REGULATORY BASIS FOR ENVIRONMENTAL DATA OPERATIONS
A Quality Assurance Review
Quality Assurance Management Staff
in conjunction with Region 10
U.S. Environmental Protection Agency
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ACKNOWLEDGMENTS
The Quality Assurance Management Staff (QAMS) has prepared this document in
conjunction with EPA's Region 10. QAMS is indebted to Barry Towns, Quality
Assurance Officer for Region 10, and his staff for their assistance and
input. QAMS is especially grateful to all of you who reviewed earlier drafts
and provided us with comments and suggestions. Your interest and assistance
contributed greatly to the accuracy and completeness of this document.
Many talented individuals have contributed to this project. The first draft
was prepared by Neil Kerwin, professor at American University. Thomas Stanley
was responsible for the final draft, while Susan Santo and other staff members
at JWK International Corporation provided major editorial and technical
support. QAMS is thankful for all of these valuable contributions.
i
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TABLE OF CONTENTS
Acknowledgments
.................... ....... ................... ..........
INTRODUCTION
Mission of EPA [[[
Acts of Congress................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purpose of the Acts[[[
Regulations and Standards..............................................
Data Collection and QA .................................................
Purpose of This Document...............................................
Scope of Documen t [[[
Format and Content......................................."........... . . .
FEDERAL ASSISTANCE PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Highlights of Current Regulations ................................. .....
Grants Author i ty [[[
40 CFR 30
General Requ i remen ts and QA ..........................................
40 CFR 31
Uniform Administrative Requirements and QA .............. ........ .....
40 CFR 35
Continuing Environmental Programs ... ....................... .... ......
AIR PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . .
Highlights of Current Regulations ............................ .... ......
Clean Air Act[[[
40 CFR 50
National Ambient Air Quality Standards ...............................
Reference Methods[[[
40 CFR 51
State Implementation Plans...........................................
Other Requirements[[[
40 CFR 52
Approval of Plans......................................... . . . . . . . . . . .
40 CFR 53
Reference/Equivalent Methods ..... ............................... .....
40 CFR 58 "
Ambient Air Quality Surveillance.....................................
40 CFR 60
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TABLE OF CONTENTS
(Continued)
40 CFR 80
Control
40 CFR 85
Emission
40 CFR 86
Emission
40 CFR 87
Aircraft
of Additives
........ ......................... ................
Control
.............. .................... ...................
Control
( New) ...............................................
Emissions
.............. .....................................
WATER PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Highlights of Current Regulations ............ ..........................
The Three Statutes[[[
Clean Water Act[[[
40 CFR 122
National Pollutant Discharge Elimination System ......................
Testing Requi rements .................................................
40 CFR 123
State Program Requ i rements ...........................................
40 CFR 125
Cr iter ia and Standards...............................................
Mon i tor ing Program[[[
40 CFR 129
Standards for Extremely Toxic Pollutants .............................
40 CFR 130
Water Quality Management.............................................
State Monitoring Programs............................................
Water Quality Management Plans .......... ... ..... .....................
Water Quality. Reports.. . ... . ............ ... .. . .. ............... . .. . . .
40 CFR 136
Test Procedures for the Analysis of Pollutants .......................
Qual it Y Con t ro 1 [[[
40 CFR 402-699
Effluent Guidelines and Standards .......... ... ..... ..................
40 CFR 402
Implementing Effluent Limitations ............. .......................
40 CFR 403
Pretreatment Regulations.............................................
Records and Reports..................................................
Safe Drinking Water Act................................................
40 CFR 141
National Primary Drinking Water Regulations ... .......................
Monitoring and Analytical Requirements ...... .........................
Reports and Records..................................................
S ta te Pr imacy [[[
40 CFR 143
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TABLE OF CONTENTS
(Continued)
40 CFR 144-147
Underground Injection Control........................................
Monitoring and Data Reports..........................................
Permi ts [[[
Surveillance and Inspection..........................................
Marine Protection, Research, and Sanctuaries Act .......................
40 CFR 227
Ocean-Dumping Permit Evaluation ....................... ......... ......
40 CFR 228
Managing Disposal Sites """"".""""""""""""""""""
Monitoring and Survey Requirements .......... .... ... ......... .........
PESTICIDE PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Highlights of Current Regulations ................................... ...
Statutes That Regulate Chemicals ........ ..... ..........................
Federal Insecticide, Fungicide, and Rodenticide Act ........... ..... ....
40 CFR 152-157
Pesticide Registration...............................................
40 CFR 158
Data Requirements[[[
Wai ver of Requirements.................... . . . . . . . . . . . . . . . . . . . . . . . . . . .
40 CFR 160
Good Laboratory Practice Standards ......... ..........................
40 CFR 162-180
Other Requirements[[[
40 CFR 162
State Registration[[[
Registration Guidelines..............................................
TOXIC SUBSTANCE PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ~ . . . .
Highlights of Current Regulations .................................. ....
Toxic Substances Control Act...........................................
40 CFR 702
Civil Suits[[[
40 CFR 704
Reporting Requirements...............................................
40 CFR 710
Chemicals Inventory..................................................
40 CFR 712
Preliminary Assessment...............................................
40 CFR 716
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TABLE OF CONTENTS
(Continued)
40 CFR 720
Premanufacture Notification Procedures ...............................
Data Reports[[[
40 CFR 750
Rule Making.............................................. . . . . . . . . . . . .
40 CFR 761-763 and 766
Restriction of Chemicals................................. . . . . . . . . . . . .
40 CFR 792
Good Laboratory Practice Standards ....................... ............
QA Requirements[[[
40 CFR 796
Chemical Fate Testing................................................
40 CFR 797
Environmental Effects................................................
40 CFR 798
Heal th Effects[[[
40 CFR 799
Testing Requirements.................................................
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Highlights of Current Regulations ............................... .... ...
The Two Statutes[[[
Resource Conservation and Recovery Act .................... .............
40 CFR 240 and 241
Waste Disposal Methods...............................................
40 CFR 240
Thermal Processing[[[
40 CFR 241
Land Disposal[[[
40 CFR 252
Guidelines for Waste Disposal Management .............................
State Implementation.................................................
40 CFR 256
State Regulatory Authority...........................................
Surveillance Requirements............................................
Program Coord ina t ion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
40 CFR 260
Hazardous Waste Management...........................................
40 CFR 261
Hazardous Waste Identification.......................................
Guidel ines/Test Procedures...........................................
40 CFR 262 and 263
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T ABLE OF CONTENTS
(Continued)
40 CFR 264
Standards for Hazardous Waste Management.............................
Genaral Facilities Standard ..........................................
Releases from Solid Waste Management Units ...........................
Standards for Miscellaneous Units .... ..... ..... ............. .........
Guidel ines and Test Methods..........................................
40 CFR 265
Interim Status Standards.............................................
40 CFR 266
Recycled Waste Standards.............................................
40 CFR 267 "
New Facility Standards...............................................
40 CFR 268
High Risk Hazardous Waste............................................
40 CFR 270
Hazardous Waste Permit Program.......................................
40 CFR 271
State Programs[[[
40 CFR 280
Underground Storage Tanks..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Comprehensive Environmental Response, Compensation,
and Liability Act - "Superfund" ......................................
40 CFR 300
National Contingency Plan...".........................................
National Priorities List/Remedial Investigations .....................
Dispersants and Other Chemicals ......................................
Ranking System/Test Procedures .. .....................................
Requirements of Other Parts............................."...............
vi
Page
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7-12
7-12
7-13
7-13
7-14
7-14
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INTRODUCTION
Section No.1
Revision No. °
Date Nov. 1, 1989
Mission
of EPA
Acts of
Congress
Purpose of
the Acts
The U.S. Environmental Protection Agency (EPA) was established
as an independent Federal agency on December 2, 1970, to
assure the protection of the environment by abating and
controlling pollution on a systematic basis. This was a
result of Reorganization Plan 3 of 1970, which transferred to
EPA a variety of research, monitoring, standard setting, and
enforcement activities related to pollution abatement and
control in order to provide for the treatment of the
environment as an integrated system. In addition to these
activities, the Agency was given the responsibility for the
coordination and support of research and antipollution
activities carried out by state and local governments, private
and public groups, individuals, and educational
institutions. EPA must also reinforce efforts among other
Federal agencies to control and minimize the impact of their
operations on the environment.
In accordance with the environmental protection mission and
authority granted under Reorganization Plan 3, EPA must imple-
ment the purpose and intent of the following Congressional
mandates as enacted and as amended:
o The Clean Air Act
o The Clean Water Act
o The Safe Drinking Water Act
o The Marine Protection, Research, and Sanctuaries Act
o The Federal Insecticide, Fungicide, and Rodenticide Act
o The Toxic Substances Control Act
o The Solid Waste Disposal Act
o The Resource Conservation and Recovery Act
o The Comprehensive Environmental Response,
Compensation, and Liability Act
As a group, these statutes require the Agency to prevent
damage to human health and the environment caused by
pollution. Some of these statutes, such as the Clean Water
Act, the Clean Air Act, and the Safe Drinking Water Act, focus
on a particular aspect of the environment. Others, such as
the Toxic Substances Control Act and the Federal Insecticide,
Fungicide, and Rodenticide Act, are aimed at controlling
particular types and classes of chemical pollutants. Still
others, such as the Resource Conservation, and Recovery Act,
and the Comprehensive Environmental Response, Compensation,
and Liability Act (Superfund), are concerned with ways to
dispose of solid waste, and with uncontrolled hazardous waste
sites. Each Public Law has distinctive requirements and
strategies for pr~tecting and improving environmental quality.
1-1
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INTRODUCTION
Section No.1
Revision No. a
Date Nov. 1, 1989
Regulations
and
Standards
Data
Collection
and QA
Purpose
of This
Document
To achieve the goals and objectives of the Congressional man-
dates, EPA develops and promulgates many environmental
standards and regulations under Title 40 of the Code of
Federal Regulations. Based on scientific evidence and results
from continuing research efforts, environmental quality
standards have been promulgated for air and water. In
accordance with these standards, there are regulations that
limit the amounts of pollutants which can be introduced to the
environment from various sources. Usually, these are
accompanied by requirements that specified procedures and
techniques must be used to monitor compliance with these
standards. Other regulations require various measures and
controls to protect public health and the ecology from the
risks posed by some toxic or hazardous materials if allowed to
enter the environment.
Like the Congressional mandates they implement, the EPA reg-
ulations and standards deal with a great variety of
pollutants, activities, and regulated parties. But at the
center of this diversity, there is a crucial element common to
all regulatory programs administered by EPA: information and
data. The Agency must collect or have access to information
and data in order to establish standards and regulations, to
monitor compliance with standards and regulations, and to
determine and report if the Congressional mandates are being
achieved. Realizing the importance of information and data to
major environmental decisions, EPA has established a policy
that all data collection operations required or supported by
the Agency must participate in a quality assurance (QA)
program to ensure that the data collected are of documented
and sufficient quality to satisfy the purpose(s) for which
they were collected.
This document reviews current environmental regulations and
identifies those environmental data collection operations for
which QA is specified in the regulation or implied by the
nature of the regulated function. Because each Congressional
Act entails a different approach to abating and controlling
pollution, the Agency's implementing regulations dealing with
data collection, data analysis, reporting, and record keeping
vary from program to program. This document is prepared
specifically for those who are responsible for managing and
directing QA for environmental data operations, whether
medium-specific or multimedia environmental programs and
activities. The document looks at the major elements of each
Public Law that EPA administers, and provides a brief descrip-
tion of the information/data collection requirements in the
implementing regulation, along with references to any specific
quality assurance and quality control (QA/QC) requirements.
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INTRODUCTION
Section No.1
Revision No. 0
Date Nov. 1, 1989
Scope of.
Document
Format and
Content
This document covers all EPA regulations as they appear under
Title 40 Code of Federal Regulations, Parts 1 - 700 to End,
1988. The information presented is limited to environmental
data operations that are, in the opinion of the authors and
reviewers, subject to the Agency's QA policy and directives.
The information/data operations discussed in this document are
perceived to include any collection and storage process for
which the precision, accuracy, bias or error rate can be
statistically determined. Although these statistical measures
of quality are necessary, the real quality of the information/
data is in its ability to satisfy the purpose(s) for which it
is collected.
The material presented, in so far as possible, follows the way
in which EPA is organized and administered. EPA has the
Congressional mandate for protecting the environment; however,
the statutes explicitly require the Agency to work coopera-
tively with state and local governments, and to make full use
of the public and private sectors in implementing the intent
of the Acts. Consequently, the bulk of environmental data
collection for environmental decisions occurs outside the
Agency and is financially supported through Federal grants and
contracts. All Agency-supported environmental data operations
are affected directly by EPA's QA policy, and this is
reflected in those regulations governing financial assistance
to state and local governments and others. Therefore, this
document begins with a review of the Agency's financial
assistance regulations, and continues on with reviews of
media- and program-specific regulations that more directly
involve environmental data collection.
The document highlights only those parts of the regulations
that are of greatest concern to QA managers. The specific
regulation should be consulted for details and fuller
comprehension. A summary opens each chapter, along with
tables showing the current status of QA as of July, 1988.
*
While this document focuses on those regulations promulgated under Title 40
of the Code of Federal Regulations, it is imperative that we cite 48 CFR
Part 1546, which covers QA requirements for all EPA-negotiated contracts
involving environmentally related measurements. "Contract Quality
Requirements" in this Part stipulate that "the Contracting Officer shall
ensure that Procurement Request Orders (EPA Form 1900-8) in excess of
$25,000 be accompanied by a Quality Assurance form for those acquisitions
in the object classification prescribed in Chapter 2 of the EPA Contract
Managers Manual." The QA Form identifies environmentally related data
operatIons that require the development of QA program plans as specified in
48 CFR Subpart 1546.246-70, and the preparation of QA project plans as
specified in 48 CFR Subpart 1546.246-71/72 (as a deliverable under the
contract).
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Section No.2
Revision No. 0
Date Nov. 1, 1989
FEDERAL ASSISTANCE PROGRAMS
Summary
State, local, and nonprofit organizations may apply to EP~ for
grants, cooperative agreements, or fellowships to support
their pollution control and research efforts. Title 40 of the
Code of Federal Regulations, Part 31, requires that all
applicants to EP~ for financial assistance sufficiently
address Q~ and show how the quality of their data will be
documented. However, because EPA's 10 Regional Administrators
administer and approve such assistance, the degree to which
the QA requirement is implemented varies significantly among
regional offices.
This chapter looks at the regulations that govern financial
assistance and explains the specific QA requirements that are
applicable across the Agency.
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Title 40, Code of Federal Regulations
Section No.2
Revision No. 0
Date Nov. 1, 1989
HIGHLIGHTS OF CURRENT REGULATIONS
Federal Assistance Programs:
Grants and Cooperative Agreements
Part 30 - General Regulation for Assistance Programs Other Than State and
Local Governments
o Research Projects - narrative QA statement for
data quality documentation
o Other Projects - QA management plans and QA
project plans
Part 31 - Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments
o
Projects Involving Environmental Measurements -
QA sufficient to document data quality that
satisfies project objectives
Part 35 - State and Local Assistance
o Continuing Environmental Programs - follow
requirements of statutes and program directives
o Grant for Construction of POTW's* - environmental
evaluations
o Cooperative Agreements for Restoration of Freshwater
Lakes - feasibility studies and environmental
evaluations
* Publicly Owned Treatment Works.
