DRAFT
Toxic Substances Control Act
Case Proceedings
Guidance Manual
U.S. Environmental Protection Agency
Office of Compliance Monitoring
Washington DC 20460
September 1992
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DRAFT
TSCA Case Proceedsings Guidance Manual
TABLE OF CONTENTS PAGE
Chapter One TSCA Background :
Chapter Contents 1-i
1 Purpose of the Manual 1-1
2 History of TSCA 1-19
3 General Operating Procedures 1-21
4 Synopsis of the Act 1-26
5 Alphabetical Index 1-47
Chapter Two Compliance Monitoring Procedures
Chapter Contents 2-i
1 Inspections 2-1
la TSCA Notification Letters 2-19
Ib Warrants 2-15
2 Subpoena Authority 2-27
3 Voluntary Disclosure . . ..... 2-55
4 Confidential Business Information 2-59
Chapter Three Evidence Assessment
Chapter Contents 3-i
1 Introduction 3-1
2 Inspection File Review 3-3
3 The Initial Assessment 3-17
4 Elements of Proof 3-21
5 Types and Adequacy of Envidence x 3-25
6 Additional Sources of Evidence 3-27
7 Additional Violations 3-41
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Table of Contents
Chapter Four Determination of Appropriate Enforcement Response
Chapter Contents 4-i
1 Introduction 4-1
2 Criteria for Determining the Level of Action 4-3
Chapter Five Notices of Noncompliance
Chapter Contents 5-i
1 Notices of Noncompliance 5-1
Chapter Six Administrative Enforcement Actions: Civil Penalty Proceedings
Chapter Contents 6-i
1 Introduction 6-1
2 Civil Administrative Complaint Preparation and Filing 6-5
3 Post Complaint Stage '. 6-47
4 Informal Settlement 6-69
5 Prehearing Exchange 6-89
6 Hearing Process 6-93
7 Appeals 6-111
Chapter Seven Judicial Enforcement: Civil Actions
Chapter Contents , ... 7-i
1 Introduction 7-1
2 Evidence to Support a Civil Action 7-3
3 Referring Judicial Actions 7-11
4 Injunctive Relief 7-19
5 Settlement Agreements 7-33
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Table of Contents
Chapter Eight Judicial Enforcement: Criminal Actions
Chapter Contents 8-i
1 Introduction 8-1
2 Overview of Criminal Enforcement 8-5
3 Criminal Investigations 8-9
Chapter Nine Oversight of Settlement Agreements
Chapter Contents 9-i
Chapter Ten Enforcement Discretion
Chapter Contents 10-i
Chapter Eleven Multi-Media Enforcement
Chapter Contents 11-i
Chapter Twelve Federal Facilities Enforcement
Chapter Contents 12-i
Appendices
Appendix Contents A-i
1 Delegations of Authority Under TSCA A-l
2 Listing of TSCA Guidelines, Strategies, and
Enforcement Response Policies A-9
3 Guidelines for the Assessment of Civil Penalties Under Section
16 of the Toxic Substances Control Act; PCB Penalty Policy A-11
4 The Consolidated Rules of Practice Governing the Administrative
Assessment of Civil Penalties and the Revocation or Suspension
of Permits , A-13
5 The Table of Contents for the General Enforcement Response
Policy Compendium ..'• A-15
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Chapter One
TSCA Background
CHAPTER CONTENTS PAGE
1 Purpose of the Manual 1-1
Reservation 1-1
The Update System 1-1
Common Acronyms and Abbreviations ' 1-3
Glossary 1-7
2 History of TSCA 1-19
TSCA Statutory History 1-19
Regulatory Process 1-20
3 General Operating Procedures 1-21
Primary Office Responsibilities 1-21
Consultation Procedures 1-25
4 Synopsis of the Act 1-26
Authorities 1-26
Synopsis of the Act 1-27
5 Alphabetical Index 1-47
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Chapter One Contents i
TSCA Case Proceedings 1-ii Guidance Manual 1992
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Chapter One
1 Purpose of the Manual
The purpose of this manual is to provide guidance to enforcement personnel regarding:
• the evaluation of evidence and information that may be used to support an enforcement
action;
• the types of enforcement actions that may be issued; and
• the steps needed to appropriately develop and implement these actions.
The manual describes the processes of case development and judicial proceedings including:
analyzing evidence collected during an investigation to determine its sufficiency in documenting
a suspected violation; issuing an enforcement action; presenting evidence in an adjudicatory
hearing; and monitoring compliance with consent decrees.
RESERVATION
The policies and procedures set forth herein and the internal office procedures adopted pursuant
hereto are intended solely for the guidance of United States Environmental Protection Agency
personnel. These policies and procedures do not create a right or benefit (substantive of
procedural) enforceable at law by a party to litigation with the United States Environmental
Protection Agency. The Agency reserves the right to take action that is alleged to be at variance
with these policies and procedures or that is not in compliance with internal office procedures.
THE UPDATE SYSTEM
As revised or additional material is developed for the manual, it will be distributed to all manual
holders. A transmittal form will accompany and explain these changes. The revised or
additional pages will be identical to the original page, but with added identification at the bottom
of the page.
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Chapter One Purpose of the Manual
TSCA Case Proceedings Page Guidance Manual (Year)
Revised
When revisions entail the addition of pages into the manual (i.e., when three pages in the manual
are replaced by five pages), the additional pages will be numbered as follows:
Original numbering: 3-3, 3-4, 3-5, 3-6, etc.
Addition of pages: 3-3, 3-4, 3-5a. 3-5b. 3-5c. 3-6, etc.
This system will allow updates to be made quickly and easily and will avoid disruption of the
chapters. New material will be numbered sequentially by chapter.
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Chapter One Common Acronyms and Abbreviations
COMMON ACRONYMS AND ABBREVIATIONS USED IN THIS MANUAL
AA — Assistant Administrator
ACB -- Analytical Chemistry Branch/BEAD
AHERA — Asbestos Hazard and Emergency Response Act
ALJ ~ Administrative Law Judge
APA — Administrative Procedures Act
APB — Antimicrobial Program Branch/RD
ASHAA -- Asbestos School Hazard Abatement Act
CACO -- Consent Agreement/Consent Order
CAFO - Consent Agreement and Final Order
CBI ~ Confidential Business Information
CCLR ~ Claims Collection Litigation Report
CDO -- Case Development Officer
C.F.R. -- Code of Federal Regulations
CID — Criminal Investigation Division
CRP -- Consolidated Rules of Practice
DCO -- Document Control Officer
DCN — Document Control Number
DOT ~ Department of Justice
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Chapter One Common Acronyms and Abbreviations
EAB -- Environmental Appeals Board
EPA - United States Environmental Protection Agency
EPCRA -- Emergency Planning and Community Right to Know Act
ERP ~ Enforcement Response Policy
FCCA - Federal Claims Collection Act
FCCS -- Federal Claims Collection Standards
FDA — Food and Drug Administration
FOIA - Freedom of Information Act
FR -- Federal Register
FTPS -- FIFRA and TSCA Tracking System
GLP - Good Laboratory Practices
GOP - General Operating Procedures
HQ - Headquarters
IAG ~ Interagency Agreement
IMD — Information Management Division
ITC — Interagency Testing Committee
LEA - Local Education Agencies
LV - Low Volume
MOU - Memorandum of Understanding
MPI -- Maximum Permitted Intake
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Chapter One Common Acronyms and Abbreviations
NCDB.-- National Compliance Data Base
NEIC — National Enforcement Investigations Center
NOC ~ Notice of Commencement
NON - Notice of Noncompliance
NOW -- Notice of Warning
OCM -- Office of Compliance Monitoring
OE -- Office of Enforcement
OGC -- Office of General Counsel
OMB - Office of Management and Budget
OPPT - Office of Pollution Prevention and Toxics
OPPTS - Office of Prevention, Pesticides, and Toxic Substances
OSHA ~ Occupational Safety and Health Administration
PAIR — Preliminary Assessment Information Rule
PCB -- Polychlorinated Biphenyl
PGD ~ Policy and Grants Division
PMN ~ Premanufacture Notice
pmm — Parts per million
SEP - Supplemental Environmental Project
SNUR -- Significant New Use Rule
TRO - Temporary Restraining Order
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Chapter One Common Acronyms and Abbreviations
TSCA -- Toxic Substances Control Act
U.S.C. -- United States Code
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Chapter One Glossary
GLOSSARY
ACT - When used in this manual, the term "Act" means the Toxic Substances Control Act
(TSCA), 15 U.S.C. §2601 et seg.
ADMINISTRATIVE LAW JUDGE -- An Administrative Law Judge appointed pursuant to 5
U.S.C. §3105 (see also. 5 C.F.R. Part 930, as amended by 37 Fed. Reg. 16,789).
ADMINISTRATOR -- The Administrator of the United States Environmental Protection Agency,
any employee or authorized representative of the Agency to whom the Administrator has
delegated the authority to carry out his or her functions, or any other person who shall by
operation of law be authorized to carry out such functions.
AFFIDAVIT -- A voluntary, written declaration of facts, the truthfulness of which is confirmed
by oath or affirmation of the party making it before an officer having the authority to
administer such oaths.
AGENCY -- The United States Environmental Protection Agency (EPA).
AMICUS CURIAE -- "Friend of the Court". A party who has an interest in the case or
controversy, but is not an actual represented party to the case. Amicus Curiae file legal
briefs to influence the court to reach an outcome favorable to their interests, e.g., The
Natural Resources Defense Council.
APPEAL — Resort to a superior court to review the decision of an inferior court or
administrative agency. An appeal may also be taken from the decision of an administrative
law judge to a trial court.
APPELLANT — The party who appeals a lower court or agency decision to a higher court.
APPELLEE -- The party who "won" the lower court or agency decision and does not want te
decision to be reversed. Also referred to as the respondent.
ARTICLE — A manufactured item that (1) is formed to a specific shape or design during
manufacture, (2) has end-use function(s) dependent in whole or in part upon its shape or
design during end use, and (3) has either no change of chemical composition during its end
use or only those changes of composition that have no commercial purpose separate from that
of the article and that result from a chemical reaction occurring upon end use of other
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Chapter One Glossary
chemical substances, mixtures, or articles. Fluids and particles are not considered articles
regardless of shape or design [40 C.F.R. §704.95].
BONA FIDE (REQUEST) ~ An official inquiry submitted by a manufacturer or importer to
EPA as to whether a chemical substance is listed on the inventory compiled and published
under Section 8(b) of TSCA [40 C.F.R. §720.25]. The requestor must demonstrate a bona
fide intent to manufacture or import the substance for a commercial purpose.
BRIEF ~ A written statement summarizing the facts and laws pertaining to a case, and the
arguments on how these laws apply to the facts in support of a legal position.
BURDEN OF PERSUASION - The obligation on a party to produce a sufficient amount of
evidence to persuade the trier of fact that an action did or did not take place. Once the
moving party meets its burden of persuasion, the burden shifts to the respondent to rebut the
evidence.
BURDEN OF PROOF ~ The legal duty of providing a fact or facts in dispute. The duty to
produce evidence as the case progresses and the duty to establish the truth of the claim.
CHAIN OF CUSTODY - An all inclusive record of the successive conveyance, transfer and
custody of evidence from the time it is gathered to the time of trial. This record
demonstrates to the Court the reliability, authenticity and quality of the evidence.
CIVIL COMPLAINT ~ A written communication alleging one or more violations of specific
provisions of TSCA or regulations promulgated thereunder [40 C.F.R. §22.03]. Each
complaint must include:
- Reference to the provisions of the Act alleged to have been violated;
- A concise factual statement of the violation;
— The amount of the proposed penalty;
— A statement of the appropriateness of the penalty;
-- Notice of the respondent's right to an adjudicatory hearing; and
~ A statement reciting the section(s) of the Act authorizing the issuance of the complaint [40
C.F.R. §22.14].
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Chapter One Glossary
CODE. OF FEDERAL REGULATIONS (C.F.R.) -- The annual cumulation of executive agency
regulations published in the daily Federal Register, combined with regulations issued
previously that are still in effect. The C.F.R. contains the general body of regulatory laws
governing practice and procedure before federal administrative agencies.
COMPLAINANT -- Any person authorized to issue a complaint on behalf of the Agency to
persons alleged to be in violation of the Act [40 C.F.R. §22.03].
CONSENT - Voluntary acquiescence or agreement to the proposition of another.
Express Consent. Consent directly given by voice or in writing.
Implied Consent. Consent manifested by actions, silence, facts or inaction which raise a
presumption that consent has been given.
CONSENT AGREEMENT ~ Any written document containing stipulations of fact; conclusions
regarding material issues of law, fact, or discretion; and a specified proposed penalty
acceptable to both complainant and respondent that results from any settlement conference
[40 C.F.R. §22.18].
CONSENT ORDER -- An order of the Regional Administrator, or Environmental Appeals Board
at Headquarters, that assesses a civil penalty and disposes of the civil penalty proceeding.
DEFAULT -- The forfeiture of a legal right or the failure to perform a legal duty.
DEFAULT JUDGMENT -- A judgement rendered against a party which has failed to plead
(answer) or defend against a properly filed and pled complaint.
DEFAULT ORDER -- An order issued pursuant to 40 C.F.R. §22.17 disposing of a matter of
controversy between respondent and the Agency upon (1) the failure of respondent to file a
timely answer to the complaint, (2) the failure of one of the parties to comply with a
prehearing or hearing order of the Presiding Officer, or (3) the failure of one of the parties
to appear at a conference or hearing without good cause being shown.
DEFENDANT — The person defending or denying the party against whom relief or recovery
is sought in an action or civil suit, or the accused in a criminal case.
DEPOSITIONS ~ A form of prehearing discovery whereby testimony is recorded, out of Court,
under oath, to be used later in the hearing. This practice is not encouraged in civil
administrative matters.
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Chapter One Glossary
DISTRICT COURT - A United States district court, the District Court of Guam, the District
Court of the Virgin Islands, and the highest court of American Samoa.
ENVIRONMENT ~ Includes water, air, and land and the interrelationship that exists among and
between water, air, land, and all living things [TSCA §3(5)].
ENVIRONMENTAL APPEALS BOARD ~ In response to an increasing level of administrative
adjudications, the Administrator created the Environmental Appeals Board (EAB), composed of
three Environmental Appeals Judges designated by the Administrator. The purpose of the Board
is to hear and decide appeals in cases that were formerly either delegated to the Agency's Chief
Judicial Officer or decided on the basis of the Judicial Officer's recommendation. The EAB also
signs all Headquarters consent agreements.
EPA - The United States Environmental Protection Agency.
EQUITY — Concept of fairness and rights dealing. Grounded in conscience rather than law.
£VIDENCE -- Concrete facts, supplied by testimony, records or other documents, which may
be legally presented in trail in order to prove something to the trier of fact.
After, or Newly, Discovered Evidence. Material evidence which was not available prior to
the rendering of a decision in a case. Depending on the significance of the evidence, after
discovered evidence may be the basis for a new hearing.
Circumstantial Evidence. Indirect evidence and inferences drawn from such evidence.
' Direct Evidence. Evidence in the form of testimony from a witness who actually saw, heard
or touched the subject of the testimony.
Hearsay Evidence. Evidence which has any tendency to make the existence of any fact that
is of consequence to the determination of the action more, or less, probably than it would
be without the evidence.
EXCLUSIONARY RULE -- Rule of evidence in Federal courts which prohibits the introduction
of certain evidence. Often used to keep out the "fruit" of an illegal search.
EX PARTE ~ A latin phrase meaning by one party only. A judicial proceeding, order,
injunction, etc., is said to be ex parte when it is taken or granted at the instance and for the
benefit of one party only, and without notice to, or contestation by, any person adversely
interested. Under the Consolidated Rules, ex parte communications with the Judicial Officer
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Chapter One Glossary
are prohibited. A TSCA subpoena may be ex parte. or at the request of the Agency with no
notice to the Respondent. Also, once a civil administrative complaint has been issued, the
opposing parties should only communicate through their legal counsels. ,
EXPERT WITNESS - A witness having specialized knowledge, scientific or technical expertise.
A witness who by knowledge, skill, experience, training, or eduction will assistance the trier
of fact in understanding the evidence.
FACILITY - Any establishment, site, or other premises subject to TSCA enforcement activity.
FEDERAL REGISTER ~ Published daily, is the medium for making available to the public
Federal agency regulations, rules, standards, and other legal documents of the executive
branch. It includes proposed changes (rules, regulations, standards, etc.) of governmental
agencies and invites public comment. Final approved regulations and rules appear in the
Code of Federal Regulations.
FINAL ORDER - An order issued by the Administrator after an appeal of an initial decision,
accelerated decision, decision to dismiss, or default order disposing of a matter in
controversy between the parties or an initial decision under 40 C.F.R. §22.27(c).
FREEDOM OF INFORMATION ACT -- Under this Act, 5 USC § 552, all governmental
agencies are required to make information available to the public. Some information is not
obtainable under the Act. Most important in civil administrative practice, is the privilege
which protects documents prepared in anticipation of litigation from discovery ("work
product rule"). See privilege.
HEALTH AND SAFETY STUDY -- Any study of any effect of chemical substance or mixture
on human health or the environment or on both, including underlying data and
epidemiological studies; studies of occupational exposure to a chemical substance or mixture;
lexicological, clinical, and ecological studies of a chemical substance or mixture; and any
test performed pursuant to TSCA [TSCA §3(6)].
HEARING - A hearing open to the public provided in Section 16(a)(2)(A) of the Act and
conducted pursuant to the provisions of Chapter 5, Subchapter II of Title 5 of the United
States Code, and the rules of practice found at 40 C.F.R. Part 22.
HEARING CLERK -- The Hearing Clerk, United States Environmental Protection Agency,
Washington, D.C. 20460. All pleadings, motions, complaints, etc., must be filed with either
the Headquarters Hearing Clerk or the Regional Hearing Clerk.
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Chapter One Glossary
INITIAL DECISION - The decision issued by the Administrative Law Judge based upon the
record of the hearing out of which the decision arises or upon the rendering of an accelerated
decision. An initial decision is supported by findings of fact and conclusions regarding all
material issues of law, fact, or discretion. This decision will become the final decision and
order of the Administrator without further proceedings unless the decision is appealed or the
Administrator orders a review of the case.
IN CAMERA ~ A cause is said to be heard in camera either when the hearing is had before the
Presideing Officer or Judge in his or her chambers, or when all spectators are excluded from
the hearing room.
INJUNCTION ~ A legal writ issued by the Court forbidding or requiring certain action.
Injunctions are issued through the District Court.
INSPECTOR - A duly designated representative of the Administrator authorized to conduct
inspections, make investigations, collect documents and samples, and otherwise monitor
compliance with TSCA.
INTERLOCUTORY APPEAL - An appeal of a matter which is not determinable of the
controversy, but which is necessary for a suitable adjudication of the merits. It is an appeal
over some point or matter, but is not a final decision of the whole controversy, e.g., an
appeal over a piece of evidence.
INTERVENOR ~ A party who is not originally a party to the suit, but claims an interest in
the subject matter and comes into the case in order to protect their right or interpose their
claim.
JUDICIAL NOTICE - Recognition by the Court of certain facts as true without the necessity
of proof. The facts are generally known and capable of verification from other recognized
sources. For the acknowledgement of laws, geography certain scientific facts and historical
events.
JUDICIAL OFFICER -- An officer or employee of the Agency designated as a judicial officer
who shall meet the qualifications and perform functions provided for in 40 C.F.R. §22.04.
JUDGEMENT -- Order or decree in a legal matter.
KNOWING AND WILLFUL - Conscious and intentional violation of a statute. This is an
element of proof required for a criminal conviction under TSCA and FIFRA.
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Chapter One Glossary
MOTION -- A written application to the Court asking for a ruling. May be filed by either
party. Some of the most used Motions are:
Motion for an Accelerated Decision as to Liability and/or Penalty. Asks the Court to render
a decision on the pleadings with no further evidence or argument.
Motion for Default. Asks the Court to render a decision in favor of the Agency when the
respondent has failed to file pleadings.
Motion for Judgement Notwithstanding Verdict. A motion that judgement be entered in
accordance with the movant's earlier motion for a directed verdict and notwithstanding the
contrary verdict actually returned by the jury.
Motion for More Definite Statement. If a pleading is so vague or ambiguous that a party
cannot reasonably be required to frame a responsive pleading, he may move for a more
definite statement.
Motion in Bar. One which, if allowed, will absolutely bar the action; e.g. plea of double
jeopardy.
Motion in Limine. A written motion which is usually made before or after the beginning of
a jury trial for a protective order against prejudicial questions and statements. Its purpose
is to avoid injection into trial of matters which are irrelevant, inadmissable and prejudicial.
Motion to Amend. Asks the Court for leave to add additional information to a pleading
already filed.
Motion to Extend Time to File. Either party may file a motion to extend time to file a
response to the opposing party's pleading or to a court order. Respondent requesting an
extension from the court to answer the complaint is a common example.
Motion to Dismiss. Asks the Court to dismiss the Agency's case for failure to state a claim
or dismiss a Respondent's Answer for failure to state a defense.
Motion to Implead. An existing party to the suit may request the court to "implead" or bring
in another party who is not a party to the suit. For instance, the respondent may believe that
a party not named in the suit is responsible for part or all of the controversy and requests the
court to name that party as an additional defendant.
Motion to Set Case for Hearing. Asks the Hearing Officer to place the case on the docket.
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Chapter One Glossary
Motion to Strike. Asks the Court to remove issues from litigation.
Motion to Strike Defenses. Asks the Court to rule that certain defenses need no litigation
because they are not supportable under the law or have been decided in prior cases (i.e.,
Statute of Limitations.)
MOV ANT - One who makes a motion before a court.
NEUTRAL INSPECTION SCHEME -- The Agency is required to formulate compliance
inspection strategies which are either for cause (based on tips and complaints) or are directed
to a certain segment of the regulated community. Inspections targets within the strategy are
then selected at random.
NEW'CHEMICAL SUBSTANCE - Any chemical substance that is not included in the
inventory compiled and published under Section 8(b) of TSCA.
PARALLEL PROCEEDINGS - Simultaneous criminal and civil litigation proceedings pursued
by the Agency.
PARTY -- Any person, group, organization, agency, or department that participates in a hearing
as complainant, respondent, or intervenor.
PERSON — Includes any individual, partnership, association, corporation, and any trustee,
assignee, receiver or legal successor thereof, and any organized group of persons, whether
incorporated or not, and any officer, employee, agent, department, agency or instsrumentality
of Federal Government, of any State or local unit of government, or any foreign government.
PETITIONER ~ Any person adversely affected by a notice of the Administrator and who
requests a public hearing.
PREPONDERANCE OF THE EVIDENCE ~ Evidence which is more convincing to the trier
of fact than the evidence offered in opposition to it. That degree of proof which, when the
evidence presented is taken as a whole, is more creditable or convincing. This is the burden
of proof in civil administrative cases.
PRESIDING OFFICER - The Administrative Law Judge designated by the Chief Administrative
Law Judge to serve as the Presiding Officer of an administrative hearing arising out of the
Act.
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Chapter One Glossary
PRIMA FACIE CASE ~ Latin phrase meaning at first sight. A case which presents sufficient
proof to support a violation unless and until rebutted by other evidence to the contrary.
PRIVILEGE -- A right created by law. Privilege against self incrimination is a right created
by the 5th Amendment to the Constitution which the defendant may invoke to protect himself
from providing the government's case through his testimony. Privileged communications are
statements made between certain persons, such as husband and wife, attorney and client,
patient and doctor. The law protects the right of the individual to make such statements with
candor by barring them from discovery in a legal case. In a civil administrative action, the
Agency encourages all attempts to settle cases and therefore protects settlement negotiations
from being introduced as evidence.
PROOF -- The establishment of a fact by evidence.
PRO SE — Latin phrase meaning in person. Generally used to identify a respondent who
represents himself before the Court rather than retaining an attorney.
REGIONAL ADMINISTRATOR -The Administrator of a Regional Office of the Agency or
his or her delegatee.
REGIONAL HEARING CLERK -- An individual duly authorized by the Regional Administrator
to serve as hearing clerk for a given Region. Correspondence may be addressed (o the
Regional Hearing Clerk, United States Environmental Protection Agency (address of
Regional Office.)
REGIONAL JUDICIAL OFFICER -- An Officer or employee of the Agency duly authorized
by the Regional Administrator to serve as the Judicial Officer for the Region as provided in
the Consolidated Rules of Practice.
RESPONDENT — Any person proceeded against in a complaint.
SEIZURE -- The initial step in a condemnation proceeding consisting of the taking of any
substance, mixture, or article manufactured, processed, or distributed in commerce in
violation of TSCA.
SERVICE OF PROCESS -- The service of writs, summonses, etc., signifies the delivering to
or leaving them with the party to whom or with whom they ought to be delivered or left;
and, when they are so delivered, they are then said to have been served. The service must
furnish reasonable notice to defendant of proceedings to afford him opportunity to appear and
to be heard.
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Chapter One Glossary
STANDARD OF PROOF -- The degree to which the evidence must convince the trier of fact.
In criminal actions, the standard is to convince the judge or jury beyond a reasonable doubt.
In civil administrative actions, the standard of proof is by a preponderance of evidence.
STATE - Any state of the United States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana
Islands, or any other territory or possession of the United States.
STATUTE -- A law enacted by the legislature, national or state.
STATUTE OF LIMITATIONS - Required time limit for filing a case. Cases brought after the
time limit has passed are "barred" and will be dismissed by the Court. Generally, statute
of limitations are not designed to "run against" government actions.
STIPULATIONS ~ Preheating agreement between the parties that certain facts are not at issue
and need not be proved in litigation. Examples are stipulated of professional credentials,
chemical structures of certain substances, and facts specific to the case.
STRICT LIABILITY STATUTE -- A statute which imposes sanctions without requiring the
showing of any intent to violate the statute. TSCA and FIFRA are strict liability statutes.
SUA SPONTE - Latin phrase meaning of one's own will. If a Judicial Officer renders a ruling
sua sponte. he does so voluntarily and not at the request of either party.
SUBPOENA — A legal writ which orders the recipient to perform certain tasks. A TSCA
subpoena may be issued by the Agency but, because the Agency lacks the power to directly
enforce a subpoena, it must be transferred to an appropriate District Court for enforcement
if the Respondent fails or refuses to comply.
Subpoena and Testificandum. A subpoena which orders someone to be present and given
testimony at a specific time and place.
Subpoena Deuces Tecum. A subpoena which orders someone to produce records, documents,
books or other tangible things.
UNITED STATES CODE (U.S.C.) -- The entire body of Federal legislation.
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Chapter One Glossary
WARRANT -- A legal writ issued by a Court or a Magistrate which authorizes an officer of the
Court to make an arrest, enter a dwelling or place of business to carry out a search or
inspection, and to seize certain evidence.
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Chapter One Glossary
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Chapter One
2 History of TSCA
TSCA STATUTORY HISTORY
The passage of the Toxic Substances Control Act (TSCA) was the result of increasing public
awareness of the previously unknown risks posed by chemical substances in the marketplace and
the increasing number of new chemicals being synthesized for commercial purposes. In the
early 1960s, public concern was raised by the findings of widespread mercury contamination of
both soil and water and the consequent high level of this substance in food, particularly fish.
The discovery of extensive PCB contamination in the Great Lakes and Hudson River in the
1970s and the linkage of this substance to cancer further heightened public concern. At about
the same time, deaths associated with exposure to asbestos were also receiving public attention.
While certain substances were regulated if they were found to be a hazard in the workplace or
entered the air or water as waste, very few chemicals were regulated in the marketplace itself.
Some of the exceptions were foods, drugs and pesticides. In 1971, the Council on
Environmental Quality reported on the increasing numbers of new synthetic chemicals being
manufactured each year in increasing volume and expressed concern that the long-term effects
of these chemicals were unknown. Also, in 1971, the first draft legislation was introduced for
the regulation of toxic substances. In subsequent years, several other versions of this legislation
were passed by either the House or Senate. However, it was not until October 11, 1976 that
a bill was finally signed into law to become effective January 1, 1977. The statute only
specifically named one chemical substance to be regulated, PCBs. However, other substances
such as CFCs, dioxins, and asbestos were selected for regulation through rulemaking pursuant
to Section 6.
In 1986, TSCA was amended by addition of Title II, the Asbestos Hazard Emergency Response
Act (AHERA). In the congressional findings of the statute, it stated that EPA guidance
regarding asbestos in schools had been insufficient and the Agency's Section 6 rulemaking failed
to require that the removal, repair or encapsulation of asbestos be done safely and completely.
The statute required the Agency to establish regulations requiring among other things, the
inspection of school buildings, implementation of abatement responses or controlling the hazards
posed by asbestos containing materials and development of management plans for responding
to asbestos-containing materials in school buildings. The Act also required the Agency to
conduct a study of asbestos containing materials in public and commercial buildings.
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Chapter One History of TSCA
The responsibility for carrying out the provisions of Title I and n has been principally delegated
to the Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances.
In 1988, Title III of TSCA, the Indoor Radon Abatement Act became law. Title HI requires
EPA to develop "A Citizen's Guide to Radon," and construction standards for controlling radon
in new buildings, studying radon in schools and federal buildings, providing assistance to states
for radon programs, and establishing regional radon training centers. The Office of Radiation
Programs has been delegated primary responsibility for carrying out the provisions of TSCA
Title in. This manual will only address TSCA Titles I and n.
REGULATORY PROCESS
The statute established a four pronged approach to the regulation of chemical substances
frequently termed "cradle to grave". This approach called for:
1. review of risks posed by new chemical substances prior to their entry into the
marketplace;
2. reporting of information regarding the types and quantities of existing chemical
substances being manufactured and their health and environmental effects;
3. testing to determine the health and environmental effects of chemical substances when
existing data is insufficient; and
4. regulation of the manufacture, processing, use and disposal of chemical substances and
mixtures that actually or potentially pose a hazard.
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Chapter One
3 General Operating Procedures
PRIMARY OFFICE RESPONSIBILITIES
The basic framework setting forth the responsibilities of each EPA office participating in
enforcement activities was established by the Administrator's memorandum of July 6, 1982,
entitled "General Operating Procedures for the Civil Enforcement Program" (GOP), and
Memorandum of October 27, 1982, entitled "General Operating Procedures for the Criminal
Enforcement Program." (See EPA's General Enforcement Policy 0GM-22. February 16. 1984.)
This chapter describes the respective roles and relationships of the various EPA offices that are
involved with TSCA administrative/civil enforcement. For procedures relating to criminal
enforcement, consult Chapter 8.
EPA's administrative/civil enforcement program includes both compliance-oriented and legal-
oriented activities. The compliance-oriented activities are primarily the responsibility of EPA's
program offices, and the legal-oriented activities are principally charged to OE and the Office
of Regional Counsel. Because many enforcement activities involve several aspects, these
activities cannot be defined as strictly "compliance" or "legal." Where both elements are
present, the EPA attorney must be especially diligent in coordinating the legal aspects with the
functions of the other participating offices. The basic relationship between the attorney and the
program office may be compared to that of an attorney-client relationship.
The basic administrative/civil enforcement functions are divided among the participating offices
as follows:
REGIONAL ADMINISTRATOR
Program Office
• Identifies instances of noncompliance;
• Establishes priorities for handling instances of noncompliance;
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Chapter One General Operating Procedures
• Establishes regional targeting priorities within the context of national program guidance;
• Coordinates with other Regions in multi-regional settlements;
• Coordinates with other Regions when the Region may be affected by settlement, for
instance a cross-region Supplemental Environmental Project;
• Evaluates the technical sufficiency of actions designed to remedy violations;
• Identifies for formal action those cases that cannot be resolved less formally;
• Provides technical support necessary for developing cases and conducting litigation;
• Issues written notices of noncompliance;
• Issues routine civil administrative complaints;
• Determines civil penalties according to applicable Enforcement Response Policies;
• Assists Regional Counsel in the negotiation and preparation of consent agreements
finalizing settlements between the Agency and respondents prior to the alleged violator's
filing of an answer or failing to file an answer to a complaint;1 and
• Monitors those conditions in consent decrees that require further reporting and
compliance, such as Supplemental Environmental Projects.
Regional Counsel
• Acts as attorney for "client" program offices;
• Assists program office in drafting or reviewing notices of noncompliance, administrative
orders, or administrative complaints;
• Ensures consistency of action with OE guidance;
• Attends negotiations whenever outside parties are represented by counsel;
• Serves as lead attorney for the Agency in administrative proceedings originating in the
Region; and
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Chapter One General Operating Procedures
• Refers requests for equitable relief through the Regional Administrator to Headquarters
for review and further referral to the Department of Justice and the appropriate United
States Attorneys Office.1
HEADQUARTERS
Office of Compliance Monitoring
• Manages national compliance/enforcement program matters;
• Establishes national enforcement compliance priorities;
• Evaluates and analyzes program accomplishments as national manager of EPA's
enforcement and compliance monitoring functions;
• Develops strategies and Enforcement Response Policies (ERPs);
• Provides overall direction to and accountability measures for the enforcement compliance
program;
• Provides technical support (including support for litigation activities);
• Takes lead role in preparing guidance and policy decisions on enforcement/compliance
issues;
• Takes lead in issuing administrative orders regarding new or existing programs;
• Consults with the Regions on enforcement actions at the earliest possible stage in the case
development process for the following actions:
~ "Non-routine" case of first impression or those of national significance,
-- Injunctions, and
— Seizures;
'Consultation with other offices is required.
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Chapter One General Operating Procedures
• Consults with the Regions on enforcement actions if proposed civil penalty settlements
involve monetary reductions greater than allowable under the appropriate Enforcement
Response Policy;
• Coordinates with OE in preparing joint guidance for areas in which compliance and legal
issues overlap;
• Participates in rule interpretation and development of guidance;
• Takes lead role on National initiatives;
• Issues multi-regional subpoenas;
• Exercises enforcement discretion; and
• Provides training to Regional, State, and tribal staff.
Office of Pollution Prevention and Toxics
• Has lead responsibility for rule development under TSCA;
• Determines status of TSCA chemical in relation to the PMN inventory (certified
statements);
• Participates in rule interpretation; and
• Provides technical guidance as appropriate, including serving as expert witnesses.
Office of Enforcement
• Provides legal advice regarding enforcement matters to the Assistant Administrator for
Prevention, Pesticides, and Toxic Substances;
• Acts as lead counsel on cases of national significance;
• Develops legal and enforcement policies and guidance;
• Confers with the Department of Justice on the potential impact of enforcement policy on
litigation matters;
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Chapter One General Operating Procedures
• Cooperates with the Assistant Administrator for Prevention, Pesticides and Toxic
Substances in the development of enforcement policies involving both enforcement
compliance and enforcement legal activities; and
• Assists and supports the Regional Counsel lead attorneys and Department of Justice
attorneys by coordinating legal activity and contributing case information to the
development process.
Office of General Counsel
• Provides legal interpretation of applicable statutes and regulations to support the TSGA
enforcement programs; and
• Has lead responsibility, in consultation with OE, for defensive litigation arising out of
enforcement actions and other actions involving the Agency (e.g., federal court challenges
to EPA's civil penalty proceedings).
CONSULTATION PROCEDURES
Generally, Headquarters has waived concurrences in routine administrative civil cases.
However, consultation is required in the following instances:
• Cases of first impression;
• Cases of unusual national significance;
• Requests for reduction of civil penalties greater than 40 percent;
• Requests for equitable relief (e.g., seizures and injunctions);
• Civil penalty appeals to the Administrator; and
• Certain types of Supplemental Environmental Projects (those involving horizontal nexus
and substitute performance).
The consultation procedures relating to each of the above actions are discussed in the section of
the manual pertaining to the individual subject matter.
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Chapter One
4 Synopsis of the Act
AUTHORITIES
The Administrator of EPA is authorized to administrator the Act in a reasonable and prudent
manner, often considering the economic, social, and environmental costs and benefits of actions
taken under TSCA. Delegations of Authority in the Agency Delegations Manual transfer
authority to exercise power to the Assistant and Regional Administrators. Redelegations of
Authority transfer authority to exercise power within an office.
Exercise of Authority
Constitution
The legal right to make and administer all laws comes from the Constitution. How Congress
will exercise its authority to provide for the common good and to regulate commerce is defined
within the laws it passes.
Statutes
All statutes passed by Congress must conform to the rights and authorities established by the
Constitution. When a bill becomes a law, it is codified in the U.S. Code. TSCA is codified
at 15 United States Code (U.S.C.) of Commerce and Trade.
Rules
Rules are promulgated by the Agency under the Statutes. There are three types of rules:
• Procedural: These rules describe routine Agency operations and are binding on the
Agency. Agency actions which fail to conform to these rules may be reversed. For
example, the rules of Practice for the Assessment of Civil Administrative Penalties (40
C.F.R. Part 22) are procedural rules.
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• Interpretive: These rules provide guidance to the public concerning the Agency's view
of its legislative mandate. They are the Agency's interpretation of the statute.
• Substantive: These rules define rights and duties of parties to be regulated and are
binding on the parties. The Administrative Procedure Act requires publication of
proposed substantive rules in the Federal Register and provision of the opportunity for
comment by interested parties. Publication of the final rule must occur 30 days before
its effective date.
The Case Development Officer, in consultation with the Attorney, is responsible for assuring
that the alleged violations are actual requirements imposed by statute or substantive rule, and that
the Agency's power to enforce these requirements is authorized by law. In addition, the Case
Development Officer is responsible for assuring that the authority to inspect and issue civil
complaints, among others, are appropriately delegated to the persons exercising the authority on
behalf of the Agency. See Appendix 1 for copies of the delegations of authority for TSCA.
SYNOPSIS OF THE ACT
TSCA authorizes the Administrator to establish regulations that govern the testing of chemical
substances and mixtures, premanufacture notification for new chemical substances or significant
new uses of existing substances, chemical substances or mixtures that pose an imminent hazard,
and recordkeeping and reporting requirements. The Act also defines TSCA's relationship with
other federal laws, authorizes research and development, and provides specific authorities for
inspections, subpoenas, and injunctive relief. In addition, TSCA protects confidential business
information submitted to the Agency. These provisions of the Act are briefly reviewed below
(from a compliance/enforcement perspective).
SECTION 4
Testing of Chemical Substances and Mixtures
40 C.F.R. Part 766, 790-799
Section 4 of TSCA authorizes EPA to promulgate rules which require that selected chemical
substances or mixtures be tested to evaluate concerns for specific effects on human health or
the environment. The Agency shall promulgate a TSCA §4 test rule if it finds that:
• a substance or mixture may present an unreasonable risk of injury to human health or the
environment or;
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Chapter One Synopsis of the Act
• a substance or mixture may enter into the environment in substantial quantities, which
could result in substantial or significant human exposure or environmental release or;
• insufficient data or knowledge exists about the health or environmental effects of a
substance or mixture in order to reasonably determine or predict the impacts of its
manufacture, processing, distribution, use and/or disposal; or
• testing is needed to develop such data.
If the Administrator devises a rule, the rule shall include:
• the identification of the substance for which testing is required;
• the standards for the development of test data; and
• a specification of the period of time for which the data shall be submitted.
Test rules issued under Section 4 are published at 40 C.F.R. 799.
Exemption
Anyone required to develop data by testing may apply to EPA for an exemption. The exemption
shall be granted if:
• the substance or mixture is equivalent to another substance for which test data has been
submitted under another rule;
and
• the submission of such data would duplicate test data which has been submitted or will
be developed.
Anyone granted an exemption must provide fair and equitable reimbursement, as determined by
EPA rules, to all persons who previously submitted or are developing test data, or who have
contributed to the cost of developing such data.
Notice
Subject to the Section 14 CBI disclosure rules, EPA shall, within 15 days of receiving any test
data, publish a notice in the Federal Register which would include the following:
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• identity of the substance;
• the intended uses and the information required by the test data development standards;
and
• the nature of the developed data.
Within 180 days of receiving test data or any other information which indicates that a substance
may present a significant risk of cancer, gene mutations, or birth defects, the Administrator
shall:
• Initiate action under sections 5 (PMNs or SNURs), 6 (Existing Chemicals), or 7
(Imminent Hazard) [See these sections for more details];
or
• Publish a finding in the Federal Register that the risk is not unreasonable.
EPA may, for good cause, extend the period for not more than 90 days.
A person not required to develop test data for a substance, but who will be subject to PMN or
SNUR requirements may petition EPA to prescribe standards for the development of test data.
The Administrator will approve or deny the petition within 60 days.
If the petition is granted, EPA will prescribe standards within 75 days. If the petition is denied,
EPA will publish the reasons in the Federal Register (subject to Section 14 disclose rules).
SECTION 5
Manufacturing and Processing Notices
Section 5 requires EPA to conduct a premanufacture review of new chemical substances, and
existing substances subject to Significant New Use Rules (SNURs) prior to their commercial
production and introduction into the marketplace or prior to undertaking a significant new use.
The review ensures that new chemicals or new uses that may pose an unreasonable risk to health
or the environment are regulated under Section 5(e).
In conducting its review of a new chemical substance, EPA assesses the risks associated with
all phases of the life cycle of the substance, including its manufacture, import, processing,
distribution in commerce, use, and disposal. The review is based on information provided by
the submitter in the notice as well as information obtained through other sources. EPA also
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considers several different factors in conducting its review, including the potential toxicity to
humans and the environment, and to a lesser extent, nonrisk factors such as the possible
economic benefits of a new chemical substance and the availability of substitutes.
TSCA §5 covers the following rules and requirements:
S5(a)m Premanufacture Notification (PMN> (40 C.F.R. Part 720):
This provision requires persons who manufacture or import new chemical substances for non-
exempt commercial purposes to submit, 90 days prior to manufacturing or importing, a pre-
manufacture notice (PMN) of their intention to conduct such activities, as well as test data in
their possession or control in accordance with 40 C.F.R. Part 720.50. A "new chemical
. substance" is defined as a substance not listed on the TSCA Chemical Substance Inventory.
Upon expiration of the review period, manufacture or importation may begin. When non-
exempt, commercial manufacture or import begins, the submitter must notify EPA of
commencement of manufacture or import by submitting a Notice of Commencement (NOC),
including the identity of the chemical substance, its premanufacture notice number, and the date
on which manufacture or import began.
If the substance does not pass PMN review, a number of responses may occur. The review
period may be extended, more information may be requested by the submitter, or the Agency
may place limits on the manufacture or use of the substance.
S5(aW2) Significant New Use Rules (SNURs) (40 C.F.R. Part 721):
EPA specifies by rule the use(s) of chemical substances which it considers to be significant new
uses. Although the substance may be listed on the Inventory, EPA must be notified 90 days
prior to commencement of any significant new use of any chemical listed in Part 721.
Extension of Notice Period
The Administrator may, for good cause, extend up to a total of 90 days the period specified in
5(a) or 5(b) before which manufacture or processing may not begin.
The extension and the reasons for it shall be published in the Federal Register, subject to Section
14 (Disclosure of Data), and shall constitute a final Agency action subject to judicial review.
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Content of Notice: Publications in the Federal Register
The submitter of a notice under §5(a)(l) or §5(a)(2) must include the following required data:
• All test data in possession or control, and a description of all test data known to, or
reasonably ascertainable by, the submitter;
• The submitter's identity;
• Chemical Identity: may include process information, if necessary to identify the
chemical, and also must provide the trade name;
• Description of impurities and byproducts;
• Proposed categories of use and estimated production volume for each use;
• Copies of any label, material safety data sheet, or other hazardous warning;
• List and description of process at each manufacturing site, including an estimate of the
number of individuals exposed; and
• Description of typical processing or use operation that includes an estimate of
environmental releases and a description of control technology to limit such releases.
Subject to Section 14 (Disclosure of Data), EPA shall, within 5 work days of receipt of a notice,
publish a notice in the Federal Register which identifies the substance (by, generic class unless
specificity is required in the public interest), lists the intended uses, and describes any tests
performed and any data developed.
At the beginning of each month EPA shall publish a list in the Federal Register regarding the
following:
• Each chemical substance for which notice was received, and notice period not expired
since previous Federal Register List.
• Each chemical substance for which the notification period expired since the previous
Federal Register List.
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S 5(Wn Submission of Test Data
A person required both to give notice under Section 5(a) and submit test data prior to the notice
under Section 4 (Test Rules) shall submit the required data at the time the notice is given.
A person required to give notice under Section 5(a) of a listed chemical substance (see §5(b)(4)),
but not required by Section 4 to submit test data prior to the notice shall submit data to EPA at
the time notice is given which shows that:
• for a new chemical, any combination of the manufacture, processing, distribution in
commerce, use, and disposal of the substance will not present an unreasonable risk or
injury to health or the environment; or
• for a significant new use, the intended use will not present an unreasonable risk or injury
to health or the environment.
Data submitted under both circumstances above shall be made available for examination by
interested persons, subject to Section 14 (Disclosure of Data).
The Administrator may, by rule, compile and keep current a list of chemical substances for
which any combination of the manufacture, processing, distribution in commerce, use, or
disposal may present an unreasonable risk to health or the environment.
S5(e) Order:
If EPA determines that the information available in support of a PMN is insufficient to make
a reasoned evaluation of the health or environmental effects of a chemical substance, EPA will
issue an order imposing controls, restrictions or prohibitions on the manufacture of the substance
in order to address the concerns of EPA.
S5ff) Order:
If EPA finds that the manufacture, import, processing, distribution, use or disposal of a chemical
substance presents or will present an unreasonable risk of injury to health or the environment
before a rule promulgated under TSCA §6 can protect against such risk, the Administrator may
issue an immediately effective proposed rule to impose controls or restrictions to protect against
such risk or may issue an Order to prohibit manufacture, processing, or distribution in
commerce.
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If the Administrator has not initiated any action under this Section, or Sections 6 or 7, before
the expiration of the applicable notification period, the Administrator shall publish in the Federal
Register, before the expiration of the Notice Period, a statement of the reasons for not initiating
action.
Summary of §5(h) Exemptions
Pursuant TSCA §5(h), certain substances and classes of substances are exempt from the full
notification and reporting requirements of TSCA §5, unless the chemical is subject to a §5(e)
or §5(f) order.
(1) Research and Development fR&D) Exemption (40 C.F.R. Part 720.36, 51 FR 15102, April
22, 1986):
Persons may be exempt from §5(a) and 5(b) requirements for chemical substances
manufactured or imported in small quantities (as defined by EPA by rule) solely for
purposes of scientific experimentation or analysis, or chemical research or analysis
(including for the development of a product).
In order to be eligible for this exemption, the manufacturer or importer is required to meet
the conditions listed at 40 C.F.R. Part 720.36 (a)-(g).
(2) Test Marketing Exemption CTME) (40 C.F.R. Part 720.38, 50 FR 16488, April 26, 1985,
as amended at 53 FR 12523, April 15, 1988):
Persons may apply for an exemption to manufacture or import a new chemical substance for
purposes of test marketing. So as not to be confused with R&D, test marketing, as defined
at 40 C.F.R. Part 720.3(gg), means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, or article containing that chemical
substance or mixture, by a manufacturer or processor, to not more than a defined number
of potential customers to explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that chemical substance,
mixture, or article in commerce.
The Agency will either approve or deny an application for a test marketing exemption no
later than 45 days after its submission, and thereafter publish a Federal Register (FR) notice
explaining the reasons for approval or denial.
(3) Low Volume Exemption (LVE) (40 C.F.R. Part 723.50, 50 FR 16488, April 26, 1985, as
amended at 53 FR 12523, April 15, 1988):
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Persons are eligible for this exemption if they are going to manufacture or import certain
chemicals in quantities of 1,000 kg or less per year. This exemption reduces the PMN
review period from 90 days to 21 days.
(4) Peel-Apart Film Exemption Notification (PAFEN) (40 C.F.R. Part 723.175, 47 FR 24317,
June 4, 1982, as amended at 53 FR 12523, April 15, 1988):
Persons are eligible for this exemption if they are going to manufacture or process new
chemical substances used on or for the manufacture or processing of instant photographic
and peel-apart film articles. Certain condition as listed in Part 723.175 must be met. This
exemption does not allow for distribution in commerce until a PMN has been reviewed by
EPA.
(5) Polymer Exemption Application (PEA) (40 C.F.R. Part 723.250, 49 FR 46086, November
21, 1984, as amended at 53 FR 12523, April 15, 1988):
Persons are eligible for this exemption if they are going to manufacture or import a
polymer, as defined in the regulations. This exemption reduces the PMN review period from
90 days to 21 days.
Other Exemptions
The Administrator may exempt any person from the 5(b) requirement to submit test data if data
has already been submitted for equivalent chemicals. The Administrator may require partial
reimbursement to all who previously paid the costs, similar to the requirement under §4(C).
The Administrator may also exempt any person from all or part of the requirement of this
Section if the Administrator determines that the manufacture, processing, distribution in
commerce, use, or disposal will not present an unreasonable risk to health or the environment.
In addition, a person may be exempt from §5(a) Notice and 5(b) submission of test data for a
chemical substance which exists temporarily as a result of a chemical reaction and to which there
is no, and will not be, human or environmental exposure.
SECTION 6
Regulation of Hazardous Chemical Substances and Mixtures
Where there is a reasonable basis to conclude that a chemical substance or mixture presents or
will present an unreasonable risk of injury to human health or the environment, the
Administrator is empowered to take a wide variety of regulatory actions which include:
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• Prohibiting or limiting the manufacture, processing, or distribution in commerce of such
substance or mixture;
• Requiring, by labeling and other means, appropriate warnings and instructions with
respect to the use, distribution in commerce, or disposal of the chemical substance or
mixture;
• Requiring recordkeeping and testing of such substance or mixture;
• Regulating the manner of disposal of the substance or mixture;
• Directing manufacturers or processors of such substance or mixture to give notice of the
unreasonable risk or to replace or repurchase the substance or mixture; or
• Imposing quality control (QC) procedures.
If the Administrator has a reasonable basis to conclude that a particular manufacturer or
processor is manufacturing or processing a substance which unintentionally presents or will
present an unreasonable risk to health or the environment, the Administrator may require such
manufacturer or processor to submit a description of the relevant quality control procedures
followed in the manufacturing or processing of the substance.
If the Administrator determines that the QC procedures are inadequate, the Administrator may
order that they be revised. If the Administrator determines that the inadequate QC procedures
resulted in distribution in commerce of substances which present an unreasonable risk of injury
to health or the environment, the Administrator may order the manufacturer or processor to:
• Give notice of such risk to processors or distributors in commerce to the extent
reasonably ascertainable;
• Give public notice of such risk; and
• Provide such replacement or repurchase of any such substance or mixture as is necessary
to adequately protect health and the environment.
In the promulgation of subsection (a) rules, the Administrator shall consider and publish a
statement as to the effects on health and the environment, the magnitude of exposure, the
benefits and availability of substitutes, and the economic consequences of the rule.
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S6 Polychlorinated Biphenyls (PCBsl Rule (40 C.F.R. Part 761):
This rule requires that the use, distribution, manufacture, and processing of polychlorinated
biphenyls (PCBs) be regulated and that PCBs be marked with clear and adequate warning. PCBs
are widely used in transformers, capacitors, hydraulic systems, and heat transfer systems.
Under the Interim Measures Program, owners of certain PCB units must visually inspect the
units, record all leaks, and begin repair of any moderate leaks within two days of discovery.
These inspections must take place once every three months, except where the unit poses an
exposure risk to food and feed products, in which case it must be inspected at least once a week.
• Prohibitions (40 C.F.R. 761.20). The following activities are prohibited:
— Processing or distributing in commerce PCBs or PCB items without an authorization
or exemption;
— Manufacturing PCBs without an exemption;
— Using PCBs or PCB items without an exemption; and
~ Servicing PCB transformers that require removal of the transformer coil.
• Recordkceping Requirements (40 C.F.R. 761.180). Facilities that keep PCB
transformers or capacitors must maintain annual records showing the weights of PCBs
in containers and transformers, number of transformers and capacitors, dates of transfer
of PCBs, and quantities of certain PCBs and PCB items remaining in service. In
addition, PCB disposal and storage facilities must keep annual records of PCBs and PCB
items that are received, stored, transferred, or disposed of.
• Marking Requirements (40 C.F.R. 761.40). PCBs and PCB items that contain more
than 50 ppm of PCBs (except PCB-contaminated transformers) and transport vehicles
carrying more than 45 kilograms of PCB liquids over 50 ppm or carrying one or more
PCB transformers must all be marked as containing PCBs.
• Storage Requirements (40 C.F.R. 761.651. PCB articles and PCB containers stored for
disposal must be stored in accordance with the PCB regulation. Specifications for
storage facilities include adequate roof and walls, floor and continuous 6-inch curbing
of impervious material, and a location above the 100-year flood level. Other
requirements include specifications for containers and time periods for temporary
storage.
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• Disposal Requirements (40 C.F.R. 761.60). PCS liquids and PCB items containing
liquids above 500 ppm PCBs must be disposed in either an EPA-approved incinerator
or any other disposal method approved by the Regional Administrator (RA). PCB
liquids and PCB items containing between 50 and 500 ppm PCBs must be disposed in
an EPA-approved landfill, an EPA-approved high-efficiency boiler, an EPA-approved
incinerator, or any other methods approved by the RA.
SECTION 7
Imminent Hazards
The Administrator may commence an action in an appropriate district court for the seizure
and/or relief of an imminently hazardous chemical substance or mixture, which is defined as one
that "presents an imminent and unreasonable risk of serious or widespread injury to health or
the environment". :
To date this section has not been utilized.
SECTION 8
Reporting and Retention of Information
Section 8 of TSCA authorizes EPA to require chemical manufacturers, importers and processors
to keep records and to report certain information. The purpose of Section 8 is to ensure that
EPA has continual access to (1) new information regarding adverse health and environmental
effects and level of exposure to all "TSCA" chemicals and (2) selected effects and exposure data
on selected chemicals. Section 8 also ensures that proper records are kept regarding allegations
of significant adverse reactions to health or the environment.
Section 8 covers existing chemicals, defined as chemicals that are already on the TSCA
Inventory. The Section covers the following rules and requirements:
S80?) Inventory (40 C.F.R. Part 710):
Under §8(b) of TSCA, EPA is required to compile and maintain an inventory of each chemical
substance manufactured, processed, or imported into the United States. During 1977, all
persons who manufactured, processed, and/or imported a chemical for commercial purposes that
was not subject to other laws were required to report. The initial TSCA Chemical Substance
Inventory (the Inventory) was published on June 1, 1979.
The inventory is divided into two parts:
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(1) Open Inventory: The published portion of the Inventory consisting of chemicals whose
identities are not confidential.
(2) Closed or Confidential Inventory: The portion of the Inventory, available only at EPA HQ,
consisting of chemicals held as TSCA Confidential Business Information (CBI).
Notice of Commencement (NOC) (40 C.F.R. Part 720.102):
Any person who commences the manufacture or importation of a new chemical substance for
a non-exempt commercial purpose for which that person had previously submitted a PMN (See
§5), must submit a notice of commencement of manufacture or import on or no later than 30
days after the first day of such manufacture or import.
NOC violations are addressed in the §5 ERP, because of their relationship with the §5 PMN
regulations and violations.
S8(a) Inventory Update Rule (TOR) (40 C.F.R. Part 710 Subpart B):
This Rule requires reporting by persons who manufacture or import chemical substances, in
quantities greater than 10,000 pounds per site, which appear on the TSCA Chemical Inventory.
The initial reporting period was August 25, 1986 to December 23, 1986. The first recurring
reporting period was August 25, 1990 to December 23, 1990. Subsequent recurring reporting
periods are from August 25 to December 23 at 4-year intervals thereafter.
S8(a) Preliminary Assessment Information Reporting Rule (PAIR) (40 C.F.R. Part 712):
This rule requires reporting by persons who manufacture or import chemicals listed at 40 C.F.R.
712.30 in quantities greater than 1,100 pounds per site.
S8(a) Comprehensive Assessment Information Rule (CAIR^ (40 C.F.R. Part 704 Subparts C and
D):
This rule requires reporting by persons who manufacture, import, or process chemicals listed
at 40 C.F.R. 704.225.
S8(a) Chemical Specific Rules (40 C.F.R. Part 704 Subpart B):
This rule requires reporting by persons that manufacture, import, and in some cases, process the
following chemicals:
TSCA Case Proceedings 1-38 Guidance Manual 1992
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Chapter One Synopsis of the Act
P-TBBA, P-TBT, P-TBB (40 C.F.R. Part 704.33)
Chlorinated napthalenes (40 C.F.R. Part 704.43)
Chlorinated terphenyl (40 C.F.R. Part 704.45)
Hexachloronorbomadiene (40 C.F.R. Part 704.142)
Hexafluoropropylene Oxide (40 C.F.R. Part 704.104)
4,4'-methylenebis(2-chloroaniline)(MBOCA) (40 C.F.R. Part 704.175)
2Polybrominated biphenyls (PBBs) (40 C.F.R. Part 704.195)
2Tris (2,3-dibromopropyl) phosphate (40 C.F.R. Part 704.205)
S8(c) Alleged Significant Adverse Reactions (40 C.F.R. Part 717):
This rule requires persons who manufacture, import, process, or distribute chemical substances
or mixtures in commerce to keep files of allegations of significant adverse reaction and provide
this information to EPA upon request. Exemptions include persons whose activities consist of
mining or other solely extractive functions; processors who are not also manufacturers if the
person does not process chemical substances to produce mixtures, or the person does not
repackage chemical substances or mixtures; and persons who are solely distributors or retailers.
SSrd) Health and Safety Studies Submission (40 C.F.R. Part 716.51):
This rule requires persons who manufacture, import, process, or propose to manufacture,
import, or process listed chemicals to submit lists or copies of unpublished health and safety
studies to EPA.
S8(e) Substantial Risk Reporting (June 1991 TSCA Section 8(e) Reporting Guide)
This immediately enforceable section requires persons who manufacture, import, process, or
distribute in commerce a chemical substance or mixture and who obtain "new" information
which reasonably supports the conclusion that such substance or mixture presents a substantial
risk of injury to health or the environment to report such information to EPA within 15 days.
SECTION 9
Relationship to Other Federal Laws
If the Administrator determines that a risk may be prevented or adequately reduced under a
Federal law administered by another agency, EPA shall submit to that agency a report describing
the risk. If that agency finds no risk, or takes action directed at the risk, EPA may not take any
:7hese rules have been "sunsetted" and replaced by SNUR's.
TSCA Case Proceedings 1-39 Guidance Manual 1992
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Chapter One Synopsis of the Act
regulatory action under TSCA sections 6 and 7 directed to that risk. If the Administrator
determines that a risk may be prevented or adequately reduced under a Federal Law
administered in whole or in part by the Administrator, the Administrator shall use such
authorities to protect against such risk.
SECTION 10
Research, Development, Collection Dissemination, and Utilization
of Data
The Administrator shall, in consultation and cooperation with the Secretary of Health,
Education, and Welfare (HEW) and other heads of appropriate departments and agencies,
conduct research, development, and monitoring as is necessary to carry out the Act. The
Administrator may enter into contracts and may make grants for research, development, and
monitoring under this subsection.
SECTION 11
Inspections and Subpoenas
A duly designated representative of EPA can inspect any establishment or facility where
chemical substances are manufactured, processed, stored, or held before or after distribution.
Such an inspection may only be made upon presentation of credentials and a written notice to
the owner, operator or person in charge of the premises to be inspected.
EPA can subpoena witnesses, documents, and other information. Failure to comply will result
in the appropriate U.S. District Court enforcing the action.
Inspections and subpoenas are covered in more detail in Chapter 2, subsections (a) and (b).
SECTION 12
Exports
(40 C.F.R. Part 707.60)
This provision requires persons who export chemicals subject to final and certain proposed rules
and orders under TSCA Sections 4, 5, 6, or 7 to notify EPA of the country of destination the
first time a chemical is shipped to that country during a calendar year. The Agency is then
responsible for notifying the importing country's government of the exportation of the chemical,
of any existing or proposed EPA regulatory action against the chemical, and of the availability
of information on the chemical submitted to EPA. (See also 45 FR 82844, December 16, 1980.)
TSCA Case Proceedings 1-40 Guidance Manual 1992
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Chapter One Synopsis of the Act
§12 Policies. Strategies, and Guidelines
• Enforcement Response Policy for Sections 8, 12, and 13.
SECTION 13
Imports
(40 C.F.R. Part 707.20)
This provision requires persons who import chemical substances to certify that each shipment
is in compliance with TSCA Sections 5, 6, or 7 or is not subject to TSCA. (See also 48 FR
34734, August 1, 1983, 19 C.F.R. Part 12.118 through 12.127 and 127.28 amended.)
§13 Policies. Strategies, and Guidelines
• Enforcement Response Policy for Sections 8, 12, and 13
SECTION 14
Disclosure of Data
Section 14 protects from disclosure any Confidential Business Information (CBI), such as trade
secrets and privileged financial data. Any health and safety studies that have been submitted
under the Act may be subject to disclosure. EPA employees are subject to criminal penalties
for the willful disclosure of CBI.
The Act also makes clear, however, that the public interest in chemical regulation must also be
considered and, in certain cases, outweighs the protection of CBI. See Chapter II, section (e)
for further details on the handling of CBI.
SECTIONS 15 AND 16
Prohibited Acts; Penalties
It is unlawful for any person to fail or refuse to comply with any order, rule, or requirement
prescribed by this Act including:
• Failing or refusing to comply with any rule promulgated or order issued under Section
4, 5, or 6 of the Act, or any requirement prescribed by Section 5 or 6;
• Using for commercial purposes a chemical substance or mixture that such person knew
or had reason to know was manufactured, processed, or distributed in commerce in
TSCA Case Proceedings 1-41 Guidance Manual 1992
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Chapter One Synopsis of the Act
violation of Section 5 or 6, a rule or order under Section 5 or 6, or an order issued in
an action brought under Section 5 or 7;
• Failing or refusing to establish or maintain records; submit reports, notices, or other
information; or permit access to or copying of records, as required by the Act or a rule
promulgated thereunder; or
• Failing or refusing to permit entry or inspection as required by Section 11.
Violations are subject to civil penalties of up to $25,000 per day, and are calculated using the
gravity based penalty matrix found in the various ERPs.
SECTION 17
Specific Enforcement and Seizure
The district courts of the U.S. have jurisdiction over certain civil actions and specific cases.
The U.S. district court for which there was a violation has the right of seizure and condemnation
of the chemical substance, mixture, or article.
SECTION 18
Preemption
Except as provided in section 18(a)(2), nothing in this Act shall affect the authority of any State
or political subdivision of a State to establish or continue in effective regulation of any chemical
substance, mixture, or article containing a chemical substance or mixture.
SECTION 19
Judicial Review
Not later than 60 days after promulgating a rule under section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e)
or 8, any person may file a petition for judicial review of such rule with the U.S. Court of
Appeals for the circuit in which such person resides or where their principal place of business
is located.
SECTION 20
Citizens Civil Actions
Any person may bring a civil suit to restrain a violation of TSCA, or to compel EPA to perform
any duty required by TSCA. No civil action may be commenced before the expiration of 60
TSCA Case Proceedings 1-42 Guidance Manual 1992
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Chapter One Synopsis of the Act
days after the plaintiff has been given notice of such violation or regarding two other criteria set
forth in section 20(b)(l)(A) et seq.
In any action under this section, the Administrator, if not a party, may intervene as a matter of
right.
When two or more civil actions brought under subsection (a) involve the same defendant and
issues, they may be consolidated for trial by order.
SECTION 21
Citizens Petitions
Any person may petition EPA to issue, amend, or repeal a rule, or order, under the testing,
reporting, or restriction sections of TSCA. Such petition shall be filed in the principle office
of the Administrator and shall set forth the facts which it is claimed establish that it is necessary
to issue, amend, or repeal a rule under section 4, 6, 8 or an order under 5(e), 6(b)(l)(A) or (B).
SECTION 22
National Defense Waiver
The Administrator shall waive compliance with any provision of this Act upon a request and
determination by the President that the requested waiver is necessary in the interest of national
defense.
SECTION 23
Employee Protection
No employer can discharge any employee or discriminate in any way against employees because
they participated in, testified in, or caused to commence a proceeding under TSCA.
Any person who believes that an employee has been discriminated against with respect to
employee's compensation, terms, condition, or privileges may file a complaint with the Secretary
of Labor alleging such discharge or discrimination.
Any employee or employer adversely affected or aggrieved by an order issued under subsection
(b) may obtain review of the order in the U.S. Court of Appeals for the circuit in which the
violation allegedly occurred.
Whenever a person fails to comply with an order issued under subsection (b)(2), the Secretary
shall file a civil action in the U.S. district court for the district in which the violation occurred.
TSCA Case Proceedings 1-43 Guidance Manual 1992
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Chapter One Synopsis of the Act
Subsection (a) does not apply to employees who deliberately cause a violation of TSCA without
direction from their employers.
SECTION 24
Employment Effects
The Administrator shall evaluate on a continuing basis the potential effects on employment
(including reductions in employment or loss of employment from threatened plant closures) of:
(a) the issuance of a rule or order under section 4, 5, or 6; or (b) a requirement of section 5
or 6.
SECTION 25
Studies
The Administrator shall conduct a study of all Federal laws administered by the Administrator
for the purpose of determining whether and under what conditions, if any, indemnification
should be given any person as a result of any action taken by the Administrator under any such
law.
SECTION 26
Administration of the Act
Upon request by the Administrator, each Federal department and agency is authorized to do the
following:
(1) make its services, personnel, and facilities available (with or without reimbursement) to the
Administrator to assist the Administrator in the administration of this Act, and
(2) furnish to the Administrator such information, data, estimates, and statistics, and to allow
the Administrator access to all information in its possession as the Administrator may
reasonably determine to be necessary for the administration of this Act.
SECTION 27
Development and Evaluation of Test Methods
The Secretary of Health, Education, and Welfare, in consultation with the Administrator, may
conduct and make grants to public and non-private entities for projects for the development and
evaluation of inexpensive and efficient methods of the following:
TSCA Case Proceedings 1-44 Guidance Manual 1992
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Chapter One Synopsis of the Act
(1) determining and evaluating the health and environmental effects of chemical substances and
mixtures, and
(2) developing test data to meet the requirements of rules declared under section 4.
SECTION 28
State and Federal Interagency Cooperation
TSCA charges EPA with the responsibility of protecting public health and the environment from
the risks associated with exposure to chemical substances or mixtures. In order to fulfill this
responsibility, EPA seeks cooperation with appropriate state and federal agencies.
TSCA Pilot Enforcement Cooperative Agreements
Section 28 of TSCA authorizes EPA to enter into Cooperative Agreements with states/tribes for
purposes of complementing (but not reducing) the authority of the Administrator under the Act.
In July of 1981, a Pilot State TSCA Enforcement Cooperative Agreement Program, involving
five states, was initiated. The five states (California, Connecticut, Maryland, Michigan, and
Ohio) conducted compliance monitoring activities related to the PCS program.
Federal Interagency Cooperation
United States Department of Justice (DOJ). EPA's working relationship with the Department
of Justice and the United States Attorney's Office continues to be governed by the June 1977
Memorandum of Understanding (MOU) between DOJ and EPA. All criminal cases, collection
and seizure actions, and warrants for inspections under TSCA must be filed by the DOJ or the
United States Attorney's Office. Also, any cases that the Regions or OE determine would more
appropriately be handled as a judicial civil action, should be referred to DOJ. EPA
Headquarters and regional components are expected to use their best efforts to ensure that a
constructive working relationship is maintained with DOJ and to provide assistance to DOJ in
the preparation of those actions. (For the procedures for referring actions involving criminal
cases, collection, seizure, or warrants, see the individual topics in this manual.)
Food and Drug Administration (FDA). Under the terms of an Interagency Agreement, EPA and
FDA cooperate closely on a laboratory inspection/data audit program. As part of the
Interagency Agreement, FDA investigators may inspect laboratories that conduct tests pursuant
to TSCA:
• To determine compliance with the Good Laboratory Practice Standards;
TSCA Case Proceedings 1-45 Guidance Manual 1992
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Chapter One Synopsis of the Act
• To ensure that the tests were conducted in accordance with accepted protocols; and
• To ensure that final study reports fully and accurately reflect the test results.
These FDA inspections are conducted at the request of EPA.
Occupational Safety and Health Administration (OSHA)
In November of 1990, EPA signed a MOU with OSHA to improve the working relationship
between EPA and OSHA on compliance and enforcement matters. The components of the MOU
are designed to strengthen the enforcement capabilities of the two Agencies. Some of key
provisions are:
• EPA and OSHA will continue to conduct joint inspections;
• Information exchange will increase, especially for maintaining contact between key
personnel in the Headquarters and field operations of the two agencies; and
• Data exchange and improved training will be emphasized to improve targeting and the
enforcement referral process.
SECTION 30
Annual Report
The Administrator shall prepare and submit to the President and the Congress on or before
January 1 of every year a comprehensive report on the administration of this Act during the
preceding fiscal year.
TSCA Case Proceedings 1-46 Guidance Manual 1992
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Chapter One
5 Alphabetical Index
Ability to Pay
- Non-profit Organizations (NPOs)
and Government Entities
Act
Administration of the Act
Administrative Actions
Administrative Law Judge
Administrative Procedures Act
Administrative Warrant (Model)
Administrator
Affidavit
Agency
AHERA
Alleged Significant Adverse Reactions
Amicus Curie
Analytical Chemistry Branch/BEAD
Annual Report
Answer to Complaint
- Assignment of Presiding Officer
- Consequences of an Insufficient
Answer
- Evaluation of Answer
- Procedural Considerations
- Sufficiency of Answer
Antimicrobial Program Branch/RD
Appeal
- Actions by the Environmental
Appeals Board
- Appeal of Initial Decision
* Environmental Appeals Board's
Action
* Jurisdiction of Administrator
* Notice of Appeal and Appellate
Brief
* Oral Argument on Appeal
6-59
6-60
1-7
1-44
4-3
1-3, 1-7
1-3 -
2E-20, 2E-21, 2E-23
1-7
1-7, 2-18, 3-6, 6-71, 2E-21
1-7
5-2
1-36
1-7, 6-43
1-3
1-44, 3-32
6-37
6-39
6-38
6-38
6-37
6-37
1-3
1-7, 6-85
6-85
6-86
6-87
6-86
6-86
6-88
TSCA Case Proceedings
1-47
Guidance Manual 1992
-------
Chapter One
Alphabetical Index
* Reply Brief
* Scope of Review
- Final Order
* Appeal from Final Order
* Timing and Content
* Motion to Reconsider and Stay
Request
- Immediately Appealable Orders
- Payment of Penalty
- Request for Stay
Appellant
Appellee
Article
Asbestos Hazard & Emergency Response Act
Asbestos School Hazard Abatement Act
Asbestos Worker Protection Rule
Ask Sam
Assistant Administrator
Authority
Bona Fide
Brief
Burden of Persuasion
Burden of Proof
Case Development Officer (CDO)
Certificate of Service
Certified Statements
Chain of Custody
Chemical Specific Rules
Chemical Substances
Circumstantial Evidence
Citizens Civil Actions
Citizens Petitions
Civil Administrative Penalties
Civil Complaint
Civil Judicial Actions
Claims Collection Litigation Report
Code of Federal Regulations
6-87
6-87
6-88
6-89
6-88
6-88
6-85
6-89
6-85
1-7
1-7
1-7
1-3
1-3
5-3
3-39
1-3
1-26
1-8
1-8
1-8
1-8, 8-14
1-3, 11-2
6-89
3-40
1-8, 3E-15
1-36
1-25
1-8
1-42
1-43
4-4
1-8, 6-5
4-5
1-3
1-3, 1-9
TSCA Case Proceedings
1-48
Guidance Manual 1992
-------
Chapter One
Alphabetical Index
Collection of Civil Penalty Assessments
- Documentation of Collection Efforts
- Follow-up to Final Demand for Payment
- Written Demands for Payment
Compliance Promotion
Complainant
Complaint preparation
- Checklist of Complaint Requirements
- Drafting the Complaint
- Filing the Complaint
- Service of the Complaint
Comprehensive Assessment Information Rule
Compromise of the Penalty
Concurrence Procedures
Confidential Business Information
- Access to TSCA CBI at Facilities Outside of OPPT
- Authority
- Court-Ordered Disclosure
- Creating New CBI Documents and Personal Working Papers
- Declaration of Confidential Business Information
- Determining Confidentiality
- Disclosure of Information to Contractors/Subcontractors
- Disclosure of Information to Protect Health/Environment
- Disclosure of TSCA CBI to Persons Outside the Agency
- Disclosure to Congress or the Comptroller General
- Disclosure to Other Federal Agencies
- Obtaining Access to TSCA CBI
- Penalties
- Sample CBI Complaint
- Telephone Calls During Which TSCA CBI is Discussed
- TSCA CBI Access Request
- Use of CBI in Administrative Hearings
- Use of CBI in Case Preparation
- Use of CBI in Civil and Criminal Proceedings
Confidentiality Clearance Reference
Consent
Consent Agreement/Consent Order
Consent Agreement and Final Order
Consent Agreement - Schedule of Activities
9-1
9-3
9-3
9-2
12-2
1-9
6-6
6-6
6-7
6-10
6-10
1-37
9-4
1-21
1-3, 1-26, 2-7, 2-57, 6E-13,
6-69
2-64
2-57
2-65
2-61
3-4, 3E-11
2-63
2-65
2-65
2-63
2-64
2-64 .
2-59
2-59
2E-68
2-62
2E-66, 2E-67
2-62
2-60
2-62
3-5
1-9
1-3, 1-9, 6-56, 6E-61
1-3
9E-8
TSCA Case Proceedings
1-49
Guidance Manual 1992
CM'; -: ' v..,,'-v
/<-.! iV. ytrrpi; !3\V (TF-7
\V;ishi"t*tO!i, DC 20400
-------
Chapter One
Alphabetical Index
Consolidated Rules of Practice
Constitution
Consultation Procedures
Continuing Violations
Criminal Enforcement
Criminal Provisions of TSCA
Criminal Investigation Division
Criminal Investigations
Criminal Judicial Actions
Criminal Warrants
Custody Records
Custody Seal
Default
Default Judgement/Order
Defendant
Delegated Authority
- Environmental Appeals Board
- Headquarters Actions
- Presiding Officer
- Regional Administrator
- Regional Judicial Officer
Department of Justice
Deposition
Development and Evaluation of Test Methods
Direct Evidence
Disclosure of Data
District Court
Discovery
Document Control Number
Document Control Officer
Double Jeopardy
Drafting the Complaint
- Amount of Civil Penalty
- Caption
- Certificate of Service
- Citation of Legal Requirements Violated
- Factual Allegations
- Jurisdiction^ Authority
- Notice of Opportunity for an
Informal Settlement Conference
1-3
1-26
1-25
6-6
8-1, 8-5
8-2
1-3
8-9
4-8
2-19
3-5
3E-14
1-9
1-9, 6E-49
1-9
6-1
6-3
6-3
6-2
6-1
6-1
1-3, 1-20, 1-43
1-9
1-44
1-8
1-41
1-10
6-64, 8-14
1-3
1-3
3-29
6-7
6-8
6-8
6-9
6-8
6-8
6-8
6-9
TSCA Case Proceedings
1-50
Guidance Manual 1992
-------
Chapter One
Alphabetical Index
- Right to Request a Hearing
- Signature Block
Dun and Bradstreet
Elements of an Inspection
Elements of Proof
Emergency Planning and Community Right to Know Act
Employee Protection
Employment Effects
Enforcement Case File
Enforcement Discretion
- Request for an Expedited Safety
Review of a Chemical Substance
Enforcement Document Retrieval System (EDRS)
Enforcement Requests
Enforcement Response Policy
Environment
Environmental Appeals Board
Equity
Exclusionary Rule
Exemptions
Ex Parte
Expert Witness
- Contractor Witness
- Headquarters Witness
- Other Government Witnesses
- Regional Witness
Exports
Evidence
Evidence Assessment
Facility
Federal Claims Collection Standards
Federal Facilities Enforcement
Federal Interagency Cooperation
Federal Register
FIFRA and TSCA Tracking System (FTTS)
Files (Agency)
- Enforcement Case File
- Files of Hearing Clerk and Presiding Officer
- Filing Requirements
- Public Access to Documents Filed
6-9
6-9
3-32
2-4
3-19
1-4
1-43
1-44
6-34
10-1
10E-4
3-38
3-39
1-4, 5-1, 6-5
1-10
1-4, 1-10, 6-3, 6-85, 6-87
1-10
1-10
1-25, 1-30, 1-31
1-10, 2-16, 6-36
1-11, 6-72
6-73
6-73
6-73
6-73.
