IH
ifexn P
OliXII GS
OUX3) IP
7 IH
WORKPLACE
EXPOSURE
13W P
M GS
(H 63
Mel GS
20UI GS
22 GS
«*X7I 1
13 W
200X21 GS
WeWI I
13k) I
20WO) 1
317
-------
90
Z
TI
30
W
•a
GO
CHART 4
TESTING
REQUIREMENTS
MONITORING
(COMPLIANCE,
EXPOSURE.
HEALTH
EFFECTS)
INSPECTIONS
RECORDS!
PREMISES
PROVISIONS FOR
TEST DATA
SUBMISSION
IAS PART OF
REGISTRATION,
CERTIFICATION.
OR PERMIT PROCESS)
NOTIFICATION
REQUIREMENTS
(PREMAIUFACTURE.
PREMARKET. ETCJ
SUBMISSION OF
REPORTS
(OPERATIONS.
OUTPUTS,
HEAITH/ENHR.
EFFECTS,
REOUIRED STUDIES!
INTERAOENCY
COOPERATION
FOR INFORMATION
AID OTHER
PURPOSES
TSCA
4
5(1)
BllX4)
30
B(iK4)
Bib)
10(1]
Sfel
11(11,6)
4(il
EOil
6
BliK7)
BhX2)
7B.X2)
BW
12ft]
40.X1I
54X2XA1
SHX1MA)
81lX2l
Sid) .-^^ ,
,*""'
•'
-, ..
40.H2XA)
61el
BMI3IIB)
9
9ld)
IB
104X1)
IBIg)
2B
27
RCRA
3001
3002
3004121
3007
3004171
3006
3010(1)
300214)
3010
300218)
3004(2)
30050))
...
''j
100B
3003
B003
BOOItol
BOOI0.1
B002ffl
8003(1)
FIFHA
3leXtKDI
SHI
3
20W,lcl
8|b)
B
3
B
BIIH2)
I2UX1XPI
170)1
3(tX2l
SHI
BliX2)
17W
11(1)
7
3
BOD
17U)
26(1X21
IB
20
28
CAA
ingxiKAi
211lbX1XAI
110I1X2HCI
110(iX2HFWil
114(1X1)
1B5(iH7)
319
114(1X2]
110(iK2KD)
110,11X41
1100)
lligXIKA)
lUfcXIMWD
165
IBSIiXB)
172ftH6]
173
2110)1(2)
moxtxAi
1BE
110UK2KC)
110IIX2XFXII)
110(1X4]
IIUHIKAI
166(1X6]
IBEIiXt)
"?
211lbX2XBI
103
323(1)
402 (PL 95-96)
CWA
104liKE)
30BUX8I
401UI
30BI1XB)
31 lira)
301le),(g)
4D1(i)
402
403UI
3110.H5]
3111cX2HDI
402(bll8l
402U)
305
30B(iXA](iil
102(1)
104
106
IIS
501ft]
SDWA
1412
1421
1413(1X2)
1421(bX1XCI
1446(1]
1413(1)121
142I(b](1XCI
144E(bXtl
14210>X1XAI
1422lbX1KA)
1414
1413
1442
1412
FFDCA
4090)1(21
5050.1
50501
S12lbl
605
E12
605
612
702
704
408
409
60S
512
706
SOS
S12
702 (el
702U)
707
OSHA
60.1(71
20liX6)
60)H7I
BleX3l
20(1X5)
8lil
aw
8(jK2l
18(cH3l
19(1)13) .
19ldl
9(eX2)
1BICX7I
IBIcXBI
20(1)15)
19UH51
7leX1)
Blcll3)
20
24
19toK4)
19liX5)
21
CPSA
7UX3XAI
Mill
MM
7UK3XCI
IBM
160.)
10
27M
13M
MliXD
160.)
16W
27to)
14lcX3)
27M
29
FHSA
11
12
14
100.1
PPPA
HMTA
lOBIil
109(c)
'
lOBtbUc)
107
109IC)
1050)1
------- |