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Section No.2
Revision No. 0
Date Nov. 1, 1989
FEDERAL ASSISTANCE PROGRAMS
Grants
Authority
40 CFR 30
General
Requirements
and QA
40 CFR 31
Uniform
Administra-
tive
Requirements
and QA
In carrying out its mission to improve and protect the quality
of the environment, EPA may award grants, cooperative
agreements, or fellowships to support: state and local
pollution control efforts; research, demonstration, or
training projects; and other projects that help the Agency
meet its objectives. The various environmental statutes
authorize EPA to provide financial assistance to, or share the
cost with, state and local agencies and non-profit organiza-
tions conducting monitoring, research, demonstration, and
planning pursuant to legislative mandates, i.e., Congressional
Acts to protect the environment, public health, and welfare.
Title 40 of the Code of Federal Regulations, Part 30, estab-
lishes "General Regulations for Assistance Programs Other Than
State and Local Governments." This Part specifies QA require-
ments for all applications for Federal assistance for projects
that involve environmentally related measurements. Applicants
for financial assistance to support environmental data
operations associated with research projects must narrate how
the quality of the data will be documented and its utility
demonstrated. Applications to assist other non-research
projects and demonstrations that involve environmental
measurements must include:
o
A written plan describing how the QA
effort will be organized and managed; and
o
A detailed QA project plan that details
the purpose of the project and the quality
of the data needed, how the data will be
collected, and how the quality of the data
will be documented and demonstrated to
satisfy the the objectives of the project.
Part 31 establishes "Uniform Administrative Requirements for
Grants and Cooperative Agreements to State and Local
Governments" that are applicable across the Federal government.
Of particular relevance to QA is Section 31.45 which states,
"If the grantee's project involves environmentally related
measurements or data generation, the grantee shall develop
quality assurance practices consisting of policies,
procedures, specifications, standards, and documentation
sufficient to produce data of quality sufficient to meet
project objectives and to minimize loss of data due to out of
control conditions of malfunctions." Detailed guidance for
meeting these QA requirements is available as part of the
Agency's application forms and instructions. EPA's 10
Regional Administrators are responsible for approval and
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Section No.2
Revision No. 0
Date Nov. 1, 1989
FEDERAL ASSISTANCE PROGRAMS
40 CFR 35
Continuing
Environmental
Programs
administration of financial assistance grants and cooperative
agreements to state and local agencies.
Part 35 regulates the administrative process for providing
financial assistance to state and local government for con-
tinuing environmental prog~ams:
o
Air Pollution Control (Section 105)
o Water Pollution Control (Section 106)
o State Administration [Section 205(j)]
o Water Quality Management Planning
[Section 205(j)]
o
Public Water System Supervision
[Section 1443(A)]
o
Hazardous Waste Management (Section 3011)
o
Pesticide Enforcement [Section 23(A)(1)]
o
Pesticide Applicator Certification and
Training [Section 23(A)(1)]
Applications for assistance under any of these continuing
programs as authorized by specific sections of the Acts may
require environmentally related information and data, and/or
adherence to some regulation that stipulates environmental
data collection and QC/QA. It is sufficient for the purposes
of this presentation to note that much of the environmental
quality planning, management, monitoring, and similar
operations of state and local agencies are supported through
the grants administration process. The EPA regional offices
monitor performance under grants and cooperative agreements to
ensure that national program objectives are being served. The
specific regulation and the referenced section of the Act
should be consulted for greater detail.
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AIR PROGRAMS
Section No. ...L
Revision No. 0
Date Nov. 1, 1989
Summary
The Clean Air Act provides a major role for EPA in the
protection of air quality. QA procedures and requirements for
air programs are defined in applicable regulations. Data
quality and collection requirements are divided into ambient
air quality, stationary sources, and mobile sources.
The ambient air Quality program, defined in 40 CFR Part 51,
contains the most specific and comprehensive.QA requirements
pursuant to the Clean Air Act. EPA sets National Ambient Air
Quality Standards for pollutants that could adversely affect
public health or welfare. Maintaining these standards is the
role of states, who must address QA requirements for sample
collection and analysis in their State Implementation Plans
(SIP's). Each SIP mandates that QA criteria be in place to
govern the operation and monitoring of stationary sources of
air pollution. Sample locations must be in accordance with
siting guidelines; approved monitoring methods must be used;
and reports to EPA on precision and accuracy are required.
QA procedures for stationary sources, covered in 40 CFR Part
61, are similar to ambient air quality requirements. EPA
establishes National Emission Standards for Hazardous Air
Pollutants and requires states to submit plans with descrip-
tions of emission-reduction systems that can achieve the
Agency's standards. The regulations include QA guidelines for
the preparation of these plans.
The control of pollution from mobile sources requires
regulation of fuels and fuel additives, which are addressed in
40 CFR Parts 79 and 80. Parts 85 and 86 deal with the control
of air pollution from motor vehicles. Engines and parts must
be certified before they enter the marketplace to ensure that
they perform in compliance with air quality emission
standards. QA requirements emphasize EPA's auditing role to
determine if the testing programs used for certification are
operating reliably. Part 87 covers sampling and analytical
test procedures for aircraft engine emissions.
This chapter takes a closer look at the regulations that
govern air programs, with emphasis on QA requirements.
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Section No. ~
Revision No. 0
Date Nov. 1, 1989
Title 40, Code of Federal Regulations
HIGHLIGlITS OF CURRENT REGULATIONS
Air Programs:
Clean Air Act
Part 50 - National Primary and Secondary Ambient Air Quality Standards (NAAQS)
o
o
o
Primary and Secondary Standards
Reference Methods (some QC)
Interpretation of NAAQS for PM10
Part 51 - Requirements for Preparation, Adoption, and Submittal of
Implementation Plans
o Air Quality Maintenance Area (AQMA) Analysis
o AQMA Plan Content
o Prevention of Significant Deterioration (PSD)
o Protection of Visibility
o Data Reports
Part 52 - Approval and Promulgation of Implementation Plans
o Interpretive Ruling for Section 52.22,
Regulation for Review of New or Modified
Indirect Sources
o Determination of S02 from Stationary Sources by
Continuous Monitors
o Performance Specifications and Test Procedures
for Monitoring Sources' Stream Gas Volume Flow
Rate
Part 53 - Ambient Air Monitoring Reference and Equivalent Methods
o Performance Testing of Automated
o Comparability Test for Candidate
Reference Methods
o Performance Test for PM10 Methods
Part 58 - Ambient Air Quality Surveillance
Methods
Methods Versus
o QA Requirements for SLAMS and NAMS
o QA Requirements for PSD Monitoring
o Ambient Air Monitoring Methodology
o Network Design for SLAMS and NAMS
o Probe Siting Criteria for Ambient Air Quality
Monitors
o Annual SLAMS Air Quality Information
o Uniform Air Quality Index and Daily Reporting
(this is the information used on TV weather
reports of air quality)
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Section No. -1-
Revision No. 0
Date Nov. 1, 1989
Part 60 - Standards of Performance for New Stationary Sources
o Reference Methods For Monitoring Emissions
o Performance Specifications for Emission Monitors
o Determination of Emission Change Rates
o Required Emission Inventory Data
o QA Procedures
Part 61 - National Emission Standards for Hazardous Air Pollutants (NESHAP's)
o NESHAP's Compliance Status Information
o Test Methods for Sampling and Analysis
o QA Procedures
Part 79 - Regulation of Fuels and Fuel Additives
o Test Data Required, Physical and Chemical
o Reports of Methods Used for Collecting Test Data
o Reports of Effects of Additives on Emissions
o Reports of Effects of Additives on Control Devices
Part 80 - Regulation of Fuels and Fuel Additives:
Control of Additives
o Standards
o Test for Determination of Phosphorus in Gasoline
o Test Methods for Lead in Gasoline (some QC in methods)
Part 85 - Control of Air Pollution from Motor Vehicles and Motor Vehicle
Engines
o Standards and Limits
o Test Procedures and Reporting
Part 86 - Control of Air Pollution from New Motor Vehicles and New Motor
Vehicle Engines
o Standards for Model Years
o Emission Sampling and Test Procedures
procedures are by reference)
o QC (in some test procedures)
(some test
Part 87 - Control of Air Pollution from Aircraft and Aircraft
Engines
o Emission Standards
o Test Procedures for Engine Exhaust Gaseous
Emissions
o Test Procedures for Engine Smoke Emissions
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AIR PROGRAMS
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
Clean
Air Act
40 CFR 50
National
Ambient Air
Quality
Standards
Reference
Methods
40 CFR 51
State
Implementa-
tion Plans
The Clean Air Act (CAA), passed unanimously by Congress in
1970, was the most comprehensive environmental law enacted in
American history. It established a major role for the Federal
government and EPA in the protection of air quality. This was
a major shift from earlier thrusts of the Congress to vest
most legal authority in the state governments. The original
Act was amended in 1977 to include more specifics based on
knowledge gained, and advances made, in measurement and
control technologies. Although the Act as amended was even
more voluminous, the essential elements were few and fairly
straightforward.
Pursuant to Section 109 of the CAA, EPA promulgated National
Ambient Air Quality Standards (NAAQS) for certain gaseous and
solid pollutants that could adversely affect public health or
welfare. The regulation set both primary and secondary air
quality standards. Primary standards are those concentration
levels of pollutants which the Administrator judges necessary,
with an adequate margin of safety, to protect public health.
Secondary standards are those levels of pollutants which the
Administrator judges to have an adverse affect on the public
welfare.
The NAAQS include primary and secondary standards for the
following:
PM10
CO
~dx
NOx
Pb
- suspended particulate matter with an
effective aerodynamic diameter <10~m
- carbon monoxide
- ozone
- sulfur oxides as sulfur dioxide
- nitrogen oxides as nitrogen dioxide
- lead associated with suspended airborne
particulate matter
. Title 40 of the Code of Federal Regulations, Part 50, also
appended reference methods for monitoring these pollutants,
along with guidance for the uniform interpretation of the
NAAQS for ozone and airborne particulate matter (PM10)' The
states may set air quality standards which are more stringent,
but not less than, the NAAQS. Other methods demonstrated to
be equivalent to the reference methods may be used to
determine compliance with the ambient air qual~ty standards.
The states are responsible for the maintenance of air quality
standards. Part 51 establishes requirements for preparation,
adoption, and submittal of implementation plans for the
maintenance of national standards in designated Air Quality
Maintenance Areas (AQMA's). The Administrator notifies the
states of those areas designated as AQMA's, and each state is
required to provide an analysis of the air quality impact of
specified pollutant emissions from existing sources, and
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AIR PROGRAMS
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
Other
Requirements
40 CFR 52
Approval of
Plans
40 CFR 53
Reference/
Equivalent
Methods
40 CFR 58
Ambient Air
Quality
Surveillance
emissions associated with projected growth and development in
the designated AQMA. The state then develops control
strategies as part of its State Implementation Plan (SIP).
The AQMA analysis and the SIP's are dependent on both numeric
survey data and on physical or chemical measurement data for
specific parameters. These data are subject to measurement
errors and must be quality controlled/quality assured.'
Other important requirements of 40 CFR Part 51 include preven-
tion of significant deterioration (PSD) of existing or
attained air quality, and the protection of visibility. The
purpose of the PSD is to protect air quality that is better
than the NAAQS, i.e., pristine areas and national parks.
Visibility, of course, affects safety, public health, and the
economy. The primary aim of the protection of visibility is
to safeguard the natural beauty of the country, which attracts
tourists and enhances the enjoyment of the American people.
As appropriate, SIP's will include monitoring and data
collection to implement the PSD and visibility protection
requirements of the regulation.
Part 52 provides a public record of the status, approval, and
promulgation of air quality implementation plans from the
50 states and 5 territories. There is little of concern to QA
except for several appendices which provide for an interpre-
tive ruling for Section 52.22(b) - "Regulation for Review of
New or Modified Indirect Sources"; procedure for the determi-
nation of S02 emissions from stationary sources by continuous
monitors; and performance specifications and test procedures
for monitoring sources' stream gas volume flow rates.
The NAAQS regulation stipulates the reference methods that are
to be used to monitor compliance, or attainment of the
standards. Methods that are demonstrated to be equivalent to
the reference methods may also be used to monitor compli-
ance. Part 53 describes procedures for testing performance of
automated measurement methods; conducting comparability test
of candidate methods versus the reference method; and testing
the performance of methods for measuring airborne particles
with diameters of 10 micrometers or less (PM10)' The
regulation also establishes format and procedures for data
submittal, approval, and promulgation of the results.
Perhaps the most important implementing regulation pursuant
to the CAA is 40 CFR Part 58, which mandates a National
Ambient Air Surveillance System to be operated by the states
in close cooperation with EPA. The ambient air quality
surveillance regulation:
3-5
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AIR PROGRAMS
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
o
Stipulated the air monitoring methodology
to be used;
40 CFR 60
New
Stationary
Sources
o
Prescribed a network design for State and
Local Air Monitoring Stations (SLAMS) and
for National Air Monitoring Stations
(NAMS) , a subset of the SLAMS;
o
Gave probe siting criteria for ambient air
quality monitoring;
o
Stipulated the QA requirements for all air
monitoring stations, including calculating
and reporting of data quality;
o
Required reporting for SLAMS air quality
information; and
o
Established a standard procedure for
determining a uniform air quality index
and daily reporting.
The implementation of 40 CFR Part 58 represents a major
portion of the national air quality protection effort. The
primary aim of this regulation is to monitor the status of the
attainment and/or maintenance of the NAAQS. Other regula-
tions, to be discussed later, are focused on controlling all
non-natural processes that prevent the attainment/maintenance
of the NAAQS, adversely affect air quality, or directly or
indirectly discharge pollutants into the air which pose an
unacceptable risk to public health or welfare.
The CAA requires the Administrator of EPA to develop perform-
ance standards for controlling designated emissions of
designated pollutants at designated facilities on a state-by-
state basis. Part 60 establishes "Standards of Performance
for New Stationary Sources" covering any construction or
modification commencing on or after publication of the
standard in this Part. Section 111(c) of the Act directs the
Administrator to delegate to each state, when appropriate, the
authority to enforce standards of performance for new
stationary sources located in that state.
After promulgation of a performance standard for the control
of a designated pollutant from a designated facility, the
Administrator must develop and publish guidelines for develop-
ing state plans for implementing the New Source Performance
Standards. The guidelines cover the monitoring, reporting,
and QA requirements for all designated pollutants and
facilities. Designated pollutants are those for which no air
quality criteria document has been developed, but that have
been determined by the Administrator to have potentially
3-6
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AIR PROGRAMS
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
40 CFR 61
National
Emission
Standards
for
Hazardous
Air
Pollutants
40 CFR 79
Regulation
of Fuels/
Additives
40 CFR 80
Control
of
Additives
adverse effects on public health or welfare. The regulation
covers about 40 different sources; reference methods, both
chemical and physical; performance specifications for emission
monitors; procedures for determination of emission rate
changes; required inventory information; and QA procedures.
Pursuant to Section 112 of the Clean Air Act, EPA, from time
to time since 1975, has designated some chemicals as hazardous
air pollutants and cited them in the Federal Register along
with a notice that serious health effects, including cancer,
could result from ambient air exposure to such substances.