1-40, 5-5
1-10, 6-68, 6-70
3-1
1-11
1-4
12-1
1-43
1-4, 1-11, 1-26, 1-29
1-4, 3-36
6-33
6-34
6-33
6-35
6-35
TSCA Case Proceedings
1-51
Guidance Manual 1992
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Chapter One
Alphabetical Index
Filing the Complaint
Filing of Consent Agreement and Order
Final Order
- Appeal from Final Order
- Oral Argument on Appeal
- Timing and Content
Financial Data
Financial Directories
Follow-up Inspections
Food and Drug Administration
Freedom of Information Act (FOIA)
General Operating Procedures
Glossary
Good Laboratory Practices (GLPs)
Hazardous Chemical Substances
Headquarters
Headquarters Actions
Hearing
Hearing Clerk
Hearing Process
Health and Safety Studies Submission
Hexavalent Chromium
Imminent Hazard
Imports
In Camera
In Rem
In Rem Actions:
-§7
- §17(B)
In Rem Complaint (Model)
Information Management Division
Initial Assessment
- Inspection File Close-Out
- Potential Enforcement Action
Initial Decision
Injunction
- §17(a) Injunctions
- §5(e) Injunctions
- §5(f) Injunctions
- §7 Injunctions
6-10
6-5
1-11, 6-88, 9-2
6-89
6-88
6-88
3-7, 3-31
3-34
9-7
1-4, 1-43
1-4, 1-11
1-4, 1-17
1-5
I1-4, 5-5
1-32
1-4
6-3
1-11
1-11
6-67
1-11, 1-36
5-4
1-26, 1-37
1-41, 5-5
1-12
7-3, 7-28
7-28
7E-31
1-4
3-16
3-17
3-16
1-12
1-12, 4-6, 7-3
7-4
7-5, 7-21
7-5, 7-21
7-5, 7-22
TSCA Case Proceedings
1-52
Guidance Manual 1992
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Chapter One
Alphabetical Index
Injunctive Relief
Inman Case, The
Inspections
- Authority
- Confidentiality
- Consent to enter and inspect
- Declaration of Confidential Business Information
- Elements of an Inspection
- Entry
- Opening Conference
- Pre-Inspection Preparation
- Purpose
- Receipt for Samples and Documents
- Report Preparation
- Sampling and Documentation
- Scope
Inspection File Close-out
Inspection File Review
Inspections and Subpoenas
Inspector
Integrated Data For Enforcement
Analysis (IDEA) System
Interagency Agreement
Interagency Testing Committee
Interlocutory Appeal
Intervenor
Inventory
Inventory Update Rule
Investigation
Judgement
Judicial Notice
Judicial Officer
Judicial Review
Jurisdiction of Administer
Jurisdictional Authority
Knowing and Wilful
Laboratory Analyses
Local Education Agencies
Low Volume
7-19
8-15
2-1
2-2
2-4, 2-6
2-3
2-7
2-4
2-5
2-6
2-5
2-1
2-7
2-8 •
2-6
2-3
3-17
3-3
1-40
1-12
3-37
1-4
1-4
1-12
1-12
1-35
1-35
8-10
1-12
1-12
1-10
1-42
6-86
6-28
1-12
3-5
1-4, 5-2
1-4
TSCA Case Proceedings
1-53
Guidance Manual 1992
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Chapter One
Alphabetical Index
Management Information Tracking
System (New Chemicals) (MITS)
Manufacturing and Processing
Notices
Marshall v. Barlow
Maximum Permitted Intake
Memorandum of Understanding
Mixtures
Model Civil Litigation Report Outline
Moody's Industrial Manual
Motions (In general)
- Examples of Motions
- Reply to Motion
- Written Motions
Motion for an Accelerated Decision
Motion for Consolidation or Severance
Motion for Default
Motion for Interlocutory Appeal
Motion for Judgment
Notwithstanding Verdict
Motion for a More Definite
Statement
Motion for Temporary Restraining Order
Motion in Bar
Motion in Limine
Motion to Amend
Motion to Dismiss
Motion to Extend Time to File
Motion to File an Amicus Brief
Motion to Implead
Motion to Intervene
Motion to Reconsider and Stay Request
Motion to Reopen a Hearing
Motion to Set Case for Hearing
Motion to Strike
Motion to Strike Defenses
Movant (Movent)
Multi-Media Enforcement
National Compliance Data Base
National Defense Waiver
3-38
1-29
2-15
1-4
1-4, 1-43
1-25
7E-11
3-34
6-39
6-40
6-40
6-39
1-13,
6-47
1-13,
6-45
1-13
1-13
7E-24
1-13
1-13
1-13
6-44
6-41
1-13,
6-48
6-43
6-48
6-43
6-88
6-82
1-13
1-14
1-14.
1-14
11-1
1-5
1-43
6-47
6-47
6-45
6-48
TSCA Case Proceedings
1-54
Guidance Manual 1992
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Chapter One
Alphabetical Index
National Enforcement Investigations Center
Neutral Inspection Scheme
New Chemical Substance
Non-Profit Organizations
Notice of Commencement
Notice of Detention
Notice of Hearing and Venue
Notice of Inspection
Notice of Noncompliance
- Asbestos Worker Protection Rule
- Exports
- Good Laboratory Practice Regulations (GLPs)
- Hexavalent Chromium
- Imports
- Procedures for Issuing an NON
- Other Persons
-PCBs
- Regional Authority to Issue NONs
- Sample Notice of Noncompliance
- TSCA Title II AHERA
Notice of Opportunity for an Informal
Settlement Conference
Notice of Warning
Notification Letters
- Model Notification Letter
- Model TSCA Notification Letter
Objections and Rulings
- Appeal of Ruling
- Rulings & Exceptions to Rulings
Occupational Safety and Health
Administration
Offers of Proof
Office of Compliance Monitoring
Office of Enforcement
Office of General Counsel
Office of Management and Budget
Office of Pollution Prevention
and Toxics
Office of Prevention, Pesticides,
and Toxic Substances
1-5
1-14
1-14
6-60
1-5, 1-27, 1-35
4-4
6-67
2-5, 3-3, 3E-8
1-5, 4-3, 5-1, 5E-8
5-3
5-5
5-5
5-4
5-5
5-1
5-3
5-4
5E-6
5E-8
5-2
6-9
1-5, 5-1
2-9
2E-12
2E-.11 , ...
6-79
6-79
6-79
1-5, 1-43
6-79
1-5,1-23
1-5, 1-17, 1-24
1-5, 1-25
1-5, 2-28
1-5, 1-24
1-5
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Guidance Manual 1992
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Chapter One
Alphabetical Index
Office of Regional Counsel
Oversight of Settlement Agreements
Parallel Proceedings
Parts per Million
Party
Payment
-Types:
Full
Installation
- Written Demands for
Penalties
Penalty Assessment Considerations
Continuing Violations
Guidelines for Determining Amount
Penalty Calculations (Documenting)
Penalty Payment
Person
Petitioner
Photographs and Video Tapes
Policy and Grants Division
Polychlorinated Biphenyl (PCBs)
Potential Enforcement Action
Preemption
Prehearing Conference
Preliminary Assessment Information
Reporting Rule
Preliminary Injunction
Premanufacture Notice
54 Preponderance of the Evidence
Presiding Officer
Prima Facie Case
Primary Office Responsibilities
Privilege
Programmed Inspection
Project Plan
Pro Se
Prohibited Acts; Penalties
Proof
Receipt for Samples and Documents
Referring Judicial Actions
1-17
9-1
1-14
1-5
1-14
9-2, 9-3
9-3
9-3
9-2
2-59, 6-81
6-5
6-6
6-5
6-58
6-89
1-14
1-14
3-7
1-5
1-5, 1-15, 1-36, 5-4
3-16
1-42
6-63
1-5, 1-38
7-20
1-5,1-20,1-26,1-27,1-29,2-
1-14, 6-68
1-14, 6-2, 6-39
1-15, 3-16
1-21
1-15
1-12
3-4
1-15
1-41
1-15
3-4, 3E-10
7-9
TSCA Case Proceedings
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Guidance Manual 1992
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Chapter One
Alphabetical Index
Referral Procedures
- Referral Parties and Minimum
Amounts
Regional Administrator
Regional Counsel
Regional Judicial Officer
Regulation of Hazardous Chemical
Substances and Mixtures
Regulatory Process
Relationship to Other Federal Laws
Reply Brief
Reporting and Retention of
Information
Request for Stay
Research, Development, Collection
Dissemination ... of Data
Respondent
Reservation
Right to Request a Hearing
Rules
Searches
Securities and Exchange Commission
Seizure
Seizure Order
Self-Disclosure Process
Service of the Complaint
- Certified Mail
- Personal Service
- State or Local Government
- U.S. Government Officials or Agency
Service of Process
Settlement Agreements
- Collection of Civil Penalty Assessments
* Documentation of Collection Efforts
* Follow-up to Final Demand for Payment
* Written Demands for Payment
- Follow-up Inspections
- Monitoring Supplemental Enforcement Projects
- Referral Procedures
* Referral Parties and Minimum Amounts
9-5
9-6
1-15, 1-21, 6-1
1-22, 2-17
1-15, 6-1
1-34
1-20
1-39
6-87
1-37
6-85
1-40
1-15
1-1
6-9
1-26
8-12
3-33
1-15, 4-8, 7-6
7-30
2-53
6-10
6-10
6-10
6-11
6-11
1-15, 2-30
9-1
9-1
9-3
9-3
9-3
9-7
9-6
9-5
9-6
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Guidance Manual 1992
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Chapter One
Alphabetical Index
- Suspension or Termination of Collection Activity
- Types of Payment
* Compromise of the Penalty
* Full Payment
* Installation Payment
Settlement Conference
Settlement with Conditions
- Supplemental Enforcement Projects
Significant New Use Rule
Specific Enforcement and Seizure
Standard of Proof
Stafford and Badgett Case, The
State
State and Federal Interagency
Cooperation
Statute
Statute of Limitations
Stipulations
Strict Liability
Sua Sponte
Subpoena
Subpoena Authority
- Alaska Pipeline Service Company Subpoena
- Documentation and Process
- Issuance
- Management Plan for the Mercury Subpoenas
- Mercury Subpoena
- Process
- Service
- Special Considerations
- Sworn Oral Testimony
Subpoena Deuces Tecum
Substantial Risk Reporting
Supplemental Environmental Project
Suspension or Termination of
Collection Activity
Standard and Poor's Register
Studies
Synopsis of the Act
Technical Opinions
9-5
9-3
9-4
9-3
9-3
6-55
6-57
6-57
1-5, 1-26, 1-27, 1-28, 1-36
1-42
1-16
8-16
1-16
1-45
1-16, 1-26
1-16
1-16
1-16
1-16
1-16, 1-37, 6-72
2-27
2-32
2-28
2-30
2-40
2-46
2-30
2-30
2-27
2-30
1-16
1-37
1-5, 6-57, 9-6
9-5
3-34
1-44
1-27
3-40
TSCA Case Proceedings
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Guidance Manual 1992
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Chapter One
Alphabetical Index
Temporary Restraining Order
Test Rules
Testimony of Witnesses
Testing of Chemical Substances and Mixtures
Toxics Release Inventory System
Toxic Substances Control Act
TSCA Enforcement Requests
TSCA Statutory History
Transcript of Hearing
Trial Brief
- Challenge to Initial Decision
- Initial Decision
- Penalties
- Procedures
- Preparation of Brief
Types and Adequacy of Evidence
- Double Jeopardy
United States Code
United States Environmental Protection
Agency
Unprogrammed Inspection
Update System
Voluntary Disclosure
- Documentation
- Self-Disclosure Process
Warrant
- Criminal Warrants
- Important Procedural Considerations
- Model Administrative Warrant
- Model Affidavit for an
Administrative Warrant
- Model Application for
Administrative Warrant
- Procedures for Obtaining a
Warrant
- Securing and Serving An
Administrative Warrant
- Seeking a Warrant Before
Inspection
1-5, 7-19
5-4
6-70
1-27
3-35
1-6
3E-41
1-19
6-80
6-80
6-82
6-81
6-81
6-81 •
6-81
3-29
3-29
1-6, 1-16
1-4
1-14
1-1
2-53
2-55
2-53
1-17, 2-15
2-19
2-16
2E-23
2E-21
2E-20
2-17
2-16
2-16
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Guidance Manual 1992
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Chapter One Alphabetical Index
Witnesses 6-74, 6-70
- Personal Appearance and Conduct 6-74
- Proper Conduct During Recess and
After the Trial 6-78
- Testifying Under Cross Examination 6-77
- Testifying Under Direct Examination 6-77
- Witness Stand Technique 6-75
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Chapter Two
Investigation Procedures
CHAPTER CONTENTS PAGE
1 Inspections 2-1
Introduction 2-1
Purpose 2-1
Authority 2-2
Scope 2-3
Confidentiality .2-4
Elements of an Inspection 2-5
la TSCA Notification Letters 2-9
Example 2E-1: Model TSCA Notification Letter 2E-11
Example 2E-2: Model TSCA Notification Letter 2E-12
Ib Warrants 2-15
Securing and Serving an Administrative Warrant 2-16
Example 2E-3: Model Application for Administrative Warrant . . . 2E-20
Example 2E-4: Model Affidavit in Support of Application for. an
Administrative Warrant 2E-21
Example 2E-5: Model Administrative Warrant 2E-23
2 Subpoena Authority 2-27
Authority 2-27
Special Considerations 2-27
Documentation and Process 2-28
Example 2E-6: Alyeska Pipeline Service Company Subpoena 2E-32
Example 2E-7: Management Plan for Mercury Subpoenas 2E-40
Example 2E-8: Mercury Subpoenas 2E-47
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Chapter Two . Contents
3 Voluntary Disclosure 2-55
The Self-Disclosure Process 2-55
Documentation 2-57
4 Confidential Business Information 2-59
Authority 2-59
Penalties 2-61
Obtaining Access to TSCA CBI 2-61
Use of CBI in Case Preparation 2-62
Disclosure of TSCA CBI to Persons Outside the Agency . 2-65
Example 2E-9: TSCA CBI Access Request, Agreement, and Approval
(Document and Computer) 2E-68
Example 2E-10:TSCA CBI Access Request, Agreement, and Approval
(Contractor/Subcontractor Employee) 2E-69
Example 2E-11 Sample CBI Complaint (with CBI Deleted) 2E-70
TSCA Case Proceedings 2-U Guidance Manual 1992
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Chapter Two
1 Inspections
INTRODUCTION
A compliance inspection is the primary enforcement mechanism used to detect and document
TSCA violations. Facilities are selected for an inspection in a number of ways: Under, an
inspection targeting strategy developed by the Compliance Branch (in coordination with the
Regions), under a neutral administrative scheme, or "for cause." A neutral administrative
inspection scheme includes, but is not limited to, a scheme that targets some members of a
regulated community on a random basis, within a definite time frame, or on the basis of neutral
and objective criteria. A "for cause" inspection is based on information from any reliable source
concerning a member of the regulated community which would lead one to reasonably suspect
that a violation of any of the EPA's regulations, including other program regulations, may have
occurred. Examples include a complaint initiated by a person outside the Agency or information
given to the Agency by a facility which would raise suspicion that a violation occurred.
Selection may be made, depending on the circumstances, by Headquarters or the Regional
Offices.
The Agency may initiate an enforcement action based on evidence of violations discovered
during an inspection.
PURPOSE
Although self-monitoring is extremely important, inspections are the backbone of EPA's
compliance monitoring programs. They are the government's main tool for determining the
compliance status of a facility or site. Such inspections fulfill the following objectives:
• Observe the facility and identify specific environmental problems, if any exist, which
will enable EPA to determine whether the facility is in compliance.
• Provide EPA with facts about a facility's or site's compliance status and/or about
certain problems.
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Chapter Two Inspections
• Collect and preserve evidence of apparent violations.
• "Show the flag"--the inspection itself creates a credible presence of the interest and
power of government in the environmental compliance status of inspected facilities and
similar facilities.
Every inspection serves all four objectives to some extent, although the design of a given
inspection will reflect the relative importance of each objective in that instance. Please refer to
the "Fundamentals of Environmental Compliance Inspections" guidance manual developed by
the Office of Enforcement.
AUTHORITY
4th Amendment to the United States Constitution
"The right of the people to be secure in their persons, houses, papers, and effects, against
unreasonable searches and seizures, shall not be violated; and no warrants shall issue but upon
probable cause, supported by oath or affirmation, and particularly describing the place to be
searched, and the persons or things to be seized."
TSCA Inspections Authorized under Section 11 (a)
For purposes of administering this Act, the Administrator, and any duly designated
representative of the Administrator, is authorized to "inspect any establishment, facility, or other
premises in which chemical substances or mixtures are manufactured, processed, stored, or held
before or after their distribution in commerce and is authorized any conveyance being used to
transport chemical substances, mixtures, or such articles in connection with distribution in
commerce." The administrator has delegated the authority to conduct inspections to Federal,
State, and contractor employees, as well as Grantee Participants.
The inspector's credential is a delegation of authority: (1) from the Administrator/Regional
Administrator to exercise the power to inspect under all laws administered by EPA, and (2) from
the Assistant Administrator/Office Director/Division Director to exercise the power to inspect
under certain laws administered by EPA.
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Chapter Two
Inspections
Consent to Enter and Inspect
An inspector must obtain the consent of a responsible facility official before conducting an
inspection. Express consent is not necessary (i.e., the absence of express denial constitutes
consent). Entry remains voluntary and consensual unless consent is withdrawn.
The responsible official should be the person in possession (i.e., the processor) of the premises,
or the person with authority to give consent at the time of inspection. An owner does not always
have possession, and so may not be authorized to give consent. If someone in possession of the
facility cannot be located, the inspector must make a good faith effort to determine who is in the
best position to consent to the entry (such as the agent-in-charge). Consent must be given
knowingly and freely, in the absence of threats, coercion, deception, or entrapment.
When the area observed is similar to an open field, an inspection which would otherwise
constitute a search becomes a nonsearch for 4th Amendment purposes. In addition, there is no
exception of privacy in an area open to the public, such as a parking lot. If there is evidence
"in plain view" then consensual entry is not required given that the inspector meets the following
criteria: must have a prior, independent justification for physically being in a position to
observe the evidence; must have immediately recognized the information as evidence; and must
have discovered the evidence inadvertently.
SCOPE
The scope of a TSCA inspection, according to TSCA Section ll(b)(l), extends to all things
within the premises or conveyance inspected (including records, files, papers, processes,
controls, and facilities) that have a bearing on whether the requirements of the Act applicable
to the chemical substances or mixtures located within such premises or conveyance have been
complied with. However, pursuant to Section ll(b)(2) of TSCA, certain types of data can only
be inspected if the nature and extent of such data are described with reasonable specificity in the
wriuen Notice of Inspection. These types of data include:
TSCA Case Proceedings
2-3
Guidance Manual 1992
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Chapter Two Inspections
• Financial data (such as an annual report or report to stock holders);
• Sales data (other than shipment data);
• Pricing data;
• Personnel data; and
• Research data (other than research data required by the provisions of TSCA).
CONFIDENTIALITY
During the course of TSCA inspections, inspectors may encounter information that company
officials claim as confidential under Section 14 of TSCA and the EPA regulations at 40 CFR
Part 2. These sections of the statute and the regulations are designed to protect confidential
business information (CBI)1 from unauthorized disclosure. CBI material includes information
considered to be trade secrets that could damage a company's competitive position if it became
publicly known.
Stringent procedures govern the handling of CBI material. These procedures are contained in
the TSCA Confidential Business Information Security Manual, which governs access to, and
control of, CBI documents by EPA personnel. (See Chapter Two, Section 4 for a further
discussion on confidentiality.)
Because TSCA inspections may involve CBI, special inspection procedures are designed to
provide adequate notification to companies of their right to declare inspection data confidential
and to ensure secure handling of this information at each stage of the inspection. These
procedures are briefly outlined in the appropriate sections of this chapter. For detailed
information, consult the TSCA Inspection Manual.
TSCA CBI material does not in any manner refer to classified National Security Information as defined in
Executive Order 12065.
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Chapter Two Inspections
ELEMENTS OF AN INSPECTION
The elements of a TSCA inspection can be grouped into the following categories: (1) pre-
inspection preparation; (2) entry; (3) opening conference; (4) sampling and documentation; (5)
records review; (6) closing conference; and (7) report preparation. These elements are common
to all inspections, but the emphasis given to each element will vary depending on the needs of
the individual inspection.
Pre-Inspection Preparation
To ensure effective use of the inspector's time, the following procedures are undertaken before
beginning an inspection: '•
• Establishing inspection objectives and preparing an inspection plan;
• Establishing the scope of the inspection;
• Conducting a review of Agency records;
• Preparing necessary documents;
• Preparing sampling equipment and safety equipment; and
• Defining the facility (establishment, premises, conveyance) as a contiguous site divided
simply by a public right-of-way for purposes of providing separate notices and
presentation of credentials.
Entry
Entry procedures are followed to obtain actual physical entry into the premises. Entry must be
at a reasonable time (normal business hours). Entry involves the following steps:
• Introduction;
• Presentation of appropriate credentials to the owner, operator, or agent in charge of the
premises or conveyance to be inspected. The inspector credential serves not only as
a means of identification, but also constitutes the official delegation of statutory
authority from the Administrator to the person designated to conduct the inspection.
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Chapter Two Inspections
authority from the Administrator to the person designated to conduct the inspection.
Credentials delegating the authority to conduct inspections under all environmental
statutes must be signed by the Administrator, Deputy Administrator, or Regional
Administer. Statute-specific credentials may be signed by the Assistant Administrator,
or the office director delegated inspection authority under the statute.
• Presentation of a Notice of Inspection detailing the suspected violation or purpose of
the inspection. The Notice of Inspection includes:
- entry time - establishes reasonable time and moment from which all inspection time
frames are measured;
- name, title, and signature of the recipient - establishes operator, owner, or agent in
charge;
- violation suspected/reason for inspection - indicates reasonable cause or neutral
administrative scheme; and
- specification of the nature of certain data to be inspected.
• Management of denial of entry when necessary (see Section Ib, Warrants).
Opening Conference
After entry, the inspector conducts an opening conference with the facility's management.
During the opening conference, the inspector is responsible for the following activities:
• Discussing the objectives and scope of the inspection;
• Presenting the TSCA Inspection Confidentiality Notice, which informs facility officials
of their right to claim inspection data as CBI. All documents, samples, and related data
taken during an inspection that have been claimed as CBI must be listed on the
Declaration of Confidential Business Information. For detailed guidance on the use of
these CBI forms, refer to the TSCA Inspection Manual:
• Advising of the availability of duplicate samples;
• Providing information on TSCA and its rules; and
• Planning meetings with personnel.
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Chapter Two Inspections
Sampling and Documentation
Reviewing facility records, taking samples, and documenting findings are the basic inspection
activities. These activities provide the evidentiary support that the Agency uses in enforcement
actions. The.inspector's responsibilities include:
• Targeting and locating facility records;
• Inspecting facility records;
• Obtaining information on company's corporate profile and financial health, such as
annual reports, statement of cash flows, and Dun and Bradstreet listings;
•' Documenting all inspection activities;
• Inspecting conditions and taking photographs, if necessary;
• Identifying conditions that indicate potential violations under other EPA programs;
• Taking necessary samples, sealing samples, and establishing "chain-of-custody";
• Preparing the Receipt for Samples and Documents. This receipt is completed for all
inspections under TSCA. While TSCA does not provide for the issuance of a receipt
for samples and documents, the receipt is the method prescribed by the Administrator
to notify the manufacturer, etc., of the information being submitted under TSCA; and
• Operating in a safe and efficient manner.
Closing Conference
The closing conference with facility officials enables the inspector to prepare receipts, answer
questions, and provide information about TSCA. At the closing conference, the inspector
"wraps up" the inspection by:
• Writing necessary receipts;
• Preparing the Declaration of Confidential Business Information. The Declaration of
Confidential Information is the Administrator's prescribed method for designating, in
writing, information which manufacturers believe to be confidential. The Declaration
must indicate that the collected information was or was not designated as confidential
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Chapter Two Inspections
in order to show that the opportunity to designate data as confidential was exercised in
accordance with 40 CFR 2.203(b) or (c). The Declaration is not completed if the
Receipt for Samples and Documents states that no information was taken during the
inspection;
• Providing regulatory assistance (Industry Outreach);
• Advising that the results of analysis of samples will be furnished if and when analysis
is completed; and
• Discussing factual aspects (only) of inspection findings. Actual determinations on
whether a violation occurred should not be discussed with facility officials.
Report Preparation
All evidence must be organized and coordinated in a comprehensive, relevant, and accurate
report including:
• Inspection report forms;
• Narrative report; and
• Other documentary support.
Suspected violations are to be documented in the above reports. Compliance enforcement
personnel will review the report file to determine the sufficiency of the evidence. Any
information needing clarification should be reviewed with the inspector.
In preparing the inspection report, CBI material preferably should be referenced in a
nonconfidential manner. (As an alternative, the report could include the confidential
information; however, the entire inspection report must then be treated and appropriately logged
in as a confidential document.)
Communication of Potential Cross-Program Violations
• Notify appropriate program of suspected violations observed during TSCA inspection.
Please reference the TSCA Inspection Manual for more detailed information. Copies of the
manual can be obtained from the Headquarters Compliance Branch, OCM.
TSCA Case Proceedings 2-8 Guidance Manual 1992
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Chapter Two
la TSCA Notification Letters
TSCA Notification letters are an optional inspection tool not required under Section 11. They
may be used for two purposes:
• To notify a company that EPA is going to inspect, and to request that certain
information be available when EPA arrives, or that it be sent to EPA prior to the
inspection. This will facilitate the effectiveness of the inspection.
• To eliminate the need for an inspection, or to request more information after an
inspection.
Notification letters are generally used when deliberate noncompliance is not suspected and the
likelihood of a response is good. Typical information requested by a notification letter may
include the following:
• Raw materials, products, byproducts, and production levels;
• Facility layout maps identifying process areas, discharge and emission points, and waste
disposal sites;
• Flow diagrams for processes and waste control, treatment and disposal systems showing
where wastewater, air emissions, and solid waste sources originate;
• Description and design of pollution control and treatment systems and normal operating
parameters;
• Recent self-monitoring reports and inventories for discharges and emissions;
• Self-monitoring equipment in use, normal operating levels, and available data; and
• Files of required records.
Example 2E-1 is a model TSCA notification letter for a scheduled inspection under Section 11.
This letter requires the facility to submit specified information to EPA prior to the inspection.
Example 2E-2 is a model notification letter that is intended to facilitate a scheduled inspection
under Sections 5 and 8. Having already received information which was submitted by the
TSCA Case Proceedings 2-9 Guidance Manual 1992
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Chapter Two
TSCA Notification Letters
facility, EPA requests that all records and documents relating to any specific submissions be
available for review at the time of the scheduled inspection.
Presentation of a
Notice of Inspection
Sampling and Documentation
Closing Conference
TSCA Case Proceedings
2-10
Guidance Manual 1992
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Chapter Two Example 2E-1
Model TSCA Notification Letter
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
Region I
John F. Kennedy Federal Building
Boston, MA 02203
Dear Mr./Ms.
The Environmental Protection Agency (EPA) will conduct an inspection -
of your facility's premises/conveyance under the authority of Section 11 of
the Toxic Substances Control Act (15 U.S.C. §2610) on .
The purpose of the inspection is to determine compliance with the
requirements of this Act applicable to the chemical substances or mixtures '.
within your facility's premises/conveyance. The inspectors will: review
records, files, and papers that are either required to be maintained by
this Act or are applicable to the chemical substances or mixtures within
your facility's premises/conveyance; observe process operations; evaluate
monitoring practices, equipment, and sites; and collect samples that may
include regulated chemical substances, air, water, waste, or soil samples,
or any combination thereof. In addition, the inspectors may wish to take
photographs of selected subjects.
Prior to arrival, the inspectors will require certain information; we
recognize that some of this material may have been submitted to EPA in the
past. If such is the case and that material is the most current
information, please simply refer to the title, date, and specific recipient
of such documents in your response to this request.
Please provide copies of the following information to EPA within
twenty (20) days of receipt of this letter: .
(List information requested.)
Pursuant to regulations appearing at 40 CFR Part 2, Subpart B and
specifically Section 2.306, you are entitled to claim any or all the
information provided to EPA or collected by EPA during the inspection as
confidential business information. Such information can be disclosed by
EPA only in accordance with the procedures set forth in the regulations
(cited above). Any such claim for confidentiality must conform to the
requirements set forth in 40 CFR Section 2.203(b).
If you have any questions, please contact .
Thank you for your assistance in this matter.
Sincerely,
TSCA Case Proceedings 2E-11 Guidance Manual 1992
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Chapter Two Example 2E-2
Model Notification Letter
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Building 53, Box 25227, Denver Federal Center
Denver, Colorado 80225
Mr. Udagawa
Tosoh (U.S.A.) Inc.
1700 Water Place, Suite 204
Atlanta, GA 30339
Dear Mr. Udagawa:
This is to confirm you telephone conversation of October 12, 1989 with
Randolph E. Morris of NEIC, during which he informed you that he will
conduct an inspection of your facility beginning at 9:00 a.m. on Wednesday,
October 25, 1989. The purpose of the inspection is to determine compliance
with the requirements of the Toxic Substances Control Act (TSCA), Sections
5 and 8, for chemicals manufactured, imported, processed or used at your
facility.
Among the specific issues to be addressed are:
Premanufacture notices (PMNS) submitted by your facility, or
requests for exemption from PMN review process, including low
volume, test marketing, and polymer exemptions.
- Research and development activities and procedures in effect at the
facility, specifically as related to compliance with the
recordkeeping requirements of the TSCA research and development
exemption.
Recordkeeping and reporting under TSCA Section 8 rules, including
Preliminary Assessment Information Rule (PAIR), Inventory Update
Rule (IUR), and Sections 8(c), 8(d) and 8(e).
Facility or corporate policies developed to ensure compliance with
Sections 5 and 8 of TSCA.
The inspector will need to interview facility personnel, review
pertinent documents, and observe process operations. He may need to obtain
copies of documents, take photographs, or obtain samples of chemical
substances.
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Chapter Two Example 2E-2
In order to expedite the above reviews, please have available at the
time of the inspection all records and documents relating to any specific
submissions which you have made to the Agency, including PMNs, requests for
exemptions, and Section 8 reports. Also have available a list of all
chemical substances manufactured, imported, processed or used by your
facility. This list should include an accepted chemical name, any synonyms
or trade names, and the Chemical Abstracts Service (CAS) Registry number
for each chemical which is manufactured (including isolated intermediates),
imported, or used as raw material in manufacturing processes. For
chemicals which are purchased for other uses, please provide as much
information as possible.
Pursuant to regulations appearing in the Code of Federal Regulations
Title 40 (40 C.F.R.) Part 2, Subpart B, and specifically Section 2.306, you
are entitled to claim as confidential business information any or all of -
the information provided to the EPA. Any such confidentially claim must
conform to the requirements set forth in 40 C.F.R. Section 2.203(b).
Confidential business information can be disclosed by EPA only in
accordance with the procedures described in the regulations cited above.
If you do not assert a confidentiality claim at the time the information is
provided to EPA, it may be released to the public without further notice.
If you have any questions, please contact Randolph E. Morris at (303) 236-
8144.
Sincerely,
Charles P. Aschwanden, Esq.
Acting Chief
Enforcement Specialist Office
cc: Michael Wood, OCM, OPTS, (EN-342)
David Bernstein, Chief, Pest. & Tox. Subst., Region IX
Randolph E. Morris, NEIC
TSCA Case Proceedings 2E-13 Guidance Manual 1992
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Chapter Two Example 2E-2
TSCA Case Proceedings 2E-14 Guidance Manual 1992
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Chapter Two
lb Warrants
A warrant is a judicial authorization for an appropriate official (e.g., EPA inspector, U.S.
Marshal, or other Federal officer) to enter a .specifically described location and perform
specifically described functions. An administrative warrant, in a TSCA inspection proceeding,
is issued by a magistrate at EPA. The warrant may be obtained (1) when facility officials have
denied entry to an inspector, (2) when consent to inspect has been withdrawn during an
inspection, or (3) in advance of inspection. EPA must first have a substantive right to enter the
premises before the use of the issuance of an administrative warrant is proper. EPA's authority
to conduct inspections under Section 11 of TSCA serves as the basis for an administrative
warrant being issued by a magistrate.
While almost every EPA statute, including TSCA, contains a provision expressly authorizing the
Administrator and/or authorized representatives to enter a subject facility to conduct an
inspection pursuant to the particular law, EPA policy is that where facility officials deny or
withdraw consent, a warrant must be obtained. The idea behind this policy is that it is less time
consuming (and less costly in the long run, given the possibility of a legal challenge) to take the
precautionary action of obtaining a warrant rather than forcibly entering the facility against the
wishes of facility representatives. EPA obtains a warrant in order to validate its statutory
authority to enter. The warrant serves as judicial confirmation of EPA entry authority.
In Marshall v. Barlow's Inc.. 436 U.S. 307 (1978), the Supreme Court addressed the need for
an administrative warrant when an Occupational Health and Safety Administration inspector
sought entry into a workplace where consent for the inspection was not voluntarily given by the
owner. The Court concluded that an administrative warrant was required to conduct such
regulatory inspections unless the industry is one with a history of extensive regulation, such as
liquor or firearms.
The 4th Amendment authorizes obtaining a warrant where there is specific reason to think that
a violation has been committed (i.e., where there is probable cause, such as an employee's
complaint or a competitor's tip). In addition, Barlow recognized that a warrant may be issued
if the Agency can show that the establishment to be inspected has been selected pursuant to a
neutral inspection scheme. As a matter of policy, the Agency will apply the requirements of
Barlow to all TSCA inspections.
The decision of whether to secure a warrant will be made by Regional Counsel in consultation
with the Compliance Division, Office of Compliance Monitoring (OCM), and the Toxics
Litigation Division, Office of Enforcement (OE). Once the Regions and EPA Headquarters have
TSCA Case Proceedings 2-15 Guidance Manual 1992
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Chapter Two Warrants
decided that a warrant should be secured, precise procedures must be followed for obtaining and
executing the warrant.
Warrants are applied for and obtained ex parte: that is, without the knowledge of the other side.
Therefore, it is inappropriate to give facility officials advance notification of an inspection that
will occur under a warrant. It may be a criminal offense for anyone to disclose the existence
of a warrant prior to its execution.
The ability to secure a warrant is important to government officials, especially to inspectors.
In addition to serving as judicial confirmation of EPA's statutory right to enter and inspect a
facility, a warrant affords substantial legal protection to an inspector from private suits for
damages. A valid warrant gives an official absolute immunity from liability for activity
conducted in conformity with the warrant.
Seeking a Warrant before Inspection
In certain circumstances, a warrant may be obtained before an inspector begins an inspection.
Such a pre-inspection warrant may be sought at the discretion of the Regional Office if:
• A violation is suspected and could be covered up within the time needed to secure a
warrant;
• Prior correspondence or other contact with the facility to be inspected provides reason
to believe that entry will be denied when the inspector arrives; or
• The facility is unusually remote from a magistrate or a district court, and thus obtaining
a warrant would require excessive travel time..
SECURING AND SERVING AN ADMINISTRATIVE WARRANT
The following procedures for obtaining and serving an administrative warrant have been
developed in accordance with Barlow.
IMPORTANT PROCEDURAL CONSIDERATIONS
• The application for a warrant should be made as soon as possible after the denial of
entry or withdrawal of consent.
TSCA Case Proceedings 2-16 Guidance Manual 1992
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Chapter Two Warrants
• In order to satisfy the requirements of Barlow, the affidavit in support of the warrant
must include a description of the reasons the establishment has been chosen for
inspection. The only acceptable reasons are specific probable cause or selection of the
establishment for inspection pursuant to a neutral administrative inspection scheme.
• A warrant must be served without undue delay and within the number of days stated on
the document (usually 10 days). The warrant will usually direct that it be served during
daylight hours.
• Because the inspection is limited by the terms of the warrant, it is very important to
specify to the greatest extent possible the areas included for inspection, records to be
inspected, samples to be taken, etc. A vague, overly broad warrant probably will hot
be signed by the magistrate.
• If the owner refuses entry to an inspector holding a warrant, but not accompanied by
a U.S. Marshal, the inspector should leave the establishment and inform the U.S.
Attorney.
Procedures for Obtaining a Warrant
1. Contact the Regional Counsel's Office. The inspector should discuss with the
Regional Counsel's Office the facts regarding the denial or withdrawal of consent or
the circumstances that give rise to the need for a pre-inspection warrant. A joint
determination then will be made as to whether or not to seek a warrant.
2. Contact Headquarters Office of Compliance Monitoring. The Regional Office should
notify OCM prior to obtaining a warrant.
3. Contact the United States Attorney's Office. After a decision has been made to obtain
a warrant, the designated regional official should contact the U.S. Attorney for the
district in which the property is located. The Agency should assist the United States
Attorney's Office in the preparation of the warrant and affidavit.
4. Apply for the Warrant. The application for a warrant should identify the statutes and
regulations under which the Agency is seeking the warrant. The name and location
of the site or establishment to be inspected should be clearly identified, and, if
possible, the owner and/or operator should be named. The application can be a one-
or two-page document if all factual requirements for seeking the warrant are stated in
the affidavit, and the application so states. The application is to be signed by the U.S.
Attorney. (See Example 2E-2.)
TSCA Case Proceedings 2-17 Guidance Manual 1992
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Chapter Two Warrants
5. Prepare the Affidavit. The affidavit in support of the warrant application is a crucial
document. It is a statement reduced to writing, and sworn to or affirmed before a
notary public, that describes in consecutively numbered paragraphs all of the facts in
support of warrant issuance; and it should be prepared by a person with firsthand
knowledge of those facts, most likely the inspector. (See Example 2E-3.)
6. Prepare the Warrant for Signature. A proposed warrant should be prepared for the
magistrate's signature. Once signed, the warrant is an enforceable document. The
warrant should contain a "return of service" or "certificate of service" that will
indicate upon whom the warrant was served. This part of the warrant is to be dated
and signed by the inspector after the warrant is served. (See Example 2E-4.)
7. Serve the Warrant. The warrant is served on the facility owner or the agent in charge
and the inspection will normally commence or continue. Where there is probability
that entry will still be refused, or where there are threats of violence, the inspector
should be accompanied by a U.S. Marshal. In this case, the U.S. Marshal is
principally charged with executing the warrant, and the inspector should abide by the
U.S. Marshal's decision.
8. Perform the Inspection. The inspection should be conducted strictly in accordance
with the warrant. If sampling is authorized, all procedures must be followed carefully,
including presentation of receipts for all samples taken. If records or other property
are authorized to be taken, the inspector must issue a receipt for the property and
maintain an inventory of anything removed from the premises. This inventory will be
examined by the magistrate to ensure that the warrant's authority has not been
exceeded.
9. Return the Warrant. After the inspection has been completed, the warrant must be
returned to the magistrate. Whoever executes the warrant (i.e., the U.S. Marshal or
whoever performs the inspection) must sign the return of service form indicating to
whom the warrant was served and the date of service. The executed warrant is then
returned to the U.S. Attorney who will formally return it to the issuing magistrate or
judge. If anything has been physically taken from the premises, such as records or
samples, an inventory of such items must be submitted to the court, and the inspector
must be present to certify that the inventory is accurate and complete.
TSCA Case Proceedings 2-18 Guidance Manual 1992
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Chapter Two Warrants
Criminal Warrants
If the primary purpose of the inspection is to gather evidence for a criminal prosecution and
there is sufficient evidence available to establish probable cause for a criminal warrant, then a
civil warrant should not be used to gain entry. Rather, a criminal search warrant must be
obtained pursuant to Rule 41 of the Federal Rules of Criminal Procedure (Fed. R. Crim. P.).
(See Agency guidelines, entitled "The Use of Administrative Discovery Devices in the
Development of Potential Criminal Cases.")
Evidence obtained during a valid civil inspection is generally admissible in criminal proceedings.
TSCA Case Proceedings 2-19 Guidance Manual 1992
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Chapter Two
Example 2E-3
Model Application for Administrative Warrant
UNITED STATES DISTRICT COURT
DISTRICT OF
IN THE MATTER OF:
Docket No.
Case No.
Application for an
Administrative Warrant
NOW COMES a duly designated representative of the Administrator of the
United States Environmental Protection Agency, by and through (name )
United States Attorney for the District of and applies for
an administrative warrant of entry, inspection, reproduction of records,
photography, and sampling to determine compliance with the Toxic Substances
Control Act, 15 U.S.C. §2601 et seq., and as authorized by Section 11 of
the Act, 15 U.S.C. §2610, of the premises at (description of the premises)
in the possession, custody, or control of the (name of company or owner).
In support of this application, the duly designated representative of the
Administrator respectfully submits an affidavit and a proposed warrant.
Respectfully submitted,
(Signature of U.S. Attorney)
United States Attorney for the
District of
(Date)
TSCA Case Proceedings
2E-20
Guidance Manual 1992
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Chapter Two
Example 2E-4
Model Affidavit in Support of
Application for an Administrative Warrant
UNITED STATES DISTRICT COURT
DISTRICT OF
IN THE MATTER OF:
Docket No.
Case No.
Affidavit in Support of
Application for an
Administrative Warrant
State of
County of
(Name of Affiant)
upon his (her) oath, according to law, deposes and says:
1. I am a compliance/enforcement officer with the
United States Environmental Protection Agency, Region
being duly sworn
division ,
, and a duly
designated representative of the Administrator of the United States
Environmental Protection Agency for the purpose of conducting inspections .
pursuant to Section 11 of the Toxic Substances Control Act, 15 U.S.C. §2601
et sea. I hereby apply for an administrative warrant of entry, inspection,
reproduction of records, photography, and sampling of the premises in the
possession, custody, or control of the (name of company or owner).
2. (Name of establishment, premises, or conveyance) is a (describe
business) that the undersigned compliance officer of the United States
Environmental Protection Agency has reason to believe is in violation of
the Toxic Substances Control Act. This belief is based upon the following
facts and information: (Describe with particularity the reasons why a
violation is suspected and the specific facts that give rise to probable
cause or summarize the neutral administrative inspection scheme used to
select the premises for inspection.)
3. The entry, inspection, reproduction of records, photography, and
sampling will be carried out with reasonable promptness, and a copy of the
results of analyses performed on any samples or material collected will be
furnished to the owner or operator of the subject premises.
TSCA Case Proceedings
2E-21
Guidance Manual 1992
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Chapter Two Example 2E-4
4. The compliance/enforcement officer may be accompanied by one or
more compliance officers of the United States Environmental Protection
Agency.
5. A return will be made to the court at the completion of the
inspection, reproduction of records, photography, and sampling.
(Signature of Affiant)
(Title)
(Division)
Region
United States Environmental
Protection Agency
Before me, a notary public of the State of
County of ; , on this day of '
19 , personally appeared ; , and upon oath
stated that the facts set forth in this application are true to his (her)
knowledge and belief.
(Signature of Notary)
A Notary Public of
My Commission Expires
TSCA Case Proceedings 2E-22 Guidance Manual 1992
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Chapter Two Example 2E-5
Model Administrative Warrant
UNITED STATES DISTRICT COURT
DISTRICT OF
IN THE MATTER OF: ) Docket No.
Case No.
) Warrant of Entry, Inspection,
) Reproduction of Records,
) Photography, and Sampling
To _ (name) _ , _ (title) _ , United States
Environmental Protection Agency, Region _ , and any other duly
designated representative of the Administrator of the United States
Environmental Protection Agency:
Application having been made by the United States Attorney on behalf
of the United States Environmental Protection Agency (EPA) for a warrant of
entry, inspection, reproduction of records, photography, and sampling to
determine compliance with regulations under the Toxic Substances Control
Act, 15 U.S.C. §2601 et seq. ; and, the court being satisfied that there has
been a sufficient showing that reasonable legislative or administrative
standards for conducting an inspection and investigation have been
satisfied;
IT IS HEREBY ORDERED that EPA through its duly designated
representatives _ (names of representatives) _ is hereby entitled
and authorized to have entry upon the following described premises:
(Describe premises.)
IT IS FURTHER ORDERED that entry, inspection, reproduction of records,
photography, and sampling shall be conducted during regular working hours
or at other reasonable times, within reasonable limits, and in a reasonable
manner .
TSCA Case Proceedings 2E-23 Guidance Manual 1992
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Chapter Two Example
IT IS FURTHER ORDERED that the warrant shall be for the purpose of
conducting an entry, inspection, reproduction of records, photography, and
sampling pursuant to 15 U.S.C. $2610 consisting of the following
activities:
(Describe specific activities. For example:
• Entry to, upon, or through the above-described premises
including all buildings, structures, equipment,
machines, devices, materials, and sites to inspect,
sample, monitor, and investigate the said premises. •
• Access to and reproduction of all records pertaining to
or relating to the use, storage, handling, and disposal
of polychlorinated biphenyls (PCBs).
• Inspection, including photographing, of any equipment,
methods, or sites used to store, or dispose of PCBs at
the facility.)
IT IS FURTHER ORDERED that, if any property is seized, the duly
designated representative or representatives shall leave a receipt for the
property taken and prepare a written inventory of the property seized and
return this warrant with the written inventory before me within 10 days
from the date of the inspection.
IT IS FURTHER ORDERED that this warrant shall be valid for a period of
10 days from the date of this warrant.
IT IS FURTHER ORDERED that the United States Marshal is hereby
authorized and directed to assist the representatives of the United States
Environmental Protection Agency in such manner as may be reasonable,
necessary, and required.
(Signature of Magistrate)
(Date)
TSCA Case Proceedings 2E-24 Guidance Manual 1992
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Chapter Two Example 2E-5
RETURN OF SERVICE
I hereby certify that a copy of the within warrant was served by presenting
a copy of same to (facility owner or agent) on (date) at
(location of establishment or place) .
(Signature of person making service)
Official title)
RETURN
Inspection of the establishment described in this warrant was completed on
(date) .
(Signature of person conducting the inspection)
TSCA Case Proceedings 2E-25 Guidance Manual 1992
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Chapter Two Example 2E-5
TSCA Case Proceedings 2E-26 Guidance Manual 1992
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Chapter Two
2 Subpoena Authority
AUTHORITY
Section ll(c) of TSCA authorizes the Administrator, in carrying out the Act, to issue subpoenas.
TSCA Section 11: Inspections and Subpoenas
Subpoenas • "In carrying out this Act, the Administrator may by subpoena require the
attendance and testimony of witnesses and the production of reports, papers, documents, answers
to questions, and other information that the Administrator deems necessary. In the event of
contumacy, failure, or refusal of any person to obey any such subpoena, any district court of
the United States in which venue is proper shall have jurisdiction to order any such person to
comply with such subpoena. Any failure to obey such an order of the court is punishable by the
court as a contempt thereof."
SPECIAL CONSIDERATIONS
Subpoena authority pursuant to Section ll(c) of TSCA may be exercised in order to inquire
about the manufacture, processing, distribution, use, storage or disposal of chemical substances,
regardless of the ultimate statutory authority used to take compliance or regulatory action. In
some instances, subpoenas may eliminate the need for an inspection when no physical samples
are required.
Section ll(c) imposes no requirement that subpoenas must be issued only to investigate discrete
charges of violations of the law. EPA need not allege that it has a suspicion or has knowledge
of any facts indicating that the law has been violated. However, an EPA subpoena is not self-
enforcing. A recipient may refrain from complying with it, without penalty, until directed
otherwise by a federal court order.
TSCA Case Proceedings 2-27 Guidance Manual 1992
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Chapter Two Subpoena Authority
Subpoenas may be issued to fulfill three purposes:
Regulation - To inquire about chemical substances in order to gather information in
connection with the development of a rule or regulation. (Affects
Headquarters only. (OMB approval required)
Investigation - To inquire into potential existence of hazards or violations posed- by the
manufacture, processing, extent or distribution, use, storage or disposal of
chemical substances. (No OMB approval required)
Litigation - To obtain witness testimony and other evidence for presentation at a civil
administrative hearing. (No OMB approval required) [also EPCRA
section 325(f)(2)]
DOCUMENTATION AND PROCESS
Documentation
Prior to issuance of a subpoena, a management plan should be prepared. The plan will serve
as the official Agency record indicating the purpose of the action. The plan may be submitted
to the district court as background information should a court order be required to enforce the
subpoena. The plan should provide:
• Background information concerning the events leading to a decision to issue a subpoena;
• Criteria used to evaluate the information;
• Description of the recipient(s); and
• Summary of the subpoena issuance, review, and evaluation process including any
standard evaluation forms.
If subpoenas are to be issued to a subset of regulated facilities, a targeting strategy should be
prepared either separately or as part of the management plan explaining the rationale for
selecting a particular facility to receive a subpoena.
TSCA Case Proceedings 2-28 Guidance Manual 1992
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Chapter Two Subpoena Authority
Several documents should be prepared in connection with the issuance of a subpoena. These
include:
• Cover letter explaining:
- the purpose of the subpoena,
- the authority to issue the subpoena, and
- the right to declare information confidential;
• Subpoena commanding:
- the production of information, and/or
- the appearance of persons to testify;
• Specifications providing:
- definitions of the terms used in the subpoena,
- directions for responding to the information requested,
- a list of information to be provided, and
- the form/format for responding to the request (optional); and
• Certificate of Service.
The subpoena can be amended, after it is issued, to:
• extend the time to respond or appear;
• request additional information; or
• delete the requirement to appear and give testimony.
TSCA Case Proceedings 2-29 Guidance Manual 1992
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Chapter Two Subpoena Authority
Process
Issuance
Investigatory subpoenas may be issued to require testimony and/or the production of documents.
It is recommended that subpoenas be issued for documents and written answers to questions
(Subpoena duces tecwri) first, and subpoenas for oral testimony (Subpoena ad testificandum) at
a later date. Scheduling the production of reports and written answers prior to appearance for
oral testimony allows the Agency time to review the documents in order to:
• formulate any questions concerning the materials; or
• determine that testimony is not required and cancel the appearance.
The subpoena recipient may be directed to provide written responses to questions in a particular
format or to complete a form provided along with the subpoena. [By providing a form, the
person reviewing the subpoena response does not have to waste time reading unnecessary
verbiage and the respondent is not burdened with providing superfluous narrative statements.]
The Agency can focus the respondent's attention on the necessary information thereby saving
time and resources.
Service
A subpoena may be served by certified mail or in person upon completion of a certificate of
service.
Sworn Oral Testimony
Testimony under a subpoena is nonpublic. Attendees are limited to:
• EPA authorized personnel;
• presiding officer (if any);
• the witness;
• the reporter of the proceedings (if any); and
• the legal representative of the witness who is not also a prospective witness.
TSCA Case Proceedings 2-30 Guidance Manual 1992
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Chapter Two Subpoena Authority
The interview is begun by requiring the witness to sign an oath and application for fees. EPA
is responsible for payment of expenses. The questions in the interview may extend to facts,
opinions, suspicions, beliefs, rumor, gossip, hearsay, or any other matter which in the opinion
of the questioner may lead to the discovery of evidence which would probably be admissible in
civil administrative proceedings. The witness cannot raise objections to the questions except to
make a claim of privilege or to challenge the investigative jurisdiction of EPA. More than one
.EPA employee may pose questions to the witness. The interview may be adjourned from time-
to-time to an hour and date certain or may be continued to a new date and time certain. The
interview should not be continued indefinitely. At the conclusion of the interview, the witness's
legal representative may ask clarifying questions of the witness concerning any subject of inquiry
of the EPA questioners. Tape or written recordings of the interview by or for the witness may-
be prevented. However, the witness may inspect any recordation made by authorized EPA
personnel.
Following are examples of TSCA subpoenas and subpoena management plans. They include:
• Example 2E-6: Alyeska Pipeline Service Company subpoena, which set the precedent;
• Example 2E-7: Management Plan for the Mercury subpoenas; and
• Example 2E-8: Mercury subpoenas, which provides a format which separates written
response from appearance; asks questions relating to FIFRA, TSCA,
and EPCRA; and provides a response form.
TSCA Case Proceedings 2-31 Guidance Manual 1992
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Chapter Two
Example 2E-6
MICHAEL J. JVALKLTv
BEFORE THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
EPA REGION 10. SUITE 1802. 1200 SIXTH AVENUE
Seattle, Washington. (206) 4*2-1098
IN THE MATTER OF:
Alyeska Pipeline Service Co., Inc.
NO. 1086-07-21-2610
SUBPOENA DUCES TECUM AND
SUBPOENA AD TESTIFICAKDUM
TO: BAY TANKERS, INC.. • corporation, 1 Chase Manhattan Plaza,
Suite 3800. New York City. Nev York, 10005; and
Its Vice-President, CHARLES NIELES,
RESPONDENT s).
YOU ARE HEREBY COMMANDED, purauant to Title 15, United States Code,
section 2610(c) [Toxic Substances Control Act section 11(c)] to
APPEAR PHYSICALLY IN PERSON at the following ti»e and place:
TIME AND DATE:
PLACE:
10:00 A.M.
THURSDAY
U AUGUST 1986
Office of Regional Counsel, EPA Region 2,
26 Federal Plaza, Nev York City, Nev York 10276
YOU ARE COMMANDED FURTHER TO TESTIFY then and there upon oath and
MAKE TRUTHFUL RESPONSE to all lavful inquiries and questions then
and there put to you on behalf of the United States Environaental
Protection Agency, and TO REMAIN IN ATTENDANCE until expreasly
excused by the attorney conducting the proceeding for EPA.
YOU ARE COMMANDED FURTHER TO BRING WITH YOU at the above stated
time and place and tine, and to then and there produce for inspec-
tion and/or copying by EPA. those item* identified and described on
the ATTACHMENT vhich are possessed by you or are under your control.
ANY FAILURE BY YOU TO COMPLY WITH THE COMMANDS OF
THIS SUBPOENA MAY RESULT IN A COURT ACTION AGAINST YOU.
Issued at Seattle, Washington, this
of July, 1986.
Contact:
ATTORNEYS for EPA
Michael J. Walker, Esq.
Keith Onsdorff, Esq.
(202) 475 - 8690
(202) 382 - 3072
SUBPOENA - Page 1 of 8
ActlhgMlegional Administrator
TSCA Case Proceedings
2E-32
Guidance Manual 1992
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Chapter Two Example 2E-6
ATTACHMENT TO SUBPOENA Cause Mo. 10*6-07-21-2610
1. DEFINITIONS^ For the purpose or this Subpoena «nd the Attach-
ment, the following terms have the following meanings:
1. "ANS CRUDE" or ""ALASKA CRUDE" means oil which was pumped
out of an Alaska well through a pipeline to the Valdez terminal.
2. "BALLAST" means liquid or solid material placed in a ship
below the main deck for purposes of•increasing stability -against
rolling of the ship about a longitudinal (fore and aft) axis.
3. "BALLAST WATER" includes, without limitation, any liquid
or semi-liquid material which is or was taker, aboard a tanker, and
was or is
(A) material as described in 1.5.(A) below; and
(B) used ballast under the assumption that it was predomi-
nantly water as described in 1.5.(A) below, and
(C) was not carried as "cargo" and was not predominantly
ANS crude containing OX to 10X water.
4. "BtflF" or "BALLAST WATER TREATMENT FACILITY" means that
portion of an onshore facility whose predominant function is to
separate out oil froo ballast water received from ships.
5.. "CHEMICAL MIXTURE" includes, without limitation, any
liquid or semi-liquid material containing chemicals, OTHER THAN
A MIXTURE OF SOLELY THOSE MATERIALS DESCRIBED IN (A) THROUGH (D)
below; the phrase EXCLUDES any material whose only components or
ingredients are SOLELY one or a combination of the following:
(A) water taken aboard the carrying tanker directly from
(and out of) the oceans oz any other body of water or any portion
thereof including bays, estuaries, or rivers.
(B) unused bunker oil suitable and deatined for, and
stored aboard for. use as fuel in the boilers of the carrying
tanker.
SUBPOENA Page 2 of B
TSCA Case Proceedings 2E-33 Guidance Manual 1992
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Chapter Two Example 2E-6
(C) unused petroleum based lubricant* suitable and des-
tined for. and stored aboard for, lubricating the equipment aboard
the carrying tanker.
(D) Alaska crude carried as cargo, or carried as the
unflushed residue of cargo in a chipboard container which in the
immediate past held Alaska crude as cargo.
6. "COMPANY" «eanc the corporation "Bay Tankers. Inc." under
that naae or any assumed naae.
7. "LOAD" and "LOADED" Bean pumped aboard a snip iron a
source or location outside the ahip.
6. "OFF-LOAD" and "OFF-LOADED" Bean gravity-flowed or pumpeo
from a tanker putatively to or into soae onshore facility.
9. "RECORD" neans the original, a true copy, or * substan-
tial copy, of a physical item containing or memorializing oata.
or information, or symbols, or an instruction, or ar. event, or *
transaction, or an utterance, which item is presently ir. documen-
tary, film, electronic impulse, magnetic disk, magnetic tape, or
some computer storage form. THIS T£RM EXCLUDES ANY RECOKD CREATED
BEFORE January 1, 1976, AND ANY RECORD CREATED AFTtS July 1. 1986.
10. "RELEASE" or "RELEASED" aear.s one or any combination of
occurrences resulting in a liquid or a semi-liquid aateriai •aovir.g
to and becoming present in a body of water whose surface is exposed
to the atmosphere. It includes each occurrence des;riD«d in 42 U.S.C.
19601(22). It includes each onboard act or omission by any officer
or other crewmeaber of any tanker.
11. -TANKEK" or "TANKERS" includes the ships Szuyvesar.c. flay
Ridge. Brooklyn, and Willimmsburg, except where the context requires
otherwise.
12. "TERMINAL" aeans a crude oil handling, storage, or trans-
fer onshore facility including (without liBitation) chose parts of
SUBPOENA - Page 3 of 6
TSCA Case Proceedings 2E-34 Guidance Manual 1992
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Chapter Two Example 2E-6
chat facility constituting a BUTF. and tnose pares of chat facility
used co reaove liquids from Alaska crude oil.
(A) "PANAMA TERMINAL" Beans the terminal a: which the tank-
ers typically (from January 1, 1978 co July 1. 1986.) off-loaded
their cargoes of Alaska crude oil which had beer, loaded at the
Valdez terminal.
(B) "VALDEZ TERMINAL" Beans Che terminal operated by
Alyeaka Pipeline Service Co., Inc.. at or near Valdez. Alaska from
January 1. 1978 co che presant.
"ll. ITEMS TO BE BROUGHT WITH YOU:
1. Each record reflecting activities aboard, or communica-
tion to or from, che canker Scuyvesar.t at any time becweer. March 1
ar.d May 31 . 1982.
2. Each record which contains or reflects communication co or
froo che canker Stuyvesar.t in che year 1982 concerning chat canker
loading, coving, carrying, off-loading, or releasing approximately
14,000 barrels of chemical mixtures or any part or porcior. chereof.
3. Each record which contains or reflects communications to or
froo one or more of che tankers which concerned char canker loading.
carrying, off-loading, or releasing any chemical mixture.
A. Each record reflecting a testing, sampling, or laboratory
analysis done on any .chemical mixture which was loided onto, ori-
loaded from, or released from one or more of Che tankers.
5. Each record indicating any chemical testing, sampling, or
scientific analysis performed on liquids or semi-liquids constitu-
ting the flushings resulting froa flushing out a tanker's cargo
spaces, cargo tanks, ballast tanks, wing tanks, or slop tanks.
6. Each record reflecting a spillage of oil or a chemical
mixture from one or more of Che cankers occurring azcer January 1.
1981, which was not reported by Bay Tankers, Inc. co che National
SUBPOENA - page 4 of 8
TSCA Case Proceedings 2E-35 Guidance Manual 1992
-------
Chapter Two Example 2E-6
Response Center ir. Washington, D.C. operated by the Coast Guard.
V
7. Each record constituing what is soaetiaes called by comparj
employees a "ship's abstract", for each voyage of each tanker frora
the Panama terminal to the Valdez terminal, which voyage begar.
between January 1. 1978. and July 1. 1986.
8. Each cargo manifest for «ach canker for -each voyage from
the Panama terminal to Che Valdez terminal, which voyage began in
one of the years 1978 through 1986.
9. A list of all company shareholders and directors as of the
time of each annual shareholder's meeting held after 1977 but
before 1986.
10. Each memo, report, letter, note, document, record, or
minutes of meetings of the coporate directors or a committee there-
of which discusses in any way an aspect of governmental investiga-
tions into occurrences or operations az the Valdez terminal durir.g
one or more of tne years 1978 through 1966.
11. Each log entry in a tanker's logs far any partior. 01 the
years 1978 through 1986 which records the release or oft-loading 01
a chemical mixture from such tanker, or which records the release
of any "ballast" at sea during that- tanker's voyage beginning at
the Panama terminal and ending at the Vaiaez terminal.
12. The logbooks for each tanker for each year 197B through
1986 which are described below, or records which contain for such
years substantially the same entries as the logbooks described
below:
(A) the "yellow" covered logbook required since 1982 by the
U.S. Coast Guard (marine pollution authorities) to be carried by
and used aboard a tanker.
(B) any logoooks preceding the one described in (A) which
were prescribed by Che U.S. Coast Guard to be carried aboard
and used aboard a canker.
SUBPOENA - Page 5 of 8
TSCA Case Proceedings 2E-36 Guidance Manual 1992
-------
Chapter Two Example 2E-6
13. Each record which reflects or indicates one or acre of the
following occurring in relation to one or more of the tankers:
(A) the loading into such tanker at or near the Panama
terminal (or anyplace after departure from the Panama terminal but
while the tanker was enroute to the the Valdez terminal) of a chemi-
cal mixture which was uaed and dealt with by the tanker involved
either
-------
Chapter Two Example 2E-6
(A) by which one or more of Che cankers were to load ANS
crude at Che Valdai terminal.
(B) by which one or more of Che tankers were to load or
off-load chemical mixtures at any location.
(C) by which one or more of Che cankers were to oft-load or
Co otherwise dispose of Che fluahings resulting from a canker
flushing out -one or more of its canks.
(D) by which one or »ore of Che cankers were to load Dallas:
on departing the Panama terminal or enroute co Valdez, Alaska.
(E) by which one or more of Che cankers were co off-load
ballast or ballast water at Che Valdez terminals.
(F) by which one or more of the tankers were co release
ballast, chemical mixtures, or ballast water from the tanker when
moored, anchored, be.'thed. or underway.
(C) by which one or more of the tankers were co report
(either to company headquarters or Co governmental authorities) a
release of oil or other liquids from such canker.
15. Each record which contains or reflects the current name
or current address of 'one or more of the following individuals:
(A) Chose whose main duties for che company in any one
or more of Che years 1978 through 1986, included communicating on
behalf of Che company headquarters wich che cankers.
(B) chose from whom such cankers received one or more
communications concerning such chemical mixtures.
(C) choae co whom auch communications were addressed.
SUBPOENA - Page 7 of 8
TSCA Case Proceedings 2E-38 Guidance Manual 1992
-------
Chapter Two Example 2E-6
(D) those who are known or believed to have fcrawi
of the existence of. the sending of. the receiving 01 , or the pre-
ser.r whereasoyts or a copy of any sucn communications.
(£) those familiar -with the personnel recoras of tne
company ror ar.y of tne years 197B through 197. the Par.&r.a irrr.ir.i. c.". tnr .'ui-r:
lemir.ni w-.ich oegar. ir. any o: tne years l&7e tr.rourr. '^50.'
(H) those faailiar vith the First M&tes of each linker
during a voyage by that canker from the Par.ana tenir.al i^ the Vai-
dex temir.al which began ir. any of the years 1978 :hrougr. *iyS6.
(I) those familiar with the organizational structure or
the company, inducing tne r.aaes and titles of each of its officers
and directors from January 1. 1978 to tne present.
(J) those vho know who the employees of trie co-piny were
who were stationed at the corporate headquarters during any or
the years 1978 through 1986.
(K) tnose who knov where there is r.ow loc&lec cr.e criitir.o:
or a true copy or a substantial copy of any record vrr.icn is both
(1) described ir this subpoena, and (2) which is nc: specilicnliy
pointed out as being produced in response to this subpoena, and
(3) whose existence is not specifically testified to in an answer
given under oath in response to this subpoena.
SUBPOENA - Page 8 of 8
TSCA Case Proceedings 2E-39 Guidance Manual 1992
-------
Chapter Two Example 2E-7
•TK&TBOY FOR
. XMOAVCB Or MBRCUKY XCTBSTXOaTXVZ SUBPOEXAS
Total Initial Universe - 20
Subgroups
Paints, Coatings and Other Mixtures Manufacturers - 10
Building Materials Manufacturers - 5
Unique Users - 5
Rationales:
Paints, Coatings, and other Mixtures Manufacturers are the
principal purchasers of PMA pesticides. In order to review this
industrial group for potential violations of environmental lavs
with respect to the chemical substance mercury, 10 PMA purchasers
will be randomly selected to inlude a range in size of quantities
purchased and geographic location.
Building Materials Manufacturers also purchase a substantial
amount of PMA pesticides. Based on purchase records, a group of
5 manufacturers will be randomly selected to represent one of each
different type of building material.
Five unique purchasers of PMA pesticides will also be
selected. The selection will be made on the basis that the types
of products that are believed to be manufactured by the company do
not have a pattern of use that would necessarily require the
incorporation of mercury.
TSCA Compliance/Enforcement 2E-40 Guidance Manual 1992
-------
Chapter Two Example 2E-7
VLftl
Authority: Section 11(c), Toxic Substances Control Act
Purpose: Mercury has been detected at extremely high levels in
individuals exposed to this substance through
inhalation. The purpose of this document is to develop
a management plan Cor the review, dissemination, and use
of information received as a result of the issuance of
subpoenas to a select group of mercury users. The
subpoenaed information will be reviewed to determine if:
1. the chemical substance, mercury, or a mixture
containing such substance presents an imminent hazard
pursuant to Section 7 TSCA requiring civil action in
District Court to grant relief; and
2. violations have occured pursuant to:
rXFRA Section 12(a)(1)(Z) - fail to include adequate
directions
FIFRA Section 12(a)(2)(B) - fail to report 6(a)(2)
information
FXFRA Section 12(a)(2)(G) - misuse a pesticide
TSCA Section 15(3) (A) - fail to record adverse reactions
XPCRA Section 325(c)(l) - fail to file a Section 313
toxic release inventory
report.
Universe: Paints, Coatings, or Other Mixtures Manufacturers 10
Building Material Manufacturers 5
Unique Users _£
Total 20
Required Response:
Submission of written answers to twenty-one
questions by March 2, 1990
Provision of oral testimony and copies of end product
sales records on March 16, 1990
TSCA Case Proceedings 2E-41 Guidance Manual 1992
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Chapter Two Example 2E-7
-2-
Process: 1. Issuance - February 15, 1990
2. Master file and logging system creation by DCO -
February 15 to February 28, 1990
A master file will be created for each respondent.
The file vill include:
o Subpoena action status summary, copy attached,
with list of the various milestones and their
completion dates.
o Copy of the subpoena
o Certificate of Service
o Certified receipt shoving delivery
o All notes of telephone inquiries
o Master copy of the written subpoena response
o A copy of the transcript of oral testimony
o A list of all referrals to other Agency offices
o Copies of all follow-up correspondence
o Copies of all enforcement actions
3. Inquiry Response - February 20, 1990 to
March 16, 1990
Contacts: Mike Calhoun 382-7865
Compliance Division
Office of Compliance Monitoring
(technical guidance)
Alice Crowe 475-8690
Toxics Litigation Division
Office of Enforcement and Compliance
Monitoring
(legal matters)
4. Receipt - March 2, 1990 deadline
Written responses to the subpoena will be
received in the Office of Compliance Monitoring
TSCA Case Proceedings 2E-42 Guidance Manual 1992
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Chapter Two Example 2E-7
-3-
5. Failure to obey the subpoena determination -
March 5, and March 20, 1990
If any company fails to provide written
information or oral testimony by thedesignated
deadline, OCX will refer the master file to OECM
along with a cover memorandum and certified
statement by the Director, Compliance Division, OCK.
The memorandum and certified statement will indicate
that no response has been received or oral testimony
provided. OECM will prepare a case for referral to
the Department of Justice to obtain a District Court
order to compel compliance.
6. Preliminary Assessment -
February 20, 1990 to March 9, 1990
The written response will receive a preliminary
assessment by the Office of Compliance Monitoring.
The assessment will categorize each response under
one or more of the following headings:
a. Potential hazard
b. Potential FIFRA violation pesticide
manufacturer
c. Potential FIFRA violation pesticide user
d. Potential TSCA violation mercury user
e. Potential EPCRA violation mercury user
f. Nonresponsive
1. no information submitted
2. submitted information nonresponsive
7. Three copies of the written response along with
the preliminary assessment will be made and provided
to OPP, OTS, and the Region in accordance with any
applicable TSCA-CBI procedures.
8. Dissemination -
February 20, to March 9, 1990
The OPP, OTS, and regional copies of the
written response and preliminary assessment will be
disseminated within 3 working days of the response.
TSCA Case Proceedings 2E-43 Guidance Manual 1992
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Chapter Two Example 2EX7
9. Preliminary Evaluation
Bach office will be given 3 working days to
evaluate the response to determine if a potential
violation «ay exist with raapaet to TSCA, FIFRA, or
EPCRA and to provide recommendations concerning
quaationa that should be posed during any oral
testimony, and the appropriateness of conducting an
immediate physical inspection.
10. Question Development
Based on the evaluation, a list of questions
will be prepared for reviev and concurrence by the
respective offices.
11. Premeeting
Prior to the presentation of oral testimony,
a meeting vill be scheduled by DECK with the
representatives of the EPA offices who vill be
attending the presentation of oral testimony. The
attendees vill organise the framework for obtaining
the oral testimony regarding the various areas
of inquiry.
12. Oral Testimony
OECM vill have lead responsibility for
developing and arranging the schedule for
presentation of oral testimony, directing the
presentations, and providing the transcripts of the
testimony to the respective offices.
13. Final Compliance Evaluation
Fifteen working days after receipt of the
transcript, OCM vill conduct a final evaluation
of both the written response and oral testimony.
The evaluation vill determine if one or more of the
following actions is warranted:
a. physical inspection of the company
b. enforcemnt action pursuant to TSCA, FIFRA,
or EPCRA, or
c. enforcemnt action to prevent an imminent
hazard.
TSCA Case Proceedings 2E-44 Guidance Manual 1992
-------
Chapter Two Example 2E-7
TftC* OCTXOV 11(0) VUBFO!
Company •ernes
Respondent:
violations
Section 12 (a) (1MB) and (1) - Evidence that the registrant failed
to provide accepted and adequate direction* for use? [Q12, 13,
14]
Section l2(a)(2)(B) - Evidence that registrant failed to report
6(a)(2) infonation? [Q 21]
seotioa 12(a)(2)(Q) - Evidence that manufacturer misused a
pesticide? [Q 4 - 16]
TBCX VTOIATIOHB
flection 15(3)(X) - Evidence that the manufacturer failed to
record adverse reactions? [Q 17, 18, 19]
BFCBA VTOIATIOM
•ection 32S
-------
Chapter Two Example 2E-7
MERCUKY 8UBFOEH* KB8FOV8E8
FOLLOW-UP QUB8TZOH8
Company Name:
Address:
Question Number: Additional Information Requested:
TSCA Case Proceedings 2E-46 Guidance Manual 1992
-------
Chapter Two Example 2E-8
UNITED STATESXNVXRONKKRXAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
IN THE MATTER OF: )
)
Investigation of the Processing, ) SUBPOENA VOCES TECUM AND
Distribution in Commerce, and Use ) SUBPOENA AD TESTIFICANDOM
of the Chemical Substance, Mercury )
TO:
YOU ARE HEREBY COMMANDED, pursuant to Title 15, United States Code,
section 2610(c) {Toxic Substances Control Act section ll(c)) TO
PRODUCE FOR INSPECTION AND/OR COPYING those reports, papers,
documents, answers to, and other information requested in the
ATTACHED SPECIFICATIONS, at the following date, time and place:
DATE AND TIME: March 2, 1990 at 3:00PM
PLACE: U.S. Environmental Protection Agency
Office of Compliance Monitoring
Compliance Division (EN-342)
401 M Street, S.K.
Washington, D.C. 20460
YOU ARE COMMANDED FUKTUKK TO BE AND APPEAR IN PERSON at the
following date, time and place:
DATE AND TIME: March 16, 1990 at 10:00AM
PLACE: U.S. Environmental Protection Agency
401 M Street, S.N.,
Washington, D.C.
ROOT 113 Northeast Mall
TO TESTIFY then and there upon oath and MAKE TRUTHFUL RESPONSE to
all lawful inquiries and questions then and there put to you on
behalf of the United States Environmental Protection Agency, and
TO REMAIN IN ATTENDANCE until expressly excused by the EPA attorney
conducting the proceeding.
FAILURE TO COMPLY WITH THIS SUBPOENA MAY RESULT IN A COURT ACTION
AGAINST YOU.
Issued at Washington, D.C. this 15th day of February 1990.
Attorney Contact: Alice Crowe, (202) 475-8690
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
TSCA Case Proceedings 2E-47 Guidance Manual 1992
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Chapter Two Example 2E-8
-2-
SPECXFXCATXaHS
I. Definitions
As used in this subpoena:
1. "Document" BMUW the original or a true, comet and
complete copy and all nonidentieal copies of any report, paper,
note, letter, correspondence , memorandum, study, data compilation,
circular, work sheet, minutes, test result, laboratory note or
memorandum, analysis or other transcription of intonation, whether
written, typed, printed, recorded on tape, microfilm, or other
device, regardless of whether circulated within the company or to
outsiders, regardless of whether generated within or without the
company and regardless of whether in the possession of your company
or any agent acting in its behalf.
2. "You" or "your" refers to both the individual addressee and
the corporate addressee.
3. "Mixture" means a combination of r**~pjn»i substances in
liquid or semi -liquid form and having no defined shape e.g. a
caulk.
4. "Mercury containing end product" means the item containing
mercury that is presented for sale upon manufacture by your
company.
5. "Mercury source material" means any material that is
purchased by your company that contains mercury.
II. Directions i
1. For your convenience in reponding to the subpoena, a fora is
attached to be used to answer the questions that have been posed.
If more space is required to respond to a question than is provided
on the form, attach a continuation sheet to the form and indicate
the number of the question to which you are providing additional
information. A form should be completed for each mercury
containing end product that you manufacture.
2. Bach question posed should be answered. If the appropriate
response is "none" or "not applicable" that information should be
so stated.
3. If you do not manufacture for sale any end product containing
mercury, complete the form using the terms "none" or "not
applicable" as appropriate. Attach a continuation sheet to the
form and provide:
TSCA Case Proceedings 2E-48 Guidance Manual 1992
-------
Chapter Two Example 2E-8
-3-
a. an explanation of the UM and/or intended use of all
purchases of mercury aourea materials for the pact 5
years e.g., research and development;
b. the net weight of mercury source material currently in
inventory; and
c. the disposal locations of any waste containing mercury.
HI. TCTOUKMTON TO BE PROVIDEDi
l.a. What is your principal line of business; and
b. What is the 4 digit standard industrial code that best
describes your business activities?
2. How many full-time employees do you nave?
3. Have you submitted a Toxic Chemical Release Inventory Reporting
Fora concerning the processing or use of mercury or mercury
compounds pursuant to Section 313 of the Emergency Planning
and Community Right-to-Knov Act (EPCRA)?
4. Identify each mercury containing end product that you
manufactured for sale in the past 5 year* including the:
a. brand name and if only a particular subset contains mercury
the names of the subset itaas e.g., interior latex paint-
only colors red and blue;
b. principal use of the product e.g., paint, coating, or other
use, include the EPA Reg No. if claims are made for use
of the product as a pesticide;
c. purpose of the mercury in the product e.g., mildewcide
d. range of lot or code numbers of product batches
containing mercury if the current end product is no
longer formulated to contain the chemical substance
mercury;
e. latest calendar year of manufacture as a mercury
formulation e.g., 1990; and
f. net weight in pounds and volume in gallons of each size
unit of the product that you sell as a paint, coating,
or other mixture or a description and net weight of any
end product that is a building material, an item of
furniture or other equipment.
5. For each end product identified above, describe your source of
mercury by the:
a. brand name of source product, including EPA Reg. No., if
it is a pesticide;
b. name of manufacturer and city/state address;
c. chemical form of the mercury e.g., phenyl mercuric acetate;
d. percentage by weight of the chemical form of mercury in
the source material;
TSCA Case Proceedings 2E-49 Guidance Manual 1992
-------
Chapter Two Example 2E-8
5. e. percentage by weight of total mercury in the source
material; and
f. net weight in pounds of standard sice unit of purchase
and the type of .immediate container the mercury is
packaged in e.g., 25 Ib. boxes containing 50-8or. water
soluble packets.
6. For each end product identified above, how many pounds of the
mercury source material do you use each year in the
manufacture of that product?
7. For each end product identified above, indicate the
percentage by weight of the mercury source material in your
product.
8. For each end product identified above, indicate the
percentage by weight of total mercury in your product.
9. For each end product identified above:
a. how many of each unit size of the end product did you sell
in the last one year period from the date of the subpoena
and what total net weight does this represent (copies of
your last f ivs years of sales records including the names
and addresses of your puchasers are to be submitted at
the time of deposition); and
b. how many of each sice unit of the end product currently
remains in your inventory and what total net weight of
the product does this represent?
10. Is mercury incorporated into your end product et the point of: .
manufacture, sale, or use?
11. For each end product identified above, what method do you use
to incorporate the mercury into your end product e.g., mixing,
spraying, etc.?
12. For each end product identified above, describe the source of
the directions that you follow to incorporate the mercury
source material into your own product e.g., manufacturer's
brochure, trade association bulletin, own calculations, etc..
13. Have you ever received directions for use from the supplier of
the mercury source material? If so, when did you receive
these directions (give specific dates if known, if not
indicate relative timeframes e.g., yearly, with each shipment
etc.)?
TSCA Case Proceedings 2E-50 Guidance Manual 1992
-------
Chapter Two Example 2E-8
14. If you have received directions from your supplier of mercury
source material, what rate of application of the source
material does the supplier recommend to manufacture each
end product identified above e.g., percent in pounds of tbe
source material and total mercury?
IS. For each paint, coating, or mixture end product identified
above, indicate:
a. the types of surfaces you recommend that it be applied to,
e.g., wood, wall board, plaster, concrete, etc.;
b. the locations of the surfaces e.g. indoor construction,
outdoor equipment, ate.;
e. the place of application of the product e.g.,.industrial,
educational, domestic, etc.;
d. the average coverage of the product in square feet;
e. the number of coats recommended for each type of
application; and
f. the method(s) of application e.g., brush, spray, etc..
16. For each product identified above that is neither a paint,
coating, nor a mixture indicate:
a. the location of the mercury in the product e.g., part of
a surface material, incorporated into a specific
component of the product etc.; and
b. the place of use of the product e.g., industrial, domestic,
etc.
17. Bave you received consumer reports regarding significant
adverse health reactions from the use of the end product
identified above? Please indicate for each product identified
above:
a. the types of reactions reported;
b. the number of complaints received regarding eacb type of
reaction;
c. the location of the file where copies of the reports are
maintained; and
d. the name and position of the person in charge of these
files.