Part 61 establishes "National Emission Standards for Hazardous
Air Pollutants (NESHAP's)" that include emission standards for
radionuclides from designated facilities. This Part is
. applicable to existing as well as new construction or
modification of any designated source.
Section 112 directs the Administrator to delegate to each
state, when appropriate, the authority to implement and
enforce NESHAP's for stationary sources located in such
state. The regulation specifies the monitoring requirements
and data reporting/retention, along with information on the
compliance status of the NESHAP's; test procedures for
sampling and analysis (some procedures are indicated by
reference); and QA procedures for gas chromatographic analysis
(some of the procedures have QA/QC included).
Emissions from motor vehicles are major contributors to air
pollution. The abatement and control of pollution from mobile
sources requires regulation of fuels, fuel additives, engine
performance, and after-combustion emission controls. Pursuant
to Section 211 of the CAA, as amended, the Administrator may
require manufacturers to register any fuel or fuel additive
entered into commerce, and to conduct, or require, such tests
as needed to show compliance with good safety and health
standards.
Part 79 regulates procedures for the "Registration of Fuels
and Fuel Additives" that include physical/chemical tests of
characteristics and composition; reports of tests used to
collect the required test data; reports of testing the effects
of the additives on exhaust emissions; and reports of testing
the effects of additives on emission-control devices. All
such data are subject to measurement error, and data quality
documentation may be warranted.
Sections 211 and 301 (a) of the CAA, as amended, allow for
the control or prohibition of fuels and fuel additives, for
use in motor vehicles and motor vehicle engines, that are
determined by the Administrator to endanger public health, or
impair performance of an emission-control device. Part 80
establishes standards for lead in gasoline; monitoring and
3-7
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AIR PROGRAMS
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
40 CFR 85
Emission
Control
40 CFR 86
Emission
Control
(New)
40 CFR 87
Aircraft
Emissions
inspection of the manufacturer, distribution, and selling of
fuels; tests for lead in gasoline, with QC included; test
procedure for the determination of phosphorous in gasoline; and
requirements for data reporting/retention.
Part 85 establishes "Control of Air Pollution from Motor
Vehicles and Motor Vehicle Engines" and covers procedures for
testing and certification of domestic and imported vehicles
and engines, including recall regulations for vehicles or
engines out of conformity with this part. Part 85 also
regulates the performance of emission-control systems,
specifies monitoring and tests, and covers test data
reporting/retention. This Part also gives procedures for
implementing an after-market auto parts certification program
for those parts that could cause changes in vehicle engine
performance, fuel consumption, and exhaust gas volume or
content.
Part 86 establishes certification and test procedures for
the "Control of Air Pollution from New Motor Vehicles and New
Motor Vehicle Engines." It sets emission standards for
light/heavy duty cars and trucks (gasoline/diesel powered) for
1977 and later model years. For the most part, the emission
standards are set for particulate matter, hydrocarbons, oxides
of nitrogen, carbon monoxide, and carbon dioxide on a weight/
mile basis with engine load or idle. Part 86 also gives
specific sampling and test procedures, dynamometer conditions,
and some QC built into the test procedures. Both combustion
engine exhaust and evaporative emissions are covered by this
regulation.
The control of air pollution from aircraft engines is stipu-
lated in 40 CFR Part 87. This regulation establishes emission
standards for hydrocarbons (HC's) and smoke density (SNo.), as
applicable, for engine fuel venting emissions and exhaust
emissions from new and in-use aircraft gas turbine engines.
The test procedures to be used, sampling and analytical, are
stipulated by reference to Appendices 3 and 5 to International
Civil Aviation Organization (ICAO) Annex 16, Volume II, First
Edition, June 1981. Sampling and analytical procedures for
measuring smoke exhaust emissions are described in Appendix 2,
Volume II, Aircraft Engine Emissions to ICAO Annex 16, First
Edition, June 1981. The test procedures cited must be used to
demonstrate compliance with Part 87, except that procedures
shown to yield equivalent results may be used if approved in
advance by the Administrator of EPA or the Secretary of
Transportation.
3-8
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WATER PROOR~
Section No.4
Revision No. 0
Date Nov. 1, 1989
Water programs are established through three major statutes.
Summary
The Clean Water Act requires dischargers of pollution into
navigable waters to obtain a permit issued by EPA or a state
that has been granted authority. States must develop water
Quality standards based on monitoring data, and the standards
must be generated in accordance with an approved QA program.
EPA uses these standards to establish pollution control
guidelines for the National Pollution Discharge Elimination
System (NPDES) Permit Program. Analyses of pollutants through
an NPDES Program must be conducted in accordance with 40 CFR
Part 136, which contains analytical QA and QC procedures for
data collection and sample analysis.
The Safe Drinking Water Act is concerned with the quality of
potable water from public systems and the health of those
consuming it, along with the protection of ground-water
resources. National Primary Drinking Water Regulations
establish maximum contamination levels for a variety of
pollutants.
Part 142 allows states to obtain primacy in implementation of
the Act if they design, among other requirements, a
certification process including a QA program for laboratories
analyzing public drinking water samples.
The underground injection control program, regulated by Parts
144-147, also has references to certain QA/QC type proce-
dures. EPA or the state may request permittees to submit
reports on ground-water monitoring and analyses of fluids
injected into the wells.
The Marine Protection, Research, and Sanctuaries Act controls
the dumping of materials into oceans. The regulations of
greatest interest to QA are Parts 227 and 228, which give
criteria for evaluating permit applications and for managing
disposal sites. For example, when a baseline survey is
conducted to determine the condition of a proposed disposal
site, EPA may require analysis of performance samples and
participation in surveys by EPA personnel.
This chapter covers the three Acts in more detail and explains
the QA requirements or implications contained in the
regulations that govern water programs.
4-1
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Section No.4
Revision No. 0
Date Nov. 1,1989
Title 40, Code of Federal Regulations
HIGHLIGHTS OF CURRENT REGULATIONS
Water Programs:
Clean Water Act
The National Pollutant Discharge
Part 122 - EPA Administered Permit Programs:
Elimination System (NPDES)
o Establishing Limitations, Standards, and Other Conditions
o Calculating NPDES Permit Conditions Applicable to States
o Discharge Monitoring Reports (DMR's)
o NPDES Permit Application Testing Requirements (by industrial
category and GC/MS fraction)
Part 123 - State Program Requirements
o Requirements for Enforcement Authority
o Criteria for Non-compliance Reporting in the NPDES Program
(calculating violations for pollutant/parameter groups)
Part 125 - Criteria and Standards for the National Pollutant Discharge
Elimination System
o
Criteria for Modifying Secondary Treatment Requirements
under Section 301 (h) of the Clean Water Act (establishment
of a monitoring program to provide data adequate to show
compliance with applicable water quality standards)
Part 130 - Water Quality Planning and Management
o Water
o Water
o Water
o Water
Quality
Quality
Quality
Quality
Standards
Monitoring
Management
Reports
Plans
Part 136 - Guideline Establishing Test Procedures for the Analysis of
Pollutants
o
Approved Test Procedures by Reference - biological,
inorganic, non-pesticide organic, pesticide, and
radiological
Sample Collection - containers, preservation techniques, and
holding times
Methods for Organic Chemical Analysis of Municipal and
Industrial Wastewater (EPA methods with QC incorporated)
Definition and Procedures for the Determination of the
Method Detection Limit
Inductively Coupled Plasma - Atomic Emission Spectrometric
Method for Trace Analysis of Water and Wastewater
o
o
o
o
4-2
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Section No.4
Revision No. 0
Date Nov. 1, 1989
Water Programs:
Safe Drinking Water Act
Part 141 - National Primary Drinking Water Regulations
o Maximum Contaminant Levels
o Monitoring and Analytical Requirements - alternative
methods, approved laboratories (EPA or state),
trihalomethane sampling and analysis
o Method for the Sampling and Analysis of Trihalomethane
o Reporting and Public Notification
o Monitoring and Prohibition on Lead Use
o Maximum Contaminant Goals for Organics
Part 142 - National Primary Drinking Water Regulations Implementation
o
Records - of tests and measurements of all public water
systems
Records - of inventories of all public water systems and
maintained for 40 years
o
Part 143 - National Secondary Drinking Water Regulations
o Secondary Maximum Contaminant Levels
o Monitoring Frequency
o Approved Methods by Reference (some methods referenced have
QC incorporated)
o Public Notification for Fluorides
Part 144 - Underground Injection Control Program
o
o
Establishing Permit Conditions
Requirements for Recording and Reporting Monitoring Results
4-3
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Section No.4
Revision No. 0
Date Nov. 1, 1989
Water Programs:
Marine Protection, Research, and Sanctuaries Act
Part 223 - Contents of Permits; Revision, Revocation, or Limitation of Ocean
Dumping Permits under Section 104(d) of the Act
o Physical and Chemical Properties of the Waste to be Dumped
o Quantity of the Material to be Dumped in Tons
o Disposal Sites, and Times at which the Dumping Will Occur
o Monitoring to Assess the Impact of Dumping
o Special Limits and Conditions Imposed by the Administrator
Part 227 - Criteria for the Evaluations of Permit Applications for the Ocean
Dumping of Materials
o Evaluation of Environmental Impact
o Need for the Ocean Dumping, and Alternatives
o Impact of the Proposed Dumping on Aesthetic Values
o Special Requirements for Interim Permits
and Use
Part 228 - Criteria for the Management of Disposal Sites for Ocean Dumping
o
o
o
o
o
o
o
o
o
Site Selection Criteria, and Regulation of Site Use
Limitations on Time and Rates of Disposal
Disposal Site Monitoring, and Evaluating Disposal Impact
Modification of Disposal Site Use
Disposal Site Baseline or Trend Assessment Surveys
Sample Design, Sampling, and Sample Preservation
Measurements, Physical and Chemical, and Oceanographic
Survey Techniques (Test Procedures) and Approvals
QA, Performance Testing and Onsite Visits
4-4
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
The Three
Statutes
Clean
Water Act
40 CFR 122
National
Pollutant
Discharge
Elimination
System
One of EPA's most difficult assignments is protecting the
quality of the nation's natural water resources. Congress has
delineated the Agency's water protection mission through the
enactment of three Public Laws, with amendments: the Federal
Water Pollution Control Act/the Clean Water Act, the Safe
Drinking Water Act, and the Marine Protection, Research, and
Sanctuaries Act. Each Act deals with a separate area of water
quality depending on the intended use(s) of the water.
The Clean Water Act is intended to protect all navigable waters
from discharges of pollution that make the waters unsuitable
for fish and wildlife and for recreational purposes. The Safe
Drinking Water Act directs the establishment of primary and
secondary water quality standards for public drinking water
systems to protect human health and welfare. As with air
quality standards, primary water quality standards are to
protect public health, and secondary are to protect human
welfare or the economy. The Marine Protection, Research, and
Sanctuaries Act mandates the investigation, control, and
monitoring of ocean dumping of waste to protect marine life and
safeguard estuaries essential to preserve wildlife. Seven of
the 10 EPA regions have coastal states with primary interests
in regulations pursuant to this Act.
Congress has directed EPA to promulgate regulations to carry
out the intent of the Acts, and to report back on how well
these Acts have protected and improved water quality nation-
wide. The implementation of each regulation requires
environmental data operations that fall within the purview of
EPA's QA program and the managers who plan and direct it.
Those parts of the regulations that appear important to QA
managers are summarized in the discussions that follow.
The Federal Water Pollution Control Act, now generally
referred to as the Clean Water Act (CWA), called for the
complete elimination of all discharge of pollution into
navigable waters of the United States and territories by
1985. The original goal of no discharge evolved into a more
obtainable interim objective of achieving and maintaining water
quality sufficient to support fish and aquatic life, help
preserve wildlife, and ensure quality suitable for recreational
purposes.
Pursuant to the more obtainable objectives of the CWA, the
National Pollution Discharge Elimination System (NPDES)
requires a legal permit for any private, public, or industrial
discharge of pollution into navigable waters. The regulated
requirements for the administration and operation of the system
are contained in 40 CFR Part. 122, which sets forth the
administrative and operative requirements for the NPDES if it
is operated by EPA. Those areas of Part 122 most important to
4-5
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1,1989
Testing
Requirements
40 CFR 123
State
Program
Requirements
understanding water quality data operations and QA include the
following:
o
Permit conditions - standards and other conditions;
o
Requirements for recording and reporting of monitoring
results (DMR's);
o
Industrial categories - permit requirements;
o
Storm sewers - special conditions; and
o
Permit application testing requirements by industrial
category.
Although the approved methods for monitoring compliance with
NPDES permits are not found in 40 CFR Part 122, permit
application testing requirements establish the basis for QA for
reviewing data collection operations, measurement methods, and
the QC employed. Part 122 prescribes testing by specific
category, including GC/MS analysis of samples for volatiles,
acids, bases/neutrals; pesticides; other chemicals, metals, and
cyanides; and non-conventional pollutants (if suspected
present) such as asbestos, toxics, and hazardous substances.
In addition, Part 122 covers special NPDES program requirements
for control of pollution from activities such as aquaculture
and silviculture, along with criteria for determining
concentrated animal and aquatic feeding areas.
It was the desire of Congress that the states would assume
primacy for the administration and operation of the NPDES
program, provided that certain conditions were met and the
state permit program was approved by the Administrator of EPA,
or his designee. Part 123 establishes conditions under which a
state may assume primacy for the NPDES operation. Those areas
of significant concern to QA include the following:
o NPDES Primacy Requirements - the states follow 40 CFR
Part 122, and develop a memorandum of understanding
with the appropriate Regional Administrator;
o
Requirements for reporting permit violations - any
monthly average which exceeds or equals the product of
the technical review criteria (TRC) multiplied by the
effluent limit, and occurs two months in six months.
4-6
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WATER PROOR~
Section No.4
Revision No. 0
Date Nov. 1, 1989
The TRC are different for Group I and Group II parameters:
40 CFR 125
Criteria and
Standards
Monitoring
Program
o Group I Pollutants (TRC
Oxygen Demand
Total Dissolved Solids
Total Suspended Solids
Nutrients (Nitrogen and
Detergents and Oils
Minerals (Ca, Cl)
= 1.4)
Phosphorus Compounds)
o
Group II Pollutants (TRC = 1.2)
Metals
Inorganics (and Cyanides)
Organics
Only approved methods may be used for monitoring compliance
with the permit, and laboratories performing the analyses may
be subjected to performance testing by EPA or the state.
Most permits under the NPDES program will contain some
technology-based control along with the effluent limitation.
Part 125 establishes criteria and standards for technology-
based treatment requirements in discharge permits, and
regulates other technology-based changes or variances that can
be permitted. The regulations set statutory deadlines for
including technology-based treatment in discharge permits for
publicly owned treatment works (POTW's), and for other
dischargers. For example, permits for POTW's must contain
effluent limitations based on secondary treatment, from the
date of issuance, and the best possible waste treatment
technology no later than July 1, 1983. Permits for other
dischargers must contain effluent limitations based on a range
of control technologies such as best practical control
technology currently available (BPT); the best conventional
pollutant control (BC); and the best available control
technology economically achievable.
Although this information is helpful in understanding the many
facets of the NPDES program, several requirements of 40 CFR
Part 125 of more importance to QA appear in Subpart G, and
Appendix A and B. Subpart G establishes criteria for modifying
secondary treatment requirements under Section 301 (h) of the
CWA. Among other requirements to protect the quality of
receiving waters, Subpart G requires the establishment of a
monitoring program to collect data sufficient to demonstrate
attainment or maintenance of water quality that assures the
protection of public water supplies; the protection and
propagation of a balanced, indigenous population of fish,
shellfish, and wildlife; and allows recreational activities.
4-7
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WATER PROOR~
Section No.4
Revision No. °
Date Nov. 1,1989
40 CFR 129
Standards
for
Extremely
Toxic
Pollutants
40 CFR 130
Water
Quality
Management
State
Monitoring
Programs
Applications for permits for any modified POTW's must include
the questionnaire in Appendix A or B, which requires
measurement data for physical, chemical, and biological
parameters relevant to an appropriate water quality standard.
For certain extremely toxic pollutants, 40 CFR Part 129
establishes effluent standards and prohibitions that must be
contained in any NPDES permit for specific or potential
discharges of any of these designated toxic substances.
Currently, these regulated toxic substances include:
polychlorinated biphenyls (PCB's), toxaphene, endrin,
aldrin/dieldrin, and other similar compounds and precursors.
The QA significance of this Part is that it sets an
environmental standard based on a measurable quantity, and
designates an acceptable analytical method for demonstrating
compliance.
Most of the environmental data operations associated with the
CWA evolve from 40 CFR Part 130, which establishes policies
and program requirements for the Water Quality Management (WQM)
process described in the Act. This regulation "provides the
authority for a consistent national approach for maintaining,
improving, and protecting water quality, while allowing states
to implement the most effective individual programs." The WQM
process, implemented Jointly by EPA and the states, has the
following major components:
o Water
o Water
o Water
o Water
Quality
Quality
Quality
Quality
Plans
Standards
Monitoring
Management
Reports
Water quality standards establish the states' goals for
individual bodies of water, and are intended to provide a legal
basis for control decisions under the Act. Physical, chemical
and biological data must be collected to establish baseline
water quality, and to determine the sources of pollution. In
accordance with Section 106 of the Act and 40 CFR Part 130,
states must develop water quality monitoring programs
sufficient to "establish monitoring methods and procedures
(including biological monitoring) necessary to compile and
analyze data on the quality of waters in the United States and,
to the extent practicable, ground ~aters." The regulation
stipulates that the "state's monitoring program will include
the collection and analysis of physical, chemical, and
biological data and quality assurance and control programs to
assure scientifically valid data." This is the only specific
reference made to QA, with some QC implied.
4-8
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. " 1989
Water
Quality
Management
Plans
Water
Quality
Reports
Water quality management (WQM) plans, used to direct the
implementation of the CWA, are part of a continuing planning
process. Plans should address problems and priorities in water
quality reports, and focus on removal of any conditions imposed
on previous plans that prevent control decisions. The WQM
plans rely heavily on monitoring and assessment to identify
water quality problems, and to determine alternative solutions
or control measures. The major elements of the WQM plan
include:
o
Total maximum daily loads (TMDL's) for major
dischargers of pollution;
o
Effluent limitations, including water quality based
limitations and compliance schedules;
o Municipal and industrial waste treatment, along with a
projection of new or modified waste treatment works;
o Non-point source management and control, including
description of best management practices selected for
regulated and non-regulated activities;
o Management agencies, along with an identification of
agencies necessary to carry out the plan, and
provisions for adequate authority to assure
intergovernmental cooperation;
o
Implementation measures, also identifying any economic,
social, or environmental impact;
o
Dredge and fill program - for control of dredge and
fill material;
o Basin plans - description of any relationship of the
WQM plan to any other water quality basin plans
developed under Section 209 of the Act; and
o Ground water - identification and development of a
program for ground-water protection.
Congress requires at least every two years a report on the
quality of all waters of the United States; an estimate of the
extent to which the CWA control programs have improved water
quality; an estimate of the environmental, economic, and social
costs and benefits needed to achieve the objectives of the CWA;
and a description of the nature and extent of ground-water
pollution. States may also include a description of their
individual ground-water pollution, and recommendations for
improving ground-water quality. This 305 (b) report may also
serve the purposes of the annual water quality report required
under Section 205 (j) of the Act. In those years in which the
4-9
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WATER PROOR~
Section No.4
Revision No. 0
Date Nov. 1, 1989
40 CFR 136
Test
Procedures
for the
Analysis of
Pollutants
305 (b) report is not required, the state may satisfy the 205
(j) report requirement by certifying that the 305 (b) report is
still current, or by supplying updates of sections of the 305
report as appropriate. In addition to these reports, the
states report annually on work programs under Sections 106 and
205 (j) of the Act, and any revisions to the state's water
quality standards. The work programs under Section 106/205
should include water quality monitoring and QA elements.
At the center of all water surveillance and protection programs
is 40 CFR Part 136, which lists those parameters and pollutants
of concern in water quality for which measurement methods have
been approved by EPA. The parameter, units of measurements,
and method description are listed along with a citation for the
source of the approved method(s). Test procedures and sample-
handling techniques are approved by reference for the
following:
o Biologicals (bacteria)
o Inorganics (and acidity,
o Non-pesticide Organics
o Pesticides
o Radiologicals
o Sample containers
o Sample preservation
o Sample holding times
alkalinity, etc.)
Approved methods, as cited in 40 CFR Part 136, have been
developed and standardized by EPA, the American Public Health
Association, the American Society for Testing and Materials
(ASTM), the U.S. Geological Survey (USGS), and several private
organizations. The methods vary widely with respect to the
level of QC incorporated in each method or procedure. In
addition to the methods approved by reference, 40 CFR Part 136
contains the following detailed write-up of methods and
procedures:
o
Methods for Organic Chemical Analysis of Municipal and
Industrial Waste Water - 17 methods;
o
Definition and Procedures for the Determination of the
Method Detection Limit (MDL); and
o
Inductively Coupled Plasma - Atomic Emission
Spectrometric Method for Trace Analysis of Water and
Waste Water.
Only the methods approved by reference, or presented in
writing, can be used for compliance monitoring. Applications
for use of an alternate test procedure may be submitted to the
appropriate EPA Regional Administrator for approval.
4-10
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
Quality
Control
40 CFR 402-699
Effluent
Guidelines
and
Standards
40 CFR 402
Implementing
Effluent
Limitations
40 CFR 403
Pretreatment
Regulations
The written methods in 40 CFR Part 136 incorporate a minimum
level of QC to document the precision and bias of any results
for the analysis of organics. For example, each written method
stipulates that "each laboratory that uses this method is
required to operate a formal quality control program. The
minimum requirement of this program consists of an initial
demonstration of laboratory capability, and an ongoing analysis
of spiked samples to evaluate and document data quality. The
laboratory must maintain records to document the quality of the
data that is generated." There are no specific QA guidelines
or procedures in Part 136, but an important part of "good" QA
is knowing what level of QC is needed to produce data of the
desired quality.
It should be apparent by this point that the NPDES is the
central focus of activities directed toward implementing the
CWA. However, the NPDES-implementing regulations rely on the.
development of effluent limitation guidelines and standards for
all major sources of discharges of pollutants. These guide-
lines and standards are based on many engineering, scientific,
and environmental studies covering a broad spectrum of modern
industrial, municipal, and private discharges of pollutants,
along with a current assessment of pollution control
technologies. Regulations promulgated at Parts 402 through 699
establish effluent limitation guidelines for existing sources,
standards of performance for new sources, and pretreatment
standards for new and existing sources pursuant to the Act.
All point sources of discharges of pollution must comply with
these effluent limitations guidelines and address them, as
appropriate, in NPDES permits issued by the states or by EPA.
Part 402 sets forth the legal authorities for implementing
effluent limitations, and stipulates that test procedures
prescribed at Part 136 "shall apply to effluent guidelines and
standards of performance, and pretreatment standards as set
forth in Parts 402 through 699." The major QA concerns were
contained in the regulations previously covered. However, 40
CFR Part 403, "General Pretreatment Regulations for New and
Existing Sources," covers some sampling methods and data
reporting requirements of QA interest (this should be covered
in the WQM plans, but it appears to warrant some additional
emphasis here).
Part 403 "establishes responsibilities of Federal, state, and
local government, industry, and the public to implement the
National Pretreatment Standards to control pollutants which
pass through, or interfere with, treatment processes in
Publicly Owned Treatment Works (POTW's) or which contaminate
sewage sludge." The regulation applies to:
o
Discharges of pollutants from non-domestic sources
covered by pretreatment standards;
4-11
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
Reports
and
Records
o
POTW's which receive waste waters from sources subject
to National Pretreatment Standards;
o States which have, or are applying for, an NPDES
program; and
o
Any new source of pollutant discharge subject to
National Pretreatment Standards.
The pretreatment regulation places certain compliance
requirements on both industrial users (IU's) and POTW's.
comply with these regulations, POTW's must:
To
o Certify the amount of flow through their systems;
o
Inventory lU's of the POTW, including the volume and
the characteristics of the pollutants from them;
o Sample and analyze effluents from the lU's; and
o
Analyze self-monitoring reports developed by the lU's.
These requirements may become part of the NPDES permits issued
by EPA or the states for POTW's and lU's.
Both POTW's and lU's are expected to observe some reporting
and record-keeping requirements as part of the pretreatment
program:
o
lU's report standard flow measures and measures of
pollutants, including type, daily maximum, and average
concentrations;
o
lU's must file a compliance report with the state or
EPA, and report semi-annually on the nature and
concentration for each pollutant discharge covered by
the pretreatment standard;
o
lU's must retain records from all monitoring activities
for three years, including sampling, analyses, and
results; and
o
POTW's have the same reporting and record-keeping
requirements as the lU's, along with compliance reports
to EPA.
Although all testing is done in accordance with test procedures
in 40 CFR Part 136, Part 403 describes sample collection
procedures for a composite method of sampling and a grab
method. Also, there is a list of industrial dischargers of
4-12
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1,1989
Safe Drinking
Water Act
40 CFR 141
National
Primary
Drinking
Water
Reg~lations
Monitoring
and
Analytical
Requirements
pollution that are subject to the National Categorical
Pretreatment Standards.
The Safe Drinking Water Act (SDWA) seeks to protect the health
of those who rely on public systems for their potable water and
to protect ground-water resources from contamination, including
contamination from underground injection of fluids.
Pursuant to Section 1412 of the Public Health Services Act, as
amended by the SDWA, 40 CFR Part 141 - "National Primary
Drinking Water Regulations" establishes a national program
for the protection of public drinking water that includes:
o
Maximum contaminant levels (MCL's) for pollutants;
o
Monitoring and analytical requirements;
o
Reporting, public notification, and record keeping;
o
Special regulations including monitoring for organic
chemicals, sodium, cor~osivity, and lead;
Maximum contaminant levels,
of substances and chemicals
based on the risk to public
for the f6llowing:
or primary standards, are amounts
allowable in public drinking water
health. Part 141 establishes MCL's
o Inorganic chemicals;
o Organic chemicals and pesticides;
o Turbidity;
o Microbiological contaminants;
o Radium-226, -228, and gross alpha radioactivity; and
o Beta particles and photon radioactivity from man-made
radionuclides.
Of major interest to QA are the monitoring and analytical
requirements promulgated at 40 CFR Part 141 to assure
compliance with the MCL's. Regulated monitoring and
analytical techniques include the following:
o
Microbiological contaminants - measurement methods are
by reference to EPA and Standard Methods, 14th Edition;
sampling site, number, and frequency of samples are by
population size served by the water system.
o
Turbidity - measurement methods and a calibration
procedure are by reference; sampling site (at entry to
water distribution system), number, and frequency, and
repeat sampling if analytical results exceed the MCL.
4-13
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
o
Inorganic contaminants - measurements are by reference
to EPA, Standard Methods, 14th Edition; Book of ASTM
Standards, Part 31 Water; USGS, Techniques of Water
Resources Investigation; sampling frequency, and repeat
sampling if MCL's are exceeded, and special sampling
and repeat sampling for fluorides.
Reports
and
Records
o
Organic contaminants - measurements are by reference
(same as for inorganic contaminants); sampling sites,
sampling frequency, and repeat sampling if MCL's are
exceeded.
o
Trihalomethanes (THM's) - measurement methods Lnclude
actual writeups, with QC, for the analysis of THM's by
a purge and trap method and a liquid/liquid extraction
method; sampling sites, sampling. frequency, and repeat
sampling if MCL's are exceeded given by population
served by the water system.
o
Alternate analytical techniques - measurement methods
alternative to the ones cited above may be used with
the written permission of the state and concurred on by
the Administrator of EPA, or his designee. The use of
an alternative test procedure does not change other
sampling and analysis requirements.
o
Approved laboratories - for purposes of determining
compliance with MCL's, "samples may be considered only
from laboratories if they have been approved by the
state, except that measuremerits for turbidity, free
residual chlorine, and pH, may be performed by any
person acceptable to the state."
Suppliers of drinking water to the public, subject to the
requirements of 40 CFR Part 141, must generate and report the
following:
o
Analyses performed by approved laboratories for all
MCL's;
o
Monthly reports to the enforcing Agency of all sampling
and analytical results;
o
Reports within 48 hours of any failure to comply with
the primary drinking water regulations;
4-14
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
State
Primacy
o Notification of the public when MCL's are exceeded or
when failure to monitor water quality occurs;
o
Retention of records for 5 to 10 years showing dates,
methods/results, performing laboratory, and actions
taken for all sampling and analysis of water quality;
and
o
Reports on a frequent basis showing results of any
special monitoring required for lead, sodium, and
corrosivity.
States may assume primacy for the safe drinking water program
for any period of which the Administrator of EPA determines
that the state has developed a program sufficient to implement
the SDWA, provided that such programs include the following:
o Water quality regulations no less stringent than those
at 40 CFR Part 141;
o
Inventories of all public drinking water systems;
o Sanitary surveys of drinking water systems;
o
A laboratory certification process, including QA, for
all laboratories analyzing safe drinking water samples,
except that a state analyzes all its own water samples
and is certified by EPA;
o
Assurance of the availability of laboratory facilities
certified by the EPA Administrator capable of
performing analyses of all MCL's in the states' water
quality regulations;
o
Inspection programs other than sanitary surveys;
o Mandatory record keeping and reporting for suppliers;
o Mandatory notification requirements for all violations
of public drinking water regulations;
o Maintenance of records of inventories of all public
drinking water systems for 40 years; and
o
An annual report to EPA, including information on any
violations of drinking water regulations and any
variances or exemptions granted by the state.
4-15
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
40 CFR 143
National
Secondary
Drinking
Water
Regulations
Monitoring
and Test
Procedures
40 CFR 144-
147
Underground
Injection
Control
Monitoring
and Data
Reports
Pursuant to Section 1412 of the SDWA, as amended, 40 CFR Part
143 - "National Secondary Drinking Water Regulations" controls
contaminants in drinking water that primarily affect the
aesthetic qualities of water related to public acceptance of
drinking water, and have economic implications. The regula-
tions are not Federally enforceable, but are intended to
provide guidelines to the states.
Part 143 sets reasonable water quality goals for various
contaminants that tend to influence public acceptance of
drinking water, and the general perception as to the quality of
the water system. Secondary MCL's are recommended for the
following:
o Chloride
o Color
o Copper
o Corrosivity
o Fluor ide
o Foaming agents
o Iron
o Manganese
o Odor
o pH
o Sulfate
o Total dissolved
o Zinc
solids (TSD)
The monitoring for these contaminants or parameters should be
at about the same frequency and conditions as for the inorganic
contaminants in the National Primary Drinking Water
Regulations. Measurement methods are by reference to EPA and
Standard Methods, 14th edition. Some of the methods have QC
incorporated, particularly the EPA methods.