IB. Bave your employees filed reports regarding significant adverse
health reactions or have incidents occured resulting in
adverse health reactions associated with the manufacture of
the end product (s) identified above? Please indicate for each
product identified above:
a. the types of reactions reported;
b. the number of reports regarding each type of reaction;
c. tbe location of the file where copies of these reports
are maintained; and
TSCA Case Proceedings 2E-51 Guidance Manual 1992
-------
Chapter Two Example 2E-8
18. d. the name and position of the person in charge of
19. Have your employees filed.reports regarding significant adverse
health reactions from the use of the mercury source material?
Please indicate for each mercury source material identified
above:
a. the types of reactions reported;
b. the ""->*•»• of reports regarding each type of reaction;
c. the location of the file where copies of these reports
are maintained; tnf
d. the name and position of the person maintaining these
file..
20. Have you received reports from consumers or employees regarding
significant adverse reactions to the environment from the use
of the end product or the mercury source material? Please
indicate for each mercury source material and end product
identified above:
a. the type of reaction reported;
b. the number of reactions reported regarding each type of
reaction;
c. the location of the file where copies of these reports
are maintained; and
d. the nnmn end position of the person maintaining these
files.
21. Have you notified your mercury source material supplier of any
reports of significant adverse health or environmental
reactions from the use of the mercury source material? Please
indicate for each mercury source material:
a. the name and address of the supplier who was notified;
b. the type of reaction reported;
c. the number of reports for each type of reaction; and
d. the name and position of the pereon maintaining thee«
files.
TSCA Case Proceedings 2E-52 Guidance Manual 1992
-------
Chapter Two Example 2E-8
CERTIFICATE OF SERVICE
UNITED STATES KHVlhOtDifirrxAli PROTECTION AGENCY
I hereby certify that on this 20th day of April, 1990, a
copy of the foregoing Subpoena Duces Tecum and Subpoena Ad
Testificandum amendment was served by certified mail, return
receipt requested, and by placement in the EPA mail room at 401 K
Street, S.N., Washington, D.C. to the following individual:
Mr. William E. Fogg, President
Wall and Floor Products
Post Office Box 26905
Philadelphia, Pennsylvania 19134
John Mason (EN-342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
TSCA Case Proceedings 2E-53 Guidance Manual 1992
-------
Chapter Two Example 2E-8
TSCA Case Proceedings 2E-54 Guidance Manual 1992
-------
Chapter Two
3 Voluntary Disclosure
The voluntary disclosure/self-confession of TSCA violations constitutes a growing and significant
portion of the complaints that the Agency issues. In addition, the majority of penalties collected
under Sections 5 and 13 of TSCA result from voluntary disclosures. The first TSCA case
involving self-confessed violations was Rocketdyne Division. Rockwell International
Corporation. TSCA Docket No. 83-H-04 (1983). At that time, there were no provisions to
allow penalty reductions for the timely self-disclosure of violations. In response to an increased
number of self-confessors, penalty reduction can now be considered as either an independent
adjustment factor with a fixed percentage reduction, or as part of the initial gravity-based penalty
assessment, such as under TSCA 8(e). In order to encourage voluntary disclosure, violation
history is not considered when calculating the penalty for self-confessors.
The statutory basis for allowing the Administrator to grant a penalty reduction for self-disclosure
can be found in TSCA Section 16(a)(2)(B) and Section 16(a)(2)(c).
Section 16(a)(2)(B):
"In determining the amount of civil penalty, the Administrator shall take into account the nature,
circumstance, extent, and gravity of the violation or violations and, with respect to the violator,
ability to pay, effect on ability continue to do business, any history of prior such violations, the
degree of culpability, and such other matters as justice may require."
Section 16(a)(2)(C):
"The Administrator may compromise, modify, or remit, with or without conditions, any civil
penalty which may be imposed under this subsection. The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be deducted from any sums owing
by the United States to the person charged."
THE SELF-DISCLOSURE PROCESS
The initial disclosure of a violation may be made orally or in writing. However, if made orally,
the initial disclosure must be immediately confirmed, and must be provided in writing within
three days. Upon notification, three factors should be considered before proceeding:
TSCA Case Proceedings 2-55 Guidance Manual 1992
-------
Chapter Two Voluntary Disclosure
• Was there a statutory violation? For example, a check should be made of the
confidential as well as public inventory before assuming there is a violation of the
Section 5 Pre-Manufacturing Notice (PMN) requirements.
• Has disclosure been made prior to being notified of a pending inspection? The person
disclosing the violation should be asked if there has already been contact by the Agency
to schedule an inspection.
• Is disclosure one that is required by Section 8(e)?
• Is there a possibility of violations of other statutes that would be discovered in an
inspection?
If, after consideration of these factors, it appears that the notification does constitute a voluntary
disclosure, the person should be advised that:
• The violative activity must cease and any such further violations may be considered
knowing and willful and subject to criminal action. Therefore, any and all existing
stocks of the illegally manufactured chemical substance must be immediately quarantined.
No further manufacture maj continue, and none of the quarantined stocks may be used
in any manner;
• Documentation must be submitted describing:
- the nature of the violation, in detail,
- when and how the person discovered the violation,
- when and how the violative conduct was discontinued, and
- whether other persons were advised of the violation;.
• A civil administrative complaint for the assessment of civil penalties will be issued in
accordance with Agency policy and adjusted to take into account the voluntary disclosure
(a copy of the appropriate penalty policy may be provided at this time);
• The civil complaint will be issued upon receipt and evaluation of the documentation
provided by the violator and any other documents, such as certified statements,
developed by the Agency; and
• All communication regarding the pending enforcement action should be directed to a
specific Agency contact point.
TSCA Case Proceedings 2-56 Guidance Manual 1992
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Chapter Two Voluntary Disclosure
DOCUMENTATION
The documentation describing the nature of the violation should be submitted within 21 days or
sooner, and should include as appropriate:
• Names and purposes of any chemical substances involved including Chemical Abstract
Service numbers and brand names;
• Locations of manufacturing or testing facilities, ports of entry, or use sites;
• The suspected nature of the violation (i.e., PMN, NOC, etc.);
• Descriptions of the manufacturing, production, or import process, or use or testing
procedures;
• Dates and amounts of chemical substances involved in each violation. This must include
a description of the batch process (i.e., number of days to produce a batch);
• Description of the types of products where the chemical substance is used;
• Description of the marketing practice of the chemical substance;
• The dates of distribution or sale of the chemical substance;
• Amounts of the chemical substance in inventory and remaining uaused in channels of
trade;
• The size of the violator's business. This should include the amount of gross sales, and
any other supporting financial information needed to warrant any mitigation in the
penalty calculation. (Although inability to pay defenses should not be encouraged, it may
be necessary to know a company's financial status in cases where suit will be taken
against a parent company); and
• Notification if any TSCA CBI will be submitted. If so, the Case Development Officer
should explain to the self-confessor how to properly handle the submission. (See Section
4 for this information.)
TSCA Case Proceedings 2-57 Guidance Manual 1992
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Chapter Two Voluntary Disclosure
NOTE: In lieu of actual documents such as batch or shipping records, the violator may provide
lists of documents by date indicating the specific quantities manufactured or distributed for that
date such as a batch or production summary. These lists should be accompanied by a letter
indicating that copies of the actual documents will be provided upon request.
In advising the violator of the steps that must be taken to meet the requirements of the voluntary
disclosure policy, the Case Development Officer should not speculate as to the actual size of the
penalty. Rather, a copy of the appropriate policy may be provided with an explanation that the
Agency will calculate the proposed penalty assessment using the factors outlined in the policy
and that until a complete evaluation of the documentation is made, no specific penalty figure can
be quoted. Settlement negotiations should not be initiated until a civil administrative complaint
is issued and an answer is filed.
The Office of Pollution Prevention and Toxics should be advised of any voluntary disclosure
involving a chemical substance that is undergoing a simultaneous review by their offices.
It is common for self-confessors to request the right to use the existing stocks of a chemical
substance which was manufactured in violation of TSCA. To allow this use, the Agency would
have to grant Enforcement Discretion. See Chapter 10 for a detailed discussion of requests for
Enforcement Discretion to use existing stocks of an illegally manufactured chemical substance.
TSCA Case Proceedings 2-58 Guidance Manual 1992
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Chapter Two
4 Confidential Business Information
Compliance/enforcement personnel will, on occasion, need to review, generate and use
information that is entitled to confidential treatment under Section 14 of TSCA and the EPA
regulations at 40 C.F.R. Part 2. That section of the statute and the regulations require EPA to
protect TSCA confidential business information (CBI)2 from unauthorized disclosure. Material
that is designated as TSCA CBI includes information considered to be trade secrets that could
damage a company's competitive position if such information became publicly known. The
following section on confidentiality and disclosure of information is included in this manual
because TSCA CBI may be used as part of an active enforcement case. For a complete guide
to TSCA CBI procedures, consult the TSCA Confidential Business Information Security Manual
(11/1/85).3 The TSCA CBI Security Manual sets forth procedures for authorizing and
approving TSCA CBI access for EPA employees and/or individual employees of other Federal
agencies who either perform work for EPA or for other agencies. Procedures for handling and
safeguarding TSCA CBI are included as well. Penalties associated with the willful unauthorized
release or disclosure of TSCA CBI are also discussed.
AUTHORITY
Section 14(a) of TSCA states that any information reported to, or otherwise obtained by, the
Administrator (or any representative of the Administrator) under TSCA and that is exempt from
disclosure under the Freedom of Information Act [Subsection (b)(4), 5 U.S.C. §552], shall not
be disclosed by the Administrator or by any officer or employee of the United States, except that
such information may be disclosed:
• To any officer or employee of the United States in connection with the official
duties of such officer or employee under any law for the protection of human
'TSCA CBI material does not in any manner refer to classified National Security Information as defined in
Executive Order 12065.
3 At the time of this writing, the Security Manual is being rewritten. To confirm that you have the most up-
to-date edition, contact your Document Control Officer (DCO).
TSCA Case Proceedings 2-59 Guidance Manual 1992
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Chapter Two Confidential Business Information
health or the environment or for specific law enforcement purposes [TSCA
§§14(a)(l)(A)andl4(a)(l)(B)];
• To contractors with the United States if the Administrator determines that such
disclosure is necessary for the satisfactory performance by the contractor of a
contract with the United States [TSCA §14(a)(2)];
• If the Administrator determines it necessary to protect human health or the
environment against an unreasonable risk of injury [TSCA §14(a)(3)]; or
• When relevant in any proceeding under TSCA, except that such disclosure is to
be made in a manner that will preserve confidentiality to the extent practicable
without impairing the proceeding [TSCA §14(a)(4)]. [See Section 22.22(a) of the
Consolidated Rules of Practice and Section 26(c) of the Federal Rules of Civil
Procedure.]
Section 14(b) of TSCA states that Section 14(a) does not prohibit the disclosure of:
(A) any health and safety study which is submitted under this Action with respect
to-
ft) any chemical substance or mixture which, on the date on which such
study is to be disclosed has been offered for commercial distribution, or
(ii) any chemical substance or mixture for which testing is required under
Section 4 or for which notification is required under Section 5, and
(B) any data reported to, or otherwise obtained by, the Administrator from a health
and safety study which relates to a chemical substance or mixture described in
clause (i) or (ii) of subparagraph (A).
However, Section 14(b) does not authorize the release of any data that disclose processes used
in the manufacturing or processing of a chemical substance or mixture, or, in the case of a
mixture, the release of data disclosing the portion of the mixture comprised by any of the
chemical substances in the mixture.
Section 14(c) of TSCA, in conjunction with 40 C.F.R. Part 2, specifies the requirements and
procedures for designating submitted information as confidential, as well as the notification
requirements that must be met prior to the release of any information so designated.
TSCA Case Proceedings 2-60 Guidance Manual 1992
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Chapter Two Confidential Business Information
PENALTIES
Section 14(d)(l) of TSCA specifies the penalties that may be assessed against any person who
knowingly and willfully discloses confidential information contrary to the provisions of the Act.
Section 14(d)(l) states:
Any officer or employee of the United States or former officer or employee of the United
States, who by virtue of such employment or official position has obtained possession of,
or has access to, material the disclosure of which is prohibited by subsection (a), and who
knowing that disclosure of such material is prohibited by such subsection, willfully
discloses the material, in any manner to any person not entitled to receive it, shall be
guilty of a misdemeanor and fined not more than $5,000 or imprisoned for not more than
one year, or both. Section 1905 of title 18, United States Code, does not apply with
respect to the publishing, divulging, disclosure, or making known of, or making
available, information reported or otherwise obtained under TSCA.4
Section 14(d)(2) of TSCA states that for the purposes of imposing criminal penalties under
Section 14(d)(l), any contractor or any employee of such contractor, who is furnished
confidential information, is considered to be an employee of the United States.
OBTAINING ACCESS TO TSCA CBI
Only those individuals whose names appear on the TSCA CBI Authorized Access List may have
access to TSCA CBI. After receiving approval for TSCA CBI access and passing the required
written test, the names of each TSCA CBI-cleared individual will be added to the Authorized
Access List. The following steps must be taken to apply for inclusion on the list:
• Authorization Form 7740-6 (Example 2E-8), titled the Federal TSCA CBI Access
Request, Agreement, and Approval (Document and Computer), must be completed
and signed by Federal employees who are seeking access. Any contractor or
subcontractor wishing to apply for access to TSCA CBI must sign the confidentiality
'In addition to these criminal penalties, EPA employees who violate CBI procedures may be subject to
disciplinary action in accordance with the procedures detailed in the EPA Conduct and Discipline Manual.
TSCA Case Proceedings 2-61 Guidance Manual 1992
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Chapter Two Confidential Business Information
agreement of the Authorization Form 7740-6A, Federal TSCA CBI Access Request,
Agreement, and Approval-Contractor/ Subcontractor Employee (Example 2E-9).
Contractors/subcontractors must also complete Standard Form 86A, a questionnaire
for sensitive positions;
• All access request forms must be signed by the requesting employee and the
employee's Division Director (or above). The Division Director (or above), i.e,
the requesting official, may only authorize access for those employees under his
or her supervision;
• Each completed and signed TSCA CBI access request form must be returned to
the Document Control Officer (DCO) who retains a copy of the form and submits
it with the written test to the Information Management Division (IMD) for
approval; and
• After an employee has received approval for TSCA CBI access and passed the
required written test, his or her name will be added to the TSCA CBI Authorized
Access List.
CBI-cleared employees may obtain a TSCA CBI document through transfer from another
employee or from the DCO. Consult the TSCA CBI Security Manual for proper procedures for
obtaining and/or transferring TSCA CBI materials. A TSCA CBI document may be logged out
or loaned to a TSCA CBI-cleared individual for a maximum of 90 days.
USE OF CBI IN CASE PREPARATION
An inspection file may contain a TSCA CBI inspection report, which includes information that
was gathered during a TSCA inspection and has been declared TSCA CBI. When an inspector
returns from an inspection with information that has been declared confidential, the information
is immediately given to the DCO, who assigns a document control number to the confidential
material. In order to account for all TSCA CBI documents, each is assigned a unique
identifying number, i.e., a Document Control Number (DCN). In addition, the inspector
informs the DCO of any physical samples that have been declared confidential. Such samples
are assigned a document control number by the DCO who, in turn, notifies the laboratory of this
number. (The document control number is used by laboratory personnel in completing the
sample chain-of-custody and laboratory analysis forms.) The CBI file may also contain the
inspection report if the inspector chooses to include CBI information on the report. Once the
TSCA Case Proceedings 2-62 Guidance Manual 1992
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Chapter Two Confidential Business Information
CBI material has been logged in by the DCO, review of the file must be done in accordance
with TSCA CBI security procedures.
Compliance/enforcement personnel, when preparing a summary; complaint; or report based on
review of the. inspection file, should either:
• Reference TSCA CBI material in a nonconfidential manner, either by the use of
Document Control Numbers or by replacing the words "CBI Deleted"; or
• Include the CBI material in their report (in which case the entire report must be
treated as a confidential document).
In preparing a complaint or other pleading that is based in total, or in part, on CBI material,
compliance enforcement personnel should prepare the pleading so that it consists of a
confidential and nonconfidential document. The nonconfidential document should be drafted so
as to state the charge or substance of the pleading without disclosing the confidential information
(see Example 2E-10). The confidential document should contain the CBI material, and the
document must be treated in accordance with TSCA CBI security procedures.
Special procedures must be used when filing a complaint or other pleading that contains CBI.
For example, when filing a CBI complaint, both the CBI document and the public (non-CBI
document or sanitized version or copy) must be hand-delivered to the Hearing Clerk for
simultaneous filing. After the original pleading has been stamped in by the Hearing Clerk,
copies of the complaint may be made. This ensures that the date and time of filing is reflected
on each subsequent copy. Only the DCO is authorized to make copies of the CBI complaint.
The DCO must cover each confidential copy, excluding the respondent's copy, with a green
cover sheet and assign each TSCA CBI copy the unique DCN and a copy number. The original
CBI complaint remains with the Hearing Clerk.
The DCO forwards a copy of the TSCA CBI complaint to the respondent, as well as a copy of
the public non-CBI complaint. The entire package is sent by registered mail, return receipt
requested. Please consult the TSCA CBI Security Manual for specific details on the proper
procedures for mailing TSCA CBI materials.
Creating New CBI Documents and Personal Working Papers
TSCA CBI is not only collected during an inspection or received by mail. It may also be
generated when taking notes at meetings or over the phone, preparing Enforcement Requests,
or responding to letters. Proper procedures must be followed to ensure that these types of TSCA
or CBI documents that are under your control are promptly and properly logged into the TSCA
TSCA Case Proceedings 2-63 Guidance Manual 1992
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Chapter Two Confidential Business Information
CBI Document Tracking System. Please consult the TSCA CBI Security Manual for proper
procedures.
Use of CBI in Administrative Hearings
Section 14(a)(4) of TSCA states that confidential information may be disclosed when it is
relevant to any proceeding under the Act provided that such disclosure shall be made in a
manner so as to protect, to the extent practicable, the confidentiality of the information without
impairing the proceeding. In addition, Section 22.22(a) of the Consolidated Rules of Practice
(CRP), which govern TSCA administrative hearing proceedings, provides that the confidentiality
of trade secrets and other commercial and financial information shall not preclude such
information from being introduced into evidence. Under the CRP, the Presiding Officer may
make such orders as may be necessary to consider such evidence in camera (i.e., in chambers;
in private), including the preparing of a supplemental initial decision to address questions of law,
fact, or discretion arising out of that portion of the evidence that is confidential. All persons,
excluding respondents, must be TSCA CBI-cleared including court reporters, etc.
Use of CBI in Civil and Criminal Proceedings
The Department of Justice represents EPA in most civil and all criminal actions. Department
of Justice employees may be furnished TSCA CBI when prosecuting cases under the Act or
providing legal assistance to EPA. (See "Disclosure of TSCA CBI to Other Agencies" in the
TSCA CBI Security Manual for proper procedures.) The Department of Justice, including the
FBI, shall be presumed to meet EPA's security requirements. However, an EPA DCO must
transfer TSCA CBI documents from EPA to the Department of Justice and all requirements for
security of CBI during transmission must be met. Authorized EPA employees, when necessary
and with permission of a Division Director or above, may discuss TSCA CBI with appropriate
Department of Justice employees, whether in person or on the phone. Any TSCA CBI discussed
must be clearly identified as such.
Telephone Calls during Which TSCA CBI Is Discussed
Federal employees with TSCA CBI access authority may discuss CBI on the telephone only with
other individuals (Federal employees or employees of Contractors) who are authorized for access
to that type of TSCA CBI. Both parties to a telephone call are responsible for verifying, by
using the TSCA CBI Authorized Access List if needed, that the other is authorized for access
to such TSCA CBI. The individual who initiates a discussion that includes TSCA CBI must
indicate that the conversation involves CBI.
TSCA Case Proceedings 2-64 Guidance Manual 1992
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Chapter Two Confidential Business Information
Determining Confidentiality
EPA's Freedom of Information Act (FOIA) regulations (40 C.F.R. Part 2 Subpart B) contain
a procedure for determining whether information is confidential.
Under this procedure, if information submitted to EPA has been claimed as TSCA CBI, the
information may not be disclosed to the public until a determination has been made that the
information is not confidential, the affected business has been given 30 days' notice of the
determination, and the affected business has been given an opportunity to challenge the decision.
Final determinations are made by the Office of General Counsel; however, program offices may
make initial determinations (see 40 C.F.R. §2.204). If the program office makes the
determination that the information may be entitled to confidential treatment, the office must:
• Deny any FOIA request for the information;
• Write to the affected business requesting substantiation of its claim; and
• Refer the matter to the EPA General Counsel's Office for a final confidentiality
determination.
If the program office determines that the information in question is clearly not entitled to
confidential treatment, the program office must give notice of the decision to the affected
business and, after the notice period ends, disclose the information to the requestor.
DISCLOSURE OF TSCA CBI TO PERSONS OUTSIDE THE AGENCY
Under certain circumstances, EPA may disclose TSCA CBI to specific persons outside the
Agency. These disclosures include disclosures to Congress or the Comptroller General [TSCA
§14(e) and 40 C.F.R. §2.209(b)], disclosures to other Federal agencies [40 C.F.R. §§2.209(c)
and 2.306(h)], disclosures to Federal courts [40 C.F.R. §2.209(d)], disclosures to contractors
[TSCA §14(a)(2) and 40 C.F.R. §2.306(j)], and disclosures when necessary to protect human
health or the environment against an unreasonable risk of injury [TSCA §14(a)(3) and 40 C.F.R.
§2.306(k)].
TSCA Case Proceedings 2-65 Guidance Manual 1992
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Chapter Two Confidential Business Information
Disclosure to Congress or the Comptroller General
The Information Management Division (IMD) must be immediately notified if a Congressional
request is received for documents or information that would require access to TSCA CBI by
Congress or the Comptroller General. Pursuant to 40 C.F.R. §2.209, access may be allowed
only if the request is made by the Speaker of the House, the President of the Senate, a chairman
of a committee or subcommittee, or the Comptroller General. Access must be recorded on a
Congressional Access Log. Generally, the requestor will be asked whether access can be limited
to EPA premises. Any notices to affected business of such access must identify the requestor,
the type of information to be disclosed, whether access will occur only on EPA premises, and
the period of time during which access will take place. The notice generally will be prepared
by IMD.
Disclosure to Other Federal Agencies
EPA may disclose TSCA CBI to another Federal agency under the following circumstances:
• When the official purpose for which the information is needed by the other
agency is in connection with its duties under any law for protection of health or
the environment or for specific law enforcement purposes; or
• When disclosure is necessary to enable the other agency to perform a function on
behalf of EPA.
In either circumstance, the procedures for authorizing another Federal agency for access must
be followed before TSCA CBI may be disclosed to the other agency. These procedures do not
apply to disclosure of TSCA CBI to individual employees of other agencies performing functions
on behalf of EPA where access is confined to EPA premises. For specific procedures for
authorizing another agency for access to TSCA CBI, consult the TSCA Confidential Business
Information Security Manual.
Access to TSCA CBI at Facilities outside OPPT
EPA will encourage other agencies to restrict their access to TSCA CBI to EPA premises.
However, where this is not practical, the provisions of this subsection must be followed before
access is granted at the other agency's premises. Other Federal agencies requiring access to
TSCA CBI on their premises must have security procedures and standards in place which equal
or surpass those set forth in the TSCA CBI Security Manual. Also, each such facility must be
inspected and approved by the TSCA Security Staff and a DCO for the facility must be
TSCA Case Proceedings 2-66 Guidance Manual 1992
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Chapter Two Confidential Business Information
appointed before CBI can be transferred there. In addition, all facilities approved for TSCA CBI
access must be inspected by the TSCA Security Staff on an annual basis.
Employees of another agency may be authorized for TSCA CBI access at OPPT's Headquarters
facilities even if the other agency's or office's facilities are not approved for CBI access.
However, the employees will not be allowed to remove from EPA premises any documents,
notes, or correspondence containing TSCA CBI and must not discuss CBI with individuals not
authorized for TSCA CBI access.
Court-Ordered Disclosure
EPA may disclose TSCA CBI to the extent ordered by a Federal court. Where possible, the
EPA office disclosing TSCA CBI should provide as much advance notice as possible to each
affected business of the type of information to be disclosed and to whom it is to be disclosed.
Disclosure of Information to Contractors and Subcontractors
TSCA CBI may be disclosed to a contractor or subcontractor if the EPA program office
managing the contract or subcontract determines in writing that such disclosure is necessary for
the satisfactory performance of the contract.
Disclosure of Information When Necessary to Protect Health or the Environment against
an Unreasonable Risk of Injury
If an EPA office determines that there is an unreasonable risk of injury to health or the
environment and it is necessary to disclose TSCA CBI, the EPA office should notify the General
Counsel in writing of the nature of the unreasonable risk or injury, the extent of the disclosure
proposed, how the proposed disclosure will serve to protect health or the environment, arid the
proposed date of disclosure.
TSCA Case Proceedings 2-67 Guidance Manual 1992
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Chapter Two
Example 2E-9
WMMngton. DC 30460
•&FR& Federal TSCA CBI Access Request, Agreement, and Approval
(Document and Computer)
l.Nam»ft*«t«nt*c;
4. Poeieon T*a
8. Prevwu* CW Aeoaa*
IJFIFRA I IRCRA I [TSCAfDeajj
10. IndicaM aaction* of TSCA required, lypa et data
4 12
9 13
6 21
a AII
2. Social Saoumy Numoar 3.Am
nu.
5. Naujuaaw (umea/DMaJon/Brejnc/IJ 6. Rm M
B. Dooumanl Control oncer and Talaefioni Nur
• Raquvad (Cftec* one or ooe\
wumant | Icomoular
to 7. Telephone Number
nber
to which aooaaa I* raqwad, and purpoa* tor which aooea* a requma
11.1 computer aeceea • raquirad. mdaaia cyawm and datiheeet to which aocaaa • requved, and duMa feat are to
1 undentand that 1 w« have aooaaa to cartain Q
USC 2801 at aaq.). This hat baan gm
1 unbaratand t>t.hy«^-nrlmpri»»w.^.l~ho»..»^l-.lrrl^tfa-tt_
13. Signature of Employe!
15. Check if HUSCO (TM) Badge i* raquirad
n Ye* fOornpfc* *am» »8ano*f7) . \~\No
16. KUSCO (TM) Areai naquirmg Aooaa* and Outai
OateolBMri lejight
Statue Coda (TSCA CBI tcf»n<*» only) Bi
16. Branch Chief eihlaii 19. Signature of Hequ
24. Signatura o( Saounry ondal
1 Ineplaoamanl
12. ADP Coonknator Matt
aneet Comrai Act (TSCA. 15
icapt a* autwrted by TSCA
id/or knprtMnmanl toi up to
ley ba mbtoct to diaotoknary
Me. I eeJmnoteogi that any
I4.bat*
••
ToBaPartormad. (Cnacia4Wiouror«.t»-4:30aooae»; l_(24-hour |_J««».4dO
Weight Eye Color
vCede Badge Number
eeang OmoM ffWiean Oracproraoow; •
OTB Saouftty Aawavil
HairCotor
•
EPA fen* 774*4 (Raw. KM) Atplaeat praviout adibona e) EPA Fenna774&« and 7740-7. both etwhienaraoMotaM.
TSCA Case Proceedings
2E-68
Guidance Manual 1992
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Chapter Two
Example 2E-10
c/wironrnvntu rroivcuon
Waaninpton. DC 20460
Federal TSCA CBI Access Request, Agreement, and Approval
Contractor/Subcontractor Employee
i Social Security Number
3, Aeoaaa Required (Cnec* on*
I iDooumern f~l Computer
4. Petition Tin*
t (Umot/DHtuon/art/tcfi)
BTPrewout CBI Aeons
0. uocument control urnotr and Telephone Number
10. Meat* Metena or
required, type of data to which i
12 21
13 All
I a required, and purpoee tor when i
11. X computer aoeett it required, indicate tymmt and otranatet to which i
i it required, and out** mat are to be performed
1Z ADPCoommoor MMts
13A. Employvr't Hunt tna Addrau
15. Contnet Number
16. Tuk Number
17. Contract ExprationDB*
ia EPA Preieet Ottocer
TcKphon* Number
19. EPA TukOHner
rfetopnone Number
13B. Emptoy»r n «n EPA
| | Contractor | |
20. Company Document Control CTtnnr
TeXpnone Numbii
14. Contnetor Name n Suboomnaor
21. Company Project CTtaoef
fMepnbne Number
CenAd
»«« to certain Confidential
i hat been granted to acoordanoe
•MyAgrwaMM
totaniauun aubmmed under 9» Toxto Subatanoaa Control Act (TSCA. 15
wtth my official dubet relatine to the DivHoiiiitenlal Protection Agency
I underatand that I wfll have i
USC 2801 at eeq.). TMa act
Drogramt.
I understand that TSCA CBI may be ueed only to connection with my official dutfet and may not be dltetoaed except at authorittd by TSCA
and Agency regulation!. I have read and underatand the procedure* tat forth to the ' .- .. .. .
agree that (will treat any TSCA CBI fumithed to me at confidential and that I will totti
I understand that under eectton 14(d) of TSCA (15 USC 2313(d)). I am Habit for a poaalMe fine of up to S5.000 and/or tmprteonmerrt tor up to
one year H I wUHulry dieOoae TSCA_CBI to any paraon not autnoraad to receive It to addition, I undantand thai I inny oc tub)eet *> dWplinan/
action tor vtotation of thit aQraernem with pananiat rancjinp, up to and tookjdmg dttmiaaal.
I eertrry that the alatemenu I have made on thit term and all attachment* thereto are true, accurate, and oornplelt. I admooleUB* that any
knowingly talee or mWaading tlatemem may be puntahable by fma or Impriaonmem or both under applicable law.
22. Sionature of Employee
23. Datt
24. Check n RUSCO (TM) Badge it required
I I Vet fComtMXB tttmt K ar»rf 26)
Flrjo
and Out
I IReptaoemem
25. RUSCX) (TM) Area* Requiring Aooett and Dutiet To Be Performed (CnecA2+tovror8.-00• 4:30aeeeuj ' ] ]24-hour 1 lajpfl.
26. Pertonal JdettUftualieii toKxiitatioii
OateofBirm
Height
Eye Color
HairCotor
StatutCode (7SC*. CBI aooaat ua* ontyj
Bar Coo*
Badge Number
27. Branch Chief toman 28. Signature of Hequeame uniaal (DfMton Dnaorortoo*)
29. Date
OTS Oauinty Apt
Coonjnnor StgnaunJ
3D. Pate Received
3l7Approvedf75C*Aeeeat
32. Oat
33. Signature of Seounty C«iciaJ
347
EPA Form 7740-M (R«v. 10-M) Praviout adnton It
TSCA Case Proceedings
2E-69
Guidance Manual 1992
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Chapter Two Example 2E-11
Sample CBI Complaint (With CBI Deleted)5
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of )
) Docket No. TSCA 91-H-13
E.A. Crowley Industries, Inc. )
)
Respondent, )
Notice of Treatment of Confidential Business Information
Portions of the attached Complaint require use of information which
Respondent submitted to the United States Environmental Protection
Agency (EPA) as Confidential Business Information (CBI). Information in
the Complaint constituting or based on CBI has been deleted as indicated
by the following: (CBI deleted). The original complaint containing CBI
is filed with the Headquarters Hearing Clerk. It will itself be treated
as confidential unless Respondent waives confidentiality thereto or EPA
releases the information in accordance with 40 C.F.R. Part 2.
5Note: This sample complaint would be part of the public record.
TSCA Case Proceedings 2E-70 Guidance Manual 1992
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Chapter Two Example 2E-11
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of )
) Docket No. TSCA 91-H-13
E.A. Crowley Industries, Inc. )
)
Respondent, . )
This is a civil administrative action issued under the authority of
Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et
sea, (hereinafter "TSCA"). The Complainant is Michael F. Wood,
Director, Compliance Division, Office of Compliance Monitoring, United
States Environmental Protection Agency (EPA), who has been duly
delegated the authority to institute this action. The Respondent is
E.A. Crowley Industries, Inc., 36 Sunshine Drive, Clark, Massachusetts
02856.
This Complaint serves as notice that Complainant has reason to
believe that Respondent has violated the reporting requirements of
Section 5 of TSCA, 15, U.S.C. Section 2604, thereby violating Section 15
TSCA, 15 U.S.C. Section 2614, as follows:
TSCA Case Proceedings 2E-71 Guidance Manual 1992
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Chapter Two Example 2E-11
Count 1
1. On (CBI deleted), respondent submitted to the United States
Environmental Protection Agency (EPA) production records revealing
that respondent manufactured (CBZ deleted).
2. Inspection of respondent's production records revealed that
respondent manufactured approximately (CBI deleted).
3. Inspection of respondent's production records revealed that
respondent manufactured a total of (CBI deleted).
4. Respondent has stated to EPA that (CBI deleted) was processed into
a product that was distributed in commerce.
5. The (CBI deleted) does not appear on the TSCA chemical substance
inventory.
6. Respondent failed to submit a notice to the Administrator of EPA
of its intention to manufacture the (CBI deleted).
7. Section 5(a)(l) of TSCA states that no person may manufacture a
chemical substance that does not appear on the TSCA chemical
substance inventory without submitting a notice to the Admini-
strator of EPA at least 90 days before manufacturing such
substance.
8. Section 15(1)(B) of TSCA states that it is unlawful for any person
to fail or refuse to comply with any requirement prescribed by
Section 5 or 6 of TSCA; Section 15(3)(B) of TSCA states that it is
unlawful for any person to fail or refuse to submit reports,
notices, or other information as required by TSCA or a rule
thereunder.
9. The conduct described in Paragraphs 2 through 6 above constituted
a violation of Sections 15(1)(B) and 15(3)(B) of TSCA in that
respondent failed to submit a notice to the Administrator of EPA,
as required by Section 5(a)(l) of the Act, before respondent
manufactured (CBI deleted).
Count 2
1. On (CBI deleted), respondent submitted production records to EPA
revealing that respondent used (CBI deleted) in the production of
(CBI deleted).
2. Inspection of respondent's production records revealed that
respondent used (CBI deleted).
3. Inspection of respondent's production records revealed that
respondent used (CBI deleted).
4. Respondent has stated to EPA that (CBI deleted) was distributed in
commerce.
TSCA Case Proceedings 2E-72 Guidance Manual 1992
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Chapter Two Example 2E-11
5. The (CBI deleted) used in the production of the (CBI deleted) does
not appear on the TSCA chemical substance inventory.
6. Respondent failed to submit a notice to the Administrator of EPA
of respondent's intention to manufacture the (CBI deleted).
7. Section 15(2) of TSCA states that it is unlawful for any person to
use for commercial purposes a chemical substance or mixture that
such person knew or had reason to know was manufactured, or
distributed in commerce in violation of Section 5 or 6.
8. The conduct described in Paragraphs 2 through 6 above constitutes
violation of Section 15(2) of TSCA in that respondent used for
commercial purposes (CBI dele-ted) that respondent knew or had
reason to know was manufactured in violation of Section 5 of the
Act.
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this Complaint, and
upon the nature, circumstances, extent and gravity of the violations
alleged, as well as Respondent's history of prior violations of TSCA,
the degree of culpability and such other matter as justice may require,
the Complainant proposes that Respondent be assessed the following civil
penalty for the violation alleged in this Complaint:
Count 1
Failure to notify of intention to
manufacture a chemical
substance not on the TSCA Inventory $
Count II
Use of an illegally manufactured
substance for commercial purposes $_
Total Penalty Assessment $_
*The remainder of the nonconfidential complaint is prepared in the same
manner as all complaints. See Example 6E-2 for typical language used.
TSCA Case Proceedings 2E-73 Guidance Manual 1992
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Chapter Two Example 2E-11
INFORMAL SETTLEMENT CONFERENCE
Whether or not you request a hearing, you may confer informally
with EPA through Ms. Ambrosino regarding the facts of this case, or
amount of the proposed penalty, and the possibility of settlement. An
informal settlement conference does not, however, affect your obligation
to file a written Answer to the Complaint.
EPA has the authority, where appropriate, to modify the amount of
the proposed penalty to reflect any settlement reached with you in an
informal conference. The terms of such an agreement would be embodied
in a Consent Agreement and Final Order ("CAFO"). A CAFO signed by EPA
and you would be binding as to all terms and conditions specified
therein upon signature by the EPA Chief Judicial Officer.
Please be advised that the Consolidated Rules of Practice prohibit
an ex parte (unilateral) discussion of the merits of any action with the
Administrator, Chief Judicial Officer, Administrative Law Judge, or any
person likely to advise these officials in the decision of the case,
after the Complaint is issued.
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or requesting an
informal settlement conference, you may choose to pay the proposed
penalty. Such payment should be made by sending a cashier's or
certified check payable to the United States of America in the amount of
the penalty assessed in this Complaint. The check should be mailed to:
EPA-Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251
TSCA Case Proceedings 2E-74 Guidance Manual 1992
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Chapter Two Example 2E-11
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 91-H-13
Complainant
BY:
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
Date:
TSCA Case Proceedings 2E-75 Guidance Manual 1992
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Chapter Two Example 2E-11
CERTIFICATION
I hereby certify that the original of the foregoing Complaint and Notice
of Opportunity for Hearing, Docket No. TSCA-91-H-13, has been filed with
the Headquarters Hearing Clerk and that copies were sent, registered
mail, return receipt requested to:
Elizabeth A. Crowley
President
E.A. Crowley Industries, Inc.
36 Sunshine Drive
Clark, Massachusetts 02856
Date Theresa I. Little (EN-342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
TSCA Case Proceedings 2E-76 Guidance Manual 1992
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Chapter Three
Evidence Assessment
CHAPTER CONTENTS PAGE
1 Introduction 3-1
2 Inspection File Review 3-3
Contents of an Inspection File 3-3
Example 3-1: Notice of Inspection 3E-8
Example 3-2: TSCA Inspection Confidentiality Notice 3E-9
Example 3-3: Receipt for Samples and Documents 3E-10
Example 3-4: Declaration of Confidential Business Information 3E-11
Example 3-5: Investigation Request . 3E-12
Example 3-6: Investigation Summary 3E-13
Example 3-7: EPA Custody Seal 3E-14
Example 3-8: EPA Chain of Custody Record 3E-15
3 The Initial Assessment 3-17
4 Elements of Proof 3-21
5 Types and Adequacy of Evidence 3-25
6 Additional Sources of Evidence 3-27
Financial Data 3-27
Toxics Release Inventory System (TRIS) 3-32
FIFRA and TSCA Tracking System (FTTS) 3-33
Integrated Data for Enforcement Analysis (IDEA) System 3-34
Management Information Tracking System (New Chemicals) (MITS) 3-34
Enforcement Document Retrieval System (EDRS) 3-35
ASK SAM 3-36
Enforcement Requests 3-36
Example 3-9: Guidance for Submitting TSCA Enforcement Requests 3E-38
TSCA Case Proceedings 3-i Guidance Manual 1992
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Chapter Three Contents
7 Additional Violations 3-41
TSCA Case Proceedings 3-ii Guidance Manual 1992
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Chapter Three
1 Introduction
Upon completion of a TSCA inspection, enforcement inspectors organize the documentary
evidence that they have collected into an inspection file. An inspection file may consist of two
separate files~a nonconfidential file and a confidential business information (CBI) file.
Information gathered during a TSCA inspection that has not been declared TSCA CBI is
organized by the inspector into a package referred to as the nonconfidential inspection file. This
file contains the inspector's report and all forms and nonconfidential documents secured by the
inspector that relate to the TSCA inspection. Once compiled, the file is sent to the Case
Development Officer (CDO), who is responsible for reviewing the inspection results for possible
enforcement action.
Information gathered during a TSCA inspection that has been declared TSCA CBI is organized
by the inspector into a package referred to as the CBI inspection file. When an inspector returns
from an inspection with information that has been declared confidential, the information is
immediately given to the Document Control Officer (DCO), who then assigns a document
control number to the confidential material. In addition, the inspector also informs the DCO of
any physical samples that were declared confidential. Physical samples are also assigned a
document control number by the DCO who, in turn, notifies the laboratory of this number. (The
document control number is used by laboratory personnel in completing the sample chain of
custody and laboratory analysis form.) Once CBI material has been logged in by the DCO,
review of the information by the CDO must be in accordance with the procedures detailed in the
TSCA Confidential Business Information Security Manual. See Chapter 2, Part 4 TSCA
Confidential Business Information for more details.
TSCA Case Proceedings 3-1 Guidance Manual 1992
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Chapter Three Introduction
TSCA Case Proceedings 3-2 Guidance Manual 1992
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Chapter Three
2 Inspection File Review
To ensure the validity and quality of documentary evidence for an administrative or judicial
enforcement proceeding, the Case Development Officer (CDO), in consultation with Regional
.Counsel, must review the inspection file (nonconfidential and CBI1) for objectivity, adequacy,
and proper identification. Additionally, the CDO must ensure that all procedural safeguards are
implemented so as not to prejudice a possible enforcement action.
In most cases, a violation will be substantiated through a combination of evidential sources. The
CDO's review must seek to substantiate each possible violation from the evidence supplied by
the inspector. Whenever necessary, the CDO should obtain additional evidence or clarification
of existing evidence from the inspector.
CONTENTS OF AN INSPECTION FILE
The following documents are the principal elements of an inspection file. If any of these
elements do not appear, consult your attorney.
• Notice of Inspection. Section ll(a) of TSCA requires the inspection file to contain
evidence that a written notice of inspection was presented. The CDO should ensure that
the inspection adhered to the terms specified in the notice. (See Example 3-1.)
• Verification of Credentials. Section 11 (a) of TSCA also requires that an inspector
present appropriate credentials to the owner, operator, or agent in charge of the
inspection premises. Therefore, the inspection file should contain evidence that proper
credentials were presented.
• TSCA Inspection Confidentiality Notice. The CDO should verify that facility officials
were informed of their right to claim inspection data as CBI. The notice should be
reviewed for proper signatures, dates, and completeness. (See Example 3-2.)
'To review the CBI inspection file, the CDO must have the appropriate clearance.
TSCA Case Proceedings 3-3 Guidance Manual 1992
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Chapter Three Inspection File Review
• Receipt for Samples and Documents. The CDO must determine whether the samples and
documents were properly collected and accurately and completely identified. Inspectors
must issue a receipt for all samples and documents collected during a TSCA inspection.
The receipt should be reviewed for proper names, addresses, and dates, as well as a
description of samples with sample numbers, duplicate samples (if provided), and a
description of documents by title. (See Example 3-3.)
• Declaration of Confidential Business Information2. The declaration should be reviewed
for signature, dates, and a complete listing of all documents and samples for which CBI
is claimed. (See Example 3-4.)
In addition, an inspection file should normally contain the following items:
• Inspection Report. The report should be reviewed for factual information, objectivity,
and comprehensiveness. The report should be signed and dated by the inspector, with
attachments clearly identified, labeled, and organized. All attachments must be clearly
legible. The relevant section of TSCA should be cited and the findings of the inspection
report should list all of the samples and documents collected in support of each relevant
section of TSCA. If statements were made by company personnel with regard to
potential violations, these statements should be duly noted in the inspection report. The
inspector should note who made the statement (include title), when it was made, and in
reference to what the statement/answer was made.
• Investigation Request (if issued). If Headquarters requested the inspection, it may have
done so by issuing an Investigation Request to the Regional Office. If issued, a copy of
the document should be included in the inspection file. (See Example 3-5.)
In the case of a voluntary disclosure, the inspection file should include the letter from the
company which details the date of discovery of violation, relevant sections of law
potentially violated, how the violation was discovered, etc. Please see Chapter 2, Section
3, Voluntary Disclosure, for more details.
• Project Plan. The Project Plan should be reviewed to determine whether it accurately
reflects the objectives, scope, logistics, and schedule. Inspectors should be prepared to
explain inspection rationale and any deviations from the proposed plan.
Declaration of Confidential Business Information and the TSCA Confidentiality Clearance References
are contained in the inspection file when materials have been claimed as confidential.
TSCA Case Proceedings 3-4 Guidance Manual 1992
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Chapter Three Inspection File Review
• Investigation Summary. The Investigation Summary provides sample information for the
FITS computer system and serves as a brief summary of the sample collection process.
(See Example 3-6.)
• Custody Records. Samples that will be used as evidence must be sealed with EPA seals,
which are placed on sample containers by the inspector. (See Example 3-7.) A complete
inventory of sample tags/seals should be maintained.
In addition, an accurate written record must be maintained to trace the possession of each
sample from the moment of collection through its introduction as evidence. Therefore,
the transfer of all samples from the inspector to other authorized persons must be
recorded on an EPA Chain of Custody Record (Example 3-8.) The Chain of Custody
Record should be reviewed to ensure that the following information is included:
- site location;
- station location;
- date and time of collection;
- sample analysis required;
- samplers' names;
- remarks; and
- accepting/relinquishing samples.
If a complete chain of custody cannot be shown for any sample, that sample may not be
used as evidence.
• Laboratory Analyses. Test results from any laboratory analyses made in connection with
the inspection should be included in the inspection file. Review for custody, methods,
quality control, and proper identification.
• Subpoena (if issued). The CDO should review the subpoena to ensure that it was issued
properly and that it complied with the requirements of the document.
• TSCA Confidentiality Clearance Reference2. The CDO should ensure that all individuals
who handled or will handle TSCA CBI have had the appropriate clearance.
^e Declaration of Confidential Business Information and the TSCA Confidentiality Clearance References are
contained in the inspection file when materials have been claimed as confidential.
TSCA Case Proceedings 3-5 Guidance Manual 1992
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Chapter Three Inspection File Review
Other Evidence Documentation. The following items may also be collected and included in the
inspection file:
• Affidavits. Affidavits are sworn statements taken by the inspector that relate to personal
firsthand knowledge of a potential violation. Affidavits may be used to substantiate a
violation or a set of circumstances surrounding a violation. Careful review should be
made of an affidavit for evidence in support of an enforcement action. The person
making the affidavit must sign it and be able to personally verify the facts contained in
the statement.
The affidavit should consist of a clear and concise written record of factual information
relating to a suspected violation. The oath taken by the person making the affidavit
serves to substantiate the truth of the statement. Affidavits may be used to verify the
dates obtained from a facility's records (e.g., the date of shipment). Review should
emphasize the admissibility of the affidavit in court. This includes determining whether
the affidavit was properly executed and whether it contributes valid evidence to any
contemplated proceeding. The affidavit itself should contain the following:
- The identity of the affiant (i.e., the person providing the sworn statement);
— The reason the affidavit was taken;
— The signature of the affiant;
~ The pertinent facts in a simple narrative style, arranged in chronological order; and
— A concluding paragraph indicating that the affiant read and understood the statement.
In addition, any corrections made to the final copy must be initialed by the affiant.
• Statements. Statements are similar in most respects to affidavits except that statements
are not taken under oath and, therefore, do not have as much evidentiary weight as
affidavits. Statements can be used to verify data collected during an inspection. For
example, a statement may be obtained from a facility representative that indicates a date
of shipment. Review should verify the person's identity and the truth of the statement
through a signature or some other written or verbal acknowledgement.
• Printed Matter. Brochures, literature, labels, and other printed matter may provide
important information regarding a firm's condition and operations. These materials may
be collected as documentation, if in the inspector's judgement they are relevant. All
TSCA Case Proceedings 3-6 Guidance Manual 1992
-------
Chapter Three Inspection File Review
printed matter should be identified with the date, the inspector's initials, and related
sample numbers.
• Records. Shipping records, invoices, sales records, and batch records may provide
additional information on a firm's operations. All records collected should be identified
with the date, the inspector's initials, and related sample numbers.
• Financial Data. Information on a company's financial health can be useful in developing
a case. This can include documentary evidence, such as the company's annual report,
or descriptions by the inspector of the facility's condition.
• Photographs and Videotapes. The documentary value of photographs ranks high as
admissible evidence. Clear photographs of a relevant subject, taken in proper light and
at proper lens setting, provide an objective record of conditions at the time of inspection.
Review must ensure that the photographs are clear, objective, and properly identified.
The photographs should be identified by location, purpose, date, time, inspector's
initials, and related sample number. This information should be recorded on the
photographs and in the inspector's field notebook.
• Drawings and Maps. Schematic drawings, maps, charts, and other graphic records can
be useful in supporting violation documentation. They can provide graphic clarification
of site location relative to height and size of objects, and other information that, in
combination with samples, photographs, and other documentation, can produce an
accurate, complete evidence package. Review should ensure that drawings and maps are
simple and free of extraneous details. Basic measurements and compass points should
be included to provide a scale for interpretation.
• Mechanical Recordings. Records produced by an electronic or mechanical apparatus can
be entered as evidence. Review of charts, graphs, and other "hard copy" should ensure
relevance and identity. The data collected should be identified by date of collection,
inspector's initials, and related sample number.
TSCA Case Proceedings 3-7 Guidance Manual 1992
-------
Chapter Three
Example 3E-1
Notice of Inspection
Uriud Staat EiMranrnvM PrcHcdon Agmey
Touuo BuDtttflOM Control Ad
NOTICE OF N8PECTON
REASON FOR MSPGCTION
«• pup«M •>
I«I»M
to «wi
TSCA Case Proceedings
3E-8
Guidance Manual 1992
-------
Chapter Three
Example 3E-2
TSCA Inspection Confidentiality Notice
I Centre! Ad
TBCA MSPECTON CONFIOEHTMUTY NOTICE
•••MkpM to MAfM* •••«•! n>llMMMa»»
TSCA Case Proceedings
3E-9
Guidance Manual 1992
-------
Chapter Three
Example 3E-3
Receipt for Samples and Documents
TOHO oubmnMS Conttol Act
HECBPT FOR 8AMPIEB AND DOCUMENTS
TSCA Case Proceedings
3E-10
Guidance Manual 1992
-------
Chapter Three
Example 3E-4
Declaration of Confidential Business Information
&EFA
PECLAPATIOMOPCOflPlDEm;
AL BUSINESS INFORMATION
1. IHVBITIOATION IQPmUCOTlOM
IbAlLVMCLNO.
LIMHIIUHJ
I.HMMAOOK
mPONMATIOM MSIOMAT^O A» CO«IPIO«NT
WENT iV CLAMANT
T&1u*w*mrmn4^^m4ii»tniti^mmlnm\,tim*it*li»*m«mtotttmi**uti
Tkt MMnlvM' vAOTflOM^ ttw cMltnfki tt CMMvMWMy
CMtim M at* «ck •••m; (21 Tin bhrautte b M. •<
••Mi (oMw tkw pi•»••«! tadW kf M •! kfltkMi M
on^ jrtlcM mintlill: IB TW hlMH^Mi« Ml katfldt Ml
tarn • *• coainf'icMpMUiit
«*f to w*, Md dm cWw •! MI IWy • k* ipliiM MIM tte lilor-
MBm H pram *t iirt*utMH> if do MtnMim n« « IBM* to
• (Mtar «w ttvwy tart w • *M*i| rt wwW M« ki i MkW «r
b «kMkn: •* (I) 0
MU WMITt-INS^CTIONFlU YtUjOW- PAauTV HNH • RtOIOMAi. OTPICC OOCO • iMS*CCTO«*» PILC
TSCA Case Proceedings
3E-11
Guidance Manual 1992
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Chapter Three
Example 3E-5
Investigation Request
VMM
(Mtfngan. DC !••"*• •*O""»««iir •«•*•»••••• MM* !»»•)
Investigation Request
1. ftoojMIMMr
J.To
5. tan Diraaor, Comptanoe DMsion
US imtmnwttl PiuMeUon Agency (EN-34Z)
WtsNngion. DC 20460
to. Bmm kt kMMgaon
1 JFcrCww llMuMIkMM
!«.[>•» niauiiarl |1?.DWR«M)
ZFloMltNiM
4.8IWI
« C«y 7.SM. eZPCod.
M. nMTTMEMn »m«i' 15 CAS NMMI
II. 0»n»« Sa» 19.UftonB»y
2aOlirnm»lolRtgml
EMFOT.M«M(|)~.MII PiMuMMmnotacw. Headquiiten
TSCA Case Proceedings
3E-12
Guidance Marital 1992
-------
Chapter Three
Example 3E-6
Investigation Summary
US ENVIRONMENTAL PROTECTION AGENCY
A f"f^A WASHINGTON. DC 20460
tf-fctHrV TOXIC SUBSTANCES CONTROL ACT
INVESTIGATION SUMMARY
1 . INVESTIGATION IDENTIF (CATION I. RegMn/SOT
Mi Inepeoor Number Mn/StQMMl
LlnepenlngOn. 1. Contract Number 5. Contract Work Order
CD ED SO
lFieHlirFunetJen7.lnMn.Tvpi 1. Renon tor liwenieiiian
). Rilirnl Aoincv 10. Wenm Required
v. o NO a
ffAMPLE IN
18. SempH Sequence Number 18. Sort. Semen Number
20.CASNumber 21 . Project Cod.
22. Sempn Midlun 21. Den Contend
24. Lot or Other Cod« 2S. Dra Shipped
26. Sempl. Idmtitionion
27. Amount futor* SimnlinQ
28. Sempn OMoription
OTHER F
29. Mimrfecnnr/ProcBBBr lOOor inen ttxntl
30. Crty 31. San* 32. 2 IP Cod.
H.DUNSNwnbw • .... .• • • ,•-„:.• .
REO
34. Oigin.1 Reoordi
35. SempM DelMnd To 36. Dra
37. Remertu
INSPECTION
38. CredentiMf PunnuU 19. Notloi ol Impettkin to. Notn of
ConfkMntielltv
D D D
44. Inpenor-iNemt
2.Stnet
13. Crty 14. Sat. 18. ZIP Cod.
16. DUNS Number 1 7. SIC Codn
ORMATION
IL Seme* Snueno Number l9.StmSin«l»Numt»r
10. CAS Number 21. PrefKt Cod.
a.SemenMe«um 23, Den Collected
14. LotorOthirCodM 25. Dra Shipped
26. SemlM Identitionion
>7. Amount Bvhxt Sempl Ing
28. Sempta DeKrlpiion
kCILITIES
29. Minufenurer/ProceBor lOtfifr M»n tbortl
30. City 31. SOU 32. ZIP Cod.
O. DUN* Number ,v '
JRDS
34. Orlgiral ReEonb
35. SempM Dtlnered To 36. Den
37. Remerki
DOCUMENTS
41.ChemofCunt>dv 42. Rnript for Semptei/ 43. Dedemion of
Documents ConfiovntialitY
ODD
46. !.__.„ iSignrtur.
EPA Form 7740-5 (3-831
INSPECTION FILE
TSCA Case Proceedings
3E-13
Guidance Manual 1992
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Chapter Three
Example 3E-7
Custody Seal
TSCA Case Proceedings
3E-14
Guidance Manual 1992
-------
Chapter Three
Example 3E-8
EPA Chain of Custody Record
Cham of Custody Otcerd
— _ 1 i
1
TSCA Case Proceedings
3E-1S
Guidance Manual 1992
-------
Chapter Three Example 3E-8
TSCA Case Proceedings 3E-16 Guidance Manual 1992
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Chapter Three
3 The Initial Assessment
The initial review of the inspection file should focus on two aspects:
• Certainty that all necessary documents and samples have been provided; and
• Certainty that the evidence will substantiate a prima facie case. A prima facie case is
one in which the evidence is legally sufficient to establish a fact.
The purpose of the initial review is to develop a recommendation for action on the violation—
either to proceed with an enforcement action or to dismiss the violation as not worthy of
prosecution.
Potential Enforcement Action
There are three actions available to the CDO and the attorney, based on a review of the
evidence. These are: Civil Administrative Proceedings, Civil Judicial Proceedings (Injunction),
and Criminal Prosecution.
In a Civil Administrative Proceeding, the CDO must show by a preponderance of the evidence,
that there is conduct in violation of TSCA or regulations thereunder. TSCA is a strict liability
statute, i.e., one which imposes sanctions without requiring the showing of any knowledge of
or intent to violate the statute. Preponderance of evidence is a standard which shows the
complainant's evidence has greater weight or is more convincing than the evidence which is
offered in opposition to it.
In establishing a prima facie case for the alleged violation in a civil administrative case, the
CDO should disregard good faith efforts or lack of knowledge of the violator. These factors
should be considered only in establishing a prima facie case for the appropriateness of the
penalty.
If the CDO proceeds with an enforcement action where a prima facie case has not been
established, a respondent may sue for fees and other expenses incurred in connection with that
proceeding under the Equal Access to Justice Act (5 U.S.C. 504):
"(a)(l) An agency that conducts an adversary adjudication shall award, to a prevailing
party other than the United States, fees and other expenses incurred by that party in
connection with that proceeding, unless the adjudicative officer of the agency finds that
TSCA Case Proceedings 3-17 Guidance Manual 1992
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Chapter Three The Initial Assessment
the position of the agency as a party to the proceeding was substantially justified or that
circumstances make an award unjust."
Further information concerning Implementation of the Equal Access to Justice Act in EPA
Administrative Proceedings can be found in 40 C.F.R. Part 17.
A Civil Administrative Proceeding results in either the issuance of a Notice of Noncompliance
(see Chapter 5), or the issuance of a Civil Administrative Complaint, which includes the
collection of penalties, and possibly some action by the Respondent (see Chapter 6).
In a Civil Judicial Proceeding for injunctive relief, the requirements are the same as for a Civil
Administrative Proceeding. Injunctive relief is when a court compels someone to do something,
or orders someone to stop doing something. Before a judge will grant injunctive relief, he or
she will look to see that the Agency has shown the following:
• Applicable administrative actions under the statute were employed to achieve an
objective, and were found to be inadequate to address the situation at hand;
• Irreparable injury, loss, or damage will result if the relief is not granted.
A preliminary injunction or temporary restraining order would require showing:
• Immediate and irreparable injury, loss, or damage will result if relief is not granted; and
• There is a likelihood of success at trial, based on facts before the court.
A Criminal Prosecution requires showing that the violation occurred and was committed
knowingly and willfully (consciously and intentionally). All elements of the crime must be
proved by the government beyond a reasonable doubt. A criminal prosecution generally results
in the imposition of a fine and/or a jail term.
Civil Judicial Proceedings are addressed in detail in Chapter 7. Criminal Actions are addressed
in Chapter 8.
Inspection File Close-Out
If, after reviewing the inspection file, the CDO determines that there are no violations worthy
of prosecution, the inspection file should be closed out. There is no Standard Operating
Procedure for this, so confer with your Branch Chief before closing out a file.
TSCA Case Proceedings 3-18 Guidance Manual 1992
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Chapter Three The Initial Assessment
At headquarters, the CDO closes out an inspection file with a memorandum (to the file) that
summarizes the potential violations noted, and explains why the evidence did not support the
violations. The memo may merely confirm the inspector's findings that no violations were
documented. The memo is then signed by the CDO and Case Support Branch Chief, and placed
in the file.
TSCA Case Proceedings 3-19 Guidance Manual 1992
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Chapter Three The Initial Assessment
TSCA Case Proceedings 3-20 Guidance Manual 1992
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Chapter Three
4 Elements of Proof
A violation is an act or failure to act as defined by statute. In addition to establishing the
essential elements of an inspection, each violation contains several elements that must be proven
in order to establish the violation. Consult the rules and regulations to determine the elements
of proof.
The Prohibited Acts of TSCA are defined under Section 15:
"It shall be unlawful for any person to-
(1) fail or refuse to comply with (A) any rule promulgated or order issued under section 4; (B)
any requirement prescribed by section 5 or 6; (C) any rule promulgated or order issued
under section 5 or 6; (D) any requirement of Title II;
(2) use for commercial purposes a chemical substance or mixture which such person knew or
had reason to know was manufactured, processed, or distributed in commerce in violation
of section 5 or 6, a rule or order under section 5 or 6, or an order issued in action brought
under section 5 or 7;
(3) fail or refuse to (A) establish and maintain records, (B) submit reports, notices, or other
information, or (C) permit access to or copying of records, as required by this Act or a
rule thereunder; or
(4) fail or refuse to permit entry or inspection as required by section 11."
Under Section 16(a) of TSCA, the Agency may issue administrative civil complaints to persons
who violate the provisions of Section 15 of the Act. In order to establish a prima facie
administrative case against a respondent, the Agency must establish, by proper evidence, each
element of the violation charged. In addition, the CDO must establish that the Respondent is
the culpable person (person who is blameworthy), and at the time of Respondent's action, the
activity was a violation of TSCA or a regulation promulgated thereunder.
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Chapter Three
Elements of Proof
VIOLATION OF TSCA Section 5(a)
Section 15: It shall be unlawful for any person to fail or refuse to comply with ...
(B) any requirement prescribed by section 5 or 6.
Section 5(a) in general. (1) Except as provided in subsection (h), no person may --'
(a) manufacture a new chemical substance on or after the 30th day after the date on
which the Administrator first publishes the list required by section 8(b) unless such
person submits to the Administrator, at least 90 days before such manufacture or
processing, a notice, in accordance with subsection (d), of such person's intention to
manufacture, or process, such substance and such person complies with any applicable
requirement of subsection (b).
ELEMENTS OF PROOF
TYPES OF DOCUMENTATION TO
SUPPORT THE VIOLATION
Manufacture;
Date of manufacture 30 days after
publication of the Inventory;
Substance is a new chemical not on
the Inventory;
Activity is not exempted under
Section 5 (h);
No PMN has been submitted 90 days
prior to the date of manufacture.
Batch Records;
Batch Records, Certified Statement
certifying the date chemical was
listed on the Inventory;
Certified Statement certifying such,
or a search of the nonconfidential
Inventory;
Activity does not fall under 5(h)
exemptions listed in the Section 5
ERP;
Certified Statement attesting to
such.
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Chapter Three
Elements of Proof
VIOLATION OF TSCA SECTION 6 PCB RULE
Section 15 - It shall be unlawful for any person to fail or refuse to comply with...
(B) any requirement prescribed by section 5 or 6.
Section 6(e) Polychlorinated Biphenyls - (2)(A). Except as provided under
subparagraph (B), effective one year after the effective date of this Act no person may
manufacture, process, or distribute in commerce or use any polychlorinated biphenyl
in any manner other than in a totally enclosed manner.
ELEMENTS OF PROOF
1. Disposal
2. Manufacturing
3. Processing
4. Distribution
5. Use
6. Storage
7. Recordkeeping
8. Marking
9. Manifesting
The citations in
relevant 40 C.F
761.60
761.20
761.20
761.20
761.20, 761.30
761.65
761.30, 761.180,
761.120 - 761.135,
761.185, 761.187,
761.193
761.40
761.202 - 761.218
bold reference the
.R. sections.
TYPES OF DOCUMENTATION TO
SUPPORT THE VIOLATION
• Inspection Forms.
• Field Notebook.
• Inspection Checklist.
• Records such as shipping records;
notice from Customs and/or notice
from exporting country to show
import; PCB Annual Document,
Transformer Service Records, and
Inspector Records.
• Statements.
• Printed Matter.
• Photographs.
• Drawings and Maps.
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Chapter Three
Elements of Proof
VIOLATION OF TSCA SECTION 6 PCB RULE
(continued)
ELEMENTS OF PROOF
TYPES OF DOCUMENTATION TO
SUPPORT THE VIOLATION
• Physical Samples/Sample Results.
If sample results or shipping papers
show PCBs greater than 50
ppm, then according to the
Regulations, the substance can be
defined as a "PCB."
• Statements by company officials.
(Under TSCA, inspectors do not
collect affidavits.)
• Inspector Observations.
* Spills.
* Transformer Nameplates.
• Detailed Inspection Report that
includes all of the above.
• A Dun and Bradstreet report to
prove Respondent is a corporation
and thus a "person" as defined by
the Regulations.
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Chapter Three
5 Types and Adequacy of Evidence
There are two types of evidence to support each element of proof-direct or circumstantial.
Direct evidence proves the existence of a fact without inference or presumption. Circumstantial
evidence includes indirect evidence and the inferences that can be drawn from such evidence.
The CDO should prepare a list of the type of evidence (direct or circumstantial) and the form
of the evidence (oral testimony, photographs, or samples) to support each element of proof.
Direct evidence, such as direct oral testimony, photographs, videotapes, samples, and business
records are the best forms of evidence to support an element of proof. However, all
corroborative circumstantial evidence should also be included to further support the Agency's
prima facie case. An example of circumstantial evidence would be if shipping records were
collected, but not batch records.
It is the CDO's responsibility to review and determine the adequacy of the documentation for
each element of proof. The CDO is also responsible for ensuring that any items presented as
evidence are authentic. Proving authenticity includes showing that:
• all items are the actual objects on which the inquiry is focused (or the best evidence
available, i.e., if the original is not available, certification that the copy is true and
accurate); and
• the condition of the items is substantially the same as it was at the time of the
investigation.
To ensure authenticity, the CDO should check that all documents are legible and have been
appropriately identified and that the chain of custody has been maintained for all collected
documents. The CDO should make a list of the weaknesses in the evidence and consult their
attorney on these matters.
Double Jeopardy
Double jeopardy results when two counts are assessed for the same offense. In order for double
jeopardy to apply, the violation charged in the first count and the violation charged in the second
count must be identical in law and fact. The appropriate test is whether the facts alleged in one,
if offered in support of the other, would sustain a conviction.
Two charges are independently assessable only if each charge results from an independent act
or failure to act. Each charge requires an element of proof not required by the other charge.
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Chapter Three Types and Adequacy of Evidence
If it appears that two potential counts have identical elements of proof and evidence to support
those elements of proof, there may be potential for double jeopardy. Consult your attorney to
determine if separate penalties may be assessed for both counts.
Continuing Violations
Under Section 16 of TSCA, the Agency has the discretion to assess civil penalties up to $25,000
per violation, with each day that a violation continues constituting a separate violation.
Assessment of such per-day penalties is reserved for repeated acts, or acts that present
considerable risk or harm, such as where someone improperly disposes of PCBs on more than
one occasion, or when someone illegally imports PCBs on separate occasions. Each day of such
violations is significant and warrants a separate penalty.
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Chapter Three
6 Additional Sources of Evidence
Frequently, the CDO will need additional information to complete the review of the inspection
file. Below is a description of the various types of data available. Most of the information is
located in various data systems available in the Regions. However, some information must be
requested from Headquarters.
FINANCIAL DATA
Sources of financial data can be used to determine the financial status of companies charged with
TSCA violations. The Agency is interested in this financial information for two reasons: (1)
to establish appropriate civil penalties in consideration of the size of the business and (2) to
challenge corporate claims that the civil penalty assessment will affect their ability to continue
in business. Data to establish the appropriate civil penalty in consideration of size of business
is required prior to filing the complaint. Refer to page 6-5 Guidelines for Determining Penalty
Amount for more details. Information regarding ability to continue in business will not be
available prior to filing the complaint. Refer to page 6-32 for more information regarding
inability to pay.
Financial information may also be useful in establishing a company's violation history by
providing information on its parent and subsidiary companies; companies with multiple
establishments generally are considered as one when determining violation history.
It is important to keep in mind that each type of financial report has its own purpose and slant.
For example, tax returns try to minimize financial health and annual reports tend to maximize
financial health.
The following provides a list of the various types of financial data available to the CDO:
Annual Reports
Description
The Income Statement, Balance Sheet and the Statement of Cash Flows are the three primary
annual reports which provide accounting information for a particular business enterprise.
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Chapter Three Additional Sources of Evidence
Although these reports are helpful tools for determining the value or financial health of a
particular business, these reports are often characterized in such a manner as to be misleading.
For example, a firm may increase or decrease (for tax purposes) its "book" value depending on
which method management chooses to calculate the depreciation of assets or the depletion of
inventory.
Regardless of which methods are chosen by the business, the CDO may request the firm to
provide annual reports which meet "Generally Accepted Accounting Procedures" (GAAP). The
CDO may also request, if available, reports which were prepared by an independent auditor who
followed "Generally Accepted Auditing Standards" (GAAS). In addition, reports from at least
two years prior to the period under investigation may be useful in determining whether the
reports are consistent. Analyzing reports from three or more consecutive years may also reveal
significant trends which may indicate a firm's ability to pay.
Balance Sheet. Sometimes referred to as a statement of financial position, the Balance Sheet is
a compendium of the resources at the disposal of the business, i.e. assets, and claims on those
assets (liabilities and net worth).
Income Statement. The Income Statement is a periodic report of revenue and expenses of the
business.
Statement of Cash Flows. The Statement of Cash Flows represents the net cash flows of the
business, i.e., inflows minus outflows for a business over a particular period of time. It depicts
cash flows resulting from a firm's operations, investments, and financing. It is important
because a business enterprise may seem profitable in an accounting sense, but may not be
generating sufficient cash flows to carry on the business.
Location
Annual reports may be requested directly from the business establishment.
Dun and Bradstreet (D&B)
Description
Dun and Bradstreet publications are used to determine the general financial condition of a
business enterprise. They can provide information on the size of a company, its gross sales, and
the names of its corporate officers. However, the general level of detail provided by the D&B
service, if used as the only source of information, may provide an incomplete and potentially
misleading picture of a company's financial condition.
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Chapter Three Additional Sources of Evidence
Location
Check to determine whether your region subscribes to the D&B service.
Dun and Bradstreet (D&B) Million Dollar Directory
Description
The Million Dollar Directory is used to determine the general financial condition of a particular
business. In order to be listed in this publication, the company (or parent company) must have
gross sales that exceed one million dollars for a given year. The information provided includes:
legal name, address, and telephone number of the corporate headquarters; gross sales; number
of employees; products or services; and the company's financial institution. It also includes a
listing of the corporate officers. The Directory supplies the name of the parent company (where
applicable) and also lists all of the subsidiary businesses. However, the general level of detail
provided by this publication, if used as the only source, can paint an incomplete and potentially
misleading picture of a company's financial condition.
Location
The Dun and Bradstreet Million Dollar Directory is available in the reference area of most
public or private libraries. The set usually consists of three volumes with the companies listed
in alphabetical order.
Securities and Exchange Commission (SEC) "10-K" and "10-Q" Statements
Description
The 10-K statement is the official annual business and financial report that must be filed by
companies that issue public stock. No other source of corporate information provides more
comprehensive or current information about a company than this report. The 10-K statement
contains the following items pertaining to a company's financial status:
• Business information identifying principal products and services of the company,
principal markets and methods of distribution, number of employees, effects of
compliance with ecological laws, etc.;
• Summary of operations for each of the past five fiscal years;
• Location and character of properties and whether held or leased;
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Chapter Three Additional Sources of Evidence
• Parents and subsidiaries;
• Description of material legal proceedings pending; and
• Executive officers and the nature of positions and offices held.
The 10-Q report is a condensed version of the 10-K and is completed by companies on a
quarterly, rather than yearly, basis. In addition to the basic location information, the 10-Q
provides the following for any specific quarter: statements of financial position; statements of
earnings and earnings retained; statements of cash flows; notes to the financial statements; and
management's discussion and analysis of financial condition and results of operations.
Location
The Securities and Exchange Commission (SEC) is located in Washington, D.C. Requests for
certified copies of 10-K or 10-Q statements must be made on Agency letterhead and include:
• Name of the company;
• Type of report required;
• Date or year of filing;
• Method of transmittal to EPA (mail, fax, etc.); and
• Phone number of EPA contact point.
The request should be sent to:
Chief, Records Management Branch
Securities and Exchange Commission
Room 1C 15, Stop C-4
450 5th Street, N.W.
Washington, D.C. 20549
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Chapter Three Additional Sources of Evidence
Financial Directories
Standard and Poor's Register
Description
The Standard & Poor's Register also provides general financial information about specific
.companies. It contains a listing of more than 55,000 businesses and is published yearly. The
information includes: legal name, address, and telephone number of the corporate offices;
corporate officers, main accounting firm, primary law firm, and primary financial institution;
yearly revenues; number of employees; products or services; and stock exchange listings. Also
listed is the parent company (where applicable) and all subsidiary businesses. Like the Million
Dollar Directory, this register, if used as the sole source, can provide an incomplete and
misleading financial summary of a company.
Location
The Standard & Poor's Register is available in the reference section of almost all public or
private libraries. The register comprises three volumes; the corporate listings are usually in
Volume 1 in alphabetical order.
Moody *s Industrial Manual
Description
Moody's Industrial Manual provides a more comprehensive financial picture of a company than
D&B or Standard & Poor's. This manual covers companies that are listed on the New York,
American, or regional stock exchanges. The majority of the information available is obtained
from the corporations themselves, stockholders' reports, and Securities and Exchange
Commission reports and registrations. The information includes: a brief history of the company;
products or services; location of corporate offices; corporate officers and directors; primary
accounting firm; number of stockholders; consolidated income account; consolidated balance
sheet; and capital stock information. For the larger corporations, the manual also lists all
properties owned and managed, all subsidiaries, debt history, and financial rating. In addition
to the Industrial Manual, Moody publishes manuals on Bank and Finance, International
Corporations, Municipal and Government Corporations, and Public Utilities. Each manual is
published yearly.
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Chapter Three Additional Sources of Evidence
Location
Moody Manuals can be found at most public or private libraries in the reference area. The
manuals are a single volume, with each volume representing a particular year. The index should
be consulted because companies can be listed in various places within the manual.
TOXICS RELEASE INVENTORY SYSTEM (TRIS)
Description
The Toxics Release Inventory System (TRIS), a key provision of EPCRA, is an annual inventory
documenting the types and amounts of toxic chemical wastes at manufacturing facilities.
Manufacturers, processors, and users of more than 300 listed toxic chemicals provide data on
their total annual releases, both routine and accidental, of these chemicals to air, water, and
land, or to off-site waste treatment facilities. Facilities are required to report TRIS data if they
meet a combination of criteria concerning the size and type of facility and the amount and nature
of their use of TRIS chemicals. Facilities must report: 1) if they are a manufacturing facility,
2) employ ten or more full-time people, 3) manufacture, import, process, or use TRIS chemicals
above threshold amounts. Facilities submit one TRIS form for each TRIS chemical at the
facility meeting reporting requirements.
The basic information contained in the TRIS includes:
• Facility information including name, location, various business and regulatory identifying
numbers, and information on the company's parent company;
• Off-site transfer information including the names, addresses, and other information for
all sites to which chemical wastes were transported;
• Chemical use information such as the identity of the TRI chemical being reported, the
uses of the chemical at the facility, and the maximum amount present on-site;
• Chemical releases and transfers, including quantities of the chemical released to air,
water, or land and quantities transported to off-site facilities;
• Waste treatment methods used to treat chemicals on-site and the efficiency of these
methods; and
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Chapter Three Additional Sources of Evidence
• Waste minimization activities to reduce waste generation and the effect of these activities
on TRI releases and transfers.
Location
TRIS can be accessed by all regions. Check with your information systems personnel to
determine the method of access for your particular region.
FIFRA AND TSCA TRACKING SYSTEM (FITS)
Description
The FIFRA and TSCA Tracking System (FTTS) is a nationwide data base that records
compliance history and other information on inspections, import reviews, samples, case reviews,
enforcement actions, and referrals. This system also produces standard and ad hoc reports on
compliance/enforcement data.
FTTS reports may cover any time period desired and provide information such as: the type and
date of an action; the case/docket number; the type of violation; the proposed penalty and the
final penalty; the investigation type; and the region in which the violation was committed. The
system also indicates whether the violation falls under FIFRA or TSCA. The type of violation
and the investigation type are coded; the code definitions can be found in the FIFRA
Enforcement Response Policies (ERP).
FTTS is useful for obtaining the violation history of a company or facility, both for information
on prior actions and the types of statutory violations previously issued. Only cases closed within
the past five years can be used in a violation history. When dealing with previous violations that
resulted in consent orders and consent agreements, it is helpful to get an actual copy of the
consent decree in order to review the terms. EPA does not take a company's violation history
into account when calculating penalties for self-confessors.
Location
Each EPA region has its own FTTS. To find information about violations within a particular
region, that region's FTTS can be accessed. If the need arises to obtain information from
another region, there is the National Compliance Data Base in the Office of Compliance
Monitoring, EPA Headquarters, Washington, D.C. The national data base contains the
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Chapter Three Additional Sources of Evidence
information from all the Regions. If, for example, a case is being built against a company that
committed a violation in Region 10, the Region 10 FITS can be used to find supplemental
compliance information on the company. It may also be useful to use the nationwide data base
to get a more comprehensive look at the company in question. The name of the company is all
that is required to use FITS.
In some instances, case history information will be required that has not yet been entered into
FITS. If this situation arises, contact your Case Support Branch (OCM) regional coordinator
for a copy of the Administrative Case List maintained by this branch from 1979-1990.
INTEGRATED DATA FOR ENFORCEMENT ANALYSIS (IDEA) SYSTEM
The Integrated Data for Enforcement Analysis (IDEA) System integrates compliance/enforcement
systems by common facility identification. It provides users with cross-program, multi-3media
integrated data for case screening, enforcement targeting, and risk assessment. It is located on
the IBM mainframe at RTF. It uses the Facility Index System (FINDS) to "point to" data in
other systems. IDEA is available in the Regions, Headquarters, and States.
In the near future, the National Compliance Data Base (NCDB) will be linked with the IDEA
System. This will support Agency multimedia activities, allow regional access to NCDB without
building a new mainframe system, and increase program visibility.
MANAGEMENT INFORMATION TRACKING SYSTEM (NEW CHEMICALS) (MITS)
MITS is an integrated data base along with a collection of computer programs designed to aid
in recording, tracking, and report generating for managing activities concerning the review of
new chemicals by OPPT. It aids the OPPT staff by keeping information necessary to their work
readily available to them through interactive computer programs. A two-year redesign effort
is near completion, which will use the new version of Natural.
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Chapter Three Additional Sources of Evidence
ENFORCEMENT DOCUMENT RETRIEVAL SYSTEM (EDRS)
Description
The Enforcement Document Retrieval System (EDRS) is an automated search and retrieval
system that contains EPA enforcement documents. It is maintained by the Office of
Enforcement (OE) and has been designed to establish a uniform method of searching and
retrieving the full text of pertinent enforcement documents.