Ground water is a major source of drinking water for a large
percentage of the nation. Therefore, the Act gives special
attention to the control of underground injection of
pollutants, and the protection of sole source aquifers.
Regulations place underground injection wells into five
different categories or "classes" according to the nature of
the substances being disposed of, and the threat imposed on
ground-water quality. The operation of these wells can be
either by general rule or by individual permit. EPA, or the
state with an approved ground-water protection plan, will be
the enforcing authority to ensure compliance with the
regulations.
For those wells operating under a general rule, the
owner/operator is required to submit to EPA, or the primacy
state, an inventory of injection wells and, for some classes,
the rate of injection. EPA or the state may also request
4-16
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
Permits
Surveillance
and
Inspection
permittees for reports on ground-water monitoring and analyses
of fluids injected into the wells. To illustrate those
requirements of interest to QA, for all Class I wells the
owner/operator is required to:
o
Install and maintain ground-water monitoring wells;
o Monitor continuously injection pressure, flow rates,
volume, and other operating characteristics;
o
Analyze injected fluids; and
o
Report quarterly/monthly data on injection pressures,
flow rates, volumes of injected fluids, results of
ground-water monitoring, and data from any tests of the
wells ordered by EPA or the state.
When the owner/operator of other classes of wells is required
by EPA or the state to install ground-water monitoring wells,
the reports of all monitoring efforts are summarized annually
in a report to the appropriate enforcing agency.
When well operation is authorized by permit, the owner/operator
must submit an application with information that the permitting
authority can determine if, and under what conditions, a permit
can be issued. When issuing the permit, EPA or the state may
require monitoring that will produce data representative of the
activity being monitored and assure maximum protection of
ground water. The permittee may be required to report these
data on a standard form given at 40 CFR Part 146. The
permittee reports any changes in the facility when they occur,
and will report any event that might endanger ground water to
the enforcing authority within 24 hours.
States may assume primacy for
program in any period of time
operational program that at a
elements:
the underground injection control
in which they develop an
minimum contains the following
o
Record-keeping and reporting requirements for
permittees;
o
Evaluation of permittees' reports and notices;
o
Surveillance and inspection programs, including
comprehensive surveys, inspections to verify the
accuracy of the monitoring by the permittee, and a
compliance tracking system.
Although there is a potential for an expanding data base on the
quality and protection of ground water, there are no specific
QA requirements although there are some elements of QA in some
of the inspection procedures.
4-17
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1,1989
Marine
Protection,
Research, and
Sanctuaries
Act
40 CFR 227
Ocean-
Dumping
Permit
Evaluation
40 CFR 228
Managing
Disposal
Sites
The Marine Protection, Research, and Sanctuaries Act (MPRSA)
was enacted by Congress to protect the open seas and U.S.
territorial waters from dumping and disposal of man-made waste
and other materials that might adversely affect marine water
quality, or degrade and endanger the marine environment and
coastal waters and estuaries. Subchapter H, of 40 CFR Parts
220 through 228, establishes authorities, procedures, and
criteria for ocean-dumping permits issued by EPA pursuant to
Section 102/103 of the Act.
The MPRSA, and regulations under Subchapter H, prohibit any
person or transport, while registered in the United States,
from transporting any material for purposes of dumping into the
ocean, or any transport of material from outside the United
States for purposes of dumping into U.S. territorial waters, or
within a zone contiguous to those waters. The implementing
regulations describe policies, authority, administration, and
fees for permit applications, and also define permit
limitations and the responsibilities of the permittee. The
regulations containing information of greatest interest to QA
are in Parts 227 and 228, which prescribe criteria for
evaluating permit applications, and for the management of
disposal sites, respectively.
Criteria set forth in 40 CFR Part 227 for the evaluation of
permit applications include:
o
Environmental impact - i.e., prohibited materials,
limits for specific wastes, limits on quantities and
disposal rates, hazards to ocean use, etc.;
o Need for ocean dumping, and alternatives;
o
Impact on aesthetic values, including other uses; and
o
Interim permits, including requirements for
environmental assessments.
The knowledge of permit requirements, and the contents of
permits, will benefit the QA manager later in evaluating
permits and reviewing associated environmental data operations.
Criteria and procedures for the management of disposal sites
for ocean dumping are prescribed at 40 CFR Part 228. The areas
covered include the following:
o Management responsibilities;
o Designation of sites, and types
o Site selection;
o Disposal site use;
o Limitations on times and rates
o Disposal site monitoring;
of permits needed;
of disposal;
4-18
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
Monitoring
and Survey
Requirements
o
o
o
o
Evaluation of disposal impact;
Modification of disposal site use;
Delegation of management authority; and
Guidelines for baseline or trend assessment.
Of particular interest to QA are the promulgated requirements
for disposal site monitoring, and for baseline and trend
assessment. Monitoring programs, if deemed necessary by the
Administrator, include baseline and trend monitoring, special
studies, and the analysis and interpretation of data from
remote or automatic sampling and/or sensing devices. When
sites are being used on a continuing basis, the monitoring
programs must include trend assessment surveys and special
studies conducted by the permittee.
The baseline or trend assessment is to determine the physical,
chemical, geological, and biological condition or structure of
a proposed disposal site. Each survey is to be planned as part
of a continual monitoring program through which changes on a
disposal site can be documented. The data collection is to be
planned so that data are representative of the site, and
obtained by techniques that are reproducible in precision and
accuracy. A plan of study must be developed and approved by
EPA that will provide a record of sampling, analysis, and
reduction.
The guidelines for baseline surveys or trend assessments
include the following:
o
Water quality sampling - sample design, sampling site
locations, frequency and number of samples;
o
Measurements - all sites must include the standard
water quality indicators, i.e., temperature, dissolved
oxygen, salinity, suspended solids, turbidity, total
organic carbon, pH, inorganic nutrients, and chloro-
phyll (at one station near the center, samples of the
water column shall be taken for the analysis of
mercury, cadmium, copper, uranium, zinc, lead, arsenic,
selenium, vanadium, beryllium, pesticides, petroleum
hydrocarbons, and persistent organohalogens; and
samples must be preserved by, or under the direct
supervision of, EPA laboratories in accordance with an
approved plan of study);
o
Measurements of the benthic region - bottom sampling,
bathymetric surveys, and nature of the bottom;
o
Other measurements - hydrodynamic features, current
measurements, water mass movement, and state-of-the-sea
observations;
4-19
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WATER PROGRAMS
Section No.4
Revision No. 0
Date Nov. 1, 1989
o
Surface phenomenon - visible observations;
o
Survey procedures - state-of-the-art and approved by
EPA; and
o
QA - EPA may require analysis of performance samples
and participation in surveys by EPA personnel.
The ocean-dumping regulations contain specific QA and QC
procedures, including detailed study plans that are called for
in the general guidance.
4-20
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Section No. -2-
Revision No. 0
Date Nov. 1, 1989
PESTICIDE PROGRAMS
Summary
Chemicals that may pose a threat to human health or the
environment are the major focus of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Toxic
Substances Control Act (TSCA). The common goal of these two
Acts is to control pollution and damage before occurrence by
requiring manufacturers and handlers of chemicals to test for
potential dangers and take protective measures as necessary.
The Federal Insecticide, Fungicide, and Rodenticide Act
establishes a product registration, labeling, and review
process for all pesticides produced and distributed for use in
the United States. Title 40 of the Code of Federal
Regulations, Part 158, establishes pesticide registration and
data submission requirements for applicants. Also specified
are requirements regarding EPA approval or denial of
experimental pesticide use permits.
Part 160 establishes Good Laboratory Practice Standards, which
include a mandatory QA unit that must be independent of the
parties conducting the registration studies. The purpose of
the QA unit is to ensure that EPA or the states are basing
registration decisions on sufficient data that have been
collected using acceptable scientific methods and
procedures. Responsibilities of the QA unit include
monitoring each study, maintaining study records and
protocols, and conducting periodic audits.
Part 162 regulates state registration of pesticides to meet
special needs and also contains guidelines for registering
pesticides.
This chapter takes a closer look at the FIFRA and requirements
for QA pesticide programs; the next chapter covers the TSCA.
5-1
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Section No. -2-
Revision No. 0
Date Nov. 1, 1989
Title 40, Code of Federal Regulations
HIGHLIGHTS OF CURRENT REGULATIONS
Pesticide Programs:
Federal Insecticide, Fungicide, and Rodenticide Act
Part 152 - Pesticide Registration and Classification Procedures
o
o
Application Procedures
Data Reviews
Part 153 - Registration Policies and Interpretations
o Toxicological Studies
o Epidemiological Studies
o Efficacy Studies
o Studies of Dietary and Environmental Residues
Part 155 - Registration Standards
o
Agency Review of Data
Part 156 - Labeling Requirements for Pesticides and Devices
o Market Surveys
Part 158 - Data Requirements for Registration
o
o
o
o
o
o
o
o
Product Composition
Production Materials
Formulation Process
Impurities
Analysis
Certified Limits
Enforcement Analytical Method
Physical/Chemical Characteristics
Part 160 - Good Laboratory Practice Standards
o General - inspection of testing facility
o Organization/Personnel - QA unit
o Facilities
o Testing Facilities Operation
o Test and Control Substances
o Protocols for the Conduct of a Study
o Records and Reports
Part 162 - State Registration of Pesticide Products
o Guidelines for Registering Pesticides; Procedures
5-2
-------
Section No. -2-
Revision No. 0
Date Nov. 1, 1989
PESTICIDE PROGRAMS
Statutes
That
Regulate
Chemicals
Federal
Insecticide,
Fungicide,
~d
Rodenticide
Act
40 CFR 152-
151
Pesticide
Registra-
tion
Regulating chemicals that may pose a threat to human health or
the environment is the major focus of two Congressional Acts:
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and the Toxic Substances Control Act (TSCA). Both Acts have a
common goal of controlling pollution and adverse effects from
the production, distribution, and use of hazardous or toxic
substances which are suspected, known, or demonstrated to
cause injury to public health or damage to the environment.
While these Acts have the same or similar goals, they each
have different implementing provisions and QA-related
information and data collection requirements. This chapter
reviews the FIFRA; the TSCA is discussed in the next.
Chemical substances manufactured and marketed for use as insect-
icides, fungicides, or rodenticides are classified as pesticides.
The FIFRA mandates the prevention of pollution and the
protection of public health and the environment by establishing
a product registration, labeling, and review process for all
pesticides produced and distributed for use in the United
States. Pursuant to the Act, EPA developed and promulgated
regulations under Title 40 of the Code of Federal Regulations
for the prevention and control of pollution resulting from the
production, distribution, and use of all chemicals and
substances categorized as pesticides under the Act.
The pesticide registration process, as mandated by the FIFRA,
is implemented in 40 CFR Parts 152-157. The regulations set
forth policies, procedures for the registration of pesticides/
products, and data collection and reporting requirements.
Major requirements for the registration of pesticides as
appear in Parts 152-157 include the following:
o
Protection of the data submitter's rights, as
well as the protection of data submitted;
o
Reporting requirement for risk/benefit in-
formation including how and what information
is submitted, the handling of data from
scientific studies, and the reporting of
incidents; and
o Special review process to cancel, deny use,
or reclassify pesticide products.
The information in this chapter is provided to facilitate a
broader understanding of pesticide programs and their
associated regulations. The regulations pursuant to the Act
that have the greatest interest for QA are 40 CFR Parts 158
and 160.
5-3
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Section No. l
Revision No. 0
Date Nov. 1, 1989
PESTICIDE PROGRAMS
40 CFR 158
Data
Require-
ments
Waiver
of
Require-
ments
40 CFR 160
Good
Laboratory
Practice
Standards
The data requirements for the registration of pesticides are
at 40 CFR Part 158, including data acceptability and the
availability of standardized technical guidelines to assist
applicants. The primary purpose of Part 158 is to prescribe
the minimum data and information required by the Agency to
make regulatory judgments concerning the risks and benefits of
chemicals and substances intended for use as pesticides. The
data prescribed in this Part are required with applications
for product registration, amended registration, or reregistra-
tion. Also, this Part specifies data submission requirements
to approve or deny experimental pesticide use permits under
the FIFRA.
The data for pesticide registration prescribed in Part 158 may
be required in any or all of the following areas:
o Product chemistry
o Residue chemistry
o Environmental fate
o Toxicology
o Reentry protection
o Aerial drift evaluation
o Wildlife and aquatic organisms
o Plant protection
o Non-target insects
o Product performance
o Biochemical/microbiological pesticides
There is some flexibility in the types of data required, depend-
ing on the proposed use of the pesticide/product. Applicants
seeking a waiver of data requirements for any reason must
contact the appropriate product manager at EPA.
Another important requirement of 40 CFR Part 158 is the
certification of limits for ingredients in pesticide
formulations. Certifiable upper and lower limits are given
for active/inactive ratios, as well as a reference method to
be used for enforcement.
To assure the quality and integrity of data generated and sub-
mitted pursuant to the FIFRA, 40 CFR Part 160 establishes Good
Laboratory Practice Standards (GLPS) that must be followed in
meeting the data requirements that were prescribed in Part
158. A key element of the GLPS is the establishment of an
independent QA unit with the following authorities and
responsibilities:
o Maintain copies of a master schedule of all studies
including descriptions and current status;
o Maintain copies of all protocols for studies for which
the unit is responsible;
5-4
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PESTICIDE PROGRAMS
Section No. -2-
Revision No. 0
Date Nov. 1, 1989
40 CFR 162-
180
Other
Requirements
o
Conduct inspections of each phase of each study on a
prescribed schedule;
o
Submit reports to management including status,
problems, and corrective actions;
o
Document any deviation from approved protocols or
standard operating procedures;
o
Review final study reports for accuracy and integrity;
and
o
Prepare a signed statement of verification to
accompany the final study report.
The QA unit will maintain all records at one location in the
testing facility, and make such data available to any
authorized representative of EPA on request~
Other Parts of Subchapter R cover:
o
Enforcement of the pesticide regulations;
o
State pesticide registration authority for
limited use permits;
o
Recommended procedures for the storage and
disposal of pesticides;
o
Exemptions of pesticides for use during
emergency conditions;
o
Worker protection standards for agricultural
pesticides;
o
Certification of pesticide applicators;
o
Experimental use permits; and
o Tolerances and exemptions from tolerances for
pesticide chemicals in or on raw agricultural
commodities (this includes an extensive
listing of chemicals that reflects the
enormity of the pesticide-control problem).
5-5
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Section No. -2-
Revision No. 0
Date Nov. 1, 1989
PESTICIDE PROGRAMS
40 CFR 162
State
Registra-
tion
Registra-
tion
Guidelines
Parts 162-180 primarily regulate the administration and
enforcement of the registration and use of pesticides.
However, Part 162 - "Regulation for the Enforcement of the
Federal Insecticide, Fungicide, and Rodenticide Act" contains
information and guidelines of interest and benefit to QA
managers. Part 162 regulates the enforcement of the Act in
several program areas:
o
Registration, reregistration, and classifica-
tion procedures (includes general description
of data to be furnished by the applicant);
o
State registration of pesticides to meet
special needs (includes procedures for grant-
ing/suspending state authority); and
o
Conditional registration procedures (also,
data required for Agency review of applica-
tions).