The EDRS is a computer-based library of documents that are considered pertinent to the
Agency's enforcement activities. The Program covers air, water, hazardous waste, and
pesticides/toxic substances. Documents within EDRS are currently divided into four categories:
Policy/Procedures, Administrative Enforcement, Judicial Action, -and Model Forms and Sample
Documents. The following types of documents are included in the four categories:
• General Enforcement Policy Compendia;
• Enforcement Guidance Manuals;
• Administrative Decisions (Initial, Final, Interlocutories, and Permit Decisions);
• Administrative and Judicial Briefs and Pleadings;
• Civil Judicial Consent Decrees, Defensive Litigation, and Decisions;
• Program Enforcement Documents (not contained in the General Enforcement Policy
Compendia); and
• Office of Enforcement Docket Procedures.
"The EDRS can provide information on past administrative and civil proceedings for a company
in violation of FIFRA or TSCA. It allows the user to search for documents in a variety of
ways. For example, documents can be selected based on issue date, title, environmental law
statute, or a specific word (e.g., dioxin, landfill, pretreatment).
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Chapter Three Additional Sources of Evidence
Location
EDRS is a menu-driven, user friendly system developed in BASIS on the NCC-IBM 3090 in
RTF, NC. The system can be accessed from terminals at EPA facilities that are directly wired
to the NCC-IBM 3090 or from computers with communications software and a modem. The
EDRS system is maintained by the Office of Enforcement. For information on accessing the
system, contact the Management Operations Branch (FTS) 260-3125. The Administrative
Decisions in EDRS contain an abstract of the decision and the complete decision.
ASK SAM
After September 1992, the Agency should have completed its question and answer data base of
past memoranda, letters, and Q&A manuals documenting regulatory interpretations and
enforcement policies from the present to approximately 1979. This data base, ASK SAM, will
provide quick access to this information using a keyword list. TSCA, PCB, and AHERA will
be covered.
ENFORCEMENT REQUESTS
Enforcement Requests (ERs) are a crucial component of virtually every TSCA enforcement
action. TSCA ERs are requested from and prepared by the HQ Office of Pollution Prevention
and Toxics. An ER takes the form of either a request for a Certified Statement or a request for
technical assistance/opinion. Requests for technical opinions are occasionally incorporated into
a request for a Certified Statement.
The Consolidated Rules of Practice at 40 C.F.R. Part 22 provides the legal basis for the
admissibility of certified statements and technical opinions.
40 C.F.R. Section 22.22 Evidence
(c) Verified statements. The Presiding Officer may admit an Insert into the record as evidence,
in lieu of oral testimony, statements of fact, or opinions prepared by a witness. The
admissibility of the evidence contained in the statement shall be subject to the same rules
as if the testimony were produced under oral examination. Before any such statement is
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Chapter Three Additional Sources of Evidence
read or admitted into evidence, the witness shall deliver a copy of the statement to the
Presiding Officer, the reporter, and opposing counsel. The witness presenting the statement
shall swear to or affirm the statement and shall be subject to appropriate oral cross-
examination upon the contents thereof.
Example 3E-9 provides guidance for requesting ERs. Consult your regional coordinator (OCM
Case Support Branch) if unique testimony is required.
Certified Statements
A certified statement is a statement of fact or policy made by an EPA Division Director or above
who has been delegated the authority for the conduct of a particular activity or development of
Agency policy concerning a specific subject. A certified statement will specify the title,
authority, responsibilities, and/or area of expertise of the person making the statement. A
certified statement is useful in formulating the testimony of an expert witness and documenting
direct evidence regarding Agency registrations, PMN reviews, and receipt of various required
reports.
Technical Opinions
A technical opinion is a statement of fact made by an expert having the greatest knowledge or
proficiency in a particular technical or scientific subject or a person having direct knowledge of
the facts at issue in a particular case. A technical opinion specifies the Agency's position on the
issue and the factual basis for that position. It is useful in providing scientific review to
determine the significance of any discrepancy in chemical composition, toxicity, or risk
assessment.
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Chapter Three Example 3E-9
GUIDANCE FOR SUBMITTING TSCA ENFORCEMENT REQUESTS
TSCA Inventory Searched/Certified Statements
o Confirm that the substance in question is used for a TSCA
regulated purpose. (FDA and FIFRA chemicals and uses will not be
reflected in the TSCA Inventory). If the use is questionable,
submit information on the use with the request for the search or
certified statement.
o Do not accept a company's assertion that what they nay be
making is excluded from TSCA reporting requirements under a
specific exemption. If such an assertion is made, require the
company to provide a detailed description of the manufacturing
process used to produce the substance so that it can be reviewed at
headquarters.
o When requesting a search or a certified statement, be sure
to first check the public inventory. This information is available
in the five volume January 1985 Edition of the "TSCA Chemical
Substance Inventory" and June 1990 supplement or the EPA regulated
Chemicals System database (which should be on-line by mid-April).
o Be sure to secure a chemical name, Chemical Abstracts
Service Registry Number (CASRN), and/or chemical structure whenever
possible. If possible, have a company representative transcribe
the information him/herself; this makes them accountable for all
transcriptions. DO NOT submit CASRN's that clearly identify items
that are NOT searchable against the TSCA Inventory Master File such
as hydrates, Colour Index Names, tradenames, etc.
o If you are provided with a CASRN only, have the company
representative associate it with a chemical name or structure in
case the CASRN is invalid. This way, the name and/or structure can
be searched. Inspectors who have access to the chemical substance
search service, CAS on-line, should determine if a CASRN is valid
and matches the chemical name. All invalid CASRN's will be
returned. Check with your library or a university library to
determine if they have CAS on-line.
o Determine if the company can identify the manner in which
they believe the substance became included in .the TSCA Inventory
(i.e. PMN, Initial Inventory Report Form Submission such as A, B,
c, or E). If the company is not sure, see if a competitor's
product name or designation (for the "same" substance) can be
obtained for purposes of comparison by headquarters personnel)
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Chapter Three Example 3E-9
o If the company obtains the substance in question from
someone else in the U.S., secure the name of the other company.
o A search should suffice if the substance has not been
manufactured or imported for commercial purposes. If the substance
has been manufactured or imported for commercial purposes, a
certified statement will be necessary (see Attachment 1: Form for
Requesting Inventory Searches).
o Be sure to provide a copy of a generic Certified
Statement with your request (see Attachment 2 for an example)
PMN and PMN Exemptions
o Be sure to include in your request a copy of the generic
Certified Statement which addresses your needs (see Attachments 3,
4, 5, 6 and 7).
o Provide as much information as possible (i.e., Case
Numbers, DCNs, dates of submission, company names, and chemical
identity). Although non-CBI requests are preferable, you roust make
sure that enough information has been provided to complete the
certified statement.
Section 8 (PAIR. CAIR. IUR. etc.)
o Be as specific as possible concerning company name, dates
of submission, DCNs and chemical identities.
o Provide a copy of a generic Certified Statement (see
Attachments 8, 9 and 10)
Technical Assistance/Opinion
o Be as specific as possible concerning the request. Include
the reason, determination to be made and the timeframe for
providing the information.
o Provide IMD with as much background information as
possible.
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Chapter Three Example 3E-9
Company Specific - Pre-inspection information
o Determine the exact documents, including the timeframe you
want covered, about which you are concerned. For instance, if you
are interested in all submissions made by a particular company,
list each type (i.e., PMN, PMN exemption applications, Bona fides,
lURs, etc.).
o Determine if you need actual copies of documents or if a
listing will be adequate.
To the extent possible, try to anticipate the need for
certified statements and request them in advance so that they are
not sent in at the last minute. Also, do not request certified
statements unless they are necessary.
General - Administrative
o Requests for certified statements or document requests
addressing TSCA Sections 4, 6 or 12 should continue to be sent to
OCM. If there is a CBI document (i.e. possibly TSCA Section
12(b)), OCM will request the appropriate information from IMD/CDB.
o REMINDER - Multiple requests within a single request (i.e.
a document search and a certified statement) lengthen the
turnaround time for the request. If you have that situation,
please separate the requests into two or more different requests
and identify which one needs to be completed first.
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Chapter Three
7 Additional Violations
Further violations may be voluntarily disclosed during the case development process. See
Chapter Two, Section 3 Voluntary Disclosure on how to handle these situations. In some
instances, review will indicate possible violations not documented by the inspector. In these
cases, the CDO should seek to secure the additional documentation for the new violation(s).
This may require further consultation with the inspector, reinspection of the facility, or subpoena
of documents from the facility.
TSCA Case Proceedings 3-41 Guidance Manual 1992
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Chapter Four
Determination of Appropriate Enforcement Response
CHAPTER CONTENTS PAGE
1 Introduction 4-1
2 Criteria for Determining the Level of Action 4-3
Administrative Actions 4-3
Judicial Actions 4-5
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Chapter Four Contents
TSCA Case Proceedings 4-ii Guidance Manual 1992
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Chapter Four
1 Introduction
Once the documentation of a violation is complete and EPA personnel have determined that an
enforcement action is warranted, EPA must decide upon the appropriate level of action that is
Justified by the severity of the violation. There are four categories of actions from which to
choose:
• Notices of Noncompliance
• Civil Administrative Action
• Civil Judicial Action
• Criminal Judicial Action
TSCA Case Proceedings 4-1 Guidance Manual 1992
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Chapter Four Introduction
TSCA Case Proceedings 4-2 Guidance Manual 1992
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Chapter Four
2 Criteria for Determining the Level of Action
ADMINISTRATIVE ACTIONS
Generally, the Agency uses administrative actions for violations of ordinary actions.
Administrative actions include the following:
• Notices of Noncompliance;
• Civil Administrative penalties; and
• Notices of detention under Section 13.
Notices of Noncompliance
A Notice of Noncompliance (NON) is a letter issued by EPA to advise a company that a
violation of TSCA has been detected. An NON can be used, for example, as notification to a
violator that the Agency is keeping track of the company's actions with respect to correcting the
violation or as an initial step in making Agency contact with a violator if negotiations will be
necessary for achieving compliance.
Although issuance of an NON is not specifically authorized by TSCA, the notice is an important
-enforcement tool and should be considered in the following circumstances.
• The violation involves only a minor technical deviation from the statutory or regulatory
requirements;
• The violation does not pose a significant threat to human health or the environment;
• The respondent has not previously violated TSCA;
• The violation is not the result of willful conduct;
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Chapter Four Criteria for Determining the Level of Action
• The violation is not one that would hamper EPA's ability to detect other violations at
the facility;
• An NON would be sufficient to bring about compliance; or
• Other regulation-specific policy considerations would apply (see Appendix 3).
Generally, an NON should not be issued when other enforcement responses are warranted. For
example, if a situation merits both issuance of an NON and an administrative civil penalty
action, only the civil penalty action should be pursued. Furthermore, if an NON is issued, but
the violation continues unabated, then the Agency should consider either an administrative civil
penalty action or an appropriate judicial proceeding.
Specific procedures for preparing and issuing NONs are found in Chapter 5, Notices of
Noncompliance.
Civil Administrative Penalties
A civil penalty, as authorized by Section 16(a) of TSCA, is the remedy of choice for most
violations. A civil penalty should be proposed where a violation:
• Presents a real or potential (but not an extreme or imminent) risk to human health or
the environment;
• Is likely to be an isolated occurrence; and
• Is apparently the result of ordinary negligence, inadvertence, or mistake.
Additionally, a civil penalty action is appropriate where a Notice of Noncompliance had been
issued, but the person to whom it was issued disregarded the notice or failed to correct the
violation.
Civil administrative penalty procedures are outlined in detail in Chapter 6, The Civil
Administrative Process.
Notices of Detention
Pursuant to Section 13 of TSCA and 48 Fed. Reg. 34,734 (1983), the United States Customs
Service may detain, by issuing a notice of detention, any shipment of chemical substances or
mixtures that is being imported into the United States and that is not in compliance with TSCA.
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Chapter Four Criteria for Determining the Level of Action
The Regions should alert customs if they have information that would lead to a notice of
detention. A notice of detention may be issued at the port of arrival by a district director of the
Customs Service when:
• A shipment contains any chemical substance or mixture that has been banned from the
customs territory of the United States by a rule or order issued under Section 5 or 6 of
TSCA;
• A shipment contains a chemical substance or mixture or article that has been ordered
seized under Section 7 (imminent hazard) of TSCA;
• The Administrator of EPA has reasonable grounds to believe that the shipment is not
in compliance with TSCA and notifies the district director to detain such shipment;
• The district director of the Customs Service has reasonable grounds to believe that the
shipment is not in compliance with TSCA; or
• The importer fails to certify compliance with TSCA.
For details concerning the handling and release of a detained shipment, refer to the TSCA
Section 13 rule promulgated by the United States Department of the Treasury at 48 Fed. Reg.
34,734 (1983).
JUDICIAL ACTIONS
. The Agency reserves judicial actions for use in violations of an especially egregious nature,
which result in serious harm to human health or the environment, and for willful or repeated
violations. Judicial actions may involve either civil or criminal proceedings.
Civil Judicial Actions
Civil Judicial Actions include:
• Injunctions under Section 5(e), 5(f), 7, and 17(a); and
• Seizures under Sections 7 and 17(b).
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Chapter Four Criteria for Determining the Level of Action
Injunctions
Injunctive actions may be initiated under the authority of Section 5(e), 5(f), 7, or 17(a).
Section 5(e) Injunctions
Injunctive relief authorized by Section 5(e) of TSCA should be considered when:
• The information available to the Administrator under Section 5 of the Act is insufficient
to permit a reasoned evaluation of the human health and environmental effects of a
chemical substance that is subject to the notice requirement of Section 5(a) and either:
~ In the absence of such information, the manufacture, processing, distribution in
commerce, use, or disposal of such substance may present an unreasonable risk of
injury to human health or the environment, or
— The chemical substance is or will be produced in substantial quantities, and such
substance either enters or may reasonably be anticipated to enter the environment
in substantial quantities or there is or may be significant or substantial human
exposure to the substance; and
• The Administrator has not issued a proposed order under Section 5(e) with respect to
the chemical substance, or the Administrator has issued such an order, however, the
order does not take effect because objections were filed pursuant to Section 5(e)(l)(C).
Section 5(f) Injunctions
Injunctive relief authorized by Section 5(f) of TSCA should be considered when there is a
reasonable basis to conclude that the manufacture, processing, distribution in commerce, use,
or disposal of a chemical substance subject to premanufacture review presents or will present
an unreasonable risk of injury to human health or the environment before a rule promulgated
under Section 6 can protect against such risk.
Section 7 Injunctions
Injunctive relief authorized by Section 7 of TSCA should be considered when a chemical
substance or mixture, or article containing such a substance or mixture, poses an imminent
hazard to health or the environment.
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Chapter Four Criteria for Determining the Level of Action
Section 17(a) Injunctions
Injunctive relief authorized by Section 17(a) of TSCA, which is the most common form of
judicial relief sought, should be considered when there is a need to:
• Restrain any violation of Section 15 of the Act. The violations specified by Section 15
include:
~ Failure or refusal to comply with any rule promulgated or order issued under
Section 4, any requirement prescribed by Section 5 or 6 of TSCA, or any rule
promulgated or order issued under Section 5 or 6,
~ Use, for commercial purposes, of a chemical substance or mixture that such person
knew or had reason to know was manufactured, processed, or distributed in
commerce in violation of Section 5 or 6 of TSCA, a rule or order under Section
5 or 6, or an order issued in an action brought under Section 5 or 7,
~ Failure or refusal to establish or maintain records; to submit reports, notices, or
other information; or to permit access to or copying of records, as required by
TSCA or its rules, and
— Failure or refusal to permit entry or inspection as required by Section 11 of TSCA;
• Restrain any person from taking any action that is prohibited by Section 5 or 6 of
TSCA or by a rule or order issued under those sections;
• Compel the taking of any action required by or under the Act; or
• Direct any manufacturer or processor of a chemical substance or mixture manufactured
or processed in violation of Section 5 or 6 or a rule or order under Section 5 or 6 and
distributed in commerce to:
- Give notice of such fact to distributors in commerce and (to the extent that they can
be reasonably ascertained) other persons who possess or may be exposed to the
chemical substance or mixture.
— Give public notice of such risk of injury, and
~ Either replace or repurchase the chemical substance or mixture.
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Chapter Four Criteria for Determining the Level of Action
Information on the use of injunctive actions can be found in Chapter 7, Section 2.
Seizures
Seizures may be initiated under the authority of Section 7 or 17(b) of TSCA.
Section 7 Seizures
Section 7(a)(l)(A) of TSCA permits the Administrator to commence a civil action in an
appropriate district court for the seizure of an imminently hazardous chemical substance or
mixture or any article containing such a substance or mixture.
Section 17(b) Seizures
Section 17(b) of TSCA authorizes the seizure of any chemical substance or mixture that was
manufactured, processed, or distributed in commerce in violation of the Act or any rule
promulgated or order issued under TSCA or any article containing such substance or mixture.
Criminal Judicial Actions
Criminal proceedings are authorized by Section 16(b) of TSCA, which states that:
Any person who knowingly or willfully violates any provision of Section 15 shall, in
addition to or in lieu of any civil penalty which may be imposed under subsection (a)
of this section for such violation, be subject, upon conviction, to a fine of not more
than $25,000 for each day of violation, or to imprisonment for not more than one year,
or both.
Section 15 of TSCA enumerates those acts considered unlawful under TSCA. (See Chapter 3
for a complete listing.)
The Agency may initiate criminal proceedings in every case in which EPA can meet the stringent
requirements of evidence and proof leading to a conviction. However, Agency policy, as well
as pragmatic resource considerations, argues against the use of criminal sanctions in any but the
most serious instances of environmental misconduct, as determined by the nature of the
violation, the history of compliance on the part of the responsible person, or the seriousness of
the environmental consequences. In addition, the Agency reserves the right to initiate both civil
and criminal proceedings in every case.
For more information regarding Criminal Judicial Actions see Chapter 8.
TSCA Case Proceedings 4-8 Guidance Manual 1992
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Chapter Five
Notices of Noncompliance
CHAPTER CONTENTS PAGE
Notices of Noncompliance 5-1
Procedures for Issuing an NON 5-2
Example 5E-1: Memorandum: Regional Authority to Issue Notices
of Noncompliance and Notices of Warning under
TSCA, FIFRA, and EPCRA 5E-7
Example 5E-2: Sample Notice of Noncompliance 5E-9
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Chapter Five Contents
TSCA Case Proceedings 5-ii Guidance Manual 1992
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Chapter Five
1 Notices of Noncompliance
A Notice of Noncompliance (NON) is issued by EPA to advise a company that a violation
of TSCA has been detected. An NON should be considered in violations as described in the
applicable Enforcement Response Policy (ERP). The CDO should refer to the appropriate
ERP and current OCM guidance for provisions appropriate for issuing an NON. An NON
does not give the alleged violator due process as does a civil administrative complaint; in
other words, the violator is not given the right to request a hearing to contest the facts set
forth in the NON.
In addition, an October 11, 1991 memorandum from Michael M. Stahl, Director, Office of
Compliance Monitoring, to the Regional Division Directors, authorized the Regions the
flexibility to issue NONs or Notices of Warning (NOWs) in circumstances where the
enforcement response policy prescribes a civil complaint. This Regional flexibility is
authorized for a one-year pilot period, with an additional one-year extension if needed. At
the end of the pilot period, the process will be reviewed, and possibly modified. Any
changes will need to be inserted into this chapter to avoid confusion. See Example 5E-1 for
a copy of this memo.
TSCA Case Proceedings
5-1
Guidance Manual 1992
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Chapter Five Notices of Noncompliance
PROCEDURES FOR ISSUING AN NON
Once evidence has been gathered to support the violation, an NON can be issued. An NON
should contain the following information (see Example 5E-2):
• Identification, citation, and explanation of the violation;
• A paragraph indicating the expected response from the recipient (including a specific
time frame for compliance), if any;
• If necessary, a statement indicating that continued noncompliance could result in
further enforcement action by the Agency; and
• The name and telephone number of an EPA contact person.
The Agency should issue an NON by certified mail, return receipt requested. A copy of the
NON should be placed in a case file, and the issuance of the NON should be put on the
computer docket, if applicable.
The ERP for AHERA, the ERP for §4 Test Rules, the §6 PCS Penalty Policy, the §§8, 12,
and 13 ERP, and the Good Laboratory Practices ERP specifically address when an non is
appropriate.
TSCA Title H AHERA
LEA Violations
Notices of Noncompliance are to be issued to Local Education Agencies (LEAs) for all
violations of AHERA and/or the AHERA regulations that are not responded to by other
enforcement mechanisms. This includes all management plan implementation violations, or
other ongoing implementation violations for which an administrative civil complaint cannot
be issued or injunctive relief is not obtained.
NONs may also be used in certain circumstances as the initial enforcement response to LEAs
that have failed to conduct an asbestos inspection and submit a management plan to the State.
That NON shall require LEAs to submit documentation within 60 days to the EPA Regional
Office that they completed the inspection and submitted the management plan to the State.
The NON shall further state that if the LEA does not submit this documentation within 60
TSCA Case Proceedings 5-2 Guidance Manual 1992
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Chapter Five Notices of Noncompliance
days after receipt of the NON, the Agency will issue an administrative civil penalty to the
LEA for its failure to conduct the inspection and/or submit the management plan. Local
Education Agencies that submit a management plan in response to the initial NON will not
be issued a civil complaint for failing to conduct the inspection or submit the plan, as long
as the LEA submits documentation of compliance within the 60 days.
Local Education Agencies that do not conduct the asbestos inspection and/or submit a
management plan by the statutory deadline and have an on-site EPA compliance inspection
to verify noncompliance, may be issued an administrative civil complaint as the initial
enforcement response.
NONs issued to an LEA indicate that repeat violations of AHERA may be considered
knowing or willful violations of TSCA, and therefore, may be subject to additional
enforcement actions including criminal penalties and court injunctions.. All NONs issued to
an LEA should be copied to the State Governor, State AHERA Designated Agency/Person,
or State Board of Education in which the LEA is located. Additionally, all NONs issued to
an LEA for substantive AHERA violations must require the LEA to submit documentation
to the EPA Regional Office within 30 days indicating that the AHERA violation has been
corrected. Regions should pursue further action (i.e., press releases, notification of the State
Governor, injunctive relief, or criminal referrals) if the LEA has not corrected the violation.
However, LEA employees designated "other persons" (and thus subject to civil penalties) may
be issued an NON for first-time violations of the less serious requirements of the AHERA
statute or its regulations.
Other Persons
NONs are usually not issued to persons other than the LEA ("other persons" such as
abatement contractors, management planners, etc.). Such violations will usually warrant a
civil complaint.
Refer to the January 31, 1989 Interim Final Enforcement Response Policy for the Asbestos
Hazard Emergency Response Act for more details.
Asbestos Worker Protection Rule
The NON is appropriate for very minor violations of the Asbestos Worker Protection Rule
which do not seriously harm or endanger employees, and in instances where the violator does
not have a history of violations. The NON is sent to the employer responsible for the
abatement work, i.e., the department or public service agency which hired the employee
committing the violation. Violations which warrant an NON are:
TSCA Case Proceedings 5-3 Guidance Manual 1992
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Chapter Five Notices of Noncompliance
• Notification is made to EPA but minor amounts of information are missing, i.e.,
information which is so insignificant that it does not affect the purpose of requiring
the information. For instance, it is still possible to ascertain the employer, place,
and dates for an abatement project, despite the missing information.
• Notification is made to EPA, but is up to three days late.
• At time of inspection records are available, but minor amounts of information are
missing. A records inspection is still possible despite the missing information.
• Failure to allow employees to observe monitoring.
TSCA Section 4 Test Rules
All NONs will involve minor violations of the TSCA §4 test rule which are not considered
substantive. An example would be the submission of a timely letter of intent to conduct
testing or a timely request for exemption from testing for each required test but failure to
provide all the required information. However, the submitter provides the additional
information to the Office of Pollution Prevention and Toxics (OPPT) by a date acceptable to
and specified by OPPT.
TSCA Section 6 PCBs
An NON may be issued in lieu of a civil penalty for any violation of Circumstance Level 4,
5, and 6, any Minor or Significant violation of Level 3, and any Minor violation of Level 2.
This decision should be made on a case-by-case basis using factors such as health and
environmental risks, history of violations, and size of business. NONs should not be issued
for any violation of Level 1, any Significant or Major violation of Level 2, or any Major
violation of Level 3. Any decision to deviate from the policy by issuance of an NON rather
than a civil administrative complaint should include a statement from the Regional Division
Director in the file outlining the justification.
TSCA Section 6 Hexavalent Chromium
An NON may be warranted in the following circumstances:
• Improper Labeling. Failure to label according to the standard prescribed in the
Rule.
TSCA Case Proceedings 5-4 Guidance Manual 1992
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Chapter Five Notices of Noncompliance
• Improper Reporting. Failure to report according to the standard prescribed in the
Rule.
TSCA Section 8
An NON is appropriate for minor violations of TSCA §8 as specified below where the
violator has not received a previous NON for a violation of that particular subsection.
Violations of TSCA §8 which warrant NONs include:
• Minor technical omissions, i.e., failure to supply required noncritical information
(such as the phone number of a technical contact);
• Failure to use certified mail in making a notification (as required by the rule); and
• Report sent to incorrect address but not identified as a TSCA §8 submission.
TSCA Section 12 (Exports) and 13 (Imports)
An NON is appropriate where the violation is a first-time violation of TSCA §§12 and 13,
and there are no other TSCA violations for the shipment.
TSCA Good Laboratory Practice (GLP) Regulations
All NONs will involve minor, technical, or form violations of the GLP regulations which are
not considered substantive. For example, an NON may be appropriate where a laboratory
meets all of its testing obligations with only an occasional inadvertent failure to make required
periodic observations, and such failure does not affect the reliability and accuracy of the test
data. Multiple nonsubstantive violations within a specific GLP regulation citation for a single
study (i.e., §792.81(b) or §792.130(e)) shall be considered a single violation.
Since laboratories are required to maintain quality assurance units, errors should be kept to
a minimum. Therefore, NONs will be issued when there are no more than two
nonsubstantive GLP regulation citation violations (not affecting validity) for separate studies
falling into the Minor Extent category; four for studies falling into the Significant Extent
category; and five for studies falling into the Major Extent category. A civil penalty will be
issued if there are more than two nonsubstantive GLP violations.
Generally, however, an NON will be appropriate for repeat offenses under Section 4 no
matter how minor or technical their nature. Repeat offenses will be considered for second
inspections of a single study or for first inspections of a repeated study. Although these
TSCA Case Proceedings 5-5 Guidance Manual 1992
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Chapter Five Notices of Noncompliance
violations do not currently affect EPA's ability to evaluate these chemicals, continued
violations may adversely affect accurate testing and assessment ability in the future.
If OCM cannot clearly identify a single entity in violation, the NON will be issued to both
the sponsor and the laboratory. Furthermore, the sponsor is to be informed of situations
when only the laboratory is cited in an NON or Administrative Civil Penalty.
TSCA Case Proceedings 5-6 Guidance Manual 1992
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Chapter Five
Example 5E-1
,#--•%,
^
UH&"
VOTED STATES BMROMUBNTAL PROTBCT1ON AGENCY
WASHNQTON,aC. 20MO
QCT ll
: Regional
and Hotioew of HhmlTig vader SBOk,
Xlcbael H. Stahl,
Ofdoa oC
to 30000 BnfcioM of
Division Directors
IBCK:
SOS
During the past fan muiitriiign of OPTS headqu
Regional aauagers, there have been a nosbar of
have aadbillt? t» issoe
civil oomplaijxfc- At tbo San Prnnei
isono by Soptanbor 30, 1991. Janet
***** Jla WF %>m o£
uorkgxonp to resolve
of the Officffi of
X ^ppTr •*•><* load
and" developed the proposal outlined in taiis mono, with reviev and
concurrence by all the Begional Branch Chiefs.
aothori.'by to <•«"«> Hotioas
and ietioes of naming Trader existing XSCA,
ozorceaent respffiip^ policies (BRFs) in thosa
"^^^•IW^M. vhere the interests of justice and
are not served by iairnnrrT of a civil administrative
that the Bagions have gained in
BCtiODS 1**1^^T *^**^ OlXIV
singly rrlfM- ttaat thare *« <»<
it
vhicn existing penalty policies do not, and perhaps
_ ___ r a-i-BBiTi it is nT*""1 r "* • *u~i1 gaM* that «<»<^»y or lUca
violativa'acts "«« have aarloedly dissiailar roal or potential
oTTo-i-i-™.m»nt'j«i or >»*•''•»*' impacts* Tt is in recognition of these
extraordinary drums Lances that best judgment at the Hojinnal
level mst bo eYarrtlsort, and that this judgment is farther
-r,***,***. by the program office vorfciag is concert with Regional
Counsel.
TSCA Case Proceedings
5E-7
Guidance Manual 1991
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Chapter Five Example 5E-1
- 2 -
m a ant-anal effort to review and
for determining future direction in penalty policy davelopBent
and revisions by the Office of Compliance Monitoring, the Bagions
will docment use of ****!T 1/1"" **^°n •*"> FTfM^*1 OCXf's Covplianca
Division Director with copies of each notions and docoBantatioxr
within too weeks after issoanoa of toe HEW/BOW. Ttiis
docaaantation xaoord will provide ttia basis for farther follownp
IB die ft'V'iq of Jteo^iooal RcnrievB* Peztaapc JKJXP ^ •j*< *n * ""^ly/
hovovar, it will allow the Policy and Grants Division to
undertake an inwdlata ravlBv cor interta rnflnearnita to odsting
penalty pnl iritt* and gnli3anae, where appropriate. Elease note
that ose of ****** authority IB not Intended to ""*' * j* use of
aa corrently provided for In existing penalty policies.
Delegations msta 5-14, BSOL 12-3*-JL, and ZPCJU. 22-3
pilot period, with an •
At the end of ttia pilot period, OCM will engage a
third party review of the process (e. g., the Office of Policy,
Planning and Evaluation's PI "y»»« Evaluation Division), If
ft to analyse its is^mc'L on OPXB* enforcenant prograB..
"""" " " or in total, if
J^J^^Je>»em XB OA2Jt^
>ontaot ve at PIS 26O-3807 or Jack Heylan at FZS 260-
7825 if you have any
oc: Begional Branch cbiefs
WtfButmt
Jack Heylan
Hike Wood
TSCA Case Proceedings 5E-8 Guidance Manual 1991
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Chapter Five Example 5E-2
Sample Notice of Noncompliance"
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
Region I
John F. Kennedy Federal Building
Boston, MA 02203
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. B. T. Dyer, Jr.
President
Dyer Industries, Inc.
36 Sunshine Drive
Clark, MA 02856
RE: Notice of Noncompliance
Dyer Industries, Inc.
Dear Mr. Dyer:
You are hereby given notice that Dyer Industries, Inc., is in violation
of the regulations governing polychlorinated biphenyls (PCBs), 40 CFR
Part 761, promulgated pursuant to the Toxic Substances Control Act
(TSCA), 15 USC §2601 et sea.
On October 31, 1983, a duly designated representative of the United
States Environmental Protection Agency (EPA) conducted an inspection of
the Firetog Industries' facility located at 36 Sunshine Drive, Clark,
Massachusetts. The inspection revealed the following violation of the
requirements governing polychlorinated biphenyls (PCBs):
Failure to mark properly PCB large high-voltage capacitors as
required by 40 CFR §761.40 (c)(2), which was promulgated pursuant
to Section 6 of TSCA, 15 USC §2614.
The above-noted violation must be corrected. Failure to do so within 30
days may result in further EPA action, including the possible imposition
of civil penalties. Please inform us of your progress in correcting the
violation.
* Note: This is a general example of a Notice of Noncompliance. It
does not represent the only appropriate format. Additional or
different paragraphs may be included as necessary to explain or fully
describe the violations and the response that the Agency expects from
the recipient.
TSCA Case Proceedings 5E-9 Guidance Manual 1992
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Chapter Five Example 5E-2
We have enclosed a copy of the current regulations governing PCBs for
your information. If you have any questions, please do not hesitate to
contact Mr. Don Duff at (312) 989-9876.
Sincerely,
John Doe
Director, Enforcement Division
Enclosure
TSCA Case Proceedings 5E-10 Guidance Manual 1992
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Chapter Six
Administrative Enforcement Actions: Civil Penalty
Proceedings
CHAPTER CONTENTS PAGE
1 Introduction 6-1
Delegated Authority 6-1
2 Civil Administrative Complaint Preparation and Filing 65
TSCA Penalty Assessment Considerations 6-5
Complaint Preparation 6-6
Drafting the Complaint 6-7
Filing the Complaint . . .' 6-10
Service of the Complaint 6-10
Example 6E-1: TSCA Civil Penalty Assessment Worksheet 6E-13
Example 6E-2: Completed Violation Worksheet 6E-14
Example 6E-3: Example Penalty Calculations 6E-15
Example 6E-4: Sample Cover Letter 6E-28
Example 6E-5: Sample Complaint 6E-29
3 Post-Complaint Stage 6-47
Agency Files . 6-47
Prohibition of Ex Parte Discussion 6-50
Answer to the Complaint 6-51
Motions 6-53
Example 6E-6: Sample Default Order 6E-63
4 Informal Settlement . 6-69
Settlement Conference 6-69
Consent Agreement and Proposed Consent Order 6-70
Filing of Consent Agreement and Order 6-71
Settlement with Conditions 6-72
Documenting Penalty Calculations *. 6-73
Ability to Pay 6-73
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Chapter Six Contents
Example 6E-7: Sample Consent Agreement 6E-76
Example 6E-8: Sample Consent Order 6E-88
5 Prehearing Exchange , 6-89
Prehearing Conference 6-89
6 Hearing Process 6-93
Notice of Hearing and Venue 6-93
Presentation of Evidence at the Hearing 6-94
Preponderance of Evidence 6-94
Hearing Rules of Evidence 6-95
Subpoenas and Summoning Witnesses 6-98
Expert Witnesses 6-98
Procedures for Requesting Witnesses from Headquarters 6-100
Appearing as a Witness 6-100
Objections and Rulings 6-105
Offers of Proof 6-105
Transcript of Hearing 6-106
The Trial Brief 6-106
Motion to Reopen a Hearing 6-108
Example 6E-9: Procedures for Requesting Witnesses from Headquarters . . 6E-109
7 Appeals 6-111
Appeal of Initial Decision 6-112
Final Order 6-114
Payment of Penalty 6-115
TSCA Case Proceedings 6-ii Guidance Manual 1992
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Chapter Six
1 Introduction
This chapter focuses on TSCA civil penalty actions and the procedures for litigating
administratively assessed penalties.
DELEGATED AUTHORITY
Authority to act under TSCA is delegated from the Administrator.
All adjudicatory proceedings for assessment of administrative civil penalties under TSCA are
governed by the Consolidated Rules of Practice Governing the Administrative Assessment of
Civil Penalties and the Revocation or Suspension of Permits. (April 9, 1980, 45 Fed. Reg.
24363, codified at 40 C.F.R. §22.01 et seq.1 This Federal Register notice incorporates changes
to the Regulations to reflect the role of the new Environmental Appeals Board (EAB) in Agency
adjudications, as described below.
Regional Administrator
In the Regions, authority to Act under TSCA is delegated from the Administrator to the Regional
Administrator. The Regional Administrator has been delegated the authority (in consultation
with the Regional Counsel's Office) to:
• Issue administrative complaints;
• Evaluate the appropriateness of civil penalties; and
• Negotiate and sign consent agreements memorializing settlements between the Agency
and respondent prior to the alleged violator's filing of an answer or failure to file an
answer to a complaint.
Regional Judicial Officer
The Regional Administrator may delegate his or her authority to a Regional Judicial Officer to
act in a given proceeding as Presiding Officer until an Administrative Law Judge (ALJ) is
TSCA Case Proceedings 6-1 Guidance Manual 1992
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Chapter Six Introduction
assigned. This delegation does not prevent the Regional Judicial Officer from referring any
motion or case to the Regional Administrator.
A Regional Judicial Officer shall be an attorney who is a permanent or temporary employee of
the Agency or some other Federal Agency and who may perform other duties within the
Agency. A Regional Judicial Officer shall not be employed by the Region's Enforcement
Division or by the Regional Division directly associated with the type of violation at issue in the
proceeding. A Regional Judicial Officer shall not have performed prosecutorial or investigative
functions in connection with any enforcement action in which he or she serves as a Regional
Judicial Officer or with any factually related enforcement action.
Once an answer is filed in a Regional civil administrative case, the case is transferred by the
Regional Hearing Clerk to the Chief Administrative Law Judge (LAW) who assigns an ALJ to
act as "Presiding Officer.
Again, the Regional Administrator or Regional Judicial Officer signs consent agreements in
regional proceedings, while the Environmental Appeals Board (EAB) signs consent agreements
in headquarters proceedings.
Presiding Officer
Every Agency proceeding is assigned a Presiding Officer. The Presiding Officer is charged with
conducting a fair and impartial proceeding. He or she must ensure that the facts are fully
elicited, adjudicate all issues, and avoid delay. The Presiding Officer has the authority, under
22.04(c), to:
• Conduct administrative hearings under these rules of practice;
• Rule upon motions, requests, and offers of proof; dispose of procedural requests; and
issue all necessary orders;
• Administer oaths and affirmations and accept affidavits;
• Examine witnesses and receive documentary or other evidence;
• For good cause, upon motion by a party or sua sponte (i.e.. upon his own motion),
order a party, an officer or an agent thereof to produce testimony, documents, or other
nonprivileged evidence and, failing the production thereof without good cause being
shown, draw adverse inferences against that party;
TSCA Case Proceedings 6-2 Guidance Manual 1992
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Chapter Six Introduction
• Admit or exclude evidence;
• Hear and decide questions of fact, law, or discretion;
• Require parties to attend conferences for the settlement or simplification of the issues,
or the expedition of the proceedings;
• Issue subpoenas authorized by the Act; and
• Do all other acts and take all measures necessary for the maintenance of order and for
the efficient, fair, and impartial adjudication of issues arising in proceedings governed
by the Consolidated Rules of Practice.
Headquarters Actions
The Director of Compliance Division has been delegated the authority to issue administrative
complaints out of Headquarters. Once an answer is filed in a HQ civil administrative case, an
Administrative Law Judge (ALJ) is assigned by the Chief Administrative Law Judge (CALJ) to
act as Presiding Officer. An Environmental Appeals Board Judge rules on all motions filed or
made before an answer to the complaint is filed. The initial decision of the ALJ becomes the
final order of the Environmental Appeals Board (EAB) 45 days after its issuance by the
Presiding Officer and without further proceedings unless:
• an appeal to the EAB is taken from it by a party to the proceeding, or
• the EAB, elects, sua sponte, to review the initial decision.
Environmental Appeals Board (EAB)
As part of the response to an increasing number of administrative adjudications, the
Administrator created the Environmental Appeals Board (EAB) to hear and decide the kinds of
appeals that the Administrator formerly delegated to the Agency's Chief Judicial Officer. The
;EAB, located at Headquarters, is a permanent body with continuing functions. It is composed
of three Environmental Appeals Judges designated by the Administrator. The EAB decides each
matter before it by majority vote in accordance with applicable statutes and regulations.
TSCA Case Proceedings 6-3 Guidance Manual 1992
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Chapter Six Introduction
TSCA Case Proceedings 6-4 Guidance Manual 1992
-------
Chapter Six
2 Civil Administrative Complaint Preparation and Filing
Issuance of a complaint initiates a TSCA Section 16(a) administrative penalty action.
40 C.F.R. Part 22. Section 22.13. Issuance of Complaint
"If the complainant has reason to believe that a person has violated any provision of the Act, or
regulations promulgated or a permit issued under the Act, he may institute a proceeding for the
assessment of a civil penalty by issuing a complaint under the Act and these rules of practice.
If the complainant has reason to believe that
(a) A permittee violated any term or condition of the permit, or
(b) A permittee misrepresented or inaccurately described any material fact in the permit
application or failed to disclose all relevant facts in the permit application, or
(c) Other good cause exists for such action, he may institute a proceeding for the
revocation or suspension of a permit by issuing a complaint under the Act and these
rules of practice. A complaint may be for the suspension or revocation of a permit
in addition to the assessment of a civil penalty."
TSCA PENALTY ASSESSMENT CONSIDERATIONS
Section 16 of TSCA provides that anyone who violates a provision of the statute is liable for a
civil penalty not to exceed $25,000 per violation/per day. These fines are collected through the
civil administrative process outlined in the Administrative Procedures Act (5 U.S.C. §551, eL
The Enforcement Response Policies (ERPs) establish the amount of the civil administrative
penalty appropriate for a violation.
Guidelines for Determining Penalty Amount
Section 16(a)(2)(B) of TSCA requires that the Agency consider the following factors in
determining the size of the penalty:
TSCA Case Proceedings 6-5 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
• The nature, circumstances, extent, and gravity of the violation(s); and
• The violator's ability to pay, ability to continue to do business, history of prior such
violations, degree of culpability, and other matters as justice may require.
Pursuant to the statutory requirements, EPA has established a general penalty assessment system,
"Guidelines for the Assessment of Civil Penalties Under Section 16 of TSCA" [45 Fed. Reg.
59770, 1980]. In some instances, section-specific penalty policy guidelines have been
developed. See Appendix 3 for a list of the specific guidelines available from OCM. See
Example 6E-1 "TSCA Penalty Assessment Worksheet," 6E-2 for an example of a "Completed
Violation Worksheet" and 6E-3 for "Example Penalty Calculations."
Continuing Violations
Since the Act provides not only that civil penalties may be assessed up to $25,000 for each
violation, but that each day a violation continues constitutes a separate violation for which
additional penalties may be assessed, there is a potential for very large penalties to be assessed
in many situations. In some cases, such large penalties will be appropriate for continuing
violations, while for others, such as late inventory reporting, assessing an additional penalty for
each day of violation would yield a penalty assessment far greater than the violation merits. The
specific penalty guidelines will discuss the types of continuing violations which should be
assessed on a per-day basis. This discussion should indicate how criteria such as this will be
applied, e.g., which continuing violations should never be penalized on a per-day basis, and
which should usually or always be so penalized.
When a penalty is assessed on a per-day basis for a continuing violation, care must be taken to
assure that the adjustment factors, "government clean up costs", and "economic benefits form
non-compliance" are spread over the entire penalty, since these figures are calculated by looking
at the entire violative situation. For example, if a continuing violation lasted four days and
generated $40,000 in government clean-up costs these $40,000 in costs should be added to the
daily penalties (although each day would still be limited to a maximum $25,000 penalty).
Continuing violations are distinguished from multiple violations and violations which occur
several separate times. These latter violations will generally be separately assessed. [From the
September 10, 1989 Guidelines for Assessment of Civil Penalties under Section 16 of the Toxic
Substances Control Act; PCB Penalty Policy.]
TSCA Case Proceedings 6-6 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
COMPLAINT PREPARATION
The goal of the complaint is to adequately inform the respondent of the charges so that an
adequate answer can be filed. Since the complaint initiates an administrative civil penalty action
: and is the focal point for all subsequent proceedings, it must be as complete as possible. Failure
to properly file a complaint may:
• Cause a delay in the proceedings; and
• Make the complaint subject to adverse motions by other parties to the proceedings
including a motion to dismiss for failure to state a claim. 22.17 (See Chapter 6, Section
4.)
Checklist of Complaint Requirements 22.14(a)
The following elements are required to establish the legal sufficiency of a civil penalty
complaint. Each complaint must include:
1. Statement reciting the section(s) of the Act authorizing the issuance of the complaint;
2. Concise statement of the factual basis for alleging the violation;
3. Specific reference to each provision of the Act and to the regulations that the
respondent is alleged to have violated;
4. Statement explaining the proposed penalty;
5. Proposed amount of civil penalty to be assessed;
6. Notice of respondent's right to request a hearing on any material fact contained in the
complaint or on the appropriateness of the amount of the proposed penalty;
7. Copy of the Consolidated Rules of Practice;
8. Notice of opportunity for an informal settlement conference;
9. Date and signature with notation of title of duly authorized official of the Agency; and
TSCA Case Proceedings 6-7 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
10. Certificate of service.
The numbers to the left of each of the previous items correspond to numbers in Example 6E-5,
"Sample Complaint." The numbers in the example identify samples of each kind of information.
DRAFTING THE COMPLAINT
Cover Letter
A cover letter must accompany every filed complaint. Example 6E-1 is the cover letter that
accompanies the sample complaint. In addition to summarizing important information from the
complaint, the cover letter informs the respondent that a copy of the "Guidelines for the
Assessment of Civil Penalties Under Section 16 of the Toxic Substances Act" (45 FR 59770,
September 10, 1980), a copy or copies of the appropriate section-specific penalty policy
guidance(s) used to assess the civil penalty are enclosed. These documents must be enclosed
when the complaint is serviced.
Each element of the complaint includes a brief description of its purpose and in some cases the
reason for its particular place in the complaint. The letters in parentheses to the right of each
element correspond to those in Example 6E-5.
Caption
Identification of Respondents (A). Respondents (i.e.. those against whom the complaint
is filed) are individually identified on the left side of the caption.
Docket Number and Subjects of the Complaint (B). The docket number and matters
addressed in the complaint are identified on the right side of the caption. Docket
numbers are assigned by the Hearing Clerk. The docket number designates the statute,
the Region involved (in Roman numerals), the year, and the case number (e.g.. Docket
Number: TSCA-VI-83-9). The docket number must be accurately stated in the caption
because it is the unique identifying number for all subsequent documents filed in the
proceedings.
TSCA Case Proceedings 6-8 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
.Jurisdictional Authority (C) 22.14(a)(l)
The complaint must contain a statement of Jurisdictional authority that informs the Presiding
Officer and the respondent of the section of the statute under which the complaint is issued.
This statement should be in the beginning of the complaint and should be specific and precise.
Factual Allegations (D) 22.14(a)(3)
The specific facts of the violation are set forth in numbered paragraphs in the body of the
complaint.
In the event that a complaint contains multiple violations or "counts," the discussion of each
separate count should contain the facts and circumstances related to that violation. It is
recommended that the paragraphs which make up the counts should be concise.
Citation of Legal Requirements Violated (E)
Specifically cite each provision of the statute, regulation, rule, or order that allegedly has been
violated. For example, if the complaint alleges that a violation of Section 15 of TSCA has
occurred, the specific subsection under Section 15 that is the basis of the violation and the
requirement of the statute, regulation, or order that was violated must be cited [e.g., PMN
violation of Sections 15(1)(B), 15(3)(B), and (5)(2)(1)].
Amount of Civil Penalty and Rationale (F, G)
This section of the complaint explains the reason for the proposed penalty (F) and demonstrates
that the Agency has considered the penalty assessment factors specified by Section 16(a)(2)(B)
of TSCA. A copy of the Agency's 1980 policy in assessing TSCA civil penalties and the
applicable ERP are attached to the complaint. Also attached is a copy of the Consolidated Rules
of Practice for the Assessment of Civil Administrative Penalties (40 CFR Part 22). 22.14(a)(5)
In addition, the Consolidated Rules of Practice require that the complaint specifically identify
the total proposed penalty amount (G) and any adjustments made up or down based on a prior
history of violations 22.14(a)(4). In addition, the proposed penalty amount should be shown for
each count.
Right To Request a Hearing (H) 22.14(a)(6)
The respondent must be informed of the right to request a hearing concerning any material fact
contained in the complaint or the appropriateness of the amount of the proposed penalty. For
TSCA Case Proceedings 6-9 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
information on requesting a hearing and on how to file a complaint refer the respondent to the
Code of Federal Regulations, a copy of which is attached to the complaint.
Notice of Opportunity for an Informal Settlement Conference (I)
The Agency encourages all respondents to pursue the possibility of settlement through informal
conferences with the Agency. Therefore, the respondent should be informed that, regardless of
whether a hearing is requested, a request may be made for an informal settlement conference
concerning any material fact contained in the complaint or the appropriateness of the amount of
the proposed penalty. The respondent should be cautioned, however, that a request for an
informal conference does not stay the running of the 20-day time period for requesting a hearing
and filing an answer.
Signature Block (J)
The complaint must be dated and signed (with notation of title) by a duly authorized official of
the Agency. It is recommended that the docket number be included on the signature pages in
the event the signature page gets separated from the complaint.
Certificate of Service (K) 22.05(a)(2)
Proof of service to the Respondent must be make by a return receipt for service by mail or by
affidavit if served in person. A signed certificate of service shall be filed with the original
complaint and a copy attached to complaint shall be served to the Respondent.
FILING THE COMPLAINT
The original and one copy of the complaint (with proof of service) must be filed with the
Regional Hearing Clerk 22.05(a)(l). For complaints with CBI, the original CBI and non-CBI
complaints, as well as two additional non-CBI copies, should be filed with the Hearing Clerk.
If a complaint contains confidential business information, two separate complaints must be filed.
One complaint contains the confidential business information and one complaint is a "sanitized"
version with the CBI deleted or with substitute designations. The nonconfidential complaint will
be accompanied by a statement explaining the deletions, and is filed by the clerk in the public
record. See Chapter 2, Section 4 for more details as well as an example of non-CBI complaint
and the non-CBI cover sheet that should accompany every non-CBI complaint.
TSCA Case Proceedings 6-10 Guidance Manual 1992
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Chapter Six Complaint Preparation and Filing
SERVICE OF THE COMPLAINT
The respondent is served with a copy of the signed original complaint in either of the following
manners: 22.05(b)
• Personal Service. The complaint and accompanying documents are served on the
respondent, an authorized representative, or a registered agent. For personal service
on an individual at a business address, the complaint should be served on the respondent
or a person who is in charge of the office, such as an office manager, or a person who
is responsible for the respondent's administrative affairs, such as a personal secretary.
For personal service upon a domestic or foreign corporation, or upon a partnership or
other unincorporated association, the complaint should be served on an officer, partner,
managing or general agent, or any other person authorized by appointment or by
Federal or State law to receive service of process. For personal service on a named
individual at a residential address, the complaint should be served on any person of
suitable age and discretion who resides there. Proof of service of the complaint shall
be made by affidavit by the person making personal service.
• Service by Certified Mail. Return Receipt Requested. The complaint and accompanying
documents are mailed to the respondent, an authorized representative, or a registered
agent. CBI versions must be sent registered mail by the DCO. The recipient of the
complaint and the address of the respondent should be verified before the complaint is
mailed. If the respondent is an individual, it should be mailed to the last known
business address by certified mail, return receipt requested. The return receipt
establishes that the complaint was received on a particular date. The receipt should be
attached to the original complaint, which is retained by the Agency. If no return receipt
is obtained, another letter should be sent. If no receipt is again obtained, personal
service may be necessary. If the respondent is a domestic or foreign corporation, or
a partnership or other unincorporated association, it should be mailed, return receipt
requested, to the last known address of an officer, partner, managing or general agent,
or any other person authorized by appointment or by Federal or State law to receive
service of process. Serving a complaint by certified mail increases the amount of time
for filing an answer by five days.
Service Upon U.S. Government Officials or Agencies 22.05(b)(l)(iii)
Service upon an officer or agency of the United States must be made by delivering a copy of the
complaint to the officer or agency, or in the manner prescribed by applicable regulations. If the
TSCA Case Proceedings 6-11 Guidance Manual 1992
-------
Chapter Six Complaint Preparation and Filing
agency is a corporation, service may be either personal or by certified mail directed to an
officer, partner, managing or general agent, or any other person authorized by appointment or
law to receive service of process.
Service on State or Local Government Entities or Officials 22.05(b)(l)(iv)
Service upon a state or local unit of government, or a state or local officer, agency, department,
corporation, or other instrumentality must either be made in the manner prescribed by state law
or upon the chief executive officer of the governmental unit or the state or local officer.
TSCA Case Proceedings 6-12 Guidance Manual 1992
-------
Chapter Six Example 6E-1
TSCA Civil Penalty Assessment Worksheet
TBCA Civil Faulty AsBMBinant «orkab««t
Name of Respondent:
Address of Respondent:
(1) Complaint I.D. Number:
(2) Date Complaint leaued:
(3) Date Answer Receivedi
(4) Date Default Order Sent:
(5) Date Coneent Agreement Signed:
(6) Date Final Order Sent:
(7) Date Remittance Received:
1. Gravity Based Penalty (CBP) from matrix. $
2. Percent increase or decrease for culpability. %
3. Percent increase for violation history. %
4. Add lines lines 2 and 3. %
5. Multiply OBP by percentage total on line 4. $
6. Add lines 1 and 5 (subtract line 5 from line 1
if negative percentage). $
7. Enter line 6 amount or $25,000, whichever is leas. $
8. Multiply line 7 by the number of days of violation. $
9. Government cleanup costs, if any. $
10. Economic gains from non-compliance, if appropriate. $
11. Add lines 8 through 10. $
12. Total of other adjustments as justice may require. $
13. If line 12 represents a net lucre*** to the penalty,
add line 12 to 11. $
-or-
If line 12 represents a net decrease to the penalty,
subtract line 12 from line 11. $
Note: Line 13 should be the proposed penalty for a given violation. This
procedure is repeated for each violation..
TSCA Case Proceedings 6E-13 Guidance Manual 1992
-------
Chapter Six
Example 6E-2
Completed Violation Worksheet
COMPLETED VIOLATION WORKSHEET
-
DATE
5/25/84
6/29/84
8/31/84
9/7/84
11/2/84
11/9/84
12/4/84
1/2/84
ACTIVITY
IMPORT/MANUFACTURE
FALSE CERTIFICATION
IMPORT/MANUFACTURE
FALSE CERTIFICATION
IMPORT/MANUFACTURE
FALSE CERTIFICATION
IMPORT/MANUFACTURE
FALSE CERTIFICATION
IMPORT/MANUFACTURE
FALSE CERTIFICATION
IMPORT/MANUFACTURE
FALSE CERTIFICATION
0 AGENCY NOTIFICATION
o PMN FILED
WRITTEN NOTICAT10N OF
AGENCY
FALSE CERTIFICATION
SUBSTANCE
M
M
M
U
H
H
H
M
H
H
H
H
H
H
AMOUNT
2,205
H
11,023
N
39,600
M
39,600
H
39,600
M
11,000
H
N/A
H
EVIDENCE
CUSTOMS ENTRY DOCUMENT
INVOICE
UNDATED/STAMPED CERTIFICATION
CUSTOMS ENTRY DOCUMENT
INVOICE
CUSTOMS ENTRY DOCUMENT
INVOICE
UNDATED/STAMPED CERTIFICATION
CUMSTOM ENTRY DOCUMENT
INVOICE
UNDATED/STAMPED CERTIFICATION
CUSTOMS ENTRY DOCUMENT
INVOICE
UNDATED/STAMPED CERTIFICATION
CUSTOMS ENTRY DOCUMENT
INVOICE
UNDATED/STAMPED CERTIFICATION
0 MEETING SIGN-OFF SHEET
o CERTIFIED STATEMENT
BADISCHE LETTER
UNDATED/STAMPED CERTIFICATION
1
.1
.
1
1
1
.
TSCA Case Proceedings
6E-14
Guidance Manual 1992
-------
Chapter Six
Example 6E-3
Example Penalty Calculations
EXAMPLE PENALTY CALCULATIONS
PENALTY CALCULATION FACTORS
NATURE: "Failure to Notify" is a "Hazard Assessment Violation".
Each date of manufacture (Importation) of each new chemical
substance constitutes one violation.
EXTENT: Calculated on the number of pounds of product manufactured.
CIRCUMSTANCES: Calculated on the basis that all the manufactured product
was distributed to customers or was part of inventory
transferred control.
CULPABILITY: Informed on April 1, 1981, that there was
no CAS NO. for the chemical substances but that they were
submitted for the Inventory and the numbers would be provided
to as soon as they were available. There 1s no document
available showing that followed up on the numbers. (.+0)
VIOLATION HISTORY: There Is no record of any prior civil administrative
actions. (+0)
GOVERNMENT CLEAN-UP COSTS: There was no monetary expenditure by the government.
(+0)
ECONOMIC GAIN FROM NON COMPLIANCE:
Invoices Indicate the product was sold
for $2.75 per pound. reported
sold 103,310 Ibs. Therefore, the
firms gross sales were approximately
$284,102.50. (+0)
TSCA Case Proceedings
6E-15
Guidance Manual 1992
-------
Chapter Six
Example 6E-3
-2-
COUNT
I
II
in
IV
V
VI
VII
VIII
DC
X
n
m
xin
xrv
XV
XVI
XVII
NATURE
HAZ-ASSESS,
FTN
n
n
n
n
n
n
n
n
n
n
n
n
n
n
n
n
EXTENT
MAJOR
3031.3 LBS.
MAJOR
5291 IBS.
SIGNIFICANT
881.8 LBS.
MAJOR
2645.5 LBS.
MAJOR
6613.8 .LBS.
MAJOR
2417 LBS.
>i n
MAJOR
19,276 LBS.
n ti n
MAJOR
18,974 LBS.
ft ft ft
MAJOR
20,178 LBS.
n n n
MAJOR
49,409 LBS.
n n n
n n n
n n n
CIRCUMSTANCES
LEVEL I
DIST. TO CUSTOMERS
n if n
n n n
n n n
nun
n n n
n n n
n n n
it n n
nun
n n n
n n n
n n n
n n n
n n n
n n n
n n n
-------
Chapter Six
Example 6E-3
COUNT
xvin
XEC
XX
XXI
xxn
XXIII
xxrv
XXV
XXVI
XXVII
NATURE
HAZ-ASSESS,
FTN
tl
n
n
n
n
n
n
n
n
TOTAL
-3-
EXTEWT
MAJOR
49,409 IBS.
n n n
MAJOR
5,079 IBS.
n n n
MAJOR
21,017 IBS.
MAJOR
21,017 IBS.
MAJOR
23,064 IBS.
n n n
n n n
n n n
IMPORT
18,463.4 IBS.
MANUFACTURE
159,414 IBS.
177,877.4 IBS.
CIRCUMSTANCES
LEVEL I
DIST. TO CUSTOMERS
n n n
n n n
n n n
n ti ti
ff n tf
n n n
n n n
n n n
n n n
TOTAL
GBP
$25,000
n
ff
n
tt
rt
n
n
n
n
$667,000
TSCA Case Proceedings
6E-17
Guidance Manual 1992
-------
Chapter Six Example 6E-3
EXTENT CALCULATION
1 - 3 - 4 LITERS
3.785 LITERS - 1 Gallon
MAX DETECTED LEVEL • 420 ppm
< 499 ppm « .70 reduction
Therefore 1 •• • « .30 Gallons Extent
Major >_ 1100 Gal Ion
Therefore >^ 3667 • Major
220 _< significant < 1100 Gallons
Therefore 733 <_ significant < 3667 - significant
Minor < 220 Gal Ions
Therefore minor < 733
Import • Manufacture • Level 1
DATE CALCULATION
o Typed or stamped date on the bill of lading
o Typed or stamped date on the latest Invoice
TSCA Case Proceedings 6E-18 Guidance Manual 1992
-------
1
DATE
5/21/85
5/29/85
6/4/85
6/6/85
6/7/85
6/11/85
6/11/85
(2)
6/13/85 ?
6/14/85
6/17/85
6/18/85
6/19/85
6/20/85
(2)
B/L NUMBER
0220943
1004
75203/J
N/A
LIV/37
0221107
N/A
916
N/A
N/A
0221103
N/A
N/A
LGHJ 13309
INVOICE
NUMBERS
578 * 586
566
568. 569. 573
665
600. 602, 606
589. 593, 670,
675, 673, 681,
683
654, 659, 657,
658
682. 688, 698
703. 704
707 ft 713
686
720
729 * 731
709,716, 730
NUMBERS OF
UNITS
11.300
5.650
16,950
5,650
16,950
30510 Total
9040
7910
11300
5650
2260
3840
5800
9640
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
SIGNIFICANT
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$25,000
$25.000
$25.000
$25,000
$25.000
$25,000
$25.000
$25,000
$25,000
$25.000
$17,000
$25,000
9
I
Cf)
R*
"H.
n"
«*»
-------
1
i1
M»
8-
g
to
2
DATE
6/25/85
6/26/B5
7/2/85
7/5/85
7/8/85
7/9/85
(3)
7/11/85
7/12/85
B/L NUMBER
N/A
1002
N/A
3925
N/A
0221419
0221404
0221392
1002
TVSCHI 9066
TVSATL 9089
TVSNYC 2039
TVSSLU 9097
TVSCHI 9065
INVOICE
NUMBERS
760
694
749. 758. 759
812. 813
818. 834.
848
857
768. 778. 781.
721, 740, 747,
748, 769, 770,
779, 795, 741,
771
855
790
780 * 782
839 « 846
739
NUMBERS OF
UNITS
3390
5120
7530
4970
1114
32690
5897
1280
10,867
2260
5650
2260
3840
2560
14310
EXTENT
LEVEL
SIGNIFICANT
MAJOR
MAJOR
MAJOR
SIGNIFICANT
MAJOR
SIGNIFICANT
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$17.000
$25.000
$25.000
$25.000
$17.000
$25.000
$17.000
$25.000
1
en
ST
-------
Is)
a
n
n
g
to
3
DATE
7/13/85
7/14/85
7/15/85
7/19/85
7/20/85
7/22/85
B/L NUMBER
022 1366
022 1323
022 1333
12/LIV
17046L
17059L
17045L
LGHT 14090
75450/J
75451/J
0221511
TVSSUN2108
TVSBAL
022 1516
022 1510
933
INVOICE
NUMBERS
837 ft 845
836
810 ft 820
894. 895, 914
827 ft 828
800. 811. 819
853
926
887 ft 888
899. 903. 905
854, 856, 911
912, 974 975
976
809
817
867, 893. 971
868 ft 869
896 ft 945
NUMBERS OF
UNITS
6400
2000
3060
100
11560
5950
5650
1130
12,730
5000
6780
3690
15470
5264
3390
2324
2410
13,388
640
2260
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
MAJOR
MINOR
SIGNIFICANT
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$25,000
$25,000
$25,000
$25.000
$5.000
$17,000
SB
1
-------
a
to
4
DATE
7/25/85
7/29/85
7/31/85
8/2/85
8/4/85
8/5/85
8/6/85
B/L NUMBER
LEOA 800
925
929
N/A
171621
17165L
17173L
75576/J
22
906
LGHI 15164
IGHJ 14949
022 1751
INVOICE
NUMBERS
910 ft 1001
982, 983. 985.
1002
984 ft 986
1018
1009
948, 970. 972.
932, 947, 969.
1010
1008
843, 870, 922
923. 933, 973
1041
1081
1088
1025. 1053,
1058. 1064,
1065, 10B4,
1085
NUMBERS OF
UNITS
2560
3840
1280
2560
10,240
2560
2260
4970
4740
3840
5430
5650
5120
1280
7440
9720
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$25,000
$25.000
$25.000
$25,000
$25,000
$25.000
$25.000
(
8
GO
VI
R*
-------
I
a
to
5
DATE
8/7/85
8/12/85
8/13/85
8/14/85
8/15/85
8/26/85
8/30/85
9/7/85
B/L NUMBER
N/A
022 1753
174 16L
022 1752
905
944
814
17499L
17501L
17502L
022 1877
022 1879
904
908
904
INVOICE
NUMBERS
1011, 1044,
1052. 1089,
1090
977, 1101,
1107, 112
1023, 1026
1045, 1059
1024 ft 1111
1016. 1114,
1123. 1042 «
1043
1124
1108 ft 1169
1152
1161. 1162
1168
1136 ft 1219
1137
1138 ft 1210
1140, 1150,
1151, 1153,
1158, 1139
NUMBERS OF
UNITS
9040
6765
5120
2260
10170
2260
14690
1130
1130
1130
5650
7910
3390
1280
' 4670
1130
5800
1224
4l$4
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
MAJOR
SIGNIFICANT
MAJOR
MAJOR
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 ( Import
PROPOSED
PENALTY
$25,000
$25,000
$25.000
$25,000
$17.000
$25,000
$25.000
$25.000
n
cr
BO
"
R-
"H.
n"
-------
1
6
DATE
9/9/85
9/12/85
9/18/85
9/19/85
9/23/85
9/24/85
10/1/85
10/7/85
10/8/85
B/L NUMBER
922
17537L
17558L
53
903
903
920(44)
0222173
LGHJ 15741
908
17725L
N/A
INVOICE
NUMBERS
1149
1297
1186. 1202,
1296
1408, 1409.
1411
1159. 1369.
1328, 1329.
1330. 1350.
1368
1284. 1285,
1351, 1410,
1457
1398. 1431,
1446
1491
1520 41551
1596 ft 1598
NUMBERS OF
UNITS
1130
880
6780
7660
5650
3690
22fiO
4670
10620
3894
8960
4520
2504
1612
EXTENT
LEVEL
SIGNIFICANT
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
MAJOR
SIGNIFICANT
SIGNIFICANT
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$17.000
$25.000
$25,000
$25.000
$25.000
$25.000
$25.000
$17,000
$17,000
o
f
-------
cn
fr
D
%
I
D
7
DATE
10/10/85
10/16/85
10/17/85
10/25/85
10/36/85
10/29/85
11/7/85
11/15/85
B/L NUMBER
17818L
17758L
17744L
87
88
90
2
89
1012
1011
1038
1020
TVS NYC 2013
74
022 2266
1797 IL
1017
INVOICE
NUMBERS
1519
1552
1425, 1521
1530, 1553
1465
1507
1569 * 1570
1603
1508
1672
1668
1630
1580. 1644
1643, 1671
1731
1779
1352
1818, 1821.
1829. 1830
1891, 1900.
1912, 1914
NUMBERS OF
UNITS
1130
1130
5650
7910
6780
1130
2410
7910
3390
1130
22,750
2260
504
5650
8414
3390
490
1130
1160
12957
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
SIGNIFICANT
MINOR
SIGNIFICANT
MAJOR
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
PROPOSED
PENALTY
$25,000
$25,000
$25,000
$17.000
$5.000
$17,000
$25.000
$25.000
n
er
to
1
C/5
R*
-------
1
B
GO
8
DATE
11/18/85
11/21/85
11/28/85
3/27/86
4/8/86
5/2/86
6/9/a6
7/23/86
B/L NUMBER
501
LGHJ 17308
GOAJ 07075
18100L
N/A
N/A
N/A
N/A
N/A
INVOICE
NUMBERS
1928
1953
1958
1951 ft 1952
499
392
663
827 ft 829
1167, 1169.
1170
NUMBERS OF
UNITS
792
3390
HI2
7910
4520
3
392
90
3540
4520
EXTENT
LEVEL
MAJOR
MAJOR
MAJOR
MINOR
MINOR
MINOR
SIGNIFICANT
MAJOR
CIRCUMSTANCES
LEVEL
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
1 (Import)
Total
PROPOSED
PENALTY
$25.000
$25,000
$25,000
$5.000
$5.000
$5.000
$17,000
$25.000
$1.454.000
1
en
R*
-------
DATE
7/25/86
8/1/86
8/2/86
B/L NUMBER
811143595
LAX600086
811144541
INVOICE
NUMBERS
M00157
M00159
H00158
H00160
M00161
H00156
H00163
H00164
M00166
M00165
H00150
H00147
H00151
MOO 152
M00154
M00155
M00148
M00153
M00149
1100176
M00175
M00169
M00171
M00172
M00173
M00170
H00179
H00177
MOO 174
M00178
M00168
M00180
NUMBERS OF
UNITS
22,477
14096
851
EXTENT
LEVEL
MAJOR
MAJOR
SIGNIFICANT
CIRCUMSTANCES
LEVEL
• 2 (Distribution In
commerce for export)
2 (Distribution In
commerce for export)
2 (Distribution In
commerce for export)
9
PROPOSED
PENALTY
$20,000
$20.000
$13,000
$53,000 Total
n
BP
»
1
-------
Chapter Six Example 6E-4
Sample Cover Letter
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON, D.C. 20460
REGISTERED MAIL
RETURN RECEIPT REQUESTED OFFICE OF
PESTICIDES AND TOXIC
Mrs. Sanda S. Rowland SUBSTANCES
President
Howland Industries, Inc.
8513 Louisiana Heron Drive
Ashland, Wisconsin 00576-4532
SUBJECT: In the Matter of: Howland Industries, Inc.
Complaint and Notice of Opportunity for Hearing
Docket No. TSCA-92-H-01
Dear Mrs. Howland:
Enclosed please find a Complaint and Notice of Opportunity
for Hearing concerning violations of the Toxic Substances Control
Act (TSCA), 15 U.S.C. 2601 fi£ sea.
The Complaint and the Rules of Practice, 40 CFR Part 22 (57
FR 5320), set forth the alternatives available to you in
responding to the alleged facts, violations, proposed penalty,
and opportunity for hearing. It should be emphasized that if you
wish to request a hearing and avoid being found in default, you
must file a written Answer within twenty (20) days of your
receipt of this Complaint.
Also enclosed is a copy of the "Guidelines for the
Assessment of Civil Penalties Under Section 16 of the Toxic
Substances Control Act" (45 FR 59770, September 10, 1980), a copy
of the TSCA Section 4 Enforcement Response Policy (May 28, 1986),
a copy of the TSCA Section 5 Enforcement Response Policy (August
5, 1988), and a copy of the TSCA Sections 8, 12, and 13
Enforcement Response Policy (May 15, 1987).
Whether or not you choose to request a hearing, you are
encouraged to explore the possibility of settlement by contacting
Mr. Andrew Cherry, Attorney, Toxics Litigation Division (LE-
134P), U.S. Environmental Protection Agency, 401 M Street, S.W.,
Room 113, Northeast Mall, Washington, D.C. 20460, telephone (202)
260-2398.
Sincerely yours,
Michael F. Wood, Director
Compliance Division (EN-342)
TSCA Case Proceedings 6E-28 Guidance Manual 1992
-------
Chapter Six Example 6E-5
Sample Complaint
Disclaimer
The following Complaint and Consent Order represent a combination of previously issued
complaints and consent orders, and are not actual documents that have been or will be issued.
Any mention of penalty amounts has been deleted in order to avoid confusion. Actual penalty
calculations will depend on factors not wholly represented in the Complaint.
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of )
)
Howland, Industries ) Docket No. TSCA 92-H-01
Incorporated )
)
Respondent, )
Notice of Treatment of Confidential Business Information
Portions of the attached Complaint require use of information which
Respondent submitted to the United States Environmental Protection
Agency (EPA) as Confidential Business Information (CBI). Information in
the Complaint constituting or based on CBI has been deleted as indicated
by the following: (CBI deleted). The original complaint containing CBI
is filed with the Headquarters Hearing Clerk. It will itself be treated
as confidential unless Respondent waives confidentiality thereto or EPA
releases the information in accordance with 40 C.F.R. Part 2.
TSCA Case Proceedings 6E-29 Guidance Manual 1992
-------
Chapter Six Example 6E-5
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
(A) ) Docket No. TSCA 92-H-01 (B)
In the Matter of ) COMPLAINT AND NOTICE OF
Rowland, Industries, Inc. ) OPPORTUNITY FOR HEARING
) UNDER SECTION 16(a)
Respondent, ) THE TOXIC SUBSTANCES
) CONTROL ACT
(1) This is a civil administrative action issued under the authority
(C) of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C.
2601 et sea, (hereinafter "TSCA"). The Complainant is Michael F.
Wood, Director, Compliance Division, Office of Compliance
Monitoring, United States Environmental Protection Agency (EPA),
who has been duly delegated the authority to institute this
action. The Respondent is Howland Industries, Inc., 8513
Louisiana Heron Drive, Ashland, Wisconsin 00576-4532.
This Complaint serves as notice that Complainant has reason to
believe that Respondent has violated the reporting requirements of
Section 4, 5, 8, 12, and 13 of TSCA, 15, U.S.C. Sections 2603,
2604, 2607, 2611, and 2612, and the regulations promulgated
thereunder at 40 C.F.R. Part 707, 710, 712, 716, and 720, thereby
violating Section 15 of TSCA, 15 U.S.C. Section 2614, as follows:
TSCA Case Proceedings 6E-30 Guidance Manual 1992
-------
Chapter Six Example 6E-5
1. On (CBI deleted), Rowland Industries, Inc., (hereinafter
"Respondent", who owns and/or controls a facility located at
8513 Louisiana Heron Drive, Ashland, Wisconsin, 00576-4532,
was inspected by a duly authorized representative of EPA,
pursuant to Section 11 of TSCA, 15 U.S.C. 2610.
2. Respondent is a corporation.
3. Respondent is a "person" as defined in 40 CFR Part 710. 2(s).
COUNT I
4. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
(2) 5. Section 4 of TSCA, 15 U.S.C. 2603, authorizes EPA to
(D) require manufactures (including importers) and/or processors
of identified chemical substances and mixtures to test
chemicals to develop health and environmental effects data.
6. On (CBI deleted), EPA promulgated a final Phase I test rule
for 1,1,1-trichloroethane (CAS t 71-55-6), 40 CFR Part
799.4400. The rule became effective on (CBI deleted).
7. 40 CFR Part 799.4400(c) requires that [a]11 persons who
manufacture (import) or process 1,1,1-trichloroethane...from
(CBI deleted), to the end of the reimbursement period shall
submit letters of intent to test, exemption applications...and
shall conduct tests and submit data as specified in this
section, Subpart A of this part and Part 790 of this
chapter....
8. The end of the reimbursement period is considered by the
Agency to be five years after the last final report is
submitted or an amount of time equal to that which was
required to develop data if more than five years after the
submission of the last final report required under the test
rule. The last final report for 1,1,1-trichloroethane was
received by the EPA on (CBI deleted).
9. 40 CFR Part 790.45(a) provides that no later than 30 days
after the effective date of a test rule described in 40 CFR
Part 790.40, each person subject to that rule and required to
comply with the requirements of that rule as provided in 40
CFR Part 790.42(a) must, for each test required, either notify
EPA by letter of his or her intent to conduct testing or
submit an application for an exemption from testing
requirements for the test.
10. 40 CFR Part 790.45(d)(l) provides that any person who was not
manufacturing (importing) or processing the subject chemical
as of or within 30 days of the effective date of the test
rule, must submit the letter of intent to test or exemption
application by the date of manufacture (importing) or
processing begins.
TSCA Case Proceedings 6E-31 Guidance Manual 1992
-------
Chapter Six Example 6E-5
11. On or about (CBI deleted), Respondent imported into the United
States 37.478 Ibs. of 1,1,1-trichloroethane. Respondent did
not submit an application for exemption from the testing
required by 40 CFR Part 799.4400 and 40 CFR Part 790.45(d)(1).
12. On (CBI deleted), Respondent provided EPA with an application
for exemption from testing for the chemical substance, 1,1,1-
trichloroethane .
(3) 13. Respondent's late submission of the application for exemption
(B) from testing, as alleged in Paragraph 11 above, constitutes a
failure or refusal to comply with 40 CFR Parts 790.40,
790.4400, which is a violation of Section 4 and Sections
15(1)(A) and 15(3)(B) of TSCA.
COUNT II
' 14. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
15. On or about (CBI deleted), Respondent submitted a
Premanufacture Notification (PMN), subsequently identified as
PMN (CBI deleted), to the EPA for the chemical substance, (CBI
deleted), hereinafter designated as Chemical A.
16. On (CBI deleted), Respondent provided EPA with records
revealing that Respondent had manufactured (imported) Chemical
A prior to their submission of the PMN.
17. An examination of Respondent's submitted information revealed
that beginning on (CBI deleted), and continuing to (CBI
deleted), Respondent imported Chemical A on (CBI deleted)
different days. The total importation during this period was
(CBI deleted).
18. Information provided to EPA by the respondent revealed that
the chemical substance mentioned in Paragraph 1 was
manufactured (imported) for use in the production of (CBI
deleted).
19. During the period between (CBI deleted) and (CBI deleted),
Chemical A did not appear on the list of chemical substances
maintained by the Administrator pursuant to 15 U.S.C.. 2607.
On (CBI deleted) Respondent submitted to EPA a Notice of
Commencement (NOC) for Chemical A. The NOC for Chemical A was
received and placed on the TSCA Inventory by the EPA on (CBI
deleted).
20. Respondent imported the chemical substance and is considered a
manufacturer under Section 3(7) of TSCA, 15 U.S.C. 2602(7).
21. Respondent failed to submit a notice to the Administrator of
EPA of its intention to manufacture (import) Chemical A during
the period stated in Paragraph 3.
TSCA Case Proceedings 6E-32 Guidance Manual 1992
-------
Chapter Six Example 6E-5
22. Section 5(a)(l) of TSCA, 15 U.S.C. 2604 (a)(l), provides that
no person may manufacture (import) a chemical substance which
does not appear on the TSCA Chemical Substance Inventory
without submitting a notice to the Administrator of EPA at
least 90 days before manufacturing (importing) such substance.
Section 15(1)(B) of TSCA, 15 U.S.C. 2614(1)(b), provides that
it is unlawful for any person to fail to comply with any
requirement prescribed by Section 5. Section 15(3)(B) of
TSCA, 15 U.S.C. 2614(3)(B), provides that it is unlawful for
any person to fail to submit information required by the Act.
23. Respondent is a "person" within the meaning of 40 CFR Part
720.3(x). 40 CFR Part 720 sets forth EPA's regulations
regarding TSCA Section 5(a)(l) Premanufacture Notification.
24. The conduct described in Paragraphs 2 through 7 above was in
violation of Section 5(a)(l), Section 15(1)(B), and Section
15(3)(B) of TSCA in that Respondent failed to submit a notice
to the Administrator of EPA at least 90 days before
manufacture (import) of the chemical substance as required.
COUNT III
25. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
26. On or about (CBI deleted), Respondent submitted a
Premanufacture Notification Form (PMN), subsequently
identified as (CBI deleted), to the EPA for the chemical
substance, (CBI deleted), hereinafter designated as Chemical
C.
27. Pursuant to Section 5(a)(l)(A) of TSCA and 40 C.F.R. Section
720.75(d), upon expiration of the PMN review period, the
submitter may manufacture a new chemical substance. The PMN
review period for Chemical C expired on (CBI deleted).
28. The chemical substance, Chemical C, is governed by TSCA and
all regulations in 40 C.F.R. Part 720 relating to
premanufacture notice for new chemical substances.
29. Pursuant to 40 C.F.R. Section 720.102(c), the notice, of
commencement must contain specific information, including the
date when manufacture commences.
30. Respondent submitted a notice of commencement for Chemical C
on or about (CBI deleted), as required by 40 C.F.R. Section
720.102(a), stating that commencement of manufacture had begun
on (CBI deleted).