Part 162 also contains "Guidelines for Registering Pesticides"
as required of the EPA Administrator by the Act. These guide-
lines include the following:
o
Registration forms;
o
Preparation of application packages;
o
Labeling of pesticide products;
o
Supporting data required;
o
Review and disposition of registration
applications; and
o
Designation of certain ingredients of
antimicrobial products as active or inert.
Those persons desiring more detail should consult the most
current regulation as it appears in the Code of Federal
Regulations, or the specific Sections of the Act which the
regulation implements.
5-6
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Section No.6
Revision No. 0
Date Nov. 1,1989
TOXIC SUBSTANCE PROGRAMS
Summary
The Toxic Substances Control Act (TSCA) authorizes EPA to take
action when chemicals pose an "unreasonable risk" to public
health. The Act contains a number of related requirements,
from an inventory of chemicals for commercial use to
premanufacture notification specifics. The levels of QA/QC
for applicable areas vary from section to section.
The TSCA regulations have extensive data collection and
reporting re~quirements. Ti tIe 40 of the Code of Federal
Regulations, Part 710, contains general reporting requirements
for all chemical substances that are manufactured, imported,
or processed: for commercial purposes.
Part 717 requires the manufacturer or processor to collect and
maintain spe!cific records on any alleged or determined adverse
health or environmental effect. These records are used by EPA
to determine~ if suggested restrictions or protective actions
are plausible.
Part 720 requires premanufacture/import notice for all new
chemicals intended for use in commerce. Test and other data
that document the health and environmental effects of a
proposed ChE!mical substance or mixture must be submitted to
EPA.
The TSCA regulations also contain requirements to control and
restrict specific chemicals (such as asbestos) that have known
adverse effects on human health and the environment.
Laboratories conducting tests under the TSCA must follow the
Good Laboratory Practice Standards (GLPS) contained in Part
792. The GLPS include the establishment of a QA unit that
oversees and evaluates each study to ensure the quality and
integrity of data generated.
Uniform guidelines for testing requirements are contained in
the regulations that cover chemical fate testing, health
effects testing, environmental effects testing, and the
identification of testing requirements for specific chemical
substances and mixtures.
This chapter discusses the TSCA regulations and QA
requirements for toxic substance programs in greater detail.
6-1
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Title LW, Code of Federal Regulations
Section No.6
Revision No. 0
Date Nov. 1, 1989
HIGIn.IGHTS OF CURRENT REGULATIONS
Toxic Substance Programs:
Toxic Substances Control Act
Part 710 - Inventory Reporting Regulations
o
All Chemicals Manufactured, Processed, or Imported for
Commercial Purposes Including Natural Occurring Substances
Chemical Identity and CAS Number
Elemental Analysis May Be Required
o
o
Part 711 - Health and Safety Data Reporting
o
o
o
Reports of Health and Safety Studies
Reports of Physical and Chemical Properties
Lists of Applicable Substances/Mixtures
Part 720 - Premanufacture Notification
o
o
Health and Environmental Effects Data
Data from Health and Safety Studies
Part 761 - Polychlorinated Biphenyls (PCB's) Manufacturing, Processing, and
Distribution in Commerce Prohibitions
o Sampling
o Test Procedures by Reference
o Record Keeping and Reports
Part 762 - Fully Halogenated Chlorofluoroalkanes
Part 763 - Abestos
o
o
Prohibitions
Records and Reports
o
o
o
o
Sampling in Schools
Sampling Friable Material
Interim Transmission Electron Microscope Analytical
Interim Method for the Determination of Asbestos in
Insulation Samples
Record Keeping
Reporting
Methods
Bulk
o
o
6-2
-------
Part 766 - Dibenzo-Para-Diodns/Dibenzofurans
Section No.6
Revision No. 0
Date Nov. 1, 1989
o Test Standards
o Testing Guidelines
o Developing the Analytical Test Method - sample selection,
sample extraction and clean-up, and sample analysis
o Specific Chemical Testing and Reporting
o Specific Reporting Requirements
Part 792 - Good Laboratory Practices
o Organization and Personnel - QA unit
o Facilities - sample/data storage
o Equipment.. maintenance and calibration
o Testing Facilities - standard operating
solutions, and animal care
Protocols - QA/QC elements
Records and Reports
Environmental Testing Provisions
procedures, reagents,
o
o
o
Part 795 - Provisional Test Guidelines
o
o
o
Chemical Fate Guidelines
Health EffE~cts Guidelines
Environmental Effects Guidelines
Part 796 - Chemical Fate Testing Guidelines
o Physical and Chemical Properties
o Transport Processes
o Transformation Processes
Part 797 - Environmental Effects Testing Guidelines
o Aquatic Guidelines - toxicity tests, bioconcentration tests
o Terrestrial Guidelines - toxicity, reproduction, growth
Part 798 - Health Effects Testing Guidelines
o General Toxicity Testing
o Subchronic Exposure
o Chronic Exposure
o Specific Organ/Tissue Toxicity
o Genetic Toxicity
o Neurotoxicity
o Special Studies
6-3
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
Toxic
Substances
Control
Act
40 CFR 702
Civil Suits
40 CFR 704
Reporting
Require-
ments
40 CFR 710
Chemicals
Inventory
The Toxic Substances Control Act (TSCA) was passed by Congress
in 1976 to protect public health and the environment from
risks posed by the manufacture, processing, distribution in
commerce, and use of chemical substances. The Administrator
of EPA was given authority under the TSCA, and was assigned
the respons:lbility for developing and maintaining an inventory
of all chem:lcals manufactured or processed for commercial pur-
poses. In addition, the Administrator is required to enforce
the reporting of new/existing chemicals, and may require the
collection and submission of data sufficient to characterize
the chemical and to assess its health and environmental
effects. The Administrator is directed to develop regulations
necessary to establish a chemical substances inventory with
data bases that can support the promulgation of regulations
which ban, limit, or control the manufacture/import,
distribution, or use of chemical substances posing a serious
threat to public health or the environment.
The TSCA also authorizes any person to initiate a civil suit
to compel the Administrator of EPA to perform as required by
the Act, provided that notice of intent is filed in advance.
Procedures to be followed by private citizens in taking such
action are prescribed in 40 CFR Part 702.
One feature of all the regulations pursuant to the TSCA is the
extensive collection and reporting of information and data
that are required, and the size and complexity of the data
base that 1.9 the result. Much of the data required will be
for specifi,e chemicals or mixtures of chemicals. For example,
40 CFR Part 704 - "Reporting and Record-Keeping Requirements"
prescribes general and specific reporting requirements for a
limited number of organic chemicals such as chloronated
naphthalenes. Although this regulation has limited interest
to QA for environmental data operations, the information is
useful in monitoring hazardous substances that are the subject
of the Act.
The first priority in carrying out the mandates of the TSCA
was to establish a preliminary file or inventory of existing
chemicals, using nationally/internationally accepted Chemi-
cal Abstract Services (CAS) registry numbers, and then to
follow this action with an updating of the data base. The
implementing regulation for this activity, 40 CFR Part 710 -
"Inventory Reporting Regulations," prescribes general
reporting requirements for all chemical substances that are
manufactured, imported, or processed for commercial purposes,
including all naturally occurring substances unprocessed or
processed only by manual, mechanical, or gravitational
means. Both the initial listing and updating are covered by a
special form provided for the latter activity. The Agency may
require additional data, i.e., elemental analysis, to assure
the efficacy of the listing for new or proposed chemicals.
6-4
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
40 CFR 712
Preliminary
Assessment
40 CFR 716
Health/
Safety
Data
40 CFR 717
Reports of
Adverse
Effects
The chemical substances inventory could provide an additional
benefit for those QA managers who are responsible for
monitoring emergency episodes involving hazardous chemicals
and toxic substances.
The TSCA further requires manufacturers and processors to
report on production, use, and exposure related information
for those chemicals on a list recommended by an Interagency
Testing Committee. A list of chemicals, general reporting
procedures, and instructions and forms for manufacturers'
preliminary assessment reports are contained in 40 CFR Part
712. Other chemicals may be added to this list and require
preliminary assessment prior to manufacture if recommended by
the testing committee.
Health and safety data may be required for chemical substances
selected for priority testing rules under Section 4(a) of the
Act. A list of priority chemical substances and mixtures are
listed in 40 CFR Part 716, along with studies to be conducted.
Various types of studies may be required to assess the health
effects or environmental safety of a substance listed in this
Part. Studies and reports of data may include acute oral,
dermal, and inhalation toxicity studies; primary eye and
dermal irritation studies; physical and chemical studies that
affect environmental fate; and analyzed aggregates of
monitoring data as appropriate and specified.
Section 8(c) of the TSCA requires the manufacturers, processors,
and distributors of chemical substances or mixtures to record
and report any allegations that chemical substances cause
adverse health reactions or damage the environment. Pursuant
to the Act, 40 CFR Part 717 requires the manufacturers, proc-
essors, and distributors of chemical substances and mixtures
to:
o
Keep records of adverse significant health or
environmental reactions, alleged to have been
caused by the substance or mixture as
determined by the Administrator by rule; and
o
Allow inspection, and submit copies of such
records upon the request of any designated
representative of the Administrator.
Part 717 also describes the types of allegations that must be
recorded, and the content and disposition of the report.
6-5
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
40 CFR 720
Premanu-
facture
Notifica-
tion
Procedures
Data
Reports
The previous chapter noted that the TSCA and the FIFRA share
a common goal: preventing pollution and injury before it
occurs rather than after the fact. In an attempt to
achieve this goal, the FIFRA requires the registration of all
substances proposed for use as pesticides, and the TSCA
requires the premanufacture/import notice for all new
chemicals for use in commerce. Part 720 prescribes the
general procedures to be followed, and the information and
data to be submitted. The notification process consists of:
o
Determining if the substance or mixture is on
inventory and subject to notification, or if
exemptions apply;
o
Preparing the notice form, and collecting the
information and data required, particularly
health and environmental effects data;
o
Disposition of notices which include
acknowledgment of receipt, correction of
errors, acceptance or rejection, publication
in the Federal Register, and the public
review period;
o
Protecting proprietary information, while
creating a public information file including
chemical identity, categories or proposed
categories of use, and data from health and
safety studies;
o
Commencing manufacture/import; and
o
Conducting inspections as needed to assure
that no manufacture/import occurs prior to
the conclusion of the notice review period.
Of important concern to the QA manager is the submission of
test and ot.her data that document the health and environmental
effects of a proposed substance or mixture. Notices must
contain all data in the possession or control of the submitter
concerning the new chemical substance in a pure, technical
grade, or formulated form. A full report or a standard
literature citation must be submitted for the following types
of data:
o Health effects data;
o Ecological data;
o Physical and chemical properties data;
o Environmental fate characteristics;
o Monitoring data; and
o Other test data related to human exposure to, or
environmental release of, the substance or mixture.
6-6
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
40 CFR 750
Rule
Making
40 CFR 761-
763 and 766
Restriction.
of Chemicals
40 CFR 792
Good
Laboratory
Practice
Standards
A full study report is required to support any data that do
not appear in the open literature. Other data concerning the
health and environmental effects of the new substance that are
known to, or reasonably ascertainable by, the submitter may
also be required with the notice. Appendix A to 40 CFR Part
720 contains standard forms and instructions for notices of
manufacture or import of new chemical substances and mixtures.
Under authority of the TSCA, the Administrator may make a rule
to govern the producing, processing, and distributing in com-
merce of any chemical substance or mixture that poses a
serious threat to human health or the environment. Procedures
for rule ma.king under Section(6) of the Act are contained in
40 CFR Part 750. All procedures from the notice of proposed
rule making to the final rule are prescribed, along with two
subparts covering manufacturing and distributing in commerce
exemptions.
One group of regulations places restriction and testing
requirements on a group of chemicals that have known adverse
effects on human health and the environment. Parts 761, 762,
763, and 766 regulate polychlorinated biphenyls, fully
halogenated chlorofloroalkanes, asbestos, and dibenzofurans,
respectively. All of these regulations carry specific control
requirements and test procedures for enforcement. For
example, 40 CFR Part 763, which restricts the use of asbestos,
mandates the sampling, calibrations, analysis by electron
microscopy, QC/QA, and data quality indicators that must be
used to demonstrate compliance with this Part.
The major CIA requirements in the TSCA implementing regulations
appear at Part 792 - "Good Laboratory Practice Standards (GLPS)."
These standards are similar to the GLPS for pesticide registra-
tion. The GLPS for toxic substances cover the following:
o Organization and personnel;
o Facilities and equipment;
o Testing facilities operation;
o Test and control substances;
o Protocol for the conduct of a study;
o Records and reports; and
o Environmental testing provisions.
The most important element of the GLPS is the requirement that
each "testing facility shall have a quality assurance unit
composed of one or more individuals who shall have the
responsibility for monitoring each study to assure management
that the facilities, equipment, personnel, methods, practices,
records, and controls are in conformance with this Part. For
any given study, the quality assurance unit shall be entirely
separate from and independent of the personnel engaged in the
direction and conduct of the study."
6-7
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
QA
Requirements
40 CFR 796
Chemical
Fate
Testing
The QA unit is required to:
o Maintain a copy of a master schedule of all
stu,:Hes, including an index of all pertinent
inf<:>rmation and dates;
o Maintain copies of all study protocols for
which the unit is responsible;
o Con:1uct inspections of a study and maintain
written records of results;
o
Prepare written reports on the status of each
study, noting any problems found and
corrective actions taken;
o
Determine that no deviations from approved
protocols or standard methods were made
without proper authorization; and
o
Prepare and si~n a statement to be included
with the final report.
Each testing facility must document the responsibilities,
procedures, and activities applicable to the QA unit along
with the method of indexing these records and information.
All records maintained by the QA unit must be kept in one
location at the testing facility, and these records, along
with othe~ required data and information, must be made
available to an authorized representative of EPA or the Food
and Drug Administration. Also, management may be required to
certify that inspections are being conducted in accordance
with documented procedures and records.
Another important aspect of the TSCA is the provision of uni-
form guidelines for the testing requirements contained in the
many regulations for registration, notification, and controls.
Guidelines are available that cover chemical fate testing,
health effects testing, environmental effects testing, and
identification of testing requirements for specific chemical
substances and mixtures. Part 796 - "Chemical Fate Testing
Guidelines" covers the following areas:
o
Physical and chemical properties, i.e., vapor
pressure, solubility;
o
Transport processes, i.e., absorption
isotherms; and
o
Transformation processes, i.e., biodegrad-
ability.
6-8
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
40 CFR 797
Environ-
mental
Effects
40 CFR 798
Health
Effects
40 CFR 799
Testing
Require-
ments
The guidelines are quite specific in terms of the procedures
described, including some references to approved methods, and
some quality criteria for the data gathered and reported.
Environmental effects testing guidelines are contained in
40 CFR Part 797. These guidelines cover the following areas:
o
Aquatic tests, I.e., acute/chronic toxicity,
bioconcentration; and
o Terrestrial tests, i.e., reproduction tests,
plant uptake and translocation tests.