31. On or about (CBI deleted), the notice of commencement of
manufacture for Chemical C was received by EPA and Chemical C
was included on the TSCA Chemical Substance Inventory
maintained by the Administrator pursuant to Section 8(b) of
TSCA, 15 U.S.C. 2607(b).
TSCA Case Proceedings 6E-33 Guidance Manual 1992
-------
Chapter Six Example 6E-5
32. Inspection of Respondent's records revealed that the first
commercial batch of Chemical C began (CBI deleted); more than
30 days prior to the Respondent submitting a notice of
commencement to the Agency.
33. Regulations promulgated at 40 C.F.R. Section 720.102 pursuant
to Sections 5 & 8 of TSCA, 15 U.S.C. Sections 2604 and 2607,
require submission of a notice of commencement on or no later-
than 30 calendar days after the first date of manufacture or
import of a chemical substance for non-exempt commercial
purpose for which that person previously submitted a Section 5
PMN.
34. Section 15(1)(C) of TSCA, 15 U.S.C. Section 2614(1)(C),
provides that it is unlawful for any person to fail or refuse
to comply with any rule promulgated or order issued under
Sections 5 or 6. Section 15(3)(B), provides that it is
unlawful for any person to fail or refuse to submit reports,
notices, or other information as required by the Act or a rule
thereunder.
35. Respondent's failure to submit a timely notice of commencement
for Chemical C, constitutes a failure or refusal to comply
with 40 C.F.R. Section 720.102 which is a violation of
Sections 15(1)(C) and 15(3)(B) of TSCA, 15 U.S.C. 2614(1)(C)
and (3)(B).
COUNT IV *•
36. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
37. On (CBI deleted), Respondent submitted a PMN to EPA for review
of a certain chemical substance, a (CBI deleted), and
hereinafter known as Chemical B. EPA designated this
submission as (CBI deleted).
38. Pursuant to Sections 5(a)(l)(A) and 40 C.F.R. S720.75(d), upon
the expiration of the PMN review period, the submitter may
manufacture or import the new chemical substance. The PMN
review period for Chemical B expired on (CBI deleted).
39. Chemical B is governed by TSCA and all regulations in 40
C.F.R. Part 720 relating to premanufacture notice for new
chemical substances.
40. On (CBI deleted), Respondent submitted an NOC for Chemical B
pursuant to 40 C.F.R. $720.102, stating that the chemical was
imported on (CBI deleted).
41. Pursuant to 40 C.F.R. $720.102(c), the NOC must contain
specific information, including the date when manufacture or
import for non-exempt commercial purposes commences.
TSCA Case Proceedings 6E-34 Guidance Manual 1992
-------
Chapter Six Example 6E-5
42. The NOC for Chemical B was received by the Agency thereby
causing the Agency to place this chemical substance on the
TSCA Inventory, a list of chemical substances maintained by
the Administrator pursuant to 15 U.S.C S2607, on (CBI
deleted). Placing a chemical substance on the Inventory
allows any other person to manufacture or import that
substance without submitting a PMN to EPA pursuant to Section
5(a)(1)(A) of TSCA.
43. At the time of inspection, (CBI deleted), Respondent had not
commenced commercial manufacture or import of Chemical B.
44. Section 720.102(b)(1) requires persons who submitted a PMN to
file an NOC on or no later than 30 calendar days after the
first date of commercial manufacture or import.
45. Section 15(1)(C) of TSCA, 15 U.S.C. 2614(1)(C), provides that
it is unlawful for any person to fail or refuse to comply with
any rule promulgated or order issued under ,-Sections 5 and 6.
Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3)'(B), provides that
it is unlawful for any person to fail or refuse to submit
reports, notices or other information as required by the Act.
46. The conduct described in Paragraph 40 and 43 was in violation
of Section 15(1)(C) and 15(3)(B) of TSCA, in that the NOC
submitted by Respondent for Chemical B was false.
COUNT V
47. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
48. Respondents are each a "person" within the meaning of 40 CFR
720.3(x). 40 CFR 720 sets forth the Agency's regulations
regarding TSCA section 5(a)(l) Premanufacturing Notification,
15 U.S.C. S2604(a)(1).
49. On (CBI deleted), EPA received a PMN for the chemical
substance (CBI deleted), hereinafter known as Chemical 1.
50. On (CBI deleted), Respondent submitted to EPA a Notice of
Commencement for Chemical 1, as required under 40 CFR 720.102.
51. The Administrator placed Chemical 1 on the TSCA inventory list
of existing chemical substances pursuant to 15 U.S.C. S2607 on
(CBI deleted).
52. Respondent's records indicate that commercial manufacture
(import) of Chemical 1 commenced on (CBI deleted), more than
thirty days before the Agency received Respondent's Notice of
Commencement.
TSCA Case Proceedings 6E-35 Guidance Manual 1992
-------
Chapter Six Example 6E-5
COUNT VI
53. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein. .
54. On or about (CBI deleted), Respondent entered into a Consent
Order with the Agency pursuant to Section 5(e) of TSCA for the
PMN substance. The Consent Order was later modified by EPA on
(CBI deleted), and (CBI deleted).
55. Paragraph II.H of the Consent Order contains the following
requirements: Before the Respondent may distribute the PMN
substance to any person, the Respondent must notify each
person of the requirements of the Order, in writing, by means
of a notification letter contained in Exhibit A of the Consent
Order. A Material Safety Data Sheet ("MSDS") must accompany
this letter. The MSDS shall include the language specified in
paragraph E of the Consent Order, which addresses the
potential health effects and appropriate worker training
safety measures for the PMN substance. The MSDS shall include
the language specified in paragraph E of the Consent Order,
which addresses the potential health effects and appropriate
worker training safety measures for the PMN substance. The
MSDS shall specify the protective equipment requirements which
the person must follow, as discussed in paragraph D of the
Consent Order. The notification' letter and MSDS must be hand
delivered or sent by Registered Mail, Return Receipt
Requested. The Respondent must receive a signed and dated
receipt certifying that the person has received the
notification letter and MSDS, before Respondent may initiate
distribution of the PMN substance to that person.
56. On (CBI deleted), a duly designated EPA representative
conducted an inspection at the Respondent's facilities located
in El Dorado, Arkansas.
57. This inspection was conducted in order to determine the
Respondent's compliance with TSCA, including the Consent Order
for the PMN substance.
58. During this inspection, a review of the Respondent's records .
indicated that, on the (CBI deleted) occasions set forth
below, Respondent distributed the PMN substance before
receiving a signed and dated receipt certifying that the
recipient of the PMN substance had received the notification
letter and MSDS, as required under Paragraph II.H of the
Consent Order specified in Paragraph 10 above.
A. On or about (CBI deleted), Respondent shipped (CBI
deleted) of the PMN substance to (CBI deleted). (CBI
deleted) did not receive the notification letter and MSDS
until (CBI deleted).
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Chapter Six Example 6E-5
B. On or about (CBI deleted), Respondent shipped (CBI
deleted) of the PMN substance to (CBI deleted). (CBI
deleted) did not receive the notification letter and MSDS
until (CBI deleted).
C. On or about (CBI deleted), Respondent shipped (CBI
deleted) of the PMN substance to (CBI deleted). (CBI
deleted) did not receive the notification letter and MSDS
until (CBI deleted).
D. On or about (CBI deleted), Respondent shipped (CBI
deleted) of the PMN substance to (CBI deleted). (CBI
deleted) dich not receive the notification letter and MSDS
until (CBI deleted).
E. On or about (CBI deleted), Respondent shipped (CBI
deleted) of the PMN substance to (CBI deleted). (CBI
deleted) did not receive the notification letter and MSDS
until (CBI deleted).
59. Section 5(e) of TSCA, 15 u.s.c. 2604(e), provides that the
Administrator may issue an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or
disposal of a chemical substance or to prohibit or limit any
combination of such activities. Section 15(1)(C) of TSCA 15
U.S.C. 2614(1)(C) provides that it is unlawful for any person
to fail or refuse to comply with any order issued under
Section 5(e).
60. The conduct described in Paragraph 13 above was in violation
of Section 15(1)(C) of TSCA in that Respondent failed to
comply with an order issued under Section 5 of TSCA.
COUNT VII
61. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
62. During Respondent's corporate fiscal year, prior to (CBI
deleted), Respondent imported for a commercial purpose over
100,000 pounds of (CBI deleted) hereinafter referred to as
Chemical C, at its Atlanta, Georgia facility.
63. 40 CFR Part 712.20(b), promulgated pursuant to the authority
of TSCA Section 8(a)(l), requires any person who imports a
chemical substance listed in 40 CFR Part 712.30, for a
commercial purpose, to submit a Manufacture's Report -
Preliminary Assessment Information.(hereinafter "PAIR").
64. Pursuant to 40 CFR Part 712.30(w), a PAIR must be submitted
for Chemical C on or before (CBI deleted).
65. Respondent did not submit a PAIR for Chemical C on or before
(CBI deleted).
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Chapter Six Example 6E-5
66. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B), provides that
it is unlawful for any person to refuse to submit reports,
notices, or other information.
67. Respondent's failure to submit a PAIR by (CBI deleted) for
Chemical C constitutes a violation of TSCA Sections 8(a)(l)
and 15(3)(B).
COUNT VIII
68. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
69. Respondent is a "person" as defined in 40 CFR Part 710.2(s).
70. On or about (CBI deleted), Respondent submitted a Partial
Updating of TSCA Data Base Production and Site Report
(hereinafter "Form U" or "IUR Report") for the reporting
period ending (CBI deleted), for the reporting period ending
(CBI deleted), for the following eight chemicals: ["*"
indicates CBI deleted]
Chemical CAS # Production Volume
B
C
D
E
F
G
H
I
71. 40 CFR Part 710.28(a) requires any person who manufactured for
commercial purposes 10,000 pounds or more of a chemical
substance which is in the Master Inventory File at the
beginning of a reporting period, at any single site owned
and/or controlled by that person, at any time during the
person's latest complete fiscal year before (CBI deleted), to
report for the Partial Updating of the Inventory Data Base.
72. 40 CFR Part 710.33(a) sets forth that persons subject to
initial reporting must so report between (CBI deleted) and
(CBI deleted).
73. 40 CFR Part 710 Subpart B was promulgated under authority of
TSCA Section 9(a).
74. Respondents failure to submit an IUR Report for the eight
chemical substances listed in paragraph 13 by the regulatory
deadline of (CBI deleted), constitutes a violation of 40 CFR
Part 710.33(a), a Rule promulgated under TSCA Section 8(a),
and thereby constitutes a violation of Section 15(3)(B) of
TSCA.
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Chapter Six Example 6E-5
COUNT IX
75. Paragraphs 1-3 are hereby incorporated and realleged as if
fully set forth herein.
76. Section 12(b) of TSCA, 15 U.S.C. 2611 and 40 CFR Part 707.60,
requires any person who exports or intends to export to a
specific foreign country a chemical substance or mixture
subject to certain actions pending under Sections 4, 5, 6, or
7 of TSCA, to submit a 12(b) export notice to the EPA as
required.
77. Under 40 CFR Part 707.65, this notice must be for the first
export or intended export to a particular country in a
calendar year, and must be postmarked within seven days of
forming the intent to export or the date of export, whichever
is earlier.
78. Under 40 CFR Part 707.67, the notice must include: the name
of the chemical, the name and address of the exporter, the
country of export, the date of export, and the applicable
section of TSCA.
79. Paragraphs 66 and 67 of Count III are incorporated and
realleged, as if fully set forth herein.
80. On or about (CBI deleted), Respondent submitted to EPA a 12(b)
export notice, listing the exports from (CBI deleted) through
(CBI deleted), for a product that contained a chemical
substance, 1,1,1-Trichloroethane, that is regulated under
Section 4 of TSCA.
81. Respondent's failure to submit the 12(b) export notice as
required under 40 CFR Parts 707.60 and 707.65 is a violation
of Section 12 and Section 15(3)(B) of TSCA, 156 U.S.C.
2614(3)(B).
COUNT X
82. Paragraphs 1-3 are hereby incorporated and realleged as fully
set forth herein.
83. An examination of Respondent's submitted information revealed
that beginning on (CBI deleted), Respondent imported Chemical
A on (CBI deleted) different days and furnished a written
statement to the U.S. Customs Service certifying that Chemical
A was not being offered for entry in violation of TSCA.
84. During the period stated in Paragraph 91, Chemical A was not
on the TSCA Inventory of Chemical Substances. Chemical A was
not placed on the TSCA Inventory until (CBI deleted), which is
the date EPA received Respondent's NOC for PMN (CBI deleted).
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Chapter Six Example 6E-5
85. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that
no person may manufacture (import) a chemical substance which
does not appear on the TSCA Chemical Substance Inventory
without submitting a notice to the Administrator of EPA at
least 90 days before manufacturing (importing) such substance.
86. Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the
Secretary of the Treasury to issue rules for the
administration of Section 13(a) which provides for the entry
of chemical substances into the customs territory of the
United States. The Customs rule at 19 CFR Part 12, Sections
12.118 through 12.127, issued under Section 13(b) provides
that the importer of a chemical substance shall certify to the
district director at the port of entry that the chemical
substance being offered for entry is not: subject to TSCA; or
in violation of TSCA or any applicable rule thereunder.
87. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B), provides that
it is unlawful to fail to submit information as required by
this Act or rule thereunder.
88. Respondent's certification to the district director at the
port of entry that Chemical A was not in violation of TSCA did
not represent the true compliance status of Chemical A.
89. The conduct described in Paragraphs 90 through 92 above was in
violation of Section 13(b) and Section 15(3)(B) of TSCA, in
that Respondent failed to submit a certification to the
district director at the port of entry adequately representing
the true compliance status of Chemical A, as required.
PROPOSED CIVIL PENALTY
(4) Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
(F) assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this Complaint,
and upon the nature, circumstance, extent and gravity of the
violations alleged, as well as Respondent's history of prior
violations of TSCA, the degree of culpability and such other
matters as justice may require, the Complainant proposes that
Respondent be assessed the following civil penalty for the
violations alleged in the Complaint:
COUNT I
(5) Failure to submit letter of intent to
(6) test or a valid request for exemption
from testing as required $
15 U.S.C. 2603(c)
15 U.S.C. 2614(1)(A)
15 U.S.C. 2614(3)(B)
TSCA Case Proceedings 6E-40 Guidance Manual 1992
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Chapter Six
Example 6E-5
COUNT II
Failure to notify of intention to
manufacture (import) a chemical
substance not on the TSCA Inventory.
15 U.S.C. 2604(a)(1)
15 U.S.C. 2614(1)(B)
15 U.S.C. 2614(3)(B)
COUNT III
Failure to comply with notice of
commencement requirements (more
than 30 days after manufacture...
40 C.F.R. 720.102(b)
15 U.S.C. 2614(1)(C)
15 U.S.C. 2614(3)(B)
COUNT IV
Submission of a false Notice of
Commencement
40 C.F.R. 5720.102
SS 5, 8, 15(1) (B) and (3) (B) of TSCA
15 U.S.C. SS2604, 2607, 2614(1) (C) and
COUNT V
Failure to provide a timely notice of commencement
on or no later than 30 days after commencement of
commercial manufacture (import) of chemicals ...... $
15 U.S.C. $2604(a)(1)
15 U.S.C. $2614(1)(C)
15 U.S.C. $2614(3)(B)
COUNT VI
Failure to comply with a TSCA
Section 5(e) Order:
15 U.S.C. 2614(1)(C)
15 U.S.C. 2604(e)
TSCA Case Proceedings
6E-41
Guidance Manual 1992
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Chapter Six Example 6E-5
COUNT VII
Failure to submit a Manufacturer's
Report - Preliminary Assessment Information
for one chemical substance $_
40 C.F.R. Part 712.20
15 U.S.C. 2614(3)(B)
15 U.S.C. 2607(a)
COUNT VIII
Failure to submit a Partial Updating of
TSCA Inventory Data Production and Site
Report for eight chemical substances by
the regulatory deadline $
15 U.S.C. 2614(3)(B)
15 U.S.C. 2607(a)
40 CFR Part 710.23
COUNT IX
Failure to submit a 12(b) export notice as
required $
15 U.S.C. 2611
15 U.S.C. 2614(3)(B)
COUNT X
Failure to provide a certification statement
to the district director at the port of entry
adequately representing the true compliance status
of a chemical substance $
15 U.S.C. 2604(a)(l)
15 U.S.C. 2612(b)
15 U.S.C. 2614(3)(B)
Total Proposed Penalty $
(6) NOTICE OF OPPORTUNITY TO
(H) REQUEST A HEARING
As provided in Section 16(a)(2)(A) of TSCA, you have the right to
request a formal hearing to contest any material fact set forth in
this Complaint or to contest the appropriateness of the proposed
penalty. Any hearing requested will be conducted in accordance
with the Administrative Procedures Act, 5 U.S.C. Section 551 et
sea., and the Consolidated Rules of Practice Governing the
Administrative Assessment of Civil Penalties. 40 CFR Part 22
("Consolidated Rules of Practice"). A copy of the Consolidated
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Chapter Six Example 6E-5
To avoid being found in default, which constitutes an admission of
all facts alleged in the Complaint and a waiver of the right to a
hearing, and having the above penalty assessed without further
proceedings, you must file a written Answer within twenty (201
days of receiving this Complaint. Pursuant to the Consolidated
Rules of Practice, your Answer must clearly and directly admit,
deny, and/or explain each of the factual allegations contained in
this Complaint with regard to which you have any knowledge. If
you have no knowledge of a particular fact and so state, the
allegation is considered denied. Failure to deny any of the
allegations in this Complaint will constitute an admission of the
undenied allegation.
The Answer shall also state the circumstances and arguments, if
any, which are alleged to constitute the grounds of defense, and
shall specifically request an administrative hearing, if desired.
If you deny any material fact or raise any affirmative defense,
you will be considered to have requested a hearing.
The Answer must be filed with:
Headquarters Hearing Clerk (A-110)
United States Environmental Protection Agency
401 M Street, S.W., Room M3706
Washington, DC 20460
Please send a copy of the Answer an all other documents which you
file in this action to Mr. Robert Fentress, the attorney assigned
to represent EPA in this matter, at:
Office of Enforcement
Toxic Litigation Division (LE-134P)
U.S. Environmental Protection Agency
401 M Street, S.W., Rm. NE 113
Washington, D.C. 20460
(8) INFORMAL SETTLEMENT CONFERENCE
(I)
Whether or not you request a hearing, you may confer informally
with EPA through Mr. Fentress regarding the facts of this case, or
amount of the proposed penalty, and the possibility of settlement.
An informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint. EPA has the
authority, where appropriate, to modify the amount of the proposed
penalty to reflect any settlement reached with you in an informal
conference. The terms of such an agreement would be embodied in a
Consent Agreement and Final Order ("CAFO"). A CAFO signed by EPA
and you would be binding as to all terms and conditions specified
therein upon signature by the EPA Chief Judicial Officer.
Please be advised that the Consolidated Rules of Practice prohibit
any ex parte (unilateral) discussion of the merits of any action
with the Administrator, Chief Judicial Officer, Administrative Law
Judge, or any person likely to advise these officials in the
decision of the case, after the Complaint is issued.
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Chapter Six Example 6E-5
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or requesting an
informal settlement conference, you may choose to pay the proposed
penalty. Such payment should be made by sending a cashier's or
certified check payable to the United States of America in the
amount of the penalty assessed in this Complaint. The check
should be mailed to:
EPA-Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251
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Chapter Six Example 6E-5
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 92-H-l
Complainant
BY:
(9)
(J) Michael J. Hood, Director
Compliance Division
Office of Compliance Monitoring.
Date:
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Chapter Six Example 6E-5
(10) CERTIFICATION
I hereby certify that the original of the foregoing Complaint and
Notice of Opportunity for Hearing, Docket No. TSCA-92-H-01, has
been filed with the Headquarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mrs. Sanda S. Rowland
President
Howland Industries, Inc.
8513 Louisiana Heron Drive
Ashland, Wisconsin 00576-4532
Date Theresa I. Little (EN-342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
TSCA Case Proceedings 6E-46 Guidance Manual 1992
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Chapter Six
3 Post-Complaint Stage
AGENCY FILES
After filing the complaint, the Agency must maintain at least two pleadings files—one that is
initiated by the Hearing Clerk and one that is initiated by the Presiding Officer upon assignment
to a case. At Headquarters, and in some regions, the Hearing Clerk maintains one original file
and one duplicate public file. Requests for official copies of the case file should be referred to
the Hearing Clerk. In addition, the Case Development Officer (CDO) should maintain a
separate file, which contains duplicates of all documents relating to the enforcement proceeding.
22.05(a)(l), 22.05(a)(2)
Any file that contains TSCA confidential business information ("CBI") must be maintained in
accordance with the procedures set forth in the TSCA Confidential Business Information Security
Manual. (See discussion in Chapter 2, Section 4.)
Files of Hearing Clerk and Presiding Officer
All documents must be filed with the EPA Hearing Clerk. The Hearing Clerk establishes a file
when the original (CBI and non-CBI) and one copy (or two non-CBI copies) of the complaint
and the accompanying certificate of service are received from the CDO (or in the case of a CBI
complaint by the DCO). All original copies of filings and communications from Agency
officials, including those from the Presiding Officer, must be maintained in the Hearing Clerk's
file.
.The documents that are filed in the pleadings file with the Hearing Clerk include: 22.05(a)
• Original and one copy of the complaint (or original CBI and non-CBI complaint and two
non-CBI copies);
• Originals and copies of certificates of service;
• Original and copies of filings of any intervenors;
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Chapter Six - Post Complaint Stage
• Original and copies of an answer received from the respondent;
• Original and copies of all motions and status reports as required by the Presiding
Officer;
• Original and one copy of rulings, orders, decisions, and other documents that are issued
by the Regional Administrator, Regional Judicial Officer, or Presiding Officer; 22.06
• Originals of direct correspondence from the Presiding Officer to the parties; and
• Copies of direct correspondence from the parties to the Presiding Officer.
Copies of the above documents are kept in the Presiding Officer's file, except correspondence
from the parties Jo the Presiding Officer. The originals of such correspondence are kept by the
Presiding Officer.
Enforcement Case File
The Agency enforcement personnel assigned to the case should maintain a separate file
containing duplicates of all documents filed in the proceeding, as well as other enforcement
documents relating to the case. Documents in this file include:
• Copies of all documents filed with the Hearing Clerk or Presiding Officer;
• Any internal EPA documents used in generating the enforcement action (e.g.,
concurrence documents, checklists, etc.);
• EPA investigative records such as laboratory reports and copies of business records;
• Original Penalty Assessment Worksheet(s) and documentation of any changes in the
penalty assessment;
• All correspondence between the respondent and EPA; and
• All correspondence between EPA and other federal or state agencies (e.g., the
Department of Justice).
This file should be retained for a minimum of five years after the case is closed.
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Chapter Six Post Complaint Stage
Filing Requirements
-.Each document that is filed should contain these elements:
• A caption on the first page of the document that identifies the respondent and the docket
number assigned for the proceeding; 22.05(c)(2)
• The signature of the filing party, counsel, or other representative (except for exhibits);
and 22.05(c)(3)
• The name, address, and telephone number of the person filing the document if it is the
initial document filed by that person. Any changes in this information must be sent to
the Hearing Clerk, Presiding Officer, and all other parties to the proceeding. If a party
fails to provide or, when appropriate, amend this information, the right to notice and
service is waived. 22.05(c)(4)
The Presiding Officer may prescribe additional requirements for the form of the documents.
22.05(c)(l)
If the applicable requirements are not met, the Hearing Clerk may refuse to accept any document
until it is properly amended. Permission to amend is granted only upon motion to the
Administrator, Regional Administrator, or Presiding Officer who refused to accept the defective
document. 22.05(c)(5)
Also, any party filing a document after the complaint has been issued must certify that copies
of the document have been sent to other parties, appropriate Agency officials, and any amicus
curiae ("friend of the court," a party who is not an actual party to the case, but has an interest
in the outcome). While the Consolidated Rules of Practice do not give explicit sanctions for
^failure to provide an appropriate certificate of service, failure to serve copies of documents on
> individuals who have a right to notice may delay the proceeding and can result in an otherwise
entirely correct proceeding being dismissed by the Presiding Officer or being overturned on
.appeal. 22.05(a)(2)
Public Access to Documents Filed 22.09(a)
Subject to any confidentiality requirements specified by law, the documents filed in the
proceeding which are not CBI must be made available by the Regional Hearing Clerk for public
inspection during business hours.
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Chapter Six Post Complaint Stage
PROHIBITION OF EX PARTE DISCUSSION
After a complaint has been issued, exparte discussions (i.e., without notice to all parties) of the
merits of the proceeding by individuals or their representatives with the Presiding Officer are
prohibited. 22.08
Although ex parte discussion about the merits of a proceeding is prohibited, if such
communication occurs, it is regarded as argument, and a copy of the ex parte communication
is served on all other parties in the proceeding. Those other parties are then afforded an
opportunity to reply. Failure to comply with these provisions of the Consolidated Rules of
Practice can taint an otherwise entirely correct proceeding and may result in its dismissal by the
Presiding Officer or in the action being overturned on appeal.
Other Agency officials subject to ex parte prohibitions are:
• Administrator;
• Regional Administrator;
• EPA Appeals Board Judges;
• Judicial Officer;
• Regional Judicial Officer; and
• Any other person who is likely to advise these officials (e.g., the Assistant
Administrator for OE and the Assistant Administrator for Pollution, Pesticides, and
Toxic Substances).
The Agency officials listed above are prohibited from participating in ex parte discussions with
the following individuals:
• An Agency official who performs a prosecutorial or investigative function in the
proceeding or a factually related proceeding;
• Any person outside the Agency who has an interest in the proceeding; and
• Any representative of the persons identified above.
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Chapter Six Post Complaint Stage
ANSWER TO THE COMPLAINT
The respondent must respond to the allegations in the complaint by filing an answer within 20
days after service of the complaint. Service of the complaint is complete when the return receipt
is signed (if the complaint was mailed) or when personal service is effectuated. If service is
made, Respondent has not answered the complaint within 20 days, and an extension of time has
•not been granted pursuant to 40 C.F.R. Section 22.07(b), the attorney should file a Motion for
Default (page 6-41). In the answer, the respondent must admit, deny, or explain each of the
factual allegations contained in the complaint. Where the respondent has no knowledge of the
allegations and makes a statement to that effect, the allegations are considered denied 22.15(b).
Failure to admit, deny, or explain any material factual allegation contained in the complaint
constitutes an admission of that allegation. 22.15(d)
Extensions of time to file an answer pending settlement negotiations are discouraged. By filing
an answer, the respondent places the issues in dispute on the table, triggers the assignment of
an ALT, and begins moving the case forward to resolution.
Procedural Considerations
Before the answer is filed, all motions are made to the EAB, or to the Judicial Officer or
Regional Judicial Officer, as appropriate. Once the answer is filed, and a Presiding Officer is
designated, all motions are made to that official. 22.16(c)
Filing a timely answer precludes the complainant from seeking a motion for default based on the
failure to file a timely answer. 22.17(a)(l)
The filing of an answer changes complainant's opportunity to amend. As a matter of right, the
complainant may amend the complaint once before the answer is filed. After the answer is filed,
a motion to amend must be made to and approved by the Presiding Officer. 22.14(d)
The complainant may withdraw the complaint, either partly or completely, without prejudice one
time before the answer has been filed. After one withdrawal before the filing of an answer or
after the filing of an answer, the complaint may be withdrawn only upon motion granted by the
Presiding Officer or Regional Administrator. 22.14(e)
Sufficiency of Answer
To be sufficient an answer must:
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Chapter Six Post Complaint Stage
• Be filed in the original with the Hearing Clerk; and
• Comply with the general filing, service, and content requirements specified by the
Consolidated Rules of Practice. 22.05
The answer must include:
• Clear and direct admissions, denials, or explanations of each factual allegation contained
in the complaint of which the respondent has any knowledge. If the respondent has no
knowledge of a particular factual allegation and makes a statement to that effect, the
allegations are considered denied. All allegations should be addressed in some manner:
• Grounds for defense, if any;
• Any facts that the respondent will put in issue; and
• Any request for a hearing. 22.15(b)
Evaluation of Answer
Upon receiving a copy of the answer, the Case Development Officer (CDO) and Attorney should
immediately review it for any deficiencies and also check with the Hearing Clerk to ensure that
the requirements concerning timely filing and the general filing requirements have been met.
Review of the answer might also indicate that a motion to amend the complaint is warranted
(i.e., if proposed penalties would be reduced or increased).
Consequences of an Insufficient Answer
If the form requirements specified by Section 22.05(c) of the Consolidated Rules of Practice are
not complied with, the Hearing Clerk may refuse to file the answer. 22.05(c)(5)
If the requirements specified by Section 22.05(b) of the Consolidated Rules of Practice are not
complied with, the insufficient answer may be regarded as an admission of all matter(s) not
sufficiently addressed. 22.15(d)
If the answer is not filed within the 20-day time requirement, the complainant may seek a default
order. (See Motion for Default, page 6-23.) 22.17(a)(l)
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Chapter Six Post Complaint Stage
'Assignment of a Presiding Officer
Once an answer is filed, the Hearing Clerk forwards the entire file including complaint, answer,
and any other documents filed in the proceeding, to the Chief Administrative Law Judge
(CALJ). The CALJ then assigns the case either to himself or to another ALT as Presiding
Officer. The Presiding Officer then obtains the case file from the CALJ and notifies the parties
of the assignment. 22.21(a)
MOTIONS
A motion is a written application to the Court requesting a ruling. Either party may file a
motion. Motions may be made during the prehearing, hearing, afid post-hearing stages of the
proceeding. Before an answer is filed and the case is assigned to an ALJ, motions are filed with
. the Regional Administrator. After the filing of an answer, motions are filed with the Presiding
Officer. 22.16(c)
Written Motions
All motions made during the proceeding, except those made orally on the record during a
hearing, must: 22.05(a)(2), 22.05(b)(2), 22.16(a)
• Be in writing;
• Specifically state the grounds or basis for the motion;
'.P
• Specifically identify the action(s) that the motion seeks;
• Be accompanied by any evidence that is being relied upon by the movant (e.g.,
affidavits and legal memoranda); and
• Be served upon the parties.
A written motion must also comply with the general filing and service provisions of Section
22.05 of the Consolidated Rules of Practice (i.e., it must be properly signed, accompanied by
appropriate certificates of service, and bear an appropriate docket number).
TSCA Case Proceedings 6-53 Guidance Manual 1992
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Chapter Six Post Complaint Stage
Procedural motions may be made orally, usually by teleconference arranged by the ALJ. The
ruling is then memorialized in writing for the file.
Reply to Motion
A response to a motion must be filed with the Regional Hearing Clerk within 10 days after
service of the motion, except in the case of a motion for a default order, which specifies a 20-
day period for replies. Like all documents filed in the proceeding, replies to motions must bear
the docket number and comply with the filing and service requirements specified by Section
22.05 of the Consolidated Rules of Practice. 22.16(b), 22.17(a)
If a response is not filed within the 10-day or 20-day period specified by Section 22.07 of the
Consolidated Rules of Practice, any objection to the motion is considered waived, and the
motion may be granted without further argument. 22.16(b)
The Administrator, Regional Administrator, and Presiding Officer, as appropriate, may set a
shorter time than 10 days for the response, and may also permit oral argument concerning
motions. 22.160))
Examples of Motions
• Motion for Accelerated Decision as to Liability and/or Penalty; 22.20
• Motion for Consolidation or Severance; 22.12(a), 22.12(b)
• Motion for Default; 40 C.F.R. Section 22.17(a)(l)
• Motion for Interlocutory Appeal;
• Motion for More Definite Statement;
• Motion for Postponement of Hearing; 22.21(c) (See page 6-43.)
• Motion in Bar;
• Motion in Limine;
• Motion to Amend the Complaint; 22.11(d)
• Motion to Dismiss; 22.20
TSCA Case Proceedings 6-54 Guidance Manual 1992
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Chapter Six Post Complaint Stage
• Motion to Extend Time to File;
• Motion to File and Amicus Curiae Brief; 22.11(d)
• Motion to Implead;
• Motion to Intervene; 22.11(a)
• Motion to Reconsider a Final Order; 22.32 (See page 6-64.)
• Motion to Reopen a Hearing; 22.28 (See page 6-58.)
• Motion to Strike an Affirmative Defense.
Motion for Default ;:~
Default orders may be issued under three circumstances:
• Against the respondent for failure to file a timely answer to the complaint; 22.17(a)(l)
• Against a complainant or respondent for failure to obey a prehearing or hearing order
that has been issued by the Presiding Officer; and 22.17(a)(2)
• Against a complainant or respondent for failure to appear at a conference or hearing
convened by the Presiding Officer pursuant to Section 22.19, without good cause being
shown.
Motions for default are made either to the Regional Administrator or Regional Judicial Officer
in each of the circumstances, or to the Presiding Officer in the second and third circumstances.
A motion for default may be filed by any person who is a party to the proceeding [as defined
by Section 22.03(a) of the Consolidated Rules of Practice] at the time the motion is made.
("Any person" apparently includes intervenors.) In addition, the Presiding Officer is permitted
to issue a default order sua sponte in the latter two default circumstances 22.17(a). See Example
6E-3 for a sample default order.
Procedures
The party making a motion for default must include a proposed default order with the motion
(see Example 6E-3). The motion for default must be served on all parties and otherwise
TSCA Case Proceedings 6-55 Guidance Manual 1992
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Chapter Six Post Complaint Stage
conform with the filing and service requirements specified by Section 22.05 of the Consolidated
Rules of Practice.
The alleged defaulting party has 20 days from service of the motion for default, which is 10
days longer than that generally specified for replies to motions. 22.16(b)
Default Order as Initial Decision
The granting of a default order constitutes an initial decision in the proceeding. As such, it
must: 22.17
• Contain findings of fact, conclusions regarding material issues of law or discretion, and
the recommended penalty; and 22.17(c)
• Be filed with the Hearing Clerk. 22.17(b)
The Hearing Clerk must serve copies of the default order on all parties to the proceeding and
otherwise comply with Section 22.27 of the Consolidated Rules of Practice, which addresses
transfer of the proceeding's record to the Hearing Clerk. The default order becomes the final
order of the Administrator within 45 days after its service upon the parties unless (1) the
default order is appealed or (2) the Administrator elects, sua sponte. to review the default
order.
Appeal
A default order may be appealed by a motion to set aside the default order to the Presiding
Officer who issued the order. Further appeal of the default order is made to the Environmental
Appeals Board (EAB) pursuant to Section 22.30 of the Consolidated Rules of Practice. 22.17(d),
22.29(a)
Consequences of Final Default Order
When the EAB issues a final order upon default against the respondent:
• The respondent is deemed to have "admitted" all facts alleged in the complaint and
waived the right to a hearing; and
• The penalty proposed in the complaint becomes due and payable within 60 days after
the final order is issued. 22.17(a)
TSCA Case Proceedings 6-56 Guidance Manual 1992
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Chapter Six Post Complaint Stage
The admission of factual allegations and waiver of hearing applies only to the immediate civil
penalty proceeding and does not affect any other proceedings. In addition, the 60-day period
for payment of the penalty begins only after the EAB has issued a final order upon default, not
after the Presiding Officer issues the initial default order.
When the EAB issues a final order upon default against the complainant, the complaint is
-dismissed with prejudice. This means that the complainant cannot reinstitute a civil penalty
proceeding that is based on the allegations contained in the dismissed complaint.
Motion to Intervene
In some instances, persons other than the named respondent may wish to "intervene" or be
considered as parties in a case.
An individual may make a motion to become an intervenor in any proceeding conducted under
the Consolidated Rules of Practice. To intervene, the individual's motion must reflect that:
• The individual has a certain interest in the proceeding that is not adequately represented
by the original parties;
• The individual's presence will not unduly prolong or otherwise prejudice the
adjudication of the original parties' rights; and
• The individual will be affected adversely by a final order.
A motion to intervene is ordinarily made before the first prehearing conference. However, the
motion may be made after that time if good cause is shown for the failure to file in a timely
^manner. A party objecting to the intervention may make an answer to the motion to intervene
:;within 10 days following service of the motion. Once an individual is permitted to intervene,
:,that individual becomes a full party to the proceeding. 22.11(a), 22.11(b), 22.11(c), 22.03(a)
Motion to File an Amicus Curiae Brief
An individual may make a motion to file an amicus curiae brief. Amicus curiae, or "friends of
the court," are usually public interest or trade groups who wish to advise the Presiding Officer
of certain implications of the case. The motion must identify the interest of the applicant and
the desirability of the proposed amicus brief. If the motion is granted, the Agency official
granting the motion specifies the time for filing the brief. Once the motion is granted, the
individual, while not considered a full party, is permitted to file amicus briefs in all subsequent
TSCA Case Proceedings 6-57 Guidance Manual 1992
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Chapter Six Post Complaint Stage
briefings during the proceeding and is served with copies of all documents relating to such
briefings. 22.11(d)
Motion for Accelerated Decision
A motion for accelerated decision (for penalty and/or liability) may be made by either party or
sua sponte (voluntarily, not at the request of either party) by the Presiding Officer and may be
issued at any time during the proceeding if the Presiding Officer finds that: 22.20
• No genuine issue of material fact exists between respondent and complainant; and
• The complainant or respondent is entitled to a judgement as a matter of law.
"Entitled to a judgement as a matter of law" means that there are no disputes of material fact
and the movant has established by evidence that all technical and legal elements in a violation
did or did not occur. Consequently, the Presiding Officer must decide a particular issue or the
entire case in the movant's favor at that time. Because there is no genuine factual dispute, there
is no need for a hearing.
Nature of a Motion for Accelerated Decision
A motion for an accelerated decision challenges the feasibility of the opposing party's claim.
The motion asserts that, under the facts of the case and law, the opposing position is entirely
without merit.
Facts
In order to rule for an accelerated decision, the Presiding Officer must find that no genuine
material issue of fact exists between the parties. This does not mean that the parties agree on
all facts, but rather that the moving party has presented uncontroverted facts that are sufficient
for deciding an issue, and no matter what other facts might also be proven, the outcome will not
change.
Affirmative Defenses
The moving party must establish that he is entitled to judgement as a matter of law. He is
required to prove the elements of the violation by undisputed or undisputable evidence, and must
also dispose of affirmative defenses raised by the respondent by presenting undisputed or
undisputable evidence to the Presiding Officer.
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Chapter Six Post Complaint Stage
Evidence and Burden
The Presiding Officer may rely on any admissible evidence, including stipulations, admissions,
expert witness testimony, deposition testimony, and officially noticed evidence offered by the
parties to reach a decision on the motion for an accelerated decision. 22.20(a)
In deciding whether to grant the motion for an accelerated decision, the Presiding Officer looks
at all of the evidence in the light most favorable to the party opposing the motion.
Motion to Dismiss
The respondent may make a motion to dismiss for:
• Failure of the complainant to establish a prima facie case; and
• Other grounds that show that the complainant has no right to relief. 22.20(a)
Partial Decision
A motion for an accelerated decision or a motion to dismiss need not dispose of all issues in the
proceeding. If a partial order is issued, the Presiding Officer will also determine if issues
remain in controversy between the parties. The Presiding Officer then issues an interlocutory
order disposing of noncontroverted issues disposed of by the accelerated decision or motion to
dismiss; all other issues remain before the Court. 22.20(b)(2)
Motion for Interlocutory Appeal
Procedures and Standards for Interlocutory Orders
A motion for interlocutory appeal of an order or ruling must be filed in writing within six days
of notice of such ruling or order. 22.29
Besides stating the grounds for appeal, the moving party must demonstrate to the appropriate
Agency official that:
* The order or ruling involves important legal or policy issues which are adamantly
contested; and
• An immediate appeal will materially advance the proceeding or that waiting for normal
review will be ineffective or inadequate. 22.29(b)
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Chapter Six Post Complaint Stage
The motion must also comply with requirements for filing, service, and content requirements
specified in the Consolidated Rules of Practice.
If the Presiding Officer does not certify the interlocutory appeal, a party may make a motion to
the Administrator within six days of service to reverse that decision on the grounds that it is
contrary to the public interest. This motion must also comply with the requirements of Section
22.16 and 22.05 of the Consolidated Rules of Practice, except that the appropriate Agency
officials receiving the motion are the Regional Hearing Clerk and the Environmental Appeals
Board. 22.29(c)
Actions by the Environmental Appeals Board
If the Presiding Officer certifies the interlocutory appeal, the Environmental Appeals Board
(EAB) may: 22.29(c)
• Deny the certification as improvidently granted;
• Take no action within 30 days and thereby dismiss the certification; or
• Grant the certification, review the interlocutory appeal, and grant or deny the appeal on
its merits.
Ordinarily, the interlocutory appeal will be decided on the basis of the submissions made by the
Presiding Officer. The EAB may, however, allow further briefs and oral argument. 22.29(c)
Request for Stay
The motion for interlocutory appeal may include a request for stay of the proceeding pending
the Administrator's decision on the certification and interlocutory appeal. The request for a stay
should be for a specific time period, not an indefinite stay. The request must demonstrate that
extraordinary circumstances exist to justify granting the stay. If the Presiding Officer grants a
request for stay of more than 30 days, its must be separately approved by the EAB. 22.29(d)
Initial Decision
If an accelerated decision disposes of all issues in the proceeding, such a decision or order is
treated as an initial decision and may be appealed to the EAB under Section 22.30 of the
Consolidated Rules of Practice. 22.20(b)(l)
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Chapter Six Post Complaint Stage
If a partial decision is rendered, an objecting party must await the issuance of a final initial
decision or obtain certification before appealing the interlocutory decision. 22.20(b)(2), 22.29
Motion to Amend the Complaint
The complaint may need to be amended for a number of reasons including:
• To add new information;
• To increase or decrease the penalty;
• To respond to a motion to dismiss for failure to state a claim for which relief can be
granted;
• To change the name of the respondent;
• To add or subtract parties; or
• To revise the language used.
The complaint may be amended once upon motion to the Presiding Officer or Regional
Administrator, as appropriate, as a matter of right at any time before an answer is filed. The
amended complaint is filed with the Hearing Clerk. After an answer has been filed, the
complaint may be amended only upon motion granted by the Presiding Officer or Regional
Administrator, as appropriate. As with the original complaint, the respondent has 20 days from
the date the amended complaint is served to file an answer.
Motion for Consolidation or Severance
"The Presiding Officer may, by motion or sua sponte. consolidate any or all matters at issue in
two or more proceedings docketed under the Consolidated Rules of Practice where (1) there exist
.common parties or common questions of law or fact, (2) consolidation would expedite and
simplify consideration of the issues, and (3) consolidation would not adversely affect the rights
of parties engaged in otherwise separate proceedings.
The Presiding Officer may also, by motion or sua sponte. for good cause shown, order any
proceedings severed with respect to any or all parties or issues.
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Chapter Six Post Complaint Stage
Motion in Limine
Either party may file a motion in limine to exclude evidence. A Respondent would typically file
a motion if the party perceives that certain questions or statements are irrelevant and may be
used to unfairly harm their case. Its purpose is to avoid injection into trial of matters which are
irrelevant, inadmissable and prejudicial.
Motion to Extend Time to File
Either party may file a motion to extend time to file a response to the opposing party's pleading
or to a court order. Respondent requesting an extension from the court to answer the complaint
is a common example.
Motion to Implead
An existing party to the suit may request the court to "implead" or bring in another party who
is not a party to the suit. For instance, the Respondent may believe that a party not named in
the suit is responsible for part or all of the controversy and requests the court to name that party
as an additional defendant.
Motion to Strike an Affirmative Defense
The party bringing the action may request the Court to rule that certain defenses are insufficient
and need no litigation because they are not supportable under the law or have been decided in
a prior case.
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Chapter Six
Example 6E-6
Sample Default Order
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
In the Matter of
Watervliet Paper Company, Inc.
Respondent
Docket No. TSCA-V-C-098-88
ORDER ON DEFAULT
This is a proceeding under the Toxic Substances .Control Act Section
2615(a) for the assessment of civil penalties for violations of the
EPA's regulations governing the manufacturing, processing, distribution
and use of polychlorinated biphenyls ("PCB Ban Rule"), 40 C.F.R. Part
761.' The EPA, Region V, instituted the proceeding by filing a complaint
on August 2, 1988, charging Respondent Hatervliet Paper Company, Inc.
with the failure to develop and maintain PCB records, to register PCB
transformers with local fire response personnel, to remove combustible
materials from within 5 meters of PCB transformers, and to mark the
means of access to its PCB transformers. A penalty of $29,000 was
requested. Respondent answered, admitting that the PCB records were
incomplete and that Respondent had failed to formally notify the local
fire department. Respondent denied storage of combustibles within five
meters of its PCB transformers. Respondent admitted that the means of
access to PCB transformers was not properly marked. Respondent
contented that the proposed penalty was unreasonably large, and stated
that it corrected some of the violations upon receipt of the EPA's
complaint. The matter is before me on the question of whether to issue
a default order as authorized by 40 C.F.R. Section 22.17.
*TSCA, Section 16(a) of the Act, provides as follows:
(1) Civil. (1) Any person who violates a provision of Section
2614...shall be liable to the United States for a civil penalty in an
amount not to exceed $25,000 for each such violation. Each day such a
violation continues shall, for purposes of this subsection, constitute a
separate violation of section 2614 of this title.
Section 15 of the Act, 15 U.S.C. 2614, provides in pertinent part
that "It shall be unlawful for any person to...(l) fail or refuse to
comply with...(C) any rule promulgated or order issued under Section
2604 or 2605 of this title...." The PCB Ban Rule was issued under
section 6(e) of the Act, 15 U.S.C. 2605(e).
TSCA Case Proceedings
6E-63
Guidance Manual 1992
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Chapter Six Example 6E-6
Respondent did not request a hearing, but asserted in its answer
its belief that it is in full compliance with EPA regulations as of the
date of filing its answer, that as a first offense it should not be
fined, and that the matter should be considered settled. I was
designated by my Order dated September 19, 1988 to preside in this
proceeding. On October 5, 1988, I wrote the parties directing the
filing of a prehearing exchange by December 6, 1988, unless the case was
settled. Complainant filed its prehearing exchange on December 6, 1988'.
On December 20, 1988, the parties were advised that Respondent was
provided until January 3, 1989 to file its prehearing exchange. Upon
notification that Respondent retained an attorney, Complainant requested
an extension of time for Respondent's prehearing exchange, which was
granted to March 20, 1989, by my Order dated January 25, 1989.
Complainant warned Respondent's attorney by letter dated January 19,
1989 that if Respondent does not file "a Pre-Hearing Exchange or a
statement that Watervliet Paper Company, Inc., is financially unable to
pay the proposed penalty within sixty days," Complainant would be
compelled to file a Motion for Default. On March 14, 1989, Respondent
filed a Statement of Financial Inability to Pay Penalties, requesting
dismissal of the complaint, and enclosing a copy of a petition in
bankruptcy under Chapter XI of the Bankruptcy Code. By my Order of May
25, 1989, Respondent's request for dismissal of the proceedings was
denied. Complainant filed a Motion for Default Order on June 23, 1989,
to which no opposition has been filed. Assuming that Respondent's
filings could be interpreted as Respondent seeking dismissal solely on
grounds of the bankruptcy proceedings, the EPA would still be entitled
to an order, albeit the matter is really one for accelerated decision,
for the reasons hereinafter stated.
The issue is whether this proceeding is subject to the automatic
stay provisions of the Bankruptcy Code, 11 U.S.C. 362. Because this is
a proceeding to assess a civil penalty for failure to comply with the
environmental laws, this proceeding is excluded from the stay provisions
by 11 U.S.C. 362(b)(4) and (b)(5).
The legislative history of 11 U.S.C. Section 362(b)(4) states that:
"where a governmental unit is suing a debtor to prevent or stop
violation of fraud, environmental protection, consumer protection,
safety, or similar police or regulatory laws, or attempting to fix
damages for violation of such a law, the action or proceeding is not
stayed under the automatic stay." H. Rep. No. 595, 95th Cong., 2nd
Sess. 343, reprinted in 1978 U.S. Code Cong. & Adm. News 5787,:5963,
6299 (emphasis added). The legislative history of 11 U.S.C. Section
362(b)(5) states that "the exception extends to permit an injunction and
enforcement of an injunction, and to permit the entry of a money
judgment, but does not extend to permit enforcement of a money
judgment." S. Rep. No. 989, 95th Cong., 2nd Sess. 52, reprinted in U.S.
Code Cong. & Adm. News 5787, 5838 (emphasis added).
TSCA Case Proceedings 6E-64 Guidance Manual 1992
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Chapter Six Example 6E-6
In In re Commonwealth Oil Refining Co.. 805 F.2d 1175 (5th Cir.
1986), cert, denied. U.S. , 107 S.Ct. 3228, 97 L.Ed 2d 734
(1987), the court held that EPA was entitled to enforce its order
requiring compliance by a debtor with the provisions of the Resource
Conservation and Recovery Act (RCRA), 42 U.S.C. Sections 6901-6991. The
court noted that "the police and regulatory exceptions [to the automatic
stay] do not depend on a showing of imminent and identifiable harm or
urgent public necessity" in response to the company's contention that
the EPA's action was merely one to correct "technical violations," Id.
at 1182, 1184. See also, United States v. Jones & Laughlin steel Corp..
804 F.2d 348 (6th Cir. 1986) (proceeding under the Clean Air Act and
Clean Water Act was held exempt from the automatic stay provision; U.S.
v. Wheeling-Pittsburgh Steel Corp.. 818 F.2d 1077 (3rd Cir. 1987)
(Chapter XI petition and economic infeasibility held not to relieve
company of compliance schedule mandated by consent decree under Clean
Air Act). See also, Penn Terra Ltd, v. Dept. of Environmental
Resources. 733 F.2d 267 (3d Cir. 1984) (state proceeding to compel
debtor to correct environmental damage not automatically stayed); NLRB
v. Evans Publishing Co.. 639 F.2d 23 (5th Cir. 1981.)*0and Ahrens
Aircraft. Inc. v. NLRB, 703 F.2d 23 (1st Cir. 1983) (unfair labor
practice proceedings before NLRB against debtor for reinstatement of
employees and for back pay not automatically stayed); In re; Tauscher, 7
Bankr. 918 (E.D. Wise. 1981) (proceeding to assess civil penalties
against debtor for violation of Fair Labor Standards Acts not
automatically stayed); Kovacs v. Ohio. 717 F.2d 984, 988 (6th Cir.
1983), affd.. 469 U.S. 274 (1985) ("a money penalty assessed...for the
environmental damage...caused...would not have been subject to the
automatic stay of [11 U.S.C.] Section 362, although enforcement of the
assessment would have been stayed."). See also, Order on Default, In
the Matter of Electric Utilities Company. Docket No. TSCA-V-C-011, dated
February 13, 1985.
Respondent has asserted in its letter dated March 14, 1989 to
Complainant that Respondent is unable to make any payments on the
proposed penalty due to the filing of the bankruptcy petition on October
13, 1988. Arguably, this proceeding could be dismissed as moot;
however, it is not moot for several reasons, as also stated in my Order
on Default, In the Matter of Electric Utilities Company, supra.
First, the assessment of a civil penalty reduces the claim to a
fixed amount against Respondent for purposes of determining its
treatment in the plan of reorganization. It is ten for the Bankruptcy
Court to decide how to treat the claim under the Chapter XI plan.
bSee Complainant's Motion for a Default Order, Exhibit 7.
Respondent's Order for Relief under Chapter 11 of the Bankruptcy Code
was granted on December 23, 1988.
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Chapter Six
Example 6E-6
Second, the EPA is entitled to a resolution of the merits of its
charges.0 A Chapter XI proceeding contemplates Respondent's continued
operation in some reorganized form; therefore, the resolution of this
matter is significant in order to carry out the purposes of TSCA.
Finally, this proceeding may be relevant in the event that the
reorganized company is cited again for a violation of TSCA, since
account must be taken of a respondent's prior history of violations in
the process of assessing a civil penalty.4
As to whether Complainant has presented sufficient evidence to
establish a prima facie case against Respondent,' Complainant has
supplied a PCB Compliance Inspection Report which summarizes in detail
the TSCA violations listed herein.' This Report is based on an
inspection performed by the Michigan Department of Natural Resources,
Haste Management Division, on February 23, 1988. The results of the
inspection as summarized in the Report fully support the allegations
made in the complaint. In its answer, Respondent admitted to all of the
facts alleged in the complaint. While Respondent maintains in its
answer that it "did not and does not store combustible materials within
five meters of it's [sic] P.C.B. transformers,"• Respondent does admit
that "at times [employees] may place a piece of cardboard, a rag or a
piece of plywood on the floor or a bench on the steel balcony grating
for a place to sit down.nh According to the PCB Compliance Inspection
Report, the combustible materials, which included wood wire spools and
some old rags, were "stored on the deck with the transformers," within
five meters of the transformers.1 I find that Respondent has not
successfully rebutted the allegations made in the complaint; therefore
Complainant has established a prima facie case.
"See Ahrens Aircraft v. NLRB. 703 F.2d at 23, and NLRB V.
Autotronics. Inc.. 434 F.2d 651 (8th Cir. 1979). (The fact that the
company had undergone Chapter XI proceedings "does not alter [the Eight
Circuit] court's jurisdiction to review the merits of the Board's order
or to consider enforcement of it.")
''TSCA, Section 16(a)(2)(B), 15 U.S.C. 2615 (a) (2) (B).
'While Complainant is not required to establish a prima facie case
under the Rules of Practice, 40 C.F.R. Section 22.17(a), I address this
issue nevertheless since Complainant has produced sufficient information
to make this determination.
'See supra.
Exhibit 1.
p. 1-2,
p. 6-7; Complainant's Prehearing Exchange
'Answer, p. 2.
'Complainant's Prehearing Exchange, Exhibit 1, p. 6.
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6E-66
Guidance Manual 1992
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Chapter Six Example 6E-6
Accordingly, Respondent is found in default for failure to make the
prehearing exchange directed in my letters of October 5, 1988 and
December 20, 1988. While Respondent did make a response in submitting
its Statement of Financial Inability to Pay Penalties, this submission
does not constitute an adequate prehearing exchange as outlined in my
letter of October 5, 1988. In the alternative, Complainant is entitled
to an accelerated decision against Respondent. The findings of fact as
set forth below are based not only on admissions in Respondent ' s answer
but on information contained in Complainant's prehearing exchange, which
is incorporated into the record in this proceeding.
Findings of Fact
1. On or about February 23, 1988, Respondent had not developed or
maintained complete annual records on the disposition of its two
pyranol PCB transformers and 30 PCB large capacitors for calendar
years 1978 through 1986, as required by 40 C.F.R. Section 761.80.
2 . Respondent had not registered its two PCB transformers with local
fire response personnel by December 1, 1985 as required by 40 C.F.R.
Section 761.30(a) (1) (vi) .
3. On or about February 23, 1988, combustible materials, including wood
wire spools and some old rags, were located within five meters of
said transformers, as prohibited by 40 C.F.R. Section
4. On or about February 23, 1988, the means of access to said
transformers, a doorway to the patio substation in which said
transformers are stored, was not marked with the PCB label as
required by 40 C.F.R. Section 761.40(j).
Conclusions of Law
1. Respondent has failed to develop or maintain complete annual records
on PCB items in violation of 40 C.F.R. Section 761. 189 (a), and TSCA,
Section 15, 15 U.S.C. Section 2614.
2. Respondent has failed to register its PCB transformers with local
fire response personnel in violation of 40 C.F.R. Section
761.30(a) (1) (vi) and TSCA, Section 15, 15 U.S.C. Section 2614.
3. Respondent has failed to remove combustible material from within
five meters of PCB transformers in violation of 40 C.F.R. Section
761.30(a) (1) (viii) and TSCA, Section 15, 15 U.S.C. Section 2614.
4. Respondent has failed to mark the means of access to its PCB
transformers in violation of 40 C.F.R. Section 761.40(j), and TSCA,
Section 15, 15 U.S.C. 2614.
TSCA Case Proceedings 6E-67 Guidance Manual 1992
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Chapter Six Example 6E-6
The Penalty
Pursuant to 40 C.F.R. 22.17(a), the penalty proposed in the
complaint of $29,000 is the penalty assessed. It is recognized that
TSCA specifies that in determining the appropriate penalty, account must
be taken of Respondent's ability to pay.J The bankruptcy proceeding
presents a special case, and the issue of Respondent's ability to pay
would seem to be merged into the question before the Bankruptcy Court of
how the claim is to be treated under the reorganization plan.
ORDER*
Pursuant to Section 16(a) of the Toxic Substances Control Act, 15
U.S.C. 2615(a), a civil penalty of $29,000 is hereby assessed against
Respondent, Watervliet Paper Co., Inc., for violations of the Act found
herein.
Payment of the full amount of the penalty assessed shall be made
within sixty (60) days of the service of the final order by submitting a
certified or cashier's check payable to the United States of America and
mailed to:
EPA - Region V
(Regional Hearing Clerk)
P.O. Box 70753
Chicago, IL 60673
Gerald Harwood
Chief Administrative Law Judge
DATED:
Washington, D.C.
JTSCA, Section 16(a)(2)(B).
^Unless an appeal is taken pursuant to 40 C.F.R. 22.30, or the
Administrator elects to review this decision on his own motion, the
Default Order shall become the final order of the Administrator. See 40
C.F.R. 22.27(c).
TSCA Case Proceedings 6E-68 Guidance Manual 1992
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Chapter Six
4 Informal Settlement
EPA encourages settlement of a civil penalty proceeding. The settlement must be consistent with
the provisions and objectives of TSCA and its applicable regulations. 22.18(a)
SETTLEMENT CONFERENCE
7 A settlement conference can be requested at any time. The parties may confer on settlement
whether or not the respondent has requested a hearing. Before an answer is filed and a
r Presiding Officer is appointed, settlement conferences may be convened by consent of the
,'. parties, although this practice is discouraged. After a Presiding Officer has been appointed,
settlement conferences are subject to the jurisdiction of the Presiding Officer who may order a
prehearing conference settlement. The parties may be directed to correspond with the Presiding
Officer concerning settlement through scheduled "status reports." 22.18, 22.19
At a settlement conference, the CDO serves as EPA's co-representative with the Regional
Counsel. The CDO and Regional Counsel should thoroughly review the case file prior to the
conference.
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Chapter Six Informal Settlement
At the conference, the CDO or Counsel should (per agreement):
• Explain that discussions are not part of the case record and are not admissible as
evidence in the proceeding;
• Explain facts on which the complaint's allegations are based;
• Review all factors taken into consideration in determining the proposed penalty;
• Describe other mitigating factors that the Agency may take into consideration (good
faith);
• Reaffirm that the violative activity has been discontinued; and
• Explain the administrative process to the Respondent.
CONSENT AGREEMENT AND PROPOSED CONSENT ORDER
If a settlement is reached, the parties must forward a written consent agreement (see Example
6E-4) and a proposed consent order to the Regional Administrator. The consent agreement must
contain the following information: 22.18(b)
• The signature of all parties or their representatives in the proceeding (e.g.. complainant,
respondent, and any intervenors);
• A statement in which the respondent admits that the Agency has jurisdictional authority
to bring the complaint;
• A statement in which the respondent admits, or neither admits nor denies, facts alleged
in the complaint; and
• A statement in which the respondent consents to the assessment of the stated civil
penalty as reflected in the consent agreement and proposed consent order.
Consent agreement negotiations typically focus on factual disputes and on the appropriate size
of the penalty to be imposed on the violator. Adjustments to the penalty are made by
considering such factors as the size of the business of the person charged, the effect on the
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Chapter Six Informal Settlement
person's ability to continue in business, and the gravity of the violation. In addition, remittance
of part of an assessed penalty by means of a Supplemental Enforcement Project (SEP) is
permitted under a Settlement With Conditions (SWC). (See Settlement With Conditions, page
6-72.)
The consent agreement includes all terms of the agreement among the parties. Consequently,
any terms to which the parties have agreed in reaching a settlement must be reflected in the
consent agreement (e.g., agreement by intervenor not to pursue private damage remedies,
agreement by the respondent to take actions that minimize the effect of the violation, etc.).
Settlement agreements and proposed consent orders must be very carefully drawn and completely
understood before being signed so that the parties understand precisely what elements of the
matter are disposed of by the consent agreement and consent order.
The consent agreement becomes final and binding on the parties after the Environmental Appeals
Board (EAB) or Judicial Officer has signed the consent order.
The proposed consent order is prepared for the Regional Administrator's or EAB's signature.
It need not restate all the terms of the consent agreement, but it must explicitly incorporate by
reference the consent agreement. 22.18(c)
The Regional Administrator, EAB, or Judicial Officer, in deciding whether to issue a final
consent order, may require the parties to appear in person to answer questions relating to the
proposed consent agreement or order.
FILING OF CONSENT AGREEMENT AND ORDER
The consent agreement and the final consent order are important documents that affect the
substantive and procedural rights of the parties. The originals of these documents are filed with
the Hearing Clerk's file, and copies must be served as required by Section 22.06 of the
Consolidated Rules of Practice. In some Regions, the Regional Administrator's Office will file
and serve the CACO, while in other Regions, this task is assigned to Regional Counsel or the
CDO.
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Chapter Six Informal Settlement
SETTLEMENT WITH CONDITIONS
In certain circumstances, a settlement in an administrative civil penalty action may be reached
that assesses a civil penalty and provides for the remedial action by the respondent. Such a
settlement is referred to as a "settlement with conditions." The criteria and procedures for using
a Settlement With Conditions are set forth in the November 5, 1983, Settlement with Conditions
Policy.
Supplemental Enforcement Projects
An example of a Settlement With Conditions that has become an integral part of many
settlements is the Supplemental Enforcement Project (SEP). These projects, under the general
heading of pollution prevention, are also known as "alternative payments," "mitigation projects,"
and "environmentally beneficial expenditures" (EBEs).
The respondent may be able to mitigate part of the proposed penalty with the implementation
of an SEP. An SEP might take one or more of the following forms: (1) an internal
environmental audit of the respondent's compliance status with TSCA; (2) a publication in a
trade journal on TSCA compliance; (3) a TSCA/EPCRA compliance seminar for customers; (4)
a yearly TSCA training course for the company's employees; or (5) expenditures to decrease the
emission of a chemical(s) on the Toxics Release Inventory System (EPCRA Section 313,
chemical). The SEP that is negotiated cannot include a project or activity that would be required
to correct the underlying violation(s). In addition, the SEP cannot include a project or.activity
already required under any Federal, State, or local law, regulation, or settlement agreement.
Although respondents do not receive a dollar-for-dollar credit for each dollar of a pollution
prevention expenditure, they may be given as great as a two-to-one ratio (one dollar reimbursed
by EPA for every two dollars expended) for certain types of projects that significantly benefit
the environment, such as reduction of carcinogenic chemical emissions. Training courses and
trade publications typically receive a lesser ratio (eight-to-one or more). Please refer to the
February 12, 1991, Policy on the Use of Supplemental Enforcement Projects in EPA Settlements
(GM-22) and the October 28, 1986, Guidance After Tax Net Present Value of Alternative
Payments (GM-51) for more details.
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Chapter Six Informal Settlement
DOCUMENTING PENALTY CALCULATIONS
It is crucial that every case file includes written documentation of reductions or additions to the
bottom line penalty that are negotiated during settlement, whether the reduction is authorized by
the various penalty policies or is a component of an SEP. Documentation and justification of
penalty adjustments is done for the purpose of oversight review of settlements and to ensure
consistency with the applicable penalty policies. The consent order or decree should specify the
milestones to be met in implementing an SEP. Chapter 9, Oversight of Settlement Agreements,
provides more details on the tracking and oversight responsibilities of the CDO. Please refer
to the August 9, 1990, memo from James M. Strode, Assistant Administrator for Enforcement,
entitled Documenting Penalty Calculations and Justifications in EPA Enforcement Actions, for
a more detailed discussion on this issue. This memo expands on the September 14, 1987,
Guidance on Processing of Consent Decrees (GM-64).
ABILITY TO PAY
Either prior to or during settlement negotiations, the respondent may claim an inability to pay
the proposed penalty. The burden is on the respondent to provide financial information that will
support its claim. If the violator fails to provide sufficient information, then the case
development team should disregard this factor in adjusting the penalty. The following
information should be provided:
Tax returns,
Balance sheets,
Income statements,
Statements of Cash Flow,
Statements of changes in financial position,
Retained earnings statements,
Loan applications,
Financing agreements,
Security agreements,
Annual reports, and
Independent reports (Dun and Bradstreet, Compustat, Value Line).
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Chapter Six Informal Settlement
EPA reserves the option, in appropriate circumstances, of seeking a penalty that might put a
company out of business. For example, if a violator refuses to correct a serious violation or has
a long history of previous violations, it is unlikely that EPA would reduce the penalty.
However, the overall goal of EPA is not to put a company out of business, but to obtain
compliance. .
If the respondent provides the case development team with the three latest years of federal tax
returns, this information can be run through the ABLE program. ABLE is a model used to
estimate a firm's ability to finance a civil penalty. ABLE is a preliminary step in ascertaining
ability to pay, and is not admissible evidence in a hearing. To obtain the ABEL User's Manual
and the ABEL User's Guide, please contact:
Program Development and Training Branch (LE-133)
Office of Enforcement Policy
Office of Enforcement
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
ABEL looks primarily at a company's cash flow and does not consider all of a company's
resources. As a result, if ABEL indicates that a respondent can pay the penalty, then EPA
should insist upon full payment. However, if ABEL indicates an inability to pay, then the CDO
must consider respondent's complete financial status. This may require the assistance of a
regional economist or the Office of Enforcement's economist.
When it is determined that a violator cannot afford to pay the penalty, the following options
should be considered:
• A delayed payment schedule, although it is recommended that full payment not be
delayed more than two years;
• Nonmonetary alternatives, such as public service activities;
• Straight penalty reductions, but only as a last recourse. As described above, the reasons
for the size of the necessary reduction should be made a part of the formal enforcement
file and the memorandum accompanying the settlement; or
• Joinder of the violator's individual owners.
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Chapter Six Informal Settlement
Regardless of the Agency's determination of an appropriate penalty amount to pursue based on
ability-to-pay considerations, the violator is still expected to comply with the law.
EPA General Enforcement Policy #GM-22, Appendix 1, pages 23-24, provides more detail on
Agency policy concerning inability to pay.
Non-Profit Organizations (NPOs) and Government Entities
Municipalities or non-profit organizations (NPOs) may also claim an inability to pay a civil
administrative penalty. In these instances, the CDO and the Attorney should consult the
Guidance for Calculating Municipal and Non-Profit Organization's Ability to Pay Civil Penalties.
Specifically, this manual addresses how to estimate ability to pay for municipalities, colleges and
universities, and non-profit hospitals. The manual describes resources that an NPO or
government entity may use to finance an enforcement penalty, and the techniques for evaluating
the penalty in terms of a Respondent's financial condition. It is ultimately up to the Agency to
determine the financial burden that will be placed on the organization under examination.
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Chapter Six Example 6E-7
Sample Consent Agreement
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of: )
)
Howland Industries, Inc. ) Docket No. TSCA-92-H-01
)
Respondent. )
CONSENT AGREEMENT
Complainant, United States Environmental Protection Agency ("EPA"),
and Respondent, Howland Industries, Inc., the Parties herein, having
consented to the entry of this Consent Agreement and Consent Order before
the taking of any testimony and without any adjudication of any issues of
law or fact herein, agree to comply with the terms of this Consent
Agreement and the attached Consent Order.
I. PRELIMINARY STATEMENT
A. EPA initiated this proceeding for the assessment of a civil penalty
pursuant to Section 16(a) of the Toxic Substances Control Act ("TSCA"
or "the Act"), 15 U.S.C. $ 2601 et sea.). and the regulations
promulgated thereunder, by issuing an administrative Complaint and
Notice of Opportunity for Hearing ("Complaint"), dated and served upon
Howland Industries, Inc. on January 5, 1992.
B. The Complaint alleged that the Agency has reason to believe that
Howland Industries violated TSCA SS 4, 5, 8, 12, 13, and 15 (15 U.S.C.
SS 2603, 2604, 2607, 2611, 2612, and 2614). Respondent has claimed as
TSCA Confidential Business Information (CBI) the names of the chemicals
involved and their dates of manufacture. In order to prevent the
disclosure of TSCA CBI and to lessen administrative burden, these
chemical substances are not identified in this Consent Agreement. The
names of the chemicals involved are set forth in the TSCA CBI versions
of the complaint and are incorporated herein by reference. In summary
form, Respondent's acts giving rise to this civil administrative
complaint against the Respondent are as follows:
1. One count of the Complaint alleged that Respondent failed to submit
a letter of intent to test or a valid request for exemption from
testing, in violation of TSCA $4, 15(1)(A), and 15(3)(B), and the
regulations codified at 40 C.F.R. Part 790.40 and 790.440.
2. One count of the Complaint alleged that Respondent failed to notify
intention to manufacture (import) a chemical substance not on the
TSCA Inventory, in violation of TSCA $5, 15(a)(l), 15(1)(B), and
15(3)(B), and the regulations codified at 40 C.F.R. Part 720.
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Chapter Six Example 6E-7
3. One count of the Complaint alleged that Respondent failed to comply
with notice of commencement requirements (more than 30 days after
manufacture), in violation of TSCA $5, 15(10)(C), and 15(3)(B), and
regulations codified at 40 C.F.R. 720.102(b).
4. One count of the Complaint alleged that Respondent submitted a
false notice of commencement, in violation of $$5, 8, 15(1)(B), and
15(3)(B), and the regulations codified at 40 C.F.R. 720.102.
5. One count of the Complaint alleged that Respondent failed to
provide a timely notice of commencement on or no later than 30 days
after commencement of commercial manufacture (import) of chemicals,
in violation of $5, 15(a)(l), 15(1)(C), 15(3)980, and the
regulations codified at 40 C.F.R. 720.102(b).
6. One count of the Complaint alleged that Respondent failed to comply
with a TSCA 5(e) Order, in violation of S5 and 15(1)(C), and the
regulations codified at 40 C.F.R.
7. One count of the Complaint alleged that Respondent failed to submit
a Manufacturer's Report-Preliminary Assessment Information for one
chemical substance, in violation of $8 and 15(3)(B), and the
regulations codified at 40 C.F.R. Part 712.20.
8. One count of the Complaint alleged that Respondent failed to submit
a Partial Updating of TSCA Inventory Data Production and Site
Report for eight chemical substances by the regulatory deadline, in
violation of $8 and 15(3)(B), and the regulations codified at 40
C.F.R. Part 710.23.
9. One count of the Complaint alleged that Respondent failed to submit
a 12(b) notice as required in violation of $12 and 15(3)(B), and
the regulations codified at 40 C.F.R. Part 707.60 and 707.65.
10. One count of the Complaint alleged that Respondent failed to
provide a certification statement to the district director at the
port of entry adequately representing the true compliance status of
a chemical substance, in violation of $13, 15(a)(l), and 15(30)(B),
and the regulations codified at 40 C.F.R. Part 707.20.
C. To avoid the disruption of orderly business activities and the expense
of protracted and costly litigation, Respondent, for purposes of this
proceeding: (1) admits that the EPA has jurisdiction over the subject
matter alleged in the Complaint; (2) admits the Findings of Fact and
Conclusions of Law in the Complaint and this Consent Agreement; and (3)
consents to the terms of this Consent Agreement and the Consent order.
D. Respondent now expressly waives its right to request a judicial or
administrative hearing on any issue of law or fact set forth in the
Complaint, including but not limited to its right under Section
16(a)(2)(A) of TSCA to request a hearing. Such waiver becomes
unconditional upon the Chief Judicial Officer's approval of this
consent agreement as indicated by his entry of the Consent Order
incorporated herein and made a part hereof.
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Chapter Six Example 6E-7
E. The terms of this Consent Agreement and Consent Order constitute a
settlement by EPA of all claims for civil penalties pursuant to Section
16(a) of TSCA for the violations of TSCA alleged in the Complaint,
Docket No. TSCA 92-H-01, which violations are incorporated by reference
in Sections II and III of this Consent Agreement. Compliance with this
Consent Agreement and Order shall not be a defense to any other actions
commenced pursuant to Federal laws and regulations administered by EPA,
and it is the responsibility of Respondent to comply with said laws and
regulations.
F. Through the execution of this Consent Agreement, Respondent certifies,
and EPA confirms, that with respect to the violations alleged in Counts
I through X of the Complaint, Howland Industries, Inc. is in full
compliance with TSCA Sections 4, 5, 8, 12 and 13 and the application
regulations.
II. EPA FINDINGS OF FACT
Paragraphs 1.through 97 of the Complaint, TSCA-92-H-01, are
incorporated herein by reference as EPA's findings of Fact in this matter.
III. EPA CONCLUSIONS OF LAW
EPA has concluded that the Findings of Fact described in Section II
above constitute violations of TSCA Sections 4, 5, 8, 12, and 13, 15(1)(B),
and 15(3)(B), 15 U.S.C. $$2603, 2604, 2607, 2611, 2612, 2614(1)(B) and
2614(3)(B), for which a penalty may be assessed pursuant to TSCA Section
16(a), 15 U.S.C. $2615(a).
IV. CIVIL PENALTY
A. Pursuant to EPA's TSCA Civil Penalty Policy (45 FR 59770 (1980)), the
TSCA Section 4 Enforcement Response Policy ("ER") ( ), the TSCA
Section 5 Enforcement Response Policy (June 8, 1989) and EPA's TSCA
Section 8, 12, and 13 ERP (May 15, 1987), EPA proposed in the Complaint
in this case a gravity-based civil penalty. Consistent with the
provisions of the TSCA Civil Penalty Policy and paragraph 2, page 19 of
the TSCA $ 5 ERP, Complainant has adjusted the gravity-based penalty
downward by 15% to reflect Tosoh's cooperation and good attitude in
expeditiously negotiating settlement of this 'case and respondent's
willingness to comply with terms of settlement described in Section V,
below. The adjusted gravity-based penalty is .
V. TERMS OF SETTLEMENT
A. Howland Industries agrees to payment of a civil penalty in the sum of
. Tosoh shall pay the civil penalty by forwarding a cashier's or
certified check within thirty (30) calendar days of Tosoh's receipt of
the executed Consent Order, payable to the order of the "Treasurer of
the United States of America". The check should indicate that it is
for "Howland Industries, Inc., TSCA Enforcement Action (TSCA 92-H-01)"
and should be mailed to:
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Chapter Six Example 6E-7
U.S. Environmental Protection Agency
Hearing Clerk
P.O. Box 360277M
Pittsburgh, PA 125251
B. To ensure a record of compliance with Paragraph V.A, Respondent shall
forward a copy of the check to EPA, in care of the following person:
Ms. Elizabeth Crowley
U.S. Environmental Protection Agency
Office of Compliance Monitoring
Case Support Branch
EN-342
401 M Street, S.W.
Washington, D.C. 20460
C. Respondent agrees to fully perform the settlement conditions as set
forth in paragraphs E, F, G and H below, and to pay to EPA as
provided in paragraph E, below. Respondent agrees that the full
balance of the $419,475 penalty will become immediately due in the
event that Respondent breaches this agreement either by failing to
fully perform the conditions or by failing to pay the as
directed.
D. TSCA Compliance Audit
Howland Industries agrees to conduct an internal audit to review and
report on Cargill's compliance with TSCA SS 4, 5, 8, 12, and 13. The
audit shall be conducted as follows:
1. Independent Third Party Auditor: Howland Industries agrees to hire
an independent auditor, expert in TSCA compliance matters, to plan,
supervise, and conduct this Compliance Audit in consultation with
Howland Industries employees, and in coordination with and through
Howland Industries employees, and in coordination with and through
Howland Industries counsel; and to prepare and submit all reports
required under paragraph V.F.3. of this Agreement. No later than
30 calendar days following the date of execution of the Consent
Order, Howland Industries shall notify EPA in writing of Howland
Industries choice of the independent third-party auditor. Howland
Industries agrees to provide EPA with sufficient information to
allow the Agency to judge the adequacy of the auditor's expertise
in TSCA compliance matters, and to include in its written agreement
with the auditor a provision requiring the auditor to prepare and
maintain contemporaneous records when conducting the audit at
Howland Industries facilities. EPA has the authority to approve or
disapprove Howland Industries choice of the independent third-party
auditor, but such approval shall not be unreasonably withheld.
Within 45 calendar days of the Agency's receipt of Howland
Industries notice of its choice of an auditor, EPA will respond in
writing to Howland Industries nomination. If EPA notifies Howland
Industries that its choice of an auditor is unacceptable, then
Howland Industries shall have an additional 30 calendar days to
nominate a different auditor, and provide the information required
by this paragraph. '
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Chapter Six Example 6E-7
2. Audit Initiation/Termination: The audit shall commence no later
than 30 calendar days following the date on which EPA approves
Howland Industries choice of the independent third-party auditor.
The audit shall be completed within 12 months of the date of
commencement.
3. Reporting Requirements: Cargill agrees to submit the following
reports during the course of the audit.
a. Initial report. The initial report shall be submitted within
30 calendar days of the commencement of the audit. The initial
report shall state the date of initiating of the audit, and
shall describe the records being audited and the procedures
employed to audit such records, and shall confirm that such
audit procedures will encompass all the records necessary to
comply with this Agreement.
b. Midcourse report. The midcourse report shall be submitted 180
calendar days after commencement of the audit. The midcourse
report shall provide a status report of Howland Industries
progress to date, a list of the products reviewed for TSCA SS
4, 5, 8, 12, and 13 applicability, and a summary of the
violations detected and the actions taken to remedy and
mitigate the violations.
c. Final report. The final report shall be submitted within 14
months following the commencement of the audit. The final
report shall provide in a cumulative fashion a list of the
products reviewed for TSCA applicability, and a cumulative
summary of all violations detected (including immediately
reportable events) and the actions taken to remedy and mitigate
the violations. The final report must also include a statement
signed by a responsible Howland corporate official certifying
that the audit has been conducted and is complete. One copy of
the final report shall be submitted to:
Ms. Elizabeth Crowley
U.S. Environmental Protection Agency
Office of Compliance Monitoring
Case Support Branch
EN-342
401 M Street, S.W.
Washington, D.C. 20460
4. Duty to mitigate: Howland agrees to mitigate potential violations
as specified below:
a. Potential PMN violations for substances that Howland is
currently manufacturing by submitting within 30 days of
discovery a PMN, low volume exemption application or polymer
exemption PMN in accordance with the low volume or polymer
regulations or policies in effect at the time of the discovery
and notifying the Agency of the first date of non-exempt
commercial manufacture.
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Chapter Six Example 6E-7
b. Potential PMN violations for substances for which Howland has
ceased manufacture by submitting within 30 days of discovery a
mock PMN, low volume exemption application or polymer exemption
PMN in accordance with the low volume or polymer regulations or
policies in effect at the time of the discovery and notifying
the Agency of the first date of non-exempt commercial
manufacture.
c. TSCA S 8(e) violations by submitting within 15 days of
discovery a TSCA S 8(e) report; and
d. TSCA S 5(e) or 5(f) violations by taking steps within 15 days
of discovery to enter into compliance and to ensure future
compliance.
5. Immediately Reportable Events: Certain TSCA violations, due to
their time-sensitive nature, will be considered Immediately
reportable Events of which EPA must be notified within 15 calendar
days of discovery and Howland must take immediate steps to remedy
or mitigate under Section V.F.4. Discovery of any of the following
acts or omissions during the period covered by the audit shall
constitute an Immediately Reportable Event:
Failure to submit a PMN for a nonexempt substance not on the
TSCA Inventory (1) which Howland has manufactured within two
years preceding the execution of this Consent Agreement and
which does not qualify as an exempt polymer under 40 C.F.R. §
723.250 or (2) is currently manufacturing;
Failure to submit a TSCA S 8(e) report; and
Violation of a TSCA S 5(e) or S 5(f) order for a substance
which Howland is currently manufacturing.
Howland Industries shall submit a written notice of each
Immediately Reportable Event discovered during the audit within 15
calendar days of the discovery. The notice shall describe the
nature and extent of the reportable event and indicate the steps
taken, or being taken by Howland Industries to remedy or mitigate
the violation.
6. Reporting Period: The purpose of the audit is for Howland
Industries to identify and settle all civil and administrative
claims and causes of action which, prior to the conclusion of the
audit, arose or could have arisen under TSCA in connection with
Howland Industries operations. Therefore, the time periods to be
covered by the audit will be based on the date when governing
regulations for each section of TSCA. first became effective. For
all other facilities, the time periods shall be as follows:
a. TSCA S 4: from November 23, 1984 through the date the Consent
Agreement is executed;
b. TSCA S 5: from October 16, 1979 through the date of the
Consent Agreement is executed;
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Chapter Six Example 6E-7
c. TSCA S 8(a): from November 19, 1982 through the date the
Consent Agreement is executed;
d. TSCA S 8(b): from January 1, 1978 through the date the Consent
Agreement is executed;
e. TSCA S 8(c): from November 21, 1983 through the date the
Consent Agreement is executed;
f. TSCA S 8(d): from October 4, 1982 through the date the Consent
Agreement is executed;
g. TSCA S 12: from October 16, 1979 through the date the Consent
Agreement is executed;
h. TSCA S 12: from October 16, 1979 through the date the Consent
Agreement is executed;
i. TSCA S 13: from October 1, 1983 through the date the Consent
Agreement is executed;
7. Stipulated Penalties: The stipulated penalties set forth below
shall apply to violations which are reported under this audit and
which are remedied. Once a violation is reported and remedied, the
stipulated penalty establishes the limit of Howland Industries TSCA
SS 4, 5, 8, 12, and 13 liability for all civil and administrative
claims and causes of action which arises or could arise regarding
that violation. EPA reserves its rights to take appropriate
enforcement action, under the applicable enforcement response
policy, for those TSCA violations not properly reported to EPA
under this audit, or for those violations reported under this audit
but which were not remedied within 30 calendar days of discovery.
Howland agrees to pay the following stipulated penalties:
a. Violations of TSCA SS 4, 5, 8, 12 and/or 13 (exclusive of TSCA
SS 5(e), 5(f), and 8(e) violations) shall be assessed on a per
chemical basis. The assessed penalty shall be $10,000 for each
chemical substance.
b. violations of TSCA SS 5(e) and 5 (f) shall be assessed on a per
order basis. The assessed penalty shall be $25,000 for each
order. Penalties assessed under this subsection are not
subject to the penalty cap described in subsection (e) below.
c. Violations of TSCA S 8(e) shall be assessed a penalty as a
single-day violation per study or reportable event in the
following manner: $15,000 per study or report involving
effects in humans, and $6,000 per study or report for any other
study or report submitted as TSCA Section 8{e) data.
d. Upon receipt of a PMN or mock PHN, or exemption application
required under Section V.F.4.a. or V.F.4.B., EPA agrees to
provide Howland with a written certification of the substance's
inventory status as a precondition to imposing the appropriate
stipulated penalty under Section V.F.7. of this Agreement.
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Chapter Six Example 6E-7
e. In any event, excluding the penalties imposed under subsection
(b) above, the total amount of stipulated penalties will not
exceed $1,200,000.
E. TSCA Seminars
Howland Industries agrees to conduct the following TSCA seminars:
1. Howland Industries will conduct for its employees a series of
education and training seminars, focusing upon TSCA compliance, EPA
TSCA policies, and implementation of the Company's TSCA Compliance
Procedures. Seminars will be completed according to the following
schedule, Day 1 being the first day after the effective date of the
Final Order in this matter:
Seminar #1 — completed by Day 180.
Seminar #2 — completed by Day 360.
At least thirty (30) calendar days before each of the two seminars
required by this provision, Canon will submit to EPA, for approval,
a detailed agenda for the upcoming seminar.
2. Howland Industries will sponsor a seminar on TSCA requirements for
the requested community. This seminar will be held no later than
two hundred and seventy (270) calendar days following the effective
date of the Final Order in this matter, unless Canon obtains
written consent from EPA to the contrary. Canon will submit to
EPA, for approval, its draft agenda and schedule for this seminar
at least thirty (3) calendar days prior to the seminar, but no
later than one hundred and fifty (150) calendar days following the
effective date of the Final Order in this matter.
3. Status Reports
With respect to the fulfillment of these Terms of Settlement,
Howland will submit to EPA periodic status reports which shall
include, but not be limited to: providing a list of attendees and
a written certification that the employee education and training
seminars required under Paragraph V.C.3. have been completed; a
complete report on the TSCA Seminar under Paragraph V.E. of this
Agreement, including summaries of the presentations of each of the
speakers, an attendance list, and such other information as Howland
deems appropriate. These reports shall be submitted according to
the following schedule, Day 1 being the first day after the
effective date of the Final Order in this matter:
Status Report #1 — provided by Day 75.
Status Report #2 — provided by Day 150.
Status Report #3 — provided by Day 225.
Status Report #4 — provided by Day 300.
Final Report — provided by Day 375.
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Chapter Six Example 6E-7
F. Howland Industries shall publish in a widely-circulated trade
journal for the fragrance industry an article on TSCA compliance,
particularly with regard to TSCA Sections 5 and 8. Howland
Industries shall submit a draft of the article for EPA's review and
comment no later than ninety (90) days after receipt of the
executed Consent Order. Upon completion of EPA's review. Howland
Industries shall submit the article for publication. Howland
Industries shall submit the article to the trade publication no
later than 30 days after EPA has returned the article to Howland
Industries. Within 30 days following publication of the article,
Howland Industries will submit a copy of the published article to
EPA.
VII. STIPULATED PENALTIES FOR NON-COMPLIANCE WITH
THE TERMS OF THE CONSENT AGREEMENT
If any of the following events occur, Cargill shall pay a stipulated
penalty in the amount prescribed below for each event. The stipulated
penalty will be waived only if Cargill's failure to perform the action in
question was the result of persons or events beyond the reasonable control
of Cargill, and Cargill provides notice of an expected delay at least three
calendar days prior to the date performance is required. If three calendar
days advance notice is not practicable under the circumstances, Cargill
shall provide such advance notice as is practicable under the
circumstances. Cargill's notice shall include an explanation of the steps
taken to avoid the delay and a new schedule for performing. The revised
schedule must be approved by EPA in writing, but such approval may not be
reasonably withheld.
A. If Cargill fails to take any of the actions required under this
Agreement other than those described in B&C below by the prescribed
deadlines, Cargill agrees to pay a $100 per day penalty. This penalty
applies to each prescribed deadline and will be imposed in addition to
all other applicable stipulated penalties.
B. If Cargill fails to complete the Compliance Audit within 12 months of
commencement of the audit, or fails to submit the final report within
14 months of commencement of the audit, then Cargill agrees to pay a
civil penalty of $10,000 per month or any portion of a month. If
Cargill fails to take any of the actions required under Section V.F.4
or V.F.5 of this Agreement by the prescribed deadline, Cargill agrees
to pay a $1,000 per day penalty.
C. Failure to hold the TSCA Seminar within the time period specified in
Paragraph V.E. above: $1,000 for each calendar day that the completion
of the Seminar is late.
D. Failure to submit to EPA a draft agenda and schedule for the TSCA
Seminar within the time period specified in Paragraph V.E. above: $100
for each calendar day that the draft agenda and schedule are late, up
to the date of completion of the TSCA Seminar.
E. Failure to conduct each of the two employee education and training
seminars within the time periods specified in Paragraph V.C.3. above:
$500 for each calendar day that completion of each seminar is late.
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F. Failure to submit to EPA a detailed agenda for each of the two employee
education and training seminars within the time periods specified in
Paragraph V.C.3. above: $50 for each calendar day that the agenda is
late, up to the date of completion of the seminar.
G. Failure to submit to EPA Status Reports numbered one (1) through four
(4) within the time periods specified in Paragraph V.G. above: $100
for each calendar day that each of the Reports is late, up to the due
date of the next such Report.
H. Failure to provide to EPA a Final Report within the time period
specified in Paragraph V.G. above: $100 for each calendar day up to
fifteen (15) that the Report is late; and thereafter, $250 for each
calendar day that the Report is late.
VI. OTHER MATTERS
A. Nothing in this Consent Agreement and Consent Order shall relieve
Howland Industries of the duty to comply with all applicable TSCA
regulations or other applicable environmental statutes.
B. The penalty specified in Paragraph IV.A., above shall represent a civil
penalty assessed by EPA and shall not be deductible for purposes of
Federal taxes.
C. This Consent Agreement shall be binding upon the Parties to this
action, their officers, directors, employees, successors and assigns.
The undersigned representative of each Party to this Consent Agreement
certifies that he or she is duly authorized by the Party whom he or she
represents to enter into the terms and bind that Party to it.
D. This Consent Agreement shall take full effect upon the signing of the
Consent Order by EPA's Chief Judicial Officer or his designated
representative.
E. Howland Industries' obligations under this Consent Agreement shall end
when it has paid the settlement amount and any stipulated penalties in
accordance with the Consent Agreement and Consent Order.
F. All of the terms and conditions of this Consent Agreement together
comprise one Agreement, and each of the terms and conditions is in
consideration for all of the other terms and conditions. In the event
that this Consent Agreement (or one or more of its terms and
conditions) is held invalid, or is not executed by all of the signatory
parties in identical form, or is not approved in such identical form by
the EPA's Chief Judicial Officer or his designated representative, then
the entire Consent Agreement shall be null and void.
G. Failure to remit the civil penalties provided herein will result in
this matter being forwarded to the U.S. Department of Justice for
collection of the amount due, plus stipulated penalties and interest at
the statutory judgment rate provided for in 28 U.S.C. S 1961 as in
effect on the date of execution of the Consent Order.
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Example 6E-7
WE AGREE TO THIS:
For Complainant:
For Respondent:
Michael F. Wood, Director
Compliance Division
Office of Compliance, Monitoring
Sanaa S. Howland
President, Howland Industries
Michael J. Walker
Enforcement Counsel for Pesticides
and Toxic Substances
Office of Enforcement
Robert D. Fentress, Attorney
Toxics Litigation Division
Office of Enforcement
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6E-86
Guidance Manual 1992
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CERTIFICATE OF SERVICE
I do hereby certify that the foregoing "Consent Agreement and Consent
Order", In the Matter of Howland Industries, Inc., Docket No. TSCA-92-H-01,
was filed and copies of the same were mailed to the parties as indicated
below:
(Interoffice) Robert D. Fentress, Esq.
Toxics Litigation Division (LE-134P)
Office of Enforcement
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
(Certified Mail) Ms. Sanda Howland, President
Howland Industries, Inc.
8513 Louisiana Heron Drive
Ashland, Wisconsin 00576-4532
Bessie L.Hammiel,Hearing Clerk
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Dated:
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Chapter Six Example 6E-8
Sample Consent Order
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
In the Matter of: )
Howland Industries, Inc.) Docket No. TSCA-92-H-01
Respondent. )
CONSENT ORDER
The United States Environmental Protection Agency ("EPA" or the
"Agency") as Complainant, and Howland Industries, Inc., of Ashland
Wisconsin having signed and consented to the entry of the Consent Agreement
hereto attached and incorporated by reference into this Consent Order,
NOW, THEREFORE, IT IS ORDERED THAT:
1. Respondent Howland Industries, Inc. shall comply with all terms of
the Consent Agreement.
2. Respondent is assessed a civil penalty of , and
3. Respondent shall, within thirty (30) calendar days of the date of
this Order, forward a certified or cashier's check, payable to the
order of the "Treasurer of the United States of America", in the
amount of to:
U.S. Environmental Protection Agency
Hearing Clerk
P.O. Box 360277M
Pittsburgh, PA 15251
IT IS SO ORDERED.
Date Ronald L. McCallum
Chief Judicial Officer
U.S. Environmental Protection
Agency
Washington, D.C.
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Chapter Six
5 Prehearing Exchange
PREHEARING CONFERENCE
When a hearing is ordered, the Presiding Officer orders a preheating conference, unless it
appears unnecessary. Prehearing conferences are intended to facilitate and expedite the hearing.
The prehearing conference may involve: 22.19(a)
• Settling the case;
• Attempting to simplify the proceeding through consolidation of issues and stipulation
by the parties;
• Amending the pleadings;
• Exchanging information concerning evidence to be presented (e.g., identities of
expert witnesses and summaries of their testimony and exchange of exhibits,
documents, and prepared testimony);
• Limiting the number of witnesses;
• Setting a time and place for the hearing; and
• Attending to any matter that may expedite the disposition of the proceeding.
Prehearing Exchange
The Consolidated Rules of Practice requires that the parties exchange witness lists, brief
descriptions of witness testimony, and copies of all documents and physical materials that will
be introduced into evidence. This requirement supports the accepted manner of hearings-one
that is forthright and avoids surprise. 22.19(b)
The CDO and Counsel are jointly responsible for ensuring that:
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• All exhibits and witnesses are identified in a timely manner before the prehearing
exchange;
• The witnesses and exhibits are prepared for the hearing; and
• The CDO is prepared to testify regarding the size of the penalty.
Amendment of the Prehearing Exchange
A party must request the permission of the Presiding Officer to amend the prehearing exchange
or to introduce a witness or a document during a hearing if that party did not exchange this
information prior to the hearing. If such permission is granted, the Presiding Officer must first
allow the other party a reasonable time to review the newly introduced evidence.
Role of Discovery
The Consolidated Rules of Practice do not create any right to discovery other than the prehearing
exchanges described above. However, the presiding officer may allow other discovery, such
as depositions. To obtain such discovery, a party must make a motion for discovery to the
Presiding Officer which demonstrates that the: 22.19(f)
• Proceeding will not be unreasonably delayed by discovery;
• Information sought cannot be obtained through alternative means; and
• Information sought is of significant probative value. 22.19(0(1)
If the discovery involves oral depositions, then a party must also show that the evidence will not
be preserved for presentation by a witness. 22.19(f)(2)
If an order for discovery issued by the Presiding Officer is not obeyed, the inference may be
drawn that revealing the withheld information would be adverse to the party withholding it. An
order for default may be issued based on a failure to comply with a prehearing or hearing order.
22.19(0(4), 22.17(a)
An order for discovery is filed with the Hearing Clerk, and copies are served in accordance with
requirements of Section 22.06 of the Consolidated Rules of Practice.
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Record of Proceedings
A transcript of a prehearing conference is generally not made, although the Presiding Officer
can order that the conference be recorded. The Presiding Officer may summarize the issues
discussed and any decisions made during the Prehearing Conference. Prehearing conferences
for the purpose of settlement are not recorded as they are confidential. This ensures that the
parties are able to negotiate freely. 22.19(c)
A transcript is usually made of the entire hearing.
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6 Hearing Process
The Presiding Officer convenes a hearing on request by the respondent or, if appropriate, sua
sponte if the matter has not yet been disposed. For TSCA penalty actions, the Presiding Officer
is one of the Agency Administrative Law Judges. The Presiding Officer is assigned the case
when the respondent files an answer. 22.21
The hearing transcript together with all exhibits, documents, and rulings filed in the case
constitute the "record." The Presiding Officer's decision will be based on evidence in the
record, and only evidence in the record can be considered.
NOTICE OF HEARING AND VENUE
If the respondent requests a hearing or if a hearing is ordered by the Presiding Officer, the
Presiding Officer must issue to all parties a notice of hearing, which identifies the time, date,
and place for the hearing. This usually is done in consultation with the parties. Such notice
must be issued at least 20 days before the date set for the hearing 22.21(b). The hearing may
be held:
• In the county where the respondent resides or conducts the business which the
hearing concerns;
• In the city in which the relevant EPA Regional Office is located;
• In Washington, D.C.; or
• In another location if the Presiding Officer determines that there is good cause to do
so.
Any party may make a motion for postponement of the hearing but the movant must demonstrate
good cause for the request. 22.21(c)
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PRESENTATION OF EVIDENCE AT THE HEARING
"Burden of Presentation" and "Burden of Persuasion" are legal terms used in the Consolidated
Rules of Practice to describe the evidentiary obligations of the parties in the hearing 22.24. The
definitions are as follows:
• Burden of Presentation (Burden of Going Forward With the Evidence)~A party must
introduce evidence to support the allegations or defenses raised in the complaint or
answer.
• Burden of Persuasion—Each party must convince the Presiding Officer of the
affirmative allegations in his or her pleading.
As the moving party and complainant, the Agency is the first to present evidence. The
complainant must establish a prima facie case; that is, the complainant must submit evidence that
the events alleged in the complaint did occur, that the events constitute a violation of the Act,
and that the proposed civil penalty is appropriate. After the complainant has established a prima
facie case, the burden of presentation shifts to the respondent who must then present a defense
to the allegations in the complaint 22.24. The burden of persuasion never shifts, but remains
with the complainant throughout the proceeding; that is, the complainant always has the
obligation of convincing the Presiding Officer, by a preponderance of the evidence, of the
allegations contained in the complaint. The respondent has the burden of presentation with
respect to any affirmative defenses raised in the answer. The burden of presentation now shifts
back to the Agency once the respondent has introduced sufficient evidence to support a favorable
finding to rebut the complainant's case.
PREPONDERANCE OF EVIDENCE
Each matter that is contested in the hearing is decided by the Presiding Officer on the basis of
a preponderance of the evidence. To prevail, a party must convince the Presiding Officer that,
on balance, his or her allegations appear more likely or probable than the other party's
allegations. This standard is different from a criminal standard which requires proof of evidence
"beyond a reasonable doubt." 22.24
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HEARING RULES OF EVIDENCE
Under the Consolidated Rules of Practice, the Presiding Officer must admit all evidence that is
not:
• Irrelevant;
• Immaterial;
• Unduly repetitious;
• Unreliable; or
• Of little probative value. 22.2(a)
When in doubt, the Presiding Officer will admit the evidence.
Confidential Information
The Consolidated Rules of Practice state that confidential business information (CBI) may be
introduced as evidence. The Presiding Officer considers such evidence in a closed hearing or,
in extreme cases, in camera. The Presiding Officer will prepare a confidential copy of the initial
decision which addresses questions concerning that portion of the evidence that is CBI. 22.22(a)
For confidential commercial information, the complainant should be aware that TSCA Section
12 and 5 U.S.C. §1901 prohibit the disclosure of such information by a government official.
(See also, Chapter 2, Section 4.)
Materiality and Relevancy
Two standards described in the Consolidated Rules of Practice concern materiality and
relevancy. Materiality and relevancy are legal terms; previous cases should be consulted to
determine how these terms have been treated by the Agency. Federal case law should also be
consulted. 22.22(a)
• Materiality. Material evidence is evidence that is pertinent to or has a legitimate and
effective bearing on the case. For example, the evidence relating to the status of an
officer within a corporation may be material to proving that he or she knowingly
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violated TSCA by manufacturing a certain chemical substance. The officer's status
within the local church, however, is not likely to be material.
• Relevancy. Evidence that is material may or may not be relevant. Relevant
evidence is evidence that has a tendency to make a fact in issue more probable or
less probable. The emphasis is on the probative value of the evidence. The
probative value of the offered evidence is assessed in light of the facts in issue. For
example, to prove that a reporting violation has occurred, evidence demonstrating
that a particular EPA report was prepared but not sent would surely be relevant. In
contrast, evidence that the firm generally failed to maintain good business records
might still be considered material but is less likely to be considered relevant .or
probative.
Although materiality and relevancy have technical distinctions, in general both standards apply
to the probative value of the evidence. If an item of evidence has probative value to the issue
for which it is introduced (i.e., it tends to prove or disprove a particular proposition), then both
criteria are satisfied.
Evidence Relating to Settlement
Evidence relating to settlement is excluded under the Consolidated Rules of Practice. This
evidence may only be admitted to prove bias of a witness or disprove a contention of undue
delay.
Testimony of Witnesses 22.22(b), 22.22(d)
Witnesses are examined orally upon oath or affirmation. The Presiding Officer, however, may
allow certain narrow exceptions to this rule (e.g., an affidavit from a dying witness). Any
witness appearing at the hearing may be cross-examined.
Verified Statements in Lieu of Direct Testimony 22.22(c)
In lieu of direct testimony, a party may ask the court to admit previously prepared statements
of fact or opinion. Such a request may be appropriate when the testimony is technical or
academic and does not lend itself to a clear, cohesive presentation through direct questions. This
type of evidence can be admitted only upon the approval of the Presiding Officer.
A copy of any written statement should be submitted to the Presiding Officer, reporter, and
opposing counsel before it is delivered. The evidence contained in the statement is subject to
the same rules of testimonial evidence that apply to oral testimony (e.g., the witness must swear
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to or affirm the truth of the statement and is subject to oral cross-examination concerning the
statement). 22.22(c)
Affidavits in Lieu of Direct Testimony 22.22(d)
When a witness is "unavailable," as defined by Rule 804(a) of the Federal Rules of Evidence,
an affidavit may be admitted into evidence in lieu of oral testimony. Under Rule 804(a),
witnesses are deemed unavailable if they are exempt by a court order, refuse to testify in spite
of a court order, claim lack of memory, are dying or physically impaired, or are absent despite
efforts to secure their attendance.
Exhibits and Physical Evidence 22.22(e)
If exhibits are introduced, the original and one copy must be filed with the Presiding Officer
where practicable. A true copy of any exhibit may be substituted for the original if submitting
the original is not possible. Copies must be furnished to each party.
Official Notice 22.22(f)
The Presiding Officer may take "official notice" of any matter judicially noticed in the federal
courts, of matters permitted under Rule 201 of the Federal Rules of Evidence, and of other facts
that are within the specialized knowledge and experience of the Agency. Official notice may
be sua sponte or upon motion by one of the parties.
Official notice is limited to facts that are not subject to reasonable dispute and that are:
• Generally known within the territorial jurisdiction of the proceeding; or
• Capable of accurate and ready determination.
Official Notice under the Consolidated Rules of Practice is broader than that permitted by Rule
201 of the Federal Rules of Evidence because the Presiding Officer may take official notice of
facts that are within the specialized knowledge and experience of the Agency. Consequently,
official notice extends to all matters about which the Agency is presumed expert.
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SUBPOENAS AND SUMMONING WITNESSES
Issuance of Subpoenas
.The Presiding Officer may issue a subpoena to require the attendance of witnesses or the
production of documentary evidence. The Presiding Officer may also grant a request for a
subpoena upon a showing by the movant of:
• The grounds and necessity of the evidence or witness; and
• The materiality and relevancy of the evidence or witness sought. 22.33(b)(l)
A request for the production of documents must describe the evidence sought as specifically as
practicable. 22.33(b)(l)
Subpoenas are served in accordance with Section 22.05(b)(l) of the Consolidated Rules of
Practice. 22.33(b)(2)
Witness Fees
Witnesses summoned by subpoena before the Presiding Officer are paid the same fees and
mileage as witnesses in the courts of the United States. The fees are paid by the party who
requested the witness's appearance. If the witness appears pursuant to a request initiated by the
Presiding Officer, the fees are paid by the Agency. 22.33(b)(3)
EXPERT WITNESSES
Administrative, civil, and criminal enforcement actions sometimes require the presentation of
expert testimony on behalf of the Agency. Witnesses should be chosen for their direct
knowledge of the circumstances surrounding the suspected violation. Below are some guidelines
to aid the EPA attorney in choosing witnesses for judicial proceedings.
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Headquarters Witnesses
Many of the records pertaining to, and technical experts with knowledge of, regulations
concerning chemical substances or mixtures are located within the Office of Pollution Prevention
and Toxics at Headquarters. Witnesses from the Office of Pollution Prevention and Toxics are
available to testify on:
• Whether a chemical substance or mixture is subject to TSCA;
• Technical data and studies relating to the health and environmental effects of a
chemical substance or mixture; and
• The significance of a discrepancy as it relates to the sample's chemical composition
or toxicity.
Regional Witnesses
Technical experts in the Regions will generally testify as to:
• Inspection procedures and the facts and findings surrounding an investigation; and
• Programmatic procedures such as inspection schemes, penalty calculations, TSCA
violations, etc.
Other Government Witnesses
EPA personnel often work with other federal government personnel in developing casework,
either through interagency agreements (lAGs) or memoranda of understanding (MOUs). Other
government employees of agencies such as the Food and Drug Administration may be called
upon to testify concerning:
• Test procedures, findings, and conclusions related to chemical device studies; and
• Information collected during an investigation but referred to EPA for enforcement.
Contractor Witnesses
Expert witnesses will occasionally have to be utilized under contract to testify as to:
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Test procedures, findings, and conclusions related to chemical or other scientific
studies they have conducted; and
Technical matters for which there are no Agency experts available for testimony.
PROCEDURES FOR REQUESTING WITNESSES FROM HEADQUARTERS
Example 6E-5 provides guidance on the Procedures for Requesting Witnesses from
Headquarters.
APPEARING AS A WITNESS
Vigorous enforcement programs will increase the probability that an inspector will be called
upon to testify in court. By the time a case has entered the judicial system, inspectors and case
development personnel will have invested many hours in developing a sound program for
prosecution. When a witness is called to testify, it is imperative that quality testimony is
provided and a professional image is projected in the courtroom.
A witness, to be effective, must make statements that are understandable and must have them
accepted as truth by the judge or jury. In addition to being truthful and honest, a witness's
principal aim should be to make a favorable impression on the court. The guidelines presented
in this section will help prepare the witness to be effective and credible.
Personal Appearance and Conduct
Dress is important. A well-groomed, neatly attired witness makes a more favorable impression
in the courtroom. Conduct should reflect the solemn nature of the judicial proceedings. In
order that a witness present the appropriate image, the following should be kept in mind at all
times.
Go to the courtroom prepared; be thoroughly familiar with your facts, and check pertinent times
and dates. Order all documents and exhibits so that testimony will be presented without
fumbling. Be on time when court opens and be available immediately when called to testify.
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In addition, as a witness you should try to avoid:
• Doing anything that may attract attention to you. Make yourself as inconspicuous
as possible;
• Sitting in groups of more than two or three colleagues. Spread out in the courtroom;
• Whispering or talking to another person or causing any disturbance in the courtroom;
• Showing incredulity or surprise at any testimony given from the witness stand or at
statements made by the defense attorney. Avoid expressing approval or disapproval
of any testimony by nod, glance, or other gesture;
• Having anything in your mouth (such as gum, toothpick, tobacco, candy, or food);
• Sitting within the enclosure unless instructed to do so;
• Discussing the case with the defendant or the defending attorney;
• Discussing the case where anyone might overhear;
• Consulting with case personnel while court is in session, unless directed to do so;
and
• Holding conversations with principals or witnesses for the opposing side. If
conversations are unavoidable, confine remarks to matters other than the trial.
Witness Stand Technique
When called to the witness stand, unless previously swom, go directly to the desk of the Clerk
of the Court to be sworn. Take the oath in a solemn manner. Then proceed to the witness
chair. If you have a long or unusual name, give a card or paper with the correct spelling to the
court stenographer. Assume and maintain proper posture, bearing, and demeanor. Sit erect,
but do not appear stiff or tense. Attempt to project an image of poise and self-control.
Speaking
Speak in a clear, distinct, and well-modulated voice. When addressing a jury, look at and speak
distinctly to them. Speak loud enough so that the farthest juror can hear you.
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Use simple language. If the subject is technical or scientific, reduce the terminology to an
understandable level or give definitions of terms used. Avoid idioms or language particular to
your profession or to the Agency.
Notes
You may bring notes with you to the witness stand. However, do not bring your field notebook
or any other documents you do not want the opposing side to examine. They have a right to see
any notes you bring to the witness stand.
Do not hesitate to ask permission to refer to your notes when testifying, provided your notes
were made at the time of, or immediately after, the event about which you are testifying. You
should not be embarrassed if you cannot recall exact details without referring to your notes. Try
not to read long passages verbatim from your notes.
Answering Questions
Wait until a question is asked in its entirety before beginning to answer. Never attempt to
answer a question you do not fully understand. Ask that the question be repeated or rephrased
if its meaning is not clear. If you do not know the answer to a question, say so. Do not try to
cover up a lack of knowledge of a particular subject.
Questions should be answered verbally—do not nod assent or shake your head. Answer only the
questions asked and answer it fully and to the point without volunteering information. Do not
"spar" or attempt to match wits with the questioning attorney.
Be truthful, and answer all questions frankly, factually, and confidently. Try to limit your
testimony to those facts about which you have first hand knowledge. Anything else may be
considerably hearsay. Do not exaggerate; state the facts accurately.
Do not express opinions or conclusions unless you are testifying as an expert witness. You
cannot assume expert knowledge in a field unless you are an expert by reason of your training
and experience. If questioned on a subject beyond your scope, admit that the subject is outside
your field or knowledge.
Try not to become listless or "deadpan" in your effort to appear impartial and unbiased. Be
natural, candid, frank, and "alive." Conversely, you should not appear impatient or overly
anxious to testify. Attempt to minimize nervous tendencies, such as arranging clothes, notes,
etc.
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Do not speak to the judge unless he or she asks you a question.
Testifying Under Direct Examination
In a proceeding arising out of an Agency judicial enforcement action, direct or re-direct
examinations will generally be conducted by an EPA attorney or a United States Attorney. The
initial questions he or she will ask will seek to establish:
• Your identity, occupation, and qualifications; and
• The relevancy of your testimony to the proceedings.
Subsequent questions will allow you to relate your testimony to the court. In order to facilitate
this questioning, you should:
• Try to give testimony in chronological order. Reveal your first connection with the
case. Then give facts in the order they occurred. Your testimony should be
memorized, if possible.
• If the opposing attorney objects to a question, do not try to get in an answer before
the judge has ruled whether the question is proper.
• Do not try unnecessarily to help the questioning attorney. He will ask additional
questions to bring out further details to complete your testimony.
• Be able to identify the defendant.
Testifying Under Cross-Examination
Cross-examination is the questioning of witnesses by attorneys representing the opposing side.
Under cross-examination you may be subjected to vigorous questioning.
Do not be afraid to admit that you discussed your testimony with government attorneys. There
is nothing improper in a practical discussion of your testimony with the attorneys.
The opposing counsel may attempt to intimidate you by attacking your veracity and integrity,
by making uncomplimentary references to your qualifications or length of service, or by
emphasizing errors you have made. Remain calm and answer any question asked unless an
objection is raised and sustained. If the opposing counsel attempts to confuse you with rapid
questions, answer the questions deliberately and at a comfortable pace. Ask the attorney to
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repeat or rephrase any question that is unclear or confusing. If asked double or "two-pronged"
question, ask the attorney to restate it, or carefully answer each part separately.
Wait several seconds before you answer a question put to you in cross-examination in order to
give the government attorney an opportunity to object. Avoid, however, undue delays in
answering. If an objection has been raised, do not answer any questions until a ruling on the
objection has been made.
Do not lose your patience or temper while testifying. A cross-examining attorney often will
deliberately bait an irascible witness to anger the witness. Try to remain calm and unruffled.
Do not become argumentative with the cross-examiner if your testimony is interrupted or for any
other reason. Beware of questions to which the cross-examiner demands a yes or no answer if
such an answer will not reveal the entire truth. These are often leading questions. If a simple
yes or no does not properly answer the question, inform the cross-examiner that the question
cannot be so answered. If the cross-examiner should misquote any of your earlier testimony,
you may correct the misquote before answering the question.
If you make an error while testifying, correct it at the first opportunity. If you discover the
error after you have completed your testimony and have been dismissed, discuss the matter with
the government attorney.
You may be asked whether you regard certain persons in the field about which you are testifying
as recognized authorities. This is often preparatory to asking you whether you agree with
certain statements that those authorities have made. If your answer is no, that you do not
recognize them as authorities, that line of cross-examination cannot be pursued. Unless you
definitely have heard of the named persons and are familiar with their works and do recognize
them as authorities, do not expose yourself by saying that you so recognize them.
Proper Conduct During Recess and After the Trial
During recess, continue to maintain the same demeanor as in the courtroom. Do not engage in
loud conversation or joking, especially about the proceedings. Be as discreet as possible when
making any comments that might be overheard.
After the trial, continue to conduct yourself in a manner that will bring credit to you and to the
Agency. Make no public display of elation or disappointment over the outcome of the trial. If
there is occasion to speak to the defendants, be courteous regardless of their demeanor.
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Chapter Six Hearing Process
OBJECTIONS AND RULINGS
Procedural objections may be stated orally during the hearing or made in writing. The form of
the objection depends on the circumstances. In general, if the objection involves a relatively
complicated argument, it should be written. If written, it must comply with the service, filing,
and content requirements specified by Section 22.05 of the Consolidated Rules of Practice.
22.23(a)
Rulings and Exceptions to Rulings
The Presiding Officer must rule on all objections and provide reasons for the rulings, on the
record. Copies of the ruling must be served on the parties by the Presiding Officer and the
original entered into the Regional Hearing Clerk's file in accordance with Section 22.06 of the
Consolidated Rules of Practice. Under Consolidated Rules of Practice, exception to an overruled
objection is automatic and is not waived by further participation in the hearing. 22.23(a)
Appeal of Ruling
A ruling on an objection is not subject to an automatic interlocutory appeal to the Administrator.
A party wishing to appeal the ruling immediately must take a motion in writing within six days
of notice of the ruling to the Presiding Officer to certify such a ruling to the Administrator. (See
also, "Appeals of Interlocutory Orders or Rulings" in this section.)
Unlike other motions made during a hearing, a request for certification of an appeal may not be
made orally, but must be made in writing. 22.29(a)
OFFERS OF PROOF
If evidence is found to be immaterial, irrelevant, etc. and cannot be introduced, the party
seeking to introduce it may not only object to its exclusion, but may also make an offer of proof.
An offer of proof places the evidence into the official record, and the Administrator on appeal
can consider such evidence. This offer consists of:
• One copy of the documentary or physical evidence; or
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Chapter Six Hearing Process
• A brief written summary, if the evidence is testamentary.
Such offers of proof are not mandatory, and the right to appeal the exclusion of evidence is
preserved under Section 22.23(a). Nonetheless, offers of proof should generally be made
whenever evidence is excluded. 22.23(b)
TRANSCRIPT OF HEARING
A hearing is transcribed verbatim, and the court reporter must send the original and copies of
the transcript to the Regional Hearing Clerk for filing. A copy is also sent to the Presiding
Officer. The Regional Hearing Clerk must notify all parties of the availability of the transcript
and permit them to obtain a copy upon payment of a reproduction fee. Payment may be waived
if a party can show that the cost is unduly burdensome. A certificate of service should
accompany each copy of the transcript (except for CBI portions of the transcript) upon payment
of a reproduction fee. 22.25
The transcript of the hearing is an important document because:
• The Presiding Officer's decision is based solely on the testimony given and evidence
introduced during the hearing;
• Many objections and motions made during the hearing are oral and are thus reflected
only in the transcript; and
• The transcript is used by the parties to draft the proposed findings of fact,
conclusions of law, and orders, which are then submitted to the Presiding Officer for
consideration in issuing the initial decision.
THE TRIAL BRIEF
At the conclusion of the hearing, the Presiding Officer orders the parties to submit proposed
findings of fact, conclusions of law, and orders to the Presiding Officer for consideration in
issuing the initial decision along with a trial brief.
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Chapter Six Hearing Process
The purpose of the proposals and supporting briefs is to allow the parties to argue their positions
and to persuade the Presiding Officer to adopt the proposals they each put before the court.
Procedures
The proposed findings of fact, conclusions of law, and orders, together with supporting briefs,
must be submitted to the Presiding Officer for consideration within 20 days of notice'of the
transcript's availability. The proposals and briefs must be served on the other parties. All briefs
must be in writing and must contain adequate references to the record and authorities relied on.
22.26
Preparation of Brief
In preparing the brief, the focus should be on issues that the Presiding Officer must address in
the initial decision.
The importance of the proposals and briefs cannot be overemphasized.
Initial Decision
The Presiding Officer must issue an initial decision as soon as is "practicable" after the period
specified for filing reply briefs to the proposed findings, conclusions of law, and orders.
The initial decision should contain the Presiding Officer's:
• Findings of fact and conclusions for all material issues of law or discretion;
• Reasons for those findings and conclusions;
• Recommended civil penalty; and
• Proposed final order.
Penalties
In determining the dollar amount of the civil penalty assessed in the initial decision, the
Presiding Officer must consider, in addition to the criteria listed in Section 16(a)(2)(b) of TSCA,
the guidelines for the assessment of civil penalties under TSCA. 22.35
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Chapter Six Hearing Process
Specific reasons must be set forth in the initial decision if the Presiding Officer increases or
decreases the amount of penalty from that originally assessed in the complaint. The Presiding
Officer, however, cannot increase the amount of penalty from that which was recommended in
the complaint if the respondent has defaulted.
Challenge to Initial Decision
The initial decision becomes a final order within 45 days after it is served unless:
• A party files a motion to reopen the hearing, which stops the 45-day period until the
motion is denied or the reopened hearing is concluded; or 22.28
• A party makes an appeal to the EAB or the EAB determines sua sponte that a review
of the initial decision is appropriate. 22.27
MOTION TO REOPEN A HEARING
If a party believes that additional evidence should be introduced into the record, that party may
make a motion to reopen the hearing. Such a motion must be made no later than 20 days after
service of the initial decision on the parties. The motion to reopen the hearing must state the
specific grounds upon which relief is sought, state the nature and purpose of the evidence to be
adduced, and show that the evidence is not merely cumulative. The party must also show good
cause why the evidence was not introduced at the hearing. The motion must be written and must
comply with the requirements specified for such motions and the filing, service^ and content
requirements for submitting documents. 22.28(a)
Replies from other parties must be made within 10 days after the motion is served. The
Presiding Officer must render a decision on the motion as soon as is practicable after the filing
of replies. 22.28(b)
Filing a motion to reopen a hearing automatically stays the running of all time periods (e.g.,
appeals) until such time as the motion is denied or the reopened hearing is concluded. 22.28(b)
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Chapter Six Example 6E-9
Procedures for Requesting Witnesses from Headquarters
1
* UMTTlOSTATlSiNVmONMIKTALWOTlCnOHAOlMCY
SUBJECT: Procedures for Requesting Witnesses Prom Headquarters
FROM: Jesse Baskerville, Acting Direcao«L
Compliance Division ??•?(•
TO: Regional Division Directors
The purpose of this memorandum is to re-establish procedures
for obtaining Headquarters witnesses in CAMS involving
violations of TSCA, FX7RA, SPOU, AHEM and B«xaval«nt Qxromiu».
Racontly, requests for Hsadquartsrs vitnsssss from tbs regions
nav* bean going to offices other than OCX. Because of this,
there have been delays in providing the regions with the
necessary personnel to testify on their behalf.
Past guidance, such as the 1M4 TSCX CoBpliance/Znforceaent
Guidance Manual and the 1983 FXTXA CaBplianee/Cnforceaent
Guidance Manual established guidance for obtaining Headquarters
witnesses in support of regional cases. This past guidance
directed the regions to submit their requests to oof. At this
tiae, Z SB requesting that all witness requests be made in
writing to the appropriate Case support Branch Begienal
Coordinator. (See attached Regional Coordinator list.) These
requests should provide a background of the case, and illustrate
in detail what areas the witness needs to testify on. These
requests should be received by the OCX coordinator as soon as the
region is aware of the scheduling of the trial, and no later than
20 working days prior to the date the witness is expected to
testify. The OCX coordinator will, in turn, arrange for the
proper witness to represent your region in court, and will
provide you with a status report on their availability.
In the future, this guidance should also be followed when
iquarters witnesses for EPOtA, AHERA and Hexavalant
> If you have any questions concerning these
», please contact me at PTS 3S2-7H3 or Sanaa Rowland of
my staff. She can be reached at TK 3S2-4S44.
:: Regional Branch Chiefs
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Chapter Six Example 6E-9
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Chapter Six
7 Appeals
Immediately Appealable Orders 22.29
The only orders or rulings that may be appealed directly to the Environmental Appeals Board
(EAB) as a matter of right without certification are:
• Accelerated decisions that decide the entire case;
• Dismissal orders;
• Default orders; and
• Initial decisions rendered after an evidentiary hearing.
All other orders or rulings issued by an Agency official during the prehearing and hearing
proceedings are considered interlocutory. As such, they must await the issuance of an initial
' decision before they can be appealed, unless the Agency official issuing such orders or rulings
certifies them to the EAB on appeal.
Actions by the Environmental Appeals Board 22.29(c)
If the Presiding Officer certifies the interlocutory appeal, the EAB may:
• Deny the certification as improvidently granted;
• Take no action within 30 days and thereby dismiss the certification; or
• Grant the certification, review the interlocutory appeal, and grant or deny the appeal
on its merits.
Ordinarily, the interlocutory appeal will be decided on the basis of the submissions made by the
Presiding Officer. The EAB may, however, allow further briefs and oral argument.
Request for Stay 22.29(d)
The motion for interlocutory appeal may include a request for stay of the proceeding pending
the EAB decision on the certification and interlocutory appeal. The request must demonstrate
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Chapter Six Appeals
that extraordinary circumstances exist to justify granting the stay. If the Presiding Officer grants
a request for stay of over 30 days, it must be separately approved by the EAR.
APPEAL OF INITIAL DECISION
Jurisdiction of Administrator
The initial decision of the Presiding Officer becomes the final decision of the Administrator .45
days after the initial decision is issued, unless an appeal is taken by a party or the EAB elects
to review the initial decision sua sponte. Once the initial decision is issued, the Regional
Hearing Clerk's file, which now includes the original initial decision, is forwarded to the
Headquarters Hearing Clerk. Consequently, the parties must send any notice of appeal and
accompanying appellate brief to the Headquarters Hearing Clerk.
If, however, a party files a motion to reopen a hearing, the Presiding Officer may rule on that
motion. A motion to reopen a hearing, however, must be filed with the Regional Hearing Clerk.
22.27(a), 22.30(a)
Notice of Appeal and Appellate Brief
The notice of appeal and appellate brief must comply with the general filing, service, and form
requirements of the Consolidated Rules of Practice where appropriate. The notice of appeal and
the appellate brief must be filed with the Headquarters Hearing Clerk within 20 days after the
initial decision is served on the parties. 22.30(a)(l)
The notice of appeal must set forth the disputed findings of fact and conclusions of law contained
in the initial decision. Specifically, it must contain:
• Alternative findings of fact;
• Alternative conclusions regarding issues of law or discretion;
• A proposed order that reflects the conclusions and findings desired by the appellant;
and
• Relevant references to the record and the initial decision. 22.30(a)(l)
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Chapter Six Appeals
The appellate brief presents the appellant's arguments as to why the appeal should be granted.
As such, it should include:
• A statement of issues presented for review;
• A statement of the nature of the case;
• Identification of the facts that are relevant to the issues presented for review;
• Specific argument on the issues presented;
• A short summary that includes the precise relief being sought; and
• Appropriate references to the record and the initial decision.
Reply Brief 22.30(a)(2)
Any other party or amicus curiae may file a reply brief with the Hearing Clerk within 15 days
of service of a notice of appeal and appellate brief. The reply brief is specifically intended to
address only the appellate brief and should be so limited. Therefore, it should respond to the
argument raised by the appellant and contain references to the relevant portions of the record,
initial decision, or appellate brief. The reply brief must also comply with service, filing, and
content requirements specified by the Consolidated Rules of Practice.
Environmental Appeals Board's Action 22.30(b)
Even if the initial decision is not formally appealed, the EAB may determine sua sponte that a
review of the initial decision is necessary within 45 days of service of the initial decision. If the
EAB determines to review the initial decision sua sponte. the Hearing Clerk shall serve notice
of such intention upon the parties. The notice includes a statement of the issues to be briefed
by the parties and a time schedule for the service and filing of briefs.
Scope of Review 22.30(c)
The appeal of the initial decision may only cover those issues raised by the parties in the
previous proceeding.
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Chapter Six Appeals
Oral Argument on Appeal 22.30(d)
Oral argument on appeal is not automatic and may be granted only if a party makes a request
to the EAB or the EAB orders it sua sponte. In assigning a time and place for oral argument,
the EAB must consider the convenience of the parties. No standards are specified in the
Consolidated Rules of Practice for deciding whether oral argument should be heard and it is
rarely done.
FINAL ORDER
Timing and Content
The EAB is required to issue a final order as soon as practicable after the final action of the
appeal process-either after filing of appellate briefs, filing of subsequent briefs if ordered by
the EAB, or oral argument, whichever occurs last. 22.31
In the final order EAB may:
• Adopt, modify, or set aside all or some of the findings and conclusions contained in
the initial decision or order; and
• Increase or decrease the recommended penalty unless the initial decision is a default
order (in which case the EAB may not increase the recommended penalty).
The Consolidated Rules of Practice require the final order to contain the reasons for any decision
that the EAB makes.
Motion to Reconsider and Stay Request 22.32
A party may file a motion to reconsider a final order within 10 days after service of the final
order. A motion to reconsider must set forth the matters claimed to have been erroneously
decided and the nature of the alleged errors. The motion may also include a request that the
final order be stayed pending a resolution of the motion to reconsider. Unless such a request
for stay is granted, the effective date of the final order is the date on which it was issued, unless
otherwise ordered by the EAB.
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Chapter Six Appeals
Appeal From Final Order
The Respondent may appeal the findings of the final order to the United States Court of Appeals
for the District of Columbia pursuant to the provisions of Section 16(d)(3) of TSCA. The
obligation to pay the civil penalty does not become due until the party has exhausted all appeals.
Because the complainant is bound by decisions of the Administrator and his or her delegates,
the complainant cannot appeal a decision of the EAB.
PAYMENT OF PENALTY
The civil penalty specified in a final order of the EAB is due and payable in full within 60 days
after the respondent receives the final order, unless otherwise agreed to by the parties. 22.31(b)
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Chapter Seven
Judicial Enforcement: Civil Actions
CHAPTER CONTENTS PAGE
1 Introduction 7-1
2 Evidence to Support a Civil Action 7-3
Injunction and In Rem 7-3
3 Referring Judicial Actions 7-9
Example 7E-1: Model Civil Litigation Report Outline and Guide 7-11
4 Injunctive Relief 7-19
Procedures for Seeking Injunctive Relief 7-19
Follow-up to Granting Motions for Injunctive Relief 7-23
Example 7E-2: Model Motion for Temporary Restraining Order (TRO) 7-24
Example 7E-3: Model Motion for Preliminary Injunction 7-25
Example 7E-4: Model Affidavit in Support of Motion for Preliminary Injunction 7-26
Example 7E-5: Model Motion for Permanent Injunction 7-27
Section 7 In Rem Action 7-28
Section 17(b) In Rem Action 7-29
Procedures for Initiating an In Rem Action 7-29
Compliance with a Seizure Order 7-30
Example 7E-6: Model Complaint In Rem 7-31
5 Settlement Agreements 7-33
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Chapter Seven Contents
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Chapter Seven
1 Introduction
Under TSCA, regulatory remedies are primarily handled through administrative actions.
However, when EPA is unable to obtain compliance through an administrative actions or in
those cases involving imminently hazardous chemical substances or mixtures, TSCA authorizes
EPA to seek relief through injunction or in rem ("the thing") proceedings.
An injunction is an order issued by a court which forbids or directs a person to do or not to do
something specific. Injunctions involve the equity power to the federal courts and are generally
viewed as an extraordinary form of relief. Consequently, they are not readily granted and a
party seeking injunctive relief has a heavy burden in demonstrating the need for such action.
Generally an injunction is used to preserve the status quo, the situation as it exists, until a full
evidentiary hearing can be held. Injunctions can be permanent or temporary.
An in rem (seizure) proceeding is one taken against property rather than against a person, and
has as its objective the disposition of property.
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Chapter Seven Introduction
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Chapter Seven
2 Evidence to Support Civil Actions
INJUNCTION AND IN REM
Civil judicial actions require supportive evidence that goes beyond the prima facie evidence
necessary to establish a violation of TSCA. In some instances the Agency may use expert
witnesses to establish the necessary elements of proof. These actions may consist of permanent
injunctions, preliminary injunctions, or temporary restraining orders. These types of injunctions
are discussed in more detail in Section 4 of this chapter.
Evidence in Injunctive Actions
Issuance of a preliminary injunction or temporary restraining order requires the plaintiff to show
that:
• Immediate and irreparable injury, loss, or damage will result if the relief is not granted;
and
• There is a likelihood of success at trial, based on facts before the court.
Traditionally, courts have required the petitioner or plaintiff to make the following evidentiary
showing. The Court will issue a permanent injunction if the plaintiff presents evidence that:
• There is an inadequate remedy at law;
• The applicable administrative remedies have been exhausted; and
• Irreparable injury, loss, or damage will result if the relief is not granted.
The above criteria are not uniform in all of the judicial districts. Some jurisdictions have
emphasized different aspects of the criteria, while other courts have developed alternative tests
that use some, but not all, of the elements listed above. For example, recent court decisions
have indicated a relaxation in the requirement of irreparable injury. In particular, where a
statute prohibits certain conduct, many courts will presume the conduct to be injurious, [see
Bradford v. SEC. 278 F.2d (9th Cir. I960)].
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Chapter Seven Evidence to Support Civil Actions
Section 17(a) Injunctions
Criteria for Use
Injunctive relief authorized by Section 17(a) of TSCA, which is the most common form of
judicial relief sought, should be considered when there is a need to:
• Restrain any violation of Section 15 of the Act. The violations specified by Section 15
include:
~ Failure or refusal to comply with any rule promulgated or order issued under
Section 4, any requirement prescribed by Section 5 or 6 of TSCA, or any rule
promulgated or order issued under Section 5 or 6,
~ Use, for commercial purposes, of a chemical substance or mixture that such person
knew or had reason to know was manufactured, processed, or distributed in
commerce in violation of Section 5 or 6 of TSCA, a rule or order under Section 5
or 6, or an order issued in an action brought under Section 5 or 7,
- Failure or refusal to establish or maintain records; to submit reports, notices, or
other information; or to permit access to or copying of records, as required by
TSCA or its rules, and
- Failure or refusal to permit entry or inspection as required by Section 11 of TSCA;
• Restrain any person from taking any action that is prohibited by Section 5 or 6 of
TSCA or by a rule or order issued under those sections;
• Compel the taking of any action required by or under the Act; or
• Direct any manufacturer or processor of a chemical substance or mixture manufactured
or processed in violation of Section 5 or 6 or a rule or order under Section 5 or 6 and
distributed in commerce to:
- Give notice of such fact to distributors in commerce and (to the extent that they can
be reasonably ascertained) other persons who possess or may be exposed to the
chemical substance or mixture,
— Give public notice of such risk of injury, and
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Chapter Seven Evidence to Support Civil Actions
~ Either replace or repurchase the chemical substance or mixture.
The general requirements mentioned above for obtaining injunctive relief apply primarily to
injunctions sought under the authority of Section 17(a) of TSCA. Notwithstanding the above
criteria, injunctions based on Sections 5(e), 5(0, and 7 of TSCA require the following
evidentiary showings:
Section 5fe):
• The information available to the Administrator, submitted in accordance with Section
5, is insufficient to permit a reasoned evaluation of the human health and environmental
effects of a chemical substance subject to premanufacture notification and either:
~ The manufacture, processing, distribution in commerce, use, or disposal of such
substance may present an unreasonable risk of injury to human health or the
environment, or
- The chemical substance is or will be produced in substantial quantities, and such
substance either enters or may reasonably be anticipated to enter the environment
in substantial quantities or there is or may be significant or substantial human
exposure to the substance; and
• The Administrator has not issued a proposed order under Section 5(e) with respect to
the chemical substance, or the Administrator issued such an order, however, the order
does not take effect because objections were filed pursuant to Section 5(e)(l)(C).
Section 5(f):
• There is a reasonable basis to conclude that the manufacture, processing, distribution
in commerce, use, or disposal of the chemical substance subject to the notice
requirement of Section 5(a) presents or will present and unreasonable risk of injury to
human health or the environment before a rule promulgated under Section 6 of the Act
can protect against such risk.
Section 7:
• The manufacture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture is likely to result in imminent and unreasonable risk of serious or
widespread injury to human health or the environment; and
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Chapter Seven Evidence to Support Civil Actions
• Such injury is likely to occur before a final rule under Section 6 of TSCA can protect
against such risk.
A Section 7 injunctive action may seek such temporary or permanent relief as may be necessary
to protect human health or the environment from the unreasonable risk associated with the
chemical substance, mixture, or article involved in the action. If the injunctive action is brought
against a person who manufactures, processes, or distributes in commerce an imminently
hazardous chemical substance or mixture or an article containing such a substance or mixture,
the action may include the issuance of a mandatory order requiring:
• In the case of purchasers of such a substance, mixture, or article known to the
defendant, notification to such purchasers for the risk associated with it;
• Public notice of such risk;
• Recall;
• Replacement or repurchase of such a substance, mixture, or article; or
• Any combination of the above actions.
Concurrent with the filing of a Section 7 civil action or soon thereafter as may be appropriate
and where practicable, the Administrator must initiate a Section 6(a) rulemaking proceeding.
Section 7 civil actions may be commenced notwithstanding the existence of a rule under Section
4, 5, r 6 or an order under Section 5, and notwithstanding the pendency of any TSCA
administrative or judicial proceeding.
In Rem (Seizure Actions)
The following evidentiary showing should be met before undertaking an in rem (seizure) action
under Section 7(a) or 17(b) of TSCA:
Section 7(a):
• The chemical substance or mixture is imminently hazardous; and
• The imminently hazardous chemical substance or mixture, or article containing such
substance or mixture, is found within the jurisdiction of the district court that will hear
the action.
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Chapter Seven Evidence to Support Civil Actions
Section
• The chemical substance or mixture was manufactured, processed, or distributed in
commerce in violation of TSCA or any rule promulgated or order issued under the Act;
and
• The chemical substance or mixture, or article containing such substance or mixture, is
found within the jurisdiction of the district court that will hear the action.
As in the case of administrative actions, civil judicial proceedings may require the presentation
of expert testimony by EPA personnel appearing as witnesses. Such testimony will establish
certain elements of proof that justify the relief sought such as the showing of immediate and
irreparable injury for obtaining an injunction. Witnesses are selected for their direct knowledge
of the circumstances surrounding the suspected violation, and they will testify based on such
knowledge to the court.
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Chapter Seven Evidence to Support Civil Actions
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Chapter Seven
3 Referring Judicial Actions
The Department of Justice generally represents EPA in judicial court actions. Section
5(e)(2)(A)(i), 5(f)(3)(A)(ii), and 7(e) of TSCA permit EPA attorneys to appear and represent the
Administrator .in such actions authorized by these sections. However, under the current EPA
delegations of authority, only Section 7 actions may be initiated without first referring the case
to the Department of Justice.
The Assistant Administrator for OE (or the Assistant Administrator's delegatee) refers requests
for TSCA civil actions to DOJ or the appropriate United States Attorneys Office. The Regional
Office has independent authority to refer requests for emergency temporary restraining orders
under TSCA to the DOJ and the appropriate United States Attorneys Office. When exercising
this authority, however, the Regional Administrator must notify the Assistant Administrator for
OE and the Assistant Administrator for Prevention, Pollution, and Toxic Substances (or their
designees). The lead attorney is responsible for preparing the "referral package," which, upon
completion, is sent from the Regional office to OE. A copy of the package should also be
forwarded to Headquarters OCM.
The referral package to DOJ contains:
• Referral Memorandum. A referral memorandum identifies the primary elements of the
proposed litigation. Specifically, the memorandum must include:
~ Identification of the potential defendants;
~ Brief factual summary of the case;
- Identification of major issues (including potential problems that may exist with the
case);
— Status of past Agency enforcement efforts; and
— Names of Agency and Department of Justice attorneys who are involved in the case,
including the lead attorney.
• Civil Litigation Report. In addition to the referral memorandum, the referral package
must contain a litigation report prepared by the designated lead EPA attorney. (See
Exhibit 7-1 for a complete outline and guide to preparing the report.) The report
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Chapter Seven Referring Judicial Actions
includes a synopsis of the facts and history of the violation. The report must cite the
specific sections of TSCA and its regulations that have been violated.
The report must show that all elements of proof of the violation have been satisfied and
indicate the supporting evidence. A copy of the necessary documentary evidence and
a summary of the expected expert testimony should be attached to the litigation report.
The lead attorney should state the specific relief to be sought (e.g., injunctive or inrem
action). The report should also list any equities that may weigh against granting the
relief sought by EPA; any expected defenses by the violator and how they will be
countered; and any past, anticipated, or pending state or federal actions (administrative
or judicial) against the violator. The report should state the likelihood that the violator
will not comply without the imposition of an injunction and why the attorney has
reached this conclusion.
Once the referral package is received by Headquarters, Enforcement Counsel attorneys will
conduct a limited final legal review to ensure completeness and consistency in application of
enforcement policy. The case will then be transmitted to the Department of Justice or the
appropriate United States Attorneys Office. OE will notify the Regional Administrator and the
Assistant Administrator for Prevention, Pollution, and Toxic Substances (or their designees)
upon the transmittal of the civil referral.
Following the referral of a case, the lead EPA attorney will be responsible for coordinating
responses to all requests for supplemental information by the Department of Justice or the United
States Attorneys Office. The lead Agency attorney also will be responsible for keeping program
officials and other previously involved Agency attorneys apprised of case developments after
referral.
The documents contained in EPA'S General Enforcement Policy Compendium to which
reference should be made are:
• Memorandum of Understanding Between the Department of Justice and the
Environmental Protection Agency (6/15/77);
• Quantico Guidelines for Enforcement Litigation (4/8/82);
• General Operating Procedures for EPA's Civil Enforcement Program (7/6/82); and
• Case Referrals for Civil Litigation (9/7/82).
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Chapter Seven Example 7E-1
Model Civil Litigation Report Outline and Guide*
Title Page
A. Identify the facility by name and location and indicate the parent
company if different from the facility name.
B. Identify who prepared the report (both legal and technical personnel)
indicating addresses and telephone numbers.
C. Show the date of completion/submission of the report.
Table of Contents (Standardized Example!
I. Information Identifying the Defendant(s) Page
II. Synopsis of the Case Page
III. Statutory Authority Page
IV. Description of Defendant's Business and Technical
Description of the Pollution Source Page
A. Facility Description Page
B. Source of Pollution Page
C. Pollutants Involved; Environmental Harm
(Where Appropriate) Page
D. Available Control Technology and/or Remedial Page
Action
V. Administrative and Enforcement History Page
The Model Civil Litigation Report Outline and Guide is to be used
for all Agency civil referrals to the Department of Justice. Civil
litigation reports, however, are most frequently used in referring
civil court actions under statutes other than TSCA. Therefore,
certain sections of the report would not need to be as detailed as
those prepared for referrals involving non-TSCA violations. For
example, since TSCA referrals involve only requests for injunctive
or in rem relief, civil penalties would not need to be discussed in
Section VII of the report (Relief Requested).
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Chapter Seven Example 7E-1
VI. Required Elements of Proof and Evidence Page
A. Elements of Proof Page
B. Evidence of Violation Page
C. Evidence of Environmental Harm (Where Appropriate) Page
D. Discovery Page
E. Evidence Favorable to Violator Page
F. Government Witnesses Page
G. Defense Witnesses Page
H. Resource Needs Page
VII. Relief Requested Page
A. Preliminary Injunction . Page
B. Standards to be Met Page
C. Compliance Schedule Page
D. Stipulated Contempt Fines Page
E. Civil Penalties Page
F. Necessary Bonds Page
VIII. Anticipated Issues Page
A. Possible Defenses Page
B. Equitable Arguments Page
C. Pending Related Administrative or Court Action Page
D. Other Issues Page
E. Discussion of any Potential Practical Problem
with the Case Page
IX. Litigation Strategy Page
A. Need for Preliminary Injunction Page
B. Potential for Summary Judgment Page
C. Settlement Potential Page
D. Other Potential Defendants Page
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Chapter Seven Example 7E-1
X. Index of Attachments Page
XI. Attachments Page
• Copies of correspondence
• Copies of relevant regulated submissions
• Copies of relevant policy memos, regulations, interpretations
Body of the Report
I. Information Identifying the Defendant(s)
A. Legal name of company
B. Address: Corporate headquarters
C. Name of facility (if different from "A")
D. Address of facility (if different from "B")
E. SIC code
F. State of incorporation
G. Registered agent for service
H. Legal counsel (name, address, telephone number)
I. Judicial district in which violator is located
J. EPCRA TRI Status
II. Synopsis of the Case
This section should be a one- or two-page articulation of the heart
of the case. It should describe both the violation and the proposed
relief. It should not describe statutory authority or intricate
legal issues in detail.
This succinct statement of the case will provide the reader a
framework in which to fit the details developed and presented in the
body of the litigation report.
The factual basis of the case should be touched upon. Purely
conclusory characterization of the case is not as useful as showing
the facts of a violation and requested relief. For example, it is
better to say a violator discharged or emitted X quantity of Y
pollutant for Z days, then to simply say that the violator did not
comply with the terms of a permit, State Implementation Plan (SIP),
or statute.
The environmental seriousness of the violation, its ongoing nature,
and a violator's recalcitrance may be touched upon in this section
(but will also be developed later in paragraph IV(C)).
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Chapter Seven . Example 7E-1
III. Statutory Authority
A. Present the substantive requirement of the law and applicable
regulations. Reference all federal statutes by U.S.C. citation
as well as by section of the pertinent Act. Summarize the
enforcement authority, jurisdiction, and venue. Specific
elements of proof are to be addressed in paragraph VI.
B. Lengthy dissertation on the law is unnecessary. Pertinent
excerpts from any applicable state laws or regulations should be
identified and attached to the litigation report.
C. Any prior interpretation of pertinent state laws or regulations
which are germane to the case should be referenced when
identifying the law violated. If a state's interpretation of
the law has been different from ours, the issue should be
discussed with the state and fully explained in this section of
the litigation report. (This section may then be referenced
when discussing potential defenses, etc., in paragraph VIII.)
D. List any other possible theories of violation under federal,
state, or common law.
IV. Description of the Defendant's Business and Technical Description of
the Pollution Source
A. Describe the violating corporation and the particular division
or facility in question. Any interesting corporate
interrelationships or subsidiaries should be noted.
B. Discuss the business of the corporation and/or division,
providing details about the facility in question, what is
produced, and what causes the pollution. Emphasis should be on
the particular process that is causing the problem. Plant and
process should be thoroughly explained, including those outfalls
or emission points not subject to this enforcement action.
Diagrams should be referenced and attached to, or included in,
the litigation report. Photographs of the source may be
helpful.
C. Discuss the types of pollutants being discharged, and potential
health and environmental effects. Although the seriousness of
the violation is not technically a requirement of proof in
enforcement of certain statutes, it is sometimes relevant to the
assessment of penalties and equitable relief. For this reason,
it should be discussed in the report although it will not be the
sole determinant of whether a case has prosecutorial merit. The
Department of Justice has suggested the following considerations
in assessing the seriousness of the violation:
TSCA Case Proceedings 7E-14 Guidance Manual 1992
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Chapter Seven Example 7E-1
• The discharge of toxics or mutagens or carcinogens is more
serious than the discharge of conventional pollutants;
• The discharge of large quantities of pollutants is more
important than the discharge of small quantities;
• Bioaccumulative wastes posing long-term threats are more
serious than biodegradable wastes;
• The discharge of pollutants in an area not attaining primary
ambient air quality standards is more important than
discharges in an area not meeting secondary standards;
• The discharge of pollutants that directly and demonstrably
affect health or the environment is more than those that have
no direct or obvious effect;
• Ongoing present violations that the Government seeks to stop
are more important than episodic violations which have
ceased; and
• A defendant with a history of violations is more worthy of
attention than a first offender.
If a case does not present obvious "serious" health effects or
environmental harm', but is compelling for some other reason
(e.g., deterrence of continued, blatant violations of the law),
this should be indicated.
D. Discuss available methods of controlling the problem. Specify
technology(s) that will achieve the imposed limits, and indicate
the time requirements for a schedule or compliance which
considers time necessary for design, contracting, construction,
and startup. (This is not inconsistent with EPA policy of not
prescribing specific compliance technologies. This information
may be necessary in court to illustrate technical feasibility if
requested by the judge.)
Cost estimates should be included, to the extent known.
Indicate the reliability of the estimates. (Reference paragraph
VII(E) as appropriate.)
V. Chronological Administrative History and/or Earlier Enforcement
Actions (State and Federal)
A. Show all attempts to exact compliance or impose sanctions
administrately or judicially that have been considered or taken.
A full historical chronology should be presented.
B. Indicate whether necessary notice pursuant to the statutory
requirement has been given to the violator prior to initiation
of court action.
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Chapter Seven Example 7E-1
VI. Required Elements of Proof and Evidence
A. List the necessary elements of proof to establish the violation
under each statute involved.
B. - Present a detailed, objective, factual analysis of all real,
documentary, and testimonial evidence corresponding to each
necessary element of proof in paragraph VI(A) above.
Indicate the location of all real evidence.
Reference each item of documentary evidence as an attachment,
except where it is too voluminous (in which case indicate its
present location).
Identify all witnesses by name (indicating whether lay or
expert), when indicating the import and substance of their
testimony. Complete addresses and phone number of witnesses
will be listed in paragraph VI(E) below.
C. Discovery. Where evidence may be made available by discovery,
indicated:
1. The type of evidence anticipated;
2. The person or organization currently having the evidence;
and
3. The type of discovery to be used.
Assess the quality of the evidence. Be objective. Any facts or
circumstances that affect the strength of the Agency's proof
should be explicitly set forth. The newness or oldness of
evidence is relevant; the dependability of testing techniques is
important. Any assumptions, and the reasons for them, should be
spelled out.
D. If establishing environmental harm is important to the case, set
forth the evidence of harm (as done in paragraph VI(B) for
elements of substantive violation).
E. List all evidence favorable to the violator, including test
results that differ from EPA's. Any relevant fact that may bear
adversely on the Government's contentions should be highlighted.
Defense witnesses, to the extent they can be anticipated, should
be listed in paragraph VI(G).
F. List all government witnesses alphabetically with business
address, and telephone number and home phone number.
Qualifications of experts should be given.
All witnesses listed should have been consulted and thoroughly
interviewed. Paragraph VI(B) should set out in succinct fashion
the actual facts and opinions to be included in the testimony.
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Chapter Seven Example 7E-1
G. List all defense witnesses anticipated, identifying their
employment, expertise, etc. The likely content of their
testimony should be set out in paragraph VI(E).
H. Indicate projected resource needs (e.g., experts, money, etc.).
VII. Relief Requested
This paragraph should include a comprehensive "bottom-line"
settlement position on all items of relief necessary, including
those set forth below. If there are policy questions or conflicts
associated with any requested relief, discuss them. This section
should be carefully detailed. It will be relied upon in determining
the acceptability of any settlement offers/proposed consent decrees.
A. Preliminary injunction.
B. Standards to be met (interim and final).
C. Compliance schedule for available technology with phasing,
duration, etc. (Reference paragraph IV(D), as appropriate.)
D. Stipulated contempt fines in conjunction with compliance
schedule.
E. Civil penalties.
1. Economic savings realized by the violator should be
analyzed. The EPA Civil Penalty Evaluation form should be
completed, discussed, and attached. Calculations should be
included as attachments. This section should include
discussion of all elements developed under EPA's civil
penalty policy, including ability of the company to pay and
recalcitrance.
2. Comment on types of credits possible (or proposed by the
violator), as well as credits considered and/or allowed for
other similar violators (including municipal POTWs).
3. If economic savings is not a relevant measure of penalty
assessment, explain what basis should be used.
F. Necessary bonds.
Witnesses necessary to establish the relief requested should be
identified by name, address and telephone number, with a brief
summary of the subject of their testimony.
VIII. Anticipated Issues
A. Possible defenses.
(Analyze only defenses that are likely to be presented; fanciful
theories can be ignored.)
TSCA Case Proceedings 7E-17 Guidance Manual 1992
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Chapter Seven Example 7E-1
1. Outline legal issues. Attach legal memoranda on threshold
legal issues (e.g., Chapter 11 Reorganization) or collateral
legal action asserted as a bar to enforcement litigation.
2. Outline factual issues.
B. Equitable arguments by the violator.
(e.g., EPA delay in promulgating guidelines; installation of
equipment that did not work; in compliance at its other
facilities; emission standard to be revised; inability to
finance; economic constraints, etc.)
Any past action, or inaction, (not necessarily judicial or
administrative) by a state or any EPA office that the company
may use as an excuse, or cite for reliance. (e.g., promises of
less stringent limits; agreement not to sue, etc.).
C. Pendency of any action involving the violator or EPA on related
issues in any court or administrative forum. (Reference
paragraph V(A), as necessary.)
D. Other possible issues that might arise at trial.
E. Discuss any potential practical problems with the case.
IX. Litigation Strategy
A. Need for preliminary injunction.
B. Potential for summary judgement.
C. Settlement potential.
1. Past contacts by EPA, the Department of Justice or the
United States Attorneys Office.
2. Present negotiating posture and assessment of potential for
settlement. Include comparison of posture with "bottom-
line" settlement position from paragraph VII.
D. Other potential defendants.
E. Other pending actions against violator.
X. Index of Attachments
XI. Attachments
TSCA Case Proceedings 7E-18 Guidance Manual 1992
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Chapter Seven
4 Injunctive Relief
PROCEDURES FOR SEEKING INJUNCTIVE RELIEF
Determine the Necessity for Injunctive Relief
• Regional Initiation. The Regions generally make the initial determination that an
injunction is necessary to restrain violations of TSCA or to prevent harm to humans or
the environment. The regional determination must be based on a careful weighing of
the facts of the violation, of the evidence available to document the severity of the
violation, and of the criteria discussed above.
• Headquarters Initiation. In some instances, Headquarters may be the initiating party
when noncompliance with the terms of the statute exists on a national level, or the
hazard to human health or the environment is of national significance (e.g., Section 7
injunctions).
Determine Type of Injunction to be Sought
• Temporary Restraining Order (Exhibit 7-2). A temporary restraining order (TRO),
sometimes known as a provisional injunction, is used for immediate temporary relief
prior to issuance of a preliminary injunction, or unless otherwise permitted by statute.
For example, issuance of a TRO may be warranted when:
~ A situation exists that justifies the use of a Section 7 civil action to prevent the
unreasonable risk of an imminent hazard before a final Section 6 rule can protect
against such risk; or
— Under a Section 5(e) or 5(f) injunctive proceeding, where the notification period
under Section 5(a), (b), or (c) may expire before the judicial proceeding is
completed.
The purpose of the TRO is to preserve the status quo until a motion for a preliminary
injunction can be heard. Its advantage is that it is the most expediently obtained form
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Chapter Seven Injunctive Relief
of injunctive relief. However, a TRO is limited in duration to only 10 days (although
it can be extended an additional 10 days by the court).
Rule 65(b) of the Federal Rules of Civil Procedure (Fed. R. Civ. P.) controls the
procedural steps for obtaining a TRO. Generally the attorney for the adverse party, if
known (or if not known, the adverse party itself), must be given oral or written notice
of the request for a TRO. This requirement, however, is suspended if (1) it is shown
by specific facts that immediate and irreparable harm will occur before the adverse
party can be heard and (2) if the government attorney certifies in writing the efforts,
if any, taken to provide notice to the adverse party and the reasons supporting the claim
that notice should not be required. The facts demonstrating immediate and irreparable
injury, loss, or damage, may appear either in a verified complaint or in a separate
affidavit signed by an EPA employee other than the attorney for the case. Along with
the motion for a TRO, a copy of the suggested TRO should be filed.
When a TRO is granted without notice (i.e., ex parte). the motion for a preliminary
injunction must be set for hearing at the earliest possible time. The party who obtained
the TRO must then proceed with the application for a preliminary injunction and if the
party does not do so, the TRO will be dissolved by the court. If a defendant moves to
modify or dissolve a TRO, there must be a hearing and the Agency must be informed
at least two days before the hearing.
Preliminary Injunction (Example 7E-3). A preliminary injunction by its very nature is
interlocutory, provisional, or temporary. It is intended to preserve the status quo
pending final determination of the action after a full hearing on the merits. It is
different from a TRO in that a preliminary injunction requires advance notice to the
adverse party, and it can last longer than 10 days.
Notice presumes a hearing and an opportunity to contest the motion for an injunction.
The applicant has the burden of establishing the right to injunctive relief. To do so, it
is advisable to rely on more than affidavits (Example 7E-4) whenever possible. Oral
testimony should be available when and if necessary to substantiate the Agency's
contentions.
The court may order the advancement and consolidation of the trial on the merits with
the hearing on the application for preliminary injunction. Consequently, the
government attorney should be prepared to go forward with the prosecution of the case
when seeking a preliminary injunction.
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Chapter Seven Injunctive Relief
• Permanent Injunction (Example 7E-5). A permanent injunction, also called a final or
perpetual injunction, is generally unlimited in duration. It is usually granted only after
a full trial on the merits. Consequently, the judgement granting a permanent injunction
constitutes final disposition of the suit, although the judgement may be appealed to a
circuit court.
Mere passage of time will not dissolve a permanent injunction, unless the judgment
itself so provides. However, the prospective features of a final injunctive decree are
subject to termination or modification by the court when warranted by changed
conditions. For example, under Section 5(e)(2)(D) of TSCA, a district court, upon
petition, will dissolve a Section 5(e) injunction if test data is submitted that is sufficient
to evaluate the human health and environmental effects of the chemical substance
subject to the injunction unless the Administrator has initiated a proceeding for the
issuance of a rule under Section 6(a) respecting the substance. If such a proceeding has
been initiated, the court will continue the injunction until the effective date of the rule
or, if the proceeding is terminated without the promulgation of a rule, upon termination
of the proceeding.
Determine the Appropriate District Court Having Jurisdiction
The Regional Office must determine which is the appropriate district court having jurisdiction
over the violator. An injunction operates in personam (meaning "against the particular person"),
so that the district court in which the motion is filed must have in personam jurisdiction over
the party against whom the injunction is sought. Usually this means that the person or
corporation who is the defendant must live or have a place of business within the state.
Furthermore, service of process, or the delivery of written notice, is subject to the territorial
limits of the state in which the district court is located unless otherwise provided for in a statute.
In some instances, an injunction may have an in rem ("against the thing") effect on property or
items that are the subject of the suit or that are within the court's in_rem jurisdiction. In rem
jurisdiction may have a broader reach for serving process than does in personam-it is easier to
get "the thing" than it is "the person." These possibilities should be explored informally with
the appropriate U.S. Attorney before formal referral of the case file.
The following specific jurisdictional requirements apply to injunctions sought under Sections
5(e), 5(f), 7 and 17(a) of TSCA:
• Section 5(e) and 5(f) Injunctions. Injunctive actions that are based on Sections 5(e) and
5(f) of TSCA may be filed in:
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Chapter Seven Injunctive Relief
- The United States District Court for the District of Columbia; or
— The United States district court for the judicial district in which the manufacturer
or processor of the chemical substance subject to the action is found, resides, or
transacts business.
• Section 7 Injunctions. Injunctive actions that are based on Section 7 of TSCA may be
filed in:
— The United States district court for the District of Columbia; or
— The United States district court for the judicial district in which the manufacturer
or processor of the chemical substance subject to the action is found, resides, or
transacts business.
According to Section 7(c)(l)(A), process in a Section 7 injunctive action may be served
on a defendant in any other district in which such defendant resides or may be found.
However, Section 7(c)(l)(B) states that in instances in which the action may be brought
in more than one judicial district, the Administrator is to take into account the
convenience of the parties. Subpoenas requiring the attendance of witnesses may be
served, pursuant to TSCA Section 7(c)(l)(C), in any judicial district.
According to Section 7(c)(2), whenever proceedings involving identical chemical
substances, mixtures, or articles are pending in two or more district courts, they are to
be consolidated for trial upon application reasonably made by any party in interest and
upon notice to all parties in interest.
• Section 17(a) Injunctions. Injunctive actions that are based on Section 17(a) of TSCA
differ on their filing location depending upon the nature of the activity that is the
subject of the action:
— If the injunctive action involves a violation of Section 15 of the Act, the action must
be filed in the United States district court for the judicial district in which the
violation occurred or where the defendant is found or transacts business; or
~ If the injunctive action involves any other activity specified by Section 17(a), the
action must be brought in the United States district court for the judicial district in
which the defendant is found or transacts business.