The main purpose of these guidelines is to develop data on the
acute toxieity of chemical substances and mixtures regulated
under the TSCA. The guidelines appear specific enough for the
experienced scientist to carry out, given the fact that
references are provided for standard tests, with some examples
of data handling and presentation of results;
Health effE!cts testing guidelines are contained in 40 CFR Part
798. TheSE! guidelines cover the following areas:
o General toxicity testing, i.e., dermal,
oral, and inhalation toxicity;
o
Sut)chronic exposure, i. e., dermal and oral
to>:icity;
o
Specific organ/tissue toxicity, i.e., dermal
sensitization, reproduction, and fertility;
o Genetic toxicity, i.e., gene mutation, growth
inhibition;
o
Neurotoxicity, I.e., motor activity; and
o
Special studies, metabolism, etc.
These guidelines are general but contain references to
standard tests, with some references to research publica-
tions. From these guidelines, the QA manager can better
appreciate the value and benefit of good laboratory practices.
Identification of special chemical substances and mixture-
testing requirements are prescribed in 40 CFR Part 799. This
Part identifies substances, mixtures, and categories for which
data are to be developed; the specific persons required to
perform the test; the test substances to be used in each case;
the test procedures required; and the test standards. The
areas covered include the following:
6-9
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Section No.6
Revision No. 0
Date Nov. 1, 1989
TOXIC SUBSTANCE PROGRAMS
o General requirements - test standards, avail-
ability of test guidelines, test results, and
submission of information and data;
o
Speeific chemicals - test rules for substi-
tutE~d aliphatic and aromatic hydrocarbons;
o MuUichemical tests - hazardous waste consti-
tuents; and
o Testing under consent decree orders.
Test methods and standards given in these guidelines are
primarily by reference to other Parts of Subchapter R, and to
the scientific literature.
The implementing regulations for the toxic substance control
program rel:f heavily on the GLPS regulations to provide all
the QA needl~d to document data quality and data quality
indicators. This approach has merit, but QA can be improved
by preparing separate guidance, or QA guidelines, which cover
all areas of testing and the various types of studies required
under the TSCA.
6-10
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Section No. l
Revision No. °
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
Summary
The ResourcE~ Conservation and Recovery Act (RCRA) of 1976, an
amendment of the Solid Waste Disposal Act, regulates all waste
disposal activities, emphasizing wastes that pose the greatest
threat to hlwan health and the ecosystem.
Guidelines for thermal processing, covered by 40 CFR Part 240,
stress the importance of meeting applicable air and water
quality standards. Thermal processing requires "eKtensive
monitoring" as well as record keeping of all problems
encountered and corrective actions. Land disposal guidelines,
covered by Part 241, also stress the achieving of applicable
air and watE~r quality standards, require sample collection and
monitoring activities, and contain record-keeping
requirements.
The states are expected to play the primary role in
establishing and managing waste control programs under the
RCRA. Feder'al funds are provided to states that develop and
maintain solid waste mana~ement plans. Guidelines contained
in Part 252 state that the plans must address monitoring and
inspection in addition to the analysis of leachate when it is
sufficient to threaten ground water.
The hazardous waste pro~ram consists of regulations for the
identification of hazardous wastes, the issuance of hazardous
waste permits, and the activities of generators, transporters,
and owners/l:>perators of hazardous waste treatment, storage,
and disposal facilities. EPA or authorized state programs may
issue permits that specify the type of monitoring to be
conducted, the interval and frequency of the monitoring, and
standards for the use of monitoring equipment.
EPA has been directed, through amendments to the RCRA, to
develop a r'8gulatory program to deal with potential threats
posed by underground storage tanks. The initial step in
accomplishing this goal was taken through Part 280, which
requires owners to report their tank's location, contents, and
status to EPA.
The Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) - "Superfund," passed by Congress in
1980, addresses the most dangerous hazardous waste sites and
receives funds from a tax on the chemical and petroleum
industries. Both the CERCLA and the Clean Water Act require
the develop:nent of a National Contingency Plan (NCP) to deal
with emergency response to oil spills or other hazardous
substances released into the environment. . Established by 40
CFR Part 300, the NCP provides for EPA coordination with all
other Federal agencies.
7-1
-------
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
Remedial investigations under the Superfund program also
require the development of a QA and sampling plan prior to
any removal action. Another QA-related area covered in Part
300 is the data requirements associated with the use of
dispersants and other chemicals used in clean-up and
containment activities. .
This chapter examines the regulatory requirements for solid
waste and elnergency response programs, with emphasis on QA
concerns.
7-2
-------
Section No. J...
Revision No. 0
Date Nov. 1,1989
Title ~,O, Code of Federal Regulations
HIGHLIGHTS OF CURRENT REGULATIONS
Resource Conservation and
Solid Waste and Emergency R1esponse Programs:
Recovery Act
Part 240 - Guidelines for Thermal Processing of Solid Wastes
o
Water Quality Protection - background data, sampling
stations, and testing program
o
Air Quality Protection - dust control, no open burning, and
decomposition gas control
Part 256 - Guidelines for the Development and Implementation of State Solid
Waste Management Plans
o Permit Program
o Surveillance Programs - sufficient to detect adverse health
and environmental effects and to monitor leachate contam-
ination
o Trained Inspectors
o Enforcement System
o Coordination with Other Environmental Programs
Part 260 - Hazardous Waste Management System
o
o
o
Definitions
Procedures for Approval of Equivalent Test Procedures
Procedures for Approval for Excluding Wastes
Part 261 - Identification and Testing of Hazardous Waste
o
o
o
o
o
o
Criteria for Identifying ,and Listing Hazardous Waste
Characteristics of Hazardous Waste
List of Hazardous Waste
Representative Sampling Methods
Chemical Analysis Treatment Methods
Methods of Analysis for Chlorinated-p-dioxins and
-dibezofurans
Part 264 - Standards for Owners and Operators of Hazardous Waste Treatment,
Storage, and Disposal Facilities
o
Releases from Solid Waste Management Units - ground-water
protection standard, point of compliance, concentration
limits, general/detection/compliance monitoring
Surface Impounds - monitoring and inspection
Waste Piles - monitoring and inspections
o
o
7-3
-------
Section No. -1-
Revision No. 0
Date Nov. 1, 1989
oLand Trea.tment - zone monitoring and record keeping
o Land Fills - monitoring and inspections, surveying, and
record ke:eping
o Incinerat.ors - waste analysis, monitoring, and inspections
o Miscellaneous Units - environmental performance standards,
monitoring, analysis, inspection, reporting, and corrective
action
o Record-Keeping Instructions
o Ground-Water Monitoring List
Part 265 - Interim Status Standards for Owners and Operators of Hazardous
Waste Treatment, Storage, and Disposal Facilities
o [Generally the same as Part 264 except
o Ground-Water Monitoring - sampling and
keeping/reporting
o Primary Drinking Water Standards
o Tests for Significance
as below]
analysis, record
Part 267 - Interim Standards for Owners and Operators of New Hazardous Waste
Land Disposal Facilities
o Environmental Performance Standards
o Monitoring and Inspections.
o Ground-Water Monitoring
Part 268 - Land Disposal Restrictions
o Treatment Standards
o Prohibition Standards
o Toxicity Characteristic Leaching Procedure
o Treatment Standards (as concentrations in the treatment
residual extract)
o List of Regulated Organic Compounds
Part 270 - EPA Administered Permit Programs; the Hazardous Waste Permit
Program
o
Permit Applications - facility identification, other
applicable permits, monitoring systems, sampling and test
procedures, data analysis, record keeping and reporting.
Permit Conditions - recording and reporting of monitoring
results .
Changes to Permits
Special Forms of Permits
o
o
o
7-4
-------
Section No. .l
Revision No. 0
Date Nov. 1, 1989
Solid Waste and Emergency R4:!sponse Programs: Comprehensive Environmental
Response, Compensation, and Liability Act - "Superfund"
Part 300 - National Oil and Hazardous Substances Pollution Contingency Plan
o Remedial Investigations
o Feasibility Studies
o QA Plans
o Sampling Plans
o Physical Testing
o Chemical Testing
o Effectiveness Testing (dispersants/other chemicals)
o Toxicity Testing
o Record Keeping and Reporting
7-5
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Section No. -2-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
The Two
Statutes
Resource
Conservation
and Recovery
Act
40 CFR 240
and 241
Waste
Disposal
Methods
40 CFR 240
Thermal
Processing
The Resourcl~ Conservation and Recovery Act of 1976, which
amended the Solid Waste Disposal Act (SWDA), established a
framework for the regulation of all waste disposal
activities. The Act mandates the environmentally sound
management of the disposal of solid and hazardous waste, as
well as the conservation and maximum use of valuable
resources. The Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 was enacted to deal
with the most dangerous hazardous waste sites. The Act
created a "Superfund," consisting in part of the proceeds from
a tax imposf~d on the chemical and petroleum industries to
clean up tht~ sites posing the most serious threats to human
health or the environment. Parties legally responsible for
the waste aJ~e required to fund clean-up. If the responsible
party cannot be determined, EPA and the U.S. Army Corps of
Engineers implement the remedial action. This chapter covers
the regulatory requirements stemming from these two statutes.
The Resourcl~ Conservation and Recovery Act (RCRA), as amended,
is primarily concerned with protecting human health and the
environment from damage resulting from the disposal of solid
and hazardous wastes. The Act places special emphasis on the
recycling/reuse of valuable resources.
There are four principle ways of disposing of man-made solid
waste: land disposal, thermal processing/incineration, ocean
dumping, and recycling/reuse. The ocean dumping of solid
waste is controlled by the Marine Protection, Research, and
Sanctuaries Act, w~ich was discussed in the chapter on water
programs. The two primary waste disposal methods used in the
United States are land fill and incineration. Title 40 of the
Code of Fed,eral Regulations, Parts 240 and 241, promulgates
guidelines for thermal processing and land disposal of solid
waste, resp1ectively. Both of these regulations have the
following common elements or provisions:
o Site selection criteria;
o Waste acceptance requirements;
o Air and water quality protection; and
o Safety and vector (carriers of disease)
control.
Of primary concern to QA managers are the requirements for
surveillance to assure the protection of air and water quality,
including ground water. For air quality, the emissions must
not exceed existing EPA air quality standards, or the state air
quality standards, if more stringent than EPA. All emissions,
including fugitive dust, must be controlled. Although no
specific air monitoring methodology or QA is cited, the
guidelines do include, by reference, parts of Title 40 that
require specific monitoring methodology, QC and QA.
7-6
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Section No. -L-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
40 CFR 241
Land
Disposal
40 CFR 252
Guidelines
for Waste
Disposal
Management
For water quality protection in the thermal processing of
solid wastes, Part 240 requires that "all water discharged
from the faeility shall be sufficiently treated to meet the
most stringent of water quality standards established in
accordance with, or effective under, the provisions of the
Federal Water Pollution Control Act, as amended.... When
monitoring :instrumentation indicates excessive discharge
contamination, appropriated adjustments should be made to
lower the concentrations to acceptable levels."
In addition to the water quality protection required for ther-
mal processing, Part 241 requires that "land disposal sites
shall be located, designed, constructed, and operated in such
a manner as to provide adequate protection to ground and
surface waters used as drinking water supplies.... Plans
should include background and initial quality of water
resources in the potential zone of influence of the land
disposal site."
The additional air quality protection requirements for
regulated land disposal of solid waste include:
o Prohibition of open burning of municipal waste;
o Dust control to protect health and safety; and
o Conerol of decomposition gases.
As with water quality protection, no specific air monitoring
methodology of QA is cited, but "the land disposal site shall
conform to all applicable air quality standards and source
control regulations established under the authority of the
Clean Air A.ct, as amended, or state or local standards
effective under the Act, if the latter are more stringent."
States with EPA-approved waste management plans may assume
responsibility and authority for implementing the SWDA as
amended by the RCRA. As directed, EPA develops guidelines for
the development of state waste disposal management plans.
These guidelines are promulgated in 40 CFR Part 252 and cover
the critical aspects of managing the disposal of various
categories of solid waste. The categories discussed include:
o Hazardous waste;
o Residential, commercial, and institutional solid
waste;
o Waste-water treatment sludge;
o Pollution control residuals;
o Mining waste;
o Agricultural wastes;
o Water treatment sludge; and
o Septic tank pumpings.
7-7
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Section No. 3-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
State
Implementa-
tion
40 CFR 256
State
Regulatory
Authority
Surveil-
lance Re-
quirements
For the categories of waste identified in Part 252, states must
develop implementation plans that cover the following areas
of concern:
o
o
o
o
o
o
o
o
o
Resource conservation;
Soul'ce separation;
Collection;
Transportation;
Stol'age;
Transfer;
Processing/resource recovery;
Treatment; and.
Disposal.
There are two areas within the EPA guidelines of concern to
QA. First, each state is required to establish the legal
authority nE~eded to comply with the RCRA, including
prohibition of new open dumping. Second, the development of
waste disposal plans must be coordinated with all other
relevant environmental programs.
Guidelines in 40 CFR Part 256 recommend that the regulatory
powers for implementing the RCRA should include:
o
Surveillance systems that require monitoring
of \-laste disposal facilities;
o
Assessment of facilities by trained inspectors,
and remedial measures;
o
State permit systems that include prohibition
of new open dump sites; and
o
Enforcement systems to include both administrative
and judicial remedies to enforce compliance
schedules and closure procedures for open dumps.
Of particular interest to QA are the recommended requirements
for surveillance systems that monitor waste disposal facili-
ties. Based on an evaluation of potential health effects, and
the environmental impact of each disposal facility, the
surveillance system should include:
o
Instrumentation, monitoring, sampling, and
inspections, as appropriate;
o
Monitoring of leachates to detect and predict
contamination of ground water; and
o
Trained inspectors and detailed instructions to ensure
compliance with permits.
7-8
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Section No. -1-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
Program
Coordina-
tion
40 CFR 260
Hazardous
Waste
Management
40 CFR 261
Hazardous
Waste Iden-
tification
Guidelines/
Test
Procedures
This legal authority, and its implementation, represent an
important area of QA concern for all regions.
With respect to coordination with other environmental programs,
"the state solid waste management plan should be developed in
coordination with Federal, state, and subs tate programs for
air quality, water quality, water supply, waste water
treatment, pesticides, ocean protection, toxic substances
control, noise control, and radiation control. This
coordination may include other Federal agencies with
environmentally related regulatory authority, or delegated
environmental protection responsibilities under the various
environmental Acts."
For all solid waste classified as hazardous and subject to the
requirements of the RCRA, Part 260 - "Hazardous Waste Management
System" gives general guidance, standards, and test procedures
applicable to Parts 260-265, and 268. Any data submitted
under these Parts must use test methods cited in the American
Society for Testing and Materials Standard Methods, and EPA
Publication SW846, as updated. Part 260 gives a definition and
a schematic diagram for distinguishing between solid waste and
hazardous waste for the purposes of the RCRA.
Those wastes that are subject to regulation as hazardous waste
are addressed in 40 CFR Part 261 - "Identification and Listing
of Hazardous Waste." This Part further defines hazardous waste,
along with general administrative and management procedures;
criteria for identifying the characteristics of hazardous waste
and for listing them; general and specific measurable
characteristics of solid wastes; and lists of hazardous wastes
by source and hazardous waste code number, along with references
to test methods where appropriate.
Appendices I-X to Part 261, except where reserved, contain the
following guidelines and test methods:
o Representative Sampling Methods;
o EP Toxicity Test Procedures;
o Chemical Analysis Test Methods;
o Basis for Listing Hazardous Waste;
o Hazardous Constituents;
o Waste Excluded in Sections 260.20 and 260.22; and
o Methods of Analysis for Chlorinated-p-dioxins and
-dibezofurans.