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Chapter Seven Injunctive Relief
Process may be served on a defendant in any judicial district in which the defendant
resides or may be found, and subpoenas requiring the attendance of witnesses at trial
may be served in any judicial district.
Prepare the Referral Package
See discussion in "Referring Judicial Actions" (Section 3) in this chapter.
FOLLOWUP TO GRANTING MOTIONS FOR INJUNCTIVE RELIEF
If an injunction is granted, the following actions should ensue:
• Preparation for the Next Stage of the Proceeding. If the court grants a motion for a
preliminary injunction or TRO, the regional attorney in conjunction with the U.S.
Attorney must begin preparation for the next stage in the proceeding, whether that be
a full trial on the merits or a more extensive and permanent type of injunction.
• Monitoring the Injunction. Although it is the court's responsibility to monitor any
equitable decree, including an injunction, the courts have limited resources and often
encounter practical difficulties in monitoring compliance. If the court does not ask the
Agency to monitor the injunction, the Region should offer to assist the court and to
report any violations of the injunction. A violation of an injunction will subject the
party to a charge of contempt of court.
If an injunction is denied, the Agency may either:
• Appeal the denial; or
• Accept the denial and pursue other legal remedies.
In both instances, the Regional Office should consult the Headquarters Case Development
Officer (HQCDO) to determine which course of action to take.
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Chapter Seven Example 7E-2
Model Motion for Temporary Restraining Order
United States District Court
District of
(Title of Action) Civil Action No.
Motion for Temporary Restraining
Order [With or Without Notice]
Plaintiff, the United States of America, herewith moves this court to grant
[*(!) forthwith and without notice to defendant or his or her attorney] a
temporary restraining order restraining defendant, his or her agents, and
employees from (set forth acts sought to be en-joined) pending a hearing and
disposition of plaintiff's motion for a preliminary injunction on the
grounds that immediate and irreparable injury, loss, or damage will result
to [*(2) plaintiff, the public, the environment] as set forth in the
attached affidavit of (name of affiant) (*(3) before notice can be given
and before defendant or his or her attorney can be heard in opposition, as
certified to be the undersigned].
(Signature of U.S. Attorney)
United States Attorney for the
District of
Date
* (1),(3) — These statements are optional depending upon whether or not
the defendant or his or her attorney receives advance
notice of the request for a TRO.
* (2) — The victim of the alleged injury can be best determined
from the actual facts of the case at hand.
TSCA Case Proceedings 7E-24 Guidance Manual 1992
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Chapter Seven Example 7E-3
Model Motion for Preliminary Injunction
United States District Court
District of
(Title of Action) Civil Action No.
Motion for Preliminary Injunction
Plaintiff, the United States of America, herewith moves this court for a
preliminary injunction enjoining the defendant (name of defendant), his or
her agents, servants, employees, and attorneys and all persons in active
concert and participation with the defendant pending the final hearing and
determination of this action, from (set forth act or acts sought to be
enjoined) on the grounds that:
(1) Unless restrained by this court, defendant will perform the acts
referred to;
(2) Such action by the defendant will result in immediate and
irreparable injury, loss, or damage to (the plaintiff, the public
interest, or the environment), as appears in the verified
complaint and the affidavit of (name of affiant), attached
hereto; and
(3) The issuance of a preliminary injunction herein will not cause
undue inconvenience or loss to defendant, but will prevent
immediate and irreparable injury to the plaintiff.
(Signature of U.S. Attorney)
United States Attorney for the
District of.
Date
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Chapter Seven Example 7E-4
Model Affidavit in Support for Motion for Preliminary Injunction
United States District Court
'District of
(Title of Action) Civil Action No.
Affidavit in Support of Motion
for Preliminary Injunction
(Name of Affiant), being duly sworn, deposes and says:
(1) The United States of America, plaintiff in the above-entitled action,
makes this affidavit in support of plaintiff's motion for a
preliminary injunction.
(2) This is an action [to enjoin defendant from engaging in any violation
of the Toxic Substances Control Act, 15 U.S.C. $2601 et sea.. or an
action otherwise authorized by the Act].
(3) [Statement of facts to support the motion].
(Signature of Affiant)
(other than EPA attorney)
Subscribed and sworn to and before me at (City and State)
_this day of , 19.
(Signature of Attesting Official)
(other than EPA attorney)
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Chapter Seven Example 7E-5
Model Motion for Permanent Injunction
United States District Court
District of
(Title of Action) Civil Action No.
Motion for Permanent Injunction
Plaintiff, the United States of America, herewith moves this court to make
permanent the preliminary injunction issued herein on (date). In support,
plaintiff submits (the opinion of the court of ]_, which is
conclusive to the effect that the (behavior or activity of the defendant)
is unlawful and no additional evidence could alter that result.
[Optional: (1) Counsel may also want to include a paragraph moving the
court to enter the mandate of a higher court, if the
grant of injunction has been unsuccessfully appealed.]
[Optional: (2) Counsel may also find it necessary to include a motion
either for the dismissal of defendant's counterclaim or
for the grant of summary judgment as to the
counterclaim.)
(Signature of U.S. Attorney)
United States Attorney for the
District of_
Date
TSCA Case Proceedings 7E-27 Guidance Manual 1992
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Chapter Seven Injunctive Relief
SECTION 7 IN REM ACTIONS
Authority
Section 7(a)(l)(A) of TSCA permits the Administrator to commence a civil action in an
appropriate district court for the seizure of an imminently hazardous chemical substance or
mixture or any article containing such a substance or mixture.
Criteria for Use
A Section 7 seizure action should be used in a situation in which a chemical substance or
mixture presents an imminent and unreasonable risk of serious or widespread injury to health
or the environment. Such risk is considered imminent if it is shown that the manufacture,
processing, distribution in commerce, use, or disposal of the substance or mixture is likely to
result in such injury before a final rule under Section 6 can protect against such risk. Imminent
hazard is determined on a case-by-case basis. However, when a chemical substance or mixture
poses an acute risk of harm to human health or the environment or is being used by large
numbers of people in many areas of the country, harm may be evident. A seizure action under
Section 7(a) may be used in conjunction with a Section 7 injunctive action. It may also be used
notwithstanding the existence of a rule under Sections 4, 5 or 6 or an order under Section 5 of
the Act, and notwithstanding the pendency of any administrative or judicial proceeding under
any provision of TSCA. A Section 7 action (either seizure or other relief) is mandatory if the
Administrator has not made a rule under Section 6(a) immediately effective with respect to the
imminently hazardous chemical substance or mixture.
Jurisdictional Considerations
A seizure action authorized by Section 7(a)(l)(A) against a chemical substance or mixture, or
article containing such substance or mixture, may be brought in any United States district court
within the jurisdiction in which the substance, mixture, or article is found.
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Chapter Seven Injunctive Relief
SECTION 17(B) IN REM ACTIONS
Authority
Section 17(b) of TSCA authorizes the seizure of any chemical substance or mixture that was
manufactured, or distributed in commerce in violation of the Act or any rule promulgated or
order issued under TSCA or any article containing such substance or mixture.
Criteria for Use
An in rem action authorized by Section 17(b) should be considered when a chemical substance
or mixture presents an unreasonable risk of injury to human health or the environment but does
not constitute an imminent hazard under Section 7. Note that a Section 7 seizure action may be
used in instances where there is no violation of TSCA, whereas a Section 17(b) in rem action
requires that the chemical substance or mixture has been manufactured, processed, or distributed
in commerce in violation of the Act.
Jurisdictional Considerations
A seizure action authorized by Section 17(b) of TSCA against a chemical substance or mixture,
or article containing such substance or mixture, may be brought in any United States district
court within the jurisdiction in which substance, mixture, or article is found.
PROCEDURES FOR INITIATING AN IN REM ACTION
Prepare the Referral Package
Upon determining that an in rem seizure action is appropriate, the Regional Office should
prepare a civil litigation referral package (see Section 3 of this chapter). The package may
include a proposed complaint in rem (Exhibit 7-6), which is prepared in accordance with Rule
C of the Supplemental Rules for Certain Admiralty and Maritime Claims that accompany the
Federal Rules of Civil Procedure. The necessary elements of the complaint in rem are that:
• It be verified by oath or affirmation;
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Chapter Seven Injunctive Relief
• It describes with reasonable particularity the property that is the subject of the action;
• It states that the property to be seized is (or will be during the pendency of the action)
within the jurisdiction of the district court that will hear the action;
• It states the allegations of the violations, as required by the statute, with sufficient
particularity that the defendant/respondent can frame responsive pleadings and
investigate the facts without moving for a more definite statement.
Execute the Warrant
Once the complaint in rem is filed with the court, an "arrest" warrant (i.e., a warrant for the
arrest of the property that is the subject of the action) will be issued. According to Rule C(3)
of the Supplemental Rules, the warrant is delivered to a U.S. Marshal for execution.
Notify Other Regions
The Region should notify other Regions of its actions if there is reason to believe that the
violative product is also in those Regions.
COMPLIANCE WITH A SEIZURE ORDER
The violation of a court-ordered seizure or decree of condemnation constitutes contempt of
court. When any such violation is found, it should be reported promptly to the U.S. Attorney
who filed the seizure action.
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Chapter Seven
Example 7E-6
Model Complaint In Rem
IN THE UNITED STATES DISTRICT COURT FOR THE
DISTRICT
United States of America
Complaint In Rem
TO THE HONORABLE JUDGE OF SAID COURT:
This is a complaint in rem filed on behalf of the United States of American
by the United States Attorney for this District, who represents as follows:
This is an action in rem instituted pursuant to Section 17(b) [or Section
7(b)(3)J of the Toxic Substances Control Act (TSCA), 15 U.S.C. §261(b), for
the seizure and condemnation of a chemical substance or mixture that has
been manufactured, processed, or distributed in commerce in violation of
TSCA or any implementing rule or order or any article containing such
substance or mixture. Authority to bring this action is vested in the •
United States Attorney by 28 U.S.C. §547(2).
II
This court has jurisdiction of the subject matter of this action pursuant
to 15 U.S.C. S2616(b).
Ill
The property to be seized is located at (exact location), which is within
the judicial district [or, the property will.be located at (exact
location), within this jurisdiction, during the pendency of the action].
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7E-31
Guidance Manual 1992
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Chapter Seven Example 7E-6
IV
(Name of chemical substance or mixture) is a chemical substance or mixture
that has been manufactured, processed, or distributed in commerce in
violation of TSCA as follows:
(State allegation with specific reference to the sections of the Act,
regulations, or orders that allegedly have been violated.)
WHEREFORE, the complainant, United States of America, prays:
(a) That the chemical substance or mixture (name of chemical substance or
mixture) or article containing such substance or mixture be seized and
condemned, and that it be disposed of as the Court may direct in
conformity with the practice of this Court.
(b) That the (name of company that manufactures, processes, or distributes
in commerce) and any or all persons having, or pretending to have any
right, title, or interest in or to the substance, mixture, or article,
be notified to appear in order that they may answer the allegations
herein set forth.
(c) That this Honorable Court may enter all such orders, decrees, and
judgments as may be necessary and grant the complainant the costs of
this proceeding.
(d) That the complainant may have such other and further relief as the
nature of the case may require.
(Signature of U.S. Attorney)
United States Attorney for the
District of
VERIFICATION
I have read the foregoing pleading and know its contents, which is true and
correct to my own knowledge, except as to matters therein stated upon my
information and belief, and as to such matters I believe it to be true.
Executed on this day of (date)
(location)
United States Attorney
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Chapter Seven
5 Settlement Agreements
By their very nature, TSCA judicial civil actions do not involve settlement agreements.
Nonetheless, an injunction or in rem (seizure) action that is granted to EPA by a district court
is usually monitored for compliance by the Agency. The violation of either type of civil action
will subject the responsible party to a charge of contempt of court.
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Chapter Eight
Judicial Enforcement: Criminal Actions
CHAPTER CONTENTS PAGE
1 Introduction 8-1
Criminal Enforcement at EPA 8-1
The Criminal Provisions of TSCA 8-2
Penalties for Environmental Criminal Violations 8-2
TSCA's Relationship to Other Federal Criminal Laws 8-3
2 Overview of Criminal Enforcement 8-5
Recognizing Potential Criminal Violations 8-5
Regional Case Screening/Enforcement Priorities 8-6
Criminal Enforcement Compared with Civil Enforcement 8-7
Parallel Criminal and Civil Proceedings 8-7
3 Criminal Investigations 8-9
Communications with Opposing Counsel 8-9
Initiating an Investigation 8-9
Conducting an Investigation 8-10
Security of Criminal Investigations . . . 8-11
Special Attention to Defendants' Rights 8-11
Searches 8-12
Compelling the Production of Information 8-13
Charging the Commission of a Crime 8-13
Discovery 8-14
Burden of Proof 8-14
TSCA Criminal Case Studies 8-14
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Chapter One Contents
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Chapter Eight
1 Introduction
The purpose of this chapter is to heighten awareness of the environmental criminal enforcement
program and to demonstrate the critical role TSCA program and enforcement specialists play in
this program. In addition to the overview in this section, special considerations related to
criminal investigations are noted, where appropriate, throughout this manual. EPA's criminal
enforcement program is a significant part of the general enforcement of environmental
requirements. The success of the criminal enforcement program has been duly noted by the
regulated community, resulting in increased compliance.
EPA's criminal investigations are handled by Special Agents of the Criminal Investigation
Division (CID). Other key members of the criminal enforcement program are the Regional
Criminal Enforcement Counsels (located in each office of Regional Counsel) and the Criminal
Enforcement Counsel Division located at EPA Headquarters in Washington, D.C. Together
these components comprise the Office of Criminal Enforcement within the Office of
Enforcement.
Potential criminal wrongdoing should be discussed with either EPA's Special Agents or Regional
Criminal Enforcement Counsel. A formal referral memorandum or "package" is not necessary
to obtain an initial assessment of the potential criminal implications of a TSCA violation.
(Several successful environmental criminal investigations and prosecutions can trace their
beginnings to a mere single telephone call by an alert TSCA program staffer.)
CRIMINAL ENFORCEMENT AT EPA
The criminal enforcement program began in fall 1982 with a staff of 23 experienced criminal
investigators and has now grown to more than 70 Special Agents, with a CID Field Office,
headed by a Special Agent in-Charge, in each Region. These agents were formerly with such
law enforcement agencies as the FBI, the Drug Enforcement Administration, the Bureau of
Alcohol, Tobacco and Firearms, and the Internal Revenue Service.
In October 1988, the 100th Congress enacted a law (18 U.S.C. § 3063) authorizing the Special
Agents of EPA to obtain and execute search and arrest warrants and to carry firearms in the
performance of their duties.
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Chapter Eight Introduction
In addition, EPA technical personnel, such as engineers and field inspectors, have received
special training to assist the criminal investigative staff when needed. As environmental criminal
enforcement has expanded, a growing number of joint investigations are conducted involving the
EPA and other Federal enforcement agencies (such as the FBI, the Fish and Wildlife Service,
and the Customs Service) and with state environmental enforcement offices.
THE CRIMINAL PROVISIONS OF TSCA
Section 15 of TSCA (15 U.S.C. Section 2614) specifically lists the unlawful acts that are
subject, not only to civil and administrative enforcement, but also to criminal investigation and
prosecution. TSCA program personnel should be aware that the commission of any of these
unlawful acts may potentially be the basis for a criminal case.
Section 16(b) of TSCA, 15 U.S.C. Section 2615, makes the knowing violation of any provision
of TSCA punishable as a crime subject to criminal penalties consisting of fines and/or a term
of imprisonment.
PENALTIES FOR ENVIRONMENTAL CRIMINAL VIOLATIONS
A person or company convicted of criminal violations of an environmental statute may be
imprisoned and/or fined. A person or firm convicted of a civil violation is only subject to
injunctive relief orders and/or financial penalties. The penalty amount for a criminal violation
of TSCA can be substantial. In 1984, Congress enacted a new criminal fine provision to make
the fine structure of the various criminal provisions in federal statutes uniform. Pursuant to 18
U.S.C. § 3571, an individual can be fined up to $250,000 for each TSCA misdemeanor offense
resulting in death and up to $100,000 if the offense does not result in death. An organizational
defendant may be fined $500,000 if the TSCA violation results in death and $200,000 if death
is not attributable to the offense.
All individual defendants convicted of environmental criminal offenses that occurred after
November 1, 1987, are sentenced pursuant to the Sentencing Guidelines, issued by the U.S.
Sentencing Commission. One part (Part Q) of those Guidelines deals directly with
environmental offenses. Organizational defendants are subject, as of November 1, 1991, to
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Chapter Eight Introduction
special Sentencing Guidelines which direct that restitution, remedial measures, and community
service are to be considered as part of the sentence. Companies may be placed on
"rehabilitative" probation that can include conditions covering inspection; compliance plans to
prevent and detect future environmental violations; a requirement to publicize, at the companies'
expense and in a media specified by the court, the fact of its conviction; and notification to its
employees and stockholders of its criminal conviction. TSCA personnel should apprise
themselves of firms and individuals on probation to ensure that convicted criminal environmental
violators are sufficiently monitored to ensure that they do not repeat their criminal activity.
TSCA'S RELATIONSHIP TO OTHER FEDERAL CRIMINAL LAWS
Criminal environmental misconduct may be prosecuted under any of the other environmental
laws or one of the general federal criminal laws, set out in Title 18 of the United States Code.
Any TSCA program personnel who uncover what they believe to be a criminal environmental
offense should bring this promptly to the attention of EPA Criminal Enforcement Counsel or
Special Agents. This is true even if the offense does not appear to be solely a TSCA violation.
For example, submission of false chemical registration information may be not only a
misdemeanor violation of TSCA, but also a violation of the Federal felony false statement statute
and conspiracy laws. The unlawful disposal of PCBs may trigger a criminal felony case under
the Clean Water Act. Factors such as the evidence available to establish an offense and the
different penalty levels of the involved statutes may determine the choice of charges which EPA
elects to pursue.
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Chapter Eight Introduction
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Chapter Eight
2 Overview of Criminal Enforcement
RECOGNIZING POTENTIAL CRIMINAL VIOLATIONS
TSCA program personnel are not expected to perform an in-depth legal or investigatory analysis
of criminal conduct alleged to have occurred (or to be occurring). The issues are complex. The
Agency has a staff of attorneys experienced in both criminal and environmental law who can
make such an assessment; they also provide legal policy guidance and training in criminal
enforcement matters. TSCA program personnel should not hesitate to contact Special Agents
or Criminal Enforcement Counsel to discuss any aspect (general or specific) of the criminal
enforcement program.
It is important that all acts of actual or suspected environmental criminal conduct be brought to
the attention to the Criminal Investigation Division for review and possible investigation.
Note that the terms "knowing" or "willful" are not defined in any federal statute. Congress has
deferred to the joint judgement of EPA and federal prosecutors to differentiate between civil and
criminal environmental violations.
Evidence of criminal wrongdoing is sometimes self-evident, e.g., the secret dumping of PCB-
contaminated fluids or repeated refusal to comply with TSCA although clearly advised of
environmental compliance responsibilities. On other occasions, criminal conduct is less obvious.
TSCA personnel should consult a Special Agent of Criminal Enforcement Counsel about the
possibility of criminal actions. The following examples may alert you to possible criminal
intent:
• Conflicting Data. Two sets of books with inconsistent monitoring reports on the
incident;
• Conflicting Stories. When a TSCA staffer is told one thing and sees something quite
different in records or in the field;
• Unsubstantiated Data. Monitoring or other recordkeeping and reporting information
which does not support records submitted to EPA;
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Chapter Eight Overview of Criminal Enforcement
• Deliberate Actions. When a company employee reports he or she was told to do
something illegal; or
• Claims of Ignorance about Requirements. Company records or government documents
show a knowledge of TSCA compliance responsibilities which contradict statements made
by the company representatives during interviews.
If any of these circumstances are present, or any other information or lack of information makes
the TSCA staffer suspicious, he or she should promptly consult with the CID about such
findings.
REGIONAL CASE SCREENING/ENFORCEMENT PRIORITIES
EPA has set national enforcement priorities. Inform TSCA program management concerning
a suspected criminal violation of TSCA to ensure that it is brought to the attention of Regional
Case Screening Committees. These committees consider the nature of the violation and
enforcement options, and Regional and established national enforcement priorities. Violations
identified as an enforcement priority enhance the merits of criminal enforcement action. TSCA
enforcement priorities include:
• Violation of Section 4 Testing Rules and the Section 5(b) Premanufactured Notification
Program. These violations have a significant impact on the Agency's ability to act under
TSCA and respond to an identified significant risk of harm from a chemical substance;
• Failure to Report Substantial Risk Information. This type of omission may present a
substantial risk of injury to community health or the environment; and
• Violation of PCB or Dioxin Regulations. These violations have the potential to cause
significant environmental contamination or human health hazards.
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Chapter Eight Overview of Criminal Enforcement
CRIMINAL ENFORCEMENT COMPARED WITH CIVIL ENFORCEMENT
This manual focuses primarily on procedures and techniques for collecting evidence that may
ultimately lead to an administrative or judicial civil action. Generally, these procedures and
techniques are employed in criminal investigations as well. However, there are several
important exceptions in the areas of search and seizure and compelling testimony. Because of
the unique legal issues involved, TSCA enforcement personnel assisting in criminal
investigations should follow the instructions of the Special Agent and Criminal Enforcement
Counsel.
PARALLEL CRIMINAL AND CIVIL PROCEEDINGS
While TSCA personnel do not routinely become involved in criminal investigations, the
distinction between civil and criminal enforcement is often unclear and TSCA staff may find
themselves associated (directly or indirectly) with a criminal investigation. Sometimes while
pursuing a criminal action, the Agency will also conduct a civil administrative action if the
environmental consequences of a violation pose a hazard requiring remedial measures by a
defendant. When there are parallel criminal and civil enforcement actions relating to the same
violation, the distinction between the two must be clear to ensure that the government is not
liable to claims of misusing criminal investigative processes for civil enforcement purposes and
vice versa. There are three rules of thumb a TSCA staffer can follow when involved in ongoing
parallel proceedings:
• Civil/administrative and criminal enforcement actions may be conducted simultaneously
whenever deemed necessary by the EPA Assistant Administrator for the Office of
Enforcement in order to seek immediate relief to protect human health or the
environment.
• Until the Agency refers a matter to the Department of Justice for possible criminal
prosecution, all EPA employees should continue to collect information (data) from
potential defendants with the understanding that it may be used either in a civil
administrative or criminal enforcement action.
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Chapter Eight Overview of Criminal Enforcement
• No EPA employee should ever tell a person or entity from whom information is being
sought that it will or will not be used by the Agency as evidence in a criminal
prosecution.
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Chapter Eight
3 Criminal Investigations
COMMUNICATIONS WITH OPPOSING COUNSEL
If at any time you are contacted by outside counsel or legal staff, ask if they are representing
or associated with any party in litigation with the Agency before talking to them. Do not discuss
any criminal matters with outside counsel without first communicating with Regional or
Headquarters Criminal Enforcement Counsel.
INITIATING AN INVESTIGATION
An "initial lead," or allegation of potential criminal activity, may come to the Agency from
several sources including state agencies, routine TSCA compliance inspections, citizens, and
disgruntled company employees. Regardless of the source of the tip, whoever receives the tip
should immediately notify the Special Agent-in-Charge (SAC) in the Region who will evaluate
the lead and, if warranted, assign a Special Agent for the follow-up, assign a case number, and
open an investigative file.
If the reliability of the lead is unclear, the Special Agent will conduct a preliminary inquiry to
determine the credibility of the allegation and make an initial assessment of the need for more
thorough investigation. This initial inquiry is brief and involves no extensive commitment of
resources or time. The agent may consult with program enforcement personnel and legal staff
to help determine whether a particular violation warrants a complete investigation or a criminal
enforcement action.
During a routine inspection, TSCA inspectors are in a unique position to follow such leads.
Inspectors should be alert to possible criminal activities such as falsified information in records
and reports and illegal handling of PCBs. Facility employees may also volunteer information
to inspectors about possible criminal activities.
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Chapter Eight Criminal Investigations
CONDUCTING AN INVESTIGATION
If after the preliminary inquiry a decision is made to pursue a thorough investigation, the Special
Agent contacts the Office of Regional Counsel and other appropriate offices to determine
whether any civil enforcement action is pending or contemplated against the investigation target.
If technical support for the investigation is needed, as is often required in complex criminal
cases, the Special Agent asks the appropriate Regional Program Division Director(s) to designate
individuals to work on the investigation. All these activities are carried out in consultation with
the Office of Criminal Enforcement.
The Special Agent manages the investigation under the supervision of the SAC and is responsible
for the following:
• Determining the basic investigative approach;
• Leading the conduct of interviews;
• Assembling and reviewing documentary evidence;
• Planning and executing surveillance;
• Coordinating with the U.S. Attorney's office and other Federal, State, and local law
enforcement agencies;
• Contacting other witnesses;
• Performing other investigative functions;
• Completing all required reports; and
• Carrying out all coordination and notification requirements.
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Chapter Eight Criminal Investigations
SECURITY OF CRIMINAL INVESTIGATIONS
Information on criminal investigations must be provided only on a "need-to-know" basis. Active
criminal investigations must not be discussed with personnel outside of the Agency, except as
is necessary to pursue the investigation and to prosecute the case.
Agency policy is to neither confirm nor deny the existence of a criminal investigation. If a
TSCA staffer receives a request for information from the news media, it must be referred to the
Special Agent, who will determine the response in consultation with other Agency offices. If
a congressional inquiry is received, the Assistant Administrator for Enforcement works with the
Congressional Liaison Officer prior to releasing any information or making any public
statements.
Written material pertaining to the investigation must receive special care and attention. The
OCE criminal investigative offices and enforcement division offices are equipped with secure
office space, filing cabinets, and evidence vaults. Similar security measures must be used by
Regional Staff assigned to an investigation.
SPECIAL ATTENTION TO DEFENDANTS' RIGHTS
The Constitution places a great responsibility on those who investigate alleged criminal activities.
Because severe penalties may be imposed on individuals and organizational defendants convicted
of criminal violations of environmental laws or other statutes, strict requirements of proof
protect their rights. It is of critical importance that all those who participate in criminal
investigations are aware of these safeguards and conduct themselves accordingly. Special Agents
of the Criminal Investigation Division guide the investigation team in these matters.
From the beginning of a criminal investigation until its completion, the constitutional rights of
defendants must be fully protected and established investigations procedures must be followed.
The principal challenges to the government's case stem from the "Exclusionary Rule," which
excludes the use of evidence during the prosecution if a defendant's constitutional rights were
violated by the procedures used to collect that evidence; The procedures used by EPA's
Criminal Investigation Division are designed to ensure protection of defendants' rights and to
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Chapter Eight Criminal Investigations
create a documentary record of the investigation that will later support the admission of the
resulting evidence.
Defendants also have a right against self-incrimination. This means that a defendant can be
silent and make the government prove its case. Therefore, a procedural challenge occurs when
a suspect provides statements to a law enforcement officer after being taken into custody. The
Special Agent must first issue a "Miranda warning" and obtain a knowing waiver of such rights
if the statements are to be admissible evidence.
Inspectors frequently ask how "Miranda rights" apply during routine interviews, particularly if
the interviewee's answers to questions begin to suggest that there may be criminal activity.
Miranda rights only apply when a person is in custody, that is, once he or she has been arrested.
Information provided in routine interviews is lawfully obtained evidence that may be used in a
criminal investigation and prosecution.
SEARCHES
EPA Special Agents may search a person or private property when seeking evidence of alleged
criminal activity only (1) with the person's or organization's consent or (2) after obtaining a
warrant. A warrant is based upon sworn testimony that there is "probable cause" to believe that
a crime has been committed and that the search is necessary to obtain evidence of that crime.
The probable cause standard for obtaining a warrant in a criminal investigation is far more
stringent than for a obtaining a warrant in a civil enforcement or administrative case.
EPA's Special Agents have the authority to seek and execute criminal warrants. TSCA program
personnel sometimes accompany the criminal investigators to assist in the investigation. In these
cases, the instructions of the Special Agents must be strictly followed since any evidence
collected outside the authority of the search warrant is illegally obtained and not admissible in
court.
Evidence of a crime discovered through civil enforcement activity is generally admissible in
criminal court. For example, information collected by TSCA programs during a routine TSCA
inspection (with consent or pursuant to an administrative warrant) may be admitted as evidence
in a criminal case because it was lawfully obtained.
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Chapter Eight Criminal Investigations
COMPELLING THE PRODUCTION OF INFORMATION
In addition to obtaining evidence through a search warrant, a prosecutor may subpoena witnesses
to testify before a Grand Jury. The prosecutor's ability to compel information in a criminal
investigation is powerful:
1. A witness who fails to appear in response to a subpoena is subject to immediate arrest;
2. An uncooperative witness can be forced to provide information through court order; and
3. Testimony provided to a grand jury is privileged. There are severe penalties for anyone
who violates that secrecy. These rules of grand jury secrecy severely limit what can
be disclosed by an agent concerning an investigation.
Subpoenas issued under a criminal proceeding differ markedly from subpoenas served for a civil
proceeding, in which information provided by the witness cannot be kept confidential if it falls
within the scope of the other side's discovery requests.
CHARGING THE COMMISSION OF A CRIME
For civil violations, the Agency files a civil administrative case resulting in an administrative
order. For criminal violations, it is the federal grand jury or U.S. Attorney who charges
persons or corporations with crimes.
A grand jury brings a charge by returning an "indictment," which generally is issued for felonies
(i.e., crimes subject to punishment by imprisonment for longer than one year). The U.S.
Attorney can bring a charge by filing an "information," which generally is used in connection
with misdemeanors (i.e., crimes subject to punishment by imprisonment for one year or less)
or where a defendant has waived his right, usually pursuant to a plea agreement, to be charged
by a grand jury.
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Chapter Eight Criminal Investigations
DISCOVERY
As a general rule, in criminal cases minimal discovery is permitted by the defendant. However,
there are exceptions to the rule. For example, case law requires a prosecutor to give the
defendant before the trial any exculpatory evidence known to the prosecutor (evidence that may
show innocence). For this reason some prosecutors have adopted an open file policy, which
allows counsel for the defendant access to the prosecutor's entire file. However, defendants in
criminal cases cannot file interrogatories or requests for admissions, or take depositions of
witnesses, as they can in civil cases. Defense counsel may therefore attempt to gain information
about the government's case by directly contacting the inspector or TSCA program personnel.
EPA employees who are contacted about a pending criminal matter are strongly encouraged to
consult first with a Special Agent or enforcement counsel.
BURDEN OF PROOF
Because criminal sanctions can be severe, the burden of proof is greater in a criminal
prosecution than in a civil enforcement case. To prove a violation in a civil enforcement case,
the enforcement attorney is required only to show a violation through a "preponderance of the
evidence" standard. To prove a criminal violation, the prosecutor must prove his or her case
"beyond a reasonable doubt." If a reasonable doubt exists in the trier's mind about the
defendant's guilt after the conclusion of a criminal case, the defendant is acquitted.
TSCA CRIMINAL CASE STUDIES
The following are examples of how TSCA violations led to environmental criminal prosecutions:
The Martha C. Rose Case: (Missouri)
On April 3, 1990, Walter C. Carolan, one of five defendants (all employees or officers of the
defendant corporation, the Martha C. Rose Chemical Company), was sentenced to two years
imprisonment and a fine of $10,000. This followed his October 26, 1989, plea of guilty to
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Chapter Eight Criminal Investigations
felony charges of conspiring to defraud EPA by falsifying records relating to the treatment and
disposal of polychlorinated biphenyls (PCBs) and of criminally causing and using a false
statement on a "Quarterly Outfall Report" related to the level of PCBs in a retention pond at the
corporation's facility.
The case was also commonly referred to as the "Martha C. Rose Chemical" case because of the
name of the corporation owned and operated by the defendant. (The corporation was forced into
bankruptcy.) The indictment, entered on March 14, 1989, had variously charged a total of
forty-three counts -for conspiracy, using false writings and falsification of records, and one
misdemeanor count of knowingly and willfully improperly storing PCBs, consisting of 1,123,042
pounds of PCB capacitor cores stored at the Martha C. Rose Chemical facility in Holden,
Missouri.
The Inman Case: (Texas)
On January 25, 1990, John McMichen, Vice President of Inman and Associates, Inc., a
demolition contractor, and his company, pled guilty to two separate informations filed against
them the previous day. Those informations charged them with environmental offenses
committed during the removal of a PCB-containing capacitor bank at the Naval Air Station at
Corpus Christi, Texas.
Inman and Associates had contracted with the Department of the Navy to replace the Naval Air
Station's electrical switching station, which included the capacitor bank in question. Among the
contract specifications for the project was compliance with environmental laws and regulation,
including CERCLA and TSCA. Notwithstanding notice regarding PCB removal and storage
requirements, McMichen ordered workers to throw PCB-containing capacitors approximately
20 feet to the ground from the bank. When the capacitors cracked and spilled approximately
100 pounds of PCB oils onto the ground, neither McMichen nor any other Inman officials
contacted the National Response Center to report the spill. Two days later the spill came to the
attention of Navel Air Station officials, who subsequently reported the spill.
The one-count information against McMichen charged him with knowingly violating TSCA
disposal requirements (15 U.S.C. § 2615(b)), which provides fines of up to $25,000 or up to
one year in prison, or both. The one-count information against Inman and Associates charged
a CERCLA felony violation for the failure to report the reportable quantity spill of PCBs (42
U.S.C. §9603(b)), which provides fines of up to $500,000. Under the plea agreement, the
company paid $40,000.
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Chapter Eight Criminal Investigations
Stafford and Badgett Case: (West Virginia)
On December 20, 1989, Harry Gordon Stafford and James Anthony Badgett were sentenced to
pay fines and serve noncustodial terms of imprisonment and were placed on probation, as a
result of their PCB-related misdemeanor convictions.
Stafford had pled guilty, on July 7, 1989, to all charges in a two-count information filed the
same day, per plea agreement. Stafford was charged with conspiracy to violate TSCA by
illegally disposing of PCBs, in violation of 18 U.S.C. 371, and with violating TSCA by failing
to properly label drums containing PCBs, in violation of 15 U.S.C. 2614(1)(C) and 2615(b).
(Codefendant Gary Lee Powell was later acquitted after trial on the same charges.) Stafford was
sentenced to pay a $5,000 fine and to serve one year in prison (suspended) and was placed on
three years probation. Per plea agreement, the government had recommended the $5,000 fine,
but had made no recommendation as to imprisonment. Stafford's violations occurred prior to
applicability of the Federal Sentencing Guidelines.
Badgett had pled guilty, on October 18, 1989, to charges in a one-count information filed the
same day, per plea agreement. Badgett was charged before a grand jury with false material
declarations, in violation of 18 U.S.C. 1623. Badgett was sentenced to two months
imprisonment (home detention) and five years probation. Per plea agreement, the government
had recommended the minimum sentence under the sentencing guidelines. The magistrate's
sentence was the minimum term of imprisonment, but the maximum term of probation (or post-
incarceration "supervised release") allowable under the Guidelines.
The charges arose out of the May 1987 dumping of seven electrical transformers and two 55-
gallons drums containing PCBs in Boothsville, West Virginia. Stafford, owner of a salvage
business, had purchased the PCB-containing materials and had sold them in 1987 to Powell, who
owns an electrical repair business. Powell allegedly discovered that the materials contained
PCBs and, determining that legal disposition was too costly, insisted that Stafford take them
back. (Powell was acquitted of all charges after trial.) Badgett, who was a driver for Stafford's
business, then picked up the transformers and drums and illegally dumped them in and around
a pond at an old strip mine site. Shortly thereafter, they were discovered by hikers and reported
to the West Virginia Department of Natural Resources.
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Chapter Nine
Oversight of Settlement Agreements
CHAPTER CONTENTS PAGE
Introduction 9-1
Collection of Civil Penalty Assessments 9-1
Types and Methods of Payment 9-3
Suspension or Termination of Collection Activity 9-5
Referral Procedures .9-5
Monitoring Supplemental Enforcement Projects 9-6
Follow-up Inspections 9-7
Example 9E-1: Consent Agreement - Schedule of Activities 9E-8
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Chapter Nine Contents
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Chapter Nine
Oversight of Settlement Agreements
INTRODUCTION
As discussed in Chapter 6, Section 3 Informal Settlement, the Agency often settles an
administrative civil penalty action with a violator prior to the actual hearing, thus obviating the
need for costly litigation. Such settlements under TSCA take the form of consent agreements
and consent orders (CACO).
The CACO contains the terms of settlement that are agreed to during negotiations. The CDO
is responsible for monitoring the Respondent's compliance with all terms of the CACO and for
notifying the Respondent's attorney of any violation of the terms of the agreement. Once the
CACO is filed, the CDO should prepare a Schedule of Activities which outlines the required
terms of the agreement with related due dates. The Attorney should send a copy of the Schedule
of Activities to the Respondent's counsel to verify that the Agency's timeline of due dates in the
schedule corresponds to the terms of the settlement. If there are stipulated penalties for late
terms, it is important that there is agreement on the dates for completion of activities. As each
requirement is met, the date of completion should be documented and retained as evidence in
the file. It is recommended that the CDO establish and maintain open lines of communication
with the appropriate person representing the Respondent regarding the terms due. Example 9E-1
contains a sample Consent Agreement Schedule of Activities.
COLLECTION OF CIVIL PENALTY ASSESSMENTS
If any person fails to pay a civil penalty within the prescribed time periods, Section 16(a)(4) of
the Act specifies that the matter be referred to the Attorney General for collection. In such an
action to recover the assessed civil penalty, the validity, amount, and appropriateness of such
penalty is not subject to review.
However, before any referral to the Attorney General, the Agency must satisfy the directives
and standards for collection set forth in the Federal Claims Collection Act (31 U.S.C. §951-953)
and the Federal Claims Collection Standards (FCCS, 13 C.F.R. §1-33).
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Chapter Nine Oversight of Settlement Agreements
FCCS procedures are mandatory. However, failure of the Agency to comply with any provision
of the standards will not be available as a defense to any party in a subsequent action for
collection.
Under the FCCS, the Agency is held to a policy standard of aggressive collection action, on a
timely basis, and with effective follow-up of all civil penalty assessments.
Written Demands for Payment
The FCCS requires the Agency to make three written demands, at 30-day intervals, to the
Respondent in terms that inform the debtor of the consequences of failing to cooperate.
The Agency's policy is to initiate the written demands concurrent with the issuance of a final
order so that the third and final demand will be made on the same day the payment period
elapses (i.e., 60 days after issuance of a final order).
Upon Issuance of the Final Order
At the time a final order is issued and served on the Respondent, he or she should receive a
written demand for any payment of such penalty and the length of time which he or she has to
pay it. Such notice should also inform the Respondent of the consequences of failing to
cooperate.
Thirty Days After Issuance of the Final Order
After 30 days have elapsed, even though the payment period has not expired, the Agency will
again serve on the Respondent a demand for the payment and again warn the Respondent of the
consequences of failing to pay. Given the possibility that the payment may be in the mail when
this second warning is sent, the Agency should also make a brief apologetic statement informing
Respondent to disregard the warning if the payment has been sent.
Sixty Days After the Issuance of the Final Order
The Respondent must pay the civil penalty 60 days after the service of a final order unless a
motion to reconsider has been made or judicial review of the final order has been sought.
Subject to those two exceptions, if payment of the penalty has not been tendered at the end of
the 60-day period, the Agency will send a final demand to the Respondent for payment of the
delinquent civil penalty assessment. This letter should be written to inform the Respondent that
unless payment is tendered within 15 days, the penalty will be referred to the United States
Department of Justice or the United States Attorneys Office for collection in a district court.
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Chapter Nine Oversight of Settlement Agreements
The letter should state that such action is routinely accomplished through a motion for summary
judgement in favor of the United States. The Respondent will be barred from raising any issues
as to fact or law that should have been raised in the administrative proceedings.
Follow-up to Final Demand for Payment
It is Office of Compliance Monitoring (OCM) policy to arrange personal interviews 'if it is
feasible and convenient for the regional officials involved in the case. In the absence of a
personal interview, the Regional Office should at least establish telephone contact with the
Respondent to urge prompt payment of the claim and to personally warn the Respondent of the
consequences of failing to pay the penalty.
Inability to arrange a personal interview or to establish telephone contact with the Respondent
should not deter the Regional Office from referring claims to the United States Attorneys Office
for collection.
Documentation of Collection Efforts
The Agency should record and maintain a file of all collection efforts and activities prior to
referral.
TYPES AND METHODS OF PAYMENT
Full Payment
The most preferable method of collection is a check for the full amount owed, payable to the
Treasurer of the United States. Such payment should be delivered to the Regional Hearing Clerk
for the Region in which the final order was issued.
Installation Payment
Section 13.18 of the FCCS provides for installation payments. This type of payment should be
used when the Respondent has demonstrated and documented an inability to pay the penalty in
a lump sum.
In the event installation payments are justified and allowed, such payment shall:
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Chapter Nine Oversight of Settlement Agreements
• Be on a regular basis;
• Bear a reasonable relation to the size of the debt and the debtor's ability to pay; and
• Be sufficient in size and frequency to liquidate the claim within three years.
Compromise of the Penalty
The FCCS provide for compromising claims when it can be assured that the Respondent's
financial ability will not permit payment of the claim in full or when litigation risks or costs
dictate such action.
Penalty assessments in final orders shall not be subject to compromise except under the most
unusual circumstances. For the most part, TSCA requires that ability to pay be considered
before a civil penalty is imposed; therefore, the inability to pay the penalty should not be an
issue in the post-final order stage of the civil penalty proceeding. However, inability to pay
should be considered where:
• The civil penalty was assessed by default, so that the Respondent's ability to pay was
never confirmed by the Respondent in determining the amount of the penalty; or
• The Respondent's financial condition has deteriorated dramatically since the time the
penalty was assessed. The Agency should be alert to the possibility that assets have
been fraudulently concealed or improperly transferred. The burden falls upon the
Respondent to affirmatively demonstrate and document any such inability.
Section 13.24 of the FCCS provides that, where an enforcement policy is concerned, a penalty
should only be compromised if the sum to be agreed upon will adequately serve the Agency's
enforcement policy in terms of deterrence and securing compliance. For these reasons, and
because Respondents usually have already had an opportunity for settlement, the compromise
provision rarely should be exercised.
-In the event a compromise is effected, it must be authorized by the Regional Administrator
because it alters the final order.
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Chapter Nine Oversight of Settlement Agreements
SUSPENSION OR TERMINATION OF COLLECTION ACTIVITY
Suspension
The Agency may temporarily suspend collection action for payment of a penalty when the
Respondent cannot be located after a diligent search and/or when future collection prospects
seem more promising than present actions.
Suspension will be for an established time period and generally will be reviewed at least every
six months to ensure the continued propriety of the suspension. Section 13.29 of the FCCS
provides further information on suspension of claims.
Termination
Collection action may be terminated and the Agency's file on the penalty closed under the
following conditions:
• Inability to collect any substantial amount;
• Inability to locate debtor;
• Cost will exceed recovery;
• Claim legally is without merit; or
• Claim cannot be substantiated by evidence.
Section 13.31 of the FCCS provides further information on termination of claims.
REFERRAL PROCEDURES
General
Claims on which aggressive collection action has been taken and which cannot be compromised
will be referred to the Department of Justice or the United States Attorneys Office. Such
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Chapter Nine Oversight of Settlement Agreements
referrals should be made as early as possible, consistent with the aggressive Agency collection
action and the standards for collection set forth in the FCCS.
Referral Parties and Minimum Amounts
Department of Justice
All penalty assessments in the amount of $100,000 or more should be referred to the Department
of Justice. The Claims Collection Litigation Report (CCLR) is used for referrals of all
administratively uncollectible claims to DOJ and to refer all offers of compromise.
United States Attorneys Office
All penalty claims in amounts less than $100,000 should be referred to the appropriate United
States Attorney in whose judicial district the debtor can be found.
When referring a claim of less than $20,000 for collection, the Regional Office must emphasize
to the United States Attorney that the referral is important to support a significant enforcement
policy.
MONITORING SUPPLEMENTAL ENFORCEMENT PROJECTS
The incorporation of Supplemental Enforcement Projects (SEPs) into Consent Agreements and
Consent Orders (CACOs) has increased the monitoring responsibilities of the CDO. The
oversight/tracking responsibilities of the CDO concerning these projects are enumerated in the
February 12, 1991, Policy on the Use of Supplemental Enforcement Projects in EPA
Settlements:
Supplemental Environmental Projects (SEPs) may require third-party oversight. In such
cases, these oversight costs should be borne by the Respondent, and Respondent must agree
as part of the settlement to pay for an independent, third-party auditor to monitor the status
of the supplemental project. The auditor will be required by the settlement to submit
specific periodic reports, including a final report evaluating the success or failure of the
supplemental project, and the degree to which the project satisfied these guidelines. All
reports must be submitted to EPA. Upon request, EPA may provide copies of the reports,
or copies of portions of the reports, to the Respondent. The timing and amount of reports
released to the Respondent shall be at EPA's sole discretion.
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Chapter Nine Oversight of Settlement Agreements
Obviously, a certain amount of government oversight will be required to monitor
compliance with the terms of an agreement that contains a supplemental project.
"Horizontal" pollution prevention or pollution reduction supplemental projects which
involve more than one Region (e.g., production changes at more than one facility) may
require additional oversight, and the estimated amount of time and resources required for
effective oversight is another criteria which the negotiators should use to determine whether
to include the project in the settlement agreement.
The consent order or decree shall specify overall timeliness and milestones to be met in
implementing the supplemental project. If the defendant/Respondent does not comply
satisfactorily with the terms of the supplemental project, he or she shall be liable for the
amount by which the assessed penalty was reduced (with applicable interest). The consent
order or decree should contain a mechanism for assuring prompt payment, e.g., through
stipulated penalties consistent with the other sections of this policy or, if appropriate,
through posting a bond (in the amount by which the assessed penalty was reduced) to be
forfeited if the supplemental project is not fully implemented.
FOLLOW-UP INSPECTIONS
In order to ensure continued compliance with TSCA, it may be appropriate to schedule a follow-
up inspection as a part of routine assignments under a neutral inspection scheme, or follow-up
inspections as part of a settlement-with-conditions agreement. Follow-up inspections that reveal
continuing violations of a settlement agreement could subject the violator to additional civil
penalty actions, to civil court actions, or to possible criminal sanctions. Consult the relevant
penalty policy for the level of action guidance appropriate in these situations.
Follow-up inspections should also be cognizant of new violations of other statutes.
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Chapter Nine
Example 9E-1
CONSENT AGREEMENT - SCHEDULE OF ACTIVITIES
(Effective date November 3, 1987)
Provision in
the Consent
Day */ Aareement
60
(January 2, 1988)
90
(February 1, 1988)
120
(March 2, 1988)
180
(May 2, 1988)
210
(May 31, 1988)
270
(July 30, 1988)
290
(August 19, 1988)
325
(September 23, 1988)
Activity
Scope of Work (Audit)
Outline & Schedule for
Employee Training (USA)
Agenda & Schedule for
Training in UK
Pay $84,000 civil penalty
Plan/Schedule for test inputs
Interim Report #1 (Audit)
Complete Training (USA)
Letters sent to Customs
Procedures developed for
- PMNs and their submissions
- Determining Status of
proposed imports
- Bonafide Intent Letters
Interim Report #2 (Audit)
Guidance Manual to EPA
Develop & Implement Import .
Agreement with :
- Suppliers
- Affiliated companies
Complete Test Inputs
Complete Training in UK
Interim Report #3 (Audit)
Attorney ' s Report re : UK
Establish Procedures
Termination Date of Audit
Final Report to EPA
Received
1/4/88
1/4/88
1/4/88
12/10/87
2/1/88
2/1/88
3/2/88
3/2/88
3/2/88
4/2/88
4/2/88
4/2/88
(Sent in
5/31/88
7/29/88
8/1/88
9/23/88
Stipulated
Penalties
$100/day
$100/day
$100/day
$50/day
$50/day
$50/day
$100/day
$50/day
CBI)
$100/day
$100/day
$500/day
TSCA Case Proceedings
9E-8
Guidance Manual 1992
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Chapter Nine
Example 9E-1
CONSENT AGREEMENT - SCHEDULE OF ACTIVITIES
Day I/
60
(August 30, 1987]
Provision in
the Consent
Agreement
Activity Received
Pay $1,000,000 civil penalty 8/17/87
Summary of Past Employee 8/19/87
Training Sessions
Stipulated
Penalties
SlOO/day
**90
(September 29, 1987)
Schedule of Future Employee 8/19/87
Training Sessions
Schedule for EPA to perform 8/10/87
Seminar for Semi-conductor
* List of Trade Magazines for
Public Service Announcements
Published
$100/day
$50/day
$50/day
9/1/87
4/15/88
* Interim Report #1 9/22/87 $250/day
(one Report able Event - 8(c)) up to
$50,000
180 Guidance Manual to EPA 12/29/87 $50/day
(December 28, 1987 (mailed 12/22/87)
* Interim Report #2 12/14/87 $250/day
(No Reportable Event) up to
$50,000
270 * Interim Report #3 3/ /88 $250/day
(March 27, 1988) (one Reportable Event up to
per letter - 5, PMN) $50,000
360 Interim Report #4 6/22/88 $250/day
(June 25, 1988) up to
$50,000
420 Termination of Survey $100/day
(August 24, 1988) up to
$15,000
465 Final Report 10/3/88 $250/day
(October 8, 1988) up to
$50,000
* Day #1 is July 1. 1987 which is the first day after the effective date (June 30, 1987) of
the CAFO in this matter.
** Days for these training sessions will be added to the compliance schedule at day 90.
TSCA Case Proceedings
9E-9
Guidance Manual 1992
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Chapter Ten
Enforcement Discretion
CHAPTER CONTENTS PAGE
Enforcement Discretion 10-1
Example 10E-1: Request for Expedited Safety Review 10E-4
Example 10E-2: Letter Denying the Right to Use Existing Stocks 10E-5
Example 10E-3: Letter Granting the Right to Use Existing Stocks 10E-6
Example 10E-4: Letter Granting the Right to Use Existing Stocks 10E-8
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Chapter Twelve
Contents
TSCA Case Proceedings
10-ii
Guidance Manual 1992
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Chapter Ten
Enforcement Discretion
Enforcement discretion can be defined as a deviation from the regulations, from an
Enforcement Response Policy (ERP), or from other Agency guidelines, on a limited case-
by-case basis. Enforcement Discretion is granted at a company's request when evidence
provided by the company convincingly demonstrates that following the regulations, the ERP,
or Agency guidelines would be unjust or excessive. The request will usually stem from a
self-confession or arise subsequent to an EPA inspection in which Section 5 violations were
apparent. Certain aspects of agency policy regarding TSCA enforcement discretion can be
found in the sections of the Penalty Policies that identify "minor" violations for issuance of
a Notice of Noncompliance (NON).
The situations and circumstances will vary from case to case. However, the most common
request for enforcement discretion, especially from self-confessors, concerns the right of
companies to use the existing stock of a chemical substance which was manufactured in
violation of TSCA. When enforcement discretion is requested, the company should be
informed that, since the law prohibits the use of any illegally manufactured substances, the
granting of the right to use such stocks is closely scrutinized on a case-by-case basis. The
right to use such stocks has been granted in certain limited circumstances only after a safety
review has been completed, and preferably after the PMN has cleared review. If the PMN
has not cleared review, an "Expedited Safety Review" must be completed (see below) before
the right to use such stocks is granted.
Enforcement discretion, where appropriate, is exercised in this type of situation in order to
avoid the unnecessary disposal of a substance that could be legitimately marketed after a
specific date. Without enforcement discretion, disposal capacity would be needlessly
diminished, to the detriment of the environment. In addition, companies may have more
of an incentive to self-disclose if they know there is a chance that, under certain
circumstances, they will be able to use their existing stocks.
In order to determine whether the exercise of such enforcement discretion is warranted, a
two-tier test must be applied.
First, if the chemical substance has not been through PMN review, a request for an
"Expedited Safety Review" must be forwarded to the Office of Pollution Prevention and
Toxics (OPPT), New Chemicals Branch (Example 10E-1). An Expedited Safety Review
is basically an abbreviated preliminary determination by OPPT of the health and
environmental risks of the chemical substance. ThH review does not take the place of the
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Chapter Ten Enforcement Discretion
"full-scale" in-depth 21 or 90 day PMN review process; however, both reviews may occur
concurrently. The Expedited Safety Review request asks OPPT to determine that based on
the result of the preliminary review, EPA finds that the substance will not present an
unreasonable risk of injury to human health or the environment. If concerns are raised
regarding potential adverse health or environmental effects, enforcement discretion to use
existing stocks should not be given (Example 10E-2). Therefore, the first tier must be
cleared in order to move on to the next tier.
The second tier requires that the company provide written details documenting any
immediate and tangible economic harm that will occur to the company (prior to the
expiration of the PMN review period) if it is not allowed to use the existing stocks of the
chemical substance. A company should explain, in detail, the following items:
• The steps the company took to minimize the violation once it was discovered (i.e.,
efforts to quarantine the chemical substance), the amount of the chemical substance
in stock, the shelf life of the existing stock, the date manufacture ceased, efforts to
notify customers, etc.;
• The requested use of the chemical substance and the precise economic loss which
will occur to the company if it does not market the quarantined chemical substance
(loss of jobs, danger of plant closing, etc.);
• The nature and availability of substitutes for the chemical substance;
• The specific need of the customers for the chemical substance;
• The percentage of the company's total contracts/sales that the quarantined chemical
constitutes;
• The other products manufactured/imported by the company;
• The schedule for future sales to existing customers; and
• The potential for temporary shut-down of operations and duration of start-up time
and costs.
A company cannot meet its burden of proof of economic harm by merely stating that its
profits will be reduced or that the company will suffer a loss of "prestige" (reputation) in
the marketplace. Because the company has violated the law, it should be compelled to bear
the loss of any economic gain which it received as a result of noncompliance.
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Chapter Ten Enforcement Discretion
If a company has successfully cleared both tiers of the test, then enforcement discretion may
be granted (Example 10E-3). Once enforcement discretion has been granted, the company
should be required to submit reports (weekly, monthly) which detail the following
information:
• The amount of the substance used during a preset reporting period;
• The customers to whom the chemical/product was shipped; and
• The amount of substance remaining in stock.
The company should also be informed that the granting of such discretion does not, in any
manner, alter any enforcement actions which may arise concerning the substance.
Generally, once enforcement discretion is granted, the company may begin to use the
existing stocks. The alternative, when the economic harm is remote in nature, is to deny
enforcement discretion at that time and instead finalize the use of existing stocks as one of
the terms of the Consent Agreement.
When possible, EPA should receive something in return for granting enforcement
discretion, such as an agreement not to contest EPA jurisdiction over the subject
matter of the complaint. See example 4 for an illustration of the conditions that can
be placed on a company.
Examples:
10E-1 Request for Expedited Safety Review
10E-2 Letter Denying the Right to Use Existing Stocks (at present) - Right to
Use Stocks to be Formalized as Part of Consent Agreement
10E-3 Letter Granting the Right to Use Existing Stocks
10E-4 Letter Granting the Right to Use Existing Stocks
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Chapter Ten Example 10E-1
MEMORANDUM
SUBJECT: Request for an Expedited Safety Review of a Chemical
Substance
FROM: Gerald B. Stubbs, Acting Chief
Case Support Branch
TO: Lawrence E. Cullen, Chief
New Chemicals Branch (TS-794)
On November 9, 1989 a company that self-confessed a potential TSCA
Section 5 violation met with EPA to discuss its illegal manufacture of
a new chemical substance. After the meeting, the company applied for a
Low Volume Exemption (LVE) for this chemical and it was assigned the
number L90-****. The issue concerning whether the company will receive
a LVE is presently under review.
For this chemical, please provided a statement regarding the
results of the PMN safety review and inventory status. If there are
any further questions regarding this matter, please contact Ms. Cindy
Coldiron of my staff at 382-3081.
TSCA Compliance Enforcement 10E-4 Guidance Manual 1992
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Chapter Ten Example 10E-2
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
KB. J.M. Smith
1010 Constitution Lane
North Elbow, TN 00543-1234
Re:
Dear Ms. Smith:
This is in response to your request of October 31, 1989,
concerning the granting of prosecutorial discretion for the commercial
use of a chemical substance which has been manufactured (imported) in
violation of the Toxic Substances Control Act (TSCA). On July 27,
1989, a representative of , Mark Jones, voluntarily disclosed
that had manufactured (imported) for commercial purposes a
chemical substance for which had not obtained a TSCA low-volume
exemption.
As you are aware, EPA will initiate a proceeding for the
assessment of a civil penalty against for violations of TSCA
involving the manufacture (importation) of this chemical prior to the
expiration of the pre-manufacture notice (PMN) review period or the
application for and receipt of a TSCA low-volume exemption. Upon
review of this matter, it has been determined that your requested
authorization to use the existing stocks should be formalized as part
of the settlement agreement between EPA and in the TSCA Section
5 case to be issued by EPA. Until a settlement is reached, no existing
inventories of the illegally manufactured substance may be commercially
used. EPA will proceed with this matter as expeditiously as possible.
Thank you for your cooperation in this matter. If you have any
questions, please contact Ms. Cindy Coldiron. She may be reached at
202-382-0000.
Sincerely yours,
Michael F. Wood, Director
Compliance Division
cc: Jon Silberman
TSCA Compliance Enforcement 10E-5 Guidance Manual 1992
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Chapter Ten Example 10E-3
Mr. Blake A. Biles
Arnold & Porter
1200 New Hampshire Avenue, N.W.
Washington, DC 20036
Dear Mr. Biles:
This is in response to your April 22, 1992 letter to Sanda Howland
of my staff, in which you disclosed possible TSCA noncompliance
situations involving the past commercial manufacture of an epoxy resin
product by a client of yours. In your letter, you specifically
requested authorization to resume shipments of the currently frozen
inventoried products upon completion of EPA's review of two PMNs (P-92-_
_ that your client has submitted concerning this epoxy resign product.
Upon review of this matter, since the Office of Pollution
Prevention and Toxics (OPPT) has determined that the chemical
substances identified in P-92- and P-92- are not expected to
present an unreasonable risk of injury to human health or to the
environment, I am granting your request to resume shipments of the
aforementioned quarantined stocks under the condition that the
following terms are met:
1. Shipments may not resume until the 90-day review period for P-
92 and P-92- have expired.
2. Prior to the initiation of any shipments, you must provide in
writing the total amount of existing stocks presently frozen
and/or quarantined.
3. Documentation must be submitted monthly—by the first of each
month—beginning July 1, 1992, with the following information:
a. the dates of the commercial use/shipment of the two
substances;
b. the company or person to which it was shipped;
c. the amount of the substance used/shipped; and
d. the amount of the substance remaining in inventory or
stock.
This documentation, in addition to the information requested in
item number 2 above, should be submitted to:
Mr. Tony Ellis
Office of Compliance Monitoring (EN-342)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460
Please note that the granting of this enforcement discretion does
not, in any manner, alter any enforcement issues which may arise
concerning these chemical substances.
TSCA Compliance Enforcement 10E-6 Guidance Manual 1992
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Chapter Ten Example 10E-3
No decision has been made with respect to your request for
consolidation of this matter with the other potential TSCA violations
stemming out of two other facilities. Headquarters is currently
coordinating with the appropriate Regional Offices on all of these
matters.
If you have any questions concerning this response, please contact
Mr. Tony Ellis of my staff at (202) 260-1119.
Sincerely yours,
Michael F. Hood, Director
Compliance Division
TSCA Compliance Enforcement 10E-7 Guidance Manual 1992
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Chapter Ten Example 10E-4
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Graham J. McClean
President
& Systems Division
Conway Park
275 N. Field Drive
Lake Forest, IL 60045-2592
In Re: Enforcement Discretion on Customer-owned Inventory
Dear Mr. McClean:
In your April 4, 1991 letter, you requested EPA to grant
prosecutorial discretion for the distribution and use of existing
stocks of any customer-owned, finished product that was manufactured
with the substances described in Polymer Exemption Notices TS-
MBF001, TS-MBF002, TS-MBF003, and TS-BF004.
As you are aware, EPA will initiate a proceeding for the
assessment of a civil penalty against , for violations of the
Toxic Substances Control Act (TSCA) involving the manufacture and use
of these chemicals prior to their inclusion on the TSCA Inventory.
In the meantime, EPA has determined to allow the distribution and
use of existing stocks of any customer-owned, finished product that was
manufactured with the substances identified in Polymer
Exemption Notices mentioned above. This decision, which is contingent
upon the conditions stated below, is based on finding the use,
distribution in commerce, or disposal of the existing stock of premade
articles containing the substances described by these polymer exemption
applications, for the use identified and in the manner reported in the
applications, would not be expected to present an unreasonable risk of
injury to human health or the environment.
In addition, EPA considered the facts stated in your letter of
April 4, 1991, and the subsequent material presented by you at an April
8, 1991 meeting with EPA officials, which we accept as accurate.
Therefore, is authorized to , and no civil
penalty will be assessed for the distribution and use of existing
stocks of any customer-owned, finished product which is manufactured
with the substances described in Polymer Exemption Notices TS-
MBF001, TS-MBF002, TS-MBF003, and TS-MBF004. Customer-owned, finished
products are those products which were produced by and owned by
customers as of April 3, 1991, and includes the mail
forwarding label currently completed and stored on 810 pallets at
Stillwater, Oklahoma plant. This authorization is contingent upon the
following conditions:
TSCA Compliance Enforcement 10E-8 Guidance Manual 1992
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Chapter Ten Example 10E-4
1. agrees to initiate immediate steps to ensure its compliance
with TSCA and certifies that all of its future manufacturing,
processing, and distribution of these chemical substances will be
in full compliance with the provisions of the Toxic Substances
Control Act;
2. agrees to promptly provide any other documents or other
information in the company's possession which the Agency seeks in
order to prepare a civil administrative case for the violations of
Section 15 of TSCA.
3. does not contest the EPA's jurisdiction over the subject
matter of the complaint which will be issued for the violations of
Section 15 of TSCA, and
4. agrees to settle this matter in accordance with the TSCA §5
Enforcement Response Policy (6/8/89).
5. In the event a substance described in Polymer Exemption
Applications presents an unreasonable risk, as determined by EPA,
agrees to immediately stop the distribution of the customer-
owned products.
Sincerely yours,
Michael F. Wood, Director
Compliance Division
I have read the above terms and agree to be fully bound by them.
Graham J. McClean
President,
Date
TSCA Compliance Enforcement 10E-9 Guidance Manual 1992
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Chapter Eleven
Multi-Media Enforcement
CHAPTER CONTENTS PAGE
Multi-Media Enforcement 11-1
TSCA Case Proceedings 11-i Guidance Manual 1992
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Chapter Eleven Contents
TSCA Case Proceedings 11-ii Guidance Manual 1992
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Chapter Eleven
Multi-Media Enforcement
EPA has moved beyond its traditional enforcement of media-specific laws towards integrating
a cross-program/multi-media perspective into all stages of enforcement planning and decision
making. With this cross-program/multi-media perspective, the Agency intends to achieve
additional public health and environmental protection results, deterrence, and efficiency which
might not be achieved through use of traditional single-media approaches alone.
EPA's commitment to cross-program/multi-media enforcement is one reflection of its greater
emphasis on better integrating consideration of health and ecological risks into inspection
targeting and case selection. While these concepts apply in single-medium cases as well, cross-
program/multi-media enforcement is intended to result in comprehensive identification and
remediation of problems at a facility. Cross-program/multi-media inspections also have the
potential of better focusing senior management in the regulated community on the broad range
of environmental compliance issues, better ensuring that they do not overlook significant
environmental problems.
An Agency-wide workgroup analyzed operational modifications that would facilitate greater use
of cross-program/multi-media approaches, and recommended modifications to the counting
methodology that had been used in the past to track and account for civil referral activity. These
adjustments are intended to more accurately reflect the greater magnitude of cross-program/
multi-media actions and the variety of violations being addressed, and to remove any accounting-
related disincentives to bringing these cases.
Data on source compliance status is needed to help target specific geographic, industry,
company, facility, or pollutant-specific sources based on compliance status, compliance history,
and/or environmental risk profile. To provide that capability, EPA has developed an automated
system, known as the Integrated Data for Enforcement Analysis (IDEA) System, which can link
information from its various mainframe computer systems. IDEA, discussed briefly in Chapter
3, Section 6, allows EPA enforcement personnel to engage in an interactive analysis of
compliance and enforcement data that is contained in the various media program data systems.
This capability also provides access to corporate identification information allowing users to
structure their analysis based on corporate parentage or structure, industrial sector, pollutants,
and/or geographic sector.
EPA is also developing cross-program/multi-media training courses for its compliance inspectors
and its technical and legal staffs; these courses also will be available to State environmental and
legal personnel. Courses will be offered under the umbrella of the National Enforcement
TSCA Case Proceedings 11-1 Guidance Manual 1992
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Chapter Eleven Multi-Media Enforcement
Training Institute (NETI), created to provide training to EPA, State, and local personnel
involved in environmental enforcement.
Multi-Media and the TSCA Case Development Officer (CDO)
Multi-media civil administrative actions may be generated and issued in a number of ways,
depending on the Regional Office involved, and whether the evidence was collected during a
planned multi-media inspection, or after the inspection.
There are two methods for conducting planned multi-media inspections. One method involves
one or more inspectors visiting a facility and conducting an inspection under more than one
statute. The second method entails a facility inspection by separate program inspectors within
a close time period, with the ultimate goal of combining violations.
Usually, separate inspection reports are completed for each statute, and Case Development
Officers (CDO) and attorneys from each program involved are assigned to review their part of
the inspection. In some instances, one complaint is issued incorporating all the violations under
the different statutes. In other instances, separate specific complaints are issued, but all on the
same day. Similarly with Consent Agreements, sometimes one combined Agreement is written,
and other times separate Consent Agreement are written.
Multi-media complaints may also be developed after a TSCA specific inspection was conducted,
either by calling other program offices to discern if they have open inspections on the facility
in question, or by making use of the Integrated Data for Enforcement Analysis (IDEA) System
described above. This system provides users with cross-program, multi-media integrated data.
IDEA may indicate that the facility inspected under TSCA has open inspections or open
complaints under other statutes. In addition, the FIFRA and TSCA Tracking System (FTTS),
described in Chapter 3, Section 6, may be used to indicate open inspections or complaints under
TSCA or FIFRA. As described above, the violations could then be combined into one
complaint, or issued as separate complaints but in a coordinated effort.
The CDO should conduct the above research as a routine part of case development in order to
obtain a complete compliance history of a company, whether or not a multi-media complaint will
be issued.
TSCA Case Proceedings 11-2 Guidance Manual 1992
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Chapter Twelve
Federal Facilities Enforcement
CHAPTER CONTENTS PAGE
Introduction . 12-1
Common Acronyms 12-1
Compliance Promotion 12-2
EPA Enforcement Response under TSCA at Federal Facilities 12-2
Example 12E-1: MOA between EPA and HQ TAC/DEEV 12E-5
Example 12E-2: MOA between EPA and USDT and USCG 12E-14
Example 12E-3: Compliance Agreement between EPA and DOE 12E-36
TSCA Case Proceedings 12-i Guidance Manual 1992
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Chapter Twelve Contents
TSCA Case Proceedings 12-ii Guidance Manual 1992
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Chapter Twelve
12 Federal Facilities Enforcement
INTRODUCTION
In November of 1988, the Office of Federal Activities published the Federal Facilities
Compliance Strategy (The Strategy), initiating a renewed effort on the part of EPA to ensure that
Federal agencies and facilities of the Federal government have their "own house in order."
Although EPA is not able to assess civil penalties against Federal agencies for violations of
TSCA, Federal agencies and facilities of the Federal government must comply with Federal
environmental laws in the same manner and degree as non-Federal entities. The Federal
Facilities Compliance Strategy establishes a comprehensive approach to achieving and
maintaining high rates of compliance at Federal facilities. The Strategy provides the basic
framework and consistent guidelines for EPA's media programs to follow in ensuring that
Federal facilities are fully integrated into Federal and State compliance monitoring and
enforcement activities. This strategy replaced the previous program document, entitled
"Resolution of Compliance Problems at Federal Facilities," dated January 1984.
Federal agencies generally must comply with all provisions of Federal environmental statutes
and regulations as well as all applicable State and local requirements, with the exception of very
limited Presidential exemptions which may be issued on a site-specific basis.
COMMON ACRONYMS
Federal facilities include the following six types of facilities:
COCO Contractor Owned/Contractor Operated
GOCO Government Owned/Contractor Operated
GOGO Government Owned/Government Operated
GOPO Government Owned/Privately Operated
JOCO Jointly Owned/Contractor Operated
POGO Privately Owned/Government Operated
TSCA Case Proceedings 12-1 Guidance Manual 1992
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Chapter Twelve Federal Facilities Enforcement
COMPLIANCE PROMOTION
Presidential Executive Order (E.G.) 12088, 3 C.F.R. 243, published on October 13, 1978>
established the Executive Branch process for ensuring Federal agency compliance with Federal,
State, and local pollution control requirements. E.O. No. 12088 provides that each Executive
agency must comply with the same substantive, procedural, and other requirements that would
apply to a private person under TSCA. Additionally, Section 1-302 of E.O. 12088 provides that
"the Administrator shall conduct such reviews and inspections as may be necessary to monitor
compliance with applicable pollution control standards by Federal facilities and activities."
A key provision of E.O. 12088 provides technical advice and assistance to Federal agencies to
ensure cost-effective and timely compliance with pollution control requirements. The Strategy
attempts to reconcile the dual responsibilities of providing the advice and assistance as outlined
in E.O. 12088 with the responsibility to take enforcement actions against Federal facilities,
where appropriate, as provided for in the various environmental statutes.
To meet the responsibility to provide technical assistance and advice to Federal agencies, the
Regions should seek to:
• Target particular agencies for courses in areas where an Agency has had a pattern of
compliance problems;
• Encourage Federal facilities to adopt environmental auditing programs to help achieve
and maintain higher levels of overall compliance;
• Identify the most environmentally significant Federal facilities across several media
programs to help achieve and maintain higher levels of overall compliance; and
• Identify the most environmentally significant Federal facilities across several media
programs as candidates for multi-media inspection.
EPA ENFORCEMENT RESPONSE UNDER TSCA AT FEDERAL FACILITIES
Unlike some other pollution control laws, TSCA does not expressly provide for the use of U.S.
EPA administrative and civil enforcement authorities against other Federal agencies. Instead,
TSCA Case Proceedings 12-2 Guidance Manual 1992
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Chapter Twelve Federal Facilities Enforcement
EPA's civil strategy for enforcing the PCB regulations against other Federal agencies relies on
E.G. 12088 and consists of issuing a notice of violation and, in appropriate circumstances,
working with the offending Federal agency to develop a Federal Facilities Compliance
Agreement (FFCA).
The only TSCA regulations enforced at Federal facilities are the PCB regulations at 40 C.F.R.
Part 761. Example 12E-1 provides a sample of typical Federal Facility Notice of Non-
Compliance for PCB violations. Note that the civil penalty is calculated according to the PCB
Penalty Policy, although no penalty is collected.
EPA's enforcement process for Executive Branch agencies is administrative, and currently does
not provide for civil judicial action or assessment of civil penalties.1 This limitation does not
apply to enforcement actions taken by States as authorized under various statutes nor to EPA
actions directed to non-Federal operators of Federal Facilities who are not officials of Executive
Branch Agencies. It also does not affect EPA's responsibility to investigate criminal wrong-
doing or refer suspected criminal cases to the Department of Justice. EPA will pursue the full
range of its enforcement authorities against GOCOs, where appropriate, and also take action
against Federal agencies at GOCO facilities in certain circumstances. Contractor operator
violations are addressed in accordance with policies for enforcement of TSCA against private
parties.
One of the first Complaints issued to a GOCO was in June 1986 against Rockwell International
Corporation for PCB violations. This case was significant in that, by agreeing to the terms of
the settlement, Rockwell admitted that the Agency had the jurisdiction to bring the enforcement
actions against them.
Prior to the settlement, Rockwell contended it was protected from such actions because it was
operating a Federal facility. The Department of Energy (DOE) intervened in the case, arguing
that any civil penalties assessed to Rockwell would have to be paid by DOE as part of its
operating contract. DOE contended that because Rocky Flats is a Federal facility, and EPA does
not seek civil penalties for violations committed by other Federal agencies, no penalty could be
assessed to Rockwell. EPA successfully opposed DOE's motion, countering that the
enforcement action is separate and distinct from the terms of the DOE/Rockwell contract.
Rockwell paid a civil penalty of $47,500, the largest civil penalty ever assessed at that time by
EPA against a contractor at a Federal facility.
'This limitation does not apply to penalties for violations of Interagency Agreements under Section 120 of
the 1986 Superfund Amendments and Reauthorization Act (SARA).
TSCA Case Proceedings 12-3 Guidance Manual 1992
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Chapter Twelve Federal Facilities Enforcement
The TSCA Enforcement Response Policy for Enforcement Against Federal Agencies, still in
draft, will supersede those provisions of the Federal Facilities Compliance Strategy of November
1988 (the "Yellow Book") that deal with enforcement of TSCA. Copies of the document, when
final, as well as the "Yellow Book" may be obtained by sending a written request to the
following address:
U.S. Environmental Protection Agency
Office of Federal Facilities Enforcement (OFFE) (OE-2261)
401 M Street, S.W.
Washington, D.C. 20460
TSCA Case Proceedings 12-4 Guidance Manual 1992
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Chapter Twelve Example 12E-1
U.S. ENVIRONMENTAL PROTECTION AGENCY
REGION 10
" _ V 1200 SIXTH AVENUE
\ SEATTLE. WASHINGTON 98101
I AUG 14 B87
,„ ,„
ATTM or SO-1 25
611 Bumet, Acting Chief
Environmental Planning Division
HQTAC/DEEV
Langley Air Force Base
Langly. Virginia 23665-5001
Re: TSCA Complaint
Docket No. 1086-11-10-2615
Dear Mr. Burnet:
Pursuant to our conversation on August 11, 1987, enclosed Is a
conformed copy of the final NOA between EPA and HQ TAG. To prevent any
further delay, EPA has agreed to the wording of the HOA as proposed by NQ
TAG on July 28. 1987.
In response to some of the concerns raised by Colonel Hyatt In his
July 28 letter, please be aware that 1t was not our Intent to Bake the
Conflict Resolution section unilateral by deleting the words 'and resolve
conflicts'; we Merely thought these words were superfluous. Our use of the
tern 'violations' In that section of the NOA referred to violations of the
HOA not to violations of TSCA. Hy apologies for the concern this caused
you. He acknowledge the difficulty we have had 1n being able to reach a
written agreement 1n this Batter, but changes Insisted upon by HQ TAG have
also substantially contributed to that delay. He were particularly
concerned when 1t became apparent that HQ TAG would not meet the August 1987
deadline for completion of Initial site stabilization It had previously
agreed to. This convinced us that the NOA had to specifically set forth all
our expectations and we added language to our third proposed NOA to reflect
this.
As you can see, we have accepted your revised wording for Milestone 10
regarding preliminary cleanup level of 10 ppa PCBs. It Is Important to
note, however, that consistent with the PCS Spill Cleanup Policy, 'spills
which occurred before the effective date of this policy are to be
decontaminated to requirements established at the discretion of EPA, usually
through Its regional offices.' It 1s misleading to Interpret the PCB Spill
Cleanup Policy as having 'new relaxed standards,' as Colonel Hyatt Indicates
In his letter of July 28, 1987. Because of the length of time Involved
since the spill occurred and the weather conditions existent at the site of
the spill. It 1s reasonable to believe that more extensive soil removal
would be required to effectuate the same degree of cleanup (I.e. the amount
of PCB cleaned up) than would have been necessary had the cleanup taken
place In a prompt and adequate manner. In this regard, we will review the
results of your post-cleanup sampling and any post-cleanup sampling that EPA
performs, and will advise you of our determination of the adequacy of the
cleanup. Similarly, we will advise you of our evaluation of the results of
your findings regarding the sewer line.
TSCA Case Proceedings 12E-5 Guidance Manual 1992
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Chapter Twelve Example 12E-1
Me are encouraged by your recent progress In soliciting bids and
preparing to award the contract for the Mt. Hebo cleanup.
Thank you for your assistance In reaching an agreement that Is
satisfactory to both parties.
Sincerely,
Deborah E. H11s*an
Assistant Regional Counsel
Enclosure
TSCA Case Proceedings 12E-6 Guidance Manual 1992
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Chapter Twelve
Example 12E-1
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12«.76 DOJ
MEMORANDUM OF AGREEMENT
Between
United States Air Force. Headquarters, Tactical
Langley A1r Force Base, Virginia
and
The Environmental Protection Agency
I. AUTHORITY
A1r Command
Region 10 of the United States Environmental Protection Agency (EPA)
and the United States Air Force. Headquarters, Tactical Air Cotnand (HQ
TAC) are parties to this agreement which 1s entered
authority of Executive Order (E.O.) 12088. October
47707). It 1s being entered Into In settlement of
against a federal facility and 1s consistent with E
policy which favor Interagency settlement over more
Into under the
13. 1978 (43 FR
an enforcement action
.0. 12088 and Agency
formal enforcement
action. Nothing In this agreement shall be construed to require a
violation of the Anti-Deficiency Act. 31 U.S.C. $1341.
11. PURPOSE
EPA and HQ TAC are entering Into this agreement to
clarify each agency's
responsibilities and commitments for conducting actions required and
authorized by the Toxic Substances Control Act (TSCA), the PCB
(polychlorlnated blphenyl) Regulations at 40 CFR Part 761, and
applicable portions of Executive Order 12088.