The methods used to identify and characterize hazardous waste
are prescribed by reference, or are available. Although some
of the methods contain QC and sampling procedures, there are
no specific QA requirements in Part 261.
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Section No. ~
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
40 CFR 262
and 263
Generators/
Transpor-
ters
40 CFR 264
and 265
Owners/
Operators
40 CFR 264
Standards
for
Hazardous
Waste
Management
The generators and transporters of hazardous wastes must comply
with regulations promulgated at 40 CFR Parts 262 and 263. They
must follow procedures prescribed for identification and classi-
fication of hazardous waste; obtain an EPA identification code
number; and meet minimum prescribed guidelines, reporting, and
record-keeptng requirements. While Parts 262/263 are in the
"for your information category," the records required by these
regulations, particularly copies of the manifest, could be of
value in an emergency episode where monitoring is required.
Of QA interE~st and concern are Parts 264 and 265, which estab-
lish standards/interim status standards, respectively, for
owners and operators of hazardous waste treatment, storage, and
disposal fa(~ilities. The purpose of these two regulations is to
establish minimum national standards that define the acceptable
management of hazardous waste.
The standards established by 40 CFR Part 264 apply to all
owners and operators of facilities that treat, store, or dispose
of hazardous waste. These standards exist for the following
areas:
o GenE~ral facility standards for management and
operations;
o
Preparedness and safety, prevention, and
maintenance;
o Contingency plans and emergency procedures;
o Man:Lfest system, record keeping, and reporting;
o Mon:Ltoring of releases from waste management units
(includes compliance monitoring and corrective
act:Lon) ;
o Closure and post closure;
o Financial requirements, including liability;
o Ground-water monitoring;
o Use and management of containers, including
special conditions and inspections;
o Tank systems;
o Surface impoundments;
o Waste piles;
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Section No. ..1.-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY EESPONSE PROGRAMS
General
Facilities
Standard
o
Land treatment;
o
Land fills;
o
Incinerators;
o
Chemical, physical, and biological treatment;
o
Underground injection;
o
Requirements for miscellaneous units, including
environmental performance standards, monitoring,
analysis, inspections, response, reporting, and
corrective action; and
o
Postclosure.
Most of these standards include some environmentally related
monitoring and test method requirements to ensure compliance
with the st.andard. There are two standards which best
demonstrate~ the monitoring and data collection of most concern
to QA managers: 1) general facilities standards; and 2)
releases from solid waste management units.
The general facilities standard, under general waste analysis,
contains t\\IO important features:
1) Before an owner or operator treats, stores, or
disposes of any hazardous waste, he or she must
obtain a detailed chemical and physical analysis
of a representative sample of the waste, and
analysis must be repeated as necessary to ensure
that it is accurate and up to date;" and
2) The owner/operator must develop and follow a
written waste analysis plan that describes the
procedures used to comply with (1) above. The
plan must be kept at the facility, and at a
minimum, include parameters measured, sampling
and test methods used, and the frequency
initial/repeat analysis.
The testing and sampling must be done with methods cited in
the appropriate Parts of this Subchapter, except that an
approved equivalent sampling method may be used.
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Section No. -L.
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
Releases
from Solid
Waste'
Management
Units
Standards
for
Miscella-
neous Units
The standard for releases from solid waste management units
includes the following requirements:
o
o
o
o
o
o
o
o
Required programs;
Ground-water protection standards;
Hazardous constituents;
Concentration limits;
General ground-water monitoring;
Detection monitoring program;
Compliance monitoring; and
Corrective action.
The basis for this standard is prescribed under Section
264.91, "Required Programs," which contains two parts:
1) A ~onitoring and response program such that
Whenever hazardous constituents from a regulated
unit are detected at a compliance point, the
owner/operator must institute a compliance
monitoring program;
Whenever a ground-water protection standard is
exceeded, the owner/operator must institute a
corrective action program;
Whenever a hazardous constituent exceeds the
concentration limits in ground water, the
owner/operator must institute a corrective
action program; and
In all other cases, the owner/operator must
institute a detection monitoring program;
2) A facility permit issued by the Regional
Administrator, which specifies the specific
elements that the monitoring and response
program must contain, based on the risks to
human health and the environment.
The elements of the monitoring and response program are
described in other sections of Part 264, and should be
consulted for more details.
The standards in Part 264, for miscellaneous units that treat,
store, or dispose of hazardous waste, include environmental
performance standards, monitoring, and analysis. The environ-
mental performance standards stipulate that "a miscellaneous
unit must be located, designed, constructed, operated,
maintained, and closed in such a manner that will ensure the
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Section No. -.:L
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY FtESPONSE PROGRAMS
Guidelines
and Test
Methods
40 CFR 265
Interim
Status
Standards
protection of human health and the environment." The permit
terms and provisions for these units will include, by
reference, those regulatory requirements that will ensure the
prevention of any releases that may have adverse effects on
human healt:h or the environment due to:
o
Migration of waste constituents in the ground-
water or subsurface environment;
o Migration of waste constituents in surface waters
or wetlands, or on the soil surface; and
o Migration of waste constituents in the air.
The monitoring and analysis standard for treatment, storage,
and disposal of hazardous waste stipulates that monitoring,
analysis, inspection, response, corrective actions, and
reporting must ensure compliance with other sections of Part
264, as appropriate.
Appendices I-X to Part 264, except as reserved, give the
following guidelines:
o
Record-keeping instruction, including units of
measure, and handling codes for treatment, storage,
and disposal methods;
o Cochran's Approximation to the Behrens-Fisher
Students T-test (to determine statistically
significant difference between monitoring data
and background data);
o
Exa~ples of potentially incompatible waste in
special groupings;
o
Political jurisdictions where certain site location
standards must be demonstrated; and
o Ground-water monitoring list that includes
parameters, suggested test methods, arid practical
quantitation limits.
The interim status standards in 40 CFR Part 265 cover the same
general areas as Part 264, with data collection operations
receiving about the same emphasis and specificity. The purpose
of Part 26:1 is to define acceptable management of hazardous
waste during an interim period of certification or closure of a
waste facility. There are some differences in the number and
content of the promulgated guidelines. Part 265 guidelines in
Appendices I-X, except as reserved, include the following:
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Section No. -1-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
40 CFR 266
Recycled
Waste
Standards
40 CFR 261
New
Facility
Standards
o
Record-keeping instructions with units of
measure, and handling codes for treatment,
storage, or disposal;
o
EPA interim Primary Drinking Water Standards;
o
Test for significance, including use of same;
and
o
Examples of incompatible waste, including
consequences of mixing certain types of wastes.
With emphasis on recycling and reuse of waste, there must be
some regulatory controls to protect human health and the
environment. Part 266 established standards for the management
of specific waste recycled or reused in such a way as to
constitute disposal. The regulations in this Part cover such
products and uses as the following:
o
Hazardous waste burned for energy recovery;
o
Used oil burned for energy recovery;
o
Recyclable materials utilized for precious metal
recovery; and
o
Spent lead-acid batteries being reclaimed.
The QA significance of these standards is that they do include
monitoring, analysis, inspections, and reporting, by reference
to other regulations in this subchapter.
Managing solid waste and hazardous wastes is a continuing and
growing problem. This fact is reflected in. 40 CFR Part 267,
which sets forth interim standards for owners and operators of
new hazardous waste land disposal facilities. This Part
establishes minimum national standards that define acceptable
hazardous waste management practices for the following:
o
Environmental performance standards;
o
Land fills;
o
Surface impoundments;
a
Land treatment;
o
Ground-water monitoring; and
o
Underground injection, including those wells that
require individual RCRA permits under 40 CFR Part 122.
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Section No. -1-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
40 CFR 268
High Risk
Hazardous
Waste
40 CFR 270
Hazardous
Waste
Permit
Program
40 CFR 271
State
Programs
The standards in this Part contain monitoring, analysis,
reporting, and other requirements by reference to appropriated
sections in other Parts of this Subchapter.
Some hazardous wastes pose such high risk to human health and
the environment that they may be restricted from disposal in
land fills and impoundments. Part 268 prescribes restrictions
for land disposal of high risk hazardous wastes. There appears
to be only limited QA interest in this Part, except for the
appendices which include the following:
o Toxicity Characteristic Leaching Procedure (TCLP);
o Treatment standards (as concentrated in the treat-
ment residual extract); and
o
A list of halogenated organics regulated by Part 268.
The TCLP is used to determine the mobility of both organic and
inorganic contaminants present in liquid, solid, and
multiphasic wastes. This procedure is not covered in the other
standards.
Only two states had approved hazardous waste management
programs as of late summer, 1988. Part 270 - "EPA Administered
Permit Programs: The Hazardous Waste Permit Program"
establishes provisions for hazardous waste permit programs
administered by EPA, and by approved states to the extent
provided in Part 271. Regulations in 40 CFR Part 270 cover the
basic EPA permitting requirements, including application
requirements, types of permits/duration, standard permit
conditions, and monitoring and reporting requirements. A
beneficial feature of Part 270 is a chart indicating where the
regulations implementing the RCRA appear in the Code of Federal
Regulations.
Requirements for the authorization of state hazardous waste
programs are prescribed in 40 CFR Part 271. This regulation
establishes the procedu~es that EPA will follow in approving,
revising, and withdrawing approval of state programs, and the
requirements states must meet to be approved by the
Administrator under the RCRA. Major provisions which must be
contained in state programs include requirements for
permitting, compliance evaluation, enforcement, public
participation, and sharing of information.
Most of the requirements for state programs are made applicable
to the states by cross references to sections of other EPA
regulations. These regulations require provisions in
applications for environmental standards, monitoring, analysis,
inspections, recording, and reporting. Although there are no
specific QA requirements in Part 271, the monitoring, analysis,
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Section ,No. .:L
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY HESPONSE PROGRAMS
40 CFR 280
Underground
Storage'
Tanks
Comprehen-
sive
Environmen-
tal
Response,
Compensa-
tion, and
Liability
Act -
"Superfund"
40 CFR 300
National
Contingency
Plan
and other emvironmental data operations are in the purview of
the QA program manager.
Amendments to the RCRA directed the Administrator to develop a
regulatory program to deal with potential threats posed by
underground storage tanks. There are a large number of these
tanks located throughout the nation, and a significant number
of these mcLY be leaking. Those that leak may create serious
health problems if any pollutants they contain contaminate
underground sources of drinking water. As a first step in what
will be a eomprehensive program, 40 CFR Part 280 requires that
all owners of underground storage tanks must report to EPA on
their tank's location, contents, and status. This information
is being used to develop substantive regulations that will
require owners to take measures to protect human health and the
environment. These regulations may well require monitoring and
data analysis which will be of concern to the QA program.
One of the most costly and far reaching environmental Acts of
modern timE!S is the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) of 1980, also known as
"Superfund," In passing the CERCLA, Congress attempted to
mobilize the full response powers of the Federal government and
to set responsibilities and liabilities for the control,
containment, and cleanup of discharges of oil to navigable
waters, and releases of hazardous substances posing an eminent
danger to public health and welfare. Of particular concern
were the discharges, or threat of discharges, of oil from super
tankers, and the investigation and cleanup of uncontrolled
hazardous waste sites across the United States. To deal with
emergency response to such situations, both the CERCLA, Section
105, and the Clean Water Act, Section 311(c)(2), stipulated the
development of a National Contingency Plan,'
The "National Oil and Hazardous Substances Pollution
Contingency Plan" applies to all Federal agencies and is in
effect for: discharges, or substantial threats of discharges,
of oil to or upon the navigable waters under the jurisdiction
of the United States; releases, or substantial threats of
releases, of hazardous pollutants into the environment; and
releases of contaminants that may present an eminent danger to
public health and welfare. The National Contingency Plan (NCP)
provides for coordination with all other Federal agencies, and
includes the following:
o
Division and specification among Federal, state, and
loeal governments, and private entities;
o Establishment of a national response organization,
ineluding response personnel and resources;
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Section Mo. 7
Revision Mo.D
Date Mov. 1, 1989
SOLID WASTE AND EMERGENCY m~SPONSE PROGRAMS
Mational
Pt"iorities
List/
Remedial
Investiga-
tions
Dispersants
and Other
Chemicals
o
Establishment of Federal, regional, and local
contingency plans;
o
Proeedures for removals under the Clean Water Act;
o
Proeedures for responses pursuant to the CERCLA;
o
Designation of trustees for natural resources for the
purposes of the CERCLA; and
o
Policies and procedures for the use of dispersants and
othl~r chemicals in removal and response acts.
It is important to note that many Federal agencies have
responsibilities for implementing the CERCLA as set forth in
40 CFR Part 300. Of most importance to QA are:
o
Hazardous site evaluation phase and national
priorities list determination; and
o
Reml~dial investigations and feasibility studies
to develop safe removal plans.
Most of the QA is contained in Section 300.65, "Remedial
Investigations and Feasibility Studies." Prior to any removal
action, the nature and extent of the proposed threat of release
must be detlarmined by the lead Agency, or the party responsible
for the removal action. If the remedial action is paid for out
of the Superfund, a QA and sampling plan must be developed and
approved by the Remedial Project Officer (RPO), with a
coordinati01l1 signature from the appropriate EPA Quality
Assurance Officer. In all other cases the lead agency must
review and approve the remedial action and the cost recovery
plan.
Other concerns of QA include the data requirements associated
with the use of dispersants and other chemicals. The on-scene
coordinator (OSC), with concurrence of the EPA representative
to the Regional Response Team (RRT) and the state with primacy
under the Clean Water Act, may authorize the use of dispersants
or other chemicals. The data requirements for approval include
the follow ing :
o
Identification of the dispersant, along with
application procedures, special handling precautions,
and shelf life;
o
Dispersant toxicity;
o
Effectiveness;
o
Chemical analysis; and
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Section No. ...1-
Revision No. 0
Date Nov. 1, 1989
SOLID WASTE AND EMERGENCY RESPONSE PROGRAMS
Ranking
System/
Test
Procedures
Requirements
of
Other
Parts
o Qualifications of the laboratories performing the
tests.
All of the dispersants, or other chemicals approved, must be on
the NCP pro,juct schedule, or submitted to EPA for approval
together with data such as that cited above.
Relevant appendices to 40 CFR Part 300 include the following:
o
Uncontrolled Hazardous Waste Site Ranking System, A
Users Manual;
o National Priorities List (By Rank); and
o
Revised Standard Dispersant Effectiveness and Toxicity
Tests.
Other Parts of the Subchapter covering Superfund deal with the
designation of hazardous waste, reportable quantities, and
notification; citizen awards for information on criminal
violations under Superfund; reimbursement to local governments
for emergen'cy response actions; emergency planning thresholds,
and notification for a list of extremely hazardous substances;
and stipulated toxic chemical release reporting and community-
right-to-know. The later information on toxic chemical
reporting is at Part 312, which includes an extensive inventory
of very hazardous substances, along with information of vital
importance in an emergency episode requiring monitoring and
measurements.
Most privat,= contractors, Federal agencies, and many private
organizations are familiar with some aspect of the QA program
associated with Superfund. But so far as the current regu-
lations are concerned, the QA requirements in this Subchapter
do not reflect the costly environmental data operations
implemented pursuant to the CERCLA.
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