MEMORANDUM OF AGREEMENT - PAGE ONE
TSCA Case Proceedings
12E-7
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Chapter Twelve
Example 12E-1
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Form OtO-IM
>2«.76 DOJ
III. SCOPE
1. This agreement Is entered Into by the parties to assure compliance
at ttt. Hebo A1r Force Station; Hebo. Oregon, by HQ TAC. with the PCB
Regulations (40 CFR Part 761) which were promulgated under the authority
of the Toxic Substances Control Act (TSCA) (15 OSC 2601 et seq. ).
2. This agreement Is not and shall not be construed to be a vehicle to
relieve HQ TAC or Its contractors of any legal obligations under TSCA
which are 1n addition to or different from matters covered In this
agreement. Neither does the agreement relieve HQ TAC of the
responsibility to comply with other environmental laws. The agreement
does not create or change any substantive or procedural rights In other
parties and 1s Intended only for the administrative purposes of EPA and
HQ TAC. Nothing In this agreement shall diminish any power or legal
responsibility which EPA or KQ TAC now have.
3. This agreement contains a "plan* as described In section 1-601 of
E.O. 12088 to achieve and maintain compliance with the PCB Regulations
at 40 CFR Part 761.
4. It 1s the goal of this Compliance Plan and Schedule to have HQ TAC
•
bring conditions it Nt. Hebo A1r Force Station Into full compliance with
Section IS of TSCA. 15 U.S.C. 2614 of the PCB Regulations. HQ TAC Is to
provide a compliance plan to EPA. This plan 1s to Include specific
KNORANDUn OF AGREEMENT - PAGE TWO
TSCA Case Proceedings
12E-8
Guidance Manual 1992
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Chapter Twelve
Example 12E-1
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fern C60.1U
u«-?e BOJ
tasks, milestones, and timetables for compliance; amendment procedures;
and quality assurance procedures. Once this plan is reviewed and
approved by EPA it becomes an Integral part of this agreement and is to
be implemented by HQ TAG.
IV. PLANNING REQUIREMENTS
This plan covers PCBs present at Mt. Hebo A1r Force Station as of the
effective date of this agreement. It does not include any PCBs which
may be present in in-service equipment at the facility which is owned by
Tillamook People's Utility District or any other non-federal utility.
It Includes:
1. A plan to identify existing PCB .spill sites and to promptly
provide cleanup for PCB Containers and spill sites.
2. A plan to award and Implement the necessary contracts or other
actions necessary to achieve compliance with Section 15 of TSCA,
15 U.S.C. 2614.
V. CONFLICT RESOLUTION
1. EPA and HQ TAC will each use a single point of contact for
implementing this Memorandum of Agreement and coordinating TSCA PCB
compl lance
f
MEMORANDUM OF AGREEMENT - PAGE THREE
TSCA Case Proceedings
12E-9
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Chapter Twelve
Example 12E-1
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torn CID-IU
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matters. The point of contact for EPA will be Mr. Minima M. Hedgebeth.
Environmental Protection Specialist, Toxic Substances Section. The point
of contact for HQ TAG will be Mr. Gil Burnet.
2. At either EPA's or HQ TAC's request, EPA and HQ TAG points of contact
will meet to discuss any questions or problems that arise.
3. HQ TAG shall notify EPA promptly In all cases where HQ TAG will not
meet a deadline In the Compliance Plan and Schedule. Anticipated non-
compliance with, or violations of, this agreement shall be resolved by
the signatories, or If necessary brought to the attention of the
Administrator of the EPA for resolution by EPA and KQ TAG. If necessary.
the Director. Office of Management and Budget shall be notified pursuant
to Sections 1-602 and 1-603 of E.O. 12088. the Director. Office of
Management and Budget, shall consider such steps as necessary to resolve
any conflicts and remedy violations.
4. Portions of this remedial action are being funded under the Defense
Environmental Restoration Act (10 U.S.C. Chapter 160). To the extent
these actions encompass activities under the Comprehensive Environmental
Response. Compensation and Liability Act. the authorities vested 1n the
Department of Defense under E.O. 12580 apply. However, should there be •
need for dispute resolution between the parties, the dispute resolution
process of E.O 12088 will apply.
MEMORANDUM OF AGREEMENT - PAGE FOUR
TSCA Case Proceedings
L2E-10
Guidance Manual 1992
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Chapter Twelve
Example 12E-1
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BS.°SF
VI. EHFORCEHEHT
While this agreement Is In effect. EPA shall not Initiate enforcement
action against HQ TAC for violations of TSCA regulations which are
already the subject of this agreement. This does not preclude EPA
enforcement actions for subsequent violations of TSCA regulations by
either HQ TAC of Its contractor(s) during the cleanup phase of the plan.
VII. EXPIRATION
This agreement will expire when compliance 1s reached as agreed between
EPA, indOlQ TAC. T
X7 /\K7 r?
^^ \ ff\^~~~~^\ t'lo-b1/
.ROME 6. (tUStLb— ^ \ " bate
Regional Administrator \
Environmental Protection Agency, Region 10
\Z3$&£^e^
-------
Chapter Twelve
Example 12E-1
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OtD.IU
DOJ
1.
2.
MILESTONES AND TIMETABLES FOR COMPLIANCE
Mt. Hebo Air Force Station. Hebo, Oregon: Site Cleanup
Architect-Engineer (A-E) Notice to Proceed with
preparation of Finding of Fact Report and Cleanup
Proposal
Early April 1987
A-E to Complete Draft Finding of Fact Report and End of Early June
Cleanup Proposal.
3. Agencies' Review Complete
4.
A-E complete Final Finding of Fact Report and
Cleanup Proposal.
5. A-E conducts meeting to discuss draft cleanup
proposal.
6. Previously identified transformers and trans-
former scrap are removed fron facility for
disposal. In addition A-E samples soil visibly
contaminated by oil and analyzes for PCB; visibly
contaminated soil with field test detectable
amounts of PCB will be removed froa facility
for disposal at chemical waste landfill or
treated in an EPA approved manner. Air Force
notifies EPA of the removal of transformers
and transformer scrap within 48 hours of such
removal.
7. A-E submits final cleanup proposal. Air Force
submits a copy of Radian Corporation's sampling
plan and proposed OA/QC procedures to EPA for
review. EPA provides review comments to the
Air Force within two weeks of receipt of
sampling plan and proposed OA/OC procedures.
8. Request for proposal for Final Design A-E
services due.
End of June 1987
Early July 1987
Mid-August 19B7
End of August 1987
Mid-September 1987
Early October 1987
8. A-E notice to proceed final design start.
10. If either the Air Force or EPA has
hydrogeologlcal data or other Information that
they feel would support allowing cleanup to a
higher or lower level than 10 ppm PCB, they
should present that Information to the other no
later than November 16. 1987. EPA and Air Force
representatives «hall make every effort to reach
agreement as to'the appropriate cleanup level.
MILESTONES/TIMETABLES - PACE ONE
Late October 1987
Mid-November 1987
TSCA Case Proceedings
12E-12
Guidance Manual 1992
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Chapter Twelve
Example 12E-1
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11. Preliminary designs are sent to agencies as
Information copy. Late December 1987
12. EPA will advise the A1r Force no later than Mid-January 1988
January 15, 1988 of Its proposed cleanup level
requirement. A-E Final Plans and Specifications
trill Incorporate that requirement and proceed as
scheduled, but nothing shall prevent the Air Force
from Invoking Conflict Resolution procedures
consistent with this Memorandum of Agreement and
E.O. 12088. In the event of disagreement, both EPA
and the A1r Force shall make every effort to
resolve such disagreement before construction Is
Initiated.
13. A-E Final Plans and Specifications complete. Late January J9R8
14. Advertise contract. Late February 1988
•
15. Award contract. Late March 19Pfl
16. Start construction. Late April 1988
(weather permitting)
17. Final verification of cleanup must be Early August I98R
completed by August 1988.
18. Complete construction. * Early August 1988
NOTE: Tentative schedule assumes:
Finding of Fact Statement of Work acceptable.
Timely Responsiveness of cements by Agencies.
f.
"*i»"tti*J 1 MILESTONES/TIMETABLES - PAGE TWO
TSCA Case Proceedings
12E-13
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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RECEIVED
NOV
"t'1989
HEARINGS CkEPK
EPA-
MEMORANDUM OF AGREEMENT
BETWEEN
THE UNITED STATES DEPARTMENT OF TRANSPORTATION
UNITED STATES COAST GUARD
AND
THE ENVIRONMENTAL PROTECTION AGENCY
.REGION 10, SEATTLE, WASHINGTON
TOXIC SUBSTANCES CONTROL ACT
DOCKET NUMBERS
1086-02-01-2615 AND 1089-03-02-2615
IN RE: COAST GUARD SUPPORT CENTER KODIAK
KODIAK, ALASKA
MEMORANDUM OF AGREEMENT: PAGE 1 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
•ntuiviri »
TSCA Case Proceedings
12E-14
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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1.
AUTHORITY
1. Region 10 of the United States Environmental Protection Agency (EPA)'
and the United States Coast Guard ("Coast Guard") are parties to this
agreement which 1s entered into under the authority of Executive Order (E.O.)
12088, October 13. 1978 (43 Federal Register 47707). It 1s being entered into
in settlement of two enforcement actions against a federal facility, as
referenced on the title page of this document, and is consistent with E.O.
12088 and Agency policy which favor interagency settlement over more formal
enforcement action. Nothing in this agreement shall be construed to require a
violation of the Anti-Deficiency Act, 31 U.S.C. § 1341.
II.
PURPOSE
2. EPA and the Coast Guard are entering Into this agreement to clarify
each Agency's responsibilities and commitments for conducting actions required
and/or authorized by the Toxic Substances Control Act (TSCA), 15 U.S.C. S 2601
et sea., tne PCB (polychlorinated biphenyl) Regulations at 40 C.F.R. Part 761.
and applicable portions of E.O. 12088.
MEMORANDUM OF AGREEMENT: PAGE 2 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
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Chapter Twelve
Example 12E-2
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III.
SCOPE
3. This agreement is entered into by the parties to assure compliance
at the Coast Guard Support Center Kodiak. by the Coast Guard, with the PCB
Regulations (40 C.F.R. Pan 761) which were promulgated under Section 6 of the
Toxic Substances Control Act (TSCA), (15 U.S.C. S 2605 (1976)).
4. This agreement is not and shall not be construed to be a vehicle to
relieve the Coast Guard or Its contractors of any legal obligations under TSCA
which are in addition to or different from matters covered in this agreement.
Neither does the agreement relieve the Coast Guard of the responsibility to
comply with any other environmental laws or regulations. The agreement does
not create or change any substantive or procedural rights in other parties and
is intended -only for the administrative purposes of EPA and the Coast Guard.
Nothing in this agreement shall diminish any power or legal responsibility
which EPA or the Coast Guard now have.
5. This agreement contains a "plan" as described in section 1-601 of
E.O. 12088 to achieve and maintain compliance with the PCB Regulations at
40 C.F.R. Part 761.
6. It is the goal of this Compliance Plan and Schedule to have the
Coast Guard bring conditions at the Coast Guard Support Center todlak, Kodiak,
Alaska. Into full compliance with Section 15 of TSCA, 15 U.S.C. S 2614. Tasks
to be conducted by the Coast Guard pursuant to this Memorandum of Agreement
MEMORANDUM OF AGREEMENT: PAGE 3 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-16
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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are Identified in Attachment I, Remedial Implementation Plan. Milestones and
timetables for the initiation and completion of the tasks identified in
Attachment I are summarized in Attachment II.
IV.
PLANNING REQUIREMENTS
7. This plan defines the scope of remedial activities necessary to
clean up PCB contamination on Coast Guard property at the Coast Guard Support
Center Kodiak.
8. The Coast Guard shall conduct all sample preservation,
chain-of-custody recordkeeping, and quality assurance/quality control (QA/QC)
procedures in accordance with EPA guidance documents and shall strictly follow
the disposal procedures outlined in 40 C.F.R. § 761.60.
9. The Coast Guard shall ensure that PCB contaminated materials and
tools are stored for disposal in Department of Transportation specification
drums identified in 40 C.F.R. § 761.65(c)(6) or (7). During excavations,
drums will be stored on visqueen liner sheets to avoid contaminating new
areas. The visqueen will be arranged in a manner to provide continuous
six-inch berating around the temporary storage area to prevent any
PCB-contannnatlon from migrating from the storage area.
MEMORANDUM OF AGREEMENT: PAGE 4 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-17
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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10. The cleanup of PCBs at the Coast Guard Support Center Kodlak will be
addressed 1n several phases. Specific tasks to be conducted are outlined in
Attachment I. The following Identifies the general areas to be addressed
under the terns of this Memorandum of Agreement.
A. Known areas of contamination:
(1) Building Pad 95
(2) Transformer Pad next to pole 685
(3) Ground and soil (9 pole sites of 66 tested)
(4) Concrete vaults (9 of 11, all tested)
(5) Underground manholes (16 of 110, percent tested
unknown)
B. Suspected Areas of Contamination: Additional Testing
11. All documentation required to be submitted by the Coast Guard to EPA
under the terns of this Memorandum of Agreement shall be sent to:
William Hedgebeth
U.S. Environmental Protection Agency
Pesticides and Toxic Substances Branch
M/S AT-083
1200 Sixth Avenue
Seattle, Washington 98101
V.
CONFLICT RESOLUTION
12. EPA and the Coast Guard will each use a single point of contact for
implementing this Memorandum of Agreement and coordinating TSCA
PCB compliance matters. The point of contact for EPA will be William
Hedgebeth, Environmental Protection Specialist, Toxic Substances Section,
telephone (206) 442-7369. The point of contact for the Coast Guard will be
Harda Quon Stothers, Chief, Planning Branch, Maintenance and Logistics
MEMORANDUM OF AGREEMENT: PAGE 5 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-18
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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Command, Pacific. MLCPAC(s), Alameda. California, telephone (415) 437-3916.
Either party may make a redesignation of its point of contact upon written
notification to the other party.
13. At either EPA's or the Coast Guard's request, the points of contact
will confer to discuss any questions or problems that arise.
14. If any event occurs which the Coast Guard believes will or may cause
delay to be anticipated in the achievement of any provision of this Memorandum
of Agreement or compliance with any deadline set forth in the Memorandum of
Agreement, the Coast Guard shall notify EPA Region 10 in writing at least
seven (7) calendar days prior to the anticipated delay. That notification
shall state the precise cause of the delay, the time required for the Coast
Guard to take appropriate measures to minimize the delay, and Include a
description of those appropriate measures.
15. If EPA Region 10 finds that the Coast Guard has complied with the
notice requirements of the preceding paragraph, then the time for performance
under this Memorandum of Agreement may be extended by mutual agreement. Such
extension shall be for a period no longer than the delay resulting from the
circumstances described. Circumstances under which EPA would be amenable to
an extension of time include but are not limited to unforeseen engineering
problems, unavoidable and unforeseen delays caused by compliance with federal
procurement statutes and regulations, labor strikes, adverse weather
conditions, natural disasters, or other circumstances beyond the control of
the Coast Guard. Delay in an Interim requirement shall not automatically
justify or excuse delay in the attainment of subsequent requirements.
MEMORANDUM OF AGREEMENT: PAGE 6 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-19
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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16. The Coast Guard shall have the burden of proving that any delays are
caused by circumstances beyond the reasonable control of the Coast Guard.
17. Both parties to this agreement shall make reasonable efforts to
Informally resolve, at the project manager or Immediate supervisor level, all
anticipated noncompllance with, or violations of, this agreement. If
resolution of the matter cannot be achieved. It will be elevated to the
signatories for resolution. If the matter cannot be resolved at the signatory
level, 1t will be elevated to the Administrator of the EPA and the Commandant
of the U.S. Coast Guard or the Secretary of the Department of Transportation
for resolution. Finally, If necessary, the Director. Office of Management and
Budget, shall be notified pursuant to Sections 1-602 and 1-603 of E.O. 12088.
In this event the Director, Office of Management and Budget, will consider
such steps as necessary to resolve any conflicts and remedy violations.
VI.
ENFORCEMENT
18. While this agreement Is In effect, EPA shall not Initiate
enforcement action against the Coast Guard for violations of TSCA regulations
which are already the subject of this agreement. This does not preclude EPA
enforcement actions for additional and/or subsequent violations of TSCA
regulations by either the Coast Guard or Its contractor(s).
MEMORANDUM OF AGREEMENT: PAGE 7 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 ft 1089-03-02-2615
TSCA Case Proceedings
12E-20
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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VII.
EXPIRATION
19. This agreement will expire when compliance Is reached as mutually
agreed between EPA and the Coast Guard. For the purposes of TSCA only, once
conditions of the Memorandum of Agreement have been satisfactorily completed,
EPA will presume any PCB contamination at the site, Identified 1n the future.
to have occurred subsequent to the completion of cleanup under the Memorandum
of Agreement. The burden of proving that PCB contamination 1s historic
(historic, for the purposes only of this Memorandum of Agreement, being
defined as prior to the completion of cleanup under the Memorandum of
Agreement) will be on the party making that claim.
20. Within 30 days of the Coast Guard's final notification of completion
of all milestones required under the Memorandum of Agreement, the Commander,
U.S. Coast Guard, Maintenance and Logistics Command Pacific, will provide EPA
with an affidavit that all conditions and terms of the Memorandum of Agreement
have been completed.
21. Within 45 days of receipt of the Coast Guard's affidavit, EPA will
acknowledge 1n writing the receipt of the affidavit. If EPA finds that the
milestones and requirements of the MOA have been completed to EPA's
satisfaction, EPA will so indicate in its written acknowledgment.
MEMORANDUM OF AGREEMENT: PAGE 8 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-21
Guidance Manual 1992
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Chapter Twelve
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22. EPA reserves the option of conducting a verifying Inspection after
the Coast Guard has provided EPA with the final notification of completion of
all milestones required under the Memorandum of Agreement. If EPA elects this
option, the verifying Inspection will be conducted within 30 days of the Coast
Guard's final notification of completion.
ROB IE 6. RUSStl
Regional Administrator \
Environmental Protection AgencyX Region 10
Date
P. A. BUNCH
Rear Admiral, U.S. Coast Guard
Commander, Maintenance and
Logistics Command Pacific
Date
MEMORANDUM OF AGREEMENT: PAGE 9 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-22
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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ATTACHMENT I
REMEDIAL IMPLEMENTATION PLAN
1. KNOWN AREAS OF CONTAMINATION. These areas have previously been
Identified through testing by the Coast Guard Pacific Strike Team or by
the joint Coast Guard/Kodiak Electric Association testing.
A. BUILDING PAD 95
(1) PROBLEM: PCB (and non-PCB) electrical equipment stored on Pad
SOLUTION: All PCB Transformers, PCB-contaminated transformers.
non-PCB transformers, and any other electrical equipment stored
on Pad 95 shall be removed from the area. Any and all PCB
Transformers and PCB-contaminated transformers shall be drained
and flushed, arranged for transport for disposal, and disposed
of in accordance with 40 C.F.R. § 761.60.
Disposal certification for the following transformers.
Identified in the 1987 sampling project as either PCB or
PCB- Contaminated Transformers, shall be provided to EPA:
1. 6E. serial t 6585808, sample * 345, 100,000 ppra.
2. Marcus, serial f 82887. sample * 352, 260 ppm.
3. 6E. serial 1 C983077-57K, sample * 353, 10,000 ppm.
4. Marcus, serial * 82888. sample I 355. 1.800 ppm.
5. GE, serial 6695203. sample 360. 640 ppm.
6. GE, serial 6700779. sample 361, 340 ppm.
7. GE. serial 6354378. sample 365, 130 ppm.
8. GE, serial 6354381 , sample 366, 100 ppm.
9. GE, serial 6700693, sample 374, 360 ppm.
10. GE. serial 6700713. sample 375. 500 ppm.
11. GE. serial 6700758. sample 376. 490 ppm.
12. GE. serial 6700734. sample 377. 830 ppm.
13. GE, serial E443045-62P. sample 1 381. 220 ppm.
14. Mestinghous . serial f 2978936. sample f 382. 75 ppm.
15. Westinghous . serial f 2960585, sample 1 385, 100 ppm.
16. GE. serial 5751494, sample f 410, 58,000 ppn.
17. GE, serial 5777783, sample 1 411. 36,000 ppm.
18. GE. serial 6416148-65K. sample I 416. 110 ppm.
19. GE, serial G416958-65K, sample 1 418, 150 ppm.
20. GE, no serial I, sample f 422, 180,000 ppm.
21. GE, no serial 1. sample f 426. 100.000 ppm.
22. GE, serial 1 6354289, sample f 436, 130.000 ppm.
23. Mestinghouse. serial f 2975556, sample f 444, 150 ppm.
24. Mestinghouse. serial 1 2964031, sample I 455, 500 ppm.
25. Mestinghouse. serial f 2968799, sample 1 456, 23.000
Ppm.
26. Mestinghouse, serial f 2968888, sample f 457, 200 ppm.
MEMORANDUM OF AGREEMENT: PAGE 10 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 i 1089-03-02-2615
TSCA Case Proceedings
12E-23
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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27. Westinghouse, serial 1 2960490, sample f 459, 270.000
PPm.
28. 6E. serial t 6700784, sample f 465. 830 ppn.
29. 6E, serial 1 6700737, sample 1 475. 210 ppn.
Any PCS Transformers or PCB- contaminated transformers
Identified on Pad 95 and not appearing on the above list shall
be Identified to EPA and disposal certifications shall be
provided to EPA.
WORK INITIATION DATE: June 19. 1989
WORK COMPLETION DATE: Hay 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation: November 30. 1989*
2. Notification of work completion: May 31. 1990
3. Disposal certifications: May 31. 1990
* It Is recognized by EPA that the Coast Guard may have
completed the tasks Identified above by the time the
Memorandum of Agreement has been signed by both parties.
(2) PROBLEM: Surface PCB-contam1nat1on of the concrete pad
designated as Pad 95 as Identified 1n the Coast Guard Strike
Team sampling program In April 1987 (ATTACHMENT III).
SOLUTION;
Remove any visible PCB liquid, double wash and rinse as follows:
(a) First rinse the surface with a non-1on1c surfactant
cleaner. Wipe the surface with a cleaner-soaked absorbent
pad for one minute per square foot. Rough surfaces shall
be scrubbed with a scrub brush or scrubbing pad after
application of the cleaner fluid. The residual cleaner
shall be removed with absorbent pads until the surface 1s
dry. The wash solution shall then be rinsed off with one
gallon of water per square foot of surface, and mopped
until the surface 1s dry.
(b) Then rinse the surface with an organic solvent such as
•ethylene chloride or kerosene, rather than a nbn-1on1c
surfactant. U1pe and rinse the surface as described In
(a) above. The rinsate from these procedures shall be
treated as PCB-contatnlnated material and disposed of in
accordance with 40 C.F.R. $ 761.60.
MEMORANDUM OF AGREEMENT: PAGE 11 OF 22
TSCA DOCKET NUMBERS 1 086- 02- 01 - 261 5 I 1089-03-02-2615
TSCA Case Proceedings
12E-24
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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(c) Sample and complete clean-up as follows:
Conduct post-rinse cleanup verification using a sample
grid established according to EPA document
1 EPA-560/5-86-017, Field Manual For Grid Sampling of PCB
Spill Sites to Verify Cleanup (Attachment IV). Wipe
samples shall be taken using a 100 cm2 template and
shall be taken as described in the EPA document identified
in this paragraph, under the section "Surface Sampling, "
page 41. Samples shall be screened with a portable gas
chromatograph or a HcGraw-Edlson PCB kit to determine 1f
further cleanup Is necessary. Duplicate samples and
blanks shall be sent to a qualified lab for confirmation.
(d) Remove all surface areas, and all subsurface areas as
determined by sampling, on Pad 95 that remain contaminated
with 100 mlcrograms per 100 cm2 or greater PCBs.
Dispose of contaminated concrete at an EPA-penn1tted TSCA
chemical waste landfill. Areas that show less than 100
mlcrograms per 100 cmz PCB contamination shall be broken
up, crushed, and leveled in place. Access to the area
will be restricted by a fence until the Coast Guard
documents that the PCB-contaml nation in the area does not
exceed 10 parts per Billion in the soil and 10 mlcrograms
per 100 cm* in the concrete.
WORK INITIATION DATE: December 9. 1989
WORK COMPLETION DATE: Nay 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation*: December 15, 1989
2. Description of wipe sample grid: December 15, 1989
3. Analytical results from wipe
sampling (initial and duplicates sent
to qualified lab): January 1, 1990
4. Notification of work completion*: May 31, 1990
* It 1s recognized by EPA that the Coast Guard may have
completed the tasks Identified above by the time the
Memorandum of Agreement has been signed by both parties.
MEMORANDUM OF AGREEMENT: PAGE 12 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-25
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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(3) PROBLEM: Soil on and around Pad 95 contaminated to 25 ppm or
greater PCBs.
SOLUTION: PCB-contam1nated soil around
excavated -and the soil cleaned up to a level
PCB. Where documented PCB contamination 1s
within a buffer area of one (1) lateral foot
Pad 95 shall be
less than 25 ppm
visible, all soil
around the visible
traces will be excavated. All excavated soil shall be disposed
of as PCs-contaminated waste at an EPA-approved TSCA chemical
waste landfill. Post-cleanup grid sampling,
EPA document 4 EPA-560/5-86-017 (Attachment
conducted prior to backfilling to verify the
as identified in
IV). shall be
adequacy of the
cleanup. The excavated area shall be backfilled with clean
soil which contains less than 1 ppm PCB.
WORK INITIATION DATE: : December 9. 1989
WORK COMPLETION DATE: Nay 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation:
2. Description of post-cleanup grid
sampling:
3. Analytical results from grid
sampling:
4. Notification of work completion:
B. TRANSFORMER PAD NEXT TO POLE 685
PROBLEM; The unused transformer pad next to
December 15. 1989
December 15. 1989
January 1, 1990
May 31. 1990
pole 685 was found
to have PCB levels ranging from 11.7 to 68.0 ug/100 cm2.
SOLUTION: The pad will be demolished and disposed of.
WORK INITIATION DATE: May 1, 1990
WORK COMPLETION DATE: December 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work initiation:
2. Notification of work completion:
MEMORANDUM OF AGREEMENT: PAGE 13 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
Hay 15. 1990
December 31 , 1 990
TSCA Case Proceedings
12E-26
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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C. GROUND AND SOIL CONTAMINATION
PROBLEM: PCB-contamlnated soil surrounding pole-mounted
transformers.
SOLUTION: Excavate soil surrounding poles containing
transformers where PCS contamination has been Identified in soil at
a concentration of 25 ppm or greater. Excavate a radius of at least
2.5 feet and a depth of 3 feet around poles. Any necessary outages
during excavation shall be coordinated with Kodiak Electric
Association. Post-cleanup sampling, as determined in EPA document
4 EPA-560/5-86-017, Attachment IV, shall be conducted prior to
backfilling to verify that the PCS concentration in all excavated
areas is below 25 ppm. The excavated area shall be backfilled with
clean soil containing less than 1 ppm PCB. Contaminated soil on
Coast Guard property in residential or other non-restricted areas
shall be cleaned to less than 10 ppm.
WORK INITIATION DATE: May 1. 1990
WORK COMPLETION DATE: December 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work initiation: May 15, 1990
2. Description of post-cleanup grid
sampling: June 15. 1990
3. Analytical results from grid
sampling: August 1, 1990
4. Notification of work completion: December 31, 1990
D. CONCRETE VAULT CONTAMINATION
PROBLEM : Clean vaults with PCB concentrations of
10 ug/100 cm2 or greater. Encapsulate if between 10 and
100 ug/100 cm? after rinsing.
SOLUTION: Remove any visible PCB liquid, and double wash and
rinse stained concrete as described in draft EPA Document dated July
8, 1987, entitled "PCS Spill Cleanup Wipe Sampling and Double
Wash/Rinse." This document is incorporated herein by reference and
included as Attachment V. All areas remaining at 10 ug/100 cm2 or .
greater shall be encapsulated with epoxy-based paint or concrete
sealer.
Post-cleanup sampling shall be conducted to verify that all vault
surfaces have PCB concentrations less than 10 ug/100 cm2. The
Coast Guard shall encapsulate all vault surface areas with an
epoxy-based paint or concrete sealer where PCB concentrations are
greater than 10 ug/100 cm2 but less than 100 ug/100 cm2. [The
' Coast Guard shall conduct semi-annual wipe sampling of the
MEMORANDUM OF AGREEMENT: PAGE 14 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-27
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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encapsulated areas for a period of two years after the completion of
cleanup to verify that there Is no detectable amount of PCBs on the
surface of the encapsulant. ]
WORK INITIATION DATE: Nay 1. 1990
WORK COMPLETION DATE: December 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation: May 15, 1990
2. Description of post-cleanup grid
sampling: June 15, 1990
3. Analytical results from grid
sampling: August 1, 1990
4. Notification of work completion: December 31, 1990
5. Analytical results from post-
completion sampling of
encapsulated areas:
1. Sample 1: June 30. 1991
11. Sample 2: December 31. 1991
111. Sample 3: June 30, 1992
1v. Sample 4: December 31, 1992
NOTE: Where repeated attempts at cleanup do not result In
achieving PCB levels of 100 ug/100 cm2, the Coast Guard
will negotiate with EPA to determine a mutually acceptable
final cleanup standard.
E. UNDERGROUND MANHOLE CONTAMINATION
PROBLEM; Clean manholes with PCB concentrations of
10 ug/100 cm2 or greater. Encapsulate 1f between 10 and 100
ug/100 on2 after rinsing.
SOLUTION: Remove any visible PCB liquid, and double wash and
rinse stained concrete as described 1n Attachment V. Post-cleanup
sampling shall be conducted to verify that all concrete surfaces in
the manholes have PCB concentrations less than 10 ug/100 cm2. All
concrete surface areas with PCB contamination remaining at
10 ug/100 on2 or greater but less than 100 ug/100 cor shall be
encapsulated with epoxy based paint or concrete sealer.
Conduct follow-up sampling to detect possible PCB contamination by
the entrance of contaminated runoff rainwater, snowmelt, and/or
residual oil into the manhole areas. This sampling shall be
conducted quarterly after completion of post-cleanup sampling and
final verification of the adequacy of the cleanup for four quarters
following such post-cleanup sampling and final verification.
Samples shall be taken at intervals of not less than three months
nor greater than four months.
MEMORANDUM OF AGREEMENT: PAGE 15 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-28
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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WORK INITIATION DATE: May 1,1990
WORK COMPLETION DATE: December 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation: May 15, 1990
2. Description of post-cleanup grid
sampling: June 15. 1990
3. Analytical results from grid
sampling: August 1, 1990
4. Notification of work completion: December 31, 1990
5. Analytical results from post-
completion water sampling:
1. Sample 1: April 30, 1991
11. Sample 2: August 31, 1991
111. Sample 3: December 31. 1991
1v. Sample 4: April 30. 1992
NOTE: Where repeated attempts at cleanup do not result in
achieving PCB levels of less than 100 ug/100 cm2,
1 the Coast Guard will negotiate with EPA to determine
a mutually acceptable final cleanup standard.
2. SUSPECTED AREAS OF CONTAMINATION
The Coast Guard shall conduct a survey of the electrical distribution
system to Identify untested Coast Guard owned property that contains PCBs
at 50 ppm or greater.
The Coast Guard shall sample and test remaining untested areas where
there 1s evidence of possible PCB contamination, for example:
Around locations of pole-mounted PCB transformers.
Vaults not yet tested that have contained known PCB equipment
[or equipment which may have contained PCBs.]
Manholes not yet tested that contained PCB equipment.
Evidence of possible contamination would Include, but not be limited to.
any record of a previous spill at a location where oil stains are still
present.
The Coast Guard shall clean up PCB contamination discovered by methods
outlined In (1) above.
If contamination 1s discovered in manholes and vaults that are no longer
1n service, they shall be adequately .cleaned up and their access point(s)
welded shut after cleaning.
MEMORANDUM OF AGREEMENT: PAGE 16 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-29
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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WORK INITIATION DATE: Nay 1. 1990
WORK COMPLETION DATE: December 31. 1990
PROVIDE DOCUMENTATION TO EPA:
1. Notification of work Initiation: May 15,
2. Description of sampling around
pole-mounted transformers: June 15.
3. Description of vault sampling: June 15.
4. Description of manhole sampling: June 15,
5. Analytical results from (2), 3),
and (4) above: August 1
6. Description of additional cleanup
to be conducted (If required): October
7. Notification of work completion: June 15,
MEMORANDUM OF AGREEMENT: PAGE 17 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
1990
1990
1990
1990
. 1990
15, 1990
1991
TSCA Case Proceedings
12E-30
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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ATTACHMENT 11
CHRONOLOGICAL SUMMARY OF MILESTONES AND T1MEFRAMES
DATE DUE MILESTONE /TASK
/June 19, 1989 Work Initiation Date: Removal of equipment from Pad
1 ~ 9b.
/November 30, 1989 Provide Documentation: Notification of work
initiation - removal of equipment from Pad 9t>.
December 9. 1989 \s* Work Initiation Date: Cleanup of Pad 95.
is Work Initiation Date: Cleanup of soil on and around
Pad 95.
December 15,_1989 ^ Provide Documentation: Notification of work
initiation - cleanup of Pad 95.
i-* Provide Documentation: Description of wipe sample
grid - cleanup of Pad 95.
• Provide Documentation: Notification of work
initiation - cleanup of soil on and around Pad 95.
•^ Provide Documentation: Description of post-cleanup
grid sampling - cleanup of soil on and around Pad 95.
January 1 . 1 990 Provide Documenation: Analytical results from grid
sampling - cleanup of soil on and around Pad 95.
Provide Documentation: Analytical results from wipe
sampling (Initial and duplicates sent to qualified
lab) - cleanup of Pad 95.
May 1, 1990 Work Initiation Date: Transformer pad next to pole
685.
Work Initiation Date: Cleanup of PCB-contami nated
soil surrounding pole-mounted transformers.
Work Initiation Date: Cleanup of vault contamination.
Work Initiation Date: Cleanup of manhole
contamination.
Work Initiation Date: Suspected areas of
contamination.
MEMORANDUM OF AGREEMENT: PAGE 18 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-31
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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May 15, 1990 Prtvlde Documentation: Notification of work
1n1t1iation - transformer pad next to pole 685.
Provide Documentation: Notification of work
initiation - cleanup of PCB-contanlnated soil
surrounding pole-mounted transformers.
Provide Documentation: Notification of work
initiation - cleanup of vault contamination.
Provide Documentation: Notification of work
initiation - cleanup of manhole contamination.
Provide Documentation: Notification of work
initiation - suspected areas of contamination.
Hay 31, 1990 Work Completion Date: Removal of equipment from Pad
95.
Provide Documentation: Notification of work
completion - removal of equipment from Pad 95.
Provide Documentation: Disposal certifications fro
PCB Transformers and/or PCB-contaminated transformers
removed from Pad 95.
Work Completion Date: Cleanup of Pad 95
Provide Documentation: Notification of work
completion - cleanup of Pad 95.
Work Completion Date: Cleanup of soil on and around
Pad 95.
Provide Documentation: Notification of work
completion - cleanup of soil on and around Pad 95.
MEMORANDUM OF AGREEMENT: PAGE 19 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-32
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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June 15, 1990 Provide Documentation: Description of sampling
around pole-mounted transformers - suspected areas of
contamination.
Provide Documentation: Description of vault sampling
- suspected areas of contamination.
Provide Documenation: Description of manhole
sampling - suspected areas of contamination.
Provide Documentation: Description of post-cleanup
grid sampling - cleangp of PCB-contami rated soil
surrounding pole-mounted transformers.
Provide Documentation: Description of post-cleanup
grid sampling - cleanup of vault contamination.
Provide Documentation: Description of post-cleanup
grid sampling - cleanup of manhole contamination.
August 1, 1990 Provide Documentation: Analytical results from grid
sampling - cleanup of vault contamination.
Provide Documentation: Analytical results from grid
sampling - cleanup of PCB-contaminated soil
surrounding pole-mounted transformers.
Provide Documentation: Analytical results from grid
sampling - cleanup of manhole contamination.
Provide Documentation: Analytical results -from
around pole-mounted transformers, vaults, and
manholes - suspected areas of contamination.
October 15, 1990 Provide Documenation: Description of additional
cleanup to be conducted (If required) - suspected
areas of contamination.
MEMORANDUM OF AGREEMENT: PAGE 20 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-33
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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December 31, 1990 Provide Documentation : Notification of work
completion - cleanup of mannoie contain nation.
Work Completion Date: Transformer pad next to pole
685.
Provide Documentation: Notification of work
completion - transformer pad next to pole 685.
Work Completion Date: Cleanup of PCB-contami nated
soil surrounding pole-mounted transformers.
Provide Documentation: Notification of work
completion - cleanup of PCB-contam1 nated soil
surrounding pole-mounted transformers.
Work Completion Date: Cleanup of vault contamination.
Provide Documentation: Notification of work
completion - cleanup of vault contamination.
Work Completion Date: Cleanup of manhole
contamination.
Work Completion Date: Suspected areas of
contamination.
April 30j_1991 Provide Documentation: Analytical results from
post-completion Mater sampling (manholes).
June 15. 1991 Provide Documentation: Notification of work
completion - suspected areas of contamination.
June 30. 1991 Provide Documentation: Analytical results from
post-completion sampling of encapsulated areas
(vaults).
August 31. 1991 Provide Documentation: Analytical results from
post-completion water sampling (manholes).
December 31 . 1 991 Provide Documentation: Analytical results from
post-completion sampling of encapsulated areas
(vaults).
Provide Documenatlon: Analytical results from
post-completion water sampling (manholes).
MEMORANDUM OF AGREEMENT: PAGE 21 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-34
Guidance Manual 1992
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Chapter Twelve
Example 12E-2
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June 30, 1992 Provide Documentation:
post-completion sampl ing
(vaults).
April 30, 1992 Provide Documentation:
Analytical results from
of encapsulated areas
Analytical results from
post-completion water sampling (manholes).
December 31, 1992 Provide Documentation:
post-completion sampling
(vaults).
Analytical results from
of encapsulated areas
January 31, 1993 Provide affidavit from Commander, U.S. Coast Guard.
per paragraph 20 of Memorandum of Agreement.
MEMORANDUM OF AGREEMENT: PAGE 22 OF 22
TSCA DOCKET NUMBERS 1086-02-01-2615 & 1089-03-02-2615
TSCA Case Proceedings
12E-35
Guidance Manual 1992
-------
Chapter Twelve Example 12E-3
COMPLIANCE AGREEMENT
BETWEEN
THE UNITED STATES DEPARTMENT OF ENERGY
AND
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C.
TOXIC SUBSTANCES CONTROL ACT
IN RE: DEPARTMENT OF ENERGY FACILITIES:
PADUCAH, KENTUCKY
PORTSMOUTH, OHIO
OAK RIDGE, TENNESSEE
TSCA Case Proceedings 12E-36 Guidance Manual 1992
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Chapter Twelve Example 12E-3
i.
PARTIES
1. The United States Environmental Protection Agency
("EPA") and the United States Department of Energy ("DOC") are
parties to this Compliance Agreement and Attachments I, II> and
XII herein ("Compliance Agreement" or "Agreement").
II.
JURISDICTION
2. This Agreement is entered into under the authority of
the Toxic Substances Control Act ("TSCA") 15 U.S.C. $2601 e£
US., Section 3004(j) of RCRA, 42 U.S.C. 6924, and Executive
Order 12088, 43 F.R. 47707 (October 13, 1978).
III.
PURPOSE
3. EPA and DOE are entering into this Agreement to
establish responsibilities and commitments for conducting actions
required and/or authorized by TSCA and the PCS (polychlorinated
biphenyl) Regulations at 40 C.F.R. Part 761, fit seo.. and
applicable portions of E.O. 12088.
IV.
SCOPE
4. This Agreement establishes a plan which is intended to
bring DOE's Uranium Enrichment Plants (and support facilities)
located in Portsmouth, Ohio and Paducah, Kentucky and DOE's
former Uranium Enrichment Plant (and support facilities) located
TSCA Case Proceedings 12E-37 Guidance Manual 1992
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Chapter Twelve Example 12E-3
in Oak Ridge/ Tennessee ("the facilities") into full compliance
with TSCA and the PCB Regulations found at 40 C.F.R. Part 761.
• 5. This Agreement is not and shall not be construed to be a
vehicle to relieve the DOE of any legal or regulatory obligations
including obligations under TSCA or RCRA -except as expressly
provided for herein.
V.
FINDINGS OF FACT
6. The following constitutes the Findings of Fact that EPA
considers the basis for this Agreement. Nothing in this
Agreement shall be considered an admission, acceptance/ or
concession by any Party, except that DOE agrees not to challenge
the following Findings of Fact contained in this section in any
action to enforce this Agreement.
7. Executive Order 12088 requires Federal agencies to
comply with TSCA. DOE is a "person" within the meaning of 40
C.F.R. $761.3.
8. DOE owns three uranium enrichment facilities. The
facilities are located in Portsmouth, Ohio; Paducah, Kentucky;
and Oak Ridge, Tennessee. When constructed in the 1940s and
1950s, the ventilation duct seams at the facilities were sealed
using gaskets impregnated with PCBs in excess of 500 ppm. PCBs
in excess of 50 ppm have also been detected in some of the
lubrication oils used in motor and compressor bearings.
Lubrication oils are drawn into the motor exhaust system.
TSCA Case Proceedings 12E-38 Guidance Manual 1992
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Chapter Twelve Example 12E-3
saturate the gasket material and leach PCBs from the gaskets onto
building floors.
9. DOE provided EPA with Information that twenty-four
buildings (building numbers C-310, C-315, C-331, C-333, C-335, C-.
337, C-100, C-101, C-102, C-200, C-300, C<-34.0,A,B and C, C-400,
C-402, C-410, C-411, C-420, C-531-1, C-532, C-533-1, C-600, C-
710, C-720, and C-750), at the Paducah, Kentucky, facility have
ventilation duct gaskets impregnated with concentrations of PCBs
which exceed 500 ppm. There are approximately 51/200 PCB
impregnated gaskets located in these buildings. Six of these
twenty-four buildings (building numbers C-310, C-315, C-331, C-
333, C-335, and C-337), have PCB contaminated oil leaching
through these gaskets. There are approximately 26,500 gaskets
located in these buildings that are actively leaking, have shown
evidence of leaking in the past, or may leak in the near future.
DOE also provided EPA with information that PCB contaminated
electrical voltage potential devices are in place at the Paducah
facility.
10. DOE provided EPA with information that there are
seventeen buildings at the Portsmouth, Ohio facility, (building
numbers X-326, X-330, X-333, X-100, X-102, X-105, X-30Q, X-342,
X-344, X-530B, X-533B, X-700, X-705, X-720, X-750, X-760, and X-
770), which have ventilation duct gaskets impregnated with
concentrations of PCBs which exceed 500 ppm. At least three of
these buildings (building numbers X-326, X-330 and X-333), have
PCB contaminated oil leaching through these gaskets. There are
TSCA Case Proceedings 12E-39 Guidance Manual 1992
-------
Chapter Twelve Example 12E-3
approximately 48,000 gaskets in these three buildings. There are
approximately 23,000 gaskets in these three buildings that are
actively leaking, have shown evidence of leaking in the past, or
•ay leak in the near future. DOE also informed EPA that PCB
contaminated process lubrication oil systems are also used at the
Portsmouth facility. DOE notified EPA that there are a minimum
of three buildings (building numbers K-29, K-31, and K-33), at
the Oak Ridge, Tennessee, facility which have ventilation duct
gaskets Impregnated with PCBs at concentrations in excess of 500
ppm and have PCB contaminated oil leaching through these gaskets.
There are approximately 11,700 gaskets in these three buildings
that are actively leaking, have shown evidence of leaking in the
past* or may leak in the near future.. These leaks have also
caused PCB contamination of electrical cables, cable trays, and-
associated equipment at all three of these facilities.
11. 40 c.F.R. $761.20 states, in pertinent part, that "(n)o
person may use any PCB, or any PCB Item regardless of
concentration in any manner other than in a totally enclosed
manner within the United States unless authorized under $761.30."
Using PCBs in ventilation duct gaskets, electrical voltage
potential devices, and process lubrication oil systems are not
authorized uses under 40 C.F.R. $761.30. DOE'S use of PCBs in
venU.lat.ion duct gaskets, electrical voltage potential devices,
and process lubrication systems represent violations of 40 C.F.R.
f761.20, 15 U.S.C. 2614.
5 .
TSCA Case Proceedings 12E-40 Guidance Manual 1992
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Chapter Twelve Example 12E-3
12. "Disposal" is defined by 40 C.F.R. $761.3 to include
"spills, leaks, and other uncontrolled discharges of PCBs". Any
disposal of PCBs which is not authorized by 40 C.F.R. $761.60 is
an unauthorized disposal. The leaking gaskets at the
Respondent's Paducah, Portsmouth, and Oak Ridge facilities, and
the leaking electrical voltage potential devices at the Paducah
facility, constitute unauthorized disposal of PCBs under 40
C.F.R. $761.60., 15 U.S.C. $2614.
13. DOE provided EPA with information that three storage
areas (in building numbers C-746B, C-746R, and C-337), at the
Paducah, Kentucky, facility contain'or contained PCB Containers
and PCB Articles in excess of 50 ppm PCBs for over one year. In
addition/ three PCB contaminated hydraulic systems at the Paducah
facility are located in the C-340 building in unapproved storage.
areas.
14. DOE also provided EPA with information that two storage
areas in building number X-333, the West End and the Center Area,
of the Portsmouth, Ohio facility contain or contained PCB
Containers and PCB Articles in excess of 50 ppm PCBs for over one
year. At this facility, DOE also temporarily stores PCB liquid
in 18--48" tall, 5-inch diameter polyethylene bottles with screw
on caps.
15. DOE provided EPA with information that three storage
areas (building numbers K-306-1, K-726 and K-711), at the Oak
Ridge/ Tennessee facility contain or contained PCB Containers and
PCB Articles in excess of 50 ppm PCBs for over one year. In
TSCA Case Proceedings 12E-41 Guidance Manual 1992
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Chapter Twelve Example 12E-3
addition, PCS contaminated and PCB transformers no longer in use
arc located in unapproved storage areas at Oak Ridge.
16. Respondent's storage of PCBs in PCB Containers which do
not conform to DOT specifications at its Portsmouth facility,
storage of PCBs, PCB hydraulic systems, PCB .contaminated
transformers and PCB transformers in inadequate storage areas at
the Paducah, Portsmouth, and Oak Ridge facilities, as well as
Respondent's storage of PCB Containers and PCB Articles with
concentrations in excess of 50 ppm for over one year at Paducah,
Portsmouth, and Oak Ridge are not in compliance with 40 C.F.R.
SS761.65 and 761.64.
VI.
APPLICABILITY
17. Ho change in ownership of the facilities will in any
way alter DOE'S responsibility under this Agreement, unless
otherwise provided by law.
18. DOE and EPA shall provide a copy of this Agreement to
all contractors, subcontractors, laboratories and consultants
retained to conduct or monitor any portion of the work to be
performed pursuant to this Agreement within seven (7) days of the
affective date of this Agreement or date of such retention.
19. DOE agrees to give notice of this Agreement to any
subsequent owner and/or operator before the transfer of ownership
or the obligation of a new contractor/operator and to
simultaneously notify EPA of any such change or transfer.
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TSCA Case Proceedings 12E-42 Guidance Manual 1992
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Chapter Twelve Example 12E-3
VII.
COVERED MATTERS
20. This Agreement addresses the requirements of TSCA and
the PCB Regulations at 40 C.F.R. Part 761 applicable to the
unauthorized use of PCBs in process lubrication oil/ ventilation
duct gaskets, and potential devices and the unauthorized disposal
and storage of PCBs and PCB Items at the facilities, as set forth
herein.
21. This Agreement also addresses the storage and disposal
of radioactive contaminated wastes generated from activities
required by this Agreement which contain hazardous waste that are
subject to the land disposal restrictions and associated storage
limitations of the Hazardous and Solid Haste Amendments of 1984.
22. The parties acknowledge that this Agreement does not
affect the rights of the EPA to address any violations which
exist or may exist at the facilities, which are not specifically
covered by this Agreement.
23. Nothing in this Agreement shall be considered an
admission by any party with respect to any unrelated claims by a
party or with respect to any claims or actions by persons not a
party to this Agreement, except that DOE agrees not to challenge
the Findings of Fact contained herein in an action to enforce the
terms of this Agreement.
TSCA Case Proceedings 12E-43 Guidance Manual 1992
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Chapter Twelve Example 12E-3
VIII.
REQUIREMENTS AND DELIVERABLE^
24. DOE shall conduct all activities as set forth in the
Attachments to this Agreement. All terns and conditions set
forth in the Attachments to this Agreement constitute enforceable
requirements of this Agreement.
25. DOE is required to secure EPA approval of a permit
pursuant to Attachment Z(2)(B). Additionally, EPA shall review
and may comment upon all dellverables generated by DOE pursuant
to the terms of this Agreement. In addition to EPA review,
comment, or approval of the permit pursuant to Attachment
I(2)(B), EPA may take a formal position on any matter related to
the implementation of this Agreement by Issuing a Written Notice
of Position to DOE. DOE shall either conform with EPA's Written
Notice of Position or subject EPA's Written Notice of Position to
dispute resolution pursuant to Section XI of this Agreement.
26. Except as otherwise provided for in this Agreement, DOE
shall strictly follow the disposal procedures set forth in
40 C.F.R. $761.60 and the storage procedures set forth in 40
C.F.R. $761.65.
27. All documentation required to be submitted to EPA under
the terms of this Compliance Agreement shall be subject to EPA's
approval and shall be submitted to the EPA Project Contact as
follows:
TSCA Case Proceedings 12E-44 Guidance Manual 1992
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Chapter Twelve Example 12E-3
Director, Compliance Division
Office of Compliance Monitoring
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Attn: DOE Compliance Agreement.
IX.
FUNDING
28. Zt is the expectation of the Parties that all
obligations established pursuant to this Agreement will be fully
funded. The DOE will take all necessary steps and use its best
efforts to obtain timely funding to meet DOE's obligations under
this Compliance Agreement, including budget requests supported by .
DOE's Environmental Restoration and Waste Management Five Year
Plan (the "Five Year Plan"). However, no provision herein shall
be interpreted to require the obligation or payment of funds in '
violation of the Anti-Deficiency Act, 31 U.S.C. Section 1341, and
DOE's performance of the commitments under this Compliance
Agreement is subject to the availability of appropriated funds
for such purposes. In cases where payment or obligation of funds
would constitute a violation of the Anti-Deficiency Act, the
dates established requiring the payment or obligation of such
funds shall be appropriately adjusted.
29. DOE prepares a Five-Year Plan to identify, integrate,
and set priorities for DOE's compliance and cleanup activities at
all DOE nuclear facilities and sites. The Five-Year Plan will
•••lit DOE in addressing environmental requirements at its
10
TSCA Case Proceedings 12E-45 Guidance Manual 1992
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Chapter Twelve Example 12E-3
facilities and sites and in developing and supporting its budget
requests. DOE updates the Five-Year Plan on an annual basis.
30. The terms of the Five-Year Plan shall be consistent
with the provisions of this Agreement, Including all requirements
and schedules contained herein; it is the Intent of the parties
that DOE's Five-Year plan be drafted and updated in a manner that
ensures that the provisions of this Agreement are incorporated
into the DOE planning and budget process. Nothing in the Five-
Tear Plan shall be construed to .affect the provisions of this
Agreement.
31. DOE is developing a national priority system for
inclusion in the Five-Year Plan. DOE's application of its
national priority system may indicate to DOE that modification of
the milestones established by this Agreement is appropriate.
Where both parties agree to the modification, the procedures of
Section XXV shall be used. Any modification of this Agreement
will be incorporated, as appropriate, in the annual update to
DOE's Five-Year Plan. Where the parties are unable to reach
agreement on a requested modification, DOE may invoke the dispute
resolution provisions set forth in Section XI. Pending
resolution of any such dispute, the provisions and deadlines in
effect pursuant to this Agreement shall remain in effect and
enforceable In accordance with the terms of this Agreement.
11
TSCA Case Proceedings 12E-46 Guidance Manual 1992
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Chapter Twelve Example 12E-3
x.
FORCE
32. DOE agrees to implement this Agreement in accordance
with the deadlines set forth in the Attachments to this
Agreement. DOE also agrees to adopt all reasonable measures to
avoid or minimize any delays in the implementation of this
Agreement. However, in the event of an unforeseeable or
unexpected event or circumstance which is beyond the control of
DOE, which could not be overcome by due diligence, and which
necessitates revision of a deadline contained in this Agreement
(hereinafter referred to as a "force majeure"), the parties agree
to review and modify the deadline, as necessary. Force najeure
events may include, but are not limited to, unforeseen and
unavoidable delays caused by labor strikes; adverse weather
conditions, natural disasters, unavailability of funds due solely
to the restrictions of the Anti-Deficiency Act and only if DOE
has demonstrated that it took all necessary steps and used its
best efforts to obtain timely funding as set forth in Section XX
of this Agreement, delays caused by compliance with applicable
environmental statutes or regulations or other circumstances
beyond the control of DOE.
33. If any event occurs which DOE believes will or may
cause a force majeure delay in achieving compliance with any
deadline set forth in this Agreement, DOE shall notify EPA in
writing at least seven (7) calendar days prior to the anticipated
delay. That notification shall state the precise cause of the
•
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TSCA Case Proceedings 12E-47 Guidance Manual 1992
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Chapter Twelve Example 12E-3
delay, the time required for DOE to take appropriate measures to
minimize the delay, and include a description of those
appropriate measures.
34. If EPA finds that DOE has complied with the notice
requirements of the preceding paragraph, and if EPA determines
that the delay or anticipated delay has been or will be caused by
a force majeure event, the EPA shall review and modify the
associated deadline(s), as necessary, to conform with the delay.
Delay in any one requirement shall not automatically justify or
excuse delay in the attainment of other requirements.
35. It EPA determines that the delay or anticipated delay
has neither been nor will be caused by a force majeure event the
existing deadline(s) shall remain in force. EPA shall notify DOE
of its determination in writing.
36. In the event that DOE disagrees with the determination
made by the EPA pursuant to the preceding paragraphs, DOE may use
Section XI (Dispute Resolution) of this Agreement to resolve such
dispute. DOE shall have the burden of proving that any delays
are caused by a force majeure event.
XI.
DISPUTE RESOLUTION
37. It • dispute arises under this Agreement the procedures
of this Section shall control. During the pendency of any
dispute, DOE agrees that it shall continue to implement those
portions of this Agreement which are not affected by the dispute
and/or which can be reasonably implemented pending final
•
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TSCA Case Proceedings 12E-48 Guidance Manual 1992
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Chapter Twelve Example 12E-3
resolution of the issue(s) in dispute. If the EPA determines
that all or part of the work affected by the dispute should stop
pending resolution of the dispute, DOE shall discontinue those
portions of work specified in writing by EPA. If DOE believes
that the work stoppage is inappropriate or nay have potential
significant adverse impacts, DOE may contact the Director,
Compliance Division, Office of Compliance Monitoring (Office of
Pesticides and Toxic Substances) to discuss the work stoppage.
Following this meeting and after further consideration of the
issues, the Director, Compliance Division, Office of Compliance
Monitoring (Office of Pesticides and Toxic Substances) will
issue, in writing, a final decision with respect to the work
stoppage. This final written decision may immediately be
subjected to formal dispute resolution. Such dispute may be
brought directly to the EPA Assistant Administrator for the
Office of Pesticides and Toxic Substances and the DOE Director,
Office of Environmental Restoration and Haste Management and/or
Assistant Secretary for Nuclear Energy at the discretion of DOE.
38. EPA and DOE will each use Project Contacts as the point
of contact for implementing this Compliance Agreement. The
Project Contact for EPA is the Director, Compliance Division,
Office of Compliance Monitoring (Office of Pesticides and Toxic
Substances). DOE has designated two Project Contacts, one for
the Portsmouth and Paducah facilities, and one for the Oak Ridge
facility. DOE's Project Contact for the Portsmouth and Paducah
facilities is the Director, Office of Operations and Facility
•
14
TSCA Case Proceedings 12E-49 Guidance Manual 1992
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Chapter Twelve Example 12E-3
Reliability (Office of Uranium Enrichment). DOE's Project
Contact for the Oak Ridge facility is Chief, the Decontamination
and Decommissioning Branch, Eastern Area Programs, Office of
Environmental Restoration. Either party may make a redesignation
of its Project Contact upon written notification to the other
party.
39. In the event of a dispute between the Parties regarding
the implementation of this Agreement, the parties shall make
reasonable efforts to Informally resolve, at the Project Contact
level, the dispute. If resolution of a dispute cannot be achieved
at the Project Contact level, the following procedures shall be
implemented to resolve a dispute: '
A. Within thirty (30) calendar days of any action by
EPA which leads to or generates a dispute, including EPA's
issuance of a Vritten Notice of Position, DOE shall submit to EPA
a written statement of dispute setting forth the nature of the
dispute, DOE's position with respect to the dispute and the
information DOE is relying upon to support its position. If DOE
does not provide such written statement to EPA within this thirty
(30) day period, DOE shall be deemed to have agreed with the
action taken by EPA which led to or generated the dispute.
B. Upon receipt of the written statement of dispute,
DOE and EPA shall engage in dispute resolution among the Project
Contacts and/or their immediate supervisors. DOE and EPA shall
have thirty (30) calendar days from the receipt by EPA of the
written statement of dispute to resolve the dispute. During this
•
15
TSCA Case Proceedings 12E-50 Guidance Manual 1992
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Chapter Twelve Example 12E-3
period the Project Contact* and/or their immediate supervisors
shall «eet as many times as necessary to discuss and attempt
resolution of the dispute.
C. If agreement cannot be reached within this thirty -
(30) day period EPA or DOE may, within ten (10) calendar days of
the conclusion of the thirty (30) day dispute resolution period,
submit a written notice to the other Party escalating the dispute
to EPA's Assistant Administrator for the Office of Pesticides and
Toxic Substances and to DOE's Director, Office of Environmental
Restoration and Naste Management and/or Assistant Secretary for
Nuclear Energy for resolution, who shall have thirty (30)
calendar days to resolve the dispute. Zf neither Party elevates
the dispute within this ten (10) day escalation period, the DOE
shall be deemed to have agreed with EPA's position with respect •
to the dispute.
D. If EPA's Assistant Administrator for the Office of
Pesticides and Toxic Substances and DOE's Director, Office of
Environmental Restoration and Waste Management and/or Assistant
Secretary for Nuclear Energy are unable to resolve the dispute
within the specified thirty (30) day period, EPA or DOE may,
within ten (10) calendar days of the conclusion of the thirty
(30) day dispute resolution period, submit a written notice of
dispute to the Administrator of EPA for final resolution of the
dispute in accordance with all applicable laws and procedures.
In the event that the dispute is not escalated to the
Administrator of EPA within the designated ten (10) day
•
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TSCA Case Proceedings 12E-51 Guidance Manual 1992
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Chapter Twelve Example 12E-3
••calation period, DOE shall be deemed to have agreed with EPA'8
position with respect to the dispute. The Administrator of EPA
will review and resolve such dispute as expedltiously as
possible. Upon request and prior to resolving the dispute, the
Administrator shall meet and confer with the Secretary of DOE to
discuss the issues under dispute. Upon resolution, the
Administrator of EPA shall provide DOE with a written final
decision setting forth the resolution of the dispute.
E. The pendency of any dispute under this Part shall
not affect DOE'S responsibility for timely performance of the
work required by this Agreement/ except that the time period for
completion of work affected by such dispute shall be extended for
a period of time usually not to exceed the actual time taken to
resolve any good faith dispute in accordance with the procedures.
specified herein. All elements of the work required by this
Agreement which are not affected by the dispute shall continue
and be completed in accordance with the applicable schedule.
F. Within thirty (30) calendar days of resolution of a
dispute pursuant to the procedures specified in this Part, DOE
shall incorporate the resolution and final determination into the
appropriate plan, schedule, or procedures and proceed to
implement this Agreement according to the amended plan, schedule,
or procedures.
G. Resolution of a dispute pursuant to this Part of
the Agreement constitutes a final resolution of any dispute
arising under this Agreement. DOE shall abide by all terms and
•
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TSCA Case Proceedings 12E-52 Guidance Manual 1992
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Chapter Twelve Example 12E-3
conditions of any final resolution of dispute obtained pursuant
to this Part of the this Agreement.
XII.
COVENANT NOT TO SUE AND RESERVATION OF RIGHTS
40. The facilities currently use, and will continue to use
as set forth in this Agreement, ventilation duct gaskets which
contain PCBs.
41. The facilities are currently storing, and will continue
to store, PCS waste co-contaminated with radioactive materials.
DOE.Is developing but does not currently have the means to
dispose of these materials.
42. DOE has undertaken in this Agreement to address the PCB
items, PCB gasket use, use of PCB potential devices, any releases
of PCB contaminated oil from the ventilation duct gaskets, PCB
process lubrication oil, and the storage of PCB waste co-
contaminated with radioactive material.
43. Therefore, based on the facts and circumstances known
to EPA as of the effective date of this Agreement, and set forth
in this Agreement, EPA hereby agrees not to initiate any future
civil administrative enforcement action against DOE or any of its
contractors, or to refer a civil judicial enforcement action
against DOE or its contractors under TSCA to the Department of
Justice for covered matters defined in Section VII herein for so
long as DOE is in compliance with the requirements of this
Agreement.
18
TSCA Case Proceedings 12E-53 Guidance Manual 1992
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Chapter Twelve Example 12E-3
44. The Parties recognize that compliance with the terms of
this Agreement will require DOE to generate radioactive nixed
wastes containing a hazardous component subject to the land
disposal restrictions of the Hazardous and Solid Waste Amendments
of 1984 for which there may be no available treatment capacity.
Therefore, as long as DOE is using best efforts to locate or
develop treatment capacity, and as long as DOE is in full
compliance with the terms of this Agreement, EPA agrees not to
initiate a civil or administrative enforcement action against DOE
and its contractor under RCRA or to refer a civil judicial
enforcement action against DOE or its contractor to the
Department of Justice for the storage of prohibited waste
generated pursuant to the requirements of this Agreement.
45. However, in the event that DOE is delayed in fulfilling
its obligations as set forth in this Agreement as a result of
Insufficient availability of funding, and the Parties are unable
to agree to an extension of schedules as provided for in Section
IX (Funding), subject to Section X (Force Majeure) and Section
XXV (Modifications), the covenant not to sue set forth above
shall terminate.
46. Further, nothing herein shall preclude any actions by
EPA to enforce the terms of this Agreement, or to address or
bring any available legal or equitable claims for: (1) any pre-
existing, current, or future violations or conditions at the
facility not specifically covered by this Agreement; (2) any
irgency condition or Imminent hazard which may exist or arise
•
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TSCA Case Proceedings 12E-54 Guidance Manual 1992
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Chapter Twelve Example 12E-3
at the facility; (3) any cleanup action pursuant to any available
authority.
47. Further, EPA filed a Complaint, Docket Number 91-H-02,
against Martin Marietta Energy Systems on October 3, 1990, for
violations of TSCA at the three uranium enrichment facilities.
The Parties agree that nothing contained in this Agreement shall
Affect that enforcement action in any way.
48. Further, except as otherwise specifically provided
herein, the Parties reserve all other rights they may have under
law with respect to any other person.
49. DOE reserves the right to request the making of a rule,
pursuant to Section 6(e)(2)(B) of TSCA/ to authorize the use of
PCBs in ventilation duct gasket material.
XXIX.
EXPIRATION
50. Within thirty (30) calendar days of DOE's final
notification of completion of the final milestones required under
this Agreement, DOE will provide EPA with a certification that
all conditions and terms of this Agreement have been completed.
51. Within thirty (30) calendar days of receipt of DOE's
certification, EPA will acknowledge in writing the receipt of the
certification. EPA will respond to DOE's certification within
one hundred and eighty (180) calendar days from the receipt of
DOE's certification. EPA's response will indicate whether DOE
has completed the requirements and milestones required by the
Agreement to EPA's satisfaction and state the reasons for its
•
20
TSCA Case Proceedings 12E-55 Guidance Manual 1992
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Chapter Twelve Example 12E-3
conclusions. Upon issuance of EPA'* final determination that DOE
has completed the requirements and milestones required by the
Agreement to EPA'a satisfaction, the requirements of this
Agreement shall be considered satisfied and this Agreement shall
be considered terminated. •
52. In addition to EPA's general inspection authorities
under TSCA, EPA specifically reserves the option of conducting a
verifying inspection after DOE has provided EPA with the final
notification of completion as provided in this Agreement. If EPA
elects this option/ the verifying inspection will be conducted
within one hundred and twenty (120) 'calendar days of DOE's
certification.
53. In the event that DOE falls to comply with the
requirements set forth in this Agreement/ subject to Section XX
(Funding)/ Section X (Force Majeure), Section XI (Dispute
Resolution), and Section XIV (Modifications), EPA may, within its
discretion, terminate this Agreement by written notice to DOE.
XIV.
MODIFICATIONS
54. Modifications to this Agreement may be requested by EPA
or DOE. Except as otherwise provided herein all such
modifications shall be by mutual agreement of the signatories to
this Agreement. All modifications requiring mutual agreement of
EPA and DOE shall be in writing and shall be effective as of the
date the last party affixed its signature.
21
TSCA Case Proceedings 12E-56 Guidance Manual 1992
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Chapter Twelve Example 12E-3
55. The Parties recognize that in the course of
implementing this Agreement there may be a need for minor field
modifications to the Attachments to this Agreement or to
deliverables submitted pursuant to this Agreement. The Parties
agree that any such minor field modifications may be made
pursuant to a mutual agreement of the Parties as set forth in a
written agreement between the Project Contacts.
56. The Parties recognize that DOE has limited treatment
and disposal capacity for PCBs and PCB items co-contaminated with
other waste materials. In the event that it should become
necessary to delay the treatment or disposal of materials covered
by this Agreement to allow for the treatment or disposal of other '
waste materials generated by DOE which pose greater risks to
human health or the environment, the Parties agree to modify this
Agreement, as appropriate.
XV.
EFFECTIVE DATE
57. This Agreement shall become effective upon execution by
authorized representatives of EPA and DOE. In the event that
authorized representatives of EPA and DOE do not execute the
Agreement on the same day, the Agreement shall become effective
upon the date which the last party affixed its signature to the
Agreement.
22
TSCA Case Proceedings 12E-57 Guidance Manual 1992
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Chapter Twelve
Example 12E-3
THE PARTIES 80 AGREE:
Thomas L. NcCall, Jr.
Deputy Assistant Administrator
for Federal Facilities Enforcement
Office of Enforcement
U.S. Environmental Protection Agency
2 I*'
Date
Michael F. Hood, Director
Compliance Division
Office of Compliance Monitoring
Office of Pesticides and Toxic
Substances
U.S. Environmental Protection Agency
Date
William H. YounoX
Assistant Secretary fofNuclear
Energy
U.S. Department of Energy
Date
10 P. Duffy
Director, Office of Environmental
Restoration and Waste Management
U.S. Department of Energy
Date
23
TSCA Case Proceedings
12E-58
Guidance Manual 1992
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Appendix
CONTENTS PAGE
Delegations of Authority Under TSCA A-l
Administrative Enforcement: Inspections A-l
Administrative Enforcement: Issuance of Complaints and
Signing of Consent Agreements A-2
Administrative Enforcement: Agency Representative in
Hearings and Signing of Consent Agreements A-4
Administrative Enforcement: Issuance of Consent Orders
and Final Orders A-5
Administrative Enforcement: Signing Penalty Remittance
Agreements and Remittance Orders A-6
Listing of TSCA Guidelines, Strategies, and
Enforcement Response Policies A-9
Guidelines for Assessment of Civil Penalties Under Section 16 of
the Toxic Substances Control Act; PCB Penalty Policy A-11
The Consolidated Rules of Practice Governing the Administrative
Assessment of Civil Penalties and the Revocation or Suspension
of Permits A-13
The Table of Contents for the General Enforcement Policy Compendium A-15
TSCA Case Proceedings A-i Guidance Manual 1992
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Appendix Contents
TSCA Case Proceedings A-ii Guidance Manual 1992
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Appendix
1 Delegations of Authority Under TSCA
(July 25, 1984)
ADMINISTRATIVE ENFORCEMENT: INSPECTIONS
1. Authority
a. To inspect any establishment, facility, or other premises in which chemical
substances, mixtures, or articles containing chemical substances or mixtures, are
manufactured, processed, stored, or held before or after their distribution in
commerce, and any conveyance being used to transport chemical substances,
mixtures, or such articles in connection with distribution in commerce. Any such
inspection shall be conducted in accordance with the applicable provisions of the
Toxic Substances Control Act (TSCA).
b. To obtain and execute warrants for the purpose of performing inspections and
conducting information gathering under TSCA.
c. To carry out or require the carrying out of any other inspection and information
gathering activities authorized by TSCA.
d. To designate representatives of the Administrator to perform the functions in
paragraphs La - I.e.
e. To require by subpoena the attendance and testimony of witnesses and the
production of reports, papers, documents, answers to questions, and other
information in accordance with TSCA.
2. To Whom Delegated
The Assistant Administrator for Enforcement and Compliance Monitoring, Assistant
Administrator for Pesticides and Toxic Substances, and Regional Administrators.
TSCA Case Proceedings A-l Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
3. Limitations
a. The Assistant Administrator for Pesticides and Toxic Substances must consult
with the Assistant Administrator for Enforcement and Compliance Monitoring or
.designee before obtaining warrants or issuing subpoenas; and must consult with
the General Counsel or designee before issuing subpoenas to collect information
for regulatory actions.
b. The Assistant Administrator for Enforcement and Compliance Monitoring and the
Assistant Administrator for Pesticides and Toxic Substances must notify the
appropriate Regional Administrator prior to exercising inspection authority under
this delegation.
4. ' Redelegation Authority
This authority may be redelegated.
5. Additional References
Sections 11 (a)-(c) of TSCA.
ADMINISTRATIVE ENFORCEMENT: ISSUANCE OF COMPLAINTS AND SIGNING
OF CONSENT AGREEMENTS
1. Authorization
To file administrative complaints against alleged violators of the Toxic Substances Control Act
(TSCA) for the purpose of proposing civil penalties as provided in the TSCA; and to negotiate
and sign consent agreements memorializing settlements between the Agency and respondents.
2. To Whom Delegated
Regional Administrators and the Assistant Administrator for Pesticides and Toxic Substances.
TSCA Case Proceedings A-2 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
3. Limitations
a. Regional Administrators must consult with the Assistant Administrator for
Pesticides and Toxic Substances or his designee before exercising any of the
above authorities. In addition, once the alleged violator files an answer or fails
to file an answer in the specified time period, the Regional Counsels or their
designees will conduct all negotiations.
b. The Assistant Administrator for Pesticides and Toxic Substances may exercise
these authorities in multi-Regional cases or cases of national significance. In
addition, the Assistant Administrator for Pesticides and Toxic Substances must
consult in advance with the Assistant Administrator for Enforcement and
Compliance Monitoring or his designees when exercising any of the above
authorities. In addition, once the alleged violator files an answered or fails to file
an answer in the specified time period, the Assistant Administrator for
Enforcement and Compliance Monitoring or his designee will conduct all
negotiations.
c. The Assistant Administrator for Enforcement and Compliance Monitoring and the
Assistant Administrator for Pesticides and Toxic Substances may waive their
respective consultation requirements by memorandum.
4. Redelegation Authority
This authority may be redelegated.
5. Additional References
a. Sections 15 and 16 of TSCA.
b. The Agency official who signed the complaint should sign the settlement
agreement.
TSCA Case Proceedings A-3 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
ADMINISTRATIVE ENFORCEMENT: AGENCY REPRESENTATIVE IN HEARINGS
AND SIGNING OF CONSENT AGREEMENTS
1. Authority
To represent EPA in civil penalty adjudications conducted under the Toxic Substances Control
Act (TSCA) and 5 U.S.C. Section 554; to negotiate consent agreements between the Agency and
respondents resulting from such enforcement actions; and to initiate an appeal from an
administrative determination, and to represent the Agency in such appeals.
2. To Whom Delegated
Assistant Administrator for Enforcement and Compliance Monitoring and Regional
Administrators.
3. Limitations
a. This authority may only be exercised after the alleged violator either files an
answer or fails to file an answer within the specified time period.
b. Only the Assistant Administrator for Enforcement and Compliance Monitoring
may exercise the authority to initiate appeals.
c. The Assistant Administrator for Enforcement and Compliance Monitoring must
consult with the Regional Administrator or designee and the Assistant
Administrator for Pesticides and Toxic Substances or designee prior to initiating
an appeal.
4. Redelegation Authority
This authority may be redelegated.
TSCA Case Proceedings A-4 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
5. Additional References
a. Sections 16 of TSCA.
b. The Agency official who signed the complaint should sign the settlement
agreement.
ADMINISTRATIVE ENFORCEMENT: ISSUANCE OF CONSENT ORDERS AND
FINAL ORDERS
1. Authorization
a. To issue consent orders memorializing settlements between the Agency and
respondents resulting from administrative enforcement actions under the Toxic
Substances Control Act (TSCA).
b. To issue final orders assessing penalties under TSCA.
2. To Whom Delegated
Regional Administrators and Headquarters Judicial Officer.
3. Limitations
The Regional or Headquarters Judicial Officers may not be employed by the Office of
Enforcement and Compliance Monitoring or by any program office directly associated with the
type of violation at issue in the involved proceeding.
4. Redelegation Authority
The Regional Administrators may redelegate this authority to their respective Regional Judicial
Officers. The Headquarters Judicial Officer may not redelegate this authority.
5. Additional References
40 C.F.R. 22.
TSCA Case Proceedings A-5 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
ADMINISTRATIVE ENFORCEMENT: SIGNING PENALTY REMITTANCE
AGREEMENTS AND REMITTANCE ORDERS
1. Authority
To sign agreements to remit all or part of a civil administrative penalty, as authorized by Section
16(a)(2)(C) of the Toxic Substances Control Act (TSCA), if conditions cited in the remittance
agreement are met by the Respondent; to sign an order remitting the penalty when the Agency
is satisfied that the conditions have been met; and to sign an order not remitting the penalty and
declaring that payment of the penalty is due, and collecting the required payment, when the
Agency determines the conditions have not been met. The authority to remit penalties with
conditions is contained in Section 16(a)(2)(C) of TSCA.
2. To Whom Delegated
Assistant Administrator for Pesticides and Toxic Substances and Regional Administrators.
3. Limitations
a. Regional Administrators must consult the Assistant Administrator for Pesticides
and Toxic Substances, or designee, before exercising any of the above authorities.
This is to ensure that similar settlements are applied to similar violative situations.
b. The Assistant Administrator for Pesticides and Toxic Substances may exercise
these authorities in multi-Regional cases or cases of national significance. In
addition, the Assistant Administrator for Pesticides and Toxic Substances must
notify any affected Regional Administrators, or designees, when exercising any
of the above authorities.
c. The Assistant Administrator for Pesticides and Toxic Substances may waive the
consultation requirements by memorandum.
4. Redelegation Authority
This authority may be redelegated to the Division Director level.
TSCA Case Proceedings A-6 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
5. Additional References
Section 16(a)(2)(C) of TSCA, which permits the Administrator to remit penalties with
conditions, and "Toxic Substances Control Act Settlement with Conditions" (November 16,
1983), which gives criteria for the use of remittance agreements, a description of the format and
contents of such agreements, and a summary of the procedures for using these agreements.
TSCA Case Proceedings A-7 Guidance Manual 1992
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Appendix Delegations of Authority Under TSCA
TSCA Case Proceedings A-8 Guidance Manual 1992
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Appendix
2 Listing of TSCA Guidelines, Strategies, and
Enforcement Policies
A listing of all the TSCA Guidelines, Strategies, and Enforcement Response Policies that are
currently in effect, as well as those documents that are obsolete. Copies of these documents may
be obtained from the Headquarters Toxics Enforcement Policy Branch (202-260-7832).
This appendix is not contained in this review draft.
TSCA Case Proceedings A-9 Guidance Manual 1992
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Appendix
List of TSCA Guidelines, Strategies, and ERPs
TSCA Case Proceedings
A-10
Guidance Manual 1992
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Appendix
Guidelines for the Assessment of Civil Penalties
Under Section 16 of the Toxic Substances Control
Act; PCB Penalty Policy
Guidelines for Assessment of Civil Penalties Under Section 16 of the Toxic Substances Control
Act; PCB Penalty Policy (September 10, 1980). This document, as well as the appropriate
Enforcement Response Policy (s), should be included with the Complaint when it is mailed to the
Respondent.
This appendix is not contained in this review draft.
TSCA Case Proceedings A-11 Guidance Manual 1992
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Appendix PCB Penalty Policy
TSCA Case Proceedings A-12 Guidance Manual 1992
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Appendix
4 The Consolidated Rules of Practice Governing the
Administrative Assessment of Civil Penalties and the
Revocation or Suspension of Permits
The Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties
and the Revocation or Suspension of Permits, as presented in the February 13, 1992 Changes
to Regulations to Reflect the Role of the New Environmental Appeals Board in Agency
Adjudications; Final Rule (40 C.F.R. Part 1, et al). This replaces the April 9, 1980
Consolidated Rules of Practice (45 FR 24360). These rules of practice govern all adjudicatory
proceedings for the assessment of any civil penalty conducted under section 16(a) of TSCA.
This document is also included with the Complaint when it is mailed to the Respondent, as noted
in the sample cover letter in Chapter Six.
This appendix is not contained in this review draft.
TSCA Case Proceedings A-13 Guidance Manual 1992
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Appendix . - ~ Consolidated Rules of Practice
TSCA Case Proceedings A-14 Guidance Manual 1992
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Appendix
Table of Contents for the General Enforcement
Policy Compendium
The Table of Contents for the General Enforcement Policy Compendium. Copies of these
policies can be obtained from the following office:
Linda R. Thompson (LE-130A)
Policy Compendium Coordinator
Office of Enforcement Policy
U.S. EPA
401 M Street, SW
Washington, DC 20460
This appendix is not contained in this review draft.
TSCA Case Proceedings A-15 Guidance Manual 1992
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